European Union legislation on Food additives, Food enzymes, Extractions solvents and Food flavourings European Commission, DG, Unit E3 Chemicals, contaminants and pesticides Serbia-Screening meeting on Chapter 12
European Union legislation on Food additives
Table of Contents 1. Framework legislation including Annex II and III 2. Regulation (EC) No 231/2012 on specifications 3. Food additives database 4. Re-evaluation Programme 5. Common Authorisation Procedure
1-Framework legislation on FA Regulation (EC) No 1333/2008 on food additives Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and flavourings.
1-Food additives Fully harmonized sector Framework Regulation (EC) No 1333/2008 Annexes to specific Directives for 3 groups of additives applied until 1 June 2013 Dir. 94/36/EC, Article 2(1) to (6), (8), (9) (10) and Annexes I to V: 40 Colours Positive lists of additives + conditions of use Dir. 94/35/EC, Article 2(1), (2), (4) and the Annex: 17 sweeteners Dir. 95/2/EC, Articles 2 and 4 and Annexes I to VI : +/- 300 other additives
1-Regulation (EC) No 1333/2008 on food additives It does not apply to: Processing aids Substances used for the protection of plant and plant products Substances added to foods as nutrients Substances used for the treatment of water for human consumption Flavourings Food enzymes-only Union list is adopted Screening meeting on Chapter 12
1-Regulation (EC) No 1333/2008 on food additives It provides for: a) Definitions b) Conditions of use c) Union list of authorised food additives d) Labelling requirements
1a-Definitions food additive means any substance: 1. not normally consumed as a food in itself, 2. not normally used as a characteristic ingredient of food, 3. intentionally added for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of food, 4. that becomes directly or indirectly a component of the food, including its by-products.
1b-Conditions of use Do not pose a safety concern to the health of the consumer at the level of use proposed; Reasonable technological need for their use which cannot be achieved by other economically and technologically practicable means; Do not mislead the consumer Advantages and benefits for the consumer
1c-Union list of food additives authorised in food Listed on the basis of the categories of food to which they may be added. Food additives which are permitted for use in foods under Directives 94/35/EC, 94/36/EC and 95/2/EC and their conditions of use have been transferred in Annex II to Regulation (EC) No 1333/2008. Established by Regulation (EU) No 1129/2012 It is already applicable from 1 June 2013. 30 amendments including review of colours, aluminium and new authorisations.
1c-Food categorisation system 0 All foodstuffs 1 Dairy 2 Fats and Oils 3 Edible Ice 4 Fruit and Vegetables 5 Confectionery 6 Cereals and Cereal Products 7 Bakery Wares 8 Meat and Meat Products 9 Fish and Fish Products 10 Eggs and Egg Products 11 Sugars and Table Top Sweeteners 12 Salt, Spices, Seasonings, Sauces etc. 13 PARNUTS 14 Beverages 15 Snacks 16 Desserts 17 Food Supplements 18 Processed foodstuffs not belonging to 1-17
1c-Union list of food additives authorised in Additives, Enzymes, Flavourings and Nutrients Annex III to Regulation (EC) No 1333/2008, established by Regulation (EU) NO 1130/2012 1. Carriers in food additives 2. Food additives other than carriers in food additives 3. Food additives including carriers in food enzymes 4. Food additives including carriers in food flavourings 5. Carriers in nutrients and other substances added for nutritional and/or for other physiological purposes Adopted on 11 November 2011 Applicable from 2 December 2012
2-Specifications of Food Additives Commission Regulation (EU) No 231/2012 adopted revised specifications in one single list and applies from 1 December 2012. The revised Directives were: Directive 2008/60/EC - purity criteria for sweeteners in foodstuffs Directive 2008/84/EC - purity criteria for food additives other than colours and sweeteners. Directive 2008/128/EC - purity criteria for colours used in foodstuffs Food. Safety Policy
4-Re-evaluation programme. Established by Commission Regulation (EU) No 257/2010 All additives authorised before 20 January 2009 Colours completed by 31.12.2015 Sweeteners completed by 31.12.2020 Exception: Aspartame. Opinion delivered Dec 2013 All other additives completed by 31.12.2018
5-Common Authorisation Procedure Reg 1331/2008 establishes a CAP for FA, FE and FF Applies to substances for which placing on the market in the EU is authorised by an Union list (food additives, flavourings, food enzymes) Does not apply to smoke flavourings or extraction solvents Procedure for updating the Union list Adding the substance on the list Removing the substance from the list Addition, removing or changing of the conditions, specifications or restrictions which are associated with the presence of the substance on the list
5-Main stages of the CAP May be started either on the initiative of the COM or following an application. Applications may be made by a MS or by an interested party. Applications shall be sent to the COM. Consultation of the EFSA except if the updates in question are not liable to have an effect on human health. Ends with the adoption by the COM of a regulation implementing the update.
