What is a Responsible Person?

“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 European Market and then to act as the Cosmeto-Vigilance contact point in Europe towards the cosmetic product he is responsible for.

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. Keep the PIF readily accessible to the Competent Authorities for a period of 10 years after the last batch was placed on the market.

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