The role of Responsible Person has been created with the entry into force of the New Regulation EC 1223/2009.
Responsible Person is a legal or natural person based within the Community who is responsible for the placing on the EU market of a cosmetic product. The responsible person shall ensure compliance with the relevant obligations set out in the Regulation.
The Responsible Person can be one of the following:
- Manufacturer within the EU
- Person designated by a manufacturer from outside the EU
- Distributor if he modifies a product already on the market in such a way that compliance with the Regulation may be affected (according to Article. 4.6) or if he places a cosmetic product on the Community market under his name or trademark
- Importer(s) (according to Article 4.5)
- Third party with a written mandate from manufacturer or importer
Obligations of responsible persons
- Retention, updating, and revision of the PIF
- Designation of the Safety Assessor
- Realisation of the product according to Good Manufacturing Practice (ISO 22716:2007)
- Performing the notification operations to the EU Commission before introduction of the products on the market
- Labelling layout and compliance with regulations
- Sustainability of the product claims
- Responsible persons who consider or have reason to believe that a cosmetic product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate.
- Furthermore, where the cosmetic product presents a risk to human health, responsible persons shall immediately inform the competent national authorities of the Member States in which they made the product available and of the Member State in which the product information file is readily accessible, giving details, in particular, of the non-compliance and of the corrective measures taken.
- Responsible persons shall cooperate with these authorities, at the request of the latter, on any action to eliminate the risks posed by cosmetic products which they have made available on the market. In particular, responsible persons shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of specific aspects of the product, in a language which can be easily understood by that authority.