1. Adoption of the draft agenda (copy attached)

The draft agenda was adopted. The order of some points had to be changed to take account of the availability of some Commission staff who could not be present for the whole day.

2. Adoption of the draft minutes of the three previous plenary meetings of the CSTEE

On the minutes of the June meeting, the 'Chrysotile asbestos WG chairperson requested the addition of a comment to the effect that the CSTEE chairman had been informed of the invitation addressed to the WG chairperson by the European Parliament social affairs committee (The WG chairperson had specifically informed the CSTEE chairman and not the CSTEE as a whole).

The rapporteur of the opinion on Arsenic had a number of specific observations to make on the account made in the minutes about the discussion on Arsenic. None of these were on the substance of the account but rather on the phraseology (the WG chairperson will send comments to make the text clearer).

The suggestion was also made to the effect that the terms of reference on any specific opinion request should be included in the minutes at the occasion of the respective presentation for the first time to the CSTEE.

On the minutes of the November 1998 plenary meeting, concerning the subject 'Cadmium', DG III commented on a small sentence in brackets (...if it had been used it could render some uses of Cadmium unacceptable). Given the potential for wrong interpretation of this sentence it was requested that it be removed.

The CSTEE expressed satisfaction for the current minutes format as presented by the CSTEE Secretariat. It was also suggested that in a final page, minutes should include an actions list for which individual committee members were made responsible during the meeting.

3. Rules of procedure of the Scientific Committee on Toxicity, Ecotoxicity and the Environment

It was confirmed that, at the occasion of the November 1998 CSTEE plenary meeting the rules of procedure had in fact been adopted.

4. Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations. Consideration of draft opinions, as presented by the respective rapporteurs, with a view to their adoption by the CSTEE, on:

(i) Cadmium

The WG rapporteur presented the latest version of the draft that had been sent to the CSTEE during the previous week. He gave an account of the discussions that had taken place at the occasion of the WG meeting of 11 January 1999. The decision had been taken then to shorten the previous draft considerably, something which had also been suggested at the previous plenary. One important remark was that the draft opinion is based on various versions of the report produced by the consultant and not only the last one (including a final additional assessment which apparently consisted in moving some of the data from the previous part 1 of the final report and presenting it in a slightly different way). The answer remains though that the reports are not of an acceptable quality as the sound scientific basis on which they should have been produced was obviously lacking. It was also pointed out that some of the methodology used in the reports had been used incorrectly (By way of example it was mentioned that the PEC values had been derived by means of a fundamentally wrong procedure that consisted in simply adding together the regional, continental and background concentrations).

The CSTEE endorsed the view that the consultants had been asked to do a risk assessment for the Cadmium burden derived from three specific uses and that the only way to address this task is to express this in the context of the total Cadmium burden, which can be measured. It is possible to measure total concentrations in different compartments and do the assessments.

The view was also expressed that there was perhaps a lack of toxicological background in the people that wrote the consultants' report. Apparently the consultants did not work at the toxicology at all as the toxicological assessment was not provided.

The WG considered its job finished with the two answers given. Perhaps it would have been useful to make a number of recommendations but the CSTEE did not feel as its charge now to make recommendations. It can do so in the future though if the Commission requester service needs it. In its present state it may be enough to say that the consultants' report on Cadmium is not a good basis for decision making by the Commission. As a final remark the CSTEE noted that the consultants' report did not address recycling.

DG III considered the opinion adopted by the CSTEE as an acceptable answer. They also gave an update on the status quo as far as the policy line they're developing was concerned. An urgent measure solving new M. States' concerns is necessary given the sensitive nature of the problem, not least of which because the 15 EU M. States seem to be very divided on what to do with Cadmium. Given that the consultants' risk assessment does not seem to be a good basis for a risk management decision, and also taking into account that the review being done is to meet the Commission's commitment in the Accession Treaty with new M. States, the Commission is probably going to prolong up to 2002 the derogations for the two M. States having stricter regulations in place. In the proposal there will be a commitment to review the directive again before that date and during this time DG III will try and get a better risk assessment for the three Cadmium uses in question. The more comprehensive risk assessment made under the 793/93 regulation being finalised by Belgium is also eagerly waited although it is not clear exactly when it will be available. Issues to do with waste (PVC waste containing Cadmium) will also be considered.

The logical consequence of such prospects is of course that the subject is likely to come back again to the CSTEE.

(ii) Azo dyes

The rapporteur described the draft opinion, starting off with a description of the terms of reference.

The finally adopted opinion, without the corresponding justification, was the following:

The CSTEE considers that the LGC report reviews adequately the situation regarding the risk of cancer for consumers as a result of the use of fabrics dyed with Azo compounds and its conclusions are in general acceptable. The Committee supports the Report's recommendation that use of Azo dyes should be restricted but a) sees no reason for distinguishing between the 14 amines classified by the EU as category I or II carcinogens and the 8 amines classified by the MAK Commission, and considers that the aim of minimising or completely avoiding their use should apply equally to all 22 and b) considers that such restriction should not be subject to prior development of validated analytical methodology.

During the debate the issue of sensitising effects of Azo dyes was raised but this was not considered to be central as reflected by the terms of reference. DG III explained that this is being looked at by means of another report that is still being carried out. This will be submitted to the scrutiny of the CSTEE as well. Worker exposure was also addressed but it was believed that long-term worker exposure to Azo dyes is confounded by aromatic amines and as such unlikely to be liable to conclusive answers at the current stage.

An important factor to consider if one takes at face value the estimated exposures in the conclusion is that children's exposures are enormous, in the region of tens of milligrams per kg/bw of carcinogens, which is the reason to be concerned about this.

Exposures to other sources of amines were not discussed in the consultant's report but given that exposure derived only from the considered source appeared to be giving rise to such a significant risk, considering risks associated to other exposures would become really an academic exercise. It was mentioned by way of example that Azo dyes in cardboard or soap have probably not completely disappeared and that consideration should be given to that in assessing risks.

5. Endocrine disrupters

(i) presentation by the Working Group chairperson of a draft report being prepared by the 'Endocrine disrupters' Working Group (outcome of 'Endocrine disrupters' Working Group meetings of the 7th and 14th of January 1999)

The chairperson of the Working Group presented the draft that resulted from two mentioned meetings, one on the 7th of January (to discuss human health effects) and another on the 14th of January (to discuss wildlife and environmental effects). The presentation was made essentially on the basis of chapters 1 (Introduction) and 7 (Conclusions/Recommendations).

In the November CSTEE plenary meeting a number of points were raised to the effect that some bits of the report were not complete and this concerned among others the health conclusions and recommendations and also the introductory part. The draft available for the plenary addressed these issues quite well.

