Critical ALERT (!) – EU Official Notice on BREXIT
On November 29th 2018, the European Commission (Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs) published an official notice to stakeholders in reference to NEW EU rules in the field of cosmetic products in relations to the Withdrawal of the United Kingdom from the European Union.
In light of the uncertainties surrounding the ratification of the Withdrawal Agreement which was agreed at negotiators levels and published on November 14th 2018, the European Union decided to remind all interested parties (manufacturers, responsible persons, importers and distributors) of legal repercussions, which need to be considered when the United Kingdom becomes a third country.
Principle elements covered by the Notice
The notice covers 4 main aspects of compliance:
- The Responsible Person (EU RP)
- Notification in the Cosmetic Products Notification Portal (CPNP)
- Product Information File (PIF)
- Product Labelling
What are the main changes?
In reference to the main aspects covered by the notice – below is a summary of the rules which will apply in the European Union immediately from the withdrawal date, (March 29th 2019) or subject to a transition period in reference to a withdrawal agreement.
- Responsible Person:
- Responsible Persons can no longer be established in the UK.
- European Importers of cosmetics from the UK, will assume the role of Responsible Persons. They will be able to designate another EU entity under a signed mandate.
- Notification to CPNP:
- Responsible Persons in the UK will no longer have access to the CPNP.
- Cosmetic products notified to the CPNP prior to the withdrawal date will need to be transferred to the CPNP account of an EU-based Responsible Person – before the withdrawal date (!)
- Product Information File:
- PIFs will need to be made available for inspection at the address of an EU-based Responsible Person and in a language easily understood by that EU Authority.
- The name & address of an EU-based Responsible Person shall appear on the label of cosmetic products imported from the UK.
- The country of origin shall appear on the label of cosmetic products imported from the UK.
These rules will apply as of March 29th 2019, in case of no EU/UK agreement. In case of a UK/EU agreement, these rules will apply immediately after the transition period. The transition period in the current withdrawal agreement indicate a transition period till December 2020.
Though this document refers only to cosmetic products, it is safe to assume similar notices will be published in the coming days by the European Commission, in reference to other product types including: medical devices, and other consumer goods.
If you would like to know more on the implications of BREXIT, please contact us.