Cosmetic Compliance After Brexit: Responsible Person Status

Current Responsible Person Status

Currently all brands selling in the EU must have a Responsible Person (RP) which can be a legal entity residing/existing within the EU. The name and address of this entity must be printed on the packaging and the Brands registered and all products notified on the CPNP (Cosmetic Product Notification Portal) with immediate effect

All brands also or only selling in the UK  must, as a brand, be set up on the UK Portal the SCPN and all products entered by the end of March 2021. The name and address of that entity must be in the UK and must be printed on the packaging

Here at Allingham Beck, we develop and manufacture for so many of you we thought it sensible to issue a statement just to show where we stand regarding Responsible Person status but we are also often approached by external Brands and as they may be based anywhere in the world we needed to spell this out as clearly as we could

In answer to these needs we have set up a sister company based in Southern Ireland with an office here in the UK to be able to offer both EU and UK RP services to explain what this extension to our existing Cosmetic Compliance services involves we can illustrate as follows;

What are the Duties and Responsibilities of a Responsible Person

The duties of the RP are many and varied with regards to the EU /UK Cosmetic Products Regulation, the function of the Responsible Person is ensure that product made available on the market is safe for human health when used under normal or reasonably foreseeable conditions of use.

The EU Cosmetic Products Regulation lists the obligations of the Responsible Person necessary to fulfil this principal requirement.

The Responsible Person must:

  • Ensure that the manufacture of the product conforms to the principles of Good Manufacturing Practice (GMP).
  • Ensure that that the cosmetic product has undergone a safety assessment on the basis of the relevant information to generate a Cosmetic Product Safety Report (CPSR).
  • Ensure that a Product Information File (PIF) exists for the cosmetic product containing all the elements specified in the Regulation. This must be made available to the appropriate Enforcing Authority on request.
  • Ensure that sampling and analysis of the cosmetic product is performed in a reliable and reproducible manner.
  • Ensure that the all data specified in the EU Cosmetic Products Regulation relating to the cosmetic product be notified on the EU Cosmetic Products Notification Portal (CPNP).
  • Ensure that the formulation of the cosmetic product conforms to the prohibitions and restrictions on ingredients as specified in the annexes to the EU Cosmetic Product Regulations.
  • Ensure that, apart from permitted exceptions, formulation does not contain substances listed as Category 2 CMR (Carcinogenic, Mutagenic or toxic to Reproduction).
  • Ensure that, for every cosmetic product that contains nanomaterials, a high level of protection of human health is ensured.
  • Ensure that any technically unavoidable traces of prohibited substances stemming from impurities in raw materials, packaging, etc., do not degrade safety of product.
  • Ensure that neither the cosmetic product nor its ingredients have been tested on animals in order to meet safety requirements of the EU Cosmetic Products Regulation.
  • Ensure that labelling includes all the mandatory elements specified in the Regulation in the format and language required.
  • Ensure that the labelling doesn’t imply that the product has characteristics or functions that it does not.
  • Make publicly available, on request, qualitative and limited quantitative information on the formulation.
  • Immediately inform relevant competent authority of any reported Serious Undesirable Effect from the cosmetic product.
  • If requested, provide competent authority with information on distributors and supply chain for any particular batch of the product.

For further advice on Responsible Person Services, EU/UK Cosmetic Compliance or Cosmetic Product Development in General please don’t hesitate to get in touch via our Contact Us Page.

If you found this article useful then our post on how The post Brexit impact on the purchasing of raw materials may also be worth a read.

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