The panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) said 2,4-di-tert-amylphenol is not of safety concern for the consumer if migration does not exceed 1mg/kg food.
It also has to be included in the 5mg/kg food restriction for 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, according to the scientific opinion.
EFSA received an application from the UK Food Standards Agency requesting evaluation of 2,4-di-tert-amylphenol, impurity and hydrolysis product of phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl) phenyl triesters.
Previous evaluation and new request
CEF said the latter was evaluated as an antioxidant in all polymers by the CEF Panel in 2011.
The panel concluded it be classified with a restriction of 5 mg/kg food (expressed as the sum of the phosphite and phosphate forms of the substance and the hydrolysis product 4-tert-amylphenol).
It also said migration of the hydrolysis product 2,4-di-tert-amylphenol should not exceed 0.05 mg/kg food.
Addivant requested a re-evaluation of the specific migration limit (SML) for 2,4-di-tert-amylphenol, established at 0.05mg/kg food, with a view to it being included within the overall SML of 5mg/kg that applies to the sum of the phosphite and phosphate forms of the antioxidant and the hydrolysis product 4-tert-amylphenol.
The firm is a supplier of antioxidants, intermediates and inhibitors, polymer modifiers, and UV stabilizers.
CEF panel testing
Specific migration tests were done using linear low-density polyethylene (LLDPE) samples containing the antioxidant (sum of the phosphite and phosphate forms) at 1336mg/kg.
Tests in contact with the food simulants 3% acetic acid, water and olive oil were done as they were appropriate for intended contact with all food types.
The migration test conditions were two hours at 100ºC followed by 10 days at 40ºC.
In these tests using 3% acetic acid and water, 2,4-di-tert-amylphenol was not detected in either of the simulants at the detection limit of 20μg/kg.
In olive oil, 2,4-di-tert-amylphenol was found at levels up to 0.1mg/kg. However, in mixed foods, hydrolysis of migrated antioxidant might result in higher concentrations.
Based on previous considerations and the negative results in two new in vitro genotoxicity tests, the panel concluded there is no evidence that 2,4-di-tert-amylphenol has any genotoxic potential.
From a 90-day oral toxicity study in rats, a no observed adverse effect level (NOAEL) of 5mg/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 1mg/kg food,” said the panel.