EU Responsible Person Service

European Cosmetics Responsible Person

In European Union (EU) countries and the wider economic area (Turkey, Switzerland, Liechtenstein, and Norway) Cosmetic Product companies are legally required to have a Responsible Person. For companies that are not a registered business in an EU country, a Responsible Person with an EU country legally registered business must be mandated to act as the Responsible Person (RP).

The duties outlined in the EU Responsible Person Service are as follows:

  • Ensure that the Cosmetic Product is safe
  • Make sure that Good Manufacturing Practices (GMP) have been followed in accordance with ISO 22716:2007 by the manufacturer
  • Identify that a Cosmetic Product Safety Assessment has been carried out by a suitably qualified person in the form of a Cosmetic Product Safety Report (CPSR)
  • Ensure that there is a Cosmetic Product Information File (PIF) containing all the information required in accordance with EU Regulation (EC) No 1223/2009 on Cosmetic Products
  • Make sure that sufficient sampling and analysis has been carried out on the Cosmetic Product
  • Registration of the Cosmetic Product on the European Cosmetic Product Notification Portal (CPNP)
  • Restricted Substances (if any) are within limits identified as safe by the EU safety commission
  • CMR (Carcinogenic, Mutagenic or toxic to Reproduction) substances are not used within the Cosmetic Product or are only used where the SCCS (Scientific Committee on Consumer Safety) have deemed them at levels to be safely used
  • Notifying the use of any Nanomaterials within Cosmetic Products that are not specifically used for UV filters, colourants or preservatives
  • Marking sure that unavoidable trace levels of prohibited substances are below levels of safety concern
  • Identify that the cosmetic company has not used any animal testing
  • Check that the labelling of the Cosmetic Product is correct and in line with the requirements of the applicable parts of the regulation
  • Verify that the product claims made about the Cosmetic Product are factual and in line with the requirements of the regulation
  • Comply with the requirements surrounding notification of undesirable effects and serious undesirable effects of the use of the Cosmetic Product as part of the products post market surveillance
  • Make available all product information to the relevant competent authorities upon request

Patient Guard provides a professional and reliable Responsible Person service. Our fully qualified regulatory experts are experienced in providing the above-mentioned obligations for our customers. If you require a Responsible Person, then please contact us today for a free consultation on your Cosmetic Product regulatory needs at cosmetics@patientguard.com

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