EU Cosmetics Regulation 1223/2009: Prohibited and Restricted Substances

EU Cosmetics Regulation (EC) No 1223/2009 contains six annexes that define which substances can and cannot be used in cosmetic products sold in the EU. Annex II alone lists over 1,600 prohibited substances. For cosmetic manufacturers — particularly those formulating for both US and EU markets — these lists are not background reading. They are the operational constraints that determine whether your formula is legally marketable in Europe.

The Structure of EU Cosmetics Regulation Annexes

EU Cosmetics Regulation (EC) No 1223/2009 uses a combination of prohibited lists, positive lists, and restricted lists to control cosmetic ingredients:

Annex	Content	Approach
Annex II	Prohibited substances	Negative list — these substances cannot be used
Annex III	Restricted substances	Conditional list — these substances can be used within specified conditions
Annex IV	Permitted colorants	Positive list — only listed colorants permitted
Annex V	Permitted preservatives	Positive list — only listed preservatives permitted
Annex VI	Permitted UV filters	Positive list — only listed UV filters permitted

For the three positive lists (Annexes IV, V, VI), the principle is strict: if a colorant, preservative, or UV filter is not on the list, it cannot be used in EU cosmetics. For Annex II, any substance on the list is prohibited regardless of concentration. For Annex III, the substance may be used but only within the specified conditions (maximum concentration, product type restrictions, labelling requirements).

Annex II: Prohibited Substances

Annex II lists substances that are prohibited in cosmetic products. The list currently contains over 1,600 entries and is updated regularly by the European Commission based on SCCS (Scientific Committee on Consumer Safety) opinions.

The prohibited substances include:

Pharmaceutically active substances: Many substances that are active pharmaceutical ingredients (APIs) in medicines are prohibited in cosmetics. This includes hormones (oestrogen, progesterone, testosterone), antibiotics (chloramphenicol, tetracyclines), and many other prescription drug substances.

CMR substances: Substances classified as carcinogenic, mutagenic, or reprotoxic (CMR) categories 1A and 1B under CLP Regulation are prohibited in cosmetics under Article 15, and many are also listed in Annex II.

Specific chemicals: Formaldehyde-releasing preservatives above certain concentrations, certain hair dye substances, specific botanical extracts with toxic components, and many industrial chemicals.

Plant-derived substances: Some botanical extracts are prohibited due to their content of toxic compounds. Aristolochic acid (from Aristolochia species) is prohibited. Certain essential oils containing high levels of specific terpenes are restricted.

How to Check Annex II Compliance

The European Commission maintains the CosIng database (Cosmetic Ingredient database) at ec.europa.eu/growth/tools-databases/cosing, which allows ingredient searches against all annexes. For each ingredient, CosIng shows whether it appears in any annex and under what conditions.

For a systematic compliance check:

1. List all ingredients in your formulation with their INCI names
2. Search each ingredient in CosIng
3. Check whether the ingredient appears in Annex II (prohibited)
4. Check whether the ingredient appears in Annex III (restricted — if so, verify your concentration and use conditions comply)
5. For colorants, preservatives, and UV filters, verify they appear in Annexes IV, V, or VI respectively

Annex III: Restricted Substances

Annex III lists substances that may be used in cosmetics but only under specified conditions. The conditions typically specify:

• Maximum concentration: The highest permitted concentration in the finished product
• Product type restrictions: Whether the substance is permitted in rinse-off products only, leave-on products only, or both
• Labelling requirements: Mandatory warnings that must appear on the label when the substance is used
• Other conditions: pH requirements, prohibited combinations, etc.

Key Annex III Restrictions

Hydrogen peroxide: Permitted in hair care products (up to 12% w/v), nail hardeners (up to 2.5%), and skin care products (up to 4%). Each use has specific labelling requirements. Hair bleaching products with hydrogen peroxide must carry warnings about professional use and eye contact.

Salicylic acid: Permitted in rinse-off hair products (up to 3%), other rinse-off products (up to 3%), leave-on products (up to 2%), and oral hygiene products (up to 0.3%). Products containing salicylic acid must carry a warning that they are not suitable for children under 3 years old (except shampoos).

Fluoride compounds: Permitted in oral hygiene products at various concentrations depending on the specific compound. Products with high fluoride concentrations require specific warnings.

Resorcinol: Permitted in hair dyes at up to 1.25% and in hair lotions/shampoos at up to 0.5%. Specific labelling requirements apply.

Formaldehyde and formaldehyde-releasing preservatives: Formaldehyde is permitted in nail hardeners (up to 5%) and oral hygiene products (up to 0.1%). Formaldehyde-releasing preservatives (e.g., DMDM hydantoin, imidazolidinyl urea) are permitted at concentrations that release up to 0.2% free formaldehyde in the finished product. Products containing formaldehyde above 0.05% must carry a warning.

Alpha-hydroxy acids (AHAs): Glycolic acid, lactic acid, and other AHAs are restricted in leave-on skin products. The SCCS has issued opinions on AHA safety, and the Commission has implemented restrictions on concentration and pH.

Positive Lists: Colorants, Preservatives, UV Filters

Annex IV: Permitted Colorants

Only colorants listed in Annex IV may be used in cosmetic products. The list specifies:

• The colorant (by CI number and chemical name)
• Whether it is permitted in all cosmetics, rinse-off products only, or products not applied near the eyes
• Whether it is permitted in products applied to mucous membranes
• Whether it is permitted in products applied to the skin

US cosmetic colorants that are not on Annex IV cannot be used in EU cosmetics. This is a common formulation gap for US brands entering the EU market — several FD&C colorants approved by FDA are not on the EU positive list.

Annex V: Permitted Preservatives

Only preservatives listed in Annex V may be used in cosmetic products for preservation purposes. The list specifies maximum concentrations and any product type restrictions.

Common preservatives and their EU status:

• Phenoxyethanol: Permitted up to 1% in all cosmetics (SCCS opinion restricts use in products for children under 3 and around the nappy area)
• Methylparaben, ethylparaben: Permitted up to 0.4% (as acid) individually, 0.8% for mixtures
• Propylparaben, butylparaben: Permitted up to 0.14% (as acid) individually, 0.14% for mixtures; prohibited in products for children under 3 for the nappy area
• Benzyl alcohol: Permitted up to 1%
• Sodium benzoate: Permitted up to 0.5% (as acid)

Preservatives not on Annex V — including several common US preservatives — cannot be used in EU cosmetics for preservation purposes.

Annex VI: Permitted UV Filters

Only UV filters listed in Annex VI may be used in cosmetic products for sun protection purposes. The EU positive list for UV filters is more restrictive than the FDA’s approach, and several UV filters commonly used in US sunscreens are not on the EU list.

Conversely, some EU-approved UV filters (e.g., Tinosorb S, Tinosorb M, Mexoryl SX) are not approved for use in US sunscreens, creating a transatlantic formulation challenge for brands targeting both markets.

Monitoring Annex Updates

The annexes to EU Cosmetics Regulation are updated regularly by the European Commission, typically based on SCCS opinions. Updates are published in the Official Journal of the European Union and implemented through Commission Regulations.

Brands must monitor these updates and assess their formulations against new or amended restrictions. A formulation that was compliant last year may not be compliant today if a restriction has been tightened or a new substance added to Annex II.

At Care Europe, we conduct EU cosmetics ingredient compliance reviews for brands entering the EU market, including systematic screening against all six annexes and monitoring of regulatory updates. Contact us at [email protected].