THE FOOD LABELLING (AMENDMENT) (WALES) (NO. 2) REGULATIONS 2005

Transcription

1 REGULATORY APPRAISAL FOOD, WALES THE FOOD LABELLING (AMENDMENT) (WALES) (NO. 2) REGULATIONS 2005 Background 1. The Food Labelling Regulations 1996 (as amended) and certain provisions of the Food Safety Act 1990 and Trade Descriptions Act 1968, govern food labelling in Great Britain. These implement Directive 2000/13/EC on the labelling, presentation and advertising of foodstuffs. Separate, but parallel legislation exists in Northern Ireland where appropriate. 2. Consumers have indicated that they wish to be better informed about the foodstuffs they purchase, and specifically about their composition, even if full ingredient labelling will inevitably mean that more information is required on the label 1. This information is particularly important for those with a food allergy or intolerance, so that they can identify the foods they need to avoid. 3. Allergen labelling rules that came into force on 25 November 2004 (The Food Labelling (Amendment) (Wales) (No.2) Regulations 2004, implementing Directive 2003/89/EC of the European Parliament and of the Council) aimed to address this issue. They removed the 25% rule (where individual ingredients making up a compound ingredient do not have to be listed if the compound ingredient makes up less than 25% of the finished product), and thereby provided for more comprehensive labelling information. They also introduced a specified list of allergens, which have to be indicated on the labelling, whenever they are used in foods, including alcoholic drinks. Manufacturers have a transition period of 12 months, after which products that do not comply with the new rules will be prohibited. 4. The specified allergens are listed at Annex A attached. This list was drawn up by the European Commission, based on scientific advice on the most common food allergies in the EU, although allergies to some of these foods, such as celery and mustard, are geographically restricted (i.e. some allergens are more prevalent in some countries than others). 5. When negotiations on Directive 2003/89/EC were being finalised, it was recognised that some ingredients derived from the specified allergenic foods, undergo significant processing which will remove the allergen, and therefore would be unlikely to trigger allergic reactions (non-allergenic derived ingredients). The UK was amongst a number of Member States pushing the Commission to make provisions for a list of such ingredients. Provision was therefore made in that Directive for such ingredients to be exempt in future from allergen labelling requirements based on supporting scientific evidence. Industry was asked to submit scientific evidence to support such a view (dossiers submitted to the European Food Safety Authority (EFSA)). This was evaluated by EFSA who 1 Consumer attitudes to food labelling (Ipsos-RSL) (2000); Better Food Labelling Initiative written responses (2000) 1

2 agreed that there was enough evidence that a number of derived ingredients should provisionally be exempt from the allergen labelling requirements. 6. Following evaluation of the scientific evidence by EFSA, the Commission originally planned to draw up a provisional list of these ingredients by November However, subsequent delays meant this list (Annex to Directive 2005/26/EC) was not published in the Official Journal of the European Union until 22 March The list can be found in Annex B attached. The exemptions apply to the ingredients listed, manufactured according to the methods and uses described in the dossiers. Member States are required to implement Directive 2005/26/EC by 21 September The Commission is due to finalise the list by 25 November 2007 following advice from EFSA. Purpose and intended effect of the measure 8. These Regulations implement, in Wales, Commission Directive 2005/26/EC establishing a list of food ingredients or substances, provisionally excluded from Annex IIIa of Directive 2000/13/EC of the European Parliament and of the Council. 9. The Regulations establish a list of ingredients derived from known allergens that are provisionally exempt from allergen labelling rules, because they are no longer allergenic. 10. The Regulations aim to ensure that consumers are properly informed about the allergens in the foods they buy and are protected from false or misleading descriptions in relation to allergens. The rules will also avoid over-labelling, preventing unnecessary restriction of consumer choice, and unnecessary labelling costs for industry. 11. Separate, but parallel legislation, will be made in respect of England, Scotland and Northern Ireland to come into force simultaneously on 25 November Risk Assessment Directive 2005/26/EC transposed into national law by the Food Labelling (Amendment) (Wales) (No.2) Regulations 2005, addresses the following risks: (i) (ii) (iii) Unnecessary restriction of consumer choice; Potential to create a false sense of security for allergic consumers; and Unnecessary labelling for industry. 13. Under The Food Labelling (Amendment) (Wales) (No.2) Regulations 2004, as of 25 November 2005, manufacturers will have to indicate the presence of the specified allergens or their derivatives in pre-packed foods, including alcoholic drinks. This indication will have to make a clear reference to the source allergen, unless this is already clear from the sale name of the food, for example, milkshake. In the case where a derived ingredient is no longer allergenic, flagging it up as an allergen would not improve consumer safety, but it would restrict consumer choice. It is therefore important to avoid this from a consumer point of view. The aim of Directive 2005/26/EC is to ensure that consumers are 2

