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Directorate-General for Health and Food Safety
1. Adoption of the draft agenda
The draft agenda was adopted with a change introduced in the order of some points.
2. Declarations of interest
No member of the CSTEE attending this meeting mentioned any interest in whatever capacity that might be considered detrimental to his/her independence.
3. Adoption of the draft minutes of the 7th CSTEE plenary meeting held on the 18th of January 1999
The draft minutes were adopted with some corrections made. CSTEE members would subsequently receive two versions of the minutes, one of which with the changes/corrections clearly highlighted for easier reference.
The minutes of all the previous CSTEE plenary meetings whose approval was still outstanding were considered adopted since no comments had been received by the deadline given (19 February 1999).
The chairman congratulated the CSTEE secretariat for the fullness of the minutes; 'they immediately draw the attention to what has been said as it is very easy for the CSTEE to forget after one week or so, what was precisely that was said'.
The CSTEE secretariat suggested the elaboration of shorter minutes. However, the chairman reiterated his wish to have this sort of minutes in the future.
4. Endocrine disrupters
(i) presentation and possible adoption of a draft report being prepared by the 'Endocrine disrupters' working group
All the chapters of the draft were discussed in detail. Compromises were reached on several aspects. The 'Endocrine disrupters' Working group chairperson explained that the version everybody received includes an executive summary and was mostly complete concerning the wildlife effects. The comments received from CSTEE and WG members were also dealt with in detail. There was a discussion on how developed the chapter on human health effects should be but a compromise was reached to leave it at the level of focus already in the draft. Another element of a more in depth discussion was the subject of ecological risk assessment for endocrine disrupting effects and how best to mention it in the report. The issue of in vitro assays for setting priorities for further testing as well as for supplying information for explaining modes of action and utilising in vitro assays for predicting in vivo endocrine disrupter effects was acknowledged to be a potential source of false positive as well as false negative results the conclusion being that major emphasis should be put on in vivo assays.
It was pointed out that the opinion dealt with mainly with the European situation and that some work still needed to be done on references but the responsible members of the WG had confirmed that they would send those soon.
The suggestions was also made that once finally agreed and edited the CSTEE opinion on EDCs should be published independently as it was the belief of the CSTEE that its scope and relevance is such that it deserves a wider circulation. It was also suggested that, given its specific focus on the wildlife situation perhaps sending the relevant bits, essentially from chapter 3 and 7, for publication in a referee journal such as Ecotoxicology or the SETAC journal could be considered; the latter in particular would have the advantage of having a circulation even across the Atlantic and furthermore the Weybridge conference on EDCs was organised by SETAC so they have an interest on the topic. Nobody objected in principle to either idea.
As regards formal adoption of the opinion the CSTEE accepted to consider it adopted at the date of the plenary. However, given the length of the document and the need to proof read it as well as to include the references still missing, it was agreed to give CSTEE members the right to come back, once they had received the final version, in case a major inaccuracy might still have been left in. Only then will it be sent for publication on Internet which has now been widely acknowledged as being the 'indication' that an opinion is final. In principle this should take place more or less within three weeks from the date of the plenary.
The issue of pagination and the need to ensure consistency regardless of publication format was raised. In principle this will be dealt with if the document is converted in PDF Acrobat format.
Finally the CSTEE secretary informed that this opinion is being eagerly waited by the Commission services, in particular DG XXIV as 'endocrine disruption' as a subject has been given priority by DG XXIV in its annual work program for this year and probably for the years to come.
(ii) presentation by other Commission services of developments on EDCs
Regarding the Commission draft policy paper on EDCs a representative of DG XI confirmed that they are working on a new version as a result of the inter-service consultation.
The CSTEE Secretary also gave information on the outcome of a meeting called 'Policy dialogue: Endocrine disrupters: perceptions and realities' organised by the International Academy of the Environment in Geneva that he had attended. Copies of the proceedings had been sent to the CSTEE. He emphasised the importance of the meeting in that, although it wasn't a scientific gathering and the proceedings reflect that, it is worth considering non-scientific issues when one discusses endocrine disrupters because of the communication and perception problems still characterising the subject. The proceedings give an idea of the kind of analysis and issues looked at when considering how we communicate on endocrine disrupters. Scientists should therefore take into account that one cannot separate totally scientific issues from policy issues and each has advantages in understanding the perspectives of the other.
A representative of DG XII informed that in June 1998 a meeting between the EU and the US on an agreement for joint R&D had taken place within which a formal agreement had been reached specifically on EDCs research. The idea was for the EU to organise a meeting on the topic in Europe. This was originally scheduled for October 1998 but finally re-scheduled for April this year in Ispra in the JRC. The aim is to discuss and reach maybe an agreement on a number of research topics linked to EDs that can be funded in part by the 5th framework programme and in part by the EPA. The meeting will take place from 19 to 21 April.
The CSTEE secretary also reminded that DG XXIV of the EC is financing two independent research projects the objective of which are contributing to validating a test method for detecting endocrine disrupters. One of the contractors is the Fraunhofer Institute and the other the Dutch RIVM. In principle they will be invited to one of the next plenary meetings and make a presentation on what they propose. This is as much something for the benefit of the CSTEE's information as for the contractors since they may have useful feed back from the CSTEE on their proposed work. In principle the Fraunhofer will present their project first as they proposed a one-year study and RIVM a longer one.
5. Tropospheric ozone - progress report on the draft opinion
The presentation was started by the WG rapporteur. He indicated that at the previous CSTEE plenary meeting in January a presentation had been made by XI/D/3 on ground level ozone and that one week later the CSTEE received the mandate with the consultation.
Several comments had meanwhile been sent to him, seven in total, the last one of which only one day before this plenary. Under such circumstances it was difficult to present a condensed version of a draft opinion based on such contributions.
He reminded that the opinion should be based essentially on comments made to the Position Paper on Tropospheric Ozone (Rev. 4.2, 23.01.99) from the ad hoc WG.
An important point to make is that already on point 1 there is some discrepancy in the answers regarding the AOT (accumulation over threshold). Two contributors to the draft are in agreement with the use of AOT and two others disagree. Given that the WG did not have time to meet a meeting seems mandatory. The WG rapporteur agreed to provide an elaborated draft within more or less 10 days but he expressed the wish to have a meeting of the WG as soon as possible.
The CSTEE commented that the apparent urgency that DG XI thought they had was no longer an issue since the problems linked to the inter-service consultation seemed to have been solved. The representatives of DG XI confirmed this but they expressed the wish to have, if possible, a preliminary opinion/impression from the CSTEE very soon in order to foster the proposal and to show that the scientific basis does not create major concerns with the CSTEE. On the other hand DG XI understood that the whole process of reviewing the approach followed and the huge nr. of pages in the provided documents needed more time from the CSTEE, hence an adoption of the opinion in May is acceptable. However a tentative opinion/views would be helpful at this stage.
The CSTEE secretary commented on the problems this sort of requests pose as there is a risk to assume that this preliminary views are 'the' opinion with people dismissing the fact that some work may still be needed. On the other hand, should the requester Commission services use information derived from this meeting that should not be a problem. What DG XI would not probably have would be a position in written form which could be understood to mean the official position of the CSTEE at a particular point in time. On the other hand information obtained from a WG meeting might reflect only the views of the WG members and not those of the CSTEE as a whole.
Some CSTEE members then commented on specific bits of the data submitted. Some would have welcomed comments on the scientific basis for discussing exceedances, particularly as the WG should have some guidance in that respect. Unfortunately those WG members who had specifically commented on those aspects were absent from the plenary today. Some others requested that the advantages of the AOT concept from a health-based standpoint be expanded upon.
One of the representatives of DG XI then attempted to explain why the AOT concept appears in the approach. First one has to distinguish between vegetation and human health. In vegetation the AOT has been used since a couple of years and it is now widely used as an example. Such reports are frequently prepared and issued by the so called co-ordination centre for effects under the UNECE convention on long range transboundary air pollution and contain, apart from acidification, the mapping of ozone in terms of AOT 40. It is therefore a well-known parameter and a well-known way of presenting the load on vegetation from ozone exposure.
On human health the AOT 60 is more a surrogate which has been used in the modelling exercises under the UNECE as well as for the purposes of developing a directive reducing the emissions all over Europe. It has been used because AOT 40 was considered as the best parameter for vegetation and in order not to require the modellers to develop a architecture purely for human health it was concluded in several meetings between vegetation related experts and those on human health that AOT 60 could be used as a technical parameter in the modelling reflecting the WHO guidelines because 60 ppb = 120µg and an AOT 60 above zero indicates a violation of the 120µg/8hours. Of course it expresses the pollution above 60 ppb in a different way because every exceedance is weighted with the excess, while simply counting the exceedances above 120 weights every exceedance with 1. This is the difference between the AOT concept and simply counting the exceedances. It is purely used for technical purposes to better handle the human health and the vegetation standards in an equal way. As can be seen from the position paper it has been proposed by the ad hoc WG rather than use the AOT 60. The traditional approach means setting a long term objective at 120µg and in addition to that proposing a target value which is also expressed in terms of exceedances of 120µg so the AOT 60 does not appear in the proposal for a standard for ozone for human health.
