Living with FIAP !

1. Living with FIAP ! Joy Hardinge

2. Dec 31st 2008- FIAP published ! • What does this mean for Industry?? • Time lines • Interpretation issues • Guidance

3. Time Line • Regulation adopted 16th December and published in the OJ 31st December 2008 • Came into force 20 days after Publication • Most sections apply 24 months after entry into force • Sections relating to the Community list apply later

4. Interpretation Issues • EFFA FLEX identified areas where guidance was needed • Definitions • BAPs • Labelling • Implementation measures

5. Definitions – Flavouring Substances • Salts of flavouring substances keep the status of the generic substance • A FS is considered as natural when it is obtained from material of vegetable, animal or microbial origin by natural processes and has been identified in nature • Identified in nature includes in materials of mineral origin • IOFI criteria for validity of identification must be met

6. Definitions – Flavouring Preparations • Intrinsic water and/or residual solvents should not conflict with GMP and where applicable comply with prescribed levels • The presence of these ingredients that are residual (not subsequently added) are considered as part of the preparation

7. Thermal Process flavourings • The process conditions are now given in the annex and it is the responsibility of the flavour company to determine if they are compliant • If not compliant authorisation is required

8. Flavour Precursor • Examples are amino acids and oligopeptides • They can belong to different categories eg amino acids are also on the Community list as flavouring substances • They can be single ingredients or mixtures

9. Source Materials • Can be food or non food • Materials for which it can be sufficiently demonstrated that they have been used for the production of flavourings are also considered as food • This covers use any where in the world prior to entry into force of the Regulation

10. “Biological Active Principles” • Risk management approach • According to the principles of HACCP flavour manufacturers have to put in place procedures to identify hazards that have to be prevented eliminated or reduced to acceptable levels

11. BAPS- Biologically Active Principles • Until the new Regulation is applicable – ie 20th Jan 2011 the old levels apply. • However Member States have been urged not to divert resources to the enforcement of these levels

12. BAPs • The levels for Safrole, estragole and methyl eugenol do not apply when a compound food contains no added flavourings and the only food ingrdients with flavouring properties which have been added are fresh dried or frozen herbs and spices. • Interpreted as saying this applies only to flavourings containing the 3 BAPs!

13. BAPs • EFFA recommends producers to • control the presence of Annex 111a substances • Communicate to the customer any relevant BAPs levels in flavourings irrespective of intended use even if the flavoured food is not covered by any food category mentioned in the Annex

14. Monitoring and reporting • MS have to establish systems to monitor the consumption of BAPs • EFFA recommends its members to commit to communicate to the Member States and the Commission all relevant data when needed to do so

15. Annex IV – Restricted Source Materials • EFFA recommends Flavour companies to ask for confirmation of the absence of the tetraploid form of Acorus calamus in calamus oil

16. Recommended Analytical Methods • The original methodology for measuring BAPs in flavourings were developed in the 70s and are now considered obsolete • The IOFI WG on Methods of Analysis is currently finalising new methodology and a validation study is expected shortly

17. Labelling • Objectives of the guidance document • To be simple and help identify the most appropriate labelling • Must not misled • Clear and easy to understand • Transparent • Aligned with market perceptions

18. B2B Labelling • Flavourings or a more specific name continues to be authorised • Roast chicken flavouring • Lemon Oil • Yeast extract

19. B2B Labelling cont. • Smoke flavouring • Smoke flavourings or a more specific name eg smoke flavouring produced from beech

20. Natural Labelling • The flavouring component can only contain natural flavouring substances and/or flavouring Preparations • The non-flavouring part does not have to be natural

21. Natural Flavouring Substances • Natural Flavouring Substances – the flavouring component has to meet the definition of a natural flavouring substance BUT other categories ie Natural X Flavouring or Natural X Flavouring with other Natural Flavourings or Natural Flavouring may be used if the conditions for them are met

22. Natural “X” Flavouring • The flavouring component has to be at least 95% “X” by weight • The flavour perception of “X” has to be easily recognisable • The other 5% has to be natural and it must not mislead eg Natural Orange Flavouring

