Safety assessment of the substance 2,4-di-tert-amylphenol, impurity and hydrolysis product 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
This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of 2,4-di-tert-amylphenol, an impurity and hydrolysis product of the antioxidant phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters evaluated in 2011 by the CEF Panel for its uses in all polymers intended for contact with all food types under any time/temperature conditions. Migration of
2,4-di-tert-amylphenol from linear low-density polyethylene made with the antioxidant was not detected in 3 % acetic acid and water, and was up to 0.1 mg/kg in olive oil. Based on previous considerations and the negative results in two new in vitro genotoxicity tests, the Panel concluded that there is no evidence that 2,4-di-tert-amylphenol has any genotoxic potential. Based on a 90-day oral toxicity study in rats, a no observed adverse effect level (NOAEL) of 5 mg/kg body weight per day was determined. Considering the metabolism of branched chain alkylphenols and remaining uncertainty related to the potential for accumulation in man, an extra factor of 3 was considered along with the default uncertainty factor of 100. By applying the resulting uncertainty factor of 300 to the NOAEL, the migration of 2,4-di-tert-amylphenol should not exceed 1 mg/kg food. The CEF Panel concluded that the substance 2,4-di-tert-amylphenol does not give rise to safety concerns for the consumer if its migration does not exceed 1 mg/kg food and it is included in the current 5 mg/kg food restriction for the substance phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters, expressed as the sum of the phosphite and phosphate forms of the substance and 4-tert-amylphenol.