Brussels, 7 May 2003
Commission publishes draft new Chemicals Legislation for consultation
Enterprise Commissioner Erkki Liikanen and Environment Commissioner Margot Wallström today presented new proposals to overhaul and modernise the EU's regulatory system for chemicals. Following discussion of their approach, the European Commission gave the go-ahead for an 8 weeks' Internet consultation on the draft chemicals legislation. The aims of the proposed new Regulation, which will replace 40 different pieces of current legislation, are to increase the protection of human health and the environment from exposure to chemicals while at the same time to maintain and enhance the competitiveness and innovative capability of the EU chemicals industry. In delivering both these aims, the proposals aims at fully conforming to the balanced approach required by sustainable development. Chemical substances are used in the manufacture of almost all products we use every day at home or at work. The industry that produces them plays a vital role in sustaining the competitiveness and innovative potential of many final product manufacturers downstream. The system for registering, evaluating and authorising chemical products should therefore boost enterprise competitiveness and product innovation, to the long-run benefit of chemicals manufacturers and importers, users, consumers and the environment. The Internet consultation will enable interested parties to comment on the detail of the future legal requirements before the proposal is finalised by the Commission.
Enterprise Commissioner Erkki Liikanen said: "Europe is a world leader in chemicals production and in the supply of the materials which assure the innovation potential of European industry, including many high tech sectors. The new draft chemicals regulation which we are now putting out for consultation should provide important opportunities for European industry to lead the world in the quality and safety of chemicals production and use which, in Europe, is already at a high level. In the system that we are in the process of designing we are making a determined effort to avoid unnecessary bureaucracy, to help enterprises meet the new requirements at minimum cost, to encourage research and innovation, and to ensure that European industry remains competitive. This major piece of legislation is a great challenge in terms of reconciling the economic, social and environmental requirements inherent in the EU's sustainable development strategy. I believe that what we have presented today is a good basis for getting the balance right, but we are of course open to further input and comments from all stakeholders."
Environment Commissioner Margot Wallström said: "Everyday, we are exposed to chemicals in our environment, at work or in our homes. However, for many of them, we do not know enough about their risks or longer-term effects. Our reform proposal therefore requires industry to provide public information on the chemicals they produce or import and the risks associated with their use. This will allow the users to choose safer alternatives. It will greatly enhance the protection of people's health and the environment because we will insist on strict authorisation procedures for the substances which cause most concern. Obliging the industry to provide information on what it produces will also help to enhance the image of the chemicals sector. Industry will finally have an interest in investing in innovation of new safe chemicals - the current trend of using old chemicals to avoid the cumbersome current evaluation procedure has stopped investment into safer chemicals."
The REACH System (Registration, Evaluation, Authorisation of Chemicals)
The draft legislation, which will replace over 40 existing directives and regulations, will implement the proposals set out in the Commission's February 2001 White Paper on the Strategy for a future Chemicals policy (see IP/01/201). At its core is REACH: a single, integrated system for the Registration, Evaluation, and Authorisation of CHemicals. REACH will place a duty on companies which produce, import and use chemicals to assess the risks arising from their use requiring new test data to be generated in justified cases - and to take the necessary measures to manage any risks they identify. This will reverse the burden of proof from public authorities to industry for putting safe chemicals on the market. Testing results have to be shared to reduce any likely animal testing. Registration of information on the properties, uses and safe use of chemical substances will be an integral part of the new system.
Scope of REACH
The exact registration requirements will vary depending on the volume in which a substance is produced, and on the likelihood of exposure to humans or the environment. A phased-in system lasting up to 11 years is foreseen. Higher tonnage substances would require the most data, and would have to be registered first; lower tonnage substances would require less data and be registered later. The latter provisions will particularly reduce the regulatory burden on small and medium sized enterprises.
Tighter controls will be introduced for the chemicals of highest concern. Thus, certain types of substances such as carcinogens, mutagens and reproductive toxicants (CMRs), persistent, bioaccumulative and toxic substances (PBTs) and very persistent and very bioaccumulative substances (vPvBs) will be subjected to an authorisation regime and would be registered early. In certain cases also other substances, for example with endocrine disruption effects, could be included on a case by case basis within the authorisation system where it is shown that they give rise to the same level of concern.
Each use of such substances will have to be authorised for a specific use. Decisions would be based on a risk assessment and consideration of other socio-economic factors.
Others, such as polymers (chemicals used as raw materials for plastics and detergents and a wide variety of other products), and substances used as intermediates (chemicals used to make other chemical substances or other products) will be subject to substantially lighter registration requirements. In many cases, where there is little risk of exposure, polymers and intermediates will be exempted from registration.
It is expected that around 80% of all substances will only have to be registered, the rest will have to undergo evaluations for safety and subsequent authorisation
The Member States will be responsible for the evaluation of substances by examining certain registration dossiers, as well as checking the application of REACH within their own territories. They will also be able to suggest restrictions on the use of substances based on a structured risk assessment - where they consider that EU legislative action is necessary, although the final decision on such restrictions would be taken by the Commission.
The Commission would grant authorisations after taking into account the views of the Agency on the risk and on the socio-economic aspects. Authorisation decisions will take into account the guarantees provided by the applicant firms and available information on alternative substances and processes that may reduce the risk posed. To simplify the system and to reduce costs, an authorisation will be valid for enterprises further down the supply chain as long as they abide by the conditions of the authorisation for the intended use and inform the Agency.
A new Agency
A new Chemicals Agency is proposed to manage REACH which will have the task of ensuring the efficient operation of the new system. This will include providing advice to the Commission, and guidance to Member States and to enterprises, including SMEs. Non-confidential data generated by REACH will be made available to downstream users of chemicals and to the general public in a publicly accessible database managed by the Agency.
Research and Innovation
Research and innovation vital for the competitiveness of many small businesses in this sector will be encouraged by allowing research and development to take place without registration for 5 years, extendable to 10 years, which is a considerable extension of existing provisions.
In order to keep the need for animal testing to a minimum and to keep costs down, a system of data-sharing among companies is proposed. In addition, important elements of flexibility are proposed within the testing requirements, allowing industry to use alternative sources of information to fill data gaps, or to argue that certain tests are unnecessary because of a lack of exposure.
Objective of Internet Consultation
The purpose of the Internet consultation is to test the workability of the proposals with stakeholders. There are about 1200 pages of legislative text, largely made up of technical annexes that are not new requirements, as well as a range of brand new procedures. The Commission would like feedback on the drafts before finalising its proposal as soon as possible.
The text of the proposals may be found at:
See also: MEMO/03/99.