Journal article

Publication year: 2015

Pages: 4242-

Journal: EFSA Journal

Volume number: 13

Issue number: 9

DOI Link: https://doi.org/10.2903/j.efsa.2015.4242

Publisher: Wiley

Abstract: 
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-(1,1dimethylpropyl) phenyl triesters, expressed as the sum of the phosphite and phosphate forms of the substance and 4-tert-amylphenol. (C) European Food Safety Authority, 2015. (C) European Food Safety Authority, 2015.

Harvard Citation style: Bolognesi, C., Castle, L., Cravedi, J., Engel, K., Fowler, P., Franz, R., et al. (2015) 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, EFSA Journal, 13(9), p. 4242. https://doi.org/10.2903/j.efsa.2015.4242

APA Citation style: Bolognesi, C., Castle, L., Cravedi, J., Engel, K., Fowler, P., Franz, R., Grob, K., Gürtler, R., Husøy, T., Kärenlampi, S., Mennes, W., Milana, M., Penninks, A., Silano, V., Smith, A., Tavares Poças, M., Tlustos, C., Toldra, F., Wölfle, D., ...Zugravu, C. (2015). 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. EFSA Journal. 13(9), 4242. https://doi.org/10.2903/j.efsa.2015.4242