UK REACH Extension (UK)

Last year (2022) the UK Government consulted on extending the registration deadlines, from the current deadlines, the first of which is as soon as October 2023.

The UK REACH Regulation contains transitional provisions that allow companies to submit initial ‘notification’ data in order to continue trading and then subsequently provide the full registration data. The transitional provisions apply to those that were registrants, downstream users or distributors under EU REACH before UK REACH came into effect. The current deadlines for completing this transitional registration process, depending on tonnage and hazard profile of the substance, are set down in Article 127P of UK REACH, and the first of these is 27 October 2023.

The UK Government published its consultation response in November 2022. It did agree to extend the deadlines. But the legislation to put this into effect is not yet issued.

We will notify subscribers to Cardinal Environment EHS Legislation Registers & Checklists, in the monthly Email Alert, as soon as this legislation has been enacted. In the meantime, questions about the deadlines should be addressed to the HSE.

The November 2022 UK Government consultation response is here.

Please note: the UK REACH legislative instrument (a Brexit amended EU-era document) is currently on the list for deletion in the REUL Project. However, we now understand that the REUL Project will remove a smaller number of EU-era documents than the current Bill wording requires, and possibly the sunset clause could itself be removed. We await the UK Governments tabled amendments to the REUL Bill, which will return to the Lords 15/17 May for its Report stage, for the detail on this.

UK REACH (Britain)

On 30th June 2022, the various organisations involved published their rationale for prioritising substances within the UK REACH programme 2022-2023. This document is here.

Priorities are established for 2 types of activity in UK REACH:

• Restriction – a mechanism that can lead to controls on the use of a substance or group of substances

• Regulatory Management Options Analysis (RMOA) – analysis produced by HSE and/or the Environment Agency to understand the risks of using a substance, or group of substances, and make recommendations for managing them.

The following are 5 priorities –

1 Per- and polyfluoroalkyl substances (PFAS) – acting on the recommendations of an ongoing RMOA, due for publication in summer 2022

2 Intentionally added microplastics – an evidence project on identifying and managing the risks they pose

3 Formaldehyde and formaldehyde releasers in articles – an RMOA to review the evidence base and evaluate a potential restriction

4 Bisphenols in thermal paper – an RMOA to review the evidence base and evaluate a potential restriction

5 Hazardous flame retardants – reviewing and updating the existing evidence on potential environmental risks, to feed into wider chemicals policy.

In addition, the HSE is running a number of calls for evidence in relation to additions to the Annex 14 (UK Authorisation List). Addition to the List means prior authorisation is needed to use, or place on the market, the relevant substance, after the specified sunset date.

Note – the DEFRA Secretary of State, together with Welsh and Scottish Ministers will need to authorise any decision.

The HSE link is here.

EU REACH and UK REACH (UK from 1st Jan)

Like CLP (see my blog post on CLP), the key principles of the European Union (EU) REACH Regulation are retained. This document is included (separated into four line entries) in our Brexit Consolidated Law project (the coloured list in Cardinal Environment EHS Legislation Registers & Checklists).

From 1 January 2021, UK REACH and EU REACH will operate independently from each other. Companies that are supplying and purchasing substances, mixtures or articles to and from the EU/EEA/Northern Ireland and Britain (England, Scotland and Wales) will need to ensure that the relevant duties are met under both systems.

EU REACH will apply to Northern Ireland from 1st Jan, while UK REACH will regulate the access of substances to the GB market.

GB- based Businesses holding EU REACH Registrations (in ECHA)

The EU REACH registration will be (and must be) legally recognised (grandfathered) in the UK REACH system after 31st Dec, but information will be supplied to the HSE (the UK REACH regulator) via an account (the holder sets up) on the new UK REACH IT system.

* initial information on the existing EU REACH registration within 120 days of 31st Dec.

* technical information (required under UK REACH) within 300 days plus either 2, 4 or 6 years of 31st Dec. The deadline depends on the tonnage and/or hazard profile of substances.

Grandfathering will be available (and will be required) for all registrations (including intermediates) held by GB-based entities, including importers and Only Representatives (ORs) based in Britain, and to sole, lead or joint registrants.

All GB-based registrations that exist on 31st Dec, and all registrations held by GB entities at any point since 29 March 2017 will be grandfathered. This means that if a GB registration was transferred to an EU/EEA/NI-based entity in the run-up to 31st Dec, it will still be grandfathered into UK REACH.

Grandfathering will not apply to registrations held by entities established outside of Britain, regardless of whether they are part of a group of companies which also has a presence in Britain. Those registrations will not be grandfathered, unless they have been transferred to a GB entity before 31st Dec.

