SCIENTIFIC OPINION. EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2, 3

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1 EFSA Journal 2014;12(4):3635 Suggested citation: EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), Scientific Opinion on the safety assessment of the substances (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer either not crosslinked or crosslinked with divinylbenzene or 1,3-butanediol dimethacrylate, in nanoform, for use in food contact materials. EFSA Journal 2014;12(4):3635, 8 pp. doi: /j.efsa Available online: European Food Safety Authority, 2014 SCIENTIFIC OPINION Scientific Opinion on the safety assessment of the substances (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer either not crosslinked or crosslinked with divinylbenzene or 1,3-butanediol dimethacrylate, in nanoform, for use in food contact materials 1 ABSTRACT EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2, 3 European Food Safety Authority (EFSA), Parma, Italy This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the additives (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer either not crosslinked or crosslinked with divinylbenzene or 1,3-butanediol dimethacrylate, in nanoform, (FCM substance Nos 998, 859 and 1043), intended to be used up to 10 % w/w as an impact modifier in rigid (unplasticized) polyvinylchloride (PVC). The final material is intended to be used for contact with all food types, at room temperature or lower, for long time storage. The monomers constituting the copolymer are listed in Regulation (EU) 10/2011). The migration from PVC of the low molecular weight fraction of the additive below 1000 Da was estimated to be about mg/kg food. Considering that these low molecular weight oligomers are made from authorised monomers, which by reaction are expected to lack the reactive functional groups, they do not give rise to safety concern. The migration of the additive in nanoparticle form from the PVC was estimated, using conservative migration modelling, to be about 1 x 10-6 mg/kg food and so consumer exposure would be very low, if any. The CEF Panel concluded that there is no safety concern for the consumer if the substances are used as additives individually or in combination at up to a total of 10 % w/w in rigid PVC used in contact with all food types at ambient temperature or below including long-term storage. European Food Safety Authority, 2014 KEY WORDS copolymer in nanoform, FCM substance No 998, FCM substance No 859, FCM substance No 1043, food contact materials, safety assessment, evaluation 1 On request from the Food Standards Agency, United Kingdom, Question No EFSA-Q , adopted on 27 March Panel members: Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Catherine Leclercq (until July 2013), Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Tavares Poças, Iona Pratt, Kettil Svensson, Fidel Toldrá and Detlef Wölfle. Correspondence: cef@efsa.europa.eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Food Contact Materials: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Roland Franz, Nathalie Gontard, Ragna Bogen Hetland, Eugenia Lampi, Jean-Claude Lhuguenot (until November 2012), Maria Rosaria Milana, Maria de Fátima Tavares Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the preparatory work on this scientific opinion. Deceased.

2 SUMMARY Within the general task of evaluating substances intended for use in materials in contact with food according to the Regulation (EC) No.1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with foodstuffs, the CEF Panel received a request from the Food Standards Agency, United Kingdom, for safety evaluation of the substances (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer in nanoform either not crosslinked or crosslinked with divinylbenzene or 1,3-butanediol dimethacrylate following a corresponding application submitted on behalf of Arkema (UK). The safety assessment of (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer either not crosslinked or crosslinked with divinylbenzene or 1,3-butanediol dimethacrylate, in nanoform (FCM substance Nos 998, 859 and 1043), was requested for use as an additive (impact modifier) in rigid (unplasticized) polyvinylchloride (PVC), at up to 10 % (w/w). The final material is intended to be used for contact with all types of foodstuffs, at room temperature or lower, for long time storage. The substance as presented in this opinion has not been evaluated by EFSA in the past. However, the monomers constituting the copolymer are listed in Regulation (EU) 10/2011. Using conservative migration modelling for rigid PVC containing the additive at the maximum requested level of 10 % w/w and modelling food contact for one year at 25 C, the migration from PVC of the low molecular weight fraction of the additive below Da was estimated to be about mg/kg food. Considering that these low molecular weight oligomers are made from authorised monomers which by reaction are expected to lack the reactive functional groups, they do not give rise to safety concern. Using the same modelling approach, and with an additional conservative assumption that all particles had a size less than 10 nm, the estimated migration of the copolymer in nanoparticle form was 1 x10-6 mg/kg food. Real migration, if any, is expected to be even lower and so consumer exposure would be very low, if any. The CEF Panel concluded that the three substances (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer, (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene and (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate, in nanoform do not raise a safety concern for the consumer if used as additives individually or in combination at up to a total of 10 % w/w in non-plasticised PVC used in contact with all food types at ambient temperature or below including long-term storage. EFSA Journal 2014;12(4):3635 2

