Responsible Person

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Responsibilities

In order to define clear responsibilities, any cosmetic product should be linked to a Responsible Person established within the Community.
The Responsible Person is the one who deals with:
– Retention, UPDATING, and revision of the PIF.
– Designation of the Safety Assessor.
– The production would be in accord to European Good Manufacturing Practice (ISO 22716:2007)
– The notification operations of the product should be notified to the EU Commission before it would be release on the market.
– Management and organization of the Cosmetic Survey for the report of possible undesirable effects to the Health Authorities of the Member State where the serious undesirable effect occurred.
– Labeling layout and compliance with health regulations.
– Sustainability of the product claims.

Requirements

In order to guarantee the compliance of every single product placed on the market, the responsible person should have (or he should be assisted by an expert) the following skills:

Technical
Cosmetics formulations
Legal/Regulatory
Manufacturing
Claim Sustainability
Quality System/Management

Thanks to our consolidated gained experience in the market and to our direct interaction with the Trade Associations and Health Authorities, Angel Consulting offers you all the pertinent information or it can fulfill itself the role of the European Responsible Person.

Regulation (EC) 1223/2009 – Art. 25

1) Except to paragraph 4, competent authorities shall require the responsible person to take all the appropriate measures, including corrective actions bringing the cosmetic product into conformity, the withdrawal of the product from the market its recall, within an expressly mentioned time limit, commensurate with the nature of the risk, where there is non-compliance with any of the following:

(a) the good manufacturing practice referred to in Article 8;
(b) the safety assessment referred to in Article 10;
(c) the requirements for the PIF referred to in Article 11;
(d) the provisions applicable to sample and analysis referred to in Article 12;
(e) the notification requirements to Articles 13 and 16;
(f) the restrictions for some substances specified in Articles 14, 15 and 17;
(g) the animal testing requirements referred to in Article 18;
(h) the labeling requirements in Article 19(1), (2), (5) and (6);
(i) the requirements about the product claim set out in Article 20;
(j) the access to information for the public referred to in Article 21;
(k) the communication about serious undesirable effects referred to in Article 23;
(l) the information requirements on substances referred to in Article 24.

2) Where it is possible, a competent authority shall inform the competent authority of the Member State in which the responsible person is established about the measures which it has required him to take.

3) The responsible person shall ensure that the measures, specified in paragraph 1, are taken in respect of all the products which are available on the market throughout the Community.

About Labelling

THE RESPONSIBLE PERSON NAME AND ADDRESS HAVE TO BE INDICATED ON THE LABEL