The intention of the WG, and of the CSTEE, was still to have the draft opinion finalised in time for its formal adoption by the CSTEE at its plenary meeting of 4th of March 1999.

Views were expressed on the convenience or not to have an executive summary. Contrary to the previous draft the current one does not have conclusions and recommendations at the end of each chapter. There are general conclusions and recommendations only at the end of the full document.

At the November CSTEE plenary meeting issues had been raised on topics such as: Stress responses; mechanisms (species differences); breast cancer (reference to a Danish study) link with organo-chlorines (article published in the Lancet); central nervous system (neuro-endocrine effects, now mentioned); exposure considerations (possibly tables to be included); low dose effects (there is currently apparently no real scientific evidence).

On human health effects comments had been made at the September CSTEE plenary meeting according to which, as reflected in the September minutes, the report should not cover in detail human health effects. The fact though is that it does but in an inconclusive way, some CSTEE members said. The CSTEE should decide whether it wants a section on human health effects. If so then the conclusions in the draft should be stronger, some members said. In the debate on human health effects that ensued the following remarks were made:

Wording was commented on and it was said that it may account for some of the apparent shyness in the conclusions. The main conclusion of the chapter on human health effects is that there is no proven causality of endocrine disruption in any health effects reported, possibly with the exception of neuro-endocrine effects.
The emphasis is on environmental species and this is due to the fact that it is where the greatest impact is felt. The human health effects part was therefore correspondingly reduced. The introduction states what the emphasis of the report is.
Whether human health effects should be covered in the report or not was something that had been discussed many times and the conclusion was that that it should be done, at least in a brief and concise way, and the WG agreed to keep it as short as possible. The inclusion of references and a short evaluation was also in line with such a view.
The human part is a very relevant statement in spite of leaving some aspects open. It would be regrettable if all the work done would have no outcome at all. It would probably be a serious omission not to include any statement on human health effects.
The comment was also made that some issues ought to be prioritised on the human health effects side.
The DG XXIV Risk Evaluation Unit (REU) expressed the view that they would certainly welcome an human health effects chapter. REU could have a role to play in sponsoring studies. In that sense any suggestions, if possible, on what exactly such an evaluation should entail would be very helpful. In short, guidance would be helpful. Very detailed guidance however was difficult for the CSTEE to do at this stage.
REU suggested that the CSTEE should make it clear whether it could accept to receive specific requests on guidance from the REU to develop specific studies and/or criteria for studies. REU favoured this approach and in that case maybe a simple ranking in terms of importance at this point would be appropriate. The REU would take that on and come back to the CSTEE and ask specific questions on how to go about it.
Exceptionally high exposures to phytoestrogens and the subsequent effects were considered as deserving specific mentioning. As regards exposure and potency, phytoestrogens are a cause for concern because exposure and potency are high.
The CSTEE WG chairperson expressed his satisfaction at such a prospect (establishing a ranking for future studies). However the problems with implying that EDCs effects exist was highlighted. So far there is no scientific evidence that there is a correlation. Efforts should be concentrated in finding the real causes of effects and not presume that this is due to an EDC effect. As an example it was mentioned that there is a need to find out whether, e.g., i) endometriosis prevalence has really increased, because nobody knew what the rate was 25 years ago, and ii) why is it increasing and can it be related to e.g. xenoestrogens.

It was pointed out that the text in the introduction makes it clear that the involvement of the CSTEE will continue even after the adoption of the report/opinion on EDCs.

DG XI also supported the chapter on human health effects. They informed the CSTEE about the fact that they launched a study this month on prioritisation of substances suspected of being endocrine disrupters, what are their critical uses, what is the life cycle of these substances, etc. It is hoped that by the end of the year more clarification will be available on that and on the possible involvement of the identified substances in affecting human health.

The wildlife section has a review on the European situation. A distinction between associations and real causal links is in the conclusions and the need for studies is highlighted (semi-field and laboratory) to compensate for all the confounding studies. The draft opinion indicates that there are real EDC effects in wildlife. To substantiate this view several examples for different species, included in the report, were described.

One important point to remember is that there is many data on the aquatic system but few on the terrestrial one. One of the recommendations is that European amphibian populations should be examined. Another recommendation is to conduct semi-field studies. One important conclusion is that long term consequences should be determined. Effects on a population can be detected but it is not clear what would it mean on a community level and on the ecosystem.

As mentioned in the November CSTEE plenary meeting the WG is considering sending the 'wildlife' part as a separate item to a peer-review referee publication.

Another problem posed is due to the fact that there is not enough information available. A potential suggestion could be to use field studies with pesticide formulations containing nonylphenolethoxylates. DG XI should consider this. Maybe there is a lot of information available for the terrestrial environment, particularly on pesticides, but this data may not have been published because most of it is confidential. Perhaps specific companies could be contacted. These problems deserve a reflection.

Although the conclusions seem quite general, given the scope of the potentially implicated problems and the various effects involved, they should be. Ecological risk assessment is important and attention must be paid to the fact that with a few test species one cannot say much about a whole ecosystem. This is a methodological problem. Recommendations are also made in the report to the effect that the capability of laboratory long-term tests to detect ecological relevant effects related to endocrine disruption should established, although it is known that this is a very difficult task.

Species focussed assessments are also necessary particularly in the case of endangered species. In this respect it was said that one of the differences between the ecological risk assessment in Europe and another countries, particularly the USA, is that in Europe we consider all the generic ecological risk assessment that meets the protection of structure and function of the ecosystem, while in the USA they use more focussed risk assessments. There are problems with the generic risk assessments in that they are not intended to protect specific species. The 2nd problem is that ecological risk assessments and ecotoxicology do not try to identify a specific mechanism for a specific type of effect but only those that really are ecologically important.

The respective chapter in the draft opinion mentions that maybe the present system does not allow for the identification of EDCs or neurotoxic effects because it is not intended to do that. However there is a concern in that certain chemicals able to produce relevant effects 'should' pass through the process, particularly with a brief evaluation that includes only acute mortality or acute toxicity data for the ecological risk assessment. They pass through the system, hence there is no concern, and clearly there should be a high concern for those particular chemicals.

The conclusion is that in ecotoxicity testing things can be improved by enhancing test systems but in some cases new test guidelines have to be developed. Enhancement can be done on the current OECD testing in mammals (407- repeated dose oral toxicity test) and it is currently being considered by the OECD to include more endocrine related parameters. Also on the 416 (the current reproduction test) the WG feels that enhancements can be made on it too. This can mean that no extra tests have to be developed, if enhancements of the current tests are carried out.

