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Safety assessment of the active substances cyclooctene homopolymer and cobalt stearate in combination for use in active food contact materials

on the Wiley Online Library

Metadata

Panel members at the time of adoption

José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Claude Lambré, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Vittorio Silano (until 21 December 2020 †), Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis and Holger Zorn.
Competing interests: R. Franz declared that Fraunhofer institute at which he is employed provides advisory services to private business operators active in the sector on food contact materials. In line with EFSA’s Policy on Independence (http://www.efsa.europa.eu/sites/default/files/corporate_publications/fi…) and the Decision of the Executive Director on Competing Interest Management, a waiver was granted to R. Franz regarding his participation to the EFSA’s Working Group on Food Contact Materials (FCMWG) in accordance with Article 21 of the Decision of the Executive Director on Competing Interest Management (http://www.efsa.europa.eu/sites/default/files/corporate_publications/fi…). Pursuant to Article 21(6) of the above‐mentioned Decision, the involvement of R. Franz is authorised as member in the FCMWG, allowing him to take part in the discussions and in the drafting phase of the scientific output, but he is not allowed to be, or act as, a chairman, a vice‐chairman or rapporteur of the working group.

Abstract

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the combined use of cyclooctene homopolymer (PCOE) and cobalt stearate (CoS) intended as a oxygen scavenger in the packaging of all kinds of food stored at room temperature or below for up to 6 months. The CoS is the oxidation catalyst and the PCOE is intentionally oxidised for the oxygen scavenging function. They are incorporated into a plastic layer that is intended to be either in direct or indirect contact with the food. The potential migration of cobalt and cyclooctene monomer were below their respective specific migration limit (SML). The potential migration of PCOE non‐oxidised oligomeric low molecular weight fraction (LMWF) < 1,000 Da was estimated to be up to ■■■■■ The Panel concluded that this fraction does not raise concern for genotoxicity potential and that the no observed adverse effect level (NOAEL) derived from a subchronic toxicity study would ensure a margin of exposure large enough to not raise a safety concern. However, the Panel considered the analysis of the oxidised PCOE LMWF not sufficiently comprehensive, i.e. that additional oxidation products of different nature may be formed, and that the limit of detection corresponding to ca. ■■■■■ for individual substances is too high. The oxidised PCOE LMWF was not covered by the genotoxicity tests or the 90‐day study on the PCOE oligomers. The assessment of the identified potential oxidised migrants was considered conclusive, but not that of the migrants having remained undetected. Therefore, the CEP Panel was not able to conclude on the safety of the proposed use of cyclooctene homopolymer and cobalt stearate together as active substances in a layer for scavenging oxygen, either in direct contact with the food or separated from the food by a passive layer of polymer.