European Chemicals Regulation (REACH) 1907/2006/EC
REACH is new legislation regarding the testing of chemicals which are used within the EU states. Its two most important aims are to improve protection of human health and the environment from the risks of chemicals and to maintain the competitiveness of EU industry. Manufacturers and importers of chemicals will be responsible for providing detailed data which can be used to assess the safety of substances, and many commonly used chemicals will need to undergo testing to meet the new requirements.
This process will mean that the number of animals used in chemical testing procedures will increase. Alternative methods and in vitro tests have now replaced many animal toxicity tests, but some tests still have no validated alternative. It is estimated that 30,000 chemicals will be tested overall, requiring many more animals than are currently used in chemical testing.
Pre-REACH EU legislation for chemical substances was a patchwork of many different Directives and Regulations which have developed since 1967 when the first Dangerous Substances Directive was introduced. This system has not produced sufficient information about the effects of the majority of existing substances on human health and the environment.
Under the current legislation there is a distinction between so-called "existing" and "new" substances, based on the somewhat arbitrary cut-off date of 1981. While new substances have to be tested extensively before they are placed on the market, there are no such provisions for "existing" substances. As a result, while information exists on the properties and uses of existing substances, more publicly available information is needed to assess and control these substances effectively.
In 2001 a White Paper on the ‘Strategy for a future Chemicals Policy’, was published, outlining a review of the current system and a new strategy for ensuring a high level of chemicals safety and a competitive chemicals industry. This should be achieved through REACH, operated by a new European Chemicals Agency, in conjunction with Member State regulatory authorities and the European Commission. The White Paper identified seven objectives which needed to be balanced in the new legislation:
• Protection of human health and the environment
• Maintenance and enhancement of the competitiveness of the EU chemical industry
• Prevention of fragmentation of the internal market
• Increased transparency
• Integration with international efforts
• Promotion of non-animal testing
• Conformity with EU international obligations under the World Trade Organisation (WTO)
Manufacturers or importers of 1 tonne or more per year, of all substances within the scope of REACH will need to submit a registration to the European Chemicals Agency. Deadlines also apply for the registration of existing substances. Once a substance is registered, the Agency will perform a completeness check of information available on the substance and a quality evaluation for some substances. Substance evaluations may be carried out if the substance is considered to be of potential concern. Those chemicals that are identified as being of very high concern to human health or the environment will be subject to authorisation. The restriction process allows EU-wide control of substances identified as causing a risk to human health or the environment. A number of substances will be exempt from various stages of the REACH process because the risk is expected to be low and/or registration would be a disproportionate requirement.
This legislation also includes EU directive 2006/121/EC