On ecotoxicity testing the bulk of the work still needs to be done. Many tests are not validated and others do not take into account that the endocrine system is an endpoint. There is emphasis now on fish testing and here more parameters should be included (biochemical/histopatological parameters to detect endocrine disruption). The WG acknowledged that the OECD role is an important one. The draft opinion now includes a clear statement to the effect that reliance on in vitro essays for predicting in vivo endocrine disruption effects may generate false negative as well as false positive results. This is in contrast with the American point of view that focuses initially mainly on in vitro testing and the WG found it important to state that clearly.

In the EU strategy for testing chemicals, which depends largely on the tonnage of chemicals produced, consideration should be given to including certain tonnages below which and according to the current EU system, chemicals are not tested for reproductive effects. If this is acknowledged consideration should also be given to include endocrine disruption effects. Even with a good testing system such as the EU one, certain chemicals will never be tested for endocrine disruption and this may mean that we will never know if this will result in endocrine disruption in the environment. This could be a costly issue but should be considered.

Concerning the OECD work on the Herschberger and uterotrofic tests it was mentioned by DG XI that the CSTEE draft opinion does not address it; only the enhancement of the 407 test is mentioned and perhaps the former should be mentioned. The answer was that this is not in the EU strategy but perhaps the report will acknowledge it. Such tests seem to have some validity but the question still remains as to whether they are really needed if we have good 407 and 416 tests. Maybe it can be said in the draft opinion that priority should be given to the 407. Basically there is not much data available on the tests mentioned by DG XI and this may account for the absence of firm views on them. The harmonisation exercise on classification systems is under way and this too is an element why, at the current stage of developments, one should dismiss the uterotrofic and Herschberger ones. On the other hand a reference could be included in the draft opinion saying that validation is still to be concluded. Still it was agreed that preference should be given to the standard ones.

It was reminded that the 7th amendment introduced the concept of reproductive studies for information in the base set. It does not make it de rigueur. Making them obligatory would cover the fifty-ton production level. In the test it now reads 100 tons. However we know that below a certain tonnage, tests are not done. The 100 tons level needs checking.

At the same time the OECD are attempting to look at a simple reproduction trial that would fit into that area. A discussion took place on the exact amount of the base set and the conclusion seemingly was that it was somewhere between 1 and 100 tons and this does not include reproductive studies.

The final point was made that the CSTEE is of the opinion that more information on reproductive toxicity should be available, even at low tonnage levels.

It was also suggested that criteria could be produced in order to evaluate if a new chemical can be classified as an endocrine disrupter e.g. on the basis of structure activity relationships. If on the basis of such criteria a compound could be classified as suspect we would need a different protocol of investigation. In the November meeting QSARs were mentioned although it is still not in the conclusions/recommendations.

The issue of multi-species testing was also mentioned and it was discussed whether this was indeed useful because these are relatively complex methods and difficult to interpret. They could be really useful if there was enough information on individual species. At this stage we do not have enough information with individual invertebrates so introducing a concept of multi species laboratory testing is not without some problems.

As an alternative, results of QSARs or of mammalian toxicity tests could be used to identify the chemicals and then a specific testing strategy could be chosen. There are new possibilities in laboratory testing particularly in the field of pesticides which are not related to the use of food chain multi species tests. There is a new cause-effect multi-species laboratory test and this will clarify the situation. There is a recommendation from the CETAC workshop saying that consideration should be given to several invertebrates at the same time; currently most of the work on invertebrates is done on Daphnia Magna and clearly the use of different species on the same testing system should be a promising alternative.

Recommendations of the EMSG (Endocrine Modulator Steering Group) were also discussed, such as development or enhancement of fish test (enhancement of the early life stage tests that should also have the partial life cycle test).

The WG is aiming to putting the finishing touches in the draft opinion without the need for another WG meeting.

(ii) presentation by other Commission services of developments on EDCs

Concerning developments on the strategy paper whose drafting DG XI are co-ordinating they have now included all the suggestions from M. States, Industry and NGOs, made at the meeting of 8 December 1998. The amended version of the policy paper will be sent soon to the cabinet of Commissioner Bjerregaard and then sent out for agreement to all the other DGs. DG XI acknowledged that there is no contradiction between both the draft CSTEE opinion on EDCs and the policy paper, not even in terms of timeframe.

6. Presentation to the CSTEE of the following terms of reference: 'Toxicological characteristics and risks of certain citrate and adipates used as a substitute for phthalates in plasticisers in certain soft PVC products'

CSTEE members were reminded of the document with the terms of reference sent to them shortly before Christmas. It is hoped that the range of chemicals to be considered will be better clarified by now. A first list of documents has now been distributed to the CSTEE. The respective documents are a first scientific backup that will give an insight in order to help the CSTEE issue an opinion on this one. Others will be coming and the DG III representative said that they will make sure that the CSTEE will get all the data that was submitted to the SCF in connection with citrates in particular. The CSTEE should receive a full package.

The debate was started with the question from the secretariat on whether the CSTEE consider the questions in the terms of reference to be useful/clear to address the issues at stake.

The answer given by the 'Phthalates in toys' WG chairperson was that, in itself the terms of reference are clear but that some related issues still remain unanswered such as 'Are adipates really substitute materials in this day and age?'. It would look as if they are rather structural modifications of phthalates and, even if this is probably a non-scientific argument, the question mark remains on whether it is really useful for Industry to put money in developing chemicals along those lines. The WG chairperson tried to do some literature searches and for the citrates there is seemingly nothing in the open literature. What has been cited in the first set of documents received from Industry as references does not seem to have sound scientific value.

Maybe the situation is totally different when looking at the various materials that Industry will supply but so far no real toxicological documentation has been made available to the CSTEE that would allow for a proper assessment. From the list provided it is difficult to read whether this is proper documentation or not. The WG should do some pre-screening of the package to check whether or not this is a valuable way of using the CSTEEs time.

