Examination of Witnesses (Questions 120
- 139)
MONDAY 2 FEBRUARY 2004
DR JOS
DELBEKE
Q120 Bob Spink: I am sorry, the first
phase of the registration is . . . Oh, yes: within three years,
both categories.
Dr Delbeke: Right. Of course we
cannot do everything at once. We have to start somewhere. Starting,
where we have the separate registration, on what is clearly having
a problem under evaluation, authorisation and the restrictions,
there we have a clear prioritisation according to what is a priority
based on the evidence we have on the table. On the registration:
bulky substances and those which happen not yet to be registered
when it comes to the CMRs.
Q121 Bob Spink: Of course the industry
would prefer to look at real risk, based on both the risk and
the exposure, rather than just theoretical intrinsic hazard, which
is the way that you have structured the legislation. The Americans
seem to have gone down just identifying real risk and controlling
that system. Do you think you have got it right and the Americans
have got it wrong?
Dr Delbeke: I think we all have
to sort out how we address things. I think that the regulation
approach may be somewhat different. But I would make one point
on this: if it is true—and nobody has debated that so far—that
for tens of thousands of substances we[7]
do not have evidence that is publicly known by the public authorities
or by the wider public, I think that then we have to start asking
the companies who have this information to share it with us[8].
And that is the registration. That is the heart of the debate,
that we can only make our judgment about what is really problematic
and what is not once we[9]
have the information. So far, on most of the substances we do
not have the information, so the comprehensive information-gathering
exercise is the start of the whole thing. We have difficulties
to see how you can already legislate all things before we have
all the information. So, once we have the information, we can
move forward. Having said that, on the substances where we know
already today there are problems, we are having in place a system
where we have already restrictions and we have labelling requirements
on the product, et cetera, but basically we have to know first
before we can go forward in dealing with the substance.
Q122 Bob Spink: Moving on to the
environment, the chemicals industry's role in solving environmental
problems, would you just say a very brief sentence about your
perception of that?
Dr Delbeke: On some issues the
chemicals industry is doing great. When it comes to waste and
water, clean-up investments that had to be done, they are doing
great. I know that the expenditure being done in the chemical
sector on some well-known environmental problems is substantive,
and we do not play that down. We know that emissions of CO2, the
greenhouse gas emissions, have gone down significantly, with tens
of percentages over the last decade. I hope there is no impression
as if the environmental equation of this debate is playing the
importance of that down.
Q123 Bob Spink: It has been suggested
that this legislation may well undermine this good work that the
industry is doing, that it may in some way inhibit industry in
cleaning up the environment and caring for the environment.
Dr Delbeke: I have no indications
that this would be the case. I think that where we have a little
bit of a difficulty in the debate is that when we would go out
and ask the man in the street what he thinks about the chemicals
industry. I think there is a major image problem of the chemicals
industry. I think that, despite the efforts that are being done,
still the chemicals industry is perceived as being a big polluter.
Q124 Bob Spink: Ninety-three per
cent of Europeans believe that chemicals negatively affect their
health. Is that not the perception which is driving you? The picking
of low fruit, as we heard, is that not driving you to push forward
and take expensive, time-consuming legislation that is not actually
focusing on the key problems of identifying the real risks and
removing those but taking just a scattergun approach on everything,
whilst there are other things going on that you are just ignoring,
like subsidising tobacco? Does that not concern you?
Dr Delbeke: It concerns me most
what new evidence relating to health and the environment shows
about the modern diseases that I was mentioning at the beginning.
I think most of the people are driven more about those concerns
than about the fumes that they can see coming out of the chimney
of one of the other chemical installations. That, by the way,
is also what we see in the United States, where health is becoming
the primary driver more than the ecological, environmental concerns.
Q125 Bob Spink: And yet chemicals
and the chemicals industry is responsible for the elimination
of many diseases and for very high levels of quality of life which
people depend on and would not give up readily.
Dr Delbeke: Yes. I think we feel
a bit unhappy that the chemicals industry seems to doubt or to
create doubt about me, for example, working in the field of the
environment, about what we appreciate coming out of the chemicals
industry. We cannot see a modern, industrialised world where chemicals
will not play a major role. That is not what I see. Chemicals
will continue to play a major role; the question is: Which chemicals?
Q126 Bob Spink: To take you back
to the original question, do you not think that your system of
prioritisation, rather than looking at actual risk and actual
contact and hazard, is better than that which the industry would
like to see? Will that deliver a better result for humanity?
