The Labelling of Food in Ireland 2007

Transcription

1 The Labelling of Food in Ireland 2007

2 The Labelling of Food in Ireland 2007 Published by: Food Safety Authority of Ireland Abbey Court Lower Abbey Street Dublin 1 Advice Line: Tel: Fax: info@fsai.ie Website: ISBN

3 1 CONTENTS FOREWORD 3 SECTION 1: INTRODUCTION Introduction to the Labelling Legislation Review of the Horizontal Foodstuffs Labelling Legislation 6 SECTION 2: HORIZONTAL LABELLING LEGISLATION Labelling, Presentation and Advertising of Food: Directive 2000/13/EC and Related Directives Batch Identification: Council Directive 89/396/EEC Nutrition Labelling: Council Directive 90/496/EEC Nutrition and Health Claims: Regulation (EC) No.1924/ SECTION 3: SEMI HORIZONTAL LEGISLATION Food Supplements Foods for Particular Nutritional Uses (Dietetic Foods) Infant Formulae and Follow-On Formulae Processed Cereal-Based Foods and Baby Foods for Infants and Young Children Dietary Foods for Special Medical Purposes Foods Intended for Use in Energy-Restricted Diets for Weight Reduction Foodstuffs Treated with Ionising Irradiation Novel Foods and Novel Food Ingredients Foods with Added Phytosterols Genetically Modified Food Food with Added Vitamins and Minerals (Fortified Foods) Additives, Colours and Sweeteners in Foodstuffs Flavourings for Use in Foodstuffs for Human Consumption Material and Articles Intended to Come into Contact with Foodstuffs 67 SECTION 4: VERTICAL LEGISLATION 70 Part A: Compositional Standards Cocoa and Chocolate Products Coffee and Chicory Extracts Fruit Juices and Fruit Nectars Caseins and Caseinates Honey Sugars Dehydrated Preserved Milk Fruit Jams, Jellies, Marmalades and Sweetened Chestnut Purée Natural Mineral Waters, Spring Waters and Other Bottled Waters 77 Part B: Common Marketing Standards Beef and Beef Products (including minced beef) Spreadable Fats Milk and Milk Products 84 (a) Protection of reserved names 84 (b) Drinking milk Quick Frozen Foods Eggs Wine Aromatised Wines Spirit Drinks Olive Oil Fishery and Aquaculture Products Poultrymeat Fresh Fruit and Vegetables 100 Part C: Quality Schemes Organic Food Protection of Geographical Indications 104 SECTION 5: OTHER MISCELLANEOUS General Food Law Hygiene Legislation 106

4 2 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 APPENDICES 108 Appendix I: 108 Legislation providing for food-related information Appendix II: 109 List of categories of ingredients which may be designated by the name of the category rather than the specific name (as per Directive 2000/13/EC as amended) Appendix III: 111 Categories of ingredients which must be designated by the name of their category followed by their specific name or EC number Appendix IV: 111 Allergenic ingredients Appendix V: 112 Food ingredients and substances provisionally exempt from labelling as allergenic (as per Commission Directive 2005/26/EC and 2005/63/EC) Appendix VI: 113 E numbers in numerical order Appendix VII: 122 E numbers in alphabetical order Appendix VIII: 131 Nutrition claims and conditions applying to them Appendix IX: 133 Catch areas (according to Commission Regulation (EC) No. 2065/2001) Appendix X: 134 EU Regulations regarding the marketing standards for fresh fruit and vegetables Appendix XI: 136 Competent authorities contact details

5 3 FOREWORD The principal function of food labelling is to inform consumers of the properties of pre-packaged food. The fundamental rule of the labelling of foodstuffs is that consumers should not be misled. Detailed labelling of a product educates consumers as to the exact nature and characteristics of the foodstuff and enables them to make a more informed choice. Further to the publication of the Labelling of Food in Ireland Report 2002, it proved necessary to produce an addendum in 2003 and a revised addendum in 2004 as a result of changes to the labelling legislation. In order to consolidate and further update these legislative changes, the Labelling of Food in Ireland Report has been revised in its totality. The aim of this 2007 report is to outline the labelling requirements for pre-packaged food up to and including April It also outlines or references the labelling provisions for un-packaged food or food sold loose where they exist. In addition, hygiene requirements for food products such as fresh meat, fish and milk are not outlined in this Report. However, reference is made to the Hygiene Package and European Food Law Regulation (EC) No. 178/2002 including certain traceability requirements in so far as the provisions may affect labelling (Section 5). Disclaimer This publication is intended to provide a summary of the subject matter covered. It does not purport to be comprehensive or to constitute legal or other professional advice. This document presents the position of the labelling requirements for pre-packaged food up to and including April Changes to the labelling legislation are expected in the future that will necessitate the update of this publication. The European Communities (Labelling, Presentation and Advertising of Foodstuffs) Regulations, 2002 (S.I. No. 483 of 2002) and its amendments is the main piece of legislation in Ireland that regulates the general labelling of pre-packaged foodstuffs for sale to consumers and also for sale to the catering industry. These Regulations implement the provisions of the European Directive 2000/13/EC and its amendments on labelling (as well as a number of other related Directives). The Labelling Directive 2000/13/EC consolidates and repeals the previous Directive 79/112/EEC and some of its amendments. Depending on the food product in question, other pieces of legislation containing labelling provisions of a more specific nature may also apply. This document attempts to consolidate all the information on the labelling of foods in Ireland. It is designed to be of benefit to consumers, manufacturers and the regulatory authorities alike to act as a guideline on the labelling of foods. Omitted from this document are labelling requirements which were considered beyond the food safety scope and which were not confined strictly to food products such as declarations on price indication, some weights and measures provisions and merchandise markings.

6 4 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 SECTION 1 INTRODUCTION TO THE LABELLING LEGISLATION 1.1 WHERE CAN I FIND THE RULES ON LABELLING? Community legislation on the labelling of foodstuffs to be delivered to the consumer can be broadly broken down into the following categories: 1. Horizontal labelling legislation This legislation solely governs labelling and is applicable to all pre-packaged foods intended for the ultimate consumer. 2. Semi horizontal legislation with labelling provisions This legislation is applicable to foods that are used for a particular purpose and contains labelling provisions applicable only to that particular food such as food intended for weight reduction. 3. Vertical legislation with labelling provisions Vertical legislation governs specific food products, such as beef or chocolate, and contains some labelling provisions applicable to that food. 4. Other miscellaneous There are other Community rules that contain labelling requirements which are not confined strictly to food products such as declarations on price indication, some weights and measures provisions and merchandise markings. These labelling requirements are outside the scope of this document but some are briefly referenced in Section In addition, the hygiene rules regarding the production and placing on the market of certain food products such as fresh meat, are also outside the scope of this Report. However, reference is made to these requirements where their provisions affect the food label (see Section 5). Appendix I details the legislation providing for all food related information on food products. The labelling provisions contained in the first category, horizontal legislation, apply to all pre-packaged food across the board. Additional labelling provisions may also apply from category two and/or three depending on the food. For example, the labelling information on a bar of chocolate must comply with the general labelling requirements provided in the horizontal legislation that is applicable to all foods as well as the specific labelling provisions for chocolate as laid out in the vertical legislation. 1. Horizontal labelling legislation Council Directive 2000/13/EC and its amendments on labelling, presentation and advertising of food to the final consumer is the main piece of EU legislation regarding the labelling of food. This Directive is based upon the principle of functional labelling. Its aim is to ensure that the consumer gets all the essential information as regards the composition of the product, methods of storage and preparation, etc. These requirements are applicable to all pre-packaged food. Producers and manufacturers may provide additional information if they wish, provided that it is accurate and does not mislead the consumer. The system for the labelling, presentation and advertising of food products throughout the European Union ensures that one standard exists for all Member States so that producers are protected against unfair competition and consumers protected against misleading products and advertising. In addition to Directive 2000/13/EC and its amendments, there are also a number of related Directives that require the provision of important information regarding the composition of a food, such as declaring the presence of caffeine and quinine flavouring on food labels (Directive 2002/67/EC). Other Directives also apply to all pre-packaged food and are thus similarly classed as horizontal legislation: Directive 89/396/EEC on batch identification, Directive 90/496/EC on nutrition labelling and Regulation (EC) No. 1924/2006 on nutrition and health claims.

7 SECTION 1 INTRODUCTION TO THE LABELLING LEGISLATION 5 2. Semi horizontal legislation Semi horizontal legislation governs foods that are used for a particular purpose such as baby foods (Directive 96/5/EC and its amendments Section 3.4) and contains some extra labelling provisions applicable to these foods in order to inform the consumer regarding their composition and intended use, e.g, a baby food must declare the age from which the food is suitable, e.g. from four months, in addition to the more general labelling provisions of the horizontal legislation. 3. Vertical legislation Vertical legislation or specific commodity legislation similarly contains mandatory labelling provisions for specific products such as beef (Regulation (EC) No. 1760/2000), fishery products (Regulation (EC) No. 104/2000 and 2065/2001) and fruit jams and jellies (Directive 2001/113/EC) in addition to the requirements of the horizontal labelling legislation. The vertical rules can be further broken down into the following categories depending on the nature of the legislation: Compositional standards: These Directives set down precise compositional criteria for specific products such as fruit juice (Directive 2001/112/EC) Common marketing standards: These Regulations set out legal requirements for placing specific foods on the market where the labelling requirements are linked to trade such as eggs (Regulation (EC) No. 1907/90) and Quality schemes: Regulations containing additional voluntary requirements for specific products for quality rather than safety reasons such as organic food (Regulation (EC) No. 2092/91). The Codex Alimentarius Commission In the absence of national or European legislation in a particular area, guidance is taken from the Codex Alimentarius Standards. The Codex Alimentarius Commission (CAC) was established in 1962 as a subsidiary body of the Food and Agriculture Organisation of the United Nations (FAO) and the World Health Organisation (WHO) to implement the Joint FAO/WHO Food Standards Programme. It is the body responsible for compiling international food codes such as standards, codes of practice and guidelines with the principal objective of protecting the health of consumers and facilitating fair practices in the food trade. The Codex Alimentarius is the collection of international food standards that have been adopted by the Codex Alimentarius Commission. Codex standards concern all aspects of the hygienic and nutritional quality of food, from raw to processed foods. Codex has also produced standards on labelling such as the General standard for the labelling of pre-packaged food (available 1 All of the above categories contain labelling provisions relevant to that particular food.

8 6 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND REVIEW OF THE HORIZONTAL FOODSTUFFS LABELLING LEGISLATION General food labelling is harmonised through Directive 2000/13/EC, a codified version of a Directive adopted in 1979, which lays down the labelling requirements that are applicable to all foodstuffs intended for the ultimate consumer, and to foodstuffs supplied to restaurants and mass caterers. The general labelling legislation has been completed through additional provisions laying down further labelling requirements, such as the Quantity of Ingredient Declaration (QUID). Though it has been amended and completed, the general labelling legislation is still designed as it was originally in Therefore, the European Commission and the Member States have undertaken a review of the horizontal labelling legislation with a view to updating it as consumers want to be more, but above all, better informed on the increasingly numerous and innovative foodstuffs supplied on the market. Labelling legislation under review The food labelling legislation is perceived as complex, spread over many pieces of legislation, and sometimes contradictory, and the structure of that legislation is questioned for these reasons. (Appendix I outlines the legislation providing for food related information on food products). However, this does not mean that a modification of the overall structure of the Community legislation on labelling would be realistic and appropriate. Therefore, the objective of the review shall be to recast and modernise the horizontal provisions, applicable to all foodstuffs, contained in Directive 2000/13/EC and other related texts, and, if possible to eliminate any inconsistency with other pieces of legislation. The Nutrition Labelling Legislation will be revised in tandem in a co-ordinated way to ensure both pieces of legislation coincide in order to avoid repetitive changes. Semi horizontal as well as vertical legislation are outside the scope of the Commission s review. Currently, the pieces of horizontal food labelling legislation for review are: Directive 2000/13/EC relating to the labelling, presentation and advertising of foodstuffs (i.e. the General Labelling Directive) and its 1st Amendment: Directive 2001/101/EC relating to the labelling, presentation and advertising of foodstuffs (i.e. the new definition of meat) and its amendment Directive 2002/86/EC as regards the date from which trade in products not in conformity are prohibited and its 2nd Amendment: Directive 2003/89/EC regarding the indication of ingredients present in foodstuffs (i.e. declaration of all allergens) and its amendment Directive 2005/26/EC establishing a list of food ingredients or substances provisionally excluded from Annex IIIa of Directive 2000/13/EC (i.e. provisionally exempting certain ingredients from being considered as allergens) and its amendment Directive 2005/63/EC (correcting 2005/26/EC) its amendment Directive 2006/142/EC adding lupin and molluscs to the list of allergens and four related Directives Directive 87/250/EEC on the indication of alcoholic strength by volume on alcoholic beverages Directive 94/54/EC concerning the compulsory indication of certain particulars (i.e. declaration of packaging gases) its 1st amendment Directive 96/21/EC concerning the compulsory indication of certain particulars (i.e. declaration of sweeteners, sugars and sweeteners, aspartame and polyols) it s 2nd amendment Directive 2004/77/EC as regards the labelling of certain foods containing glycyrrhizinic acid and its ammonium salt (i.e. extracts from the liquorice plant) Directive 1999/10/EC providing certain derogations as regards quantitative ingredient declarations Directive 2002/67/EC on the labelling of food containing quinine and of food containing of caffeine.

9 SECTION 1 INTRODUCTION TO THE LABELLING LEGISLATION 7 Workplan for revising the Horizontal Labelling Legislation The Health and Consumer Protection Directorate General of the European Commission (DG SANCO) commissioned an evaluation of the food labelling legislation with a view to its simplification and modernisation in The aim of the evaluation was to allow the Community to reassess its policy on food labelling and to potentially identify if legislative changes are needed in order to meet demands from consumers. The Report on The Evaluation of the Food Labelling Legislation commissioned by DG SANCO was published in 2003 (available at 1 Amongst other findings, the Report concluded that the overall policy objective of the legislation i.e. the right of the consumer to be informed, was not being met due to the number of cases of non or partial application of the Directive i.e. the number of exemptions from the labelling requirements. Further to this evaluation, a European wide consultation has being carried out by DG SANCO on the revision of the labelling legislation. The Food Safety Authority of Ireland (FSAI) has carried out a national consultation based on that of DG SANCO and reported to the Department of Health and Children. On foot of the comments received and following the finalisation of the impact assessment, DG SANCO is due to draft a new legislative proposal before the end of 2007 on food labelling. A legislative proposal on nutritional labelling will be produced in tandem, according to the consumer needs as identified. This will require the revision of The Labelling of Food in Ireland 2007 in due course.

10 8 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 SECTION 2 HORIZONTAL LABELLING LEGISLATION 2.1 LABELLING, PRESENTATION AND ADVERTISING OF FOOD: DIRECTIVE 2000/13/EC AND RELATED DIRECTIVES Legislation European legislation Community legislation governing the general provisions for the labelling of food is laid out in European Parliament and Council Directive 2000/13/EC on the labelling, presentation and advertising of food and has been amended by: Commission Directive 2001/101/EC regarding the new definition of meat in meat products its amendment Commission Directive 2002/86/EC changing the date of implementation Commission Directive 2003/89/EC regarding the declaration of allergenic ingredients its amendment Commission Directive 2005/26/EC provisionally exempting certain ingredients from being considered as allergens its amendment Directive 2005/63/EC correcting Commission Directive 2005/26/EC its amendment Commission Directive 2006/142/EC adding lupin and molluscs to the list of allergens. There are also a number of related Directives which specifically contain labelling provisions in order to further inform the consumer on the composition and/or properties of certain foods: Commission Directive 87/250/EEC on the indication of alcoholic strength by volume on alcoholic beverages Commission Directive 94/54/EC requiring the presence of packaging gases to be declared its 1st amendment Council Directive 96/21/EC requiring certain declarations due the presence of sweeteners, sugars and sweeteners, aspartame and polyols it s 2nd amendment Commission Directive 2004/77/EC requiring the labelling of certain foods containing glycyrrhizinic acid Commission Directive 1999/10/EC providing certain derogations from quantitative ingredient declarations Commission Directive 2002/67/EC on the labelling of food containing quinine and/or caffeine flavouring. National legislation These general labelling requirements are controlled in Ireland under the European Communities (Labelling, Presentation and Advertising of Foodstuffs) Regulations, 2002 (S.I. No. 483 of 2002) and its amendments: European Communities (Labelling, Presentation and Advertising of Foodstuffs) (Amendment) Regulations, 2003 (S.I. No. 257 of 2003) European Communities (Labelling, Presentation and Advertising of Foodstuffs) (Amendment) (No.2) Regulations, 2003 (S.I. No. 451 of 2003) European Communities (Labelling, Presentation and Advertising of Foodstuffs) (Amendment) (No.3) Regulations, 2003 (S.I. No. 528 of 2003) European Communities (Labelling, Presentation and Advertising of Foodstuffs) (Amendment) Regulations, 2005 (S.I. No. 228 of 2005) European Communities (Labelling, Presentation and Advertising of Foodstuffs) (Amendment) (No.2) Regulations, 2005 (S.I. No. 514 of 2005) European Communities (Labelling, Presentation and Advertising of Foodstuffs) (Amendment) (No. 3) Regulations, 2005 (S.I. No. 647 of 2005). European Communities (Labelling, Presentation and Advertising of Foodstuffs) Regulations, 2002 to 2005 implement the provisions of the European Directives above specifically: (S.I. No. 483 of 2002) gives effect to: Council Directive 2000/13/EC Commission Directive 87/250/EEC Commission Directive 94/54/EC Council Directive 96/21/EC Commission Directive 1999/10/EC.

11 SECTION 2 HORIZONTAL LABELLING LEGISLATION 9 (S.I. No. 257 of 2003) gives effect to Commission Directive 2001/101/EC and applies only to products which contain meat as an ingredient. (S.I. No. 451 of 2003) extends the exemption for sugar confectionary products to cocoa and chocolate products, whereby products with a net weight less than 50 grams do not have to declare the net quantity. (S.I. No. 528 of 2003) gives effect to Commission Directive 2002/67/EC on the labelling of food containing caffeine and quinine. (S.I. No. 228 of 2005) gives effect to Commission Directive 2003/89/EC regarding the declaration of allergens. (S.I. No. 514 of 2005) gives effect to Commission Directive 2004/77/EC regarding the labelling of foods containing glycyrrhizinic acid and its ammonium salt. (S.I. No. 647 of 2005) gives effect to Commission Directive 2005/26/EC and Commission Directive 2005/63/EC provisionally exempting certain ingredients from being considered as allergens. The intention of placing information on the label is to inform the consumer about the food being purchased. These Regulations apply to the labelling of pre-packaged foodstuffs for sale to the ultimate consumer i.e. at retail level as well for supply to mass caterers (such as restaurants, hospitals, canteens etc.). The supply of food, otherwise than by sale, from any food premises such as special offers, promotions and give-aways, are also covered by the Regulations These labelling rules do not apply to food sold in restaurants and generally not to food sold loose although there are some exceptions (see Section on origin and Section on exemptions to the labelling rules) Definitions The definitions of labelling, pre-packaged, presentation, advertise, sell and food are provided for under European and National legislation. According to the Labelling Directive 2000/13/EC: Labelling shall mean any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a foodstuff and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such foodstuffs. Pre-packaged foodstuff shall mean any single item for presentation as such to the ultimate consumer and to mass caterers, consisting of a foodstuff and the packaging into which it was put before being offered for sale, whether such packaging encloses the foodstuff completely or only partially, but in any case in such a way that the contents cannot be altered without opening or changing the packaging. Presentation of foodstuffs refers in particular to their shape, appearance or packaging, the packaging materials used, the way in which they are arranged and the setting in which they are displayed. According to the Labelling Regulations, 2002 (S.I. No. 483 of 2002): Advertise includes every form of advertising, whether in a publication, by video, sound broadcasting, television, electronic communication or radio, by display of notices, signs, labels, showcards or goods, by distribution of samples, circulars, catalogues, price lists or other material, by exhibition of pictures, photographs, models or films, or in any other way. Sell includes an agreement or offer to sell, or displaying for sale, or inviting an offer to buy, and cognate words shall be construed accordingly. According to Regulation (EC) No. 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority (EFSA) and laying down procedures in matters of food safety: Food means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. Food includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment (it includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC on the quality of water for human consumption). 2

12 10 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND When do the labelling rules apply? Certain criteria must be adhered to regarding the labelling, presentation and advertising of foodstuffs where the foods are: pre-packaged (i.e. packaged before sale) and available for sale to consumers and/or for supply to mass caterers. However, there is a derogation from the labelling requirements (Section 2.1.5) where a pre-packaged food is: for supply only to mass caterers (for preparation, processing, cutting etc) or intended for the ultimate consumer but marketed prior to sale to the ultimate consumer and where sale to mass caterers is not involved at that stage, e.g. food sold to or from wholesalers or via an intermediary. In such cases, the labelling information (i.e. the compulsory requirements under Section 2.1.5) need only appear on the commercial documents referring to the consignment of food such as a delivery docket. The commercial documents containing the labelling information can either accompany the food to which they refer or be sent before the delivery of the food. However, certain essential information must also appear on the external packaging of the foodstuff, i.e. the name of the food, date of minimum durability and the name and address of the manufacturer or packager, or seller in the EU. If the food is a beverage with greater than 1.2% by volume of alcohol, the actual alcoholic strength by volume must also appear on the external packaging General requirements Labelling must not mislead the consumer The principle underlying the labelling of food is that the purchaser must not be misled. The information on the label must be clear and unambiguous and must not be such as could mislead the consumer to a material degree: as to the characteristics of the foodstuff and, in particular, as to its nature, identity, properties, composition, quantity, durability, origin or provenance, method of manufacture or production by attributing to the foodstuff, effects or properties which it does not possess by suggesting that the foodstuff possesses special characteristics when in fact all similar foodstuffs possess such characteristics. For example, it is not permitted to state that a food is free from. or without something where all similar foodstuffs have similar properties. Such expressions may not be used either where a substance is not normally present in a certain type of foodstuff or where the use of a certain additive is not permitted. Information provided on the label of a food must not be false or misleading to the consumer. The onus is on the manufacturer/packager of a food to be able to demonstrate that all the information provided on a label (whether compulsory or provided voluntarily) is true. Current legislation enables the general public or competitors to take action against advertising deemed misleading and covers all products and services. The Regulation (EC) No. 1924/2006 on nutrition and health claims (Section 2.4) aims to prevent misleading labelling and advertising regarding nutritional and health properties of foods, before it is used and then possibly contested Size of information The compulsory labelling information below (Section 2.1.5) must be easy to understand, marked in a conspicuous place in such a way as to be easily visible, clearly legible and indelible. It cannot be hidden, obscured or interrupted by other written or pictorial matter or by price labels, sealing tapes etc. The size of the text must not be too small in relation to other information and decorations and the text should be in contrast to the background. There is no prescribed font or text size under the legislation but this issue is being considered under the review of the labelling legislation Language The general labelling requirements in Ireland are that foods must be labelled in English or in Irish and English. The food may also be labelled in other languages but only in addition to English (or in addition to Irish and English). Where the address of the food business on the label of a product is within a Gaeltacht area, the legal status of the address in Irish should be taken into account and it is acceptable for food business addresses to be in Irish only. Our national Health (Country of Origin of Beef) Regulations, 2006 (S.I. No. 307 of 2006) as amended, allows for the country or countries of origin of beef on advertisements, menus or other presentations to be in Irish, English or both languages (see also Section on origin).

13 SECTION 2 HORIZONTAL LABELLING LEGISLATION Claims Nutrition and health claims on food are now tightly regulated according to the provisions of Regulation (EC) No. 1924/2006 (Section 2.4). Under these rules a claim is defined as: any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics. In addition, the Labelling Directive 2000/13/EC sets out the fundamental rules regarding claims in general. Claims on a food must not be false or misleading to the consumer (Section ) and medicinal claims are prohibited. Meaningless claims such as added vitality, wholesome, healthful and sound and claims as to good hygienic practice, such as hygienically produced may be misleading. There are specific rules in force that allow for the use of some health claims under certain conditions for particular foods and these are provided under the following: the European Communities (Foodstuffs Intended for Particular Nutritional Uses) Regulations, 2005 (S.I. No. 66 of 2005) regulating specially manufactured foods that claim to provide particular nutritional requirements for certain groups of individuals such as for infants or persons with digestive disorders (see Section 3.2) the European Communities (Natural Mineral Waters, Spring Waters and Other Waters in Bottles or Containers) Regulations, (S.I. No. 79 of 2005) which prohibits bottled waters from making claims that they are natural mineral waters unless they meet certain compositional requirements (see Section 4.9) and the European Communities (Dietary Foods for Special Medical Purposes) Regulations, 2001 (S.I. No. 64 of 2001) regulating specially processed foods intended to provide particular nutritional requirements for the dietary management of patients under medical supervision such as patients with an impaired capacity to metabolise food (see Section 3.5) Commission Directive 2006/141/EC on infant formulae and follow-on formulae permits the labelling of infant formulae to bear specific nutrition and health claims in accordance with the appropriate conditions for their use (see Section 3.3). Functional food claims Functional food is an emerging category of foods which are generally presented as possessing characteristics that can help achieve or maintain good health. Although functional foods are not specifically regulated for in their own right, the legal requirements regarding food safety and labelling, including any claims made, apply to such foods as well as to food in general. Therefore the provisions of the horizontal labelling rules (Section 2) will apply including Regulation (EC) No. 1924/2006 on nutrition and health claims. The FSAI has produced a leaflet Functional Food which gives a broad guide to functional food detailing the relevant legislation regulating such foods. This leaflet is available at and should be consulted for further information. Medicinal claims In order to be permitted to make a medicinal claim, a product must be classed as a medicine in accordance with the Community code relating to medicinal products for human use. The manufacture, importation, distribution and supply of medicinal products for human use in Ireland are regulated by the Irish Medicines Board (IMB). Further information is available from the IMB at Compulsory labelling The following mandatory information must appear on the packaging of a pre-packaged food or on a label attached: the name under which the product is sold* (Section ) the list of ingredients (Section ) the quantity of certain ingredients (Section ) the net quantity* (Section ) the date of minimum durability* (Section ) any special storage instructions or conditions of use (Section ) the name or business name and address of the manufacturer or packager, or of a seller within the European Union (Section ) place of origin of the foodstuff if its absence might mislead the consumer to a material degree (Section ) instructions for use where necessary (Section ) beverages with more than 1.2% alcohol by volume must declare their actual alcoholic strength* (Section ). 2 * Field of Vision The name of the foodstuff, the date of minimum durability and the net quantity must appear on the label in the same field of vision. If the product is an alcoholic beverage greater than 1.2% alcohol by volume, its actual alcoholic strength by volume must also appear in this field of vision. The intention is that all the information can easily be seen at the same time under normal purchasing conditions.

14 12 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND Name under which the product is sold The name of the foodstuff must be stated in order to inform the purchaser of the true nature of the product. The legal name of the food must be used where one exists. In its absence its customary name or a description of the foodstuff may be given. Legal name The name under which a foodstuff is sold must be the name provided for in Community legislation. The legal name of a food is the name specified in legislation for a product meeting particular specifications, e.g. compositional criteria are detailed in the Vertical Directives for butter, jam, fruit juice, sugar, chocolate, coffee, whiskey, natural mineral waters etc. (see Section 4). Customary name In the absence of a legal name, a name customary in the Member State where the product is sold to the ultimate consumer may be used. The customary name of a food is a name that has come to be accepted by consumers as the name of a food without needing further explanation such as fish fingers, spaghetti and muesli. However, a description of the product may be warranted and its intended use detailed in order to indicate the true nature of the product and to distinguish it from other foods, which might otherwise confuse the consumer (note the product name Chicken and Vegetable Pie accompanied by a description of the product following). Sales name The use of a sales name as the name of a food is permitted in all Member States where the food has been legally manufactured and marketed in the Member State of production. However, the sales name shall be accompanied by a product description in proximity to the sales name where the labelling information provided would not enable consumers in the Member State of marketing to know the true nature of the food and to distinguish it from food with which they could confuse it. In exceptional circumstances the sales name of the Member State of production may not be used as the name of the food in the Member State of marketing. This provision is to protect consumers where the composition or manufacture of the food is so different from the food known under that name even where a product description is given (see below the brand name Reggio accompanying the customary name spaghetti ).

15 SECTION 2 HORIZONTAL LABELLING LEGISLATION 13 Trade mark/brand names The use of a trade mark, brand name, or fancy name is permitted in addition to the name of the food. However, such names cannot appear instead of the legal or customary name, as it does not provide sufficient information for consumers. Details of physical condition Details of the physical condition of the foodstuff or processes it has undergone must accompany the legal name of the food such as powdered, freeze-dried, deepfrozen, concentrated, sterilised and smoked. Foodstuffs that have been frozen and that are retailed without further processing should be labelled as frozen products. However, it is important to ensure that an accurate indication of the processes or treatment to which the food has been subjected is indicated on the label. Food which is sold fresh but has been previously frozen should be labelled as 'previously frozen' and if applicable not suitable for home freezing so the consumer is aware of the true nature of the product. A further example is a product that contains a smoked flavour but that has not been smoked but treated with a solution which imparts a smoked flavour and colour (see also Section 3.13 on flavourings). Additional considerations include minced or pressed products, such as contained in breaded scampi and fish fingers. These foods would need to carry an appropriate indication on the label in cases where the consumer is likely to be misled by the general appearance of the food or its labelling. Fruit and vegetables which have simply been cut in portions such as sliced melon and which are sold to the consumer in transparent packaging are exempt and need not indicate this treatment unless they are otherwise further processed such as shredded cabbage. Irradiated products Any food which has been treated with ionising radiation must declare irradiated or treated with ionising radiation (see also Section 3.7 on foods treated with ionising radiation) Ingredients An ingredient is defined as any substance, including additives, used in the manufacture or preparation of a foodstuff and still present in the finished product even if in an altered form. If an ingredient of a foodstuff is made up of a number of other ingredients, the latter (i.e. the individual ingredients of the compound ingredient) is regarded as the ingredients of the foodstuff in question. Substances not regarded as ingredients The following are not considered as ingredients: the constituents of an ingredient which have been temporarily separated during manufacturing, which are later added to a foodstuff but not in excess of their original quantity. For example, the yolk and white of an egg need not be considered as separate ingredients and identified separately in the ingredients list if they are separated during manufacture. The ingredients list of the final food would simply need to declare egg as the ingredient, provided they are not in excess of the original amounts additives serving no technological function in the final food where their presence in food is only because they were contained in one or more of the ingredients of that foodstuff. For example, sulphur dioxide used as a preservative in dried fruit such as raisins (to prevent them browning) will have no function when the dried fruit is added to a cake mix* (see also sub section (b) on additives) additives used purely as processing aids such as enzymes, alcohols and acids. For example, alcohols used to speed up the reactions of certain additives or enzymes such as rennet used in cheese production. However, if they leave residues and perform a technological function they must be considered as additives and fall under the definition of an ingredient* substances only used in quantities required as solvents or media for the functioning of additives or flavourings. For example, diethyl ether which is used in the preparation of flavourings from natural flavouring materials* substances which are not additives but are used in the same way and with the same purpose as processing aids and are still present in the finished product, even if in altered form* 2 * These exemptions do not apply to additives, processing aids and other substances which have been derived from allergenic ingredients listed in Appendix IV. As such additives, processing aids and other substances derived from allergenic ingredients are considered as ingredients and must always be declared in the list of ingredients (Directive 2003/89/EC as amended by Directive 2005/26/EC and Directive 2005/63/EC, amending Directive 2000/13/EC as regards the indication of ingredients present in foodstuffs).

16 14 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 List of ingredients There must be a list of all the ingredients in descending order of weight as recorded during the manufacturing of the foodstuff often referred to as the mixing bowl stage. The list must start with a heading that includes the word ingredients. The list of ingredients must be easy to understand by the consumer and such that similar products can be easily distinguished from each other depending on the ingredients, e.g, consumers must be able to readily distinguish between a strawberry or raspberry fruit yoghurt. There are some additional requirements when listing the ingredients on the label: added water and volatile ingredients (i.e. substances that quickly evaporate such as alcohol), shall be listed in the list of ingredients by their weight in the final product and not their weight as added at the mixing bowl stage. The amount of water added as an ingredient is calculated by subtracting the total weight of other ingredients from the weight of the finished product. However, the amount of added water need not be listed as an ingredient if it does not exceed 5% by weight of the finished product (see also sub section on declaration of water content below) (In addition water need not be declared in the list of ingredients if it is added to frozen or quick frozen chicken carcasses in accordance with Commission Regulation (EC) No. 1906/90 (as implemented by Regulation (EC) No. 1538/91 as amended) on certain marketing standards for poultry (see Section 4.20 on poultrymeat) concentrated or dried ingredients that are reconstituted at the time of manufacture may be listed according to their weight before their original concentration or dehydration such as milk powder in the case of concentrated or dried foods which are to be reconstituted by the addition of water by the consumer, such as powdered soup or sauces, the ingredients may be listed by the order of their proportion after the reconstitution of the product provided that this is indicated, e.g. ingredients of the reconstituted product or ingredients of the ready-to-use product where fruit, vegetables or mushrooms, none of which significantly predominates in terms of weight and which are used in proportions that are likely to vary, are used in a mixture as ingredients of a foodstuff, they may be grouped together in the list of ingredients under the designation fruit, vegetables or mushrooms followed by the phrase in varying proportions, immediately followed by a list of the fruit, vegetables or mushrooms present; in such cases, the mixture shall be included in the list of ingredients in descending order of weight on the basis of the total weight of the fruit, vegetables or mushrooms present* in the case of mixtures of herbs and spices, where none significantly predominate, those ingredients may be listed in another order provided it is accompanied by an expression such as in variable proportion ingredients constituting less than 2% of the finished product may be listed in a different order after the other ingredients and * where ingredients which are similar or mutually substitutable are likely to be used in the manufacture or preparation of a foodstuff without altering its composition, its nature or its perceived value, and in so far as they constitute less than 2% of the finished product, they may be referred to in the list of ingredients by means of the phrase contains and/or, where at least one of no more than two ingredients is present in the finished product. This provision shall not apply to additives or to ingredients listed in Appendix IV as allergenic ingredients*. * As set out in Directive 2003/89/EC as amended, amending Directive 2000/13/EC as regards the indication of ingredients present in foodstuffs.

