Responsible Person for Cosmetics
WE OFFER THE SERVICES OF A RESPONSIBLE PERSON FOR MANUFACTURERS OR IMPORTERS AND DISTRIBUTORS OF COSMETIC PRODUCTS IN THE EUROPEAN UNION.
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.
A manufacturer or importer (distributor) 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 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 production 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
If we represent you as a responsible person, your key requirements as the manufacturer, importer (distributor) are:
- Traceability within the supply chain for raw materials/products
- Saving of certificates of analysis and othe 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)
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 easy understood and very modular for easier acess to the information required.