APPENDIX 5
Memorandum from the Environment Agency
1. SUMMARY
The Agency sees the development of the new EU
Chemicals Strategy and the proposed system of Registration, Evaluation
and Authorisation of Chemicals (REACH) as a valuable opportunity
to provide much needed information on chemicals to assist our
day-to-day regulatory activities and for improved controls on
chemicals at source. The Agency supports the UK Government's objectives
during the negotiations of the REACH proposal and wishes to see
a fast, efficient and workable process put in place.
Key issues for the Agency are:
— REACH proposals must be compatible
with existing and proposed legislation eg the Integrated Pollution
Prevention and Control and Water Framework Directives.
— REACH should promote the substitution
of substances of most concern with more acceptable alternatives.
— Prioritisation of resources to focus
on chemicals of most concern will be essential if the system is
to be workable.
— Environmental monitoring of trends
in the levels of chemicals in the environment can contribute greatly
to assessing their risks and the success of management initiatives.
The information on the use and risks of chemicals gained through
REACH could be used to help develop targeted monitoring programmes
for chemicals of concern.
— Future enforcement of REACH should
be considered in the development of the legislation and resulting
arrangements should be adequately planned and resourced.
— The Agency has a role in the current
UK Competent Authority assessing environmental risks on behalf
of Defra. The Agency believes that any future arrangements must
adequately address risks to the environment or human health as
a result of environmental exposure.
2. INTRODUCTION
2.1 The Agency welcomes the opportunity
to submit evidence to the House of Commons Science and Technology
Select Committee Inquiry on the proposed EU Chemicals legislation.
2.2 The Agency considers REACH to be an
important opportunity to improve the control of chemical risks
at source and to provide information on chemicals to assist in
the day-to-day regulatory activities for which it is responsible.
2.3 The Agency recently published its strategy
"Managing Chemicals for a Better Environment".
This focuses on chemicals that may directly affect the environment
or human health through environmental exposure. A summary of the
strategy is provided in Annex 1 (not printed), the full document
can be provided on request or is available from www.environment-agency.gov.uk/chemicalstrategy
2.4 The Agency's future management of chemicals
will be underpinned by an increasing understanding of our environment
and how chemicals affect it. As resources allow it will promote
research and improved monitoring approaches, develop new approaches
to support chemicals management and set and measure progress towards
the achievement of environmental targets.
2.5 The Agency supports the UK Government's
objectives during the negotiations of the REACH proposal. It wishes
to see a fast, efficient and workable process of testing, screening
and assessing substances of concern, starting with the most harmful—because
of the potential impact on human health and the environment.
2.6 The Agency continues to contribute significantly
to the development of the UK position on REACH providing technical
and policy advice in support of Government.
3. LINKS TO
EXISTING LEGISLATION
3.1 The new EU chemicals strategy is a complex
piece of legislation that will have interfaces with various existing
environmental protection legislation, in particular the Integrated
Pollution Prevention and Control (IPPC) and Water Framework Directives.
3.2 In this context, the Agency is concerned
about certain exemptions from authorisation. The current proposal
states that risks to health or the environment arising from emissions
from an installation for which a permit has been granted under
Integrated Pollution Prevention and Control or from a point source
governed by a requirement for prior regulation under the Water
Framework Directive should not be considered.
3.3 The implication is that emissions of
the most hazardous substances are adequately controlled by these
Directives. The Agency believes that all risks from emission points
(even if regulated by other regimes) should be considered in the
authorisation dossier. This is necessary to fully assess whether
a substance is adequately controlled or whether further controls
on marketing and use are required where, for example, exposure
is through both point and diffuse sources.
4. SUBSTITUTION
OF THE
MOST HAZARDOUS
CHEMICALS
4.1 The substitution of the most hazardous
chemicals is a key issue for the development of the new EU Chemicals
Strategy. We fully support the substitution principle and we would
wish to see every effort made to substitute substances of most
concern with more acceptable alternatives. If developed correctly,
REACH will provide a strong incentive for innovation in the chemical
industry and a stimulus for the development of alternatives to
the most hazardous chemicals.
