Chemicals: EU Legislation
The formation of EU policy comes from the European Commission. Information on EU environmental policy in general, including that on chemicals, can be found on the Commission's environment website.
Information can also be found on chemicals policy on the Commission's enterprise website. Please note that information on the current European legislation, from a more scientific perspective, is also available at the European Chemicals Bureau.
- Existing substances (Regulation 793/93/EEC)
- Risk: assessment and management
- New substances (Directive 92/32/EEC)
- Marketing and Use Directive (76/769/EEC)
- Classification and labelling of substances (Directive 92/32/EEC)
- Further information
The Existing Substances Regulation will exist alongside REACH for one year (up to 15 June 2008) to help facillitate the transition to REACH. It will then be replaced.
An "existing substance" is defined as one that is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS).
This list contains some 100,000 chemicals that were on the market, within the European Community, between 1 January 1971 and 18 September 1981.
Regulation 793/93/EEC set up a programme designed to identify and control the risks posed by EINECS substances of high production volumes. There are four stages to this programme:
- Data Collection: Depending on whether companies import or produce existing substances in quantities between 10 and 100 tonnes per year, they are required to provide data sets on those substances. Such data has to be updated at least once every three years.
- Priority Setting: The European Commission draws up lists, in consultation with Member States, of priority substances that require immediate attention. The data provided by companies is put to use in priority setting.
- Risk Assessment: Chemicals that have been priority listed will be subjected to a scientific assessment of the risks they pose to human health and the environment. Member States are responsible for up reports on risk assessments.
- Risk Reduction: In the light of a chemical's risk assessment, risk reduction measures may be needed in addition to any that might already be in place. If so, a draft strategy is developed by the Member State responsible for the risk assessment, to be agreed by all Member States.
- Acrylamide Risk Reduction Strategy (PDF 250 KB)
- Napthalene Risk Reduction Strategy (PDF 500 KB)
- Nonylphenol Risk Reduction Strategy (PDF 600 KB)
- Octabromodiphenylether (PDF 700 KB)
- Octylphenol Risk Reduction Strategy (PDF 400 KB)
- Pentabromodiphenylether Risk Reduction Strategy (PDF 450 KB)
- SCCPs in leather processing (PDF 90 KB)
- Trichloroethylene Risk Reduction Strategy (PDF 700 KB)
- Tetrachloroethylene Risk Reduction Strategy (PDF 600 KB)
- Hexavalent Chromium Risk Reduction Strategy (PDF 1.1 MB)
- Assessment reports are available from the European Chemicals Bureau website
The Government has also published the following risk reduction strategy although not under ESR but as a national measure
- Perfluorooctane sulphonate Risk Reduction Strategy (PDF 900 KB)
A new substance is one which was first marketed after 18 September 1981. The European List of New Chemical Substances (ELINCS) provides a definitive list of these.
Before a new substance can be placed on the market, manufacturers are required, in accordance with Directive 92/32/EC, to:
- Provide information on themselves as manufacturers, and on the identity of the substance they are producing.
- Carry out tests in order to identify the physico-chemical properties of the substance, as well as gather data on toxicology and ecotoxicology.
- Provide information on the processes used in the production of the new substance, as well as the proposed use/s.
- Propose guidelines for classification and labelling, as well as safety precautions.
- Draft a risk assessment.
The amount on information that must be included in the manufacturer's dossier increases with the quantity of substance produced.
The Marketing and Use Directive will continue to exist alongside REACH for two years (up to 1 June 2009) to help facilitate the transition to REACH. It will then be replaced.
There are two primary routes in Europe for introducing measures to restrict or ban dangerous substances:
- The European Commission has the right to propose any restrictions.
- Individual Member States are able to develop proposals for national measures, which must be notified to the Commission under a procedure set out in the Technical Standards Directive (98/34/EC).
The legislative framework for such proposals is provided by the Marketing and Use Directive, which harmonises Community measures to control the marketing and use of dangerous substances. The restrictions made under the Directive are listed in an accompanying annex that is subject to amendments by subsequent directives.
Examples of substances controlled by this route are polychlorinated biphenyls (PCBs), polychlorinated terphenyls (PCTs), asbestos, cadmium and carcinogens.
Mercury: proposal for a Commission Directive on restrictions on the marketing and use of mercury in certain measuring devices
Defra consulted in 2006 about a European Commission proposal to restrict the marketing of mercury in certain measuring devices. The EU proposal sought to contribute to a high level of protection of the environment and human health by preventing significant amounts of mercury entering waste streams. All responses to Defra's consultation were in favour of the proposed restrictions, and following continuing interest in the proposal, the consultation document and summary of responses are available below:
The proposal has now been adopted by the Member States of the European Union, the Council of Ministers and the European Parliament. It will be implemented by a new Directive amending the existing Marketing and Use Directive (76/769/EEC), to prohibit the sale of (a) clinical thermometers generally; and (b) new mercury measuring devices (including barometers) to the general public. Points to note are:
- a two year derogation for the sale of domestic barometers, to give industry time to adapt
- no restrictions on the use, repair/renovation or sale of existing (second-hand) or antique instruments
- devices intended for scientific and/or industrial use are exempt.
Following recommendations from the consultation on mercury in certain measuring devices new restrictions for mercury have been introduced and will be effective from from 3 April 2009 for certain measuring devices containing mercury. Details of this regulation as a Statutory Instrument (SI) can be found at The Office of Public Sector Information:
Advice for business on the introduction of these new restrictions can be viewed on the Business Link website.
Consolidated approach to the Marketing and Use Directive – The Controls on Dangerous Substances and Preparations Regulations 2006
The Controls on Dangerous Substances and Preparations Regulations 2006 came into force on 7 January 2007, following a consultation held in 2006.
The Marketing and Use Directive which is used for placing restrictions on the marketing and use of specific hazardous chemicals has led to a large number of separate transposition instruments. These address a number of substances with various restriction requirements and derogations which we believe businesses find cumbersome to comply with.
- The Controls on Dangerous Substances and Preparations Regulations 2006, SI 2006/3311 (on OPSI website)
The Health and Safety Executive's website has information on legislation for substance classification and labelling; Chemicals Hazard Information and Packaging for Supply Regulations (CHIP).
- EU environmental policy in general, including that on chemicals: Commission's environment website
- EU chemicals policy: Commission's enterprise website
- Information on the current European legislation, from a more scientific perspective: European Chemicals Bureau
Page last modified: 2 June 2008
Page published: 4 December 2002