The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019/758) and the REACH etc. (Amendment etc.) (EU Exit) (No. 2) Regulations 2019 (SI 2019/858)
Commencement: These Regulations come into force on the day the UK leaves the EU (‘Exit Day’)
The REACH Enforcement Regulations 2008
Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
The REACH (Appointment of Competent Authorities) Regulations 2007
European Regulation 1907/2006 (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 some duties and restrictions on downstream users of some very hazardous chemicals.
REACH is a directly acting Regulation, meaning that it has direct application in EU member states, and breach of the regulation can be prosecuted by national regulators.
These amendments change how REACH will apply in the UK on the basis that the UK leaves the EU without a transition period. In the event that the UK leaves the EU with a deal, it is anticipated that there will be a transition period during which EU Regulations will continue to be directly applicable in the UK. In that event, the UK Government will pass additional legislation which is likely to change the implementation timescales in these Amendment Regulations.
On the day the UK leaves the EU (‘Exit Day’) the REACH Regulation in its form immediately before ‘Exit Day’ is incorporated into UK domestic legislation (i.e. it will continue to be enforceable in the UK). This is enacted by the European Union (Withdrawal) Act 2018. Subsequent amendments to REACH made by the EU after ‘Exit Day’ are not incorporated into UK domestic law unless by separate UK legislation.
The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 and The REACH etc. (Amendment etc.) (EU Exit) (No. 2) Regulations 2019 make multiple changes to REACH to ensure that it operates effectively in the UK.
The REACH Enforcement Regulations 2008
The REACH Enforcement Regulations 2008 provide for the enforcement of the REACH Regulation in the United Kingdom. The REACH Enforcement Regulations 2008 do not directly create any duties for manufacturers or suppliers of chemicals, but rather they list which agency is responsible for enforcement of each relevant provision of the REACH Regulation, and cover powers of enforcement, exemptions, offences and penalties, appeals and revocations and amendments.
The key change to this regulation is to transfer functions which were performed by the European Commission and the European Chemicals Agency back to UK Ministers and the Health and Safety Executive (HSE). The REACH Enforcement Regulations 2008 are amended to change certain references from EU institutions to UK institutions, and to delegate enforcement functions for some aspects of the revised REACH Regulation to the HSE (or HSE Northern Ireland).
The changes to the REACH Enforcement Regulations do not create any duties for businesses.
Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals
In order to ensure that REACH works effectively within UK jurisdiction and context, parts of REACH need to be amended insofar as they apply to the UK. These amending Regulations therefore make multiple technical revisions to REACH.
The effect of these changes is that following ‘Exit Day’, there are two parallel “REACH regimes”. The EU REACH regime which remains unchanged, and a similar but not identical UK REACH regime.
Under the UK REACH regime, the general principles and concepts in EU REACH remain unchanged, and the duties of businesses that make or supply chemicals are essentially the same. However, the administration and regulation of REACH is significantly changed. UK organisations will no longer be able to access EU bodies such as the European Chemicals Agency (ECHA). Therefore in the UK, the Health and Safety Executive (HSE) will perform similar functions to that of the ECHA in the EU, and organisations making or selling chemicals in the UK will need to register those chemicals with the HSE.
The key amendments are summarised briefly below:
Terminology and definitions
- ‘EU REACH’ is defined to mean the REACH Regulation (i.e. Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals) as it has effect in the EU.
- ‘REACH’ is defined to mean the REACH Regulation insofar as it is retained in UK legislation and amended by these amending Regulations. For clarity in this summary, REACH as it applies in the UK is referred to below as ‘UK REACH’.
- EU REACH as published on the European Commission website has been revised by the EU multiple times but the latest published version does not contain the most recent revisions. Consequently these amending Regulations revise UK REACH to reflect correct up to date references to EU legislation.
- Multiple references to EU entities and EU legislation are changed to references to UK entities (e.g. the Secretary of State, the HSE, Food Standards Agency, Medicines and Healthcare Products Regulatory Agency etc.) and UK legislation.
- EU REACH contains multiple references and requirements for ensuring harmonisation across the EU e.g. requirements for cooperation and communication between national competent authorities, member states and ECHA. These references and requirements are revised to provide for cooperation and communication where relevant between different UK regulators and the HSE.
UK regulators and powers
- Powers of the European Commission (EC) under EU REACH are mostly allocated to the Secretary of State under UK REACH.
