Munich

An uneasy compromise has been struck to see Europe's chemical-safety law off the starting blocks. The European Parliament last week gave a preliminary go-ahead to legislation that will bring in extensive toxicity testing of both new and existing chemicals.

But the deal struck during the vote, which would see fewer chemicals tested than originally planned and a drive towards animal-free tests, has left most stakeholders dissatisfied.

The controversial law, known as REACH (Registration, Evaluation and Authorization of Chemicals), is one of the most complicated pieces of legislation that Europe has attempted (see Nature 438, 144–146; 2005). It raises the standards for safety testing of chemicals and puts full responsibility for safety assurance in the hands of industry.

Chemicals produced at levels of more than 1,000 tonnes per year will have to go through a full range of tests that for each compound will cost about €2 million (US$2.3 million) and will use some 4,000 animals.

Activists argue that Europe's toxicity tests will kill too many animals. Credit: P. GOETGHELUCK/SPL

REACH replaces 1981 legislation that required data on the toxicity of new chemicals to be registered. But its range will also extend to some 30,000 chemicals that were in commercial use before 1981, for which no safety data are currently listed. Most of these compounds will now have to be tested.

Since being proposed by the European Commission more than two years ago, REACH has been the focus of intense lobbying, particularly by industry, which argues that it will be too expensive, and by animal-rights supporters, who complain that the testing will cost too many animal lives.

The compromises introduced at the parliamentary reading on 17 November aim to meet some of these objections. Less safety information than planned will now be demanded for compounds in chemical classes that are generally agreed to be non-toxic and are produced in relatively low amounts each year. Of these, any produced at less than 10 tonnes per year will be exempt from all testing.

In response to animal-welfare concerns, the revised law increases the influence of the European Centre for the Validation of Alternative Methods (ECVAM) in approving testing strategies that do not use animals. For example, it gives ECVAM, based in Ispra, Italy, the right to check that a manufacturer is not using animal tests when alternatives exist. And it requires that regulators adopt any alternative test validated by ECVAM within 14 days — something that currently takes months or years.

REACH also obliges industry to share data on safety testing so that each compound is tested only once. A new European Chemicals Agency will be established in Helsinki, Finland, to administer the legislation.

But animal-welfare groups complain that the changes don't go far enough in reducing the number of animals needed for testing. And industry groups maintain that the tests and administration remain prohibitively expensive. Environmental groups, meanwhile, say that the compromises mean that some potentially dangerous chemicals will go untested.

The parliamentary vote is the first step in a process during which the draft law can still be altered. REACH is scheduled for approval next year and should be implemented in 2007.