Regulatory & Compliance

Allergen Labelling in Cosmetics — EU and GCC Rules

Allergen labelling in cosmetics is one of the most technically detailed areas of cosmetics regulation — and one where the rules differ meaningfully between the EU and GCC markets. For brands manufacturing in the UAE for international export, understanding which allergens trigger labelling obligations, at what concentrations, and in which markets is essential for producing compliant label artwork that works across multiple destinations.

What are cosmetic allergens?

In the cosmetics context, allergens are substances that can trigger an allergic reaction in sensitive individuals when applied to the skin, scalp, or mucous membranes. The most commonly regulated cosmetic allergens are fragrance allergens — specific chemical compounds that occur naturally in essential oils and fragrance blends, or that are added directly to products. Preservative allergens and colour-related allergens are also regulated in some contexts, but fragrance allergens are the primary focus of both EU and GCC labelling rules.

EU allergen labelling — current rules

EU Regulation 1223/2009 Annex III sets out a list of fragrance substances that must be declared on the ingredient list if present above specified concentration thresholds. Under the rules that have applied since the original regulation, 26 fragrance allergens must be declared on the label when present above: 0.001% (10 ppm) in rinse-off products such as shampoos and body washes, and 0.01% (100 ppm) in leave-on products such as moisturisers, perfumes, and deodorants. These allergens must be listed by their INCI name in the ingredient list — they cannot simply be included under the generic term ‘Parfum’ or ‘Fragrance’ if present above the thresholds.

EU allergen labelling — expanded list

The European Commission has been expanding the list of regulated fragrance allergens. Under Commission Regulation (EU) 2023/1545, the list is being extended to include over 80 additional fragrance substances, with a phased implementation timeline. This is a significant change that affects fragrance formulas globally, as many commonly used fragrance ingredients that were previously unlisted are now subject to declaration requirements. The expanded list includes additional natural extract components such as oak moss extracts, tree moss extracts, and a range of individual chemical components that commonly appear in fine fragrance and personal care formulas. Brands planning to enter or continue in the EU market should review their fragrance formulas against the expanded allergen list with their fragrance supplier and safety assessor.

GCC allergen labelling rules

The GCC technical regulation (GSO 1943) aligns with EU regulation on allergen labelling in principle, adopting the requirement to declare fragrance allergens above specified thresholds. However, the specific list and thresholds in GCC regulation may not always be updated at the same pace as EU amendments. For practical compliance, most manufacturers working with both EU and GCC markets apply the EU allergen declaration requirements to all export products — this ensures compliance with the more demanding standard and simplifies label management across markets.

Preservative allergens

Some preservatives used in cosmetics are well-recognised allergens and are regulated through concentration limits and sometimes labelling requirements. In the EU, certain preservatives — including methylisothiazolinone (MI) and methylchloroisothiazolinone/methylisothiazolinone (MCI/MI) — have had concentration limits tightened following evidence of sensitisation at previously permitted levels. Products containing MI above certain concentrations in leave-on products now carry mandatory warnings. For GCC markets, similar restrictions apply for the most problematic preservatives. Working with a formulator who keeps current with preservative regulation is important — substituting preservatives after label artwork is committed to production is expensive.

Colour allergens — carmine and other sensitisers

Some colour ingredients are known allergens or sensitisers. Carmine (CI 75470, derived from cochineal insects) is a natural red pigment used in lip products, blush, and eye cosmetics. It is a significant allergen for some individuals and, in the EU, must be declared on the ingredient list as ‘Carmine’ or ‘CI 75470’. Its Halal status is also debated — relevant for GCC markets. Certain synthetic colourants are also known sensitisers, particularly in hair dye formulations. PPD (p-phenylenediamine) and related compounds in permanent hair colour are regulated allergens requiring specific labelling in both EU and GCC markets.

Practical implications for label artwork

When preparing label artwork for products containing fragrance, check the fragrance formula — your fragrance supplier should provide an allergen disclosure document listing all regulated allergens present and at what concentration. If any allergen exceeds the threshold for your product type (rinse-off or leave-on), it must be listed by INCI name in the ingredient list. Update the ingredient list to include any above-threshold allergens by name, placed within the ingredient list in descending concentration order alongside other ingredients. Note that allergens present below threshold can still be covered by ‘Parfum’ or ‘Fragrance’. Review against the expanded EU allergen list if the EU is a target market. If producing GCC and EU versions of the same product with the same formula, applying EU allergen declaration requirements to both simplifies label management significantly.

How manufacturers support allergen compliance

A GMP-certified manufacturer with experience in export markets will have processes in place to support allergen labelling compliance. Key questions to ask your manufacturer: Can you provide allergen disclosure documentation for all fragrances used in our formula? Do you monitor updates to the EU allergen list and proactively flag impacts on existing formulas? Can you supply INCI-formatted ingredient lists with allergen identification? What is your process for formula change notification when allergen regulation changes affect an active formula? Having clear answers to these questions before committing to a formula and label design avoids the most common and costly allergen labelling mistakes.