Select Committee on European Scrutiny Twelfth Report


The European Scrutiny Committee has made further progress in the matter referred to it and has agreed to the following Report:—




COM(01) 88

Commission White Paper - Strategy for a future chemicals policy.


Legal base:
Document originated: 27 February 2001
Forwarded to the Council: 28 February 2001
Deposited in Parliament: 13 March 2001
Department: Environment, Transport and the Regions
Basis of consideration: EM of 23 March 2001
Previous consideration: None
To be discussed in Council: June 2001
Committee's assessment: Politically important
Committee's decision: For debate in European Standing Committee A


1.1  In economic terms, the Community chemicals industry is of major significance, accounting for 31% of the global chemical production of about 400 million tonnes. Within the Community itself, it is the third largest manufacturing industry, employing 1.7 million people directly (with up to 3 million jobs dependent on it), and in 1998 the 100,000 or so different substances registered on the market generated a trade surplus of 41 million euros. On the other hand, it has long been recognised that certain chemicals can cause serious damage to human health and the environment. Consequently, along with a broad range of other substances, the production, marketing and use of chemicals is governed by a number of important legal instruments,[1] which regulate their testing, determine risk reduction measures, and establish duties regarding the safety information provided to users. However, according to the Commission, increasing concern within the Environment Council that these measures do not provide sufficient protection led it to review them in 1998, and the action now proposed is set out in this White Paper. It was also foreshadowed in the Commission's Communication on the Sixth Environmental Action Programme for the European Community, Europe 2010: Our future, Our choice, on which we reported recently.[2]

The current document

1.2  The Commission says that its review identified a number of major problems. In particular, the present system distinguishes between "existing substances" (declared to be on the market in September 1981) and "new substances" (placed on the market since that date). In the case of the 2,700 new substances, the risks to human health and the environment must be assessed before they can be marketed in volumes above 10 kg, with the emphasis on "base set" testing for acute effects for quantities up to 1 tonne, and more in-depth (Level 1 and Level 2) testing, focussing on long-term and chronic effects, being provided for those involving higher volumes (above 100 and 1,000 tonnes respectively). However, the 100,000 or so existing substances are not subject to the same requirements, and only some 140 of them have been identified as priority substances (and thus subject to comprehensive risk assessments carried out by Member State authorities). The Commission adds that there is a general lack of knowledge about the properties and uses of existing substances, due to the slowness and resource-intensive nature of the risk assessment process, and the fact that, although manufacturers and importers are required to provide information about them, this obligation does not apply to down-stream users.

1.3  The Commission also highlights two major procedural flaws. First, decisions on further testing of a substance can only be requested from industry after the relevant authorities have demonstrated that it may present a serious risk. However, without test results, it is almost impossible to provide such proof, so that final risk assessments have been completed for only a small number of substances. Secondly, it says that current liability regimes are insufficient to remedy the problems found by the review, as they require a causal link to be found, which is often impossible in the absence of adequate test data and where cause and effect occur far apart in time.

1.4  The Commission identifies a number of objectives which it believes must be met in order to achieve sustainable development in the chemical industry within the framework of the Single Market. The most significant of these is the protection of human health and the environment, where it proposes that both existing and new substances should become subject to a new system called REACH. This would be based on the following three elements:

— the registration of the basic information (including data on properties and intended use, a preliminary risk assessment, and proposed risk management methods), which the manufacturers would be required to provide for about 30,000 existing and new substances whose production exceeds 1 tonne: in about 80% of such cases, the Commission considers that no further action would be necessary;

— an evaluation of about 5,000 of those substances whose production exceeds 100 tonnes, as well as of those of a lower tonnage where there is cause for concern; and

— in addition, about 1,400 substances — including the majority of endocrine disrupting chemicals - giving rise to very high concern because they are persistent organic pesticides, or have carcinogenic, mutagenic or reprotoxic properties, would need a special authorisation before they could be used for particular purposes demonstrated to be safe.

1.5  In the case of existing substances, this new system would be phased in over a period according to the volumes produced, though there would be sufficient flexibility to allow it to be applied more quickly to substances which give cause for concern. Thus, in the case of registration, the new system would apply from the end of 2005 where production exceeds 1,000 tonnes, from the end of 2008 where it exceeds 100 tonnes, and to all existing substances (over 1 tonne) from the end of 2012: in the case of evaluations, Level 2 testing (for substances above 1,000 tonnes) would have to be completed by 2010, and Level 1 testing (for those above 100 tonnes) by 2012.

