In Europe, Regulation (EC) No.1223/2009, enforces the obligation to inform consumers of the presence of 26 chemically-defined substances identified as potential allergens in cosmetic products. Following the publication of the Scientific Committee on Consumer Safety’s document (SCCS/1459/11), it was proposed by industry stakeholders that consumers be made aware of additional fragrance allergens present in cosmetics products and confirmed that the 26 allergens already listed in Annex II were still of concern.

Following this SCCS opinion, the European Commission then published a public consultation in 2014 where it proposed to amend Annex III of the Cosmetics Regulation by including 61 additional contact allergens in addition to the 26 allergens already listed in Annex III. Currently, there is no published update to the list of potential allergens, however, the industry is preparing for changes that could be implemented in the coming weeks or months. If the extension of the list is confirmed, cosmetic manufacturers will need to ensure that ingredients in products are properly identified and that labelling is revised to meet the latest expectations of the regulation. Accurate determination of the levels of these allergens in cosmetic products is essential to ensure proper labelling, however, these tests are very difficult to perform for these types of complex samples.

Therefore, LaCoMeD laboratory has created a white paper to get you ready for the extension of the list of allergens: click here to download our white paper on the 57 allergens.

Intertek’s experts, who have over 15 years’ experience in developing analytical chromatography methods to meet the regulatory demands of the cosmetic industry, have developed a superior method using gas chromatography-mass spectrometry/mass spectrometry (GC-MS/MS) to identify and quantify the volatile compounds which are suspected to be allergens in fragrances and raw materials used in cosmetic products.

Using an approach called Multiple Reaction Monitoring (MRM), Intertek’s method is optimized for the determination of 57 allergen substances present in cosmetic samples. In comparison to existing GC-MS methods, Intertek’s is more efficient to run (it uses only one chromatography column with a single injection) and also avoids the risk of false positives which might occur when the presence of other substances in the samples give rise to “matrix effects” during testing. Intertek’s method is fit-for-purpose over a wide range of concentration levels and accuracy can be demonstrated to ensure confidence in the results.

Sylvie Lebrat, Director, LaCoMeD Laboratory, Intertek, said “Our scientists have developed a unique approach to allergen determination in cosmetics which is optimised for specificity, efficiency and accuracy. The data we generate brings our clients confidence in the results, drives greater insight into understanding their raw materials and helps them to fulfil their regulatory obligations to ensure safer products.”

Intertek provides development and manufacturing support services for the global cosmetics industry, helping clients to overcome quality, safety, purity and innovation challenges through comprehensive analysis, clinical research, regulatory consultancy, auditing, and supply chain management solutions.