Among several comments subsequently made by CSTEE, the following are worth mentioning:

Data should be obtained on those chemicals that are really used. Otherwise a big toxicological evaluation will be done on a great number of chemicals neglecting whether they are really used or not hence being a sheer waste of time.
As regards adipates perhaps they should be looked at somewhat differently in that these are chemicals that someone might wish to use to replace phthalates. The point that they're really not necessarily less risky substitutes should be looked at and evaluated before giving an opinion. Certainly in the open literature there should be enough information to give an opinion along those lines. If that is what the Commission wants the committee will do that.
The procedure that will have to be followed implies that Industry should provide the information on exactly which substances are used as substitutes and which ones are not. The work will be pursued more actively as and when information is provided either in the way of clarification on exactly which substitutes are the real ones or when receiving other relevant scientific information. It was understood that such an initiative should be pursued in parallel with others concerning eventually action to be taken by the Commission on the basis of the CSTEE's opinions on 'Phthalates in toys'. In other words, such action is not, in principle, dependent upon the adoption of an opinion on 'phthalates substitutes'.
If it proves very difficult to obtain the needed information in order to produce a proper opinion, perhaps the Commission cannot just stop doing anything about phthalates. It was acknowledged though that this is risk management measure, hence a responsibility of the Commission.
One CSTEE member expressed the view that risk management should cover human health risks and environmental ones as well. It has been clear that the Commission asked the CSTEE a question focussing on a risk for cancer or other health effects but perhaps the same principle should apply here as in other opinion requests in that the CSTEE could comment on environmental risks due to the introduction and the processing of other chemicals. If the Commission does want explicitly to dismiss environmental effects then this should be clearly indicated in the opinion title such as 'toxicological characteristics and risks for children of certain products', because otherwise there is a need to cover also other problems related to the substitution of this kind of articles.
Finally, a representative of DG III of the Commission informed the committee that, based on the CSTEE opinion of 27 November, they have been quite busy drafting a proposal for a directive on phthalates in toys and child-care articles. As is well known the CSTEE made a distinction between DINP and DEHP stating that DINP was of some concern while DEHP was of clear concern, adding on some uncertainties on top of that. The proposal still being discussed within the Commission but that would be presented to M. States for their views very early in February, is based on the following elements: a) To put a limit value for the migration of DINP in toys and child-care articles for children under three; b) On DEHP however, which is of an higher concern having a lower margin of safety, a proposal for a ban will be made. Regarding the other four phthalates for which it is not really possible to estimate the degree of risk since they are not used (thus making it very difficult to estimate the exposure), the DG III proposal will follow a precautionary line and include their banning. However, temporarily, a review clause will be built in on this ban allowing for more information to be gathered to make a final decision. These are the main elements in the proposal currently being discussed at Commission level. It is not an official Commission proposal yet but these are the elements along which DG III is currently working and they will be presented to M. States in early February.

7. Strategies for dealing with additional chemicals (opinion requests submitted by other DGs of the Commission):

a) Ground level ozone - opinion request from DG XI/D/3

A presentation was made by representatives of the requester Commission service (Air quality unit, XI/D/3). The CSTEE were informed from the outset that Unit XI/D/3 are working on drafting a number of questions for submission to the CSTEE and amassing a package of documents. This should be done by the end of the week.

It was explained that the situation is that, in terms of timing, the Commission is currently in the middle of a very substantial programme of revising EC legislation on air quality. There is a directive, 96/62/EC on ambient air quality assessment and management, known as the air quality framework directive. It has been fully adopted and M. States should have transposed it by now. Then there is a first daughter directive before the Council and the E. Parliament. It is at the stage of common position and it is expected that it will be fully adopted in March this year at the latest.

The aims of the framework directive are the following: (i) to define and establish objectives for ambient air quality [and those must be designed to protect human health and all the environment as a whole]. (ii) to see that air quality is assessed on the basis of common methods and criteria; (iii) information about air quality.

A few key features of the framework directive were then described: - The framework directive is only a framework, there are no targets in it for air quality, and therefore there has to be daughter legislation to fill it in. It says that limit values should be set for a number of pollutants and that limit values must be met. Once met they must not be exceeded but for ozone a target value can be set, either in addition to a limit value or instead. This is one way of recognising the special trans-boundary problems of ozone. As the work has gone it seems to be universally agreed that a limit value for ozone makes no legal sense because it is not just controllable by individual M. States.

Target values for ozone seem therefore to be what makes sense and M. States will have to make their best efforts and prove it. On the other hand the Commission will have to continue thinking about whether or not more measures are needed at EU level in order to see that things 'happen' for ozone. One possibility is to set alert thresholds for ozone. Those are concentrations at which special information must be given to the public. Public must have information at all times but if an alert threshold is passed special steps need to be taken to tell them and if there is anything that can be done to reduce concentrations quickly it should be done.

The way Unit XI/D/3 goes about producing legislation was then described. There is a co-operative programme with WHO that started in 1993. Basically what it consists of is that essentially DG XI paid a very substantial part of the bill for WHO to develop new air quality guidelines. WHO guidelines and any other relevant information are taken as the basis for target setting. The path being pursued to work on this is by looking at the effects and then decide what the targets ought to be. Then there is a second stage where an evaluation is made on whether they can reasonably be met or not (the timetable in any legislation depends on whether or not they can reasonably be met). In some cases a decision may have to be made that there is no foreseeable date by which the target could be met and an interim target must be developed. Later on, when the issue is revisited, one sees whether one can get further towards the ideal target later.

On the internal process XI/D/3 has done as much as possible to give ownership of this process to as many stakeholders as possible. There is a steering group with all the M. States, Industry, WHO, UNECE, the E. Environment Agency and NGO's. It has been agreed that for each pollutant there will be a technical WG which prepares a technical position paper. That WG will not have people from all the M. States on it. There is an additional economic evaluation and then an analysis is made of all the information obtained, including non-technical information and of what is thought to be actually possible.

This information is relevant to the CSTEE to give it an idea of how most use of it can be made in the process. The technical WGs are not normally chaired by the Commission. As far as possible ownership of the technical side of things has been given to other people. WGs are normally chaired by an expert who will be a scientist or otherwise qualified in air quality matters from a M. State. There will also be scientists and technical people from up to five other M. States, one expert from Industry, one expert from NGO's, WHO, UNECE and anybody else deemed needed. The job of those groups is to look at the scientific and technical issues, not to political ones, and to write a technical position paper recommending limit values on effects grounds, e.g. what are the effects of whatever nature on the health and the environment and what should be the target. They are then asked to give advice later on, on what can be done in practice but it is important to understand that they are trying to do a technical and scientific job.

Then the steering group is asked to review the scientific and technical work and the conclusions, but of course more political issues also come in at this stage, e.g. M. States views on what they will and will not be able to do. This has been a very successful process the proof being that common position on the first daughter directive was arrived at in record time. Besides, on the whole, it seems to be working scientifically and technically quite well.

However, there is room for improvement and there have been occasions when it would have been very convenient to ask the CSTEE for advice. Apart from the value of a peer review there are quite often moments when in small WGs there is not enough depth of scientific expertise on a particular issue. There are very likely some specific things on which the advice of the CSTEE would be very helpful. One example is that since WHO develops its guidelines there has been more work published on benzene. The WG didn't have enough depth of expertise on health effects to know how to take that into account, and we had to put together an additional scientific group to help. In spite of the fact that no agreement has been reached yet between DGs XI and XXIV on the modalities of consultation of scientific committees, Unit XI/D/3 cannot wait and therefore advice is being sought from the CSTEE.