4.2 The Agency fully supports the inclusion
of substances which are persistent, bioaccumulative and toxic
(PBT), very persistent and very bioaccumulative (vPvB) and substances
of equivalent concern such as endocrine disrupters in the authorisation
process. Under the proposed authorisation process, REACH will
introduce what is essentially a positive approval regime for substances
of most concern (including those that are carcinogenic, mutagenic
and toxic to the reproductive system). Substances that are subject
to authorisation should only be able to be used if industry can
demonstrate that there is no risk to human health or the environment
from a particular use or that the socio-economic benefits outweigh
the risks.
5. PRIORITISATION
ON CHEMICALS
OF MOST
CONCERN
5.1 In relation to prioritisation, much
of the current discussion in the EU and in the UK has been centred
on identifying chemicals—based on current knowledge—where
we urgently need to clarify risks and take appropriate risk management.
This is, in fact, a significant aspect of the Agency's own Chemical
Strategy.
5.2 The Agency—together with certain
international bodies—are already proactive in identifying
possible chemicals of concern and have been using screening techniques
such as those outlined in the recent report from the Royal Commission
on Environmental Pollution[1]
(RCEP). The Agency has supported the authorisation of chemicals
which are persistent, bioaccumulative and toxic, very persistent
and very bioaccumulative as a means of focusing regulatory activity
on these chemicals which can be of high concern where there is
potential for environmental exposure. The Agency has actively
been screening substances for these persistent, bioaccumulative
and toxic properties.
5.3 However, the screening criteria are
very crude indicators of concern for persistence and bioaccumulation.
The Agency urges some caution when using screening and we would
recommend that the next step following a screen would usually
be to seek better information. The Agency is particularly concerned
about the use of screening data to assess bioaccumulation potential
in the absence of any toxicity information. The Agency has been
working with the European Chemicals Bureau, other Member State
Authorities, the UK Chemicals Stakeholder Forum and industry to
confirm the properties of those substances screening positive
for persistence, bioaccumulation and toxicity. The aim being to
accelerate the identification of substances likely to require
authorisation.
5.4 The Agency believes that the RCEP report
is unduly optimistic on the current applicability of the expert
systems used in the pharmaceutical industry to successfully identify
substances of concern to the environment. We believe that there
are a number of factors that need to be addressed before these
types of system can be used with confidence, making the approach
a long-term goal rather than a short-term solution:
— the complexity of industrial chemicals,
many of which are not "pure" substances;
— the diversity of biological systems
being protected;
— the lack of experimental data on
many species/taxa hindering both development and validation of
Quantitative Structure-Activity Relationships (QSARs) and other
computational techniques;
— pharmaceutical screening seeks to
remove dangerous substances from consideration. In other words
tests are conducted on the ones predicted to be safe. This acts
as a failsafe. No such failsafe would exist for screening of industrial
chemicals where chemicals screened as being safe would not be
tested; and
5.5 The Agency believes that early consideration
should be given to how data gathered under REACH can contribute
to the future development of QSARs and other predictive techniques.
5.6 However, the new EU chemicals strategy
brings a different aspect of prioritisation into the equation.
In time, REACH will deliver basic information on all chemicals
manufactured or supplied in the EU above 1 tonne per year—an
estimated 30,000 chemicals. Clearly, resources will not allow
all of these chemicals to be assessed in detail. It will, therefore,
be crucial to develop a system of prioritisation which will enable
a quick screen of the information supplied at registration to
identify chemicals which may be of concern and for which evaluation
should be prioritised. This screening level assessment will also
allow rapid identification of chemicals of most concern which
should be subject to authorisation.
5.7 The UK Government has clearly emphasised
the importance of prioritisation if REACH is to be made workable,
which we fully support.
5.8 There has also been some pressure to
introduce a system of prioritisation prior to registration to
identify chemicals which should be subject to REACH in the early
stages. Although on the surface this sounds attractive, we have
concerns about this proposal. We believe that the lack of information
on the majority of chemicals currently on the EU market will make
this process very difficult, if not impossible. The current proposal
to phase-in existing substances according to tonnage and to some
extent hazard (ie the inclusion of carcinogenic, mutagenic and
substances toxic to reproduction in the early stages of REACH),
although not perfect, does seem to provide an adequate framework.
