Prohibited Substances (Annex II)
What are Prohibited Substances (Annex II)?
Prohibited substances in cosmetics are ingredients that may not be used in any cosmetic product placed on the EU market under any circumstances. Under Regulation (EC) No 1223/2009, Annex II sets out the full list of substances that are banned from use in cosmetic products. Unlike restricted substances listed in Annex III, there are no permitted conditions or concentrations under which a prohibited substance may lawfully be incorporated into a cosmetic product sold to EU consumers.
Why It Matters
Annex II represents an absolute prohibition. Where a substance appears on this list, its presence in a cosmetic product — regardless of concentration, product type, or intended use — renders that product non-compliant with the EU Cosmetics Regulation. There are no exceptions and no thresholds below which the substance becomes permissible.
For manufacturers and Responsible Persons, the consequences of placing a cosmetic product containing a prohibited substance on the EU market are significant. Competent authorities can require immediate withdrawal of the product, and enforcement action against the Responsible Person may follow. In cases where consumer safety has been compromised, the matter may also be escalated through the Safety Gate rapid alert system.
For cosmetic brands, formulators, and safety assessors, rigorously checking every ingredient against the current Annex II list before formulating or placing a product on the market is a non-negotiable compliance obligation.
Key Requirements
Who Is Required to Comply with Annex II?
Compliance with Annex II is required for all parties involved in formulating and placing cosmetic products on the EU market, including:
- Manufacturers and formulators responsible for the composition of 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 II
Annex II 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 Prohibited 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 II before placing the product on the market
- Ensuring no prohibited substance is present in the finished product, including as a component of raw materials or as a contaminant
- Documenting compliance with Annex II in the Cosmetic Product Safety Report and Product Information File
- Monitoring for updates to Annex II and reviewing formulations where new substances are added to the prohibited list
- Taking immediate corrective action, including product withdrawal, if a prohibited substance is identified in a product already on the market
Prohibited Substances vs. Restricted Substances
These are distinct categories under the EU Cosmetics Regulation. Prohibited substances listed in Annex II may not be used in cosmetic products under any circumstances. Restricted substances listed in Annex III may be used but only within the specific conditions set out in the annex, such as maximum permitted concentrations or mandatory labelling warnings. Where a substance appears in Annex II, no conditions of use can make its inclusion in a cosmetic product lawful.
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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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