Responsible Person for Cosmetics

Only those cosmetic products for which a legal or natural person in the European Union has been designated as "the Responsible Person" may be placed on the EU market. Our mission is to act as a Responsible Person for your cosmetic products

In case the client is not familiar with the legal regulations of the EU from which certain obligations and responsibilities arise, or the client (legal or natural person) is not based in the EU, or for some other reason does not want to be the Responsible Person for cosmetic products, a partner of Proteko Cosmetics company can assume the role of Responsible Person and all the obligations defined by Regulation (EC) No 1223/2009 on cosmetic products.

Our Mission

Our mission is to act as a Responsible Person for your cosmetic products, which is mandatory for their placement on the EU market.

We support our clients in dealing with any kind of legal obstacles or requirements effectively and expertly, by providing prompt and accurate solutions in assisting companies to place regulatory compliant cosmetic products on the EU market. We guarantee our service due to our well-rounded expertise in EU regulations and background science, allowing us to support and guide the client throughout the whole process, with us doing the hard work.

Responsible Person Obligation

The EU market has an abundance of opportunities for growth and success for the businesses, but is also presenting constant challenges with its numerous legislations and regulations.

Cosmetics are strictly regulated in the EU to ensure consumer safety, governed mainly by the harmonized EU legislation, EU Cosmetics Regulation 1223/2009, which defines requirements related to among others: responsibility / liability, product safety, registration, product dossier content, product labelling etc.

Since the regulation 1223/2009 on cosmetic products, a Responsible Person (RP) must be designated for each cosmetic product placed on the EU market.

Responsible Person is liable for:

  • PIF - product information file
  • Product safety report
  • Compliant formulation
  • Labelling - ensuring the labelling of a cosmetic product is in accordance with the legal regulations
  • CPNP notification of cosmetic product
  • Information to general public
  • Animal testing
  • GMP - Good Manufacturing Practice
  • Cosmetic claims
  • Samples and analyses
  • Cosmetovigilance, adverse effect - gathering information on the serious undesirable effects of a cosmetic product (resulting from the use of the cosmetic product)
  • Nanomaterials

Responsible Person Services

The required steps and service provided by us for your cosmetic product:

  • EU legal representative - acting as a Responsible Person for your product in the EU, allowing you to delegate all your EU regulatory activities and confidential information to only one party
  • Product portfolio analysis
  • Product dossiers compiling and managing
  • PIF - product information file compiling and managing
  • Product safety assessment and report
  • Product compliance assessment and adjustments until achieved compliance with the EU legislation
  • Product registration (CPNP) for your products on the EU market (pre- and post-registration management)
  • Product labelling according to the strictly defined cosmetics labelling rules
  • Consulting and developing future strategies for the newly proposed EU legislation

In order to avoid delays of product launching or post-launch readjustments, which can be time consuming and costly, it is important to consult and establish strategies for regulatory compliance in the early stages of the development of your product. Our specialists cover all the aspects of a successful product placement with clear requirements for your product.

Data protection and confidentiality are values we cherish, therefore we exclusively operate under Non Disclosure Agreements (NDA).

 

Our work

Ladria

  • Research and Development of new Cosmetic Products
  • Regulatory Support
  • Cosmetics Laboratory Testing
  • Cosmetic Brand Design
  • Clinical Testing of Cosmetics and Cosmetic Claims Substantiation
  • Manufacture of Cosmetics
  • Responsible Person for Cosmetics

MNLY

  • Research and Development of new Cosmetic Products
  • Regulatory Support
  • Cosmetics Laboratory Testing
  • Clinical Testing of Cosmetics and Cosmetic Claims Substantiation
  • Manufacture of Cosmetics
  • Cosmetic Brand Design
  • Responsible Person for Cosmetics

Moja oaza

  • Cosmetic Brand Design
  • Research and Development of new Cosmetic Products
  • Regulatory Support
  • Cosmetics Laboratory Testing
  • Clinical Testing of Cosmetics and Cosmetic Claims Substantiation
  • Manufacture of Cosmetics
  • Responsible Person for Cosmetics

Luxea

  • Cosmetic Brand Design
  • Research and Development of new Cosmetic Products
  • Regulatory Support
  • Cosmetics Laboratory Testing
  • Clinical Testing of Cosmetics and Cosmetic Claims Substantiation
  • Manufacture of Cosmetics
  • Responsible Person for Cosmetics