At this stage some CSTEE members requested further clarification on the AOT concept and one of the DG XI representatives volunteered to in the following way:
Because they had had a long discussion in the ad hoc WG on how really to define an AOT 40 as regards vegetation, WHO and the respective WG under the UNECE convention defined the AOT 40 as a parameter (there are in fact more than two AOT 40s, but here we refer to that related to vegetation and natural ecosystems) that the vegetation period that should be considered is three months and that the values should be used over daylight hours, these being defined at the time between fifty watt per square meter radiation coming from a clear sky. Admittedly this is quite complicated for regulatory purposes and this is the reason why attempts have been made to find out whether it's possible to define a fixed vegetation period of three months. Secondly a fixed daylight window was expressed in terms of simply hours and not requiring a calculation of radiation or even measurements (and an evaluation of data was done from various M. States in order to find out whether this is true for a northern latitude and as well for the Mediterranean area) and it turned out that the differences if fixed windows or several fixed windows were set between north and southern Europe would not be large (less than 10%).
Also the vegetation period could be set between May and July as it has been proposed without creating large differences. Of course the vegetation period is longer in the southern European area, however we had to confine ourselves to three months. That had been proved with real data from Spain and the difference was again below 10%. The conclusion therefore was that for regulatory purposes, for the purposes of the directive in order to give the authorities who measure the ozone and who have to calculate these AOT values to check them against the target values and the long terms objectives, that they should calculate that strictly starting on the 1st of May and ending on the 31st of July taking all one hour values between 8 a.m. and 8 p.m. i.e. 12 hours and this is a very clear and precise definition. It is also believed that this uncertainty could be emphasised, and the lack of accuracy low enough to justify that strict definition.
Hourly levels over a given period are summed up and that is a product of the concentration and the time, i.e. the basis is a timed series of one-hour values. Such data is available widely in Europe because of the current directive and then calculations are made for every hour between 8 a.m. and 8 p.m. The difference is calculated between the obtained value and 80 µg. If this difference is negative there is no need to use it in the accumulation, if it is positive it is summed up over the whole period of three months and a number expressed in µg/m3 times hours is obtained, so it's a concentration times time but neglecting the whole range of concentrations below 80µg.
The statement that the difference is less than 10% of course refers to the AOT 40 and as was explained this is the one part which contributes to the AOT 40 and the ozone in particular above 80µg. This is exactly the point because even though the daylight window is larger in northern countries ozone is low and in most cases below 80µg so it does not contribute to the AOT value as such.
This can be seen in the position paper in chapter 3 that has been produced by Sweden. From pictures on the X axis several ways of setting the window are depicted and this 8 a.m. to 8 p.m. does not differ very much from the light hours case which is the closest to the original WHO guidelines. The difference for all these stations is clearly less than 10% and even lower than 5 because the ozone above 80µg/m3 occurs in all cases in the afternoon so it does not matter whether one takes into account hours between e.g. 6 a.m. and 8 a.m. or even 8 p.m. to 10 p.m. as this is not contributing to the AOT hence the reason why this difference is surprisingly small.
On the issue of the boundaries of science and management DG XI were asked to explain why they had phrased the questions in the way they did. DG XI answered with one concrete example in question 6 on the information threshold and the so-called alert threshold because it could be inferred from the responses of several CSTEE members that, in particular the information threshold proposed to be set under 80 µg was raising the question whether this is scientifically justified and advisable. In this respect it should perhaps be said that the information in the alert threshold has purely the purpose of informing the public i.e. of advising people to behave in a different way in order to enable them to reduce their personal exposure to ozone. So this is not a standard for ozone and it has to be agreed that the question of 180µg is an arbitrary choice. However from the point of regulating this it would be an advantage to stick to 180 because it already appears in the current directive which has been in force since four or five years now and the public are used to that level and they know what it means. In other words they are familiar with the way the information is provided and also with the advises given.
Therefore if there are no real scientific objections against it this would have more the purpose of best regulating this kind of task that stems from the framework directive and the ozone directive. The same is true for 240 but from the notes it would appear that the CSTEE would endorse that as a level where the general population is affected in a way that advice should be given. The bottom line is that this had clearly a regulatory purpose. There is also the question of setting a standard for ozone at 120 rather than 160 and these are the two questions which are most important for us at the moment.
In spite of insistent requests from DG XI to have the views, even informal ones, from the CSTEE on the 120 versus 160 issue, CSTEE members expressed reluctance about giving advice at this stage on it before having a discussion in the WG.
The tentative date of 26 March was provisionally agreed for the WG meeting.
6. 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
The WG chairperson presented this topic. The documentation in connection to this topic (only on citrates) previously distributed had been considered and a small paper had been prepared that tried to summarise the data. One conclusion was that the data are not very good neither from a qualitative nor a quantitative standpoint. Deficiencies were related to being old, not up to modern standards and with a series of important end-points not being addressed at all. On such a basis it proved impossible to move forward relative to citrates.
On the other hand, document CSTEE/98/17-Add 33, a so-called Morflex study (Preliminary Risk Characterisation for Acetyl Tributyl Citrate Used as a Plasticiser in Polyvinyl Chloride Children's Toys" prepared by Andrey I. Nikiforov, Ph.D. Program Director TRS - February 1999), adds substantive information which may enable the CSTEE to move forward because it is pointed out, but without giving references, that there is a modern two generation reproductive study with a clear defined NOAEL, including also valuable information as to the leachability of the citrates compared to DINP. The potential usefulness of such data indicates that it would be important to have this documentation made available to the CSTEE as soon as possible. This would put the CSTEE in a much better position to address the questions which have been posed with respect to the citrates.
Another point made was that these studies don't give any information as to whether these are the 'main' citrates or what proportion of the total market in respect to these products are these used for.
With respect to the adipates the chairperson had not done much more than an open search in the available databases and found that there are quite a number of data and reports on only one adipate. No specific data related to the exposure part which directly addresses the leachability of adipates from children's toys was found.
In general CSTEE members concurred in that information in the documents distributed was of bad quality. As an example it was mentioned that no references were made to the metabolic pathways. Another problem, admittedly not addressed by the terms of reference, is that PVC contains huge amounts of cadmium and as such, in terms of repercussions to health, this should be addressed as well. Still other possible problem not addressed in the data provided to the CSTEE is that that concerns pharmacological effects of citrates including impairment of muscular responses and a possible risk of adverse neurological effects.
The conclusion is that the reports that are discussed in the Reilly documents are needed. Once they are reviewed perhaps the CSTEE can come up with some answers to the questions posed for this specific citrate. The WG chairperson therefore urged the Commission's services to make available any other information that is available on other citrates and adipates depending on whether these materials are at all in use as discussed at the last meeting
The CSTEE secretary explained that a decision had been taken at a M. States meeting organised by DG III in February (Directive 76/769) to the effect that M. States and Industry should make available to DG III the data they have. This would subsequently be made available to the CSTEE secretariat. DG III concurred and informed that so far only Sweden had made some limited information, essentially confirming that there was very little data available in the public domain on phthalate's substitutes.
The representative of the requester service (XXIV/A/4) confirmed that documentation would be pursued more actively, not only from industry but also from the Scientific Committee for Food as this scientific committee is known to have looked to these chemicals, although apparently without any conclusive evidence.
Regarding the issue of obtaining data for answering opinion requests, and in response to a specific question asked by the WG chairperson, the CSTEE secretary confirmed that although it is nice to have CSTEE's members collaboration in obtaining relevant data, this cannot be considered an obligation on their part and that it is the responsibility of the requester Commission service to obtain the information that will essentially allow for answers to be given to the questions in the terms of reference;
The chairman concluded this point saying that the committee will react when they receive the next instalment of information on the subject.
7. Possible revision of the opinion on Creosote containing less than 50 ppm benzo-[a]-pyrene
A new version of the opinion was adopted. A draft, previously revised by some WG members, had been circulated by the CSTEE secretariat before the plenary.
The requester service, DG III, although concurring that some of the changes were not, strictly speaking, minor ones, they were not such that would lead them to change the risk management measures they had envisaged anyway. The CSTEE secretary informed that the revised version would replace the 'older' one on Internet as soon as possible.
8. Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment - information concerning the mandate for a working group and possible presentation and discussion of working paper
This activity stems from a very old proposal on hazard assessment for the terrestrial environment from the classification and labelling committee four years ago on development of classification criteria. Since then the process for risk assessment had developed a lot and looking for a comparison the observation was made that there was a real lack of scientific basis for both hazard and risk assessment for the terrestrial environment.
Spain and other M. States have created a WG for the Classification & Labelling (C&L) system and a workshop was hosted in November 1998 in Madrid by the Spanish ministry of the environment (to which CSTEE members were invited with some attending).
How and when the CSTEE should be involved is an issue that can still be discussed. In the meantime collaboration with the ESR risk assessment group is being attempted, particularly considering the involvement on the risk assessment for industrial chemicals, pesticides, veterinary medicines and biocides.
Good agreement seems to exist on the scientific basis for the risk assessment for the aquatic environment, which are also in agreement with the priority setting of water quality objectives by the previous committee (CSTE). On the other hand the scientific basis does not exist for the terrestrial environment and very different approaches have been observed such as very different taxonomic groups being addressed, very different methods being used and even very different margins of safety for the same taxonomic groups/organisms exposed through the same route, a fact that does not have scientific sense.
An attempt was made by the appointed WG chairperson to summarise all the problems in these proposals. For the hazard assessment the main topic was the above soil compartment of the workshop held in Spain. There were five different proposals for criteria for the soil compartment but there was only one proposal for the above soil compartment hence the need to focus on that. This should not mean developing classification criteria, although it might make sense to consult the CSTEE on that in the future. At an ECB WG meeting it was agreed between M. States that it was a good idea to involve the committee also in the development of classification criteria but not now because a large meeting for the more regulatory aspects will take place by the end of the year. This will also involve people from pesticides in view of having first a compromise and then look for more scientific views. In any case it is very important to start this right now because if the CSTEE is consulted for classification criteria it is important to know what are the scientific basis and gaps.
The CSTEE should start by addressing what are the intrinsic properties of chemicals in the terrestrial environment that can be used in hazard assessment, including dose/response effects assessment used in the risk analysis.
For the risk assessment the WG chairperson attempted to summarise the facts with five different points that represent the approaches that are used for the aquatic system and are more or less agreed. An attempt was also made to summarise the different approaches followed for other risk assessments comparing the industrial chemicals with the TGDs recommendations for pesticides, veterinary products and the new draft for biocides.
In some cases it can be observed that a chemical is at the same time an industrial chemical, a pesticide, a PPP and a biocide and it has no sense that for the same chemical the final concentration in the environment is assessed in a different way depending on whether you consider the molecule as a pesticide or a biocide. The exposure should be different because it should be related to the use but the effect that you should expect for the same concentration of the same chemical in the soil should be the same and therefore we need some kind of general agreement.
As a conclusion the WG chairperson proposed that the WG should address the very basic scientific concepts for the hazard and risk assessment for the terrestrial environment without this being related neither to any existing opinion specifically for the development of classification criteria nor for the risk assessment of existing chemicals. The idea would rather be do something along the lines of what was done on EDCs, a state of the art assessment, particularly for the above soil compartment. Different items need to be covered and in principle, because there is not much basic information available apart from the risk assessment reports, the proceedings of the Madrid workshop and other basic information, it seems realistic to aim to finalise the report by the end of the year.
As regards membership/expertise in the WG, apart from CSTEE members, at least 4 external experts should be needed to cover soil/ecotoxicity effects and exposure on plants, wildlife animals, in particular top predators and invertebrates. The WG chairperson informed the CSTEE of the suggestions he had to make for members of the WG and these were accepted. Two other CSTEE members also made suggestions of possible outside experts to be appointed to the WG and these were also accepted. In passing comments were made on the particular difficulty posed by assessment of effects on plants. The title of the report should be very general such as 'Scientific basis for the hazard and risk assessment for the terrestrial environment' if possible 'with particular attention to the above soil compartment'.
The CSTEE secretary asked the WG chairperson to make available as soon as possible a table of contents for the report. The WG chairperson confirmed that he would send one soon.
9. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission
DG III gave the information that on cadmium a favourable opinion had been given by the TPC in February which allows for Sweden and Austria to keep their national legislation up to 2003. Before that date the Commission will again review provisions. There is hope to have by then results from the Existing Substances Regulation evaluation on Cadmium that is ongoing and a few additional studies that may be needed. But since the timetable for the evaluation on cadmium under the ESR is still a little bit uncertain DG III have decided to launch an additional study trying to fill the gaps that were identified by the CSTEE in the previous study and the committee will be consulted on the specifications.
Furthermore DG III also informed that they have two more studies ongoing, one on sensitising azo dyes on which information had been given at the previous meeting and whose results are expected before the summer of 1999. Early this year (1999) a risk assessment of Methylene chloride was also launched. This is a 6-month study being carried out by the TNO of NL.
10. Feedback from the competent services of the Commission on the follow up to the opinions adopted by the CSTEE on:
(i) Water Framework Directive
The texts agreed upon by the EP and the Council were adopted in the first opinion of the EP in 11 February with a total of 122 amendments. Next week the Council is likely to adopt the first stage of the common position but some of these points do not really regard the recommendations of the committee. Most of them were far stronger political issues of disagreement such as the phasing out of hazardous substances, the generous deadline the Council gave itself and the charging of water costing.
On the other hand a few of them are actually related to more technical issues such as a closer association of wetlands to the proposal which the Council accepted and the Commission has put forward in our amended proposal. The EP as such did not address any other technical issues apart from the odd suggestion for a better formulation. They did not actually pursue any ideas of the CSTEE or any other ideas that had come to them from outside parties so the annexes remain as the June text Council made the political agreement last year.
DG XI had little basis under those circumstances to take issues much further in its amended proposal because that would be founded on the proposed amendments from the EP. A few formulations have been accepted which should give a more transparent text but from the big issues raised by the CSTEE one thing that has been addressed by the EP and that has been accepted by the Council text as well is to change the terminology from moderate to what it really is, fair, i.e. not very good quality. Two additional categories have also been added, the poor and bad categories. They are not in any way as detailed in a normative definition as some would have liked but they are there as a foothold for further developments at least and it is reassuring to see that the Council quite readily accepted to put in those two categories.
The major issue of finding indicators and in particular indicators of function rather than ecological structure as the definitions include today has not been developed further in the text of the Council and the committee thinks that this is something that requires quite a lot of research to make it operational. Theoretically it is there but to find real indicators on which functions would be chosen to actually represent an ecosystem is the big issue. Not being able to pursue those issues inside the present text and with Council not giving the possibility of amending the annexes by a committee procedure that was rejected for almost everything in the annexes means that a completely new proposal with EP and all the institutions involved is necessary and therefore this is a long term project.
The decision was taken instead to insert a revision clause in the article on the management committee, then the CSTEE's expertise could be used to issue guidelines. This is where a big possibility is for exploring the issues raised by the CSTEE in its recommendations. In order to prepare for that the Commission services drafted an implementation plan which has been discussed with M. States and has been sent to outside Commission parties as well. This was done because it could be seen that given the political controversies between Council and EP it could take quite some time before this proposal was adopted, not withstanding that, one of the major issues of dispute between the two institutions ironically is shortening the timetable for implementation. They are certainly taking their time but various other issues were explored with a view to take the questions forward in guidelines. The JRC in Ispra has been contacted not least on the issue of structure function where Ispra has got experience at lest with one functional parameter, the phosphorus cycle and also on the question raised by the CSTEE on biomarkers which will be pursued in a research initiative sometime this year or next year.
The CSTEE will hear more of this in the course of DG XI's contacts with the EEA. They were involved in the whole technical part of the directive and the Marine Topic Centre is trying to describe the hydro-morphological and other characteristics of estuaries and what are now called transitional waters. This is an activity that started very recently. The Fresh Water Inland Topic Centre is permanently involved in it and contacts are established almost weekly on developing for instance hydromorphology as the Council as such did not want to have it as an independent parameter. However DG XI are trying to discuss with the topic centre ways to have the hydromorphology better represented indirectly via the biology and the ecology of the waters. In that context a couple of study contracts were launched last year where the WRC (water research centre) in the UK and a couple of other organisations are looking further into some of the questions related to hydromorphology and biomarkers.
It is expected that a report comes out some time soon where the questions raised in the recommendations of the CSTEE are specifically addressed and the draft that was made available indicates a sort of refined questioning on them and ongoing research and experience are identified. There will certainly be some food for thought in that report to continuing discussing those issues once those two reports are ready.
The reports are really two 'brothers' or 'sisters', one is focussing on monitoring and monitoring requirements and the respective research needs and the other is focussing on classification definitions and research needs.
