On 30 December 2006, a new regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (regulation 1907/2006) (“REACH”) was enacted by the European Parliament and Council. Although REACH comes into force on 1 June 2007 and has direct effect1 in the UK, the deadlines for compliance are a number of years away. At present, it is not clear what, if any, legislation will be enacted by the UK government to assist the operation of REACH.
REACH will require producers and importers of chemicals to register those chemicals together with information needed to use them safely. The European Parliament and Council hope that the better management of chemicals will improve the protection of human health and the environment and also enhance the competitiveness of the EU chemicals industry. REACH will encourage the chemicals industry to replace the most dangerous substances with safer alternatives.
Why is REACH needed?
One of the main problems with existing EU chemicals legislation is that there is an arbitrary distinction between “existing” and “new” chemicals, with classification depending on when the chemical was placed on the market. Chemicals placed on the market before 1981 are listed on the European Inventory of Existing Commercial Chemical Substances. Often, only a small amount of information is known about how these substances should be controlled and their potentially dangerous effects. In contrast, substances placed on the market after 1981 are known as “new” substances and have been more rigorously tested. Consequently, considerably more is known about “new” substances. The number of “existing” substances (approximately 100,000) greatly outnumbers the number of “new” substances (approximately 4,000). This distinction is viewed as a major problem.
Other perceived problems with the current system include its slow and resource intensive nature, the fact that responsibility for the assessment of substances is currently placed on regulatory authorities rather than producers and the lack of information on uses of substances.
Which substances will REACH apply to?
REACH will apply to all substances (defined as a chemical elements and their compounds, whether natural or manufactured), whether they are on their own, in preparations (mixtures of two or more substances) or in articles (manufactured objects). REACH will only be triggered where more than one tonne of a particular substance (in whatever form) is produced or imported by a particular person.
The obligations under REACH will apply to both “existing” and “new” substances, as well as substances that are discovered in the future. The EU estimates that REACH will apply to approximately 30,000 substances in use today.
REACH will cover four main areas.
- Registration. REACH will, in certain circumstances, require importers and manufacturers of substances, whether on their own, in the form of a preparation or in articles, to submit a registration to the European Chemicals Agency (the “ECA”). (The ECA is a new organisation with responsibility for co-ordinating the new regime. The ECA will be based in Helsinki and is expected to be up and running by June 2008.) REACH includes provisions to deal with the possibility that a substance may be manufactured or imported by more than one company.
Downstream users may submit further information to their suppliers about their own use of a particular substance to assist in the preparation of a registration dossier.
In most cases, the following registration deadlines will apply:
- November 2010 – For substances manufactured or imported in quantities of 1000 tonnes or more, or manufactured in smaller quantities but considered to be of very high concern.
- June 2013 – For substances manufactured or imported in quantities of 100 tonnes or more.
- June 2018 – For substances manufactured or imported in quantities of 1 tonne or more.
REACH will prevent the manufacture of substances in the EU as well as the import of substances which have been manufactured outside the EU unless they have been registered by the relevant deadline.
- Evaluation. Once a registration dossier has been submitted, the ECA will consider whether or not further information is required or whether further testing ought to be undertaken.
- Authorisation. REACH requires that certain dangerous substances should not be placed on the EU market on their own, in preparations or in the form of articles unless they have been authorised by the Commission in accordance with REACH. This requirement is aimed at substances of very high concern. Manufacturers and importers will be required to show that the risks associated with the substance are adequately controlled or that those risks are outweighed by the benefits.
REACH imposes a further requirement on all manufacturers, importers and downstream users of these substances of very high concern to analyse the availability of alternatives and the feasibility of substitution. It has been argued by some NGOs that this requirement does not go far enough as it allows manufacturers and importers to continue to use substances of very high concern even when safer alternatives are available.
- Restriction. REACH imposes specific restrictions on the use of particular substances. These substances cannot be manufactured in the EU, placed on the EU market or used in the EU unless the substance in question complies with the restriction2. (In Annex XVII, substances and their restrictions are listed in tabular form.)
REACH will place a heavy burden on companies manufacturing chemicals in the EU or importing chemicals into the EU as they, rather than the regulatory authorities, will be responsible for assessing the risks of particular substances. Despite the fact that the registration deadlines are some way off, manufacturers and importers should be thinking about whether or not they will have obligations under REACH, when they will have to comply and what they will need to do.
The Commission is currently in the process of preparing technical guidance documents to help industry implement the requirements of REACH, although these are unlikely to be available before November 2007.