Dr Delbeke: The system that you
describe of prioritisation is a system we have today. That is
exactly what we do today: If there is an impression that something
is wrong, we bring it on the table. We do that, but we all agree.
There is no one who stood up so far, not even in the chemicals
industry, defending the old legislation. That is exactly what
we do. We have, at the level of the public authorities, a lack
of comprehensive data to compare also through computerised methods,
to compare risks we run on this and that. The more we know, the
more we can rationalise the ways to approach this, to weigh risks,
et cetera. That is exactly the system that is described
under REACH.
Q127 Bob Spink: You spoke earlier
about the migration of the chemicals industry and therefore jobs
to other countries. This is something that you do not think will
happen, is it?
Dr Delbeke: There is no strong
evidence that this will happen due to this Regulation. I am not
debating the fact that there is a re-organisation or a restructuring
of the activity on the way already. I have sometimes the impression
that that is what we discussed in the extended impact assessment
internally; that is, that this restructuring of the chemicals
industry, which is felt as painful, is now, you know, being sold
as if it was the result of REACH. I think that we have to distinguish
the fact that there is competition going on, that there are new
players, like the Chinese and others coming in. I think that is
going on. If you were not to continue REACH, let's suppose—which
is not the case, because the proposal is there and the debate
is on—I would not think that this process of restructuring
would look completely different. Just the opposite. I think we
have to specialise ourselves in the things which are sustainable,
convincing for the long term, et cetera. Like the chemical industry,
I repeat, successfully did in the past on CFCs, on pesticides,
on biocides, et cetera.
Q128 Dr Turner: Dr Delbeke, as well
as your Directorate, the Enterprise Directorate is co-responsible
for this legislation. How do you divide the responsibility between
the two Directorates? Do you find there are any divisions, perhaps
creative tensions involved? How does it work between you?
Dr Delbeke: I think you describe
it very well, sir: creative tensions. Let's not hide that we have
different points of departure, but at the same time I think that
at the end of the negotiations we will see that these creative
tensions were producing the proposal as it stands today with a
number of trade-offs between economic and environment/health concerns
which we thought were in the middle. So we have our internal negotiation
process but it proves at least one thing, that it is possible
to come forward with the proposal, it is possible to take an extended
impact assessment. And so, although we have our heated discussions
internally, I would not hide that, we come forward with products
which the Commission, the college stands for in a collegial manner.
I think that is the thing we have to do when we make decisions
about clever trade-offs which we have to find—the economy,
environment, administrative requirements, et cetera—you
know, there are many trade-offs. And I think so far we dealt with
that. How do we do that? We prepare both of us our files, we come
together, compare notes, define on what we can agree and on what
area we have to make our trade-offs. My counterpart in the DG
Enterprise, I have almost a daily contact with him. Sometimes
we have a little bit of a heated discussion.
Q129 Chairman: Over what issue have
you had a little spat?
Dr Delbeke: We have often many
things. For example, on the impact assessment—you know,
in the cost figures. There has been a lot of evidence brought
on the table. Depending, you know, whether it comes from the enterprise
side or whether it comes from the NGO side, we may expect that
one or the other evidence may be rather at the high side, because
there are always interests involved, and then it is a question
of seeing what is real and what is maybe an add-on to make the
point in the public opinion, et cetera. That is basically
what we are doing. I would see it as the work we have to do.
Q130 Dr Turner: There could be an
impression, mistaken or otherwise, that the green lobby groups
and the NGOs have undue influence with your Directorate. Does
this worry you?
Dr Delbeke: I would just reply
and ask those who are saying that, to point me in the proposal
to where we would have it, as the Commission, disproportionately
wrong. In particular, if you compare the version on the table,
the official version, with, for example, what we had in the White
Paper and what we had in the internet proposal, if we try to balance
out what happened, I would not claim that the green NGOs were
having a disproportionately forceful role in bringing forward
the debate. They were influential, yes they were, and they should
be, but whether they were in a disproportionate way I would debate.
Q131 Dr Turner: There is the converse,
of course, in that others might say that the Enterprise Directorate
is acting on behalf of the chemicals industry. Do you have any
comment on that?
