In recent years, the analysis of allergenic ingredients in cosmetic products has gained increasing importance — and for good reason. More and more consumers experience adverse reactions to certain products and demand transparency, safety, and regulatory compliance from brands.
Although European legislation regulates the use of sensitising substances in cosmetics, many companies are still unaware of their real obligations or underestimate the impact of an insufficient assessment of their formulations.
What are allergens in cosmetics?
Allergens are substances or ingredients that can trigger allergic reactions in some individuals, especially after repeated exposure. They may be found in fragrances, preservatives, colourants, and natural extracts — even in products labelled as “natural” or “hypoallergenic.”
The issue is not merely their presence, but also their concentration, route of exposure (dermal, mucosal, or inhalation), and type of consumer: a product harmless to most may be problematic for a sensitive minority.
What does the legislation say?
The Cosmetics Regulation (EC) No 1223/2009 requires that companies:
- Include the most common allergens on the label when present above specific concentration thresholds.
- Conduct a safety assessment of the cosmetic product, taking into account all ingredients, including potentially sensitising substances.
- Update the Product Information File (PIF) whenever a formulation change affects the product’s allergenic profile.
Note: The list of declarable allergens is currently being expanded by the European Commission, which means many brands will need to review both their formulas and labelling.
Why is allergen testing important?
- Consumer protection: Prevents adverse reactions that could lead to reputational damage, product recalls, or even legal actions.
- Legal compliance: An incomplete analysis can result in penalties or market withdrawal.
- Competitive advantage: Brands that show real commitment to safety and transparency build stronger consumer trust.
Is the consumer being properly informed?
Unfortunately, practices such as greenwashing can confuse consumers and make informed choices more difficult.
However, both regulatory authorities and responsible brands are increasingly committed to carrying out thorough analyses, ensuring that allergen levels are minimal or clearly indicated on labels. This not only enhances consumer safety but also reinforces trust in brands and the cosmetics industry as a whole.
How can you know if your product contains allergens?
Allergen assessment should not rely solely on the ingredient list review — it must also include laboratory testing of the final product and a toxicological interpretation of the available data.
At ServiREACH, we support cosmetic manufacturers and distributors throughout the allergen evaluation process:
- Detect and quantify allergenic ingredients in your formulation.
- Assess their impact on product safety.
- Evaluate whether their presence must be declared on the label.
- Help you adapt to upcoming regulatory changes.