3 provided with accurate food safety information, whilst avoiding unnecessary restriction of choice. 14. Labelling products as allergenic when they are no longer allergenic may devalue the strength of allergen labelling in protecting consumers. Allergic consumers may know from past experiences, or their own research, that products containing certain ingredients derived from allergenic ingredients are safe to eat. Labelling these products as containing allergens will confuse these consumers and reduce their trust in the protection given through allergen labelling. They may also be tempted to consume other products that contain allergens under the misperception that these are also safe for them to consume. 15. Where there is no longer any health risk (i.e. where ingredients are no longer allergenic) it would be sensible for industry not to have to label the non-allergenic derived ingredients listed as exemptions. Options Do Nothing 16. In respect of this legislation the Do nothing option is not an option as it would lead ultimately to infraction proceedings against the National Assembly for Wales by the European Commission. Therefore, the Make the legislation option, to implement the changes required to comply with European legislation, is being implemented. Make the Legislation 17. Implementing Directive 2005/26/EC would fulfil the Agency s commitment to ensure that consumers are properly informed through accurate labelling to enable them to make a fully informed choice, and avoid unnecessary re-labelling costs for industry. There may also be some associated benefits for businesses as a result of increased consumer confidence in products carrying more informative labels. 18. These Regulations would fulfil the UK s obligation under the EC Treaty, ensure consistent labelling rules across the EU, facilitate informed consumer choice, and allow UK manufacturers to operate freely and competitively within the single market. Benefits Make the Legislation 19. Of consumers, people with allergies are most likely to benefit from this proposal. It is not entirely clear how many people are affected by food allergy and food intolerance in the UK % of the UK population think that they have an adverse reaction to certain foods 2. However, the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment reported estimates of proven allergy to be 6-8% of children and 1-2% of adults. In a population of around 3 million in Wales this would represent in the region of 9000 people. A recent study has shown an incidence of gluten 2 Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment. Adverse reactions to food and food ingredients

4 intolerance of about 1% in the UK 3. For lactose intolerance the figure in the general population is about 5% but it is higher in certain ethnic populations where milk is not traditionally part of the adult diet, for example, 75% of black Africans and 90% of Asians are lactose intolerant. Although these figures are taken from cohort studies undertaken in regions of England they are thought to be representative of all parts of the UK; England, Scotland, Wales and Northern Ireland. 20. The Food Standards Agency does not consider that implementing these Regulations will have any impact on racial equality, sustainability or rural issues. 21. These Regulations would fulfil the Agency s commitment to ensure that consumers are properly informed through accurate labelling to make a fully informed choice. Where a derived ingredient (as specified in Annex 2 attached) is no longer allergenic, allergen labelling would not be required, and therefore would not restrict consumer choice. 22. There may also be some associated benefits for businesses as a result of increased consumer confidence in products carrying more informative labels, and would avoid unnecessary re-labelling costs. Costs 23. The proposed new Regulations establish a list of ingredients provisionally exempt from the allergen labelling rules. As a result the food industry will not have to extend allergen labelling to products containing derived non-allergenic ingredients. Therefore there are no additional financial implications on the industry as a result of these Regulations. 24. Enforcement of food labelling legislation is the responsibility of Local Authority Public Protection Departments and Port Health Authorities. Directive 2005/26/EC does not specify any additional levels of inspection. Therefore it is not anticipated that there will be any additional costs for Local Authorities. Enforcement authorities in general were invited to identify and comment on any additional costs they envisage may arise. One enforcement authority in England responding to the English consultation indicated there to be no additional costs. 25. Neither the Local Authorities Co-ordinators of Regulatory Services (LACORS) (the Co-ordinating body for Local Authority Trading Standards departments in England and Wales) or the Welsh Local Government Association responded to the consultation. No additional costs to Welsh Local Authorities or the Assembly have been identified. Small Firms Impact Test 26. The Food Standards Agency have been unable to identify any negative impacts on small firms as a result of the proposal, we believe that the proposals could be beneficial to small firms. The views of small firms and their representatives have been actively sought during the consultation process. 3 Bingley et al., Undiagnosed coeliac disease at age seven: population based prospective birth cohort study. BMJ. 328:

