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Directorate-General for Health and Food Safety
Introduction
Prof. Dybing made an introduction with information on logistical arrangements for the day regarding meals, etc.
1. Adoption of the draft agenda
The draft agenda was adopted. The order of some points was changed with point 13 of rev. 1 of draft agenda becoming the 7th (Strategies for dealing with additional opinion requests submitted by other DGs of the Commission).
2. Presentation of new CSTEE members
The information was given that Profs. Terracini, Wennig and Tarazona had sent apologies for absence.
A 'tour de table' took place allowing for Commission staff and CSTEE members to present themselves giving information on background, academic and/or professional experience, particular scientific interests developed, etc. The need for this was due to the fact that this was the first meeting of the three newly appointed members to the CSTEE, Profs. Mark Costello, Katarina Victorin and Janneche Utne Skare. The CSTEE chairman welcomed, with the arrival of 'new' members, expertise in environmental related matters to the committee.
3. Declarations of interest
No member of the CSTEE attending this meeting mentioned any interest in whatever capacity that might be considered prejudicial to his/her independence considering the nature of topics in the agenda. The CSTEE secretary also informed CSTEE members that, other than forms for signing declarations of interest, forms for confidentiality rules were available as well.
4. Information from the CSTEE secretariat
The CSTEE secretary expressed on behalf of the Commission his most vivid thanks to Prof. Dybing and his Institute for providing the facilities to allow the CSTEE plenary meeting to take place in Oslo. It was reminded that the choice of venue was due to the convenience of having the CSTEE plenary meeting back to back with EUROTOX' 99 which had taken place in Oslo and ended the day before.
Particularly for the benefit of the three new members, the CSTEE secretary gave some information namely related to the rules of procedure of the committee (copies were available) as well as some other on reimbursements, etc.
Confidentiality rules were also explained and briefly discussed between members. It was in particular made clear that information exchange of confidential data between CSTEE members and eventually other (third) parties would have to be conditional upon information being given at the outset about the fact that confidentiality rules apply.
The CSTEE secretary drew the attention of the new members in particular to a number of documents available as 'room documents' and explained their purpose. Some of them were 'thematic' documents for use in the discussions on some of the agenda items and some others were for allowing for an easier follow up of the subjects from meeting to meeting. These included lists of all documents submitted in connection with any technical subject being the object of a CSTEE activity, opinion requests or own initiative reports, others being e.g. lists of documents sent since the previous plenary meeting.
The CSTEE chairman explained that a lot of the CSTEE's activities are due to requests from Commission services but that the CSTEE adopts reports/opinions on its own initiative as well. As regards the way in which the CSTEE works he said that a lot of activities are done in working groups before the subject is discussed at plenary meetings.
5. Adoption of the draft minutes of the 9th CSTEE plenary meeting held on the 7th of May 1999 in Brussels
The minutes were not yet available. The CSTEE secretary took the commitment of sending them later by post for possible adoption by written procedure.
6. Progress reports on opinion requests related to the 'Water framework directive':
A.
I) Report from a study on Technical specifications for classification and presentation of ecological status of surface waters, March 1999 and
II) Report from a study on Technical specifications for monitoring of ecological status of surface waters, March 1999
B. Revised proposal for a list of priority substances in the context of the Water Framework Directive (COMMPS procedure) and Draft Final Report on the Assessment of options of the statistical treatment and evaluation of monitoring data within the COMMPS procedure
Due to the absence of the chairperson/rapporteur for this particular opinion request no detailed presentation/discussion took place. Still the chairperson had sent an e-mail commenting that so far very scant contributions had been received from other working group and/or CSTEE members. Dates for a future working group meeting were discussed.
The CSTEE secretary further gave the information that a message had been received from the Commission requester service with the indication that a report on 'Intercalibration' was missing from the report Technical specifications for monitoring of ecological status of surface waters, March 1999'. This would be sent later when available. The message also included information on the political side of things in that discussions were continuing at Council level. There had been some problems with translation of texts and legal revisions of drafts but that, as far as progress was concerned from the CSTEE involvement side, everything was under control.
Regarding section B of the opinion request the information had been received from the Commission requester service by the CSTEE secretariat that the schedule previously agreed (adoption of part B of the opinion by September or November 99 at the latest) is in principle acceptable to them.
7. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission:
i) Opinion request on a proposed "ready biodegradability" approach to update detergent legislation (EC - DG III/C/4)
A representative of the Commission requester service (DG III/C/4) presented this point. The information was given that the Commission is currently updating the legislation on detergents since the one still in force dates from the early 70's. Then it had been introduced mostly to deal with the problem of detergents in rivers and so it was based on primary biodegradability.
More modern legislation is now being envisaged, the principle is to base EU legislation on ready biodegradability instead. Discussions with M. States have been taking place since quite some time now and the idea is of course to include testing of ready biodegradability in the EU legislation. In essence the issues on which the CSTEE's views will be sought are related to the methodological aspects of the biodegradability tests. Terms of reference have already been submitted in June 99 with the questions that concern the approach using ready biodegradability. There is also a question about the suitability of different tests. It includes still other questions on topics that have been raised during the discussions with M. States. On the other hand the Commission has a 'problem' with timing. An opinion is necessary by October or November 99 at the latest. This is a consequence of the agreed schedule which includes an inter-service consultation within the Commission in view of having a Commission proposal adopted by the first quarter of next year.
The CSTEE secretary read out the questions included in the terms of reference since apparently not all CSTEE members had received the terms of reference in time for the meeting.
The CSTEE chairman invited those present to volunteer to the working group which will have to deal with this opinion request. He pointed out that it is basically an environmental issue and that therefore people with an expertise in this field would be the logical candidates. He also pointed out that it would be convenient to include people with expertise in test methods. If needed perhaps external experts could be identified.
Some CSTEE members volunteered to participate but it was understood that suggestions for external experts could be made with some CSTEE members to inform the CSTEE secretariat later of possible nominees.
ii) Other
The information was given by the CSTEE secretariat that a new opinion request will be submitted soon. It follows up from an obligation which Member States have, in the framework of EU law, to notify the Commission of any measures they intend to take which impinges on either existing EU law or may be considered to be in conflict with internal market rules.
The Danish authorities have notified the Commission about their intention of banning, where possible, all uses of lead (ban on importing, selling and manufacturing in the Danish territory, but not on exports). This of course they intend to do on the grounds of health and environmental protection.
Because such a measure implies, as was said, problems in terms of internal market and free circulation of goods, the Commission has to avail itself of the well-founded nature of such an intention. This is the reason why the CSTEE will be asked whether the arguments, based on health and environmental protection grounds, put forward by the Danish authorities are well founded or not.
On the other hand the opportunity will be taken to ask the CSTEE another question, a general one this time, on the general risks of lead and its compounds to human health and the environment. In principle the CSTEE was to receive, probably in the course of the week after the plenary, a specific set of terms of reference. There is urgency in having these opinions adopted as, for legal reasons (Commission reply to the Danish notification), the matter is urgent.
The DG III/C/4 representative then commented on the nature of the documentation which, on their side, will be submitted to the committee. A report on heavy metals submitted by the Danish EPA, which is essentially a review of the state of the art, with the targets and the reduction instruments for heavy metals, including of course also lead. The second report is an environmental project, also carried out by the Danish EPA, specifically on lead. The first one dates from 1994. The second from 1998 and it focuses in a comprehensive way on the problems of lead in Denmark. They have both been translated into English and will be made available to the CSTEE in the course of the week after the plenary. Both reports cover human health and environmental issues.
Another Commission representative (XXIV/A/4) confirmed that other documentation is being prepared for submission to the CSTEE. Contacts with the WHO are being established to obtain data. Confirmation was given that the objective of the general opinion request on lead compounds is to ascertain whether there is a need to take measures at community level and in principle the already significant amount of documentation obtained is the most relevant part, although in respect of some data only the references and abstracts had been obtained. In any case they will be made available to the CSTEE. One particularly interesting piece of data mentioned is an "American" piece of research on child health related effects.
On top of that it is known that other Commission services, i.e. DG V, also have other reports on the subject which could be made available to the CSTEE.
At this stage of the presentation by Commission representatives, CSTEE members expressed interest in knowing in more detail what the questions to the committee could be like. To this question the answer was that, for the moment (plenary meeting) it was difficult to say as the problems raised can be extremely comprehensive.
The CSTEE chairman suggested that given that it was not possible for the moment to have a clear idea of what the exact nature/scope of the questions will be like, it would be better to form a 'core' working group, and for that the previously, 'metals' working group of the CSTEE could be a starting point, leaving the 'door open' to chose the necessary external experts depending on the 'subtlety' of the questions. Some possible names were mentioned and the sensitivity of having 'the' Danish CSTEE member in the working group was also discussed. In the end it was not considered a problem as the rules on 'declarations of interest' should be enough to settle the matter. In any case his contribution would take place, in principle, rather on a 'consultative' basis.
In general terms the CSTEE expressed the view that, should the questions be as comprehensive as it looked they will from the presentations, the task is likely to be a very daunting one. This however would need to be checked vis à vis a clear mandate to the CSTEE as related to the needs/objectives of the opinion request in question. A concern that a specific CSTEE member expressed was whether the questions would be only on lead or whether there might be extrapolations to other metals as well. The question stemmed from the realisation that, very often, data looked at on one chemical includes conclusions on others and the temptation may be there for widening the scope of the conclusions.
Other aspects discussed (although admittedly not the kind of subjects falling within the remit of the CSTEE) were possible internal marketing implications coming about from a general ban on a chemical in one single country.
