REGULATIONS
product, withdraw it from the market or recall it to the manufacturing company. This applies to all EU Member States where the product is available. If for any reason the Responsible Person does not or cannot take necessary measures to correct any non-compliance, the competent national authorities may intervene and take actions as deemed necessary.
If a product which complies with the requirements of the Regulation presents or could present a serious risk to human health, the competent national authority shall take all necessary provisional measures to withdraw, recall or restrict the availability of the product on the market.8 The Responsible Person can be a third party individual or company, so from that perspective it takes away any immediate concerns of companies that currently outsource preparation of their Product Information Files and suchlike. The key change is that the third party individual or company must be suitably placed to complete all of the activities and fulfill all of requirements of Articles 4 and 5 of the Regulation.
Article 4
Responsible Person: 1 Only cosmetic products for which a legal or natural person is designated within the Community as “responsible person” shall be placed on the market.
2 For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation.
3 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.
4 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.
5 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.
12 PERSONAL CARE April 2012
6 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.
Article 5
Obligations of Responsible Persons: 1 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 24.
2 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.
3 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.
Online notification system for cosmetic products According to Article 13 of the new Regulation, The European Commission must be notified of the launch of all cosmetic products. The system is called the Cosmetic Products Notification Portal (CPNP). A full user manual explaining how to register for and use the CPNP has been published.9
(It can be accessed online at:
http://ec.europa.eu/consumers/sectors/ cosmetics/files/pdf/cpnp_user_manual_ en.pdf).
The introduction of this system will certainly have an impact on the industry and will potentially become very time- consuming. Completion of this requirement is the role of the Responsible Person, so this is an activity that can theoretically be outsourced to a third party company or individual, however they must of course have full access to all of the information necessary to fulfil all of the requirements as described in Article 13 of the Regulation.
Article 13 1 Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission:
a) the category of cosmetic product and its name or names, enabling its specific identification;
b) the name and address of the responsible person where the product information file is made readily accessible;
www.en.wikipedia.org
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