- EU REACH creates the ECHA, referred to as ‘the Agency’. UK REACH redefines ‘the Agency’ to mean the HSE.
- Detailed provisions under EU REACH concerning the composition, legal status and funding of ECHA are removed from UK REACH.
- Note that after ‘Exit Day’, UK organisations can no longer register substances with the ECHA, but rather will have to do so with the HSE.
- The scope of the HSE’s functions, and also those of the Secretary of State, are defined. The scope of the HSE’s functions under UK REACH are very similar but not identical to those of ECHA under EU REACH.
- In some cases the HSE is required to seek consent of devolved government in England, Wales, Scotland and Northern Ireland prior to exercising certain functions, and also to consult with other bodies such as UK environmental regulators when exercising its functions under REACH.
- The EC can specify certain fees under EU REACH. Under UK REACH, similar fees may be specified in Regulations by the Secretary of State.
- Requirements for cooperation with other EU countries and national authorities are removed.
- EU REACH sets out certain dates or timescales for action to be taken by ECHA, the Commission or other bodies. UK REACH updates or slightly revises dates and timescales for action by the HSE, Secretary of State or other bodies.
- EU REACH provides for creation of certain administrative bodies including the ‘management board’, ‘Committee for Risk Assessment’, ‘competent authorities’, ‘Board of Appeal’ etc. UK REACH does not provide for these bodies. Certain functions of the ‘management board’ or ‘competent authorities’ under EU REACH are allocated to the Secretary of State or HSE under UK REACH.
- Article 129 of EU REACH provides for EU countries to take provisional measures to protect human health or the environment pending review by ECHA and the EC. UK REACH provides similar powers for appropriate authorities and devolved government.
The internal market
- The ‘internal market’ (i.e. the EU) is changed to the UK market.
- EU REACH prohibits EU countries from restricting the manufacture, import, placing on the market etc of substances governed by REACH. This requirement is removed from UK REACH (i.e. the UK Government can prohibit or restrict substances in the UK which cannot be prohibited or restricted by EU countries in the EU).
Candidate list, authorisation list, restriction list
- The HSE must include in its ‘Candidate List’ all substances in the ECHA’s ‘Candidate List’ immediately before ‘Exit Day’.
- The HSE will be required to make its first recommendations for inclusion of substances in Annex XIV (the ‘authorisation list’) by 01.06.2020. The Secretary of State can make Regulations to remove substances from the authorisation list if they are no longer determined to meet the criteria for inclusion in Annex XIV.
- The Secretary of State can make Regulations to add substances to Annex XVII (the ‘restriction list’).
- EU REACH allows EU countries to submit dossiers proposing restriction of certain substances posing significant risk to human health or the environment. UK REACH provides for the HSE to be able to submit such dossiers to the Secretary of State.
- The Secretary of State may determine that a substance on the restriction list should be re-examined, in which case the re-examination is completed by the HSE.
- The Regulation defines which scientific knowledge and advice the HSE must take account of when forming opinions in relation to authorisation or restriction applications.
Registration of substances
Note that under the provisions below, even where an organisation does not have an immediate requirement to register a substance with HSE, they may be required to file certain information with HSE within defined timeframes.
EU REACH contained phased transitional arrangements for certain substances (‘phase-in substances’) over a number of years to give organisations time to reach compliance. Provisions for these transitional arrangements are removed from UK REACH (as the dates within EU REACH have already passed).
Existing EU registrations (i.e. registrations held with ECHA)
These are copied across on ‘Exit Day’ to become UK registrations (referred to as ‘transferred UK registrations’), held with HSE, provided that the holder of the registration is or was established in the UK within the 2 years prior to ‘Exit Day’.
- The UK registrant of a ‘transferred UK registration’ must submit certain information to the HSE within 60 days of ‘Exit Day’, and other information within 2 years of ‘Exit Day’. Schedule 2 of the these Regulations set out further details concerning this process.
- A manufacturer can continue to manufacture a substance covered by a ‘transferred UK registration’ unless informed otherwise by the HSE.
- There is no fee payable for ‘transferred UK registrations’.
- Existing decisions made by ECHA in relation to an EU registration before ‘Exit Day’, will become decisions of the HSE in relation to a registration which becomes a transferred UK registration. Registrants must notify the HSE of any decisions within 60 days of ‘Exit Day’ and supply any further information as required by the HSE.