It was pointed out that what the CSTEE will have to look at are the risks and give opinions on risks. The task of judging the proportionality of any measures is not the CSTEE's responsibility but for making such a judgement a good scientific basis is necessary.
Given the schedule of meetings with the following plenary due to take place by the end of September, on the understanding that the responsible Commission services would like to have an opinion adopted by the November plenary, a working group meeting as soon as possible in view of having at least a draft ready for presentation at the September plenary was judged indispensable.
The CSTEE chairman said that this should not be too problematic since the representatives of Commission services had given reassurances that both the terms of reference and the data would be provided in the course of the week after the 10th CSTEE plenary.
8. Euromarker in oil system - progress report
Some aspects of the discussion on this topic as they had taken place at the occasion of the previous plenary meeting were reminded. The chairperson/rapporteur for this particular opinion request was entrusted with the task of obtaining more data if possible and in particular to contact BASF, manufacturers of the product (solvent yellow 124). Furthermore more data was also obtained by the Commission requester service, sent to the CSTEE secretariat and subsequently distributed to the CSTEE.
However what was obtained was scarce and not necessarily very informative. Furthermore the problems raised by the Danish authorities may not be strictly speaking due to the chemical under consideration but either to other dyes or even to effects of the fuel itself and not the marker. The kind of effects observed (i.e. skin and throat irritation, coughing, etc.), are all perfectly attributable to the fuel itself.
Patch tests have been carried out with dyes, oils and other compounds and the results were that at given concentrations (below 10%) the dyes did not have any irritating effects particularly if used in open air. On the other hand it is known that the oils have irritating properties. It would look as if this might have been due to their solubility allowing for an easier skin penetration.
The concentration of the dyes being in the region of 3 to 5 ppm, and therefore very low, they would indicate, given the above, that the effects cannot be attributable to it. On the other hand toxicology data on those dyes is missing. Things get more complicated if one bears in mind that there are other dyes too, i.e. one blue which has to be added to the yellow to give the fuel its known greenish colour and the blue dye is not listed in any of the publications consulted.
It was reminded again that the Danish concerns stemmed also from an accident in Sweden and that the Swedish authorities carried out a very thorough investigation. Apparently the Swedish data points out that the dye is toxic to aquatic organisms and that it can bioaccumulate. Unfortunately no copy of the SW study was available in English to the CSTEE. The new SW member of the CSTEE commented on her experience with the so-called Swedish accident. Apparently the "problem" arose when the two azo colorants were added to a so-called environmentally classified fuel used essentially in wood cutting devices for forest processing. It was especially in that sector that people experienced irritations. There were so many cases that investigations were carried out, with and without the colouring agents. Other tests done were combustion exhaust tests, chemical analysis, and determination of mutagenic substances used in the test and so on. Skin tests with the oil were also done, as well as volunteer studies with people working with such machinery and not exposed people as controls.
Some of the tests that were carried out were closed chamber experiments where the exhausts would be introduced. The battery of tests also included function tests, inflammatory and even psychological tests. It was therefore quite a thorough study.
The conclusions were that there was no difference dependent on whether the colouring agents had been used or not. The conclusion was also that the so-called environmentally good fuel was more irritating to the skin as it contained less aromatic compounds and more long chain aliphatic ones making it obviously more irritating to the skin.
The inevitable conclusion was that there was an unfortunate time coincidence in that both the colouring agent and the new fuel (environmental friendly) oil specification were introduced simultaneously. However, given the results of the thorough testing conducted, it was obvious that it had been the change in oil specification and not the adding of the colouring agent that was at the source of the health problems observed.
The toxicological data on these colouring agents was looked at but there was not much information although it would look as if, given the structure of the yellow dye, one could expect some carcinogenic effects, in spite of the fact that no testing had been conducted on that.
Under such circumstances the Swedish authorities had to conclude that, from the toxicological data available, none of the colorants looked 'nice'. However, other alternatives used by other countries, on which there was also very little toxicological information, did not seem to be better either.
Prof. Dybing informed the CSTEE about the interest that the Norwegian authorities have on a decision on this opinion request as they wanted to pass legislation on the blue and the yellow colorants. The situation is complicated in Norway as it has a special agreement within the EEA agreement. If Norwegian authorities were to decide on their own regardless of such agreements the yellow colorant as such would probably pass the Norwegian classification system.
This is the reason why the Norwegian authorities are interested in knowing whether there are any ongoing plans to evaluate these chemicals within the EU system. This is important because their system is harmonised to the EU one but different decisions could be taken on given compounds.
It was reminded that classification issues are the province of DG XI but nobody from that Directorate General was present to give information.
The terms of reference submitted by DG XXI were reminded to help focus the discussion but in spite of the fact that the question was explicitly centred on one dye it was the opinion of some CSTEE members that, to the extent that there might be three dyes involved, one could not exclude that the risk assessment should focus on all three and not just one. One other aspect was that, in spite of the fact that the concerns seemed to be on acute effects, chronic ones should be a cause for concern as well.
A CSTEE member expressed the view that, even though tests might have been carried out in Sweden one could not say that there are no risks as very sensitive methods would be needed to register effects. The CSTEE ought to make a toxicologically based evaluation of these colouring agents.
As far as the toxicological information available was concerned this was extremely poor, both for the blue and the yellow colouring agents and also for some of the other agents that were looked at and some that were actually used, there were no toxicological information at all.
What one should ask for is of course that the producers of these compound should make more thorough investigations of the health effects or even ecotoxicological effects of these compounds; and even if the concentration in the oil is just 5mg per litre, still huge quantities of oil are being used, so the total quantity of these agents that are being produced cannot be so small.
Two aspects were also reminded: one was that the chemical should definitely be produced in large quantities and so this should require a certain amount of toxicological and ecotoxicology information apparently not currently available. But because these are existing chemicals, and this seems to be the case, data can be asked for. On the other hand the presence of these chemicals is in the ppm region. The logical conclusion is that the oil must be the toxic element and not the dyes.
It was also suggested that the previous azo-dyes working group could take on the task of discussing the subject and that to start a draft could be produced and circulated between members. Depending on the initial results of this approach one could consider either stick to the limited scope of the terms of reference or expanding to some recommendations.
Concerns were subsequently expressed about the ecotoxicological effects of the dyes as acute toxicity tests had been carried out on daphnia and growth reduction in green algae was also observed.
It would look as if these two compounds, the blue and the yellow colouring agents, are not biologically degradable. Based on physical and chemical data they are seemingly potentially bio-accumulative, the conclusion being that these chemicals can be environmentally hazardous and therefore one probably should somehow evaluate the risks of these dyes against what is known and what can be reasonably predicted on the basis of scientific data today.
To conclude the rapporteur confirmed the brief given to him. In principle the task is to address the terms of reference as they stand and not to cover environmental aspects unless a different decision is taken. A draft will be circulated between other members of the working group for comments. In principle the CSTEE should aim to adopt the opinion by the September 99 plenary.
9. The use of measured exposure data in risk assessments - progress report
Prof. Jansson made the presentation of this point on which a paper had been previously distributed. He said that some sort of the combined modelling/measuring activity could be very useful. The paper contains some recommendations accordingly.
On important premise is to make the existing data more available and this was considered essential. As to combined monitoring data, they are not published in a regular way. That has been discussed in the European Environment Agency together with OECD, and a meeting is being envisaged to discuss that. Another possibility to improve the data base for measuring data for compounds to be risk assessed is following the Japanese experience where they have been working on at least more than a thousand compounds. They have now some data on the compounds and they have divided the work between the prefectures in Japan. Local laboratories have taken a couple of compounds each and developed the methods necessary and then made a measured survey.
Many of these data are very useful but one has also to realise that some of the measurements are quite old. There are much better methods today and some of them should be repeated. Perhaps even for some of them a special survey for the European situation should be carried out and some sort of survey programme should be set up in support of the risk assessment procedures. At least get some sort of basic information on the levels of these compounds in the environment which is something that is also going to be discussed in the EEA where a meeting will take place with people involved in monitoring in the EU.
But perhaps this is not the most clever use of the measurements in the process and one could say that possibilities to include some resources in the risk assessment procedure for complementary measurements would be very useful. In many cases this is not needed, but in some other cases where one can see possible problems it might be useful, especially if it is coming out from estimates from models of exposure.
It would be desirable to have the possibility to go in and verify this exposure data in some way. One can just mention the possibility to use the JRC for this; if one could find some resources within the JRC to be used in the risk assessments in the EU it would be a good way to do it.
And lastly it is recommended that the communication channels between users and developers of models should be as open as possible as the users sometimes are not very experienced in modelling. They are using these models as black boxes and they have difficulties to judge the outcomes. Including people that know about models in that work is essential. The reverse is also true: when the use of the models indicates that something is wrong, there should be a feed back to the developers to improve the models.
There are still some question marks about how that should be done. The situation is probably improving and a meeting took place last year where it was obvious that the communication was not working well between those developing models and those using models and doing the monitoring. The third element of the process would be the inclusion of measurement activities in the risk assessment procedures. Perhaps the CSTEE could put forward ideas to improve the situation.
The CSTEE chairman wrapped up the discussion saying that since the CSTEE has a working document and that there are several issues, firstly it is probably better for the CSTEE not to "reinvent the wheel". But perhaps paying some attention to modelling should not go amiss if tackled in a generic sense. Consistency of information when one is getting exposure assessment from e.g. consultants, is necessary. It is the sort of framework that one ought to recommend for exposure assessment information.
It is important for surveillance and on certain chemicals or substances one is looking at, one ought to flag those up as needing some sort of surveillance program. These are all key issues. A working group is probably needed but it need be a focussed working group. On the other hand the committee should come up with some views on what are the key issues and how one might move forward.