1.6  The Commission says that the main aim would be to provide a reliable basis for deciding on adequate safety measures, based on two distinct elements - one identifying a chemical's hazardous properties and potency, and the other estimating the exposure arising from its use. This information would in turn constitute the basis for classifying chemicals, and hence for deciding on the appropriate labelling, and on any restrictive measures judged necessary to protect consumers, as well as those needed in relation to such factors as water and air pollution, waste management and the prevention of major accidents. However, the Commission also comments that, whilst it might appear reasonable to test chemicals until all hazardous properties are known, this is neither possible (due to limitations in the available testing methodologies) nor desirable (due to the costs involved and ethical considerations over animal testing). It therefore stresses the need for a balanced approach under which the acquired knowledge offers proportionate benefits in terms of managing risks, particularly where low volumes are marketed. More specifically, it suggests that, for both new and existing substances, the current testing threshold should be raised from 10 kg to 1 tonne, but that, in the case of Level 1 and Level 2 testing, manufacturers would be required to submit a strategy for further testing to the relevant authority, which would decide on the appropriate course of action. In addition, the testing required could be waived or extended according to particular exposure levels.

1.7  The Commission also sets out in some detail the procedures it envisages for authorising substances of particular concern. It comments that a significant number of these will be identified only through Level 1 and Level 2 testing when they are already used in substantial amounts, and that a transitional period is needed to generate the necessary information. It therefore envisages a two-step decision-making process under which the substances which will be subject to authorisation will first be identified, and a precise date set for the prohibition of all unauthorised uses, together with the scope for any exemptions (for example, in well controlled industrial uses, or research laboratories). Subsequently, decisions will be taken on the particular uses to be authorised on the basis of a risk assessment covering the whole life cycle, including disposal, in cases where the use presents a negligible risk, or is justified by the overall socio-economic benefits which arise. The Commission stresses that, in contrast to the present system, which requires the authorities to provide convincing arguments before restrictive measures are taken, the proposed authorisation process will require industry to take a pro-active role.

1.8  The White Paper also sets out the Commission's thinking on the way in which the new system would be administered, and the likely costs and benefits. It says that Member States would broadly retain their current responsibilities, and would collectively be responsible for substance registration and evaluation, as they are at present for notifications of new substances. However, in order to provide better consistency of decision-making, as well as scientific and technical support, the Commission proposes the establishment of a "central entity", in the form of an expanded European Chemicals Bureau. This would receive registration dossiers and circulate these to other Member State authorities, establish and maintain a comprehensive central database on all registered chemicals, perform spot-checks and computerised screening of the registered substances for properties raising particular concern, and support Member States in the evaluation of substances. Its other functions would include providing access for the public to non-confidential information, establishing an efficient and secure data exchange network with Member States for commercially sensitive information, and providing an operational framework for the authorisation procedure.

1.9  As regards the potential costs and benefits, the Commission estimates the cost of base-set testing at around 85,000 euros per substance, and that for Level 1 and Level 2 tests at about 250,000 and 325,000 euros respectively. On that basis, it puts the total cost of testing approximately 30,000 existing substances at about 2.1 billion euros over the 11 years until 2012. It adds that the administrative costs — which it does not attempt to assess — would be recovered through a fee-based system. It suggests that the potential benefits would stem from improved risk management, leading to safer handling, and reduced exposure of consumers and the environment to dangerous substances. However, it says that it is difficult to estimate these accurately in monetary terms, but that, if as a result, some human lives could be saved, or the incidence and prevalence of allergic or chronic diseases could be reduced by some percent, the money would have been well spent.

1.10  In addition to the central aim of protecting human health and the environment, the Commission identifies a number of other policy objectives for the proposed strategy, as follows:

— Maintaining the competitiveness of the Community chemical industry

The Commission says that it is essential to promote the competitiveness of the Community chemical industry, and in particular to encourage the development of safer chemicals. It envisages this being achieved by the proposed increases in the current thresholds for notification and testing, by extending the conditions for derogation for research and development, and by enabling test data to be submitted in a flexible way, having regard to the resource implications. Also, importers will be obliged to assess the safety of their chemicals, to provide information, and to share the costs of testing.

— Preventing fragmentation of the internal market

The Commission states that any Community strategy on chemicals aimed at ensuring a high level of health, safety and environmental protection should also ensure the proper functioning of the internal market in the sector, and that this will be achieved by the new policy being based on full harmonisation at Community level.

— Increased transparency

The Commission says that, subject to commercially sensitive information being "suitably protected", the public has a right of access to information about the chemicals to which it is exposed, so as to enable it to make informed choices and to avoid products containing harmful chemicals. It suggests that transparency will be improved by the creation of a single system which will eventually be applied to all chemicals.

— Integration with international efforts on the safety of chemicals

The Commission points out that a global network of countries and international organisations has developed to promote the safe use of chemicals, and that in particular the Intergovernmental Forum on Chemical Safety (IFCS) was established to co-ordinate the many national and international activities, to promote chemical safety, and to oversee implementation of the programme of environmentally sound management of chemicals adopted in 1992 by the Earth Summit in Rio. It suggests that the recommendations in this White Paper will feed into the international programmes, and make a major contribution to achieving safe use of chemicals at a global level, and also regionally (for example, by helping to protect the marine environment of the north-east Atlantic against pollution).

