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REACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. It came into force on 1st June 2007 and replaces a number of European Directives and Regulations with a single system.
REACH has several aims:
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!
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:
Some substances, covered by more specific legislation, have tailored provisions, including:
Other substances have tailored provisions within the REACH legislation, as long as they are used in specific conditions:
It is estimated that there are around 30,000 substances on the European Market in quantities of 1 tonne or more per year. Registering all of these at once would be a huge task for both industry and regulators. To overcome this, the registration of those substances already being manufactured or supplied is to take place in three phases. These phases are spread over 11 years; details of this timeline can be found by clicking here. To benefit from these phased-in deadlines manufacturers or suppliers need to pre0register their substances from 1st June to 30th November 2008 (inclusive). Pre-registration is not a legal requirement of REACH but it is strongly advised by the UK Competent Authority. Further information on registration can be found on the ECHA website by clicking here.
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 information on registration can be found on the ECHA website by clicking here.
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.
Dossiers submitted in support of registration will be subject to evaluation under REACH as follows:
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.
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. The European Chemicals Agency (ECHA) in Helsinki will publish a list containing substances to be considered for the authorisation process by 1st 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. 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.
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.
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. 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.
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.
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.
Almost every business in the UK will have a new responsibility under 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.
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. Registrants should consider pre-registration of substances between 1st June 2008 and 30th November 2008.
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.
REACH enforcement activities have already begun in earnest. From 1 December 2008 the UK Competent Authority (i.e. HSE) REACH Compliance email account and phone line went live, and has already experienced a surprisingly large number of enforcement enquiries. The HSE’s enforcement webpage contains some useful simplified information on enforcement and compliance issues, as well as contact information, and is well worth a visit: http://www.hse.gov.uk/reach/enforcement.htm
The HSE has also begun to carry out a number of REACH compliance investigations. Currently this course of action is reactively driven, though proactively they are in the final stages of putting together a robust inspection procedure and will begin proactive enforcement activity very soon.
The HSE have been running a series of inspector training events on REACH up and down the country during January and into February. And so you can expect inspectors to begin questioning company compliance.
The UK will also take part in an EU-wide co-ordinated inspection project centred on registration in the second half of this year (this was agreed at the last European Chemicals Agency enforcement forum meeting).
Other enforcement activity includes the establishment and first meeting of the UK REACH Enforcement Liaison Group (Nov 08) This Group has taken responsibility for progressing the draft UK REACH Enforcement Strategy and the Memorandum of Understanding on REACH Enforcement, both of which should be finalised during the first half of this year.