Product Review and Registration – EU (CPSR/CPNP)
Cosmetics must be demonstrated safe for use under normal or reasonably foreseeable conditions, and detailed product safety assessments must be compiled and be kept on file with a Responsible Person local to the EU.
The requirements for cosmetics in the EU are identical across the Member States, and each must comply with the requirements and restrictions outlined in the European Union Cosmetics Directive, Regulation (EC) No 1223/2009. There are three important considerations when launching your cosmetic in the EU: The Product Information File (PIF); notification to the regulators (the Cosmetic Product Notification Portal, CPNP); and designating a party responsible for the product in the EU. First, the Product Information File (PIF) must be compiled to assess and summarize the safety of the product before it is placed on the market. The main part of the PIF is a very detailed, Cosmetic Product Safety Report (CPSR), which includes information about the product’s composition, stability, microbiological quality, packaging materials, foreseeable use and exposure, and toxicological profile of the ingredients. CPSRs include a large amount of data and can potentially delay a launch date if the data is not efficiently and correctly assembled and evaluated. A qualified safety assessor must sign a safety assessment for the product, and the PIF must be updated when necessary. The PIF must be maintained on file in the EU by a “Responsible Person”, who is an individual or company accountable for the safety and compliance of the product in Europe. The name and address of the Responsible Person is required to appear on the product label.
Finally, prior to launching any cosmetic product in the EU, the product must be notified via the Cosmetic Product Notification Portal (CPNP), an electronic notification completed for the first European country in which the product will be marketed. The CPNP includes the product categorization and label, as well as the details of the Responsible Person and formulation including the presence of nanomaterials and / or substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR substances). Once the CPNP has been completed, the product can be sold anywhere in the EU.
NHP Consulting has expertise in the European market, and can compile Product Information Files (PIFs) and cosmetic product safety reports (CPSRs) for your product. We have qualified safety assessors who can sign the safety assessments for your products, as well as submit cosmetic notifications and advise on compliant product labelling and packaging for the EU, including translation into local language(s).