Technical Library: EU REACH and UK REACH
- What is EU REACH?
- UK REACH – Post BREXIT
- EU and UK REACH
- Aims of UK REACH
- Your duties under UK REACH
- Scope and Exemptions under UK REACH
- Sources of Information for EU and UK REACH
- EU Press Releases
- Aims of EU REACH
- No data, no market – EU REACH
- Scope and exemptions under EU REACH
- Registration under EU REACH
- Joint registration and data sharing under EU REACH
- Evaluation under EU REACH
- Authorisation under EU REACH
- Restrictions under EU REACH
- Classification and labelling under EU REACH
- Substances of very high concern under EU REACH
- Information in the supply chain under EU REACH
- What is your role in EU REACH?
What is EU REACH?
EU REACH is a European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. It came into force on 1st June 2007 and replaced a number of European Directives and Regulations with a single system.
UK REACH – Post BREXIT
UK REACH is a regulation that applies to the majority of chemical substances that are manufactured in or imported into Great Britain, (GB), (England, Scotland, Wales). This can be:
- A substance on its own
- A substance in a mixture, for example ink or paint
- A substance that makes up an ‘article’ – an object that is produced with a special shape, surface or design, for example a car, furniture or clothes.
REACH stands for registration , evaluation, authorisation and restriction of chemicals.
These individual topics can be explored further at the preceding links to the HSE website.
EU and UK REACH
Under the European Union, (Withdrawal), Act 2018, the EU REACH Regulation was brought into UK law on 1 January 2021 and is known as UK REACH.
EU REACH, and related legislation, were replicated in the UK with the changes needed to make it operable in a domestic context. The REACH Statutory Instruments that made these changes can be found on legislation.gov.uk. The key principles of the EU REACH Regulation were retained in UK REACH.
Consequently, with that in mind many of the original sections on this page which related to the EU REACH regulations have been retained in this updated version, but you should still consult the UK REACH regulations for the final word on this topic, as it relates to goods destined for the GB/home market.
NB The UK REACH and the EU REACH regulations operate independently from each other. You must ensure you comply with both regulations, where necessary.
UK REACH regulates chemicals placed on the market in GB.
Under the terms of the Northern Ireland Protocol, EU REACH continues to apply in Northern Ireland.
Aims of UK REACH
The aims of UK REACH include to:
- provide a high level of protection of human health and the environment from the use of chemicals
- make the people who place chemicals on the market, (manufacturers and importers), responsible for understanding and managing the risks associated with their use
- promote the use of alternative methods for the assessment of the hazardous properties of substances – for example quantitative structure-activity relationships, (QSAR), and read across
Your duties under UK REACH
Your business must identify and manage the risks presented by substances you manufacture and place on the market in GB. You must be able to demonstrate how the substance can be used safely and you must communicate the risk management measures to the users.
You will need to consider your role in the supply chain in GB and how you use chemicals to determine what your obligations may be. Your previous role under EU REACH may have changed significantly under UK REACH, so you should review your role(s), (previous GB downstream users under EU REACH may now be importers under UK REACH).
UK REACH:
- covers all sectors manufacturing, importing, distributing or using chemicals as raw materials or finished products, (not only the chemical industry)
- applies regardless of your company size
- makes you responsible for the safe use of the substances you place on the market or use
- requires every actor in the supply chain to communicate information on the safe use of chemicals
Scope and exemptions under UK REACH
Generally, UK REACH applies to all individual chemical substances on their own, in mixtures or in articles. Some aspects of UK REACH only apply at one tonne per year or more. For more information go to the HSE guidance on UK REACH registration.
Some substances are specifically excluded:
- Radioactive substances
- Substances under customs supervision
- The transport of substances
- Non-isolated intermediates
- Waste
- Some naturally occurring low-hazard substances
Some substances, covered by more specific legislation, have tailored provisions under UK REACH, including:
- Human and veterinary medicines
- Food and foodstuff additives
- Plant protection products and biocides
- Isolated intermediates
- Substances used for research and development
NB You can subscribe to updates on the HSE website here.