Ozone is something that will have to be dealt with in a slightly different way because the ozone work has to be co-ordinated very closely with other work being done on acidification. The Commission chaired the WG, not in order to control the answer, but in order to control the process.

Everybody wanted to join this WG. It did have somebody from all the M. States and it had to be split into two sub-groups, one looking at risks and another one looking at assessment. It is on the risk side that advice will be asked from the CSTEE. The following are examples of the kind of questions to be put to the CSTEE.

Ozone is a very difficult pollutant and there will likely be a lot of controversy over it. M. States are going to have lots of views. On the science though, there is a fairly broad consensus and it is fair to say that as far as the health effects are concerned there is only one dissenting voice, that of Industry. The questions to be submitted to the CSTEE will be discussions between the majority and the one dissenting voice. The first question is: At what concentrations does ozone have significant effects on public health? WHO came to the conclusion that there are no detectable thresholds for the effects of ozone on public health. It was possible they would not give clear guidelines specially since they felt that as far as they could see there maybe a threshold but if there is, it is below background, taking background as 100 or below.

They did nevertheless manage to come up with a guideline which is 120µg/m3. Leading from that there is a question of, not politically what should the target do but, what concentration would provide a high level of protection for public health, assuming that one can be identified. The CSTEE will be asked questions in that area. Targets have a number of meanings here. In order to frame the legislation the future has to be predicted.

The first thing needed is to model what is going to happen to ozone concentrations given legislation already agreed and if that is not good enough it is necessary to agree on what can be done and then model again, optimising for how close it is possible to get. Then some legislation has to be drafted with a legislative target in it. There are two sorts of targets to think about and the first is: What sort of target should be put into a modelling exercise? WHO, when it comes to human health, did adopt a guideline (120µg/m3 measured over 8 hours). If the CSTEE does not disagree with WHO and the DG XI WG did not, one can assume that that is the best target to put into the modelling.

Then, in looking at what tools are available, the best tool to use for looking at ozone is one developed by IASA, a group of people in Vienna. It may be not a perfect model but it is the model being used in the UNECE work on ozone and acidification. It is multinationally agreed, its limits are understood and seems to be the best available. It is based on AOTs (Accumulation Over Threshold). A threshold is one chosen and it works in ppb, like 60 ppb, then multiplying time and concentration in excess of that.

If this model is to be used an AOT is needed. There were questions about whether this was a good thing to do or whether one might end up producing an unclear pattern of distribution of ozone. This has been addressed too and everybody felt comfortable that it was a good way of trying to capture the effects on human health.

It was decided by the WG that the best target was AOT 60. This was because everybody was essentially in agreement with WHO that there were significant effects on public health down to at least 120µg/m3 60 ppb. The CSTEE's views will be asked on that target. Industry would have preferred the use of AOT 80. Everybody else felt that that would simply miss a lot of significant effects on public health and would not give a good answer.

Having decided which target to feed into the model and which one to try and optimise on, allows for different levels of ambition, and costs are different. A decision is made on a certain level of ambition, mainly on practical grounds, but as close as possible to the ultimate target. The following question is: How to 'frame' that. Mostly it was felt that it needed to be framed as a concentration over 8 hours.

No matter what number was used as a target, AOT 60 or 70 or 80 or other, if it is found that the practical level of ambition is still quite a long way above no exceedance of the WHO guideline then there is the question of how to frame the legislative target. No matter what was fed into the model it is completely open whether one chooses say 120 with a lot of allowed exceedances or 140 with fewer.

The CSTEE's views will also be required on the health and the air quality science issues and also about alert thresholds. WGs are inclined to have two, at 180 and 240µg/m3.

The issues at stake are not only public health ones. There are also issues with vegetation and effects on ecosystems too. The WG was asked to look at those and the Commission should propose targets for vegetation and ecosystems and they were built into the modelling. There are open scientific questions as well. Different crops, different ecosystems have different sensitivities to ozone. Furthermore it depends on how sensitive a particular thing is, it depends on what else is happening and in particular on how much water is available, so it depends on rain and/or irrigation. The advice from UNECE which has been followed by WHO is that at the moment it is not possible to come up from the science side with a very complicated view on different critical levels for different crops and ecosystems depending on how much water there is available. UNECE is working on it and the WHO has adopted a target based on a AOT 40. This does not mean to say that 40ppb is a threshold for effects on vegetation but it was agreed by the UNECE task force and WHO that an AOT 40 of 3-ppm hours per year over the growing system would be a good compromise value for protection of crops and vegetation. The views of the CSTEE on this will be welcomed.

Another thing needed as part of this process and for which there are consultants doing the work, is an economic analysis. The CSTEE will not be asked to do an economic analysis but what costs need be looked at, as well as the benefits. A decision has to be made on what effects of ozone should to put into this exercise. The CSTEE could help by saying what it thinks the significant effects of ozone are and also what it thinks are their relative importances for public health and environmental protection. In particular the CSTEE is likely to be asked about how important the effects of ozone are on premature mortality.

The DG XI representative then expressed the view that this consultation is not just a bureaucratic exercise. The Commission has a timetable and it needs to bring forward a proposal as soon as possible for a number of reasons. The CSTEE will receive the material as fast as possible and any background information it may deem necessary will be chased by the requester service as well.

The question was then asked on what is the time-scale for a completed opinion. The answer was that the proposal will be put for inter-service consultation next month (February 1999) and although the requester service knows that they will not have the adopted opinion by then they also know that they will not be able to finish inter-service consultation before they get it.

Questions were also asked on the size of the documentation pack to be submitted to the CSTEE. The answer was that although the full position paper is voluminous the most important section for the CSTEE is chapter three 'Risk assessment' which is around 30 to 40 pages long. The CSTEE will also be provided with the original texts of WHO guidelines where similarities between the position paper and the WHO guidelines may be perceived. The other sections will provide a sort of a background information. They start from dealing with the general description of the ozone problem and its chemistry, to framing and outlining the legislative context. The risk assessment chapter includes proposals for targets and thresholds.

There is also a section on monitoring ozone, suggestions for building up monitoring networks and something on the strategy since this is a parallel exercise which the WG also dealt with following the scenario analysis. The analysis will be not only used for setting target values and interim objectives for the daughter directive, but also for underpinning the so-called directive on national emission ceilings. That is what is needed in order to reduce the emissions and get a better air quality in terms of ozone or other pollutants.

The benefits analysis is also something which should be looked at by the CSTEE, but not in depth. If the CSTEE wants it can be provided with some references and other background papers. The information was also given that most documents are available in electronic form except perhaps the WHO guideline for the vegetation for which a text in electronic form does not exist.

