1. Adoption of the draft agenda

The draft agenda was adopted. Some points, namely the 6th, were discussed more than once during the meeting to take account of the various changes introduced to the draft opinion.

2. Declarations of interest

No member of the CSTEE attending this meeting mentioned any interest in whatever capacity that might be considered prejudicial to his/her independence considering the nature of topics in the agenda. The opportunity was taken to ask from the three CSTEE members who had their annual declarations outstanding to do so during the meeting; they would later comply.

3. Adoption of the draft minutes of the 8th CSTEE plenary meeting held on the 4th of March 1999

The minutes could not be adopted at the plenary because some members requested more time to analyse them in detail. They would subsequently be adopted by written procedure with minor amendments requested by a few members and also by some Commission services (III/C/4, XI/E/1).

A short debate took yet again place on the issue of the length and level of detail of the minutes with most CSTEE members expressing their preference for the detailed information format, which had become a feature of minutes of CSTEE plenary meetings. From the side of the CSTEE secretariat the message was given that this may well be the last time that minutes will have this format, given the considerable effort needed to produce them under the circumstances of staff shortage. Besides that, perhaps a uniform format should be followed across all committees and in general minutes of other scientific committee meetings are significantly shorter.

The secretary explained that for new opinion requests, particularly those that are of a complex nature and on which a lot of detailed information is given by the requester service, a fuller account makes the issues more understandable from the outset. However, once debates reach a sort of 'cruising' speed the account made of the discussions can be shorter. The basic principle is still that minutes should not serve the purpose of formal 'accountability' but also that of a source of factual information.

A few CSTEE members (H. Greim, P. Chambers in particular) lent their support to this perspective as it is important to have as informed a view of the status of the discussions as possible. Minutes should also be seen as a continued working document. The 'detailed' format has the advantage that it also avoids "reinventing the wheel", as the tendency is there to rehearse arguments previously made.

The CSTEE secretariat informed the CSTEE that account would be taken of the views expressed and that a decision would be taken so as not to jeopardised the ultimate usefulness of minutes.

4. Presentation by representatives of the Fraunhofer-Institut für Umweltchemie und Oekotoxikologie, Schmallenberg, Germany, of their ongoing research project relating to the development and validation of a test method for the identification of endocrine disrupting chemicals

The CSTEE secretary introduced this point explaining the reasons why this topic had been put in the agenda (The European Commission published call for tender with a view to have a test method for detecting endocrine disrupting chemicals validated). Basically the reason for putting this point in the agenda stems from a concern to have transparent processes as regards financing projects such as this one. Given the nature of the project and bearing in mind the competence of the CSTEE on the field of endocrine disrupters (not least of which because the CSTEE had adopted in March 1999 an opinion on the subject of endocrine disruption) submitting the project of the Fraunhof. I. to the "scientific scrutiny" of the CSTEE would be a means of ensuring such transparency.

The CSTEE secretariat explained that calls for tender published at the initiative of DG XXIV are different from those of DG XII in that those of DG XXIV address different needs and approaches (the one in question is in support of activities/fields for which scientific committees are responsible). As supplementary information it was said that in the following weeks a call for expression of interest will be published in order to allow for Universities/laboratories/companies etc., to be included in a list from where the Commission might be picking useful candidates.

The two representatives of the Fraunhofer-Institut (Fraunhof. I.) presented themselves (Prof. G. Vollmer and Dr A. Wenzel).

A presentation of the project mentioned by two representatives mentioned took then place. In general terms the CSTEE endorsed the approach described. After the presentation a question time followed with CSTEE members asking some questions such as the following ones:

CSTEE - Where does the Frauhoffer approach differs from the EDSTAC approach?

Fraunhof. I - the answer was that Fraunh. I. selected only a limited number of assays; if one looks to its assay list it can be shown that what it proposes is in the areas of high throughput screening. These are all interesting topics but the question is whether one can find methods to define whether potential xenoestrogens may have an adverse effect at lower concentrations than before it has any other toxicological effects. A lot of such substances, at a certain concentration at least, will have additional effects not related to endocrine disruption, so from an endocrinologist's viewpoint the question is can we find methods that will allow us to predict towards endocrinology versus any other given toxicological effect and for such purpose a huge panel of tests like the proposed by EDSTAC is probably not necessary.

CSTEE - Does that mean that there is a concern with false positives?

Fraunhof. I - No, because if we use screening and have positive results then in vivo tests are carried out, but if one wants to have a oestrogen-related assay, in the Fraunhof. I. perspective it is sufficient to have a selected panel of assays. A whole panel like the one proposed by EDSTAC, which includes steroidegenesis, androgen effects, oestrogen effects, prostate effects, etc , is certainly highly valuable, but from an endocrinologist's standpoint the question is do we really need these wide panel of assays, and our answer is no.

CSTEE - What are your views on the possibility that compounds could have an endocrine disrupting activity without being mediated through a receptor?

Fraunhof. I. - That is far from our understanding, the only thing that can probably be said on it is that you should be able to discriminate between direct receptor mediated effects and others which should be referred to as "other effects".

CSTEE - Does it not mean that you have a very narrow definition of endocrine disruption? The fact is that most of the definitions of endocrine disruption are that it creates a disturbance of the endocrine functions, consequently it has a negative effect on health and if a compound has an influence on the synthesis of hormones or on the metabolism of hormones it still is an endocrine disrupting effect...

Fraunhof. I. - We have the in vitro and in vivo elements and the only thing to be debated is whether or not do we need this big variety of tests, but our feeling is that if we have a battery of in vivo and in vitro, although not as wide as the EDSTAC one, it still should detect endocrine related effects. More comprehensive approaches make us run the risk of this becoming a never-ending story.

CSTEE - Your battery is not very different from that of EDSTAC, you start with in vitro screening and the possibility is there for false negative results. Since this is a problem for screening if the effect is not receptor mediated how do you cope with such problems? Should you not carry out an in vivo test for every single compound, like the uterotrophic assay for the estrogenic activity or an early life stage test in zebra fish?

Fraunhof. I. - Yes, but the main intention is also to provide tests which are applicable in a large variety of laboratories. This is relevant since some laboratories do not have easy access to radioactive facilities. On the other hand Industry want to have an immediate result in an attempt to escape from well-known assay systems. Modify them to make them faster is another element that we would like to cover.

CSTEE - What are your arguments/position in respect of our recently adopted opinion on EDCs? There we said that one should rely more on in vivo studies and improve the existing studies rather than do a lot of screening before. And what is your ultimate goal? Is it either to do a big investigation using different systems in order to sort out those that are really relevant and have some indication for the in vivo situation or is it to establish a big screening programme which has to be used by everyone later on?

Fraunhof. I. - We read your paper and in general agree with it because it proposes exactly what we said before, i.e. pre-screening tools will provide no definitive answers, mechanistic or other, but in our perspective there are elements to pre-screening that can provide first indications as in the case of new substances. On the 2nd question, it is clear that the ultimate goal is to find out which strategy for example, can be applied finally to solidify already existing tools. The intention is not wanting to make a real screening battery but rather to compare in view of finding out what is the most sensitive, the fastest, etc.

CSTEE - But don't you agree that the problem is not what is the most sensitive, the problem is what is the most relevant test for the in vivo situation. This is the issue on all these different tests, which are presently available, and the other problem of many of those tests is that none is standardised.

Fraunhof. I. - Our opinion is that the uterotrophic assays combined with gene expression analysis could be one such a tool but in order to standardise you need to work out which genes and also maybe which animals and one should come up with one or two relevant strains.

CSTEE - From an epidemiologist's viewpoint there may be some misunderstanding on the meaning of the word screening which is a process through which you want to recognise in a universe those elements which have a different characteristic. Usually the validity of tests is measured through sensitivity and specificity. You mentioned that some of your screening tests have a low specificity because you said they have a high false positive rate and therefore my question is how do you recognise false negatives and then you measure sensitivity and second what is your golden standard because presumably one is needed?

Fraunhof. I. - Whether or not this may interfere for example with the oestrogen receptor is what we mean by screening. We take one assay that we would consider as a screening assay and one assay that we would consider an in vitro testing, whole cell. The likelihood of having two false negatives would then be rather low. The intention is to have a tool that can be used quickly if someone asks for a pre-screening. Certainly we do not want to screen 70000 substances, that's what we mean with screening.

