Responsible person (manufacturer, importer etc.)

Manufacturers and importers are responsible for the products that they place on the European market. They must guarantee and ensure that their products are safe, that they do not pose a danger to human health, and that they comply with the relevant regulations. For this purpose, they are classed as responsible persons pursuant to European rules.

Both may appoint a person who is based in the Community as a responsible person. The appointment must be in the form of a written mandate, and accepted inn writing.

Obligations of the responsible person

Among other things, the responsible person must:

• Place products on the market that are safe for human health.
• Adhere to good manufacturing practices.
• Assess safety and prepare a product safety report prior to placing the cosmetic product on the market. The safety assessment must be carried out by a person who holds a diploma or qualification certifying university training in pharmacy, toxicology or medicine.
• Keep an up-to-date product information file (PIF) available to the competent authority for a period of ten years from the date on which the last batch was placed on the market.
• Test and monitor the durability of the products.  
• Ensure proper storage and transport conditions.
• Notify the products on the European Union's Cosmetic Products Notification Portal (CPNP) before placing them on the market.
• Notify the European Commission six months prior to placing cosmetic products that contain nanomaterials on the market.
• Comply with restrictions, including conditions of use, applicable to prohibited substances, restricted substances, colorants, preservatives and ultraviolet filters.
• Include the mandatory product information (labelling).
• Ensure that the wording of the claim relating to the cosmetic product complies with the common criteria in Annex I of Regulation 655/2013, and is consistent with the documents attesting to the claimed effect of the cosmetic product in the PIF.
• Make easily accessible to the public the qualitative and quantitative formula of the cosmetic product, as well as existing data on undesirable effects and serious undesirable effects caused by a cosmetic product following its use.
• Immediately implement any corrective measures required to bring the product into compliance, or withdraw or recall the product, if the marketed product is not compliant.
• In the event of risk to human health, immediately inform the national authorities in the countries where the product is available, and the national authority in the country where your registered office is located, providing details on the non-compliance and corrective measures taken:
  
  For Luxembourg, using the address cosmet@ms.etat.lu, or through the Safety Business Gateway.

• Cooperate with the authorities on any measures intended to eliminate the risks posed by cosmetic products.