Some reservations were subsequently expressed by the CSTEE at the size of the task ahead in the relatively short time necessary. These worries were tempered with the realisation that what is being asked from the CSTEE is an opinion on reports and not producing an assessment from scratch.

The situation was summarised by one CSTEE member as follows: There are three elements in the tropospheric ozone problem:

The first is the toxicology problem in that we do not understand the thresholds of the protective mechanisms. The anti-oxidative system in the lung is affected and we do not understand until what level of ozone exposure this anti-oxidative system is tolerating this oxidative stress. This is one of the very good examples of a lot of work having been done from the biochemical point of view, with everyone having been able to demonstrate what kind of anti-oxidative systems is working in the lung but with anybody having done a proper dose-response curve with no consequent idea of a threshold.

The second is epidemiology: There are so many confounders that people are reluctant to come up with some data. There are exposures of volunteers and that is why the ADPPM data are discussed everywhere instead of the AOT 60. The latter is there because of exposure studies at under 66µg/m3 with marginal effects observed, the rest being confounders in epidemiology (is it acid aerosol which is affecting the outcome?).

And the third is what is tolerable. The American EPA say we tolerate an impairment of lung function by 20% and if you accept this you can come up with higher exposure concentrations. If you do not tolerate anything you are lost because ozone is an irritant and at whatever concentration is around, it is affecting the lung function. These are the three major problems and that is why everybody talks it back and forth and every group comes up with a different solution.

The CSTEE secretary asked whether, for defining terms of reference, it would be necessary to work them out with the help of WG members or whether DG XI would be doing that on their own. They said that a proposal would be sent by the end of the week. In case of need a dialogue with WG members to refine it is acceptable.

A CSTEE WG under the name 'Tropospheric ozone' was formed. The DG XI representative said that it would be helpful to establish a link between experts in their WG and the CSTEE. Their co-ordinates will also be provided to the CSTEE secretariat. Given that, as set up, the WG does not have an ecotoxicologist, CSTEE members will propose names to the CSTEE secretariat.

The question was also asked on whether fixing a date for a WG meeting was convenient/necessary. The CSTEE chairman then said that what is necessary is to have a meeting of the WG as quickly as possible. It was agreed that the CSTEE secretariat should co-ordinate positions/availability in view of trying to arrange a WG meeting. WG members will communicate by e-mail so that everybody is kept up to date on progress made once the terms of reference and the documentation pack reaches them.

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

(i) Water Framework Directive

The responsible Commission service had informed the CSTEE Secretariat that they did not have new information to give since the previous CSTEE plenary of November 1998. They commented on the minutes of the November meeting saying that they are basically correct and suggested minor amendments that the CSTEE Secretariat could accommodate without difficulty.

As and when new developments will take place the CSTEE will be informed, including any news on its consultation.

(ii) Council Regulation (EEC) 793/93:

- 2-(2-butoxyethoxy)ethanol

- 2-(2-methoxyethoxy)ethanol

- alkanes, C10-13, Chloro

- benzene, C10-13-Alkyl derivs

No representative of the responsible Commission service (Unit XI/E/2) was available to inform the CSTEE on the follow up given to the opinions it had adopted on these substances.

However the opportunity was taken by some CSTEE members to comment on some of the features of the current 793/93 Risk assessment program. Views were expressed on the fact that exposure seems to be regularly 'overestimated', something which does not seem to be scientifically justified. This was said to be a question of principle and it should be discussed more in depth. Perhaps the idea is to force the provision of data and thus make the need for overestimations redundant? Some CSTEE members lent support to the idea that in case of lack of data then we will have to take the precautionary principle approach. Finally other comments made were such as the following:

Comments from the CSTEE would be useful for the process to try to accompany the risk assessment with strategic measurements, i.e. to put real measurements into the process. Identifying critical points of exposure from the modelling exercise and the toxicity data were also mentioned as relevant. It was also suggested that an interactive measurement strategy should be added to the process where real measured data could be obtained to see whether there is a problem.
Looking at the philosophy of the system the risk assessments should be based on real measured concentrations. Modelling calculations should be useful only when Industry do not supply the data. But there are two different situations: In some cases Industry do not provide the data because they do not want to and then obviously the use of high levels of precaution should be good. But in other cases modelling can produce a more real estimation of the measurements, particularly when focussing on different applications, different uses, different parts of the life cycle of the substances. The example of Cadmium is good in that one can monitor the total Cadmium burden but not those related to some parts. Therefore maybe at least the CSTEE should be involved in the development of the models that should be applied, not when Industry do not want to provide the data but when modelling is scientifically better than trying to estimate concentrations in either the environment or when human exposure is involved.
In many cases the problem seems to be that there are no data and the consequence is that, since exposure estimations have to be included for the risk assessment process, some calculations are necessary leading to tremendous overestimations (e.g. considering showering three times a day, etc.). This obviously is incorrect and the CSTEE should check and comment whenever it gets one of those documentation packages. This is probably the easiest way to address the problem.
This will be particularly the case when dealing with chemicals produced in lower and lower volumes and thus with fewer and fewer exposure data or measurements and hence we will be relying heavily on modelling in the future.
(iii) Phthalates in toys

Given that there was no new opinion request (submitted by the Commission services) pending, it was decided that it was not appropriate to rediscuss the previous conclusions arrived at by the CSTEE, and this in spite of new documents submitted by Industry

The CSTEE did not consider appropriate even to comment on the data submitted on the very day of the meeting as a minimum notice is necessary before the CSTEE can comment on purported new data. Some CSTEE members said that the validity of any new data needs to be thoroughly checked before being endorsed as meriting discussion.

Feedback on developments at the level of follow up to opinions by the competent Commission services was subsequently given. An important development was the fact that the USA the consumer safety committee has also published a study which amongst others included new in vivo data. When trying to analyse those some of the values that were found there were seemingly higher than even the higher ones that were found in the NL study and the Austrian study. The Commission is at the moment trying to reunite all the information about the in vivo tests both from the NL and the Austrian study and the US study to see what kind of picture comes out of putting all of those data together provided that that would be acceptable from a scientific point of view. Furthermore the Commission has the intention to follow the CSTEE's recommendation to do some further research on buccal absorption. The idea is, since there are a number of issues to be considered, to take them all together rather then review the CSTEE's opinions as a sort of piecemeal process. That would also better tie in with the legislative process(es) to come.

