Royal Commission on Environmental Pollution

The Royal Commission on Environmental Pollution has highlighted the need for an improved system for assessing the risks posed by chemical substances and ensuring appropriate steps are taken to control their marketing and use. The Royal Commission believes that management of the risks from new chemical substances is generally effective, and the cause for concern relates to substances which were in use prior to 1981. Although European Community legislation covering over 100,000 existing substances has been in operation since 1993, and over 100 such substances have been selected for priority attention, not one case has yet reached the stage of agreed action.

In the Royal Commission's view, the solution lies in industry taking greater responsibility for the substances it produces and markets, subject to appropriate safeguards. This approach would build on initiatives already taken by the UK Chemical Industries Association. Legislation should be modified to reflect the greater responsibility taken by industry, preserve accountability, and achieve consistency between the regulation of different types of chemicals. Because the effects of chemical use may extend to other countries, and because many of the companies involved are multinational, policies in this field must continue to have a European and international focus.

For public trust to be maintained, decisions about the marketing and use of chemicals must take into account the concerns ordinary citizens have. That applies in particular to strategic decisions, about how chemicals should be prioritised for attention, and about finding substitutes for substances which present particularly high risks. To inform such decisions, people's values must be articulated effectively, and this will require the use of relatively unfamiliar procedures, such as consensus conferences.

The Royal Commission has expressed these views in response to a consultation paper issued by the government.

The text of the response is below.

Additional Information:

The Royal Commission on Environmental Pollution is an independent standing body, established in 1970. Its terms of reference are to advise on matters, both national and international, concerning the pollution of the environment; the adequacy of research in this field; and the future possibilities of danger to the environment. The Chairman and Members are appointed by Her Majesty The Queen on the advice of the Prime Minister and serve part time. The present Chairman is Sir Tom Blundell FRS, Head of the Department of Biochemistry at Cambridge University.

The Royal Commission's 21st Report, Setting Environmental Standards was published in October, and is available from the Stationery Office (Cm 4053, ISBN 0 10 140532 4), price £21.40.

The government's consultation paper on chemicals in the environment, Sustainable production and use of chemicals, was published by the Department of the Environment, Transport and the Regions in July.

Contact:

SUSTAINABLE PRODUCTION AND USE OF CHEMICALS

RESPONSE BY THE ROYAL COMMISSION ON ENVIRONMENTAL POLLUTION TO THE CONSULTATION PAPER PUBLISHED IN JULY 1998 BY THE DEPARTMENT OF THE ENVIRONMENT, TRANSPORT AND THE REGIONS

1. Regulation of the marketing and use of chemicals is a crucial aspect of environmental protection. The Royal Commission on Environmental Pollution welcomes the government's review of policy in this field. It believes that control of the risks from new chemical substances through the present notification scheme is generally effective, within the inherent limitations of scientific assessments, although vigilance is necessary to ensure that all new substances are duly notified. The main concern is reducing the risks posed by chemical substances which were in use prior to 1981.
2. The Royal Commission endorses the policy aims which the government has proposed, which are to protect the environment as a whole from harmful effects of chemical use while ensuring that the benefits of chemicals are still available to society. In pursuing those aims, important issues arise about:
   • public involvement
   • the European and international framework
   • consistency as between different types of chemical
   • the case for industry to take greater responsibility for ensuring that the chemicals it produces and markets will not damage human health or the natural environment
3. The consultation paper Sustainable production and use of chemicals invited views on some of these issues. Others are more general issues highlighted by the Royal Commission's recent report, Setting Environmental Standards (Cm 4053).

