“Only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market” (Art.4, p.1).
As clearly indicated by the EC 1223/2009, designating a Responsible Person is a mandatory requirement.
“Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24” (Art.5, p.1).
The RP is responsible to ensure that all the obligations related to product conformity have been carried out prior to placing the product onto the EU Market and then to act as the Cosmeto-Vigilance contact point in Europe towards the cosmetic product he is responsible.
In daily practice, the Responsible Person is engaged in:
- Ensure compliance with requirements of the regulation (requirements such as: safety,GMP, PIF, notification, composition, labeling, claims, and communication of serious undesirable effects…).
- Immediate corrective measures, withdrawal/recall if appropriate in case of non-conformities.
- Immediate information to competent authorities (CA) and other economic operators in case of risk to protection of human health
- Provide information and documentation to demonstrate conformity as per requests by competent & national authorities.Keepe the PIF readily accessible to the Competent Authorities for a period of 10 years after the last batch was placed on the market.
DUTIES OF RESPONSIBLE PERSON
- Providing a 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.
- Ensuring that product claims are substantiated
- Ensuring correct labelling
- Ensuring that the Product Information File is compliance the Regulation, that the products were produced according to (GMP), that the safety assessment report has been conducted etc.
- Performing the notification of the cosmetic products to the CPNP portal
- Communicating any undesirable or serious undesirable effects to the competent authorities
- In case of non-conformity of the product with the EU regulation, taking any appropriate measures includingrecall, 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.WHO CAN BE A RESPONSIBLE PERSON?The regulation says that the Responsible person (RP) 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. They have an option to either appoint their importer or a distributor as the RP, which is not recommended, since the RP has to keep the Product Information File and all the product secrets with it; or they can appoint a third person or a company to act as the RP. This person or a company must accept this role in writing.
- The Responsible person has to be in the EU.
- The Responsible person must be designated by a written mandate, and has to accept this role in writing.
- The Responsible person can be the manufacturer (if established in the EU), a distributor, an importer, or a professional (designated) Responsible person
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