3 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background as provided by the legislation... 4 Terms of reference as provided by the legislation... 4 Assessment Introduction General information Data available in the dossier used for this evaluation Evaluation... 6 Conclusions... 6 Documentation provided to EFSA... 6 References... 6 Glossary... 8 EFSA Journal 2014;12(4):3635 3

4 BACKGROUND AS PROVIDED BY THE LEGISLATION Before a substance is authorised to be used in food contact materials and is included in a positive list EFSA s opinion on its safety is required. This procedure has been established in Articles 8 and 9 of the Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food 4. According to this procedure the industry submits applications to the Member States competent Authorities which in their turn transmit the applications to the EFSA for their evaluation. The application is supported by a technical dossier submitted by the industry following the SCF guidelines for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation (EC, 2001). In this case, EFSA received an application from the Food Standards Agency, United Kingdom, requesting the evaluation of the additive (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer either not crosslinked or crosslinked with divinylbenzene or 1,3-butanediol dimethacrylate, in nanoform, with the FCM substance Nos 998, 859 and TERMS OF REFERENCE AS PROVIDED BY THE LEGISLATION According to Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food EFSA is asked to carry out an assessment on the risks related to the indented use of the substance and to deliver a scientific opinion. 4 Commission Regulation (EC) No 1935/2004 of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC. OJ C 117, , p. 1. EFSA Journal 2014;12(4):3635 4

5 ASSESSMENT 1. Introduction The European Food Safety Authority was asked by the Food Standards Agency, United Kingdom, to evaluate the safety of (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer either not crosslinked or crosslinked with divinylbenzene or 1,3-butanediol dimethacrylate, in nanoform, FCM substance Nos 998, 859 and The request has been registered in the EFSA s register of received questions under the number EFSA-Q The dossier was submitted on behalf of the applicant Arkema. 2. General information According to the applicant, the substances (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer either not crosslinked or crosslinked with divinylbenzene or 1,3-butanediol dimethacrylate, in nanoform, are used as additives (impact modifiers) in rigid (unplasticized) polyvinylchloride (PVC) plastics. The level of use is up to a total of 10 % w/w and the PVC is processed into materials or articles at a maximum temperature of 220 C. The final materials and articles are intended to be used for contact with all types of foodstuffs, at room temperature or below, for long term storage. The substances have not been evaluated by SCF or EFSA in the past. However, the monomers constituting the copolymers are listed in Regulation (EU) 10/2011 as follows: Ethyl acrylate is subject to an SML(T) of 6 mg/kg, expressed as acrylic acid. Methyl methacrylate has an SML(T) of 6 mg/kg expressed as methacrylic acid. Butadiene is subject to a restriction of a maximum residual quantity in the plastic, QM, of 1 mg/kg and with an SML that it should be not detectable at a detection limit of 0.01 mg/kg food. Styrene is listed without any restriction. Divinylbenzene is listed with an SML(T) that it should be not detectable at a detection limit of 0.01 mg/kg food, and is listed together with ethylvinylbenzene with the further requirement that there be no more than 45 % of ethylvinylbenzene in the divinylbenzene. 1,3-Butanediol dimethacrylate is not listed in the Regulation. It is an ester of 1,3-butanediol with methacrylic acid. 1,3-Butanediol is listed without any restriction and methacrylic acid is listed with an SML(T) of 6 mg/kg. 3. Data available in the dossier used for this evaluation The studies submitted for evaluation followed the SCF guidelines for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation (EC, 2001). Non-toxicity data: - Data on identity - Data on physical and chemical properties of the substance - Data on intended use and authorisation - Data on residual starting substances 5 FCM substance No 998: (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer in nanoform FCM substance No 859: (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene FCM substance No 1043: (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate EFSA Journal 2014;12(4):3635 5

