Regulation 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a regulation that applies to the majority of chemical substances with the aim of improving the protection of human health and the environment from the risks that can be posed by chemicals. Duties are held by manufacturers, importers, distributers and downstream users.

Organisations which place chemicals on the market in GB and the EU or NI have to comply with both versions of REACH.

Organisations who were previously covered by EU REACH who now need to transition to UK REACH will need to reapply for authorisation. This reapplication process involves the submission of previously submitted data which can be obtained from the ECHA for a fee or organisations can pay to redo the studies and research.

This can lead to significant costs to both organisations and the chemicals industry with an estimated cost of around £2 billion by 2030. Concerns are raised that this cost might lead to organisations not registering, reducing the amount substances available and causing supply chain issues.
Proposed changes
Following an in-depth analysis of the current UK REACH requirements, the Department for Environment, Food and Rural Affairs (Defra), alongside the HSE and the Environment Agency (EA) have devised an Alternative Transitional Registration model (ATRm) for UK REACH.

The aim of this model is to help reduce costs to organisations transitioning from EU to UK REACH uphold existing human health and environmental protections by gaining better information on the use and exposure of substances in Great Britain.

These changes are proposed under a consultation which can be found here, with the policy paper found here.
Key points

Key points in the consultation include the following:

For LUS subscribers you can view this consultation and many more on the links below:

Health and safety consultations
Environment consultations

Jurisdiction: Great Britain

Commencement: 19th July 2023

Amends: GB Retained: Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Mini Summary

Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (the “REACH” Regulation) concerns the registration, evaluation, authorisation and restriction of chemicals. The Regulation places duties primarily on the manufacturers and importers of chemical substances. There are also duties and restrictions on downstream users of some very hazardous chemicals.

Application in Great Britain

Following the UK’s departure from the European Union (EU), the European Union (Withdrawal) Act 2018 incorporated all directly acting EU Regulations into law in Great Britain (GB). The GB versions of those EU Regulations have been amended to revise various definitions, terminology, authorities, etc. to GB rather than EU references and to provide for regulation and enforcement by GB rather than EU bodies. This entry describes the GB version of the REACH Regulation.

N.B. HSE guidance refers to ‘UK’ REACH’, even though UK REACH applies only in Great Britain. In order to remain consistent with HSE documentation, this summary uses the same terminology i.e. ‘UK’ REACH but it is important to note that UK REACH only applies in Great Britain.

Application in Northern Ireland

Although Northern Ireland has also left the EU, under the terms of the Northern Ireland Protocolthe EU version of REACH continues to apply in Northern Ireland, not the UK version. There are however different arrangements for certain goods imported from Northern Ireland into GB. See the section about transitional arrangements and Northern Ireland in the duties section below.

Application to all substances

REACH concerns all chemical substances whether or not they are hazardous. However, certain substances are excluded entirely or almost entirely from REACH including radioactive substances, waste, food and food stuffs, cosmetics and medicines.

The REACH Regulation complements the GB version of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (the ‘GB CLP Regulation’). Both apply duties primarily to manufacturers, importers and suppliers. There are also some more limited implications for downstream users. Organisations involved in manufacture and supply of chemicals need to be familiar with both Regulations.

Registration

Organisations which manufacture or import into GB 1 tonne or more of any chemical substance (whether or not it is hazardous) have a duty to gather information on the properties of the substance and register the information in a central database managed by the Health and Safety Executive (“HSE”). An organisation which manufactures or places substances on the market without registering them commits an offence.

Supplying information

Manufacturers and suppliers must provide information to customers about any hazardous properties of the substances they manufacture or supply. This duty is usually complied with by supplying Safety Data Sheets.

Very hazardous substances

One of the objectives of REACH is to restrict and ultimately phase out the use of some of the most hazardous substances (see “substances of very high concern” below). In pursuance of this objective and in accordance with REACH, the HSE will maintain lists of some ‘substances of very high concern’. Manufacturers, suppliers and downstream users must apply to the HSE for authorisation to manufacture, supply or use some of these substances. There are specific restrictions which apply to some of the listed substances. Eventually, GB may prohibit entirely the manufacture, supply and use of some of these most hazardous substances.