CSTEE - Which implies that in your terms pre-screening and screening are synonymous?

Fraunhof. I. - To a certain extent yes, if for example a substance of a colleague was tested positive in a pre-screening then we would screen with in vivo assays.

CSTEE - We agree with you when you say that with this model we can screen for binding to the oestrogen receptor but the question is whether we want to screen or to test for endocrine disruption, for hazard identification. Another question is whether this in vitro model is a screen for hazard identification, for endocrine disruption. That is also the point of the CSTEE opinion on EDCs. In toxicology we want to apply hazard identification and then the point is what is the value of these in vitro assays?

Fraunhof. I. - This is very important because I think we may come to the same position. We were talking about oestrogenicity mainly but there are still mechanisms of oestrogenicity that may not be covered by those tools I showed. But if one considers general mechanisms of disruption then we clearly need to have androgen-related assay systems and our assay systems are not androgen related. Thyroid hormones may become an increasing problem too as there are indications that this might be the case. We are aware of this but with an oestrogen dependent model we can't cover thyroid hormone disruption.

CSTEE - You said earlier that we have no real oestrogen receptor blocker but there are some experimental ones, which have been looked at in the pharmaceutical industry over time perhaps more in terms of inhibitory effect?

Fraunhof. I. - We are talking about the week estrogens superimposed on the strong oestrogens namely the endogenous estradiol and of course there are potent estrogens but the question is that if we have a week antiestrogenic activity superimposed on a strong oestrogenicity would you detect it? We think that we do not have very qualified assays to detect comparatively week anti oestrogenic activities superimposed on a strong oestrogenicity.

CSTEE - Why are you proposing to use calcium release changes in intracellular concentrations? It would look as if this is a very general change when any toxic agent interacts with the cell. Other agents which are not endocrine disrupters can induce this effects.

Fraunhof. I. - The reason why it is mentioned is because this is a mechanism also triggered by estradiol and there might be estrogenic pathways. But the main point is that we need not only focus on receptor mediated effects. Steroidegenesis would be something else but there are also immediate, maybe membrane effects. On the other hand I also agree with your opinion on phytooestrogens when you say that environmental exposure is probably well below what we get by food.

To conclude the point the CSTEE secretary asked whether CSTEE members were willing to comment on the soundness of the overall project. The answer was in general that the project seemed positive. Some of the CSTEE's remarks related to the hazard identification usefulness of the project. If one restricts its scope to in vitro work leading to the identification of compounds that have an effect on the endocrine system through binding to endocrine receptors than the project seems very good.

Another aspect of the project that was really appreciated was the modelling in the zebra fish where Fraun. I. came up with a full-blown reproduction test, an area that many groups have reported as where tests are really necessary. The CSTEE's opinion on EDCs also makes this clear.

Finally the CSTEE expressed the view that they would be very interested in seeing how the project develops in the future.

5. The use of measured exposure data in risk assessments

This is a CSTEE initiative essentially stemming from a concern that it had recognised with the use of models in risk assessment since, given the apparent inconsistencies that some of them show, some should be "validated" by measured exposure data. A presentation was made by one CSTEE member on the topic.

In spite of their intrinsic weaknesses models are useful and risk assessors have been relying on them more and more. However care is needed as absolute values may not be obtainable and in some cases they can just be used for ranking. There are a few examples as in the case of chlorinated paraffins. Sometimes the truth is somewhere between what the models provide and an empirical prediction.

The same thing can be seen in risk assessments of brominated flame-retardants and other substances with high log kow. The 'modellers' say that the major human intake is via root crops at about 98% and again the assessors do not believe it. This shows that there are problems with the uses and, according to results from a known laboratory experiment modellers predictions were not confirmed.

Apparently models have difficulties predicting concentrations of very lipophilic substances but there are several examples of this kind of which we are still not aware. Every opportunity should be taken to verify the models that are being used and the way to do that is to use measured data. In many instances measured data can be found to see whether models are reliable but there are problems with measured data as they are not always easily available.

For instance, when a new substance is found in the environment this is published in the open literature but very quickly the specialised journals loose interest and when surveys are carried out it normally ends up in an obscure report with the consequence that afterwards it is very difficult to retrieve that information. The general conclusion is that it is very difficult to find measured data.

When one looks at measured data that can be found we have of course to be careful with its quality. It should be remembered that in many instances in risk assessment we should use measured data, even if the quality in not very high, to get a rough estimate and see whether we have a problem or not. The absolute quality is not that important as it is perhaps still on the safe side and can still probably be used. Besides, the problem is not only to do with analytical quality but with sample quality as well.

The information from the WFD work says that the data provided by the Fraunhofer Institute is a very good database, a large database anyhow, for measured data of chemicals in the environment and this should be made available. We will probably see a number of substances on these lists that are rather exotic and since there is not a lot of measured data for these substances we have to decide on how to handle that. One way is to set up some sort of international co-operation to allow for measuring the substances that are on the lists. For that we need new resources which are probably not easy to find in many countries today. One eye should be kept at the ongoing monitoring programmes and if there is a possibility to make room for measurements of new substances in those monitoring programmes interesting conclusions could be derived.

On the other hand, apparently most of the capacity is bound up by international agreements so it is difficult to change this. On the marine side new substances will be studied and another possibility is to integrate, if possible, some measurement capacity in the risk assessment process in its early stages where the easily available data has been gathered. Then do rough risk assessments to see whether this is a real problem or not avoiding the need to measure too much. Critical exposures need also to be identified as well.

People with responsibility for risk assessments should have a say on this as well. Perhaps the discussions on the monitoring systems could take place in Copenhagen in the Environment Agency with people of the monitoring institutes participating, by early this fall, to discuss this.

Subsequently a link was established in the discussion with activities on the 'Water Framework Directive'. It was mentioned that the monitoring data has been given an important weight in the Fraunhofer I. report. This is one of its strengths but there is a significant lack of data and also different regimes apply.

If criteria for representativness are introduced in the monitoring exercise, then the number of substances on which there is information available drops significantly. The critical point here is, and the CSTEE opinion on the WFD could be very helpful, to enhance monitoring systems to harmonise them across the community and put more emphasis on substances that are of potential concern. The WFD will provide a framework within which it would be possible to set up more specific requirements for that, hence comments of the CSTEE would be very welcomed.

A CSTEE member insisted that committee's statements should have a scientific basis but also an evaluation of advantages and disadvantages. Since it is very difficult to get relevant data, when it is asked for everyone declines responsibility for providing it. Therefore regulatory agencies have normally to do that but such activities are expensive and it is normally unknown what kind of data are actually required and under what circumstances. If there is an indication that the exposure is low in ambient air, water or soil, it is not very helpful to launch a big study but should there be an indication that it is relevant and there are high concentrations, then the situation is different; however having a big screening programme is always expensive and decision makers hesitate with pursuing these activities.

Another CSTEE member insisted on representativness of monitoring data. The case of pesticides is an example in that very often monitoring data are very frequently found in water. Going more in depth some are found because they are searched and others not because the methodology is difficult and costly. The Fraunhofer document indicates that there is no comparability between the modelling based data priority list and the monitoring based priority list but one cannot be sure that the modelling based one is less reliable. This needs careful evaluation as in some cases monitoring data are few and could be not really representative.

On the other hand differentiation between different kinds of monitoring is necessary if the CSTEE is to discuss it. There is monitoring where one tries to follow up measures. PCB is being monitored to see whether we will get rid of it or not. There is also monitoring of critical situations such as with the use of pesticides but data for risk assessment is always a cause for concern, particularly for exotic chemicals as these are not monitored with the consequence that we will rely more and more on models which may not be accurate. Care is needed on how resources are spent to fill the essential data gaps.

Normally risk assessment reports have all a chapter on monitoring data but the problem is the information included there. For modelling three different scenarios are possible: local, regional, and continental. It is not surprising if in the Fraunhofer study there were no correlations between the different tools as the basis were different. There was also no specific information on emission sources. Since it is difficult to work with all data, clearly a form for comparing monitoring and modelling is requested.

