Cosmetics regulatory services
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EU/UK cosmetics responsible person is an EU/UK based cosmetic product manufacturer, importer, distributor, or another person established within the EU/UK who has to accept this role in writing. The role of the responsible person is to ensure that the cosmetic products placed on the EU/UK market are safe for use and compliant with the EU Regulation 1223/2009 and UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. A responsible person is basically a legal representative of a cosmetic product in the EU/UK.
EU Cosmetics Regulation 1223/2009, which came into effect on July 11, 2013, 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/UK to be able to put the products on the EU/UK market.
There has to be only one Responsible person per product for the whole EU and only one Responsible person per product covering the whole 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) |
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.
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) |
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).
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:
Article | Referring to | Article | Referring to |
---|---|---|---|
3 | Safety | 16 | Nanomaterials |
8 | Good manufacturing practice | 17 | Traces of prohibited substances |
10 | Safety assessment | 18 | Animal testing |
11 | Product information file | 19 | Labelling |
12 | Sampling and analysis | 20 | Product claims |
13 | Notification | 21 | Access to information for the public |
14 | Restriction for substances listed in the Annexes | 23 | Communication of serious undesirable effects |
15 | Substances classified as CMR substances | 24 | Information on substances |
Responsible person (RP) can be any legal or natural person who is based within the EU/UK. Usually, though, the RP is one of the following:
Therefore, if the manufacturer is from the EU/UK, they usually act as the EU/UK RP themselves. Cosmetics manufacturers from outside of the EU/UK, on the other hand, can’t act as the RP themselves. We also need to point out that RPs based in the EU can’t act as the UK RPs and UK based RPs can’t act as EU RPs. 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 (such as CE.way) to act as the RP. This person or a company must accept this role in writing.
To sum up then:
Based on the description of the Responsible person’s duties, you can see that the Responsible person’s job is very important and requires expertise in various areas. What are the advantages of having a professional Responsible person?