17 SECTION 2 HORIZONTAL LABELLING LEGISLATION 15 Foodstuffs that do not require a list of ingredients The following foodstuffs are not required to indicate a list of their ingredients: fresh fruit and vegetables including potatoes (unless they have been somehow processed, e.g. peeled or chopped) carbonated water provided that it can be understood from the name that carbon dioxide has been added to the water for example sparkling water fermentation vinegars derived from a single basic product (where no other ingredient has been added) cheese, other than fresh or processed cheese, where no other ingredient has been added except those that are required for its manufacture (i.e. salt, lactic acid products, enzymes and microorganism cultures) such as cheddar and edam cheese butter, fermented milk and fermented cream where no other ingredient has been added (except for lactic acid products, enzymes and microorganism cultures essential to their manufacture) products comprising a single ingredient where the trade name is the same as the ingredient name, or the trade name enables the nature of the ingredient to be clearly defined, for example, pepper beverages that contain more then 1.2% volume of alcohol (see also Section on alcoholic beverages). Declaration of water content The amount of added water need not be listed as an ingredient if it does not exceed 5% by weight of the finished. In addition, the water content need not be indicated where: the water is used during the manufacturing process purely for the reconstitution of an ingredient that is used in a concentrated or dehydrated form or where the water is a liquid medium that is not usually consumed such as kidney beans in salted water. Name of ingredients The names used for ingredients should be their legal name, in the absence of a legal name, a customary name or a description of the ingredient must be given (as per the requirements for the name of the food Section ). In other words, the name of an ingredient must be sufficiently specific to describe the ingredient. Where the ingredient starch (or modified starch) originates from a source that contains gluten such as starch from wheat, oats, barley or rye, the source of its cereal origin must always be given, e.g. wheat starch. See below a dried soup declaring Corn Starch and a readymeal declaring Modified Maize Starch in their lists of ingredients) INGREDIENTS: Corn Starch, Sugar, Onion Powder, Skimmed Milk Powder, Whey Protein Concentrate, Beef Fat, Dried Potato, Dried Leeks Salt, Flavour Enhancers (Monosodium Glutamate, Disodium 5 Ribanuceotides), Wheat Flour, Flavourings, Dried Glucose Syrup, Herbs, Spices Categories of ingredients Ingredients of a foodstuff that belong to a certain category of ingredients as listed in Appendix II need only be indicated by their designated category rather than their specific name. For example, where fish is an ingredient of a foodstuff all species of fish may be indicated simply as the category fish in the list of ingredients provided the label does not refer to a specific species of fish. Directive 2003/89/EC, amending Directive 2000/13/EC, deleted the following ingredient categories from Appendix II: Crystallised fruit and Vegetables. INGREDIENTS Cooked noodles, Soy Sauce, Red Pepper, Pineapple, Sugar, Chinese Mushrooms, Water, Chicken, Bamboo Shoots, Modified Maize Starch, Spices, Garlic Puree, Salt, Sesame Oil, Ginger Puree. 2

18 16 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 See below Original Beef Lasagne where the category of ingredient cheese need only be declared as such in the list of ingredients because a particular type of cheese is not specified in the product description. (a) Definition of meat Commission Directive 2001/101/EC, amending Directive 2000/13/EC for the first time, added the category meat to the list of categories of ingredients in Appendix II. The aim of the new requirements is to improve consumer information on pre-packaged meat products such as cooked meats, prepared dishes and canned meat. The new definition of meat brings the legislation in line with what consumers generally perceive meat to be i.e. muscle-meat not fat or offal. The labelling provisions outlined below apply to all food products that contain meat as an ingredient (including all products previously defined as meat products and meat preparations now falling under EC (Food and Feed Hygiene) Regulations, 2005 (S.I. No. 910 of 2005) Section 5). However, raw meat cuts sold without further processing are excluded such as a sirloin steak. In addition, sandwiches, rolls, soups, pizza and similar products containing meat ingredients are also excluded from these labelling requirements. The new definition of meat (as set out in Appendix II) defines meat as the skeletal attached muscles i.e. muscle meat only and other parts of the animals such as fat and offal, e.g. the heart, liver and kidneys, are excluded and must be declared separately in the list of ingredients. Secondly, the species from which the meat came from must also be indicated in the list of ingredients such as bovine meat or beef meat or simply beef. This information is very important for consumers to help them make an informed choice on the basis of their personal preferences. A separate Guidance Note has been produced on these meat products labelling requirements - Guidance Note 14: The application of Commission Directive 2001/101/EC as amended by Commission Directive 2002/86/EC on the Definition of Meat. The intention of this Guidance Note is to enable those involved in the manufacturing, packaging and selling of meat products to better understand the new labelling requirements. In addition, Guidance Note 17:The Labelling of Meat provides guidance on the documentation, labelling and traceability information required for all meats throughout the marketing chain. Both Guidance Notes are available at (b) Additives Ingredients of a foodstuff which belong to one of the categories of additives as listed in Appendix III must be named in the list of ingredients by: the name of the category of additive and its specific name or it s designated E number. For example, sulphur dioxide which is a preservative commonly used in sausages must be listed in the list of ingredients as Preservative: Sulphur Dioxide or Preservative: E220. If the additive belongs to more than one category (as listed in Appendix III) the category name given shall correspond to its main function in that particular food. Additives which perform the same function in a food could be grouped together for ingredient listing purposes, e.g. Colours: E110, E120 or Colours: Sunset Yellow, Cochineal (see also Section 3.12 on additives, colours and sweeteners). See below an indication of the additives present in the ingredients list of a packet of sausage rolls. INGREDIENTS Pork, Rusk, Salt, Milk Proteins, Soya Protein Isolate, Spices, Stabiliser: E450, Flavour Enhancer: E621, Dextrose, Modified Starch, Colours: E160, E128, Water, Preservative: E223, Hydrolysed Vegetable Protein, Wheat Flour, Margarine (with Emulsifier E471, Flavouring), Antioxidants: E301, E331, Herbs. Minimum 20% Meat. Every additive is given a number for identification purposes and most have an E prefix before the number which means it has been approved by the European Community as safe for use at specified levels in certain foods. There are approximately 400 approved additives for use in foods in Europe. However, some additives do not have an E number. Additives lacking the E prefix have undergone a safety evaluation in one or more Member States but are still awaiting EU wide approval.

19 SECTION 2 HORIZONTAL LABELLING LEGISLATION 17 Appendix VI and VII provide a list of all additives and their designated E numbers currently in use in the EU, in numerical and alphabetical order respectively as listed in the additives register in the Additives Directives (see Section 3.12). The following are the most recent changes in the register of additives: E233 Thiabendazole metabisulpihte has been deleted from the register E180 Litholrubine BK the spelling has been amended from Latolrubine BK E230 Biphenyl, diphenyl is to be deleted and transferred to the pesticides register E231 Orthophenyl phenol is to be deleted and transferred to the pesticides register E232 Sodium orthophenyl phenol is to be deleted and transferred to the pesticides register. In addition, the following additives have been added to the register: E650 Zinc acetate E907 Hydrogenated poly-1-decene E955 Sucralose E962 Salt of aspartame-acesulfame E1517 Glyceryl diacetate (diacetin) E1519 Benzyl alcohol. Although some ingredients may have additive functions in food, acting as sweeteners, colours etc. (such as sugar, coffee, salt, concentrated fruit juice) they are not additives as defined according to the additives legislation (Directive 89/107/EEC and its amendments) and do not need to be listed as such. It should be noted that only substances listed in Appendix III are recognised as categories of additives for labelling purposes such as antioxidants that are used to extend the shelf life of foods and protect them against rancidity. Flavourings are not considered as additives as they do not perform a technological function in the food and are regulated separately to additives (see Section subsection (c) and 3.13 on flavourings). For detailed information on food additives please refer to the report by the FSAI on Legislation, intake and usage of food additives in Ireland available at The European Commission has adopted a new package of legislative proposals regarding additives, flavourings and food enzymes, see Sections 3.12 and 3.13 in this regard. Additives carried over from other ingredients Some additives may be present in a food because they were contained in one of the ingredients. They need only be indicated in the list of ingredients if they perform a significant technological function in the final food (see previous sub-section on substances not regarded as ingredients). Whether or not the additive performs a technological function in the final product will depend both on the ingredient containing the additive and the food to which it is added. For example, preservatives used in fruit puree will not necessarily be performing the same function when the fruit is added to a heat-treated yoghurt. However, carry-over additives that are derived from allergenic ingredients (i.e. those listed in Appendix IV but excluding those listed in Appendix V) are considered as ingredients and must always be declared in the list of ingredients (see also sub-section (e) on allergens). (c) Flavourings Flavourings are used in or on foodstuffs to impart a taste and/or odour. Flavourings must be indicated in the list of ingredients by the word flavouring(s) or by a more specific name or description, for example, Flavouring: vanilla. See Section 3.13 detailing the specific rules on flavourings including the new package of legislative proposals regarding additives, flavourings and food enzymes. Caffeine and quinine flavouring Commission Directive 2002/67/EC on the labelling of foodstuffs containing quinine, and of foodstuffs containing caffeine however, requires more detailed information on the label. The Directive requires that where quinine or caffeine are used as a flavouring in the production or preparation of a foodstuff, such as in soft drinks they must always be declared in the list of ingredients immediately after the term flavouring, such as flavouring: quinine. Quinine and caffeine may cause hypersensitivity or temporary behavioural changes in certain individuals. As current labelling rules do not require the specific naming of flavourings in ingredient lists, caffeine or quinine used as a flavouring, might not therefore be listed. 2

20 18 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 In addition, drinks containing caffeine in excess of 150mg/l such as high energy drinks must also provide a warning message on the label followed by an indication of the caffeine content such that: High caffeine content (Xmg/100ml). These provisions do not apply to beverages based on coffee, tea or coffee or tea extract. Natural flavouring Detailed rules on the use of the term natural with regard to flavourings are provided in the European Communities (Flavourings for use in Foodstuffs for Human Consumption) Regulations, 1992 (S.I. No. 22 of 1992) (see Section 3.13). Smoke flavourings See Section 3.13 on flavourings. Liquorice flavouring (Glycyrrhizinic Acid) Commission Directive 2004/77/EC amends Directive 94/54/EC as regards the labelling of certain foods containing glycyrrhizinic acid and its ammonium salt. This Directive provides for additional labelling of confectionery and beverages containing glycyrrhizinic acid or its ammonium salt above certain limits because of the possibility that these flavourings can give rise to hypertension. Glycyrrhizinic acid naturally occurs in the liquorice plant Glycyrrhiza glabra while its ammonium salt is manufactured from aqueous extracts of the liquorice plant. Glycyrrhizinic acid and its ammonium salt are included in the Community register of flavouring substances (Commission Decision 1999/217/EC see Section 3.13). Exposure to glycyrrhizinic acid and its ammonium salt occur mostly via consumption of liquorice confectionery, including chewing gum, herbal teas and other beverages. An upper limit of 100 mg/day for regular ingestion is regarded as providing a sufficient level of protection for the majority of the population. Consumption above this level may give rise to hypertension. However, it is recognised that within the human population there are subgroups for which this upper limit might not offer sufficient protection. These subgroups comprise of people with medical conditions related to disturbed water and electrolyte homeostasis. As flavourings are not normally required to be specifically named in the list of ingredients (Directive 2000/13/EC) it is necessary to provide labelling which gives the consumers clear information on the presence of glycyrrhizinic acid or its ammonium salt in confectionery and beverages as detailed below. In the case of high contents of glycyrrhizinic acid or its ammonium salt in these products, the consumers, and in particular those suffering from hypertension, should in addition be informed that excessive intake should be avoided. To ensure a good understanding of the labelling information by the consumer, the term liquorice extracts should be used. For confectionery or beverages containing glycyrrhizinic acid or its ammonium salt at a concentration of 100mg/kg or 10mg/l or above, the statement contains liquorice must be added immediately after the list of ingredients, unless the term liquorice is already included in the list of ingredients or in the name under which the product is sold. In the absence of an ingredients list, the statement should appear near the name under which the product is sold. For confectionery containing glycyrrhizinic acid or its ammonium salt at concentrations of 4g/kg or above, the statement contains liquorice people suffering from hypertension should avoid excessive consumption must be added after the list of ingredients. In the absence of an ingredients list the statement must appear near the name under which the product is sold. For beverages containing glycyrrhizinic acid or its ammonium salt at concentrations of 50mg/l or above, or of 300mg/l or above in the case of beverages containing more than 1.2% by volume of alcohol, the statement contains liquorice people suffering from hypertension should avoid excessive consumption must appear after the list of ingredients. In the absence of a list of ingredients a statement should appear near the name under which the product is sold. These levels apply to the products ready for consumption or as re-constituted according to the instructions of the manufacturer. These requirements came into force on 20th May Trade in products not in compliance with these provisions is prohibited from 20th May (d) Compound ingredients The rules for the labelling of compound ingredients have changed under Directive 2003/89/EC. The aim of this amendment is to achieve a high level of health protection for consumers and to guarantee their right to information by ensuring they are appropriately informed of the composition of food.

21 SECTION 2 HORIZONTAL LABELLING LEGISLATION 19 It is now obligatory to include the list of all ingredients and other substances present in a food, however, some minor exemptions will be permitted (see below). In addition, it has also become mandatory to include on the label of a food as well as alcoholic beverages, all ingredients with allergenic effect (see sub-section (e) below on allergens). A compound ingredient is an ingredient which is itself made up of several other ingredients, such as jam in a biscuit. A compound ingredient can be included in the list of ingredients under its own specific name provided it is followed immediately by a list of its ingredients, e.g. jam (fruit, water, sugar etc.). Alternatively, the ingredients of the compound ingredient may be shown in the list of ingredients without making reference to the name of the compound ingredient, e.g....fruit, water, sugar. Below is the list of ingredients of a vegetarian lasagne where the compound ingredient textured wheat and pea protein is given under its own specific name followed by a list of its ingredients. INGREDIENTS: Water, Tomato, Textured Wheat and Pea Protein (contains: Wheatflour, Wheatfibre, Yeast Extract, Malt Extract, Emulsifier; E471), Onion, Vegetarian Cheddar Cheese, Basil, Garlic, Puree, SUgar, Milk, Cooked Fresh Free Range Egg Pasta, Tomato Puree, Carrot, Wheatflour, Vegetarian Flavourings, Double Cream, Modified Starch, Vegetable Oil, Salt, Oregano, Paprika, Pepper, Nutmeg. However, listing the ingredients of a compound ingredient is not required: a) where the composition of the compound ingredient is defined in current Community legislation (such as in the Vertical Directives Section 3, e.g. fruit jams and jellies) and where the compound ingredient constitutes less than 2% of the finished product. However, this provision does not apply to additives (b) for compound ingredients consisting of mixtures of spices and/or herbs that constitute less than 2% of the finished product, with the exception of additives, and (c) where the compound ingredient is a foodstuff for which a list of ingredients is not required under Community legislation (such as alcoholic beverages). (e) Allergens European Directive 2003/89/EC which came into force on 25th November 2004 recognises that certain ingredients, additives, processing aids and other substances can cause allergies or intolerances in consumers. Thus, it sets out labelling rules to assist consumers who have allergies or intolerances by providing them with more comprehensible information on the composition of foods. The objective of Directive 2003/89/EC is to ensure that all allergenic ingredients or substances will appear on the label of a food. The allergens required to be indicated are listed in Appendix IV such as eggs and fish. Lupin and molluscs were most recently added to this list (as per Directive 2006/142/EC). These allergenic ingredients must be declared on the label with a clear reference to the name under which the allergen is known, so that consumers suffering from an allergy or intolerance shall be able to identify the ingredient they are sensitive to. The European Commission has drawn up Guidelines for implementing Article 6 paragraph 10 of Directive 2000/13/EC as amended by Directive 2003/89/EC. These guidelines offer informal guidance on the interpretation and implementation of some of the labelling requirements for allergenic ingredients. (This document is available at Europa - the European Union On-Line ). Appendix V lists the ingredients or substances that are provisionally excluded from being labelled as allergens (as per Directive 2005/26/EC and Directive 2005/63/EC). To this end businesses had to notify the Commission of the studies being conducted to establish whether certain ingredients or substances under specific circumstances are not likely to trigger adverse reactions. Businesses seeking a permanent extension to this exemption from labelling beyond November 2007, must submit a request to the Commission containing the final results of the scientific studies carried out. Only the derivatives that are listed (Appendix V) are provisionally exempt from labelling as allergenic pending further scientific evaluation. All other allergenic derivatives must be labelled appropriately. Twenty one requests for permanent exemptions from allergen labelling were received by the European Food Safety Authority (EFSA) (nine have EFSA opinions, ten have draft opinions and two are pending). The Commission foresees that a new Directive will be published before November 2007 (within the permitted time frame) which will provide permanent exemptions from allergen labelling for some substances. The FSAI has also produced an information leaflet on allergens and is available at: 2

22 20 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Indication of allergenic ingredients There still exist some minor possible derogations from labelling ingredients in pre-packaged foods: 1. foods for which no ingredient list is required (Section ) 2. sub ingredients of certain compound ingredients (Section (d)) and 3. ingredients which belong to defined categories (Section ). However, despite these exemptions from ingredients labelling, where an ingredient is a known allergen listed in Appendix IV or originates from an ingredient in that list, the derogations no longer apply and the allergenic ingredients must be clearly labelled. Therefore, any ingredient that is used in the production of a food and still present in the finished product even if in altered form and is listed in Appendix IV as an allergenic ingredient or originates from an ingredient in this list, must be indicated on the label with a clear reference to the name under which the allergen is known. For example, where the ingredient of a food is a cereal which contains gluten, such as wheat, the ingredient name wheat must appear clearly on the label. However, the declaration wheat is not required elsewhere on the label if the name under which the food is sold clearly refers to this ingredient such as Wheat bread. Therefore, any declaration on the label indicating the presence of the allergen can be considered as fulfilling the requirements of the Directive whether the allergenic ingredient is declared in the list of ingredients, the sales names or somewhere else on the label provided it is clearly stated. Similarly a product called cake with almonds is considered as declaring the allergenic ingredient almonds in the sales name. Thus the allergenic ingredient almonds does not have to be repeated or declared elsewhere on the label to fulfil the requirements under this Directive. The declaration of the category name flavour alone in the list of ingredients is acceptable even where the flavour has been made with the use of almond extracts. Indication of allergenic substances There is a derogation from the labelling of certain substances in pre-packaged foods where certain substances are not regarded as ingredients such as carry-over additives and thus do not have to be declared on the label (Section ). However, any substance including additives and processing aids which are used in the production of a food and still present in the finished product even if in an altered form and originates from the allergenic ingredients listed in Appendix IV, is considered as an ingredient and must be indicated on the label with a clear reference to the name of the ingredient from which it originates, e.g..additive A from wheat could appear in the list of ingredients. The exemption whereby the declaration of the allergenic ingredient can appear in the sales name of the food only does not extend to allergenic substances such as carry over additives or processing aids. Substances originating from allergenic ingredients must be declared somewhere on the label such as in the list of ingredients but not solely in the sales name. Name under which food is sold Normally if the sales name of a food declares the allergenic ingredient in the name of the food, e.g. cake with almonds, the allergenic ingredient does not have to be declared elsewhere or repeated on the label (except for allergenic substances above). Milk-based products (cheese, butter, fermented milk and cream) are particularly concerned by this provision as they are exempted from ingredient listing. The trade names of certain dairy products such as cheese, butter and yoghurt are considered as referring to the allergenic ingredient milk by normally informed consumers and thus are not required to declare the allergenic ingredient elsewhere on the label. However, the name of some products may not imply the presence of an allergen such as cheese sold under a trade name or appellation which does not refer explicitly to milk. In such cases, any supplement to the name of the product which implies a reference to the allergenic ingredient is acceptable such as adding cheese to the sales name. Repetition of allergens Allergenic ingredients and substances need only be declared once, it is not necessary for the allergens to be repeated on the label. Any presentation making clear that different ingredients or substances in a food originate from a single allergenic ingredient or substance is acceptable such as by way of a footnote to the list of ingredients. SO 2 Sulphur dioxide and sulphite shall appear on the label under its full name, where it is present at levels exceeding 10mg/kg or 10mg/l as consumed or as reconstituted according to the manufacturers instructions.

23 SECTION 2 HORIZONTAL LABELLING LEGISLATION 21 Definition of products thereof Appendix IV lists the known allergenic ingredients which must comply with the labelling requirements. In listing the allergenic ingredients, products thereof are also considered as being allergenic and subject to the labelling requirements such as fish and products thereof. Due to different wordings in other official languages the scope of this definition has been questioned. Products thereof include all products derived from an allergenic ingredient after one or more processing stages. Microorganisms that have been fed substrates are not considered as derived from these substrates. However, where these substrates contain allergenic ingredients and a food is prepared with microorganisms that are likely to contaminate a food, manufacturers will have to decide if labelling, precautionary or other wise, is required (although precautionary labelling is not normally advised). The scope of the Directive applies only to ingredients voluntarily used for manufacturing food and not to involuntary contamination. List of allergenic ingredients The current list of allergenic ingredients (Appendix IV) contains the most common food allergens. This list will be systematically re-examined and, where necessary, updated on the basis of the most recent scientific knowledge. It is possible for ingredients to be deleted from this list where it has been scientifically established that it is not possible for certain derivatives of these allergens to cause adverse reactions. To this end, provision was made for interested parties to notify the Commission of studies being conducted to establish whether ingredients that are derived from allergenic ingredients are not likely to trigger adverse reactions (as outlined above). Currently the derivatives that are listed in Appendix V are provisionally exempt from labelling as allergenic pending further scientific evaluation. All other allergenic derivatives must be labelled appropriately Quantitative Ingredient Declaration (QUID) In certain circumstances it is necessary to state on the label the quantity, in percentage terms, of an ingredient or category of ingredients (as listed in Appendix II) used in the manufacture or preparation of a foodstuff. The percentage quantity should be in or next to the name of the food or be in the list of ingredients. The QUID requirement applies to all foods, including beverages, with more than one ingredient unless specially exempt. QUID will also apply to products exempt from ingredients listing (see Section ). For these products, the ingredient quantity will have to be indicated in or immediately next to the name under which the product is sold unless a list of ingredients is voluntarily indicated on the label. The European Commission has produced a document with the aim of providing informal advice on the implementation of QUID entitled General guidelines for implementing Quantitative Ingredient Declaration (QUID) It is advisable to consult this document in conjunction with Directive 2000/13/EC for a more detailed explanation of the QUID rules. (This guide is available at the European Union On-Line In addition, the Food and Drink Federation of the Irish Business and Employers Confederation (IBEC) have developed Guidance Notes on Quantitative Declaration of Ingredients (QUID), February This guideline was drawn up to provide guidance to manufacturers and suppliers on the introduction of QUID in Ireland. When a Quantitative Ingredient Declaration (QUID) is required It is necessary to state the quantity as a percentage on the label where the ingredient or category of ingredient is: included in the name of the food, e.g. a ham and mushroom pizza, would need to have the ham and the mushroom quantified usually associated with the name of the food (most likely when a food is described by it s customary name, e.g. Chilli con carne would need to have the minced beef quantified) emphasised on the label in words, pictures or graphics, e.g. a food emphasising with butter would need to have the butter quantified essential to characterise and distinguish the food from products with which it might be confused because of its name or appearance, e.g. the composition of marzipan, with respect to its almond content, may vary between Member States although it is still marketed under the same name. Marzipan should therefore have the almond ingredient quantified. 2

24 22 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 See below the list of ingredients for a cheese and onion quiche where the cheese and onion are quantified. INGREDIENTS: Pasteurised Egg, Whole Milk, Wheat Flour, Full Fat Hard Cheese (13%), Onion (12%), Vegetable Oil and Hydrogenated Vegetable Oil, Modified Maize Starch, Flour Treatment Agent (L-Cysteine Hydrochloride), Salt, Dextrose. See below the list of ingredients for a traditional bolognese where the beef, pasta and tomato are quantified as they are associated with the name of the food. INGREDIENTS Beef 20%, Water, Tomato 10%, Tomato Puree, Onion, Carrot, Celery, Modified Starch, Cooked Pasta (Durum Wheat Semolina), Salt, Sugar, Garlic, Oregano, Pepper, Basil When a Quantitative Ingredient Declaration is not required Ingredients or categories of ingredients need not be quantified where: an ingredient or category of ingredient is in the name of a food, but is in such a small quantity so as not to affect consumers purchasing decisions, such as malt in malt whiskey the quantity of an ingredient or category of ingredient is determined by Community provisions. No such provisions exist at present no ingredient or category of ingredient significantly predominates by weight such as in a mixture of fruit or vegetables. See below the list of ingredients for cheese flavoured nachos where the quid declaration for nacho cheese flavour is given as it is a flavouring present at levels greater than 2%. INGREDIENTS Maize Flour (68%) Vegetable Oil Nacho Cheese Flavour (7%) (Dried Cheese Salt Dried Onion Dextrose Dried Garlic Acids Tomato Dried Yeast Sugar White Pepper Yeast Extract Anti-Caking Agent: E551 Flavouring Colours: E160(c), E100 A pictorial representation of the food as a serving suggestion would not normally be regarded as giving special emphasis and hence not require a QUID. Serving Suggestion a solid foodstuff is presented in a liquid medium where the liquid medium is in addition to the essential elements of the food such as kidney beans in salt water. In such cases, the drained net weight as well as the net weight must be declared (see Section on drained net weight) and the quantity of ingredient can be calculated from the weight indications already given existing legislation already requires the quantity of an ingredient or category of ingredients in question to be indicated on the label. For example, Council Directive 2001/112/EC on Fruit Juices and certain similar products requires the fruit content of a fruit nectar to be declared such that fruit content: X % minimum (Section 4.3 on fruit juices) a small quantity of an ingredient or category of ingredient, 2% or less at the mixing bowl stage, is used for flavouring such as garlic in garlic bread

25 SECTION 2 HORIZONTAL LABELLING LEGISLATION 23 QUID does not apply to constituents naturally present in foods that have not been added as ingredients such as caffeine in coffee. In addition, QUID does not apply where the declaration with sweetener(s) or with sugar and sweetener(s) accompanies the name of a food in accordance with Directive 96/21/EC (Section ). Similarly, no declaration of quantity is required where vitamins and minerals are added to a food and are subject to nutrition labelling (Section 2.3). Expression of quantity The quantity of an ingredient is calculated on the basis of the recipe at the moment the ingredients are added i.e. the same method as is used for determining the order of the list of ingredients - at the mixing bowl stage. However, where a food has lost moisture following treatment such as cooking, the QUID declaration should correspond to the quantity of the ingredient in the finished product. In such cases where the quantity of an ingredient or the total quantity of all ingredients exceeds 100%, the QUID declaration should be replaced by the weight of the ingredient used to prepare 100g of finished product. The quantity of volatile ingredients should be indicated on the basis of their proportion by weight in the finished product. The quantity of ingredients used in concentrated or dehydrated form and reconstituted during manufacture may be indicated on the basis of their proportion by weight as recorded before their concentration or dehydration. In the case of concentrated or dehydrated foods which are intended to be reconstituted by the addition of water, the quantity of the ingredients may be indicated on the basis of their proportion by weight in the reconstituted product. QUID declarations should relate to the ingredients as identified in the list of ingredients. Therefore, some ingredients will be required to be quantified in the raw state as their names give no indication of processing and thus imply the basic food has been used such as chicken and egg. Other ingredients that are identified by names that indicate they have been somehow processed should also be quantified as used such as cooked pasta and roast chicken. Declarations of processed ingredients may be supplemented with raw equivalent declarations, since this would help consumers compare similar products which have used ingredients in different forms. The quantities indicated on labelling designate the average quantity of the ingredient or category of ingredients to be mentioned. Average quantity means the quantity of ingredient or category of ingredients obtained by complying with the recipe and good manufacturing practice, allowing for the producer s normal manufacturing variations. The stated quantity of an ingredient should generally be expressed as a percentage that has been rounded to the nearest whole number or to the nearest 0.5 decimal place in those cases where it is below 5% Net quantity All pre-packaged foodstuffs must be labelled with information on the net quantity of the foodstuff i.e. its weight or volume, which does not include the packaging material. The net quantity must be expressed using the metric system i.e. litres or millilitres for liquids or kilograms or grams for solids. The use of imperial units (i.e. pounds and ounces) in brackets and with less prominence is permitted in addition to the net quantity in metric until December However, imperial units must not appear instead of the quantity in metric. Viscous foodstuffs such as honey may be labelled by either weight or volume. The indication of a certain type of quantity such as minimum quantity, average quantity and nominal quantity is required under other Community provisions. The detailed requirements under these rules are outside the scope of this document although a brief overview has been outlined below. Declaration of quantity The quantity declaration is governed by very specific weights and measures legislation enforced by the Legal Metrology Service, a division of the National Standards Authority of Ireland (NSAI). The Legal Metrology Service is a statutory body and it exercises it functions according to the Metrology Acts, 1980 to The legislation governing quantity declaration is: packaged Goods (Quantity Control) Act, 1980 and packaged Goods (Quantity Control) Regulations, 1981 (S.I. No. 39 of 1981). All goods sold by quantity whether pre-packaged or loose must comply with legal requirements. A Guidance Manual for Packers and Importers has also been produced by the Legal Metrology Service containing detailed instructions for implementing a suitable packing system. The guide is available at under Legal Metrology Service. 2

26 24 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Products sold in pre-packaged constant quantities, require representative samples of a production batch to be tested to confirm compliance with the legal requirements. The legislation allows that the nominal quantity declared on the package remains within certain limits. Slight differences in tolerances are allowed depending on whether the package is a once off (i.e. catchweight) or produced as a result of small to large production runs of the same declared value. The e-mark (see below), which often follows the quantity declaration, is placed on prepackaged goods to indicate conformance to the EU Directives regulating the average system (i.e. the contents of each pre-package in a batch must on average be equal to the indication on the package). The mark which consists of a small 'e', at least 3mm high, is placed on a package in the same field of vision as the indication of nominal quantity and must have the form and dimensions specified in the Regulations. Range of sizes for pre-packaged goods Specific requirements for the size of pre-packaged goods (including food products) and the notices/labels to be attached are set out in the Merchandise Marks legislation and regulated by the Office of the Director of Consumer Affairs (ODCA). The range of products falling under this legislation is set out in the Principal Act (No. 10 of 1970). Common Position (EC) No. 34/2006 has been published with a view to adopting a Directive laying down new rules on nominal quantities for pre-packed products. The proposal is to abolish nominal quantities of pack sizes for most sectors. It is, however, recognised that nominal quantities will still need to be maintained for a limited number of sectors and products (including wine, spirits, coffee and white sugar). This proposal concerns only the legislation of ranges of sizes/quantities and not the metrological requirements which will be the subject of a later Commission proposal For further information contact the Department of Enterprise, Trade and Employment website or The European Union On-Line Multipacks The e-mark, permitted under certain circumstances by this legislation, has the effect of allowing free movement of packages as regards quantity across the EU. Prior to applying the e-mark packers must notify the Legal Metrology Service. The rule for weight indications on multipacks of foodstuffs depends on whether or not the items being sold can be sold in individual units. Multipacks of items that can be sold individually For multipacks containing two or more individual packs of the same product, with the same net quantity and where the items can be sold individually, the net quantity shall be expressed as: the net quantity of each individual pack and the total number of such packs. For example, the net quantity of a multipack containing six of the same products weighing 125g each and where each product may be sold individually can be expressed as 6 x 125g on the outside of the packaging. However, an indication of these particulars is not necessary where: Goods that are not sold in pre-packaged constant quantities and are sold using a measuring instrument such as fruit and vegetables must contain or have delivered the minimum quantity stated. All offences committed through breaches of the Acts or Regulations may be prosecuted by the Director of Legal Metrology. Further information is available on NSAI website under Legal Metrology Service/Legislation. the number of items in the pack and at least one net quantity for one item can be clearly seen from the outside, e.g. through clear plastic packaging.