The chairman reminded that what the concentration should be about should be exposure assessment as it informs the risk assessment process. There have been suggestions that we ought to look at a monitoring strategy and that one of the issues is bringing together monitoring and modelling in some sort of common framework. There have also been suggestions that one ought to concentrate on either a particular medium or particular sorts of chemicals which are more of a difficult group to model.

Exposure assessment is so wide that we need to narrow it down to something which is achievable and the CSTEE is very conscious of the importance of it because considering the activities of the risk assessment of the harmonisation group one can see that this is an issue on which agreement is difficult because some prefer taking existing frameworks rather than having a strategy for moving forward.

The chairman welcomed the presentation and suggested that a concise paper could help shape what the issues are and subsequently a group could be formed perhaps with outside members to develop such issues. Subsequently a more developed paper could be prepared, the idea being to come up with a report that would set out guidance/recommendations on how to use measured exposure data in risk assessment. This was agreed. A document will be made available for the next meeting and then a decision will be taken on what to do with that and whether to form a working group or not. Experts in modelling may be needed then.

6. Tropospheric ozone - consideration and possible adoption of draft opinion

An initial presentation was made by a representative of the Commission requester service (XI/D/3) on the approaches being followed in this activity. She mentioned the difficulties with proposing in legal texts monitoring requirements for research purposes because these are not normally endorsed by the Council.

The draft opinion sent to the CSTEE before the meeting was discussed together with four new documents submitted by DG XI. The questions were treated one by one. The concept of AOT 40 in particular was extensively discussed. After an extensive discussion the CSTEE felt confortable with the concept. Some comments were made as follows.

In ecotoxicology, it is frequently the case that we cannot deal with the mechanisms since, as far as they are representative of real ecological mechanisms, our understanding of them is poor.

A tiered approach, from short-term laboratory data to semi-field or field data is usually employed.

The available information includes higher tier information, semi-field/field studies, using an end-point, biomass reduction, which is ecologically relevant for plants. In fact, most ecotoxicity tests on terrestrial plants, aquatic plants and algae consider toxicity end-points related to plant growth and biomass production. Therefore, regarding protection of vegetation, the available semi-field/field information is considered highly relevant.

The CSTEE concurred that the AOT 40 is supported scientifically as a check of biomass reduction and it is probably protective for other effects on plants. Furthermore there might be different AOTs for different specialist regions.

AOT is suitable for plants but its adequacy for humans is not identical. We use the old approach which a standard with exceedances. Are the effects on plants the same as in humans (oxidative attack)? The chemical target initially is probably the same although the consequences might be different and we believe that Habber's rule is probably obeyed in both cases.

Animals should also be considered as part of the environment. In theory one could be in favour of using a different approach but in practice the criteria should be the same, however it cannot be applied if there is no specific data.

If one believes that the mechanistic basis of the effects in humans, mammals and plants is not different one ought to consider the possibility of using an AOT approach for humans also. Both this approach and also the previous concept of threshold and number of exceedances have advantages and disadvantages. An exceedance throws away information, and there are small and big exceedances. The frequency of exceedances is important especially for acute rather than chronic accumulating effects. Rarely occurring exceedances allow time for recovery but the AOT would also suffer from a similar disadvantage.

There are also problems using the AOT for humans. We have solid data for evaluating certain exposures and they are given in µg/m3. It is difficult to transform this into an AOT concept and one has to be aware of the human situation because there are so many different aspects such as adaptation to ozone, recovery of the effects, etc.

One reason not to use AOT in humans may be that we lack information to support it. It would be difficult to transform an evaluation which we did on the basis of the Habers rule supporting now 20 µg for more or less 8 hours which is the apparent threshold considered. There would be problems transferring this to the AOT concept.

It is important to have a scientific based system in assessing exceedances. One thing is setting standards and everything is OK of we stay below those but one has to realise that in the real world there are exceedances above those thresholds that have been identified and a scientific based system is needed addressing those. As a long-term goal it would be preferable to try to develop the concept of a curve type dose description rather than just count exceedances without taking into account the level of exceedance and their duration and spacing. This is also an area which is being discussed under other scientific auspices such as OECD and IPCS. This committee could be proactive in setting up discussions on how to address this, not in respect of this specific opinion request but more as a long term plan and see whether one could have an harmonised approach to multiple exceedances that impinge on more chronic type health outcomes. Nobody has done experiments allowing for an area under the curve approach to be developed so far but this would be useful.

There are two issues to consider, the use of AOT and use of end point of biomass changes and it had been understood by a few members that it was the latter point that was emphasised as being slightly less satisfactory scientifically as it does not tell about mechanisms.

Fundamentally the CSTEE did not object to the concept but expressed some reservations. The key aspect is whether there is science to support the AOT either from mechanisms or from end point studies. The CSTEE expressed reservations on the mechanisms as the data is probably inadequate but it endorsed the concept in terms of a particular end point namely reduction in biomass where there is good evidence in favour of using an AOT.

The DG XI representative felt that the wording in the question could have been better. DG XI was not proposing that AOT 60 should be adopted as a legislative target for protecting human health because there is no data to support it. But from a management rather than a scientific point of view they also felt that having a target where it could be explained to the public what was happening from day to day rather than wait till the end of the season was a desirable objective in its own right.

What was looked for was a concentration and averaging time (which provided 120 over 8 hours). On the other hand the need was felt for a simulation in a modelling exercise in order to find out how far one could expect to go in reducing concentrations so that it was exceeded less often and also to find the most cost-effective way of doing it.

Therefore the question to put was whether AOT 60 was a satisfactory way of capturing exceedances of 120 µg/m3 just for the purposes of the model. The confusion with the question led the WG to mean an interim standard that was there to be applied which is a rather different interpretation.

The CSTEE also expressed the view that the concept has potential for development. In terms of time periods, when one thinks in terms of AOT things have "passed" before getting there rather than seeing something that one is able to monitor to see where the hazard is. It might be a much shorter time period than the AOT is looking at and this may be the reason why it is good for plants because one is looking at biomass over time. If one looks at toxic effects that could have high exceedances in a very short time and probably not really interpreting this correctly within this AOT concept, one can move far away from reality. The other issue is to do with mechanisms for plants and animals which are not the same.

The issue of understanding was particularly relevant to question 4 whose terms were initially not totally clear. The concept of cumulative dose over time is a difficult one particularly with regard to human health because very little is known about thresholds, reversibility, adaptation and individual susceptibility. This applies also to AOT 40 and 60 and if there is a need for additional research on problems of threshold, reversibility, adaptation and individual susceptibility, whether one considers AOT 40 or 60 does not probably make much difference.

The question that the CSTEE was asked was whether it thinks AOT it is a good measure of exposure in a modelling exercise to predict the effects of different attempts to change the levels of ozone. The aim of that exercise (reduce ozone levels) needs to cover both human and vegetation protection but the question the CSTEE was asked (4) is whether AOT is a concept that ought to be used as an indicator of exposure and whether that is scientifically satisfactory when one assesses biological effects. If this is so, to the extent that the CSTEE has expressed doubts about its applicability to human health assessment the answer should probably be no, because the wrong messages might come true.

DG XI explained that the questions were not about AOT as such. Work has been done that indicates that using an AOT allows for predicting different patterns of ozone from what we actually see and if you're interested we can show you. One important issue is that there are people who think that there could never possibly in any circumstances be any reason to try and reduce ozone levels below 160 µg/m3. The advocates of this view argue that the AOT concept should not be used at all and this is why the exercise was carried out, i.e. to make sure that it did not predict odd exceedance patterns.

When debating the relevance of 160µg/m3 based on the information available from studies with volunteers, epidemiological data, etc. but also from animal studies, one realises that this is a reliable indicator, where people under certain conditions are in an area of marginal effects. But this is the human situation and not the environmental one where one has effects at lower concentration (40 AOT) therefore one has really to differentiate the human data and that for the environment.

The DG XI representative explained that an AOT 40 was used for the modelling exercise as well but as regards the human health situation things are a little different. A 120 µg as an 8 hour value has been used for setting a standard in air quality legislation while, for the modelling exercise where other aspects come into play, it was proposed at an experts meeting between involving external experts, analysts and modellers, that the AOT 60, which is a surrogate for the 120µg/8 hours, is a good one in terms of compliance/non compliance with AOT 60.