Note that registrations and authorisations granted by the European Chemicals Agency (‘ECHA’) to GB-based organisations prior to the end of the Brexit implementation period (31st December 2020) are automatically transferred across to the GB system, though the relevant organisation holding the registration or authorisation is required to notify certain information concerning the registration or authorisation to the HSE – see the transitional arrangements section below.

Duties
Various duties apply.
Amendment

Following Brexit, in order to allow the Government time to develop a new transitional registration model for REACH, the following UK REACH information submission deadlines are extended by 3 years to:

  • October 2026 for substances included on the EU REACH candidate list before UK REACH came into effect on 31st December 2020. This refers to substances listed in Article 127Pa and includes:
    • substances that are carcinogenic, mutagenic or toxic for reproduction and manufactured or imported in quantities of 1 tonne a year or more;
    • substances that are very toxic to aquatic life and manufactured or imported in quantities of 100 tonnes or more a year; and
    • all substances manufactured or imported in quantities of 1,000 tonnes or more a year.
  • October 2028 for substances added to the UK REACH candidate list before the October 2026 submission deadline, and for all substances manufactured or imported in quantities of 100 tonnes or more a year. This refers to substances listed in Article 127Pb.
  • October 2030 for all substances manufactured in Great Britain or imported in quantities of 1 tonne or more a year per manufacturer or importer.

The period during which the Health and Safety Executive (HSE) is required to carry out compliance checks on at least 20% certain types of registration dossiers is extended to 27th October 2027.

It is expected that it will take until late 2024 to develop and legislate for the new model for transitional REACH registrations.

 

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Jurisdiction: Northern Ireland & EU

Commencement: 8th January 2022

Amends:

Mini Summary
The Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)  incorporate the registration, evaluation, authorisation and restriction of chemicals.  Duties are placed primarily on the manufacturers and importers of chemical substances. There are also duties and restrictions on downstream users of some very hazardous chemicals.

REACH is a directly acting Regulation, meaning that it has direct application in European Union (EU) Member States, and breach of the Regulation can be prosecuted by national regulators. They also continue to be directly enforceable in Northern Ireland (under the terms of the Northern Ireland Protocol). Following the UK’s departure from the EU, the REACH Regulation was copied (with amendments) into law in Great Britain and a separate version of REACH is now enforceable in Great Britain.
Application to substances
REACH concerns all chemical substances whether they are hazardous or not. However, some substances are not covered by REACH including radioactive substances and waste. Substances going into food stuffs and medicines are exempted from the majority of the requirements under REACH.

The REACH Regulation complements Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (the CLP Regulation). Both apply duties primarily to manufacturers, importers and suppliers. Organisations involved in the manufacture and supply of chemicals need to be familiar with both Regulations. There are also some more limited implications for downstream users.
Registration
Organisations that manufacture chemicals or import them from outside the EU in quantities of 1 tonne or more (whether or not it is hazardous) have a duty to gather information on the properties of the substance and register the information in a central database managed by the European Chemicals Agency (“ECHA”). An organisation which manufactures or places substances on the market without registering them commits an offence.
Supplying information
Manufacturers and suppliers must provide information to customers about any hazardous properties of the substances that they manufacture or supply. This duty is usually complied with by supplying Safety Data Sheets.
Very hazardous substances
One of the objectives of REACH is to restrict and ultimately phase out the use of some of the most hazardous substances (see “substances of very high concern” below). In pursuance of this objective and in accordance with REACH, the ECHA maintains lists of ‘substances of very high concern’. Manufacturers, suppliers and downstream users must apply to the ECHA for authorisation to manufacture, supply or use some of these substances, and there are specific restrictions which apply to some listed substances. Eventually, the EU will prohibit entirely the manufacture, supply and use of some of these most hazardous substances.

There has been a phased implementation programme for the requirements under REACH. Many of the implementation dates have already passed. For information, the key implementation dates are listed below.