Sources of information for EU and UK REACH
EUROPA website
HSE website
REACH Impact website
ECHA website (European Chemicals Agency)
Eurofer also have a useful and up to date datasheet, that relates specifically to stainless steels, which can be obtained from here.
EU Press Releases
ECHA 9th October 2008
ECHA 4th November 2008
All the subsequent Press Releases up to the present date from the ECHA can be found here.
Aims of EU REACH
EU REACH has several aims:
- To provide a high level of protection of human health and the environment from the use of chemicals.
- To make the people who place chemicals on the market responsible for understanding and managing the risks associated with their use.
- To allow the free movement of substances on the EU market
- To enhance innovation in the competitiveness of the EU chemicals industry.
- To promote the use of alternative methods for the assessment of the hazardous properties of substances
No data, no market – EU REACH
A major part of REACH is the requirement for manufacturers or importers of substances to register them with a central European Chemicals Agency, (ECHA). A registration package will be supported by a standard set of data on that substance. The amount of data required is proportionate to the amount of substance manufactured or supplied. If you do not register your substances, then the data on them will not be available and as a result, you will no longer be able to manufacture or supply them legally, i.e. no data, no market!
Scope and exemptions under EU REACH
REACH applies to substances manufactured or imported into the EU in quantities of 1 tonne per year or more. Generally, it applies to all individual chemical substances on their own, in preparations or in articles, (if the substance is intended to be released during normal or reasonably foreseeable conditions of use from an article).
Some substances are specifically excluded:
- Radioactive substances
- Substances under customs supervision
- The transport of substances
- Non-isolated intermediates
- Waste
- Some naturally occurring low-hazard substances
- Some substances, covered by more specific legislation, have tailored provisions, including:
- Human and veterinary medicines
- Food and foodstuff additives
- Plant protection products and biocides
- Other substances have tailored provisions within the REACH legislation, as long as they are used in specific conditions:
- Isolated intermediates
- Substances used for research and development
Registration under EU REACH
Registration is a requirement on industry, (manufacturers/importers), to collect and collate specified sets of information on the properties of those substances they manufacture or supply at or above 1 tonne per year. This information is used to perform an assessment of the hazards and risks that a substance may pose and how those risks can be controlled. This information and its assessment is submitted to the European Chemicals Agency in Helsinki. Further updated information on registration can be found on the ECHA website by clicking here.
Joint registration and data sharing under EU REACH
This is the principle that for any one substance, a single set of information on its intrinsic properties is produced and is shared by all the companies that manufacture or supply that substance. Business specific, (e.g. company name), and business sensitive, (e.g. how it is used), information is submitted separately by each company. The companies will work together to get an agreement on information sharing through a Substance Information Exchange Forum, (SIEF), the details of how this information is shared is the responsibility of the businesses involved. Companies who submit joint registrations via a SIEF benefit from a reduced registration fee.
Evaluation under EU REACH
Dossiers submitted in support of registration will be subject to evaluation under REACH as follows:
- Compliance checking: This is a check of the quality of the information submitted by industry. It will be undertaken by the European Chemicals Agency in Helsinki and will be on a sample, (at least 5%), of dossiers submitted at each tonnage level.
- Dossier Evaluation: For substances registered at the highest tonnage levels, (≥100 tonnes/annum), a proposal is made by the registrant detailing those animal tests they consider are required from the list of standard tests. The ECHA will evaluate these testing proposals to prevent unnecessary animal testing.
- Substance evaluation: This is undertaken by national Competent Authorities on substances that have been prioritised for potential regulatory action because of concerns about their hazardous properties. A key regulatory outcome of evaluation could be the imposition of restrictions on the manufacture, supply or use of a substance. Substance evaluation may also lead to a substance being added to the priority list for authorisation or a proposal to change the classification and labelling. All dossiers will undergo an automated completeness check to ensure that all the relevant pieces of information are present. This completeness check will not assess the quality or suitability of the information. Further information on evaluation can also be found on the ECHA website by clicking here.