Dr Delbeke: They are the Enterprise
DG, they have more frequent contacts with industry. We have them
as well and the industry is happy, I appreciate that, to make
that point vis-a"-vis us. Both sides, the green side
and the enterprise side, have seen that both their best interests
in the long term is that both sides buy into the same product.
Suppose that the REACH proposals get ultimately adopted and the
green side, if it were, is radically or deeply disappointed, then
we would not be able to stabilise the regulatory framework for
years to come, because when we have the adoption of the new framework
the green side may ask for a new one immediately. That would not
stabilise the amounts. On the other hand, if the greens were not
seeing that what is brought on the table as a regulatory framework
is being taken care of by industries who are the major actors
in the fields, they also would see that we are not getting anywhere.
I think both sides are therefore forced to compromise and are
in the end ultimately willing to compromise. That is what I deduct
from all these discussions we have been having internally. I see
that also politically emerging: I see the major Member States
speaking out—whatever the letters they write to my President,
et cetera—that there is an interest that all parts
of the equation are brought into the water and are combined on
this proposal. Otherwise it would be a major mistake for both
of them, because we would not have a stable regulatory environment
for industry where comments and points can be made in a professional
way, and, on the other hand, the greens would find it as a most
useless exercise, et cetera, et cetera. I think there is
more logic in what we are doing, but we have quite difficult interests
that have to be combined and that makes the exercise extremely
difficult—and not only in the Commission, but in every capital
and every union, and, I would say, in every political party, because
in every political party there are pros and cons, whether they
are from the right or left or centre, which proves that the trade-offs
are not easy but that there is a willingness to find trade-offs.
Q132 Dr Turner: I believe that quite
recently there was a sort of reshuffle (as we would call it) amongst
the different director generals within the Commission. You are
relatively recently in post. Presumably there has been a change
at Enterprise. Have these changes at the top of your Directorates
had any particular effect on the process?
Dr Delbeke: Of course, you are
more neutral players to appreciate whether it had or did not have.
I would hope that the economic analysis that we are undertaking
these days is more sophisticated to what we did before, and that
is exactly one of the vehicles, how difficult it is, that brings
us together with industry, with greens, with the DG Enterprise
and other DGs as well, whether they are ECFIN or JRC or Research
Development, et cetera. That is a quite helpful vehicle
to look in a factual way again at where the problem lies and then
to make a trade-off, a decision, that combines to some extent
in a proportional way both sides of the equation.
Chairman: Incidentally, WWF did say that
it was easier to get to see you than to see Enterprise!
Q133 Dr Iddon: REACH seems to be
based on the hazard of the chemical and the volume of the sale
of the chemical. The chemicals industry says that the risk ought
to be based on those factors plus another important factor and
that is the exposure of the public to the chemical. I have noticed
that the European Centre for Eco-Toxicology and Toxicology of
Chemicals has a targeted risk assessment tool. The chemicals industry
is saying that would form a good basis for presenting with the
bases in the risk proposal. Do you agree or disagree with their
findings?
Dr Delbeke: I think that is a
way that we have been following in the past to a large extent
and that is embedded also in the REACH proposal. The only thing
that we add in this legislation which is the collecting of the
information that we need in order to steer the other part of the
equation you outlined about risk, exposure, et cetera.
To have all the elements in place, you have to have a comprehensive
collection of information, and that is what we try to do with
registration. So that is the phase preceding what you just outlined.
I think we have to collectively underline the lack of information
that exists on tens of thousands of chemical substances, the lack
of information that I assume does exist in companies but is not
accessible by any form of public authority, and that is the change
that this proposal would like to overcome.
Q134 Dr Turner: I have a difficulty
with the greens argument on substitution. Their argument is that
if a chemical is causing persistence in the environment or health
risk to humans, it should be substituted. My understanding . .
. Perhaps I ought to declare an interest, Chairman. I forgot to
say that I have a registered interest, which is declared in the
Members' Register, and perhaps I ought to add that I am Chairman
of the All Party Parliamentary Group on the Chemicals Industry.
I should have registered those interests at the beginning, Chairman.
I am sorry. On substitution, my understanding is that there is
not always a chemical that can be substituted. Could the criteria
for substitution be strengthened in the REACH proposals to provide
an obligation to industry to substitute only if there is a safer
alternative available?
