Select Committee on Science and Technology Minutes of Evidence

Examination of Witnesses (Questions 280 - 299)



  Q280  Dr Harris: One substance one registration implies effectively an obligation to form consortia. Is the Commissioner—the lead Commission—on 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 substances—and I cite cement as another example—should 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 annex—annex two—that 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 substances—and we would see those as being the ones of most high concern, the ones that fit into the authorisation category—we 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 it—which means those affected by it as well as those making money from it—to 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 traditional—if 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 tone—a more pro-industry tone—than 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 demonstrated—pretty 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 organisations—including industry organisations—have 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 Europe—consistency of application—and 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 bureaucracy—I just wanted to put that on the record—whether 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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