Following Brexit, UK Establishes New Chemical Regulatory Regimes
The United Kingdom (UK) completed its withdrawal from the European Union (EU) on December 31, 2020, and, as of January 1, 2021, is a “third country” from the EU perspective. Companies worldwide must be aware of the significant implications for compliance under the following newly established independent chemical regulatory regimes: the Great Britain (England, Scotland, and Wales) (GB) Biocidal Products Regulation (GB BPR); the GB Classification, Labeling, and Packaging Regulation (GB CLP); the GB Prior Informed Consent (PIC) Regulation (GB PIC); Regulation (EC) 1107/2009 concerning plant protection products (PPP); and the UK REACH Regulation. On February 5, 2021, the UK Health and Safety Executive (HSE) provided a brief overview of the new chemical regulatory regimes and links to resources available online.
According to HSE, the existing EU Biocidal Products Regulation (EU BPR) has been copied into GB law and amended to enable it to operate effectively in GB. HSE states that this means that most aspects of EU BPR will continue in the same way under the new GB BPR.
HSE has posted the following resources:
- HSE’s biocides guidance provides details of the GB BPR requirements for biocidal products in GB;
- HSE’s updated biocides Brexit page highlights similarities and differences between EU BPR and GB BPR;
- HSE has published a series of fact sheets with detailed information for businesses that want to gain or maintain access to the GB market after December 31, 2020; and
- The list of GB authorized biocidal products provides details of biocidal products that can be supplied in GB.
The classification of chemicals placed on the market in GB is regulated by the GB CLP. HSE notes that it is the GB CLP agency and carries out certain CLP functions formerly undertaken by the European Chemicals Agency (ECHA). HSE’s updated CLP website contains guidance on how to comply with the GB CLP.
GB PIC concerns the export and import of certain hazardous chemicals. Businesses exporting or importing PIC-listed chemicals from or to GB are required to comply with the new GB PIC and must notify their intention to export PIC-listed chemicals to countries outside GB by completing a PIC export notification form. GB PIC is similar to the existing EU regime. The two regimes operate independently of each other, however, and there are different procedures for notifying exports under GB PIC. Under the Northern Ireland Protocol, EU PIC will continue to apply to Northern Ireland. More information on GB PIC is available on HSE’s website.
All relevant EU law in relation to the regulation of PPPs has been retained in GB law and retains the same official titles, for example, Regulation (EC) 1107/2009. Northern Ireland will continue to be subject to existing EU law. The GB PPP regime makes independent decisions on active substances and maximum residue levels (MRL). HSE’s website includes:
- Guidance on the changes to legislation and how Brexit may affect the regulation of PPPs; and
- Information on using, storing, and disposing of PPPs and getting a PPP to market.
The UK brought EU REACH into law on January 1, 2021, as UK REACH. As of January 1, 2021, GB-based businesses procuring chemical substances directly from EU REACH-registered suppliers are considered importers under UK REACH. The GB-based company must obtain a UK REACH registration to continue importing from the EU REACH-registered suppliers, unless its supplier appoints a GB-based OR to register under UK REACH on the importer’s behalf. To maintain supply chains and to ensure continued access to the GB market, GB importers must complete a notification to the HSE in the Comply with UK REACH information technology system.
The substance must subsequently be registered within the applicable timeframe, which is 300 days plus two, four, or six years from the end of the transition period, depending on the tonnage and hazard profile of the imported substances. In light of these requirements, GB-based importers are encouraged to consult with their suppliers regarding the notification and subsequent registration of substances under UK REACH. Either the importing customer or its supplier should ensure that a notification is completed by October 28, 2021, which is within 300 days of the end of the transition period.
EU REACH Article 9 exemptions for substances imported or manufactured in GB for purposes of product(s) and process-oriented research and development will be grandfathered into UK REACH if basic information is provided to the HSE within 120 days (by April 30, 2021), and they will be subject to the same conditions imposed by ECHA.
HSE’s website includes:
- Updated REACH after Brexit guidance to help companies understand whether there are actions your business needs to take; and
- Information on the transitional provision for GB-based existing downstream users and distributors is available in the guidance on Downstream User Import Notification (DUIN).
As of January 1, 2021, the UK and the EU began operating independently from each other. Companies that supply or purchase substances, mixtures, or articles to and from the EU/European Economic Area (EEA) and the UK will need to ensure that they meet the requirements under both the relevant UK and EU statutes.
From offices in Manchester, UK, and Brussels, Belgium, The Acta Group (Acta®) provides local expertise and boots-on-the-ground representation to assist clients in gaining and maintaining compliance in both jurisdictions. Acta’s Manchester office can be reached at +44 (0) 330 223 0610.