Before transferring any registrations, the HSE asks you to consider how this would affect your operations in the EU/EEA and Northern Ireland, and your ability to access the EU/EEA and NI markets in future.

The HSE says any ECHA decisions relevant to a registration(s) will remain valid.

Access to the technical information used for EU REACH registration may require renegotiating commercial contracts/letters of access which were originally put in place for EU REACH under a Substance Information Exchange Forum (SIEF).

UK REACH will not require GB companies to form a Substance Information Exchange Forum (SIEF) to submit registration data, including under the grandfathering provisions. UK REACH will include a similar Article 26 substance inquiry system to EU REACH to facilitate the principle of ‘one substance, one registration’ which will be retained under UK REACH.

This link gives access to HSE details of the information that must be submitted (scroll down)

Separate Rules apply for GB- based businesses that are downstream users and distributors if they continue to be supplied from the EU/EEA – read here.

GB- based businesses importing non EU/EEA substances Businesses that act only as importers of substances will not be able to appoint an Only Representative (OR) under EU REACH (only a manufacturer, formulator or producer of articles can do so). This means that, as a GB-based importer, you will not have the option to transfer your EU REACH registrations to an EU-based entity OR to continue selling into the EU/EEA or Northern Ireland.

To sell chemicals to EU/EEA or NI customers you should:

* help your EU/EEA and NI-based customers to register with ECHA as importers

or

* work with the non-EU/EEA or NI-based manufacturer who supplies you to encourage them to appoint an OR based in Northern Ireland or an EU/EEA country, who can register the substance with ECHA. The HSE advises you will need to consider in each case whether this registration will be sufficient to allow you to export the substance into the EU/EEA or Northern Ireland.

For mixtures to be placed on the EU/EEA or NI markets you should ensure that each substance at one-tonne or over is registered with ECHA in accordance with EU REACH directly by someone EU-based in your supply chain (again see above re OR).

GB- based Businesses holding EU REACH Authorisations (in ECHA)

Again, these will be grandfathered. The deadline here is 60 days from 31st Dec for information supply to HSE –

* the information included in the application for the authorisation

* any other information provided to ECHA by the applicant for the authorisation which was material to the formation of ECHA’s opinion

* any information required to be submitted or recorded before 31st Dec under any condition under which the authorisation is granted.

Separate Rules apply for GB- based businesses that are downstream users and distributors if they continue to be supplied by anyone with an EU REACH authorisation – read here.

Link to HSE information for GB- based Businesses bringing to GB NI- registered goods under EU REACH (qualifying Northern Ireland goods – QNIGs) – here.

Link to HSE information for NI- based businesses trading QNIGs – here.

Note : see above re GB holders of EU REACH registrations.

LINK to HSE for further scenarios.

REACH Chemical Legislation (UK Brexit)

On 1 September, DEFRA updated its existing webpage guidance for – How to comply with the EU’s REACH chemical regulations when using, making, selling or importing chemicals in the EU, and how to prepare for 1 January 2021 – here.

Per the webpage –

UK REACH, 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.

UK REACH will maintain EU REACH’s aims and principles. These include:

• the “no data, no market” principle

• the “last resort” principle on animal testing

• access to information for workers

• the precautionary principle

The government intends to extend the deadlines for submitting data under UK REACH transitional provisions subject to scrutiny by parliament and the devolved administrations. This guidance includes these extension dates rather than those currently provided in UK REACH legislation.

Please note the new deadlines in the DEFRA updated webpage.

GB-based companies currently registered with EU REACH will no longer be able to sell into the EEA market without transferring their registrations to an EU/EEA-based organisation. This registration transfer stipulation is set out in the EU instruction notice – here.

Registration transfer to an EU/EEA-based Organisation will not apply in Northern Ireland. We await confirmation on the application of UK REACH in Northern Ireland.

Per the webpage –

Under the Northern Ireland Protocol, the process for Northern Ireland businesses moving goods to and from the European Union under EU REACH will not change from 1 January 2021. Further guidance will be published for NI businesses moving goods into the GB market.

EU REACH registrations held by UK-based companies will carry across directly into UK REACH, legally ‘grandfathering’ the registrations into the new regime.

UK-based holders of existing EU REACH registrations may continue the ‘grandfathering’ process by providing basic information to the Health and Safety Executive (HSE) by 30 April 2021.

Holders must complete the grandfathering process within 2, 4 or 6 years of 28 October 2021, depending on their Tonnage Band Deadlines.

Per the webpage –

The information UK-based holders need to provide will be the same or very close to what holders previously provided. Defra will publish any changes to the information needed in September 2020.

