ZMUni Compliance Centre

ZMUni Compliance Centre

News

>

Regulatory Updates

Regulation 2009/1223 and the Cosmetic Products Enforcement Regulations 2013: Great Britain
Publication date:2022-11-07

On 5 September 2022, the UK government updated Regulation 2009/1223 and the Cosmetic Products Enforcement Regulations 2013: Great Britain. This regulation applies to cosmetic products being supplied in or into Great Britain. This article is an excerpt from the regulation, including the scope of the application and main changes to regulations.

Introduction

1) This Guide is for businesses placing cosmetics products on the market in Great Britain (GB). Great Britain is England, Scotland, and Wales. If you are placing cosmetic products on the market in Northern Ireland, you should read the separate guidance for placing cosmetic products on the market in Northern Ireland. This guide is designed to help you understand Regulation (EC) No 1223/2009 on Cosmetic Products, as amended by the Product Safety and Metrology, etc. (Amendment etc.) (EU Exit) Regulations 2019. The Regulation sets out requirements that must be met before cosmetics products can be placed on the GB market. The purpose of the Regulation is to safeguard public health and establish a fully competitive market.

 

Main Changes to Regulations

2) The main changes to note that will take effect from the end of the Transition Period on 31 December 2020 are:

  • Placing on the market: the term ‘placing on the market’ means the first making available of a product on the market of Great Britain after the end of the transition period. “Making available” refers to supply on the GB market; [Article 2]
  • Responsible Person: There must be a Responsible Person based in the UK under the new regime; [Articles 4, 5 and 5A]
  • Product Information File: An up-to-date Product Information File (PIF) must be maintained in English, and made available to market surveillance and enforcement authorities at the UK address provided when asked to do so; [Article 11]
  • Labelling: There will be a 5-year transition period from 1 January 2021 before businesses have to include the UK Responsible Person details on product labels, provided the EU responsible person details are included. This will enable existing stocks to make their way through the supply chain and reflects the typical shelf-life of a cosmetic and business’ labelling cycles; [Article 19]
  • UK Submit Cosmetic Product Notification (SCPN) service: The UK Government has established a cosmetic product notification service to replace the EU’s Cosmetics Products Notification Portal (the ‘CPNP’) in Great Britain; [Article 13]
  • Notification of cosmetic products to Secretary of State (via UK SCPN service):
    • UK Responsible Persons will need to notify existing products (previously available in the UK, EU or EEA and notified to CPNP) by 31 March 2021 to the Secretary of State via the UK SCPN service if they are placing them on the GB market after the end of the transition period. There is a reduced amount of information required where this is the case– and you can use the same information you have previously provided to the EU CPNP service.
    • For products that have not previously been notified to the Commission via the CPNP or have not been placed on the EEA market, or are placed on the GB market after 31 December 2020, UK Responsible Persons will need to provide full information to the Secretary of State via the UK SCPN service before they can be placed on the market. [Article 13]
  • Serious Undesirable Effects (SUEs): SUEs should be notified on the new UK SUE form. Information on any SUE should be notified to OPSS at seriousundesirableeffects@beis.gov.uk; [Article 23]
  • Products with nanomaterials: Where the inclusion in a cosmetic product of relevant nanomaterials has not been notified to the Commission prior to the end of the transition period on 31 December 2020, a cosmetic product containing novel nanomaterials not used for the purposes of colourant, preservative, or UV-filter must be notified to the Secretary of State, via the UK’s Submit Cosmetic Product Notification Portal by the Responsible Person 6 months prior to it being placed on the GB market; [Article 16]
  • Importers: From 1 January 2021 UK Businesses who bring cosmetic products into GB from an EU Member State will become ‘importers’ where they would previously have been ‘distributors’. The importer of a cosmetic product, whether from the EU or another country, becomes a Responsible Person by default, although they may appoint an agent to act as the Responsible Person for them. There are particular provisions for Northern Ireland businesses that place products from countries outside of the UK (including the EEA) on the market in Great Britain; [Articles 2 and 4]
  • Unfettered access: The government has committed to delivering unfettered access for qualifying Northern Ireland goods to the rest of the UK market. Cosmetic products that are placed on the market in Northern Ireland (in accordance with the European Union Regulation (EC) No 1223/2009 on Cosmetic Products, as it applies in Northern Ireland) can be sold in the rest of the UK with no additional approvals. To protect consumers across the UK, Northern Ireland businesses who are Responsible Persons, must notify the GB regulator via the UK Submit Cosmetic Product Notification (SCPN) service with the cosmetics’ ingredients and alert the GB regulator if their product is found to be unsafe. This will not require any new information to be collated: only that the same information provided to the EU via the CPNP service is also provided to the Secretary of State. This only applies to products that are placed on the GB market after the transition period. This approach applies to qualifying Northern Ireland goods. Further detail is available in Appendix 7.

To Note: for cosmetic products also contained in aerosol dispensers, the aerosol dispensers will need to meet the requirements of the Aerosol Dispensers Regulations 2009, which includes the requirement to mark the dispenser with UKCA compliance mark, which is replacing the reversed epsilon mark. There is dual recognition of the reversed epsilon (“3”), until 31 December 2021. The switch to the UKCA marking is compulsory from 1 January 2022. Until 31 December 2025, the UKCA marking may be affixed to a label affixed to or a document accompanying the dispenser.