5-Reg 234/2011-Implementing measures It provides for The content, drafting and presentation of the application The arrangements for checking the validity of applications The type of information that must be included in the opinion of EFSA
European Union legislation on Food Enzymes and Extraction Solvents
Table of Contents 1. Food enzyme legislation 2. Guidance on food enzymes 3. Submission of enzyme applications 4. Extraction solvents legislation 5. Labelling of extraction solvents
1-Food Enzymes Legislation 1. Regulation (EC) No 1332/2008 (enzyme Regulation) as amended by Comm. Reg. No 1056/2012. 2. Regulation (EC) No 1331/2008 establishing a CAP for FA, FE and FF. 3. Commission Regulation (EC) No 234/2011 implementing CAP Reg. as amended by Comm. Regulation (EC) No 562/2012. 21
1- Reg 1332/2008 The Regulation No 1332/2008 lays down rules on food enzymes used in foods, including such enzymes used as processing aids. Scope: Food enzymes that are added to food to perform a technological function in the manufacture, processing, preparation, treatment, packaging, transport or storage of food, including enzymes used as processing aids.
Definition of food enzyme Product obtained from plants, animal or microorganisms or products thereof including a product obtained by a fermentation process using microorganisms: Containing one or more enzymes capable of catalysing a specific biochemical reactions Added to food for a technological purpose at any stage of the manufacturing, processing, preparation, treatment, packaging, transport or storage of foods. Screening meeting on Chapter 12
1-Food Enzymes Legislation Reg 1332/2008 does not apply to Enzymes used exclusively in the production of FAs and PAs. Enzymes intended for human consumption, such as enzymes for nutritional purposes. Microbial cultures that are traditionally used in the production of food, such as cheese and wine, which may contain enzymes but are not specifically used to produced them. 24
1-Regulation 1332/2008 provides for 1a) A Union list of approved food enzymes 1b) Conditions of use of food enzymes in foods. 1c) Rules on the labelling of food enzymes sold as such.
1a)-Establishment of the Union list of Food Enzymes Union list in one single step. After EFSA has delivered its opinion (no deadline for EFSA) on all the FE listed in the Register. Until the date of application of the Union list, national provisions in force on food enzymes shall continue to apply in the MS. There is no Union list yet
1b-Conditions of use Do not pose a safety concern to the health of the consumer at the level of use proposed; Reasonable technological need for their use; Its use does not mislead the consumer 27
1-Regulation (EC) No 562/2012 This amendment provides for: Derogation from submitting toxicological data; Possibility of grouping dossiers This amendment does not apply to: GMM derived enzymes
1c-Labelling on enzymes 1) If food enzymes are sold as such to food manufacturers 2) If food enzymes are sold as such to final consumers 3) If food enzymes are present in foods intended for final consumers. For options 1 (B2B) and 2 the legal provisions are laid down in Art 10-12 of the enzyme Regulation. For option 3: Dir 2000/13/EC (to be replaced by Reg 1169/2011 as of 13 Dec 2014)
2-Guidance 1-Article 3 of Reg 234/2011-The applicant shall take into account the practical guidance on the submission of applications made available by DG SANCO's website http://ec.europa.eu/food/food/faef/index_en.htm 2-Article 5 of Reg 234/2011-The applicant shall take into account the latest guidance documents adopted or endorsed by EFSA. Available at EFSA and SANCO website GMM-derived enzymes http://www.efsa.europa.eu/en/efsajournal/pub/2193.htm Conventional food enzymes http://www.efsa.europa.eu/en/efsajournal/pub/1305.htm
3-Submission of Food Enzyme Applications WHEN: It started from 11 September 2011 Deadline: 48 months after the date of application of Reg 234/2011 (11 March 2015 at midnight). Validity check: COM together with EFSA WHY?: The COM shall submit the applications for new authorisations to EFSA for its opinion (Art 17.3 of Reg 1332/2008)
Update on the food enzyme dossiers First four opinions to be adopted by March/April 2014. Expected No of dossiers: ~300 Bulk of the dossiers expected in 2014 Few dossiers expected in the first trimester 2015
4-Extraction Solvent Legislation Directive 2009/32/EC (Recast) Why a recast? Council Directive 88/344/EC has been substantially amended several times. Scope: Extraction solvents used or intended for use in the productions of foodstuffs or food ingredients. It does not apply to: Extraction solvents used in the production of food additives, vitamins and other nutritional additives
4-Extraction Solvent Legislation It provides for: The establishment of a single list of extraction solvents for the preparation of foodstuffs or food ingredients, Conditions of use Where necessary, maximum residue limits General and specific purity criteria specified.
