Select Committee on Science and Technology Written Evidence


APPENDIX 16

Memorandum from the Scientific Alliance

1.  INTRODUCTION

  1.1  The Scientific Alliance is an independent non-profit membership-based organisation fostering rational discussion and debate on environmental issues.

  1.2  The Scientific Alliance and its members are concerned about the many ways in which science is often misinterpreted, and at times misrepresented, both within policy circles and in the media. The Alliance thus works to overcome these problems by aiming to:

    —  promote sound science in the environmental debate;

    —  ensure that scientific arguments remain prominent throughout the policy making process; and

    —  facilitate an informed dialogue between all stakeholders involved in the   environmental debate through events and publications.

  1.3  The Scientific Alliance is guided by a Scientific Advisory Forum, consisting of senior independent scientists. In drawing up this Memorandum, the Scientific Alliance has drawn on the advice of two relevant experts in particular:

    —  John Mellor, Emeritus Professor of Chemistry, University of Southampton.

  Professor Mellor is a Fellow of the Royal Society of Chemistry, Editor of the Journal of "Chemical Research" and Chair of the World Universities Network Group on "Outreach in Chemistry".

    —  Anthony Trewavas, Professor in Plant Biochemistry, University of Edinburgh.

  Professor Trewavas is a Fellow of the Royal Societies of London and Edinburgh, and of the World Innovation Foundation. He has been awarded the title of "Most Highly Cited Researcher" by the Institute of Scientific Information.

  Both Professors have highly respected and extensive bodies of published work in their respective fields of expertise.

2.  THE SCIENTIFIC ALLIANCE'S VIEW ON REACH (REGISTRATION, EVALUATION AND AUTHORISATION OF CHEMICALS)

  2.1  The Scientific Alliance welcomes the concept of harmonising and simplifying the regulatory framework for chemicals in the EU. This approach is essentially sound, and the creation of the European Chemicals Agency is a useful step towards centralisation of the approval process.

  2.2  It is the opinion of the Scientific Alliance that the actual REACH proposals for the new framework, even in their modified form, remain deeply flawed, and do not seem to be based upon a rational, science-based approach to risk.

  2.3  There is little clear evidence of the supposed benefits of this legislation. Projections for health improvements are extremely doubtful, both in terms of the dubious assumptions made about the negative effects of chemicals and the net economic benefit of reducing them[36].

  2.4  For example, there is no convincing evidence that synthetic chemical pollutants are an important factor in causing human cancer[37]. Attempting to reduce minute hypothetical risks when major risks still account for virtually all premature cancers is poor policy. For example, the primary carcinogen hazards in the UK are smoking, obesity (lifestyle affecting hormone levels) and sunshine, and categorically not industrial chemicals.

  2.5 The Scientific Alliance does not accept the principles upon which the present REACH proposals are constructed. Nonetheless it is keen, given the terms of reference of the inquiry, to engage as constructively as possible to ensure that the UK, in future discussions on the legislation, contributes actively towards the implementation of a more practicable and scientific approach to safe use of chemicals.

3.  THE PRECAUTIONARY PRINCIPLE AND RISK ASSESSMENT

  3.1  The REACH legislation is fundamentally predicated on public perception, rather than scientific analysis, of risk[38]. While measures have been proposed to improve the extent to which the risk associated with any chemicals is measured more realistically, the legislation does not go far enough in this respect.

  3.2  The prioritisation of assessment of chemicals in REACH is still based on hazard and/or volume. Hazards, either theoretical or present under laboratory conditions, are quite different from genuinely significant risks that may be experienced by the general population.

  3.3  The UK Control of Substances Hazardous to Health Regulations 2002 (COSHH) is based on risk not hazard, an approach which the Scientific Alliance fully endorses. The REACH framework, in contrast, we see as a retrograde and counter productive step because it is not based on a proper scientific assessment of risk.

  3.4  Science offers numerous ways to produce even more precise risk assessments, for example, progress in genetics will inform testing and regulatory regimes in a more accurate fashion than REACH prescribes. REACH does not appreciate or allow for the continuous development of science to meet the requirements to which it pertains, in a more efficient, mutually beneficial and realistically achievable fashion.

  3.5  Theoretical hazards can be identified for a wide range of naturally occurring compounds as well as virtually all the chemicals that REACH intends to encompass. Potential hazard is not a reason to introduce the stringent regulations proposed.

  3.6  There are many examples that serve to highlight the counter productive nature of the current assessment criteria:

    —  Warfarin is used as rat poison, but also at low doses as a medicine for people with heart disease;

    —  common cleaning products contain chemicals, which can be deemed hazardous according to REACH, but offer minimal risk to consumers when used appropriately; and

    —  aspirin can cause stomach bleeding and worse, yet it also plays a vital role in reducing the risk of heart disease and deep vein thrombosis.

