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The cosmetics regulation defines the main players in cosmetics. These definitions are very important because they make it possible to clarify the obligations and/or rights of each:
- the manufacturer is any natural or legal person who manufactures or has a cosmetic product designed or manufactured and markets this product under his name or trademark.
- the importer is any natural or legal person established in the Community who places a cosmetic product from a third country on the Community market.
- the distributor is any natural or legal person forming part of the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market.
Thus are considered as distributors, when they sell these products, for example, large and medium-sized stores (GMS), department stores, stores specializing in the sale of cosmetic products, perfumeries, parapharmacies, pharmacies, institutes beauty, hairdressers…., we will talk about their obligations in another article.
- the end user is a consumer or a professional who uses the cosmetic product.
Thus professionals, such as hairdressers or beauticians, who use cosmetic products as part of their profession are considered as end users.
What qualifications are required to market a cosmetic product?
Diplomas are required for the person in charge of the safety assessment (safety assessor) of the cosmetic product.
Indeed, according to article 10 of the cosmetic regulation, the safety assessment must be carried out by a person who holds a diploma or title attesting to university education in pharmacy, toxicology, medicine or a similar discipline or training recognized as equivalent by a Member State.
No particular diploma is required for the person responsible.
As regards the manufacture, packaging, control and storage of cosmetic products, the standard NF EN ISO 22 716 relating to good manufacturing practice requires that the persons involved have appropriate training to produce, control and store products of a defined quality. A
knowledge of GMP is essential.
Is it mandatory to designate a responsible person?
Yes, each cosmetic product placed on the market is associated with a responsible person established in the Community (Article 4 of the Cosmetic Regulation). This person can be a natural or legal person. This person has many obligations and responsibilities, including
- to ensure that the cosmetic product placed on the market and with which he is associated is safe for human health when used under normal or reasonably foreseeable conditions of use
- to ensure compliance with the requirements of the Cosmetic Regulation, for each cosmetic product placed on the market.
Who can be the responsible person?
The manufacturer established in the Community, for a cosmetic product manufactured in the Community and not subsequently exported and re-imported into the Community.
He may designate a person established in the Community as the responsible person. This person must be designated by written mandate and must have accepted this responsibility in writing.
-A person established in the Community, designated by the manufacturer established outside the Community, by written mandate and having accepted this responsibility in writing, for a cosmetic product manufactured in the Community and not subsequently exported and reimported into the Community.
Thus, the mandate is mandatory if the product is manufactured in the Community and the manufacturer is established outside the Community
-Each importer for each imported cosmetic product, i.e. coming from a third country, that he places on the market.
The importer may designate a person established in the Community as the responsible person. This person must be designated by written mandate and must have accepted this responsibility in writing.
-The distributor, where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that its compliance with the applicable requirements may be affected. The mere translation of information relating to a cosmetic product already placed on the market shall not be considered as a modification that may affect its compliance
with the requirements of the Cosmetic Regulation.
What are the obligations of the responsible person?
Ensure for each cosmetic product placed on the market compliance with the Regulation
The responsible person shall ensure that each cosmetic product placed on the market for which he is designated complies with the provisions of the Cosmetic Regulation and that it is safe for human health; this concerns :
- the safety of the product in accordance with article 3 of the cosmetic regulation
- Good Manufacturing Practices (GMP) in accordance with Article 8 (see point I.10 of this document)
- safety assessment according to article 10 (see point III.2 of this document)
- Product Information Package (PIP) in accordance with Article 11 (see point III.1 of this document)
- sampling and analysis of cosmetic products in accordance with Article 12
- notification to the European Commission in accordance with Article 13
- the substances listed in the annexes of the regulation: prohibited substances, restricted substances, authorized substances of colorants, preservatives and UV filters according to article 14
- substances classified as carcinogenic, mutagenic or toxic to reproduction, known as CMR, in accordance with Article 15
- nanomaterials used in the composition of the cosmetic product in accordance with Article 16
- traces of prohibited substances in accordance with Article 17
- animal testing in accordance with Article 18
- Labelling in accordance with Article 19
- the claims concerning the cosmetic product in accordance with article 20
- public access to certain information provided for in Article 21 and Article R.5131-5 of the Public Health Code.
- the communication of serious undesirable effects in accordance with article 23
- information on substances "in case of serious doubts" about their safety in accordance with article 24.
The responsible person must be able to demonstrate that the cosmetic product placed on the market meets the requirements of the Cosmetic Regulation.
If the responsible person considers that the product with which he is associated does not comply with the provisions of the Cosmetic Regulation, he must immediately take the necessary corrective measures to bring the said product into compliance, withdraw it from the market or recall it, as the case may be (Articles 5 and 25).
Be the first point of contact for the competent authorities of the Member States
The responsible person is the interlocutor of the competent authorities. He keeps the DIP permanently at the disposal of the competent authority, at his address, which must appear on the product label.
Inform the competent authorities of the Member States (article 5 of the cosmetic regulation and article L.221-1-3 of the consumer code)
If the cosmetic product presents a risk to human health, the person responsible must immediately inform the competent authorities of the Member States where the product is marketed (ANSM and DGCCRF in France) and the one of the Member State where the D IP is held. It must provide details of the non-compliance, the corrective measures adopted and the actions taken to eliminate the risk to consumers.
The information from the ANSM is sent to the Surveillance Department (DS) at the following e-mail address: cosmetovigilance@ansm.sante.fr . Information from the DGCCRF is done in accordance with the Notice to economic operators on the implementation of the obligation to report risks and measures taken-JORF of February 11, 2012 at the following address:
http://www.economie.gouv.fr/dgccrf/signalement-des-risques-et-des-mesures-prises-article-l-221-1-3-code-consommation-avis-au-jor
Cooperate with the competent authorities of the Member States (Articles 5 and 24)
At the request of the competent authorities of the Member States, the responsible person shall cooperate with the latter on any measure aimed at eliminating the risks posed by the cosmetic product with which he is associated. He shall provide the competent authority that makes a reasoned request with all the necessary information and documentation (Article 5).
The responsible person shall communicate a list of all cosmetic products for which he is responsible containing a given substance:
- in case of serious doubts on the safety of this substance and
- upon reasoned request of the competent authority (ANSM and/or DGCCRF) that has a product containing this substance on its market.
It indicates the concentration of this substance in cosmetic products.
Communicate serious adverse reactions (SARs) to the competent authority of the Member State where the SAR was observed (ANSM in France) (article 23)
In case of serious adverse reactions (AR), the responsible person shall notify without delay :
- all the SAEs of which it is aware or can reasonably be expected to be aware,
- the name of the product allowing its specific identification,
- the corrective measures taken, if any.
It may also report other adverse reactions and reactions likely to result from misuse of the product (articles L.5131-5 and R.5131-9 of the CSP)
Identify the supply chain (article 7):
At the request of a competent authority, the responsible person must identify the distributors it supplies with cosmetic products. This obligation applies for a period of 3 years from the date of availability of the batch to the distributor.
Communicate information to the public (article 21):
The responsible person shall ensure that the following information is made readily available to the public by appropriate means:
- the qualitative and quantitative formula of the cosmetic product, the quantitative information relating only to dangerous substances within the meaning of Article 3 of Regulation (EC) No 12 72/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (known as the CLP Regulation).
- in the case of perfume and aromatic compositions: the name and code number of the composition as well as the identity of the supplier.
- existing data on adverse reactions and serious adverse reactions.
Article R.5 131-5 of the CSP specifies that the person responsible must send this information within three weeks of receiving the request.
If you need a responsible person, do not hesitate to contact us.