- Existing EU decisions on testing proposals in relation to UK based registrants or downstream users have effect as though decisions of the HSE after ‘Exit Day’.
- If a registration received by ECHA by 01.06.2016 contained certain testing proposals, EU REACH required the ECHA to submit a draft decision by 01.06.2022. UK REACH allows HSE to prepare a draft decision by 01.06.2023.
Research and Development exemptions
EU REACH allows 5 years or longer extended exemptions from registration requirements, when the substances which would otherwise be subject to registration, are used for research and development. Where a UK based person benefits from that exemption under EU REACH immediately before ‘Exit Day’ the same exemption applies in UK REACH after ‘Exit Day’. The manufacturer or importer or producer must notify the HSE of certain specified information within 60 days after ‘Exit Day’.
EU REACH makes provision for data sharing between different organisations registering the same substance. There are minor procedural changes to data sharing under UK REACH.
Under EU REACH, a UK based ‘distributor’ or ‘downstream user’ who imported chemicals from a registrant based in another EU country, was not required to register those chemicals with ECHA (because import from one EU state to another did not trigger registration requirements).
Under UK REACH, an existing UK distributor or downstream user who imports 1 tonne or more of a substance from outside the UK will be required to register them with HSE. However, if the existing UK distributor or downstream user was classed as a distributor or downstream user under EU REACH in the 2 years prior to ‘Exit Day’, and they are importing from outside the UK, and the relevant supplier in that state is either an EU registrant or downstream user or an only representative of the manufacturer, under EU REACH, then the existing UK distributor or downstream user will not be required to register chemicals imported (whether in on its own, in a, mixture or article) within 2 years after ‘Exit Day’:
- UK users or distributors importing 1 tonne or more of a substance must supply information set out in the Regulation to the HSE within 180 days of ‘Exit Day’. The information which must be supplied is slightly different depending on whether the quantity imported is 1-10 tonnes, or more than 10 tonnes.
- The non-UK manufacturer can appoint a UK based only-representative who can make the notification instead of the UK user or distributor.
Notification of articles
Existing article notifications: UK based producers or importers of articles which have been notified to the ECHA must submit the same information to the HSE within 60 days after ‘Exit Day’.
Existing EU Authorisations
- If a UK based person or organisation has an ‘authorisation’ issued under EU REACH on ‘Exit Day’, the holder must supply certain specified technical information to the HSE within 60 days after ‘Exit Day’.
- Authorisations granted under EU REACH to a holder not based in the UK, are not recognised under UK REACH.
Existing applications for authorisations under EU REACH
Where a UK based applicant has an outstanding application for authorisation under EU REACH on ‘Exit Day’, and they notify the Secretary of State and provide certain specified information, the Secretary of State must decide the application within 6 months.
Existing authorised downstream users
- A UK based person who is an existing authorised ‘downstream user’ under EU REACH on ‘Exit Day’, becomes authorised under UK REACH. An ‘authorised downstream user’ is a user who is using a substance in accordance with the conditions in an authorisation granted to a person up their supply chain. The UK based authorised downstream user must notify the HSE of certain specified information concerning the authorisation within 60 days of ‘Exit Day’.
- Where an authorisation under EU REACH ceases to be be valid, the downstream user will also cease to be authorised.
EU REACH includes asbestos in Annex XVII (the restriction list), but makes certain limited exceptions to the restriction of asbestos. UK REACH removes those exceptions, because all asbestos products have been prohibited in the UK since 1999.
Safety data sheets
- Safety Data Sheets only need to be compiled in English (N.b. for organisations selling chemicals to customers in the EU, even though UK REACH only requires Safety Data Sheets in English, EU based distributors will require Safety Data Sheets in the languages of the intended destination countries).
- EU REACH requires Safety Data Sheets to include details of relevant national exposure limits. UK REACH will only require UK based exposure limits.
Retention of information
- Manufacturers, importers, distributors and downstream users have an obligation under EU REACH to retain certain information for 10 years. Where a UK based person or organisation was obliged to retain such information under EU REACH prior to ‘Exit Day’ that obligation continues for the remainder of the 10 year period post ‘Exit Day’.
- EU REACH provides for appeals against certain decisions initially to ECHA then to the Board of Appeal. UK REACH provides for appeal to the HSE then to the First-tier Tribunal. The appeal process under UK REACH is slightly modified from that under EU REACH. [April / May 2019]