  An analysis based solely on hazards, without effective risk/benefit assessment, would have been a very significant barrier to the introduction of these products.

4.  PRIORITISATION

  4.1  The revised REACH regulatory system remains unnecessarily skewed towards evaluating those substances which are used at the highest volumes, as well as those judged to be a hazard.

  4.2  The REACH legislation presumes that there are numerous chemicals causing harm, that must be removed from the supply chain. If one accepts this presumption, which the Scientific Alliance does not, the legislation is still not constructed to deal with the perceived problem in the most efficacious manner possible.

  4.3  Prioritisation should be based primarily upon evidence that suggests genuine potential for harm because of the nature or mode of use of individual chemicals. In cases where actual risks are identified, the chemicals in question should be processed through the system as quickly as possible.

5.  A RATIONAL, SOUND SCIENTIFIC APPROACH TO RISK

  5.1  Despite some amendments, the testing and verification systems in place for REACH still do not proffer a clearly delineated and sound scientific classification of cost versus benefit based on risk assessment.

  5.2  The temporary decision to remove polymers from the REACH framework "until sound scientific criteria have been developed for defining which polymers might be registered"[39] is cautiously welcomed, but should be extended and expanded.

  5.3  There is only a need to test those chemicals that may give rise to genuine risk, which the above decision implicitly acknowledges. This approach should be extended to the many other cases where the physical form and/or end use of final products makes the real risk associated with potential hazards vanishingly small. One example is glycol, which is used in car radiators as an anti freeze. As glycol is both inflammable and poisonous its use can only be justified on the basis of risk assessment, ie in use the risk it presents is minimal.

  5.4  In addition to the need to assess real risks rather than base evaluations on loosely defined hazards, the benefit side of the equation must be an integral part of any assessment. For example, doubts have been raised about the use of fire retardants in furniture, but their use has saved many lives[40].

  5.5  Regulatory decisions within REACH need to be based on sound science and risk analysis, ensuring that levels of exposure, the concentration of a substance within an product, the use of a substance and the overall degree of risk, are all taken into account.

6.  THE BURDEN OF PROOF

  6.1  The burden of proof within the modified REACH legislation is still placed heavily on the chemicals industry and is so to a debilitating extent. The European chemicals industry, and scientists, will find their ability to innovate severely restricted, as available funding is channelled increasingly towards the testing necessary to fulfil the obligations under REACH (also see section 7).

  6.2  The Scientific Alliance does not argue against the extent of the burden of proof contained in existing safety evaluations, which lies with manufacturers, and the science community as a whole, although more rapid and efficient processes would be welcomed. However, there is a concern that the REACH proposals do not prescribe the same level of justification of cost versus benefit by risk assessment.

  6.3  "Striking the balance". Considerations regarding human health should always be at the forefront of any initiative where there is a possibility that this could be affected. Nonetheless, this has to be tempered with a realistic approach to the extent health can be protected, or is at risk. We have to accept that life can never be risk-free. Steps that attempt to achieve this will not succeed, and are likely both to reduce existing benefits and our quality of life.

  6.4  The evaluation process for pre-1981 chemicals should be more reactive than proactive. An evaluation process should be enacted to investigate the chemicals where credible evidence of harm exists. If no evidence exists, there is no need for a costly assessment process.

7.  THE EFFECT ON INNOVATION

  7.1  The Scientific Alliance welcomes the measures introduced in the REACH proposals promoting innovation, including exemptions on registration of chemicals for the purposes of research and development, and the reduction in registration costs to assist the introduction of new substances aimed at promoting innovation.

  7.2  Nevertheless these measures do not go far enough, for the following reasons:

    —  The incentives are heavily skewed towards encouraging innovation for the substitution of chemicals deemed too "hazardous" for continued use, in the short or long term.

    —  If the proposed criteria of assessment are not altered, the result will be scientific endeavour focused on unnecessary substitution, and this will severely impact both the quality of true research and development and the competitiveness of the EU chemicals industry.

    —  Even if the risk assessment criteria are made more rational and evidence-based, the regulatory framework still needs to encourage more research and development for innovations, in order to improve the competitiveness of the European chemicals industry.

  7.3  REACH in its current form prevents the use of chemicals with similar cost and benefits profiles to, for instance, Aspirin.

8.  ANIMAL TESTING

  8.1  The Scientific Alliance accepts the need for animal testing to ensure that products are satisfactorily assessed for safety, but also understands the unpopularity of such practices and advocates the use of testing only when it is essential to do so.

