Overview of UK Chemical Regulations post-Brexit

In this feature article, Caroline Raine explains what has happened post Brexit to the UK Chemicals Regulations.

Background

The transition period ended on 31 December 2020 and so, at 11pm on 31 December 2020, EU laws no longer applied to Great Britain and many new regulations came into force. Many of the existing EU regulations have been copied into GB law and amended to enable it to operate effectively in GB. This means that most aspects of the EU regulations apply and will continue in the same way under the new stand-alone regimes. This feature will discuss some of the changes introduced for REACH, CLP and Poison centres.

REACH

UK REACH came into force on 31 December 2020 and requires companies that previously held registrations to grandfather them into the UK regime, or for those who were previously downstream users to submit a downstream user notification (DUIN). More information on UK REACH is available in our dedicated topic.

Key dates

30 April 2021 — Grandfathering

27 October 2021 — DUIN/Only Representative Inquiry

27 October 2023 — first registration deadline.

27 October 2025 — second registration deadline.

Deadline

Tonnage

Hazardous property

27 October 2023

1000 tonnes or more per year

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 of 31 December 2020)

27 October 2025

100 tonnes or more per year

Candidate list substances (as of 27 October 2023)

27 October 2027

1 tonne or more per year

27 October 2027 — third registration deadline.

CLP

The EU CLP Regulation as amended, is retained in GB law. These arrangements mean that Great Britain continues to adopt GHS, independently of the European Union. All existing EU harmonised classification and labelling in force on 31 December 2020, are retained in Great Britain as GB mandatory classification and labelling (GB MCL).

GB MCLs are listed in the GB mandatory classification and labelling list.

In order for GB CLP to operate fully and effectively in Great Britain, the EU CLP Regulation has been amended. This means there are changes to the requirements or allowances in existing processes and procedures. The following should be noted:

  • the main duties to classify, label and package remain

  • HSE becomes the relevant GB CLP Agency overseeing GB CLP functions for substances and mixtures placed on the GB market

  • the GB CLP Regulation applies to GB-based manufacturers, importers, downstream users and distributors supplying the GB market

  • substances and mixtures placed on the market in Northern Ireland are subject to the EU CLP Regulation (placed on the market includes import into the territory)

  • the GB CLP Regulation applies to NI based manufacturers, downstream users and distributors (collectively referred to as 'NI suppliers') who directly supply the GB market, with no intermediate NI supply, with qualifying NI goods (QNIGs)

  • substances and mixtures are goods in this context

  • GB-based manufacturers and importers and NI suppliers directly supplying the GB market with QNIGs will have to notify HSE within one month of placing 'new' substances on the GB market unless one of the exemptions applies

  • all existing EU harmonised classification and labelling in force on 31 December 2020, are retained in Great Britain as GB mandatory classification and labelling (GB MCL)

  • the classification and labelling of substances and mixtures placed on the GB market must comply with GB MCL where relevant. GB MCLs are listed in the GB mandatory classification and labelling list

  • GB-based manufacturers, importers or downstream users wanting to submit information to support new or revised mandatory classification and labelling proposals should read the GB MCL guidance 'Submitting a new or revised GB MCL proposal'

  • HSE and ministers, including ministers in the devolved administrations, acting as GB CLP competent authorities can also propose new and revised GB MCLs

  • the allowance to request the use of alternative chemical names remains

  • GB-based manufacturers, importers or downstream users or NI-based suppliers, directly supplying the GB market with QNIGs, wanting to use a new alternative chemical name in Great Britain should apply to the HSE

  • GB-based importers and downstream users and NI-based downstream users directly supplying the GB market with QNIGs should be aware of the arrangements for submitting information to the UK National Poisons Information Service (NPIS) known as the National poison Centre.

Poison centres

The requirements to make notifications to poison centres within the EU remains the same there are no changes. The challenge is for GB based companies who sell into the EU.

GB based companies will not be able to make notifications via the ECHA harmonised submission portal, and notifications previously made by GB based companies will not be deleted but legally will be ‘void’.

The obligation to make the notification lies with the importer, which in many cases is the European customer. Of course, a GB company may make a voluntary notification using an EU legal entity if they wish to reduce the burden on their customers.

Scotland, England and Wales

Poison centres will remain voluntary and if you wish to make a voluntary notification you only need to send a copy of your Safety Data Sheets to the National Poison Information Service (NPIS).

You should send this information by email to sds.npis@nhs.net. The submission of a SDS to the NPIS does not in itself mean that a given product is approved for sale.

There is no obligation to generate or submit a unique formula identifier (UFI) code in Great Britain but the NPIS will register your product with its associated UFI if one has already been generated. To support the NPIS, please ensure the UFI is clearly identifiable on the front page of the SDS.

Northern Ireland

Northern Ireland will follow the Annex VIII requirements, but not through the ECHA portal. Instead, once the Annex VIII dossier has been created it should be sent to the NPIS.

Because NPIS does not have access to the European Chemicals Agency (ECHA) poison centre notification (PCN), submissions for NI must be provided in the form of a PCN and sent directly to NPIS Birmingham as the appointed body.

In order for submissions to be valid, they must be either:

  • produced directly in the ECHA-approved IUCLID desktop/cloud platform and exported as an .i6z dossier

  • if produced using a third-party tool, the submission must then be imported into the ECHA PCN, and exported as an .i6z dossier. This exported dossier will be accepted by NPIS as a submission.

These submissions should be made via email to sds.npis@nhs.net.

You must also include a UFI in the submission of information and on the label or, in some cases, the packaging of the products that contain a hazardous mixture.

More information on Northern Ireland and Poison centres can be found here.

Conclusions

  • Make sure that you understand your legal obligations.

  • Check your role in the supply chain.

  • Understand the regulatory deadlines.

  • Make sure you meet any deadlines.

  • If in doubt, ask for help and guidance.