Substitution
66. The extent to which the Commission issues Authorisations
rather than insist on the substitution of a substance is highly
contentious. The industry has claimed that substitution already
forms part of the strategies of chemical companies, that enforced
substitution could diminish competitiveness and that substitutes
might not necessarily be safer.[86]
The CIA argues that inflexible imposition of substitution plans
on EU producers would cause downstream users to switch sourcing
of ingredients rather than cooperate with the substitution process.[87]
The Royal Society of Chemistry is concerned that safe compounds
may be withdrawn because they generate insufficient profit to
cover the cost of testing. Leigh's Paints argues that the reformulation
of products resulting from substitution would result in gaps in
product availability and niche products might have to be withdrawn.[88]
The CBI is content with the principle of substitution but argues
that decisions must take "a holistic view of all relative
hazards and risks on a case-by-case Evaluation" and be made
in a transparent fashion.[89]
67. The environmental NGOs take a harder line and
espouse the precautionary principle, as articulated by Mark Strutt
from Greenpeace: "if it is possible to avoid any risk then
that is what you should do … and particularly if that risk
is imposed on the general public by industry".[90]
WWF considers that the use of chemicals of very high concern should
only be authorised when there is no safer alternative, and where
there is an overwhelming societal need, and when measures to minimise
exposure are in place. They are sceptical about the use of risk
management strategies, suggesting that it is impossible to predict
all possible scenarios.[91]
The UK Environment Agency "wish to see every effort made
to substitute substances of most concern with more acceptable
alternatives".[92]
Alun Michael's view is that "We are in favour of appropriate
substitution… If you are too simplistic you say that if there
is any risk at all there ought to be a substitute, but you need
to be sure that there is a safe substitute".[93]
68. Greenpeace is scathing about the provision for
"adequate control": "Are phthalates in toys 'adequately
controlled'? When brominated flame retardants burn in an incinerator
or landfill fire are they adequately controlled? If hormone disrupting
chemicals are showing up in breast milk are they adequately controlled?".[94]
69. A key issue is how socioeconomic benefit is assessed.
Andrew Lee from WWF said that "of course there may be some
cases where chemicals will be authorised because the risks outweigh
the benefits, but many more cases where there are substitutes
or where the purpose to which the chemical is put is perhaps non-essential;
that it is nice to have, and there we think substitution should
take place".[95]
The use of flame retardants is a useful example as many are toxic
yet their application will have saved many lives.
70. Dr Delbeke from the Commission's Environment
Directorate General felt that there had been scaremongering over
the substitution issue. He felt that it was good news for industry
as it would provide market and public relations value by adding
"a gloss to the substances or the products that they are
producing". Equally, he believed that under the current Proposals
"a lot of substitution is going to happen".[96]
71. The Government supports the principles of substitution
but expresses concern as to how this would work in practice; for
example how the Commission will determine what is a suitable alternative
chemical, how socioeconomic need will be interpreted or whether
the risk management plan submitted by the company is adequate.
The Government suggests that there could be an independent review
of available substitutes, which could be part of the socio-economic
analysis, paid for by industry as part of the Authorisation fee,
but carried out by a third party.[97]
It also has concerns about legally enforceable substitution, recognising
that:
a) There have been a number of well known
examples where an apparently safer substitute introduced by legislation
has led to different effects to those of the substituted substance
but of equivalent concern;
b) Substitution is seldom a simple matter of
substituting one chemical for another. It can be a costly process
involving the consideration of a number of new substances and
their full life-cycle impacts as well as changes to production
processes.[98]
72. A lot centres on the term "adequate control".
The term is defined in Annex 1, section 6. This states that for
any exposure scenario, the exposures of humans and the environment
can be considered to be adequately controlled if:[99]
a) The exposure levels do not exceed the
appropriate derived no-effect levels or the predicted no-effect
concentration;
b) The likelihood and severity of an event occurring
due to the physicochemical properties of the substance is negligible.