Public involvement

4. It is essential that the arrangements for controlling the environmental hazards associated with chemical substances merit and retain public confidence. The key requirements are transparency, openness and accountability. The government has invited the UK Round Table on Sustainable Development to provide advice on the mechanisms that might be used to improve transparency and the information available to the public about chemical substances.
5. In turn, decisions about environmental policies must be informed by an understanding of people's values. A rigorous exploration of such values requires discussion and debate to allow a range of perspectives and viewpoints to be considered. Values should be articulated and developed at the earliest stages in formulating policies. That applies in particular to such strategic issues in chemicals policy as the selection of the criteria on which prioritisation of chemical substances for assessment is based, the form of assessment used, and the extent to which substitutes should be sought for hazardous substances. These issues must be approached in the light of the precautionary principle and a recognition of the nature and scale of the uncertainties inherent in scientific assessments.
6. Environmental non-governmental organisations (NGOs) have proposed that the criteria for prioritisation should be the intrinsic properties of persistence, potential for bioaccumulation and toxicity; and that targets should be set for reducing, and eventually eliminating the use of chemical substances with those properties. In other words, prioritisation, and in some cases action, would be based on a hazard assessment alone.
7. The chemical industry has voiced objections to prioritisation on the basis of intrinsic properties, and advocated the use of simplified risk assessment procedures which would consider the extent of potential exposure to a given substance as well as the intrinsic hazard it represents. This approach presupposes accurate knowledge, not only of production volumes, but of the uses to which a substance will be put.
8. The consultation paper suggests that the government should obtain advice on (among other things) criteria for selecting chemicals for assessment from a 'stakeholder forum' involving 'industry, environmental NGOs, Government officials, and experts from academia'. Stakeholder fora, and other traditional forms of consultation, have a valuable part to play in appropriate contexts. However the Royal Commission does not believe the concept of a 'stakeholder' can usefully be stretched to cover either the concerns ordinary citizens have about protection of the environment or the contributions to the decision process made by science and other disciplines. Nor does it believe that negotiations between stakeholders are likely to be successful in meeting the considerable challenges posed by the agreed policy aims (paragraph 2 above).
9. More appropriate and effective procedures for arriving at decisions about environmental policies are described in the Royal Commission's report Setting Environmental Standards. For the present purpose consideration should be given to the use of one or more of the approaches described and explained in box 7A on page 107 of that report, for example a consensus conference. Use of such procedures may enable a consensus to be achieved about strategic issues. Even if different viewpoints persist, articulation of public values is likely to play an important role in creating or identifying policy choices which will command wide support.

The European and international framework

10. The effects of chemical use are seen across the globe, in some cases regardless of the original point of use. Moreover chemicals are produced and traded internationally by companies which are themselves often multinational. Comprehensive co-ordination of the assessment of chemical substances is desirable in order to prevent unnecessary duplication of work and consequential delays, both to companies in introducing technological innovations and to regulators in devising and applying appropriate control measures.
11. Regulation of the marketing and use of chemical substances in the UK is carried out under European Community (EC) legislation on the basis of an integrated programme of assessments by Member States. The European Commission is carrying out its own review of policy in this field. The EC Existing Substances Regulations, which cover substances recorded as having been marketed in the EC between 1971 and 1981, and which came into effect in 1993, have thus far failed to deliver decisions on risk management for a single chemical substance. The European Commission and many Member States acknowledge that the present situation is unsatisfactory.
12. There is less agreement about the reasons for this situation. Lack of resources at European level appears to be an important factor. For its part, the European Commission has stated that one of the reasons for the lack of progress in reviewing existing substances is an absence of commitment and resources on the part of Member States. The Royal Commission concluded in Setting Environmental Standards (paragraph 3.44) that this slow rate of progress 'demonstrated the need for an entirely fresh approach' to assessment of existing chemical substances. The form that fresh approach should take is discussed below.
13. Adopting a fresh approach will entail amendments in due course to EC legislation. The objective for the UK government should be to try to bring about appropriate changes. Several other Member States are advocating substantive changes. Meanwhile, progress can be made in the right direction either through negotiations with the chemical industry (at UK or European level) or through UK legislation that complements the existing EC legislation.
14. The European Union's programme of assessments of existing chemical substances is co-ordinated with those of other developed countries through the Chemicals Programme of the Organisation for Economic Co-operation and Development (OECD). Co-ordination at that level will continue to be essential. Global co-ordination, with full involvement by developing countries, is a desirable long-term objective. The UK government should give strong support to making the Intergovernmental Forum on Chemical Safety (IFCS) effective in building up the capability of the governments of non-OECD countries, in establishing wider co-operative work programmes, and in harmonising (ultimately through the creation of international legal instruments) the classification and labelling of chemicals.
15. An important part of the information that a procedure of the kind proposed in paragraph 9 above will have to consider is the existence and content of internationally co-ordinated assessment programmes. Another important part is policy developments in other contexts which have major implications for the use of chemical substances, such as the Persistent Organic Pollutants Protocol of the United Nations Economic Commission for Europe and the Esbjerg Declaration by the parties to the OSPAR Convention. Consideration should be given to holding a consensus conference, or a similarly effective forum, at European level, as well as, or instead of, holding one at national level.

