Registration, Evaluation and Authorisation of Chemicals (Reach)

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Mr. Michael Jabez Foster (Hastings and Rye) (Lab): The Minister suggests that it would be unnecessary for certain organisations to carry out testing on animals if a single registration system operated. However, would there be a bar on unnecessary experimentation if the chemicals were okay? More especially, would the Government take the view that licences should be refused where the registration requirements had been accepted?

Alun Michael: I consider the matter from the narrow point of view of REACH. Our purpose is to ensure that the requirements of REACH are achieved and that the testing done is necessary for human health and the environment. There should be no requirement to test over and above that.

I want to respond as positively as I can to my hon. Friend's point about the licensing arrangements. It would be for the licensing authorities to consider an application if the testing was not necessary under REACH. I am sure that they would be very clear that anyone wanting to carry out duplicate testing that was not needed under REACH could not use REACH as an excuse for seeking a licence. We would ensure that all licensing authorities were aware of the specific requirements of REACH so that they could make that judgment.

Sue Doughty: The summary discusses the requirement to pre-register phase-in substances by submitting the names of substances and listing available test data. That is aimed at minimising the duplication of testing and encouraging data sharing of valuable test data. There is a suggestion that sanctions may be imposed if the owner of the test does not want to share the data. Obviously it is very important that data is shared. What sanctions do the Government propose if data is not made available?

Alun Michael: That is part of the debate about how we achieve compulsory consortiums or the alternative of ensuring that information is shared. There is a careful line to be drawn between the sharing of information on the testing of the substances to ensure that they meet human health and environmental protection standards, and commercial confidentiality and research or work on the uses to which a chemical can be put. We will draw the line in the right place so long as we are clear about the principle of sharing data in order to meet the requirements of REACH and do not seek to cross over into the areas of legitimate commercial confidentiality. That is the principle that we are seeking to pursue.

Richard Ottaway: I want to take the subject of animal testing a step further. The Minister will agree that transparency is essential. He talks of minimising animal testing, but the truth is that it will be increased. He used figures that he admitted were simply raw data, which, so far as I can see, do not appear in the documents made available to the Committee. As an illustration, even if we go from 1X to 5X in several

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animal tests, and if his worthy objective of the one substance, one registration proposal minimises testing, we still end up with 3X. Does he agree that there will be an increase, which will be exacerbated by the fact that each country may well conduct its own evaluations and animal testing, 25 times over?

Alun Michael: That is precisely the sort of outcome that we want to avoid. There will be an increase in the examination of chemicals on which we have very little information, with priority being given to chemicals of concern—those that are believed to have some impact on human health or the environment, in general or in particular circumstances. I am sure that the hon. Gentleman would agree with that priority. We shall know more about chemicals about which the public have every right to know more, to increase public and environmental safety. The fact that we shall seek that greater knowledge not only in the UK but across Europe inevitably means that more work will be done. An element of that is more animal testing. However, we cannot separate the increase in animal testing from the increase in scientific work to protect human health and the environment.

The hon. Gentleman suggests that duplicate testing would go on across Europe. Without the one substance, one registration approach, such vast duplication of registrations, perhaps on inconsistent or differing evidence, would be possible. There could be a considerable increase in the number of animal tests. One of our negotiating considerations is the wish to avoid such a possible consequence of REACH. That is one reason for our belief that the one substance, one registration approach is right in principle and right for the minimisation of animal testing.

It is important to underline the fact that the proposal focuses on information rather than data. There is flexibility to use all available information—not just test data—to satisfy registration requirements. We shall continue to emphasise the importance of requiring information, where that is necessary for risk management, not testing for testing's sake. I hope that that shows clearly how we are proceeding.

I think that I am right in saying that if animal tests have already taken place REACH would not require them to be repeated. The information available from previous tests could be used as part of the information put forward in support of a particular chemical.

