Registration, Evaluation and Authorisaton of Chemicals (REACH) was a hotly debated, far reaching policy initiative in the European Union because it entailed unprecedented regulatory changes for European and outside companies wanting to sell their products to the European market.
In 1998 a review of European chemicals policy was initiated, which started with the publication of a detailed report on the workings of the above regulations. This study found a large number of problems, with the two most important being related to Existing Chemicals: a lack of available information on the hazards and uses; and an undue burden on the regulator to assess their risks.
In 1999 the European Chemicals Bureau analyzed the data it had received from industry on the properties of existing chemicals produced at over 1,000 tonnes per annum (often called high production volume or HPV chemicals). This study, "Public Availability of Data on EU High Production Volume Chemicals" found that
- only 14% of the EU High Production Volume Chemicals had data publicly available at the level of the base set used for new chemicals marketed at 1 tonne per annum or above;
- 65% had some data but less than base set;
- 21% had no data.
Without this data it was impossible to reliably assess whether most existing chemicals fulfilled the criteria for prioritization for further evaluation in the existing chemicals program. It was also unclear how industry was managing to carry out its responsibilities, such as classification and labeling of chemicals and assessing risks to workers, given the lack of safety information.
Even when there was sufficient data available to place a chemical on the priority lists for assessment by Member State and European Commission experts, difficulties remained as experts tried to complete the risk assessment and management studies. These studies frequently required more data than was available on hazards, and required use information that was either difficult to find or was not available at all.
As a result of these problems, at the end of 2004 only 141 of the over 100,000 existing substances had been placed on priority lists, and only 126 of these 141 substances had at least a first draft risk assessment, with only 70 of these risk assessments being finalized. Of these 70, it was concluded that 57 needed risk reduction measures and 2 needed further information. For only 11 of the 70 substances were further risk reduction measures agreed to be unnecessary (Source: European Chemicals Bureau Newsletter). The fact that so many of the selected substances required further risk reduction measures clearly indicates the need for proper assessment of the risks posed by existing substances.
As a result of the problems found with the current EU system for regulating chemicals, it was decided that a new system should be devised, taking the current system, updating it and making it more comprehensive and effective. Below are some of the policies which REACH replaced.
REACH was finalized in 2006. The REACH Archives offers a summary of the debate, reports, and other information surrounding the legislation. For information on chemicals in the European Union and its Member States prior to REACH, see the European Member States prior to REACH page