5 The Agency has consulted the Small Business Service, who are happy with this approach and are in favour of the new provisions. Competition Assessment 27. The results from the competition filter indicate that the proposed Directive will have no significant impact on the competitive structure within the pre-packed food sector. Additional labelling costs are avoided by granting exemptions from allergen labelling requirements, to products containing specific nonallergenic ingredients derived from allergenic foods. Furthermore, there are no effects on entry barriers to this sector. Consultation With Stakeholders 28. Given that The Food Standards Agency Wales carried out a full 12 week consultation on the Food Labelling (Amendment) (Wales) (No.2) Regulations 2004 which set out labelling rules on the indication of ingredients particularly allergenic ingredients in pre-packed foods and, the short time-scale between publication of Directive 2005/26 and the transposition deadline, a shortened consultation was carried out on these Regulations from 23 May 2005 to 20 June Stakeholders including industry, enforcement, consumer representatives and the National Assembly for Wales were invited to comment on the draft Regulations and the draft Regulatory Appraisal. A list of those consulted in Wales is attached at Annex C. A copy of the consultation package was also posted on the Agency s website. Parallel consultations were carried out in England, Scotland and Northern Ireland responses were received UK wide in response to the consultation; 1 in response to the Wales consultation; 14 in response to England; and 7 in response to Scotland. No responses were received in response to the consultation conducted in Northern Ireland. Overall, the responses demonstrated that there would be no disproportionate impact on businesses as a result of the new Regulations coming into force. 30. The response from one individual to the Wales consultation supported the new provisions. All seven responses received to the Scotland consultation raised no major concerns, and were broadly in support of the new provisions. 31. Respondents to the England consultation were also broadly in favour of the new provisions. 32. One respondent wanted all gluten-sourced ingredients labelled, for example wheat-based maltodextrins, glucose syrups based on barley, and gluten cereals used in distillates. The evidence evaluated by European Food Standards Agency (EFSA) supported the view that the level of gluten remaining in some derived ingredients after processing was so low that it would not cause adverse effects in those with gluten intolerance. 33. Another respondent wanted to know how one could be certain of the nonallergenicity of the exempted ingredients. EFSA evaluated the derived ingredients on a case by case basis, only recommending ingredients where 5

6 there was sufficient evidence to support the view that it does not present a risk to allergic consumers. 34. Another respondent requested that the Agency should encourage local authorities to take into account the delay in publication of the list of exempted ingredients in enforcing the allergen rules. 35. No policy changes to the draft Regulations were identified as a consequence of the public consultation. With Subject Committee 36. The Regulations were notified to the Health and Social Services Committee via the list of forthcoming legislation on 13 July 2005, (HSS(2)-09-05, (p. 2b), item no. FS 41(05)), but were not identified for detailed scrutiny. Implementation and delivery plan 37. Under Directive 2005/26/EC Member States are required to adopt and publish the laws, regulations and administrative provisions of Directive 2005/26/EC by 21 September The Agency will issue accompanying guidance notes at this time. Post-implementation review 38. The list of exempt derived ingredients in Annex B attached are provisional and will be reviewed by the European Commission, following evaluation of further safety studies by EFSA at the latest by 25 November The finalised list will be incorporated into UK legislation by means of an amending statutory instrument, providing full and permanent exemption for the listed ingredients. 39. The effectiveness of the Regulations will be monitored via feedback from stakeholders as part of the ongoing policy process. Agency mechanisms for monitoring and review include, stakeholder meetings; surveys; Consumer Committee and general enquiries from the public. 40. Guidance notes on the application of the new requirements are being drawn up in full consultation with stakeholders and their impact will be kept under regular review. Summary and recommendations 41. The proposals here provide for a new Regulation establishing a list of ingredients provisionally exempt from allergen labelling rules. As a result this ensures that consumers are provided with accurate food safety information, whilst avoiding unnecessary restriction of choice and industry will not have to extend allergen labelling to products containing derived non-allergenic ingredients. Contact point Ms Hilary Neathey Food Standards Agency Wales 11 th Floor, South Gate House Wood Street Cardiff 6

