The agency’s CEF panel delivered its positive opinion on co-monomer N-(2-aminoethyl)ethanolamine after a request from a Switzerland-based company via a Netherlands government office.
The experts said there is no concern for the use of N-(2-aminoethylamino)ethanol if the migration of the substance does not exceed 0.05mg/kg food.
The request was submitted by the Netherlands Ministry for Health, Welfare and Sports, on behalf of Valspar Packaging Corp AG, Switzerland.
Coating in cans
The additive is intended for use as a coating in the ends of canned items such as non-acidic, acidic and alcoholic beverages.
The safety evaluation was requested to extend its use as additive in plastics to use as a co-monomer in modified polyester coatings at levels up to 1.5% (w/w) intended for direct contact with foodstuffs.
However, the panel noted further structural and quantitative information is needed for a conclusion concerning genotoxicity or other toxicity end points of the oligomeric fraction after they found many oligomers, a molecule that consists of a few monomers, are formed during the manufacturing process which may migrate into food.
They added there was only limited information on the identities in the fraction below 1000 Da and the toxicological data needed will depend on the identity and level of migration of the oligomers.
For the use as co-monomer to manufacture coatings, the worst case migration of the substance was calculated from the total mass transfer of its residual content in the coating under the most unfavourable contact area-to-food volume to be 0.14 µg/kg food, the experts said.
The substance, with CAS number 111-41-1, European Commission reference number 35284 and the FCM substance number 262, had already been evaluated as an additive in plastics by the SCF in 2000.
It was classified in SCF_List 3 with a restriction of 0.05 mg/kg food and not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC and for indirect food contact only, behind a PET layer.
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