1. Welcoming address, apologies for absence and declarations of interest

An apology was received from Prof. Soterios Kyrtopoulos.

2. Adoption of the draft agenda

The draft agenda was adopted. Some agenda points would be addressed more than once during the meeting.

3. Prof. Philip Chambers - in memoriam

The CSTEE chairman presented this point. It was reminded that Prof. Philip Chambers was the longest standing member of the CSTEE, of the committee that preceded it (the CSTE) and indeed the oldest serving committee member across all scientific committees of the Commission. Prof. Chambers served the EU for a very long time in a very impressive way. He did a lot of work for the EU and also for many international scientific committees and for many international bodies as well. Wherever he went he would make an impression both scientifically and from his strength of personality which was always positive, friendly and helpful. Prof. Chambers pursued other interests as well, namely his interest in wines (he was the cellar man for the University College Dublin for some 20 years) and whoever saw how he built up the wine cellars in his college would be extremely impressed by his assiduous approach to this as well as to his science. Most of those who knew Prof. Chambers well knew he was not an Irishman at all, he was just pretending, because really he had come from Yorkshire and then move to Ireland. But like many people who move from one country to another he took on all the best characteristics of the Irish people, and because he took on the best characteristics of the Irish it is appropriate to remember him for what he achieved in life rather than just in a rather sad and mournful way as Prof. Chambers was one of those characters who even after his death will be remembered always in a very positive spirit.

A book of condolences was made available to CSTEE members to write a memory of Prof. Philip Chambers; it would then be sent to Prof. Chamber's wife. A minute of silence was respected. Finally the CSTEE chairman reminded that if anybody had any suggestion on other ways of remembering Prof. Chambers those suggestions would be welcomed.

4. Possible changes to the rules of procedure of the CSTEE

This point was an opportunity to discuss several different issues, all with a bearing on the possible need to introduce changes to the rules of procedure of the CSTEE. Copies of the rules of procedure were distributed to CSTEE members for their reference.

The CSTEE chairman explained that most of the rules are very straightforward, they concern, e.g. confidentiality, delegation of responsibility, notice about meetings, etc., but over the last few months there have been several issues that came up and that should make committee members think about the possible need to change the rules of procedure.

Among such issues were :

a) The problem posed by the sometimes enormous amount of data sent to the CSTEE in connection with opinion requests. The secretary explained that, because of the amount of data itself, it is difficult to make a selection from the outset at the level of the secretariat.

b) Subcontracting of work. There is now a recognised list of sub-contractors within DG XXIV. Should CSTEE members believe that the list should include somebody or some institution that ought to be in this list, it is important that this person or institution expresses an interest and there is a standard documentation for this.

c) The nature of the work that the CSTEE is asked to do from time to time. In urgent cases, exemplified in particular by the recent MMMFs opinion request, the CSTEE was expected to produce an opinion between two plenary meetings. That is a very short time scale and so the whole discussion/adoption had to be carried out by written procedure.

This raised the interesting issue as to whether one should differentiate between an opinion of this kind, which may be of a comparable quality to others, but still it is an opinion that has not been generated by the normal procedure. The question therefore is should the CSTEE use the same expression in that it is an opinion of the CSTEE or should a different terminology for this type of situation be used?

The CSTEE secretary explained the reasons why the opinion request on MMMFs had been submitted so late. This was due to the fact that, according to Article 95 of the Amsterdam Treaty, the Commission has to respond in 6 months time to M. State's notifications and this period includes the full consultation of the CSTEE.

The CSTEE chairman said that, should the committee be submitted this sort of opinion requests in the future, its members should think rather hard about the right procedure to dealing with that. The bottom line however, should be that the full text of a draft opinion should come to the full Committee in order to have a full range view. Regarding this context for a procedure, there will be some recommendations coming from the working party of harmonisation of risks in terms of how risk assessments are presented. Since the CSTEE chairperson is chairing this working group the format to be adopted will be one with which the CSTEE will be familiar.

d) Another issue concerned still other types of opinion requests, i.e. the currently pending opinion request on "Lead". Here the committee is facing a situation where questions are being requested from the CSTEE without any particular emergency situation. On the one hand the committee is being asked for a comment on the Danish application for a derogation, but on the other we are being asked for a general review of the "Lead" situation regarding human toxicity and lead environmental toxicity, with a very short time scale and practically no database to making the assessment. It was highlighted that those who are used to writing monographs know well that this is not a feasible proposition, nor is it something that the CSTEE can possibly take on, in particular in the absence of data made available by Commission services (the size of the task was illustrated by the chairman who had carried out a data search on "Lead" references in Medline and Toxline where upwards of 52000 were found on human health effects alone). Given that some of the timescales of the Commission are short, there is always a risk that the quality may not quite be of the level one wishes to achieve and at the end of the day the committee must produce quality opinions or no opinions at all.

The committee agreed on the fact that producing monographs of this kind is not to be considered within its remit.

5. Election of the second vice-chairperson

The CSTEE chairman introduced this point. Because of the passing away of Prof. Philip Chambers, one of the two vice-chairmen of the CSTEE, the election of a 2nd vice-chairman had to take place. The CSTEE chairman reminded briefly the obligations of a vice-chairman. In thinking of nominees, CSTEE members should perhaps also bear in mind bringing in different scientific skills from those already covered by the chairman and the other vice-chairman.

Several CSTEE members supported this view and Dr José Tarazona was proposed given that he would allow for the general area of ecotoxicology to be covered as well. Dr Tarazona accepted that his name be proposed.

The other proposed CSTEE member was Prof. Robert Wennig and he too accepted being proposed. Both then made a brief description of their fields of interest/background to the committee.

The CSTEE secretary read out the rules for electing the chairperson and vice-chairpersons as defined by the rules of procedure of the CSTEE which stated that "The ballots shall be secret and in writing. Subject to unanimous decision by the CSTEE, the secrecy required for the ballots may be waved. The candidate receiving the majority of the votes of the members of the CSTEE shall be elected chairperson, and the same rules apply to the election of the vice-chairpersons as well. If no candidate receives the necessary majority, a second ballot shall take place between the two candidates with the highest individual totals of votes in the first ballot. The procedures shall be repeated until one candidate obtains the majority required". The committee were further informed that the number of votes necessary to elect the 2nd vice chairperson would be nine as the CSTEE is currently made up of seventeen members.

Dr Tarazona was elected 2nd vice-chairperson of the CSTEE with 13 votes expressed at the first ballot in his favour. Prof. Wennig received 2 votes and one vote was blank.

6. Information from the CSTEE secretariat

The CSTEE secretary presented Mr Juan Crespo-Arce, a new official, who was recruited for supporting the CSTEE secretariat to whose workforce he has been assigned. For the time being he has been put in charge of a few administrative matters related to the organisational work needed for keeping the CSTEE running. He will be gradually involved in the follow up of a few specific dossiers which are keeping the CSTEE busy, such as the activity on the available scientific approaches to assess the potential effects and risks of chemicals on terrestrial ecosystems.

Some documents distributed as room documents were also presented such as an updated list of documents sent to the CSTEE since the Oslo plenary meeting and a compilation of the various lists of documents distributed in connection with the topics in the agenda of the meeting. CSTEE members were asked to check whether such lists were an accurate reflection of what they should have received and this was confirmed.

