The EU law REACH - Registration, Evaluation and Authorisation of Chemicals - will see some 30,000 chemicals being tested and reviewed by the newly formed European Chemicals Agency (EChA) with the aim of banning those that pose a significant health threat and finding safer substitutes. As a result of the law, big business, downstream users and the cosmetics industry will all be expected to carry the onus on the safety status of the chemicals they use.
Although it will be European companies that will be primarily hit by this regulations, global players, including many of the bigger names in the US, will also have to take careful note if they want to maintain their share of the pie by complying. The law, which was passed by the European Parliament and Council of Ministers last December, comes into being after more than three years of debate between industry, environmentalists and consumer groups.
Opposition has been strong, with arguments ranging from increased animal testing and increased costs, to the law just not being viable and would affect trade flow. The European Commission estimated the new law would cost the chemical industry between €2.8bn and €5.2bn over the next decade. But, on the plus side, the law would save Europe €54bn over 30 years, as less people would become ill as a result of exposure to dangerous chemicals, it claimed.
Germany's Federal Institute for Risk Assessment (Bundesinstitut fur Risikobewertung/BfR) claimed the law would increase the number of animal testing experiments so as to meet the safety regulations, but the refined regulation now states that animal testing should be replaced by tests that do not involve animals. To further reduce animal testing, a project has been developed between European pharmaceutical companies and animal welfare agencies, which will produce a shared database on the results of chemical tests on animals, thereby reducing unnecessary duplicate tests.
While the law comes into force now, it is not until June 1, 2008 when manufacturers, importers, distributors and users must be registering with the EChA. If a producer pre-registers before December 1, 2008, then it is granted the right to spread the full registration over the 11 years to 2019, depending on the tonnage produced. REACH replaces much of the current patchwork of over 40 pieces of EU legislation relating to chemicals, and means businesses will now need to prove the safety of thousands of chemicals previously not regulated.
The new law also aims to encourage the replacement of hazardous chemicals with safer ones and to spur the chemical sector into researching and developing more new products.
It is expected it will take about four years before the first substances are either registered or banned.