What is REACH?
REACH is a European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of Chemicals. It came into force on 1 June 2007 and replaced a number of European Directives and Regulations with a single system.
Aims
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 (manufacturers and importers 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 and the competitiveness of the EU chemicals industry
- to 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
Scope and exemptions
REACH applies to substances manufactured or imported into the EU in quantities of one tonne or more per year. 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 and 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 they are used in specified conditions:
- isolated intermediates
- substances used for research and development
The registration process
No data, no market
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.
Registration
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 one 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 information on registration can be found on the ECHA website.
Joint registration and data sharing
This is the principle that for any one substance, a single set of information on its intrinsic properties is produced that is shared by all those companies that manufacture or supply that substance. Business specific (for example, company name) and business sensitive (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 in the SIEF. A role for national authorities in this aspect of REACH is not foreseen.
Companies who submit joint registrations via a SIEF benefit from a reduced registration fee.
Other REACH processes
Evaluation
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 (ECHA) 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 in Annexes IX and X of REACH. 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.
Substances of Very High Concern
Some substances have hazards that have serious consequences, for example 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 (bioaccumulative). These are substances of very 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.
Authorisation
Some of the substances with properties that are deemed to be of "very high concern" are added to Annex XIV of REACH. For these, in order to place the substances on the market for a use or for their own use industry must apply for an authorisation. The European Chemicals Agency (ECHA) in Helsinki will publish an initial list containing substances to be considered for the authorisation process by 1 June 2009. 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, taking advice from the ECHA and member states. Applicants will have to demonstrate that risks associated with uses 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 arealternatives available, but it would take time to implement these alternatives, then they must prepare substitution plans; if not then they should provide information on research and development activities (if appropriate).
Restrictions
Any substance that poses a particular threat that is deemed to require Community-wide action 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 not require registration. This part of REACH takes over the provisions of the Marketing & Use Directive.
Supply/use duties
Classification and labelling
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 REACH. A new EU CLP regulation will come into force from January 2009 and will dovetail with REACH.
Information in the supply chain
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 able 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.
Resources
UK REACH, the UK’s independent chemicals regulatory framework, starts on 1 January 2021. Anyone importing, manufacturing or distributing chemicals in GB and/or Northern Ireland needs to understand how the UK REACH and EU REACH rules might affect their business after 1 January 2021.