7. Adoption of the draft minutes of the 9th CSTEE plenary meeting held on the 7th of May 1999 in Brussels, Belgium and of the 10th CSTEE plenary meeting held on the 1st of July 1999 in Oslo, Norway

The draft minutes were adopted with minor wording/editorial corrections.

8. Toxicological characteristics and risks of certain citrates and adipates used as a substitute for phthalates in plasticisers in certain soft PVC products - for opinion

The presentation was made by the working group chairperson starting with a summary of the situation to provide a general "picture" first, followed by a more in-depth look at the various detailed aspects of the draft opinion as presented.

The terms of reference were described as well as the approach followed by the working group. The more important general conclusion was that there are important limitations in the toxicological database, particularly bearing in mind that a special attention was devoted to two compounds where data is better, i.e. O-Acetyltributyl citrate (ATBC) and Diethylhexyl adipate (DEHA). A detailed description of the data gaps took place per each of the chemicals evaluated in the draft opinion.

The view was expressed that, in general, it is somewhat surprising that these high volume chemicals are not supported by a more definite and better database. Considering the various requirements for testing such as those applying to pesticides and food additives, it would look as if these are compounds that have passed through the safety net.

Considering the terms of reference submitted to the CSTEE, which ask for a comparison between the citrates and the adipates with the phthalates evaluated by the CSTEE in its previous opinions, the committee argued that since there are important limitations in the database, such an exercise could not be carried out properly.

Regarding question 3 in the terms of reference, the committee also expressed the view that there is not enough data to do an evaluation and consider this as a possible or safe alternative or substitute for phthalates. In order to support substitution you must have a well-developed database to ensure that the substitute material really is of less possible toxicity and risks.

The committee expressed the view that, at present, the CSTEE cannot set limits for this type of compounds given the very poor exposure information and specifically there is no information regarding extractability from soft PVC toys in order to see what the exposures are.

The answer to the 4th question in the terms of reference is that in order to do these comparisons a much better data base is needed and as was mentioned before it is somewhat surprising to see that for these high volume chemicals that have been in use, one has still to see developed a database which would allow for a proper evaluation of these compounds.

The WG chairperson explained that a proper database would include both data on effects assessment and exposure. He further explained that the draft text included a clarification on the risks posed by PVC per se in the articles/applications under consideration. This was not part of the terms of reference submitted to the committee but as it was realised that the polemic over this subject has meant that messages have been put across according to which the risk might be in PVC, the committee decided to include a word about the presumed risks of PVC per se in the articles/applications under consideration. The point was also made that the CSTEE opinions on phthalates and phthalates substitutes, particularly as put to the committee according to the terms of reference, should not be used for supporting a general PVC risk management strategy.

The committee pointed out that PVC is a polymeric material and as such is not bioavailable and thereby non-toxic. But PVC materials must contain additives in order to have the technical qualities that are needed in order to make them valuable for certain applications. So in order to evaluate the whole issue of the safety of PVC products, one needs to know whether or not there are e.g. monomers that are above the levels which could induce some toxic effects and the whole range of their toxicological profile has to be known in order to assess the safety or unsafety of the PVC product.

The view was also expressed that saying that PVC per se is safe is probably not right as PVC contains Cadmium and as such the CSTEE should probably refrain from sending the message that PVC is safe. This was countered on the grounds that Cadmium would have to be considered as an additive and therefore the statement on the safety of PVC, as given above, would cover Cadmium as well.

The committee took also the opportunity to say a word about the principles of evaluation of alternatives to soft PVC. In the case of some elastomers for example, these should also be evaluated using exactly the same principles of risk assessment followed for soft PVC. If the elastormers are polymeric materials then they are not in principle bioavailable by definition and they will not be absorbed into the body and thus not be able to generate toxic effects. But in order to evaluate these other elastomers, the committee will have to look at whether they contain e.g. monomers or additives at a level that may induce toxic effects. And therefore one has to use exactly the same principles in safety evaluation for these products, but so far the committee has not been presented with any of those data and therefore it cannot make any evaluations. The CSTEE was concerned with inequalities in processes addressing safety of materials for children, and by inference if one looks at the whole picture one should also look at the other materials with the same principle methodology for risk assessment.

A representative of DG XI in the meeting took the opportunity to inform the committee about the initiatives that DG XI has ongoing on PVC, on which several studies are being carried out addressing issues such as incineration, the waste phase, behaviour of PVC in lawn fields, etc. He concurred that perhaps the opinions of the committee on phthalates should probably be out of the point as far as PVC concerns may be at stake, but it was also important to point out that the meaning of "safe" needs clarification as the applications in question may imply a safe use but there is also the PVC horizontal approach to be taken account of and here the toxicity to the environment has to be considered as well.

A suggestion for rewording the conclusions of the opinion (section 5.5) to saying that only those materials where there is evidence of risk or evidence of release of dangerous substances should be risk assessed according to a methodology similar to that used in the case of phthalates was refused by the committee as such an evidence would imply that a risk assessment had been carried out and therefore this would be redundant. The committee also pointed out that addressing the safety of children in this case should include a risk assessment of substitutes according to the rules described, i.e. according to the substitution principle. The view was expressed that, since these materials may already be in use as replacement for phthalates this raises the issue of the safety of substitutes already on the market.

A representative of DG III informed the committee that in the framework of Directive 76/769 on the limitations of marketing and use of certain dangerous substances and preparations the issue of substitutes for phthalates and/or for soft PVC had been discussed. A study on alternatives should be commissioned soon to check the market situation and obtain the kind of information that would allow for a proper endorsement of the substitution principle in this case. In this context the mentioned representative explained that it would help if the committee could specify what is meant in the opinion in terms of the scope of the articles to be covered. The CSTEE concluded that the scope of the opinion should indeed be made clear, i.e. that its provisions apply in an exposure scenario of teething rings/teeters and not to toys in general.

The discussion on this point ended after editorial corrections were introduced to the text of the draft opinion submitted for discussion.

9. Discussion and possible adoption of draft opinions on the TNO and LGC reports (for possible validation of the so-called "Dutch consensus Group study")

The working group chairperson and rapporteur described the format chosen for the presentation of the draft opinion. Some of the fundamental issues discussed were to do with the target value/migration limit to be chosen for the migration test and the various features of the test itself. To address the former, and in order to be consistent with the previous positions of the CSTEE, the opinion of 24th April 1998 was regarded as a reference. Most of the discussions/assumptions were relative to DINP.

The CSTEE opinion from 27th November 1998 was another reference with the target value for the migration limit for the validation test set at 9 µg. The data of the Dutch Consensus Group study was the third reference document; the Austrian study, the US CPSC study and the Ispra report (which contains all the data) were also considered. Another set of data looked at was the Spanish method for the analysis, but being just a technical improvement of the method it did not affect the CSTEE's conclusions.

Among the issues discussed was that of what was the acceptable variation. It would look as if the repeatability (within laboratory variation) and reproducibility (between laboratory variation) as presented were not in keeping with the desired standards with the consequence that the methods may not discriminate the samples between migration bellow or above 6.7 µg/m of DINP.

Regarding the LGC report, it was pointed out that standard PVC discs were not the same as those used in the Dutch study. The LGC report was also considered poor in terms of the very limited data on the test samples. On the other hand the late availability of the Ispra report complicated the evaluation carried out by the working group. The comments of the Ispra report are slightly different but they support the conclusions of the CSTEE. The variation in results among laboratories is high and that is what the CSTEE opinion reflects. The JRC report also recommended an extended validation exercise as the CSTEE does.