In the EU chemical framework what is needed is exposure assessment for the sort of materials being dealt with and a suitable document within the Community in this area probably does not exist. But clearly one needs to highlight this as a part of the research needs, because of the gap, and one should draw on anywhere where that is being done in order not to "reinvent the wheel".
Later, some more detailed information may be needed after that because when one gets reports from consultants or others, e.g. DG3, other information becomes available. It may not reflect the situation in nature and because of the way in which is presented, assumptions are made. One should look for some consistency in some strong sense coming through the exposure, rather than a "wait and see" approach.
One should also be concerned with verification of the data. It is true that the European Environment Agency if they have a contact list of the national authorities responsible for air and water quality in each country then one can just e-mail them and say: "can you confirm the following data of monitoring data or exposure data, or models, chemical in your country?", and if they say "no", you will have had no assessment done, and if the say "yes", this is confirmed by the analysis at that laboratory.
The CSTEE chairman called a halt to the debate suggesting that a small working group be formed. Himself with the secretary and Prof. Jansson will try to write some sort of brief, the idea being not to deal with the total problem all at once. Membership was suggested and an informal composition agreed. The preparation of the brief will take place as soon as possible and will subsequently be circulated for comments. The chairman concluded the point expressing the view that this could well be one of the most important activities that the CSTEE could engage into.
10. Toxicological characteristics and risks of certain citrates and adipates used as a substitute for phthalates in plasticisers in certain soft PVC products - progress report on the request for an opinion
Before the presentation of this point started, a brief discussion took place on the availability of the following reports:
Consumer Safety Research Report - LGC Technical Report Number : LGC/1999/DTI/004 - June 1999 "Interlaboratory Validation of Laboratory-based Agitation Methods for the Determination of Phthalate Plasticiser Migration from PVC Toys and Childcare Articles" (CSTEE/97/1-Add 148/D) and
Validation of the method "Determination of Diisononylphthalate in saliva simulant" - TNO report V99.598 from Rinus Rijk & Karl Ehlert (TNO Nutrition and Food Research Institute) - 27 May 1999 (CSTEE/97/1-Add 149).
The former had been sent to the CSTEE before the meeting at the request of LGC who had sent copies. Copies of the latter were distributed during the meeting. The CSTEE chairman welcomed the submission of the reports and, on behalf of the committee, congratulated himself for realising that the recommendations of the CSTEE in its previous "Phthalates" opinion had seemingly been endorsed in practice (validation attempt of the conclusions of the so-called Dutch study on a possible standardisation of test method to measure phthalate release).
The representative of DG XXIV/A/4 recapped the sequence of events on this opinion request, particularly as regards the provision of data on citrates/adipates to the CSTEE. It was pointed out that the limited resources available to Commission services did not allow to carry out an ideal data search. In spite of this the CSTEE got some. Some had been provided by Industry and some other via the Scientific Committee for Food (SCF) who had evaluated a few of these chemicals. This did not prove to be an easy process, mainly for logistical reasons, but a synoptic document was provided and should the CSTEE deem it necessary, the underlying dossiers can be provided as well.
The CSTEE was asked whether, since Mrs Knaap (from the SCF) is a member of "Phthalates and substitutes" working group, the perspectives/conclusions of the SCF would not be represented anyway. The question was also asked whether perhaps direct contacts between the chairpersons of the CSTEE and of the SCF would not be a means of obtaining such data.
The CSTEE chairman answered saying that, as chairman of the committee he would be quite happy to talk to the SCF chairman but that in any case more detailed data would have to be provided because the CSTEE could not operate on the basis of summary information.
The DG XXIV/A/4 representative also gave the information that a two generation reproductive study on acetyltributylcitrate should be available soon as reassurances have been given that it is in the stage of completion.
A recurrent issue (raised in previous CSTEE meetings and again during this one) was that of which of these substances (citrates/adipates) were in effect used in toys. From information provided by producers of such substances (included in a documentation package submitted before this meeting) in respect of citrates, apparently only one of the substances is being used or considered for use in toys. It would look from that information that the relevant citrate is only one, and it happens to be the one for which the conclusion of a two generation study is still pending.
The question was asked whether the other citrates are not used or whether this is not known, to which the answer was that they are apparently not considered by toy manufacturers. Another indication seems to be that the American Toy Manufacturers have also suggested that ATBC was a potential candidate for a plasticiser in toys.
On adipates, checks have been carried out on the available data but the adipates identified were included in information that came by the end of last year, from government laboratories who tried to identify plasticizers in toys. On the other hand there was no co-operation whatsoever from producers of adipates in identifying substances, nor have Commission services had any co-operation in this area from the toy manufacturers. Therefore, with regard to adipates, Commission services can only tell the CSTEE that the adipates that have been specifically mentioned in the terms of reference were those which were reported by some national government laboratories as something they have found themselves in toys.
Apart from this there is very little else that can be said but apparently there are other substitute materials. This information has been made available by DG III. This seems corroborated by some surveys carried out by M. States' authorities on what kind of materials and substitutes are found in the market. Of course such data are all sort of "snapshots" of the situation in different moments, but one of the surprising things that was discovered would be that there were enormous amounts of other materials being used. That might be something to take into consideration. It looks as if we have a very confusing situation, and we have not been able to further narrow down the terms of reference.
A CSTEE member asked the question of whether there was a legal framework on what is allowed in children's toys to which the answer was that there is a toys directive but that one should probably work more on a sort of assumption that there should be nothing dangerous in there, rather than prescribing all the things. One of the characteristics of the toys directive is that it does not go into the details of which substances are allowed or not.
From the side of the CSTEE secretariat the information was given that the toys directive is a new approach directive based on a number of presumptions: number one that a product is safe if it is in conformity with the "upper-stream" directives (in this respect the toys directive is subsidiary of other legislative instruments). This means for instance that the toys directive must comply also with other directives in force, for instance the directive on limitations of marketing and use, but certainly with chemicals legislation in general. In practice, should phthalates be banned in the framework of the limitations directive, they could be automatically banned in toys if such were the scope of the measure. But the situation is such that, from a legal point of view there is no ban until now on these phthalates. But this is where DG3 is making progress and where work is ongoing at community level and this is the current legal situation.
Currently, in order to follow the essential requirements, the manufacturer has two possibilities: either to follow harmonised standards or abide to a certification and that is when a certification body is needed.
The CSTEE secretary reminded that as regards the data supplied on the availability of substitutes, the origin of the data sent to de committee stemmed from an agreement reached at a member state's experts meeting in February where a request was made for the information they had available on alternatives to phthalates in toys to be submitted to Commission services (DG III). However this seems to have been understood to mean alternatives not only to phthalates (plasticisers) but also to other matrix materials. A document submitted by Greenpeace (CSTEE/98/17-Add. 35) describes substitute materials to soft PVC.
The CSTEE secretary reminded the exact scope of the terms of reference submitted to the committee. The CSTEE has been specifically asked about Phthalates substitutes but on the other hand other stakeholders are bringing in the issue of the substitution of PVC into the discussions. From the documentation made available to the CSTEE, and the correspondence from Sweden is revealing, the issue there does not seem to be so much related with phthalates or other plasticisers but rather with PVC and with the perceived need to replace PVC itself. In terms of the scope of the forthcoming CSTEE opinion this should be borne in mind.
At this point the CSTEE chairman tried to summarise the situation saying that there are a number of issues to consider. One was whether the CSTEE needs to revise its opinions on phthalates, perhaps simply updating it. On the other hand there are some new test methods which the CSTEE should look at in the light of whether it fits the proposal the CSTEE made in its previous opinion. Finally there is the issue of citrates and adipates as alternatives but that is where the following presentation made by the working group chairperson would enlighten the committee.
The phthalates working group chairperson welcomed the provision of data from both responsible Commission services and made an initial presentation on the state of play as regards data so far made available to the CSTEE and its intrinsic usefulness. Unfortunately the conclusion had to be that there is still a "lack of data problem" and this in spite of the data obtained from the SCF who have taken a look to citrates and adipates and from them one knows what was available or not.
The one chemical on which more data has been provided is ATBC, on which there is some toxicological data, but previous assessments of the SCF could not establish an acceptable daily intake or a tolerable daily intake about this substance because there was not enough data available. However this has now recently been evaluated or re-evaluated by JECFA (Joint Expert Committee on Food Additives) in Rome just at the beginning of the previous month of June 99 and as soon as that report is available the CSTEE will consider it. Contacts will be established with JECFA to ensure that this is done
The working group chairperson then made a detailed description of the conclusions so far possible on the range of chemicals considered (citrates/adipates). The overwhelming conclusion was that, at the time of the presentation, data was seemingly not available, or not of sufficient quality, that could allow for a proper characterisation to be made of those chemicals, particularly bearing in mind the nature of the questions asked in the terms of reference submitted to the CSTEE back in December 1998. On the other hand the confidentiality issues raised in particular by one manufacturer posed the problem of how should that data be used in this consultation.
The DG XXIV/A/4 representative made an account of the contacts established with industry to try and find more data. There are basically two industry sectors involved: citrates producers and phthalates producers. Citrates producers are a completely different line of business from the phthalates producers if only because the phthalates producers are the old companies.
