Product Review and Registration – EU (CPSR/CPNP)
In the European Union (EU), cosmetic products are regulated on a community-wide level, and pre-market notification is required. 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, a Product Information File (PIF) must be compiled to 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.
After the PIF is assembled, a qualified safety assessor must review the data, confirm the safety of the product, and sign a safety assessment for the product. 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 of the cosmetic in the EU.
Finally, prior to EU launch, the product must be notified via the Cosmetic Product Notification Portal (CPNP). The CPNP notification is an electronic registration completed for the first European country in which the product will be marketed. The CPNP notification includes the product categorization and a copy of the label, as well as the details of the Responsible Person and the formulation including the presence of nanomaterials and / or substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR substances). Once the CPNP notification has been completed, and the above-noted requirements in place, the product can be sold anywhere in the EU.
NHP Consulting has expertise in the European market. We can compile Product Information Files (PIFs) and cosmetic product safety reports (CPSRs) for your product. We have qualified safety assessors on staff who can sign the safety assessments for your products, as well as submit CPNP notifications and advise on compliant product labelling and packaging for the EU, including translation into local language(s).