1. Vilnius, 18 October 2011 This presentation expresses the views of the author and does not, in any case, bind the European Commission Directorate-General for Health & Consumers Food Additives – the EU Regulatory Framework Jiri Sochor Unit E3: Chemicals, contaminants and pesticides

2. This presentation expresses the views of the author and does not, in any case, bind the European Commission Food Improvement Agents Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and flavourings. Regulation (EC) No 1332/2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97 Regulation (EC) No 1333/2008 on food additives Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties amending Council Regulation (EEC) no 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC

3. This presentation expresses the views of the author and does not, in any case, bind the European Commission Framework Regulation (EC) No 1333/2008  Annexes to specific Directives for 3 groups of additives still apply  Positive lists of additives authorised to the exclusion of all others + conditions of use Dir. 94/36: Roughly 30 Colours authorised Ex. E 160d (lycopene), E 129 (allura red)… Dir. 94/35: Roughly 15 Sweeteners Ex. E 950 (Acesulfame K), E 951 (Aspartame)… Dir. 95/2: Roughly 300 additives other than Colours and Sweeteners Ex. E 260 (acetic acid), 220 (sulphur dioxide)…    Legal framework for food additives Fully harmonized sector

4. Regulation (EC) No 1333/2008 on food additives Replaces Directive 89/107/EEC Most provisions have applied since 20/01/2010 One single Regulation on food additives: colours, sweeteners and miscellaneous additives Comitology: Simpler regulatory procedure for additive authorisation (changes due to Lisbon Treaty) to set up a re-evaluation programme for existing food additives. Deadlines for EFSA and the Commission with regard to new authorisations

5. General conditions of use of food additives Conditions of use: Does 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 Does not mislead the consumer Advantages and benefits for the consumer

6. Additional conditions for colours restore the original appearance of food of which the colour has been affected by processing, storage, packaging and distribution, whereby visual acceptability may have been impaired make food more visually appealing give colour to food otherwise colourless

7. Additional conditions for sweeteners replace sugars for the production of energy- reduced food (*), non-cariogenic food or food with no added sugars replace sugars where this permits an increase in the shelf-life of the food produce food intended for particular nutritional use

8. This presentation expresses the views of the author and does not, in any case, bind the European Commission Establishment of EU lists Food additives in Annex II shall be 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 shall be entered in Annex II to this Regulation after a review of their compliance with Articles 6, 7 and 8 thereof. The review shall not include a new risk assessment by the Authority. The review was to be completed by 20 January 2011. Food additives and uses which are no longer needed shall not be entered in Annex II.

9. This presentation expresses the views of the author and does not, in any case, bind the European Commission Food categorisation system 0All foodstuffs 1Dairy 2Fats and Oils 3 Edible Ice 4Fruit and Vegetables 5Confectionery 6Cereals and Cereal Products 7Bakery Wares 8Meat and Meat Products 9Fish and Fish Products 10Eggs and Egg Products 11Sugars and Table Top Sweeteners 12Salt, Spices, Seasonings, Sauces etc. 13PARNUTS 14Beverages 15Snacks 16Desserts 17Food Supplements 18 Processed foodstuffs no belonging to 1 - 17

10. This presentation expresses the views of the author and does not, in any case, bind the European Commission Category 14 beverages 14.1Non-alcoholic beverages 14.1.1 Waters (inc Natural mineral waters, source waters, table waters and soda waters) 14.1.2Fruit and vegetable juices 14.1.3Fruit and vegetable nectars 14.1.4Flavoured drinks 14.1.5Coffee, coffee substitutes, tea, herbal infusions, and other hot cereal and grain beverages, excluding cocoa

11. This presentation expresses the views of the author and does not, in any case, bind the European Commission Category 14 beverages 14.2Alcoholic beverages, including alcohol-free and low-alcoholic counterparts 14.2.1Beer and malt beverages 14.2.2Grape wines 14.2.3Cider and perry, 14.2.3.1 Cider and perry, including aromatised products 14.2.3.2Cidre Bouché, 14.2.4Fruit wines and made wine 14.2.5Mead

12. This presentation expresses the views of the author and does not, in any case, bind the European Commission Category 14 beverages 14.2Alcoholic beverages, including alcohol-free and low-alcoholic counterparts 14.2.6Distilled spirituous beverages 14.2.6.1 Spirit drinks as defined in Reg 110/2008 14.2.6.2 Spirituous beverages containing less than 15 % of alcohol 14.2.7Aromatized wine based products as defined in Regulation (EEC) No 1601/91 14.2.7.1Aromatized wines 14.2.7.2Aromatized wine based drinks 14.2.7.3aromatized wine based products 14.2.8mixtures

13. State of play EU list (Annex II to Regulation (EC) No 1333/2008) One single list Additives listed on the basis of the categories of food to which they may be added Positive opinion at the SCoFCAH, on 4 April 2011 3 Months scrutiny EP start on 15 July 2011 Expected adoption and publication 11/11/11 Date of application 1 June 2013

14. Food additives database See: Food Improvement Agents website Food Improvement Agents website See: Food Additives Database Food Additives Database

15. This presentation expresses the views of the author and does not, in any case, bind the European Commission COMMISSION REGULATION (EU) No 257/2010, re-evaluation programme. New risk assessment by EFSA All food additives which were authorised before 20 January 2009 Re-evaluation programme Colours completed by 31.12.2015 Some “southampton colours” voted 9.09.2011 Further work will start during 2012 Sweeteners completed by 31.12.2020 All others completed by 31.12.2018

16. This presentation expresses the views of the author and does not, in any case, bind the European Commission Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings Lays down the procedural arrangements for updating the lists of substances the marketing of which is only authorised when included in a Union list. ‘Updating the Union list’ means: (a) adding a substance to the list; (b) removing a substance from the list; (c) adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance

17. This presentation expresses the views of the author and does not, in any case, bind the European Commission Timing for an authorisation Opinion of EFSA: nine months Proposal of the Commission at the Standing Committee: nine months Regulatory procedure with scrutiny: 2 months Time needed for adoption by the Commission and publication in the official journal

18. This presentation expresses the views of the author and does not, in any case, bind the European Commission Food Additives-Implementation Implementing measures Deadline Programme for re-evaluation, REGULATION (EU) No 257/2010 25.03.2010 Implementing measure, REGULATION (EU) No 234/2011 10.03.2011 Practical Guidance for applicants 11.09.2011 Review of current authorisations 07.04.2011 New Regulation on specifications 04.07.2011 Regulation of additives in additives, enzymes and nutrients. 07.04.2011 Specifications for new substances Ongoing Request for new additives/extension of uses Ongoing Revisions following re-evaluation by EFSA Ongoing Guidance for appropriate information for table top sweeteners Guidance on common methodology for gathering intake data

19. Better Training for Safer Food Starting in 2012 12 x 3-day training 540 overall No of participants Content: legislation, authorisation procedure, RA, RM, RC, understanding the EU list, specifications, monitoring, national control plan, inspections, laboratory analysis This presentation expresses the views of the author and does not, in any case, bind the European Commission

20. Thank you for your attention