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REACH Processes

Registration

Manufacturers and Iimporters are required to collect and collate specified sets of information on the properties of the substances they manufacture or supply ³1 tonne per year. Manufacturers and Importers must then use this information to perform an assessment of the hazards and risks that a substance may pose and how those risks can be controlled. If the substance is manufactured or imported in quantiiteis ³ 10 tonnes per year, this assessment must be formalised in the Chemical Safety report.

This information and its assessment must then be submitted to the European Chemicals Agency in Helsinki using the IUCLID 5.0 softweare.

As part of the registration process, Manufactuers and Importers are encourages to share data and submit a joint registration. Companies will work together to get an agreement on information sharing through a Substance Information Exchange Forum (SIEF). There are no requirements for how the SIEF will work it is up to the companies involved. the details of how this information is shared is the responsibility of the businesses involved. It is expected that one company, appointed as the lead registrant will submit a single dossier on the intrisic properties of the substnace. Each individual company will also submit a dossier with their business specific (e.g. company name) and business sensitive (e.g. how it is used) information. Companies who submit joint registrations via a SIEF benefit from a reduced registration fee.

Evaluation

Dossiers submitted in support of registration will be subject to evaluation under REACH. Two types of Evaluation are envisaged:

Compliance checking

	All dossiers will undergo an automated completeness check to ensure that all the relevant pieces of information are present.
	At least 5% of dossiers submitted will then undergo a check of the quality of the information submitted.

Promote alternative methods for the assessment of hazards of substances

Substances identified as being of concern due to their hazardous properties may be evaluated by Member State Competent Authorities. This may lead to requests for further information, and possibly to the substance being added to the priority list for authorisation.

Authorisation

Substances identifed as being of very high concern will be subject to the Authorisation process. The Authorisation process will require companies to submit an application for authorisation to the European Chemicals Agency (ECHA) in Helsinki. Applicants will have to demonstrate that the risks associated with the use of the substance are adequately controlled or that the socio-economic benefits of it’s use outweighs 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.

Substances of Very High Concern are those 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). 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.

Restrictions

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 not require registration. This part of REACH takes over the provisions of the Marketing & Use Directive.

Information in the supply chain

The passage of information up and down the supply chain is a key feature of REACH. The Safety Data Sheet is a key part of this process and REACH extends this document to include additional information on how the substance can be safely used an handled. Communication is a two-way process, and REACH also obliges users of chemicals to provide information to their suppliers on how they use the substances and on any new hazards they may identify.

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.