Authorisation under EU REACH
In order to place on the market or use any substance with properties that are deemed to be of ‘very high concern’ industry must apply for an authorisation. A company wishing to market or use such a substance must submit an application to the ECHA for an authorisation. Decisions on authorisation are made by the European Commission. Applicants will have to demonstrate that risks associated with users of these substances are adequately controlled or that the socio-economic benefits of their use outweigh the risks. Applicants must also analyse whether there are safer suitable alternatives or technologies. If there are then they must prepare substitution plans, and it not then they should provide information on research and development activities if appropriate. Further details on authorisation can be found on the ECHA website by clicking here.
Restrictions under EU REACH
Any substance that poses a particular threat can be restricted. Restrictions take many forms, for example, from a total ban, to not being allowed to supply it to the general public. Restrictions can be applied to any substance, including those that do no require registration. This part of REACH takes over the provisions of the Marketing & Use Directive. Further information on restrictions can be found on the ECHA website by clicking here.
Classification and labelling under EU REACH
An important part of chemical safety is clear information about any hazardous properties of a substance. The classification of different chemicals according to their characteristics, (for example, those that are corrosive, or toxic to fish, etc.) currently follows an established system, which is reflected in EU REACH. Over the next few years, work is underway to establish in the EU a classification and labelling system based on the United Nations Globally Harmonised System, or GHS. REACH has been written with GHS in mind. Further information on classification and labelling can be found on the ECHA website by clicking here.
Substances of very high concern under EU REACH
Some substances have hazards that have serious consequences, e.g. they cause cancer, (carcinogenic), or they have other harmful properties and remain in the environment for a long time, (persistent), and gradually build up in animals, (bio-accumulative). These are ‘substances of high concern’. This category also includes substances demonstrated to be of equivalent concern, such as “endocrine disruptors”. One of the aims of REACH is to control the use of such substances via authorisation and encourage industry to substitute these substances for safer ones.
Information in the supply chain under EU REACH
The passage of information up and down the supply chain is a key feature of REACH. Users should be able to understand what manufacturers and importers know about the dangers involved in using chemicals and how to control risks. However, in order for suppliers to be bale to assess these risks they need information from the users about how they are used. REACH provides a framework in which information can be passed both up and down supply chains. REACH adopts and builds on the previous system for passing information – the Safety Data Sheet. This should accompany materials down through the supply chain, providing the information users need to ensure chemicals are safely managed. In time these safety data sheets will include information on safe handling and use.
What is your role in EU REACH?
Almost every business in the UK will have certain responsibilities under EU, (& thus UK), REACH. There are three main types of REACH duty holder, which are explained below – you may also wish to look at the navigator tool provided by the European Chemicals Agency, (ECHA), to see how you fit in.
Manufacturers/Importers
Businesses that manufacture or import, (from outside of the EU), 1 tonne or more of any given substance each year are responsible for registering a dossier of information about that substance with the European Chemicals Agency. Because substances in articles also count, (if these substances are intended to be released), it’s possible that some manufacturers/importers of such articles will be registrants.
The registrant directs downstream users in the appropriate risk management measures for any particular use of the substance and responds to other players on other aspects of REACH.
Downstream Users
Downstream users include any business using chemicals, which probably includes most businesses in some way. Companies that use chemicals have a duty to use them in a safe way, and according to the information on risk management measures that should be passed down the supply chain. There is also an opportunity to pass information about use back to registrants so that this can be taken account of when assessing the risks of chemical used. Downstream users may need to supply risk assessment and risk management measures to the European Chemicals Agency if they don’t want their supplier to know about how they use the chemicals. Some users may also be importers and have a duty to register.
Other actors in the supply chain
Businesses that sell chemicals have specific duties to pass information down to their customers, and also to pass information back to their own suppliers when customers ask them to do so.
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