27 SECTION 2 HORIZONTAL LABELLING LEGISLATION 25 Multipacks of items not for individual sale For multipacks containing two or more individual inner packs that are not sold individually, the net quantity shall be expressed as: the total net quantity of the contents of the entire package and the total number of individual packs e.g. a package containing 10 packets of crisps could be expressed by Total weight 300g. Contains 10 packs. 10 x 27g, 270g There are exceptions for multipacks that are not sold individually. An indication of the total number of individual packs is not required for: two or more individually wrapped slices of cheese or two or more individually wrapped pieces of sugar confectionery, e.g. sweets where they are required only to state the total weight of the entire package. Exemptions from indicating the net quantity on the label It is not necessary to indicate the net quantity in the case of: foodstuffs that are normally sold by number, such as a tray of apples, provided the number of items can clearly be seen and easily counted or it is written on the label foodstuffs which are less than 5gm or 5ml in weight (except herbs and spices) and foodstuffs that are subject to considerable losses in their weight and which are sold by number (or are weighed in the presence of the purchaser). Sugar, cocoa and chocolate confectionery products less than 50gm in weight are exempt from declaring the net quantity on the label however, the remaining general labelling rules apply (as per European Communities (Labelling, Presentation and Advertising of Foodstuffs) (Amendment) (No.2) Regulations, 2003 (S.I. No. 451 of 2003)). Drained net weight Where a solid food is in a liquid medium (such as water, salt solution, sugar solution, brine, vinegar, fruit or vegetable juices, mixtures of these or where frozen or quick frozen) the drained net weight of the foodstuff must be provided in addition to the net quantity. This requirement only applies to foodstuffs that are placed in a liquid medium where the liquid medium is in addition to the essential elements of the foodstuff and is not the main reason for the purchase, e.g. red kidney beans in salted water. However, foods placed in other mixtures such as oil, sauce or jelly may be the reason for the purchase and as such are not regarded as liquid media. Such mixtures do not need to declare their drained net weight, an indication of the overall net quantity will suffice such as sardines in tomato sauce Date of minimum durability The date of minimum durability of a foodstuff is defined in Directive 2000/13/EC as the date until which a foodstuff retains its specific properties when properly stored. All foods must be date marked unless exempt in legislation. There are two types of date markings, a best-before and a use-by date: a best-before date is not defined under the Directive but can be described as the date up until which the foodstuff can reasonably be expected to retain its optimum condition i.e. the specific properties that are normally associated with that foodstuff. Most foods fall into this category a use-by date is defined in the Directive is required for foods which from a microbiological point of view are highly perishable and are therefore likely after a short period to constitute an immediate danger to human health. The use-by date declaration should only be applied to particular foods which fulfil both criteria of being highly perishable as well as after a short period of time pose a danger to human health. Generally, foods that require refrigeration to maintain their safety rather than their quality and that have a relatively short shelf life after manufacture would require a use-by date. Such products may be ready-to-eat foods or foods requiring cooking or reheating such as meat, fish, poultry and some dairy products. 2

28 26 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Certain perishable food products such as margarine and butter which do not support the growth of food poisoning organisms would not require a use-by date but a bestbefore date. In addition, frozen food products require a best-before date. However, where scientific evidence shows that pathogens can grow in certain foods such as E. coli O157 in apple and orange juice, such products would require a use-by date. Foods that are vacuum packed or packaged in a modified atmosphere, such as cooked ham slices that must be kept at refrigeration temperatures for safety reasons, should carry a use-by date and storage instructions (see following). In addition, pre-packaged fresh poultry meat is required to carry a use-by date under Council Regulation (EC) No. 1906/90 on marketing standards for poultry meat (Section 4.20). The use-by date is the date up to which the food may be used safely i.e. consumed, cooked or processed, once it has been stored correctly. A product with a use-by date of the 4th August can be used safely up to midnight on the 4th August. The use-by date only applies to the product in the state in which it is purchased. For example, a ready-to-eat food such as cooked ham should be eaten by the use-by date. However, certain foodstuffs require treatment by the consumer before consumption, such as cooking fresh poultry. In such cases, the use-by date means process or cook by the date declared. Therefore, food should be sold in the physical state intended by the manufacturer as this is the physical condition of the food to which the use-by date applies i.e. a chilled product should be sold chilled and not frozen and vice versa. The date of minimum durability for fresh eggs (Section 4.14) must not be more than 28 days after laying. An indication of the date of minimum durability is not required for: fresh fruit and vegetables including potatoes which have not been peeled, cut, treated or processed (except for sprouting seeds and similar products such as bean sprouts which do require a date of minimum durability) wines, liqueur wines, sparkling wines, aromatised wines and similar products obtained from fruits other than grapes, and beverages falling within CN codes* , and and manufactured grapes or grape musts beverages with greater than 10% volume of alcohol soft drinks, fruit juices, fruit nectars and alcoholic beverages in individual containers greater than five litres intended to supply mass caterers only bakery products which are normally consumed within 24 hours of manufacture such as baguettes and cream buns vinegar (including wine vinegar) cooking salt (mineral and herbal salts are not included) solid sugar (sucrose). This exemption does not apply to fructose or sweeteners or mixtures of sugars confectionery products consisting of mostly flavoured or coloured sugars such as hard sweets. Toffee, winegums and fruit jellies are not exempt chewing gums or similar products individual portions of ice-cream. However, Guidance Note 18: Determination of Product Shelf-Life produced by the FSAI and available at recommends that best practice should be the inclusion of a date of minimum durability on the labels of all these food products. The date declaration Any form of expressing the date that can be understood by the consumer is acceptable provided that the date is shown in the order required, the day, month and year where appropriate, e.g or 23rd September 2007 etc. The actual date can be separate from the terms bestbefore and use-by, providing that the words are followed by an indication of the location of the date stamp, e.g. best-before: see lid. However, it should be noted that the name of the food, the date of minimum durability and the net quantity must all appear in the same field of vision (Section ). For best-before declarations, the actual date of minimum durability should be preceded by the words best-before where the day is indicated, otherwise Best-before end can be declared where the month or year is indicated. * The CN (Combined Nomenclature) Code is the tariff classification system used by customs for goods within the EU.

29 SECTION 2 HORIZONTAL LABELLING LEGISLATION 27 The date declared depends whether the product has a short shelf-life or a long shelf-life: foods that will not keep for more than three months, an indication of the day and month is sufficient, e.g. Best-before: 23rd January. foods that will keep for more than three months but not more than 18 months, an indication of the month and year is sufficient, e.g. Best-before end: March 2007 and foods that will keep for more than 18 months, an indication of the year is sufficient, e.g. Best-before end: For use-by declarations, the date of minimum durability should be indicated by the day, month and optionally the year, e.g. Use-by 24th December. Any storage conditions, which need to be observed in order for the food to retain its specific properties until the date shown must follow the use-by date and should follow the best-before date if need be, e.g. keep refrigerated. These storage conditions should be simple and clear and if strict storage temperatures are required to maintain the products safety, as in highly perishable foods, a maximum temperature should be indicated so that the unopened food lasts until the date specified, e.g. store at 3 o C. If the product is suitable for freezing, a star marking panel (below) may be included on the label. FOOD FREEZER STAR MARKED FROZEN FOOD COMPARTMENT ICE MAKING COMPARTMENT STORAGE INSTRUCTIONS until best before date* until best before date* 1 month 1 week 3 days REFRIGERATOR 24 hours * Should be -18 O C or colder Do not re-freeze after defrosting Additional special storage instructions (Section ) and instructions for use (Section ) concerning certain practices once the packaging of the food has been opened may also be required. The date of minimum durability of a product depends on a number of variables - its composition, processing method, packaging, storage temperature, handling etc. The decision whether a best-before or use-by date is required and what that date should be is the responsibility of those labelling the product, usually the manufacturer or packer, as they are in the best position to assess the properties of the food in question. Guidance Note 18: Determination of Product Shelf-Life produced by the FSAI should be consulted for further information. There is no legal requirement against packaged foodstuffs being offered for sale on or after their best-before date provided that the foodstuff still is in a fully acceptable condition (an exception to this is fresh eggs which must be delivered to the consumer within a maximum time limit of 21 days of laying i.e. at least seven days before their bestbefore date). However, if out of date stock is to be sold to the consumer, it is strongly advisable to indicate that the foodstuffs are past their best-before date. This may assist in ensuring that the consumer is not misled as to the true nature of the product which is an offence. Foodstuffs with a use-by date must not be offered for sale after this date due to the possible deterioration of these highly perishable products and the associated risk of illness if they are consumed. Regulation (EC) No. 178/2002 sets down general food safety requirements, according to which, food must not be placed on the market if it is unsafe (i.e. injurious to health or unfit for human consumption) see Section 5. Once labelled, pre-packaged foods must not be re-labelled with an altered use-by or best-before date or re-wrapped other than by the manufacturer Special storage instructions or conditions of use The label should outline any special storage conditions to enable the consumer to maintain the quality of the product. Details on how the product should be stored once the packaging is opened should be outlined such as refrigerate after opening, store in a cool dry place. Other options for the storage of the food can also be detailed in order to maintain the specific properties of the opened food such as suitable for freezing. 2

30 28 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND Name and address The label must declare the name or business name and address of the manufacturer or packager, or of a seller established within the Community. Following a court case in September 1997 (the Dega Case C-83/96*) the European Court clarified exactly what way this was to be interpreted. The European Courts judgement declared that the expression established within the Community refers only to the seller. In other words, as regards manufacturers and packagers, the label on the packaging may indicate details of either one or the other, whether established within the Community or outside the Community; and as regards the seller, the label may only indicate details of a trader established within the Community. The provision of information detailing the manufacturer, packager or seller on the label is to enable the consumer to contact a person responsible for the foodstuffs with a view to expressing any positive or negative criticism about the product purchased. This can only be achieved if the ultimate consumer can easily identify the person responsible for the product. In that respect, producers and packagers differ from sellers. The former are generally established, easily identifiable traders, meaning that the fact that they might be situated outside the Community does not present a problem. In contrast, sellers are generally much smaller traders and, consequently, more difficult to identify, particularly if they are established outside the Community. That is why the Community legislature, for the purposes of the rules on labelling of foodstuffs, laid down different rules in relation to traders depending on whether they are manufacturers or packagers, on the one hand, or sellers, on the other. The contact details of the manufacturer, packager or seller must be precise enough to enable a complainant to contact the named agent where necessary i.e. a full postal address. A web address is not an acceptable address on its own but could be provided in addition to the postal address Origin On the label an indication of the place of origin or provenance of the foodstuff is required only where its absence might mislead the consumer to a material degree as to the true origin or provenance of the foodstuff. In other words the requirement to provide details on the place of origin, not necessarily the country, should be indicated where the consumer might be otherwise misled. Consumers could be misled through pictorial representations, such as a flag or a map of a country other than the one in which it was produced. Consumers could also be misled where the name given to a food or its brand name includes a reference to a place that could imply that the food comes from or has been made in a particular area such as American beef burgers that were made in Ireland. In such instances, the true place or origin should be made clear i.e. made in Ireland. In addition, Brie cheese made in Tipperary would have to indicate its place of origin as it is a product normally associated with France and consumers might be misled to believe the product comes from France and not Ireland unless otherwise stated. In addition, the omission of the place of origin may mislead the consumer to a material degree where the label as a whole suggests a food comes from another place. The country or place of origin of a foodstuff could be considered as the place in which it last underwent a substantial change i.e. the country of manufacture where processing or treatment takes place and not where the food is grown. For example, potatoes grown in Cyprus but processed into crisps in Ireland could bear the indication Made in Ireland. * Judgement of 17/09/1997, Provincia autonoma di Trento and Ufficio del medico provinciale di Trento v Dega di Depretto Gino SNC (see the European Court Reports 1997, p )

31 SECTION 2 HORIZONTAL LABELLING LEGISLATION 29 Many of the rules regulating specific food commodities (i.e. the Vertical Directives, Section 4) contain specific rules on origin marking such as those for wine (Section 4.15), beef (Section 4.10) and eggs (Section 4.14) and take precedence over the general labelling rules. With regard to the question of whether it is permissible to use the term Irish or Ireland in respect of products originating in Northern Ireland, this would be legitimate because Northern Ireland is considered part of the Island of Ireland. Therefore, it would be unrealistic to preclude the use of the terms Irish and Product of Ireland in respect of general products not subject to specific controls which originate in Northern Ireland. This situation is without prejudice to any product specific labelling requirements which may require more detailed information such as the beef labelling rules (Section 4.10). There is national legislation, Health (Country of Origin of Beef) Regulations, 2006 (S.I. No. 307 of 2006) as amended which extend the existing beef labelling rules (Section 4.10) to caterers. Caterers are required to provide information on the origin of the beef served or supplied to the consumer at the point of choice by way of clearly displayed information on a menu, poster, blackboard or other point of sale material. The information required under these rules include all countries from which the premises is sourcing its beef and the statements of origin information must be verifiable and be capable of linkage with the delivery records to the establishment. The FSAI has produced an information leaflet for caterers on these country of origin labelling requirements and is available at See below American Style Burgers indicating Produced in Ireland Instructions for use The label must contain instructions on how to use the product if it is necessary so the consumer can make appropriate use of the food, e.g. cook, reheat, mix, not suitable for frying (see following, the instructions indicated for a packet of dried soup). COOKING INSTRUCTIONS: Empty the contents of this packet into a saucepan and gradually add 850 ml (1 1 2 pints) of cold water, stirring until blended. Bring to the boil, stirring continuously; partially cover and simmer for 10 minutes, stirring occasionally. The FSAI issued voluntary advice in September 1999 to major retailers for the indication of appropriate instructions for the cooking of pre-packaged raw minced beef and minced beef products as a result of the risk of E.coli from these products (see an example below). Cook with Care Value Stores Select provides you with very real assurances in terms of food safety. However this meat product may contain bacteria that could potentially cause illness if not cooked thoroughly. For your safety, please follow these simple instructions 1. Store in refrigerator or freezer. Thaw in fridge or microwave. 2. Always make sure that raw products do not come into contact with ready to eat or cooked products. Wash all work surfaces and utensils thoroughly after preparing raw food. 3. Be sure to cook thoroughly until the juices run clear. 4. Ensure hot foods are kept hot. Refrigerate leftovers immediately. 2

32 30 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND Alcoholic beverages The labelling of alcoholic beverages containing more than 1.2% by volume of alcohol must indicate the actual alcoholic strength by volume on the label where it is for sale to the ultimate consumer. Commission Directive 87/250/EEC sets down the rules for the indication of alcoholic strength as follows: The figure of alcoholic strength should be given to not more than one decimal place followed by the symbol % vol. and may be preceded by the word alcohol or the abbreviation alc. For example a bottle of beer could indicate alc 4.5% vol. Derogation from listing ingredients Beverages that contain more then 1.2% volume of alcohol are not required to declare their ingredients. The derogation from the labelling of ingredients in alcoholic beverages was set out in the original labelling Directive in This was intended to be a temporary derogation and that rules to this effect were to be determined at a later date. No such rules have been prescribed to date. Declaration of allergens Where an allergenic ingredient is present in an alcoholic beverage (i.e. beverages containing more than 1.2% by volume of alcohol) the allergenic ingredient must be declared on the label such that contains (name of allergenic ingredient). This is necessary as alcoholic beverages are not required to list their ingredients. However, where the ingredient concerned is already included in the list of ingredients (if given) or in the name under which the beverage is sold such as Wheat Beer the declaration contains (name of allergenic ingredient) is not required Other compulsory labelling requirements Packaging gases Commission Directive 94/54/EEC regarding the compulsory indication on the label of certain particulars, requires that packaging gases that are used in the packaging of a food must be indicated on the label so consumers understand that the shelf-life of the product has been extended. This enables consumers to understand why the food has a longer shelf-life than similar products packaged differently. Food products whose durability has been extended by means of packaging gases must declare packaged in a protective atmosphere on the label (see below the declaration packaged in a protective atmosphere near the list of ingredients for ham slices in modified atmosphere packaging). Keep refrigerated. Eat within 48 hours of opening. Packed in a protective atmosphere. Modified atmosphere packing (MAP) is a packaging process that is used as a food preservation method generally for chilled products. The normal gas environment of the food product in the packaging is altered, which reduces the rate of respiration of fresh foods as well as the growth of bacteria thus extending the shelf-life of the product. Established products packaged under MAP include many fresh products such as red meats, pasta, ready meals, fruit and vegetables. Packaging gases are authorised under Council Directive 89/107/EC and its amendment Directive 95/2/EC (i.e. Additives Directives Section 3.12). Sweeteners Foodstuffs containing a sweetener or sweeteners (as authorised by Directive 94/35/EC) must be labelled with sweeteners(s) near the name of the food (as per Directive 96/21/EC amending Directive 94/54/EC) (see also Section 3.12 on sweeteners). Sugars and sweeteners Foodstuffs containing both an added sugar or sugars and a sweetener or sweeteners (as authorised by Directive 94/35/EC) must be labelled with sugar(s) and sweeteners(s) near the name of the food (as per Directive 96/21/EC amending Directive 94/54/EC) (see also Section 3.12 on sweeteners). Aspartame Aspartame is a low-calorie sweetener used to sweeten a wide variety of reduced-calorie foods and beverages, including low-calorie tabletop sweeteners. Aspartame contains phenylalanine, an essential amino acid which is also found naturally in protein containing foods. Certain individuals are sensitive to phenylalanine, a rare inherited metabolic disease known as Phenylketonuria (PKU). Foodstuffs containing aspartame must be labelled contains a source of phenylalanine (as per Directive 96/21/EC amending Directive 94/54/EC) (see also Section 3.12 on sweeteners).

33 SECTION 2 HORIZONTAL LABELLING LEGISLATION 31 Polyols Polyols also called sugar alcohols, are a group of low calorie, carbohydrate-based sweeteners. Polyols have the taste and texture of sugar with half the calories. They are used as a food ingredient in many sugar-free and lowcalorie foods such as chewing gums and ice-cream. Foods containing polyols have high amounts of low-digestible carbohydrates and as such should be consumed in moderation. Over consumption of polyol containing foods may cause laxative effects similar to prunes, beans or certain high-fibre foods. Foodstuffs containing more than 10% added polyols must be labelled excessive consumption may produce laxative effects (as per Directive 96/21/EC amending Directive 94/54/EC) (see also Section 3.12 on sweeteners) Exemptions to the general labelling rules Food for sale without pre-packaging Each Member State can set their own rules regarding the labelling of food for sale without pre-packaging i.e. sold loose, packaged food for direct sale or food packaged on the sales premises at the consumers request. In Ireland, as in most Member States, non pre-packaged food, does not to have comply with the labelling requirements in their entirety. The labelling provisions set out below for food sold without pre-packaging are the current minimum legal requirements. In light of the revision by the European Commission of the labelling legislation which may prescribe tighter rules for un-packaged food in the future and to ensure consumers receive adequate information, the FSAI recommends additional information be provided where foods are sold without pre-packaging. The FSAI recommends that food sold without pre-packaging should also detail the date of minimum durability (Section ), the presence of any allergenic ingredients ( (e)) and the species of animal and meat content for meat products (Section (a)). (a) Un-packaged food Food without pre-packaging for sale to consumers or mass caterers need only indicate the name of the food either on the label or displayed on a notice near the food. This notice and the information displayed on it must be visible, legible, indelible and not obscured in any way. For example, fresh cheese sold loose at a deli counter. It should be noted that other labelling requirements falling under the Vertical Directives (Section 4) may also apply, e.g. fresh fish sold loose over the counter need only declare the name of the food such as Cod, on a notice nearby according to horizontal labelling legislation. However, the vertical legislation for fish also requires certain information to be declared on a label or notice nearby regarding origin (Section 4.19). (b) Food pre-packaged for direct sale Pre-packaged food that is packaged by a person who sells them for retail sale on the same premises (or from a vehicle used by that person) need only indicate the name of the food on the label, e.g. coleslaw pre-packed into containers on the premises need only declare the name coleslaw on the label. However, where the person packaging the food sells it from another premises owned by him/her, or onto another business, the exemption no longer applies and the food must be labelled in full. (c) Pre-packaged flour confectionery for direct sale Pre-packaged flour confectionery for sale on the premises from which they are produced, need only indicate the name of the food on the label, e.g. a pre-packaged Madeira Cake baked on the premises from which it is sold need only indicate Madeira Cake on the label. (d) Food pre-packaged on the sales premises at the consumers request Food packed on the premises at the request of the consumer or mass caterer such as sandwiches made up at the consumers request, need only indicate the name of the food either on the label or displayed on a notice near the food. This notice and the information displayed on it must be visible, legible, indelible and not obscured in any way. Sandwiches, rolls, soups, pizza and similar products containing a meat ingredients are not required to declare the species and percentage meat (see Section (a)). (e) Other exemptions Individually wrapped fancy confectionery Individually wrapped fancy confectionery not enclosed in any further packaging and intended for sale as a single item need only indicate the name of the product and the name and address of the manufacturer, packer or seller on the label. Fancy confectionery is taken to mean a product in the form of a figure, an animal, egg etc. or in any other fancy form. 2

34 32 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Milk in reusable glass bottles Milk and milk products in glass bottles intended for re-use only require the name of food, the net quantity, the date of minimum durability and the name or business name and address of the manufacturer or packager, or of the seller established within the Community. Small packages Packaging or containers where the largest surface is less then 10cm 2 only require the name of the food, the net quantity and the date of minimum durability. The European Commission recommends that labelling information on allergens should be provided on such small food packages in addition. Butter Butter produced at a national level for the domestic market need only indicate either the manufacturer, packer or seller on the label or the creamery number. When these Regulations do not apply These Regulations do not apply to foods for export to another country other than a Member State of the European Union Competent authority The policy functions in relation to the Directive on the Labelling, Presentation and Advertising of Foodstuffs are the responsibility of the Department of Health and Children. The FSAI has the overall responsibility for the enforcement of the European and national Regulations on labelling in collaboration with the official agencies that work under service contract to the FSAI according to the Food Safety Authority of Ireland Act, 1998 (No. 29 of 1998) as amended. The agencies currently responsible for enforcing the labelling requirements under the European Communities (Labelling, Presentation and Advertising of Foodstuffs) Regulations, 2002 to 2005 on behalf of the FSAI are: Department of Agriculture, Fisheries and Food Sea-Fisheries Protection Authority Health Service Executive Local Authorities and Office of the Director of Consumer Affairs (ODCA)*. 2.2 BATCH IDENTIFICATION: COUNCIL DIRECTIVE 89/396/EEC Legislation European legislation Council Directive 89/396/EEC regulates the indications or marks identifying the lot to which a foodstuff belongs Amended by: Council Directive 91/238/EEC and Council Directive 92/11/EEC. National legislation European Communities (Identification of Foodstuff Lot) Regulations, 1992 (S.I. No. 110 of 1992) Introduction to batch identification This legislation sets down horizontal labelling requirements applicable to all foods in order to establish a common lot identification system. It s purpose is to facilitate the withdrawal of food from the market where the food may constitute a health hazard to consumers. Regulation (EC) No. 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (see Section 5) also sets out some traceability requirements. The FSAI has produced Guidance Note 10: Product Recall and Traceability in this regard. Guidance Note 10 addresses the main issues concerning the traceability of foodstuffs and outlines the key considerations for a traceability system. The guide is available at Labelling requirements These regulations require an indication or mark identifying the manufacturing lot or batch to which a foodstuff belongs. The letter L must precede the lot mark except in cases where it is clearly distinguishable from the other indications on the label. The lot identification should appear on the label of a prepackaged food. Food that is sold without pre-packaging, the lot number can appear on the packaging or on the container or, failing that, on the relevant commercial documents. The lot identification must be easily visible, clearly legible and indelible. * The ODCA is part of the National Consumer Agency. For further details see

35 SECTION 2 HORIZONTAL LABELLING LEGISLATION 33 It is the responsibility of the producer, manufacturer or packager (or the first seller established within the Community) to determine the lot and affix the corresponding indication. The concept of a lot implies that several sales units of a food have almost identical production, manufacture or packaging characteristics. The requirements therefore do not apply to bulk products or products which due to their diverse nature are not considered as forming an identical batch. The durability date can double up as a lot mark provided it is sufficiently precise to identify a particular batch i.e. the day and the month. An indication merely of the month and year would not be sufficient. See below the lot L 0200A indicated on pre-packaged tea. JUL 2002 L0200A These requirements do not apply to: a) agricultural products intended for storage, preparation or packaging stations; transported to producers' organisations or collected for immediate integration into an operational preparation or processing system b) food without pre-packaging, food packaged at the request of the purchaser or food pre-packaged for immediate sale c) packaging or containers, the largest side of which has an area of less than 10cm 2 or d) to individual portions of ice cream where the indication enabling the lot to be identified can appear on the combined package Competent authority The policy functions in relation to the Regulations on lot marking are the responsibility of the Consumer Protection Unit, Department of Enterprise, Trade and Employment. These Regulations are enforced by the FSAI and the Environmental Health Department of the Health Service Executive pursuant to its service contract with the FSAI, for the purposes of ensuring compliance with these Regulations Officers of the Office of the Director of Consumer Affairs are also authorised under the Regulations to enforce its provisions. 2.3 NUTRITION LABELLING: COUNCIL DIRECTIVE 90/496/EEC Legislation European legislation Council Directive 90/496/EEC regarding nutrition labelling Amended by: Commission Directive 2003/120/EC. National legislation European Communities (Nutrition Labelling For Foodstuffs) Regulations, 2005 (S.I. No. 65 of 2005) Introduction to nutrition labelling Consumer awareness and interest in diet and health issues has increased dramatically over recent years. There is a greater demand for healthy alternatives to certain foods as consumers are encouraged to become more aware in what they are eating to combat many health problems such as obesity and heart disease. Consumers are no longer contented with purely accepting the food that is presented for sale, they want to know the exact properties of the food they are purchasing and how it was produced. Provision of nutrition information on the label enables consumers to make more informed choices with regard to the nutrition characteristics of the foodstuff. Nutrition labelling is voluntary but is compulsory where a nutrition claim is made on the label. However, if a label carries nutrition labelling, even when it is not required, it must comply with the Regulations. Revision of the Nutrition Labelling Directive In 2003 the Health and Consumer Protection Directorate General of the European Commission launched a survey, in the form of a questionnaire, on the application of Directive 90/496/EEC on nutrition labelling and on the desirability of revising it. The Commission prepared a report on the application of Directive 90/496/EEC on nutrition labelling based on the responses from the various Member States (available at the European Union Online under Food Safety). The responses show that overall Member States and stakeholders welcome a revision of the Nutrition Labelling Directive and that the focus should be on the simplification of nutrition labelling legislation in order to better serve consumers. 2

36 34 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 In light of this Report, the Commission pursued its consultation on nutrition labelling on the basis of more targeted considerations in The overall objective for the revision will be the improvement of the existing nutrition labelling rules in order to facilitate consumer understanding and informed choice. The need for full mandatory nutritional labelling is just one of the areas being considered under this revision. In order to facilitate this revision a study has been carried out for DG SANCO of the European Commission on the potential impact of the introduction of mandatory nutrition labelling for pre-packaged food products across the EU. Work has been divided into three areas: the impact of mandatory nutrition labelling on consumers, the food industry and the control authorities who have the responsibility for enforcing legislation (the report is available at the European Union Online under Food Safety). The impact assessments numerous conclusions included that the introduction of nutrition labelling on all prepackaged foodstuffs is a potentially important element in the overall strategy to combat obesity and noncommunicable diseases. Improving the level of information available to consumers has (in conjunction with a spectrum of other nutrition-related initiatives) the potential to improve consumer understanding of different foods which in turn would stimulate changes in patterns of food choice and ultimately improve consumer health. The Commission initially reviewed the technical issues in the Directive (such as tolerances, conversion factors, definitions, reference values etc.) in 2006 and will draft a Commission Proposal before the end of The revision of the nutrition labelling legislation is being carried out in tandem with the revision of the horizontal labelling legislation (see Section 1.2) Labelling Nutrition claims A nutrition claim is one that states, suggests or implies that a foodstuff has particular nutrition properties due to the energy (i.e. the amount of calories) and/or the nutrients (such as protein or fat) that it does or does not provide at increased or reduced rates. Nutrition claims include the declaration low fat and high fibre provided certain conditions are met. Regulation (EC) No. 1924/2006 on nutrition and health claims made on foods (see Section 2.4) specifies the conditions for the use of nutrition and health claims and ensures that only nutrition and health claims that are in conformity with the labelling, presentation and advertising requirements will be allowed on the market. To this end only nutrition claims fulfilling specific criteria that are listed in Appendix VIII are permitted. TABLE A Vitamins and minerals which may be declared on the label and their Recommended Daily Allowances (RDA) Vitamin/Mineral RDA Vitamin A 800µg Vitamin B6 2mg Vitamin B12 1µg Vitamin C 60mg Vitamin D 5µg Vitamin E Pantothenic Acid Calcium Biotin Thiamin Phosphorus Riboflavin Iron Niacin Magnesium Zinc 10mg 6mg 800mg 0.15mg 1.4mg 800mg 1.6mg 14mg 18mg 300mg 15mg Folacin 200µg Iodine 150µg Nutrition information The type of nutrition claim made dictates the information that must be given on the label. Nutrition information must be presented in one of two formats, Group 1 or Group 2 Format, depending on the nutrient that is the subject of the claim. All nutrient values must be stated per 100g or 100ml of the foodstuff. Values per serving or per portion may also be declared provided that the number of servings or portions per packet is specified.

37 SECTION 2 HORIZONTAL LABELLING LEGISLATION 35 Nutrition labelling in Group 1 format must declare the following where a nutrition claim is made for one or more of these nutrients: Energy value (specified numerically in kilo joules and kilo calories) Amount of protein, carbohydrate and fat (specified numerically in grams). NUTRITION LABELLING IN GROUP 1 FORMAT Nutrition Information Energy Protein 4.0g Carbohydrate 5.3g Fat 1.2g See below nutrition information given in Group 1 format on a packet of dried sauce mix. NUTRITION INFORMATION PER 100G PER 190ML SERVING Energy 1557 kj 255 kj 369 kcal 60 kcal Protein 9.6 g 1.6 g Carbohydrate 62.0 g 10.2 g Fat 9.2 g 1.5 g Average Values per 100g 170kJ/40kcal Group 2 format requires nutrition information to be given on a more extensive list of eight nutrients where a nutrition claim is made for sugars, saturates, fibre or sodium. Nutrition labelling in Group 2 format must declare the following: energy value (specified numerically in kilo joules and kilo calories) amount of protein, carbohydrate, sugars, fat, saturates, fibre and sodium (specified numerically in grams). NUTRITION LABELLING IN GROUP 2 FORMAT Nutrition Information Energy Protein Carbohydrate (of which sugars) In addition, where sugar and/or polyols and/or starch are declared the nutrient declared must be shown as a component of carbohydrate in the nutrition table such as: Carbohydrate g of which Sugars g Polyols g Starch g Fatty acids are the basic units of fats and are broken into three main categories: saturates, monounsaturates and polyunsaturates. Where the amount of mono-unsaturates and/or polyunsaturates and/or the cholesterol rate is given, the total amount of saturates shall also be given. In addition, where the amount and/or type of fatty acids and/or cholesterol rate is declared the nutrient declared must be shown as a component of total fats in the nutrition table such as: Fat g of which Saturates g Monounsaturates g Polyunsaturates g Cholesterol mg Per 100g 1150kJ/270kcal 13g 46g (18g) Fat 3.5g (of which sugars) (0.6g) Fibre 29g Sodium 0.9g 2

38 36 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Additional information may also be provided on the label for amounts of one or more of the following (but the declaration must include the nutrient which is the subject of the nutrition claim): Starch (specified numerically in grams) Polyols (specified numerically in grams) Monounsaturates (specified numerically in grams) Polyunsaturates (specified numerically in grams) Cholesterol (specified numerically in milligrams) Vitamins and minerals (specified numerically in the units indicated in Table A). See below the nutrition information for brown sliced bread where sugars are indicated as a component of carbohydrate and saturates, monounsaturates and polyunsaturates as a component of fat. NUTRITION INFORMATION Typical Analysis Composition per 100g, (2 Slices approx.) Energy 826kJ (194kcal) Protein 8.70g Carbohydrate 39.40g of which sugars 0.32g Fat 1.30g of which saturates 0.74g mono-unsaturates 0.35g polyunsaturates 0.21g Sodium 0.60g Fibre 5.70g Table B shows an example where nutrition information is given on a label in Group 2 Format. In addition to the legal requirements, additional voluntary nutrition information is also given on vitamins, minerals and and per 40g serving. Where nutrition information regarding the vitamin and mineral content of a food is given on the label (whether voluntary or a result of a claim being made) the following information must also be provided on the label in addition to the declaration of their quantity: an indication of the percentage of the Recommended Daily Allowance (RDA) that the vitamins and/or minerals provide (as listed in Table A) and there should be at least 15% of this RDA present in either 100g or 100ml of the product (or 15% of this RDA present per packet of the foodstuff where the packet only contains a single portion). TABLE B Nutrition labelling in Group 2 Format with additional non-compulsory information Nutrition Information Per 100g Per serving (40g) Energy 1150kJ/4270kcal 700kJ/170kcal Protein 13g 9g Carbohydrate 46g 25g (of which sugars) (18g) (14g) Fat 3.5g 3.5g (of which saturates) (0.6g) (1.5g) Fibre 29g 12g Sodium 0.9g 0.4g Vitamins (%RDA) (%RDA) Vitamin D 3.1µg (65) 1.3µg (25) Thiamin (B1) 0.9mg (65) 0.4mg (30) Minerals Calcium 340mg (45) 300mg (45) Iron 8.8mg (65) 3.6mg (65) Recommended Daily Allowances (RDAs) are the level of intake of nutrients that, on the basis of scientific knowledge, are judged to be adequate to meet the known nutrient needs of practically all healthy people. RDAs are generally assessed and prepared by nutritionists in individual countries depending on the type of foods that are eaten and subsequently the nutrients that are obtained from these foods in individual sections of the community or the country as a whole. The RDA's in Table A originated from the European Council Directive 90/496/EEC on nutrition labelling and are based on the European population. However, in 1999, the FSAI published Recommended Dietary Allowances for Ireland based on the health of the population specifically in Ireland. Although there are only minute differences between the European and Irish RDA's, the RDA's contained in Table A according to Directive 90/496/EEC must be used for nutrition labelling purposes. Energy value The energy value of a food that is to be declared can be calculated by using the conversion factors in Table C as detailed in the Nutritional Labelling Regulations. The conversion factor is the amount of energy (which is measured in either kilo calories or kilo joules) obtained per gram of the specified nutrient. For example, you get four kilo calories of energy per gram of carbohydrate in food whereas you get 9 kilo calories of energy per gram of fat in food. The energy value of a nutrient is calculated by multiplying the amount of the nutrient (in grams) present in a food by its energy value i.e. the conversion factor.

