♦ In its laboratory in Rouen, SGS, the world leader in testing, inspection and certification, has specialized in chemical, physico-chemical and ecotoxicological analyses for several decades.
♦ Since 2021, SGS has been offering cosmetics manufacturers and distributors a unique analytical method for testing the 57 allergens defined in SCCS Opinion 1459/11 of June 2012, which is currently the subject of a draft European regulation, with an expected entry into force in Q1 2022.
♦ Adapted from IFRA, this new method was developed using gas chromatography (GC) coupled with mass spectrometry (MS). Its reduced number of injections per sample saves time in the reprocessing of data. Beyond the ingredients, the analyses focus particularly on the finished products because the presence of possible allergen precursors and the instability of certain formulas, can generate allergens not predicted during the development phase.
After nickel allergy, perfume allergy is the most common skin allergy. However, fragrances are almost always present in cosmetic products, whether in the form of synthetic substances or of natural origin, such as essential oils. They can potentially trigger a contact allergy affecting the skin, usually the face, armpits and hands or cause skin irritation in some individuals such as eczema.
The SGS laboratory in Rouen, which specialises in chemical, physico-chemical and ecotoxicological analyses, has more than 100 employees and processes around 50,000 samples per year, in all sectors of activity, including cosmetics, detergents and hygiene products.
It has state-of-the-art equipment including chromatographic and spectral techniques to search for trace chemical substances, covered by the regulations.
To meet the needs of cosmetic manufacturers and distributors for the 57 allergens identified in CSAS Notice 1459/11 of June 2012, SGS has developed a single method of analysis. Adapted from the Ifra method, it was developed using gas chromatography coupled with mass spectrometry (GC/MS). It makes it possible to detect and quantify that the 57 fragrance substances, including some isomers, have a concentration of less than 0.001% in unrinsed products and 0.01% in rinsed products. Beyond these concentrations, allergens will have to be labelled to inform the consumer.
" In order to allow the analysis of finished products and complex matrices, we have adapted the IFRA method, initially developed for perfumery ingredients. We use two columns of different polarity and carry out a systematic matrix doping to guarantee the reliability of our results. Based on our feedback, we recommend carrying out these analyses on finished products because of the possible interactions during the mixing of ingredients, the possible presence of allergen precursors and the instability of certain formulas over time. In this way, customers will be able to guarantee the conformity of their products until their estimated end of life. " says Audrey Guibet, strategic expert Cosmetics & Hygiene, SGS France.
The consumer will be notified of the allergenic components in the list of ingredients labeled on the product (INCI List). The higher the concentration of an ingredient present, the more the ingredient in question will find itself in pole position in the INCI list.
" This analysis on finished products allows us to guarantee manufacturers, distributors, and therefore consumers, a marketing of cosmetic products that comply with current and future regulations," concludes Carine Dumas, Head of Cosmetics & Hygiene Development, SGS France.
Reminder of regulatory requirements*:
- To date, 25** allergens are tested and must be labelled in case of presence (** Lirai banned since August 2021).
- CSAS Notice 1459/11 of June 2012, which recommended informing the consumer of the presence of 62 additional allergens, is the subject of regulations that will come into force in 2022.
- In total, 87*** allergenic substances will have to be monitored.
Of these 87 substances, 57 are now technically analyzable, updated in September 2021 of the standard NF EN 16274. Not all allergens are covered by this method as some are complex mixtures such as plant extracts.
- Adoption of the regulation: 1st quarter 2022
- 2* ™ quarter 2025: prohibition to place on the market non-compliant products.
- 2nd quarter > 2027: withdrawal of non-compliant products from the market.