7 CF10 1EW Tel:

8 LIST OF ALLERGENIC INGREDIENTS AS SPECIFIED UNDER DIRECTIVE 2003/89/EC cereals containing gluten (ie wheat, rye, barley, oats, spelt, kamut or their hybridised strains) crustaceans eggs fish peanuts soybeans milk the following nuts: Almond, Hazelnut, Walnut, Cashew, Pecan nut, Brazil nut, Pistachio nut, Macadamia nut and Queensland nut celery mustard sesame seeds sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO 2.

9 Annex B LIST OF NON-ALLERGENIC DERIVED INGREDIENTS AS SPECIFIED UNDER DIRECTIVE 2005/26/EC Column 1 Column 2 Allergenic ingredient Exempt ingredients originating from allergenic ingredient Cereals containing gluten Wheat based glucose syrups including dextrose 1. Wheat based maltodextrins 1. Glucose syrups based on barley. Cereals used in distillates for spirits. Eggs Lysozym (produced from egg) used in wine. Albumin (produced from egg) used as fining agent in wine and cider. Fish Fish gelatine used as carrier for vitamins and flavours. 2 Fish gelatine or Isinglass used as fining agent in beer, cider and wine. Soybean Fully refined soybean oil and fat 1. Natural mixed tocopherols (E306), natural D alpha tocopherol, natural D alpha tocopherol acetate, natural D alpha tocopherol succinate from soybean sources. Phytosterols and phytosterol esters derived from vegetable oils obtained from soybean sources. 3 Plant stanol ester produced from vegetable oil sterols from soybean sources. Milk Whey used in distillates for spirits. Lactitol. Milk (casein) products used as fining agents in cider and wines. Nuts Nuts used in distillates for spirits. Almonds and walnuts used as flavour in spirits. Celery Celery leaf and seed oil. Celery seed oleoresin. Mustard Mustard oil. Mustard seed oil. Mustard seed oleoresin. Note 1 And their products, in so far as the process that they have undergone is not likely to increase the level of allergenicity assessed by the European Food Safety Authority for the relevant product from which they originated. 2 The Commission has indicated a corrigendum to Directive 2005/26/EC will be published to include fish gelatine used as a carrier for carotenoids. 3 This text is taken from the UK Statutory Instrument, which differs slightly from Directive 2005/25/EC. The Commission has agreed this description, which is clearer but essentially has the same meaning as the text in the Directive. 9

10 ANNEX C LIST OF STAKEHOLDERS CONSULTED IN WALES Company Name Abergavenny Fine Foods Ltd ADAS Wales Age Concern Cymru Contact A J Craske Cate Barrow - Food Business Development Manager Ms Deborah Meehan B. Sidoli & Sons Ltd Bar and Restaurant Foods Ltd Biotrace Limited Blaenau Gwent CBC Bridgend County Borough Council British Institute for Allergy and Environmental Therapy Business Connect Heart of Wales Caerphilly County Borough Council Cardiff Local Health board Carmarthenshire County Council Ceredigion County Council Chartered Institute of Environmental Health in Wales Clark's Original Pies Commission for Racial Equality Conwy County Borough Council - Social Services Department Co-operative Group (CWS) Ltd Mr Mark Dukes Colin Hunt Mike Cole, Act.Head of Quality Planning and commissioning Dave Parratt, Principal Assistant - Health Alliance The Secretary Claire Carter Claire Harding Senior Health Officer Bernard Boniface, Head of Health and social care & wellbeing Anne Duff Health Policy Co-ordinator Lucy Hancock Health Alliance Co-ordinator Mr Paul Handby, Development Co-ordinator Ceri J Baillie Dr Mashuq Ally Patti Fitton Health & Wellbeing Co-ordinator Wendy Cave Dairy Strategy Group Dee Dairy Services Mrs J Higginbothom 10