39 SECTION 2 HORIZONTAL LABELLING LEGISLATION 37 Commission Directive 2003/120/EC amending Directive 90/496/EEC on nutrition labelling adds salatrims 6kcal/g 25kj/g to the table of conversion factors for the calculation of energy value (Table C). Salatrims are a type of reducedcalorie fats and have been approved for use as novel food ingredients in energy-reduced bakery products and confectionery. TABLE C Nutrient Conversion Factors kcal/g or kj/g Carbohydrate (except polyols) 4 17 Polyols Protein 4 17 Fat 9 37 Alcohol (ethanol) 7 29 Organic acid 3 13 Salatrims 6 25 General requirements In general, nutrition information on the nutrient content of a food relates to the foodstuff before preparation or cooking i.e. as purchased. It may, however, relate to the product after preparation provided that sufficient preparation instructions are given and the label clearly states that the information relates to the food as prepared for consumption. The information, if space permits, must be presented together in one place in tabular form with the numbers aligned. If, however, there is insufficient space on the label the information may be presented in linear form. The labelling must be legible, indelible, in a conspicuous location and written in English. The information may appear in other languages, including Irish, in addition to the English declaration if desired. The supply of food otherwise than by sale from any food premises, such as special offers, promotions and give-aways, are covered by the Regulations. Exemptions from the Nutrition Regulations Nutrition Labelling does not apply to the following: natural mineral waters (which are regulated under EC (Natural Mineral Waters, Spring Waters and Other Waters in Bottles or Containers) Regulations, 2005 (S.I. No. 79 of 2005) Section 4.9) and food supplements (Section 3.1) Competent authority The policy functions in relation to nutrition labelling are the responsibility of the Food Unit, Department of Health and Children. These Regulations are enforced by the FSAI and the Environmental Health Department of the Health Service Executive, pursuant to its service contract with the FSAI, for the purposes of ensuring compliance with these Regulations. The Health Promotion Unit of the Department of Health and Children has produced leaflets and further information on nutrition and healthy eating. 2.4 NUTRITION AND HEALTH CLAIMS: REGULATION (EC) NO. 1924/ Legislation European legislation Corrigendum to Regulation (EC) No. 1924/2006 on nutrition and health claims made on foods Introduction to nutrition and health claims This Regulation was produced in response to the proliferation of the number and type of nutrition and health claims appearing on food labels within the Community, and due to the divergent national measures introduced by some Member States, to regulate their use. The Regulation applies to all nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer. It covers such claims made on all foods, including foods for particular nutritional uses (PARNUTS), natural mineral waters, water intended for human consumption and food supplements. Foods intended for supply to mass caterers (such as restaurants, canteens etc.), unpackaged food and trade marks construed as a nutrition or health claim also fall under the terms of the Regulation with some exceptions (see Section 2.4.5). 2

40 38 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 The Regulation aims to ensure that consumers receive accurate and meaningful information while food producers will be able to use serious and scientifically substantiated claims as a marketing tool. According to the rules, nutrition and health claims must not: (a) be false, ambiguous or misleading; (b) give rise to doubt about the safety and/or the nutritional adequacy of other foods; (c) encourage or condone excess consumption of a food; (d) state, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general; (e) refer to changes in bodily functions which could give rise to or exploit fear in the consumer, either textually or through pictorial, graphic or symbolic representations. The Regulation also specifies the conditions for the use of nutrition and health claims and ensures that only nutrition and health claims that are in conformity with the labelling, presentation and advertising requirements will be allowed on the market. To this end, only nutrition claims that are listed in Appendix VIII are permitted and all health claims must undergo an approval and authorisation process at European level, appear on a Community authorised list and adhere to conditions necessary for their use. Foods or certain categories of foods must comply with specific nutrient profiles in order to bear nutrition or health claims. These nutrient profiles are to be established by the Commission by 19th January 2009 at the latest. Nutrient profiles will particularly take account of: the fat, saturated fat, trans fat, sugar and salt/sodium content of foods bearing claims the role and importance of the food and the contribution to the diet of the general population or certain risk groups the overall composition of the food and the presence of nutrients that have been scientifically recognised as having an effect on health. In general, foods placed on the market or labelled prior to 1st July 2007 which do not comply with the requirements of this Regulation may be marketed until their expiry date but not later than 31st July In addition, health claims describing or referring to the role of a nutrient or other substance in the growth, development and the functions of the body may be made until the adoption of the Community approved list of health claims provided that they comply with the Regulation. For further details on nutrition and health claims including transition times, the authorisation process and how to submit a claim for authorisation is available at Notification of health claims All health claims must undergo an approval and authorisation process at European level, appear on a Community authorised list and adhere to conditions necessary for their use. The authorisation procedure and the subsequent inclusion of a health claim on a Community permitted list is dependent upon the type of health claim being made: a) food business operators making reduction of disease risk claims and claims referring to children's development and health are required to submit a detailed dossier (including copies of scientific studies that are relevant to the claim), to the FSAI for assessment by the European Food Safety Authority (EFSA); b) food business operators making health claims describing or referring: to the role of a nutrient or other substance in growth, development and the functions of the body; or to psychological and behavioural functions; or slimming or weight control or reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet can be authorised for inclusion on a Community list of permitted claims under alternative procedures where the submission of a full dossier is not required. However, these claims must be based on generally accepted scientific evidence and well understood by the average consumer. Submissions can be made to the FSAI for assessment by EFSA via the European Commission;

41 SECTION 2 HORIZONTAL LABELLING LEGISLATION 39 c) the addition of claims to the Community list of permitted claims (fulfilling the requirements for health claims in (b) above) which are based on newly developed scientific evidence and/or applications which include a request for the protection of proprietary data, shall be required to adhere to a similar but separate approval procedure. Submissions can be made to the FSAI for assessment by EFSA. However, all claims referring to children s development and health shall be authorised in accordance with (a) above Labelling Nutrition and health claims are only permitted where they adhere to certain general conditions for use, e.g. the substance in respect of which the claim is made, must have been shown to have beneficial nutritional or physiological effect, as established by generally accepted scientific evidence. Nutrition claims A nutrition claim is any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to the energy and/or the nutrients or other substances that it does or does not provide/contain at a reduced or increased rate. Nutrition claims are only permitted if they are listed in Appendix VIII. Where a nutrition claim is made, nutrition information must be provided on the label in accordance with Directive 90/496/EC on Nutrition Labelling (Section 2.3). Comparative nutrition claims A comparison may only be made between foods of the same category, e.g. cheese, taking into consideration a range of foods in that category. The comparison must relate to the same quantity of food and the label must state: the difference in the quantity of a nutrient and/or the energy value. Comparative nutrition claims must compare the composition of the food in question with a range of foods of the same category, which do not have a composition which allows them to bear a claim, including foods of other brands. Health claims A health claim is any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. Health claims are prohibited unless they are authorised and included in a Community list of permitted claims and comply with the prescribed general and specific requirements (the latter are detailed below). Where a health claim is made on foods (with the exception of generic advertising) nutrition information must be provided on the label in a Group 2 format in accordance with Directive 90/496/EC on Nutrition Labelling (Section 2.3). A Group 2 format requires nutrition information to be given on the following eight nutrients (see table below): energy value (specified numerically in kilo joules and kilo calories) amount of protein, carbohydrate, sugars, fat, saturates, fibre and sodium (specified numerically in grams). Nutrition information Energy Protein Carbohydrate of which sugars Fat of which saturates Fibre Sodium Per 100g X KJ X Kcal X g X g X g X g X g X g X g 2

42 40 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Additional information may also be provided voluntarily in this table on certain other specified nutrients (Section 2.3.3). However, where the amount of a substance to which a claim relates cannot appear in the nutrition information, according to Nutrition Labelling Directive 90/496/EC, it must appear in the same field of vision of this nutrition information panel respecting the requirements of the Directive, e.g. quantities are expressed per 100g and apply to the food as sold etc. Health claims are only permitted if the following information is included in the labelling, or if no such labelling exists, in the presentation and advertising: a) a statement indicating the importance of a varied and balanced diet and a healthy lifestyle b) the quantity of the food and pattern of consumption required to obtain the claimed beneficial effect c) where appropriate, a statement addressed to persons who should avoid using the food, and d) an appropriate warning for products that are likely to present a health risk if consumed to excess. Reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may only be made if accompanied by a specific health claim included in one of the Community lists of authorised claims. There are a number of restrictions on the use of certain health claims. The following health claims are not permitted: (a) claims which suggest that health could be affected by not consuming the food (b) claims which make reference to the rate or amount of weight loss (c) claims which make reference to recommendations of individual doctors or health professionals and other associations (not including recommendations of or endorsements by national associations of medical, nutrition or dietetic professionals and health-related charities). Trade marks Trade marks, brand names etc. used in the labelling, presentation or advertising of a food which may be construed as a nutrition or health claim may be used without undergoing the authorisation procedures provided that it is accompanied by a related nutrition or health claim in the labelling in accordance with the Regulation. Products bearing trade marks or brand names existing before 1st January 2005 which do not comply with this Regulation may continue to be marketed until 19th January 2022 after which time the provisions of the Regulation will apply. Generic descriptors which have traditionally been used to indicate a particular class of food or beverage such as digestive or cough drop which could imply an effect on human health, may apply for a derogation from the above. The Commission will adopt and make public, the rules according to which such applications shall be made, so as to ensure that the application is dealt with transparently and within a reasonable time.

43 SECTION 2 HORIZONTAL LABELLING LEGISLATION 41 Unpackaged food Food sold loose (such as fresh fruit, vegetables and bread) to the final consumer or to mass caterers, food packed at the point of sale at the request of the purchaser or prepackaged with a view to immediate sale must adhere to the provisions of the Regulation with some exceptions. However, where a health claim is made, such foods are not required to declare nutrition information or comply with all the specific labelling conditions. Alcoholic beverages Beverages containing more than 1.2% by volume of alcohol cannot bear health claims and only the following nutrition claims are permitted: nutrition claims referring to low alcohol levels the reduction of the alcohol content the reduction of the energy content Competent authority The policy functions in relation to the Regulation on nutrition and health claims will be the responsibility of the Food Unit, Department of Health and Children. The Regulations will be enforced by the FSAI along with any of named agencies pursuant to their service contract with the FSAI the purposes of ensuring compliance with these Regulations.

44 42 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 SECTION 3 SEMI HORIZONTAL LEGISLATION SEMI HORIZONTAL LABELLING RULES The provisions of the horizontal labelling rules for prepackaged foodstuffs (Section 2) apply to the foodstuffs outlined in this chapter in addition to the specific requirements detailed in the various pieces of legislation below unless stated otherwise. 3.1 FOOD SUPPLEMENTS Legislation European legislation Directive 2002/46/EC regulates food supplements Amended by: Directive 2006/37/EC amending Annex II to Directive 2002/46/EC as regards the inclusion of certain substances. National legislation European Communities (Food Supplements) Regulations, 2003 (S.I. No. 539 of 2003) Introduction to food supplements Food supplements are considered as foods which contain concentrated sources of nutrients or other substances with a nutritional or physiological effect whose purpose is to supplement the normal diet. Food supplements falling under these rules must be pre-packaged for sale to the ultimate consumer and marketed in dose form such as pills, tablets, capsules, liquids in measured doses etc. Directive 2002/46/EC on food supplements which was applicable from 1st August 2005 establishes harmonised rules for the labelling of food supplements and introduces specific rules on vitamins and minerals in food supplements. The aim of the Directive is to harmonise the legislation and to ensure that these products are safe and appropriately labelled so that consumers can make informed choices. An adequate and varied diet can, under normal circumstances, provide all the necessary nutrients for normal development and maintenance of a healthy life. However, surveys show that this ideal situation is not being achieved for all nutrients and by all groups of the population across the Community. In order to ensure a high level of protection for consumers and facilitate their choice, food supplements put on to the market must be safe and bear adequate and appropriate labelling. Food supplements may contain a wide range of nutrients (i.e. vitamins and minerals) as well as other ingredients such as amino acids, essential fatty acids, fibre and various plants and herbal extracts. However, only certain permitted vitamin or mineral preparations, listed in Annex II of the Directive, may be used for the manufacture of food supplements. The Amendment Directive 2006/37/EC includes in this Annex, certain vitamin and mineral substances that have been evaluated by EFSA and have received a favourable scientific evaluation. In addition, this amendment replaces the category heading folic acid in Annex II in order to take account of the inclusion of other forms of folate. Specific rules regarding other ingredients of food supplements will be laid down at a later stage based on scientific data. The trade of products containing vitamins and minerals not listed in Annex II was prohibited from the 1st of August However, vitamin and mineral substances may be considered for inclusion in the permitted lists in the Directive following the evaluation of an appropriate scientific dossier concerning the safety and bioavailability of the individual substance. Detailed guidance on this procedure is available at the European Union On-line plements/index_en.htm. Member States may, however, from 1st August 2005 until 31st December 2009 provide derogations for vitamins and minerals and their forms not included in the Directive. Thus ingredients not included in the Annexes to the Directive may stay on the market if the product containing that ingredient was on sale before 12th July 2002 and a safety dossier on it was submitted to the European Commission through Member States by the 12th of July Petitioners should contact the competent authorities in the individual Member States if they wish to obtain such derogations (details are available at the European Union On-line Ireland will grant derogations until 31st December 2009 for ingredients and ingredient sources on application to the FSAI as long as they do not pose a risk to public health in Ireland. This occurs only where a safety dossier has been submitted to the FSAI (or to the relevant authority of another EU Member State) and this dossier has been forwarded to EFSA.

45 SECTION 3 SEMI HORIZONTAL LEGISLATION 43 The FSAI has granted derogations for a number of ingredient sources to date thus allowing them to continue to be used in food supplements. These ingredients (used by any operator) are allowed to remain on the market until 31st December 2009 providing EFSA has not given an unfavourable opinion. (Further information on ingredient dossiers is available at Food supplement or a medicine? Under certain circumstances a product containing vitamins and/or minerals can come within the terms of medicinal product legislation by virtue of its composition, concentration, labelling, presentation and/or medicinal claims (see Section ). Medicinal products fall under the jurisdiction of the Irish Medicines Board (IMB) and hence Directive 2002/46/EC on food supplements will not apply (see also Similarly, Directive 2002/46/EC will not apply to products falling under definitions in other food categories such as foods for particular nutritional uses (Section 3.2) and foods for special medical purposes (Section 3.5) Labelling Food supplement is the prescribed name for products sold under this Directive. The labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties (i.e. making a medicinal claim). In addition to the labelling requirements of Directive 2000/13/EC (Section 2.1), the label of a food supplement must declare: (a) the names of the categories of nutrients or substances that characterise the product or an indication of the nature of those nutrients or substances (b) the portion of the product recommended for daily consumption (c) a warning not to exceed the stated recommended daily dose (d) a statement to the effect that food supplements should not be used as a substitute for a varied diet (e) a statement to the effect that the products should be stored out of the reach of young children. The labelling, presentation and advertising of food supplements must not state or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general. The amount of the nutrients or substances with a nutritional or physiological effect present in the product must be declared on the labelling in numerical form (the units to be used for vitamins and minerals are specified in Annex I of the Directive). The amounts of the nutrients or other substances shall be declared per portion of the product as recommended for daily consumption on the labelling. These declared values are the average values based on the manufacturers analysis of the product. In addition, the percentage of the Recommended Daily Allowance (RDA) shall also be declared for vitamins and minerals as per the Nutrition Labelling Directive 90/496/EEC (Section 2.3). However, the Nutrition Labelling Directive 90/496/EC itself does not apply to food supplements. This percentage may also be given in graphical form. Notification of food supplements To facilitate efficient monitoring of food supplements, Member States may require the manufacturer or the person placing the product on the market to notify the competent authority in their territory. In Ireland, the FSAI must be notified where food supplements are manufactured in or are imported into Ireland and are being placed on the Irish market for the first time. The provision of supplementary material, such as the labelling of the product, marketing material and certificates proving the products/ingredients are fit for human consumption may also be required. Reformulated products must also be notified. The FSAI has developed a form that manufacturers and importers may use to help them with their notification and is available on the FSAI website Competent authority The policy functions in relation to the Regulations on food supplements are the responsibility of the Food Unit, Department of Health and Children. These Regulations are enforced by the FSAI and the Environmental Health Department of the Health Service Executive, pursuant to its service contract with the FSAI, for the purposes of ensuring compliance with these Regulations. 3

46 44 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND FOODS FOR PARTICULAR NUTRITIONAL USES (DIETETIC FOODS) Legislation European legislation Council Directive 89/398/EEC regarding food intended for particular nutritional uses Amended by: Directive 96/84/EC, Directive 1999/41/EC and Regulation (EC) No. 1882/2003. Commission Directive 2001/15/EC on substances that may be added for specific nutritional purposes in foods for particular nutritional uses Amended by: Directive 2004/5/EC, Directive 2004/6/EC and Directive 2006/34/EC. National legislation European Communities (Foodstuffs Intended for Particular Nutritional Uses) Regulations, 2005 (S.I. No. 66 of 2005) Introduction to dietetic foods Foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population are called "foods for particular nutritional uses", "dietetic foods" or "dietary foods. Directive 89/398/EEC and its amendments sets out a framework of rules for the composition, marketing and labelling requirements of dietetic foods, including measures to ensure the appropriate use of such foods and to exclude any risk to human health. Foods intended for particular nutritional uses are clearly distinguishable from foods for normal consumption owing to their special composition or manufacturing process which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate their suitability. Such foods are only permitted for retail sale in pre-packaged form where the packaging completely covers the food. Foods for particular nutritional uses must comply with the provisions applicable to foods for normal consumption in addition to the provisions of these Regulations. The 2005 Regulations gives effect to all of the above Directives and revokes the European Communities (Foodstuffs Intended for Particular Nutritional Uses) Regulations 2002 (S.I. No. 379 of 2002) and its amendment (S.I. No. 441 of 2002). Framework Directive and its daughter Directives The Framework Directive 89/398/EEC and its amendments lists the following groups of dietary foods for which specific rules shall be set out by Commission Directives: infant formulae and follow-on formulae (Commission Directive 2006/141/EC, see Section 3.3) processed cereal-based foods and baby foods for infants and young children (Commission Directive 2006/125/EC, see Section 3.4) food intended for use in energy-restricted diets for weight reduction (Commission Directive 96/8/EC, see Section 3.6) dietary foods for special medical purposes (Commission Directive 1999/21/EC, see Section 3.5) foods intended to meet the expenditure of intense muscular effort, especially for sports people*. These specific Directives (commonly called the daughter Directives) detail specific provisions including certain labelling requirements for each group of food for particular nutritional uses. It is intended that a specific Directive be laid down to detail specific provisions for foods intended to meet the expenditure of intense muscular effort, especially for sports people. There is a wide range of products marketed as foods for sports people. Those products range from products intended for competition athletes to consumers making occasional intense muscular effort through sport and other related activities. A Commission proposal has been produced and includes definitions, specific labelling rules and where necessary and scientifically possible, compositional criteria. The former Scientific Committee for Food adopted a report on the subject (available at which forms the basis for the technical provisions in the proposal. Substances added to foods for particular nutritional uses The nutritional substances that can be added to foods for particular nutritional uses are controlled through positive lists included in Commission Directive 2001/15/EC and its amendments. These lists were based on the scientific advice of the former Scientific Committee for Food (SCF) and apply to all dietary food groups that are covered by the Framework Directive 89/398/EEC. *Foods intended to meet the expenditure of intense muscular effort, especially for sports people.

47 SECTION 3 SEMI HORIZONTAL LEGISLATION 45 The chemical substances which may be used in the manufacture of foodstuffs for particular nutritional uses includes vitamins, minerals, amino acids, carnitine, taurine, nucleotides, choline and inositol. These chemical substances have been selected on the basis of their safety, their availability for use by humans and their organoleptic and technological properties. The specific daughter Directives such as infant formulae, follow-on formulae and weaning foods also include lists of nutritional substances that may be added to these particular foods. Additional substances may be considered for inclusion in these lists based on the evaluation of an appropriate scientific dossier concerning the safety and bioavailability of the individual substance. Further details are available at the European Union On-line Labelling Foods for particular nutritional uses must fulfil the particular nutritional requirements for the following classes of individuals: 1. persons where their digestive metabolism is disturbed or 2. persons with special physiological conditions requiring controlled consumption of certain substances or 3. infants or young children in good health. The term dietetic and dietary may be used in the labelling, advertising or presentation of foods to describe foodstuffs for groups of individuals in classes 1 and 2 above. However, the use of these terms or other similar words is prohibited where the foods are for normal consumption i.e. where they have not been specifically manufactured for the individuals needs. In addition, the labelling, presentation and advertising of foods for particular nutritional uses must not attribute properties for the prevention, treatment or cure of human disease or imply such properties. The specific daughter Directives, such as dietary foods for special medical purposes, details the specific labelling requirements for that particular category of food. In addition to the labelling requirements under their own specific legislation and the general labelling legislation (Section 2.1) these foods must also detail the following on the label: 1. Products fulfilling the nutritional requirements of individuals in classes 1 and 2 must declare: the designation under which the product is sold and an indication of its particular characteristics. 2. Products fulfilling the nutritional requirements of individuals in class 3 must declare: the designation under which the product is sold and a reference to the purpose for which it is intended. Foods that have no specific Directives governing them (but are specifically manufactured for individuals in class 1 or 2) must detail the following provisions on the label: the composition or special manufacturing process of the foodstuff that enables it to fulfil its particular nutritional purpose the amount of carbohydrate, protein and fat (per 100g or 100ml) of the food as marketed and where appropriate, as consumed and the available energy value (in kilo joules or kilocalories per 100g or 100ml) of the food as marketed and where appropriate, as consumed. However, if the energy value of the food is less than 50kJ (12kcals) per 100g or 100ml these particulars may be replaced by the statement energy value less than 50kJ (or 12kcals) per 100g (or 100ml). Notification of foods for particular nutritional uses The FSAI must be notified before a food for a particular nutritional use is placed on the Irish market for the first time. The duty to notify falls on the manufacturer if the product is manufactured in Ireland and on the importer if the product is imported into Ireland. The notification process requires that a notification form be completed and a sample label of the product along with any associated documentation supporting the use of this product be submitted to the FSAI. The notification form can be found at 3

48 46 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND Competent authority The policy functions in relation to the Regulations on foods intended for particular nutritional uses are the responsibility of the Food Unit, Department of Health and Children. These Regulations are enforced by the FSAI and the Environmental Health Department of the Health Service Executive, pursuant to its service contract with the FSAI for the purposes of ensuring compliance with these Regulations. 3.3 INFANT FORMULAE AND FOLLOW-ON FORMULAE Legislation European legislation Commission Directive 2006/141/EC on infant formulae and follow-on formulae. National legislation European Communities (Infant Formulae and Follow-on Formulae) Regulations, 2004 (S.I. No. 242 of 2004) European Communities (Infant Formulae and Follow-On Formulae) (Amendment) Regulations, 2007 (S.I. No. 242 of 2007) Introduction to infant formulae and follow-on formulae Infant formulae are breast milk substitutes suitable for use by infants during the first months of life as the sole source of nourishment. Follow-on formulae are products which may be used when complementary feeding is introduced and constitute the principal liquid element of a progressively diversified diet. Directive 2006/141/EC on infant formulae and follow-on formulae is a daughter Directive to Council Directive 89/398/EEC on foodstuffs intended for particular nutritional uses (Section 3.2). Directive 2006/141/EC sets out compositional, labelling and some presentation and advertising requirements for infant formulae and follow-on formulae intended for infants in good health. Commission Directive 2006/141/EC on infant formulae and follow-on formulae repeals and replaces the previous Directive 91/321/EEC and its many amendments from 1st January 2008 in the interests of clarity. The recast Directive 2006/141/EC also takes account of the latest scientific advice on compositional requirements for infant formulae and follow-on formulae as well as international developments, such as within Codex Alimentarius, in relation to the timing of the introduction of complementary foods into the diet of infants. In addition, in order to provide better protection for the health of infants, the rules on composition, labelling and advertising give due regard to the principals and the aims of the International Code of Marketing of Breast milk Substitutes. Commission Directive 2006/141/EC also amends Commission Directive 1999/21/EC on dietary foods for special medical purposes as regards as regards the minimum level of manganese in foods intended for infants (Section 3.5). The Annexes of the Directive set criteria for the composition of infant formulae and follow-on formulae (such as protein, carbohydrate, fat) including, where necessary, minimum and maximum levels. Infant formulae and follow-on formulae must be labelled in such a way that it enables consumers to make a clear distinction between these products so as to avoid any risk of confusion between infant formulae and follow-on formulae. The FSAI has produced a leaflet on the Marketing of Infant Formulae and Follow-on Formulae and is available at Labelling: infant formulae The labelling of infant formulae shall be designed to provide the necessary information about the appropriate use of the products so as not to discourage breast-feeding. The use of the terms humanised, maternalised, adapted or similar terms are prohibited. The labelling should not include pictures of infants or other pictures or text which may idealise the use of the product. It may however, have graphic representations for easy identification of the product and for illustrating methods of preparation. The designated name under which the products are sold shall be infant formula. Where the products are manufactured entirely from cows milk proteins the name under which the products are sold shall be infant milk.

49 SECTION 3 SEMI HORIZONTAL LEGISLATION 47 In addition to the labelling requirements for foodstuffs intended for particular nutritional uses (Section 3.2) the following information must appear on the label of infant formulae: a statement to the effect that the product is suitable for particular nutritional use by infants from birth when they are not breastfed the energy value (in kj and kcal) per 100ml of the product ready for use the content of proteins, carbohydrate and fat expressed in numerical form per 100ml of the product ready for use the average quantity of each vitamin and mineral expressed in numerical form per 100ml of the product ready for use the average quantity of choline, inositol and carnitine expressed in numerical form per 100ml of the product ready for use where applicable instructions for appropriate preparation, storage and disposal of the product a warning regarding the health hazards of inappropriate preparation and storage a statement preceded by the words Important Notice regarding: (i) the superiority of breastfeeding and (ii) a recommendation that the product be used only on the advice of independent persons having qualifications in medicine, pharmacy, nutrition or similar. The labelling of infant formulae may bear nutrition and health claims outlined below in accordance with the appropriate conditions for their use. Nutrition and health claims for infant formulae and conditions warranting a corresponding claim: 1. Nutrition Claims Nutrition claim related to: Lactose only Lactose free Added LCP or an equivalent nutrition claim related to the addition of docosahexaenoic acid Nutrition claims on the addition of the following optional ingredients: Conditions warranting the nutrition claim: Lactose is the only carbohydrate present. Lactose content is not greater than 2.5mg/100kJ (10mg/100kcal). The docosahexaenoic acid content is not less than 0.2% of the total fatty acid content. Taurine Voluntarily added at a level that would be appropriate for the intended particular use by infants and in accordance with the conditions set out in Annex I of Directive 2006/141/EC. Fructo-oligosaccharides and As above galacto-oligosaccharides Nucleotides As above 3

50 48 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND Health claims (including reduction of disease risk claims) Nutrition claim related to: Reduction of risk to allergy to milk proteins. This health claim may include terms referring to reduced allergen or reduced antigen properties. Conditions warranting the health claim: (a) objective and scientifically verified data as proof to the claimed properties must be available (b) the infant formulae shall satisfy the provisions set out in point 2.2 of Annex I of the Directive and the amount of immunoreactive protein measured with methods generally acceptable as appropriate shall be less than 1% of nitrogen containing substances in the formulae (c) the label shall indicate that the product must not be consumed by infants allergic to the intact proteins from which it is manufactured unless generally accepted clinical tests provide proof of the infant formulae s tolerance in more than 90% of infants (confidence interval 95%) hypersensitive to proteins from which the hydrolysate is manufactured (d) the infant formulae administered orally must not induce sensitisation, in animals, to the intact proteins from which the infant formulae are manufactured. In addition, the label may bear an indication of the average quantity of certain nutrients listed in Annex III of the Directive (not already declared) expressed in numerical form, per 100ml of the product ready for use. The following requirements, as outlined above, also apply to the presentation of the products concerned (such as their shape, appearance, packaging, display) and to advertising: information about the appropriate use of the products so as not to discourage breastfeeding the prohibition regarding the use of the terms humanised, maternalised, adapted or similar terms the requirements detailed under the Important Notice graphics or text which may idealise the use of the product nutrition and health claims and their condition for use and the labelling of infant formulae and follow-on formulae in such a way as to enable consumers to make a clear distinction between the products Labelling: follow-on formulae The labelling of follow-on formulae shall be designed to provide the necessary information about the appropriate use of the products so as not to discourage breastfeeding. The use of the terms humanised, maternalised, adapted or similar terms are prohibited. The designated name under which the products are sold shall be follow-on formula. Where the products are manufactured entirely from cows milk proteins the name under which the products are sold shall be follow-on milk. In addition to the labelling requirements for foodstuffs intended for particular nutritional uses (Section 3.2), the following information must appear on the label of follow-on formulae: a statement that: the product is suitable only for particular nutritional use by infants over the age of six months it should form only part of a diversified diet it is not to be used as a substitute for breast milk during the first six months of life the decision to begin complementary feeding, including any exception to six months of age, should be made only on the advice of independent persons having suitable qualifications based on the individual infants specific needs.

51 SECTION 3 SEMI HORIZONTAL LEGISLATION 49 the energy value (in kj or kcal) per 100ml of the product ready for use the content of proteins, carbohydrate and fat in numerical form per 100ml of the product as ready for use the average quantity of each vitamin and mineral in numerical form per 100ml of the product as ready for use the average quantity of choline, inositol and carnitine in numerical form, in 100ml of the product ready for use, where applicable instructions for appropriate preparation, storage and disposal of the product a warning regarding the health hazards of inappropriate preparation and storage. In addition, the label may bear an indication of: the average quantity of certain nutrients listed in Annex III of the Directive (not already declared) expressed in numerical form, per 100ml of the product ready for use and in addition to numerical information, information on vitamins and minerals included in Annex VII of the Directive, expressed as a percentage of the reference values per 100 ml of the product ready for use Competent authority The policy functions in relation to the Regulations on infant formulae and follow-on formulae are the responsibility of the Food Unit, Department of Health and Children. These Regulations are enforced by the FSAI and the following agencies, pursuant to its service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Environmental Health Department of the Health Service Executive Department of Agriculture, Fisheries and Food. 3.4 PROCESSED CEREAL-BASED FOODS AND BABY FOODS FOR INFANTS AND YOUNG CHILDREN Legislation European legislation Commission Directive 2006/125/EC on processed cerealbased foods and baby foods for infants and young children. National legislation European Communities (Processed cereal-based foods and baby foods for infants and young children) Regulations, 2004 (S.I. No. 433 of 2004) Introduction to baby foods and weaning foods Processed cereal-based foods and other baby foods are specifically intended for infants and young children as they progress onto a mixed family diet. Cereal-based foods and baby foods for infants and young children are used as part of a diversified diet and do not constitute the sole source of nourishment of infants and young children. The essential composition of the products must be appropriate for the nutritional requirements of infants and young children in good health. Directive 2006/125/EC is a daughter Directive to Council Directive 89/398/EEC on foodstuffs intended for particular nutritional uses (Section 3.2). Commission Directive 2006/125/EC sets rules on the composition and labelling of processed-cereal based foods and other baby foods. The Annexes to the Directive set criteria for the composition of weaning foods including, where necessary, minimum and maximum levels following relevant scientific advice. Commission Directive 2006/125/EC on processed cerealbased foods and baby foods for infants and young children repeals and replaces the previous Directive 96/5/EC and its many amendments in the interests of clarity and rationality. The 2004 Regulation gives effect to the previous Directive 96/5/EC and its amendments and will be replaced in due course in order to implement the terms of the new Directive 2006/141/EC. 3

52 50 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 These rules cover foodstuffs that are intended for use by infants while they are being weaned, by young children as a supplement to their diet as well as for their progressive adaptation to ordinary food. Such foodstuffs are divided into the following groups: a) processed cereal-based foods: simple cereals (which are reconstituted using milk or other nutritious liquids) cereals with an added high protein food (which are reconstituted using water or other protein free liquids) pastas (for use after cooking in boiling water or other appropriate liquids) rusks and biscuits (which are used directly or pulverised after the addition of suitable liquids) and b) baby foods. The rules relate to products such as cereals and preparations including meat, poultry, fish, vegetables and fruits that may be introduced as part of the weaning diet of the infant and young child. The composition and labelling of these products are tightly regulated. The Directive does not apply to milks intended for young children. Under the Regulations infants are children under the age of 12 months and young children are children aged between one and three years. The Annexes of the Directive set criteria for the composition of processed cereal-based foods and baby foods (such as protein, carbohydrate, fat) including, where necessary, minimum and maximum levels Labelling In addition to the requirements for foodstuffs intended for particular nutritional uses (Section 3.2) the label must state the following: the available energy value (in kilojoules and kilocalories) and the protein, carbohydrate and fat content expressed in numerical form per 100g or 100ml of the product as sold and where appropriate as consumed the average quantity of each of the specified vitamins and minerals as listed Annex I and Annex II of the Directive, in numerical form per 100g or 100ml of the product as sold and where appropriate as consumed and instructions for the appropriate preparation of the product when necessary and a statement regarding the importance of following those instructions. In addition, the label may declare: the average quantity of certain nutrients listed in Annex IV of the Directive (not already declared) in numerical form per 100g or 100ml of the product as sold and where appropriate as consumed and in addition to numerical information, information on vitamins and minerals listed in Annex V of the Directive expressed as a percentage of their reference values per 100g or 100ml of the product as sold and where appropriate as consumed, provided that the quantities present are at least equal to 15% of the reference values Competent authority The policy functions in relation to the Regulations on processed cereal-based foods and baby foods for infants and young children are the responsibility of the Food Unit, Department of Health and Children. These Regulations are enforced by the FSAI and the Environmental Health Department of the Health Service Executive, pursuant to its service contract with the FSAI, for the purposes of ensuring compliance with these Regulations. a statement regarding the appropriate age from which the product may be used depending on its properties however, this must not be less than four months for any product. Products recommended for use from the age of four months may indicate that they are suitable from that age unless advised otherwise by a relevant professional the presence or absence of gluten if the specified age from which the product may be used is less than six months

53 SECTION 3 SEMI HORIZONTAL LEGISLATION DIETARY FOODS FOR SPECIAL MEDICAL PURPOSES Legislation European legislation Commission Directive 1999/21/EC on dietary foods for special medical purposes Amended by: Commission Directive 2006/141/EC on infant formulae and follow-on formulae. National legislation European Communities (Dietary Foods for Special Medical Purposes) Regulations, 2001 (S.I. No. 64 of 2001) European Communities (Dietary Foods for Special Medical Purposes) (Amendment) Regulations, 2007 (S.I. No. 241 of 2007) Introduction to dietary foods for special medical purposes Dietary foods for special medical purposes are specially formulated processed foods intended for the dietary management of diseases, disorders or medical conditions of individuals who are being treated under medical supervision. Directive 1999/21/EC is a daughter Directive of Council Directive 89/398/EEC on foodstuffs intended for particular nutritional uses and lays down compositional and labelling provisions for dietary foods for special medical purposes. Commission Directive 2001/15/EC as amended, sets out detailed rules on the sources of certain nutritional substances that may be used in foods for special medical purposes (Section 3.2). Dietary foods for special medical purposes are specifically defined in the Regulations and can only be marketed as such if they comply with rules such as the compositional requirements laid down in the Annex to the Directive. Commission Directive 2006/141/EC on infant formulae and follow-on formulae amends Commission Directive 1999/21/EC as regards as regards the minimum level of manganese in foods intended for infants (Section 3.3) Labelling The prescribed name under which a dietary food for special medical purposes is sold is Food(s) for special medical purposes. In addition to the labelling requirements for foodstuffs intended for particular nutritional uses (Section 3.2) the following must appear on the label of dietary foods for special medical purposes: the energy value (in kj and kcal) and the protein, carbohydrate and fat content in numerical form per 100g or 100ml of the product as sold and where appropriate as ready for use in accordance with the manufacturers instructions. This information may be provided per serving in addition provided the number of servings is also indicated on the label the quantity of each vitamin and mineral (as listed in the Annex of the Directive) in numerical form per 100g or 100ml of the product as sold and where appropriate as ready for use in accordance with the manufacturers instructions. This information may be provided per serving in addition provided the number of servings is also indicated on the label the content of components of protein (such as amino acids), carbohydrate (such as starch or fibre), fat (such as saturates) and/or other nutrients where their declaration is necessary for the appropriate intended use of the product. Where appropriate this information should be declared in numerical form per 100g or 100ml of the product as sold and where appropriate as ready for use in accordance with the manufacturers instructions. This information may be provided per serving in addition provided the number of servings is also indicated on the label information on the osmolarity (i.e. the measure of the osmotic pressure) or osmolality (i.e. the solute concentration) of the product where appropriate and information on the origin and the nature of the proteins in the product where appropriate. 3

54 52 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 The label shall also declare the following preceded by the words important notice : a statement that the product must be used under medical supervision a statement whether the product is suitable for use as the sole source of nourishment a statement that the product is intended for a specific age group and a statement that the product poses a health hazard when consumed by persons who do not have the disease, disorders or medical conditions for which the product is intended. The label shall also declare the following: the words For the dietary management of where the disease, disorders or medical conditions for which the product is intended should be inserted a statement concerning adequate precautions and contra-indications a description of the properties and/or characteristics that make the product useful such as the nutrients that have been increased, reduced or eliminated and a warning that the product is not for parenteral (intravenous) use where appropriate. The label must also provide instructions for the preparation, the use and the storage of the product after the opening of the container. Notification of Dietary Foods for Special Medical Purposes Notification of dietary foods for special medical purposes is a statutory requirement under the Directive. The FSAI must be notified where a food for special medical purposes is placed on the Irish market. The duty to notify falls on the manufacturer if the product is manufactured in Ireland and on the importer if the product is imported into Ireland. The FSAI has produced Guidance Note 19: The Notification of Dietary Foods for Special Medical Purposes under the European Communities (Foods for Special Medical Purposes) Regulations, 1999 (S.I. No. 64 of 2001). This guide and the notification forms are available on the FSAI s website Competent authority The policy functions in relation to the Regulations on foods for special medical purposes are the responsibility of the Food Unit, Department of Health and Children. These Regulations are enforced by the FSAI and the Environmental Health Department of the Health Service Executive, pursuant to its service contract with the FSAI, for the purposes of ensuring compliance with these Regulations. 3.6 FOODS INTENDED FOR USE IN ENERGY-RESTRICTED DIETS FOR WEIGHT REDUCTION Legislation European legislation Commission Directive 96/8/EC on foods intended for use in energy-restricted diets for weight reduction. National legislation European Communities (Foods Intended for Use in Energy-Restricted Diets for Weight Reduction) Regulations, 1998 (S.I. No. 242 of 1998) Introduction to foods intended for use in energy-restricted diets for weight reduction Directive 96/8/EC is a daughter Directive to the Framework Directive 89/398/EEC on foodstuffs intended for particular nutritional uses (Section 3.2) and specifies compositional and labelling requirements for foods specially manufactured for energy restricted diets intended to replace part or whole of the daily diet. The compositional criteria include energy, protein quantity and quality, fat quantity and type, minimum and maximum levels for dietary fibre and minimum levels for certain vitamins and minerals based on the advice of the former Scientific Committee for Food. The sources of nutritional substances that can be used in these products are given in Commission Directive 2001/15/EC (Section 3.2). These specially formulated energy reduced foods are divided into two categories: products to replace the whole daily diet and products to replace one or more meals of the daily diet.

