Regarding the background to REACH, the existing system for managing chemicals involves drawing a distinction between chemicals which were in use before 1981 and those which were used after that date. The chemicals in existence before 1981 are not very well regulated. There are about 30,000 of these chemicals in existence. The chemicals that came on to the market after 1981 are subject to a very demanding regulatory regime. The result is that very few chemicals have come on to the market since 1981 because it is very difficult to get them to market. This has led to a situation where hazardous chemicals have continued to be used and innovation in the chemical industry has been damaged because of the difficulties involved in bringing new chemicals to the market. The idea behind REACH is to rectify the faults of the existing system.
The European Commission took part in a very long consultation process over REACH. It began in 2001 with a White Paper. The Commission then issued various proposals, including an Internet consultation. There was so much interest in the Internet consultation that 6,000 responses were received. The Commission examined the responses in detail and came up with a revised proposal, which tried to meet the concerns expressed through the Internet consultation. From a competitiveness perspective, we believe the revised proposal is much better than the older proposal. Despite that, the chemical industry still believes there is room for further improvement. On the other hand, environmentalists are concerned that the revised proposal has gone too far in the competitiveness direction and would like to see some of the previous provisions re-enacted in the regulation.
REACH takes its name from the fact that the system is concerned with the registration, evaluation and authorisation of chemicals. Registration obliges any manufacturer or importer which is manufacturing or importing in quantities above one tonne to get a certain amount of information on its chemicals and to register that information in a dossier with a central agency, which will be located in Helsinki, Finland. The information requirements become more demanding depending on the volumes of chemicals manufactured or imported. The information requirements are relatively easy if manufacturers or importers are manufacturing or importing just one tonne of chemicals. The information requirements are relatively difficult if 1,000 tonnes of chemicals are being manufactured or imported. If a company is manufacturing extremely hazardous chemicals such as carcinogens or chemicals that are toxic to reproduction, the information requirements become more demanding.
Owing to the resource-intensive nature of REACH, it was decided that it would not be possible to introduce it all at once. The Commission proposes a system whereby the highest volume chemicals will be registered first. Therefore, chemicals in amounts of 1,000 tonnes or more must be registered three years after the regulation comes into force. Chemicals in amounts of 100 tonnes or more must be registered six years after REACH comes into force and chemicals in amounts of one tonne or more must be registered 11 years after REACH comes into force.
The next step of REACH is evaluation, of which there are two types. There is an evaluation of the dossier to ensure that any of the tests proposed therein are not duplicated where animal testing is concerned. Tests may be undertaken to ensure the information contained in the dossier complies with the provisions of the regulation. Subsequent evaluation is probably more important. The idea behind this is that the authorities will decide which substances are likely to be the most hazardous and will evaluate them to assess whether the risks warrant further action. The outcome of the evaluation process may require companies to provide more information or the competent authorities to decide a substance is so dangerous it must be authorised or restricted.
The third step in the REACH process is authorisation. This does not necessarily follow from registration and evaluation as authorisation can happen for substances that have not been registered or evaluated. If a substance is in the lower tonnage range, it can still be subject to authorisation earlier in the process. Authorisation means that a list of substances will be drawn up on an incremental basis containing substances that the competent authorities, the Commission and the agencies believe are so highly dangerous they should be banned unless a company is specifically authorised for their use. A company applying for an authorisation for a listed substance must show it is either controlling the risks adequately or that there is no substitute for the substance. Economically and socially, it is better to use the substance than to ban it.
There is a restriction process in the regulation that is the same as the process in operation under the existing legislation and I will not dwell on it. I have mentioned that a new chemical agency is to be established in Helsinki and that each member state must nominate a competent authority for itself.
I will discuss briefly what has occurred in connection with REACH. The regulation is being negotiated in both the Council and the European Parliament. The Competitiveness Council is the lead council but the Environment Council is heavily involved. There is a special Council ad hoc working group that meets in Brussels every two or three weeks to which I am a delegate and these extensive negotiations are currently taking place there. Several hundred working documents have been prepared and significant progress has been made during the negotiations. The UK is taking over the Presidency on 1 July and it has indicated its hope to reach a political agreement on this dossier by the end of its term.
Eight committees of the European Parliament are examining this dossier due to its importance. There are three lead committees, including the Committee on the Environment, Public Health and Food Safety, the Committee on Industry——
