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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