55 SECTION 3 SEMI HORIZONTAL LEGISLATION Labelling In addition to the labelling requirements for foodstuffs intended for particular nutritional uses (Section 3.2) the label must bear the following indications: the name under which the product is sold. For products replacing the whole daily diet, the specified name is Total diet replacement for weight control and for products replacing one or more meals a day the specified name is Meal replacement for weight control, the energy value (in kj and kcals) and the quantity of protein, carbohydrate and fat in numerical form, per specified quantity of the product ready for use as proposed for consumption the average quantity of the vitamins and minerals listed in the Regulations, in numerical form, per specified quantity of the product ready for use as proposed for consumption instructions for the appropriate preparation of the product and where necessary a statement as to the importance of following those instructions if the product provides a daily intake of polyols greater than 20g per day when used according to the manufacturers instructions, a statement shall be provided that the food may have a laxative effect and a statement regarding the importance of maintaining an adequate daily fluid intake. In addition to the labelling requirements above: 1. Products replacing the whole daily diet must be contained in the same package and the label must contain a statement that the product: provides adequate amounts of all essential nutrients for the day and should not be used for more than three weeks without medical advice. 2. For products replacing one or more meals of the daily diet, the label must contain: a statement that the products are useful for the intended use only as part of an energy-restricted diet a statement that other foodstuffs are necessary as part of the diet and the quantity of certain vitamins and minerals listed in the Regulations expressed as a percentage of their reference values (or RDA) (as given in Directive 90/496/EC on nutritional labelling Section 2.3). The labelling, advertising and presentation of the products concerned shall not make any reference to: the rate or amount of weight loss that may result from their use or to a reduction in the sense of hunger or an increase in the sense of satiety Competent authority The policy functions in relation to the Regulations on foods for use in energy restricted diets are the responsibility of the Food Unit, Department of Health and Children. These Regulations are enforced by the FSAI and the Environmental Health Department of the Health Service Executive, pursuant to its service contract with the FSAI, for the purposes of ensuring compliance with these Regulations. 3

56 54 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND FOODSTUFFS TREATED WITH IONISING IRRADIATION Legislation European legislation Council Directive 1999/2/EC concerning foods and food ingredients treated with ionising radiation Council Directive 1999/3/EC establishing a Community list of food and food ingredients treated with ionising radiation. National legislation European Communities (Foodstuffs Treated with Ionising Irradiation) Regulations, 2000 (S.I. No. 297 of 2000) Introduction to ionising radiation Irradiation is a physical treatment of food with high-energy ionising radiation. It can be used to prolong the shelf-life of food products and/or to reduce health hazards associated with certain foods due to contamination with pests or pathogenic microorganisms. The legislation applies to the manufacture, marketing and importation of food and food ingredients treated with ionising radiation. Directive 1999/2/EC is the Framework Directive and covers the general and technical aspects for carrying out the irradiation process, labelling of irradiated foods and conditions for authorising food irradiation. The Directive stipulates that the treatment with ionising radiation of a specific food item may only be authorised if: there is a reasonable technological need it presents no health hazard and is carried out under the conditions proposed it is of benefit to the consumer it is not used as a substitute for hygiene and health practices or for good manufacturing or agricultural practice. However, Member States may continue to irradiate particular foods that had national authorisations prior to implementation of this Directive. For example, the UK had authorised that potatoes can be treated with ionising radiation up to maximum of 0.2kGy. Member States may also retain existing restrictions or bans on irradiated foods not on the EU-authorised list. A requirement was introduced in Directive 1999/2/EC that the Commission should forward a proposal to complete this Community positive list of foodstuffs authorised for irradiation. Before preparing a proposal for a Community positive list, the Commission services launched an open discussion with consumer organisations, industry organisations and other interested parties in 2000 on the strategy for drawing up the positive list. A consultation paper outlining a strategy was launched, inviting comments. The comments revealed strong views, both in favour and against. Some arguments were to the effect that the conditions for authorisation, especially technological need, benefit to the consumers and no substitute for good hygiene are subject to a wide range of interpretations. As a result of the comments received on the consultation paper, the Commission adopted a Communication on food and food ingredients authorised for treatment with ionising radiation in the Community. In essence, the Communication concludes that given the complexity of the issue, a broader debate is opportune at this stage. A positive opinion from EFSA would be needed to place a specific food item on the EU-wide list of products authorised for irradiation. There are no authorised food irradiation facilities in Ireland and therefore any irradiated foodstuffs or food ingredients on the Irish market are imported. Ireland does not ban or restrict the import of any of the foods irradiated by other Member States. The FSAI has produced a leaflet on irradiated food and is available at Directive 1999/3/EC is the implementing Directive and specifically provides an EU list of foodstuffs that may be treated with ionising radiation and the maximum dose allowed. To date, only a single food category is listed on this EU-wide positive list for irradiation treatment: dried aromatic herbs, spices and vegetable seasonings. The permitted maximum overall average absorbed dose is 10kiloGray (kgy).

57 SECTION 3 SEMI HORIZONTAL LEGISLATION Labelling Products that are intended for sale to the ultimate consumer or mass caterers must indicate the words irradiated or treated with ionising radiation as follows: (i) Irradiated foodstuffs For individual irradiated food items, these words must appear on the label of the product. For irradiated products sold in bulk, the words must accompany the name of the product either on a display or notice above or adjacent to the container in which the products are placed. (ii) Irradiated ingredients For individual non-irradiated food items containing irradiated ingredients, these words must accompany the name of the irradiated ingredient in the list of ingredients. For non-irradiated products containing irradiated ingredients sold in bulk, these words must accompany the name of the product either on a display or notice above or adjacent to the container in which the products are placed. (iii) Irradiated compound ingredients Irradiated ingredients used in a compound ingredient of a foodstuff (which itself is not irradiated) must also indicate these words. Irradiated foodstuffs and non-irradiated foodstuffs containing irradiated ingredients not intended for sale to the ultimate consumer and mass caterers such as sale to wholesalers must indicate the following: the words irradiated or treated with ionising radiation the identity and address of the irradiation facility or its reference number. An indication of the treatment shall be given in all cases on the documents that accompany the irradiated foodstuff. In addition, materials used for packaging foodstuffs to be irradiated must be suitable for the purpose. Irradiated foods imported from third countries must also comply with the conditions set out in the Directive. The third country irradiation facility must be approved by the Community and appear on a list of authorised facilities. Foods irradiated in third countries must be accompanied by documents showing the name and address of the facility that carried out the irradiation treatment Competent authority The policy functions in relation to the Regulations on ionising radiation are the responsibility of the Food Unit, Department of Health and Children whereas the Radiological Protection Institute of Ireland (RPII) is the body responsible for irradiation facilities in Ireland. These Regulations are enforced by the FSAI and the Environmental Health Department of the Health Service Executive, pursuant to its service contract with the FSAI, for the purposes of ensuring compliance with these Regulations. Two Public Analyst Laboratories in Cork and Galway have been identified as 'designated' laboratories for the purpose of food analysis in accordance with the legislation. 3.8 NOVEL FOODS AND NOVEL FOOD INGREDIENTS Legislation European legislation Regulation (EC) No. 258/97 concerning novel foods and novel food ingredients Amended by: Regulation (EC) No. 1829/2003 on genetically modified food and feed. National legislation The EU Regulations concerning food have yet to be transposed into Irish legislation (see also Section ) Introduction to novel foods Regulation (EC) No. 258/97 governs novel foods and novel food ingredients which are defined as foods and food ingredients that have not been used for human consumption to a significant degree within the European Community prior to May 15th Food and food ingredients within the scope of this Regulation must not present a danger for, mislead, or be nutritionally disadvantageous for the consumer. The Regulation is not applicable to food additives, flavourings or extraction solvents. Regulation (EC) No. 258/97 has been amended by Regulation (EC) No. 1829/2003 which now governs the authorisation and labelling of genetically modified (GM) food and feed (see Section 3.10). 3

58 56 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Before being placed on the market, novel foods and novel food ingredients must undergo a Community safety assessment procedure following which an authorisation decision may be taken. The authorisation decision defines the scope of the authorisation and specifies the conditions of use, the designation of the food or food ingredient, its specification and any specific labelling requirements. The FSAI has produced a leaflet on novel foods. This leaflet and further information on novel foods is available at Labelling Regulation (EC) No. 258/97 provides specific labelling requirements for novel foods in order to ensure that the final consumer is informed of: any characteristics such as its composition, nutritional value and the intended use of the food which renders it no longer equivalent to existing foods the presence of materials which may have implications for the health of certain sections of the population and the presence of materials which may gives rise to ethical concerns. The list of foods authorised within the EU under the novel food Regulation is available at the European Union Online: od/authorisations_en.htm Competent authority The policy functions in relation to Regulation (EC) No. 258/1997 on novel foods are the responsibility of the Food Unit, Department of Health and Children. These Regulations are enforced by the FSAI and the Environmental Health Department of the Health Service Executive, pursuant to its service contract with the FSAI, for the purposes of ensuring compliance with these Regulations (see also Section regarding genetically modified food). 3.9 FOODS WITH ADDED PHYTOSTEROLS Legislation European legislation Commission Regulation (EC) No. 608/2004 regulates the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters. National legislation The EU Regulations have yet to be transposed into Irish legislation Introduction to phyosterols Phytosterols or plant sterols are naturally occurring compounds that are structurally related to cholesterol. Some of these substances have been proven to reduce serum cholesterol levels and have therefore been approved for use as novel food ingredients under Commission Regulation (EC) No. 258/97 concerning novel foods and novel food ingredients (Section 3.8). The labelling requirements under the Novel Foods Regulations must be complied with as well as the specific labelling provisions outlined below. A number of food manufacturers have sought and received authorisation for the placing of specific food products on the market with some of these added substances under specific Decisions. In its opinion regarding the effects of consumption of phytosterols, phytosterol esters, phytostanols and phytostanol esters from multiple sources, the former SCF confirmed the need to label these substances in order to allow consumers to restrict their consumption of these substances to a maximum of 3g/day. The SCF also indicated that there was no evidence of additional benefits at intakes higher than 3g/day and that high intakes might induce undesirable effects. Therefore, plant sterol intakes exceeding 3g/day should be avoided Labelling In order to facilitate consumer understanding the word phyto on the label should be replaced with the word plant. Therefore, for labelling purposes, phytosterol, phytosterol ester, phytostanol and phytostanol ester shall be designated respectively by the terms plant sterol, plant sterol ester, plant stanol or plant stanol ester or their plural form, as appropriate.

59 SECTION 3 SEMI HORIZONTAL LEGISLATION 57 The labelling of foods or food ingredients with added phytosterols, phytosterol esters, phytostanols or phytostanol esters shall contain the following: the words with added plant sterols/plant stanols shall appear, easily visible and legible in the same field of vision as the name under which the product is sold the amount of added phytosterols, phytosterol esters, phytostanols or phytostanol esters content shall be stated in the list of ingredients (expressed in % or as grams of free plant sterols/plant stanols per 100g or 100ml of the food) a statement that the product is intended exclusively for people who want to lower their blood cholesterol level and in the same field of vision a statement that the consumption of more than 3g/day of added plant sterols/plant stanols should be avoided a statement that patients on cholesterol lowering medication should only consume the product under medical supervision an easily visible and legible statement that the product may not be nutritionally appropriate for pregnant and breastfeeding women and children under the age of five years advice shall be included that the product is to be used as part of a balanced and varied diet, including regular consumption of fruit and vegetables to help maintain carotenoid levels and there shall be a definition of a portion of the food or food ingredient concerned (preferably in g or ml) with a statement of the plant sterol/plant stanol amount that each portion contains. Commission Decision 2004/333/EC, Commission Decision 2004/334/EC, Commission Decision 2004/335/EC and Commission Decision 2004/336/EC also contain some presentation requirements that are applicable only to the products and companies to whom the Decisions are addressed Competent authority The policy functions in relation to the Regulations on phytosterols are the responsibility of the Food Unit, Department of Health and Children. These Regulations are enforced by the FSAI for the purposes of ensuring compliance with these Regulations GENETICALLY MODIFIED FOOD Legislation European legislation Regulation (EC) No. 1829/2003 regulates genetically modified food and feed Implemented by: Commission Regulation (EC) No. 641/2004 setting out detailed rules for the implementation of Regulation (EC) No. 1829/2003 Regulation (EC) No. 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms. National legislation The EU Regulations concerning food have yet to be transposed into Irish legislation. The Department of Health and Children and the Department of Agriculture, Fisheries and Food are responsible for the policy functions in relation to Regulation (EC) No. 1829/2003 and Regulation (EC) No. 1830/2003 regarding genetically modified food and feed respectively. The Department of Agriculture, Fisheries and Food has transposed the relevant provisions regarding genetically modified feed Introduction to genetically modified food Genetically modified organisms (GMOs) are organisms in which the genetic material (DNA) has been altered in a way that does not occur naturally. The most common types of GMO s that have been developed and commercialised are genetically modified plant species such as maize, soya bean, oilseed rape and cotton varieties. These plants have been genetically modified in order to provide resistance to certain insect pests and/or to certain herbicides. Until April 2004, genetically modified (GM) food was regulated as a novel food under Regulation (EC) No. 258/1997 (Section 3.8). Under these rules food derived from 18 GM events were approved for use. However, the entire body of GMO legislation has been amended in 2004, leading to the creation of a new legal framework. 3

60 58 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Since April 2004, GM food and feed are regulated in the European Community under Regulation (EC) No. 1829/2003 on genetically modified food and feed. Regulation (EC) No. 1829/2003 also repeals Regulation (EC) No. 1139/98, 49/2000 and 50/2000. This new Regulation provides for a single Community procedure for the authorisation of all GM food and feed i.e. food and feed consisting of, containing or produced from genetically modified organisms. For example, a frozen ready meal containing GM maize powder falls under the Regulation. Although the Regulation covers food containing material derived from a genetically modified source there are some exceptions such as processing aids which are not normally considered as ingredients. The authorisations granted under the new framework are entered in the Community Register of GM Food and Feed. Commission Regulation (EC) No. 641/2004 sets out detailed rules for the implementation of Regulation (EC) No. 1829/2003 with regard to the preparation and submission of food applications, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation. Directive 2001/18/EC on the deliberate release into the environment of GMOs regulates both the experimental release of GMOs into the environment and the placing on the market of live GMOs. Regulation (EC) No. 1830/2003 amends Directive 2001/18/EC in relation to the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms. Regulation (EC) No. 1830/2003 covers all live GMOs and food and feed products derived from GMOs. It establishes a traceability and labelling system for GMOs and food produced from GMO s whereby operators retain, for a period of five years, information pertaining to the immediate receipt and distribution of GM ingredients. GMOs and food products produced from GMOs that are placed on the market must satisfy labelling and traceability conditions under Regulations (EC) No. 1829/2003 and Regulation (EC) No. 1830/ Labelling: Regulation (EC) No. 1830/2003 Regulation (EC) No. 1830/2003 provides a framework for the traceability and labelling of products containing, consisting of or produced from GMOs. Traceability From the first stage of placing on the market, foods or ingredients containing or consisting of GMOs must be accompanied by the following documented information: that the product contains or consists of a GMO the unique indentifier number assigned to the GMO. Operators must retain information on each food or ingredient for a period of five years. From the first stage of placing on the market, foods or ingredients produced from GMOs must carry an indication of each of the ingredients produced from a GMO. Where identification systems such as lot numbering exist and is clearly visible on the packaging, operators may instead retain the lot number information which will include information on the GM ingredients. Traceability applies only to foods or ingredients where greater than 0.9% contain, consist of or were produced from GMOs. Labelling Clear labelling of GMO s enables consumers to make informed choices and avoids potentially misleading consumers regarding the method of manufacture or production. Generally speaking, in the case of pre-packaged products consisting of or containing GMOs, Regulation (EC) No. 1830/2003 requires operators to state on a label that This product contains genetically modified organisms. In the case of non-pre-packaged products offered to the final consumer, these words must appear on, or adjacent to the product display Labelling: Regulation (EC) No. 1829/2003 Food products containing, or consisting of GMOs, produced from or containing ingredients produced from GMOs to be delivered as such to the final consumer or to mass caterers (restaurants etc.) must follow specific labelling requirements. These labelling provisions, as set out in Regulation (EC) No. 1829/2003, apply even where the final product does not contain detectable DNA or protein from GM source such as for highly refined foods like oil from GM maize or cotton seed. (a) Where the food consists of more than one ingredient, the words genetically modified or produced from genetically modified (name of the ingredient) shall appear in the list of ingredients in parentheses immediately following the ingredient concerned.

61 SECTION 3 SEMI HORIZONTAL LEGISLATION 59 (b) Where the ingredient is designated by the name of a category, the words contains genetically modified (name of organism) or contains (name of ingredient) produced from genetically modified (name of organism) shall appear in the list of ingredients. (c) Where there is no list of ingredients, the words genetically modified or produced from genetically modified (name of organism) shall appear clearly on the labelling. (d) The indications referred to in (a) and (b) may appear in a footnote to the list of ingredients. In this case they shall be printed in a font of at least the same size as the list of ingredients. Where there is no list of ingredients, they shall appear clearly on the labelling. (e) Where the food is offered for sale to the final consumer as non-pre-packaged food, or as pre-packaged food in small containers of which the largest surface has an area of less than 10cm 2, the information required under this paragraph must be permanently and visibly displayed either on the food display or immediately next to it, or on the packaging material, in a font sufficiently large for it to be easily identified and read. In addition, the labelling shall also mention any characteristic or property where the food: is different from its conventional counterpart as regards its composition; nutritional value or nutritional effects; intended use of the food; implications for the health of certain sections of the population; may give rise to ethical or religious concerns. GM labelling threshold Foods or ingredients that have a GM content of no greater than 0.9% (of authorised GM material) do not require specific GM labelling provided the operator can demonstrate that the GM presence is due to adventitious or technically unavoidable mixing that can occur during harvesting, storage, transport or processing. Adventitious or technically unavoidable traces of unauthorised GM material at no greater than 0.5% are tolerated in food until April 2007 provided they have benefited from a favourable opinion from a Community Scientific Committee or EFSA, the application for its authorisation has not been rejected and detection methods are publicly available Competent authority The policy functions in relation to Regulation (EC) No. 1829/2003 and Regulation (EC) No. 1830/2003 is the responsibility of the Food Unit, Department of Health and Children and the Department of Agriculture, Fisheries and Food regarding genetically modified food and feed respectively. The food related provisions of both these Regulations are enforced by the FSAI and the Environmental Health Department of the Health Service Executive, pursuant to its service contract with the FSAI, for the purposes of ensuring compliance with these Regulations. The Department of Agriculture, Fisheries and Food enforces the feed related provisions of Regulation (EC) No. 1829/2003. The Environmental Protection Agency (EPA) is the competent authority for Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms while the Department of the Environment, Heritage and Local Government is responsible for policy matters FOOD WITH ADDED VITAMINS AND MINERALS (FORTIFIED FOODS) Legislation European legislation Regulation (EC) No. 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods. National legislation The EU Regulations have yet to be transposed into Irish legislation Introduction to fortified foods Fortified foods are ordinary foods to which nutrients such as vitamins, minerals, amino acids and essential fatty acids, are voluntarily added. Nutrients may have been added to foods for a number of reasons such as the replacement of nutrients lost during manufacture, the equivalence of products and fortification. The Regulation sets out harmonised EU rules for adding vitamins and minerals and certain other substances to foods. It lists the vitamins and minerals which can be added to foods and, establishes the criteria for setting minimum and maximum levels for such nutrients on the basis of scientific advice. 3

62 60 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 The Regulation also applies to foods for particular nutritional uses (Section 3.2) novel foods and novel food ingredients (Section 3.8), genetically modified food (Section 3.10) and food additives and flavourings (Sections 3.12 and 3.13 respectively). However, the Regulation does not apply to food supplements, such as vitamin pills, which are clearly sold as concentrated sources of nutrients and are not considered as fortified foods (Section 3.1). The Regulation prohibits the fortification of unprocessed foodstuffs, such as fruit, vegetables or meat that should be preserved in their natural state, and alcoholic beverages. The addition of certain vitamins or minerals to some foods is mandatory in some Member States such as adding the mineral iodine to salt to prevent iodine deficiency diseases. National Regulations will be produced to give effect to the Regulation in due course Labelling Fortified foods must respect the labelling rules set for food in general such as the horizontal labelling rules (Section 2) including any labelling provisions outlined in the Regulation (EC) No. 1924/2006 on nutrition and health claims (Section 2.4). The labelling, presentation and advertising of foods to which vitamins and minerals have been added shall not: include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients mislead or deceive the consumer as to the nutritional merit of a food that may result from the addition of these nutrients. Nutrition labelling must be provided where vitamins and minerals have been added to a food under this Regulation. The nutrition information must be provided in a Group 2 Format according to Directive 90/496/EEC on nutrition labelling (Section 2.3) and the total amounts of vitamins and minerals present must be declared. The labelling of products to which vitamins and minerals have been added may bear a statement indicating this addition under the conditions set out in Regulation (EC) No. 1924/2006 on nutrition and health claims (Section 2.4) Competent authority The policy functions in relation to Regulation on foods with added vitamins and minerals are the responsibility of the Food Unit, Department of Health and Children. In due course the Regulations will be enforced by the FSAI along with any named agencies pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations ADDITIVES, COLOURS AND SWEETENERS IN FOODSTUFFS Legislation European legislation Directive 89/107/EEC concerning food additives authorised for use in foodstuffs intended for human consumption Amended by: Directive 94/34/EC. National legislation European Communities (Additives, Colours and Sweeteners in Foodstuffs) Regulations, 2000 (S.I. No. 437 of 2000) Amended by: (S.I. No. 342 of 2001), (S.I. No. 344 of 2002), (S.I. No. 380 of 2002), (S.I. No. 61 of 2005) (S.I. No. 192 of 2005) and (S.I. No. 193 of 2005) Introduction to additives, colours and sweeteners package of legislative proposals Community legislation The Community legislation on food additives is governed by the Framework Directive 89/107/EEC and is based on the principle that only authorised additives may be used in the manufacture or preparation of foodstuffs. Prior to their authorisation, food additives are evaluated for their safety by EFSA. Prior to EFSA s role in evaluating food additives which began in 2003, the evaluations were carried out by the Scientific Committee on Food (SCF).

63 SECTION 3 SEMI HORIZONTAL LEGISLATION 61 In effect, a 'positive list' of approved additives has been developed. Specific conditions for the use of the food additive may include the foodstuff to which it can be added, the conditions under which it may be added and the maximum permitted levels of use. Most food additives may only be used in limited quantities in certain foodstuffs. The FSAI has produced a report Legislation, intake and usage of food additives in Ireland. This report and further information on food additives is available at In addition, to the general criteria for food additives, the Framework Directive recommends that the detailed provisions, depending on the category of food additive, be included in separate Directives. Three technical Directives have addressed the use of the following: Council Directive 94/35/EC on sweeteners for use in foodstuffs Directive 94/36/EC on colours for use in foodstuffs Directive 95/2/EC all other additives i.e. food additives other than colours and sweeteners also known as 'miscellaneous additives' Directive. These Directives list the individual permitted additives and the general and specific food categories in which each additive is permitted. Furthermore, these Directives also lay down any necessary maximum levels of use. Our national Regulations (S.I. No. 437 of 2000) and its amendments give effect to most of the European Directives governing additives, colours and sweeteners in food including the Framework Directive 89/107/EEC, Council Directive 94/35/EC on sweeteners and Directive 94/36/EC on colours and their various amendments. The Miscellaneous Additives Directive 95/2/EC and its amendments is implemented by European Communities (Food Additives other than Colours and Sweeteners) Regulations, 2004 (S.I. No. 58 of 2004) and its amendment (S.I. No. 369 of 2005). Additives are defined in the Framework Directive 89/107/EC as: any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of a food whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods. The following are not considered as additives and are not governed by the Framework Directive 89/107/EC: processing aids substances used in the protection of plants and plant products in conformity with Community rules relating to plant health flavourings for use in foodstuffs (as regulated by Council Directive 88/388/EEC see Section 3.13) and substances added to foodstuffs as nutrients such as vitamins and mineral. Additives can be sold either directly to the ultimate consumer or to manufacturers for use in food. Sweeteners are used to impart a sweet taste to foodstuffs or used as a table-top sweetener and can be for sold to the ultimate consumer or for use in the manufacture of foodstuffs. Council Directive 94/35/EC and its amendments Directives 96/83/EC, 2003/115/EC and 2006/52/EC regulating sweeteners for use in foodstuffs, outlines what sweeteners are permitted in particular foods and at what level. For example, aspartame (E951) is permitted in energy-reduced soups at a maximum usable dose of 110mg/l. Council Directive 95/2/EC (miscellaneous additives) and its amendments (including most recently Directive 2006/52/EC) specifically regulate food additives other than colours and sweeteners and outlines what additives are permitted in particular foods and at what level. For example, citric acid (E330) is permitted in fruit juices at a maximum level of 3g/l Labelling The provisions for labelling the presence of an additive, where it is an ingredient in a food, are contained in Directive 2000/13/EC (horizontal labelling legislation, Section 2.1). The Framework Directive 89/107/EEC on food additives sets out specific labelling provisions for food additives sold direct to food producers and consumers. Directive 94/35/EC sets out labelling requirements for tabletop sweeteners and Directive 96/21/EC provides additional labelling provisions concerning the details that must appear on the label of a food containing a sweetener (see also Section ). All these requirements are outlined below. 3

64 62 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Directive 2003/114/EC an amendment to the Miscellaneous Additives Directive 95/2/EC does not set out labelling requirements but contains labelling related provisions that impact on the declaration of additives present in flavourings (see also Section 3.13). Where an additive is from a genetically modified source it must also adhere to the labelling requirements of Regulation (EC) No. 1829/2003/EC and 1830/2003/EC for genetically modified food and feed (Section 3.10). Labelling: additives The Framework Directive 89/107/EEC outlines the labelling requirements for food additives for sale to the ultimate consumer and food additives not intended for sale to the ultimate consumer i.e. to food producers. Food additives for sale to the ultimate consumer may be marketed only if their packaging or containers bear the following information, which must be conspicuous, clearly legible and indelible: name under which the product is sold and it s E number (see also section (b) on E numbers and Appendix VI and VIII) name and E number of each food additive, whether sold singly or mixed together, in descending order of weight and the name and E number of any substances or additives incorporated into the additives in descending order of weight one of the following statements: for use in food or restricted use in food or a more specific reference to its intended food use special conditions of storage and use where necessary directions for use where necessary a lot or batch number the name or business name and address of the manufacturer or packager, or of a seller established within the Community the net quantity and the date of minimum durability. Food additives not intended for sale to the ultimate consumer may be marketed only if their packaging or containers bear the following information, which must be conspicuous, clearly legible and indelible: name and E number of each food additive, whether sold singly or mixed together, in descending order of weight (and the name and E number of any substances or additives incorporated into the additives in descending order of weight*) one of the following statements: for use in food or restricted use in food or a more specific reference to its intended food use special conditions of storage and use where necessary directions for use where necessary* a lot or batch number* the name or business name and address of the manufacturer or packager, or of a seller established within the Community* an indication of the percentage of any component which is subject to a quantitative limitation in a food* and the net quantity. Labelling: additives other than colours and sweeteners The use of additives is sometimes necessary to ensure the safety and quality of flavourings and to facilitate their storage. If the presence of an additive in a foodstuff, due to the use of a flavouring, is generally low and the additive does not have a technological function in the foodstuff, it is then not considered as an ingredient (Section ). The additive in question is therefore not required to be listed in the ingredients list. However, if under certain circumstances, the additive does have a technological function in the compound foodstuff, it should be considered as an additive of the compound foodstuff and not as an additive of the flavouring. Hence the additive is considered as an ingredient of the food and should be declared in the list of ingredients. Other relevant rules relating to the additive in the particular food will also apply. * These indications need only appear on the commercial documents accompanying the consignment provided intended for the manufacture of foodstuffs and not for retail sale appears as a conspicuous part of the packaging or container of the product in question.

65 SECTION 3 SEMI HORIZONTAL LEGISLATION 63 Labelling: sweeteners Council Directive 94/35/EC on sweeteners for use in foodstuffs outlines the labelling requirements for sweeteners. Sweeteners are a category of food additive which are used to impart a sweet taste to foods or used a table-top sweetener. These rules also make it compulsory to declare the following information on the label of a table-top sweetener: the term.- based table-top sweetener to be added to the sales description where the name(s) of the sweetening substances used in its composition should be inserted the words excessive consumption may induce laxative effects where the sweetener contains polyols the words contains a source of phenylalaine where the sweetener contains aspartame and the words contains a source of phenylalaine where the sweetener contains salt of aspartame and acesulfame (Directive 2003/115/EC amending Directive 94/35/EC). Directive 96/21/EC amending Directive 94/54/EC on the compulsory indication of particulars on the labelling of certain foodstuffs provides additional labelling provisions concerning the details that must appear on the label of a food containing a sweetener to makes its presence clear as follows (Section ): foodstuffs containing a sweetener or sweeteners (as authorised by Directive 94/35/EC) must be labelled with sweeteners(s) near the name of the food foodstuffs containing both an added sugar or sugars and a sweetener or sweeteners (as authorised by Directive 94/35/EC) must be labelled with sugar(s) and sweeteners(s) near the name of the food foodstuffs containing aspartame must be labelled contains a source of phenylalanine and foodstuffs containing more than 10% added polyols must be labelled excessive consumption may produce laxative effects. The European Commission has adopted a package of legislative proposals which upgrades current rules for flavourings and additives and will introduce harmonised EU legislation on food enzymes for the first time. The texts aim to clarify and update current legislation in this area and to create a simplified common approval procedure for food additives, flavourings and enzymes, based on scientific opinions from EFSA. For additives and flavourings which are already covered by EU legislation, the proposals bring the rules into line with the latest scientific and technological developments and will improve the clarity of the legislation. With regard to food enzymes, the draft Regulation proposes replacing divergent national legislation with new, harmonised EU rules. Further details are available at _leg_en.htm. At the time of print these legislative proposals were not yet completed therefore, the current legislation as outlined above still applies Competent authority The policy functions in relation to Regulations on additives are the responsibility of the Food Unit, Department of Health and Children pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Environmental Health Department of the Health Service Executive Local Authorities Department of Communications, Energy and Natural Resources. 3

66 64 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND FLAVOURINGS FOR USE IN FOODSTUFFS FOR HUMAN CONSUMPTION Legislation European legislation Council Directive 88/388/EEC relating to flavourings for use in foodstuffs Completed by: Commission Directive 91/71/EEC. National legislation European Communities (Flavourings for use in Foodstuffs for Human Consumption) Regulations, 1992 (S.I. No. 22 of 1992) Introduction to flavourings Community legislation Flavourings are used in or on foodstuffs in order to impart odour and/or taste. Flavourings mean flavouring substances (i.e. a defined chemical substance with flavouring properties, obtained by a variety of means), flavouring preparations (i.e. flavourings containing more than one flavouring substance), process flavourings (flavourings obtained during manufacturing to a temperature not exceeding 180 o C for a period not exceeding 15 minutes) and smoke flavourings (a smoke extract used in traditional foodstuff smoking processes). The Framework Directive 88/388/EEC sets out the definitions for the different types of flavourings, such as natural, nature-identical or artificial flavouring substances. General rules for their use and labelling requirements are also given. Use of flavourings must not result in the presence in foodstuffs of undesirable substances in quantities greater than those specified in the Directive. The following are not considered flavourings and are therefore not governed by the current Framework Directive 88/388/EEC: edible substances and products intended to be consumed as such, with or without reconstitution substances which have exclusively a sweet, sour or salt taste material of vegetable or animal origin, having inherent flavouring properties, where they are not used as flavouring sources. With respect to flavouring substances, a major initiative is underway to develop a list of flavouring substances approved for the use in foodstuffs. Council Regulation 2232/96/EC, sets out procedures for the use of these substances in or on foodstuffs in the EU. Subsequently Commission Decision 1999/217/EC as amended by 2000/489/EC, 2002/113/EC, 2004/357/EC, 2005/389/EC and 2006/252/EC adopted an EU Register of flavouring substances used in or on foodstuffs which will form the basis of an evaluation programme of these flavouring substances. It is envisaged that all flavouring substances will be evaluated and the list completed by Labelling The labelling requirements for flavourings depend on whether or not they are intended for sale to the final consumer. Commission Directive 91/71/EEC amends the Framework Directive on Flavourings, to prescribe labelling requirements for flavourings sold as such to the final consumer. Flavourings intended for sale to the final consumer may not be marketed unless their labels indicate the following information, which should be easily visible, clearly legible and indelible: 1) the word flavouring or a more specific name or description of the flavouring 2) the words for foodstuffs or a more specific reference to the foodstuff for which the flavouring is intended 3) the date of minimum durability 4) special conditions for storage and use of the flavour where necessary 5) instructions for use if its omission would prevent the appropriate use of the flavouring 6) the net quantity expressed in units of mass or volume 7) the name and business name and address of the manufacturer or packer, or of a seller established within the Community 8) an indication or mark identifying the batch (see also Council Directive 89/396/EC Section 2.2) and 9) in the case of a mixture of flavourings with other substances a list in descending order of weight of the categories of flavourings and the names of each of the other substances (or where appropriate their 'E' number see Section (b)) as contained in the mixture.

