Cosmetics - what are the obligations of a Responsible Person?
The obligations of the Responsible Person are many and are all geared to ensuring compliance and safety of the cosmetic product. The RP shall cooperate at all times with the authorities providing all data deemed necessary in a language easily understood by the authority.
The role of Responsible Person (RP) may automatically fall to you depending on your company activities and/or the location of your company (within/outside) the EU, or can be assigned to a 3rd party service provider such as The Regulatory Company.
Responsible Person obligations are:
- Ensuring safety for human health under normal and reasonably foreseeable conditions of use (including labelling, instructions and warnings).
- Compliance with good manufacturing practice
- Performance and continuous updating of the safety assessment
- Building and maintaining a product information file
- Sampling and analysis of a cosmetic product
- CPNP notification prior to placing a cosmetic product on the market
- Product composition in accordance with the annexes II-VI of the Cosmetics Regulation and updates thereof
- Product composition not to contain CMR substances
- Proper evaluation and notification of a cosmetic product containing nanomaterials
- Product safety with regards to the non-intended and technically unavoidable presence of prohibited substances under GMP
- Compliance with non-animal testing requirements
- Compliant product labelling
- Public access to product composition data, specifically regarding hazardous substances, and the history of (seriously) undesirable effects
- Product claims in line and limited to the characteristics and functions of a cosmetic product
- Timely communication and adequate handling in the event of a serious undesirable effect (also applies to distributors)
- Traceability of raw materials and substances in all cosmetic products under the RP's responsibility