SCIENTIFIC PANEL ON FOOD CONTACT MATERIALS, ENZYMES, FLAVOURINGS

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1 FIP UNIT SCIENTIFIC PANEL ON FOOD CONTACT MATERIALS, ENZYMES, FLAVOURINGS AND PROCESSING AIDS (CEF) Minutes of the 28 th plenary meeting of the Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids Held on , Parma (Agreed on ) Participants Panel Members: Ulla Beckman Sundh, Leon Brimer, Laurence Castle, Karl-Heinz Engel, Roland Franz, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Kettil Svensson, Catherine Leclercq 2, Jean-Claude Lhuguenot, Wim C. Mennes (Vice-Chair), Maria Rosaria Milana, Iona Pratt (Chair), Fátima Pocas, Fidel Toldrá 3. Hearing Experts: Martinus Løvik (for Flavourings), Karin Kristiane Nørby (for Flavourings). European Commission: Annette Schäfer and Bastiaan Schupp 4. EFSA: o FIP Unit: Eric Barthelémy, Anna F. Castoldi, Maria Carfi, Cristina Croera, Alexandre Feigenbaum, Claudia Heppner (Head of Unit), Ilse Koenig, Alina Lupu, Kim Rygaard Nielsen, Hanne Pedersen, Dimitrios Spyropoulos, Elisavet Thessalonikeos, Anne Theobald. o Other EFSA Units/Directorates: Catherine Geslain-Lanéelle (Executive Director) 5, Marco Castaldini (IT Department) 6. Observers: None. 1 The publication of the minutes shall be made without delay in compliance with the Founding Regulation and no later than 15 working days following the day of their agreement. 2 Only present day 1 and 2. 3 Only present day 1. 4 Available by tele-web conferencing. 5 Visited the Panel. 6 Presented the new DoI IT tool. European Food Safety Authority Via Carlo Magno 1/a, Parma, ITALY Tel: (+39) Fax: (+39)

2 Others: None. 1. Welcome and apologies for absence The chair of the CEF Panel welcomed the members to the 28 th CEF plenary meeting. Apologies for absence were received from Mona-Lise Binderup, Nathalie Gontard and Detlef Wölfle (CEF Panel Members). 2. Adoption of agenda The draft agenda was adopted without changes. 3. Declarations of interest The HoU informed the Panel about the new Decision of the Executive Director implementing EFSA s Policy on Independence and Scientific Decision-Making Processes regarding Declaration of Interests which took effect from 1 st of July 2012 with a four-month transition period (starting on 1 st of July) during which the declarations of interests for all members of the CEF Panel and CEF WGs will be reviewed. In accordance with EFSA s Policy on Independence and Scientific Decision-Making Processes regarding Declarations of Interests (DoIs) 3 and the Decision of the Executive Director implementing this Policy 4, EFSA screened the Annual Declarations of interest (ADoI) and the Specific Declarations of interest (SDoI) filled in by the experts invited for the present meeting. For further details on the outcome of the screening of the ADoI and SDoI, please refer to Annex I. 4. Agreement of the minutes of the 27 th Plenary meeting held on 22/ , Parma The draft minutes were discussed and some editorial changes were suggested. The agreed minutes can be seen on: 5. Report on written procedures since 27 th Plenary meeting None 6. Scientific outputs submitted for discussion and possible adoption The chair of the CEF Panel expressed her appreciation to the members of the working groups and to EFSA staff for the preparatory work of these drafts. 6.1 Flavourings and Smoke Flavourings Flavouring substances FGE.226 (old FGE 200Rev1), Epoxydecenal (EFSA-Q ) The Flavour Industry has provided additional genotoxicity studies for the substance FL-no: in FGE.226. Based on these new data the Panel concluded that it did not induce gene mutations in bacterial cells but was positive in an in vitro micronucleus assay, so, it is considered an in vitro genotoxic agent. The negative results obtained in an in vivo micronucleus assay cannot overrule the positive results of the in vitro micronucleus assay with and without S9-mix due to the lack of cytotoxicity in the bone marrow. The Panel considered that lethality may indicate that the bone marrow was exposed, however this is not 2