67 SECTION 3 SEMI HORIZONTAL LEGISLATION 65 Flavourings not intended for sale to the final consumer may not be marketed unless their packages bear the following information, which should be easily visible, clearly legible and indelible: 1) the name and business name and address of the manufacturer or packer, or of a seller established within the Community 2) the sales description: either the word flavouring or a more specific name or description of the flavouring 3) the statement for foodstuffs or a more specific reference to the food for which the flavouring is intended 4) a list in descending order of weight of the categories of flavouring substances and flavouring preparations classified as natural flavouring substances, naturalidentical flavouring substances, artificial flavouring substances and smoke flavourings etc.* 5) in the case of a mixture of flavourings with: additives necessary for the storage and use of flavourings or products used for dissolving or diluting flavourings a list in descending order of weight of the categories of flavourings and the names of each of the other substances (or where appropriate their E numbers) as contained in the mixture* 6) an indication of the maximum quantity of each flavouring component* 7) an indication identifying the consignment and 8) the nominal quantity expressed in units of mass or volume. Natural flavourings On a label the word natural applying to a flavour or any word having substantially the same meaning, e.g. pure, may only be used where the flavouring component is derived from flavouring substances or flavouring preparations to which nothing has been added and which have been subjected only to such processing as to render them suitable for human consumption. Acceptable natural processing methods to obtain flavouring compounds may be achieved by physical, enzymatic or microbiological processes such as freezing, concentration, drying, distillation, traditional cooking processes and pasteurisation. Foods could be described as made from natural flavourings and unflavoured products as natural only if these criteria are met. Foodstuffs containing flavourings obtained by artificial methods would not be permitted to use the word natural on the product, e.g. flavourings obtained by chemical means, heating processes and smoking are excluded such as bleaching, hydrogenation and smoking with chemicals. If the name of the flavouring contains a reference to the source of the flavouring such as its vegetable or animal origin, as in natural chicken flavour then the word natural may only be used if the flavour was obtained purely from a chicken source by natural processes. If however, as above, the flavour was obtained through any chemical or similar artificial process then the term natural may not be used. Similarly, the wording natural apple flavour for a foodstuff may only be used where the actual apple flavour was obtained solely from apples by natural processing methods as above. The term natural would have to be omitted and the words apple flavour only permitted where the apple flavour was obtained by artificial means. In addition, the word natural flavour may be used where the flavour was obtained naturally but not solely from apples. Directive 2003/89/EC, an amendment to the general labelling Directive 2001/13/EC (see Section (e) on allergens), requires that if a flavouring or processing aid is derived from one of the allergenic sources listed by the Directive, the name of the source must be declared clearly by name in the ingredient list. Smoke Flavourings Regulation (EC) No. 2065/2003 regulates smoke flavourings used or intended for use in or on foods. This Regulation establishes a procedure for the safety assessment and authorisation of smoke condensates to be carried out by EFSA, which will result in a positive list of primary products and specific conditions of use in, or on, foods. 3 * Points 4), 5) and 6) above need only appear on the trade documents relating to the consignment which are to be supplied with or prior to delivery. However, the indication intended for the manufacture of foodstuffs and not for retail must appear in a conspicuous part of the packaging of the product.

68 66 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Smoke flavourings do not have to be specifically declared in the list of ingredients the name flavouring(s) is sufficient (Section (c) on flavouring). However, details of the physical condition of the foodstuff or processes it has undergone must accompany the legal name of the food such as smoked (Section ). It should be noted that a product being sold as having undergone a smoking process such as smoked chicken would be misleading to the consumer where in fact it was treated with a smoked flavouring. In this case, the name of the food should declare chicken with smoked flavourings so the consumer is informed of the true nature of the product. Quinine and caffeine flavourings Commission Directive 2002/67/EC on the labelling of foodstuffs containing quinine and of foodstuffs containing caffeine requires that, where caffeine or quinine are used as a flavouring in the production or preparation of the food, they should be declared by name in the ingredients list, immediately after the term flavouring (Section ) Additives, diluents and carriers Directive 2003/114/EC amends for the fifth time Directive 95/2/EC on food additives other that colours and sweeteners and introduces new provisions relating to the use of additives in flavourings. A new carry-over provision has been inserted specifically for foods containing flavourings. The presence of a food additive in a foodstuff is permissible in a foodstuff where a flavouring has been added, to the extent to which the food additive is permitted in the flavouring in compliance with this Directive and has been carried over to the foodstuff via the flavouring, provided the food additive has no technological function in the final food. The level of additives in flavourings shall be limited to the minimum necessary to guarantee the safety and quality of the flavourings and to facilitate storage. Furthermore, the presence of additives in flavourings must not mislead the consumer or present a hazard to their health. If the presence of an additive in a foodstuff, as a consequence of adding flavourings, has a technological function in the foodstuff, it shall be considered as an additive of the foodstuff and not as an additive of the flavouring. Package of legislative proposals The European Commission has adopted a package of legislative proposals which would upgrade current rules for flavourings and additives and introduce harmonised EU legislation on food enzymes for the first time. The texts aim to clarify and update current legislation in this area and to create a simplified common approval procedure for food additives, flavourings and enzymes, based on scientific opinions from EFSA. For additives and flavourings, which are already covered by EU legislation, the proposals bring the rules into line with the latest scientific and technological developments and will improve the clarity of the legislation. With regard to food enzymes, the draft Regulation proposes replacing divergent national legislation with new, harmonised EU rules. Further details are available at _leg_en.htm. At the time of print, these new legislative proposals were not yet completed therefore, the current legislation as outlined above still applies Competent authority The policy functions in relation to the Regulations on flavourings for use in foodstuffs are the responsibility of the Food Unit, Department of Health and Children. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Environmental Health Department of the Health Service Executive Department of Communications, Energy and Natural Resources. The FSAI has been nominated as the competent authority for receiving dossiers on smoke flavourings in accordance with Regulation (EC) No. 2065/2003.

69 SECTION 3 SEMI HORIZONTAL LEGISLATION MATERIAL AND ARTICLES INTENDED TO COME INTO CONTACT WITH FOODSTUFFS Legislation European legislation Regulation (EC) No. 1935/2004 on materials and articles intended to come into contact with food. National legislation European Communities (Plastics and other materials) (Contact with food) Regulations, 2006 (S.I. No. 139 of 2006) Introduction to materials and articles intended to come into contact with food The underlying principle of the legislation is that any material or article intended to come into contact with food, directly or indirectly, must be sufficiently inert to preclude substances from being transferred to food in quantities large enough to endanger human health. In addition, the possible migration of substances to the food must not bring about an unacceptable change in the composition of the food or a deterioration in its organoleptic properties. The Framework Regulation (EC) No. 1935/2004 sets general requirements for all food contact materials and repeals the Framework Directive 89/109/EEC and Directive 80/590/EEC. The new framework Regulation takes into account new types of materials and articles designed to actively maintain or improve the condition of the food (active food contact materials and articles) as well as other types of new materials which are designed to monitor the condition of the food (intelligent food contact materials and articles). Specific Directives have also been drawn up which cover some of the particular materials and articles listed in the Framework Regulation: Ceramic Articles (Council Directive 84/500/EEC amended by Commission Directive 2005/31/EC) Plastic Material (Commission Directive 2002/72/EC amended by Commission Directive 2004/1/EC, Commission Directive 2004/19/EC and Commission Directive 2005/79/EC) Regenerated Cellulose Film (Commission Directive 93/10/EEC amended by Commission Directive 1993/111/EC and Commission Directive 2004/14/EC). There are also Directives on individual substances or groups of substances used in the manufacture of materials and articles intended for food contact: Materials Containing Vinyl Chloride Monomer (Council Directive 78/142/EEC and its implementing measures Commission Directive 80/766/EEC and Commission Directive 81/432/EEC) Elastomers or Rubber Teats and Soothers: Release of N-nitrosamines and N-nitrosable Substances (Commission Directive 93/11/EEC) Materials Containing Certain Epoxy Derivatives (Commission Regulation (EC) No. 1895/2005). Where a specific Directive has not yet been introduced for a given food contact material or article, then it must comply with the general provisions of the Framework Directive. In due course, it is proposed to introduce Directives on paper and board, glass, metal and alloys, wood including cork, textile products and microcrystalline waxes. Our national 2006 Regulations give full effect to Regulation (EC) No. 1935/2004 and Commission Regulation (EC) No.1895/2005 on certain epoxy substances from food contact materials. It also transposes the specific Directives on plastics, regenerated cellulose film, ceramics, vinyl chloride monomer and elastomer or rubber teats. These Regulations consolidate and repeal the previous national rules on food contact materials (i.e. S.I. No. 307 of 1991 and its amendments). The Regulations deal with the importation and sale of materials intended to come into contact with food, the descriptions which must accompany them and specifies labelling requirements for when materials and articles are sold for food contact use but are not already in contact with food. 3

70 68 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 The legislation controls the use of materials and articles for use in contact with foodstuffs, specifically with regard to the control of the potential contamination that can occur through the migration of substances from the contact material to the foodstuff. The contamination can affect the appearance, taste or odour of the foodstuff or can cause toxicological effects depending on the degree and nature of the contaminants. The legislation applies to all materials and articles which in their finished state are intended to come into contact with food or water, including cutlery, coffee machines, etc. However, the main focus of concern is food-packaging materials where there is greater potential for contamination to occur as a foodstuff spends most time in contact with the packaging Labelling The Framework Regulation requires that materials and articles (intended for food contact use) which are not yet in contact with food when placed on the market, must be accompanied by the following information: (a) the words for food contact, or a specific indication as to their use, such as coffee machine, wine bottle, soup spoon, or the following symbol This information is not obligatory for any articles which, because of their characteristics, are clearly intended to come into contact with food. (b) special instructions to be observed for safe and appropriate use where necessary (c) the name/trade name and the address or registered office of the manufacturer, processor, or seller responsible for placing the material or article on the market established within the Community (d) adequate labelling or identification to ensure traceability of the material (required from 27th October 2006) (e) in the case of active materials and articles, information on the permitted use or uses and other relevant information such as the name and quantity of the substances released by the active component so as to enable food business operators who use these materials and articles to comply with any other relevant legislative provisions such as food labelling (Directive 2000/13/EC, Section 2.1). All of this information must be conspicuous, clearly legible and indelible. In addition, retail trade in materials and articles shall be prohibited if the information required under (a), (b) and (e) is not given in a language easily understood by purchasers. At the retail stage, this information shall be displayed either on the materials and articles themselves, the packaging, or on the labelling. This information may also appear on a notice in the immediate vicinity of the materials and articles provided it is clearly visible to purchasers. However, information regarding (c) above may only appear on a notice where for technical reasons, that information or a label bearing it cannot be affixed to the materials and articles at either the manufacturing or the marketing stage. At the marketing stages other than the retail stage, the information required above can be displayed on the accompanying documents, the labels, the packaging or the materials and articles themselves. The Framework Regulation also requires that: the labelling, advertising and presentation of a material or article shall not mislead consumers intelligent materials and articles shall not give information about the condition of the food which could mislead consumers active and intelligent materials and articles already brought into contact with food, e.g. filled food packaging, shall be adequately labelled to allow identification by the consumer of non-edible parts, e.g. sachets contained in the package with the food active and intelligent materials and articles shall be adequately labelled to indicate that the materials or articles are active and/or intelligent. Additionally, the specific measures on particular materials may specify additional labelling requirements and the accompaniment of materials and articles by written declarations of compliance with the legislation.

71 SECTION 3 SEMI HORIZONTAL LEGISLATION Competent authority The policy functions in relation to the Regulations on materials and articles to come in contact with food are the responsibility of the Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Environmental Health Department of the Health Service Executive Local Authorities Department of Communications, Energy and Natural Resources. 3

72 70 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 SECTION 4 VERTICAL LEGISLATION VERTICAL LABELLING RULES The provisions of the horizontal labelling rules for prepackaged foodstuffs (Section 2) apply to the foodstuffs outlined in this chapter in addition to the specific requirements detailed in the various pieces of legislation below unless stated otherwise. PART A: COMPOSITIONAL STANDARDS 4.1 COCOA AND CHOCOLATE PRODUCTS Legislation European legislation Directive 2000/36/EC relating to cocoa and chocolate products intended for human consumption. National legislation European Communities (Marketing of Cocoa and Chocolate Products) Regulations, 2003 (S.I. No. 236 of 2003) Introduction to cocoa and chocolate products Directive 2000/36/EC repealed Council Directive 73/241/EEC and was introduced to simplify Community provisions. The Directive lays down rules for the composition and labelling of cocoa and chocolate products and defines different categories of chocolate products including chocolate, milk chocolate, family milk chocolate, white chocolate and filled chocolate. The new rules were required in order to take account of technolocigal progress and changes in consumer tastes and to be brought in line with general Community legislation on labelling, sweetners, additives, flavourings etc. Cocoa and chocolate products may not be marketed in the Community unless they conform to the definitions and rules laid down in the Directive Labelling The labelling requirements for cocoa and chocolate products are as follows: the prescribed names for cocoa and chocolate products as listed and defined in the Directive must be used in trade as their sales names such as chocolate, milk chocolate, drinking chocolate, couverture chocolate, plain chocolate, cocoa butter, cocoa powder, filled chocolate etc. However, these names can be used for other products in accordance with custom provided these other products cannot be confused with the products defined in the Directive such as chocolate cakes. the labelling of chocolate products which contain vegetable fats other than cocoa butter must be supplemented by the statement contains vegetable fat in addition to cocoa butter. This statement must be conspicuous, clearly legible and in the same field of vision as the list of ingredients and clearly separated from this list. This statement must be in lettering at least as large and in bold with the sales name nearby (the sales name of the product may also appear elsewhere on the label) where certain chocolate products are sold in assortments the sales name may be replaced by assorted chocolates or assorted filled chocolates. In this case, there may be a single list of ingredients for all the products in the assortment for specific products (such as powered chocolate, drinking chocolate, chocolate, milk chocolate, family milk chocolate, chocolate a la taza and chocolate familiar a la taza) an indication of the total dry cocoa content must be given by a declaration cocoa solids...% minimum fat-reduced cocoa and sweetened cocoa/drinking chocolate must indicate the cocoa butter content

73 SECTION 4 VERTICAL LEGISLATION 71 the sales names chocolate, milk chocolate and couverture chocolate may be supplemented by declarations or adjectives relating to quality provided the product contains the following: chocolate: not less than 43% total dry milk chocolate: not less than 30% total dry cocoa solids and not less than 18% dry milk solids obtained by partly or wholly dehydrating whole milk, semi- or full-skimmed milk, cream, or from partly or wholly dehydrated cream, butter or milk fat, including not less than 4.5% milk fat couverture chocolate: not less than 16 % of dry non-fat cocoa solids. In Ireland and the UK, the sales name milk chocolate may be used to describe Family Milk Chocolate provided the amount of dry milk solids is indicated by the declaration milk solids % Competent authority The policy functions in relation to the Regulations on cocoa and chocolate products are the responsibility of the Food Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Environmental Health Department of the Health Service Executive Department of Agriculture, Fisheries and Food. 4.2 COFFEE AND CHICORY EXTRACTS Legislation European legislation Directive 1999/4/EC regulates coffee extracts and chicory extracts. National legislation European Communities (Marketing of Coffee Extracts and Chicory Extracts) Regulations, 2000 (S.I. No. 281 of 2000) Introduction to coffee and chicory extracts Directive 1999/4/EC repealed Directive 77/436/EEC on coffee and chicory extracts in order for the legislation to be brought in line with general Community legislation on foodstuffs, particularly labelling and methods of analysis. The legislation prescribes standards for the composition and labelling of coffee extracts and chicory extracts Labelling The following labelling provisions apply to coffee and chicory extracts: the product names coffee extract, soluble coffee extract, soluble coffee or instant coffee, or in the case of chicory extracts, chicory extract, soluble chicory or instant chicory apply only to the products defined in the Directive and must be used in trade to designate them. These names must be supplemented by the words paste or in paste form or liquid or in liquid form as appropriate. The names may also be supplemented by the term concentrated as follows: (a) liquid coffee extract: the coffee based dry matter content is more than 25% by weight or (b) the liquid chicory extract: the chicory based dry matter content is more than 45% by weight the labelling must include the term decaffeinated if the product meets the specified requirements. This information must be written within the same field of vision as the sales description for particular products with added sugars (such as liquid coffee extract and liquid chicory extract) the labels must include the terms with..., preserved with..., with added... or roasted with... followed by the name of the types of sugar(s) used. This information must also appear within the same field of vision as the sales description the dry matter content must be expressed as a percentage by weight of the finished product in the case of dried coffee extract, coffee extract paste, dried chicory extract and chicory extract paste. 4

74 72 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND Competent authority The policy functions in relation to the Regulations on coffee and chicory extracts are the responsibility of the Food Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the Department of Agriculture, Fisheries and Food pursuant to its service contract with the FSAI, for purposes of ensuring compliance with these Regulations. Officers authorised under these Regulations by the Health Service Executive and the Office of the Director of Consumer Affairs may also enforce these provisions. 4.3 FRUIT JUICES AND FRUIT NECTARS Legislation European legislation Directive 2001/112/EC relating to fruit juices and certain similar products intended for human consumption. National legislation European Communities (Marketing of Fruit Juice and Certain Similar Products) Regulations, 2003 (S.I. No. 240 of 2003) Introduction to fruit juices Directive 2001/112/EC repealed Directive 93/77/EEC and prescribes and harmonises within the European Union, standards for the composition and labelling of fruit juices and certain similar products. The Community provisions regarding fruit juices were recast in order to make the rules on manufacturing and marketing conditions for fruit juices and similar products more accessible and in line with general Community legislation on foodstuffs, particularly legislation on labelling, colouring matter, sweeteners and other authorised additives. One of the main changes introduced by the new legislation is the fact that fruit juice from concentrate must be called as such now under its sales name (rather than the declaration made from concentrate ). This provision will help consumers to differentiate between fruit juice and fruit juice from concentrate and therefore inform them of the true nature of their purchase The Department of Agriculture, Fisheries and Food in conjunction with the FSAI has produced a guide on the Labelling of Fruit Juices and Related Products and should be consulted for a more detailed guide to the legislation. It is available at Labelling The following labelling provisions apply to fruit juices and similar products intended for consumption: the prescribed names for fruit juices and similar products as listed and defined in the Directive must be used in trade as the name of the product such as fruit juice, fruit juice from concentrate, fruit nectar etc. However, by way of derogation, certain designations have been recognised as the product name in the language and under the conditions laid down such as vruchtendrank for fruit nectars in German Where the product comes from a single kind of fruit, the name of the fruit must be substituted for the word fruit such as orange juice. For products manufactured from two or more fruits the product names shall be supplemented by a list of the fruits used, in descending order of the volume of the fruit juices or purées included. However, in the case of products manufactured from three or more fruits, the indication of the fruits used may be replaced by the words several fruits or a similar wording, or by the number of fruits used fruit juices which have been sweetened by the addition of sugars, the sales name shall include the word sweetened or with added sugar, followed by an indication of the maximum quantity of sugar added, calculated as dry matter and expressed in grams per litre the restoration of fruit juices and similar products to their original state, by means of the substances strictly necessary for this operation, shall not entail an obligation to enter on the labels a list of the ingredients used for this purpose. However, the addition to fruit juice of extra pulp or cells shall be indicated on the labelling without prejudice to QUID requirements (Directive 2000/13/EC, Section ), for mixtures of fruit juice and fruit juice from concentrate, and for fruit nectar obtained entirely or partly from one or more concentrated products, the labelling shall bear the words made with concentrate(s) or partially made with concentrate(s), as appropriate. That information shall be entered close to the product name, standing out well from any background, in clearly visible characters As fruit juice and fruit juice from concentrate are considered two separate products (having their own legal names) where they are ingredients in a composite product, they must appear in the list of ingredients under their own designation.

75 SECTION 4 VERTICAL LEGISLATION 73 for fruit nectars, the labelling shall indicate the minimum content of fruit juice, fruit purée or any mixture of those ingredients, by the declaration fruit content: % minimum. That information shall be located in the same field of vision as the product name the labelling of concentrated fruit juice not intended for delivery to the final consumer shall bear a reference indicating the presence and quantity of added sugars, or added lemon juice or acidifying agents (as permitted by Directive 95/2/EC on food additives other than colours and sweeteners). This reference shall appear on the packaging, on a label attached to the packaging or on an accompanying document. Ireland permits the addition of vitamins and minerals to fruit juices and similar products defined above in accordance with Directive 90/496/EEC on nutrition labelling (Section 2.3) Competent authority The policy functions in relation to the Regulations on fruit juices are the responsibility of the Food Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Environmental Health Department of the Health Service Executive Department of Agriculture, Fisheries and Food. 4.4 CASEINS AND CASEINATES Legislation European legislation Council Directive 83/417/EEC relating to certain lactoproteins (caseins and caseinates) intended for human consumption. National legislation European Communities (Caseins and Caseinates) Regulations, 1985 (S.I. No. 248 of 1985) Introduction to caseins and caseinates Caseins are the principal protein of milk and caseinates are the products obtained by drying caseins treated with neutralizing agents. These rules regulate the composition and manufacturing characteristics of caseins and caseinates intended for human consumption either as such or incorporated in another foodstuff and the labelling and marking of edible caseins, caseinates and mixtures of these Labelling The product names edible acid casein, edible rennet casein and edible caseinates are reserved for the products defined in the Directive. These names must be used in trade as the name of the product. It is unlawful to use them for any product unless it complies with the prescribed heat-treatment process and technological adjuvants and bacterial cultures. Casein and caseinates must delare the following on the package, containers or label: a) the reserved name as above and in the case of caseinates an indication of the cation or cations. b) products marketed as mixtures: the words mixture of. followed by the names of the different products which make up the mixture, in decreasing order of weight, an indication of the cation or cations in the case of caseinate(s), the protein content in the case of mixtures containing caseinates. c) the quanity in metric (or where specifically authorised in imperial units until December 2009) d) the name or business name and the address of the manufacturer or packager, or of a seller established within the Community. In the case of national production Member States may maintain national provisions requiring details of the manufacturing or packaging establishment to be mentioned. e) country of origin where the products have been imported from third countries f) the date of manufacture or similar marking to identify the batch. Certain particulars a), b), e) and f) must be in language easily understood by the purchaser. In addition, certain particulars need only appear on the accompanying documents. Further derogations are also provided for products transported in bulk. All of the labelling requirements must be clearly visible, easily legible and in indelible characters. 4

76 74 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND Competent authority The policy functions in relation to the Regulations on casein and caseinates are the responsibility of Milk Policy, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI. Officers authorised under these Regulations by the Minister of Agriculture, Fisheries and Food may also enforce these provisions. 4.5 HONEY Legislation European legislation Directive 2001/110/EC relating to honey Corrected by: Corrigendum to Council Directive 2001/110/EC of 20 December 2001 relating to honey. National legislation European Communities (Marketing of Honey) Regulations, 2003 (S.I. No. 367 of 2003) Introduction to honey Directive 2001/110/EC on honey repeals and replaces Directive 74/409/EEC. European Communities (Marketing of Honey) Regulations, 2003 revokes the previous Regulations and implements the Directive 2001/110/EC. These rules prescribe standards for the composition and labelling of honey. Compositional criteria are laid down in respect of sugar content, fructose and glucose content, moisture content, water-insoluble content, electrical conductivity and free acid Labelling requirements Products can only be marketed as honey if they comply with the definition and compositional requirements as set out in the Directive. The following information must appear on the package, container or label of honey and the information must be conspicuous, clearly legible and indelible: the prescribed names as listed and defined in the Directive such as blossom honey must be used in trade to designate the product or the simple product name honey may replace the prescribed name (except in the case of filtered honey, comb honey, chunk honey or cut comb in honey and baker's honey ) for baker's honey, the words intended for cooking only shall appear on the label in close proximity to the product name for filtered honey and baker's honey, under certain circumstances the product names may be supplemented by information on: its floral or vegetable origin, regional, territorial or topographical origin, specific quality criteria. where baker's honey has been used as an ingredient in a compound foodstuff, the term honey may be used in the product name only of the compound food instead of the term baker's honey (however, this exemption does not apply to the list of ingredients) the country or countries of origin where the honey has been harvested shall be indicated on the label. However, if the honey originates in more than one Member State or third country, that indication may be replaced with one of the following, as appropriate: blend of EC honeys blend of non-ec honeys blend of EC and non-ec honeys Competent authority The policy functions in relation to the Regulations on honey are the responsibility of the Horticulture Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Department of Agriculture, Fisheries and Food Environmental Health Department of the Health Service Executive.

77 SECTION 4 VERTICAL LEGISLATION SUGARS Legislation European legislation Directive 2001/111/EC relating to certain sugars intended for human consumption. National legislation European Communities (Marketing of Sugar Products) Regulations, 2003 (S.I. No. 289 of 2003) Introduction to sugars Directive 2001/111/EC repeals and replaces Council Directive 73/437/EEC. European Communities (Marketing of Sugar Products) Regulations, 2003 revokes the previous Food Standards (Certain Sugars) Regulations, 1975 and 1981 and implements the Directive. This legislation defines several kinds of sugar such as white sugar, glucose syrup and fructose and sets down rules for their labelling and packing. These provisions however, do not apply when the products take the form of icing sugars, candy sugars or sugars in loaf form Labelling The following labelling provisions apply to sugars: the prescribed names as listed and defined in the Directive such as semi-white sugar must be used in trade to designate the products. The prescribed name sugar or white sugar can also be used as the name for extra-white sugar. Qualifying terms that are commonly used are also permitted in addition to the compulsory products name. In addition, the prescribed names may also be used in product names made up to designate other products, in accordance with custom. In both cases, the names must not be liable to mislead the consumer. pre-packaged products weighing less than 20g are not required to declare net weight. The following information must also appear on the label: the dry matter and invert sugar content of sugar solution, invert sugar solution and invert sugar syrup the qualifying term crystallised for invert sugar syrup incorporating crystals in the solution where glucose syrup or dried glucose syrup contain fructose in proportions greater than 5% on a dry matter basis, they shall, in respect of their product name and as ingredients, be labelled as glucose-fructose syrup or fructose-glucose syrup and dried glucose-fructose syrup or dried fructose-glucose syrup, respectively, to reflect whether the glucose component or the fructose component is in greater proportion Competent authority The policy functions in relation to the Regulations on sugars are the responsibility of the Crops Policy and State Bodies Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Department of Agriculture, Fisheries and Food Environmental Health Department of the Health Service Executive. 4.7 DEHYDRATED PRESERVED MILK Legislation European legislation Council Directive 2001/114/EC relating to certain partly or wholly dehydrated preserved milk for human consumption. National legislation European Communities (Dehydrated Preserved Milk) Regulations, 2003 (S.I. No. 298 of 2003) Introduction to dehydrated preserved milk Council Directive 2001/114/EC repeals and replaces Council Directive 76/118/EEC relating to certain partly or wholly dehydrated preserved milk for human consumption. European Communities (Dehydrated Preserved Milk) Regulations, 2003 (S.I. No. 298 of 2003) gives effect to Directive 2001/114/EC and revokes the previous Dehydrated Preserved Milk Regulations, 1980 to The new requirements bring Directive 2001/114/EC into line with general Community legislation on foodstuffs, particularly legislation on labelling, authorised additives, hygiene and health rules. The rules relating to partly or wholly dehydrated preserved milk for human consumption detail the compositional requirements for different types of dehydrated milk, the use of reserved descriptions, manufacturing specifications and the labelling of products. 4

78 76 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND Labelling The prescribed names as listed and defined in the Directive such as condensed milk and whole milk powder must be used in trade to designate the products. However, a number of other prescribed names have been permitted for use as trade names across the various Member States. For labelling in English: the term evaporated milk denotes the product condensed milk where it contains, by weight, at least 9% fat and 31% total milk solids the term evaported semi-skimmed milk denotes the product condensed partly skimmed milk where it contains, by weight, between 4% and 4.5% fat and not less than 24% total solids the term semi-skimmed milk powder or dried semi-skimmed milk denotes the product dried partly skimmed milk with a fat content of between 13% and 26%. The labelling must state the percentage of milk fat, expressed by weight in relation to the finished product. This requirement is not applicable to unsweetened and sweetened condensed skimmed milk and skimmed milk powder. The percentage fat-free dried milk extract must also be given for partly dehydrated milk products. Both of these labelling particulars must be appear near the trade name. Totally dehydrated milk products must state: the recommendations as to the method of dilution or reconstitution, including details of the fat content of the product when diluted or reconstituted that the product is not intended as a food for infants under 12 months. Products weighing less than 20kg per unit that are packaged in outer packaging, the mandatory particulars above need only appear on the outer package except for the reserved name Competent authority The policy functions in relation to the Regulations on dehydrated preserved milk are the responsibility of the Milk Policy Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Department of Agriculture, Fisheries and Food Environmental Health Department of the Health Service Executive. 4.8 FRUIT JAMS, JELLIES, MARMALADES AND SWEETENED CHESNUT PURÉE Legislation European legislation Directive 2001/113/EC relating to fruit jams, jellies and marmalades and sweetened chestnut puree intended for human consumption. National legislation European Communities (Marketing of Fruit Jams, Jellies, Marmalades and Sweetened Chestnut Puree) Regulations, 2003 (S.I. No. 294 of 2003) Introduction to fruit jams Directive 2001/113/EC revokes and replaces Directive 79/693/EEC on fruit jams, jellies and marmalades and sweetened chestnut puree. The Marketing of Fruit Jams Regulations, 2003 revokes the previous 1982 Regulations and gives legal effect to Directive 2001/113/EC. The legislation prescribes and harmonises, within the European Union, standards for the composition and labelling of fruit jams, jellies, marmalades and sweetened chestnut puree products. The provisions do not apply to products intended for the manufacture of fine bakery wares, pastries or biscuits. For the purposes of this Directive, tomatoes, the edible parts of rhubarb stalks, carrots, sweet potatoes, cucumbers, pumpkins, melons and watermelons are considered as fruit. The Department of Agriculture, Fisheries and Food, in conjunction with the FSAI, has produced a comprehensive leaflet on the Labelling of Jams, Jellies and Marmalades and should be consulted for further information. It is available at

79 SECTION 4 VERTICAL LEGISLATION Labelling The prescribed names as listed and defined in the Directive such as jam and marmalade must be used in trade to designate the products. Products cannot be marketed unless they comply with the definitions for these products. However, these prescribed product names may be used to designate other products in accordance with custom such as jelly provided it cannot be confused with jelly as defined in the Directive. The product names shall be supplemented by an indication of the fruit or fruits used, in descending order of weight of the raw materials used. However, for products manufactured from three or more fruits, the indication of the fruits used may be replaced by the words mixed fruit or a similar wording, or by the number of fruits used. The following must also appear on the label: the fruit content* by including the words prepared with g of fruit per 100g of the finished product, after deduction of the weight of water used in preparing the aqueous extracts, if appropriate the total sugar content* by the words total sugar content g per 100g, the figure indicated representing the value determined by refractometer at 20 C for the finished product, subject to a tolerance of ±3 refractometric degrees. The sugar content need not, however, be indicated where a nutrition claim is made for sugars on the labelling pursuant to Directive 90/496/EEC on nutrition labelling (Section 2.3) where the residual content of sulphur dioxide is more than 10mg/kg, its presence shall be indicated on the list of ingredients Competent authority The policy functions in relation to the Regulations on fruit jams are the responsibility of the Food Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Department of Agriculture, Fisheries and Food Environmental Health Department of the Health Service Executive. 4.9 NATURAL MINERAL WATERS, SPRING WATERS AND OTHER BOTTLED WATERS Legislation European legislation Council Directive 80/777/EEC regarding the exploitation and marketing of natural mineral waters Amended by: Council Directive 96/70/EC. Commission Directive 2003/40/EC on establishing the list, concentration limits and labelling requirements for the constituents of natural mineral waters and the conditions for using ozone-enriched air for the treatment of natural mineral waters and spring waters Council Directive 98/83/EC on the quality of water intended for human consumption. National legislation European Communities (Natural Mineral Waters, Spring Waters and Other Waters in Bottles or Containers) Regulations, 2007 (S.I. No. 225 of 2007) Introduction to natural mineral waters, spring waters and other bottled waters Council Directive 80/777/EEC and its amendment set rules regarding the exploitation and marketing of natural mineral waters. Commission Directive 2003/40/EC establishes the list of constituents of natural mineral waters which may present a risk to public health as well as labelling requirements for certain constituents. It also defines the conditions for using ozone-enriched air for separating certain compounds and appropriate labelling provisions. The 2007 Regulations repeal and replace the 2005 Regulations and implements the European Directives above as well Council Directive 98/83/EC on the quality of water intended for human consumption which relate to "other waters in bottles or containers". There are three types of water which can be bottled: natural mineral water spring water all other waters. 4 * The declaration of fruit content and total sugar content must appear in clearly visible characters and the same visual field as the product name.