There is also an interesting new player, the European River Restoration Centre, which started as a co-operation between the UK, DK, DE, the NL and is later this month (March 99) going public with participants from the wider European area. It can be said that they are establishing an exchange centre on further development of river restoration at the end of this month and going into the pan-European context. They are very closely linked to the interest and need in defining practical reference conditions for various status or improvements of the waters in particular rivers.
This should provide an unexpected input into the question of establishing proper reference conditions and comparing the various types of reference conditions and it should provide some experience with the inter-calibrations so that some soundness to the available principles can be ensured and also ability to compare across the community even between different climatic and ecological regions. Annex V is now virtually finished but we have the possibility of issuing guidance which DG XI intends to pursue quite vigorously.
The terminology and definitions will also be pursued in that context. It is too early to start thinking of revising Annex V but there will be a need for not just non-legally binding guidance but probably to fix in a legally binding text at some stage when one we gets closer to that.
The various ideas and recommendations available on choice of indicators such as which organisms and what they represent, functions, structures, how is hydromorphology reflected, etc, these will be pursued as well in that context. Apart from what was mentioned a specific institutional context does not exist but it is one of the issues DG XI is trying to take forward discussing with the M. States in a shadow implementation plan.
On the priority substances the Fraunhofer Institute has finalised the revised report and that should arrive in the coming week and will immediately be submitted to the CSTEE for further discussion. On the 19th of April there will be a meeting to discuss the way forward with the priority substances and in particular the Fraunhofer revised report and their proposals/suggestions for actual priority substances. The 'Water Framework Directive' WG chairperson will be invited.
That's where we are but DG XI would like to keep the close contacts they have had with the CSTEE and provide it with the various reports and results as they come. Hopefully there will be a point on the agenda of a CSTEE meeting where, probably towards summer, the results of the two studies we are expecting on classification and monitoring can be discussed. Regarding what will come out of the hydromorphology and classification or characterisation studies of the marine topic centre and the Ispra JRC this is a long-term activity.
Finally the DG XI representative emphasised again that they have been extremely happy for working with the CSTEE and the exchange of points of view and the recommendations that it gave DG XI as a firm basis to pursue some of the important issues on the WFD.
(ii) Council Regulation (EEC) 793/93:
- 2-(2-butoxyethoxy)ethanol
- 2-(2-methoxyethoxy)ethanol
- Alkanes, C10-13, Chloro
- Benzene, C10-13-Alkyl derivs
Due to the absence of a representative from the competent Commission service (XI/E/2) no feed back to the CSTEE was given.
(iii) Phthalates in toys
A representative from DG III informed that the Commission internal debate on the long-term harmonised measures for phthalates in toys was still ongoing.
The representative of DG XXIV/A/4 further informed the CSTEE that action would be taken stimulating research efforts on some of the areas identified in the CSTEE opinion as needing further research. Research on buccal absorption is likely to be launched and an eye is generally being kept on different ideas about migration methods and their validation.
On the other side of the Atlantic the US have set up an independent panel under the guidance of the US surgeon general to look further into the issue of the use of phthalates in PVC consumer products and the focus of the preoccupation of this group seems to be the potential carcinogenicity of phthalates.
The WG chairperson indicated that the US consumer product safety commission has issued a report in December 1998 that was made available to him. He expressed the view that it deserves being distributed among the WG and CSTEE as not only does it substantiate what the CSTEE said in its opinions, it also addresses some of the CSTEE's uncertainties and besides it is always helpful to see what the US are doing.
Finally some CSTEE members reminded the secretariat that they had suggested that a specialised meeting, e.g. a workshop, should be organised by the Commission on peroxisome proliferation as one of the conclusions in the CSTEE's opinions had been that this was an area where an international consensus is necessary.
(iv) Directive 76/769 (EEC):
- Chrysotile asbestos and substitute fibres
The representative of the responsible Commission service (DG III) informed that the work on Commission directive on asbestos was ongoing. They had almost finalised all outstanding questions and a proposal for a directive on asbestos will be put before the TPC for voting.
- Cadmium
- Tin
- Pentachlorophenol
On Cadmium, Sweden and Austria are allowed to keep their national legislation till 2003 pending further risk assessments and further developments. The directive will be reviewed again before that date. As regards Tin and PCP these are subject to the same Commission directive and they were put to the voting committee of M. States who gave a favourable opinion. This is now up to formal adoption by the Commission. The directive on Tin includes a ban on the so-called free association paints, the ones with an uncontrolled leaching, and it also includes a ban on the use of TBTO in fresh water. Furthermore there will be a review before 2003 following developments in the IMO because it is expected that the IMO assembly will take during the Spring of 1999 a decision for a global ban on TBTO. This will allow the Commission to introduce that into the directive as soon as this happens. On PCP a total ban has been introduced but it will not be total until 2008 for M. States who have a maritime climate. For other M. Sates it takes effects immediately.
- Azo dyes
Following the opinion of the committee on the risk of cancer caused by textiles and leather goods coloured by azo dyes DG III has prepared a draft proposal for a directive banning carcinogenic azo-dyes.
The CSTEE Secretary informed the committee of a slight change made to the Azo dyes opinion. The correction (removal of one sentence) was considered of no consequence in terms of the risk management strategy that the requester service had envisaged for it. In spite of this, as DG III are having a meeting next Monday it is important to make sure that we agree on the change (the change was agreed).
11. Information on matters not covered elsewhere in the agenda:
(i) Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
In the absence of the CSTEE chairman the secretary made a brief presentation essentially based on data obtained from the minutes of the 21-22 January SSC meeting. Of particular interest to the CSTEE was the activity on 'harmonisation of risk assessment procedures' in respect of which the representative of XXIV/B/1 informed that since January 1999 the only progress made is that the first meeting of the risk assessment WG will take place on the 17th of March, the day before the next SSC plenary. The chairman of the risk assessment group has still to send a draft for discussion
The CSTEE secretary informed that another point raised concerned the need to increase the capacity of the secretariats to provide scientific support to the committees. Still another point raised was that on industry representatives in WG meetings.
(ii) Developments on the subject of the brief of the CSTEE
As regards the brief of the CSTEE there were no developments worthy of note apart from the fact that the committee will be consulted on biocides. It is possible also that the CSTEE may be involved in a different area of work which is to do with materials used in water pipes used for human consumption involving the possible issue of migration of chemicals from these water pipes into water itself.
12. Arrangements for the next meeting of the CSTEE
The CSTEE secretary informed that the prospects for the May plenary meeting of the CSTEE were that it would be a one day meeting only as apparently the only substantive topic for discussion will be 'Tropospheric ozone'.
Unless confirmation arrives soon that it will be necessary to hold it over two days, the decision was taken to hold it Friday, the 7th of May 1999.
13. Any other business
One CSTEE member commented on the fact that he had been approached on behalf of a group of Cadmium pigment producers, requesting information on the amendments to the Cadmium paper and enquiring on whether it would be possible to receive from the Cadmium WG chairperson guidance on what work was needed to clarify the remaining uncertainties from the previous Cadmium Risk assessment and to recommend who best to be commissioned to carry it out. The WG chairperson had declined to answer because he thought it would be incorrect to do so without consulting the CSTEE first.
The CSTEE secretary confirmed that attempts have been made in the past to give out this sort of information to whoever approaches CSTEE members individually. The CSTEE were reminded that in similar circumstances all they should be saying is that contacts should be established either at the level of the CSTEE secretariat or the Commission service responsible for the particular opinion request at stake. This approach was endorsed by the CSTEE explicitly and they called on the Commission to produce a code of conduct for lobbyists as soon as possible.
Given the current prospects in terms of workload, the July plenary meeting of the CSTEE will in principle be a one-day meeting. The CSTEE secretary will check whether the necessary authorisation for it to take place in Oslo after the Eurotox meeting can be obtained. The chairman of the Eurotox congress, member of the CSTEE, pointed out that it is important to decide, in case the July plenary meeting takes effectively place in Oslo, whether it will be a one or two day one as those who are planning to participate in the congress should register ASAP to get the low registration fee.
