The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) said the substance, which is a polymeric additive manufactured using authorised monomers, is of no safety concern for use in food contact materials (FCM).
The amount of methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene used were very low in the additive so guidelines would not be exceeded, said the panel (read the full scientific opinion here).
It has not previously been evaluated by EFSA but the monomers constituting the copolymer are listed in Regulation (EU) No 10/2011.
The safety assessment of the copolymer in nanoform was requested for 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).
Arkema said plastics are processed into materials or articles at a maximum temperature of 220 °C.
The request from the UK Food Standards Agency followed an application on behalf of Arkema (UK).
The first application was in January 2013 with updated versions in January and September last year.
Using conservative migration modelling for rigid PVC and PLA containing the additive at maximum requested levels and modelling food contact for one year at 25 °C, migration of the low-molecular-weight fraction of the additive below 1,000 Daltons (Da) was estimated to be about 0.008 mg/kg food from PVC and about 0.007 mg/kg from PLA.
Considering these low-molecular-weight oligomers are made from authorised monomers, which are expected to lack the reactive functional groups, they are not of safety concern, said the panel.
Using the same approach and an additional conservative assumption that all particles were less than 10 nm in size, estimated migration of the copolymer in nanoparticle form was in the range 1 to 1.3 × 10–6 mg/kg food.
This was done by the applicant because current recognised migration modelling is not directly applicable to nanoparticle migration estimation.
Real migration is expected to be even lower and so consumer exposure would be very low, said CEF.
Copolymers in regulation
Final material are intended to be used for contact with all food types, at room temperature or below, for long-term storage.
Methacrylic acid is authorised with a group total specific migration limit, SML (T), of 6 mg/kg food.
Ethyl acrylate has an SML (T) of 6 mg/kg, expressed as acrylic acid and 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 and 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.
Any materials or articles made using the additive would have to comply with restrictions in Regulation (EU) No 10/2011 on these monomers.