80 78 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Natural mineral water Under the Directive, a natural mineral water is defined as a microbiologically wholesome water originating in an underground water table or deposit and emerging from a spring tapped at one or more natural bore exits. It is clearly distinguished from ordinary drinking water by its nature as a result of its mineral content, its constituents and its original state. Natural mineral waters must not be subjected to any treatment or addition although there are some exemptions such as the introduction of carbon dioxide under special conditions. A natural mineral water may only be exploited subject to permission from the responsible authority of the country where the water has been extracted. In Ireland the responsible authority is the National Standards Authority of Ireland (NSAI). The NSAI has produced an Irish Standard 432:2005 on Packaged Water which covers water that is placed in a sealed container or package and is offered for sale, or supply for human consumption. Compliance with this standard is voluntary on the part of producers (Further information is available at The natural mineral water rules apply to water extracted from the ground in any Member State of the EU as well as to 3rd country imports. A list of all approved natural mineral waters is published in the Official Journal of the European Communities (available at and Spring water Spring Water is a description reserved for water which is intended for consumption in its natural state, comes from an underground source, protected from all risk of pollution and is bottled at source. Only very limited treatments are permitted. Water which does not meet the requirements of a natural mineral water but is a spring water must comply with the natural mineral waters legislation above and with the rules on drinking water. All other water in bottles and containers Water which is intended for human consumption and is not a natural mineral water or a spring water and is placed on the market in either bottles or containers must be free from any micro-organism and parasites and from any substances which in numbers or concentrations, constitute a potential danger to human health. 'Other waters' must meet the minimum requirements set out in the legislation. The natural mineral water rules do not effect the use of natural mineral waters and spring waters in the manufacture of soft drinks. The rules also do not apply to: waters which are medicinal products (according to European Directive 2001/83/EC as amended on the Community code relating to medicinal products for human use see Section ) natural mineral waters used at source for curative purposes in thermal or hydromineral establishments or natural mineral waters for export to countries outside the European Union Labelling: natural mineral waters The packaging or container of a natural mineral water must be fitted with closures designed to avoid adulteration and contamination. The label of a natural mineral water must state the following: (i) the label must declare the sales description natural mineral water as defined in the Directive or for effervescent natural mineral waters the sales names: naturally carbonated natural mineral water i.e. any water whose carbon dioxide content is the same from the spring after decanting and bottling as it is at source or natural mineral water fortified with gas from the spring i.e. any water whose carbon dioxide content from the spring after decanting and bottling is greater than that at source or carbonated natural mineral water i.e. any water to which carbon dioxide has been added other then the spring from which the water comes. Natural mineral waters which have undergone total or partial elimination of free carbon dioxide exclusively by physical methods must supplement the sales description with the words fully de-carbonated or partially de-carbonated as appropriate. (ii) a statement of the analytical composition detailing the characteristic constituents of the natural mineral water

81 SECTION 4 VERTICAL LEGISLATION 79 (iii) the place where the spring is exploited and the name of the spring. The place where the natural mineral water spring is exploited or the name of the locality may appear in the trade description provided the spring is exploited at that place and this does not mislead the consumer with regard to the place of exploitation of the spring. Where the trade description is different from the name of the spring or its place of exploitation, the name of the spring on the label or anywhere during its advertisement must be one and half times the height and width of the letters of the trade description. (iv) details of certain permitted treatments undergone. It is not permitted for labels, packaging or advertising of natural mineral waters to use designations, proprietary names, trade marks, brand names, illustrations etc. which suggest the natural mineral water has characteristics which the water does not possess especially regarding its origin, date of authorisation of exploitation, results of analysis or guarantees of authenticity. It is prohibited to market more than one natural mineral water from the same source under a different trade description. In addition, and in accordance with Directive 2003/40/EC the label of a natural mineral water with a fluoride concentration exceeding 1.5mg/l must declare: the words contains more than 1.5mg/l of fluoride: not suitable for regular consumption by infants and children under 7 years of age. This information must be in the immediate proximity to the trade name in clearly visible characters and the actual fluoride content in relation to the physicochemical composition in terms of its essential constituents (as per point (ii) above). The labelling of natural mineral waters which have been treated with ozone-enriched air shall bear the words water subjected to an authorised ozone-enriched air oxidation technique in proximity to the analytical composition of characteristic constituents Labelling: spring waters The term spring water is reserved for water that is intended for human consumption in its natural state and bottled at source. It must adhere to certain conditions of exploitation, microbiological requirements, labelling provisions and a limited number of permitted treatments (according to Directives 80/777/EEC as amended). However, spring waters must also comply with the provisions of Directive 80/778/EC relating to the quality of water intended for human consumption. Labels of spring water must detail the following: (i) the place where the spring is exploited and the name of the spring. The place where the spring is exploited or the name of the locality may appear in the trade description provided the spring is exploited at that place and this does not mislead the consumer with regard to the place of exploitation of the spring. Where the trade description is different from the name of the spring or its place of exploitation the name of the spring on the label or anywhere during its advertisement must be one and half times the height and width of the letters of the trade description. (ii) details of certain permitted treatments undergone. The packaging, labels or advertising of spring waters must not use designations, proprietary names, trade marks, brand names, illustrations or other signs whether emblematic or not, which are liable to cause confusion with natural mineral waters, in particular the description mineral water. It is prohibited to market more than one spring water from the same source under a different trade description. In addition, and in accordance with Directive 2003/40/EC the labelling of spring waters which have been treated with ozone-enriched air shall bear the words water subjected to an authorised ozone-enriched air oxidation technique in proximity to the analytical composition of characteristic constituents. 4

82 80 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND Labelling: other waters in bottles and containers The packaging, labels or advertising of other waters must not use designations, proprietary names, trade marks, brand names, illustrations or other signs whether emblematic or not, which are liable to cause confusion with natural mineral waters, in particular the description mineral water Competent authority The policy functions in relation to the Regulations on natural mineral waters, spring waters and other waters are the responsibility of the Food Unit, Department of Health and Children. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: National Standards Authority of Ireland (NSAI) Environmental Health Department of the Health Service Executive. PART B: COMMON MARKETING STANDARDS 4.10 BEEF AND BEEF PRODUCTS (INCLUDING MINCED BEEF) Legislation European legislation Council Regulation (EC) No. 1760/2000 establishes a system of identification and registration of bovine animals and the labelling of beef and beef products Commission Regulation (EC) No. 1825/2000 laying down detailed rules for the application of Regulation (EC) No. 1760/2000 as regards the labelling of beef and beef products Amended by: Commission Regulation (EC) No. 275/2007 as regards the labelling of beef and beef products. National legislation National provisions not derived from European legislation Health (Country of Origin of Beef) Regulations 2006 (S.I. No. 307 of 2006) Introduction to beef and beef products The Regulations require a mandatory traceability system for all E.U. bovines from farms to slaughterhouses and a mandatory system of traceability and origin labelling for beef from slaughterhouses to end consumers. This labelling system for beef consists of two elements, a compulsory beef labelling system and a voluntary beef labelling system, with the objective of providing maximum transparency during the marketing of beef. The requirements apply to all fresh or frozen beef, either carcasses, de-boned meat, cut meat or minced meat, which are marketed in the E.U. The information required under the Beef Labelling Regulations should be applied to or attached to individual pieces of meat or to their packaging material. Where beef is not wrapped, the information is required to be provided in a written and visible form to the consumer at point of sale. Two guides have recently been published by the FSAI: Guidance on beef labelling which outlines in detail the requirements for the labelling of beef (available at and Guidance Note 17: The labelling of meat which provides an overview of the legislative requirements for the documentation and labelling of all meats including beef (available at These guides should be consulted for a more detailed account of the labelling of meat including beef Labelling: compulsory beef labelling system Compulsory beef labelling requires operators or organisations to label beef with specific information at all stages of marketing up to and including the point of sale to the consumer. It should be noted that where the name of country is required on the label this means that either the name of the Member State or the name of the third country (a country outside the European Union) must be provided. European Communities (Labelling of Beef and Beef Products) Regulations, 2000 (S.I. No. 435 of 2000) Amended by: European Communities (Labelling of Beef and Beef Products) Regulations, 2002 (S.I. No. 485 of 2002).

83 SECTION 4 VERTICAL LEGISLATION 81 Operators or organisations are required to label beef with the following information: 1) the reference number or code of the animal or group of animals from which the beef was derived 2) the country of the slaughterhouse and approval number. The indication should read:- Slaughtered in (name of country) (approval number). 3) the country of the cutting hall and approval number. The indication should read:- Cutting in (name of country) (approval number). 4) Origin of the beef. (i) If the beef is derived from animals born, raised and slaughtered in the same country, the indication on the label may be given as Origin: (name of country).for example, Origin: Ireland (ii) If the beef is derived from animals from different countries the label must indicate: country of birth country (or countries) of fattening country of slaughter e.g. Born in France Reared in France Slaughtered in Ireland. Minced meat There is an exception to the compulsory beef labelling system for minced beef. An operator or organisation preparing minced beef can indicate on the label: prepared in (name of country) depending on where the meat was prepared origin (name of country) where the country or countries of origin are not the same as the country of preparation a reference number or reference code ensuring the link between the meat and the animal or group of animals and the name of the country where the animal was slaughtered. In addition, an operator or organisation preparing minced beef may add the following to the label: one or more of the compulsory indications above for beef if they wish, such as where fattening took place and the date on which it was prepared. Operators and organisations involved in the production and marketing of beef, when implementing the requirements of the compulsory beef labelling system should ensure that a system is in place to guarantee the accuracy of the information on the labels. Trimmings and cut meats As a result of problems encountered by producers of cut meats and trimmings and producers of minced meat in the practical application of the Regulations on the labelling of beef and beef products, Commission Regulation (EC) No. 275/2007 was adopted. In order to resolve the vast majority of these issues, Regulation (EC) No. 275/2007 redefines the size and composition of an animal group while ensuring traceability. Experience has also shown that operators often have difficulties in applying the labelling provisions in outlets for the sale of non pre-packaged cut meats to the final consumer. In this respect, the Regulation (EC) No. 275/2007 sets out additional labelling requirements for trimmings, pre-packaged cut meat and non pre-packaged cut meat. 4

84 82 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Beef from third countries By way of derogation, beef imported into the Community for which not all the information referred to above is available, shall be labelled with the words: Origin: non-ec ; Slaughtered in (name of third country). Labelling where information is not available Meat derived from animals born in the Community before 1st January 1998, where there is no information regarding the place of birth and/or the place of rearing, the label should state: Born before 1st January Meat derived from animals imported live into the Community where there is no information regarding the place of birth and/or the place of rearing, the label should state: Live import into the EU or Live import from (name of 3rd country). Simplification of the indication or origin Beef derived from animals that have been reared for 30 days or less in the country of birth or the country of slaughter, are not required to have this country on the label provided that the animal has been reared for a period longer than 30 days in another country (i.e. the country where the animal spent the longest period of time appears on the label) Labelling: voluntary beef labelling system Council Regulation (EC) No. 1760/2000 permits operators to put additional information on labels. Operators wishing to place information on the label additional to the requirements of the compulsory labelling system must first submit an application for approval to the competent authority where the sale or production of the beef takes place. In Ireland it is the responsibility of the Department of Agriculture, Fisheries and Food. The competent authority is obliged to examine the application thoroughly, particularly to ensure that the traceability system is capable of verifying the information on the label. The costs of the controls carried out by an independent control body must be borne by the operators. Approval by the Department of Agriculture, Fisheries and Food of the information to be provided on the label will depend on the application submitted by the operator or organisation indicating: the information to be included on the label the measures to be taken by the operator or organisation to ensure the accuracy of the information the control system to be applied at all stages from production through to the point of sale including checks to be carried out by an independent control body designated by the applicant for this purpose. These bodies must comply with the criteria set out in European Standard EN/ For example, labels wishing to contain the following type of information, relating to the animals from which the beef was produced, must be approved: method of fattening information on slaughtering, e.g. age at slaughter or date of slaughter, sex method or length of maturation of beef breed other information not easily checked at point of sale County of origin of beef for caterers The Department of Health and Children introduced national legislation to better inform consumers on the origin of beef sold to consumers by the service sector (restaurants, canteens and similar premises). The Health (Country of Origin of Beef) Regulations, 2006 (S.I. No. 307 of 2006) as amended, require caterers serving beef to clearly identify the country or countries of origin of the beef on any advertisement, menu or other presentation used. The FSAI has produced an information leaflet entitled Advice for Caterers on the Country of Origin Beef Labelling Requirements and is available at Competent authority The policy functions in relation to the Regulations on beef labelling are the responsibility of the Meat Policy and Meat Hygiene Divisions, Department of Agriculture, Fisheries and Food.

85 SECTION 4 VERTICAL LEGISLATION 83 These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Department of Agriculture, Fisheries and Food Environmental Health Department of the Health Service Executive Local Authorities SPREADABLE FATS Legislation European legislation Council Regulation (EC) No. 2991/94 laying down the standards for spreadable fats Implemented by: Commission Regulation (EC) No. 445/2007 laying down certain detailed rules for the application of Council Regulation (EC) No. 2991/94 laying down standards for spreadable fats and of Council Regulation (EEC) No. 1898/87 on the protection of designations used in the marketing of milk and milk products - Codified version. National legislation The EU Regulations have yet to be transposed into Irish legislation Introduction to spreadable fats Regulation (EC) No. 2991/94 sets compositional requirements for a wide range of spreadable fats, from dairy fats, to the more diverse mixtures of dairy and vegetable fats. Detailed rules for its application are set in Commission Regulation (EC) No. 445/2007. Regulation (EC) No. 445/2007 is a codified version of previous rules and was adopted in order to ensure the consistency between Community legislation, namely Regulation (EC) No. 2991/94 and (EEC) No. 1898/87 (Section 4.12). The aim of the latter two Regulations is essentially the same, namely to avoid any confusion in the mind of the consumer as to the true nature of the products in question. Therefore, the use of the designation butter should be regulated in a single text Labelling Only milk fats, fats and fats composed of plant and/or animal products adhering to the prescribed compositional requirements are covered by this Regulation. The spreadable fats must declare the following information in the labelling and presentation of the products: the sales description as defined in the Regulation such as Butter, Margarine and Dairy Spread X% Derogations to the sales descriptions for spreadable fats are permitted for traditional products or where the designations are used to describe characteristic qualities of a product, including the following English language terms: Brandy butter, sherry butter or rum butter : for a sweetened alcoholic product with a minimum milk-fat content of 20%; and Buttercream : for a sweetened product with a minimum milk-fat content of 22.5%. the total percentage fat content by weight at the time of production (the average fat content must be declared without the use of decimals), the vegetable, milk or other animal fat content in decreasing order of weighted importance as a percentage by total weight at the time of production for compound fats composed of plant and/or animal products and the percentage salt content in a legible manner in the list of ingredients. The information provided on the label must be easy to understand and marked in a conspicuous place in such a way as to be easily visible, clearly legible and indelible. The following may be provided on the label in addition to the mandatory requirements: the sales description may be used in conjunction with one or more terms to define the plant and/or animal species from which the product originates, or the intended use of the product or the production methods used as long as these terms are not in contradiction with other Community provisions such as Protected Geographical Indication (see Section 4.23) the term vegetable may be used in addition to the sales description of certain fats provided that the product contains only fat of vegetable origin with a tolerance of 2% of the fat content of animal fats the sales description minarine or halvarine may be used for half-fat margarine products 4

86 84 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 the term reduced fat may be used to replace the term three-quarter-fat or used for products where the fat content is between 41% and 62% and the term low fat or light may be used to replace the term half-fat or used for products where the fat content is less than 41%. Butter The designation butter may be used for composite products of which an essential part is butter if the end product contains at least 75% milk fat and has been manufactured solely from butter and the other added ingredients mentioned in the description. The designation butter may also be used for composite products containing less than 75% butter but at least 62% milk fat if the other specified requirements are met and if the product designation includes the term butter preparation. The designation butter may be used in association with a word or words to designate Alcoholic butter (butter containing alcoholic beverages and sugar) where it contains at least 34% milk fat. Where the designation butter is used in composite products the milk fat content and the total fat contents (if the other added ingredients contain fat) must be indicated in the labelling and presentation of the product in a conspicuous place and be easily visible and clearly legible Competent authority The policy functions in relation to the Regulations on spreadable fats are the responsibility of the Milk Policy Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Department of Agriculture, Fisheries and Food MILK AND MILK PRODUCTS (a) Protection of reserved names Legislation European legislation Council Regulation (EEC) No. 1898/1987 on the protection of designations used in marketing of milk and milk products Amended by: Commission Regulation (EEC) No. 222/1988. Implemented by: Commission Regulation (EC) No. 445/2007 laying down certain detailed rules for the application of Council Regulation (EC) No. 2991/94 laying down standards for spreadable fats and of Council Regulation (EEC) No 1898/87 on the protection of designations used in the marketing of milk and milk products - Codified version. National legislation The EU Regulations have yet to be transposed into Irish legislation Introduction to reserved names for milk and milk products Milk is defined as the normal mammary secretion obtained from one or more milkings without either addition thereto or extraction therefrom. Milk products are defined as products derived exclusively from milk. Substances necessary for their manufacture may be added provided that the substances are not used for replacing any milk constituents in part or whole. Council Regulation (EEC) No. 1898/1987 as amended regulates the protection of designations used in the marketing of milk and milk products. This Regulation defines milk and milk products and designates reserved names exclusively for milk products. The intention of the Regulation is to detail the difference between milk products and other food products including those consisting partly of milk components. (See Section 4.11 regarding Regulation (EC) No. 445/2007).

87 SECTION 4 VERTICAL LEGISLATION Labelling The term milk can only be used in marketing where: milk is treated without altering its composition or has undergone fat standardisation the term is used in association with words used to describe the milk in relation to its type, grade, origin and/or intended use or to describe the physical treatment or the modification in composition to which it has been subjected provided that the modification is restricted to an addition or removal of natural milk constituents. The following terms are reserved exclusively for milk products: the designations: whey, cream, butter, buttermilk, butteroil, caseins, anhydrous milkfat (AMF), cheese, yoghurt, kephir, and koumiss and designations or names used for milk products according to the Labelling Directive 2000/13/EC (see Appendix II). However, this provision does not apply to the designation of products the exact nature of which is clear from traditional usage and/or when the designations are clearly used to describe a characteristic quality of the product. The term milk and and the designations used for milk products may also be used in association with other words to describe composite products where the milk constituents are not replaced and where milk or milk products form an essential part of the product (in terms of quantity or characterization of the product). The origin of milk and milk products must be stated if it is not from a bovine source such as goats milk. Products other than milk and the reserved designations above may not claim, imply or suggest in the labelling, advertising or presentation of a product that it is a dairy product. However, in the case of a product containing milk or a milk product, the name milk or the reserved designations above may only be used to describe the raw materials as would be listed in the list of ingredients. (b) Drinking milk Legislation European legislation Council Regulation (EC) No. 2597/1997 lays down additional rules on the common organisation of the market in milk and milk products for drinking milk Amended by: Council Regulation (EC) No. 1602/1999 laying down additional rules on the common organisation of the market in milk and milk products for drinking milk Introduction to drinking milk This Regulation ensures that milk products contain at least the natural protein content of milk and to permit enrichment of drinking milk with milk proteins, mineral salts or vitamins or the reduction of its lactose content. It also lays down requirements concerning the composition of drinking milk. The European Regulations were implemented by the European Communities (Hygienic Production and Placing on the Market of Raw Milk, Heat-Treated Milk and Milk-Based Products) Regulations, 1996 (S.I. No. 9 of 1996). However, the 1996 Regulations have now been repealed by European Communities (Food and Feed) Regulations, 2005 (S.I. No. 910 of 2005) see Section Labelling The following sales descriptions shall be used for drinking milk, which is intended for delivery to the consumer without further processing: Raw milk milk that is not heated at above 40 C or treated otherwise but having an equivalent effect Whole milk heat treated milk which is either (a) fat standardised whole milk with a minimum 3.5% milk fat or (b) non fat standardised whole milk with a minimum 3.5% milk fat where the milk fat content has not been altered since the milking stage Semi-skimmed milk heat treated milk with its fat content reduced to a minimum of 1.5% and a maximum 1.8% Skimmed milk heat treated milk with a fat content reduced to a maximum of 0.5%. 4

88 86 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 The following modifications to drinking milk are permitted: a) modification of the natural fat content by the addition or removal of cream or the addition of whole, semiskimmed or skimmed milk in order to meet the milk fat criteria set out above b) enrichment of the milk with milk proteins, mineral salts or vitamins and c) reduction of the lactose content by conversion to glucose and galactose. Modifications to drinking milk according to b) and c) above are only permitted if the modification is indelibly indicated on the packing of the product so it can be easily seen and read. It should be noted that the provisions of Directive 90/496/EEC on nutrition labelling apply along with the provisions of the general labelling Directive 2000/13/EC, where milk or milk products are enriched and/or make a nutrition claim (see Section 2) Competent authority The policy functions in relation to the EU Regulations on reserved names for milk and drinking milk are the responsibility of the Milk Policy Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Department of Agriculture, Fisheries and Food QUICK FROZEN FOODS Legislation EU Legislation Council Directive 89/108/EEC relating to quick-frozen foodstuffs for human consumption. National legislation European Communities (Quick-Frozen Foodstuffs) Regulations 1992 (S.I. No. 290 of 1992) Amended by: European Communities (Monitoring of Temperature in the means of Transport, Warehousing and Storage of Quick-Frozen Foodstuffs and Sampling Procedure and Methods of Analysis for Control of the Temperatures of Quick-Frozen foods intended for human consumption) Regulations, 1995 (S.I. No. 370 of 1995) Introduction to quick frozen food Quick freezing is a rapid freezing process designed to preserve the characteristics of foodstuffs by ensuring a temperature of 18 o C or lower is reached at all points of the product. At this temperature all microbiological activity likely to impair the quality of a foodstuff is suspended. However, it is necessary to maintain at least that temperature during the storage and distribution of the quick-frozen foodstuffs until sale to the ultimate consumer. Certain temperature increases are inevitable and may be tolerated provided the tolerances do not exceed 3 C and provided they do not harm the quality of the products. Air, nitrogen and carbon dioxide are the only cryogenic (freezing) media permitted. According to the Directive quick-frozen foodstuffs are defined as foodstuffs: which have undergone a freezing process known as quick-freezing whereby the zone of maximum crystalisation is crossed as rapidly as possible depending on the type of product and where the resultant temperature of the product (after thermal stabalisation) is continuously maintained at 18 o C or lower at all points and which are marketed in such a way as to indicate that they possess this characteristic (such as quick-frozen ). Products cannot be marketed as quick-frozen unless they comply with the definition above. The requirements of the Directive do not apply to icecream and other edible ices Labelling Foods intended for sale to the ultimate consumer or mass caterer The following must appear on the label of quick-frozen foods intended to supply without further processing the consumer, restaurants, hotels, mass caterers, etc: the term quick-frozen added to the sales name the date of minimum durability (defined as the period during which quick-frozen products may be stored by the purchaser), the storage temperature and/or the type of storage equipment required a reference number or an equivalent mark in order to the identify a batch and a clear declaration: do not refreeze after defrosting.

89 SECTION 4 VERTICAL LEGISLATION 87 Quick frozen foodstuffs intended for supply to the ultimate consumer must be packed by the manufacturer or packer in suitable pre-packaging which protects them from microbial or other external contamination and against drying. Foods not intended for sale to the ultimate consumer or mass caterer Less restrictive requirements apply where the product is not intended for sale to the final consumer, restaurants, hospitals, canteens and other similar mass caterers. The following shall appear on the label, packaging, container or wrapping of the products not intended for sale to the ultimate consumer or mass caterer: the term quick-frozen added to the sales name the net quantity in units of mass a reference number or an equivalent mark in order to the identify a batch and the name or business name and address of the manufacturer, packager or seller established within the European Union. This information can appear on the packaging, container, wrapping or label Competent authority The policy functions in relation to the Regulations on quick frozen food are the responsibility of the Food Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Department of Agriculture, Fisheries and Food Health Service Executive Department of Communications, Energy and Natural Resources Local Authorities Office of the Director of Consumer Affairs (authorised under legislation) EGGS Legislation EU Legislation Council Regulation (EC) No. 1028/2006 on marketing standards for eggs Implemented by: Commission Regulation (EC) No. 557/2007 on marketing standards for eggs. National legislation European Communities (Marketing Standards for Eggs) Regulations, 2005 (S.I. No. 172 of 2005) Introduction to eggs Regulation (EC) No. 1028/2006 lays down the conditions for marketing eggs within the Community. It applies to both eggs produced in the Community and imported from third countries. The marketing conditions also apply to eggs for export outside the Community. Regulation (EC) No. 1028/2006 repeals and replaces the previous Regulation (EEC) No. 1907/1990 from 1st July A new implementing Regulation (EC) No. 557/2007 has recently also been published which sets detailed rules to implement Regulation (EC) No. 1028/2006, including detailed labelling requirements and repeal the previous implementing rules (i.e. Regulation (EC) No. 2295/2003). Our national Regulations will be required to be amended accordingly. The Regulations do not apply to eggs sold directly to the final consumer by the producer on the production site or in a local public market or by door-to-door selling in the region of production. However, such eggs must be marked with the producer s distinguishing code (see Section ). Eggs are graded by quality (depending on certain characteristics such as shell and cuticle shape) into one of two categories: Class A or fresh or Class B. Class A eggs are also graded by weight as follows. (a) XL-very large: weight 73g; (b) L-large: weight 63g and < 73g; (c) M-medium: weight 53g and < 63g; (d) S-small: weight < 53g. 4

90 88 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND Labelling Marking of eggs Class A eggs must be marked with the producer code. Class B eggs must be marked with the producer code and/or with another indication. Member States may exempt Class B eggs from this requirement where those eggs are marketed exclusively on their territory. The marking of eggs must take place at the production site or at the first packing centre to which the eggs are delivered. Eggs sold by the producer to the final consumer on a local public market in the region of production must be marked with the producer s distinguishing code. However, Member States may be exempt from this requirement for producers with up to 50 laying hens, provided that the name and address of the producer are indicated at the point of sale. It is the responsibility of packing centers to grade and pack eggs and label their packs. The producer code (as detailed in the Annex to Directive 2002/4/EC on the registration of establishments keeping laying hens) must be easily visible and clearly legible and be at least 2mm high. Where it is not possible for technical reasons to mark cracked or soiled eggs, marking with the producer code shall not be compulsory. Indications on Class B eggs The markings on Class B eggs shall be a circle at least 12mm in diameter around the letter B at least 5mm high, or an easily visible colour spot of at least 5mm in diameter. Packs marked as extra The words extra or extra fresh may be used as an additional quality indication on packs containing Class A eggs until the ninth day after laying of the eggs. However, the laying date and the time limit of nine days shall be shown on the pack in such a way as to be easily visible and clearly legible. Time limits Eggs must be graded, marked and packed within ten days of laying. Extra or extra fresh Class A eggs must be graded, marked and packed within four days of laying. Weight grading The weight grading shall be indicated by the corresponding letters or terms as detailed above or by a combination of both, which may be supplemented by the corresponding weight ranges, e.g. XL-very large: weight 73g. Other additional indications may also be used, provided that such indications are not likely to be mistaken for the weight grading letters or terms and they comply with the general labelling Directive 2000/13/EC (see Section 2.1). Where Class A eggs of different sizes are packed together in the same pack, the minimum net weight of the eggs shall be given in grams and the indication Eggs of different sizes or equivalent terms shall appear on the outer surface of the pack. Marking of eggs delivered directly to the food industry The marking requirements on eggs shall not apply to eggs produced in the Community, collected by the food industry operator for processing until 30th June Subsequently, from 1st July 2008, Member States may exempt operators at their request from the marking of eggs where eggs are delivered directly from the production site to the food industry. Marking of egg packs Packs containing Class A eggs shall bear on the outer surface in easily visible and clearly legible type: (a) the packing centre code (b) the quality grading: packs shall be identified either by the words Class A or the letter A whether alone or in combination with the word fresh (c) the weight (d) the date of minimum durability (e) the wording washed eggs where appropriate (f) the following special storage condition: an indication advising consumers to keep eggs chilled after purchase. In addition, packs containing Class A eggs shall indicate: the farming method on the outer surface which must be easily visible and clearly legible For the identification of the farming method, only the terms listed in Annex I of Regulation (EC) No. 557/2007 are permitted in accordance with specific conditions. Terms for organic production are also permitted in accordance with Council Regulation (EEC) No. 2092/91 on organic production (Section 4.22) The farming method may be complemented by one of the indications listed in Annex I of Regulation (EC) No. 557/2007 in accordance with certain requirements the meaning of the producer code shall be explained on or inside the pack.

91 SECTION 4 VERTICAL LEGISLATION 89 Packs containing Class B eggs shall bear on the outer surface in easily visible and clearly legible type: (a) the packing centre code (b) the quality grading: packs shall be identified either by the words Class B or the letter B (c) the packing date. Member States may require, for packs of eggs produced on their territory, that the labels be affixed in such a way so as to be broken when opening the packs. Indication of the date of minimum durability The date of minimum durability is set at not more than 28 days after laying. Where the period of laying is indicated, the date of minimum durability shall be determined from the first day of that period. Information to be displayed for loose egg sales For loose egg sales, the following information shall be given in such a manner as to be easily visible and clearly legible to the consumer: (a) the quality gradings (b) the weight grading (c) an indication of the farming method (d) an explanation of the meaning of the producer code (e) the date of minimum durability. Industrial eggs Industrial eggs shall be marketed in packaging containers with a red band or label. Those bands and labels shall show: (a) the name and address of the operator for whom the eggs are intended (b) the name and address of the operator who has dispatched the eggs (c) the words industrial eggs in capital letters 2cm high, and the words unsuitable for human consumption in letters at least 8mm high. Information displayed on transport packaging At the production site, each transport packaging containing eggs shall be identified by the producer by: (a) the producer s name and address (b) the producer code (c) the number of eggs and/or their weight (d) the laying date or period (e) the date of dispatch. Marking of eggs for cross-border delivery Eggs delivered from a production site to a collector, a packing centre or non-food industry situated in another Member State shall be marked with the producer code before leaving the production site. Import of eggs In accordance with the equivalence of rules (including regarding marking and labelling, farming methods and controls), eggs imported from third countries may be marked with a distinguishing number equivalent to the producer code. If sufficient controls are not provided, imported eggs from the third country concerned must bear a code permitting the identification of the country of origin and the indication that the farming method is unspecified Competent authority The policy functions in relation to the Regulations on eggs are the responsibility of the Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the Department of Agriculture, Fisheries and Food, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations. 4

92 90 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND WINE Legislation EU Legislation Council Regulation (EC) No. 1493/1999 on the common organisation of the market in wine and its many amendments Implemented by: Commission Regulation (EC) No. 1622/2000 on the common organisation of the market in wine and establishing a Community code of oenological practices and processes and its amendments Amended by Commission Regulation (EC) No. 389/2007 Application: Commission Regulation (EC) No. 753/2002 as regards the description, designation, presentation and protection of certain wine sector products and its amendments Amended by: Commission Regulation (EC) No. 382/2007. There are also a number of other related Regulations. National legislation The EU Regulations have yet to be transposed into Irish legislation Introduction to wine Council Regulation (EC) No. 1493/1999 as amended regulates the marketing of wine. Numerous implementing measures and related Regulations have also been published which are not detailed in this guide. The common organisation of the market in wine comprises of rules governing wine-production potential, market mechanisms, producer organisations and sectoral organisations, oenological practices and processes, description, designation, presentation and protection, quality wine psr and trade with third countries. These rules apply to many different products such as wine of fresh grapes (including fortified wines) and wine vinegar. The Regulation defines various types of wine such as wine, table wine, sparkling wine, semi-sparkling wine, liqueur wine and quality wines produced in specified regions. The two main categories of wine are however quality wines produced in specified regions and table wines. Quality wines produced in specified regions, known as quality wines psr, are wines that comply with certain criteria and come from certain areas. Only certain products are suitable for yielding a quality wine psr and a number of production rules must be respected. Each Member State must notify the European Commission of quality wines psr in their area. The list of quality wines psr is published in the Official Journal of the European Union. Table wines are generally wines other than quality wines psr where certain conditions such as vine varieties and alcoholic strength are met. Regulation (EC) No. 1493/1999 contains eight Annexes detailing exactly how wine should be produced and marketed: Annex I defines product names such as wine, table wine, liqueur wine and sparkling wine Annex II defines alcoholic strengths such as actual, potential, total and natural alcoholic strength Annex III details approved wine-growing zones, such as the wine-growing zone C II which in Spain includes the area under vines in the province of La Rioja Annex IV lists authorised oenological processes and practices, such as acidification, and sweetening for the purpose of ensuring the proper refinement of the product, Annex V sets limits and conditions for certain oenological practices, such as a total sulphur dioxide content of 160mg and 210mg for red and white wine respectively (with exceptions) Annex VI details provisions for quality wines produced from specified regions Annex VII details the description, designation, presentation and protection of certain products other than sparkling wine and Annex VIII details the description, designation, presentation and protection of sparkling wine. Specifically Title V, Chapter II and Annex VII and VIII of the Regulation set out the rules for the description, designation and presentation of wine including some labelling requirements. The description, designation and presentation of products covered by this Regulation can significantly effect their marketability. Therefore, this Regulation lays down rules which take into account the legitimate interests of consumers and producers and promotes the smooth operation of the internal market and the production of quality products.