Dr Delbeke: I think that what
is today in the proposal on substitution does not resemble in
its mandatory part what was there at the internet proposal. Substitution
is a global driver and interest in the proposal, and when it comes
to very problematic chemicals, that is in the authorisation/restriction
phase, every forced withdrawal of a product or forced substitution
for a change will be the subject of a separate socio-economic
analysis, to make sure that the product is not driven out of the
market if it turns out to be necessary for one or the other economic
or social functions. Having said that, I think the substitution
issue, in my personal impression, has been taken a little bit
as a single issue with which a bit of scaremongering is going
on. I would turn it around and I would say that substitution,
as I saw it in the past, is an essential economic interest that
should drive the chemicals industry, because if the point can
be made that product or substance X is better than product or
substance Y, then there can be a market value or it can have a
public relations value in order to have higher sales. Although
I know substitution is a point that has been made consistently
by the green constituency, this drives now in general terms the
proposal. We think that a lot of substitution is going to happen,
because businesses are going to decide that. I would look forward
also to businesses that take a pro-active stance on substitution
because it gives a gloss to the substances or the products that
they are producing. It is good news. Actually it is good news
for industry in this.
Q135 Dr Harris: Could I take you
back to this point Brian raised earlier about this risk-based
prioritisation because I get the impression that there is a tension
between those who say that the decisions on evaluation and authorisation
need to be made on the basis of risk (which is hazard times exposure)
and others who feel that if there is hazard that is a good enough
reason to put it as a high priority. Could you explain what your
position is on that, and whether you accept, in particular, the
industry's argument that there are methods whereby you could go
wholly for a risk-based prioritisation?
Dr Delbeke: I think there is a
bit of confusion here. I think when we talk evaluation and authorisation
we have this prioritisation the way you describe it—and
I look at my expert Ms Hendrix. Where we had a discussion on more
prioritisation is on the registration. The registration is, indeed,
deliberately a comprehensive data collection exercise and that
is set up mainly on tonnages and the first three years on top
of[10]
the big tonnages—
Q136 Dr Harris: I am sorry?
Dr Delbeke: Tonnages, more than
a thousand tonnes. So what we are in fact discussing here is this
registration phase, compared or to be distinguished from evaluation,
authorisation and possibly restrictions. There we have the prioritisation
very much like you describe it. It is in the registration, where
this sharing of information with the public authorities, I repeat
it, does not exist today[11],
there is the weakness of the current system, and there we have
to find an operational way of feeding in over time the registration
of these substances.
Q137 Dr Harris: I do not think you
have clarified my question. Is it sensible to prioritise something,
or to have that done first in terms of registration simply because
it is one thousand tonnes, compared to something of equal hazard,
which may be small, but more exposure potentially, which is 990
tonnes. Surely one should think at that point on what is the sensible
thing to do rather than have these rules.
Dr Delbeke: The current legislation
is doing something today; that is, that those small tiny and very
nasty, if I may say so, chemicals are already known today and
dealt with today. What we do not have today; that is, of the thousands
of chemicals that we use in extremely high volumes, there we do
not know almost anything at the level of the public authority.
That is the distinction and, I would strongly plead, the relatively
new element that REACH is contributing to the legislation that
we have today.
Q138 Dr Harris: Do you think there
will be an increase in animal testing as a result of this?
Dr Delbeke: It may but only marginally.
I will try to explain why. Once we have all this information brought
to the Agency, that will be computerised. Where the Joint Research
Centre, for example, has been great worldwide is that we have
computerised testing—simulation, almost—Q(SARS) as
they are called—and read-across methods. Once you start
knowing more about the number of chemicals, you can have very
easy and light and automatic checks computerised, on similarities
based in the substances which are being brought on the table.
So the more we know, the more we are able to prevent animal testing
and if there is animal testing to translate the results of this
testing towards other products.
Q139 Dr Harris: What do you say to
people who say that animal testing is pointless? That it is scientifically
not sound and not morally right to do? Do you have a view on that,
firstly? Do you promulgate that view or do you leave it to other
people to argue with the point of view I have just put?
Dr Delbeke: According to all the
evidence I saw so far, with this registration and computerised
methods we will need far less animal testing compared to what
we otherwise need.
7 Note by the Witness: This refers to authorities
as well as industry. Back
8
Note by the Witness: If they do not have this information,
they need to generate it. Back
9
Note by the Witness: This refers to authorities as well
as industry. Back
10
Note by the Witness: . . . focusing on . . . Back
11
Note by the Witness: Comprehensive knowledge does not
exist either today. Back
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