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

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2013;11(10):3389 [8 pp.].
doi
10.2903/j.efsa.2013.3389
Panel members at the time of adoption
Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Catherine Leclercq (until July 2013), Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Tavares Poças, Iona Pratt, Kettil Svensson, Fidel Toldrá and Detlef Wölfle
Acknowledgements

The Panel wishes to thank the members of the Working Group on Food Contact Materials: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Roland Franz, Nathalie Gontard, Ragna Bogen Hetland, Eugenia Lampi, Jean-Claude Lhuguenot (until November 2012), Maria Rosaria Milana, Maria de Fátima Tavares Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the preparatory work on this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Food Standards Agency, UK
Question Number
EFSA-Q-2013-00175
Adopted
25 settembre 2013
Published in the EFSA Journal
16 ottobre 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

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 °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.

Keywords
polyglycerol; polyglycerine; CAS No 25618-55-7; FCM substance No 01017; food contact materials; safety assessment; evaluation
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Number of Pages
8