In between them is the European Council of Plasticisers and the European Chemical Industry. So far the Chemical Industry and the plasticisers Council have apparently followed the phthalates producers line. The only sources of industry information on alternative plasticisers have been the citrates' who have supplied data. Industry has been asked many times to co-operate, by DG3 and by DG XXIV to supply the information that is available to them and therefore there is nothing more that can be done. Generally one assumes that when we are being told by industry that a certain substance is used for certain applications and not for others one would be generally inclined to take that information as valid because it would not be in their interest to cheat on that. Also if the same information comes from a completely different source of toy manufacturers in the US, one would be inclined to think that that is a serious piece of information.
On the other hand the surveys that have been carried out are not necessarily representative if anything because some of them have been carried out with the intention of finding phthalates.
One of the new CSTEE members asked whether one could assume that the question asked was whether citrates/adipates were "better" than phthalates to which the chairman answered saying that, by inference, one could accept this to be in fact the question. However, in practical terms a positive answer could not be given as long as comparable data is not available since it is dangerous in toxicology to say something is safer because there is less data. That would make compounds on which there were no data the safest of all (absence of evidence is not evidence of absence).
A CSTEE member raised the point that it could in principle be possible to make conclusions on a chemical that is hydrolysed but some commented back saying that the breakdown rate of hydrolysis is not known and that, furthermore, hydrolysis products can be active. Even if ones contends that this is not likely, data is needed to prove that.
The discussion of this point was concluded in that a draft needed be prepared and circulated among working group members. A decision on whether to organise a meeting before the plenary would be taken depending on a number of variables as perceived need, availability of members, status of draft, etc.
Some suggested that, on the discussion on methods of phthalates extraction measuring, the important thing to do is decide what is the best method, also considering other methods in the US.
It was also suggested that the first issue to address is the draft on citrates/adipates. The 2nd issue is the tests and although the CSTEE has not been formally asked an opinion on those it would be interesting to see whether the working group thinks that they meet the criteria set by the CSTEE.
The representative of DG XXIV/A/4 reminded the CSTEE that, bearing in mind that there are a number of other materials which presumably are or can be used as replacements of soft PVC, if there is any remark that the CSTEE would like to make on those other materials its views will be extremely welcome. The DG III representative pointed out that any suggestions for the CSTEE to take on other tasks such as the one described should be discussed between the services before.
Finally the representative of DG XXIV/A/4 explained how they would like to proceed with the analysis of the TNO and LGC reports. In a first instance they submitted them to the 'Risk evaluation unit' of DG XXIV. On the basis of their analysis the issue will be discussed with other Commission services and a decision will be made on what questions will be asked to the CSTEE on this.
The CSTEE chairman suggested that the committee could as a starter just say whether they fit the criteria set by the CSTEE in their last opinion. A detailed analysis will not be carried out before the Commission submits terms of reference.
Regarding a possible update of the "Phthalates opinion" this will take place if necessary as and when data is provided that will indicate such a need.
11. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
On behalf of the chairperson of this working group the CSTEE secretary gave the committee information submitted by him. Basically a range of activities at OECD level, SETAC, etc. were mentioned, all of which should provide the CSTEE useful input on the subject. The CSTEE secretary also gave the information that, at the competent authorities meeting that had taken pace in Berlin in mid June and which the CSTEE secretary attended, M. States representatives were informed about the fact that the CSTEE had engaged in this activity with some of them showing interest in following it and/or participating. DE in particular have already contacted the CSTEE secretariat suggesting experts to integrate the CSTEE working group. Suggestions will be submitted to the working group chairperson for his appreciation.
12. Feedback from the competent services of the Commission on the follow up to the opinions adopted previously by the CSTEE
The representative of DG III made an account of the situation on Arsenic. The information on the possible voluntary commitment with industry given at the previous meeting was confirmed, but according to the procedures other EU institutions will have to be informed (EP, Council). A formal procedure will start soon.
Regarding asbestos the Commission proposed a more stringent directive (ban) than was the case before and EU M. States voted favourably but at the same time there is a WTO complain against France which is being assisted by the EC and the position of the CSTEE has been used in this context. However, even though the directive was voted favourably by M. States it needs to be formally adopted and in this case it is the Commission who should do so but the procedure has been momentarily suspended at the request of Commissioner L. Britain because of other WTO cases.
Regarding Creosote, the opinion stemmed from a request from M. States to keep their more stringent legislation and these decisions are at the stage if inter-service consultation. Some formal legal changes were considered necessary with the entry into force of the new Treaty, and that is why there have been delays.
The Creosotes opinion has been the subject of a letter from Tar manufacturers who wondered why there has been a revision of the opinion. The working group explained that this was due to the fact that the initial figures used in the calculations were incorrect.
On azo dyes there is a proposal for a ban which is also going through inter-service consultation and some comments are being taken into account before the proposal is finalised soon.
On Cadmium, PCP and Tin organic compounds a directive has also been proposed with which the M. States agreed and which has been published in the Official Journal. However, on Cadmium, as reported last time, DG III would like to review the Cadmium provisions as what has been done in the directive was giving the new M. States, Sweden and Austria, the possibility to keep their stricter legislation for an additional period of time as there is a lack of information. More data will be available under the existing substances regulation and perhaps also an update of the study which the CSTEE peer reviewed and found not very satisfying will be carried out. A draft specification for a study is being elaborated by the relevant Commission service.
A paper criticising the CSTEE approach in its opinion on tropospheric ozone was described and some of its content analysed vis à vis the previous debates on the subject. The criticisms in the paper are levelled vis à vis the AOT 40 concept in particular and were judged by the CSTEE difficult to accept as, from the paper, it was impossible to ascertain whether an argument was being either made in favour or against it.
13. Information related to the opinion on Human and Wildlife Health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on Ecotoxicology Test Methods
A short discussion on this topic took place. The message was reiterated by the CSTEE secretariat and endorsed by the CSTEE, that it should keep the watching brief, i.e. keep an eye on developments in view of improving/changing/updating the CSTEE opinion as and where it might become necessary.
The working group chairperson further informed that, by the look of the latest developments it seemed as if repeated low dose findings should not be considered any longer an issue. Effects are seldom reproduced, hence the doubts surrounding this issue. On the other hand, on the issue of tests, the in vitro ones are still preferred.
14. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
The CSTEE chairman informed the committee about the new rules of SSC membership. The SSC has continued its activities on BSE, this time on disposable fallen stock , dead animals which might have been contaminated. Other issue under its programme is antibiotic resistance on which an important meeting will take place during the current month of July and one important point already raised is that there is quite a knowledge gap on problems related to the environmental dissemination of antibiotics.
15. Arrangements for the next meeting of the CSTEE
The next plenary meeting was confirmed for the 27/28th of September 1999 in Brussels.
16. Any other business
The information was given that a consultation of the CSTEE might take place in the short term future on the Technical Guidance Document in support of the Biocides Directive (98/8/EC).
Prospects of a future consultation of the CSTEE on future finalised risk assessments produced under Regulation 793/93 were discussed. As DG XI had provided a list of the substances in the priority lists whose risk assessments are likely to be ready sooner, these were discussed The point to note is that none should be ready for submission before October 99. Hence presumably by the September plenary no news will be available yet.
The DG III representative gave the information that the CSTEE should expect to be consulted in a not too distant future on methylene chloride, textile chemicals and, as already said, on Cadmium.
Annexes:
I - Final agenda
II - Attendance list
SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE)
10th PLENARY MEETING - 1st of July 1999, 9H30 a.m.
National Institute of Public Health (Folkehelsa)
Geitmyrsveien 75 (access via Lovisenbergaten), Oslo, Norway
- DRAFT AGENDA (rev. 2)-
1. Adoption of the draft agenda
2. Presentation of new CSTEE members
3. Declarations of interest
4. Information from the CSTEE secretariat
5. Adoption of the draft minutes of the 9th CSTEE plenary meeting held on the 7th of May 1999 in Brussels
6. Progress reports on opinion requests related to the 'Water framework directive':
A.
I) Report from a study on Technical specifications for classification and presentation of ecological status of surface waters, March 1999 and
II) Report from a study on Technical specifications for monitoring of ecological status of surface waters, March 1999
B. Revised proposal for a list of priority substances in the context of the Water Framework Directive (COMMPS procedure) and Draft Final Report on the Assessment of options of the statistical treatment and evaluation of monitoring data within the COMMPS procedure
7. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission:
i) Opinion request on a proposed "ready biodegradability" approach to update detergent legislation (EC - DG III/C/4)
ii) Other
8. Euromarker in oil system - progress report
9. The use of measured exposure data in risk assessments - progress report
10. Toxicological characteristics and risks of certain citrates and adipates used as a substitute for phthalates in plasticisers in certain soft PVC products - progress report on the request for an opinion
11. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
12. Feedback from the competent services of the Commission on the follow up to the opinions adopted previously by the CSTEE (note: given the exceptional nature of the venue most of the information under this agenda item may have to be provided via the CSTEE secretariat)
13. Information related to the opinion on Human and Wildlife Health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on Ecotoxicology Test Methods
14. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
15. Arrangements for the next meeting of the CSTEE
16. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James W. BRIDGES, Prof. Philip L. CHAMBERS, Prof. Erik DYBING, Prof. Bo JANSSON, Prof. S. KYRTOPOULOS, Dr. Ole LADEFOGED, Prof. Dr. José RUEFF, Prof. Mirja SALKINOJA-SALONEN, Prof. Marco VIGHI, Prof. Joseph VOS, Prof. Dr. Helmut GREIM, Dr. Claude LAMBRE, Prof. Katarina VICTORIN, Prof Janneche U. SKARE, Prof. Marc COSTELLO
European Commission:
DG XXIV: Mrs M. de SOLÀ, Mr. J. COSTA-DAVID, Mrs A. FOKKEMA.