  8.2  The amended REACH proposals have restricted in vivo testing to a level which will be insufficient for a full safety evaluation. If the testing does not satisfactorily assess safety, the process of REACH will not achieve its stated aims.[41]

  8.3  We suggest two options, either of which should be included in REACH to ensure a reasonable limitation on animal testing; both are dependent on the burden of proof and nature of the system being altered as suggested in section 7. One is more expensive, but more focused on animal welfare, the other is more reasonable and proportionate, but less likely to appease opponents of all animal testing.

    —  A framework to encourage, with allocation of sufficient development funds, more non-animal testing to analyse risks of potentially harmful chemicals, as recommended in the House of Lords European Union Committee report on chemicals policy[42]; and

    —  The number of chemicals required for registration is reduced in accordance with a more rational, sound science approach to risk, thus reducing the amount of animal testing, but that the level of testing for individual compounds is increased to a level satisfactory for a full safety evaluation.

9.  CONCLUSION

  9.1  In December 2002 the UK Government set out the following three overarching objectives for EU legislation on chemicals.

    —  Creating a fast, efficient and workable process of testing, screening and assessing chemical substances to provide the information necessary to control those substances of concern, starting with the most harmful to human health and the environment.

    —  Keeping animal testing to the absolute minimum necessary to protect human health and the environment; and

    —  Maintaining or enhancing the competitiveness of the chemical industry[43].

  9.2  As this submission has outlined, none of these overarching objectives are satisfactorily met by the existing REACH proposals.

  9.3  It is the view of the Scientific Alliance that ultimately it is not possible to amend REACH to make it scientific, rational and operational in accordance with the stated aims of the UK Government.

  9.4  However, in order to achieve the best possible regulatory framework, and in accordance with the terms of reference of this inquiry, it is suggested that the following amendments are made, in order of priority:

    —  Regulatory decisions: to be based solely on sound science and risk assessment;

    —  Prioritisation: the process should prioritise chemicals where evidence exists of genuine and high concern of harmful effects;

    —  Evaluation process: the evaluation process for pre-1981 chemicals should be more reactive than proactive. A full evaluation process should only be enacted to investigate the chemicals where evidence exists that they cause harm;

    —  Innovation: the regulatory framework needs to encourage research and development for innovations as well as substitution in order to maintain the competitiveness of the EU chemicals industry;

    —  Animal Testing: the number of chemicals to be tested should be reduced via a rational process of evidence-based risk assessment. Any testing that takes place should be at a sufficient level to guarantee a satisfactory safety evaluation; and

    —  Animal Testing: Funding should be allocated from outside industry to assist development of non-animal testing that will achieve the same or improved level of safety evaluation.

  9.5  The Scientific Alliance urges the Committee to do all it can to assist and influence the UK Government in introducing these essential amendments to the draft legislation.

January 2004



36   The cost/benefit studies produced for the European Commission by the RPA (Risk Policy Analysis Ltd) is based on data that is predominantly 50 years old and on conditions not relevant today. The economic costs through impact to industry severely underestimate the effect of proposals; most notably as the considerations do not take into account that the EU is part of a global market. Back

37   Some tests have suggested a reduction in cancer rates in rodents where exposure rates of suspected synthetic chemical carcinogens are lower than the test norm (but higher than human rates of consumption). Irrespective of this, most tests that conclude a substance is carcinogenic are undertaken on rodents at levels way in excess of human consumption levels. Back

38   Public perception of risk is exemplified by the reticence many have to flying by aeroplane. This is more to do with high profile media coverage of accidents than the statistical likelihood of an accident occurring. Aviation is in fact, a less "risky" form of transport than the motor car per passenger mile. A realistic and balanced view of risk must be taken by policy makers if all members of society are to be appropriately protected. Back

39   Source: Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) of the European Parliament and of the Council concerning the registration, evaluation, authorisation and restriction of chemicals, 29/10/2003. Back

40   There have been studies undertaken which have concluded that Brominated Fire Retardants increase the smoke hazard while reducing flames. This has been categorically disproved. While the toxic Hydrogen Bromide is released by BFR-treated materials at high temperatures, BFRs actually reduce ignitability. This ultimately results in less smoke produced. Furthermore the toxic hazard of the resulting smoke undergoes an overall net reduction where BFRs are used. (Source: Fatalities in Furniture Fires, DTI, 1994). Back

41   Issues such endocrine disruption and potential neurotoxicity are still not covered, despite being highlighted in the then DETR commissioned report, "Testing requirements for proposals under the EC White Paper Strategy for Future Chemicals Policy"; MRC; 2001. Neither are there requirements in place for further detailed testing if safety problems are identified. Back

42   House of Lords European Union Committee, Thirteenth Report - Regulating Industrial Chemicals, Feb 2002. Back

43   "New EU Chemicals Strategy - Position Statement by the UK Government and the Devolved Administrations", Defra Dec 2002. Back


 
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