The EU chemical regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), entered into force in June 2007, replacing some 40 existing directives. It is both comprehensive and complex, involving an integrated approach to regulating the production, import and use of chemicals in Europe. It gives us more knowledge about the chemicals used on the European market, since it puts new demands on those who produce or import chemicals to present data on the characteristics of the chemical and its potential risks to health and the environment. When it comes to the chemical safety of products produced or used on the EU market, the burden of proof now lies with the chemical producer and importer, not public authorities.
More knowledge about chemicals
REACH requires that producers submit a base set of data for all chemicals produced above 1 tonne per year. This includes carrying out tests to determine if the substance is hazardous. The information is then used to decide whether further measures are necessary. If the required data for a chemical is not presented, the substance will not be allowed in the EU, in line with the “no data – no market” principle.
Substituting with safer alternatives
A key aim of REACH is to encourage the substitution of hazardous chemicals with safer alternatives. The existence of the REACH Candidate list and the authorisation process sends a strong message to businesses that they should review the chemicals used in their products and start replacing hazardous substances with safer alternatives. As a result, the legislation helps promote innovation, safer processes and the use of alternative techniques. If substitution is not possible for economic or technical reasons, then substances will only be allowed when the socio-economic advantage outweigh the risks.
Development of REACH
The first step in the development of the REACH legislation was taken in 1998, followed by a long, nine-year process of analysis, debates and discussions. Few, if any, legislative proposals in the EU have created so much passionate debate and intensive lobbying from industry and other interest groups.
In October 2003, the European Commission presented its proposal for a new EU chemicals policy. It included large concessions to the chemical industry, and was therefore strongly criticized by environmental, health, women’s and consumer groups since it did not do enough to protect human health and the environment. Nonetheless, even this “watered down” proposal was groundbreaking, representing the most progressive chemicals legislation in the world. The REACH proposal worked its way through the legislative process in the European Parliament and the Council of Ministers. The final regulation was adopted in December 2006 and the new chemicals regulation entered into force in June 2007. The new European Chemicals Agency (ECHA) oversees and implements the REACH system from Helsinki, Finland.
The fact that EU authorities, with the backing of its 27 member states, and with input from industry, civil society and the scientific community, have established criteria for defining high concern chemicals is a major step forward in modern chemicals management. It also gives clear guidance to consumers and industry concerning chemicals that should be avoided, while opening opportunities to introduce homogenous rules, predictability and certainty on the marketplace. Its success depends on the speed and effectiveness of the process to identify the most hazardous chemicals on the European market and replace them with safer alternatives. This in turn will promote more innovation, greater competitiveness and cleaner production.