Dr. Rudi Vis (Finchley and Golders Green) (Lab): I have no problem, if the amendment tabled by the hon. Member for Salisbury is taken on board. I hear what my right hon. Friend says; perhaps it is an improvement that the Science and Technology Committee's sixth report has been made available to European Standing Committee A. That should happen more often. I should like him to review page 15 of the Select Committee report—I do not need an answer now. Cement has not been included, despite the good reasons given by Greenpeace for its inclusion.

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Alun Michael: This is a matter of priorities more than anything else. Some chemicals used in association with cement raise certain issues. However, as my hon. Friend seemed to want a thoughtful answer, I am happy to write to him on the point. I have examined it with some care, but I am happy to pass the details to him and perhaps to talk to him about it again, if that would help.

Sue Doughty: I am afraid that I often ask Environment Ministers about their timetable and how soon can we expect things to be done. Recommendations 18 and 19 of the excellent report of the Science and Technology Committee are about developing alternatives to animal testing and possible lead times. The Committee suggests putting research funding into environmental toxicology tests, so that we can get rid of animal testing as much as possible. How does the Minister propose moving from the aspirational to a firm plan? That would take us forward to the point where some tests will not be needed immediately; and animals may not be needed for many tests.

Alun Michael: The hon. Lady makes a fair point. We are keen to promote alternatives to animal testing. Alternatives are being developed, or increased in sensitivity. That would be part of our approach, as discussed in our continuing negotiations. As I said, we are positively engaged in looking at the applicability of alternatives and scientific evidence of their dependability. I am advised that we have not yet arrived at the situation where we can contemplate an end to all animal testing. It is a long-term goal—one to be met whenever possible—but I am happy to agree with the hon. Lady. The Department and colleagues across Government very much support that goal.

Mr. Foster: Does my right hon. Friend agree that the most obvious way to reduce testing would be to rely on robust evidence that may have been found elsewhere? Do the provisions allow research and testing undertaken in the United States or Australasia and the like to be substituted for testing in the European Community? If robust testing has already taken place, would he accept it as a reasonable way forward?

Alun Michael: My understanding is that, as long as the data are dependable and can be verified, they can be used whether or not they are from Europe. I agree with the implication of my hon. Friend's question that we should look for existing evidence whenever possible, partly to reduce animal testing. Also, if robust information is already available, why duplicate it?

The current UK budget for research into alternatives to animal testing, which is administered by the Home Office, will double from £330,000 to £660,000 in this financial year. Other research in that area is carried out by industry. Many industries recognise the attractiveness of moving towards testing that does not involve animals. The Government also support the work of the European Centre for the Validation of Alternative Methods—known as ECVAN—which has a research budget for 2003 to

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2006 of euro 35.2 million. If that work leads to the validation of alternatives to animal testing, and if it is accepted right across Europe, that would be a positive step forward.

Richard Ottaway: In answer to my previous question, the Minister confirmed that there has been an increase in animal testing. I take him now to the substitution principle, which has been argued by Greenpeace, Friends of the Earth and WWF, and to an apparent loophole in the proposals. Even if a safer alternative were available at a comparative price, does he agree that production of the chemical of high concern could continue? What is his reaction to those who argue that if a safer substitute is available at a reasonable cost, the principle should be put into effect—hazardous substances should be substituted by less hazardous substances, and the hazardous substances should no longer be permitted for use?

Alun Michael: The Government support the principle of substitution. I have discussed the matter with a variety of stakeholders, including some non-governmental organisations with a particular interest in this aspect. We agree that the new European chemical strategy should take steps to phase out the more hazardous substances in favour of safer alternatives. However, the question whether there is a safer substitute is often complex. If it was straightforward, there would be a straightforward answer. It is seldom possible simply to swap one chemical for another.

We also feel strongly—considering my recent discussions with some non-governmental organisations, I do not think they would disagree—that we need to ensure that substitution is not rushed, perhaps by substituting a substance with one that has not been through the same rigorous testing to ensure that it is safer, and that there are no unanticipated side effects. However, it is important that we find a way to encourage substitution and drive it forward. Discussions on that issue have been among our most interesting talks with stakeholders in recent months.

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