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What is REACH?

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.

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[1] and importers[2] responsible for understanding and managing the risks associated with their use.)
  • To allow the free movement of substances[3] 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 e.g. quantitative structure-activity relationships (QSAR) and read across.

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)[4] 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!

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Scope and exemptions

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[5] or in articles[6] (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[7]
  • 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:

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Pre-registration

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:

To benefit from these phased-in deadlines manufacturers or importers need to pre-register their substances from 1st June to 1st December 2008.

Pre-registration is not a legal requirement of REACH but is strongly advised by the UK Competent Authority.

For more information on pre-registration see the ‘what do I need to do?[11]’ page.

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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 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 link to external website[12].

For further information on timing, see the when do I have to comply with REACH[13] page.

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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 (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[14] (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.

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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 labeling.

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.

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Authorisation

In order to place on the market or use substances 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 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 are then they must prepare substitution plans and if not then they should provide information on research and development activities if appropriate.

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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.

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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.

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Substances of Very High Concern

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 (bioaccumulative). These are substances of very high concern PDF[19]. 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.

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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 PDF[20]. 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.

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