Safety assessment of the substance phosphorous acid, triphenyl ester, polymer with alpha‐hydro‐omega‐hydroxypoly[oxy(methyl‐1,2‐ethanediyl)], C10–16 alkyl esters, for use in food contact materials
Meta data
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 has been provided under confidentiality and it is redacted awaiting the decision of the Commission: The number average and molecular weight of the substance, molecular mass range and fraction below 1000 Da, starting substances, impurities, products of thermal degradation, hydrolysis percentage, phosphorous content of the substance, identity of the analytical standards/migrating compounds in the qualitative migration study, details of the study reports on genotoxicity testing, composition of low molecular weight (LMW) version of the substance in the phosphate form used in the 90‐day study. -- 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 (http://www.efsa.europa.eu/sites/default/files/corporate_publications/fi…), 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.
Abstract
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the substance ‘phosphorous acid, triphenyl ester, polymer with alpha‐hydro‐omega‐hydroxypoly[oxy(methyl‐1,2‐ethanediyl)], C10–16 alkyl esters’, obtained by reaction of ■■■■■, when used as an additive at up to 0.2% w/w in high impact polystyrene. The plastic, in the form of films and articles, is intended for contact with aqueous, acidic, low‐alcohol and fatty foods for long‐term storage at room temperature and below, after hot‐fill and/or heating up to 100°C for up to 2 h. Based on genotoxicity tests with negative results, the Panel considered that there is no evidence of mutagenicity and chromosomal damage of the substance and its phosphate form. From a repeated dose 90‐day oral toxicity study in rats, the Panel identified the no‐observed‐adverse‐effect level as 50 mg/kg body weight (bw) per day. No effects of induced delayed neurotoxicity in hens were observed. Migration from high impact polystyrene containing the substance at 0.2%, measured through the phosphorous content of the substance, reached 0.001 mg/kg in 10% ethanol and 0.1 mg/kg in 95% ethanol. Migration into acidic food/simulant is expected to be below 0.001 mg/kg. Regarding the oligomers and other reaction/degradation products detected, the phosphorous‐containing substances were adequately represented in the toxicity experiments conducted. Those not containing phosphorous were hydrolysis products either listed in Regulation (EU) 10/2011 and their estimated worst‐case migrations were well below their respective specific migration limits (SMLs) or no alerts for genotoxicity were noted. Overall, the CEP Panel concluded that the substance ‘phosphorous acid, triphenyl ester, polymer with alpha‐hydro‐omega‐hydroxypoly[oxy(methyl‐1,2‐ethanediyl)], C10–16 alkyl esters’ does not raise a safety concern for the consumer if it is used at up to 0.2% w/w in high impact polystyrene materials and articles and its migration does not exceed 0.05 mg/kg food.