On the issue of validation it was pointed out that an intercalibrariton exercise may mean many things such as validating one step after the other, so one can identify what actually are the problems, and therefore dismissing the validation out-rightly is not necessarily the only correct approach. This was contested by others who said that that was what TNO and LGC had done and that that was the reason why the CSTEE was criticising their approaches.

It was pointed out that the number of variables/parameters involved make a lax reproducibility target a risky approach. There are the metrics, the metrics components, the force and the saliva and definitively the distribution of the plasticiser. A brief discussion also took place on the possible advantages of the "gnawing machine" used by the JRC. It allows for increased force to be applied until the target migration value of 9 µg is reached. In the US experiment pistons are used and more than 3 µg are obtained.

The CSTEE endorsed the idea that the same reference material should be used inasmuch as possible. The Commission should certainly be encouraged to making sure that a sort of reference material is available in some way.

In essence the draft opinion presented was adopted with some editorial corrections made to it. While concluding that, as presented by LGC and TNO, the test methods cannot be considered by the CSTEE as validated at this stage, if object of some improvements, they may reach the status of validation. To this effect the CSTEE made a series of recommendations in the opinion, which, if followed, can contribute to achieving that objective.

10. Progress reports and/or possible adoption of opinions related to the 'Water framework directive' on:

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

No progress could be made on this part of the opinion request submitted by DG ENV of the Commission since, in spite of both reports having been submitted as final, the information was subsequently sent to the CSTEE secretariat that they were not really the final reports and that the CSTEE should wait for these. The representative of DG XI confirmed this and said that the reports in question had not been formally finalised yet but this should happen fairly soon.

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

Regarding the consultation of the CSTEE on the list of priority chemicals to be included in the Water Framework Directive a draft opinion was presented for discussion. The WG chairperson expressed satisfaction for seeing almost all the previous CSTEE opinion on the WFD reflected in the approach followed by the Fraunhofer Institute, including those elements relating to the list of priority chemicals.

It was subsequently pointed out that one of the most important issues to which the CSTEE should be drawing the attention of the Commission is the inadequacy of the definition of pollution. This was not included in the mandate, but it was considered very important by the committee and was therefore considered as the first point. The definition of pollution should express clearly that pollution represents the level of contamination that impairs ecological qualities, i.e. with a link between presence and effects or, in other words, risk based. At least from a scientific point of view it can be a real problem if the definition is not clear because the quality studies focused on the specificity of this kind of definitions, i.e. the excellent status means no contamination, the good status means no pollution, and the fair status means that you have pollution.

So the differences between the definitions of contamination and pollution is not just a question of words, it is a question of what are the ecological parameters and the effects one expects to have. So at least from a scientific point of view, there is a clear need to include this comment in the opinion, but it is crucial, because the essential difference between what is good and what is not good is the definition of pollution, and if the definition of pollution is not the good one, and the EC definition of pollution is in reality a definition of contamination, that means that everything after that can be misunderstood.

Regarding the general opinion on the prioritisation methods, the CSTEE considered the report of the Fraunhofer Institute as a sound report, perhaps with only a few small problems. The CSTEE opinion is structured in three different parts: the first point is the comparison between monitoring and model estimation which also follows a previous comment in the CSTEE's previous opinion; the CSTEE held the view that both approaches must be considered, and the only relevant point that is commented later on is the kind of chemical that has been incorporated either in the monitoring or in the modelling estimation. The second point looks at the comparison between metals and organic chemicals. It is clear that both kinds of substances must be considered in a different way, and this was also a recommendation of the previous CSTEE opinion, but here the CSTEE are saying that the way in which the Fraunhofer Institute has done this, i.e. considering the same endpoints, but excluding the potential for bioacummulation and biomagnification for metals because of the difficulties to assess these particular end points, is not scientifically sound.

Specifically talking about essential metals, the Fraunhofer Institute have produced a system in which they are more or less comparable, but bioacummulation is considered for organic chemicals, not for metals. The CSTEE considers that bioacummulation and biomagnification is clearly a crucial point for some metals. Finally, the combination of both lists using expert judgement is a clear improvement when comparing the current version with the old one.

The CSTEE also considered that, although a transparent procedure is obviously better, with the current information, expert judgement is an essential requirement for setting the priority list.

The CSTEE also had some remarks to make on the availability of monitoring data (which exists for few substances and obviously only those substances for which M. States have produced enough monitoring data), and again for the modelling data (for which only substances appearing in some previous priority lists were considered), and that has created a problem in that some substances may not be there just because they were not in the monitoring nor in the modelling list.

The CSTEE also made comments on specific exclusion criteria as for example for the cut-off value/molecular weight of 700; such values are to be considered with care because some chemicals of higher molecular weight can be toxic, and also on the exclusion of the historic pollutants since it is clear that even pollutants totally banned in the EU as DDT can still produce problems. For cases as PCB the restrictions are not enough to be sure that there is no continuous environmental release of these chemicals from different sources.

On the specific questions submitted to the CSTEE there was one on metals and a more specific question on mercury. Starting with metals the Fraunhofer report considered that bioacummulation is very difficult to assess for metals, the solution seemingly being that bioacummulation should not be considered at all. This cannot be accepted by the committee.

There are also a lot of differences on how metals must be treated in that there are a lot of substances which contain metals, e.g. all the substances which contain copper are related with the final concentration of copper in the environment, and furthermore consideration needs to be given to the "background" of existing metals.

On the final specific question, on mercury, the CSTEE view is that mercury has not been included in the final list because biomagnification and even bioacummulation have not been included in the rationale. Its transformation into trimetilmercury with a potential for biomagnification in the food chain is an issue not only for salt water systems but also for fresh water and therefore the CSTEE considers that mercury should be also in the final list of priority substances.

It was also pointed out that one of the major weakness of using monitoring data is the lack of comparability between different monitoring data sets. Therefore one must underline the need for standard protocols for the reporting of monitoring data, protocols including the description of criteria for selecting sampling sites for selecting chemicals to be analysed, analytical methods and so on, in order to making monitoring data sets comparable at the European level. How sampling is done in practice should also be better described. There should be provisions for including data on chemicals which are a significant cause for concern, such as production volumes, at the margins of monitoring and modelling, because modelling addresses essentially the exposure part, and the effects part focuses on toxicity and ecotoxicity.

Monitoring of "historic" pollutants was also defended by some CSTEE members and the case of PCB contamination of Nordic countries from Russia was given as an example. The DG XI representative explained that "historical" pollutants are excluded from the priority lists because they are already covered by other EU legal provisions. In principle this should mean that control measures are in place but on the other hand one might argue in favour of including "historical" pollutants in priority lists for checking whether such control measures are indeed effective. But then the question would arise "what does one want to do if they have already been banned"? Furthermore "regional" measures must also be considered, as the significance of pollution is different across the EU.

It was pointed out by the WG chairperson that one of the problems is due to the fact that one is looking at a very small part of the directive; looking at the Directive as a whole, most of the expressed concerns are not so important, because in any case e.g. PCBs or DDT or other chemicals still may be important in one specific river of one specific estuary where they should be detected.

The representative of DG XI confirmed that mercury would indeed be included in the priority list because of its bioacummulation potential, and also TBT.