DG III/C/4: Mrs L. PERENIUS
Prof. Dybing made an introduction with information on logistical arrangements for the day regarding meals, etc.
1. Adoption of the draft agenda
The draft agenda was adopted. The order of some points was changed with point 13 of rev. 1 of draft agenda becoming the 7th (Strategies for dealing with additional opinion requests submitted by other DGs of the Commission).
2. Presentation of new CSTEE members
The information was given that Profs. Terracini, Wennig and Tarazona had sent apologies for absence.
A 'tour de table' took place allowing for Commission staff and CSTEE members to present themselves giving information on background, academic and/or professional experience, particular scientific interests developed, etc. The need for this was due to the fact that this was the first meeting of the three newly appointed members to the CSTEE, Profs. Mark Costello, Katarina Victorin and Janneche Utne Skare. The CSTEE chairman welcomed, with the arrival of 'new' members, expertise in environmental related matters to the committee.
3. Declarations of interest
No member of the CSTEE attending this meeting mentioned any interest in whatever capacity that might be considered prejudicial to his/her independence considering the nature of topics in the agenda. The CSTEE secretary also informed CSTEE members that, other than forms for signing declarations of interest, forms for confidentiality rules were available as well.
4. Information from the CSTEE secretariat
The CSTEE secretary expressed on behalf of the Commission his most vivid thanks to Prof. Dybing and his Institute for providing the facilities to allow the CSTEE plenary meeting to take place in Oslo. It was reminded that the choice of venue was due to the convenience of having the CSTEE plenary meeting back to back with EUROTOX' 99 which had taken place in Oslo and ended the day before.
Particularly for the benefit of the three new members, the CSTEE secretary gave some information namely related to the rules of procedure of the committee (copies were available) as well as some other on reimbursements, etc.
Confidentiality rules were also explained and briefly discussed between members. It was in particular made clear that information exchange of confidential data between CSTEE members and eventually other (third) parties would have to be conditional upon information being given at the outset about the fact that confidentiality rules apply.
The CSTEE secretary drew the attention of the new members in particular to a number of documents available as 'room documents' and explained their purpose. Some of them were 'thematic' documents for use in the discussions on some of the agenda items and some others were for allowing for an easier follow up of the subjects from meeting to meeting. These included lists of all documents submitted in connection with any technical subject being the object of a CSTEE activity, opinion requests or own initiative reports, others being e.g. lists of documents sent since the previous plenary meeting.
The CSTEE chairman explained that a lot of the CSTEE's activities are due to requests from Commission services but that the CSTEE adopts reports/opinions on its own initiative as well. As regards the way in which the CSTEE works he said that a lot of activities are done in working groups before the subject is discussed at plenary meetings.
5. Adoption of the draft minutes of the 9th CSTEE plenary meeting held on the 7th of May 1999 in Brussels
The minutes were not yet available. The CSTEE secretary took the commitment of sending them later by post for possible adoption by written procedure.
6. Progress reports on opinion requests related to the 'Water framework directive':
A.
I) Report from a study on Technical specifications for classification and presentation of ecological status of surface waters, March 1999 and
II) Report from a study on Technical specifications for monitoring of ecological status of surface waters, March 1999
B. Revised proposal for a list of priority substances in the context of the Water Framework Directive (COMMPS procedure) and Draft Final Report on the Assessment of options of the statistical treatment and evaluation of monitoring data within the COMMPS procedure
Due to the absence of the chairperson/rapporteur for this particular opinion request no detailed presentation/discussion took place. Still the chairperson had sent an e-mail commenting that so far very scant contributions had been received from other working group and/or CSTEE members. Dates for a future working group meeting were discussed.
The CSTEE secretary further gave the information that a message had been received from the Commission requester service with the indication that a report on 'Intercalibration' was missing from the report Technical specifications for monitoring of ecological status of surface waters, March 1999'. This would be sent later when available. The message also included information on the political side of things in that discussions were continuing at Council level. There had been some problems with translation of texts and legal revisions of drafts but that, as far as progress was concerned from the CSTEE involvement side, everything was under control.
Regarding section B of the opinion request the information had been received from the Commission requester service by the CSTEE secretariat that the schedule previously agreed (adoption of part B of the opinion by September or November 99 at the latest) is in principle acceptable to them.
7. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission:
i) Opinion request on a proposed "ready biodegradability" approach to update detergent legislation (EC - DG III/C/4)
A representative of the Commission requester service (DG III/C/4) presented this point. The information was given that the Commission is currently updating the legislation on detergents since the one still in force dates from the early 70's. Then it had been introduced mostly to deal with the problem of detergents in rivers and so it was based on primary biodegradability.
More modern legislation is now being envisaged, the principle is to base EU legislation on ready biodegradability instead. Discussions with M. States have been taking place since quite some time now and the idea is of course to include testing of ready biodegradability in the EU legislation. In essence the issues on which the CSTEE's views will be sought are related to the methodological aspects of the biodegradability tests. Terms of reference have already been submitted in June 99 with the questions that concern the approach using ready biodegradability. There is also a question about the suitability of different tests. It includes still other questions on topics that have been raised during the discussions with M. States. On the other hand the Commission has a 'problem' with timing. An opinion is necessary by October or November 99 at the latest. This is a consequence of the agreed schedule which includes an inter-service consultation within the Commission in view of having a Commission proposal adopted by the first quarter of next year.
The CSTEE secretary read out the questions included in the terms of reference since apparently not all CSTEE members had received the terms of reference in time for the meeting.
The CSTEE chairman invited those present to volunteer to the working group which will have to deal with this opinion request. He pointed out that it is basically an environmental issue and that therefore people with an expertise in this field would be the logical candidates. He also pointed out that it would be convenient to include people with expertise in test methods. If needed perhaps external experts could be identified.
Some CSTEE members volunteered to participate but it was understood that suggestions for external experts could be made with some CSTEE members to inform the CSTEE secretariat later of possible nominees.
ii) Other
The information was given by the CSTEE secretariat that a new opinion request will be submitted soon. It follows up from an obligation which Member States have, in the framework of EU law, to notify the Commission of any measures they intend to take which impinges on either existing EU law or may be considered to be in conflict with internal market rules.
The Danish authorities have notified the Commission about their intention of banning, where possible, all uses of lead (ban on importing, selling and manufacturing in the Danish territory, but not on exports). This of course they intend to do on the grounds of health and environmental protection.
Because such a measure implies, as was said, problems in terms of internal market and free circulation of goods, the Commission has to avail itself of the well-founded nature of such an intention. This is the reason why the CSTEE will be asked whether the arguments, based on health and environmental protection grounds, put forward by the Danish authorities are well founded or not.
On the other hand the opportunity will be taken to ask the CSTEE another question, a general one this time, on the general risks of lead and its compounds to human health and the environment. In principle the CSTEE was to receive, probably in the course of the week after the plenary, a specific set of terms of reference. There is urgency in having these opinions adopted as, for legal reasons (Commission reply to the Danish notification), the matter is urgent.
The DG III/C/4 representative then commented on the nature of the documentation which, on their side, will be submitted to the committee. A report on heavy metals submitted by the Danish EPA, which is essentially a review of the state of the art, with the targets and the reduction instruments for heavy metals, including of course also lead. The second report is an environmental project, also carried out by the Danish EPA, specifically on lead. The first one dates from 1994. The second from 1998 and it focuses in a comprehensive way on the problems of lead in Denmark. They have both been translated into English and will be made available to the CSTEE in the course of the week after the plenary. Both reports cover human health and environmental issues.
Another Commission representative (XXIV/A/4) confirmed that other documentation is being prepared for submission to the CSTEE. Contacts with the WHO are being established to obtain data. Confirmation was given that the objective of the general opinion request on lead compounds is to ascertain whether there is a need to take measures at community level and in principle the already significant amount of documentation obtained is the most relevant part, although in respect of some data only the references and abstracts had been obtained. In any case they will be made available to the CSTEE. One particularly interesting piece of data mentioned is an "American" piece of research on child health related effects.
On top of that it is known that other Commission services, i.e. DG V, also have other reports on the subject which could be made available to the CSTEE.
At this stage of the presentation by Commission representatives, CSTEE members expressed interest in knowing in more detail what the questions to the committee could be like. To this question the answer was that, for the moment (plenary meeting) it was difficult to say as the problems raised can be extremely comprehensive.
The CSTEE chairman suggested that given that it was not possible for the moment to have a clear idea of what the exact nature/scope of the questions will be like, it would be better to form a 'core' working group, and for that the previously, 'metals' working group of the CSTEE could be a starting point, leaving the 'door open' to chose the necessary external experts depending on the 'subtlety' of the questions. Some possible names were mentioned and the sensitivity of having 'the' Danish CSTEE member in the working group was also discussed. In the end it was not considered a problem as the rules on 'declarations of interest' should be enough to settle the matter. In any case his contribution would take place, in principle, rather on a 'consultative' basis.
In general terms the CSTEE expressed the view that, should the questions be as comprehensive as it looked they will from the presentations, the task is likely to be a very daunting one. This however would need to be checked vis à vis a clear mandate to the CSTEE as related to the needs/objectives of the opinion request in question. A concern that a specific CSTEE member expressed was whether the questions would be only on lead or whether there might be extrapolations to other metals as well. The question stemmed from the realisation that, very often, data looked at on one chemical includes conclusions on others and the temptation may be there for widening the scope of the conclusions.
Other aspects discussed (although admittedly not the kind of subjects falling within the remit of the CSTEE) were possible internal marketing implications coming about from a general ban on a chemical in one single country.
