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Jean-Yves Gilg

Editor, Solicitors Journal

REACH's impact on personal injury

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REACH's impact on personal injury

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New requirements under European chemicals legislation will have major implications for safety lawyers, says Victoria Handley

Reach is perhaps one of the most important pieces of legislation to affect manufacturers and importers of chemicals to have come out of the European Union. It is also of vast importance to solicitors concerned with health and safety law and injury claims in particular.

It came into force on 1 June 2007 and replaces a number of European Directives and Regulations with a single system. Reach means: Registration, Evaluation, Authorisation and restriction of Chemicals. By 1 June 2018 all chemicals will be classified together with their effects and side-effects on humans and the environment. Thus for personal injury claims there will be a wealth of documentation available for disclosure in relation to chemical use and testing together with the potential side-effects on the public and employees.

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.

Manufacturers or importers of substances are required to register all chemicals they use or manufacture with a central European Chemicals Agency (ECHA). The registration package is to 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 a substances is not registered, then the data on them will not be available and as a result, the importer or manufacturer will no longer be able to manufacture or supply them legally. This restriction is in place to ensure compliance with the legislation, that is no data, no market!

When does REACH apply?

REACH applies to substances (individual chemical substances on their own, in preparations or in articles) manufactured or imported into the EU in quantities of one tonne per year or more. Some substances are specifically excluded such as radioactive substances, substances under customs supervision, the transport of substances, non-isolated intermediates, waste and some naturally occurring low-hazard substances.

Some substances, covered by more specific legislation, have tailored provisions, including such as human and veterinary medicines, food and foodstuff additives and plant protection products and biocides.

Other substances have tailored provisions within the REACH legislation, as long they are used in specified conditions.

For industrial disease, health and safety and personal injury lawyers, the registration of an estimated 30,000 substances on the European Market will assist greatly in the identification of chemicals and their side effects. Research into exposure limits and effects on employees and the public will be in the public domain.

The registration of chemicals will be a huge task and thus for those substances already being manufactured or supplied registration is to take place in three phases spread over 11 years.

However, to benefit from these phased-in deadlines manufacturers or suppliers need to pre-register their substances from 1 June 2008 to 30 November 2008 (inclusive). Pre-registration is not a legal requirement of REACH but is strongly advised by the UK Competent Authority.

What will registration entail?

Manufacturers and importers are required 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 will then be 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.

It is expected that once information is gathered into the control of these chemicals and their use there will be a duty placed on each manufacturer and importer to adhere to proper control measures.

Anyone dealing with chemicals will be aware that their chemicals carry specified risks and be expected to introduce risk control. Their date of knowledge will run from this research (if such research has not already been carried out). Information on chemical safety will have to be clear.

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. In future there will be an EU classification and labelling system based on the United Nations Globally Harmonised System, or GHS.

Joint registration and data sharing

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.

It is expected 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 (for example how it is used) information is submitted separately by each company.

Companies are expected to 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. Effectively many businesses will be expected to share sensitive information on produce use and profitability. This has implications for patent lawyers in terms of data sharing.

Chemicals 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) that is 'substances of high concern'. 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.

To place on the market or use substances with properties that are deemed to be of 'very high concern' the industry must apply for authorisation by submitting an application. 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. The European Chemicals Agency is to publish a list containing substances to be considered for the authorisation process by 1 June 2009. Decisions on authorisation are made by the European Commission.

Where a substance poses a particular threat it can be restricted. This can take the form of 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.

Reach has far reaching consequences for manufacturers, importers and users of chemicals but for employees, the public and lawyers involved in personal injury and health and safety the legislation is vastly important. Information gained through registration, research and data sharing will impact in businesses risk assessment procedures and safety procedures when using chemicals.

Liability decisions will be quicker and more transparent. In time chemicals of 'high concern' will be phased out in favour of chemicals which are kinder to humans and the environment. Eventually, instances of industrial disease and injury as a result of chemical use will diminish. This can only be a positive step for future generations.