The issue of which chemicals to include, particularly those that might be defined as "emerging new chemicals of concern" was debated. It was recognised that new (notified) chemicals are risk assessed anyway and that therefore they should be in principle of no concern. As for non-notified chemicals, obviously consideration should be given to their being included in priority lists.

The text of the draft opinion was finally adopted after some editorial changes have been introduced.

11. Euromarker in oil system - for opinion

The CSTEE secretariat managed to obtain a few more data that was sent to the rapporteur whose draft was presented for discussion.

The CSTEE secretary made the point that, given the difficulties with finding data for helping sort out the issues involved in this opinion request an exercise of data gathering was carried out. This was used as an example of how the process of data gathering can be a tedious, slow and time consuming process, providing results that can be unpredictable and sometimes of little use. Therefore carrying out such an exercise, for the reasons mentioned above, is not a task that the CSTEE secretariat should engage on systematically and less so in cases where the scope of an opinion request, e.g. "lead", is overwhelmingly larger (to prove the points above, a table was made available as a room document showing when, what and with which results contacts have been established).

The working group chairperson introduced the point. During the discussion the points particularly emphasised were the following:

The data pack available to the CSTEE on dyes, particularly solvent yellow 124, was scarce and therefore the opinion may be limited by that factor. Therefore it was pointed out that a full risk assessment could not be provided. The scope of the opinion was discussed and several views were expressed pointing out that the environmental effects of the chemical should ideally be addressed as well given that this was a high volume chemical with the potential to cause damage to the environment in case of accidental spills (one litre of the marked oil can contaminate three millions of water, if we assume 2 micrograms per litre on acute toxicity for daphnia). This may be compounded by the potential to bioaccumulate and by the biopersistence of the chemical. Human health concerns would come about as a consequence of this as well.

It was also pointed out that solvent yellow 124 might be a potential carcinogen and as such, issues to do with acute toxicity are not the only concern to which the CSTEE should probably be looking. The limitations to considering this are mainly due to the fact that the problem arises if the chemical degrades, i.e. if the azo bound is split, but it is not known whether this will inevitably happen (e.g. according to DE regulations azo compounds are considered genotoxic or carcinogenic unless it can be proved that the azo dye is stable). But there is no information on the stability of solvent yellow 124. This should be addressed in the database but the fact is that there is no carcinogenicity data.

It was again pointed out that the concern expressed by the Danish authorities was essentially related to an accident that had taken place in Sweden, some two years ago, the consequence of which was that workers who got in contact with the chemical suffered intoxication. According to the most likely explanation, the toxic effects observed were probably related to the fuel formulation that had changed roughly at about the same time that the marker had been introduced.

The major information that was used was a paper by Fisher and Bjarnasson on sensitisation and irritation of three diesel oil classes and three indicator dyes. According to this paper dyes themselves did not show major problems but the mineral oil itself in these preparations showed effects.

According to the available data, which is difficult to make sense of, given the amount of mineral oils and their varied composition, it would look as if mineral oils are toxic, they have among others, irritative properties and it is these properties that might have contributed to the symptoms observed in the "Swedish accident". On the other hand, given that the concentration of solvent yellow 124 is in the area of ppm, up to 6 ppm, the conclusion is that the effects must be due to the mineral oils and not to the dye.

One important conclusion of the reports on the "Swedish accident" is that other dyes being used are not necessarily safer than solvent yellow 124, i.e. changing to another dye is unlikely to improve the situation. It was also pointed out that the concern is essentially an occupational one.

The conclusion was that the CSTEE opinion should address basically the human health situation, but given the large data gaps including ecotoxicological data, it is worth indicating that this situation should be improved. Discussing the environmental impact is not possible for the moment. The opinion was adopted along these principles.

12. Opinion request on a proposed Ready biodegradability approach to update detergent legislation - progress report

As a follow up to the working group meeting that took place on the 3rd of September 1999 a progress report prepared by the WG chairperson/rapporteur was presented.

The WG chairperson introduced the point. It was explained that during the working group meeting an agreement had been found on most questions posed in the terms of reference submitted to the committee. The WG chairperson described the documents submitted by the Commission requester service to the committee in connection with the opinion request.

Subsequently the terms of reference, with its six different questions, were also described. The first question asked whether the proposed biodegradability test does constitute an improvement from the environmental point of view in relation to the existing approach based on primary biodegradability, in the sense that all surfactants passing the "ready" test would pass as well the "primary" test. The second question asks whether the proposed tests ISO headspace, OECD B and OECD D are suitable for surfactants and that they can constitute a direct permission to marketing, on grounds related to biodegradability, in case of passing. The third question requests advice on the circumstances, if any, under which the tests OECD A, OECD C, OECD E and OECD F might be allowed in this respect. The fourth question requests advice on the desirability to allow pre-adaptation. The fifth requests advice on the desirability to keep the "10 days window" and the sixth the appropriate criteria and supplementary information needed for decisions or derogations for surfactants failing the ready test and passing the primary biodegradability.

A preliminary general comment was made on the concern for the aquatic environment about detergents and surfactants, because in quantitative terms detergents are the most important pollutants for the aquatic environment as they are completely discharged in water. So detergents and chemicals related to detergents are chemicals of high concern and for this reason, in particular because of problems relating to persistent and degradability of these chemicals, they must be taken into account.

Regarding the answer to the first specific question the method proposed could be assumed to be an improvement from an environmental point of view in relation to the previous approach .

Regarding question 2, the ISO headspace appeared as completely reliable for this kind of chemicals and the report on the ring test demonstrated the reliability and repeatability among different laboratories and is recommended for inclusion in the directive. The other two methods, the OECD B and D are also suitable but there are some limitations related to some particular characteristics of the experimental models, so they could be applied but with some limitations. About other methods, the OECD A, C, E and F, all these methods present some limitations, in particular some of these methods require high concentration of the substance which could cause problems, in particular with possibly toxic chemicals. There are also other limitations relating to the solubility or lack of it, of some chemicals. For this reason these four OECD methods are less suitable for surfactants than the previous.

Regarding pre-adaptation (4th question), the problem it poses for regulatory testing methods is that it cannot be considered as a desirable approach. In general pre-adaptation could be a good procedure, not in regulatory, but in research approaches, so it is the opinion of the working group that pre-adaptation is not desirable for notification of surfactants degradation method.

About the problem of the ten days window criterion, one of the aspects of surfactant degradation is the production of metabolites, and these metabolites can behave in different ways in comparison with the parent product, and can also interfere with the degradation processes of the parent product, and for this reason the ten days window processing the ultimate biodegradability is not considered a good approach.

And finally, again for the reason of the production of metabolites, a more or less unknown element, for chemicals which pass the primary biodegradability but fail the ready test there is a need for a careful risk assessment with particular emphasis on the possible metabolites produced during the first step of the biodegradation products.

On the subject of the ten days window it was commented that, according to some experts, this is the real measure of the rate of degradation. Therefore a clarification should be in order in that the comment in the opinion applies only to detergents and not to other chemicals because there are absolutely different degradation rates, as reflected in the TGD for ready biodegradable chemicals, passing or not the ten days window. And there are still quite some discussions still going on considering this point as critical. If this clarification is not made it can be taken as a contradictory position from the committee.

The WG chairperson took on the task of making this clearer in the next draft, the final version of which will be made available soon to the CSTEE before submission to the November 99 plenary meeting of the CSTEE.