Annexes: I - Draft agenda
Scientific committee on Toxicity, Ecotoxicity and the Environment (CSTEE) - 8th plenary meeting - Brussels - 4th march 1999, 9h30a.m. - agenda -
1. Adoption of the draft agenda
2. Declarations of interest
3. Adoption of the draft minutes of the 7th CSTEE plenary meeting held on the 18th of January 1999
4. Endocrine disrupters -
(i) presentation and possible adoption of a draft report being prepared by the 'Endocrine disrupters' working group;
(ii) presentation by other Commission services of developments on EDCs
5. Tropospheric ozone - progress report on the draft opinion
6. 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
7. Possible revision of the opinion on Creosote containing less than 50 ppm benzo-[a]-pyrene
8. Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment - information concerning the mandate for a working group and possible presentation and discussion of working paper
9. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission
10. Feedback from the competent services of the Commission on the follow up to the opinions adopted by the CSTEE on:
(i) Water Framework Directive
(ii) Council Regulation (EEC) 793/93:
- 2-(2-butoxyethoxy)ethanol
- 2-(2-methoxyethoxy)ethanol
- Alkanes, C10-13, Chloro
- Benzene, C10-13-Alkyl derivs
(iii) Phthalates in toys
(iv) Directive 76/769 (EEC):
- Chrysotile asbestos and substitute fibres
- Cadmium
- Tin
- Pentachlorophenol
- Azo dyes
11. Information on matters not covered elsewhere in the agenda:
(i) Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
(ii) Developments on the subject of the brief of the CSTEE
12. Arrangements for the next meeting of the CSTEE
13. Any other business
List of participants
CSTEE:
Prof. Philip L. CHAMBERS, Prof. Erik DYBING, Prof. Bo O. JANSSON, Prof. S. KYRTOPOULOS, Dr. Claude LAMBRÉ, Prof. Dr. José RUEFF, Prof. Mirja SALKINOJA-SALONEN, Dr. José V. TARAZONA, Prof. Marco VIGHI, Prof. Joseph VOS,
European Commission:
DG XXIV: Mrs M. de SOLÀ, Mr. J. COSTA-DAVID, Mrs. M. LAURIDSEN, Mrs A. FOKKEMA
DG III: Mrs. L. PERENIUS, Mr. SORO
DG XI: Mr. T. PETRIE, Mrs. H. NOVER
DG XII: Mr. L. BONTOUX
The draft agenda was adopted with a change introduced in the order of some points.
2. Declarations of interest
No member of the CSTEE attending this meeting mentioned any interest in whatever capacity that might be considered detrimental to his/her independence.
3. Adoption of the draft minutes of the 7th CSTEE plenary meeting held on the 18th of January 1999
The draft minutes were adopted with some corrections made. CSTEE members would subsequently receive two versions of the minutes, one of which with the changes/corrections clearly highlighted for easier reference.
The minutes of all the previous CSTEE plenary meetings whose approval was still outstanding were considered adopted since no comments had been received by the deadline given (19 February 1999).
The chairman congratulated the CSTEE secretariat for the fullness of the minutes; 'they immediately draw the attention to what has been said as it is very easy for the CSTEE to forget after one week or so, what was precisely that was said'.
The CSTEE secretariat suggested the elaboration of shorter minutes. However, the chairman reiterated his wish to have this sort of minutes in the future.
4. Endocrine disrupters
(i) presentation and possible adoption of a draft report being prepared by the 'Endocrine disrupters' working group
All the chapters of the draft were discussed in detail. Compromises were reached on several aspects. The 'Endocrine disrupters' Working group chairperson explained that the version everybody received includes an executive summary and was mostly complete concerning the wildlife effects. The comments received from CSTEE and WG members were also dealt with in detail. There was a discussion on how developed the chapter on human health effects should be but a compromise was reached to leave it at the level of focus already in the draft. Another element of a more in depth discussion was the subject of ecological risk assessment for endocrine disrupting effects and how best to mention it in the report. The issue of in vitro assays for setting priorities for further testing as well as for supplying information for explaining modes of action and utilising in vitro assays for predicting in vivo endocrine disrupter effects was acknowledged to be a potential source of false positive as well as false negative results the conclusion being that major emphasis should be put on in vivo assays.
It was pointed out that the opinion dealt with mainly with the European situation and that some work still needed to be done on references but the responsible members of the WG had confirmed that they would send those soon.
The suggestions was also made that once finally agreed and edited the CSTEE opinion on EDCs should be published independently as it was the belief of the CSTEE that its scope and relevance is such that it deserves a wider circulation. It was also suggested that, given its specific focus on the wildlife situation perhaps sending the relevant bits, essentially from chapter 3 and 7, for publication in a referee journal such as Ecotoxicology or the SETAC journal could be considered; the latter in particular would have the advantage of having a circulation even across the Atlantic and furthermore the Weybridge conference on EDCs was organised by SETAC so they have an interest on the topic. Nobody objected in principle to either idea.
As regards formal adoption of the opinion the CSTEE accepted to consider it adopted at the date of the plenary. However, given the length of the document and the need to proof read it as well as to include the references still missing, it was agreed to give CSTEE members the right to come back, once they had received the final version, in case a major inaccuracy might still have been left in. Only then will it be sent for publication on Internet which has now been widely acknowledged as being the 'indication' that an opinion is final. In principle this should take place more or less within three weeks from the date of the plenary.
The issue of pagination and the need to ensure consistency regardless of publication format was raised. In principle this will be dealt with if the document is converted in PDF Acrobat format.
Finally the CSTEE secretary informed that this opinion is being eagerly waited by the Commission services, in particular DG XXIV as 'endocrine disruption' as a subject has been given priority by DG XXIV in its annual work program for this year and probably for the years to come.
(ii) presentation by other Commission services of developments on EDCs
Regarding the Commission draft policy paper on EDCs a representative of DG XI confirmed that they are working on a new version as a result of the inter-service consultation.
The CSTEE Secretary also gave information on the outcome of a meeting called 'Policy dialogue: Endocrine disrupters: perceptions and realities' organised by the International Academy of the Environment in Geneva that he had attended. Copies of the proceedings had been sent to the CSTEE. He emphasised the importance of the meeting in that, although it wasn't a scientific gathering and the proceedings reflect that, it is worth considering non-scientific issues when one discusses endocrine disrupters because of the communication and perception problems still characterising the subject. The proceedings give an idea of the kind of analysis and issues looked at when considering how we communicate on endocrine disrupters. Scientists should therefore take into account that one cannot separate totally scientific issues from policy issues and each has advantages in understanding the perspectives of the other.
A representative of DG XII informed that in June 1998 a meeting between the EU and the US on an agreement for joint R&D had taken place within which a formal agreement had been reached specifically on EDCs research. The idea was for the EU to organise a meeting on the topic in Europe. This was originally scheduled for October 1998 but finally re-scheduled for April this year in Ispra in the JRC. The aim is to discuss and reach maybe an agreement on a number of research topics linked to EDs that can be funded in part by the 5th framework programme and in part by the EPA. The meeting will take place from 19 to 21 April.
The CSTEE secretary also reminded that DG XXIV of the EC is financing two independent research projects the objective of which are contributing to validating a test method for detecting endocrine disrupters. One of the contractors is the Fraunhofer Institute and the other the Dutch RIVM. In principle they will be invited to one of the next plenary meetings and make a presentation on what they propose. This is as much something for the benefit of the CSTEE's information as for the contractors since they may have useful feed back from the CSTEE on their proposed work. In principle the Fraunhofer will present their project first as they proposed a one-year study and RIVM a longer one.
5. Tropospheric ozone - progress report on the draft opinion
The presentation was started by the WG rapporteur. He indicated that at the previous CSTEE plenary meeting in January a presentation had been made by XI/D/3 on ground level ozone and that one week later the CSTEE received the mandate with the consultation.
Several comments had meanwhile been sent to him, seven in total, the last one of which only one day before this plenary. Under such circumstances it was difficult to present a condensed version of a draft opinion based on such contributions.
He reminded that the opinion should be based essentially on comments made to the Position Paper on Tropospheric Ozone (Rev. 4.2, 23.01.99) from the ad hoc WG.
An important point to make is that already on point 1 there is some discrepancy in the answers regarding the AOT (accumulation over threshold). Two contributors to the draft are in agreement with the use of AOT and two others disagree. Given that the WG did not have time to meet a meeting seems mandatory. The WG rapporteur agreed to provide an elaborated draft within more or less 10 days but he expressed the wish to have a meeting of the WG as soon as possible.
The CSTEE commented that the apparent urgency that DG XI thought they had was no longer an issue since the problems linked to the inter-service consultation seemed to have been solved. The representatives of DG XI confirmed this but they expressed the wish to have, if possible, a preliminary opinion/impression from the CSTEE very soon in order to foster the proposal and to show that the scientific basis does not create major concerns with the CSTEE. On the other hand DG XI understood that the whole process of reviewing the approach followed and the huge nr. of pages in the provided documents needed more time from the CSTEE, hence an adoption of the opinion in May is acceptable. However a tentative opinion/views would be helpful at this stage.