Using the AOT 40 for modelling in terms of it being a parameter is different from the value of 80 µg/m3/8 hours because apparently other parameters which affect this 40 ppm or 80 µg/8hours may be introduced and influence the significance/correlation.

As final explanations a DG XI representative said that the AOT 40 went into the modelling exercise because it looked consistent. There are still issues to do with cost effectiveness. When the ideal long term target for ozone, that is 120 µg over 8 hours, was set, as a long term target never exceeded, one had to model how far it could go in practice. The best seemed to be the model which is designed to use AOT values. Then there are two questions: if we use an AOT value is the pattern of high peaks that we model completely different from what happens in practice? When looking at what ozone patterns the model produced it turned out that they are like reality. Nothing odd was being produced like one exceedance going on for days and all the area under the curve coming under one place.

The next question was 'what number do you use in the AOT'. If one models 120 µg/m3 over 8 hours never exceeded, AOT 60 is obviously the right answer. But if one admits that there're going to be some exceedances over 120 µg/m3 and that is what one wants to model, questions can be asked about what the number should be because then that depends on the level of ambition, i.e. how close can one get to 120µg/m3 never exceeded.

A halt was called to the ozone discussion. At 16.00 a revision of a new text took place, the chairman insisted that consideration should be given only the substantial changes and not the typographical ones. Comments were made and the text fine-tuned.

The CSTEE secretary is to receive comments by e-mail in view of having the opinion adopted by written procedure (it would be adopted on the 21st of May 1999).

7. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report

The working group chairperson informed the committee that a first meeting of the working group had taken place on the 27th of April 1999 and that a provisional decision had been taken on a draft table of contents. This is another CSTEE initiative. The table of contents may still need developing a little depending on decisions on the scope of the opinion.

He drew the attention of the committee to the fact that the idea behind this activity is not to deal with specific regulatory issues but just the scientific ones. For information, copies of the proceedings of the Madrid workshop would be provided to CSTEE members. It was also made clear that the working group will not comment on specific proposals for classification as being good or bad, the only purpose being setting the scientific basis for hazard identification/classification and the scientific basis for risk assessment.

In the table of contents were included the general principles for ecological risk assessment, effects assessment, hazard identification, exposure assessment, effects assessment related to risk assessment and finally risk characterisation. Recent proposals on the subject will be looked at, as well as the current state of the art at the scientific level on uncertainties in regulatory use. The idea was to try and have a 2nd meeting of the WG before the July plenary but apparently this is not going to be possible (see point 14 - A.O.B.).

One CSTEE member commented that, according to the TGD in support of Regulation 793/93 the elements in risk assessment are: hazard identification, exposure assessment, dose response and then risk. He recommended to have these four elements as headers and include other elements subsequently as appropriate. This would avoid having to put in headings like 'hazard identification' and 'effects assessment' which to some are the same. Should they mean different things, then hazard identification is preferable as a header.

The WG chairperson confirmed that, for the environment, at least in the TGD, effects assessment would include hazard identification and dose response and then the exposure assessment but the proposal mentioned can be accommodated anyway. It is preferable to address this subject more at a basically scientific level than at the level of the TGD or classification issues as this is a subject not amenable to being commented upon on the basis of the specific procedure which has been included in the TGD. In fact, for the terrestrial environment, the TGD considers the assessment as provisional assessment and this makes it relatively unsuitable for this subject.

The CSTEE chairman still expressed the wish that the 'classical' framework be followed as much as possible if only because the group on harmonisation of risk assessment set up across the various scientific committees is using that framework. If this committee comes up with a completely different one it would be a bit unfortunate as the first stage of harmonisation.

Commenting on whether the working group in its present composition had all the necessary expertise, the WG chairperson said that, in spite of the potential advantages of considering further additions, the WG is already a big one. Once a draft is ready and subsequently, for specific points, we can invite to meetings of the WG specific experts on that specific file. As a general rule the actual WG should be sufficient.

The CSTEE chairman asked whether, as indicated under point 3.4 of the table of contents, laboratory animal data on rats, rabbits and others can be related to the ecological framework as well as to human risk assessment.

The WG chairperson confirmed that this was an important element, in particular for pesticides. There is an agreement that we can use the same data that has been produced for human health but using different endpoints even in the same study. Particularly for long term studies you need to consider a different NOAEL because it should be ecologically relevant and in most cases end points that are quite relevant for individual health are not ecologically relevant. In theory we are talking about vertebrates for laboratory data. The idea is to use that information anyway.

The CSTEE chairman concluded the point saying that on behalf of the whole CSTEE he was looking forward for the first draft of the report.

8. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission

a) Opinion requests related to the 'Water framework directive':

A.

I) Report from a study on "Technical specifications for classification and presentation of ecological status of surface waters", March 1999 and

II) Report from a study on "Technical specifications for monitoring of ecological status of surface waters", March 1999.

A presentation was made by the representative of the Commission requester of this opinion (XI/D/1).

He started off informing the committee that the bit of the opinion request he is responsible for concerns the mandate for one of the two terms of reference the CSTEE would get during the plenary meeting. This is a follow up to the opinion of the CSTEE of May 1998 and addresses other questions related to the ecological status, assessment and monitoring in the WFD. Two studies were requested and they are now available. They are looking, inter alia, and not least to the questions raised by the CSTEE previously, in particular to the question of function related to the structure, where structure is the major emphasis of the approach in the annexes, and a number of other questions for classification, identification, reference conditions, inter-calibration etc.

The monitoring study deals with some other questions raised by the CSTEE too. What the committee is being asked is to comment on how it feels that this has developed and to what extent it is taking further the challenge the CSTEE suggested in its previous WFD opinion. There is no extreme urgency in answering this as the framework directive is not close to adoption. It'll probably take more or less a year from now still, due to the political situation with EP and Council being on quite different courses on a number of essential elements.

The intention is use the CSTEE's advice to issue guidance and in due time, when necessary of course, through the management committee, to amend annexes V and II where relevant. In the short term the intention is to use this in the scientific discussions the Commission has engaged on with M. States. The 2nd part of it is mentioned in the introduction to the terms of reference. The CSTEE is also invited to come up with ideas and inform, through its network of contacts, potential applicants to the 5th framework research programme where the framework directive on water and the questions raised by the CSTEE are very centrally placed in the evaluation criteria. There is a recent call for tender which runs out by mid June 99 and there will be a 2nd later in 1999 as well. A paper is being prepared saying what kind of research could be useful for the 5th framework research programme to focus on. It will be ready very soon and the CSTEE is welcomed to comment, but the main element of the CSTEE contribution is its opinion on the content and of course the quality of the two studies.

B.

Revised proposal for a list of priority substances in the context of the Water Framework Directive (COMMPS procedure) and Draft Final Report on the Assessment of options of the statistical treatment and evaluation of monitoring data within the COMMPS procedure.

The representative of the Commission requester service (XI/E/1) started off his presentation by reminding that the decision, to establish a list of priority substances had taken place in February 1998 in experts' meetings. The CSTEE had also been asked for comments on the procedure which was proposed at that time called COMMPS procedure (Combined monitoring-based and modelling-based Priority Setting). Then a first Fraunhofer Institute for Environmental Chemistry and Ecotoxicology (hereafter referred to as Fraunhofer Institute) study was presented in July 1998 and subsequently M. States and experts were requested to give comments particularly on the database that was used which included monitoring data as well as effects data. In the next step the Frauhofer Institute has received this information and data and included them in a revised study finalised in March 99 and presented to experts at a meeting on the 19th of April 99.

The main reason or aim of such a meeting was actually to discuss and to ask experts for their opinion for the choice and recommendation of priority substances made by the Frauhofer Institute. They have identified a number of candidate priority substances from the automated ranking lists and have then made judicious judgements on each of these substances and whether they should be included or not in the list.

Then the representative of the Commission requester service presented some transparencies indicating the substances which came from the monitoring based exposure data and which are the first twenty ranked. He further explained that since there is no reason for any of those data to exclude them from the priority list (since no default have been used for the effects data for example), the proposal was to include these 20 as they are in the list. The 2nd slide included the ranked substances from the modelling based exposure data and it could be seen that there are substances which have this high ranking probably because of defaults used, either in the exposure scenario, in the distribution model or other. By way of example chlorine was mentioned as it is certainly a substance that is decomposed rapidly in the water and that is not taken into account in the modelling approach that was used.

