Fragrance Allergens (PDF format)

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Article 19 of the Cosmetic Regulation 1223/2009 provides, in point (g)(ii), that “Perfume and aromatic compositions and their raw materials shall be referred to by the terms ‘Parfum’ or ‘Aroma’” " in the list of ingredients that must appear on the labelling of a cosmetic product. Moreover, “the presence of substances, the mention of which is required under the column ‘Other’ in Annex III, shall be indicated in the list of ingredients in addition to the terms ‘Parfum’ or ‘Aroma’.” The text thus designates 26 “labelable allergens” which must therefore appear in the list of ingredients as soon as they are more than 0.01% present in rinse-off products and more than 0.001% in no-rinse products.

On 26 and 27 June 2012, the SCCS (Scientific Committee for Consumer Safety) published an Opinion on fragrance allergens in cosmetic products, in which it is stated that the consumer should be aware of more fragrance ingredients present in cosmetic products, in addition to those already subject to individual labelling, and establishes a list of 62 additional allergens. The Scientific Committee also recommends maximum percentages allowed in the formulas, as well as the prohibition of three previously accepted substances.
This Opinion provoked a strong reaction from industry, which questioned its relevance, feasibility, and particularly the mandatory labelling on the packaging of so many allergens, suggesting instead electronic (online) labelling.

From proposition to contestation, the dossier continues to be debated and its finalisation is delayed for several years, first with the creation of the IDEA project, aimed at accurately assessing the risks related to fragrance allergens, and then with the taking into account of industry comments on labelling requirements.
In December 2018, the European Commission launched a first impact assessment on the latter point. And further phases of consultation are already planned before a final decision is taken…

It is therefore an issue that is still “ongoing”, but the consequences of which may have very important implications for cosmetic companies. To help them prepare, this ebook first recalls the crucial elements to be taken into account before focusing on allergens currently subject to labelling or already banned, through 26 technical sheets detailing the current regulations and their expected changes.