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

i) Evaluation of Technical Notes for Guidance in support of Directive 98/8/EC concerning the placing of biocidal products on the market

The CSTEE Secretariat reminded committee members that they had received a copy of the TNsG mentioned above (Part 1, guidance on data requirements for active substances and biocidal products, version 4.0 June 1999). Given that some members have volunteered to participate in a working group, decisions should be made, if possible, on the final composition of the working group and on date(s) for working group meeting(s). It was reminded that this process should now be easier from the side of the CSTEE secretariat if every CSTEE member dully sends regularly back the tables of unavailable dates sent by the CSTEE secretariat for updating. The CSTEE were reminded that the responsible Commission service requested that an opinion be adopted by the November 1999 CSTEE plenary meeting.

The representative of DG XI further explained the context of this opinion request. The Directive in its article 33 says that to facilitate the day to day implementation of the directive the Commission will draw up a technical notes for guidance document.

The Legal Service of the Commission was asked what the status of the technical notes for guidance should be and their opinion was that according to the wording this guidance should be a reference, which means should be a recommendation from the Commission to follow this guidance, but without legally binding effects. Competent authorities were also asked their views and Member States more or less agreed with this interpretation. This does not concern the specific data requirements for active substances and biocidal products, where once they have been used in practice, Member States would like to have them adopted with legally binding effects. Ideally they should be used for some time in practice, and then maybe having an amendment to the annexes 2 and 3 of the directive, which contain the common core and the additional data requirements respectively, and have them adopted as legally binding instruments.

The version of the TNsG made available to the CSTEE was discussed in expert group meetings in the ECB in Ispra. It was a draft and minor changes were expected and may be some additions, e.g. in this guidance document the specific data requirement for metabolites had not been included. To make progress on this issue, there will be a meeting of experts in Ispra again in October 99 and it is expected to have the next draft ready to be distributed to the CSTEE by the end of October 99.

Committee members expressed concern on the prospect of having to work on a version that would subsequently be changed and possibly render the work of the committee obsolete. If a more final version is to be made available in late October then this makes for an adoption in November a very difficult task to the committee.

Given that the DG XI representative gave the information that, as it stands, the text should be up to 90% correct, any extra changes needed would always be minor. In any case it was hoped that any changes would be properly highlighted in the text making the task of the CSTEE easier. A working group was subsequently formed to tackle this opinion request.

ii) Lead

The CSTEE secretary introduced this point informing the committee that the trigger of this opinion request was a Danish notification (98/595/DK).

The documents sent to the CSTEE in connection with this opinion request were reviewed. It was pointed out that the documents are subdivided in two parts, part A called General question on the human and environmental effects of lead and its compounds and part B called Danish notification 98/595.

The Danish notification part was described as a straightforward question and that in essence the committee should be basing its evaluation of the problem on the data set submitted by Commission services, which were essentially the data submitted by the Danish authorities. This could be complemented, according to the terms of reference submitted to the CSTEE on this opinion request, possibly with other evidence which the CSTEE may find or which may be available to it.

Regarding question A, the general one, concerns were expressed. This issue had been commented upon the day before under point 5 of the draft agenda (Possible change to the rules of procedure of the CSTEE). The concerns were related to the extremely wide ranging brief submitted to the CSTEE as per the set of specific questions submitted in the terms of reference for Part A. Another reason for concern was the fact that the onus of sorting the data out was, also according to the terms of reference, being put on the committee. It was reminded that, according to the rules of procedure of the CSTEE, the committee can ask the Commission services to provide more data if that is considered necessary and not the contrary.

The general question on lead requests the committee to express an opinion on such diverse aspects of the problems such as toxicological and ecotoxicological profile of lead and its compounds, NOAELS, NOELS, PNECs, blood lead concentrations, environmental contamination and human exposure routes, levels of lead contamination/concentration in the Community, risks for especially vulnerable groups and areas of uncertainty and needs for further research.

In terms of question B (Danish notification), the committee has been provided with a reasonable set of data to give and answer within a reasonable time scale but not for the general question which is really looking for a complete review of all the impacts of lead on humans and the environment, identification and uncertainties and suggestions for further research.

Regarding the problem with obtaining the data needed to answer the general question, the CSTEE chairman said, as an indication of the daunting nature of the task ahead, that a check only on Toxline and Medline revealed upwards of 52,000 publications on the subject of human health effects, and while obviously not all of those will be relevant, if the CSTEE were to do what it has been asked it should need to look at such sources. The CSTEE could also start with the 1995/96 WHO review and simply look at updates since then, which might be a more practical proposition, but even then it is a very daunting task, when the question is so broadly presented.

The CSTEE chairman pointed out that committee members have full time jobs and as such they cannot be expected to provide a good quality answer to the general question within a reasonable time scale, let alone within the time scale suggested by the terms of reference.

The CSTEE chairman appreciated that the issue might be important but suggested that the Commission should look at other means of obtaining the data that the committee needs to answer the general question, perhaps subcontracting a major review to an external consultant which the CSTEE could then peer-review.

By way of example it was reminded that WHO documents very often take two or three years to finalise. Therefore the committee's concern is that it could not possibly do the sort of high quality job that is required in a short time scale.

On the issue of the DK notification, which is for a ban on import, sale and manufacture of lead and products containing lead, it was acknowledged that there are also quite a complex series of questions being asked to the CSTEE. This is because the DK notification addresses, for example, risks to young children from lead and lead products, stress impacts on the environment, particularly plant life and that it indicates that lead contamination is inhibiting recycling therefore raising issues of sustainability. It indicates also that there are financial benefits from less lead use.

There are probably a lot of issues that are going to be difficult for the CSTEE to deal with as, for example, the DK case is not addressing particular lead products, it is addressing lead generically, and therefore the committee cannot conduct a traditional approach of risk assessment in the normal way, simply because there are so many potential sources and local and wider contamination. It is rather unclear from the Danish documentation what the total impact will be in terms of reduction of lead if the measures are adopted, simply because on the one hand there have been already extensive measures to reduce lead e.g. from leaded petrol and a whole range of other issues to deal with handling waste metals and so on, where the full impacts probably have not been realised yet.

Therefore any additional measure is going to be rather hard to evaluate. There is no indication at all of what substitutes will be used if lead is banned, whether there will be any benefits to the environment at all overall.

And lastly the CSTEE has to be concerned with the serious implications with following this route, paving the way to similar approaches on other metals, where the argument could be regarded as rather similar, particularly in cases such as cadmium, mercury, and other metals. So these are some of the issues that will be of concern to the committee when answering this question.

It was acknowledged that the existing expertise within the group that addressed the previous questions on metals mean that an answer to question B can be provided fairly promptly. But the committee believes that the questions will be rather complex to address anyway and the documentation so far is not really fully adequate to explain the details of why there is concern, they are rather broadly "painted" rather than specific.

A representative of DG III explained the general provisions that allow Member States to send notifications to the Commission. Member States have a right under the Treaty to propose national legislation in order to protect health and the environment, unless this legislation is an arbitrary barrier to trade. To do this Member States have to notify the Commission and other M. States about their intentions to introduce national legislation. This is exactly the case with Denmark now. They notified the Commission and M. States about these restrictions they would like to introduce on lead, and the Commission services have been trying to evaluate this from a legal point of view, from a trade point of view but also from the point of view of whether it is justified.

One CSTEE member expressed the view that what the CSTEE can probably do within the timeframe suggested by the services of the Commission, is just to address the major, the critical end points for human health, and this is a question of what kind of exposure one considers. However, this is a major problem because there is quite some controversy over the issue. The documents submitted were subsequently briefly described and their adequacy for answering the questions discussed.

