Persons Responsible and Their Tasks

Changed on: 21.04.2021
Young vendor woman holding beauty care product in plastic bottle with information blank label while using digital tablet with copy space screen, female seller interested ingredients of hygienic means
Cosmetics entrepreneur/seller

The person responsible is (legal or natural person):

  • the manufacturer (any natural/legal person who produces a cosmetic product or
  • a natural/legal person who commissions a third party to manufacture or develop a cosmetic product and places it on the market under its own name or brand) or 
  • the importer or
  • the distributor under specific circumstances or 
  • a person residing inside the EU who has been designated, by written mandate, by the manufacturer, importer or distributor to be the person responsible and has accepted this mandate.

The person responsible must ensure compliance with the relevant obligations under this regulation for any cosmetic product placed on the market by that person, in line with Art. 4 and 5.

Obligations of the person responsible

Safety (Art. 3) – cosmetic products must be safe for human health when used under normal or reasonably foreseeable conditions of use

Notification (Art. 13) - prior to placing the cosmetic product on the market the person responsible must notify the Commission of the product by electronic means

Manufacturing according to good manufacturing practice (Art. 8)

Set up and keep a product information file and safety assessment (Art. 10 + 11)

CMR substances (Art. 15) and restricted substances (Art. 14 in connection with Annex II) must not be used, the substances listed in Annexes III-VI may only be used in line with the restrictions defined.

Nanomaterials (Art. 16)  - cosmetic products containing nanomaterials must be notified to the Commission by electronic means six months prior to placing them on the market, in addition to the notification in line with Art. 13

Labelling (Art. 19) and product claims (Art. 20)

Communication of serious undesirable effects (Art. 23)

Access to information of the public on the qualitative and quantitative composition and on (serious) undesired effects (Art. 21)