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Frequently Asked Questions

The European Union's Cosmetics Directive regulation requires that cosmetics products placed on the EU market be safe; that is, they "must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use." As in the U.S., manufacturers are responsible for ensuring that cosmetics products comply with the law and are safe for their intended uses before they are marketed. Regulations are enforced at the EU member country level, and each country has an authoritative body that is responsible for ensuring compliance.

EU cosmetics regulation 1223/2009 provides a definition of the cosmetic products in the EU: “‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours”.

Yes, the requirement applies to all cosmetics as defined under Article 2 of the Cosmetics Regulation.

Yes, it applies to all existing products still placed on the market as of 11 July 2013 and all new products subsequently placed on the market [Article 11(1) & 11(4)]. It does not apply to products still on shelves, but no longer being placed on the market after 10 July 2013.

Yes, it applies to all existing products still placed on the market as of 11 July 2013 and all new products subsequently placed on the market [Article 11(1) & 11(4)]. It does not apply to products still on shelves, but no longer being placed on the market after 10 July 2013.

No, the information should be accessible only in one of the Member States and at one single place. The choice of the location of the P.I.F. is at the discretion of the responsible person (as long as it is one of the responsible person’s addresses).

To the Responsible Person (company or physical person) placing a cosmetic product on the EU market

Responsible person can be any legal or natural person who is based within the EU. Therefore, if the manufacturer is from the EU, they usually act as the RP themselves. Cosmetics manufacturers from outside of the EU, on the other hand, can’t act as the RP themselves, unless they also have a branch in the EU. They have an option to appoint their importer, their distributor, or a third person or a company to act as the RP. This person or a company must accept this role in writing.

Each product placed on the EU market needs to have a responsible person assigned. The regulation established this obligation by saying: “Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market.

  • The RP has to ensure the following compliance requirements:
  • the product is produced according to the relevant GMP standard.
  • The product information file (PIF) for the product is compiled and is compliant with the regulation.
  • No animal testing has been performed.
  • Notification to the CPNP.
  • Ensure that the product labels are according to the regulation and that the claims made are substantiated, provide access to the information for the public (if necessary)
  • communicate any undesirable or serious undesirable effects to the competent authorities.
  • RP acts as the contact point for any EU competent authorities (usually different ministries of health) and has to keep the product information file at the address specified on the labels. If case of any non-conformity, the RP has to take appropriate measures, including product recall from the market or taking any corrective action to bring the product info conformity.
  • On request of the competent authorities, the RP has to cooperate with them to eliminate any risk posed by the cosmetic product.

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