The CSTEE secretary commented on the problems this sort of requests pose as there is a risk to assume that this preliminary views are 'the' opinion with people dismissing the fact that some work may still be needed. On the other hand, should the requester Commission services use information derived from this meeting that should not be a problem. What DG XI would not probably have would be a position in written form which could be understood to mean the official position of the CSTEE at a particular point in time. On the other hand information obtained from a WG meeting might reflect only the views of the WG members and not those of the CSTEE as a whole.
Some CSTEE members then commented on specific bits of the data submitted. Some would have welcomed comments on the scientific basis for discussing exceedances, particularly as the WG should have some guidance in that respect. Unfortunately those WG members who had specifically commented on those aspects were absent from the plenary today. Some others requested that the advantages of the AOT concept from a health-based standpoint be expanded upon.
One of the representatives of DG XI then attempted to explain why the AOT concept appears in the approach. First one has to distinguish between vegetation and human health. In vegetation the AOT has been used since a couple of years and it is now widely used as an example. Such reports are frequently prepared and issued by the so called co-ordination centre for effects under the UNECE convention on long range transboundary air pollution and contain, apart from acidification, the mapping of ozone in terms of AOT 40. It is therefore a well-known parameter and a well-known way of presenting the load on vegetation from ozone exposure.
On human health the AOT 60 is more a surrogate which has been used in the modelling exercises under the UNECE as well as for the purposes of developing a directive reducing the emissions all over Europe. It has been used because AOT 40 was considered as the best parameter for vegetation and in order not to require the modellers to develop a architecture purely for human health it was concluded in several meetings between vegetation related experts and those on human health that AOT 60 could be used as a technical parameter in the modelling reflecting the WHO guidelines because 60 ppb = 120µg and an AOT 60 above zero indicates a violation of the 120µg/8hours. Of course it expresses the pollution above 60 ppb in a different way because every exceedance is weighted with the excess, while simply counting the exceedances above 120 weights every exceedance with 1. This is the difference between the AOT concept and simply counting the exceedances. It is purely used for technical purposes to better handle the human health and the vegetation standards in an equal way. As can be seen from the position paper it has been proposed by the ad hoc WG rather than use the AOT 60. The traditional approach means setting a long term objective at 120µg and in addition to that proposing a target value which is also expressed in terms of exceedances of 120µg so the AOT 60 does not appear in the proposal for a standard for ozone for human health.
At this stage some CSTEE members requested further clarification on the AOT concept and one of the DG XI representatives volunteered to in the following way:
Because they had had a long discussion in the ad hoc WG on how really to define an AOT 40 as regards vegetation, WHO and the respective WG under the UNECE convention defined the AOT 40 as a parameter (there are in fact more than two AOT 40s, but here we refer to that related to vegetation and natural ecosystems) that the vegetation period that should be considered is three months and that the values should be used over daylight hours, these being defined at the time between fifty watt per square meter radiation coming from a clear sky. Admittedly this is quite complicated for regulatory purposes and this is the reason why attempts have been made to find out whether it's possible to define a fixed vegetation period of three months. Secondly a fixed daylight window was expressed in terms of simply hours and not requiring a calculation of radiation or even measurements (and an evaluation of data was done from various M. States in order to find out whether this is true for a northern latitude and as well for the Mediterranean area) and it turned out that the differences if fixed windows or several fixed windows were set between north and southern Europe would not be large (less than 10%).
Also the vegetation period could be set between May and July as it has been proposed without creating large differences. Of course the vegetation period is longer in the southern European area, however we had to confine ourselves to three months. That had been proved with real data from Spain and the difference was again below 10%. The conclusion therefore was that for regulatory purposes, for the purposes of the directive in order to give the authorities who measure the ozone and who have to calculate these AOT values to check them against the target values and the long terms objectives, that they should calculate that strictly starting on the 1st of May and ending on the 31st of July taking all one hour values between 8 a.m. and 8 p.m. i.e. 12 hours and this is a very clear and precise definition. It is also believed that this uncertainty could be emphasised, and the lack of accuracy low enough to justify that strict definition.
Hourly levels over a given period are summed up and that is a product of the concentration and the time, i.e. the basis is a timed series of one-hour values. Such data is available widely in Europe because of the current directive and then calculations are made for every hour between 8 a.m. and 8 p.m. The difference is calculated between the obtained value and 80 µg. If this difference is negative there is no need to use it in the accumulation, if it is positive it is summed up over the whole period of three months and a number expressed in µg/m3 times hours is obtained, so it's a concentration times time but neglecting the whole range of concentrations below 80µg.
The statement that the difference is less than 10% of course refers to the AOT 40 and as was explained this is the one part which contributes to the AOT 40 and the ozone in particular above 80µg. This is exactly the point because even though the daylight window is larger in northern countries ozone is low and in most cases below 80µg so it does not contribute to the AOT value as such.
This can be seen in the position paper in chapter 3 that has been produced by Sweden. From pictures on the X axis several ways of setting the window are depicted and this 8 a.m. to 8 p.m. does not differ very much from the light hours case which is the closest to the original WHO guidelines. The difference for all these stations is clearly less than 10% and even lower than 5 because the ozone above 80µg/m3 occurs in all cases in the afternoon so it does not matter whether one takes into account hours between e.g. 6 a.m. and 8 a.m. or even 8 p.m. to 10 p.m. as this is not contributing to the AOT hence the reason why this difference is surprisingly small.
On the issue of the boundaries of science and management DG XI were asked to explain why they had phrased the questions in the way they did. DG XI answered with one concrete example in question 6 on the information threshold and the so-called alert threshold because it could be inferred from the responses of several CSTEE members that, in particular the information threshold proposed to be set under 80 µg was raising the question whether this is scientifically justified and advisable. In this respect it should perhaps be said that the information in the alert threshold has purely the purpose of informing the public i.e. of advising people to behave in a different way in order to enable them to reduce their personal exposure to ozone. So this is not a standard for ozone and it has to be agreed that the question of 180µg is an arbitrary choice. However from the point of regulating this it would be an advantage to stick to 180 because it already appears in the current directive which has been in force since four or five years now and the public are used to that level and they know what it means. In other words they are familiar with the way the information is provided and also with the advises given.
Therefore if there are no real scientific objections against it this would have more the purpose of best regulating this kind of task that stems from the framework directive and the ozone directive. The same is true for 240 but from the notes it would appear that the CSTEE would endorse that as a level where the general population is affected in a way that advice should be given. The bottom line is that this had clearly a regulatory purpose. There is also the question of setting a standard for ozone at 120 rather than 160 and these are the two questions which are most important for us at the moment.
In spite of insistent requests from DG XI to have the views, even informal ones, from the CSTEE on the 120 versus 160 issue, CSTEE members expressed reluctance about giving advice at this stage on it before having a discussion in the WG.
The tentative date of 26 March was provisionally agreed for the WG meeting.
6. 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
The WG chairperson presented this topic. The documentation in connection to this topic (only on citrates) previously distributed had been considered and a small paper had been prepared that tried to summarise the data. One conclusion was that the data are not very good neither from a qualitative nor a quantitative standpoint. Deficiencies were related to being old, not up to modern standards and with a series of important end-points not being addressed at all. On such a basis it proved impossible to move forward relative to citrates.
On the other hand, document CSTEE/98/17-Add 33, a so-called Morflex study (Preliminary Risk Characterisation for Acetyl Tributyl Citrate Used as a Plasticiser in Polyvinyl Chloride Children's Toys" prepared by Andrey I. Nikiforov, Ph.D. Program Director TRS - February 1999), adds substantive information which may enable the CSTEE to move forward because it is pointed out, but without giving references, that there is a modern two generation reproductive study with a clear defined NOAEL, including also valuable information as to the leachability of the citrates compared to DINP. The potential usefulness of such data indicates that it would be important to have this documentation made available to the CSTEE as soon as possible. This would put the CSTEE in a much better position to address the questions which have been posed with respect to the citrates.
Another point made was that these studies don't give any information as to whether these are the 'main' citrates or what proportion of the total market in respect to these products are these used for.
With respect to the adipates the chairperson had not done much more than an open search in the available databases and found that there are quite a number of data and reports on only one adipate. No specific data related to the exposure part which directly addresses the leachability of adipates from children's toys was found.
In general CSTEE members concurred in that information in the documents distributed was of bad quality. As an example it was mentioned that no references were made to the metabolic pathways. Another problem, admittedly not addressed by the terms of reference, is that PVC contains huge amounts of cadmium and as such, in terms of repercussions to health, this should be addressed as well. Still other possible problem not addressed in the data provided to the CSTEE is that that concerns pharmacological effects of citrates including impairment of muscular responses and a possible risk of adverse neurological effects.