He further mentioned that individual judgement on a substance by substance basis was an important step in the process. The main idea presiding at the judgement process was to look at additional monitoring data since for some of the substances monitoring data have been provided by one or two M. States. On the other hand some substances have been considered but have been excluded from the monitoring based list because only few M. States represented them. They had therefore been excluded on the basis of representativness criteria included in the COMMPS procedure. Nevertheless if these monitoring results that have been provided are used to calculate an approximate exposure score and then to calculate a rank which the substances would have on the monitoring list, it would be possible then to compare it with the monitoring based data. Should they fall within the range of those monitoring based data which have been selected, Fraunhofer Institute proposed to take them into the priority list.

Then there are 10 candidate substances from the sediment based ranking list. Monitored sediment data for the exposure part are used and again there was no clear evidence for excluding any substance. As a consequence the Fraunhofer Institute proposed to include them in the list. The other substances had been already selected on the basis of the previous two lists.

The most difficult part is the metals. Five top metals were found by the automated ranking based on aquatic monitoring data and it may be not completely surprising that Hg is not within the five. In fact it was on the bottom of the different ranking used in the Fraunhofer study, therefore Hg is mentioned with a question mark and a particular question to the committee is whether it thinks that for Hg there is enough evidence to include it in the 1st priority list. At the experts meeting of the 19th of April 1999 many said that there is still great concern with Hg particularly with biota which has not been taken into account in the ranking procedure, the reason being because there simply is no data for ranking in biota. This was out of the scope of the COMMPS procedure. This is a particularly important point for individual judgement where we need an expert view to make a decision.

The main question to the CSTEE would be what is its opinion about the choice of substances from these candidate lists as substances for the first priority list and it should also be pointed out that the Commission has the intention of having a 1st proposal in the Autumn of 1999. Therefore the Commission is under a bit of time pressure and an opinion would be welcomed by the end of August at the latest if possible.

The WFD working group chairperson expressed the view that the work of the Fraunhofer Institute seems very good. When one compares the situation with that of one year ago at the occasion of another M. State's meeting, after the direct application of the system there is a possibility now of an expert judgement, chemical by chemical and some additional problems are now clearer. Regarding the question on Hg, justifying its inclusion should not be a problem since because in the Frauhofer study bioaccumulation has not been considered for metals but only for organic chemicals, an additional weighting needs to be put in for that. He further expressed the view that this is clearly an environmental issue and needs to be justified from the scientific point of view. A meeting of the WG, at least, or probably two are necessary.

A CSTEE member commented that, regarding Hg, the problem is not only due to accumulation, but with biotransformation too. The WG chairperson concurred, saying further that, particularly when one considers speciation of metals. Persistence is not an issue since they are obviously persistent, but speciation can be considered in terms of differences on bioavailability and biotransformation.

The WG chairperson further confirmed that the current composition of the former working group could be kept and other inputs would be welcomed but as regards the external experts the former ones should stay in. A CSTEE member to take on the task of considering exposure assessment was also suggested and accepted.

Another CSTEE member pointed out that boron presents similarities with Hg. It has not been monitored more than occasionally for historical reasons but there is a lot of evidence to consider seriously that it should be included in the monitoring list because of reproduction toxicity and other effects.

Some other members requested clarification on whether the lists had been drawn up considering also the effectiveness of risk management because, e.g. in the case of trichlorobenzene, a lot of risk management measures had been taken with the consequence that its use is negligible. Therefore it is possible that the amounts have been lowering for several years. It is therefore important to include in these considerations the effectiveness of risk management because one continues to have lists without considering these effects.

The representative of the requester Commission service said that if one looks at the study, when establishing this candidate list from the automated rankings, there were two things done: one was the grouping of substances which are normally occurring as mixtures because of their specific use or for example naturally, with the consequence that one finds some groups of substances together; and the 2nd was excluding substances which were labelled or that could be considered as historic pollutants. These are substances which are still found in the environment but actually, at least under the WFD, no further controls are possible, particularly with substances which are no longer produced but which may still be found in the waters because of sources in sediments. That is something which is not in the scope of the controls envisaged under the WFD and that was the reason for not including some substances in the priority list. In that sense the risk management or the measures that have been already taken for those substances are accounted for.

Finally a discussion on precise deadlines took place. For questions on the report from a study on "Technical specifications for classification and presentation of ecological status of surface waters", March 1999 and the report from a study on "Technical specifications for monitoring of ecological status of surface waters", March 1999, the indication is that the CSTEE has more flexibility than on the other (B) item. It the latter it is clear that what the CSTEE has been essentially asked to do is to comment on the priority list and not so much a detailed analysis of the report as on the other requests.

This was confirmed and the information given that there is a note under way to DG XXIV with the questions. It was again emphasised that the metals list and the modelling list are topics on which an expert judgement is extremely important.

The discussion on this agenda item was concluded with the WG chairperson pointing out that a draft would probably initially be circulated among WG members until a date for a WG meeting could be set.

b) Opinion request on:

Euromarker in oil system

The CSTEE secretary introduced this point by saying that this is probably the first opinion request from DG XXI. He further informed the committee that the BASF safety data sheet which was distributed as a room document should be numbered CSTEE/99/3 - Add.6.

The representative of the Commission requester service started off by thanking the committee for accepting to dealing with the request at such short notice. He pointed out that the problem has arisen as a result of the Commission's attempt to introduce a standard marking system for mineral oils throughout the community. Mineral oils specially gasoil, and to a lesser extent kerosene, can be used for a variety of different purposes. In the case of gasoil it can be used as diesel road fuel and can also be used for domestic and industrial heating purposes. In most member states the duty rate, and therefore the price of the final product, varies greatly between the two products. Broadly speaking road fuel is taxed at higher rates and heating fuel at much lower rates and therefore there has always been an "incentive" to misuse heating fuel for road vehicles.

For the last 40 years a number of M. States have employed a system to identify oil which has been released at a lower rate of duty and a number of different chemicals are currently in use within the EC. In addition a dye is used as well, but because of problems of cross-border misuse and smuggling where often the member state of receipt could not take legal action because the marker use was that from another member state, and therefore not covered by their legislation, it was agreed that a standard marking system should be introduced instead or in addition to a standard national system.

The idea was that all 15 M. States would implement it so that if the misuse of fuel was discovered in any M. State the appropriate legal action could be taken regardless of where the fuel originated from. The responsible Commission service asked for manufacturers to submit different products and this they did some three years ago. Subsequently, 5 were short-listed and they were given a substantial testing of various kinds. Finally one was selected which satisfies most of the requirements. It is fair to say that it is not a perfect solution but it is better than the rest. However a problem has now arisen in that this product, the solvent yellow 124 system which is manufactured or patented by BASF, although it is also manufactured by other companies, was introduced into Sweden several years ago and possibly related problems were reported with emissions and injuries.

These were investigated and it was discovered eventually that the problems stemmed from a change in the fuel specification rather than the marker, it was just unfortunate that the marker was introduced at the same time. Therefore in the eyes of some sectors of the public the marker took part of the blame for this problem.

DK is currently the only M. State which does not employ a marking system. It was due to introduce solvent yellow 124 about a year ago but there was an outcry in the press relating apparently with problems with the tanker drivers who would have to handle the product and who felt that there were health risks associated with the product.

The Commission's particular project has not done any substantive health testing as the Commission relied on the testing of the manufacturer. Since the product has been used for the last 10 years and has therefore a reasonable good track record, there appears not to have been problems emanating from its use. However, clearly DK is unhappy with the prospect of this product being introduced and it does have the possibility not to introduce it under the appropriate directive for health and safety reasons. But clearly the Commission would rather have all 15 M. Sates using the product because if one or more opt out, the effectiveness of the whole process is reduced.

The Commission is willing to consider that the fuel itself poses hazards. Essentially what the CSTEE's contribution could be, if it is possible to do it, is confirm whether the marked product, provided it is handled according to normal safety rules, is or not more dangerous to health than the unmarked product.

