Safety of potassium polyaspartate (A-5D K/SD) for use as a stabiliser in wine

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Article
Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2016;14(3):4435 [25 pp.].
doi
10.2903/j.efsa.2016.4435
Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Agneta Oskarsson, Dominique Parent-Massin, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes.
Acknowledgements
The Panel wishes to thank the members of the Working Group on Applications for the preparatory work on this scientific output and EFSA staff members: Paolo Colombo, Juho Lemmetyinen, Camilla Smeraldi and Alexandra Tard for the support provided to this scientific output. 
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2015-00222
Adopted
9 March 2016
Published in the EFSA Journal
17 March 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract
Potassium polyaspartate (A-5D K/SD) is proposed for use as a stabiliser in wine, with a maximum use level of 300 mg/L and typical levels in the range of 100-200 mg/L. The data provided in support of the current application were in accordance with the Tier 1 requirement of the Guidance for submission for food additive evaluations issued by the ANS Panel in 2012. In the in vitro tests provided by the applicant, potassium polyaspartate (A-5D K/SD) showed minimal proteolytic digestion and no absorption of the intact compound. Potassium polyaspartate (A-5D K/SD) tested negative in a bacterial reverse mutation assay performed in accordance with OECD TG 471 and in an in vitro mammalian cell micronucleus test performed in accordance with OECD TG 487. From a 90-day oral toxicity study in rats performed in accordance with OECD TG 408, a no observed adverse effect level (NOAEL) was set at 1,000 mg/kg bw per day, the highest dose tested. The Panel considered these data as fulfilling the requirements for the evaluation of the new food additive and did not request additional testing for chronic toxicity and carcinogenicity, nor for reprotoxicity and developmental toxicity. Exposure estimates to potassium polyaspartate (A-5D K/SD) from its proposed use were calculated for both typical and maximum use levels. In the worst case scenario of high-level intakes of potassium polyaspartate (A-5D K/SD) when used at the maximum proposed use level of 300 mg/L, the maximum estimated intake would be 1.8 mg/kg bw per day in the elderly and 1.4 mg/kg bw per day in adults, resulting in a margin of safety of approximately 550. The Panel concluded that there was no safety concern from the proposed use and use levels of potassium polyaspartate (A-5D K/SD).
Keywords
food additive, wine stabiliser, potassium polyaspartate, A-5D K/SD
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Number of Pages
25