The conclusion is that the reports that are discussed in the Reilly documents are needed. Once they are reviewed perhaps the CSTEE can come up with some answers to the questions posed for this specific citrate. The WG chairperson therefore urged the Commission's services to make available any other information that is available on other citrates and adipates depending on whether these materials are at all in use as discussed at the last meeting
The CSTEE secretary explained that a decision had been taken at a M. States meeting organised by DG III in February (Directive 76/769) to the effect that M. States and Industry should make available to DG III the data they have. This would subsequently be made available to the CSTEE secretariat. DG III concurred and informed that so far only Sweden had made some limited information, essentially confirming that there was very little data available in the public domain on phthalate's substitutes.
The representative of the requester service (XXIV/A/4) confirmed that documentation would be pursued more actively, not only from industry but also from the Scientific Committee for Food as this scientific committee is known to have looked to these chemicals, although apparently without any conclusive evidence.
Regarding the issue of obtaining data for answering opinion requests, and in response to a specific question asked by the WG chairperson, the CSTEE secretary confirmed that although it is nice to have CSTEE's members collaboration in obtaining relevant data, this cannot be considered an obligation on their part and that it is the responsibility of the requester Commission service to obtain the information that will essentially allow for answers to be given to the questions in the terms of reference;
The chairman concluded this point saying that the committee will react when they receive the next instalment of information on the subject.
7. Possible revision of the opinion on Creosote containing less than 50 ppm benzo-[a]-pyrene
A new version of the opinion was adopted. A draft, previously revised by some WG members, had been circulated by the CSTEE secretariat before the plenary.
The requester service, DG III, although concurring that some of the changes were not, strictly speaking, minor ones, they were not such that would lead them to change the risk management measures they had envisaged anyway. The CSTEE secretary informed that the revised version would replace the 'older' one on Internet as soon as possible.
8. Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment - information concerning the mandate for a working group and possible presentation and discussion of working paper
This activity stems from a very old proposal on hazard assessment for the terrestrial environment from the classification and labelling committee four years ago on development of classification criteria. Since then the process for risk assessment had developed a lot and looking for a comparison the observation was made that there was a real lack of scientific basis for both hazard and risk assessment for the terrestrial environment.
Spain and other M. States have created a WG for the Classification & Labelling (C&L) system and a workshop was hosted in November 1998 in Madrid by the Spanish ministry of the environment (to which CSTEE members were invited with some attending).
How and when the CSTEE should be involved is an issue that can still be discussed. In the meantime collaboration with the ESR risk assessment group is being attempted, particularly considering the involvement on the risk assessment for industrial chemicals, pesticides, veterinary medicines and biocides.
Good agreement seems to exist on the scientific basis for the risk assessment for the aquatic environment, which are also in agreement with the priority setting of water quality objectives by the previous committee (CSTE). On the other hand the scientific basis does not exist for the terrestrial environment and very different approaches have been observed such as very different taxonomic groups being addressed, very different methods being used and even very different margins of safety for the same taxonomic groups/organisms exposed through the same route, a fact that does not have scientific sense.
An attempt was made by the appointed WG chairperson to summarise all the problems in these proposals. For the hazard assessment the main topic was the above soil compartment of the workshop held in Spain. There were five different proposals for criteria for the soil compartment but there was only one proposal for the above soil compartment hence the need to focus on that. This should not mean developing classification criteria, although it might make sense to consult the CSTEE on that in the future. At an ECB WG meeting it was agreed between M. States that it was a good idea to involve the committee also in the development of classification criteria but not now because a large meeting for the more regulatory aspects will take place by the end of the year. This will also involve people from pesticides in view of having first a compromise and then look for more scientific views. In any case it is very important to start this right now because if the CSTEE is consulted for classification criteria it is important to know what are the scientific basis and gaps.
The CSTEE should start by addressing what are the intrinsic properties of chemicals in the terrestrial environment that can be used in hazard assessment, including dose/response effects assessment used in the risk analysis.
For the risk assessment the WG chairperson attempted to summarise the facts with five different points that represent the approaches that are used for the aquatic system and are more or less agreed. An attempt was also made to summarise the different approaches followed for other risk assessments comparing the industrial chemicals with the TGDs recommendations for pesticides, veterinary products and the new draft for biocides.
In some cases it can be observed that a chemical is at the same time an industrial chemical, a pesticide, a PPP and a biocide and it has no sense that for the same chemical the final concentration in the environment is assessed in a different way depending on whether you consider the molecule as a pesticide or a biocide. The exposure should be different because it should be related to the use but the effect that you should expect for the same concentration of the same chemical in the soil should be the same and therefore we need some kind of general agreement.
As a conclusion the WG chairperson proposed that the WG should address the very basic scientific concepts for the hazard and risk assessment for the terrestrial environment without this being related neither to any existing opinion specifically for the development of classification criteria nor for the risk assessment of existing chemicals. The idea would rather be do something along the lines of what was done on EDCs, a state of the art assessment, particularly for the above soil compartment. Different items need to be covered and in principle, because there is not much basic information available apart from the risk assessment reports, the proceedings of the Madrid workshop and other basic information, it seems realistic to aim to finalise the report by the end of the year.
As regards membership/expertise in the WG, apart from CSTEE members, at least 4 external experts should be needed to cover soil/ecotoxicity effects and exposure on plants, wildlife animals, in particular top predators and invertebrates. The WG chairperson informed the CSTEE of the suggestions he had to make for members of the WG and these were accepted. Two other CSTEE members also made suggestions of possible outside experts to be appointed to the WG and these were also accepted. In passing comments were made on the particular difficulty posed by assessment of effects on plants. The title of the report should be very general such as 'Scientific basis for the hazard and risk assessment for the terrestrial environment' if possible 'with particular attention to the above soil compartment'.
The CSTEE secretary asked the WG chairperson to make available as soon as possible a table of contents for the report. The WG chairperson confirmed that he would send one soon.
9. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission
DG III gave the information that on cadmium a favourable opinion had been given by the TPC in February which allows for Sweden and Austria to keep their national legislation up to 2003. Before that date the Commission will again review provisions. There is hope to have by then results from the Existing Substances Regulation evaluation on Cadmium that is ongoing and a few additional studies that may be needed. But since the timetable for the evaluation on cadmium under the ESR is still a little bit uncertain DG III have decided to launch an additional study trying to fill the gaps that were identified by the CSTEE in the previous study and the committee will be consulted on the specifications.
Furthermore DG III also informed that they have two more studies ongoing, one on sensitising azo dyes on which information had been given at the previous meeting and whose results are expected before the summer of 1999. Early this year (1999) a risk assessment of Methylene chloride was also launched. This is a 6-month study being carried out by the TNO of NL.
10. Feedback from the competent services of the Commission on the follow up to the opinions adopted by the CSTEE on:
(i) Water Framework Directive
The texts agreed upon by the EP and the Council were adopted in the first opinion of the EP in 11 February with a total of 122 amendments. Next week the Council is likely to adopt the first stage of the common position but some of these points do not really regard the recommendations of the committee. Most of them were far stronger political issues of disagreement such as the phasing out of hazardous substances, the generous deadline the Council gave itself and the charging of water costing.
On the other hand a few of them are actually related to more technical issues such as a closer association of wetlands to the proposal which the Council accepted and the Commission has put forward in our amended proposal. The EP as such did not address any other technical issues apart from the odd suggestion for a better formulation. They did not actually pursue any ideas of the CSTEE or any other ideas that had come to them from outside parties so the annexes remain as the June text Council made the political agreement last year.
DG XI had little basis under those circumstances to take issues much further in its amended proposal because that would be founded on the proposed amendments from the EP. A few formulations have been accepted which should give a more transparent text but from the big issues raised by the CSTEE one thing that has been addressed by the EP and that has been accepted by the Council text as well is to change the terminology from moderate to what it really is, fair, i.e. not very good quality. Two additional categories have also been added, the poor and bad categories. They are not in any way as detailed in a normative definition as some would have liked but they are there as a foothold for further developments at least and it is reassuring to see that the Council quite readily accepted to put in those two categories.
The major issue of finding indicators and in particular indicators of function rather than ecological structure as the definitions include today has not been developed further in the text of the Council and the committee thinks that this is something that requires quite a lot of research to make it operational. Theoretically it is there but to find real indicators on which functions would be chosen to actually represent an ecosystem is the big issue. Not being able to pursue those issues inside the present text and with Council not giving the possibility of amending the annexes by a committee procedure that was rejected for almost everything in the annexes means that a completely new proposal with EP and all the institutions involved is necessary and therefore this is a long term project.
