Annex III — EU Restricted Substances List
The list of substances restricted to specific conditions of use in cosmetic products under EC 1223/2009. Annex III specifies maximum concentrations, product types, warnings, and other conditions under which listed substances may be used.
Annex III of the EU Cosmetics Regulation (EC 1223/2009) lists substances that cosmetic products must not contain except subject to specific restrictions. Unlike Annex II (completely prohibited), Annex III substances may be used in cosmetics provided they comply with the conditions specified for each entry.
Each Annex III entry specifies: the substance identification (chemical name, INCI name, CAS/EC numbers), the product type or body part restriction (e.g., "rinse-off products only," "not to be used in products for children under 3"), the maximum authorized concentration, conditions of use and warnings that must appear on the label, and any other specific conditions.
Examples of important Annex III restrictions include: salicylic acid (max 2% in rinse-off, max 0.5% in leave-on, not for children under 3); hydrogen peroxide (max 12% in hair products, max 0.1% in oral care products); retinol and retinol esters (max 0.3% retinol equivalent in body products, max 0.05% in hand cream); and various fragrance allergens that must be individually declared on the label above specified concentrations.
Annex III is frequently updated as the SCCS issues new opinions on ingredient safety. Recent amendments have addressed substances including butylated hydroxytoluene (BHT), aluminum compounds in antiperspirants, and additional fragrance allergens identified by the SCCS.
Related Terms
EU Cosmetics Regulation (EC 1223/2009)
The primary European Union law governing cosmetic products, establishing requirements for safety assessment, CPNP notification, responsible person designation, ingredient restrictions (Annexes II-VI), labeling, and post-market surveillance across all EU/EEA member states.
IngredientAnnex II — EU Prohibited Substances List
The list of over 1,600 substances prohibited from use in cosmetic products under the EU Cosmetics Regulation (EC 1223/2009). Annex II substances may not be used as cosmetic ingredients under any conditions, regardless of concentration.
OrganizationScientific Committee on Consumer Safety (SCCS)
An independent scientific committee that advises the European Commission on health and safety risks of non-food consumer products, including cosmetic ingredients. SCCS opinions form the scientific basis for EU ingredient restrictions in the Cosmetics Regulation annexes.
IngredientFragrance Allergens
Specific fragrance substances identified as common causes of allergic contact dermatitis that must be individually declared on cosmetic product labels when present above specified concentrations. The EU currently requires declaration of 80+ fragrance allergens under updated EC 1223/2009 Annex III rules.
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