RESPONSIBLE PERSON

Who May Be the Responsible Person (RP) for Cosmetic Products in the EU, and What Are the Duties of the Responsible Person According to the EU Cosmetics Regulation?

According to the EU Cosmetic Regulation (Article 4 of Regulation (EC) No 1223/2009), the Responsible Person (RP) is a key figure in ensuring compliance with the regulation for cosmetic products placed on the market.
The RP can be any individual or legal entity established within the European Union. It's important to note that the Responsible Person can be:
  • Manufacturer: If the cosmetic product is manufactured within the EU, the manufacturer automatically becomes the RP.
  • Importer: If the product is imported from outside the EU, the first importer into the EU market takes on the role of the RP.
  • Distributor: If a distributor places the product on the market under their own name or trademark, they become the RP.
  • Third-party entity: Any natural or legal person established within the EU can be designated as the RP through a written contract with the manufacturer, importer, or distributor. This is a common option for small companies who lack the resources or expertise to handle the RP responsibilities themselves.

Obligations of the Responsible Person

The RP has a wide range of obligations under the EU Cosmetics Regulation, ensuring the safety and compliance of the cosmetic product throughout its lifecycle.
Individual or Legal Establishment: The Responsible Person must be established within the European Union. This means having a physical or operational presence within the EU.
Contact Point: The Responsible Person must be the contact point for competent authorities in the EU. This includes providing their name and address to the relevant authorities.
Product safety: The RP is responsible for ensuring the product is safe for human health under normal or reasonably foreseeable conditions of use. This involves conducting safety assessments, keeping a Product Information File (PIF), and notifying the product to the Cosmetic Product Notification Portal (CPNP).
The Responsible Person must ensure that the cosmetic product undergoes a safety assessment by a qualified Safety Assessor. The safety assessment is a critical step in ensuring the product's safety.
The Responsible Person is responsible for creating and maintaining the Product Information File (PIF) for each cosmetic product. The PIF should contain detailed information about the product, including safety assessments, product labeling, and other relevant data.
Before placing a cosmetic product on the market, the Responsible Person must submit certain information to the European Commission through the Cosmetic Products Notification Portal (CPNP). This includes details about the product and its composition.
Compliance with Regulation: The Responsible Person is responsible for ensuring that the cosmetic product complies with the requirements of the EU Cosmetic Regulation.
The RP must ensure the product labeling is accurate, complete, and in the appropriate language for the EU market. They're also responsible for ensuring the packaging is safe and doesn't mislead consumers.
Quality control and manufacturing practices: The RP must oversee the manufacturing process and implement appropriate quality control measures to ensure product consistency and safety.
Adverse reaction reporting: The RP must have a system for recording and reporting any serious adverse reactions associated with the product.
Market Surveillance: The Responsible Person must cooperate with competent authorities during inspections and provide them with all necessary information to ensure market surveillance, safety of the products and compliance checks.

Rules and Responsibilities of a Responsible Person for Cosmetic Product Labeling and Claims:

  • Labeling requirements:
    • Mandatory information: Product name, name and address of the RP, list of ingredients (INCI nomenclature), nominal product content, minimum durability period/period after opening (if applicable), special precautions for use, batch number, country of origin (if not EU).
    • Additional information: Function of the product, warnings and indications, specific claims.
    • Claims - supported by evidence: Claims must be substantiated by appropriate scientific evidence, truthful, supported by data, and not be misleading or deceptive.
    • Language: Labeling must be in the official language(s) of the member state where the product is marketed.
    • Clarity and accuracy: Information must be easily readable, complete, and accurate, avoiding misleading claims or ambiguities.
  • Responsibilities:
    • Ensuring that the cosmetic product labeling is accurate, complete, and complies with the regulatory requirements outlined in the EU Cosmetic Regulation.
    • Ensuring that all labeling elements, including ingredient lists, instructions, and warnings, are provided in the appropriate language(s) for the EU market.
    • Approving claims and maintaining supporting evidence.
    • Implementing a batch coding system to trace and identify each batch of the cosmetic product. The RP should ensure that the batch code is easily accessible and understandable.
    • Reviewing marketing materials associated with the cosmetic product to ensure alignment with the product labeling and regulatory requirements.
    • Keeping labeling and claims documentation readily available for authorities.
    • Notifying the CPNP (Cosmetic Product Notification Portal) before placing the product on the market.
    • Cooperating with authorities during inspections and providing any necessary information.

IMPORTANT CONSIDERATIONS:

  • The RP is legally liable for any non-compliance with the EU Cosmetics Regulation.
  • Choosing a qualified and experienced RP is crucial for ensuring the safety and compliance of cosmetic products.
  • If you're unsure about the RP requirements or choose to designate a third-party entity, seek professional advice to ensure you're fulfilling your obligations correctly.