Annex 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.
Annex II of the EU Cosmetics Regulation (EC 1223/2009) lists substances that are prohibited from use in cosmetic products. As of 2026, it contains over 1,600 entries covering individual substances and substance groups that may not be used as ingredients in cosmetic products sold in the EU/EEA.
Substances are added to Annex II based on scientific assessment — typically by the SCCS — that they pose an unacceptable risk to human health when used in cosmetics at any concentration. Common categories of prohibited substances include known carcinogens, substances toxic to reproduction, certain heavy metals and their compounds, banned antibiotics and hormones, and certain dyes and pigments.
Notable Annex II prohibitions include formaldehyde (as an ingredient, though formaldehyde-releasing preservatives are permitted under Annex V conditions), hydroquinone (except in professional-use nail systems and hair dye formulations under Annex III conditions), and specific phthalates. The EU's prohibition list is significantly longer than the US FDA's list of banned cosmetic ingredients.
Annex II is regularly updated through Commission Regulations published in the Official Journal of the European Union. Recent additions have included substances identified as endocrine disruptors and substances restricted under REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) that are also used in cosmetics.
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 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.
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.
IngredientCMR Substances (CMR)
Substances classified as Carcinogenic, Mutagenic, or toxic to Reproduction under EU CLP Regulation (EC 1272/2008). CMR substances are generally prohibited in cosmetics under EC 1223/2009, with very limited exceptions requiring SCCS review and Commission authorization.
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