Amendment

Annexes VII to XI of the REACH Regulation set out in detail what information must be supplied about a chemical when an application is made to register it. This amendment amends Annexes VII to XI and makes revisions to some information required.

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EU Regulations were incorporated into law in Great Britain on 1st Jan 2021. But what happens to the GB versions of those Regulations when the EU continues to make amendments?

EU Regulations were incorporated into law in Great Britain on 1st January 2021. What happens to the GB versions of those Regulations when the EU continues to make amendments to their version of the Regulations?

Jonathan Teale looks at the treatment of these amendments in Great Britain and looks at a particular example where EU manufacturers and importers of hazardous mixtures are required to supply ‘unique formula identifiers’ to national poisons authorities.

Interpreting and summarising the changes to legislation resulting from Brexit has been an interesting, and at times very complex, challenge for Legislation Update Service.

Many of you will already be aware that EHS European Regulations were ‘copied’ into law in Great Britain by the European Union (Withdrawal) Act 2018. (These copied Regulations are referred to as ‘GB Retained Regulations’). The key date for this was 11pm on 31st December 2020, i.e. any European Regulation which was directly applicable in Great Britain before that time and date was copied into GB law as at 1st January 2021.

So far so good.

But what happens when the European Union issues amendments to European Regulations which have been copied into GB law? For example, the European Union frequently issues amendments to the ‘REACH’ Regulation or the CLP Regulation.

The answer in relation to Amendment Regulations is the same as for the Principal Regulations; if an amendment was issued and became operative prior to 11pm on 31st December 2020, it is incorporated into the GB version of the regulations, but anything after that date is not. That means that amendments issued by the European Union which become operative on or after 1st January 2021 will appear in the updates section of the EU version of the regulations in LUS but will not appear in the GB version. In this way, the GB Retained versions of regulations will start to diverge from their original EU counterparts. Of course, the UK Government may choose to keep the GB Retained version in line with their EU counterparts, but they are not bound to do so.

There is an added level of complexity which (confession time) did catch us out for a short time. Amendment Regulations usually state something like “This Regulation shall enter into force on the day after its publication in the Official Journal of the European Union”. So presumably if it ‘came into force’ before 1st January 2021 it gets included in GB retained law? Seems straightforward – right? However, there is sometimes a difference between when the Regulation ‘comes into force’ and when it ‘becomes operative’. The Regulation may ‘come into force’ before 1st January 2021, but individual provisions within the Amendment Regulation may state something like “importers and downstream users shall comply with this Annex from 1st January 2024”. In this case, those provisions will not ‘become operative’ until 1st January 2024. In this case, the European Union (Withdrawal) Act 2018 specifically provides that those provisions will not be incorporated into GB law.  

Earlier this year, in a small number of cases, we incorporated amendments into the LUS entries for GB Retained Regulations, where those amendments had ‘come into force’ before 1st January 2021, but which had not yet ‘become operative’. We have since identified those amendments and revised them to make it clear that they do not become law in Great Britain. The most significant of these was an amendment to the CLP Regulation which provided detail concerning the requirement for producers and importers to supply national poisons authorities with ‘unique formula identifiers’ in relation to hazardous mixtures. Those provisions which apply to the EU version of the Regulation do not apply in Great Britain.

Reminder: if you are a producer or importer in Northern Ireland, you continue to apply the EU version of the Regulation, not the GB Retained version.

Like we said at the beginning of this article … at times complex!
To summarise:

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Jurisdiction: GB

Amends: Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as amended
Mini Summary
Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) imposes requirements on manufacturers and importers of chemicals and restricts the use of certain high risk chemicals.

