Directorate-General for Health & Consumers

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

2. 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 This presentation expresses the views of the author and does not, in any case, bind the European Commission

3. Legal framework for food additives Fully harmonized sector 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. 95/2: Roughly 300 additives other than Colours and Sweeteners Ex. E 260 (acetic acid), 220 (sulphur dioxide)… 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)… This presentation expresses the views of the author and does not, in any case, bind the European Commission

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. 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. This presentation expresses the views of the author and does not, in any case, bind the European Commission

9. 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 no belonging to 1 - 17 This presentation expresses the views of the author and does not, in any case, bind the European Commission

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

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

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

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 • See:Food Additives Database

15. 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 This presentation expresses the views of the author and does not, in any case, bind the European Commission

16. 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 This presentation expresses the views of the author and does not, in any case, bind the European Commission

17. 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 This presentation expresses the views of the author and does not, in any case, bind the European Commission

18. Food Additives-Implementation This presentation expresses the views of the author and does not, in any case, bind the European Commission

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