European Parliament gives REACH proposal first reading

On 17 November, a European parliament plenary session gave a first reading to the UK Presidency compromise draft for a new Regulation on registration, evaluation and authorisation of chemicals, known as REACH.

The Regulation will ensure that residual gaps in available knowledge about the intrinsic properties of tens of thousands of substances in use in industry are filled. After adoption, now expected in late 2006/early 2007, there would be phased implementation of the Regulation beginning with registration deadlines in 2009/2010 for the highest hazard chemical product categories and for those manufactured in the largest quantities; the process would not be complete until around 2017/2018, after which all products manufactured in quantities above one tonne/year will have been brought under the new regime.

A recent assessment of the monetary value in terms of health benefits of REACH for workers, commissioned from Sheffield University by the European research, education and health and safety body ETUI-REHS (The impact of REACH on occupational health with a focus on skin and respiratory diseases, ETUI-REHS, 2005, http://hesa.etui-rehs.org/uk ), concluded that - considering only occupational and skin diseases - that the new controls would prevent tens of thousands of cases of both asthma and dermatitis annually, and reductions in the incidence of other chronic lung diseases of the same order. It concluded that the health benefits will represent a saving to the European economy of as much as 160 billion over 30 years.

At the same time, the chemical industry's first estimates of costs of compliance were so high - billions of euros - that two European heads of state intervened in 2003 to limit the impact of the legislation. A French study concluded that there would be a 1.6% reduction in GDP and the loss of 360,000 jobs in France over 10 years.

One of the compromises accepted during the first reading negotiations was that the requirements for registration of substances only produced in small quantities should be lightened, an acknowledgement of the lower global level of risk involved.

Besides its worker protection aims, the new regime also deals with protection of human health generally, environmental protection, promotion of non-animal testing regimes, increased transparency and data sharing relating to chemical safety and prevention of fragmentation of the internal market.

The new regime will bring to an end the artificial distinction in current law between "existing" and "new" chemicals. This was established in 1979 when the Sixth Amendment Directive come into force introducing a pre-market testing regime for all chemicals not on the market prior to September 1981.

About 3,000 "new substances" have since been put on the market in the EU - each having been tested for possible environmental and health risks. However, few of the estimated 30,000 "existing substances" in circulation before then have been subjected to similar testing procedures and therefore there is limited publicly available knowledge about their properties and uses.

The REACH regime, to be managed by a new European Chemicals Agency, located in Finland, will remedy this situation by introducing phased registration so that all firms manufacturing or importing more than one tonne of any chemical substance per year would have to register it in a central database together with details of test results and assessment of risks arising from the chemical's use.

The proposal will now be examined by the council of ministers in December. If a common position is reached at this council, it would be the most significant step yet towards formal adoption of a regulation that would rationalise 300 existing directives, regulations and decisions on chemical safety that the European Commission began work on more than a decade ago. However, as this proposal is subject to the co-decision procedure, there is still some way to go before final adoption.