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EFSA backs Arkema FCM proposal

By Joe Whitworth+

18-Apr-2014

EFSA CEF panel issues two safety evaluations
EFSA CEF panel issues two safety evaluations

A safety evaluation application by Arkema for an additive in rigid PVC plastics has been backed by a European Food Safety Authority (EFSA) panel.

The substance in the opinion had not been evaluated by the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) or Scientific Committee on Food (SCF) before.

EFSA received an application from the UK Food Standards Agency, 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.

Use of additive

Arkema UK, the applicant, said it would be used as an additive (impact modifier) in rigid (unplasticized) polyvinylchloride (PVC).

The level of use is up to 10% w/w and the PVC is processed into materials or articles at a maximum temperature of 220 °C.

Final materials and articles are to be used for contact with food at room temperature or below, for long term storage.

The migration from PVC of the low molecular weight fraction of the additive below 1, 000 Daltons under these conditions was estimated to be about 0.009mg/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,” said the panel.

Assuming the particles had a size less than 10nm the estimated migration of the copolymer in nanoparticle form was 1 x10-6 mg/kg food.

The panel said that the intended use of these nanoparticulate substances does not give rise to exposure of the consumer via food and would not be of toxicological concern if used as described.

Gas barrier layer

In a separate opinion, CEF assessed the safety of kaolin which is used with polyacrylic acid, sodium salt and incorporated in a gas barrier layer of ethylene-vinyl alcohol (EVOH) copolymer.

The EVOH copolymer is used as an inner layer in multi-layer food contact materials.

Kaolin (99.5%) with polyacrylic acid, sodium salt (0.5%) intended to be incorporated in EVOH copolymer to enhance its gas barrier properties.

The EVOH is used as inner layer in a multi-layer, not in direct contact with the food.

The mixture is incorporated typically at 4% in the EVOH copolymer, but depending on the application the concentration can range from 1% to 12%.

EVOH copolymer end use

The EVOH copolymer is intended to be used in food contact materials for beverages (alcoholic and non-alcoholic), sauces and dressings and sausages stored at room temperature up to six months.

Both substances have been evaluated and authorised for use as additives in plastic materials and articles in contact with foods, said the panel.

EFSA received an application from the Agencia Española de la Seguridad Alimentaria y Nutrición, Spain and the dossier was submitted by the applicant, NanoBioMatters Industries, S.L.

Kaolin is authorised as additive for plastic materials and articles in food contact with no restriction.

Polyacrylic acid, sodium salt, is authorised as an additive for plastic materials and articles in contact with foods, with a specific restriction of 6 mg/kg, expressed as acrylic acid.

The CEF panel concluded that kaolin in the form of particles with a thickness less than 100 nm does not raise a safety concern when incorporated up to 12% in EVOH copolymer.

The EVOH inner layer containing the particles should be used behind a functional barrier that prevents migration of kaolin particles into the food, it concluded.