DirectorateGeneral for Health Consumers Food Additives Wim Debeuckelaere

Directorate-General for Health & Consumers Food Additives Wim Debeuckelaere Unit E 3: Chemicals, contaminants and pesticides Clitravi 3 October 2011 This presentation expresses the views of the author and does not, in any case, bind the European Commission

Food Additives Legislation Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and flavourings. Commission Regulation (EU) No 234/2011 implementing Regulation (EC) No 1331/2008 Regulation (EC) No 1333/2008 on food additives Commission Regulation (EU) No 257/2010 setting up a programme for the re-evaluation of Food additives. This presentation expresses the views of the author and does not, in any case, bind the European Commission

Current list of authorised food Additives Current authorisations Until 1 June 2013, these provisions of the old directives apply: Article 2(1), (2) and (4) of Directive 94/35/EC and Annex; Article 2(1) - (6), (8), (9) and (10) of Directive 94/36/EC and Annexes I - V; Articles 2 and 4 of Directive 95/2/EC and Annexes I - VI. In the meantime, authorisation of new additives or conditions of use can already apply according to the Annexes to Regulation EC 1333/2008.

Future list of authorised food Additives New EU lists will be established amending Annex II and III to Regulation EC 1333/2008 with: EU list of food additives approved for use in foods and their conditions of use (Annex II) EU list of food additives for use in food additives, food enzymes, food flavourings and nutrients (Annex III)

Reg. (EC) No 1333/2008 -review 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 shall 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

Food categorisation system 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Additives authorised in all foodstuffs Dairy Fats and Oils Edible Ice Fruit and Vegetables Confectionery Cereals and Cereal Products Bakery Wares Meat and Meat Products Fish and Fish Products Eggs and Egg Products Sugars and Table Top Sweeteners Salt, Spices, Seasonings, Sauces etc. PARNUTS Beverages Snacks Desserts Food Supplements other processed food This presentation expresses the views of the author and does not, in any case, bind the European Commission

Category 8 Meat 08. 1 Unprocessed meat 08. 1. 1 Unprocessed meat other than meat preparations as defined by Regulation (EC) No 853/2004 08. 1. 2 Meat preparations as defined by Regulation (EC) No 853/2004 08. 2 Processed meat 08. 2. 1 Non heat treated processed meat 08. 2. 2 Heat treated processed meat 08. 2. 3 Casings and coatings and decorations for meat 08. 2. 4 Traditionally cured meat products with specific provisions concerning nitrites and nitrates 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 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

Reg. (EC) No 1333/2008 -Implementation Implementing measures Deadline Implementing measure 10. 03. 2010 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 Revision followingre-evlation by EFSA Ongoing Guidance for appropriate information for table top sweeteners Guidance on common methodology for gathering intake data 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 Community list. ‘Updating the Community list’ means: (a) adding a substance to the Community list; (b) removing a substance from the Community 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

Main stages of the common procedure (art. 3) The common procedure may be started either on the initiative of the Commission or following an application by a Member State or by an interested party. Applications shall be sent to the Commission. . The Commission shall seek the opinion of the European Food Safety Authority, unless the updates in question are not liable to have an effect on human health The common procedure shall end with the adoption by the Commission of a regulation implementing the update. This presentation expresses the views of the author and does not, in any case, bind the European Commission

Implementing measures Within a period of no longer than 24 months from the adoption of each sectoral food law, implementing measures shall be adopted by the Commission in particular: a) the content, drafting and presentation of the application; b) the arrangements for checking the validity of applications; c) the type of information that must be included in the opinion of the Authority. 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: maximum nine months Proposal of the Commission at the Standing Committee: maximum nine months Regulatory procedure with scrutiny: 2 months/4 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

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