The CSTEE secretary asked the committee whether it was right to understand that the committee would be willing to answer the question on the DK notification while waiting for the Commission service's reaction to the position of the committee regarding the general question.

To conclude the chairman said that the DK notification question could be answered within a reasonable time frame but not the general question in the same timeframe as it is a very broad one and it requires an enormous amount of effort to tackle. So there is no possibility for the committee to answer both in the same time frame, unless the argument is the committee delays any comment on the Danish question for at least a year.

14. The use of measured exposure data in risk assessment - progress report

Following the presentations made by Prof. Jansson at the May and July 99 CSTEE plenary meetings it was now important that more formal decisions should be made on how to pursue this activity. It was reminded that in the mentioned plenary meetings the decision was taken (and already applied in the context of the activities of the WG 'Water Framework Directive') to establish the necessary links with other opinion requests (the WFD was a logical candidate).

The WG chairperson presented the topic. He said that since the July CSTEE plenary meeting a response was obtained from the ECB, European Chemicals Bureau, in Ispra. As is well known, they are very active in the field of risk assessment of existing chemicals and of new chemicals. The ECB reacted in a very positive way to the position of the CSTEE in the Oslo plenary meeting.

They still had some reservations though on the reasons why the CSTEE was carrying out this activity and which is the target for the CSTEE's actions in this field. However they believe that it can contribute to improve the speed with which risk assessments for which they are responsible are carried out. On the other hand, given the limitations of the approach they also understand that models may not work perfectly.

The WG chairperson confirmed that as a next step the committee could seek to pursue this activity in co-operation with the Environmental Protection Agency in Copenhagen; discussions could be taken up there on monitoring to make data more available and to see whether they would accept to co-operate in looking at new compounds/emerging compounds. An interesting element of information obtained from the ECB was that, in the risk assessment process, it is possible for the Commission to go out and ask industry for exposure data. This came as a surprise as the understanding was that in principle one could request effects data from Industry but not exposure data.

Clarification was provided by a DG XI representative in that, for existing substances, producers are obliged to supply exposure data if they have it but in practice unfortunately it is often the case that they do not fulfil their duties and one has to use default assumptions. In case such default assumptions point to an unacceptable level of risk, sometimes the necessary exposure data "appears". For substances in the priority lists of Regulation 793/93 both effects and exposure data has to be provided according to Article 15 but apparently there is not one single case of Article 15 having been resorted to.

Among the issues that should be addressed in the framework of this activity on which the committee has engaged, communication between modellers and the users of models is to be pursued as the one that exists seems to be working well. Perhaps a meeting could be arranged in early November for gathering representatives of the "monitoring communities" within the Union to discuss this question. The intention is to discuss exposure data for risk assessment and monitoring of emerging chemicals and new chemicals on different lists.

On the other hand on the second week of November the OECD organises a meeting of the task force for Environmental Exposure Assessment.

The CSTEE chairman then said that it was important for the committee to decide on how to pursue/promote activities in this particular area. The formation of a WG was mentioned but it was not clear what question the WG would address from this sort of very broad issues. It could establish communication networks, or pursue other specific scientific issues that the CSTEE would feel if would be beneficial to have a WG tackling. The CSTEE chairman then pointed out that, in his capacity as chair of the harmonisation risk assessment group for DG XXIV, he was conscious that this is one of the big gaps where the group is not making any progress at all, and it would certainly be helpful if the CSTEE could begin to address one or two of the questions.

A CSTEE member suggested that another possible task of the WG, mentioned the previous day, was the need to adopt more or less standard protocols for harmonising monitoring plans at European level, standard protocols for reporting and so on.

The attention was drawn to some terminology issues, where, e.g. it is said that risk assessment depends on both hazard and exposure information, and it might be preferable to say effects and exposure information, hazard identification being a qualifier. In reply the CSTEE chairman informed the committee that producing a glossary should be one of the tasks of the "harmonisation of risk assessment" group.

Finally the task of the working group was elaborated and described in the following terms:

1. To propose a way to include measurements of critical exposure in the risk assessment process.

2. To discuss the possibilities for standardised reporting format for measured exposure data;

3. Check the possibilities to harmonise ongoing and future monitoring programs. Further to the CSTEE members that make up the working group, the participation of a representative from the JRC-ECB was considered desirable.

15. Discussion on the CSTEE opinion on MMMF classification - DE request for a derogation under Article 100a (4) - Maastricht Treaty

The point was presented by the WG chairperson and rapporteur of the opinion adopted by written procedure on the 10th of September 1999. A long debate took place on the means of adoption of this opinion that did not involve any discussion in a plenary meeting as is normally the case. By and large committee members expressed dissatisfaction at this form of adopting opinions and went as far as suggesting that a qualifier different from "opinion" should probably be found for making it clear that the status of such documents should be considered different, in order to differentiate them of properly prepared, high quality, opinions.

In reply the CSTEE secretary explained that the circumstances of this consultation were quire exceptional in that Commission services quite simply did not have time to wait for the September plenary meeting of the committee as the deadlines involved were extremely short (Commission services needed to have an official answer ready for the DE authorities in early November and given the procedural steps involved and the time foreseeably needed to complete them, having an opinion adopted by the 10th of September was as far as Commission services could go).

On the other hand the involvement of the CSTEE in this sort of legal cases (notifications under Article 95 of the Amsterdam Treaty) has been decided fairly recently and as such the involvement of the committee could not be sought sooner.

The WG chairperson made a general presentation on the recent historical perspective of classification of the various types of MMMFs. He drew on several inconsistencies compounding the problem, particularly insofar as the various classification systems (in the EU, the US and the IARC) are sort of contradictory. The applicable labelling of fibres as per the EU system of classification does make for a complex system with various classification categories for carcinogenic effects with notas to compound the problem further still.

He then went on to explain the reasons why the DE authorities have not accepted the system that was voted about two years ago under the EU Classification and Labelling Directive, in particular for the provision of exemptions relating to nota Q suggesting a different, more stringent, set of criteria for exemptions.

DG XI submitted the DE argument s to a panel of three experts and it is the report that these experts have elaborated that the CSTEE has been asked to check and express an opinion on. The opinion that the CSTEE voted favourably by written procedure is in any case marred by the limited circumstances of the consultation and the relative closed nature of the questions. The WG chairman commented that it would have been helpful to express a view on the mechanisms of action of fibres but this was outside the terms of reference submitted to the committee and admittedly would probably not be relevant given the legal framework in which the problem had been wrapped.

The CSTEE secretary further informed the committee that, given the form of adoption of this opinion there was no time to include an addition suggested by a CSTEE member addressing the protection of the environment as this comment was submitted after the deadline set for adoption of the opinion. However the point could be raised at the plenary. It was also said that the mechanism of danger for humans for the fibres is absolutely different from the mechanism of danger for the environment. So it should not be accepted that carcinogenicity is the only important issue for fibres as the protection of the ecosystem is extremely relevant also. In such a respect small fibres can be also quite important, and can produce a lot of effects, as has been already demonstrated, but using very different mechanistic approaches.

Another problem was whether the nature of the discussions during the plenary, to the extent that they might be considered relevant in the framework of the DE notification, should or could be taken into consideration by the relevant Commission service in the preparation of the reply to the DE authorities.