It also suggests that the lack of data on existing chemicals is a global concern, with the United States having recently launched initiatives to obtain systematically information about the most abundant chemicals on its own market. The Commission says that studies performed in the US should not have to be repeated in the Community (and vice versa) and that test results carried out under OECD auspices should enable the number of tests performed within the Community to be reduced. It also points out that the enhanced testing requirements within the Community will be of benefit to those developing countries which import chemicals.

— Promotion of non-animal testing

The Commission says that, although measures to increase testing thresholds will limit the need for testing, such requirements should, as far as practicable, be met through the use of existing non-animal test methods. It also considers that the development of new non-animal tests should be encouraged.

— Conformity with the Community's WTO obligations

The Commission stresses that the new policy must not discriminate against imports, and that under the relevant World Trade Organisation (WTO) provisions, the Community will require a sound scientific evaluation of the potential threats to human health and the environment if it is to defend itself against any challenges from third countries.

The Government's view

1.11  In his Explanatory Memorandum of 23 March 2001, the Parliamentary Under-Secretary of State at the Department of the Environment, Transport and the Regions (Mr Bob Ainsworth) says that the Government agrees that the slow progress in assessing the hazards and risks posed by substances already on the market is unsatisfactory, and it welcomes the White Paper's emphasis on the responsibility of industry to provide safety information to down-stream users, and to prepare risk assessments; the principles of deadlines for registering information on existing chemicals, exposure- driven testing requirements, and discouraging duplicate testing; and increased transparency in decision-making and public access to information. On the other hand, he says that the Government is concerned that the Commission's proposals will not take effective action on the chemicals of most concern, nor provide a system which is workable and cost-effective, with the minimum bureaucracy and regulatory burden on business. It is also particularly concerned that the provisions to minimise animal testing are inadequate.

1.12  The Minister points out that the Government's own approach to the sort of issues dealt with in the Commission's White Paper was contained in its Chemical Strategy, Sustainable Production and Use of Chemicals - a strategic approach, of December 1999. He says that this set out a process for identifying rapidly the chemicals of most concern in the environment and taking action, and that the UK Chemicals Stakeholder Forum which has been set up to assist in the implementation of the UK strategy has identified the relevant criteria. The Government will be seeking to ensure that the measures taken by the Community reflect a similar targeted approach. It will also want to consider carefully the precise balance between the roles of the Member States and the Community in this area, in the light of the functions which the Commission envisages for the proposed "central entity".

1.13  The Minister also comments on the Commission's cost estimates set out in paragraph 1.8 above. He suggests that the figure of 2.1 billion euros is likely to be a significant under-estimate as it only covers the cost of testing existing substances, and that, in any case, the lack of clarity in the proposals makes it difficult to have confidence in the costings and the assumptions behind them. In particular, he points out that, because the White Paper envisages waiving testing requirements in some circumstances and accepting data from other international sources, the extent to which additional testing may be required is not clear at this stage. He adds that the same is true of the administrative costs, on which the Government has begun a Regulatory Impact Assessment.


1.14  This is clearly a subject of major importance, in terms of both the economic and environmental significance of the issues with which it deals, and we therefore have no hesitation in recommending the present White Paper for debate in European Standing Committee A, even though it is likely to be followed by specific legislative proposals. Moreover, although there are still a number of outstanding points on it - including the Regulatory Impact Assessment promised by the Government - we understand from the Minister's Explanatory Memorandum that the Swedish Presidency aims to complete Council Conclusions in June to direct the Commission in developing proposals for an effective and workable system. We therefore think it desirable for any debate to take place before then, if at all possible.

1.15  We also suggest that the main focus for the debate should be the points identified by the Minister in his Explanatory Memorandum, and summarised in paragraphs 1.11-1.13 above. However, we think it would be helpful if the Government could indicate more precisely, before the debate takes place, the main ways in which the approach set out in the UK's own 1999 strategy document differs from that in the Commission White Paper, and those aspects of the latter on which it has the greatest reservations about the effectiveness of what is proposed.

1   The most significant of these are Council Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances (OJ No. L 196, 16.8.67, p.1); Directive 88/379/EEC relating to the classification, packaging and labelling of dangerous preparations (OJ No. L 187, 16.7.88, p.14); Council Regulation (EEC) 793/93 on the evaluation and control of risks of existing substances (OJ No. L 84, 5.4.93, p.1); and Directive 76/769/EEC relating to restrictions on the marketing and use of certain substances (OJ No. L 262, 27.9.76, p.201). Back

2   (22132) 5771/01; see HC 28-xi (2000-01), paragraph 5 (4 April 2001). Back

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