11 Denbighshire County Council Department of Food Science & Technology Farmers' Union of Wales Federation of Small Businesses (North Wales) Flintshire County Council Food Consultancy Food Quality Panel Food Safe Friends of the Earth Cymru G C Hahn & Co Ltd Good Food Distributors Gwynedd Council Halo Foods Ltd Iceland Frozen Foods Cathy Curtis Nelson H,SC,WB Strategy Manager Dr David Lindsay Mr Arwyn Owen, Director of Policy Gwyn Evans, Chairman Vicky McCourt Strategic Planning Manager Diane McCrea Lynn Hoskins Mr R Dailley Gordon James The Secretary Mr K F Powell Shan Lloyd Williams, H, SC & WB Lead Officer Elizabeth Williams Rhodri Glyn Thomas AM Ann Jones AM Jonathan Morgan AM Val Lloyd AM Gwenda Thomas AM John Griffiths AM Jocelyn Davies AM Kirsty Williams AM David Melding Chair David Melding AM, Chair Peter Lee 11

12 Institute of Consumer Sciences Institute of Rural Health Isle of Anglesey County Council LACORS (Welsh Officer) Medicines and Healthcare Products Regulatory Agency (MHRA) Meridian Foods Merthyr Tydfil County Borough Council Monmouthshire County Council Monmouthshire Food Initiatives Officer National Association of Health Stores National Farmers Union (Wales) National Federation of Womens Institutes Neath Port Talbot CBC Neath Port Talbot County Borough Council Pembrokeshire County Council Peters Food Service Ltd Powys Food Futures Group PRP Training Ltd Rachel's Dairy Red Star BioProducts Rhondda Cynon Taf Local Health Board Royal National Institiute for the Blind Ruddock & Sherratt School of Environmental Sciences Sharon Morris, Executive Officer Lonsdale House Jane Randall-Smith Chief Executive Gareth Llwyd Principal Planning Officer Ms Susan Perkins Dr Leigh Henderson Mrs Brenda Davies Kath Griffiths, Health & Social Care & Wellbeing Manager Graham Perry Project Manager HCS & WB Strategy Ms T Turner Ralph A Pike, Director Mrs Mary James Rhian Connick, Head of Wales Office Mike Catling, Health, SC and WB Strategy manager Carey Edwards Health Alliance Co-ordinator Sue Swan Health and Well-being Manager David Jackson Richard Pitts Charles Stevens Joanna Tett Mr Derek Mitchell, Quality Manager Jayne Komor Health Alliance Co-ordinator W Price, PA/Director R A Ennion Professor G Coleman 12

13 T/A Source Foods The Association of Public Analysts The Centre for Business The Speciality Sauce Co. Ltd Tillery Valley Foods Ltd Torfaen Local Health Board Tovali Ltd University of Wales Aberystwyth UWIC Vale of Glamorgan Council Vydex Nutrition Wales Centre For Health Wales Council for the Blind Wales Council for the Deaf Wales Council for Voluntary Action Wales Young Farmers' Club WDA Agri-Food Development Mr P Chaplin Paul Lenartowicz - Vice President Brian Jones Health, Social Care & Wellbeing Manager Chris Price-Jones Mr T B Dickens Sue Evans Director of Planning and Commissioning Eurwyn Harries Miss Norma Wells Katherine Gallimore James Crinion Health, SC & Wellbeing Coordinator Ms Maureen Iliffe David Seal Ms Vanessa Webb Mrs Merryl Roberts Delyth Higgins Lowri Jones Mr Arwyn Davies WDA Food Directorate Welsh Beekeepers Association Welsh Consumer Council Welsh Food Alliance Welsh Food Microbiological Forum Welsh Local Government Association Wrexham Local Health Board Ms M M Phillips Viv Sugar, Chair Elinor Plow, Secretary Mrs Ceri Edwards, Secretary Mr Steve Thomas, Director Gail Thomas 13

14 Zorba Foods Gerry Devine 14