Published online 30 November 2010 | Nature | doi:10.1038/news.2010.636

News: Explainer

Can European companies meet the deadline for registering chemicals?

Impact of new REACH safety rules will become clear later in the year.

Worker inspecting rows of chemical drumsThe deadline for companies to submit safety data for thousands of chemicals is today.Lester Lefkowitz/CORBIS

The European Union's REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) legislation is the world's most extensive attempt at improving the safe use of chemicals. By today all chemicals produced or sold in quantities of more than 1,000 tonnes a year must be registered, their existing toxicity data must be submitted along with proposals for additional tests to fill in gaps in safety information. Nature has investigated whether the European chemicals industry will meet the deadline and what will happen if it does not.

What are the aims of REACH and why is it controversial?

Under REACH, companies were charged with producing toxicity data for the chemicals they produce. From June 2007, when the legislation came into force, the industry has been gathering data for the estimated 30,000 chemicals produced in Europe for which safety information was not publicly held. Initially, the legislation was highly controversial, with the chemicals industry warning that the new requirements would cost them billions of euros to implement and animal-welfare groups fearing that millions more animals would be used in toxicity tests. A compromise was agreed which reduced the testing requirements for chemicals produced in small volumes.

What has to be done by today's deadline?

The European Chemicals Agency (ECHA) based in Helsinki, which is responsible for implementing REACH, estimates that more than 4,700 chemicals produced at the 1,000 tonne a year level will need to be registered by today. As of 30 November, 3,662 substances have been logged.

What happens to chemicals that are not registered?

According to the rules, substances that miss the 30 November deadline will be withdrawn from the market until they are registered. Some chemical companies, including BASF, headquartered in Ludwigshafen, Germany, have expressed concern that the deadline is too tight. Users of chemicals, including the UK-based manufacturers' organisation EEF, are worried that their business will be disrupted if materials they use are suddenly withdrawn from the market.

Will companies make the deadline?

The Brussels-based European Chemical Industry Council (Cefic), which represents the EU's chemical industry, is confident they will. Erwin Annys, director of chemicals policy for Cefic told Nature that the 4,700 figure for substances requiring registration by today is likely to be an overestimate. "Our members have not contacted us to say that there is a difficulty," he says. But adds that companies shed "blood, sweat and tears" in order to meet the deadline. A spokeswoman from BASF said in a statement that the company "is sure to be able to submit all required registrations in time".

What about chemicals produced in smaller amounts?

Substances that are manufactured or imported in volumes of between 100-1,000 tonnes a year have to be registered by 1 June 2013 and those in volumes between 1-100 tonnes per year by 1 June 2018.

How many more animals will be used in toxicity tests?

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The European Commission estimates that a total of around 9 million additional animals will be used in the extra tests needed for the new rules. But this figure has been criticized for being too low by Thomas Hartung, former head of the European Centre for the Validation of Alternative Methods in Ispra, Italy (see 'Chemical-safety costs uncertain'). Earlier, lower estimates from the commission which suggested that between 2.1 million and 3.9 million additional animals would be used were widely criticized by toxicologists for not being realistic. A clearer indication will come early next year once ECHA has evaluated the registered toxicity data and proposals for additional tests.

What about alternative non-animal testing methods?

The registration data will also show to what extent companies have proposed the use of alternative testing methods and whether ECHA will deem these methods valid. In particular, much hope is being pinned on the acceptance of streamlined assessments of the effects of chemicals on animals' reproductive systems, which could save the lives of millions of animals. On 17 November a committee of the Organisation for Economic Co-operation and Development agreed on draft guidelines detailing how such streamlined studies should be carried out. The EU will be able to use the guidelines to inform their decisions on whether such studies will be permissible under REACH. 

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