1. 1 Package on food improvement agents Food additives Food enzymes Flavourings Common procedure Developments since earlier consultation

2. 2 This presentation was produced by the author as a tool for presenting the working paper on food enzymes and represents the views of the author. These views have not been adopted or in any way approved by the Commission and should not be relied upon as a statement of the Commission's or DG Health & Consumer Protection's views. This material is information of a general nature and the European Commission does not guarantee the accuracy of the data included in this presentation, nor does it accept responsibility for any use made thereof.

3. 3 89/107/EEC to the Present Day Next Steps in Legislation on Food Additives in the European Union Mark Willis Health & Consumer Protection DG

4. 4 Problem identification Codecision - takes time to amend legislation Procedures for requesting amendments to the legislation are not laid down Does not reflect the establishment of the European Food Safety Authority Processing aid definition open to differences in interpretation Legislation is not always up to date

5. 5 Consultation Process The issue of amending/replacing 89/107/EEC has been discussed several times in recent years In February 2005 a working document and questionnaire was circulated to stakeholders

6. 6 Impact assessment Based on comments to the draft proposals and replies to the Questionnaires, an impact assessment has drafted to accompany the final proposal Main points raised by industry: revised processing aids definition time-limited authorisation transition periods

7. 7 Key aspects to the future proposal on food additives (I) One single Regulation Introduction of comitology ‘Regulation’ directly applicable Introduction of controls on additives in additives and enzymes Uniform procedures and deadlines and clear requirements Re-evaluation programme for existing food additives

8. 8 Consideration of concerns raised during consultation and ways forward Consideration of concerns raised during consultation and ways forward: Processing aid definition Time limited authorisation Transition periods

9. 9 Consideration of concerns raised during consultation and ways forward Consideration of concerns raised during consultation and ways forward: Time limited authorisation: Information to be provided on actual uses where this is requested for a particular purpose

10. 10 Developments of a future legislation on food enzymes in the European Union Olga Solomon Health & Consumer Protection DG

11. 11 Key aspects to the future proposal on food enzymes General requirements (safety, technological need, mislead consumer) Uniform procedures and deadlines and clear requirements Establishment of a Community list of food enzymes Labelling

12. 12 Impact assessment Based on comments to the draft proposals and replies to the Questionnaires, impact assessment was drafted and comments taken into account Main points raised by industry: revised processing aids definition time-limited authorisation labelling marketing of new enzymes during the transitional period until the initial establishment of the positive list

13. 13 Initial establishment of the positive list:  Implementing measure will set provisions for content, presentation of applications and validity criteria. 24 months to submit applications for existing and new products  EFSA issues opinions on all enzymes for which applications submitted within the transition period  Within 9 months after receiving all opinions Commission prepares measure for the initial establishment of the Community list

14. 14 Time National rules apply Legislation in force across Community Only enzymes which are contained within positive list may be marketed from this date. Provisionally, new food enzymes which are under evaluation by EFSA at the time of the adoption of the positive list may continue to be marketed until decision is taken on their inclusion or not in the list. EFSA Complete evaluation of ‘A’ Enzymes Industry have 24 months to submit application Implementing Commission Regulation is in force 24 Months Register containing ‘A’ enzymes with valid application published by Commission (Art. 8 (2)) 9Months Adoption of initial positive list (including ‘A’ enzymes) 3 Months An implementing Commission Regulation will set provisions for the content and presentation of an application, criteria for the validity and transitory measures. This Regulation will be adopted at the latest 24 months after adoption of this Regulation Establishment of the initial Community list

15. 15 Labelling on food: Enzymes in food Enzyme used as processing aid (only residues present/ no technological effect in the final food) No labelling Enzyme functional in the final food Labelled with their function and specific name (idem as today e.g. lysozyme) Enzymes produced by GMO in food Within the scope of 1829/2003 Labelling according to 1829/2003

16. 16 Common Authorisation procedure Common Authorisation procedure: Basic pillars: Application procedure and validity checks EFSA opinion on safety assessment Evaluation of other criteria (technological need; mislead consumer) If favourable, inclusion in a positive list with appropriate conditions of use and specifications Food additives and enzymes subject to ongoing review

17. 17 Timing Interservice consultation launched on 17.11.2005 Foreseen date of adoption by the Commission: end 2005 Package on food improvement agents: Food additives, Food enzymes, Flavourings