EU Cosmetics
Regulation

The EU cosmetics regulation states the information required to be printed on the cosmetic label (Article 19) and the criteria for the justification of claims (655/2013). It also has different annexes with millions of prohibited and restricted ingredients.

Ensuring that the cosmetic complies with the requirements of the EU regulation before placing it on the EU market is essential, thus a preliminary formula and labeling revision are necessary.

The Cosmetic Product Safety Report or CPSR is a mandatory document that proves your cosmetic product is safe for human use, as required by Regulation (EC) No 1223/2009. It includes toxicological analysis, exposure data, and a safety conclusion signed by a qualified professional. Without a CPSR, the product cannot be placed on the EU market.

The Product Information File (PIF) is a legal requirement for all cosmetics sold in the EU. It must include detailed information on the product’s formulation, manufacturing process, claims substantiation, and the Cosmetic Product Safety Report (CPSR). The Responsible Person is in charge of maintaining and updating the PIF for each product.

The CPNP (Cosmetic Product Notification Portal) is an online system where products must be notified before being sold in the EU market. The information submitted is subject to be reviewed by the Competent Authorities and shall be updated with each change applied to the product.

Only one notification per product will be valid for all EU countries as long as national requirements (language, recycling…) are followed. A notification shall only be made once the product has been evaluated as safe.

Before the cosmetic enters the EU market, companies must conduct certain tests to check the safety of the product. These Cosmetic tests include challenge, stability, and compatibility (which are mandatory depending on the nature of the product and its packaging) or to check efficacy and substantiate marketing claims.

Every cosmetic product sold in any EU country should have a linked EU-based legal representative, known as the Responsible Person, who verifies the compliance and safety of the product. Having a formal Responsible Person that is up to date with regulations and monitors the products they act for is indispensable to avoid any possible problem. The Responsible Person represents the brand to the competent authorities during inspections and when complaints are lodged by consumers. They also manage post-market surveillance (cosmetovigilance). regulation is clear that the information must be precise and always up to date.