The comparative testing that has been carried out is basically on the combustion of the products. The results of testing of marked and unmarked fuel using a standard test cycle show that there was no discernible difference in the emissions from the tail pipe of the engine, whether the product was marked or unmarked. This might be obviously a pointer that, perhaps because of the very low marking levels, effectively there is no difference between the two products, but the Commission services accept that combustion testing is one thing and human testing is another.

Basically the final decision will be taken by the excise committee on the basis of a qualified majority. In effect that qualified majority is there because only two M. States have said so far that they cannot agree with the current proposal but the Commission would like to have everyone on board. At the moment inter-laboratory comparison testing are being carried out for the actual test procedures. That is due to be finished in September and the earliest date for a vote in the excise committee will be October 99. This gives some idea of the time scale, while it is understood that any amount of testing could be a very lengthy process.

A more technical discussion subsequently ensued and confirmation was obtained that in terms of toxicological information the data provided so far by the Commission requester service is everything that they had available.

Having checked the data submitted to the CSTEE, one of its members said that seemingly what had been done was an evaluation of the concentration of the different chemicals in the exhaust, the conclusion apparently being that the addition of a marker did not bring in any changes and the concentration of the chemical itself in the exhaust should be the primary basis for the risk assessment. On the other hand the safety data sheet provided does not mean anything regarding long term effects. As usual it is about acute toxicity and as such toxicologists would disregard it considering the concerns under question.

Regarding the concerns raised a guess could be quite obvious given that the concentration is so low that it cannot harm. But such a statement needs to be based on scientific information, presumably from BASF as they are the ones who produce the chemical. Because this product was developed in the1980's, the testing was probably not as comprehensive as the testing that would be required today to develop a similar product, but this needs to be confirmed.

The principle is that if you have 2% of marked fuel in 98% of unmarked fuel the product should still be detectable; the actual recommended marking level is 6 ppm, it should never be more than that but of course could well be less. And on the basis of the acute toxicity data there is no acute effect to be expected but we don't know about mutagen or irritant effects and these data are required. It is doubtful that BASF would produce this without evidence.

If this substance was produced before 1981 it is in EINECS and the provision of data is obligatory according to the provisions of article 6 of the 67/548 directive for inherent properties. It is a responsibility of the company that produces the product.

There have been a lot of national activities both in SW and NO regarding these substances and from the perspective in those two countries no data pertaining to direct genotoxicity studies or carcinogenicity studies of this substance has been found. One would have expected that if those were available, through various pressures they would have come forward.

Data on the parent compound and on the combustion product are necessary as well as on metabolites. On the other hand the tonner trigger regulation implies that if one should use it in the whole EEC, then certainly a carcinogenicity study is needed because that would imply it being produced in high volumes.

According to the information provided by the Commission requester service the calculated amount of production of that chemical is somewhere between 900 and 1200 tons per year for the whole community and therefore, if this information is correct, BASF should have done the appropriate studies but so far they apparently did not have a reason to give it. It is a matter of contacting them to get the information (Prof. Greim to do it).

The CSTEE chairman subsequently confirmed that, from a committee point of view they are happy to oblige but the data is needed otherwise there is nothing to work from.

Asked about the exact nature of the accident in Sweden previously mentioned the representative of the Commission requester service informed that there were problems during the 1990's where people were overcome by fumes from central heating units. This occurred at the same time as the introduction of the marker but as it is now understood, and this was investigated by the SW authorities, that they have apparently identified the cause as a change in fuel specification, but the Commission services do not have any specific information on this.

It was further suggested that Prof. Victorin, a CSTEE member to be, might be of help in clarification of the "Swedish accident" characteristics as she had been involved in the assessment of the case.

Furthermore the representative of the Commission requester service confirmed that there were other problems with the detection process in that it had to be suitable for a roadside use, and therefore being quick and simple. Such requirements did not seem to be currently achievable and so in effect what was made was the safe choice. The "marker" chosen was, out of all those tested, the one that was in use in a number of M. States, with people having experience with it and feeling happier than with an unknown product. The technical subcommittee had made the choice of yellow 124 or at least its recommendation.

What the CSTEE is being asked is whether there are problems with that particular product and if this cannot be resolved, because of health and safety reasons, another look at the problem may be necessary, probably also involving the CSTEE in the future. As for the parameters considered in the choice process there were seven parameters altogether but basically they were all given the same weight. The excise committee met and couldn't decide between themselves whether certain parameters should or not be given priority and basically it was just said that the product should be safe and that the manufacturers data would have to be supplied in order to substantiate this.

The chairman concluded that, in principle the data that is likely to be available are sort of data sheets which are probably of little help in making a judgement on the sort of impacts that could occur. He suggested that the azo dyes group previously formed should take responsibility for this opinion request as they have the necessary experience. He also suggested that, in addition to looking to this particular chemical, it might be helpful if the working group could set out some criteria for an acceptable material from a health safety and environmental point of view and then have that as a framework for dealing with the opinion request in such a context.

This may of course imply expanding a little on the terms of reference but it does seem that in view of the lack of parameters that are available for this type of material it might be helpful if some sort of framework is set where to judge this particular substance because there might be other similar cases. Like in most azo dyes it would be a mixture and therefore had the product not been tested and the statements be based on the properties of the individual components one could have problems of identification in the databases.

The CSTEE secretary requested clarification on the exact nature of the so-called Danish concerns and the answer given was that apparently there was a campaign in the DK press against the introduction of the marker on the grounds that it was carcinogenic implying that the marked fuel was therefore more dangerous than the unmarked fuel to the people that were handling it. From the Commission's point of view this was not a large number of people and basically one is talking basically about tanker drivers who should be taking normal health and safety precautions anyway.

Apparently the tanker drivers said "we are not going to touch it and if you introduce this marker we will not move it" and the DK authorities have delayed the introduction until, if it is possible, we have the reassurance that there is no more risk from the marked fuel than from the unmarked fuel. The DK authorities accepted that, to a degree, this is a presentational problem perhaps rather than a real problem with people requiring reassurances.

One CSTEE member made the remark that fighting against the misperceptions about risks is a very difficult uphill battle. Another one expressed the concern that should this chemical be approved it will be produced in large amounts and with diffuse sources throughout the EU. Therefore environmental risks should be part of the equation as well, particularly considering the possibility of spillages.

In the end, yet again the issue of provision of data to the CSTEE was raised. One committee member said that it is unfair to the CSTEE to expect it to find the data on their own. The CSTEE should not accept a task it is not equipped to take on. Otherwise the CSTEE will have as a basis only something to think about and hope about and perhaps do some QSAR about. He firmly suggested the CSTEE should put back whatever it is supposed to do until the CSTEE is provided with the data.

Even if the CSTEE starts working on the criteria it cannot deal with this compound until it gets the data to support it and in principle the CSTEE as a whole agrees with this. Other CSTEE members said that criteria maybe not necessary as this is probably a compound of more than one thousand tons per year production and so toxicology data should be submitted.

Clarification was then requested on the exact wording of the question(s). The CSTEE secretary explained that this could be found in the basic document CSTEE/99/3. In its last page, last paragraph before the list of five documents it reads, "it would be very helpful if the committee could examine this problem and if possible conclude that he health risks from the marked product are no greater than those exposed by the unmarked fuel". It is strictly speaking not a question but it gives an indication of the kind of issues that DG XXI would like the CSTEE to address. In so doing they also implicitly ask the question but perhaps a question can be fine tuned if that is considered necessary.

The CSTEE considered that the sentence was clear enough in that it could translate it into a question that they could operate.

Finally the following considerations were made. One CSTEE member raised worker's protection issues in that every worker has the right to have the material safety data sheet. Another possibility could be to ask to put this substance on the next priority list for risk assessment. The representative of the Commission requester service volunteered to get back to BASF and attempt to get all that is available and forward that to the CSTEE. Depending on the outcome of this approach the CSTEE will tackle the opinion request accordingly.

c) Other

No other opinion requests were submitted by Commission services.

9. Feedback from the competent services of the Commission on the follow up to the opinions adopted previously by the CSTEE

a) Feedback from DG III/C/4

Representatives from DG III/C/4 presented the state of play on developments related to proposals which have been prepared based, among others, on opinions of the CSTEE. These concerned the subjects azo dyes, chrysotile asbestos, arsenic, cadmium, creosote, Tin and PCP.