6 - Data on identification and quantification of low molecular weight oligomers - Physical properties of the finished nanocomposite - Migration modelling Toxicity data - None 4. Evaluation The substances are polymeric additives manufactured using authorised monomers. The monomers constituting the copolymers are listed in Regulation (EU) 10/2011. The residual amounts of all the monomers used, were each very low in the additives such that their relevant SML values would not be exceeded. Butanediol dimethacrylate is the simple ester of two authorised monomers and the low residual concentration in the additives does not give rise to toxicological concern when used in this way as a cross-linking monomer. When incorporated in the PVC matrix, the substances are in form of spherical nanoparticles larger than 20 nm in diameter and at least 95 % (using the number size distribution) of the particles are in the nm range. Recognised migration modelling (JRC, 2010) was used to estimate migration from rigid PVC containing the additives at the maximum total requested level of 10 % w/w after food contact for one year at 25 C (simulating long-term storage of foods at or below ambient temperature). The migration from PVC of the low molecular weight fraction of the additive below Da under these conditions was conservatively estimated to be about mg/kg food. Considering that these low molecular weight oligomers are made from authorised monomers, which by reaction are expected to lack the reactive functional groups, they do not give rise to safety concern. Recognized migration modelling, as currently settled, is not directly applicable to nanoparticle migration estimation. For this reason, the applicant applied additional conservative assumptions to estimate migration of the nanoparticles from the nanocomposite material, in particular the assumption that all particles had a size less than 10 nm. The estimated migration was 1 x10-6 mg/kg food. Real migration, if any, is expected to be even lower and therefore consumer exposure would be very low, if any (Bott et al., 2014). Consequently, the Panel considered that the intended use of these nanoparticulate substances does not give rise to exposure of the consumer via food and therefore would not be of toxicological concern if used only in rigid PVC individually or in combination up to a total of 10 % w/w and for the food contact applications described. CONCLUSIONS Having considered the above mentioned data, the CEF Panel concluded that the three substances (butadiene, ethyl acrylate, methyl methacrylate, styrene copolymer, (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene and (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate, in nanoform, do not raise a safety concern for the consumer if used as additives individually or in combination at up to a total of 10 % w/w in nonplasticised PVC used in contact with all food types at ambient temperature or below including long-term storage. Any materials or article made using the additive would have to comply with the restrictions in Regulation (EU) 10/2011 on these monomers. DOCUMENTATION PROVIDED TO EFSA 1. Dossier AR June Submitted on behalf of Arkema (UK). REFERENCES Bott J, Störmer A, and Franz R, A comprehensive study into the migration potential of nano silver particles from food contact polyolefins. In: Chemistry of Food and Food Contact Materials: From production EFSA Journal 2014;12(4):3635 6

7 to plate. Benvenuto M A, Ahuja S, Duncan T V, Noonan G, Roberts-Kirchhoff E. Eds: ACS Symposium Series 1159, American Chemical Society, Washington DC, US. doi: /bk ch005. EC (European Commission), (2001). Guidelines of the Scientific Committee on Food for the presentation of an application for safety assessment of a substance to be used in food contact materials prior its authorisation; JRC (Joint Research Center), (2010) Applicability of generally recognised diffusion models for the estimation of specific migration in support of EU Directive 2002/72/EC, JRC Scientific and Technical Report, EUR EN; _cs_2010_09_24_final.pdf%5b1%5d.pdf EFSA Journal 2014;12(4):3635 7

8 GLOSSARY CEF EC EFSA EU FCM PVC SCF SML(T) Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids European Commission European Food Safety Authority European Union Food Contact Materials polyvinylchloride Scientific Committee on Food Specific Migration Limit (total) EFSA Journal 2014;12(4):3635 8