Fragrance ingredient found unsafe by SCCS

Fragrance ingredient found unsafe by SCCS

In a meeting on 16 December 2014, the SCCS (Scientific Committee of Consumer Safety) adopted the SCCS/1541/14 opinion on the safety of the presence of vetiveryl acetate in leave-on and rinse-off type cosmetic products.

The opinion states that the available data is insufficient to properly assess the safety of the substance. However, there is evidence that vetiveryl acetate is a moderate skin sensitizer; additionally, genotoxic/mutagenic effects have been observed in an Ames test of vetiveryl acetate.

Therefore, the substance is not safe for use in cosmetics at the concentration limits proposed by the IFRA.

Consequently, the Committee has called for further information on the composition of the test substances used in the submitted toxicological studies.

What is Vetiveryl acetate and what are the main concerns with its safety?

Vetiveryl acetate is a fragrance mixture frequently used in luxury perfumes and is prepared by the acetylation of vetiver oil. Depending on the geographic and botanic origins of the starting material, there are different manufacturing processes which lead to the distinct qualities of the vetiveryl acetate used in the perfume industry.

The ingredient vetiveryl acetate was not included in the “Initial List of Perfumery Materials which must not form part of Cosmetic Products except subject to the restrictions and conditions laid down” which formed part of the Annex III to the Directive 76/768/EEC outlined in the Regulation (EC) 1223/2009/EC, but the SCCS (formerly SCCNFP) aimed to discuss additional substances for possible inclusion at a later date.

In its first opinion on vetiveryl acetate (sensitisation only) issued in 2006, the SCCS concluded that the information submitted was insufficient to assess the safe use of the substance and called for additional evidence such as characterization of the test substance and clarification on purity and impurities.

IFRA recommended a safe concentration limit for vetiveryl acetate when it is specifically used for cosmetic products and only if produced by methods that lead to a reduction in the allergenic materials based on test results of RIFM. However, the data submitted to SCCS was considered insufficient by the Scientific Committee for a reliable safety assessment.

Next steps

Following the procedure, comments on the committee’s report were due in February 2015. The deadline was extended to May 19th, 2015 to allow interested parties to provide additional perspectives and/or clarification on the evaluation and interpretation of the SCCS opinion.

Based on the final decision, the Responsible Persons and cosmetics manufacturers must take the necessary steps for cosmetic product compliance with the provisions.

Further amendments based on information provided in response to this call for evidence or subsequent public consultation might be expected.

If you would like to know more on cosmetics products regulatory compliance, please contact us.

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