What is the Responsible Person in the cosmetic industry?
The responsible person for cosmetic products is an entity (person or company) that acts as the Legal Representative and it’s located in one of the EU members states and/or the UK, depending of the market where the client sells their products. Because it’s the first contact for the authorities, they must have the full product dossier for inspection and monitoring and, also, its name and the address of the Responsible Person must appear in the label of the product.
Classification and identification of proper cosmetic regulation
Product Information File (PIF): Keeping and updating the product’s full dossier
Incident reporting and complaint assessment
Communication of Serious Undesirable Effects
Support on GMP Compliance
Surveillance guidance after market entry
Guidance on labelling requirements, labelling review and official languages
Guidance on the allowed cosmetics claims (dermatologically tested…)
The Responsible Person is a key figure in EU and UK cosmetic regulation. It is the individual or legal entity who holds the legal responsibility for ensuring compliance with the standards and safety requirements regarding cosmetic products placed on the market.
The obligations of the Responsible Person include ensuring that cosmetic products are manufactured in accordance with the standards and safety requirements, maintaining the necessary records and documentation, providing information to the public and competent authorities if any safety issues are identified, and cooperating with competent authorities in any investigations.
The Responsible Person can be any individual or legal entity established in the EU or UK, including manufacturers, importers, distributors, and retailers.
The Responsible Person is designated through a written contract between the manufacturer (or importer) and the Responsible Person. The contract must clearly establish the obligations and responsibilities of both parties.
The sanctions can vary depending on the country and specific infringement, but they may include fines, product market withdrawal, registration suspension or revocation, and in serious cases, criminal action against the Responsible Person.
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