Safety assessment of the substance basic copper (II) carbonate for use in intelligent food contact materials

food contact materials;active and intelligent materials;freshness indicator;basic copper (II) carbonate;CAS No 12069-69-1;FCM substance No 21
First published in the EFSA Journal
21 July 2016
23 June 2016
Scientific Opinion

Note: 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


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.

Panel members at the time of adoption

Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
fip [at]
EFSA Journal 2016;14(7):4537
Question Number
On request from
Ministerio de Sanidad Servicios Sociales e Igualdad - Agencia Española de Seguridad Alimentaria y Nutrición, Dirección Ejecutiva, Spain