IP/01/201

Brussels, 13 February 2001

Commission sets out the path towards sustainable use of chemicals

The European Commission today adopted a White Paper setting out the strategy for a future Community Policy for Chemicals. The main objective of the new Chemical Strategy is to ensure a high level of protection for human health and the environment, while ensuring the efficient functioning of the internal market and stimulating innovation and competitiveness in the chemical industry. Commenting today's announcement Environment Commissioner Margot Wallström said: "This is one of the most important initiatives the Commission has taken in the context of sustainable development. We have decided on a step-by-step approach to phase out and substitute the most dangerous substances the ones that cause cancer, accumulate in our bodies and in our environment and affect our ability to reproduce. This decision is crucial for future generations". Enterprise Commissioner Erkki Liikanen said: "Today's decision is crucial to get good and reliable information on the basis of which we can start analysing the many chemicals on the market on which we have no knowledge of their effects on the environment and our health. At the same time the decision is important to create a proper internal market for chemicals products and thus a level playing field for our industry. The scheme which we have agreed today will also help stimulating innovation and will provide industry a clear framework within which they can work on a competitive footing with other global players.

The White Paper balances the essential need to protect human health and promote a non-toxic environment with the requirement to maintain and enhance innovation and the competitiveness of the EU chemical industry. It also takes account of the need to increase transparency by improving access to information on chemicals and increasing the transparency of the decision making process. The EU policy will strive for integration with international efforts as the global nature of the chemical production and trade and the transboundary impact of certain chemical substances have made chemical safety an international issue. The guiding principle is the Precautionary Principle and an important objective is to encourage the substitution of dangerous by less dangerous substances where suitable alternatives are available.

Key elements of the new strategy

• A single efficient and coherent regulatory framework which provides equivalent knowledge about the hazards of substances marketed before and after September 1981 ("existing" and "new" substances) and their uses in order to provide coherence in the level of protection.

• Reversal of responsibility from authorities to industry for testing and risk assessment of chemicals.

• Promotion of innovation and competitiveness without compromising the high level of protection.

• Introduction of a tailor-made authorisation system where stringent control is ensured for the most dangerous substances.

• Increased transparency and information about chemicals.

The White Paper seeks to convert the current dual system for existing and new substances, with their related difference in testing requirements, into a single efficient and coherent system for dealing with the majority of chemical substances. The strategy addresses the problems inherent in the current system of risk assessment and risk management of chemicals and seeks to deal, in particular, with the large quantities of existing substances on the market whose effects on human health and on the environment are largely unknown. Under the new scheme, the industry producing a particular substance will be responsible for supplying data about that chemical and the authorities will be called in to evaluate the data provided by industry and to decide on substance-tailored testing programmes following industry proposals. Increased responsibility will also pass to users in the manufacturing chain (formulators and downstream users) who will have to supply data on the particular uses they make of a substance.

The new system for assessing both existing and new chemicals is known as the REACH system. It will contain the following three elements:

• Registration of basic information for around 30,000 substances (all existing and new substances exceeding a production volume of 1 tonne) submitted by companies in a central database. It is estimated that around 80 percent of these substances would only require registration;

• Evaluation of the registered information for all substances exceeding a production volume of 100 tonnes (around 5,000 substances corresponding to 15 percent) or, in case of concern, also for substances at lower tonnage; the evaluation will be carried out by authorities and include the development of substance-tailored testing programmes focussing on the effects of long-term exposure;

• Authorisation of substances which are carcinogenic, mutagenic or toxic to reproduction (CMRs) and persistant organic pollutants (POPs).

Substances for further research

PBTs⁽¹⁾ (excluding the above mentioned POPs) and VPVBs⁽²⁾ will be identified through further research. The Commission will decide at a later stage how substances with these properties should be treated.

Deadlines for registration

The suggested deadlines for submission of registration dossiers, subject to certain conditions, are for substances exceeding a production volume of:

• 1,000 tonnes - at the latest by end of 2005,

• 100 tonnes - at the latest by end of 2008,

• 1 tonne - at the latest by end of 2012.

Next steps

The next steps will be to submit the White Paper to the Council and the European Parliament. Stakeholders will be invited to conferences both in Brussels and in Member States whose aim is to launch the White Paper, explain its implications and discuss the way forward. Then the major task of translating this strategy, with its underlying principles and challenging objectives, into implementing legislation can truly begin.

Background

The present system for general industrial chemicals distinguishes between "existing substances" i.e. all chemicals declared to be on the market in September 1981, and "new substances" i.e. those placed on the market since that date.

There are some 2,700 new substances. Testing and assessing their risks to human health and the environment are required before marketing in volumes above 10 kg. For higher volumes more in-depth testing focussing on long-term and chronic effects has to be provided.

Existing substances amount to more than 99% of the total volume of all substances on the market, and are not subject to the same testing requirements. The number of existing substances reported in 1981 was around 100,000 - the current number of existing substances marketed in volumes above 1 tonne is estimated at 30,000.

There is a general lack of knowledge about the properties and the uses of existing substances. The risk assessment process is slow and resource-intensive and does not allow the system to work efficiently and effectively. The allocation of responsibilities is inappropriate because authorities are responsible for the assessment instead of enterprises which produce, import or use the substances. Thus, information on uses of substances is difficult to obtain and information about the exposure arising from downstream uses is generally scarce. Decisions on further testing of substances can only be taken via a lengthy committee procedure and can only be requested from industry after authorities have proven that a substance may present a serious risk. Without test results, however, it is almost impossible to provide such proof. Final risk assessments have therefore only been completed for a small number of substances.

Further information

The White Paper and other information can be found at:

http://ec.europa.eu/environment/chemicals/index.htm

^{(1)PBT = substances which are persistent, bioaccumulative and toxic.}

^{(2)VPVB = substances which are very persistent and very bioaccumulative.}