Safety assessment of the active substances cyclooctene homopolymer and cobalt stearate in combination for use in active food contact materials
Meta data
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 following information have been provided under confidentiality and they are deleted awaiting the decision of the Commission: the trade names of the applied and tested mixtures, the identity and amount of the impurities in the active components, the manufacturing process of the applied PCOE, purity specifications of cobalt stearate, the maximum process temperature of the polymer containing the active components, information on bioaccumulation of unoxidised oligomers and read‐across to another compound, information and safety assessment of the oxidised oligomers, consolidated list of migrants from PCOE and from the matrix, percentage of PCOE and cobalt stearate.
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.