EFSA Journal 2015;13(2):4008 SCIENTIFIC OPINION Scientific Opinion on the safety assessment of the substance (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform for use in food contact materials 1 EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2,3 ABSTRACT European Food Safety Authority (EFSA), Parma, Italy This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the additive (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform, FCM substance No 01016, intended to be used at up to 10 % w/w as an impact modifier in rigid non-plasticised polyvinylchloride and up to 15 % w/w in non-plasticised polylactic acid. The final materials are intended to be used for contact with all food types, at room temperature or below, for long-term storage. The monomers constituting the copolymer are listed in Regulation (EU) No 10/2011. The migration of the low-molecular-weight fraction of the additive below 1 000 Da was estimated to be about 0.008 mg/kg food from polyvinylchloride and about 0.007 mg/kg food from polylactic acid. 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 concerns. The migration of the additive in nanoparticle form from the polyvinylchloride and polylactic acid was estimated, using conservative migration modelling, to be in the range 1 to 1.3 10 6 mg/kg food. The CEF Panel concluded that there is no safety concern for the consumer if the substance is used as an additive at up to 10 % (w/w) in rigid polyvinylchloride and up to 15 % (w/w) in non-plasticised polylactic acid, used in contact with all food types at ambient temperature or below for long-term storage. European Food Safety Authority, 2015 KEY WORDS copolymer in nanoform, FCM substance No 01016, food contact materials, safety assessment, evaluation 1 On request from the Food Standards Agency, United Kingdom, Question No EFSA-Q-2013-00100, adopted on 27 January 2015. 2 Panel members: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. Correspondence: fip@efsa.europa.eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Food Contact Materials (until July 2014) and the standing Working Group on Food Contact Materials (2014 2017): Mona-Lise Binderup, Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Riccardo Crebelli, Roland Franz, Konrad Grob, Nathalie Gontard, Ragna Bogen Hetland, Martine Kolf-Clauw, Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima Tavares Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the preparatory work on this scientific opinion and EFSA staff member: Marisa Escudero Hernandez for the support provided to this scientific opinion. Suggested citation: EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2015. Scientific Opinion on the safety assessment of the substance (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform for use in food contact materials. EFSA Journal 2015;13(2):4008, 7 pp. doi:10.2903/j.efsa.2015.4008 Available online: www.efsa.europa.eu/efsajournal European Food Safety Authority, 2015
SUMMARY Within the general task of evaluating substances intended for use in materials in contact with food in accordance with 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 EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) received a request from the Food Standards Agency, United Kingdom, for a safety assessment of the substance (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform, following a corresponding application submitted on behalf of the applicant Arkema (UK). The safety assessment of the substance (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform was requested for its use as an additive (impact modifier) in rigid non-plasticised polyvinylchloride (PVC) at up to 10 % (w/w) and in non-plasticised polylactic acid (PLA) at up to 15 % (w/w). The final materials are intended to be used for contact with all types of foodstuffs, at room temperature or below, for long-term storage. The substance as such has not been evaluated by the European Food Safety Authority (EFSA). However, the monomers constituting the copolymer are listed in Regulation (EU) No 10/2011. Using conservative migration modelling for rigid PVC and PLA containing the additive at the maximum requested level of 10 % and 15 % (w/w), respectively, and modelling food contact for one year at 25 C, the migration of the low-molecular-weight fraction of the additive below 1 000 Da was estimated to be about 0.008 mg/kg food from PVC and about 0.007 mg/kg from PLA. 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 concerns. Using the same modelling approach, and with an additional conservative assumption that all particles were less than 10 nm in size, the estimated migration of the copolymer in nanoparticle form was in the range 1 to 1.3 10 6 mg/kg food. Real migration, if any, is expected to be even lower and so consumer exposure, if any, would be very low. The CEF Panel concluded that the substance (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform does not give rise to a safety concern for the consumer if used as an additive at up to 10 % w/w in non-plasticised PVC or up to 15 % w/w in nonplasticised PLA, used in contact with all food types, at room temperature or below, including longterm storage. EFSA Journal 2015;13(2):4008 2
TABLE OF CONTENTS Abstract... 1 Summary... 2 1. Introduction... 4 1.1. Background and Terms of Reference as provided by the legislation... 4 2. Assessment... 4 2.1. Introduction... 4 2.2. General information... 4 2.3. Data available in the dossier used for this evaluation... 5 2.4. Evaluation... 5 3. Conclusions... 6 Documentation provided to EFSA... 6 References... 6 Abbreviations... 7 EFSA Journal 2015;13(2):4008 3
