Minutes Of The 6 Meeting - European Food Safety Authority

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FOOD INGREDIENTS AND PACKAGING UNITScientific Network of the food ingredients andfood packaging (FIP) Unit on food contactmaterials (FCM), the ‘EFSA FCM Network’Minutes of the 6th meetingHeld on 10-11 July 2018, Parma(Agreed on 27 July 2018)1Participants Network Representatives of Member States (including aCyprusCzech ia1NameThomas SchwartzBirgit MertensSnezhana TodorovaNino DimitrovAntigoni AchilleosJitka SosnovcovaKatrin KempiMerja VirtanenGilles RivièreStefan MerkelStella KontouBanka SzilvassyJoseph HannonRiccardo CrebelliMaria Rosaria MilanaSkirmante AmbrazieneDirk van AkenMarzena PawlickaMaria de Fatima Tavares PoçasMilada SycovaThe publication of the minutes shall be made without delay in compliance with the Founding Regulation andno later than 15 working days following the day of their agreement.European Food Safety Authority Via Carlo Magno 1A 43126 Parma ITALYTel. 39 0521 036 111 Fax 39 0521 036 110 www.efsa.europa.eu

SpainUnited KingdomIcelandNorwaySwitzerland Perfecto Paseiro LosadaJuana Bustos Garcia De CastroTim ChandlerGrimur OlafssonInger-Lise SteffensenStefan KucseraIntergovernmental organisation Council of Europe:Eugenia Dessipri as a substitute of Susanne Bahrke European Commission:Jonathan Briggs (DG SANTE)Eddo Hoekstra (DG JRC) Member of Committee and Panels invited as speakers:Laurence Castle (member of EFSA Panel on Food additives and flavourings (FAFPanel)) EFSA:Food Ingredients and Packaging (FIP) Unit:Claudia Roncancio Peña, Head of the FIP UnitEric Barthélémy, FCM Network Coordinator, ChairAnna Federica Castoldi, FCM Team LeaderJulia Cara Carmona, FCM TeamCristina Croera, FCM TeamAlexandros Lioupis, FCM TeamEllen Van Haver, FCM TeamKatharina Volk, FCM TeamPesticides Risk Assessment (PRAS) Unit:Stefania Barmaz and Andrea Terron on behalf of Domenica Auteri, participated inagenda item 131. Welcome and apologies for absenceClaudia Roncancio Peña, Head of FIP Unit, opened the meeting.2

She underlined that the EFSA Strategy 2020, with one of its strategic objectivesbeing the building capacity in the area of scientific risk assessment also at thelevel of the Member States, is a main pillar for the Network. She stressed theimportance of sharing knowledge and expertise on methodologies and challengesin the safety assessment of chemicals, as well as information on related ongoingprojects, and Guidance documents to support harmonisation in risk assessment.Besides the direct exchange between Member States during this meeting,further knowledge on risk assessment can also be gained through the a series of2-day specialised training courses and 2-hour webinars on certain aspects offood safety risk assessment offered by EFSA (see email sent on 2 July).The members of the Network were also informed about the reduction of themeeting duration to one day which is linked to general budget restrictions. Asthe Network is considered an important platform for collaboration, it was decidedto guarantee the continuation of this work for improving harmonisation of riskassessment of non-EU regulated food contact materials (FCM).Following the recommendations made at the last review of the general operatingframework Networks across EFSA in 2012, an external evaluation is beingperformed to assess Networks’ functioning, format, frequency, and to identifypoints for improvement and commonalities.The Chair welcomed the participants, thanking them for their presence and spiritof collaboration and for sharing knowledge which is essential to achieve practicaloutcomes in terms of better harmonisation of safety assessment of non-EUregulated FCM.The Chair informed about changes as regards new MS representatives andalternates as well as substitutes for the meeting. New participants introducedthemselves.Apologies were received from the following MemberLuxembourg, Malta, Romania, Slovenia and Sweden.States:Denmark,2. Adoption of agendaThe agenda was adopted with the addition, after agenda item 16, of apresentation from Belgium on a prioritisation strategy based on non-animalmethods for genotoxic substances in printed paper and board food contactmaterials (see section 5.9.4).3. Agreement of the minutes of the 5th meeting of the EFSA FCMNetwork, held on 10-11 July 2017, Parma.The minutes were agreed by written procedure on 22 July 2017 and publishedon the EFSA website on 1 August 2017. An updated version of the minutes waspublished on 18 August 2017.4. Declaration of interests and statement of confidentialityAll Network representatives signed a statement of confidentiality through thesubmission of their Annual Declaration of Interests.3