 
Amendment
The REACH Regulation requires registrants (i.e. those who have registered chemicals under REACH) to update their registrations with any relevant new information. However, no deadlines are provided within which updates must be submitted.  Regulation (EU) 2020/1435 is an implementing Regulation which supplements REACH by setting out deadlines for updating of registrations. Where any of the following changes in circumstances apply, the registrations should be updated within the time frames summarised below:

  1. Registrant’s identity: within 3 months of the change.
  2. Composition of the substance registered: within 3 months of manufacture or import of the changed substance.
  3. Tonnage band: where the quantity manufactured or imported changes, taking the registration into a higher tonnage band, within 3 months of the change (see Article 3 for additional detail).
  4. Cessation of manufacture or import: within 3 months.
  5. Identified new uses of the substance: within 3 months.
  6. Advice against identified use: where new advice is identified against a known use, within 3 months.
  7. New knowledge of risks to human health and/or the environment: within 3 months of the knowledge being identified.
  8. Classification and labelling under ‘CLP’ (Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures): a change in classification or labelling of a substance due to it being in some way re-assessed should be submitted within 6 months. A change to the hazard classification or labelling categories of CLP (i.e. where the CLP Regulation itself is changed) which affects the substance, must be notified by no later than when the change takes effect.
  9. Chemical safety report/ guidance in safe use: within 12 months of a change in either of these.
  10. New testing required under Annexes IX and X: within 6 months of the registrant identifying that new testing is required for a substance, or 12 months if the testing is identified as necessary as part of a testing strategy for a group of substances.
  11. Change in access granted: within 3 months of the change.
  12. New testing required in relation to 1-6 & 8 above: if any of 1-6 & 8 above leads to a requirement to carry out further testing, the deadline for submission of the update is changed to 3 months from the receipt of the test report.
  13. Combined updates: where any of the above circumstances applies and this also triggers the need to update or amend a chemical safety report or the guidance on safe use, the combined update should be submitted within 12 months from the date when the final test reports needed for the update have been received.
  14. Joint submissions: where an update by a member of a joint submission is dependent on a lead registrant making a prior update, the deadline for the member to make the update is:

The deadline is from when the HSE informs the lead registrant that their update registration is complete.

Updates of Annexes to REACH
Where any of the Annexes to REACH is amended, resulting in a change of information required to be submitted in support of a registration, the registration must be updated by the date from which that amendment to the Annex applies.

Process for updating registrations
Registrations should be updated through the ECHA. Information for registrants can be found via the ECHA website.

 

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Jurisdiction: Northern Ireland

Commencement: Depending on the section18th December 2020, immediately before IP completion day and IP completion day

Amends: 

  1. Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)  
  2. The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019/758)  
  3. The REACH etc. (Amendment etc.) (EU Exit) (No. 2) Regulations 2019 (SI 2019/858)  
  4. The REACH etc. (Amendment etc.) (EU Exit) (No. 3) Regulations 2019 

Mini Summary
Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) imposes requirements on manufacturers and importers of chemicals and restricts the use of certain high risk chemicals.

Following the UK’s departure from the EU, this EU Regulation has been incorporated directly (with amendments) into UK law. This entry describes the UK version of REACH. N.b. in Northern Ireland, the EU version still applies.

 
Amendment
These Regulations amend REACH and also amend the three REACH (Amendment)(EU Exit) Regulations passed in 2019 (see below). The 2019 Amendments assumed that Northern Ireland would mirror the regulatory approach in Great Britain following the UK’s exit from the European Union. However, the subsequent Withdrawal Agreement and associated Northern Ireland Protocol provide that Northern Ireland will continue to follow EU rules in many respects including REACH. These 2020 Amendments revise the 2019 Amendments to restrict their scope to Great Britain, and to provide arrangements concerning movement of chemicals between Great Britain and Northern Ireland. The ‘summary and duties’ text above, and the text of the 2019 Amendment below, has been revised to reflect these 2020 Amendments.

 

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Jurisdiction: EU

Commencement: 1st July 2020, but doesn’t apply until 1st March 2022

Amends: Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
Mini Summary
Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures introduces a globally harmonised system of classification and labelling of chemicals into European law. It supplements the REACH Regulation for the registration, assessment, authorisation and restrictions concerning chemical substances. The Regulations require that substances and mixtures are classified according to the physical hazards, the health hazards or the environmental hazards that they create. They also detail the labelling and packaging requirements.
Amendment
The list of harmonised classification and labelling of hazardous substances in Part III of Annex VI is updated, to remove or insert multiple chemicals. This is following the conclusion of opinions issued by the Committee for Risk Assessment of the Agency (RAC) for these substances.

