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Regulation

The regulation of having to have a responsible person inside the European Union, came into force in the year 2013 and is written in the annexes of European Regulation (EC) No. 1223/2009.

Here is a summary of what a responsible person is in the European Regulation (EC) No. 1223/2009, Article 4:

 

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. 9002.21.22 NE Official Journal of the European Union 22.12.2009 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.

 

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.

 

 

In the European Regulation (EC) No. 1223/2009, there are also written obligations of a responsible person in Article 5:

 

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.

 

The RP has to take a stand in certain matters. Meaning - even though the law may not be clear or guidelines may be inadequate, the RP’s duty is than to turn to local inspectorate and check on their opinion. Or maybe contact directly the Cosmetic Europe and try to gather as much information possible – and then explain them to clients in the most understanding way possible. RP informs customers for any changes in written form with which we than stand before our competent organization.

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