Each cosmetic product needs a compliant Product Information File (PIF) before being marketed in the UK. The compilation and review of the PIF is the corner stone for the successful notification of a compliant product.
Overview
Under the UK Cosmetics Regulation, the requirements on the contents of a PIF remain the same as in the EU. The only difference is that the PIF must now be made available in the registered address of the UK RP. Moreover, the PIF must be provided in English, but this does not disrupt Obelis and our clients in any way, as our working language for all services, including cosmetics, has always been English.
Hence, each cosmetic product must have a PIF that includes:
- A description of the product;
- The Safety Assessment Report (SAR) issued by a qualified Safety Assessor;
- Laboratory testing;
- Proof of compliance with Good Manufacturing Practice (GMP);
- Labelling and the documentation substantiating the claims made;
- And more.
A Safety Assessment Report is the toxicological evaluation of a cosmetic product in which the Safety Assessor concludes whether the product is safe or not according to the law requirements.
The Safety Assessor who runs the toxicological assessment of the product, on the basis of the PIF documentation, must have UK-recognised qualifications. The UK will continue to accept EU qualifications which are currently recognised as equivalent.