1. Introduction 1.1. Background and Terms of Reference 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 (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform, FCM substance No 01016. 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. 2. Assessment 2.1. Introduction The European Food Safety Authority (EFSA) was asked by the Food Standards Agency, United Kingdom, to evaluate the safety of the substance (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform, FCM substance No 01016. The request was registered in the EFSA s register of received questions under the number EFSA-Q-2013-00100. The dossier was submitted on behalf of the applicant, Arkema (UK). 2.2. General information According to the applicant, the substance (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform is used as an additive (as an impact modifier) in rigid non-plasticised polyvinylchloride (PVC) and in non-plasticised polylactic acid (PLA) plastics. The level of use is up to 10 % w/w in PVC and up to 15 % w/w in PLA and the plastics are 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 longterm storage. The substance has not been evaluated by the Scientific Committee on Food (SCF) or EFSA. However, the monomers constituting the copolymer are listed in Regulation (EU) No 10/2011 as follows: Methacrylic acid is authorised with a group total specific migration limit, SML (T), of 6 mg/kg food. Ethyl acrylate is subject to an SML (T) of 6 mg/kg, expressed as acrylic acid. n-butyl acrylate is authorised with 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 so that it is non-detectable at a detection limit of 0.01 mg/kg food. 4 This Regulation replaces Directive 89/109/EEC of 21 December 1988, OJ L 40, 11.2.1989, p. 38. EFSA Journal 2015;13(2):4008 4
The substance is in nanoform and EFSA s Scientific Committee has published a scientific opinion on The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety (EFSA, 2009). 2.3. 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 the 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 data on migration of the substance migration modelling data on identification, quantification and migration of low-molecular-weight oligomers physical properties of the finished nanocomposite. Toxicity data: none. 2.4. Evaluation The substance is a polymeric additive manufactured using authorised monomers. The monomers constituting the copolymer are listed in Regulation (EU) No 10/2011. The residual amounts of all the monomers used were each very low in the additive such that their relevant SML values would not be exceeded. When incorporated in PVC, the substance is in the form of spherical nanoparticles larger than 20 nm in diameter, and approximately 73 % (using the number size distribution) of the particles are in the 20 100 nm range. It is expected that the particle size distribution will be similar when incorporated into PVC or PLA. Conservative migration modelling (JRC, 2010) was used to estimate migration from rigid PVC and PLA containing the additive at the maximum requested level of 10 % (w/w) and 15 % (w/w), respectively, after food contact for one year at 25 C (simulating long-term storage of foods at or below ambient temperature). The migration of the low-molecular-weight fraction of the additive below 1 000 Da under these conditions was conservatively estimated to be about 0.008 mg/kg food from PVC and about 0.007 mg/kg food from PLA. 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 concerns. Recognised migration modelling, as currently used, 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 materials, in particular the assumption that all particles were less than 10 nm in size. The estimated migration from PLA and PVC was in the range EFSA Journal 2015;13(2):4008 5
1 to 1.3 10 6 mg/kg food. Real migration, if any, is expected to be even lower. Taking into account the recent published literature on the migration of nanoparticles, the CEF Panel considers that these estimates are conservative (Bott et al., 2014). Consequently, the CEF Panel considered that the intended use of this nanoparticulate substance does not give rise to exposure of the consumer via food and, therefore, would not be of safety concern if used in non-plasticised PVC at up to 10 % w/w and in non-plasticised PLA at up to 15% for the food contact applications described only. 3. Conclusions Having considered the above-mentioned data, the CEF Panel concluded that the substance (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform does not give rise to safety concerns for the consumer if used as an additive at up to 10 % w/w in non-plasticised PVC and up to 15 % w/w in non-plasticised PLA, used in contact with all food types, at room temperature or below, for long-term storage. Any materials or articles made using the additive would have to comply with the restrictions in Regulation (EU) No 10/2011 on these monomers. DOCUMENTATION PROVIDED TO EFSA 1. Dossier AR0938603. January 2013. Submitted on behalf of Arkema (UK). 2. Additional data for dossier AR0938603. January 2014. Submitted on behalf of Arkema (UK). 3. Additional data for dossier AR0938603. September 2014. Submitted on behalf of Arkema (UK). REFERENCES Bott J, Störmer A and Franz R, 2014. 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 to Plate. Eds Benvenuto MA, Ahuja S, Duncan TV, Noonan G and Roberts- Kirchhoff E. ACS Symposium Series 1159, American Chemical Society, Washington DC, USA. doi:10.1021/bk-2014-1159.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 to its authorisation. Available online: http://ec.europa.eu/food/fs/sc/scf/out82_en.pdf EFSA (European Food Safety Authority), 2009. Scientific Opinion on the potential risks arising from Nanoscience and Nanotechnologies on food and feed safety. The EFSA Journal 2009, 958, 1 39. JRC (Joint Research Centre), 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 24514 EN 2010. Available online: http://publications.jrc.ec.europa.eu/ repository/bitstream/111111111/14935/1/reqno_jrc59476_mathmod_v10_cs_2010_09_24_final.pd f%5b1%5d.pdf EFSA Journal 2015;13(2):4008 6
ABBREVIATIONS CEF Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids EC FCM EFSA EU PVC PLA QM SCF SML (T) European Commission food contact material European Food Safety Authority European Union polyvinylchloride polylactic acid compositional limit in the plastic Scientific Committee on Food specific migration level (total, for a group of substances) EFSA Journal 2015;13(2):4008 7