Under Article 4 of Regulation (EC) No 1223/2009, every cosmetic product placed on the EU market must have a designated Responsible Person (RP). The RP plays a key role in ensuring that the product complies with the applicable regulatory requirements.
The Responsible Person must be a natural or legal person established within the European Union. Depending on the circumstances, this role may be fulfilled by:
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Manufacturer: For a cosmetic product manufactured within the EU and not subsequently exported and re-imported into the EU, the manufacturer established within the EU is the RP, unless they designate another person established within the EU as the RP by written mandate, which that person accepts in writing. Where such a cosmetic product is manufactured by a manufacturer established outside the EU, that manufacturer must designate a person established within the EU as the RP by written mandate, which must be accepted in writing.
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Importer: Each importer is the RP for the specific cosmetic product they place on the EU market, unless they designate another person established within the EU as the RP by written mandate and that person accepts the mandate in writing. In this role, the importer must ensure that the product meets the applicable EU cosmetic regulatory requirements before it is placed on the market.
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Distributor: A distributor becomes the RP if they place a cosmetic product on the market under their own name or trademark, or modify a product already placed on the market in a way that may affect its compliance with the applicable requirements. Translating information about a product already placed on the market does not, by itself, constitute such a modification.
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Third-party entity: Where permitted under Article 4 of Regulation (EC) No 1223/2009, a manufacturer or importer may designate another natural or legal person established within the EU as the RP by written mandate, which must be accepted in writing. This may be a practical option for businesses that require external regulatory support.
The
Responsible Person has legal obligations under the EU Cosmetics Regulation to ensure that cosmetic products meet the applicable safety and compliance requirements before and after they are placed on the market.
Establishment: The Responsible Person must be a natural or legal person established within the European Union, in accordance with Article 4 of Regulation (EC) No 1223/2009.
Contact with Competent Authorities: The RP must be identifiable and accessible to the competent authorities and provide the information required within the scope of their legal powers. The name and address of the RP must appear on the product label in accordance with the applicable requirements.
Product Safety: The RP must ensure that the cosmetic product is safe for human health under normal or reasonably foreseeable conditions of use, in accordance with Regulation (EC) No 1223/2009.
Cosmetic Product Safety Assessment: The RP must ensure that a
safety assessment has been carried out and that a Cosmetic Product Safety Report (CPSR) has been prepared in accordance with Annex I of Regulation (EC) No 1223/2009. The safety assessment must be carried out by a qualified
Safety Assessor who meets the requirements of Article 10(2) of that Regulation.
Product Information File (PIF): The RP must ensure that a
Product Information File (PIF) is prepared and kept up to date for each cosmetic product. The PIF must contain the information required by Article 11 of Regulation (EC) No 1223/2009, including the
Cosmetic Product Safety Report (CPSR), a description of the product, information on the manufacturing method and compliance with Good Manufacturing Practice, proof of claimed effects where justified, and data on any animal testing covered by that Article.
The PIF must be kept readily accessible, in electronic or other format, to the competent authority of the Member State in which the PIF is kept, at the address of the RP indicated on the product label. It must be retained for ten years following the date on which the last batch of the cosmetic product was placed on the market.
Regulatory Compliance: The RP must ensure that the cosmetic product complies with all applicable requirements of Regulation (EC) No 1223/2009, including those relating to composition, safety, documentation, labeling and claims.
The RP must ensure that the
product labeling complies with the applicable requirements, including the accuracy and completeness of mandatory information and the language requirements of the relevant EU Member State. Product information and presentation must not mislead consumers.
Good Manufacturing Practice and Quality: The RP must ensure that the cosmetic product is manufactured in accordance with the applicable Good Manufacturing Practice (GMP) requirements and that the relevant quality and safety requirements are met.
Serious Undesirable Effects: The RP must comply with the reporting obligations under Article 23 of Regulation (EC) No 1223/2009. Serious undesirable effects associated with the cosmetic product must be notified without delay to the competent authority of the Member State where the effect occurred, together with the information required by that Article.
Market Surveillance: The RP must cooperate with the competent authorities during market surveillance and provide the information and documentation required by law. If the RP considers, or has reason to believe, that a cosmetic product is not compliant, appropriate corrective measures must be taken immediately, including bringing the product into compliance, withdrawing it from the market or recalling it from end users, as appropriate. Where the product presents a risk to human health, the RP must immediately inform the relevant competent authorities in accordance with Article 5(2) of Regulation (EC) No 1223/2009.
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Labeling requirements:
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Mandatory Information: Cosmetic product labeling must comply with Article 19 of Regulation (EC) No 1223/2009 and include the required information, subject to the applicable conditions and exceptions. This includes the name and address of the RP, the list of ingredients using the required ingredient nomenclature, nominal content where required, the date of minimum durability or period after opening as applicable, particular precautions for use, the batch number or identification reference, the function of the product unless clear from its presentation, and the country of origin for imported cosmetic products.
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Additional Information: Any additional warnings, instructions or other information required for the specific cosmetic product must also be provided. All claims must comply with the applicable regulatory requirements.
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Claims – Supported by Evidence: Claims made for cosmetic products must be truthful, supported by adequate and verifiable evidence, and must not mislead consumers.
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Language: Mandatory labeling information subject to national language requirements must be provided in the language determined by the EU Member State in which the product is made available to end users, in accordance with Article 19(5) of Regulation (EC) No 1223/2009.
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Clarity and Accuracy: Mandatory information must be clearly visible, easily legible and accurate, and the labeling and presentation of the product must not mislead consumers.
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Responsibilities:
- Ensuring that cosmetic product labeling is accurate, complete and compliant with the applicable legal requirements.
- Verifying that the required instructions, warnings and ingredient information are correctly presented on the product label, in accordance with the applicable requirements.
- Ensuring that cosmetic product claims, including those used in advertising and marketing materials, comply with the applicable requirements, are supported by adequate and verifiable evidence, and do not mislead consumers.
- Ensuring that each batch of the cosmetic product bears the required batch number or identification reference.
- Keeping relevant labeling and claims substantiation documentation up to date and making it available to the competent authorities where required.
- Cooperating with the competent authorities and providing the information they are legally entitled to request.
Before placing a cosmetic product on the EU market, the Responsible Person must submit the required information to the European Commission through the Cosmetic Products Notification Portal (CPNP), in accordance with Article 13 of Regulation (EC) No 1223/2009.