Safety assessment of the substance basic copper (II) carbonate for use in intelligent food contact materials
This opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of basic copper (II) carbonate, CAS No 12069-69-1, for use as intelligent substance in the ink of a freshness indicator applied in labels inside trays of fresh poultry meat at temperatures from 2°C to 10°C and for a period of up to 12 days. Being a salt of carbonic acid, basic copper (II) carbonate is authorised and listed under Regulation (EU) No 10/2011 (food contact material (FCM) substance No 21: carbonic acid, salts) as, according to Article 6 of Regulation (EU) No 10/2011, salts of copper are authorised even if they are not included in the Union list. The residual amount of solvents in the printed label was determined and assuming total mass transfer from a 0.02 dm2 label into 400 g food would give a worst-case migration in the order of ■■■■■. No migration of copper is expected taking into account the nature of the application with no direct contact between the substance and the food. However, even complete transfer in case of incidental direct contact would remain several orders of magnitude lower than the migration limit applicable at the date of the assessment (5 mg/kg). The CEF Panel, having considered the above-mentioned data, concluded that the use of the substance basic copper (II) carbonate as a freshness indicator for packed poultry meat does not raise a safety concern to the consumer if the migration limit of copper is met.
The full opinion will be published in accordance with Article 10(6) of Regulation (EC) No 1935/2004 once the decision on confidentiality, in line with Article 20(3) of the Regulation, will be received from the European Commission. The quantitative composition of the ink, the amount of the intelligent substance and the reaction product per label and the residual amount of solvents has been provided under confidentiality and it is deleted awaiting the decision of the Commission