What is a Responsible Person?
Since the Cosmetics Regulation no.°1223/2009 entered into force, a Responsible Person (RP) must be designated for each cosmetic product placed on the European market. That person is responsible for ensuring that the product complies with the Cosmetic Regulation. They must also compile the Product Information File (PIF) and ensure the safety of the product with regards to human health under normal or reasonably foreseeable conditions of use.
The Regulation specifies that the RP can be any natural or legal person established within the European Community who will act as the unique representative for that product throughout the EU. The RP’s role is to ensure that every product placed on the market complies with the Cosmetic Regulation.
Duties of the Responsible Person
The Responsible Person is responsible for ensuring that the cosmetic product complies with Regulation 1223/2009 and its amendments. Therefore, they play a key role in marketing the cosmetic products for which they are responsible.
The Responsible Person has various roles. In particular, they must:
Ensure the safety of the cosmetic product
The RP must ensure that the cosmetic product complies with Article 3 of Regulation 1223/2009. Therefore, they make sure that the safety of the product is assessed based on relevant information, and that the safety report for each product is drawn up in compliance with Annex I of the Regulation.
Guarantee the existence and completeness of the Production Information File for any cosmetic product placed on the European market
The RP must keep the PIF for 10 years following the marketing of said product. They ensure that the competent authorities in the Member State in which the file is stored can easily access the file at the address indicated on the label (this must be the RP’s address)
Ensure the quality of the manufacturing processesThe RP must ensure compliance with Good Manufacturing Practices (GMPs) as stipulated in Article 8 of the Cosmetic Regulation. The declaration of compliance must be included in the PIF for each cosmetic product.
Guarantee compliance of the cosmetic formulaCertain ingredients are prohibited or restricted (and certain ingredients are allowed) by the Cosmetic Regulation. Therefore, it is up to the RP to ensure that the formula complies with the regulatory requirements by checking that the composition complies with the restrictions imposed by the Cosmetic Regulation.
Ensure compliance with the prohibition on the performance of tests on animals
By virtue of Article 18 of Regulation 1223/2009, animal tests have been prohibited in Europe since March 2013 – both on raw materials and on the finished product. Therefore, the RP must monitor compliance with the prohibition on the performance of tests on animals.
Check the compliance of the product packaging and labelling
A certain number of conditions must be fulfilled to ensure the compliance of the cosmetic product’s labelling. To find out more about labelling and claims, visit our page on the matter.
Carry out the CPNP notification in their own name
Article 13 of the Cosmetic Regulation dictates that the RP must register the products intended use to be placed on the European market and submit to the authorities a certain amount of information about the product within the framework of the CPNP notification, such as:
- the category and name(s) of the product
- the name and address of the RP
- the country of origin in the case of import
- the first Member State in which the product is to be placed on the market
- the presence of substances in the form of nanomaterials
- the name and the Chemicals Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI.
- the frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties.
Be the main point of contact for the competent authorities in the event of an audit.
Who can be a Responsible Person?
The Cosmetic Regulation defines the manufacturer as “any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark”.
If the manufacturer is established within the European Community, it becomes the Responsible Person for the cosmetic products that it manufactures (within the Community) if they are not exported and imported back into the EU.
The manufacturer may designate, by written mandate, any person established within the Community. This person will assume all the manufacturer’s responsibilities as laid down by the Regulation.
According to Article 2 of the Cosmetic Regulation, an importer is “any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market”.
Each importer is a Responsible Person if the cosmetic product manufactured outside of the EU is imported into the European Union.
However, the “importer” may designate as a Responsible Person any natural or legal person established in the European Community. This person will assume all the importer’s responsibilities as laid down by the Regulation.
The distributor is defined by Regulation 1223/2009 as “any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market”.
The distributor becomes the Responsible Person where it places a cosmetic product on the market under its name or trademark, or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected (if it packages the product for example).
Any person established in the European Community
In this case, the only formality demanded by Requirement 1223/2009 is that the agreement is made in writing. In other words, you must designate your Responsible Person by written mandate and this person must also accept in writing. The agreement must also specify the products in question.
This designated person may be any natural or legal person capable of assuming the RP’s responsibilities.
Note that EcoMundo can take on the role of Responsible Person. Benefit from our expertise to secure the placing on the market of your cosmetic products.