3 a proof. In addition, the negative results of this in vivo micronucleus assay do not allow to exclude site of contact effects. On this basis, an in vivo Comet assay in rodents is recommended in order to verify possible genotoxic effects at the first site of contact (e.g. stomach/duodenum cells) FGE.205: Consideration of genotoxicity data on representatives for 13 alpha,beta-unsaturated aliphatic ketones with terminal double bonds and precursors from chemical subgroup of FGE.19 (EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q ) The rapporteur presented the draft opinion. The Panel suggested revising the draft opinion. It will be presented again for possible adoption in the CEF Panel meeting of September FGE.07Rev 4: Saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids (EFSA-Q , EFSA-Q , EFSA-Q , EFSA- Q , EFSA-Q ) A hearing expert was invited to discuss the possibility to use dermal contact allergy data of a substance to predict possible allergy after ingestion. A new literature search will be done to retrieve additional information on allergenicity of the flavouring substance. The opinion will be revised by the flavouring working group and presented for possible adoption in a further CEF plenary meeting FGE.08Rev5: Aliphatic and alicyclic mono-, di-, tri-, and polysulphides with or without additional oxygenated functional groups (EFSA-Q , EFSA-Q , EFSA-Q ) The Panel was requested to evaluate 80 flavouring substances in FGE.08. Since the publication of the last revision of this FGE, the EFSA has been requested to evaluate additional toxicological data submitted for FL-no: and FL-no: For FL-no: , FL-no: , FL-no: and FL-no: data on use as flavouring substances in Europe were not available. For FL-no: , , , , , , , , , , and no appropriate NOAEL was available and additional data are required FGE.09Rev4: Secondary alicyclic saturated and unsaturated alcohols, ketones and esters containing secondary alicyclic alcohols (EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q ) The Panel was requested to evaluate 21 flavouring substances (including 4 new substances FL-no: , FL-no: , FL-no: and FL-no: ) in FGE 9. For three of the candidate substances [FL-no: , and ] it has been concluded that a concern for genotoxicity, indicated by the presence of a structural alert, 3

4 could be ruled out based on experimental data for supporting substances. Genotoxicity data are available only for a limited number of the flavouring substances in the present group and the genotoxicity cannot be assessed adequately. However, the data available did not preclude evaluation of the substances using the Procedure. The Panel concluded that 20 substances [FL-no: , , , , , , , , , , , , , , , , , , and ] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. For FL-no: , additional toxicity data are requested (further metabolism and/or toxicity studies) FGE.63Rev1 Consideration of aliphatic secondary alcohols, ketones and related esters evaluated by JECFA (59th and 69th meetings) (EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q ) Due to lack of time, the opinion was postponed to a further Plenary meeting FGE.99 Consideration of Furanone derivatives evaluated by the JECFA (63th and 65th meetings) (EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q ) Due to lack of time, the opinion was postponed to a further Plenary meeting FGE [(4-Amino-2,2-dioxido-1H-2,1,3-benzothiadiazin-5-yl)oxy]-2,2- dimethyl-n-propylpropanamide (EFSA-Q ) The draft opinion was presented and discussed. It was decided to analyse again the genotoxicity data and the evaluation by the A side may be reconsidered by the flavouring working group. The draft opinion will be re-presented at a further Plenary meeting Smoke Flavourings Smoke flavouring Primary Product SmokEz C Update (EFSA-Q The CEF Panel updated the safety assessment of the smoke flavouring Primary Product SmokEz C-10 as new data on use levels, chemical data and a new 90-day toxicity study were provided by the applicant. In 2009, the Panel concluded that the margins of safety for this Primary Product were insufficient and the proposed use levels were considered of safety concern. Based on newly submitted normal use levels, the margins of safety are 56 and 68 (total dietary exposure) and 58 and 80 (use in traditionally smoke foods only) depending on the exposure scenario used. Given that these margins of safety are based on a 90-day toxicity studies, and given the absence of data on reproduction, developmental toxicity and of long term studies, it is concluded that the uses and use levels of Primary Product would require a larger margin of safety. The Panel concluded that the proposed use of the Primary Product at the uses and use levels specified is of safety concern Smoke flavouring Primary Product SmokEz Enviro C Update (EFSA- Q ) 4

