Cosmetic products worldwide
The EU Cosmetics Regulation (Regulation (EC) No 1223/2009) requires both manufacturers and distrib-utors to bring cosmetic products to market in a safe manner. As the ‘responsible person’, you are re-sponsible for subjecting the cosmetic product to a comprehensive safety assessment prior to its placing on the market. The focus here is on human health and the safety of cosmetic products.
To ensure compliance with the specifications of Regulation (EC) No 1223/2009, the help and advice of a qualified safety assessor has become indispensable. As an expert in the field, the safety assessor en-sures that the cosmetic product meets all requirements in terms of health safety and safe handling dur-ing normal and reasonably foreseeable use or application of the product.
However, a safety assessment alone is not enough. The safe placing on the market requires further steps, with which we will be glad to assist you. Working with partners in all parts of the world, we are also able to answer and keep track of all your cosmetics-related questions.
We advice you on cosmetics
Cosmetic products are subject to strict regulations as regards prohibitions and restrictions on ingredients and permitted concentrations. How is a product to be labelled as legally ‘compliant’? We advise and assist you by checking your formulation and/or compiling identification information for you.
The CPNP EU notification procedure
Pursuant to the Regulation (EC) No 1223/2009, the responsible person is required to notify a cosmetic product prior to its placing on the market. To this end, the Cosmetic Products Notification Portal (CPNP) has been created.
We will be happy to take on this task for you.
Safety assessment/Product information file (PIF)
A safety assessment is prepared in accordance with all the requirements of Article 10 and Annex I of Regulation (EC) No 1223/2009. These requirements focus on the toxicological profiles of all the ingredients and on the expected exposure conditions.
Article 11 of Regulation (EC) No 1223/2009 describes the compilation of a “Product Information File” (PIF). The person responsible for the cosmetic product shall keep a PIF, which shall contain, in addition to the aforementioned safety assessment, a detailed description of the product, the method of manufacturing, a statement on compliance with good manufacturing practice (GMP), data on animal testing and, where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product.
Marketing review/Marketability tests worldwide
It is often not easy to correctly classify the product and to comply with the necessary statutory requirements. As the properties of a product increase and the number of product types continues to grow, a product previously classified as a cosmetic product may fall into the category of medical product, biocide (disinfectant) or washing and cleaning agent.
We keep track of such ‘borderline’ products and make sure that your product complies with all legal provisions worldwide.