Brussels, 13th December 2006
With the agreement of the European Parliament today, the REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals) comes near to final adoption. The European Commission welcomes this vote which brings to an end over three years’ negotiations on a comprehensive reform of manufacturing, marketing, import and use of chemical substances. The compromise reached between Council and Parliament will improve health and environment while safeguarding innovation and competitiveness. The Council is expected to finally adopt the package at the Environment Council on 18 December, so that REACH can enter into force on 1 June 2007. )
Commission Vice-President Günter Verheugen responsible for enterprise and industry policy, said: “I welcome the end to a long period of uncertainty which has hung over these negotiations. This compromise is good for health and environment, while keeping European businesses competitive and encouraging innovation. It is very important that the final agreement also takes into account the special situation of the SMEs. In addition, replacing over 40 legislative instruments with a one single regulation is yet another practical example of Better Regulation and cutting red tape in Europe. Another positive aspect is that every effort has been made under REACH to reduce animal testing to the absolute minimum.”
Commissioner Stavros Dimas, responsible for environmental policy, said: “REACH is an extremely important piece of legislation, which will significantly improve the protection of human health and the environment. It will increase our knowledge about chemicals, enhance safety, and spur innovation while encouraging substitution of highly dangerous substances by safer ones."
Once in force, REACH will require the registration, over a period of 11 years of some 30.000 chemical substances in use today, a process which will allow to fill information gaps on the hazards of substances and to identify appropriate risk management measures to ensure their safe use. The onus will be on industry to generate the data required and to identify the measures needed to manage the risks. In addition, REACH will allow the further evaluation of such substances where there are grounds of suspicion of risks and foresees an authorisation system for the use of substances of very high concern. This applies to substances that cause cancer, infertility in men and women, genetic mutations or birth defects and to those which are persistent and accumulate in our bodies and the environment. The Authorisation system will strongly encourage companies to switch to safer alternatives. In fact, all applications for an authorisation need to include an analysis of alternatives and a substitution plan where a suitable alternative exists.
REACH will also enable more rapid total or partial bans where unacceptable risks are detected. In addition, measures are foreseen to ensure that animal testing is kept to the strict minimum and to encourage the use of alternative testing methods. Finally, REACH ensures a comprehensive flow of information about the risks of substances throughout industry and to consumers.
REACH is an example of better regulation as it simplifies the EU legislation on chemicals by replacing 40 existing pieces of legislation and creating a single system for all chemicals.
The day-to-day management of the new requirements will be carried out by the new European Chemicals Agency (ECHA) which will be established in Helsinki
The benefits for health and environment as well as business benefits from, for example, improved consumer confidence in chemicals are expected to outweigh by far the initial increased costs for companies. Moreover, the agreement between the Parliament and the Council has also on balance reduced the administrative and financial burden for companies, in particular for the substances supplied in lower volumes benefiting mainly SMEs. The positive incentives for innovation in the proposal have also been strengthened by encouraging substitution of highly dangerous substances.
The first REACH obligation, pre-registration, will take place from 1 June 2008 to 30 November 2008. It will be followed by registration in three and half, six or eleven years, depending on the volume band or level of concern of the substance. This information and evidence demonstrating the safe use of the substance need to be submitted in a registration dossier to the new Agency.
Companies and authorities should now intensify their preparatory activities so that they will be ready to fulfil their duties in time. Detailed guidance documents and specific IT-tools are currently being developed to make the transition to the new system as easy as possible (see Memo/06/488). Users of chemicals are advised to communicate proactively with their suppliers to ensure that their uses are covered by the registration dossiers of manufacturers and importers.
More information about REACH can be found under:
More information and a complete set of links can be found in Memo/06/488
A short explanation of REACH is available on: