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1、Living with FIAP !,Joy Hardinge,Dec 31st 2008- FIAP published !,What does this mean for Industry? Time lines Interpretation issues Guidance,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 af
2、ter entry into force Sections relating to the Community list apply later,Interpretation Issues,EFFA FLEX identified areas where guidance was needed Definitions BAPs Labelling Implementation measures,Definitions Flavouring Substances,Salts of flavouring substances keep the status of the generic subst
3、ance 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,Definitions Flavo
4、uring 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,Thermal Process flavourings,The process c
5、onditions 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,Flavour Precursor,Examples are amino acids and oligopeptides They can belong to different categories eg amino acids are also on the C
6、ommunity list as flavouring substances They can be single ingredients or mixtures,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 w
7、orld prior to entry into force of the Regulation,“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,BAPS- Biologica
8、lly 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,BAPs,The levels for Safrole, estragole and methyl eugenol do not apply when a compound food contains no
9、 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!,BAPs,EFFA recommends producers to control the presence of Annex 111a substances C
10、ommunicate 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,Monitoring and reporting,MS have to establish systems to monitor the consumption of BAPs EFFA recommends its members t
11、o commit to communicate to the Member States and the Commission all relevant data when needed to do so,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,Recommended Analytical Methods,
12、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,Labelling,Objectives of the guidance document To be simple and he
13、lp identify the most appropriate labelling Must not misled Clear and easy to understand Transparent Aligned with market perceptions,B2B Labelling,Flavourings or a more specific name continues to be authorised Roast chicken flavouring Lemon Oil Yeast extract,B2B Labelling cont.,Smoke flavouring Smoke
14、 flavourings or a more specific name eg smoke flavouring produced from beech,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,Natural Flavouring Substances,Natural Flavouring S
15、ubstances 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,Natural “X” Flavouring,The flavouri
16、ng 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,Natural “X” Flavouring,The 5% must only be used to adjust natural variations in the flavour profile to ens
17、ure 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,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 L
18、emon and Lime flavouring,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 Or
19、ange Flavouring with other natural flavourings,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 flav
20、ouring with other natural flavourings,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,Final food Labelling,This covers only the indicat
21、ion 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,Community List,List of all flavouring substances and all “Other flavourings”. Flavouring source materials , flavo
22、uring preparations, precursor flavourings from non food Thermal process flavourings made out side the guidelines and/or from non food,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 a
23、fter publication Any flavouring substance not listed may not be placed on the market after the list is applicable,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 impleme
24、ntation measures EFFA/IOFI currently working on one dossier Rum Ether,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 ?,Content of Community
25、 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,Community List - Flavouring Substances,Not all
26、 data requests will be completed by the supposed cut off of mid 2009 Interim solution needed Work under way on constructing Community List,Current status of materials submitted for inclusion in Community List,Currently 1906 ready for inclusion 1215 have passed through system successfully 643 went th
27、rough JECFA before cut off point 48 went through SCF/C of E,Status of Evaluation Program,Number of Materials to be evaluated 1822 Materials Evaluated 1352 Materials deferred 137 Materials pending 470 Mainly FGE 19,Evaluations still required by EFSA,A number of FGEs are still to be completed- EFSA ar
28、e committed to finalising these in time Issues with FGE 19 Newly Notified Substances (NNS),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 nee
29、ded (17 sub groups 170 substances) Industry working on this However further evaluation of 1. has lead to some of these being moved into 2,Newly Notified Substances,Commission has indicated that these have been passed to EFSA for inclusion in evaluation program for CL Since the register was establish
30、ed we have 92 + 23 + 12 Between Dec and Feb a further 5 were submitted.,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,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,THANK YOU FOR YOUR INVITATION AND ATTENTION,