Safety assessment of the substance phosphoric acid, mixed esters with 2‐hydroxyethyl methacrylate, for use in food contact materials
Competing interests: R. Franz declared that Fraunhofer institute at which he was 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/fil...) and the Decision of the Executive Director on Competing Interest Management (http://www.efsa.europa.eu/sites/default/files/corporate_publications/fil...), a waiver was granted to R. Franz regarding his participation to the EFSA's Working Group on Food Contact Materials (FCM WG) in accordance with Article 21 of the Decision of the Executive Director on Competing Interest Management. Pursuant to Article 21(6) of the above‐mentioned Decision, the involvement of R. Franz is authorised as member in the FCM WG, 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.
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 redacted awaiting the decision of the Commission: the percentage, the molecular weight and the log Po/w of the components of the substance phosphoric acid, mixed esters with 2‐hydroxyethyl methacrylate (called HEMAP) and the identity and percentage of a related impurity; the identity and percentage of the components other than the substance in the HEMAP‐containing product; the commercial name of the HEMAP‐containing product; physical and chemical properties of the HEMAP‐containing product such as the melting point, the boiling point, the decomposition temperature and the solubility; the maximum content of the HEMAP‐containing product in the final composite, manufacture of the composite articles; the results of the screening of migrating oligomers and reaction products related to HEMAP.
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the substance phosphoric acid, mixed esters with 2‐hydroxyethyl methacrylate, FCM substance No 1082, which is intended to be used at up to ■■■■■% w/w ■■■■■ for the production of kitchen countertops and sinks. These composite articles are intended for repeated contact with all food types. The contact time is not expected to exceed several hours at room temperature or a short time at high temperature (1 h at 70°C). The substance is thermally stable under the manufacturing conditions. Under conservative conditions of testing, the specific migration into 10% ethanol, 95% ethanol and 3% acetic acid was up to 24.8 μg/6 dm2. Screening tests for migrating oligomers and reaction products resulting from the use of the substance ■■■■■. Based on the negative results observed in the Ames and in vitro micronucleus tests, the Panel concluded that the substance does not raise concern for genotoxicity. The CEP Panel concluded that the substance phosphoric acid, mixed esters with 2‐hydroxyethyl methacrylate, is not of safety concern for the consumer if used as a co‐monomer at up to ■■■■■% to manufacture ■■■■■ food preparation surfaces, such as countertops or sinks, intended for repeated contact with all food types. Additionally, the migration of phosphoric acid, mixed esters with 2‐hydroxyethyl methacrylate should not exceed 0.05 mg/kg food expressed as the sum of the mono‐, di‐ and triesters of phosphoric acid and the mono‐, di‐, tri‐ and tetraesters of diphosphoric acid.