In terms of environmental concern, tonnage can provide a reasonable
surrogate of likely exposure in most cases.
6. MONITORING
6.1 The Agency believes that better information
on chemicals would improve the targeting of monitoring programmes
and we believe that REACH could be a significant contributor to
this. This would include information on production, use, and biological
effects. This information is essential in the design of cost-effective
monitoring programmes.
6.2 The Agency recognises that information
on trends of chemicals occurring in the environment (including
accumulation in biological organisms and foods) can make a very
valuable contribution to assessing their risks or the success
of risk management measures put in place to mitigate these.
6.3 The Agency believes that the success
of risk management under REACH needs to be considered and that
monitoring could have a role to play in this. In particular, the
Agency believes that environmental monitoring information could
be valuable when assessing chemicals of most concern and where
authorisation is granted some form of "post approval monitoring"
funded by industry should be considered.
6.4 As part of the Agency's Chemical Strategy
a paper will be published which explores the Agency's role in
developing a more strategic approach to monitoring to support
decision taking on chemicals. The Agency is also currently developing
views on the role industry could play in monitoring. The Agency
recognises that many monitoring programmes are driven by Directives
rather than a strategic evaluation of potential impacts in the
environment.
6.5 The vast majority of the Agency's monitoring
programmes for chemical residues is carried out to assess compliance
with water related EC Directives and for other international reporting
commitments for the aquatic environment. Other Government Departments
are responsible for monitoring residues in food (FSA) and Drinking
Water (DWI). Although the Agency regulates monitoring of emissions
to air and Defra monitor for a limited range of compounds in their
ambient air quality monitoring networks, there is little information
on the impacts of these emissions on the environment or human
health. Likewise, the information on chemical residues and impacts
on soil and soil biota is limited and not well co-ordinated. There
is also only limited information on the bioaccumulation of chemicals
in biota.
6.6 In the development of the Agency's monitoring
strategy for chemicals, the value of surveillance of residues
and biota in the environment obtained by the Agency and others
is recognised, and we will recommend a more co-ordinated and integrated
approach to monitoring for chemical residues and their impacts.
We currently carry out a very limited amount of exploratory and
general surveillance work.
6.7 Because the Agency is only funded to
carry out monitoring to assess compliance with Directive requirements
additional resources would be required for this important work.
7. ENFORCEMENT
7.1 The Agency believes that future enforcement
arrangements for REACH should be considered in the development
of the legislation.
7.2 Whatever the future arrangements for
enforcing REACH, these must be adequately planned and appropriately
resourced.
8. UK COMPETENT
AUTHORITY
8.1 The composition of the UK Competent
Authority will need to be re-considered under REACH. The Agency
plays a valuable role assessing the environmental risks of chemicals
on behalf of Defra in the current UK Competent Authority. The
Agency believes that any new arrangements must adequately address
the risks of chemicals to the environment or human health arising
as a result of environmental exposure.
9. CONCLUSIONS
— The Agency sees the development of
the new EU chemicals strategy (REACH) as a valuable opportunity
to improve the control of chemicals at source and provide much
needed information on chemicals to enable effective environmental
management.
— The Agency supports the UK Government's
objectives during the negotiations of the REACH proposals and
wishes to see a fast, efficient and workable process in place.
— The linkage to existing and proposed
environmental legislation and enforcement must be given proper
attention.
— The Agency has identified opportunities
for better use of prioritisation, substitution and monitoring
within the current proposals.
— The composition of the UK Competent
Authority under REACH will need to be considered in due course.
The Agency believes that any future arrangements must adequately
address the risks of chemicals to the environment or human health
arising resulting from environmental exposure.
December 2003
1 Royal Commission on Environmental Pollution's 24th
Report "Chemicals in Products: Safeguarding the Environment
and Human Health", 2003. Back
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