Additionally, new scientific data has been made available, suggesting that the current available data may not be appropriate for:

Therefore, until the RAC issues a revised opinion of the new data, the hazard class will not be modified and lead massive will not be included in Annex VI.

*acute toxicity (inhalation) substances cause an adverse response from one or multiple doses within 4 hours of inhalation.

The amendments to Annex VI will come into effect on 1st March 2022.

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Jurisdiction: EU

Commencement: 1 January 2021

Amends: Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as amended
Mini Summary
Annex II to the REACH Regulation sets out requirements concerning the content and format of Safety Data Sheets. Annex II will be revised from 1st January 2021 (though old Safety Data Sheets may continue to be provided until 31st December 2022).

 
Amendment
Annex II to ‘REACH’ sets out the requirements for content and format of Safety Data Sheets. Annex II is amended to incorporate revisions to the Globally Harmonised System for classification and labelling of chemicals. The changes include a requirement for provision of information where relevant, about endocrine disruptors (natural and man-made chemicals which mimic or interfere with the body’s hormones). The new requirements apply from 1st January 2021, but Safety Data Sheets which do not comply with the revised requirements will still be accepted until 31st December 2022.   

 

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Jurisdiction: Republic of Ireland

Commencement: 29th January 2020

Amends: European Union (Restriction of Certain Hazardous Substances in Electrical and Electronic Equipment) Regulations 2012
Mini Summary
European Union (Restriction of Certain Hazardous Substances in Electrical and Electronic Equipment) Regulations 2012 implement European Directive 2011/65/EU on the Restriction of the use of certain hazardous substances in electrical and electronic equipment (EEE). These Regulations aim to improve the safety of electronic products and prevent the release of hazardous substances into the environment.
Amendment
This amendment implements the additions to Annex III of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment.

Annex III contains a list of applications which are exempt from the Directive and which are therefore exempt from these implementing Regulations. This is done by updating the definition of the Directive to include reference to them:

These exempt applications are very specific and do not make overarching changes to the EEE to which these Regulations apply.

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Jurisdiction:  EU

Commencement: Comes into force on the 30th of January 2020. Applies from the 1st of January 2020 

Amends: Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures

 
Mini Summary

Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures introduces a globally harmonised system of classification and labelling of chemicals into European law. It supplements the REACH Regulation for the registration, assessment, authorisation and restrictions concerning chemical substances. The Regulations require that substances and mixtures are classified according to the physical hazards, the health hazards or the environmental hazards that they create. They also detail the labelling and packaging requirements.

Amendment
Amendments are made to article 25 (Supplemental information on the label) and article 29 (Exemptions from labelling and packaging requirements) to give additional clarification on where unique formula identifiers* (‘UFIs’) are to be placed on products.

* A unique formula identifier is a unique code of letters and numbers that links the information on the composition of a mixture or a group of mixtures to a specific mixture or group of mixtures.

Amendments are also made to Annex VIII (Harmonised information relating to emergency health response and preventative measures), which was introduced by Regulation (EU) 2017/542 amending Regulation (EC) 1272/200 on classification, labelling and packaging of substances and mixtures by adding an Annex on harmonised information relating to emergency health response (‘2017 Regulations’), in order to streamline its interpretation and mitigate some unintended consequences of its introduction.
Amendment to unique formula identifier labelling 
Amendments are made to provide clarification on the placing on labels of UFIs. The places that a UFI can be displayed are:


Extension to the compliance date for consumer products

The deadline for submitters placing hazardous mixtures on the market for consumer use (as outlined in Annex VIII of Regulation (EC) 1272/2008) to start complying with the new rules has been extended from 1st January 2020 to 1st January 2021. This is to allow sufficient time to develop necessary solutions to unforeseen problems with the 2017 Regulations (e.g. the difficulty of knowing the exact composition of products in cases involving complex supply chains).

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