PERSON RESPONSIBLE FOR THE EUROPEAN UNION
The figure of the "Responsible Person" (RP) for cosmetic products in Europe is a central pillar within the regulatory framework established by Regulation (EC) No. 1223/2009 on cosmetic products. This regulation clearly establishes the need for a RP as the entity or person responsible for ensuring that each cosmetic product placed on the European Union (EU) market complies with all applicable legal requirements.
Who is the Responsible Person in Europe?
The Responsible Person is a natural or legal person established within the European Union, designated by the manufacturer, importer or distributor of a cosmetic product. This RP acts as the legal representative in the EU and assumes responsibility for the product's compliance with current safety and labelling regulations.
Responsible Person: Importance in Europe
The role of the PR is essential to ensure that only safe and compliant cosmetic products reach consumers in the European Union. The responsibility of the PR not only protects public health, but also ensures that manufacturers and distributors comply with their legal obligations, avoiding sanctions and damage to the brand's reputation.
Appointment of the RP in Europe
The appointment of the PR must be carefully considered. The PR can be the manufacturer itself if established in the EU, the importer if the manufacturer is based outside the EU, or a third party entity specifically designated for this role. It is crucial that the PR has a thorough knowledge of the European regulations and maintains continuous communication with the regulatory authorities.
Main Responsibilities of the Responsible Person.
Compliance
of Regulations
-
The RP is primarily responsible for ensuring that the cosmetic product complies with all provisions of Regulation (EC) No 1223/2009 before it is placed on the market in the EU. This includes verifying that all necessary safety assessments have been carried out and documented.
Labeled
It is the responsibility of the PR to ensure that product labelling complies with EU requirements, including information in the official language of the country of marketing, list of ingredients, minimum shelf life date, and precautions for use.
In addition, the PR must ensure that the product's advertising claims are not misleading and are supported by adequate scientific evidence.
Notification in
the CPNP
-
Before a product is placed on the market in the EU, the PR must notify it via the Cosmetic Product Notification Portal (CPNP). This notification is a mandatory requirement and contains key information about the product, such as composition, labelling and safety features.
Incident Management and Post-Marketing Follow-up
The PR must implement a monitoring system to identify any safety issues once the product is on the market. If a health risk is identified, the PR must inform the competent authorities and take the necessary corrective measures, such as a recall of the product from the market.
In addition, the RP is responsible for managing any serious incidents related to the product, notifying the relevant authorities.
Information File
of the Product
(PIF)
The RP must compile and maintain the updated Product Information File (PIF), which includes all documents demonstrating the conformity of the product. This file must be available to the competent authorities in case of inspection or audit.
The PIF should include details such as product description, safety reports, manufacturing methods, evidence of beneficial effects, and data on animal testing (if applicable).
Cooperation
with the Authorities
-
The RP should be prepared to cooperate with national and European authorities during inspections or audits, providing access to the PIF and any other required documentation.
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