It was pointed out that what the CSTEE will have to look at are the risks and give opinions on risks. The task of judging the proportionality of any measures is not the CSTEE's responsibility but for making such a judgement a good scientific basis is necessary.
Given the schedule of meetings with the following plenary due to take place by the end of September, on the understanding that the responsible Commission services would like to have an opinion adopted by the November plenary, a working group meeting as soon as possible in view of having at least a draft ready for presentation at the September plenary was judged indispensable.
The CSTEE chairman said that this should not be too problematic since the representatives of Commission services had given reassurances that both the terms of reference and the data would be provided in the course of the week after the 10th CSTEE plenary.
8. Euromarker in oil system - progress report
Some aspects of the discussion on this topic as they had taken place at the occasion of the previous plenary meeting were reminded. The chairperson/rapporteur for this particular opinion request was entrusted with the task of obtaining more data if possible and in particular to contact BASF, manufacturers of the product (solvent yellow 124). Furthermore more data was also obtained by the Commission requester service, sent to the CSTEE secretariat and subsequently distributed to the CSTEE.
However what was obtained was scarce and not necessarily very informative. Furthermore the problems raised by the Danish authorities may not be strictly speaking due to the chemical under consideration but either to other dyes or even to effects of the fuel itself and not the marker. The kind of effects observed (i.e. skin and throat irritation, coughing, etc.), are all perfectly attributable to the fuel itself.
Patch tests have been carried out with dyes, oils and other compounds and the results were that at given concentrations (below 10%) the dyes did not have any irritating effects particularly if used in open air. On the other hand it is known that the oils have irritating properties. It would look as if this might have been due to their solubility allowing for an easier skin penetration.
The concentration of the dyes being in the region of 3 to 5 ppm, and therefore very low, they would indicate, given the above, that the effects cannot be attributable to it. On the other hand toxicology data on those dyes is missing. Things get more complicated if one bears in mind that there are other dyes too, i.e. one blue which has to be added to the yellow to give the fuel its known greenish colour and the blue dye is not listed in any of the publications consulted.
It was reminded again that the Danish concerns stemmed also from an accident in Sweden and that the Swedish authorities carried out a very thorough investigation. Apparently the Swedish data points out that the dye is toxic to aquatic organisms and that it can bioaccumulate. Unfortunately no copy of the SW study was available in English to the CSTEE. The new SW member of the CSTEE commented on her experience with the so-called Swedish accident. Apparently the "problem" arose when the two azo colorants were added to a so-called environmentally classified fuel used essentially in wood cutting devices for forest processing. It was especially in that sector that people experienced irritations. There were so many cases that investigations were carried out, with and without the colouring agents. Other tests done were combustion exhaust tests, chemical analysis, and determination of mutagenic substances used in the test and so on. Skin tests with the oil were also done, as well as volunteer studies with people working with such machinery and not exposed people as controls.
Some of the tests that were carried out were closed chamber experiments where the exhausts would be introduced. The battery of tests also included function tests, inflammatory and even psychological tests. It was therefore quite a thorough study.
The conclusions were that there was no difference dependent on whether the colouring agents had been used or not. The conclusion was also that the so-called environmentally good fuel was more irritating to the skin as it contained less aromatic compounds and more long chain aliphatic ones making it obviously more irritating to the skin.
The inevitable conclusion was that there was an unfortunate time coincidence in that both the colouring agent and the new fuel (environmental friendly) oil specification were introduced simultaneously. However, given the results of the thorough testing conducted, it was obvious that it had been the change in oil specification and not the adding of the colouring agent that was at the source of the health problems observed.
The toxicological data on these colouring agents was looked at but there was not much information although it would look as if, given the structure of the yellow dye, one could expect some carcinogenic effects, in spite of the fact that no testing had been conducted on that.
Under such circumstances the Swedish authorities had to conclude that, from the toxicological data available, none of the colorants looked 'nice'. However, other alternatives used by other countries, on which there was also very little toxicological information, did not seem to be better either.
Prof. Dybing informed the CSTEE about the interest that the Norwegian authorities have on a decision on this opinion request as they wanted to pass legislation on the blue and the yellow colorants. The situation is complicated in Norway as it has a special agreement within the EEA agreement. If Norwegian authorities were to decide on their own regardless of such agreements the yellow colorant as such would probably pass the Norwegian classification system.
This is the reason why the Norwegian authorities are interested in knowing whether there are any ongoing plans to evaluate these chemicals within the EU system. This is important because their system is harmonised to the EU one but different decisions could be taken on given compounds.
It was reminded that classification issues are the province of DG XI but nobody from that Directorate General was present to give information.
The terms of reference submitted by DG XXI were reminded to help focus the discussion but in spite of the fact that the question was explicitly centred on one dye it was the opinion of some CSTEE members that, to the extent that there might be three dyes involved, one could not exclude that the risk assessment should focus on all three and not just one. One other aspect was that, in spite of the fact that the concerns seemed to be on acute effects, chronic ones should be a cause for concern as well.
A CSTEE member expressed the view that, even though tests might have been carried out in Sweden one could not say that there are no risks as very sensitive methods would be needed to register effects. The CSTEE ought to make a toxicologically based evaluation of these colouring agents.
As far as the toxicological information available was concerned this was extremely poor, both for the blue and the yellow colouring agents and also for some of the other agents that were looked at and some that were actually used, there were no toxicological information at all.
What one should ask for is of course that the producers of these compound should make more thorough investigations of the health effects or even ecotoxicological effects of these compounds; and even if the concentration in the oil is just 5mg per litre, still huge quantities of oil are being used, so the total quantity of these agents that are being produced cannot be so small.
Two aspects were also reminded: one was that the chemical should definitely be produced in large quantities and so this should require a certain amount of toxicological and ecotoxicology information apparently not currently available. But because these are existing chemicals, and this seems to be the case, data can be asked for. On the other hand the presence of these chemicals is in the ppm region. The logical conclusion is that the oil must be the toxic element and not the dyes.
It was also suggested that the previous azo-dyes working group could take on the task of discussing the subject and that to start a draft could be produced and circulated between members. Depending on the initial results of this approach one could consider either stick to the limited scope of the terms of reference or expanding to some recommendations.
Concerns were subsequently expressed about the ecotoxicological effects of the dyes as acute toxicity tests had been carried out on daphnia and growth reduction in green algae was also observed.
It would look as if these two compounds, the blue and the yellow colouring agents, are not biologically degradable. Based on physical and chemical data they are seemingly potentially bio-accumulative, the conclusion being that these chemicals can be environmentally hazardous and therefore one probably should somehow evaluate the risks of these dyes against what is known and what can be reasonably predicted on the basis of scientific data today.
To conclude the rapporteur confirmed the brief given to him. In principle the task is to address the terms of reference as they stand and not to cover environmental aspects unless a different decision is taken. A draft will be circulated between other members of the working group for comments. In principle the CSTEE should aim to adopt the opinion by the September 99 plenary.
9. The use of measured exposure data in risk assessments - progress report
Prof. Jansson made the presentation of this point on which a paper had been previously distributed. He said that some sort of the combined modelling/measuring activity could be very useful. The paper contains some recommendations accordingly.
On important premise is to make the existing data more available and this was considered essential. As to combined monitoring data, they are not published in a regular way. That has been discussed in the European Environment Agency together with OECD, and a meeting is being envisaged to discuss that. Another possibility to improve the data base for measuring data for compounds to be risk assessed is following the Japanese experience where they have been working on at least more than a thousand compounds. They have now some data on the compounds and they have divided the work between the prefectures in Japan. Local laboratories have taken a couple of compounds each and developed the methods necessary and then made a measured survey.
Many of these data are very useful but one has also to realise that some of the measurements are quite old. There are much better methods today and some of them should be repeated. Perhaps even for some of them a special survey for the European situation should be carried out and some sort of survey programme should be set up in support of the risk assessment procedures. At least get some sort of basic information on the levels of these compounds in the environment which is something that is also going to be discussed in the EEA where a meeting will take place with people involved in monitoring in the EU.
But perhaps this is not the most clever use of the measurements in the process and one could say that possibilities to include some resources in the risk assessment procedure for complementary measurements would be very useful. In many cases this is not needed, but in some other cases where one can see possible problems it might be useful, especially if it is coming out from estimates from models of exposure.
It would be desirable to have the possibility to go in and verify this exposure data in some way. One can just mention the possibility to use the JRC for this; if one could find some resources within the JRC to be used in the risk assessments in the EU it would be a good way to do it.
And lastly it is recommended that the communication channels between users and developers of models should be as open as possible as the users sometimes are not very experienced in modelling. They are using these models as black boxes and they have difficulties to judge the outcomes. Including people that know about models in that work is essential. The reverse is also true: when the use of the models indicates that something is wrong, there should be a feed back to the developers to improve the models.
There are still some question marks about how that should be done. The situation is probably improving and a meeting took place last year where it was obvious that the communication was not working well between those developing models and those using models and doing the monitoring. The third element of the process would be the inclusion of measurement activities in the risk assessment procedures. Perhaps the CSTEE could put forward ideas to improve the situation.
The CSTEE chairman wrapped up the discussion saying that since the CSTEE has a working document and that there are several issues, firstly it is probably better for the CSTEE not to "reinvent the wheel". But perhaps paying some attention to modelling should not go amiss if tackled in a generic sense. Consistency of information when one is getting exposure assessment from e.g. consultants, is necessary. It is the sort of framework that one ought to recommend for exposure assessment information.
It is important for surveillance and on certain chemicals or substances one is looking at, one ought to flag those up as needing some sort of surveillance program. These are all key issues. A working group is probably needed but it need be a focussed working group. On the other hand the committee should come up with some views on what are the key issues and how one might move forward.
