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Responsible Person - EU

Med-di-dia can act as your cosmetics' responsible person in the EU

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What is a Responsible Person?

EU Cosmetics Regulation 1223/2009, which came into effect on July 11, 2013, established the concept of a Responsible Person (RP) for cosmetic products.

 

An RP is responsible for ensuring that the cosmetic product they place on the market complies with the Regulation. An RP can be an individual or a legally registered company and they must be located in the European Economic Area (EEA). There must be an RP for every cosmetic product placed on the market in the EEA.

 

 

Before placing a cosmetic product on the market in the EEA, the RP must ensure that the cosmetic product is safe for use and meets the requirements of the Regulation. The name and address of the RP must be on the label of the cosmetic product and in the product information file (PIF).

 

A cosmetic product does not require approval or a licence before being placed on the market. However, the RP must ensure the cosmetic product meets the requirements of the Regulation.

Under the EU Cosmetics Regulation, the Responsible Person will include the following responsibilities:

  • Notification of the product on the European database, the Cosmetic Products Notification Portal or CPNP;
  • Documentation that the product is manufactured in accordance with Good Manufacturing Practice guidelines (ISO 22716);

  • Preparation and maintenance of a product information file (PIF) at the address of the Responsible Person;

  • Preparation of a cosmetic product safety report (CPSR) consisting of a safety assessment carried out by a toxicologist or suitably qualified expert;

  • Data on animal testing (if applicable);

  • A system for documenting and reporting serious undesirable effects experienced as a result of product use;

  • Appropriate labelling as per Article 19 of the Regulation;

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Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market. (EU Regulation 1223/2009, Article 4.1)

In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community. (EU Regulation 1223/2009, Article 11)

For the purpose of effective market surveillance, a product information file should be made readily accessible, at one single address within the Community, to the competent authority of the Member State where the file is located. (EU Regulation 1223/2009, Article 17)

Benefits of using Med-Di-Dia as your Responsible Person

  • Register you on ECAS (European Commission Authentication Service) and SAAS (Sanco Authentication and Authorisation System)
  • Assess your existing Product Information Files (PIFs)
  • Carry out notifications on the CPNP on your behalf
  • Provide guidance on permitted claims for cosmetic products
  • Provide guidance on labelling requirements (including label review)
  • Compile Product Information Files (PIFs) including the Cosmetic Product Safety Report (CPSR)
  • Provide advice regarding Good Manufacturing Practice (GMP)
  • Advise on your Regulatory Strategy
  • Offer advice and guidance re International Nomenclature for Cosmetic Ingredients (INCI)
  • Provide an annual surveillance service
  • Assess your advertising and marketing materials
  • Assist with Global Regulations through - Global Regulatory Services 

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