Regarding azo dyes the information was given that, after the CSTEE opinion delivered on the 18th of January this year, DG III proceeded with the drafting of legislation banning the carcinogenic azo dyes and the matter now is under discussion in the Commission, the inter-service consultation has been launched.

A positive response from all M. States to the Commission's draft proposal was obtained and therefore there are good hopes to proceed quickly despite the situation of a Commission in care taking capacity for the moment. On chrysotile asbestos a committee meeting took place on the 4th of May, where a favourable opinion to the Commission's proposal for a Commission directive banning the use of asbestos was given. The proposal will subsequently be forwarded for adoption by the Commission with hopes that a decision will be taken within a couple of weeks.

On arsenic, as reported earlier, a volunteer commitment has been discussed and Industry has offered to meet the concerns mentioned in the CSTEE opinion on Arsenic. The technical work on this volunteer commitment has been finalised and this will be presented as a Commission recommendation adopted by the Commission introducing these different elements that Industry is voluntarily commitment themselves to live up to. There has been quite some progress in this area. According to the procedures on environmental voluntary agreements other institutions have to be informed about this. From a procedural point of view other institutions like the EP will also receive that information.

Regarding cadmium, it is part of the review for the new M. States. A review before the year 2003 was foreseen, following the completion of appropriate risk assessments. It is the Commission's intention to proceed as fast as possible to get this next revision started in order to avoid time constraints. Some information is available from the Belgian authorities making the comprehensive risk assessment under the ESR and the decision has been taken, in spite of progress shown by the Belgian authorities, that a new study will be launched trying to improve the previous one the CSTEE gave an opinion on. A call for tender will likely be published soon.

Regarding creosote, and following the CSTEE's opinion on the report of the Fraunhofer Institute on the risks of creosote, the Commission has been able to propose decisions on the different requests from M. States for derogations to keep their national legislation. These are requests under article 100a4 of the Treaty (which is now article 95 under the new Treaty) and it poses some interesting questions there. However these proposed decisions are subject now to inter-service consultations and discussions it is not possible to say when the decisions will be made formally. It depends on the situation of not having a Commission.

On Tin the intention is to carry out the new review before the year 2003 which is the year when the IMO will probably have the global phase out of TBT. There is some information that the environmental protection committee has planned a meeting at IMO in July and the Commission services are hopping that progress will take place there. When a decision will have been made more formally in the IMO, Commission services will start a new review of this directive in order to implement a total ban on TBT. There are no news on PCP for the moment.

For future work the only foreseeable activity is that on the Cadmium study, otherwise activities are suffering a little bit from the absence of a Commission. Work will continue on creosote and work will also continue on chlorinated paraffins where the CSTEE also adopted an opinion under regulation 793/93.

One CSTEE member commented that one of the problems raised at IMO was the transglobal movement of biota together with the disease processes that are part of that biota. Apparently there is a feeling that unless there is a sufficiently suitable agent to prevent this transglobal movement from the maritime states there are some very hard feelings on loosing a very good agent for ships hulls. This has been looked particularly in Ireland where oyster beds stand to loose because of major disease processes brought transglobally. Unless very shortly IMO will be banning organotins there may be an international risk that needs discussing unless there are very good replacing agents.

The Commission representative commented that they have not taken part in the discussions in the IMO as another Commission service is dealing with that but it would look as if there is quite a consensus about phasing out TBT for anti-fouling by the year 2003. M. States have also been very keen on having tough measures on the use and they have been pushing quite hard on the IMO. Regarding substitutes DG XI have an ongoing project trying to identify and develop less environmental hazardous substitutes to TBT and that has been ongoing for sometime as well.

A CSTEE member said that TBT is a clear-cut example of a compound which has been causally related to ecotoxicology effects such as imposex in snails. It is a clear case of a chemical one should get rid off because of ecotoxicological concerns. Hopefully substitutes will be available which will avoid any problem. One fundamental principle that one should feel concerned about is that when something is banned there should be a replacement that should be less harmful than the one being banned.

The CSTEE thanked the Commission representative of DG III/C/4 for the update.

b) Phthalates in toys and/or articles intended and/or likely to be mouthed by children

One CSTEE member requested from Commission services information on the state of play regarding this follow up to the CSTEE opinions on the subject (only III/C/4 was available to give feed back). He pointed out that, as he saw it, the CSTEE opinions should apply exclusively to teeters and he had noticed that the conclusions were being extrapolated for toys in general which, according to his view, would not be correct as it is an over-interpretation of the CSTEE's statement.

Exposure of children has been checked under certain exposure conditions and the situation with toys in general is much different. The CSTEE's concern regarding low MOS is just about teeters and not toys in general because the exposure time is much shorter and so the MOS should be much more than 100. The mentioned CSTEE member had attended a presentation the day before made by a member of DG XXIV who has been using the CSTEE's conclusions and making a statement on toys in general.

The representative of III/C/4 presented her service's views on the issue pointing out that care would be taken with the wording. The situation was that there were different opinions between the different services of the Commission with two different proposals being discussed on how to deal with the phthalates problem. The situation was that a halt had to be called to the internal Commission discussions as the political situation (Commission in a care taking capacity) did not allow for decisions to be taken and decisions were needed at the highest level of the Commission, the Commissioners themselves, on how to proceed. Progress will take place presumably after the summer break and hopefully by then Commission services will agree on a solution.

Another CSTEE member said that from a pragmatic standpoint the situation was a bit disconcerting as it would look that risk perception prevails in this area and no matter what the scientific input will be those will not be the decisive input anyway and therefore one wonders why do the CSTEE does this at all.

He further said that, given that the CSTEE has been given by the Commission the task to undertake the 'Phthalates in toys' review, and given the importance attached to risk perception and communication, perhaps these aspects should be considered before the Commission delineates the specific questions to the CSTEE. Another aspect is the addressing of the overall situation in terms of how useful will these plasticisers be in the future. Maybe that would lead the Commission to revise its questions or even direct the CSTEE into other fields which would be a more effective expense of resources.

10. Information related to the opinion on Human and Wildlife Health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on Ecotoxicology Test Methods

The CSTEE and its secretariat are attempting to give the CSTEE opinion on EDCs as much publicity as possible since a lot of stakeholders have expressed interest in the opinion. The CSTEE secretariat is still exploring possibilities for publishing this opinion separately and as quickly as possible.

The EDCs WG chairperson indicated that, on the issue of separate publication of the Wildlife part of the opinion, "Ecotoxicology" and the SETAC journal were considered as candidates. "Critical Reviews on Toxicology" is also a possibility which very recently showed interest on endocrine disruption. The standard of this publication is very high. A letter was sent to the editor and he responded showing interest in having the 'Wildlife' section of the CSTEE opinion submitted to the journal, plus some tables and inserts. It was proposed that the authors mentioned be the members of the working group.

The chairman requested comments on the options described and on how the CSTEE should follow up progress on the subject. Some CSTEE members requested information from the Commission on exactly which use is it going to be made of it.

As a response the CSTEE secretary said that, in terms of follow up to this there is more than one possibility. Specific requests can be submitted from Commission services at any time. On the other hand the CSTEE should not forget that the opinion being the result of a CSTEE initiative one should rely on a similar sense of initiative to keep it updated as and when new data will become available. This may take place by updating only the bits of the CSTEE opinion that deserve updating. Given the expected rate of progress on knowledge about this subject perhaps changes on the report will make sense in the future.

The CSTEE secretary also requested from representatives of other Commission services present whether they had any information on the subject from their side.

The representative of DG XII said that DG XII had started its 5th framework programme and within it there are key actions where endocrine research can be investigated, particularly in "Quality of life", in the key action "Environment and health", in "Sustainable environment and energy" and in "Water quality". Also a meeting took place with the US in Ispra to discuss the possibility of collaboration with the US on endocrine disruption. The meeting went very well and areas with potential for collaboration were mostly in line with the CSTEE report.

Finally the information was given that on the 20/21st of May 99 there will be another meeting in Como, Italy, and "Endocrine disruption" will be a topic for discussion.