In the EU chemical framework what is needed is exposure assessment for the sort of materials being dealt with and a suitable document within the Community in this area probably does not exist. But clearly one needs to highlight this as a part of the research needs, because of the gap, and one should draw on anywhere where that is being done in order not to "reinvent the wheel".
Later, some more detailed information may be needed after that because when one gets reports from consultants or others, e.g. DG3, other information becomes available. It may not reflect the situation in nature and because of the way in which is presented, assumptions are made. One should look for some consistency in some strong sense coming through the exposure, rather than a "wait and see" approach.
One should also be concerned with verification of the data. It is true that the European Environment Agency if they have a contact list of the national authorities responsible for air and water quality in each country then one can just e-mail them and say: "can you confirm the following data of monitoring data or exposure data, or models, chemical in your country?", and if they say "no", you will have had no assessment done, and if the say "yes", this is confirmed by the analysis at that laboratory.
The CSTEE chairman called a halt to the debate suggesting that a small working group be formed. Himself with the secretary and Prof. Jansson will try to write some sort of brief, the idea being not to deal with the total problem all at once. Membership was suggested and an informal composition agreed. The preparation of the brief will take place as soon as possible and will subsequently be circulated for comments. The chairman concluded the point expressing the view that this could well be one of the most important activities that the CSTEE could engage into.
10. Toxicological characteristics and risks of certain citrates and adipates used as a substitute for phthalates in plasticisers in certain soft PVC products - progress report on the request for an opinion
Before the presentation of this point started, a brief discussion took place on the availability of the following reports:
Consumer Safety Research Report - LGC Technical Report Number : LGC/1999/DTI/004 - June 1999 "Interlaboratory Validation of Laboratory-based Agitation Methods for the Determination of Phthalate Plasticiser Migration from PVC Toys and Childcare Articles" (CSTEE/97/1-Add 148/D) and
Validation of the method "Determination of Diisononylphthalate in saliva simulant" - TNO report V99.598 from Rinus Rijk & Karl Ehlert (TNO Nutrition and Food Research Institute) - 27 May 1999 (CSTEE/97/1-Add 149).
The former had been sent to the CSTEE before the meeting at the request of LGC who had sent copies. Copies of the latter were distributed during the meeting. The CSTEE chairman welcomed the submission of the reports and, on behalf of the committee, congratulated himself for realising that the recommendations of the CSTEE in its previous "Phthalates" opinion had seemingly been endorsed in practice (validation attempt of the conclusions of the so-called Dutch study on a possible standardisation of test method to measure phthalate release).
The representative of DG XXIV/A/4 recapped the sequence of events on this opinion request, particularly as regards the provision of data on citrates/adipates to the CSTEE. It was pointed out that the limited resources available to Commission services did not allow to carry out an ideal data search. In spite of this the CSTEE got some. Some had been provided by Industry and some other via the Scientific Committee for Food (SCF) who had evaluated a few of these chemicals. This did not prove to be an easy process, mainly for logistical reasons, but a synoptic document was provided and should the CSTEE deem it necessary, the underlying dossiers can be provided as well.
The CSTEE was asked whether, since Mrs Knaap (from the SCF) is a member of "Phthalates and substitutes" working group, the perspectives/conclusions of the SCF would not be represented anyway. The question was also asked whether perhaps direct contacts between the chairpersons of the CSTEE and of the SCF would not be a means of obtaining such data.
The CSTEE chairman answered saying that, as chairman of the committee he would be quite happy to talk to the SCF chairman but that in any case more detailed data would have to be provided because the CSTEE could not operate on the basis of summary information.
The DG XXIV/A/4 representative also gave the information that a two generation reproductive study on acetyltributylcitrate should be available soon as reassurances have been given that it is in the stage of completion.
A recurrent issue (raised in previous CSTEE meetings and again during this one) was that of which of these substances (citrates/adipates) were in effect used in toys. From information provided by producers of such substances (included in a documentation package submitted before this meeting) in respect of citrates, apparently only one of the substances is being used or considered for use in toys. It would look from that information that the relevant citrate is only one, and it happens to be the one for which the conclusion of a two generation study is still pending.
The question was asked whether the other citrates are not used or whether this is not known, to which the answer was that they are apparently not considered by toy manufacturers. Another indication seems to be that the American Toy Manufacturers have also suggested that ATBC was a potential candidate for a plasticiser in toys.
On adipates, checks have been carried out on the available data but the adipates identified were included in information that came by the end of last year, from government laboratories who tried to identify plasticizers in toys. On the other hand there was no co-operation whatsoever from producers of adipates in identifying substances, nor have Commission services had any co-operation in this area from the toy manufacturers. Therefore, with regard to adipates, Commission services can only tell the CSTEE that the adipates that have been specifically mentioned in the terms of reference were those which were reported by some national government laboratories as something they have found themselves in toys.
Apart from this there is very little else that can be said but apparently there are other substitute materials. This information has been made available by DG III. This seems corroborated by some surveys carried out by M. States' authorities on what kind of materials and substitutes are found in the market. Of course such data are all sort of "snapshots" of the situation in different moments, but one of the surprising things that was discovered would be that there were enormous amounts of other materials being used. That might be something to take into consideration. It looks as if we have a very confusing situation, and we have not been able to further narrow down the terms of reference.
A CSTEE member asked the question of whether there was a legal framework on what is allowed in children's toys to which the answer was that there is a toys directive but that one should probably work more on a sort of assumption that there should be nothing dangerous in there, rather than prescribing all the things. One of the characteristics of the toys directive is that it does not go into the details of which substances are allowed or not.
From the side of the CSTEE secretariat the information was given that the toys directive is a new approach directive based on a number of presumptions: number one that a product is safe if it is in conformity with the "upper-stream" directives (in this respect the toys directive is subsidiary of other legislative instruments). This means for instance that the toys directive must comply also with other directives in force, for instance the directive on limitations of marketing and use, but certainly with chemicals legislation in general. In practice, should phthalates be banned in the framework of the limitations directive, they could be automatically banned in toys if such were the scope of the measure. But the situation is such that, from a legal point of view there is no ban until now on these phthalates. But this is where DG3 is making progress and where work is ongoing at community level and this is the current legal situation.
Currently, in order to follow the essential requirements, the manufacturer has two possibilities: either to follow harmonised standards or abide to a certification and that is when a certification body is needed.
The CSTEE secretary reminded that as regards the data supplied on the availability of substitutes, the origin of the data sent to de committee stemmed from an agreement reached at a member state's experts meeting in February where a request was made for the information they had available on alternatives to phthalates in toys to be submitted to Commission services (DG III). However this seems to have been understood to mean alternatives not only to phthalates (plasticisers) but also to other matrix materials. A document submitted by Greenpeace (CSTEE/98/17-Add. 35) describes substitute materials to soft PVC.
The CSTEE secretary reminded the exact scope of the terms of reference submitted to the committee. The CSTEE has been specifically asked about Phthalates substitutes but on the other hand other stakeholders are bringing in the issue of the substitution of PVC into the discussions. From the documentation made available to the CSTEE, and the correspondence from Sweden is revealing, the issue there does not seem to be so much related with phthalates or other plasticisers but rather with PVC and with the perceived need to replace PVC itself. In terms of the scope of the forthcoming CSTEE opinion this should be borne in mind.
At this point the CSTEE chairman tried to summarise the situation saying that there are a number of issues to consider. One was whether the CSTEE needs to revise its opinions on phthalates, perhaps simply updating it. On the other hand there are some new test methods which the CSTEE should look at in the light of whether it fits the proposal the CSTEE made in its previous opinion. Finally there is the issue of citrates and adipates as alternatives but that is where the following presentation made by the working group chairperson would enlighten the committee.
The phthalates working group chairperson welcomed the provision of data from both responsible Commission services and made an initial presentation on the state of play as regards data so far made available to the CSTEE and its intrinsic usefulness. Unfortunately the conclusion had to be that there is still a "lack of data problem" and this in spite of the data obtained from the SCF who have taken a look to citrates and adipates and from them one knows what was available or not.
The one chemical on which more data has been provided is ATBC, on which there is some toxicological data, but previous assessments of the SCF could not establish an acceptable daily intake or a tolerable daily intake about this substance because there was not enough data available. However this has now recently been evaluated or re-evaluated by JECFA (Joint Expert Committee on Food Additives) in Rome just at the beginning of the previous month of June 99 and as soon as that report is available the CSTEE will consider it. Contacts will be established with JECFA to ensure that this is done
The working group chairperson then made a detailed description of the conclusions so far possible on the range of chemicals considered (citrates/adipates). The overwhelming conclusion was that, at the time of the presentation, data was seemingly not available, or not of sufficient quality, that could allow for a proper characterisation to be made of those chemicals, particularly bearing in mind the nature of the questions asked in the terms of reference submitted to the CSTEE back in December 1998. On the other hand the confidentiality issues raised in particular by one manufacturer posed the problem of how should that data be used in this consultation.
The DG XXIV/A/4 representative made an account of the contacts established with industry to try and find more data. There are basically two industry sectors involved: citrates producers and phthalates producers. Citrates producers are a completely different line of business from the phthalates producers if only because the phthalates producers are the old companies.