73. WWF's concerns seem to stem from how adequate
control has been interpreted previously: "past experience
with the risk assessment process under the current legislation,
suggests that what industry considers to be "adequate control
of the risk" may fall below the necessary level of health
and environmental protection".[100]
It argues that if the Commission accepts industry's arguments
that the risks of such chemicals are adequately controlled, they
must authorise the use of the chemical, even if a safer alternative
is readily available.[101]
WWF argues that "It is very difficult to ensure chemicals
are properly controlled during their entire life cycle, and even
good control measures can result in appreciable exposures".[102]
The Government also has concerns over the interpretation of adequate
control, on the basis that it relies on exposure ratios and that
it is not clear whether such models can be applied to PBTs and
vPvBs. It says that "The difficulties in defining 'adequate
control' in PBTs and vPvBs could lead to inconsistencies, uncertainty
for industry and, if large numbers of chemicals of high concern
are authorised through the first track, a failure to protect human
health and the environment from some of the most hazardous chemicals
covered by REACH".[103]
74. WWF seems to have a lack of confidence in the
Commission. It fears that it will accept everything that industry
tells it and that substitution will never be demanded. We see
little evidence to justify this fear since the legislation seems
to have been initiated with high environmental ideals and the
Proposals clearly state that "burden of proof is placed on
the applicant to demonstrate that the risk from the use is adequately
controlled or that the socio-economic benefits outweigh the risks".[104]
Nevertheless, the Government's concern that the definition does
not apply to PBTs and vPvBs is a genuine one and needs to be resolved.
75. A further concern is that considerations over
the risk management of chemicals will result in the system "floundering".[105]
This should be taken seriously but is not an excuse for making
irrational decisions and refusing Authorisations when the health
and environmental dangers are negligible. Instead, attention needs
to be given to ensuring that the Commission's decision-making
processes are rapid and transparent.
76. In an ideal world, highly toxic chemicals would
not be produced, but companies must be able to argue that the
risk of exposure is small during and after the lifecycle of the
product. To insist that a substance is substituted in such cases
could lead to a situation in which a company is disadvantaged
without any health or environmental benefits. Nevertheless, the
legislation's definition of adequate control needs to be tightened.
WWF is concerned about the provisions for chemicals of concern
for substances of "equivalent concern" in Article 54.
This stems from an insertion stating that these need to have been
"identified as causing serious and irreversible effects to
humans or the environment" and WWF expresses concern that
"there is a need to act on very persistent and very bioaccumulative
chemicals, irrespective of currently known toxicity".[106]
We believe these concerns to be misplaced. A previous section
of Article 54 covers "substances which are very persistent
and very bioaccumulative", which implies that this is indeed
irrespective of known toxicity. Thus we do not find WWF's argument
convincing as REACH has been designed to identify chemicals of
concern.
77. The CIA rejects the requirement for a substitution
plan as a condition for Authorisation. It says also that substitution
plans would need to engage downstream users.[107]
We do not find the Proposals' requirements for substitution excessively
onerous. Where a substance of high concern is involved, it seems
reasonable that any Authorisation should require that attention
is given to the use of alternatives. We do not contest the fact
that this imposes a burden on companies, but nor should they contest
the importance of ending the production of substances of high
concern.
78. The WWF's hard line on substitution is weakened
by Andrew Lee's own admission that "we know there are companies
already diversifying, already getting out of the production of
some of these chemical concerns, retailers are already demanding
substitution of chemicals because of consumer pressures".[108]
This implies that substitution could occur through market mechanisms
alone.
79. A further issue relating to substitution was
raised by David Thomas, a legal consultant to the BUAV. The environmental
NGOs have focused on those chemicals which have proven toxicity.
Mr Thomas argued that abstinence was an option, that if a chemical
could not be proven safe using non-animal tests then "society
has the ethical choice whether to allow that substance onto the
market".[109]
80. Greenpeace complains that Article 57 allows for
the issuing of an Integrated Pollution and Prevention and Control
permit, which sets allowable discharge limits.[110]
It argues that IPPC permits were not designed to deal with persistent
and bioaccumulative chemicals and that the REACH Proposals should
cover emissions from industrial processes. The UK Environment
Agency and the Government also express concern about this exemption.[111]
The Commission says that this decision was taken so as "not
to interfere with such other competences and to avoid differences
between the decisions taken under different regulatory regimes
as well as the resources in examining an impact twice". It
is sensible for REACH to be compatible with existing EU legislation.
