EU Cosmetics Regulation 1223/2009 established the concept of a Responsible person (RP) for cosmetic products:
Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market. (EU Regulation 1223/2009, Article 4.1)
It is therefore obligatory to appoint a cosmetics Responsible person in the EU to be able to put the products on the EU market.
The Responsible person has to ensure compliance of the cosmetic products with the EU Cosmetics Regulation before they are placed on the EU market, and make sure that the products remain compliant with the Regulation while they are on the market.
The Responsible person therefore has to provide or ensure the following:
- Registered address in the EU where the Product Information File is kept readily accessible to the local competent authority in a language easily understood by that competent authority for inspection even 10 years after the last batch of the product has been placed on the market.
- Product claims substantiation.
- Correct cosmetic product labelling.
- Product Information File (PIF) compliance with the Regulation, that the products were produced according to Good manufacturing practice (GMP), that the safety assessment has been conducted etc.
- CPNP notification of cosmetic products.
- Communication of any undesirable or serious undesirable effects to the competent authorities.
- In case of non-conformity of the product with the EU regulation, take any appropriate measures including recall, removal of the products or taking corrective action to bring that product into conformity. At the request of the competent authorities, the Responsible person must cooperate with the former to eliminate the risk posed by cosmetic products which they are the Responsible person for.