93 SECTION 4 VERTICAL LEGISLATION 91 The fundamental principles of these rules is to provide for the obligatory use of certain terms so as to identify the product and provide consumers with certain important items of information and the optional use of other information. The rules include provisions on the prevention of fraudulent practices, penalties at Community level to be applied in the event of improper labelling, use of languages, in particular when different alphabets are involved, and the use of brand names, especially when these could cause confusion amongst consumers. In view of the differences between products covered by this Regulation and their markets, and the expectations of consumers and traditional practices, the rules are differentiated according to the products concerned. Rules are also applied to the labelling of imported products, in particular to clarify their origin and to avoid any confusion with Community products. In addition, the use of geographical indications and other traditional terms is permitted Labelling The requirements relating to the description, designation, presentation and protection of wine as set out in Council Regulation (EC) No. 1493/1999 are very detailed. The following is a summary of the main provisions, however, the Regulation should be read in conjunction with this section for a full list of the labelling and presentation requirements. Compulsory labelling The following mandatory information must appear on the label of table wines, table wines with geographical indication and quality wines psr, wines originating in third countries, liqueur wines, semi-sparkling wines and aerated semi-sparkling wines: the sales designation of the product such as liqueur wine or the name of the product (as defined in the Regulation) the nominal (average) volume the actual alcoholic strength by volume the lot number (see also Section 2.2 on the identification of foodstuffs lot). Table wines, table wines with geographical indication and quality wines psr, and wines originating in third countries must also include on the label: the name or corporate name of the bottler, the local administrative area and the Member State or, for containers with a nominal volume of more than 60 litres, the consignor, for imported wines, the importer or, when bottling took place in the Community, the bottler. The sales description must also be provided on the label for the various types of wine as follows: A. Table wines the words table wine the Member State of origin or where the wine is a mixture of products from a number of Member States, the declaration mixture of wines from different countries of the European Community or where wine is produced in one Member State from grapes harvested in another, the declaration wine obtained in.from grapes harvested in., the words retsina and vino tinto de mezcla for certain table wines. B. Table wines with geographical indications the words table wine the name of the geographical unit such as the locality or wine growing region under certain conditions the term regional wine, in which case the words table wine will not be required. C. Quality wines psr the production area or specified region of origin, the words quality wine produced in a specified region or quality liqueur wine psr or quality semisparkling wine psr as appropriate. D. Imported wine the word wine must be provided in addition to the name of the country of origin or in addition to the name of the geographical area if the wine is designated with a geographical indication. E. Other wines The names liqueur wine, semi-sparkling wine or aerated semi-sparkling wine as appropriate. 4

94 92 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Language All information on the label must be given in one or more of the official languages of the Community so that the final consumer can easily understand the items on the label. However, the following must be given solely in the official language of the Member State where the product was prepared: the name of the specified region the name of another geographical unit the traditional specific terms and the additional traditional particulars the name of the vineyards or their associations and bottling particulars. Brand names The description, presentation and advertising of the various wine products may be supplemented by brand names. However, such brand names may not contain any words, parts of words, signs or illustrations which are likely to cause confusion or mislead the consumer. Table wines, table wines with geographical indication and quality wines psr may declare the following on the label in addition to the mandatory provisions above: the names, titles and addresses of the persons that took part in the marketing the type of product a particular colour in accordance with the rules laid down by the Member State of production. Table wines with geographical indications and quality wines psr may also declare: the vintage year the name of one or more vine varieties an award, medal or competitive achievement indications concerning the means used to obtain the product or methods used in its manufacture other traditional terms in accordance with the provisions laid down by the Member State of production the name of a vineyard a term indicating where the wine was bottled such as on the estate or by a group of vineyards. Quality wines psr may also: reference geographical areas in certain circumstances in order to specify the origin of the wine provide information to the effect that bottling took place in the specified region, provided that such information is traditional and customary in the specified region concerned Competent authority The policy functions in relation to the EU Regulations on wine are the responsibility of the Food Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the Department of Agriculture, Fisheries and Food AROMATISED WINES Legislation EU legislation Council Regulation (EEC) No. 1601/1991 laying down general rules on the definition, description and presentation of aromatised wines, aromatised winebased drinks and aromatised wine-product cocktails Amended by: Council Regulation (EC) No. 3279/1992, Council Regulation (EEC) No. 3378/1994, Council Regulation (EC) No. 2061/1996, Regulation (EC) No. 1882/2003. National legislation European Communities (Definition, Description and Presentation of Aromatised Wines, Aromatised Wine- Based Drinks and Aromatised Wine-Product Cocktails) Regulations, 1998 (S.I. No. 254 of 1998) Introduction to aromatised wines The Regulations lay down the general rules on the definition, description and presentation of aromatised wines, e.g. Vermouth, aromatised wine-based drinks, e.g. Sangria and Glühwein, and aromatised wine-product cocktails. The rules on aromatised drinks ensure consumers receive more detailed information on the labelling of these products in view of the nature of the drinks in question.

95 SECTION 4 VERTICAL LEGISLATION Labelling Aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails are defined in the Regulations and these reserved sales descriptions must be used in trade to designate them. Products not falling under the Regulations are not permitted to use these names. A description of a particular category of aromatised wine as detailed in the Regulations may replace the words aromatised wine on the label. In addition, the description aromatised wine may be replaced by wine-based aperitif (the use of the term aperitif is without prejudice to the use of the term to define products which do not fall within the scope of this Regulation). A description of a particular category of aromatised wine-based drinks or aromatised wine-product cocktails as detailed in the Regulations, may replace the sales description in the Member State of production or maybe used to supplement these words in the other Member States. The reserved names aromatised wine and aromatised wine-based drink or their permitted descriptions may also include the following particulars under certain circumstances: extra-dry dry semi-dry semi-sweet and sweet. The terms semi-sweet and sweet may be replaced by an indication of the sugar content, expressed in grams of invert sugar per litre. The reserved sales descriptions may be supplemented by a reference to the main flavouring used. Certain geographical designations are permitted and may replace the reserved descriptions or supplement them forming composite descriptions. The permitted geographical designations cannot not be translated. Aromatised drinks which do not comply with this Regulation may not be marketed for human consumption by associating words or phrases such as like, type, style, make, flavour or any other similar indications with any of the descriptions mentioned in this Regulation. Where the alcohol used in the manufacture of the drinks covered by this Regulation comes from one sole raw material (for example, solely wine alcohol, molasses alcohol or grain alcohol), the nature of the alcohol may be indicated on the label. However, where the alcohol comes from several raw materials, no special indication relating to the nature of the alcohol can appear on the label. The labelling must be in one or more official languages of the Community in such a way that the final consumer can readily understand each item, unless purchasers are provided with the information by other means. In the case of drinks originating in the Community and intended for export, the labelling particulars may be repeated in another language Competent authority The policy functions in relation to the Regulations on aromatised wines are responsibility of the Food Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Department of Agriculture, Fisheries and Food Health Service Executive SPIRIT DRINKS Legislation EU legislation Council Regulation (EEC) No. 1576/1989 laying down general rules on the definition, description and presentation of spirit drinks Amended by: Council Regulation (EEC) No. 3280/1992, Regulation (EC) No. 3378/1994 and Regulation (EC) No. 1882/2003. Commission Regulation (EEC) No. 1014/1990 laying down detailed implementing rules on the definition, description and presentation of spirit drinks Amended by: Commission Regulation (EEC) No. 1180/1991, Commission Regulation (EEC) No. 1781/1991, Commission Regulation (EEC) No. 3458/1992, Commission Regulation (EC) No. 2675/1994, Commission Regulation (EC) No. 1712/1995, Commission Regulation (EC) No. 2626/95, Commission Regulation (EC) No. 2523/1997 and Commission Regulation (EC) No. 2140/

96 94 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 National legislation European Communities (Definition, Description and Presentation of Spirit Drinks) Regulations, 1995 (S.I. No. 300 of 1995) Amended by: European Communities (Definition, Description and Presentation of Spirit Drinks) Regulations, 1996 (S.I. No. 60 of 1996) and Regulations, 1998 (S.I. No. 7 of 1998). Irish Whiskey Act, 1980 (S.I. No. 33 of 1980) Introduction to spirit drinks Council Regulation (EC) No. 1576/1989 and its amendments lay down the general rules on the definition, description and presentation of spirit drinks. Further detailed rules for its implementation are contained in Commission Regulation (EC) No. 1014/1990 and its amendments. Our national Regulations, 1995 to 1998, give effect to both EU Regulations. These rules set out the production, composition and minimum alcoholic strengths for each product covered by the legislation and their labelling requirements. The Irish Whiskey Act, 1980 defines the production and labelling requirements of Irish whiskey and blended Irish whiskey Labelling Spirit drinks are defined as alcoholic liquids intended for human consumption, which have particular organoleptic qualities and, have (with the exception of advocaat and two Barenfang products) a minimum alcoholic strength of 15% volume. The following mandatory information must appear on the label of a spirit drink: the reserved name of the spirit drink such as whiskey, brandy, gin, vodka, etc. Only products complying with the specific definitions and requirements as defined in the legislation have the exclusive use of the reserved name such as Irish Whiskey or Irish Whisky. Spirit drinks that do not meet the specific requirements of the reserved names (whiskey, brandy etc.) may only be described as spirit drinks or spirits. the protected geographical designation reserved exclusively for spirit drinks may supplement or replace (in certain circumstances) the reserved names provided they were produced in the geographical area indicated. For example, the geographical designation Irish Cream may appear on it s own or accompanied by its reserved name liqueur (the list of the protected geographical designations for spirit drinks are contained in Annex II to Council Regulation (EC) No. 1576/89 as amended) (see also Regulation (EEC) No. 2081/1992 Section 4.23) geographical indications other than those which are protected may supplement the reserved names provided they do not mislead consumers such as Irish vodka the minimum alcoholic strength by volume as prescribed for each product such as Whiskey 40%; Rum, Gin and Vodka 37.5% and Brandy 36% a reference to the place of manufacture and/or origin and/or source of the spirit drink for certain spirit drinks. One or more of the following labelling requirements may also be provided in addition to the declarations above: where the labelling indicates the raw material used to produce the ethyl alcohol of agricultural origin, each agricultural alcohol used must be mentioned in descending order of quantity used the term blend name may be provided in addition to the name of the spirit drink where the product has undergone blending and the maturation period may be specified only where it refers to the youngest alcoholic component and provided that the product was aged under supervision Competent authority The policy functions in relation to the Regulations on spirit drinks are the responsibility of the Food Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations; Department of Agriculture, Fisheries and Food Health Service Executive.

97 SECTION 4 VERTICAL LEGISLATION OLIVE OIL Legislation EU legislation Commission Regulation (EC) No.1019/2002 on the marketing standards for olive oil Amended by: Commission Regulation (EC) No. 1176/2003, Commission Regulation (EC) No. 406/2004 and Commission Regulation (EC) No. 1044/2006 on the marketing standards for olive oil. Council Regulation (EEC) No.136/1966 on the establishment of a common organisation of the market in oils and fats and its amendments Implemented by: Commission Regulation (EEC) No. 2568/1991 on the characteristics of olive oil and olive-residue oil and on the relevant methods of analysis and its numerous amendments. National legislation European Communities (Marketing Standards for Olive Oil) Regulations, 2004 (S.I. No. 397 of 2004) Introduction to olive oil Commission Regulation (EC) No. 1019/2002 lays down marketing standards for the retail-stage marketing (i.e. sale to the final consumer) of olive oils and olive-pomace oils presented in the natural state or incorporated in a foodstuff. It sets rules on the labelling of different categories of olive oil, designation of origin, packaging requirements and optional labelling indications. Our national Regulations 2004 implements Commission Regulation (EC) No. 1019/2002 as amended. The basic Regulation (EEC) No. 136/1966 is mainly a market support Regulation. It sets out the classifications for nine different types of olive oil and olive-pomace oils. This Regulation has been amended many times as has its implementing measure Commission Regulation (EEC) No. 2568/1991. It is currently being reviewed and this review may result in changes to the classifications of olive oils in the next few years. Commission Regulation (EEC) No. 2568/91 further defines these nine categories and distinguishes them from each other and from other oils/fats. Other EU rules exist covering the appropriate methods of analysis, measures to improve the quality of olive oil production and controls for the designation of extra virgin and virgin olive oil Labelling: Regulation (EC) No. 1019/2002 In addition to the trade description (as set out in Article 35 of Regulation (EC) No. 136/1966) extra virgin olive oil, virgin olive oil, olive oil and olive-pomace oil must indicate, in clear and indelible lettering, the following information on the category of oil: (a) extra virgin olive oil: superior category olive oil obtained directly from olives and solely by mechanical means (b) virgin olive oil: olive oil obtained directly from olives and solely by mechanical means (c) olive oil composed of refined olive oils and virgin olive oils: oil comprising exclusively olive oils that have undergone refining and oils obtained directly from olives (d) olive-pomace oil: oil comprising exclusively oils obtained by treating the product obtained after the extraction of olive oil and oils obtained directly from olives or oil comprising exclusively oils obtained by processing olive pomace oil and oils obtained directly from olives. Only extra virgin and virgin olive oils may bear a designation of origin (i.e. reference to a geographical area) on the packaging or the label under certain conditions (in accordance with Regulation (EEC) No. 2081/1992 (see Section 4.23)). Where a designation of origin mentions a Member State or the Community, the designation of origin must correspond to the geographical area in which the olives concerned were harvested or in which the mill, where the oil was extracted from the olives, is situated. If the olives have been harvested in a Member State or third country other than that in which the mill where the oil was extracted from the olives is situated, the designation of origin shall indicate both the area where the olives were harvested and the area where the oil was obtained using the following wording: (extra) virgin olive oil obtained in (the Community or the name of the Member State concerned) from olives harvested in (the Community or the name of the Member State or country concerned). 4

98 96 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 In the case of blends of extra virgin olive oils or virgin olive oils in which more than 75% originated in the same Member State or in the Community, the main origin (the geographical area in which the olives concerned were harvested or in which the mill, where the oil was extracted from the olives, is situated) may be designated followed by an indication of the minimum percentage (75% or more) which is actually from the main place of origin. Extra virgin olive oil, virgin olive oil, olive oil and olivepomace oil may also indicate the following on the label as appropriate under certain conditions: first cold pressing for virgin or extra virgin olive oils cold extraction for virgin or extra virgin olive oils indications of organoleptic properties indication of the acidity or maximum acidity. In a blend of olive oil (or olive-pomace oil) and other vegetable oils where the presence of olive oils (or olivepomace oils) is highlighted on the labelling elsewhere than in the list of ingredients, using words, images or graphics, the blend concerned must bear the following trade description: Blend of vegetable oils (or the specific names of the vegetable oils concerned) and olive oil (or olivepomace oil), directly followed by the percentage of olive oil (or olive-pomace oil) in the blend. The presence of olive oil (or olive-pomace oil) may be highlighted by images or graphics on the labelling of a blend only where it accounts for more than 50% of the blend concerned. Generally, where the presence of olive oil (or olive-pomace oil) in a foodstuff (other than in a blend as detailed above) is highlighted on the labelling elsewhere than in the list of ingredients, using words, images or graphics, the trade description of the foodstuff shall be directly followed by the percentage of olive oil (or olive-pomace oil) relative to the total net weight of the foodstuff. The percentage of added olive oil (or olive-pomace oil) relative to the total net weight of the foodstuff may be replaced by the percentage of added olive oil (or olivepomace oil) relative to the total weight of fats, adding the words percentage of fats. Extra virgin olive oil, virgin olive oil, olive oil and olivepomace oil must be presented to the final consumer in packaging of a maximum capacity of five litres. The packaging shall be fitted with an opening system that can no longer be sealed after the first time it is opened Competent authority The policy functions in relation to the Regulations on olive oil are the responsibility of the Crops Policy Section, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Department of Agriculture, Fisheries and Food Health Service Executive Office of the Director of Consumer Affairs (authorised under Regulations) FISHERY AND AQUACULTURE PRODUCTS Legislation EU Legislation Council Regulation (EC) No. 104/2000 on the common organisation of the markets in fishery and aquaculture products. Implemented by: Commission Regulation (EC) No. 2065/2001 laying down the rules for the application of Council Regulation (EC) No. 104/2000 as regards informing consumers about fishery and aquaculture products. National legislation European Communities (Labelling of Fishery and Aquaculture Products) Regulations, 2003 (S.I. No. 320 of 2003) Introduction to fishery and aquaculture products Our National Regulations 2003 give effect to Article 4 of Council Regulation (EC) No. 104/2000 and to Commission Regulation (EC) No. 2065/2001 laying down the conditions for informing consumers about fishery and aquaculture products. The Regulations set out specific information which must be included on the label where fishery products are sold at retail level to consumers. In addition, for the purposes of traceability, this information must be included on the commercial documents for the fishery products throughout the marketing chain, such as during processing, at wholesale level and for use by mass caterers.

99 SECTION 4 VERTICAL LEGISLATION 97 The FSAI has published Guidance Note No. 7: The Labelling of Fish and Aquaculture Products according to the European Communities (Labelling of Fishery and Aquaculture Products) Regulations, 2003 (S.I. No. 320 of 2003) Revision 1. The guide specifically details the labelling and packaging requirements for fishery and aquaculture products and should be consulted for a more detailed guide to the legislation. The guide is available at Labelling The labelling requirements of the Regulations apply only to raw fish and aquaculture products to which no other ingredients have been added (except salt) and include: live fish fresh, chilled and frozen fish fish fillets and other fish meat (whether minced or not) dried, salted or brined fish smoked fish (whether hot or cold smoked fish) crustaceans (except those which are both cooked and peeled) molluscs (except when cooked). Processed products such as breaded fish fillets, crab sticks, ready-to-eat dishes or tinned fish are not covered by the Regulations. The fishery and aquaculture products listed above which are offered for retail sale to the final consumer must indicate on the label: 1) the commercial designation of the species of fish, 2) the production method, whether farmed or caught at sea or in freshwater and 3) the catch area. These requirements apply only to products for retail sale to the final consumer. In other words, these rules apply to products which are sold at retail level whether they are pre-packaged or sold loose over the counter. Where the products are sold loose, this information could be stated clearly at the point of sale on a notice or sign near the food. These provisions do not apply to fishery products sold by mass caterers such as in restaurants and takeaways. However, this information must be passed throughout the marketing chain i.e. from producer, to processor, wholesaler and caterer, either on the labelling or packaging of the product or on the commercial documents accompanying the food. These labelling requirements do not apply to small quantities of fishery products sold directly to consumers by either fishermen or producers provided these products do not exceed the value of EUR 20 for each purchase. The source of these small quantities may only be the sellers own business. Commercial designations The commercial designation (or trade name) is the name associated with the particular species of fish, e.g. the commercial designation for Gadus morhua is Cod. The full list of commercial designations recognised in Ireland can be found in the schedule attached to the Regulations (S.I. No. 320 of 2003) or on the FSAI s website Member States are required to draw up and publish a list of the commercial designations of fishery products accepted in their territory. This list must also indicate the scientific name for each species, its name in the official language(s) of the Member State and any other accepted names. Member States must however recognise the commercial designations laid down by other EU Member States where they are for the same species in the same language. Therefore, commercial designations appearing in the English, Scottish, Welsh and Northern Irish Regulations may be applied and used in Ireland. Manufacturers, processors and packagers selling to a market outside Ireland must use the commercial designation of the country/area to which they are exporting so the final consumer of that area knows what is being purchased. It is the responsibility of those marketing any fishery products to obtain the necessary information to ensure the products are accurately labelled. For further information regarding commercial designations for fishery products, export operators should contact Bord Iscaigh Mhara. The production method The method of production i.e. the means by which the fish have been obtained must also be indicated. In other words, whether they have been caught either at sea or in freshwater, or produced (farmed) by aquaculture. The production method must be declared as follows: caught where the fish were caught at sea or caught in freshwater where the fish were caught in freshwater or cultivated or farmed' where the fish are produced from aquaculture. 4

100 98 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 However, where it is obvious from the commercial designation and/or the catch area (see below) that the fish were caught at sea, then the method of production may be omitted, e.g. cod may be described as Cod - Caught in the North East Atlantic. Alternatively the expression North East Atlantic Cod would also be acceptable. Such authorisation may not be granted if there is doubt as to the production method such as for Atlantic Salmon. The catch area The catch area must be indicated as follows: products caught at sea must detail the name of the area where they were caught according to Appendix VIII such as North-East Atlantic This is the minimum amount of information that must be provided. However, in addition, more detailed information regarding these catch areas may also be given, e.g. fish caught in the Irish Sea must declare North - East Atlantic but additional information such as Caught off the East Coast of Ireland may also be declared products caught in freshwater must reference the Member State or third country of origin such as Irish Eel farmed products must reference the Member State or third country in which the product undergoes the final development stage, e.g. if a fish started its life in Scotland and underwent final development in Ireland, the labelling could state Farmed Irish fish or similar Where the product is farmed in more than one Member State or third country, the Member State where the product is sold to the final consumer shall authorise which Member State or third country is to be indicated. It is recommended that as much information as is practical is provided to the consumer, to allow them to make informed choices about the fish they are buying. Labelling exceptions for fishery combinations Where different species of fishery products are for sale, information regarding the commercial designation, the production method and the catch area shall be given for all species, e.g. for a seafood platter containing plaice, monkfish and shrimps, the commercial designation, production method and catch area must be detailed for all three species. Where fishery products are of the same species but derived from a different production method, the production method for each batch must be indicated. For example, where a salmon platter contains both salmon caught at sea and cultivated salmon, the commercial designation salmon must be provided, the production method for each batch i.e. caught at sea and cultivated as well as the catch area. Where fishery products of the same species are offered for sale but derived from a variety of catch areas or fishfarming countries, the catch area of the batch which is most represented by quantity must be at least declared in addition to the indication that the products come from different catch or fish-farming areas. For example, the indication a mix of tuna from the Pacific Ocean and other areas could appear on the labelling. As far as is practical it is recommended that batches are composed in such a way that the fish comprising them originate from the same production method or catch area, and this is clearly specified on the labelling. Traceability The information required above i.e. the commercial designation, the production method and the catch area, must be available at each stage of marketing for each species in addition to the scientific name for the purpose of traceability. These details can be provided on the labelling or packaging of the products or on the commercial document accompanying the product such as an invoice or delivery documents Competent authority The policy functions in relation to the Regulations on fishery and aquaculture products are the responsibility of the Department of Communications, Energy and Natural Resources. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Health Service Executive Department of Communications, Energy and Natural Resources (authorised under Regulations) Officers authorised under the Labelling Regulations.

101 SECTION 4 VERTICAL LEGISLATION POULTRYMEAT Legislation EU Legislation Council Regulation (EC) No. 1906/1990 on certain marketing standards for poultrymeat Amended by: Council Regulation (EEC) No. 317/1993, Council Regulation (EC) No. 3204/1993, Council Regulation (EC) No. 1101/1998 and Council Regulation (EC) No. 1029/2006. Commission Regulation (EEC) No. 1538/1991 introducing detailed rules for implementing Regulation 1906/1990/EEC on certain marketing standards for poultrymeat and its numerous amendments. National Legislation European Communities (Labelling and Marketing Standards for Poultrymeat) Regulations, 2004 (S.I. No. 42 of 2004) Amended by: European Communities (Labelling and Marketing Standards for Poultrymeat) (Amendment) Regulations, 2004 (S.I. No. 50 of 2004) Introduction to poultrymeat The EU Regulations lay down marketing standards for certain types and presentations of poultrymeat. Poultrymeat marketed in the EU must be graded for quality and weight and marketed, packed, labelled, transported and presented for sale in accordance with the requirements of these Regulations. Our National Regulations implement the EU Regulations except for Council Regulation (EC) No. 1029/2006. The FSAI has published Guidance Note No. 17: The Labelling of Meat which provides an overview of the legislative requirements for the documentation and labelling of all meats including poultrymeat. This guide is available at and should be consulted for a more detailed account of the labelling requirements for poultrymeat Labelling The following labelling requirements apply only to poultrymeat as defined in these Regulations and include: fresh frozen and quick frozen cuts and carcasses of chickens ducks geese turkeys guinea fowl. The requirements do not apply to: New York Dressed (NYD) Poultry (i.e. poultry which is not eviscerated immediately after slaughter and is sold in carcass form to the retailer or consumer) poultrymeat preparations, e.g. chicken nuggets, chicken burgers, chicken sausages. Where poultry is packaged, the required information below must be indicated on each pack. In the case of unpackaged poultry, the following information must be displayed in a notice or sign, visible to the consumer, near the product: (a) the name under which the product is sold: whole carcasses must indicate the species ( chicken, broiler, turkey etc) and the form of presentation ( partially eviscerated, with giblets or without giblets ) cuts of poultry must indicate the species and the cut ( chicken breast fillet, turkey drumstick etc) (b) a use-by date for fresh poultrymeat, a best-before date for frozen poultrymeat (c) class (poultrymeat must be graded into Class A or Class B) (d) in the case of fresh poultrymeat, the total price and the price per weight unit at the retail stage (e) condition (i.e. fresh, frozen or quick-frozen) and recommended storage temperature (f) approval number of the slaughterhouse or cutting plant (as per Article 4 of Regulation (EC) No. 853/2004) except in the case of cutting and boning at the place of sale (g) in the case of poultrymeat imported from third countries, an indication of the country of origin. It is not necessary to classify poultrymeat or to indicate the particulars above in the case of deliveries to cutting or processing establishments. 4

102 100 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Where claims concerning types of farming, e.g. free range, are made on poultry labels, it is necessary that the producer and processor of the poultry be registered for this purpose with the Department of Agriculture, Fisheries and Food. Regulation (EC) No. 1538/1991 as amended allows for the use of following terms on the labelling of poultrymeat under certain conditions as appropriate: (a) Fed with % of (b) Extensive indoor ( Barn reared ) (c) Free range (d) Traditional free range (e) Free range total freedom. These terms may be supplemented by indications referring to the particular characteristics of the respective types of farming. When free-range production (points c, d and e) is indicated on the label for meat coming from ducks and geese kept for the production of foie gras, the term from foie gras production shall also be indicated. Intra-trade sales of poultrymeat (such as supply to wholesalers) and food sold to mass caterers must indicate the following information on the commercial documents accompanying the food in addition to the particulars outlined in Section (in accordance with the Labelling Directive 2000/13/EC): the class of poultrymeat and the condition in which the poultrymeat is marketed, e.g. fresh, frozen, and the recommended storage temperature. Optional labelling An indication of the use of one of the methods of chilling may appear on the labelling: air chilling air-spray chilling immersion chilling. Small quantities Member States may derogate from the requirements of Regulation (EC) No. 1906/1990 in cases of direct supply of small quantities of poultrymeat (as referred to in Article 1(3)(d) of Regulation (EC) No. 853/2004) by a producer with an annual production of under 10,000 birds Competent authority The policy functions in relation to the Regulations on poultry are the responsibility of the Pigmeat/Eggs and Poultry/Meat Hygiene Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the FSAI and the following agencies, pursuant to their service contract with the FSAI, for the purposes of ensuring compliance with these Regulations: Department of Agriculture, Fisheries and Food Local authorities FRESH FRUIT AND VEGETABLES Legislation EU legislation Council Regulation (EC) No. 2200/1996 on the common organisation of the market in fruit and vegetables and its numerous amendments. National legislation European Communities (Marketing of Fruit and Vegetables) Regulations 1997, (S.I. No. 122 of 1997) Introduction to fresh fruit and vegetables Council Regulation No. 2200/1996 sets up the common organisation of the market with regard to fruit and vegetables. Under the Regulation, products (listed in Annex I of the Regulation such as apples) which are to be supplied fresh to the consumer are subject to certain marketing standards. The information particulars required by the quality standards must be shown legibly in an obvious position on one side of the packaging, either indelibly printed directly onto the package or on a label which is an integral part of or firmly affixed to the package. Specific EC marketing standards exist for the following fruit, vegetables, salads and nuts (also listed in Appendix I): Fruit Apples (dessert), Apples (culinary), Apricots, Avocados, Cherries, Citrus Fruit, Kiwifruit, Melons, Nectarines, Peaches, Plums, Strawberries, Table grapes, Watermelons Vegetables Artichokes, Asparagus, Beans, Brussels Sprouts, Cabbage, Carrots, Cauliflower, Celery, Courgettes, Garlic, Leeks, Mushrooms, Onions, Peas, Spinach

103 SECTION 4 VERTICAL LEGISLATION 101 Salads Aubergines, Chicory, Cucumbers, Lettuce, Endive, Sweet Peppers, Tomatoes Nuts Walnuts in shell, Hazelnut in shell. Appendix IX lists the EU Regulations regarding the marketing standards for all fruit and vegetables listed above. There are also other Regulations relating to the marketing of fresh fruit and vegetables which are not outlined in this guide. For further detailed information regarding the marketing standards of fresh fruit and vegetables please see the information leaflet of the Department of Agriculture, Fisheries and Food European Community Marketing Standards for Fresh Fruit and Vegetables available at rds/marketing_standards.pdf. The Regulations regarding the marketing standards for fresh fruit and vegetables ensure that regulated produce offered to the consumer is of acceptable quality and accurately labelled. Produce may be offered for sale only if it conforms to the specified standards and produce of unsatisfactory quality is kept off the market. The standards do not apply to processed or prepared fresh produce (example, packs of sliced carrots) Labelling Fresh fruit and vegetables of all quality classes must be sound, clean and of marketable quality, and that each container or display of produce is clearly marked with the correct information regarding quality class, origin and in certain cases, variety. The main requirements of the Regulations relate to quality classification and information labelling of the produce. Only the labelling requirements are detailed below. The label of all fruit and vegetables are required to state the following: nature of produce (if not visible) origin of produce quality class packer and/or dispatcher identification official control marking (optional). It is the responsibility of the retailer to ensure that produce on display is labelled properly. The labelling information required is usually marked on the packages in which the fresh produce is supplied. However, if the produce is unlabelled when received the retailer still has responsibility to ensure the produce is labelled when put on display for sale. Variety-marking requirements exist for some products such as apples, avocados and oranges classified as Extra, Class I and Class 2. Additional information on the nature of produce and/or commercial specification is required for some marketing standards. The relevant Regulation should be consulted in this regard. Produce displayed loose Products may be presented unpackaged, provided that the retailer displays with the goods offered for sale, a card showing prominently and legibly the information particulars specified in the quality standards relating to variety, origin of the product and class. Produce sold in original packaging All packages shall be labelled with all the information required, i.e. nature of produce, origin of produce, quality class and packer and/dispatcher identification. In the case of packer and/dispatcher identification it is acceptable to use either: (i) the name and address of the packer and/or the dispatcher or (ii) an officially issued or accepted code representing the packer and/or dispatcher, indicated in close connection with packer and/or dispatcher. Produce sold in pre-packs Produce that is offered for sale in pre-packs must display all the information required, i.e. nature of produce, origin of produce, quality class and packer and/dispatcher identification. In addition, the net weight or number (if not clearly visible) must be stated. The packer and/or dispatcher must be identified on the pre-pack using either: (i) the name and address of the packer and/or the dispatcher or (ii) the name and address of a seller established within the Community indicated in close connection with the mention Packed For. An officially issued code representing the packer s name and address shall also be included. 4

104 102 FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007 Mixed consumer packs The same principles for labelling of original packaging apply. If, however, products of more than one type are in the same package, the name of each of the products/types contained in the package must be stated. The products contained in the mixes must be of the same commercial class. Individual origins must be indicated (broader descriptions like Produce from various countries or EC Produce are not acceptable). Varieties or commercial type of the produce must be stated where this is required by the relevant standard. Single over wrapped items Single over wrapped items, e.g. individually film wrapped cucumbers, are not considered pre-packs and therefore do not need to carry full labelling information. However, details of origin, quality class and variety, if necessary, must be indicated, in clear characters, on a show card with the produce. Miniatures Aubergines, cauliflowers, cabbages and courgettes may be marketed in the form of miniature produce, subject to rules on presentation and labelling. An indication of mini or baby or other appropriate term for miniature, where appropriate, must be given. Where several types of miniature produce are mixed in the same package, all products and their respective origins must be mentioned. The size requirements shall not apply to miniature produce. However, they must be reasonably uniform in size Competent authority The policy functions in relation to the Regulations on fresh fruit and vegetables are the responsibility of the Horticulture and Plant Health Division, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the Department of Agriculture, Fisheries and Food. PART C: QUALITY SCHEMES The Regulations under this section on Quality Schemes do not specifically fall under the umbrella of food safety legislation. However, the Regulations do contain some labelling provisions and are thus detailed below ORGANIC FOOD Legislation EU legislation Council Regulation (EC) No. 2092/1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs and its many amendments. National legislation European Communities (Organic Farming) Regulations, 2004 (S.I. No. 112 of 2004) Introduction to organic food Organic food is produced in accordance with standards laid down in Council Regulation (EC) No. 2092/1991 and its 40 amendments. Our national 2004 Regulations give effect to Regulation (EC) No. 2092/1991 and the majority of its amendments. The Regulations governing the production of organic food do not fall under the umbrella of food safety legislation. However, the standards laid down do contain some labelling provisions. The Department of Agriculture, Fisheries and Food is the competent authority charged with overall responsibility for ensuring that operators producing, preparing, importing or marketing organic products do so according to certain standards as laid down in the Regulations. An organic operator must be registered with the Department and submit their enterprise to inspection by an approved inspection body. There are currently three organic inspection and certification bodies approved by the Department, Demeter Standards Ltd, Irish Organic Farmers and Growers Association (IOFGA) and Organic Trust Ltd, certifying that organic operators are meeting the stipulated standards for organic food production. Further information on organic food is available from The Department of Agriculture, Fisheries and Food at Also the FSAI has produced a leaflet on Organic Food and is available at

105 SECTION 4 VERTICAL LEGISLATION Labelling An organic product produced according to the Regulations should bear the indication organic in the labelling, advertising material or commercial documents. Packaged organic food, which must remain closed from packaging until point of retail sale, must indicate the name and/or code number of the organic certification body. The words "Certified Organic" or "Organic Certification" should appear on the product label followed by one of the following three codes depending on which private inspection body in Ireland is certifying the produce: IRL-OIB1-EU IRL-OIB2-EU IRL-OIB3-EU IRL-OIB1-EU is assigned to the Demeter Standards Ltd, IRL- OIB2-EU is used by the Irish Organic Farmers and Growers Association (IOFGA) and IRL-OIB3-EU is used by Organic Trust Ltd. Whilst not required by Regulation, each of the certification bodies may also include their own name and/or logo on the product label: The provisions of the general labelling rules (Council Directive 2000/13/EC Section 2.1) also apply to packaged organic food. No claim may be made on the label or advertising material that suggests to the purchaser that the product constitutes a guarantee of superior organoleptic, nutritional or salubrious quality. The above labelling provisions apply to organic produce at point of sale only. However, for intra-trade, the producers or processors details or license number must be provided on all internal documentation such as delivery dockets, invoices, etc. so that full traceability is maintained. Organic products imported from outside the EU (i.e. third country imports) must be produced in conformity to EU standards. At present, the following countries are recognised by the European Commission as having equivalent organic production and inspection rules to those of the European Community: Argentina, Australia, Hungary, Israel, Switzerland and the Czech Republic. Where a third country does not have equivalence recognition, the Department, as the competent authority, must satisfy itself that the product being imported was produced in accordance with production rules equivalent to those in the EU. 4 IRL-O1B1-EU Demeter Standards Ltd. IRL-O1B2-EU Irish Organic Farmers and Growers Association IRL-O1B3-EU Organic Trust Products prepared partially from ingredients of organic origin may only make reference on the label to the organic production method provided they adhere to the conditions set out in Article 5 of Council Regulation (EC) No. 2092/91 as amended. The Community logo may be provided in addition on the label indicating that products are covered by the specific inspection scheme. The provision of the logo is voluntary but where it is provided the technical reproduction rules must be adhered to (such as colours, size, background etc.) and certain conditions must be met (such as an indication of the name and/or business name of the producer, preparer or vendor). The Community logo in black and white: Competent authority The policy functions in relation to the Regulations on organic food are the responsibility of The Organic Unit, Department of Agriculture, Fisheries and Food. These Regulations are enforced by the Department of Agriculture, Fisheries and Food. The FSAI also has responsibility with regard to labelling issues.