The Proposals replace around 40 existing Directives and it is
not clear why one - the IPPC Directive - is unaffected when it
allows the emission of hazardous substances. We recommend that
risks from emission points be considered in the Authorisation
process.
81. We conclude that the current wording of the
Proposals with regard to substitution is acceptable, provided
that "adequate control" is interpreted so that the risks
of exposure to humans or the environment are remote during and
after the lifecycle of the product. Substitution is an important
element of the legislation and must be encouraged but its enforcement
must be pragmatic.
Review of Authorisations
82. The Proposals state that "Authorisations
may be subject to conditions, including review periods and/or
monitoring".[112]
Greenpeace would like to strengthen this provision, arguing that
all Authorisations should be temporary and not subject to renewal.[113]
WWF agrees and suggests that Authorisations should be reviewed
at least every five years.[114]
While we appreciate that Greenpeace does not accept that a chemical
can be adequately controlled, we conclude that if review and monitoring
has been shown to be effective in controlling a chemical, it would
be unreasonable not to renew Authorisations. This element of the
Proposals could be strengthened to insist that all Authorisations
should be subject to review at a stated time, at the discretion
of the Commission. The Government believes that decisions about
what precise time limits should apply for Authorisations can only
be made on a case-by-case basis, and would need to strike the
balance between acting as an effective incentive while avoiding
imposing deadlines which are unrealistic. This is a sensible approach
and we believe that time-limited Authorisations should be made
subject to these criteria.
Restrictions
83. A fourth element of the REACH Proposals is Restriction.[115]
Annexes XVI and XVII contain a list of restrictions for substances
on their own, in preparations or in articles. If listed they may
not be placed on the market or used unless in compliance with
the condition of the Restriction. Restrictions will be made in
response to dossiers, which can be drawn up by the ECA at the
Commission's request or by Member States. The process is largely
uncontroversial. The CBI wishes to see "detailed criteria
for the imposition of Restrictions drawn up as soon as possible
in order to assist harmonisation".[116]
The Government is seeking clarification about the inclusion of
products made from recycled or recovered material and whether
Restrictions can be challenged or reviewed. It expresses concern
that Member States and the ECA could duplicate effort if working
on the same substance. We discuss the functions of the ECA in
more detail below but we believe that this could be easily resolved
if Member States are obliged to notify the ECA before assembling
a dossier.
79 According to Directive 67/548/EEC Back
80
As above Back
81
As above Back
82
In accordance with the criteria of Annex XII. Back
83
As above Back
84
Annex XIII Back
85
DEFRA, UK Consultation paper on the New EU Chemicals Strategy
- REACH, March 2004, para 99 Back
86
Ev 67 Back
87
Ev 67 Back
88
Ev 55-56 Back
89
Ev 92 Back
90
Qq 19-20 Back
91
Ev 73-74 Back
92
Ev 61 Back
93
Q 288 Back
94
Ev 57 Back
95
Q 31 Back
96
Q 135 Back
97
DEFRA, UK Consultation paper on the New EU Chemicals Strategy
- REACH, March 2004, para 109 Back
98
As above, para 107 Back
99
Annex 1, Section 6 (4) Back
100
Ev 75 Back
101
Ev 73-74 Back
102
Ev 74 Back
103
DEFRA, UK Consultation paper on the New EU Chemicals Strategy
- REACH, March 2004, para 110 Back
104
Proposals section 1.7 Back
105
Ev 75 Back
106
Ev 76 Back
107
Ev 67 Back
108
Q 37 Back
109
Q 89 Back
110
Ev 57; Council Directive 96/61/EC of 24 September 1996 concerning
integrated pollution prevention and control Back
111
Ev 84; DEFRA, UK Consultation paper on the New EU Chemicals Strategy
- REACH, March 2004, para 113 Back
112
Article 57 Back
113
Ev 57 Back
114
Ev 77 Back
115
Article 64 Back
116
Ev 96 Back
