SCCS Opinion in Regulatory Toxicology and Pharmacology Journal : Hydrolysed Wheat Proteins, Sensitisation only

Revision of the opinion on hydrolysed wheat proteins – Sensitisation only

Authors: Scientific Committee SCCS (European Commission, Directorate General for Health and Food Safety, Luxembourg)& Pieter-Jan Coenraads (University Medical Center Groningen, Groningen, The Netherlands)
References : Regulatory Toxicology and Pharmacology (2015)
Received 12.06. 2015, revised and accepted 03.08.2015, available online 14.08.2015; in Press, corrected Proof

SCCS Opinion of reference:
Opinion SCCS/1534/14 “Opinion on Hydrolysed wheat proteins- Sensitisation only “, adoption 18.06.2014, revision of 22.10.2014
Conclusion : “In view of the numbers of reported cases of immediate-type contact urticarial and systemic allergic reactions, the overall risk of sensitization to Hydrolysed Wheat Proteins (HWP) appears to be low, with the exception of an ‘epidemic’ in Japan associated with one particular HWP product used in some brands of soap. Scientific concerns with regard to the use of HWP in cosmetic products include that :
• there is evidence that sensitisation to HWP is via exposure to cosmetics, not via food
• there are indications that the risk of sensitisation is higher when HWP’s of higher molecular weight are used on the skin, in particular as an ingredient of products that have strong surfactant properties such as soaps and liquid soaps.
-> The SCCS considers the use of hydrolysed wheat proteins safe for consumers in cosmetic products, provided that the maximum molecular weight average of the peptides in hydrolysates is 3,5 kDa.”


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