5-Labelling of Extraction solvents Extraction solvents may not be marketed unless their packaging, containers or labels carry the following particulars: Commercial name (e.g. propane, butane) Indication that the material is of quality suitable for use for the extraction of food or food ingredients. Net quantity given as units of volume Batch, and name and address of the company
European Union legislation on food flavourings
Table of Contents 1.Framework legislation on flavourings 2.Smoke flavourings 3-Flavouring database
1-Framework legislation Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC It provides for: Union list of flavourings and source materials Conditions of use of flavourings and food ingredients with flavouring properties Labelling rules for flavourings
Scope of the Regulation 1334/2008 It applies to: 1) Flavourings 2) Food ingredients with flavouring properties 3) Food containing flavourings and/or food ingredients with flavourings properties 4) Source materials of flavourings and/or source materials for food ingredients with flavouring properties
Scope of the Regulation 1334/2008 It does not apply to: 1)Substances which have exclusively a sweet, sour or salty taste 2)Raw foods 3)Non-compound foods and mixtures such as, but not exclusively, fresh, dried of frozen spices and/or herbs, mixtures of tea and mixtures for infusion as such as long as they have not been used as food ingredients.
Conditions of use do not pose a safety risk to the health of the consumer; and their use does not mislead the consumer.
Definitions Flavourings shall mean products: not intended to be consumed as such, which are added to food in order to impart or modify odour and/or taste; made or consisting of the following categories: flavouring substances flavouring preparations thermal process flavourings smoke flavourings flavour precursors or other flavourings or mixtures thereof;
Definitions Food ingredient with flavouring properties = a food ingredient other than flavourings which may be added to food for the main purpose of adding flavour to it or modifying its flavour and which contributes significantly to the presence in food of certain naturally occurring undesirable substances; Source material = material of vegetable, animal, microbiological or mineral origin from which flavourings or food ingredients with flavouring properties are produced; it may be: (i) food or; (ii) source material other than food;
Flavourings and food ingredients with flavourings properties for which evaluation and approval are not required Article 8 flavouring preparations obtained from food thermal process flavourings obtained from food which comply with the conditions for the production of thermal process flavourings and maximum levels for certain substances in thermal process flavourings set out in Annex V flavour precursors obtained from food food ingredients with flavouring properties
Flavourings and source materials for which evaluation and approval are required Article 9 flavouring substances flavouring preparations, thermal process flavourings, flavour precursors obtained from non-food thermal process flavourings obtained from food but which do not comply with the criteria in Annex V smoke flavourings other flavourings source materials other than food
Labelling Labelling of flavourings not intended for sale to the final consumer Labelling of flavourings intended for sale to the final consumer Designation of flavourings in the list of ingredients (amendment to Directive 2000/13) flavourings or a more specific name or description of the flavouring, if the flavouring component contains flavourings defined in flavourings Regulation smoke flavouring(s) or smoke flavouring(s) produced from food(s) or food category or source(s) (e.g. smoke flavouring produced from beech), if the flavouring component contains smoke flavourings and imparts a smoky flavour to the food. Specific requirements for use of the term "natural"
Annex I - Union list of flavourings and source materials Part A Flavouring substances Commission Implementing Regulation (EU) No 872/2012 lays down the list of flavouring substances Around 2100 authorised flavouring substances Around 300 flavouring substances under evaluation which may continue to be placed on the market (footnotes) All other substances are not permitted New flavouring substances to follow the CAP
Union List Part A Table 1 48
Annex I Part B to F - Other categories of flavourings and non-food source materials Commission Regulation (EU) No 873/2012 of 1 October 2012 on transitional measures concerning the Union list of flavourings and source materials set out in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council Deadline for submitting applications: October 2015
Annexes II to V II: List of traditional food preparation processes III: Presence of certain substances Part A: Substances which shall not be added as such (directly) to food e.g. capsaicin, hypercine, coumarin Part B: Maximum levels of certain substances, naturally present in flavourings and food ingredients with flavouring properties, in certain compound food as consumed to which flavourings and/or food ingredients with flavouring properties have been added IV: List of source materials to which restrictions apply for their use in the production of flavourings and food ingredients with flavouring properties V: Conditions for the production of thermal process flavourings and maximum levels for certain substances in thermal process flavourings
Smoke Flavourings Regulation Regulation (EC) No 2065/2003 of the European Parliament and the Council of 10 November 2003 on smoke flavourings used or intended for use in or on food. It applies to : Smoke flavourings used or intended for use in or foods Food in or on which smoke flavourings are present
Smoke Flavourings Regulation General use and safety requirements Sufficiently demonstrated that the smoke flavouring does not present risks to human health The use does not mislead the consumer Union list of authorised primary products Exclusion of all others for use as such in or on foods and/or for the production of derived smoke flavourings
Union List of smoke flavourings Commission Regulation 1321/2013, just published last December 2013 Contains 10 primary products Authorised for defined food categories and with maximum limits Products can be mixed in formulations respecting the individual limits 53
Contents of Union List of smoke flavourings Unique code Name of the product Name and address of authorization holder Description and characterisation of the product Conditions of its use Date from which it is authorised Date until it is authorised (10 years) 54
THANK YOU FOR YOUR KIND ATTENTION QUESTIONS?