11. Toxicological characteristics and risks of certain citrates and adipates used as a substitute for phthalates in plasticisers in certain soft PVC products - progress report on the request for an opinion

Following up from the statements made at the occasion of the previous CSTEE plenary meeting in March 99, where already because of the shortage of data no progress could be made, it was reiterated by the CSTEE that the situation had not changed as far as provision of new data was concerned.

A proposal had been made by representatives of the Citrates Industry to provide via an expert from the USA some information to the CSTEE via informal contacts with the respective Working Group chairperson. Given the sensitivity of the dossier the CSTEE secretariat declined this offer since activities on this subject have to be characterised by as much transparency as possible and such passing of information is best achieved in an open manner in CSTEE Working Group meetings.

The CSTEE secretary informed that he had received from the "Phthalates in toys and substitutes" WG chairperson an enquiry asking whether he had been supposed to do something about this (getting data). The answer had been (and is) no, particularly where this could be perceived to be an obligation on the part of CSTEE and/or WG members.

The CSTEE secretary expressed vehemently that it is understood that the requester Commission service(s) have to provide the data. It is not the job of the secretary to chase the data particularly on cases such as this one where it proves practically impossible to obtain a complete set of information.

On the other hand it is true however that some data is available from the activities of the Scientific Committee for Food (SCF). Some has been obtained but most of it is not available in the SCF's premises and logistical problems prevent those to be easily obtained (they are in another Commission building distant from DG XXIV's premises and the consultation of the archives is a time consuming process which is best carried out by somebody familiar with them).

A list of monomers and additives used in plastics and evaluated by the SCF, was provided by e-mail but it turned out to be a chunky package of about 300 pages. It is essentially a listing. It does lack the detailed information which is necessary, the primary documentation.

The CSTEE secretary further reminded of something he had said at the occasion of the March 99 CSTEE plenary meeting and which had been confirmed by the representative of DGIII/C/4 on that occasion: following a M. States meeting in February (Directive 76/769/EEC) this year, the agreement (which is believed to stand), was that M. States and industry would use DG III as the focal point for centralising the sending of this information. DG III would subsequently distribute it to the concerned Commission services and that would include DG XXIV which in turn would send it to the CSTEE. However, so far, the CSTEE secretariat had not received anything.

The DG III representative informed that attempts had been made to try to collect information from M. States but the response has been a rather piecemeal one. Some information has been received but only on what some M. States think are used as substitutes. The understanding is however that the information obtained so far is not, on its own, worth a lot.

The discussion on this point was concluded with the understanding that the activity would be reactivated as and when data would be made available.

12. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE

Prof. Bridges commented on exposure assessment as one of the areas in which the scientific committees will be working more in the future. This activity is becoming increasingly important and the CSTEE chairman requested contributions from members for the next stage of the harmonisation of risk assessment procedures. There are lots of areas where there is a need for some specific pieces of work done.

He expressed the hope that since the CSTEE deals with a wider range of issues than most, particularly the issue of how to harmonise or not human risk assessment and environmental risk assessment, when moving to the next stage he would be looking to set up a small working group on specific aspects of this activity.

The chairman then reported on his trip to the JRC in Ispra where he visited the Environmental Institute. It is clear that they would be interested in collaborating with the CSTEE. As a first stage they have agreed to have some exchange of documentation on exactly what they do. Afterwards somebody from the institute may come and talk to the CSTEE on their priority projects. This is to be regarded as a useful step forward as the CSTEE ought to be aware of what research is going in the EU on environmental issues which is a main area supported directly by the Commission.

The last thing to report on was "hormones in meat". There has been a report by the veterinary and public health S.C.. The CSTEE chairman was part of the WG that put together the report but not the final opinion. The CSTEE's attention was drawn in particular to the fact that in that risk assessment there was no consideration of environmental impacts on the use of these hormones and whether there is indeed an environmental impact. It may be an issue that will need to be addressed in the near future and if it becomes an 'hot' one, one could expect that the EDCs WG actually tackles it.

13. Arrangements for the next meeting of the CSTEE

The CSTEE secretary informed the committee that prospects of organising the next CSTEE plenary meeting (1st of July 1999) in Oslo seem promising as the necessary authorisation had been given by the Director General of DG XXIV. However the news that no funds might be available for meetings (see AOB) may play havoc with this and the matter needs to be clarified. It will be a one-day meeting. The practical implications for Commission staff are that less will be there. The chairman insisted that the activity on exposure assessment be given some priority. The CSTEE secretariat will establish with the EUROTOX'99 organisation the necessary contacts to take care of the necessary details. In principle the venue will be the same as that of EUROTOX'99.

Prof. Dybing, the chairman of EUROTOX' 99, commented that it would be important to have that information before May 21st because by then decisions will have to be taken on a number of detailed issues relating to arrangements like flights, hotel catering and others.

14. Any other business

In the course of the plenary meeting the information was given to the CSTEE secretary and immediately given to the committee that the EP had blocked a so-called 2nd instalment of the EC's budget for meetings such as the CSTEE's ones. CSTEE members were advised not to buy tickets or make any kind of arrangements whereby they would commit themselves financially in connection with CSTEE or working group meetings on which they might have received some sort of notice but in respect of which no official invitation had been sent by the services of the Commission. This is to apply from the 1st of June 99 onwards until further notice.

The Commission will try and see what can be done in view of confirming some of the meetings that had been foreseen, including the plenary ones, but as regards new meetings not previously foreseen and which might be considered convenient the message was that these had to be put on hold.

Annexes: I - Draft agenda

II - List of participants

CSTEE/99/plen.age.07.05.99

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE) 9th PLENARY MEETING, 7 May 1999, 9H30 a.m., Centre Albert Borschette - 36, rue Froissart, Brussels - DRAFT AGENDA (rev.1) -

1. Adoption of the draft agenda

2. Declarations of interest

3. Adoption of the draft minutes of the 8th CSTEE plenary meeting held on the 4th of March 1999

4. Presentation by representatives of the Fraunhofer-Institut für Umweltchemie und Oekotoxikologie, Schmallenberg, Germany, of their ongoing research project relating to the development and validation of a test method for the identification of endocrine disrupting chemicals

5. The use of measured exposure data in risk assessments

6. Tropospheric ozone - consideration and possible adoption of draft opinion

7. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report

8. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission

a) Opinion requests related to the 'Water framework directive':

A.

I) Report from a study on "Technical specifications for classification and presentation of ecological status of surface waters", March 1999 and

II) Report from a study on "Technical specifications for monitoring of ecological status of surface waters", March 1999.

B.

Revised proposal for a list of priority substances in the context of the Water Framework Directive (COMMPS procedure) and Draft Final Report on the Assessment of options of the statistical treatment and evaluation of monitoring data within the COMMPS procedure.

b) Opinion request on:

Euromarker in oil system

c) Other

9. Feedback from the competent services of the Commission on the follow up to the opinions adopted previously by the CSTEE

10. Information related to the opinion on Human and Wildlife Health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on Ecotoxicology Test Methods

11. Toxicological characteristics and risks of certain citrates and adipates used as a substitute for phthalates in plasticisers in certain soft PVC products - progress report on the request for an opinion

12. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE

13. Arrangements for the next meeting of the CSTEE

14. Any other business

LIST OF PARTICIPANTS

CSTEE:

Prof. James W. BRIDGES, Prof. Philip L. CHAMBERS, Prof. Erik DYBING, Prof. Bo JANSSON, Prof. S. KYRTOPOULOS, Dr. Ole LADEFOGED, Prof. Dr. José RUEFF, Prof. Mirja SALKINOJA-SALONEN, Dr. José V. TARAZONA, Prof. Marco VIGHI, Prof. Joseph VOS, Prof. Dr. Helmut GREIM, Prof. Benedetto TERRACINI, Prof. Dr. Robert WENNIG.

European Commission:

DG XXIV: Mrs M. de SOLÀ, Mr. J. COSTA-DAVID, Mr. T. DASKALEROS.

DG III: Mrs. L. PERENIUS, Mr. O. ROHTE. DG XI: Mr. WIMMER, Mrs. H. NOVER, Mrs. L. EDWARDS, Mr. M. LUTZ, Mr; A. OLSEN. DG XII:Mr. J.F. JUNGER. DG XXI: Mr M. BOTT. JRC (ECB) ISPRA: Mr. Peter PÄRT.