Responsible Person
What is?
It is a “legal” or “natural” person designated within the EU
Why?
It is requested by Reg. 1223/2009, art.4
How?
Responsible Person: assume full, heavy, technical and legal responsibilities
Responsibilities of the Responsible Person: - the retention, UPDATING, and conservation of the Cosmetic Dossier – PIF
- designation of the Safety Assessor
- realisation of the product according to European Good Manufacturing Practices (ISO 22716:2008)
- management of the notification operations of the introduction on the market to the EU Commission and the concerning supply chain
- management and organisation of the Cosmetic Survey for the report of possible undesirable occurrences to the health authorities of the country
- labelling layout and compliance with health regulations
- sustainability of the product claims
Requirements of the Responsible Person
The RP has to have (or he has to be assisted by expert that would have) following skills:
-Technical
-Formulation
-Legal/Regulatory
-Manufacturing
-Claim Sustanability
-Quality System/Management
Thanks its 10 years of experience and its constant communication with Trade Associations and Health Authorities, Angel Consulting can offer you all the pertaining information or take on the role of European Responsible Person, as it has the necessary requirements.
For any free information CONTACT US or call on +39 3405180274, Dr. Matteo Zanotti Russo
Need More details? See below:
Regulation 1223/2009 art. 25:
Non-compliance by the responsible person
1. Without prejudice to paragraph 4, competent authorities shall require the responsible person to take all appropriate measures, including corrective actions bringing the cosmetic product into conformity, the withdrawal of the product from the market or 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 product information file referred to in Article 11;
(d) the provisions on sampling and analysis referred to in Article 12;
(e) the notification requirements referred to in Articles 13 and 16;
(f) the restrictions for substances referred to in Articles 14, 15 and 17;
(g) the animal testing requirements referred to in Article 18;
(h) the labelling requirements referred to in Article 19(1), (2), (5) and (6);
(i) the requirements related to product claims set out in Article 20;
(j) the access to information for the public referred to in Article 21;
(k) the communication of serious undesirable effects referred to in Article 23;
(l) the information requirements on substances referred to in Article 24.
2. Where applicable, a competent authority shall inform the competent authority of the Member State in which the responsible person is established of the measures which it has required the responsible person to take.
3. The responsible person shall ensure that the measures referred to in paragraph 1 are taken in respect of all the products concerned which are made available on the market throughout the Community.
