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Product Information File (PIF), Safety Assessor and CPSRs in the UK

The compilation and review of a complete and up-to-standard PIF is the corner stone for the successful notification of a compliant product. The RP that is entrusted with this review must, therefore, have expertise on the regulatory requirements for cosmetic products in a given jurisdiction and be able to handle the authorities’ enquiries on the PIF, post-notification.

Under the draft UK Cosmetic 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 of non-UK manufacturers. Moreover, there is the requirement that 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.

The Safety Assessor that will run 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 qualification which are currently recognised as equivalent.

Lastly, the Safety Assessment Report (CPSR) that is to be issued must refer to the UK RP. This means that all products for which there currently is a valid CPSR for the EU, must also have another CPSR issued with the UK RP’s details to make it valid in the UK.

 

Appoint Obelis UK Ltd. as your UK RP today.

Appoint Obelis UK LTD. as your UK RP