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Duties of Responsible Persons under the European Union Cosmetics Regulation (EC) No 1223/2009

1. Definition of responsible person
   The responsible person must be a natural or legal person within the European Union who is responsible for ensuring the compliance of the cosmetic product. The responsible person may be the manufacturer, importer, distributor or an authorized third party.
2. Main Duties and Responsibilities

a. Ensure product safety
The responsible person must ensure that all cosmetic products placed on the market are not harmful to human health under normal or reasonably foreseeable conditions of use. This requires a detailed safety assessment and review by a qualified person.
b. Information Retention and Product Information File (P.I.F.)
The Responsible Person is required to retain details of each product in accordance with section 11 of the statute, including:

• Product formulation and raw material information
• Product Manufacturing Methods
• Product labeling and packaging information
• Product Safety Assessment Report
  This information must be readily available so that it can be provided upon request by the competent authority.
  c. Compliance with labeling requirements
  The name and complete address of the responsible person must be shown on each cosmetic label. If there are multiple addresses, the address where the P.I.F. is kept should be highlighted. In addition, the label must contain information on the product category, country of origin, presence of nanomaterials, CMR substances, etc.

d. Submission of notifications
Prior to placing a product on the market, the Responsible Person must submit product information through the European Cosmetic Product Notification Portal (CPNP), including:

• Responsible Person Information
• Product Formulation and Ingredients
• Product labeling and packaging information

1. Cosmetovigilance
   Under Section 23 of the statute, responsible persons and distributors must report all known or reasonably anticipated serious adverse reactions. Serious adverse reactions include any reaction that results in hospitalization, disability or fatality. The responsible person is required to report serious adverse reactions to the competent authorities of the Member State in which they are detected and to take the necessary corrective action.
2. Corrective Action and Product Recalls
   If a cosmetic product is found to be non-compliant, the responsible person must take prompt corrective action to bring the product into compliance with the regulatory requirements. In some cases, the responsible person is required to recall the product from the market if it poses a risk to the health of consumers.
3. Selection of Responsible Persons
   Under section 4 of the statute, the responsible person may be:

• Manufacturer: If the cosmetic is manufactured in the EU and not exported, the manufacturer is the responsible party.
• Importer: If the cosmetics are imported from a non-EU country, the importer is the responsible party.
• Distributor: If a distributor sells cosmetics under his own name or trademark, or makes significant modifications to the product, the distributor is the responsible party.

1. Practical Guide
   a. Compliance Check
   The responsible person is required to regularly check whether the cosmetic products comply with the latest applicable regulations, including the ingredients, labeling and safety assessment.
   b. Product Safety Report (CPSR)
   The responsible person must conduct a comprehensive product safety assessment and retain all relevant data to form a CPSR, which should be regularly updated with the latest scientific and regulatory information.
   c. Notification and Filing
   Responsible Persons are required to submit product information via CPNP (EU Markets) and SCPN (UK Markets) to ensure the legitimacy of the product in each market.
   d. Customs clearance
   The Responsible Person will need to ensure that all necessary documents and declarations are available at the point of entry into the EU to enable a smooth customs clearance process.

Conclusion
Responsible Persons play a vital role in the Cosmetics Regulation (EC) No 1223/2009. By ensuring product safety, compliance and transparency, Responsible Persons help to safeguard the health and safety of consumers. In order to successfully fulfill these responsibilities, Responsible Persons need to have in-depth knowledge of the regulations and strict operational procedures.

Overall, choosing a suitable responsible person and ensuring that they are able to effectively fulfill all regulatory requirements are key steps in selling cosmetics in the EU market. With professional support and strict compliance management, cosmetic companies can enter the EU market smoothly and ensure that their products comply with all regulations and safety standards.