The key role when placing cosmetic products in EU markets is that of the responsible person. Without the responsible person assigned to the cosmetic product, it would not be possible to legally sell it within the EU.
In this guide, we address common questions associated with this role and explain what importers and manufacturers must know about the duties of the responsible person.
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What is a responsible person?
The responsible person is a legal or natural person who is based in the EU. This means that a legal entity like a company can also fulfil the role of a responsible person.
The responsible person must ensure that each cosmetic product assigned to it complies with the requirements of the Cosmetic Products Regulation before the product is placed in the EU market.
Why do I need a responsible person?
To establish clear responsibilities, each cosmetic product placed in the EU market must have a responsible person within the EU assigned to it.
If a product doesn’t have a responsible person, it may be prohibited or restricted from entering the EU market. If such products are found to be present in the market, they may be withdrawn or recalled.
Who can be a responsible person?
The responsible person can be a legal or natural person based in the EU. Specifically, the responsible person in relation to the cosmetic product can be a:
a. Manufacturer based in the EU – defined as a natural or legal person (e.g. a company) who manufactures a cosmetic product or has it designed or manufactured, and markets it under his name or trademark.
b. Importer based in the EU – defined as a natural or legal person (e.g. a company) based in the EU who places products from third countries into the EU market.
c. Distributor based in the EU – defined as a natural or legal person (e.g. a company) in the supply chain, other than the manufacturer or the importer, who makes the product available in the EU market.
d. A legal or natural person based in the EU and not connected to your supply chain may be the responsible person for a given cosmetic product. For this to be possible, the person or business needs to accept in writing a written mandate from either:
- A manufacturer
- An importer
Thus, non-EU sellers may approach persons and businesses based in the EU to act as their responsible persons.
However, careful consideration would be needed when assigning a responsible person as they are in charge of ensuring compliance with the cosmetic product regulation and this would necessarily involve the handling of sensitive documents. Preferably, a person or company with regulatory expertise should be approached.
Note that a distributor based in the EU must take on the role of a responsible person if either:
a. He sells the cosmetic product under his name or trademark
b. He modifies a cosmetic product already placed on the market
Must the responsible person be based in the EU?
Yes, the responsible person must be based in the EU. However, sellers from non-EU countries have the option of engaging independent persons or companies offering “responsible person” services based in the EU via a written mandate.
What is a responsible person required to do?
Under the Cosmetic Products Regulation, the responsible person is in charge of the safety of the product and is the primary point of contact for EU authorities.
Below we list some key responsibilities of the responsible person, stated under Article 5:
a. Good manufacturing practice (GMP) – The responsible person must ensure that the product is produced according to the relevant GMP standard.
b. Safety assessment – The responsible person must ensure that the safety assessment is carried out. This process ultimately leads to the creation of the cosmetic product safety report and necessarily involves:
- The collection of documents relating to the cosmetic product
- Engaging a safety assessor
c. Testing requirements – When testing the product, the responsible person must ensure that:
- The product does not contain restricted substances
- Sampling and analysis are carried out in a reproducible and standardised manner
- No animal testing is done
d. Product information file – The responsible person must compile the Product information file according to the requirements of the cosmetic product regulation.
e. Cosmetic Products Notification Portal – The responsible person must use the portal to indicate the cosmetic products it intends to place in the market. Through this portal, competent authorities are notified about the entry of cosmetic products into EU markets.
f. Product labelling – The responsible person must ensure that the labelling information and instructions that come with the product are compliant with the cosmetic product regulation and that claims made are substantiated. Additionally, he must communicate any undesirable or serious undesirable effects associated with the product.
What companies offer responsible person services?
Here we list some examples of companies that offer “responsible person” services:
- Obelis Group
- MDSS Cosmetics