5. Topics for discussion5.1. European Commission SANTE activitiesJonathan Briggs presented ongoing and future activities of the EuropeanCommission DG SANTE. The summary provided by the speaker is reportedbelow.“The European Commission is undertaking an evaluation on the EU legislation onFood Contact Materials (FCMs). The purpose of the evaluation is to assess theoverall effectiveness, efficiency, relevance, coherence and EU added value of theFCM legislation and in particular the rules and tools provided for by thislegislation. It will also examine the situation concerning materials for which thereare no EU specific measures and which may be subject to national measures.The evaluation will result in a Staff Working Document, which will provide abasis for the Commission to consider what, if any, possible steps need to betaken in the future concerning the regulation of FCMs in the EU.The Commission is also working to fully implement Commission Regulation (EC)No 282/2008 and authorise approximately 140 decisions on the recycling ofplastic for FCMs. The decisions will be complemented by monitoring to centralisedata on occurrence of recurring contaminants, given the relatively limitedknowledge on incidental contamination. This will provide knowledge oncontaminant levels in view of a changing market, to inform risk assessment andto enforce and eventually improve and standardise waste collection. Work onrecycling should continue in the future in light of the EU wide strategy onplastics.Other on-going work by the Commission includes the development of newlegislation to lower limits for lead and cadmium from ceramic FCMs, with thepossibility to include other metals as well as glass materials within the scope;work to clarify rules on biocides in FCMs; coordinate monitoring of FCMs;updates and improvements to the online database of substances as well asfurther amendments to Regulation (EU) No 10/2011.”During the discussion following the presentation, it was questioned what thecurrent status of the draft EU specific measure for printing inks was. During the5th Network meeting of 2017, DG SANTE informed on the intention to developsuch a measure in the near future to notably address the notification of aGerman draft ordinance. DG SANTE answered that an important and first step inthis process is to define an approach for how to best regulate this complex anddiverse group of chemicals. DG SANTE stressed the importance of the currentlyon-going evaluation of the general FCM legislation, which aims at answeringquestions about e.g. effectiveness and efficiency of the system currently inplace. The outcome of this evaluation study will help to inform the decisionmaking process for possible future draft regulations which are not yetharmonised at EU level. Until its finalisation no concrete work on specificmeasures is foreseen.With respect to the information provided on monitoring under Regulation (EC)No 284/2011, it was stressed that this is not strictly linked to certainsubstances, but that – pending a more concrete control plan – Member Statescould decide to monitor further substances of interest in the area of FCM.4

As regards the area of plastic recycling, it was questioned how the authorisationof decisions on recycling processes (foreseen for early 2019) would articulatewith the planned amendment of Regulation (EC) No 282/2008. DG SANTEclarified that changes notably aim to make the adoption and handling ofdecisions simpler and more manageable. It is planned to adopt the amendedRegulation before or at the same time as the decisions on the recyclingprocesses. The Member States will have the possibility to comment on the draftamendment through the Working Group on EC level.5.2. EFSA activitiesKatharina Volk presented ongoing and future EFSA activities. The summaryprovided by the speaker is reported below.“The Network was informed about the renewal of the EFSA Panels, which hadtheir inaugural meetings on 5-7 July. For the Panels that fall within the workingarea of the FIP Unit there have been changes in the mandate, i.e. theassessment of flavourings will be taken up by the FAF Panel (former ANS) thatwill now deal with flavourings and food additives, while the CEP Panel (formerlyCEF) will deal with food contact materials, enzymes and processing aids. As aconsequence of the renewal of the Panels, also new Working Groups are beingestablished.The launch of a call for the tasking grant “Entrusting support tasks in the area ofFood Ingredients and Packaging” was advertised to the participants. Until 3September Article 36 competent authorities can submit their proposals forscientific advice and assistance in the area of e.g. implementation of evidencebased risk assessment for the re-evaluation of BPA and substances for use inFood Contact Materials. For further information the following website can beconsulted: 6/180502.The Network was also informed about on-going activities as regards the reevaluations of phthalates and BPA. While for the re-assessment of phthalates theestablished Working Group is already operational and the opinion is expected bythe end of the year, the re-evaluation of BPA is just about to start. A protocolthat defines a priori the approach and methodology for performing the BPAhazard characterisation was published in December 2017. Currently, there is acall for data on-going that aims at gathering human and animal hazardstudies/data (published, unpublished or newly generated) relevant to BPA safetyevaluation. Relevant data can be submitted to EFSA until 31 August 2018.Additional information on the call for data can be found at the following s/call/180309-0.”A follow-up question to the presentation was related to the use of biomonitoringdata, such as the on-going biomonitoring European study (HBM4EU), in theassessment of phthalates and BPA. As regards the re-evaluation of BPA it wasclarified that the focus will be on the assessment of hazard data. For the reevaluation of phthalates instead EFSA will mainly use the dataset that was alsoused by the ECHA RAC in their assessment of phthalates published in March2017 and which includes information on hazard and exposure, among othersalso a biomonitoring study. Additionally, it has to be considered that the urinarybiomonitoring data will inform about exposure from all sources, i.e. dietary and5