Businesses importing chemicals from the EU currently relying on a registration held by an EU/EEA-based company can continue importing substances as they do now on 1 January 2021. They will need to take subsequent actions to ensure that the chemical is registered for UK REACH purposes.

These UK downstream users must notify the HSE using a Downstream User Import Notification (DUIN) of their intention to continue importing substances from the EU/EEA by 27 October 2021.

A new registration must then be submitted to the HSE within 2, 4 or 6 years of 28 October 2021. Alternatively, UK downstream users can encourage their EU/EEA supplier to appoint a UK-based Only Representative (OR), or change their source to a UK registered supplier.

It’s possible to submit DUINs if a chemical is covered by a registration held by an EU/EEA-based OR and then sold into the UK.

The online service ‘Comply with UK REACH’ will go live on 1 January 2021. Businesses can use the service to:

• validate existing UK-held EU registrations (‘Grandfathering’)

• submit downstream user import notifications (DUIN)

• submit new substance registrations

• submit new product and process orientated research and development (PPORD) notifications

Businesses will need to coontact the HSE to ensure that they:

• validate existing UK-held product and process orientated research and development (PPORDs), known as ‘grandfathering’

• provide information on any authorisation matter,including new authorisation application, grandfathering of existing authorisations, and downstream user notifications of authorised uses

The above is NOT a full list of the stipulations in the updated webpage. Please read all parts of the webpage for all instructions.

Environment Bill (England & UK Brexit)

Exit day is 31st October (this date is set out in a Statutory Instrument)

Today, the announced new Environment Bill was given its First Reading. This Bill encompasses the governance aspects already announced by the previous administration (Bill that lapsed) and covers a range of matters, including Waste and Air Quality.

The Policy Statement is here. The Bill generally extends to England only, but its provisions are intended to create a UK wide approach, and some provisions clearly directly extend to the UK (e.g. UK REACH, below) –

On UK REACH – the Environment Bill gives the Secretary of State the power to amend two pieces of legislation regulating the use of chemicals in the UK.

(1) The REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation regulates the manufacture, placing on the market and use of chemicals. This is a Retained EU Law.

(2) The REACH Enforcement Regulations 2008 set out how the requirements of the REACH Regulation are enforced. This is a domestic UK Law.

Both of these laws are amended by Brexit Law effective from Exit day. Subscribers will find them in the Brexit Consolidated Law List in EHS Legislation Registers & Checklists.

The Policy Statement asserts the powers will enable the Secretary of State to take further steps where necessary to ensure a smooth transition to a UK chemicals regime following the UK’s exit from the EU.

The Policy Statement asserts it will also make it possible to keep the legislation up to date and respond to emerging needs or ambitions for the effective management of chemicals.

The Bill text is not yet public. I will issue further Blog posts once the text is public.

UK Chemicals Regulation (UK Brexit)

Exit day is 31st October 2019

I posted before on UK Chemicals Regulation after UK Exit. This is a reminder post.

On the 25th March, HSE (the UK REACH chemicals regulator) published further instructions on access to UK REACH – here.

[the UK documents endlessly refer to a “Deal” – this is the Withdrawal Agreement, and for our purposes merely provides a new Exit day of 31st December 2020, not new trade arrangements with the EU]

These HSE instructions make it clear the online service ‘Comply with UK REACH’ will replace ECHA’s REACH-IT platform for UK REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), from Exit day.

Live on Exit day, the new online system will allow:

* Businesses that have existing UK-held REACH registrations to validate their registrations (‘grandfathering’)

* Businesses that import chemicals from the EEA to submit downstream user import notifications

* Business to register new substance registrations or PPORD notifications (Product and Process Orientated Research and Development)

In order to minimise disruption to in the event of a no-deal Brexit, businesses that currently hold a REACH registration are encouraged to access their ECHA REACH-IT account and ensure that all the information relating to their business is downloaded. Information required to comply with UK REACH includes registration confirmation documents and ECHA decisions.

Under the new requirements, from Exit day –

* UK businesses that manufacture a chemical (those currently registered to EU REACH) will need to validate their existing registration with the Health and Safety Executive (HSE) within 120 days of the UK leaving the EU.

* UK businesses that import a chemical substance from the EU will need to notify HSE within 180 days of the UK leaving the EU.

* UK businesses that export chemicals to the EU will need to have an EU REACH registration in place once the UK leaves the EU.

In addition, more technical information will need to be submitted by businesses to HSE within two years of EU Exit.

Current HSE instructions are here.

[the Exit day may change, please continue to follow this Blog]