Responsible person

EU Cosmetics Regulation 1223/2009 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 to be able to put the products on the EU market.

There has to be only one Responsible person per product for the whole EU.

In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community. (EU Regulation 1223/2009)
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)

 

OBLIGATIONS/TASKS OF THE RESPONSIBLE PERSON

The Responsible person has to ensure compliance of the cosmetic products with the EU Cosmetics Regulation before they are placed on the EU 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.

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/EC, Article 5.1.)

The Responsible person therefore has to provide or ensure the following:

  • 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.
  • Product claims substantiation
  • Correct cosmetic product labelling
  • 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.
  • CPNP 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 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.

WHO CAN BE A COSMETICS RESPONSIBLE PERSON?

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 (such as CE.way) to act as the RP. This person or a company must accept this role in writing.

To sum up then:

  • The Responsible person has to be established 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

WHY CHOOSE A PROFESSIONAL RESPONSIBLE PERSON?

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?

  1. It is the professional Responsible person’s full time job to keep track of the ever-changing EU legislation, making sure that you are familiar with the legislative updates so that you can keep your products compliant with the EU legislation.
  2. Its employees assist the clients with regulatory advice, their expertise enabling them to provide answers faster and more accurately. A professional RP can be your single contact point for any regulatory issue in the EU. Experts in the field help clients to compile the Product Information File faster and better, making sure that the products are fully compliant with the Regulation.
  3. A Professional Responsible person knows the notification process, performing the notification faster and without errors.
  4. Even if you change your distributor, your Responsible person remains the same, eliminating the need to reprint your labels (labels have to state the name and address of the Responsible person) and the need to notify your products once again.
  5. A professional Responsible person can easily answer the questions any of the 28 different EU competent authorities might have, and handle any crisis that might arise in any of them.
  6. You can be sure that a professional Responsible person will treat your Product Information Files with care, keeping all of your secrets confidential.
  7. A professional Responsible person’s task is to ensure the compliance of your products, and is therefore not bothered by the conflict of interest with your commercial interests.