non-dietary, whereas the assessment from EFSA would rather focus on thecontribution of plastic FCM to the overall dietary exposure.5.3. European Commission JRC activitiesEddo Hoekstra presented ongoing and future activities of the EuropeanCommission DG JRC. The summary provided by the speaker is reported below.“The presentation gave an overview of relevant issues performed by theEuropean Union Reference Laboratory for Food Contact Materials (EURL-FCM),established within the EC DG JRC. It addressed a project carried out togetherwith the European Plastics Converters (EuPC). This concerns the migration ofnon-intentionally added substances (NIAS) from 70 articles that arerepresentative for the EU market. This project aims to set up a procedure toprioritise the migrating NIAS for potential concern.Another topic was the monitoring of mineral oil residues in food. The EURL-FCMis in charge of writing monitoring guidelines. The part on sampling and reportingof results to EFSA is in its final stage.The “Guidelines on Testing Conditions for Articles In Contact With Foodstuffs(With A Focus on Kitchenware)” is under revision. It aims to harmonise testconditions. It will cover test conditions for all food contact materials. On requestof DG SANTE the EURL-FCM will work in the near future on the development oftesting conditions for cookware and bakeware and on the development of amonitoring and reporting approach for recycling processes. Results and progressof two proficiency tests were presented.”During the discussion on the prioritisation exercise on NIAS, and especially thecriteria for the scoring, it was proposed to investigate the possibility for adifferentiation between genotoxic and non-genotoxic substances. JRC willforward the proposal to EuPC which conducted the NIAS scoring. With regards tothe substances included in the raw data set and for which no CAS could beidentified, it was suggested to investigate in the future the frequency ofoccurrence to draw possible conclusions about material-specific NIAS andprioritisation.Timeline for finalising the work on developing the testing conditions for ceramiccookware and bakeware was communicated to be the end of 2018. This may bequite challenging and the effective finalisation might affect the timeline forrevising the directive on ceramics.5.4. Council of Europe activitiesEugenia Dessipri presented ongoing and future activities of the Council ofEurope. The summary provided by the speaker is reported below.“Council of Europe activities in the area of Food Contact Materials (FCM) startedunder the former Council of Europe Partial Agreement (18 Member States) in theSocial and Public Health Field and in 2009 were transferred to the EuropeanDirectorate for the Quality of Medicines and Health Care (EDQM – 38 MemberStates) .6