After the adoption of the CSTEE opinion on Phthalates at the end of November 1998, DG XXIV submitted the opinion to the REU to get their views on what the risk management conclusions to be drawn from it would be. They looked at the whole picture including the uncertainties and in a summarised way came to the conclusion that the Commission should be looking for a phase out of phthalates as soon as feasible. The Commission services had a short discussion with M. States about the CSTEE's scientific opinion in early December where it was found that generally a number of M. States were interested and encouraged by the CSTEE's views. Some would have wanted to have more precise data from the CSTEE on other sources of phthalates. On that occasion the Commission was informed of a number of developments at the political level. Finland was announcing that they were taking measures to prohibit phthalates. The Netherlands were announcing that they would do so too if by mid February 1999 there was not a validated method to measure migration. There were also rumours from Greece who were for the first time considering to take measures but that they would in any case wait until after the next meeting of the 1st of February that DG III is organising before they even finish the national consultations among the various ministries. Norway announced measures as well. The technical experts who were working on the validation of the method have also looked at your opinion and they found that they need to redraft the program that they had originally developed so as to take the target value that was included in the CSTEE opinion into account.

The efforts sponsored by the EC are for the moment waiting for the decision making about the number of phthalates that would have to be included in this method because internal discussions between the Commission services are beginning now much to focus on DINP as the key point.

There is general agreement about the other phthalates in that we can either prevent their use or eliminate it. The meeting organised by DG III on the 1st of February is one where it is hoped the Commission will have yet more up to date input from the M. States. The Commission hopes that within a reasonable number of weeks it will be ready to start drafting proposals which could be proposals at different levels, certain proposals dealing with short term actions and others dealing with other measures.

There have also been discussions with Consumer groups and with Industry. Consumer and environmental organisations have been extremely clear and have also manifested their views directly to Commissioner Bonino. They are asking for a prohibition also on the basis of the opinion of the CSTEE and the Commission has been exploring some form of co-operation on an agreement with Industry but there has been no concrete results from that yet.

The definition of the scope to which the measures would apply would be one of the subjects of discussion. In the measures they have taken a number of M. States are generally applying it to toys destined for children under the age of 3. The notable exception is the US measures which indeed are restricted to teeters and rattles. The question is does the child read those and does it notice the difference. Therefore, from a consumer perspective there is reason to believe that one should include everything. The formula that is tending to be used is objects that are likely to be mouthed given their size and shape or parts of objects that are likely to be mouthed. But there is obviously a lot of room for changes there as well.

The Commission has no clear timetable for the moment for the legislative process but the CSTEE will be informed in due time when such a timetable exists. In the meantime the Commission would like to get whatever information there is or is likely to be in the short term together before the CSTEE is submitted a request for a revised opinion. Given the pace of the legislative process in the EU institutions there will be many occasions where new information and new input from the CSTEE can influence the final shaping of the policy. At least the question of substitutes and the respective information available to the CSTEE is an important element of information that will influence the final provisions

(iv) Directive 76/769 (EEC):

- Creosote containing less than 50 ppm benzo-[a]-pyrene

It was acknowledged that the data (exposure) on the basis of which the opinion had been adopted by the CSTEE at the last plenary probably needed checking. Revised exposure data may lead to revised risk estimates.

Given that a revision of the opinion was not foreseen in the agenda of this plenary meeting it was proposed that any changes to the text should only take place after the necessary justifications could be looked at by the CSTEE as a whole. The Creosotes WG members will check that this is done in view of a possible adoption of a revise opinion at the next CSTEE plenary meeting in March 99.

DG III confirmed that they could accept this course of action. In any case the changes presumably to be introduced into the text of the opinion are not such that they will change what they are intending to do.

- Tin

Tin is also part of the new M. States review in the same way as Cadmium. It is basically Sweden and Austria that have further restrictions on the use of TBT as an anti fouling for ships. The opinion adopted by the CSTEE on Tin confirms the conclusions of the independent consultants that the risks posed by the use of TBT for antifouling are unacceptable. On the other hand the Commission was told last Autumn that after years of discussion IMO are now moving rapidly towards a global ban on the use of TBT for ship hulls. The WG of IMO has proposed a ban on the use of TBT globally by the year 2003 and it is expected that the assembly of the IMO is to make a decision this Spring. Based on the CSTEE opinion on Tin and on the underlying risk assessment, a Commission proposal to ban the use of TBT on all ships operating on fresh waters will be made. This was one of the sensitive areas identified. A banning of the use of TBT antifouling paints with uncontrolled leaching will also be made. These are the more 'old fashioned' paints on the market which are more dangerous to the environment. They are called free association paints. A proposal will be made to put a ban on these old type paints and only allow the use of more modern ones with controlled leaching. However, since this use is unacceptable the Commission welcomes the work in the IMO.

The proposal will therefore have to include a review clause stating that this directive on Tin will be reviewed before the year 2003 in order to take full account of the work in the IMO. The shipping business is global and it is very difficult for the EU to take a unilateral stance here but there is a will to make it clear in the directive that these provisions will be reviewed and that full account of the IMO ban will be taken as soon as the date is known. In this case the opinion served the purpose of trying to put an end to the use of TBTO in ships firstly by taking these interim measures in fresh waters and on the old fashioned paints and making it very clear that the IMO will be followed as soon as possible.

- Pentachlorophenol

This is also in the same review for the new M. States. The independent consultant report on PCP was not of the same quality and the CSTEE was not very happy about this report in its opinion. It also stated that there were further risks specially in the so called hot spots from the use of PCP and based on this opinion together with the internal market situation according to which many M. States have already placed a ban on the use of PCP, the Commission proposes to ban its use. However, certain M. States which have a specifically humid climate - called the oceanic M.States in the proposed directive, that is the M. States facing the Atlantic from the UK and Ireland down to Spain and Portugal with France in the middle - will be given a certain possibility for allowing the use of PCP during a transitional period. It is optional. These M.States can choose whether or not to use this derogation. The reason to give a transitional period to these M. States is that the substitutes available on the market are not considered to be effective enough under the specific climatologic conditions (high humidity together with specific fungal growth).

- Chrysotile asbestos and substitute fibres

Since the 15th of September two meetings of the Commission WG took place, one on the 29th of October and one on the 15th of December. The first of those meetings was attended by the CSTEE chairperson and by the 'Chrysotile asbestos' WG chairperson as well. The Commission service responsible for this dossier welcomed that presence for representing the CSTEE and putting up a very robust defence of the opinion against some Industry concerns. As a result of the opinion and also taking into account political and economic considerations the risk management decision was taken to propose a ban on Chrysotile asbestos with some exceptions. That proposal was first presented on the 29th of October to M. States and essentially it foresees an almost complete ban on the new uses of Chrysotile. There will be in the proposal a five-year transitional period which would allow the Industries that are mainly affected, time to convert and also for the various national political and administrative work to be done. There are two exceptions to the ban. One of those is for the use in electrolysis in chlorine alkaline plants. It is a very specialised use, and therefore the longer transitional period of 2010 is proposed with the possibility that that may be extended further. The reason for this is that for that particular use there are no suitable alternatives at present. There is also an exception for the existing stock of asbestos, in other words the ban would not prevent people from continuing to use products that are already installed or in service. M. States were given, within the directive, a certain amount of flexibility on how to deal with that existing stock.

