CIR Gives Wheat Proteins Tentative “Safe” Review Despite Uncertainties
This article was originally published in The Rose Sheet
Executive Summary
The CIR Expert Panel issued a tentative final safety assessment for hydrolyzed wheat protein and hydrolyzed wheat gluten at its September meeting, along with a list of stipulations in order for the ingredients to be used safely.
At its Sept. 9-10 meeting in Washington, the Cosmetic Ingredient Review Expert Panel advanced a safety report on hydrolyzed wheat protein and hydrolyzed wheat gluten while acknowledging that questions remain regarding HWP’s link to adverse reactions in Japan.
HWP and HWG are used as hair- and skin-conditioning agents in more than 1,000 products on the market in the U.S.
The panel unanimously issued a tentative final safety assessment for the ingredients, each mixtures of amino acids and peptides derived from wheat sources, with the caveats that they must be formulated with peptide chain lengths less than 30, not used on damaged skin, not used on exposed mucus membranes and not used in products that could be inhaled.
Panelists initially disagreed on the best way to handle the report, the team led by Dr. James Marks expressing discomfort with pushing the review through with so many stipulations.
Marks, chairman of the department of dermatology at Penn State University’s College of Medicine, said his team was “quite concerned” about the type of skin reactions and anaphylaxis associated with HWP in reports out of Japan.
“We didn’t quite understand or feel that we had the expertise to come to a conclusion,” he said referring to his team’s discussion of the ingredient. “There are over 1,000 uses – this is very important [due to the] serious adverse events.”
The team suggested tabling the review of HWP and asking an expert to speak to the panel to help them sort through the data, the adverse event reports and the intricacies of the ingredient.
Dr. Donald Belisto, professor of dermatology at Columbia University Medical Center, maintained on behalf of his team that with the caveats in place, HWP can be safely used.
He likened the conditions for use to the panel’s review of formaldehyde and methylene glycol. In September 2011, the group determined that those ingredients could be used safety at certain concentration limits, but were unsafe for use in heated hair-smoothing products (Also see "Final CIR Assessment: Formaldehyde Unsafe In Heated Hair-Smoothers" - HBW Insight, 3 Oct, 2011.).
“We were particularly concerned about reports coming out of Japan about hydrolyzed wheat protein causing reactions in soaps, [but] we’ve gotten a lot of new data” indicating that reactions have been limited to use of HWP formulated with long peptide chains or on damaged skin and/or mucous membranes, Belsito explained.
Moreover, he characterized the stratum corneum as “an excellent barrier” to the ingredient which would protect against potential adverse interactions.
“What we’re concerned about is areas of skin with no stratum corneum or weak stratum corneum and mucosa, which has no stratum corneum,” Belsito said. “That’s when you’re going to start absorbing the proteins. Our restrictions are very extensive.”
With the restrictions, approximately 100 products currently on the market would be impacted, he noted.
Ultimately, both teams agreed to move the report ahead with a tentative “safe” assessment, given the caveats, in the interest of not delaying a final decision on HWP.
Marks formally recommended that an expert be brought to the panel’s next meeting to offer perspective on the ingredient and related adverse events, and noted that the CIR panel could table review of the report at that time if safety questions are still unanswered.
“If I was going to err, I’d prefer to err on the safe side,” he said.
The panel initially issued an insufficient data announcement for HWP and hydrolyzed wheat gluten at its Dec. 11 meeting, requesting information regarding hydrolyzed wheat protein’s composition (Also see "CIR: New Research On Controversial Ingredients Should Be Considered" - HBW Insight, 17 Dec, 2012.).
In March, the expert panel tabled further discussion on the ingredients in order to analyze information on the adverse events reported in Japan (Also see "CIR Panel To Re-Review Cosmetic Preservative In Light Of New Allergy Data" - HBW Insight, 25 Mar, 2013.).
Eight Final Reports Issued
The CIR Expert Panel issued eight final safety assessment reports during the meeting. Alkyl PEG-PPG ethers, hydroxypropyl bis(n-hydroxyethyl-p-phenylenediamine) HCl, methyl glucose polyethers and esters, polyquaterniums, tromethamine, achillea millefolium-derived ingredients, dialkyl sulfosuccinate salts and isethionate salts all received “safe as used” rulings.
The panel opted not to reopen a review of preservative iodopropynyl butylcarbamate, despite tighter restrictions on the ingredient in Europe where its use is confined to lower concentrations than in the U.S. (Also see "CIR Meeting Preview: Preservatives Top-Of-Mind For Expert Panel" - HBW Insight, 9 Sep, 2013.).
The EU’s restrictions – imposed almost a decade ago – mostly stemmed from concern about iodine exposure from cosmetics containing IPBC. CIR panelists asserted that the connection between iodine exposure and IPBC is not a concern, and affirmed their earlier conclusion that the ingredient is safe when used at concentrations of less than or equal to 0.1%.
The CIR Expert Panel’s next meeting will be Dec. 9-10 in Washington.