Responsible Person in EU Cosmetics: Understanding the Role and Regulations
The “Responsible Person” is a vital figure in the beauty and cosmetics sector, acting as the primary contact for ensuring cosmetic goods are in line with the rigorous safety and regulatory standards established by the EU frameworks. In the European Union, this duty is detailed under the EU Cosmetics Regulation. For businesses in the cosmetics realm operating within these territories, recognizing and appointing a suitable Responsible Person is fundamental to ensure the compliance of their products and the safety of their consumers.
In the following article, we will delve deeper into the intricacies of the “Responsible Person” role, breaking down the EU regulations, and providing insights on the critical importance of this position in ensuring cosmetic product safety and compliance.
Who is the responsible person in the EU cosmetics industry?
Article 4 of Regulation (EC) no. 1223/2009 (click here for the last consolidated version) is dedicated to the central figure in the field of cosmetic products, that is the Responsible Person:
“a natural or legal person designated as such within the Community”
Article 4 of the Regulation defines that:
“Only cosmetic products for which a natural or legal person has been designated as a ‘responsible person’ within the Community ” shall be placed on the market.”
In Article 4, it is stipulated that for every cosmetic product introduced to the market, the “Responsible Person” must ensure adherence to the regulations set by the Directive. Appointing a Responsible Person within the European Union is a critical prerequisite for marketing a cosmetic product within the Community.
When multiple addresses are associated with the Responsible Person, the label should prominently display the address where the Product Information File (P.I.F.) is accessible to the authorities.
Who is eligible to be the Responsible Person?
Having outlined the role of the Responsible Person, let’s delve deeper into Article 4 to understand who can assume this position:
“for cosmetic products manufactured within the Community and subsequently not exported and reimported into the Community, the manufacturer established within the Community is the responsible person. The manufacturer may, by written mandate, designate a person established within the Community as the responsible person, who shall accept in writing.” or, where the manufacturer is established outside the European Community:
“If the manufacturer of a cosmetic product manufactured within the Community and subsequently not exported and re-imported into the Community is established outside the Community, he shall designate by written mandate a person established within the Community as the responsible person, who shall accept in writing.”
Therefore, the essential requirement is that a Responsible Person be appointed within the territory of the European Union.
“the respective importer is the person responsible for the specific cosmetic product that he places on the market. The importer may designate by written mandate a person established within the Community as the responsible person, who shall accept in writing.” Therefore, in case of importation of a non-EU product on European territory, if a Responsible Person is not appointed, it is the Importer himself who automatically becomes the Responsible Person.
“The distributor is the person responsible when placing a cosmetic product on the market under his name or trademark or modifying a product already placed on the market in such a way that compliance with the applicable requirements may be compromised.“
Thus, a distributor is deemed the Responsible Person only if they introduce a cosmetic product to the market under their own name or trademark, or if they make significant modifications to the product. However, translating information is not considered a substantial change that would jeopardize compliance with the Regulation’s requirements.
In summary, the following entities can be designated as the Responsible Person:
- The Manufacturer
- The Importer
- The Distributor
- An external natural or legal person appointed by written mandate and accepted in writing. Such designation shall be mandatory if the manufacturer of a cosmetic is established outside the Community.
Requirements of the Responsible Person
The Responsible Person, established within the Community, must at all times be able to demonstrate that the product he has placed on the market complies with the requirements of the Regulation. In order for the Responsible Person to fulfill this role, it is necessary that he retains the product-specific information (PIF) and the Safety Assessment prepared by the Safety Assessor that the Responsible Person has appointed.
So the Responsible Person has the following requirements:
- Must be registered and resident in the European Union;
- Must have received an appropriate mandate;
- You must be in a position that allows the competent authorities to have access, as and when deemed appropriate, to the information document (P.I.F.) at the address indicated on cosmetics by the Responsible Person.
Conversely, if the Responsible Person delegates production to a subcontractor, there is a requirement to verify and evaluate the subcontractor. This verification can be conducted by an individual designated by the Responsible Person. In situations involving third-party productions, it’s often prudent to establish a contract between the involved parties, specifically between the customer (the Responsible Person) and the subcontractor.