5 The CEF Panel updated the safety assessment of the smoke flavouring Primary Product SmokEz Enviro23 as new data on use levels, chemical data and a new 90-day toxicity study were provided by the applicant. In 2009, the Panel concluded that the margins of safety for this Primary Product were insufficient and the proposed use levels were considered of safety concern. Based on newly submitted normal use levels, the margins of safety are 62 and 77 (total dietary exposure) and 65 and 89 (use in traditionally smoked foods only) depending on the exposure scenario used. Given that these margins of safety are based on 90-day toxicity studies, and given the absence of data on reproduction, developmental toxicity and of long term studies, it is concluded that the uses and use levels of Primary Product would require a larger margin of safety. The Panel concluded that the proposed use of the Primary Product at the uses and use levels specified is of safety concern Food Contact Materials (FCM) Food Contact Materials substances FCM Substance No 988; 1,3-bis(isocyanatomethyl)benzene (EFSA-Q ) The EFSA had been requested to evaluate the risk for consumers health related to the use of the substance 1,3-bis(isocyanatomethyl)benzene, FCM Substance No 988, in materials in contact with food. The rapporteurs presented the draft opinion which was discussed, modified and adopted. No safety concern was identified if the substance is used according to the restrictions proposed. The full opinion is available through: FCM Substance No 872; 2-Phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine (PPPBP) (EFSA-Q ) The EFSA had been requested to evaluate the risk for consumers health related to the use of the substance 2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine (PPPBP), FCM Substance No 872, in materials in contact with food. The rapporteurs presented the draft opinion which was discussed, modified and adopted. No safety concern was identified if the substance is used according to the restrictions proposed.the full opinion is available through: Recycling processes The Panel evaluated the Polyethylenterephthalat (PET) recycling processes, issues , and on the agenda, following the procedure described in the scientific opinion of EFSA on the criteria to be used for safety evaluation of a mechanical recycling process to produce recycled PET intended to be used for manufacture of materials and articles in contact with food, available through: These three opinions cover ten PET recycling processes grouped according to the applied technology used. 5

6 The Panel identified from the challenge test the critical steps and the values of the operating parameters of these steps to ensure sufficient decontamination of the final PET recyclate. In all cases, the Panel used the analytical data on the concentration of surrogate contaminants of the challenge test to calculate the decontamination efficiency of the processes. The processes are run under conditions at least as severe as those obtained from the challenge test. Therefore their decontaminations efficiency is considered to be at least equal to this calculated from the challenge test. The information on the numerical values of all operating parameters has been provided to EFSA as sensitive proprietary information. However, in view of the need of the values of the critical steps for enforcement purposes and of the diligent work of the EFSA WG on Recycling of plastic FCM, EFSA will make this information available to the MS Authorities. In all three opinions, the Panel concluded that the recycling processes would not give rise to safety concerns if the proportion of PET from non-food consumer applications does not exceed 5 %, and these processes are operated under the defined conditions EC Register No RECYC004; PETUK SSP (EFSA-Q ) The rapporteur presented the draft opinion on PETUK SSP, EC register number RECYC004, where the English National Competent Authority, following a request from the applicant, had asked EFSA to evaluate the risk for consumers health related to the above recycling process for production of recycled post-consumer PET for use in the manufacture of food contact materials EC Register No RECYC008, RECYC025, RECYC024 and RECYC027 (EFSA-Q ; EFSA-Q ; EFSA-Q ; EFSA-Q ) The rapporteur presented the draft grouped opinion on LuxPET, PolyQuest, Jayplas and CIER recycling processes based on Vacurema Prime technology where MS Authorities had asked EFSA, following a request from the applicants, to evaluate the risk for consumers health related to the above recycling processes for production of recycled post-consumer PET for manufacture of food contact materials EC Register No RECYC012, RECYC042, RECYC054, RECYC068 and RECYC080 (EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q , EFSA-Q ) The rapporteur presented the draft grouped opinion on Preformia, STF, MPTS, PET to PET and Eco Plastic recycling processes based on STARLINGER IV+ technology, where MS Authorities, following a request from the applicants, had asked EFSA to evaluate the risk for consumers health related to the above recycling processes for production of recycled postconsumer PET for manufacture of food contact materials. 6

