Strategy for a future Chemicals Policy

1) OBJECTIVE

To develop a strategy for a future chemicals policy promoting sustainable development.

2) ACT

Commission White Paper of 27 February 2001 on the strategy for a future chemicals policy [COM(2001) 88 final - Not published in the Official Journal].

3) SUMMARY

Background Although Community legislation already prohibits some harmful chemicals (asbestos, for example), there are gaps in the Community legislation with regard to existing chemical substances. There is a lack of information on the effects of many existing substances placed on the market prior to 1981, when the requirement for the testing and notification of new substances was introduced. Such substances account for approximately 99% of the total volume of substances available on the market and, although the Commission has initiated an assessment of these substances, it is a lengthy process and does not subject existing substances to the same stringent test criteria as new substances. In view of concerns about the harmful effects of chemical substances on human health and the environment, the Commission considers that a strategy must be developed to guarantee the protection of human health and the environment in a context of sustainable development.

The White Paper mainly refers to four legal instruments on chemicals currently in force in the Community: existing legislation on the marketing and use of certain dangerous substances and preparations, the classification, packaging and labelling of dangerous substances and of preparations and the evaluation and control of the risks of existing substances.

Political objectives and key elements The objectives are in line with the overriding goal of sustainable development and seek to make the chemical industry accept more responsibility by respecting the precautionary principle and safeguarding the Single Market and the competitiveness of European industry. The main objectives are as follows:

Protection of human health and promotion of a non-toxic environment In order to improve the level of protection the Commission proposes creating a single system for all substances. In terms of assessing risks, priority will be given to substances that lead to a high exposure or cause concern. The substitution of less dangerous chemicals for dangerous chemical substances as soon as feasible will be encouraged.

Application of the precautionary principle This principle stipulates that action must be taken even if there is still scientific uncertainty as to the precise nature of the risks.

Maintenance and enhancement of the competitiveness of the EU chemical industry It is essential that the strategy should promote rather than jeopardise the competitiveness of the EU chemical industry. The Commission therefore seeks to stimulate competitiveness and the development of safer chemicals, particularly through regulation.

Prevent fragmentation of the internal market Similarly, the strategy should aim at ensuring the proper functioning of the Internal Market. It must therefore be based on full harmonisation at Community level.

Increased transparency These measures will aim to ensure that consumers have full access to information to enable them to make informed choices. This will be achieved by the creation of a single, more transparent regulatory system. However, commercially sensitive information will be suitably protected.

Integration with international efforts The proposed measures should concord with the international initiatives taken to promote the safe use of chemicals worldwide. There are several international organisations in this field (the Intergovernmental Forum on Chemical Safety (IFCS)) and many international treaties, such as, for example, the OSPAR Convention for the Protection of the Marine Environment of the North East Atlantic and the Rotterdam Convention on the prior informed consent (PIC) procedure for certain hazardous chemicals and pesticides in international trade.

The many tests conducted outside the European Union (EU) should also be recognised: the results of which can help to fill in the gaps in European data and prevent the duplication of efforts.

Promotion of non-animal testing Programmes using animal tests should be curtailed as far as possible and the development of new methods of non-animal testing promoted.

Conformity with EU international obligations under the World Trade Organisation (WTO) As the EU is a member of the WTO, Community legislation governing chemical substances may not create a direct or indirect obstacle to trade with third countries.

The REACH system The REACH system is a single system for both existing and new substances covering all phases of the procedure. An eleven-year transition period has been scheduled for existing substances to be assimilated into the new single system. A specific timetable and taskforce have accordingly been planned to assess the data which already exists.

Registration Registration is mandatory for all substances exceeding a production volume of 1t. The general check carried out by the authorities under the previous system will be replaced by spot checks and computerised screening.

Evaluation The industry will be responsible for testing and assessing risks. Tests will be prescribed according to a number of criteria such as, for example, the production volume of the substance, the level of exposure, etc. However, evaluation for all substances exceeding a production volume of 100t or, in case of concern, also for substances at lower tonnage will be carried out by the relevant national authorities in accordance with substance-tailored testing programmes focussing on the effects of long-term exposure. In general, for additional tests, the procedure currently used for new substances will be continued.

Authorisation Specific substances or specific uses of a substance that give rise to very high concern will be subject to special authorisation. Authorisation will be granted for specifically defined purposes, regardless of the volume of production. This will apply to the following substances:

• substances that are carcinogenic, mutagenic or toxic to reproduction (including the majority of endocrine disrupters);
• substances with the characteristics of Persistent Organic Pollutants (POPs);

Uses which do not give rise to concern may be subject to general exemptions from the authorisation procedure. Moreover, use-specific authorisation may be granted if warranted by the socio-economic benefits of using the substance.

An accelerated risk management procedure will be used for any other substance giving rise to concern. This procedure will include accelerated evaluation and acceleration of the legislative process for relevant legislation.

Further research is needed before deciding on the definitive approach to be adopted for PBT (persistent, bio-accumulative and toxic) and VPVB (very persistent and very bio-accumulative) substances other than POPs.

The conditions for exemptions for chemical substances used for research and development will be amended in order to facilitate research.

Specific research and development efforts should be directed at developing alternatives to animal testing methods.

Further research is needed before deciding on substances marketed in the form of constituents of products (toys, for example) that have been exempt from the requirements of other Community legislation.

Role, rights and responsibilities of industry As has been pointed out, responsibility for testing and assessing the risks of chemicals will be transferred from the competent authorities to the industry i.e. the manufacturers, importers and downstream users. The industry is required to provide the competent authority with specific information as part of the registration of the substance. Safety Data Sheets and the labelling of the packaging will continue to be the main carriers of user information. There are plans to amend both of these in order to make them more efficient.

As regards property rights for test data, like the previous legislation, the new system seeks to avoid the duplication of tests on animals, particularly vertebrate animals. It also seeks to ensure fair competition. The introduction of exposure-triggered testing and new obligations on downstream users to test could give rise to distortions of competition by encouraging manufacturers and other users to restrict or delay testing in order to take advantage of other parties' test results at a later date. The new system will require any person using data from a previous test to reimburse the party who owns the property rights for the first test.

Classification and labelling In view of the vast quantities of existing substances which have not yet been classified, the Commission considers that it will not be possible to draw up a comprehensive harmonised list and therefore proposes restricting harmonised classification to the most relevant properties and calling upon the industry to provide a comprehensive list of information on the classification and labelling of all dangerous substances on the market. This list is to be accessible to the public.

It has been proposed that the Community labelling system should be aligned with the Globally Harmonised System (currently being negotiated) which would involve simplifying it.

Administration of the system The Member State authorities should retain most of their current responsibilities, in other words they will be collectively responsible for substance registration and evaluation. However, the Commission proposes to establish a central entity (an expanded European Chemicals Bureau) for the administration of some general aspects of the system in order to ensure coordination and consistency between the various entities involved in the new system. It will thus provide the operational framework for the authorisation procedure, will maintain a central database, open to the public, will be a receiving body for the registration dossiers and will provide the national authorities with technical and scientific support.

The key responsibilities within the system will be distributed among the Community and the national authorities. The main decision on authorising a substance and its use will be at Community level. The Member States will be responsible for the authorisation of other more specific uses within the scope of the decision taken by the Community. All decisions on the accelerated risk management procedure will be taken at Community level.

Implementation The Member States are responsible for compliance with the legislation on their territory. Some existing measures have to be amended with a view to ensuring compliance with the legislation and consistency between the Member States. The Commission proposes reviewing the strategy once the new legislation has taken effect.

Last updated: 19.07.2005