EU Regulatory Bulletin contents
- Data Requirements & PPP
- Active substance Renewals
- Cosmetics & responsible person
- REACH Annex XIV
On 11 July 2013 the European regulation on cosmetic products will be applicable in its entirety (articles 15(1) and (2) and article 16 (3) are already applicable). This regulation entered into force in 2009 and codifies the various different instruments adopted on this matter since Directive 76/768/EEC into a single legal text.
The harmonization of the applicable rules on cosmetic products pursues three different objectives:
- To remove legal uncertainties and inconsistencies - these inconsistencies can be explained by the high number of amendments (55 to date) and the complete absence of any set of definitions;
- To avoid divergences in national transposition which do not contribute to product safety but instead add to the regulatory burden and administrative costs and
- To ensure that cosmetic products placed on the EU market are safe in the light of innovation in this sector.
The approach adopted by the Commission is very similar to the one that inspires the European food legislation. The provisions of Regulation 1223/2009 that will now apply include those related to market surveillance and in particular, those referring to the responsible person.
According to Article 4 of the regulation, the responsible person is a legal or natural person designated within the EU for the product placed on the market. The responsible person is the point of contact for national and European authorities as well as consumers and distributors and is responsible for ensuring the safety of the product.
Prior to placing the product on the market the responsible person shall ensure that the mentioned products have undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I (article 10). The responsible person is also in charge of maintaining the product information file which it shall keep for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market (article 11).
For instance, in relation to this obligation to keep the file, where a cosmetic product has been placed on the market before 11 July 2013 but is no longer placed on the market as from that date, and a distributor introduces that product in a Member State after that date, that distributor shall communicate several details to the responsible person (article 13). The responsible person also ensures the traceability of the product (although only partially) as it is obliged to identity the distributors to which it supplies.
Also, it is the duty of the responsible person to take all appropriate measures in the event that the product is non-compliant, including the withdrawal of the product from the market or its recall.
Infringement of the provisions of this regulation will result in the imposition of penalties as determined by every Member State; the penalties provided must be effective, proportionate and dissuasive.
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