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Cosmetics (Europe)

The new European Cosmetic Products Regulation (EU Regulation 1223/2009) came into full force as from 11 July 2013.  This regulation reinforces product safety, taking into account the latest technological developments (including the use of nanomaterials).

All existing EU Safety Assessments should now be in the required new format which includes more data from the Product Information Pack (PIP) - also known as a "Product Information File" (PIF) - particularly adverse event data. 

There is a Filing Portal, CPNP (Cosmetic Products Notification Portal), for all EU Cosmetic submissions which allows for harmonisation of the regulations throughout Europe and therefore, a cosmetic can be marketed throughout Europe without having to make applications to each individual Member State.

The Cosmetic Regulation reinforces the link between the PIP, the Cosmetic Product Safety Report (Annex I of the Regulation) and the Cosmetic Product Safety Assessment (Annex I Part B of the Regulation) and sets out clearly the responsibilities of the Responsible Person and the Safety Assessor.

Current Key Requirements

Responsible Person (RP)
The RP’s name and address must be included on the packaging and they must ensure the completed Product Information File (PIF) is made available to Trading Standards (UK), or other regulatory body, within three days of it being requested.

Note: The RP doesn't necessarily have to hold the PIP. 

Other responsibilities for the RP include:

  • ensuring the PIP is kept up-to-date;
  • reporting significant adverse events;
  • running a public recall (should that ever be required); and
  • registering the product before import.

Compliance with other legislation
Cosmetic Products may also be subject to:

  • Weights and Measures legislation
  • Protection from Misleading Advertising
  • REACH (Registration, Evaluation, Authorisation and restriction of CHemicals)
  • Packaging and Labelling requirements
  • Permitted/restricted ingredients (including ozone-depleting substances)

European Safety Assessments
Compliant safety assessments are mandatory before the product is placed on the market.  Global Regulatory Services is happy to provide their cosmetic clients with the expertise of a cosmetic specialist who, on average, can assess and provide the required certification within a two week period.  This assumes data is readily available and is of good quality.

Global Regulatory Services is able to provide a full service portfolio (including a 'Responsible Person' service) to the cosmetic industry via their subsidiary, Crème de la Crème Ltd.  A dedicated website for Crème de la Crème Ltd will be available in the near future. In the meantime, you are welcome to contact us with your specific regulatory compliance requirements.