Responsible Person

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.

The importer or manufacturer may, by written mandate, designate a person established within the Community as the Responsible Person who shall accept in writing.

Beauty Insight Associates Ltd is such a designated Responsible Person. We are experienced partner for Importers. We release them from the obligations of so-called Responsible Person and represent them in front of the local authorities. We support all the process of introducing skin care and make up products at the European Community market and take over the responsibility for all the required documentation.

OBLIGATIONS OF RESPONSIBLE PERSONS according to article 5th of the REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

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 Responsible Person shall ensure that:

a) the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment;

b) an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources;

c) the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.

When a cosmetic product is placed on the market, the Responsible Person shall keep a product information file for it.

The product information file shall contain the following information and data which shall be updated as necessary:

a) a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;

b) the cosmetic product safety report referred to in Article 10(1);

c) a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8;

d) where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;

e) data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.

 

 

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