Last reviewed 9 October 2020
Caroline Raine discusses developments in the chemical industry in relation to Brexit and explains what the UK has planned for chemical compliance post 31 December 2020.
The UK voted to leave the EU on 23 June 2016. The original leave date of 29 March 2019 has now passed, and the transition period ends on 31 December 2020. The Department for Environment, Food & Rural Affairs (DEFRA) recently announced that the UK’s independent chemicals regulatory framework starts on 1 January 2021. Anyone making, selling or distributing chemicals in the UK and the EU needs to follow UK REACH and EU REACH rules.
In addition, the Health and Safety Executive (HSE) has provided information on other parts of the chemical regimes namely; Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), The Classification, Labelling and Packaging (CLP) Regulation, Biocides, Prior Informed Consent (PIC) and Plant Protection Product (PPP).
See the feature article, An Introduction to UK REACH for detailed guidance on REACH chemical compliance post 31 December 2020.
At the end of the transition period, so from 1 January 2021, the EU CLP Regulation will be replaced by the GB Classification, Labelling and Packaging of substances and mixtures Regulation (GB CLP). GB CLP will adopt the United Nations Globally Harmonized System of the classification and labelling of chemicals (UN GHS).
Instead of dealing with ECHA and the European Commission those functions will be undertaken by the HSE, with support from other government departments/agencies and the Welsh and Scottish Governments.
The duties and obligations of GB-based businesses supplying the GB market include the following:
GB-based manufacturers, importers and downstream users must classify substances and mixtures in line with GB CLP before they place them on the GB market;
GB-based suppliers (ie manufacturers, importers, downstream users and distributors) must label substances and mixtures before they place them on the GB market to reflect the hazard classification; and
GB-based suppliers (ie manufacturers, importers, downstream users and distributors) must package the substances and mixtures they place on the GB market safely and securely.
Under GB CLP there are no changes to the current requirements for;
CLP labelling that may appear alongside those for transport
Packaging requirements. The requirements for child resistant closures and tactile warning devices will remain in place.
Testing arrangements, including the prohibition of testing on humans or primates for the purposes of GB CLP, will still apply.
From 1 January 2021, GB-based downstream users and distributors supplying the GB market that are currently supplied from the EU/EEA will become importers under GB CLP. This will mean they will need to undertake the full duties of an importer.
Also, from 1 January 2021, the HSE will put in place new arrangements for GB mandatory classification and labelling (GB MCL). These arrangements will allow future new and revised classification and labelling to be proposed, considered in collaboration with the devolved administrations and given effect on the GB market. GB MCLs will be listed in the GB mandatory classification and labelling list. This will mean that GB will be able to make its own decisions on mandatory hazard classification and labelling, including whether or not to align with decisions made in the EU or other countries.
A new GB notification database will be created and managed by the HSE to make classification and labeling notifications. Poison centre notifications remain voluntary to the UK poison centre.
The HSE have created a Scenario table to help you prepare www.hse.gov.uk/brexit/clp-scenario-table.pdf.
The UK will retain the Biocidal Products Regulation (BPR) and its subsidiary regulations in national law using the provisions of the EU Withdrawal Act. The HSE will be the competent authority and will be the body for applications rather than ECHA. The main points have been summarised by the HSE as;
Certain EU functions have been removed (eg on Union authorisations and mutual recognition) as they will no longer operate in a Great Britain only context.
Active substance approvals and new biocidal product authorisations will be specific to Great Britain.
Authorisations and approvals valid in Great Britain will remain valid
If you hold a biocidal product authorisation that is valid in Great Britain, it will remain valid after 1 January 2021 until its normal expiry date. However, the authorisation holder will need to be established in the UK within one year (by 1 January 2022).
Active substance approvals will also remain valid until their normal expiry date, if the information originally provided to the evaluating authority is provided to HSE.
A new Article 95 GB, it will mirror the current Article 95 list. To remain on this list, businesses will need to submit supporting information to HSE. This is the same information submitted to ECHA, for example, an active substance dossier or a letter of access to data held by HSE. Suppliers will also have to ensure they are established in the UK. A two-year phase-in period will be provided to ensure businesses have time to meet these requirements.
From 1 January 2021, Great Britain will operate a Prior Informed Consent (PIC) regulatory regime. The main points of the system have been summarized by the HSE as;
If you are exporting listed chemicals from Great Britain, you will continue to notify those exports to the Health and Safety Executive (HSE) as the GB PIC Designated National Authority (DNA).
Businesses exporting or importing listed chemicals from or to Great Britain (including to or from EU countries and Northern Ireland) will need to comply with the requirements of the new GB PIC regime.
Companies exporting PIC-listed chemicals from Great Britain will no longer be able to use ePIC and will need to notify HSE of exports of listed chemicals using the new notification procedures.
