Understanding UK REACH Regulations and Compliance

Global REACH-like regulations: UK REACH the introduction Marcin Wilczy ski, REGARTIS Marcin@regartis.com Belgrade, 12.09.2024 11:45

Post-BREXIT reality Under the European Union (Withdrawal) Act 2018, the EU REACH Regulation was brought into UK law on 1 January 2021 and is known as UK REACH UK REACH. UK REACH regulation applies in: England, Scotland and Wales. UK REACH regulation does not apply in the Northern Ireland, as a result of the Northern Ireland Protocol. There European REACH continously apply. Today, UK REACH obligations are mirroring the EU REACH. Both regulations exist separately and have different technical aspects (Agency, platform, restrictions, etc).

Consolidated UK REACH text https://www.legislation.gov.uk/eur/2006/1907/ contents

Who needs to complete UK REACH registration? Manufacturers in Great Britain (GB) Importers in GB Enterprises outside of GB should appoint a GB-based Only Representative (OR) to handle the UK REACH registration.

Responsibilities under UK REACH The principles are the same as they are in EU REACH, including exemptions. Your business is required to identify and manage the risks associated with the substances you manufacture and market in Great Britain. You must demonstrate that these substances can be used safely and communicate the necessary risk management measures to users. Additionally, you need to consider your role within the supply chain in Great Britain. Investigate your: business, locations, supply chains, products: substances/ mixtures/ articles/ other, their annual volumes, their classification, regulatory restrictions/

How to you comply with UK REACH? New registration remains the only option to cover manufacture and import into GB. This applies to: brand new registrations of novel substances (never registered in the EU before), new registrations of existing substances ( NRES NRES ).

Registration procedure Procedure is in principles the same as in EU REACH: 1. Prepare basic chemical analysis of the subject substance. 2. Start with an inquiry to HSE in IUCLID format. 3. After receiving the inquiry numer, verify the connected Substance Group (UK equivalent of the SIEF/Joint Substance Group (UK equivalent of the SIEF/Joint Submission) Submission) and verify the Lead Registrant or volunteer to become one. 4. Proceed with the registration in IUCLID format. Today mostly blank registrations are being uploaded due to a transition period and creations of Substance Groups. The Letters of Access market slowly begins. 5. Pay respective administrational fee to HSE.

Platform - Comply with UK REACH Comply with UK REACH: submit and manage chemical registrations and notifications - GOV.UK (www.gov.uk)

Registration deadlines The submission deadlines for substances of different tonnage bands and hazards are as follows: Tonnage Band Hazards Date >=1000 tpa Carcinogenic, mutagenic or toxic for reproduction (CMRs) - 1 tonne or more per year; Very toxic to aquatic organisms (acute or chronic) - 100 tonnes or more per year; Candidate list substances (as December 31, 2020); October 27, 2026 >=100tpa Candidate list substances (as of October 27, 2023); October 27, 2028 >=1 tpa October 27, 2030

Authorization There are appointed an constantly updated: UK REACH Candidate List of substances of very high concern (SVHCs) for Authorisation Recommendations to add substances to Annex XIV (Last updated: 16 January 2024) UK REACH Authorisation List (Annex 14) https://www.hse.gov.uk/reach/svhc.htm

Restrictions UK REACH restrictions apply to chemicals on their own, in mixtures or in articles and they limit, ban or set conditions on the manufacture, placing on the market or use of a substance or group of substances. List of restrictions List of restrictions and the Registry of restriction Registry of restriction intentions intentions are continuously updated.

Fees and charges UK REACH will apply fees to the same processes that were charged under EU REACH. The starting point for the UK REACH fees are the EU REACH fees and these have been converted from Euro to GBP, based on the average conversion rate for 2017. Your invoice and instructions for payment will be issued to you by the email held in your Comply with UK REACH account.

GB CLP GB introduced the EU-CLP regulation and updates it separately to the EU. There is a harmonised approach for the classification named Madatory classification (MCL). Madatory classification (MCL). https://www.hse.gov.uk/chemical- classification/classification/harmonised- classification-self-classification.htm https://www.hse.gov.uk/chemical- classification/new-revised-proposal.htm https://www.hse.gov.uk/chemical- classification/assets

UK PCN Notification Information companies placing hazardous mixtures on the UK market (such as manufacturers, importers, downstream users and distributors) should submit to the National Poisons Information Service. https://www.gov.uk/guidance/submitting- chemicals-information-to-the-national- poisons-information-service

Takeaways UK REACH is very similar to EU REACH. Now there is a transitional period: Substance groups are forming, then the consortia and the market of Letters of Access will expand. Fees are on the equivalent level to EU REACH. UK has own classification, restriction and authorization terms.

For more information and to ensure compliance, please contact REGARTIS. experts@regartis.com