Fragrance Allergens: European Cosmetic Regulation Tightens

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Cosmetics

Woman outdoors spraying perfume into the air with sunlight highlighting the mist.

05 Mar 2026

Allergens: A core concern for the cosmetics and perfume industry

Fragrances are key components of cosmetics, but their ubiquity poses a major challenge: certain fragrance substances are common causes of skin allergies that affect a significant portion of the population. The European Union (EU) estimates that 1 to 9% of the population is allergic to fragrance substances, with allergic manifestations that require vigilance from manufacturers and clear information for consumers.

EU regulators are implementing multiple measures for both primary and secondary prevention. Primary prevention seeks to protect the population from developing fragrance allergies; secondary prevention aims to protect already‑sensitive individuals from experiencing allergic symptoms.

The European cosmetic regulatory framework challenged by allergens

Cosmetic products in the EU are strictly regulated by Regulation (EC) No 1223/2009, which imposes rigorous safety and labelling requirements. Recognizing the evolution of scientific knowledge on allergens, the EU later adopted Regulation (EU) 2023/1545.

The latter regulation amends EU cosmetic regulation Annex III to significantly strengthen consumer protection against allergenic fragrance substances, increase transparency, and expand the list of substances to be declared.

Allergens: What changes are expected in 2026?

Previously, Regulation (EC) No 1223/2009 required declaring 24 allergenic fragrance substances when their concentration exceeded a certain threshold.

Following Regulation (EU) 2023/1545, new restrictions are expected:

Expansions to the allergen list: the list of individually declarable substances will more than triple—‍from 24 to 81 allergens—‍based on the opinion of the Scientific Committee on Consumer Safety.
To simplify allergen labelling, certain substances will be grouped under a single designation called a “grouping name.” When determining if the labelling threshold is exceeded, one must consider the sum of all substances included under this designation, including all present sources, direct or indirect. If this regulatory threshold is exceeded, it is mandatory to use the relevant grouping name.
Detailed regulatory thresholds for declaration: labelling will be mandatory when the concentration of allergens exceeds a certain regulatory threshold in the finished product:
001% for leave-on products (creams, perfumes, lotions, etc.); and
01 % for rinse‑off products (shampoos, shower gels, etc).

Transition periods and application deadlines: to allow industry to adapt, the following deadlines have been granted:

A timeline showing European Cosmetic Regulations

Conclusion: Towards safer and more transparent cosmetics

These new provisions represent a major advance in consumer safety, providing allergy-prone individuals crucial information to make informed choices. However, for industry, they may require thorough revisions of formulations, manufacturing processes, and labels. A rigorous understanding of this regulatory framework is essential to maintain product conformity and strengthen consumer trust in a constantly evolving sector.

Laura Dijoux

Regulatory Affairs Specialist, Intertek Assuris

Laura is passionate about the world of cosmetics and perfumes, with a professional journey rooted in the rich olfactory heritage of her native Reunion Island. This vocation led her to pursue a FOQUAL Master’s degree, where she specialized in the formulation, quality, and analysis of cosmetics, perfumes, and aromas.

Following an apprenticeship in Grasse where she managed finished product compliance for the EU, US, and Middle Eastern markets Laura joined Intertek as a Regulatory Affairs Specialist. She now supports clients by ensuring their raw material portfolios meet international requirements. On a daily basis, she ensures that scientific rigor translates into the safety and compliance of products brought to market.

Lise Lafosse

Regulatory Affairs Specialist, Intertek Assuris

Lise holds a master's degree in ecotoxicology, which she chose to focus on regulatory affairs. She joined Intertek in 2024 and ensures customer satisfaction in the cosmetics sector, where she secures their raw materials portfolio. Her responsibilities cover all European and international regulations relating to cosmetics and perfumes.