Cosmetic Fragrance Allergen Screening and Testing for Expanded EU Allergens List by GC-MS/MS

Cosmetic fragrance allergens testing for cosmetic safety assessment. Supporting industry focus to go beyond the 26 EU fragrance allergens list to include 57 chemically defined allergens via a unique GC-MSMS method.

Fragrance allergen screening testing for cosmetics products helps to identify and quantify substances identified as common fragrance allergens. Fragrance ingredients can potentially cause allergic contact dermatitis, pigmented cosmetic dermatitis, and photosensitivity. To mitigate the risk of cosmetic allergy agents, manufacturers are obliged to provide appropriate cosmetic label data with a fragrance allergen list to help ensure that consumers are provided with appropriate allergen ingredient information.

Regulation and the list of 26 EU fragrance allergens
In Europe, regulation 1223/2009 defines the requirement for the presence of any of 26 substances listed on the EU 26 allergens list (Annex III, such as Linalool, Limonene, and Cinnamal) to be included on the label ingredients list. If the product is a rinse-off cosmetic, then these perfume allergens should be listed on the packaging when present at levels greater than 0.01%. If the product is a leave-on cosmetic such as skin cream allergens should be listed on the packaging when present at levels greater than 0.001%.

Industry stakeholders are considering an expansion of the list of 26 allergens potentially including an additional 61 contact allergens. Currently, there is no published update to the list of potential allergens, however, the industry is preparing for changes in the near future. If the expansion of the allergen list is confirmed, cosmetic manufacturers will need to ensure that ingredients in products are properly identified, and that allergen labelling is revised to meet the latest expectations of the regulation.

Resource | White Paper Download: A NEW METHOD FOR THE DETERMINATION OF 57 ALLERGENS IN COSMETIC PRODUCTS. For more information about the current EU list of 26 allergens and the potential expanded list, download our white paper now

Fragrance allergen screening testing to support cosmetic safety assessment
Accurate determination of the levels of these allergens in cosmetics is essential to allow suitable labelling for consumers, however, this testing is highly challenging for these complex sample types. Our scientists have developed a gas chromatography-mass spectrometry/mass spectrometry (GC-MS/MS) using Multiple Reaction Monitoring (MRM) to identify and quantify 57 volatile compounds which are suspected to be allergens in fragrances and raw materials used in cosmetic products. In comparison to conventional GC-MS methods, it is efficient to run and avoids the risk of false positives which might occur when the presence of other substances in the samples gives rise to “matrix effects” during testing. The method is fit-for-purpose over a wide range of concentration levels and accuracy can be demonstrated to ensure confidence in the results.

With over 15 years of experience in developing cosmetic analytical testing methods to meet the regulatory demands of the personal care product industry, our scientists based at our Centre of Excellence for Cosmetic Testing, LaCoMed, use this method which is optimised for specificity, efficiency, and accuracy, to generate robust data, helping clients to meet regulatory requirements whilst driving a greater understanding of raw materials and 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.

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