Environmental Protection: Chemicals
EU chemicals policy - REACH
Questions and answers: Regulatory and political process
Why has a new EU chemicals strategy been developed?
The current EU legislative framework for chemical substances is a patchwork of many different Directives and Regulations which has developed since 1967 when the first Dangerous Substances Directive was introduced. There are different rules for “existing” and “new” substances. However, this system has not produced sufficient information about the effects of the majority of existing substances on human health and the environment. The identification and assessment of risks – covering the hazard of a substance as well as exposure of humans and the environment to it – have proved to be slow, as have been the subsequent introduction of risk management measures. The current system, in particular for new substances, is believed by some to have hampered research and innovation causing the EU chemicals industry to lag behind its counterparts in the US and Japan.
The current distinction between so-called "existing" and "new" substances is based on the, somewhat arbitrary, cut-off date of 1981. All substances that were put on the market before 1981 are called "existing" substances. In 1981, they numbered 100,106 different substances (listed on EINECS – the European Inventory of Existing Chemical Substances). Substances introduced to the market after 1981 (about 3,000) are termed "new" substances.
While new substances have to be tested extensively (and expensively) before they are placed on the market, there are no such provisions for "existing" substances. As a result, although some information exists on the properties and uses of existing substances, there is generally a lack of sufficient information publicly available in order to assess and control these substances effectively.
The current allocation of responsibilities is also considered by many EU Member States, the European Commission and others, to be inappropriate: Public authorities are responsible for undertaking risk assessments of substances rather than the enterprises that manufacture, import or use them. Since 1993, 141 existing substances have been identified for risk assessment and possible recommendations for risk reduction. Although draft risk assessments are now available for most of these, only a limited number (approximately 70) have gone through the entire process.
On the other hand, all “new” substances have to be notified and tested starting from volumes as low as 10 kg per year and risk assessments prepared. This has resulted in extensive knowledge about the hazards and risks of new substances. However, some have questioned the disproportionate amount of effort that has been put – by both industry and the authorities – in regulating new chemicals given that they account for around 1% of the total tonnage of chemicals currently on the EU market.
In addition, current legislation requires the manufacturers and importers of chemicals to provide certain information, but does not impose similar obligations on downstream users (industrial users and formulators) unless the substance has to be classified and a safety data sheet has to be supplied with it further down the supply chain. As a result, information on uses of substances may be difficult to obtain and information about the exposure arising from downstream uses scarce. In addition, the much more rigorous requirements for new substances are a disincentive to innovation.
If EU-wide controls (e.g. bans and restrictions) are considered to be necessary, the current legislation allows restrictions on the marketing and use of substances to be introduced. The introduction of restrictions started in 1976 (Directive 76/769/EEC) and restricts the marketing or use of about 100 substances, including the use of some of them in articles. Restrictions on the marketing to the general public of about 900 substances classified as carcinogenic, mutagenic or toxic to reproduction is also included under the Directive.
But is REACH the answer?
Legislation in this area is not new. The current system is fragmented, complex and implemented to different degrees. There is real need for the existing system to be replaced by one, coherent regulatory framework to be implemented in a harmonised way across the EU. Over 40 pieces of EU legislation already apply and these are all being replaced by one Regulation. This will ensure the proper functioning of the internal market. A level playing field must exist to ensure the efficient and fair operation of the internal market for all companies manufacturing, importing or using chemicals in the EU. The UK Government therefore strongly supports the aims of REACH.
What are the objectives of REACH?
The two most important aims are to improve protection of human health and the environment from the risks of chemicals, alongside the promotion of alternative methods for assessing hazards, and to maintain the competitiveness of EU industry.
The White Paper on the ‘Strategy for a future Chemicals Policy’, published in February 2001 (COM (2001) 88), identified seven objectives, subsequently endorsed by the European Council of Ministers and the European Parliament, that needed to be balanced within the overall framework of sustainable development:
The challenge for all those involved in formulating and developing REACH was to achieve the right balance between these potentially competing objectives.
What was the legislative decision-making process for the REACH proposal?
The REACH proposal was considered by the European institutions through the Co-decision Process. Co-decision means that the European Parliament and the Council of Ministers of the European Union (referred to as “the Council”) have to agree on the text of the legislation. Members of the European Parliament are directly elected by citizens of the European Union whilst the Council represents Member State Governments including the UK.
The process started with a European Commission legislative proposal in October 2003. The European Parliament then completed its First Reading of REACH on 17 November 2005, and proposed a number of amendments to the Commission’s proposal. The Council completed its deliberations on 13 December 2005 and reached political agreement on a revised text which contained significant differences to the Parliament’s agreed text. Following some technical legal processes the text of the political agreement, was formally adopted by the Council as its "Common Position" on 27 June 2006.
The Common Position text, as the formal, agreed position of all the EU Member State Governments, was the version of REACH that formed the basis of the Second Reading stage of the co-decision procedure. Following negotiations between the three institutions (Parliament, Council and Commission) the European Parliament’s at its second reading concluded with a vote on 13 December 2006 approving the final version of the REACH Regulation. That was endorsed unanimously by the Council of Ministers on 18 December 2006, paving the way for the REACH Regulation to come into force on 1 June 2007.
What are the main elements of the REACH Regulation, agreed by the European Parliament and the Council of Ministers (EU Member States) in December 2006?
- Main elements of reach regulations
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How will the REACH Regulation ensure a high level of protection of human health and the environment?
REACH follows risk-based approaches to regulating chemicals, thus ensuring a high level of protection of human health and the environment. The registration information requirements for the tonnage bands follow a targeted approach: increasing from a standard baseline set for substances in the 1-10 tonne band, through the 10-100 tonne, 100-1000 tonne, and 1000+ tonne bands. Tonnage is a proxy for exposure risk, and registration deadlines reflect this, with the largest tonnage band (and certain substances of high concern) first. The other registration deadlines follow in decreasing size order of tonnage band.
As well as standard information requirements increasing with larger tonnage band size, within each band further information requirements are also placed on substances that are identified as being potentially risky. The increased levels of information arising from registration will be utilised in improved chemical safety assessments and safety data sheets, and lead to better risk management measures and safer handling and use.
REACH improves coherence and consistency with the existing legislative framework for controlling chemical risks. It also reduces the costs on enterprises for regulatory compliance, so maximising the efficient use of resources whilst not compromising protection of human health and the environment. The strengthened requirements for substitution in authorisation will help ensure improved control of substances of very high concern.
Will REACH require animal testing?
Where there is no suitable, validated alternative to animal tests, some animal testing will be needed but this will be kept to the strict minimum necessary to provide the information needed for the protection of human health and the environment. Several mechanisms are included in the final text to ensure that this is the case. For example:
New methods to limit and reduce the need for testing on animals continue to be developed for the purposes of registration. The UK has carried out research to establish the status of the development and validation of alternative methods. It has recently run an international workshop to identify knowledge gaps, thereby contributing to the 6th EU Framework Programme on developing alternative test methods. The UK is contributing funding to this EU programme and also working on a joint research project with industry and academia to develop integrated testing strategies to be used in the REACH testing programme. A project on developing alternatives to using fish in tests is being supported by the UK.
Now that the legislative process is completed, what are the next steps?
REACH will enter into force on 1 June 2007. Once this happens, the various implementation deadlines given in the Regulation come into play. For existing (‘Phase-in’) substances, these are staggered over an 11-year period depending on the tonnages produced/imported per year, with the largest volumes being dealt with first. For new (‘Non-phase-in’) substances, registration requirements apply immediately. A summary registration timeline is shown below:
Page last modified: 11 May 2007
Page published: 28 March 2006