Consistency as between different types of chemical

16. It is desirable that there should be consistency between the policies adopted towards different types of chemical, so that risk reduction measures taken in one field are not out of proportion to measures taken in other fields. Certain types of chemical which have the potential to cause damage to human health and the natural environment (plant protection products, biocides and veterinary medicines) are regulated under separate EC legislation and excluded from the legislation on new and existing chemical substances.
17. A significant difference between the different codes of EC legislation is that, whereas it is permissible to market and use new and existing chemical substances unless the regulator intervenes to require additional risk reduction measures, prior approval is required from regulators for each active ingredient in plant protection products, biocides and veterinary medicines, and then for each product in which that active ingredient is used. A point of similarity is that criticisms have been made of the lack of progress in implementing the EC Plant Protection Products Directive of 1981, which has affected both approval of new active ingredients and the review of existing active ingredients.
18. Environmental NGOs have proposed that all chemicals should be subject to positive approvals procedures, and authorised for specific applications and use in specific products. Requiring approval and listing of uses for all types of chemical would work against the objective of speeding up the assessment and regulation of existing chemical substances. It would also be likely to inhibit innovation. However, the Royal Commission does not consider that the present distinction between types of chemical for which there is and is not positive listing is a satisfactory and logical one.
19. Another significant difference between legislative codes is that the most recent EC legislation, the 1998 Biocides Directive, incorporates the principle of comparative assessment; a biocide can be refused approval if there is another active ingredient for the same product type which presents a significantly lower risk to humans, animals and the environment. The Royal Commission concluded in Setting Environmental Standards (paragraph 3.45) that 'the criterion of comparison with the risk presented by other available substances should be introduced into all regulatory procedures for the marketing and use of chemicals'. The way in which the availability of substitutes is taken into account in regulatory decisions will properly depend on the circumstances of each case.

