Responsible Person Service
EU/UK cosmetics responsible person
Who is a responsible person (RP)?
Cosmetics responsible person is a person or a company whose main task is to make sure that the cosmetic products placed on the EU/UK market are safe for human health and are compliant with the relevant regulations, the EU Regulation 1223/2009 (for the EU) and UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (for the UK).
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)
Who can be a cosmetics responsible person?
EU/UK responsible person can be any legal or natural person based in the EU/UK. The responsible person can therefore be any EU/UK based:
Cosmetic product manufacturer
Importer
Distributor
A third person or a company, who accepts this role in writing
Every cosmetic product placed on the EU/UK market needs to have a responsible person appointed and there has to be only one responsible person per product for the whole EU and only one responsible person per product for the UK.
In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community. (EU Regulation 1223/2009, Article 11)
For the purpose of effective market surveillance, a product information file should be made readily accessible, at one single address within the Community, to the competent authority of the Member State where the file is located. (EU Regulation 1223/2009, Article 17).
To sum up:
The Responsible person has to be established in the EU/UK.
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/UK), a distributor, an importer, or a professional (designated) Responsible person.
Obligations, tasks of the responsible person
The Responsible person has to ensure safety and compliance of the cosmetic products with the EU Cosmetics Regulation and/or UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 before they are placed on the EU/UK market, and make sure that the products remain compliant with the Regulation while they are on the market.
The obligations of the cosmetics Responsible person are described in the Article 5 of the Regulation (see what they're referring to in the table below).
For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation. (EU Regulation 1223/2009, Article 4.2)
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. (EU Regulation 1223/2009, Article 5.1.)
The Responsible person, therefore, has to provide or ensure the following:
Registered address in the EU/UK 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 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.
Product claims substantiation.
Correct cosmetic product labelling.
CPNP (EU) or SCPN (UK) 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/UK 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.
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