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An Introduction to REACH

REACH is the new European Union (EU) Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, which entered into operation on 1st June 2008. A key element of the REACH regulation is that it shifts the ‘burden of proof’ from the authorities to industry, placing greater responsibility on industry to manage the risks that chemicals may pose. In the future, chemicals will only be available for specific uses for which an appropriate risk assessment has been undertaken and where suitable measures are in place to protect both human health and the environment.

The key aims of REACH are to:

  • Ensure a high level of protection of human health and the environment from the risks that may be posed by chemicals;
  • Make manufacturers and importers who place chemicals on the market responsible for understanding and managing the associated risks;
  • Enhance the competitiveness of the EU chemicals industry, a key sector for the economy of the EU;
  • Promote the use of alternative methods for the assessment of hazards of substances;

Allow the free movement of chemical substances within the EU market. REACH replaces about 40 existing EU Directives and Regulations on chemicals with a single, streamlined regulation which applies a consistent approach to controlling risks.

Under REACH there is a general obligation for manufacturers and importers of substances in quantities of 1 tonne or more per year to submit a registration dossier to the European Chemicals Agency (ECHA), within which it must be demonstrated that any risks are appropriately controlled. This applies to all individual chemical substances on their own, in preparations or in articles. Failure to register means that the substance will no longer be allowed to be manufactured or imported, and their use will become illegal. As part of a phased registration opportunity, certain substances were eligible for pre-registration with the Agency between 1st June and 1st December 2008.

Once the registration dossier is received, ECHA may check it to ensure it is compliant with the Regulation and will evaluate (link to evaluation info page) any testing proposals made by industry to prevent any unnecessary testing on animals.

For substances of very high concern, authorisation is required for their use and placing on the market. Registrants will have to demonstrate that the risks associated with the use of these substances are adequately controlled.

In addition, the EU authorities may place restrictions on the manufacture, use or placing on the market of certain dangerous substances which pose an unacceptable level of risk.

IOM can help you to determine how REACH might affect your business by identifying the chemical identity of the substances you use or supply and if these substances fall within the scope of REACH, and also whether any of the substances are potentially of 'very high concern' that may be withdrawn from the market (e.g. carcinogens, mutagens, reproductive toxins, substances that are persistent in the environment or toxic to aquatic organisms). IOM can also ensure that you are up to speed on what your organisation needs to do to comply with REACH. Additionally, if you are a downstream user IOM can help you planned for the eventuality of specific chemicals not being available for your use in the future.

Are you ready for REACH? IOM's dedicated REACH team have the expertise required to help you find a way through this complex new regulation. Our full range of REACH services includes: