Examination of Witnesses (Questions 280
- 299)
MONDAY 9 FEBRUARY 2004
RT HON
ALUN MICHAEL
MP, DR COLIN
CHURCH, MS
GIULIA MUSTO
AND MR
PATRICK WALSH
Q280 Dr Harris: One substance one
registration implies effectively an obligation to form consortia.
Is the Commissionerthe lead Commissionon this issue
still considering your proposal for mandatory consortia?
Alun Michael: We are certainly
continuing to maintain that view.
Q281 Dr Harris: That was not my question.
Do you think he is still open to that?
Dr Church: The Commission rarely
says that it is not listening. The question as to whether Commissioner
Liikanen or Commissioner Wallström are open in principle
or in practice to a significant change to the text that they struggled
long and hard to agree between them is perhaps a question to address
to them. Our perception is that if we can demonstrate a workable
way of doing things then they are not so stupid as to turn it
down.
Q282 Dr Harris: I asked question
197 of a draft transcript: "Commissioner Liikanen, you are
saying that obligatory, mandatory consortium is a dead duck".
His one word answer was "Yes".
Alun Michael: One has to ask what
he meant by that and what was meant by the question. If you start
off from saying that we will encourage you to form voluntary consortia
and if that does not happen across an industry then we will go
to compulsion, in a sense we would suggest that that sort of backup
is necessary. However, we would not start with a compulsion because
if industries can get their act together without heavy handed
intervention, so much the better. I believe that is something
we are agreed on across government.
Mr Walsh: The mandatory consortia,
as an element of one substance one registration, is something
we have advanced for some time but I think that we would accept
that it would not be the only mechanism that can achieve the important
objective which is one substance one registration. I think also
I would add that the Commissioner, as I recall, did not say that
he regarded one substance one registration as something which
could not be pursued; I think he described his position as not
final final, or words to that effect. It seems to me that they
are still open to being persuaded on the issue.
Alun Michael: I think it is also
the case that there is interest in a number of other member states
which obviously helps because if we were the only people taking
an interest then our position would be that much weaker, but obviously
a number of countries can see the benefit of a consistency which
avoids inconsistencies and therefore difficulties in competition.
Q283 Dr Turner: Before we finish
beating one substance one registration to death, there is just
one caveat that has been expressed to us and I would like to know
how you would propose we deal with it. That is the same substance
produced by different companies using different processes could
contain different ranges and amounts of impurities. What caveats
would you introduce into one substance one registration protocols
to deal with that problem?
Alun Michael: I think the question
illustrates some of the difficulties of being precise because
different uses and different impurities can affect the hazard
profile. It is reasonable to assume that the system should be
flexible enough to allow registration as a separate substance
if the differences are so great as to result in that.
Dr Church: This question of when
is a substance the same as the substance in another form is one
that exercises us already in the current arrangements so with
the system for notification of new substances, this is always
a question when somebody says, "I've got a substance which
I think has already been notified". The question is, "Have
you or have you not?" It is an inevitable question whether
you take the one substance one registration approach or, indeed,
if you take the approach purely laid out by the Commission. How
will somebody know that that substance is a substance for which
the animal test data already exists and therefore can go to the
Commission? What they will have to do is go to the Commission
with information about their substance and say, "How does
this match?" We would concede that there is a very similar
process working in one substance one registration. There would
need to be that early contact between potential members of the
consortium and the Agency to say, "Does this range of impurities
satisfy you as still being the same substance or not?"
Q284 Dr Turner: One can see the possibility
of impurities at a level below the sort of minimal level at which
REACH applies, but which are in themselves sufficiently toxic
in particular applications to be a very major concern but which
could potentially be left out of the scope of REACH.
Dr Church: In terms of the question
of an impurity in a substance you would be looking at the substance
which may be marketed at something like 70% purity which is a
fairly common commercial grade of a number of substances. You
would assess that commercial grade product as sold and that would
have to take into account the impurities that are in it. If you
were selling that material at above a thousand tonnes a year then
you would look at that material, including its impurities, at
that level of detail. I think that would be the way you would
have to handle it, unless you could change the process to get
a higher purity.
Q285 Dr Iddon: The CIA have argued
that REACH should be risk based and I agree with that, but risk
is a combination of two factors, the chemical hazard and the exposure.
The new proposals have lifted the volume from 12 kilograms to
one metric tonne, which has reduced the number of chemicals that
will have to be registered initially from about a hundred thousand
down to the thirty thousand figure we have been mentioning all
afternoon. Are you happy that that will catch most of the chemicals
with serious hazards to human health? Or could it be that some
high hazard chemicals that can damage human health will miss out
the REACH proposals?
Alun Michael: I am not sure that
it would have that effect. I think the problem is that in many
cases there is only limited information on chemicals and we remain
to be convinced that a risk based approach could be made workable
unless industry submitted a minimum set of data, but that would
place a major burden on manufacturers, particularly on SMEs at
a pre-registration stage. As we have indicated, what we want to
do is to keep bureaucracy to a minimum and to the level that is
appropriate to the risk that is involved. I agree with you that
it is not a straightforward issue.
Ms Musto: They have used tonnage
as the proxy for exposure so the substances that are produced
over one tonne are the ones that are most likely to be at a level
where people are going to be exposed to it where the greatest
risk is at one tonne. It is a reasonable level at which to set
it.
Dr Church: It is a balance of
practicality and ideal. There is not a hard and fast scientific
rule that you can come up with for any given level, so it is a
question of something that works that gives industry predictability
and that has some relationship to this.
Q286 Dr Iddon: The WWF put a lovely
press release out in the last few days about canaries being killed
by Teflon frying pans and they claim this is a new risk. They
claim that the release of per fluora isobutene and per fluorinated
chemicals in general is a newly aspired risk, but it is not. I
have known about it for at least 30 years. On to another topic.
Polymers have been rightly excluded. Does the Government think
that any other substancesand I cite cement as another exampleshould
be excluded, like polymers have already?
Alun Michael: I think the problem
with some of the questions is that some substances look as if
it is unreasonable to be concerned about and cement is a good
case in point where it is a question of what elements are involved
and what do we mean by safety? We know that there are possibilities
of severe skin disorders where good practices are not pursued,
for instance, and chromium occurs in the production of cement
and is a sensitizer and it could cause allergic contact dermatitis,
sometimes so severe that it becomes debilitating. Although I understand
the immediate reactions to the fact that cement is included, actually
it is not so unreasonable. Of course it is not that long since
people regarded asbestos as a safe inert substance, so to be asking
the question I think is appropriate. There are issues in relation
to ores, alloys and metals. There are issues where there is already
strict regulation as with pesticides, for instances, which lie
outside the scope.
Ms Musto: There is an annexannex
twothat specifically lists some substances that are being
excluded and we will look at that to see whether anything should
be added onto that and whether the ones that are on there should
actually be on there. Generally, as the Minister says, there are
a lot of substances that are claimed to be safe because they have
been there for a long time but that may not necessarily be the
case.
Q287 Dr Iddon: Toxicity and environmental
threshold data are going to be established for a wide range of
chemicals. Who should set the levels for the REACH proposals?
Is it the Agency in Helsinki or the commissioners or who?
Alun Michael: There is not an
easy answer I think is the response I would give.
Dr Church: It does depend. I think
there is an argument for no safe level being available for certain
categories of chemicals and the one that people often quote is
carcinogens where theoretically at least one molecule is sufficient
to cause a mutation that creates cancer. For a number of substancesand
we would see those as being the ones of most high concern, the
ones that fit into the authorisation categorywe would argue
quite strongly that there is no such thing as a totally safe level
for most of those. For a range of others it is part of the evaluation
process to determine what the concentrations are likely to be
in the environment and what the risk levels are likely to be.
That seems to us to be a combination of two things, one is a scientific
process of modelling and monitoring and the other is the more
sociological question of what is an acceptable risk and that is
where we feel very strongly that you should have the involvement
of the Central Agency but also the member states and other stakeholders,
which, I think, is a replication of the CIA answer. It should
be something for everybody who has a stake in itwhich means
those affected by it as well as those making money from itto
input to that process.
Q288 Chairman: One thing I am worried
about is the substitution principle which I guess DEFRA supports.
What does that mean in mandatory terms if there is a possibility
of having regulation that is mandatory where there is a substitute?
Would you support that kind of position?
Alun Michael: We are in favour
of appropriate substitution; I suppose that is the simple answer.
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.
Q289 Chairman: If there is one and
they will not use it, what do you do?
Alun Michael: Then it comes down
to the level of risk; what is the threat to human health to or
the environment?
Q290 Chairman: So there is less risk
with the substitute than the original, what do you do then?
Alun Michael: It depends on the
significance of the lesser risk and the dependability of the knowledge
of the alternative. It is difficult to give an absolute answer,
but if there was something where there was minimal risk with the
alternative, that it had been properly evaluated, the use of the
alternative then ought to be required.
Q291 Chairman: What does that mean,
ought to be required? That is what I am pressing you on. Would
you go the whole hog and make it mandatory, they must use it?
Alun Michael: If the risk is that
high, yes. I think we want to see the REACH proposals encompass
that at the end of the day. The problem is that most of it is
not straightforward black and white, which you will appreciate.
Q292 Chairman: I understand that
but you have to be prepared to grasp the nettle.
Alun Michael: You have to be prepared
to grasp the nettle when the comparison leads in that direction.
Q293 Dr Turner: This process started
out with a White Paper. How much input did the UK Government have
in formulating the original White Paper? Did the discussions include
alternative structures to REACH or different models or not?
Alun Michael: As you go back to
before my comparatively recent responsibility for this area of
policy I will ask colleagues to refer to the history.
Dr Church: Obviously the UK was
partially responsible for asking the Commission to start off because
it was under the UK presidency in 1998, when the request came
from environment ministers to the Commission to start doing this.
Again, unfortunately, it pre-dates me in terms of the exact detail,
but what I do know is that one or two colleagues from the British
Civil Service were seconded to relevant parts of DG Enterprise
and DG Environment at the time of the drafting, so one can actually
see some of that thinking coming in there. Certainly we were talking
to the Commission at that stage but I could not give you a blow
by blow account and I could not describe to you whether or not
there was a detailed discussion of different alternatives. My
sense is that there was not because my sense is that the Commission's
openness to discussing this with member states and other stakeholders
has increased dramatically over the last three or four years from
a position of traditionalif I may put it this way"It's
our job, leave us to do it" to a much more open and engaged
process as we saw with the internet consultation and the various
other consultations.
Mr Walsh: Could I just add that
my recollection is that in the White Paper there is reference
to a stakeholder event which preceded the publication of the White
Paper. That is my recollection, so it was discussed before publication.
Q294 Dr Turner: I would like to turn
to the famous letter written by the three heads of states. This
seemed to have a slightly different tonea more pro-industry
tonethan DEFRA's stated position. Were you involved in
the initiation and the drafting of the Prime Minister's letter?
Alun Michael: I understand fully
the time honoured sport of trying to put pieces of cigarette paper
between either the Prime Minister and other ministers or between
government departments. I appreciate that the labour members of
this Committee have a sense of humour as well as a sense of the
need to investigate. I have to say that it is a sport that does
not work on this particular issue. The letter which the Prime
Minister signed precisely states a priority of getting something
that would be workable in protecting human health and the environment
but would not produce an unproductive bureaucracy as a substitute
for actually protecting human health and the environment. I have
been very pleased with the cooperation that we have had across
departments. David Sainsbury and I have met industry and NGOs
separately but also together and what the joint meetings have
done is to demonstrate a capacity on all sides to try to tease
through what are, as the questioning of this Committee has demonstratedpretty
complex issues even if you do not get into the chemistry. These
are difficult issues. It is new territory; it is new territory
not just within government but across government and across Europe.
I think it has been approached in a very mature way. I made the
comment at the beginning that the way a number of organisationsincluding
industry organisationshave recognised that there are issues
to be addressed in relation to the opinions of other bodies rather
than seeing themselves in a situation where they have to defend
their particular interest against all comers, I think is very
encouraging, as the interest of this Committee is in what is not
an easy issue to deal with (he said with feeling).
Q295 Dr Turner: Can I just ask what
input the Health and Safety Executive and Department of Health
have had in formulating the British approach to this legislation?
Alun Michael: I think all government
departments have been involved.
Dr Church: So far as how we operate
within government, we have, as you might imagine, a series of
concentric rings of interested departments and agencies and the
HSE is part of the inner ring of that, as is the Department of
Health. They have different perspectives from us which is part
of the reason we are very keen to have them in. The Department
of Health has been superb in offering us advice on some of the
testing issues, some of the general public health issues. The
Health and Safety Executive have a lot of experience because they
run the new substances regime, so they have been giving us expertise
there. They have a lot of toxicological expertise within them
and a lot of experience of operating in these areas. I would say
that both of them have made significant contributions to the UK
position.
Q296 Chairman: In the coming meeting
on 18 February with President Chirac and Gerhard Schröder,
are you briefing the Prime Minister? Is this issue going to be
raised there?
Dr Church: I believe Mrs Hewitt
is attending and I believe we have produced a briefing for her.
Q297 Mr McWalter: The chemical industry
would like a more powerful centralised chemicals agency which
sounds potentially slightly alarming. Do you agree with that?
Alun Michael: It sounds alarming
if you put it in one form. On the other hand if it achieves consistency
across Europeconsistency of applicationand has the
authority to require the exchange of information (going back to
one of the earlier issues, how do you achieve those sort of changes)
then that would be a good thing. You would be reassured to know
that we are not in favour of excessive bureaucracyI just
wanted to put that on the recordwhether it is European
or other. What we want is systems in place that will actually
work and it is the outcome that is important.
Q298 Mr McWalter: You can get consistency
through a sort of lowest common denominator approach. If country
X has a long distinguished history of knowledge in this area and
country Y has very little, consistency might consist of simply
imposing a level of understanding that is dismally low. Are you
satisfied that the Agency will have the appropriate expertise
to be able to carry out these functions?
Alun Michael: That is certainly
what we will be looking for. I take your point about the lowest
common denominator. I suppose that is why some of the accession
states, for instances, are slightly nervous about REACH and its
implications whereas in the UK with a well developed and responsible
chemicals industry we can look to standards. It was quite interesting
with some of the regulations; we had this with one statutory instrument
just recently where there was enthusiasm for greater regulation
by the UK industry (this was in relation to substances in paint)
where they have already gone further voluntarily than many other
countries would and therefore lifting the threshold to a level
of consistency across Europe would be good for the competitiveness
of this country. Rather than seeing it as being bureaucratic they
were seeing it as lifting everyone's standard to the standard
of the best. I think that is the way we are trying to approach
it. It is important to have the protection of health of people
in this country and in other countries and that includes the accession
states. It is important for that to occur within the context of
consistency across Europe and the international trading obligations
that we have.
Ms Musto: In terms of the role
of the Agency, one of the things we are trying to do in terms
of reducing the bureaucracy, is making sure that they take on
more of the procedural aspects of the work. It would free up the
expertise in member states to actually concentrate on the more
specific issues such as authorisation and the level of detail
you get into on those kinds of aspects. One of the other areas
is, for instance, that the Agency would actually take on more
of a role in driving the system forward so that perhaps under
the evaluation stage the Agency could sub-contract work to the
member states so if they have the resources then they could bid
for the work to carry out evaluations. Again, it is more of a
co-ordinating role that is being carried out by the member states,
but it is those kinds of areas where we are trying to streamline
the system and reduce bureaucracy.
Q299 Mr McWalter: We know when these
things get bureaucratised, as it were, that people will begin
to say that if we have regulation X then we will get a competitive
advantage from that, whereas if you have regulation Y you will
get a competitive advantage from that, so let us have a bit of
X and a bit of Y and we will exclude all those other people who
are not going to benefit from it. Do you not think that when it
comes to the crunch that that will start to predominate and we
will end up with this, particularly if the different countries
are different briefings, say one country has greater control of
registration and another authorises a particular group of chemicals
and so on, and you can actually start to get this sort of European
horse trading which means that it becomes the standard Eurocratic
nightmare that people are desperately worried about?
Dr Church: I think we can certainly
find and build into the system approaches that will avoid that
as a problem.
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