In between them is the European Council of Plasticisers and the European Chemical Industry. So far the Chemical Industry and the plasticisers Council have apparently followed the phthalates producers line. The only sources of industry information on alternative plasticisers have been the citrates' who have supplied data. Industry has been asked many times to co-operate, by DG3 and by DG XXIV to supply the information that is available to them and therefore there is nothing more that can be done. Generally one assumes that when we are being told by industry that a certain substance is used for certain applications and not for others one would be generally inclined to take that information as valid because it would not be in their interest to cheat on that. Also if the same information comes from a completely different source of toy manufacturers in the US, one would be inclined to think that that is a serious piece of information.
On the other hand the surveys that have been carried out are not necessarily representative if anything because some of them have been carried out with the intention of finding phthalates.
One of the new CSTEE members asked whether one could assume that the question asked was whether citrates/adipates were "better" than phthalates to which the chairman answered saying that, by inference, one could accept this to be in fact the question. However, in practical terms a positive answer could not be given as long as comparable data is not available since it is dangerous in toxicology to say something is safer because there is less data. That would make compounds on which there were no data the safest of all (absence of evidence is not evidence of absence).
A CSTEE member raised the point that it could in principle be possible to make conclusions on a chemical that is hydrolysed but some commented back saying that the breakdown rate of hydrolysis is not known and that, furthermore, hydrolysis products can be active. Even if ones contends that this is not likely, data is needed to prove that.
The discussion of this point was concluded in that a draft needed be prepared and circulated among working group members. A decision on whether to organise a meeting before the plenary would be taken depending on a number of variables as perceived need, availability of members, status of draft, etc.
Some suggested that, on the discussion on methods of phthalates extraction measuring, the important thing to do is decide what is the best method, also considering other methods in the US.
It was also suggested that the first issue to address is the draft on citrates/adipates. The 2nd issue is the tests and although the CSTEE has not been formally asked an opinion on those it would be interesting to see whether the working group thinks that they meet the criteria set by the CSTEE.
The representative of DG XXIV/A/4 reminded the CSTEE that, bearing in mind that there are a number of other materials which presumably are or can be used as replacements of soft PVC, if there is any remark that the CSTEE would like to make on those other materials its views will be extremely welcome. The DG III representative pointed out that any suggestions for the CSTEE to take on other tasks such as the one described should be discussed between the services before.
Finally the representative of DG XXIV/A/4 explained how they would like to proceed with the analysis of the TNO and LGC reports. In a first instance they submitted them to the 'Risk evaluation unit' of DG XXIV. On the basis of their analysis the issue will be discussed with other Commission services and a decision will be made on what questions will be asked to the CSTEE on this.
The CSTEE chairman suggested that the committee could as a starter just say whether they fit the criteria set by the CSTEE in their last opinion. A detailed analysis will not be carried out before the Commission submits terms of reference.
Regarding a possible update of the "Phthalates opinion" this will take place if necessary as and when data is provided that will indicate such a need.
11. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
On behalf of the chairperson of this working group the CSTEE secretary gave the committee information submitted by him. Basically a range of activities at OECD level, SETAC, etc. were mentioned, all of which should provide the CSTEE useful input on the subject. The CSTEE secretary also gave the information that, at the competent authorities meeting that had taken pace in Berlin in mid June and which the CSTEE secretary attended, M. States representatives were informed about the fact that the CSTEE had engaged in this activity with some of them showing interest in following it and/or participating. DE in particular have already contacted the CSTEE secretariat suggesting experts to integrate the CSTEE working group. Suggestions will be submitted to the working group chairperson for his appreciation.
12. Feedback from the competent services of the Commission on the follow up to the opinions adopted previously by the CSTEE
The representative of DG III made an account of the situation on Arsenic. The information on the possible voluntary commitment with industry given at the previous meeting was confirmed, but according to the procedures other EU institutions will have to be informed (EP, Council). A formal procedure will start soon.
Regarding asbestos the Commission proposed a more stringent directive (ban) than was the case before and EU M. States voted favourably but at the same time there is a WTO complain against France which is being assisted by the EC and the position of the CSTEE has been used in this context. However, even though the directive was voted favourably by M. States it needs to be formally adopted and in this case it is the Commission who should do so but the procedure has been momentarily suspended at the request of Commissioner L. Britain because of other WTO cases.
Regarding Creosote, the opinion stemmed from a request from M. States to keep their more stringent legislation and these decisions are at the stage if inter-service consultation. Some formal legal changes were considered necessary with the entry into force of the new Treaty, and that is why there have been delays.
The Creosotes opinion has been the subject of a letter from Tar manufacturers who wondered why there has been a revision of the opinion. The working group explained that this was due to the fact that the initial figures used in the calculations were incorrect.
On azo dyes there is a proposal for a ban which is also going through inter-service consultation and some comments are being taken into account before the proposal is finalised soon.
On Cadmium, PCP and Tin organic compounds a directive has also been proposed with which the M. States agreed and which has been published in the Official Journal. However, on Cadmium, as reported last time, DG III would like to review the Cadmium provisions as what has been done in the directive was giving the new M. States, Sweden and Austria, the possibility to keep their stricter legislation for an additional period of time as there is a lack of information. More data will be available under the existing substances regulation and perhaps also an update of the study which the CSTEE peer reviewed and found not very satisfying will be carried out. A draft specification for a study is being elaborated by the relevant Commission service.
A paper criticising the CSTEE approach in its opinion on tropospheric ozone was described and some of its content analysed vis à vis the previous debates on the subject. The criticisms in the paper are levelled vis à vis the AOT 40 concept in particular and were judged by the CSTEE difficult to accept as, from the paper, it was impossible to ascertain whether an argument was being either made in favour or against it.
13. Information related to the opinion on Human and Wildlife Health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on Ecotoxicology Test Methods
A short discussion on this topic took place. The message was reiterated by the CSTEE secretariat and endorsed by the CSTEE, that it should keep the watching brief, i.e. keep an eye on developments in view of improving/changing/updating the CSTEE opinion as and where it might become necessary.
The working group chairperson further informed that, by the look of the latest developments it seemed as if repeated low dose findings should not be considered any longer an issue. Effects are seldom reproduced, hence the doubts surrounding this issue. On the other hand, on the issue of tests, the in vitro ones are still preferred.
14. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
The CSTEE chairman informed the committee about the new rules of SSC membership. The SSC has continued its activities on BSE, this time on disposable fallen stock , dead animals which might have been contaminated. Other issue under its programme is antibiotic resistance on which an important meeting will take place during the current month of July and one important point already raised is that there is quite a knowledge gap on problems related to the environmental dissemination of antibiotics.
15. Arrangements for the next meeting of the CSTEE
The next plenary meeting was confirmed for the 27/28th of September 1999 in Brussels.
16. Any other business
The information was given that a consultation of the CSTEE might take place in the short term future on the Technical Guidance Document in support of the Biocides Directive (98/8/EC).
Prospects of a future consultation of the CSTEE on future finalised risk assessments produced under Regulation 793/93 were discussed. As DG XI had provided a list of the substances in the priority lists whose risk assessments are likely to be ready sooner, these were discussed The point to note is that none should be ready for submission before October 99. Hence presumably by the September plenary no news will be available yet.
The DG III representative gave the information that the CSTEE should expect to be consulted in a not too distant future on methylene chloride, textile chemicals and, as already said, on Cadmium.
Annexes:
I - Final agenda
II - Attendance list
SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE)
10th PLENARY MEETING - 1st of July 1999, 9H30 a.m.
National Institute of Public Health (Folkehelsa)
Geitmyrsveien 75 (access via Lovisenbergaten), Oslo, Norway
- DRAFT AGENDA (rev. 2)-
1. Adoption of the draft agenda
2. Presentation of new CSTEE members
3. Declarations of interest
4. Information from the CSTEE secretariat
5. Adoption of the draft minutes of the 9th CSTEE plenary meeting held on the 7th of May 1999 in Brussels
6. Progress reports on opinion requests related to the 'Water framework directive':
A.
I) Report from a study on Technical specifications for classification and presentation of ecological status of surface waters, March 1999 and
II) Report from a study on Technical specifications for monitoring of ecological status of surface waters, March 1999
B. Revised proposal for a list of priority substances in the context of the Water Framework Directive (COMMPS procedure) and Draft Final Report on the Assessment of options of the statistical treatment and evaluation of monitoring data within the COMMPS procedure
7. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission:
i) Opinion request on a proposed "ready biodegradability" approach to update detergent legislation (EC - DG III/C/4)
ii) Other
8. Euromarker in oil system - progress report
9. The use of measured exposure data in risk assessments - progress report
10. Toxicological characteristics and risks of certain citrates and adipates used as a substitute for phthalates in plasticisers in certain soft PVC products - progress report on the request for an opinion
11. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
12. Feedback from the competent services of the Commission on the follow up to the opinions adopted previously by the CSTEE (note: given the exceptional nature of the venue most of the information under this agenda item may have to be provided via the CSTEE secretariat)
13. Information related to the opinion on Human and Wildlife Health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on Ecotoxicology Test Methods
14. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
15. Arrangements for the next meeting of the CSTEE
16. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James W. BRIDGES, Prof. Philip L. CHAMBERS, Prof. Erik DYBING, Prof. Bo JANSSON, Prof. S. KYRTOPOULOS, Dr. Ole LADEFOGED, Prof. Dr. José RUEFF, Prof. Mirja SALKINOJA-SALONEN, Prof. Marco VIGHI, Prof. Joseph VOS, Prof. Dr. Helmut GREIM, Dr. Claude LAMBRE, Prof. Katarina VICTORIN, Prof Janneche U. SKARE, Prof. Marc COSTELLO
European Commission:
DG XXIV: Mrs M. de SOLÀ, Mr. J. COSTA-DAVID, Mrs A. FOKKEMA.
DG III/C/4: Mrs L. PERENIUS