7 EC Register No RECYC069 ( (EFSA-Q ) Due to the lack of time the discussion was deferred to the next Plenary meeting. 7. New Mandates This item was not discussed 8. Feedback from the Scientific Committee/the Scientific Panel, Working Groups, EFSA, the European Commission 8.1 Scientific Committee and other Scientific Panels The agenda of the Scientific Committee meeting included discussion on various issues of which the most important the new composition of the Scientific Committee and all Scientific Panels, except for the ANS and CEF Panels. The Scientific Committee also endorsed the Work programme 2013 and adopted the list of organisations which will make up EFSA s Stakeholder Consultative Platform. The FIP Scientific Network mandate was presented. Bisphenol A (BPA) could be a first issue to be discussed by the Network. 8.2 Working groups (WG) WG BPA toxicology The members of the CEF Panel were informed that the 2 nd meeting of the WG BPA toxicology had taken place on 26 th June. The structure and the table of content of the opinion concerning the section on hazard characterization were discussed and updated. The criteria to be used for study inclusion/exclusion from the new risk assessment opinion were defined. A merging of the draft section on exposure and toxicology is foreseen at the beginning of The two WGs will meet together to develop the opinion further. The draft opinion will be presented for adoption later that year. WG BPA exposure The members of the CEF Panel were informed that the 2 nd meeting of the WG BPA exposure will take place on the 11th July. At this meeting it is foreseen to establish the work program in order to finalise the exposure assessment part until the end of The call for BPA occurrence data in food and beverages intended for human consumption, migration data from and occurrence data in food contact materials has been published at EFSA webpage: Stakeholders were informed and invited to submit data until the 31 st July through the EFSA web interface Data Collection Framework (DCF) ( 8.3 EFSA EFSA s new Implementing Rules for the Declarations of Interest (DoIs) were presented by Claudia Heppner. The EFSA Executive Director, Catherine Geslain-Lanéelle visited the meeting to express her appreciation to the CEF Panel and to thank its members for their achievements over the past years in the field of risk assessment of chemicals. There are ongoing contacts with ANSES on the BPA hazard identification. A conference call was held. 8.4 European Commission None. 7

8 9. Other scientific topics for information and/or discussion 9.1 Information on the Scientific Colloquium organised by EFSA on low dose response in toxicology and risk assessment (June 2012). The event was successful and many experts exchanged views and debated the possible health effects of low levels of certain chemicals and the current and future challenges these pose for food and feed risk assessment. It was considered that EFSA will need to look more in detail at the data underlying the low-dose hypothesis as it could have an important impact on EFSA s work in several areas. It needed to be considered how the low dose response can be implemented in the RA process. 10. Any Other Business The meeting dates for the 2013 Plenary meetings of the CEF Panel have been scheduled January March May July September November 2013 The presentation on the Document Management System (DMS) was postponed to a future meeting. A few comments linked to the new Implementing Rules of DoIs were raised. These will be further communicated internally at EFSA. 11. Questions from and answers to Observers (in application of the guidelines for Observers2) Not applicable for this meeting as no observers were present. 8

9 Annex I INTERESTS AND ACTIONS RESULTING FROM THE SCREENING OF ADOI OR SDOI a) CONFLICT OF INTEREST: In his SDoI Dr Franz declared interests for the draft group opinion on recycling processes based on Vacurema Prime technology (LuxPET, PolyQuest, Jayplas and CIER) and for the draft group opinion on recycling processes based on Starlinger IV+ technology (on Preformia, STF, MPTS, PET to PET and Eco Plastic), as his organisation has prepared the dossiers for these applications. These were considered as conflicts of interest and the expert left the room when the opinions were discussed. Furthermore, he was also asked to leave the room when the other PET recycling opinions were discussed (PET UK), due to competitivity considerations. Dr Milana declared that she had been involved in a project funded by Istituto Superiore della Sanità (a public organisation) and by a federation of food industries (mineral water) to assess the scope of recycled PET. Since this was a pre-normative research and as it was not run for the benefit of a single company but for the entire sector, and furthermore this project is not overlapping with the work carried out in CEF Panel, this is not a conflict. 9