It was finally concluded that, because the Commission can decide on a response to the DE authorities at the margins of the CSTEE opinion and the CSTEE's views, it is up for the Commission services to decide on how to use which arguments in preparing the official response. In any case, because the debate was considered to be such that further clarifications from the CSTEE would be beneficial from a scientific standpoint, a statement will be attached to the minutes of the September 99 plenary meeting including those further points that the CSTEE decided make up for a clearer picture of the problem as seen by the CSTEE.

The WG chairman pointed out that, in his view, the crucial point was not so much to do with whether there was new evidence since 5 December 97 but whether the interpretation of the scientific evidence should or not be different after that date.

The CSTEE chairman concluded the debate on this point saying that the outcome proved the point that it is very important that such issues are discussed at a plenary meeting before adopting opinions.

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

A working group meeting had taken place on the 20th of September 99. The WG chairperson presented an oral report.

He pointed out that, as not all WG members could attend the working group meeting there were still decisions to be made; however the suggestion was to start with a specific procedure to address the opinion. The main chapters of the report had been identified and these should in principle form the structure of the opinion. The system implies that a rapporteur should be nominated for each chapter and then he/she will receive additional contributions from all the other members of the WG to address specific topics within the subject covered and will produce specific contents for that particular chapter, to be agreed with other members of the WG, and obviously to be distributed at the plenary meeting. This should be the basis for work.

Agreement has been reached for the content of several chapters, but not all of them. There are also some problems to identify the rapporteur for all the chapters that were submitted, because there have been some changes in the composition of the WG for those external members that are not members of the Committee. But it is hoped that in no more than two weeks all the chapters will have a final rapporteur. When the rapporteurs will have produced the first draft, including the specific contents of the chapter, this will be distributed to all members of the WG and the CSTEE.

The question then was asked on whether there were any volunteers for the missing chapters and what were exactly the areas where expertise was being sought. The answer was that there was indeed in reality one chapter for which a rapporteur was missing and that was the chapter on the general review on ecological risk assessment and their use in regulatory aspects.

The WG chairperson concluded the point confirming that the committee would be kept regularly informed of progress on this initiative.

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

As no representative of any Commission service was present when this point was taken the CSTEE secretary gave out very quickly the information which had been provided in writing by DG III who very succinctly gave the information that the Directive on crysotile asbestos had been adopted as well as the Directive on TBT, Cadmium and PCP.

18. Information related to:

a) The CSTEE opinion on Human and Wildlife Health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on Ecotoxicology Test Methods

The CSTEE secretary informed the committee that the printing in brochure form of the CSTEE opinion on Human and Wildlife health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on Ecotoxicology Test Methods was under way and that the prospects of having it available soon were good. In principle a batch of 500 copies will be printed.

The "Endocrine disrupters" working group chairperson also informed the committee that the environmental part of the report was sent in July 99 to Critical Reviews in Toxicology, as a review article and that an answer from the editorial board is being waited for.

b) Other information related to the subject "Endocrine disrupters"

The WG chairperson also commented on a paper on endocrine disruption, an executive summary of a full report of the American Council on Science and Health. Finally the WG chairperson also informed the committee that he would participate at the invitation of the Japanese Environment Agency in a meeting to take place in December 99 in Kobe. It is an International Symposium on Environmental Endocrine Disrupters and one of the big issues that will be discussed will be Dioxins, as well as all the testing procedures and the wild-life aspect of endocrine disruption.

On the 27/28 September 1999 (coinciding with the 11th CSTEE plenary meeting) a meeting took place, organised by DG XI, to discuss the elaboration of a list of potential and known endocrine disrupters (this was the title given). Prof. Greim had been invited, as well as Dr Dick Vethaak from the EDCs working group.

The CSTEE will be informed of the outcome of this initiative in case it is relevant to its brief.

19. Research programme of the Commission - suggestions of the CSTEE

This point was included in the CSTEE's plenary meeting agenda so that members could benefit from the presentation of representatives of DG XII in view of later being able to advise on possible fields/areas/topics/subjects which should be privileged by the Commission research programme(s) (Key action 4 - Environment & health). The following "pointers" had been previously given to the committee as possible 'fields' to be covered: a)Reduction of health effects related to environmental factors; b)Assessment and reduction of environmental health hazards; c)support to health and environmental policy-making and public information; d)Analysis and quantification of the impact of environmental factors on human health; e)Assessment of the relative importance of, and interactions between, factors impinging on health; f)Development of an integrated approach to risk management taking into account environmental and public health aspects; g)Development of new methods of diagnosis, risk assessment and processes to reduce causes and harmful environmental health effects.

A representative of DG XII made a detailed presentation of his DG procedures for financing projects, from the publication stage to the final selection one. It was mentioned that, where possible, clustering of projects is privileged so that they can benefit from networking and synergies. It was also explained that future links with other DGs such as DG XI and XXIV will allow for their respective policy priorities to be taken into account enriching the stage 2 of the selection exercise where scientific criteria has been left out (taken account of in stage 1).

Regarding thematic areas there were proposals related to toxicology in a broad sense, on occupational and environment health, on bioassays, electromagnetic fields and others.

It was indicated that during stage 1 of the selection process proposals are rated according to the scientific and managerial merits; then in the stage 2 other three relevant criteria come into play in which 20 per cent will go to the community added value, 20 per cent on the social benefit and 10 per cent on economic development and STD projects. This was a balance that was arrived at after long discussions and while the system can be criticised it has proven its merits. So the results of that were that a threshold has been put on the first stage, in the sense that only very good proposals on science could go to the second stage. There was a threshold of 4 on 5, as proposals could score 1, 2, 3, 4 or 5, and there was a threshold of 4 for science, and 4 for management and resources. The stage 2 followed. This meant that 50 proposals went to stage 2 and in stage 2 the panels had a somewhat different composition in that they were multidisciplinary as they needed to look at the relevance criteria. The DG XII presenter then described the fields covered by the last call for tender. He also indicated that inclusion of political/social criteria in the stage 2 has proven a difficult element to put into practice but that this is probably part of the "learning curve" given the new character of the approach.

A CSTEE member asked whether considering decreasing the amount of money per project, in a way that could allow for more high quality projects from a scientific point of view to be financed had been considered.

The answer was that while one looks for better value for money the final decision is always limited by the technical feasibility of the project because cutting too much on costs may undermine the scientific feasibility of the project. On the other hand the figures proposed for travel and subsistence expenses are sometimes too high and this has to be cut.

Another CSTEE member expressed surprise about the success rate on cellular phones projects to do with EMF and queried on how were quality criteria ensured at a consistently high level. The answer was that the success rate of proposals from that panel going to stage 2 was the same as that for other panels in toxicology. Proposals to do with cellular phones went through the same process and during stage 2 they were also ranked. In the end they came up being similarly scrutinised and selected. The subject "endocrine disrupters" was submitted to a similar process.

The presenter explained that the work program is adapted every year and that in fact this should be the case after every call, with one or two deadlines; normally it would be one call one deadline. DG XII is now in the process of preparing the 2000 work program and it has to go rather quickly because the deadline is the 15th of December for closing in the 15th of March.

Any CSTEE suggestions can still be accommodated in the future for the three following years and the three future calls. Work programmes are subject to a "dynamic adaptation" and topics can be closed or reopened. Feedback from Commission services are one of the elements that can make change the process.