The PIC regime will apply to listed chemicals that are exported from Great Britain, including to EU countries and to NI. Companies that currently only move listed chemicals within the EU single market and do not export them outside the EU or NI will have to start to notify these to HSE.
Where explicit consent has been given by an importing country to another EU country under the current EU PIC arrangements, it will be necessary to seek the consent of that country for GB exports of the chemical. HSE will seek consent on the exporter’s behalf.
Exporters and importers will need to include in the information they submit to HSE in the first quarter of each year, details of the quantities of listed chemicals exported to or imported from EU countries and NI, as well as other countries.
The HSE have created a scenario table.
If you are…
You want to…
a company exporting listed chemicals from GB
export from GB to anywhere, including the EU or Northern Ireland
notify the export to HSE (the Designated National Authority for GB)
at least 35 days before the first export. You must then notify at least 35 days before every first export to each importing country in each subsequent calendar year
a company exporting listed chemicals to GB
continue to export to GB
comply with the EU PIC Regulation. Exports of listed chemicals to GB must be notified before export
Refer to the guidance on ECHA’s website
a company exporting chemicals (excluding from the EU or NI) listed in Annex III of the Rotterdam Convention to the UK
export to the UK
comply with any obligations you may have under the Rotterdam Convention
Refer to guidance on the Rotterdam Convention website
From 1 January 2021, GB will establish an independent plant protection product (PPP) regulatory regime. The HSE summarises what the PPP regulatory regime will look like as;
All existing active substance approvals, plant protection product (PPP) authorisations and Maximum Residue Levels (MRLs) will continue to be valid in Great Britain. Active substance approvals expiring within 3 years of the end of the transition period will each be extended for 3 years.
Under the terms of the Withdrawal Agreement and Northern Ireland Protocol, the EU pesticides regime will continue to apply in Northern Ireland after the end of the transition period, in essentially the same way as during the transition period.
New applications for active substance approvals, PPP authorisations and MRLs will need to be submitted under both the GB and EU regimes to gain access to both markets.
The Health and Safety Executive (HSE) remains the national regulator for the whole of the UK, on behalf of the UK Government and the devolved administrations.
Documentation supporting an application will remain the same. The HSE will accept applications in the same way and will still need a registration report in the same format in support of an application for authorisation.
The HSE will aim to reach decisions more quickly under the new national regime. The HSE plan to deliver active substance, MRL and PPP decisions within 2 years of submission.
New decisions taken under the EU regime will not apply in GB. This includes active substance and MRL decisions and any new EU PPP legislation.
GB will have no formal role in EU decision making processes.
Applicants, authorisation holders and approval holders can be based anywhere in the world.
All existing active substance approvals and PPP authorisations will remain valid in GB. Applicants will need to continue to meet any existing conditions under the new GB pesticide regime.
Applicants can continue to submit applications in the same format to the HSE. There will be minor changes to the application form but otherwise no changes in data requirements or format for supporting information for future applications.
Existing PPP authorisations remain valid until their current expiry date.
An active substance must be approved in GB before it can be included in any PPP that is authorised for use in GB. When an active substance is approved in GB, it will be included in a statutory active substance register. This register will be published on the HSE website from 1 January 2021.
A GB programme for the review of the safety of active substances will be developed. Active substance approvals expiring in the first three years will each be extended for three years to allow time for the necessary evaluation work. HSE will retain the power to review active substance approvals at any time, should new evidence identify any concerns to human health or the environment.
The HSE will no longer be able to accept new applications for mutual recognition of authorisations in EU Member States but will process any existing applications to a conclusion under the national GB regime.
The HSE will no longer be able to accept new applications for parallel trade permits in GB. Existing parallel trade permits will continue until their current expiry date or until 31 December 2022, whichever is the sooner.
Treated seed that has been treated with a product authorised for that purpose in an EU Member State can continue to be traded and used in GB until 31 December 2023. After that time treated seed can only be traded and used in GB if it has been treated with a PPP authorised for that purpose in GB. This period of time will allow applicants to seek any new GB PPP authorisations that may be required.
After the end of the transition period we will set MRLs for GB based on our own assessments. All existing MRLs will remain valid until such time as they are amended.
Existing PPP authorisations made under the EU regime remain valid in GB. Authorised PPPs can be placed on the market and used in the same way as before.
Under the Northern Ireland Protocol, the process for Northern Ireland businesses moving goods to and from the European Union under EU regulations will not change from 1 January 2021. Further guidance will be published in due course.
Now is the time to start to prepare for Brexit (if you haven’t already)!
Take time to understand your markets.
Identify your role in the supply chain and what your suppliers and customers will be doing post Brexit.
Understand that there are regulations other than REACH that will require actions.
CLP and REACH will require EU legal entities if you wish to continue to trade in these countries. This duty will lie with the importer. If you want your company to be the importer, you don’t have long to establish an EU legal entity.