23. Natural “X” Flavouring • The 5% must only be used to adjust natural variations in the flavour profile to ensure a consistent quality and/or to introduce special notes to the flavouring such as a more pungent ripe or green note and/or to modify the flavour profile

24. Natural “X” and “Y” Flavouring • The total of X and Y must be 95% and the largest contributor on a weight basis has to be given first Eg Natural Lemon and Lime flavouring

25. Natural “X” flavouring with other natural Flavourings • Flavouring materials from X must be present and easily recognisable • This has to be determined at company level based on expert opinion • In case of uncertainty EFFA recommends using the term Natural Flavouring eg Natural Orange Flavouring with other natural flavourings

26. Natural “X” and “Y” Flavouring with other Natural Flavourings • Source material from X and Y must be present • The flavour perception of both must be easily recognisable • The major contributor by weight needs to be listed first eg Natural lemon and lime flavouring with other natural flavourings

27. Natural Flavouring • The term Natural Flavouring is only permissible where there is no clear relationship between the source materials and the overall flavour profile • In case of uncertainty this term should be used

28. Final food Labelling • This covers only the indication in the ingredient list • It is the responsibility of the food manufacturer • In case of uncertainty the food manufacturer is recommended to consult the flavouring supplier for assistance

29. Community List • List of all flavouring substances and all “Other flavourings”. • Flavouring source materials , flavouring preparations, precursor flavourings from non food • Thermal process flavourings made out side the guidelines and/or from non food

30. Community List • The list of Flavouring Substances has to be adopted by 31st Dec 2010. Still some uncertainty over dates • The list will apply at the earliest 18 months after publication • Any flavouring substance not listed may not be placed on the market after the list is applicable

31. Position of materials other than flavouring substances which require evaluation • EFSA have until mid 2009 to propose the data requirements • The Commission have two years to produce implementation measures • EFFA/IOFI currently working on one dossier – Rum Ether

32. Sell out clauses • EFFAs interpretation is that the transition period applies to the final foodstuff • Placing on the market includes offering without charge • It does not include the further use of the flavouring ??

33. Content of Community List - Flavouring Substances • EFSA have speeded up considerably • Committed to completing their work in 2009 • This does not mean that all submitted substances will be finalised • Particular issues with group 19 materials where further data has been requested

34. Community List - Flavouring Substances • Not all data requests will be completed by the supposed cut off of mid 2009 • Interim solution needed • Work under way on constructing Community List

35. Current status of materials submitted for inclusion in Community List • Currently – 1906 ready for inclusion • 1215 have passed through system successfully • 643 went through JECFA before cut off point • 48 went through SCF/C of E

36. Status of Evaluation Program • Number of Materials to be evaluated – 1822 • Materials Evaluated – 1352 • Materials deferred – 137 • Materials pending – 470 • Mainly FGE 19

37. Evaluations still required by EFSA • A number of FGEs are still to be completed- EFSA are committed to finalising these in time • Issues with FGE 19 • Newly Notified Substances (NNS)

38. FGE 19 – Approximately 360 materials • Placed in 28 subgroups • Divided into 2 • 1. Those for which existing data was enough for an evaluation (11 sub groups -190 substances) • 2. Those for which additional data was needed (17 sub groups – 170 substances)– Industry working on this • However further evaluation of 1. has lead to some of these being moved into 2

39. Newly Notified Substances • Commission has indicated that these have been passed to EFSA for inclusion in evaluation program for CL • Since the register was established we have 92 + 23 + 12 • Between Dec and Feb a further 5 were submitted.

40. Content of Community List - Flavouring Substances • Name of Substance and identifying data • Eg CAS number FEMA number • Specification • JECFA or the one submitted in the dossier • Any restrictions • Likely only in the few cases where there are intake issues

41. Will we have a community List in 2011 ???????????? • Probably BUT • It may not be complete • Industry working to ensure that there will be a long enough transitional period

42. THANK YOU FOR YOUR INVITATION AND ATTENTION