DG XII can consider amending its work program, but amending does not mean change it dramatically, but any feedback from the CSTEE would be more than welcome. To have more information on what the CSTEE feels would be relevant in the future but the committee should avoid giving titles of projects.

The DG XII representative also said that there is an evaluation a posteriori of research projects that have been financed, some 36 months to 48 months after (scientific results become manifest more or less 18 months after the end of the project. Interim reports can only give slight indications on whether you have to stop the proposal or you have to continue; this is being analysed not only on a scientific basis but also in terms of the dissemination and exploitation of the results.

One CSTEE member commented on the research needs suggested by the CSTEE in the opinion the committee had adopted on the subject "Water Framework Directive" and queried whether these had been properly endorsed at the level of research projects being financed by DG Research. Its representative said that the research needs under the Water Framework Directive is a case where there is a key action that corresponds very closely to a need of another DG. DG XII keeps very close contacts with DG XI in order to ensure that they can help them to get all the tools they need for the implementation of the Water Framework Directive.

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

The CSTEE chairman presented this point and confirmed that the SSC continues to dedicate almost all of its time to BSE related matters. One aspect of this subject that may be of interest to the CSTEE is due to the fact that the centre of attention is turning towards the storage of potentially contaminated meat and bone-meal material. Because of having introduced the program of slaughtering animals at 30 months and having a program for incineration, there is a significant lot of materials that is being produced, which is not being disposed off. Members may have heard/read of certain incidents in the UK and France, where potentially contaminated materials might be at the origin of specific problems. Given that the CSTEE chairman has been told that he is supposed to chair the WG dealing with that issue, if any members have strong feelings about meat and bone meal and how we can deal with it from the scientific point of view, contributions would be welcomed.

Furthermore, it is a priority of the harmonisation risk assessment WG to agree firstly on definitions and secondly on lead documents on particular issues. So as soon as there is a reasonable list of agreed definitions it will be circulated to CSTEE members for identification of other terms that the committee should also try to harmonise. A particular issue for the moment is how the WG describes for the public what is meant by very low risk, and so far there are candidate terms that are being used to describe exactly the same thing by DG XXIV.

21. Arrangements for the next meeting of the CSTEE

The CSTEE secretary confirmed that the next CSTEE plenary meeting had been scheduled for the 25-26 of November 1999. Given that it will likely be a one day meeting, the final date should be the 25th of November 99. Whether it is going to be a 1 or 2 day meeting depends on certain developments still needing clarification.

22. Any other business

The CSTEE secretary informed the committee that, regarding Regulation 793/93, no new information, relative to that provided at the previous CSTEE plenary meeting, had been provided by the responsible Commission service. This concerned when the future new pack of substances for the CSTEE to peer-review/express an opinion on would be submitted. At the Oslo plenary meeting the indication had been given that the CSTEE should not expect to receive the first finalised risk assessment pack before October 99

The CSTEE secretary also informed the committee that DG III had communicated that they would carry out soon as study on alloys and this should later be submitted to the committee.

Finally the CSTEE secretary also informed the committee that a workshop on the monitoring of particulate matter in the ambient air would take place soon and that the possible participation of a CSTEE member to making a presentation on human health effects of particulate matter was being considered by the organising committee. The CSTEE will be informed in due course of developments on this initiative particularly where the CSTEE involvement will be sought.

The opportunity was also taken to inform the committee on the nature of the ongoing changes in the structure of scientific committees being managed by DG XXIV. There is a group of three "wise men" who are looking at the role of the scientific committees and checking whether they still should be under DG XXIV in the future, whether they should be separated in some way from DGXXIV, whether there might be a new agency (which might be a consumer agency, a public health agency or some other kind of agency). Their report is due in November 99 but meanwhile the committee will carry on with its work as normal, and wait the new fate of the committees.

The information was also given that the mandate and the names of the three experts advising the Commission on the future of the scientific committees are available on the internet site of DG XXIV. The mandate is really a review of the current system, and recommendations for changes. Not necessarily changes that would go up to the creation of something radically new, but changes on the current system.

Without any other business the meeting was closed at 18H00.

Annexes: I - Draft agenda

II - List of participants

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE)

11th PLENARY MEETING, 27th of September 1999, 10H30 a.m., Centre Albert Borschette, rue Froissart, 28th of September 1999, 9H30 a.m., 232 rue Belliard, room 4/11, Brussels, Belgium

- AGENDA -

1. Welcoming address, apologies for absence and declarations of interest

2. Adoption of the draft agenda

3. Prof. Philip Chambers - in memoriam

4. Election of the second vice-chairperson

5. Possible changes to the rules of procedure of the CSTEE

6. Information from the CSTEE secretariat

7. Adoption of the draft minutes of the 9th CSTEE plenary meeting held on the 7th of May 1999 in Brussels, Belgium and of the 10th CSTEE plenary meeting held on the 1st of July 1999 in Oslo, Norway

8. Toxicological characteristics and risks of certain citrates and adipates used as a substitute for phthalates in plasticisers in certain soft PVC products - for opinion

9. Discussion and possible adoption of draft opinions on the TNO and LGC reports (for possible validation of the so-called "Dutch consensus Group study")

10. Progress reports and/or possible adoption of opinions related to the 'Water framework directive' on:

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

A.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

11. Euromarker in oil system - for opinion

12. Opinion request on a proposed Ready biodegradability approach to update detergent legislation - progress report

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

i) Evaluation of Technical Guidance Document (TGD) in support of Directive 98/8/EC concerning the placing of biocidal products on the market

ii) Lead

14. The use of measured exposure data in risk assessments - progress report

15. Discussion on the CSTEE opinion on MMMF classification - DE request for a derogation under Article 100a (4) - Maastricht Treaty

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

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

18. Information related to:

a) The CSTEE opinion on Human and Wildlife Health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on Ecotoxicology Test Methods

b) Other information related to the subject "Endocrine disrupters"

19. Research programme of the Commission - suggestions of the CSTEE

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

21. Arrangements for the next meeting of the CSTEE

22. Any other business

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE)

11th PLENARY MEETING, 27th of September 1999, 10H30 a.m., Centre Albert Borschette, rue Froissart, 28th of September 1999, 9H30 a.m., 232 rue Belliard, room 4/11, Brussels, Belgium

LIST OF PARTICIPANTS

CSTEE:

Prof. James W. BRIDGES, Prof. Erik DYBING, Prof. Bo JANSSON, Dr. Ole LADEFOGED, Prof. Dr. José RUEFF, Prof. Mirja SALKINOJA-SALONEN, Prof. Marco VIGHI, Prof. Joseph VOS, Prof. Prof. Helmut GREIM, Dr. Claude LAMBRE, Prof. Katarina VICTORIN, Prof Janneche U. SKARE, Dr. Marc COSTELLO, Dr. José TARAZONA, Prof. Benedetto TERRACINI, Prof. Robert WENNIG

External expert:

Dr Suresh RASTOGI

European Commission:

DG XXIV

Mrs M. de SOLÀ, Mr. J. COSTA-DAVID, Mrs A. FOKKEMA, Mr E. HANSSON, Mr P. DASKALEROS

DG III/C/4

Mrs L. PERENIUS

DG XI

Mr. A. PAQUOT, Mr. J. D'EUGENIO, Mr. A. OLSEN, Mr. L. FOCK, Mr. W. CORTELLINI

DG XII

Mr. J. F. JUNGER, Mr. A. VANVOSSEL