Scientific Opinion on the safety assessment of the substance, polyglycerol, CAS No 25618-55-7, for use in food contact materials

This scientific opinion of EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the additive polyglycerol with the CAS No 25618-55-7, the FCM substance No 01017 for use as plasticizer at a maximum use level of 6.5 % w/w in polymer blends of aliphatic-aromatic polyesters. Final articles are intended to be used in contact with all type of foods for any time at room temperature. Specific migration from a material containing the maximum requested concentration for polyglycerol was calculated by migration modelling to be up to 50 mg/kg food under contact conditions of 10 days at 40 degrees C. Polyglycerol esters were evaluated by JECFA who established an ADI of 0-25 mg/kg bw, and are listed as a food additive (E 475) at levels between 500 and 10 000 mg/kg in certain foods. Up to 7 % of free glycerol/polyglycerol is allowed in E 475 (i.e. 700 mg/kg). No accumulation of polyglycerol in body tissue was observed in an ADME study. The Panel considered that impurities and glycerol which is authorised as a food contact material substance in Regulation (EU) No 10/2011 without a specific migration limit do not raise a safety concern. The CEF Panel concluded that the substance polyglycerol does not raise a safety concern for the consumer if the substance is only to be used as plasticizer at a maximum use level of 6.5 % w/w in polymer blends of aliphatic-aromatic polyesters in contact with all type of foods for any time at room temperature and below. (C) European Food Safety Authority, 2013