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

被引:1
作者
Sundh, Ulla Beckman [1 ]
Binderup, Mona-Lise [1 ]
Bolognesi, Claudia [1 ]
Brimer, Leon [1 ]
Castle, Laurence [1 ]
Di Domenico, Alessandro [1 ]
Engel, Karl-Heinz [1 ]
Franz, Roland [1 ]
Gontard, Nathalie [1 ]
Guertler, Rainer [1 ]
Husoy, Trine [1 ]
Jany, Klaus-Dieter [1 ]
Kolf-Clauw, Martine [1 ]
Leclercq, Catherine [1 ]
Lhuguenot, Jean-Claude [1 ]
Mennes, Wim [1 ]
Milana, Maria Rosaria [1 ]
Pocas, Maria de Fatima Tavares [1 ]
Pratt, Iona [1 ]
Svensson, Kettil [1 ]
Toldra, Fidel [1 ]
Woelfle, Detlef [1 ]
机构
[1] EFSA, Parma, Italy
关键词
polyglycerol; polyglycerine; CAS No 25618-55-7; FCM substance No 01017; food contact materials; safety assessment; evaluation;
D O I
10.2903/j.efsa.2013.3389
中图分类号
TS2 [食品工业];
学科分类号
0832 ;
摘要
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
引用
收藏
页数:8
相关论文
共 3 条
  • [1] Guidelines of the Scientific Committee on Food for the presentation of an application for safety assessment of a substance to be used in food contact materials prior its authorisation, (2001)
  • [2] Toxicological evaluation of certain food additives with a review of general principles and of specifications, (1974)
  • [3] Howes D., Wilson R., James C.T., The fate of ingested glycerine esters of condensed castor oil fatty acids [Polyglycerol polyricinoleate (PGPR)] in the rat, Food and Chemical Toxicology, 36, pp. 719-738, (1998)