It was recognised that part of the basis or the core of the directive stems from the advice given by the CSTEE including a reference to it in one of the recitals. The part of the opinion that called for more research on Chrysotile asbestos and also its substitutes as been acknowledged by building in a review by about 2003. This would be a review of the scientific situation at that point, in other words any new data, new findings that might emerge during the next few years. Perhaps this a very early warning that there might be a need to revisit this whole question particularly in relation to the substitutes in two to three years time.

The next stage for the proposal is that it will be put out formally in the 11 languages and M. States will be asked to vote on it at a technical progress committee meeting in March or possibly April 1999. If a qualified majority is obtained at that meeting and at present that is expected, then it will be adopted by the Commission three to four weeks later. The other issue to raise is that in the background to all this there is a case still continuing at the WTO. This is the dispute between Canada and France. Canada has changelled the French ban on Chrysotile asbestos that was introduced in 1996. That has reached the stage where an expert panel is being established, and that panel is expected to meet for the first time in about March or April. That process will take another 6 months or so before it is resolved.

9. Information on matters not covered elsewhere in the agenda:

(i) Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee

The chairman gave a brief outline of the SSC activities, still basically dominated by BSE problems, a subject which is not of a particular interest to the CSTEE in general.

(ii) Developments on the subject of the brief of the CSTEE

An important subject that has come to the fore is 'how do we model exposure in the future' and how the CSTEE might be proactive in identifying a strategy for modelling exposure. This topic will be in the agenda of a future CSTEE meeting and one of its members will produce a paper for discussion. This was believed an important point because the CSTEE have to have a consensus about whatever models they use.

Another area in need of reflection is that of the nature of information that the CSTEE can accept before triggering a review of a previous opinion it had adopted. This is basically due to the lobbying aspect which can be behind some submissions.

There is a procedure for accepting documents whereby the CSTEE should have at least a week's notice. It would be inappropriate to receive anything from an outside source in less. From the secretariat side it was acknowledged that the best solution would be for documents to be transmitted through the responsible Commission services.

(iii) Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment - Further information on the Workshop on Hazard identification systems and the development of classification criteria for the terrestrial environment (Madrid, 4-6 November 1998)

The draft proceedings of the workshop should be presented to the ECB soon. As soon as they are approved they will be distributed to the CSTEE.

(iv) Polyvinylpyrrolidone in fish food

The Secretary of the Scientific Committee on Animal Nutrition (SCAN) made the announcement that the WG had been dissolved because the company that produces the chemical does not want the product assessed any more.

On another topic, a demand has come to SCAN on copper to reassess the safety of this feed additive, in particular its environmental impact. The WG had not yet been created because the SCAN plenary would take place the following week but the question was put to the CSTEE members on whether they would be interested (probably two members to join the group on copper compounds).

It was agreed that the members of the WG that addressed the opinion requests on metals submitted by DG III recently should address this one too.

10. Arrangements for the next meeting of the CSTEE

It was agreed to have a one-day meeting only on the 4th of March unless the workload justifies otherwise. Two members confirmed they would not attend, including the CSTEE chairman, hence the meeting will in principle be chaired by the first vice-chairman. Main topics for discussion will likely be EDCs and air quality (ozone).

11. Any other business

Upon a specific request from the CSTEE chairperson the CSTEE Secretariat gave the information that the necessary action was taken with a view to fill in the four posts still open to serve as CSTEE members.

The question was put to the CSTEE on whether they were in agreement to disclose their CV's to a consultancy firm that had requested them in a letter to Mr Reichenbach.

The unanimous response by the CSTEE members was that would not like this to be done.

Without any other business, the meeting was closed at 18h00.

AGENDA

1. Adoption of the draft agenda

2. Adoption of the draft minutes of the three previous plenary meetings of the CSTEE

3. Rules of procedure of the Scientific Committee on Toxicity, Ecotoxicity and the Environment

4. Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations. Consideration of draft opinions, as presented by the respective rapporteurs, with a view to their adoption by the CSTEE, on:

(i) Cadmium

(ii) Azo dyes

5. Endocrine disrupters - (i) presentation by the working group chairperson of a draft report being prepared by the 'Endocrine disrupters' working group (outcome of 'Endocrine disrupters' working group meetings of the 7th and 14th of January 1999); (ii) presentation by other Commission services of developments on EDCs

6. Presentation to the CSTEE of the following terms of reference: 'Toxicological characteristics and risks of certain citrate and adipates used as a substitute for phthalates in plasticisers in certain soft PVC products'

7. Strategies for dealing with additional chemicals (opinion requests submitted by other DGs of the Commission):

a) Ground level ozone - opinion request from DG XI/D/3

b) Other

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

(i) Water Framework Directive

(ii) Council Regulation (EEC) 793/93:

- 2-(2-Butoxyethoxy)ethanol

- 2-(2-methoxyethoxy)ethanol

- alkanes, C10-13, Chloro

- Benzene, C10-13-Alkyl derivs

(iii) Phthalates in toys

(iv) Directive 76/769 (EEC):

- Creosote containing less than 50 ppm benzo-[a]-pyrene

- Tin

- Pentachlorophenol

- Chrysotile asbestos and substitute fibres

9. Information on matters not covered elsewhere in the agenda:

(i) Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee

(ii) Developments on the subject of the brief of the CSTEE

(iii) Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment - Further information on the Workshop on Hazard identification systems and the development of classification criteria for the terrestrial environment (Madrid, 4-6 November 1998)

(iv) Polyvinylpyrrolidone in fish food

10. Arrangements for the next meeting of the CSTEE

11. Any other business

LIST OF PARTICIPANTS

CSTEE:

Prof. Bridges, Prof. Chambers, Prof. Dybing, Prof.Greim, Prof. Jansson, Prof. Kyrtopoulos, Dr. Lambré, Prof. Salkinoja-Salonen, Dr. Tarazona, Prof. Terracini, Prof. Vighi, Prof. Vos

European Commission:

DG XXIV

Mrs de Solà, Mr. E. Thevenard, Mrs Fokkema, Mr Costa-David, Mr Daskaleros

DG III

Mrs L. Perenius, Mrs S. Pakalin, Mrs A.-F. Taminiaux, Mr. K. Berend, Mr. N. Burge

DG XI

Mrs Nover, Mr. M. Lutz, Mrs L. Edwards