Main elements of a fresh approach

20. The Royal Commission believes a fresh approach to chemicals policy must be based on chemical companies taking greater responsibility for ensuring that the substances which they produce and market will not damage human health or the natural environment. It is encouraging that statements and communications by the UK and European associations for the chemical industry have indicated willingness to take a greater role. Increased industry involvement has the potential to accelerate the assessment of existing chemical substances and measures to redice risks taken in response to the assessments.
21. Self-assessment by industry also offers the prospect of early action to bring about other improvements in the present arrangements for controlling the risks associated with new and existing chemical substances. Lack of information about the uses to which chemical substances are put after production and marketing has handicapped the assessment of exposure. Although positive listing of all chemicals in relation to specific uses would be too inflexible, assessments should always be made in the light of the fullest possible information about the conditions under which a substance will be used. The Royal Commission therefore welcomes voluntary action by industry which is intended to increase knowledge of what happens to chemicals once they pass out of the hands of the company which has produced or marketed them. The well established philosophy of 'responsible care' has been extended into the concept of 'product stewardship', defined by the UK Chemical Industries Association as 'the responsible and ethical management of the health, safety and environmental aspects of a product from its invention through its processes of production to its ultimate use and beyond'.
22. Another respect in which self-assessment is capable of bringing early progress is the scope for substitution. Whereas the legislative requirement under the EC Biocides Directive (paragraph 19 above) has the aim of discouraging the introduction of chemicals which pose greater risks than existing substances used for the same purpose, it is equally important that chemicals already in use which present particularly high risks should be replaced if a satisfactory alternative which presents lower risks can be identified or developed. Industry must necessarily play a large part in achieving that aim.
23. A third important aspect which ought to loom large in self-assessment is the pursuit of greater eco-efficiency, by reducing the energy and materials required for a given purpose and the wastes created. The UK Chemical Industries Association has already entered into an agreement on energy efficiency with the Department of the Environment, Transport and the Regions.
24. In a system based to a large extent on self-assessment, transparency, openness and accountability become even more necessary. The safeguards required in order to build public trust and maintain the quality of assessments include:
    • guidelines for assessment procedures, including the data requirements for assessments
    • consultation on, and peer review of, draft assessments
    • publication of assessments
25. Methods for toxicity and ecotoxicity testing have become increasingly standardised across the world. Again, OECD has contributed by producing guidelines for tests in order to avert an escalation of testing to meet different data requirements by individual governments for the same substance; tests are also required to be carried out in accordance with good laboratory practice as specified by OECD. Work within the OECD Chemicals Programme has resulted in guidance to governments and industry about gathering data, making initial assessments and reporting results. This guidance is periodically updated to reflect the state of the art and experience gained by OECD member countries.
26. One of the questions posed in the government's consultation paper was whether data requirements under the notification scheme for new chemicals are too onerous for industry. Procedures which require data to be generated to fill a series of boxes in a data set regardless of relevant considerations (such as the intrinsic nature of a chemical or its use pattern) can be very wasteful. There may well be a case for streamlining the data requirements and making them smarter, provided the level of protection is not thereby impaired. OECD can play an important role in such an exercise, and more generally in elaborating and keeping under review the safeguards required in a system based to a large extent on self-assessment.
27. While in the short term a greater reliance on self-assessment by industry must operate within existing legislation, early changes should be sought in EC legislation in order to give greater recognition to self-assessment. Present legislation on new and existing chemical substances gives companies an essentially passive role of submitting notifications and data to a regulatory body which then carries out an assessment as the basis for decisions. In reality it is both desirable and the usual practice for companies to carry out their own assessments of the risks posed by new substances and submit those assessments to the regulator. The same practice should be extended to assessment of existing chemicals, and should be reflected in the legislation in both contexts.
28. New legislation should follow the broad approach adopted in UK health and safety legislation and place a duty on companies to act responsibly in taking decisions about the production and marketing of chemicals and to make their own assessments of the risks that production and use would present for human health and the natural environment. Such assessments should be made in relation to a specific use or uses. There should also be a statutory duty on the company to indicate the purposes for which a substance is suitable and, where appropriate, the methods that should be adopted for disposal after use; to take reasonable steps to ensure that the substance will not be used for other purposes; and to keep itself informed about the purposes for which the substance is actually used and the circumstances in which it is used. Requirements on these lines would give legal form to the concept of product stewardship which is already accepted by the UK chemical industry. In taking decisions about the production and marketing of chemicals, companies should also be required to take into account the availability of substitutes, and the relative risks posed by the substance under consideration and the available substitutes.
29. Concerted enforcement projects have revealed some non-compliance with present EC legislation, and highlighted the significance for compliance of adequate internal systems within companies. Legislation on the lines envisaged above will stimulate companies to establish effective systems for controlling and monitoring all the relevant aspects of their operations.
30. The Royal Commission does not regard self-regulation by industry as a substitute for statutory regulation, but as complementing and reinforcing statutory regulation. There must continue to be provision for government regulators to take decisions on substances and they must have the ability to obtain all the information they need for that purpose. Statutory regulation would provide assurance that humans and the natural environment will be protected. The primary safeguard however will be the duties placed on companies themselves. The legislation will have to specify the circumstances in which the regulator will intervene, and make provision for circumstances in which self-regulation would not be appropriate, for example because a company did not have the capability to carry out assessments or had in some respect defaulted on its obligations. New legislation should also make statutory the necessary safeguards for self-assessment discussed above.
31. Given the very large number of existing chemical substances for which assessment will be necessary, there will have to be statutory provision for scheduling the assessments of such substances made by companies, based on a clear and logical definition of priorities.
32. The purpose of placing duties on companies will be to increase the effectiveness of the protective mechanisms by speeding up their operation, making them more proactive and raising the level of compliance. An approach on these lines will also provide a promising basis for consolidating into a single code the inconsistent approaches followed at present in relation to different types of chemical.

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