Back to GlossaryIngredient

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.

See how Cosmetica automates compliance

Replace manual regulatory work with AI-powered automation — from ingredient screening to submission filing.