Responsible person for cosmetics

The details of the responsible person are described in Regulation (EC) No. 1223/2009, Article 4. Only cosmetic products for which a responsible person (legal or physical) is pre-determined may be placed on the market in the European Union.

The responsible person for cosmetic products is:

  • An EU-based manufacturer for products manufactured in the EU
  • An EU-based importer for imported cosmetic products in the EU
  • Third-person to whose order a cosmetic products are manufactured

A responsible person should be designated for each cosmetic product placed on the European market. The responsible person shall be based within the EU and their address should appear on the cosmetic product packaging. If, in addition to the address of the responsible person, the address of the manufacturer, importer or a distributor appears on the packing, the address of the responsible person should be in bold characters.

We offer the services of a responsible person for manufacturers and importers of cosmetic products in the European Union.

A manufacturer or importer may also appoint a person established in the EU with the written consent of the responsible person. We can represent you as a responsible person in the EU. This means that we also take all the communication with the inspection.

According to Regulation (EC) No. 1223/2009 The Responsible Person is responsible for:

  • Compliance of product produced in accordance with requirements of Good Manufacturing Practice (GMP)
  • Product information file documentation and safety assessment
  • Meet the requirements for sampling and analysis
  • Compliance with the notification to CPNP requirements
  • Meet the restrictions on substances identified in the regulation
  • Comply with requirements regarding animal testing
  • Compliance with labeling and claims requirements
  • Comply with requirements regarding access to public information
  • Comply with requirements regarding the notification of serious adverse reactions
  • Comply with requirements in relation to information on the substances

Documentation on cosmetic products should be available to any health inspector or other legal entity in Slovene and English language (languages that inspectors understand). The form in which data are available to inspectors is not prescribed; however, it has to provide inspectors with rapid and simple insight into all prescribed data. We have our own format which is very easily understood and very modular for easier access to the information required.

Responsibilities of the manufacturer or importer are:

  • Product information files creation (safety assessment)
  • Notification of cosmetic products with EU portal CPNP
  • Compliance with labeling and claims requirements
  • Keep all the documentation of cosmetic product for a period of 10 years
  • Reported a serious adverse effect of the cosmetic product (if needed)

If we represent you as a responsible person, your key requirements as the manufacturer or importer are:

  • Traceability within the supply chain for raw materials/products
  • Saving of certificates of analysis and other relevant documents (if you are manufacturer)
  • Manufacturing in accordance with GMP for cosmetic (if you are manufacturer)
  • Suitable storage and transport conditions for cosmetic products
  • Corrective actions in the event of product non-compliance
  • Reported a serious adverse effect of the cosmetic product (if needed)

The distributor is the responsible person where the cosmetic product on the market with their name or under their own trade mark or the product that is already on the market, be amended so as to affect the conformity with the applicable requirements. Translation information about the cosmetic product that is already on the market, shall not be considered as a modification of the product, which may affect compliance with the applicable requirements of the regulation.

Responsibilities of the distributor are:

  • The cosmetic product is labeled in accordance with applicable law
  • All the requirements regarding the language
  • Cosmetic product has not expired date of minimum durability
  • Storage or transport conditions do not jeopardize its compliance with the requirements of the regulation
  • Reported a serious adverse effect of the cosmetic product (if needed)

Product development

We can develop various natural and organic products for our clients. It is common for us to turn customers’ wishes from ideas into concepts and guide you through the entire process of development and production. We develop new cosmetic and food products in our labs.

Product manufacture

We can arrange the production of products for our customers in a state-of-the-art laboratory with the possibility of producing even smaller boutique quantities (for example 200-500 pieces). Production can also be arranged for larger quantities on automatic production lines.

Documentation and support

The responsible person must ensure that an assessment of the safety of the cosmetic product for human health has been made before placing a cosmetic product on the market. Since it is important to have a safety report, we can also prepare all the relevant documentation.