Obligations of the Responsible Person
The responsibilities borne by the Responsible Person are extensive, and we’ll delve deeper into them in the subsequent section. It’s clear to see that the Responsible Person holds a pivotal role in the cosmetic marketing process.
Responsible Person and CPNP
Article 13 of Regulation (EC) 1223/2009 indicates that, before placing a cosmetic on the market, the Responsible Person is obliged to transmit the notification of the product to the European CPNP portal by transmitting the following information:
a) category of the cosmetic product on the market and the name or names that allow its specific identification;
b) name and address of the Responsible Person from whom the product information file is kept immediately available;
c) the country of origin in the case of imports;
d) the Member State in which the cosmetic product is to be placed on the market;
e) information enabling a natural person to be contacted in case of need;
f) the presence of substances in the form of nanomaterials;
g) the name and Chemical Abstracts Service (CAS) number or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008;
h) the framework formulation enabling prompt and appropriate medical treatment to be provided in the event of impairment of health.
Responsible person and obligations related to the P.I.F.
The Responsible Person, as indicated even in the guidelines of Cosmetics Europe, the association of European cosmetic actors, regarding P.I.F., has specific obligations:
- ensure that a cosmetic product placed on the EU market is harmless to human health under normal or reasonably foreseeable conditions of use;
- maintain specific information on the product it places on the market as established by Article 11 of Regulation 1223/2009;
- demonstrate following a request from the competent authorities of the Member State that the product placed on the market meets the requirements of the Regulation;
- ensure that the Safety Assessment of the cosmetic has been carried out by a Safety Assessor, or by an appropriately qualified and experienced person;
- keep the Product Safety Assessment and the data on which it is based as part of a “Cosmetics Safety Report” in the P.I.F. and update it in anticipation of further related information produced after the placing of the product on the market;
- make sure you have the P.I.F. available in order to respond to requests from the competent authority in the place where the P.I.F. is stored and to prove the conformity of the product with the Regulation
The Responsible Person’s Crucial Role in Cosmetic Safety Reports
In European cosmetic regulation, the responsible person plays a pivotal role in connection with the Cosmetic Product Safety Report (CPSR). They are responsible for commissioning, overseeing, and ensuring the accuracy of CPSRs, which are indispensable for assessing the safety and compliance of cosmetic products with EU Cosmetic Regulation (EC) No 1223/2009. This dynamic relationship between the responsible person and the CPSR is vital, with the former acting as the guardian of product safety and the latter serving as the essential document that verifies compliance with stringent regulatory standards, ultimately ensuring consumer safety in the cosmetics industry.
Responsible person and cosmetovigilance
Article 23 of Regulation (EC) 1223/2009 states that:
“In the event of serious undesirable effects, the responsible person and the distributors shall notify the competent authorities of the Member State in which serious undesirable effects have been detected as soon as possible”
The Responsible Person must therefore notify the Competent Authorities of:
- all serious undesirable effects known to you or which can reasonably be expected to be known to you;
- the name of the cosmetic product concerned, allowing specific identification of the cosmetic product;
- any corrective measures you have taken.
Obligations of the Responsible Person in case of non-compliance
If a cosmetic product doesn’t adhere to the regulations, the Responsible Person must implement corrective actions to ensure its compliance. In certain situations, such as when non-compliance could pose a health risk to the end consumer, the Responsible Person is obligated to recall the cosmetic product from the market.
Is the contract manufacturer a Responsible Person?
The contract manufacturer isn’t inherently deemed the Responsible Person, given that they offer services to a third-party company and not under their own name. Nevertheless, through a written agreement, if the third-party producer is designated as the Responsible Person, their name and address must be displayed on the label.
The Role of the “Responsible Person” in UK Cosmetics Regulation
Regarding the duties of the responsible person in the UK, they remain consistent with prior regulations, as outlined in the country’s specific regulation (you can review it here). The primary distinction, since the UK’s departure from the EU on 31 December 2020, is that the responsible person must now have their registered office in the UK. Furthermore, the notification process, which takes place on the CPNP portal in Europe, will be conducted on the SCNP portal in the UK.
If you’re uncertain about the specifics of the “Responsible Person” in your particular scenario, or if you’re contemplating the idea of designating Taobè as your RP for compliance and peace of mind, please don’t hesitate to get in touch.