Thereafter, the Committee of Experts P-SC-EMB (Committee of Experts on FoodContact Materials) began a review of the existing resolutions and ons-policy-statements).Initialpriority was given to the work on metals and alloys that are used in food contactmaterials and articles and in June 2013, Council of Europe member statesadopted Resolution CM/Res(2013)9 on metals and alloys used in food contactmaterials and articles. A Technical Guide that presents this Resolution als). The second edition of thisResolution is currently being prepared.Activities are steered since 2018 by the Committee for food contact materialsand articles (Partial Agreement – 38 Member States) (CD-P-MCA). Currentpriority is the elaboration of a Resolution for all FCM (under the scope ofRegulation EC no. 1935/2004) that are not covered by specific harmonisedlegislation at a European level. The aim is to provide general principles and bestpractices to ensure the quality and safety of these materials. Material specifictechnical guides would complement this Resolution. Work is in progress for theelaboration of Technical Guides for FCM from paper and board, coatings, corkand ion exchange resins as well as guidelines relevant to the analysis ofcontaminants from printing inks.”With regards to the elaboration of a framework resolution for all FCM, it wasclarified that this will not contain any list of evaluated substances, but will makereference to material specific technical guides in which the lists of evaluatedsubstances, whenever included, are presented. The lists would be based onexisting European and national evaluations. To this purpose, the mutualrecognition of evaluations undertaken by other Member States, and mainlybased on the SCF guidelines, is of high importance as this will further help toincrease the level of harmonisation. It was questioned how different restrictionsfor the same substance would be considered and reported in the lists. It wasproposed to make clear how the list was built and to address this question in thetechnical guides. For the sake of transparency it was proposed that the source ofthe restriction applied was referenced in the lists. It was identified the need toclarify the meaning of “not CMR”. Likely, it is misconsidered as “not present inEU list of CMR”. In such a case, the fact that a substance is not known to be aCMR does not necessarily mean that the substance was proven not to be a CMRbased on toxicological data. It was stressed that the “10 ppb no CMR” is oftenmisused. The question of addressing the potential genotoxicity for anyintentionally added substance, including those that do not migrate (LoD of 10µg/kg food), was raised.5.5. Report back from the EFSA partnering Grant on coatingsDirk van Aken, Perfecto Paseiro and Riccardo Crebelli reported back on the EFSApartnering grant on coatings. The summaries provided by the speakers arereported below.NL: “The issue of national regulations for coatings was discussed already inprevious meetings of the EFSA FCM scientific Network. More recently the JRCstudy on non-harmonised FCM made clear that convergence between national7

provisions is very limited. In a dedicated FCM Network teleconference inFebruary 2017 with Member States (NL, SP, IT, BE, CR, SL) having expressedinterest in cooperating on coatings within the FCM Network, it was agreed that atask force should investigate the possibilities for more harmonisation. Later thatyear, an application for an EFSA Partnering Grant was submitted to facilitate thiswork. The Grant has been awarded, the Grant Agreement has been signed and akick-off meeting was held in January 2018. The project is planned to be finalisedby mid July 2019.The timeline, methodology and planned deliverables were briefly explained andthe FCM Network members; invited to give input, both during the meeting andlater.”SP: “A part of the planned deliverables of the task force on varnishes andcoatings for food contact materials is to establish a list of essential terms anddefinitions used in the evaluation of coatings for Food Contact Materials.The aim is to clarify the meaning of some scientific, technical or legal terms,which are frequently used by operators and agencies involved in risk assessmentof chemical substances in the Food Contact Material (FCM)/coatings field.Through that, solutions could be proposed to the problems that have beenidentified: a) Ambiguous terms, the meanings of which should be inferred fromthe context; b) Disagreements in the definitions used by recognisedorganisations, institutions, agencies and legal texts, both on EU and internationalor national levels and c) Lack of definitions and/or appropriate references for theterms used in the legal texts, generating uncertainties about which substancesare authorised and whether or not they should be subject to risk assessment.The task force concluded that the terminology used in the field of coatings(coating, polymer, oligomer, pre-polymer, resin, etc.) is ambiguous and it maygenerate confusion to stakeholders (incl. risk assessors), when the term is notinferred rightly from the context; b) regardless the meaning of the terms, itshould be considered the risk assessment of substances with molecular weightless than 1000 Da (polymers or pre-polymer, or oligomers or differently named),that remain in the coating and can potentially migrate into the food; and c) itshould be considered if it is appropriate, from a food safety point of view, toapply the generic authorisation for pre-polymers of the plastics Regulation (EU)No 10/2011 also into the field of coatings, since pre-polymers are broadly usedin their manufacturing.”IT: “In the framework of the activities finalised to the harmonization of nationalapproaches for the safety assessment of substances used in food conta

methods for genotoxic substances in printed paper and board food contact materials (see section 5.9.4). 3. Agreement of the minutes of the 5th meeting of the EFSA FCM Network, held on 10-11 July 2017, Parma. The minutes were agreed by written procedure on 22 July 2017 and published on the EFSA website on 1 August 2017.

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