Regulation (EC) N° 1223/2009 on cosmetic products is the main regulatory framework for finished cosmetic products when placed on the EU market.
One of the most significant changes introduced by Regulation (EC) N° 1223/2009 is:
Introduction of the notion of ‘responsible person’
Only cosmetic products for which a legal or natural person is designated within the EU as a ‘responsible person’ can be placed on the market. The new cosmetics regulation allows the precise identification of the responsible person is and clearly outlines their obligations.
The followings list what responsible persons do and their obligations.
- Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market.
- For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation.
- For a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer established within the Community shall be the responsible person.The manufacturer may designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.
- Where, for a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer is established outside the Community, he shall designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.
- For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market. The importer may, by written mandate, designate a person established within the Community as the responsible person who shall accept in writing.
- The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.The translation of information relating to a cosmetic product already placed on the market shall not be considered as a modification of that product of such a nature that compliance with the applicable requirements of this Regulation may be affected.
Obligations of responsible persons
- Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2) and (5), as well as Articles 20, 21, 23 and 24of this Regulation(Regulation (EC) N° 1223/2009)
- 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.