Safety assessment of the substance phosphorous acid, mixed 2,4‐bis(1,1‐dimethylpropyl)phenyl and 4‐(1,1‐dimethylpropyl)phenyl triesters for use in food contact materials

摘要

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the substance phosphorous acid, mixed 2,4‐bis(1,1‐dimethylpropyl)phenyl and 4‐(1,1‐dimethylpropyl)phenyl triesters. The substance was evaluated by the CEF Panel in 2011 and 2,4‐di‐tert‐amylphenol, an impurity and hydrolysis product was re‐evaluated by the CEF Panel in 2015. In this application, the applicant requested an increase of the specific migration limit of the substance, currently established at 5 mg/kg food, to 10 mg/kg food, and provided new toxicological studies. Findings from three new in vitro mutagenicity assays on the oxidation products support the conclusion from 2011 that the substance and its oxidation products are not genotoxic. A new toxicokinetic study on the substance supports the consideration from the evaluation in 2011 that the substance does not raise concern for accumulation. The outcome of a new delayed neurotoxicity study on a structurally related substance, phosphorous acid, tris (2,4‐di‐tert‐butylphenyl) ester, which was considered not to cause neurotoxicity in hens, strengthens the conclusion of the Panel in 2011 that the substance does not represent a concern for neurotoxicity. From a new two‐generation reproduction toxicity study and a prenatal developmental toxicity study on the substance, a new subchronic toxicity study on its oxidation products that completes the one submitted in 2011 on the substance itself, and a 2‐year oral toxicity study on the structurally related substance, the lowest NOAEL was 58–147 mg/kg bw per day (from the 2‐year oral toxicity study). Compared to the requested increase of the migration limit, this gives an acceptable margin of safety of 348. Therefore, the CEF Panel concluded that an increase of the specific migration limit of the substance from 5 to 10 mg/kg food is not a safety concern for the consumer.