Restricted Substances (Annex III)
What are Restricted Substances (Annex III)?
Restricted substances in cosmetics are ingredients that may be used in cosmetic products placed on the EU market only under specific conditions, such as maximum permitted concentrations, product types, or labelling requirements. Under Regulation (EC) No 1223/2009, Annex III sets out the full list of substances that are permitted for use in cosmetic products subject to these restrictions. Using a restricted substance outside of the conditions specified in Annex III is a breach of the EU Cosmetics Regulation.
Why It Matters
Annex III exists to ensure that substances which present a potential risk to human health can still be used in cosmetics where that risk can be adequately managed through controlled conditions. The restrictions set out in Annex III define the boundaries within which a substance may be safely incorporated into a cosmetic product. These include maximum concentrations, permitted product types, and mandatory labelling warnings.
For manufacturers and Responsible Persons, failing to observe the conditions set out in Annex III is a compliance breach that can result in the product being considered unsafe and non-compliant. Competent authorities can require non-compliant products to be withdrawn from the market, and the Responsible Person may face enforcement action.
For cosmetic brands, formulators, and safety assessors, understanding and correctly applying the restrictions in Annex III is an essential part of formulating compliant products and completing a valid Cosmetic Product Safety Report.
Key Requirements
Who Is Required to Comply with Annex III?
Compliance with Annex III is required for all parties involved in formulating and placing cosmetic products on the EU market, including:
- Manufacturers and formulators incorporating restricted substances into cosmetic products
- Responsible Persons who are legally accountable for ensuring the product meets all applicable requirements
- Safety assessors evaluating the product’s compliance as part of the Cosmetic Product Safety Report
This requirement applies under:
- Regulation (EC) No 1223/2009 — EU Cosmetics Regulation, Article 14 and Annex III
Annex III is updated periodically by the European Commission following scientific assessment by the Scientific Committee on Consumer Safety (SCCS). Manufacturers and Responsible Persons must ensure they are working from the most current version of the annex.
Responsibilities Relating to Restricted Substances
While specific obligations depend on the role in the supply chain, responsibilities commonly include:
- Checking all ingredients in a cosmetic formulation against the current version of Annex III before placing the product on the market
- Ensuring any restricted substances are used only within the conditions specified, including maximum concentrations and permitted product types
- Including any mandatory labelling statements or warnings required by Annex III on the product label
- Documenting compliance with Annex III restrictions in the Cosmetic Product Safety Report and Product Information File
- Monitoring for updates to Annex III and reviewing formulations where restrictions change
Restricted Substances vs. Prohibited Substances
These are distinct categories under the EU Cosmetics Regulation. Restricted substances listed in Annex III may be used in cosmetics but only under specified conditions. Prohibited substances listed in Annex II may not be used in cosmetic products at all. Where a substance appears in Annex II, no amount or condition of use can make its inclusion lawful in a cosmetic product placed on the EU market.
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Euverify provides Responsible Person services for cosmetic brands and manufacturers placing products on the EU market under the EU Cosmetics Regulation. Our team supports CPNP notification, product information file management, regulatory communication, and ongoing compliance management.
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