The decision was taken instead to insert a revision clause in the article on the management committee, then the CSTEE's expertise could be used to issue guidelines. This is where a big possibility is for exploring the issues raised by the CSTEE in its recommendations. In order to prepare for that the Commission services drafted an implementation plan which has been discussed with M. States and has been sent to outside Commission parties as well. This was done because it could be seen that given the political controversies between Council and EP it could take quite some time before this proposal was adopted, not withstanding that, one of the major issues of dispute between the two institutions ironically is shortening the timetable for implementation. They are certainly taking their time but various other issues were explored with a view to take the questions forward in guidelines. The JRC in Ispra has been contacted not least on the issue of structure function where Ispra has got experience at lest with one functional parameter, the phosphorus cycle and also on the question raised by the CSTEE on biomarkers which will be pursued in a research initiative sometime this year or next year.
The CSTEE will hear more of this in the course of DG XI's contacts with the EEA. They were involved in the whole technical part of the directive and the Marine Topic Centre is trying to describe the hydro-morphological and other characteristics of estuaries and what are now called transitional waters. This is an activity that started very recently. The Fresh Water Inland Topic Centre is permanently involved in it and contacts are established almost weekly on developing for instance hydromorphology as the Council as such did not want to have it as an independent parameter. However DG XI are trying to discuss with the topic centre ways to have the hydromorphology better represented indirectly via the biology and the ecology of the waters. In that context a couple of study contracts were launched last year where the WRC (water research centre) in the UK and a couple of other organisations are looking further into some of the questions related to hydromorphology and biomarkers.
It is expected that a report comes out some time soon where the questions raised in the recommendations of the CSTEE are specifically addressed and the draft that was made available indicates a sort of refined questioning on them and ongoing research and experience are identified. There will certainly be some food for thought in that report to continuing discussing those issues once those two reports are ready.
The reports are really two 'brothers' or 'sisters', one is focussing on monitoring and monitoring requirements and the respective research needs and the other is focussing on classification definitions and research needs.
There is also an interesting new player, the European River Restoration Centre, which started as a co-operation between the UK, DK, DE, the NL and is later this month (March 99) going public with participants from the wider European area. It can be said that they are establishing an exchange centre on further development of river restoration at the end of this month and going into the pan-European context. They are very closely linked to the interest and need in defining practical reference conditions for various status or improvements of the waters in particular rivers.
This should provide an unexpected input into the question of establishing proper reference conditions and comparing the various types of reference conditions and it should provide some experience with the inter-calibrations so that some soundness to the available principles can be ensured and also ability to compare across the community even between different climatic and ecological regions. Annex V is now virtually finished but we have the possibility of issuing guidance which DG XI intends to pursue quite vigorously.
The terminology and definitions will also be pursued in that context. It is too early to start thinking of revising Annex V but there will be a need for not just non-legally binding guidance but probably to fix in a legally binding text at some stage when one we gets closer to that.
The various ideas and recommendations available on choice of indicators such as which organisms and what they represent, functions, structures, how is hydromorphology reflected, etc, these will be pursued as well in that context. Apart from what was mentioned a specific institutional context does not exist but it is one of the issues DG XI is trying to take forward discussing with the M. States in a shadow implementation plan.
On the priority substances the Fraunhofer Institute has finalised the revised report and that should arrive in the coming week and will immediately be submitted to the CSTEE for further discussion. On the 19th of April there will be a meeting to discuss the way forward with the priority substances and in particular the Fraunhofer revised report and their proposals/suggestions for actual priority substances. The 'Water Framework Directive' WG chairperson will be invited.
That's where we are but DG XI would like to keep the close contacts they have had with the CSTEE and provide it with the various reports and results as they come. Hopefully there will be a point on the agenda of a CSTEE meeting where, probably towards summer, the results of the two studies we are expecting on classification and monitoring can be discussed. Regarding what will come out of the hydromorphology and classification or characterisation studies of the marine topic centre and the Ispra JRC this is a long-term activity.
Finally the DG XI representative emphasised again that they have been extremely happy for working with the CSTEE and the exchange of points of view and the recommendations that it gave DG XI as a firm basis to pursue some of the important issues on the WFD.
(ii) Council Regulation (EEC) 793/93:
- 2-(2-butoxyethoxy)ethanol
- 2-(2-methoxyethoxy)ethanol
- Alkanes, C10-13, Chloro
- Benzene, C10-13-Alkyl derivs
Due to the absence of a representative from the competent Commission service (XI/E/2) no feed back to the CSTEE was given.
(iii) Phthalates in toys
A representative from DG III informed that the Commission internal debate on the long-term harmonised measures for phthalates in toys was still ongoing.
The representative of DG XXIV/A/4 further informed the CSTEE that action would be taken stimulating research efforts on some of the areas identified in the CSTEE opinion as needing further research. Research on buccal absorption is likely to be launched and an eye is generally being kept on different ideas about migration methods and their validation.
On the other side of the Atlantic the US have set up an independent panel under the guidance of the US surgeon general to look further into the issue of the use of phthalates in PVC consumer products and the focus of the preoccupation of this group seems to be the potential carcinogenicity of phthalates.
The WG chairperson indicated that the US consumer product safety commission has issued a report in December 1998 that was made available to him. He expressed the view that it deserves being distributed among the WG and CSTEE as not only does it substantiate what the CSTEE said in its opinions, it also addresses some of the CSTEE's uncertainties and besides it is always helpful to see what the US are doing.
Finally some CSTEE members reminded the secretariat that they had suggested that a specialised meeting, e.g. a workshop, should be organised by the Commission on peroxisome proliferation as one of the conclusions in the CSTEE's opinions had been that this was an area where an international consensus is necessary.
(iv) Directive 76/769 (EEC):
- Chrysotile asbestos and substitute fibres
The representative of the responsible Commission service (DG III) informed that the work on Commission directive on asbestos was ongoing. They had almost finalised all outstanding questions and a proposal for a directive on asbestos will be put before the TPC for voting.
- Cadmium
- Tin
- Pentachlorophenol
On Cadmium, Sweden and Austria are allowed to keep their national legislation till 2003 pending further risk assessments and further developments. The directive will be reviewed again before that date. As regards Tin and PCP these are subject to the same Commission directive and they were put to the voting committee of M. States who gave a favourable opinion. This is now up to formal adoption by the Commission. The directive on Tin includes a ban on the so-called free association paints, the ones with an uncontrolled leaching, and it also includes a ban on the use of TBTO in fresh water. Furthermore there will be a review before 2003 following developments in the IMO because it is expected that the IMO assembly will take during the Spring of 1999 a decision for a global ban on TBTO. This will allow the Commission to introduce that into the directive as soon as this happens. On PCP a total ban has been introduced but it will not be total until 2008 for M. States who have a maritime climate. For other M. Sates it takes effects immediately.
- Azo dyes
Following the opinion of the committee on the risk of cancer caused by textiles and leather goods coloured by azo dyes DG III has prepared a draft proposal for a directive banning carcinogenic azo-dyes.
The CSTEE Secretary informed the committee of a slight change made to the Azo dyes opinion. The correction (removal of one sentence) was considered of no consequence in terms of the risk management strategy that the requester service had envisaged for it. In spite of this, as DG III are having a meeting next Monday it is important to make sure that we agree on the change (the change was agreed).
11. Information on matters not covered elsewhere in the agenda:
(i) Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
In the absence of the CSTEE chairman the secretary made a brief presentation essentially based on data obtained from the minutes of the 21-22 January SSC meeting. Of particular interest to the CSTEE was the activity on 'harmonisation of risk assessment procedures' in respect of which the representative of XXIV/B/1 informed that since January 1999 the only progress made is that the first meeting of the risk assessment WG will take place on the 17th of March, the day before the next SSC plenary. The chairman of the risk assessment group has still to send a draft for discussion
The CSTEE secretary informed that another point raised concerned the need to increase the capacity of the secretariats to provide scientific support to the committees. Still another point raised was that on industry representatives in WG meetings.
(ii) Developments on the subject of the brief of the CSTEE
As regards the brief of the CSTEE there were no developments worthy of note apart from the fact that the committee will be consulted on biocides. It is possible also that the CSTEE may be involved in a different area of work which is to do with materials used in water pipes used for human consumption involving the possible issue of migration of chemicals from these water pipes into water itself.
12. Arrangements for the next meeting of the CSTEE
The CSTEE secretary informed that the prospects for the May plenary meeting of the CSTEE were that it would be a one day meeting only as apparently the only substantive topic for discussion will be 'Tropospheric ozone'.
Unless confirmation arrives soon that it will be necessary to hold it over two days, the decision was taken to hold it Friday, the 7th of May 1999.
13. Any other business
One CSTEE member commented on the fact that he had been approached on behalf of a group of Cadmium pigment producers, requesting information on the amendments to the Cadmium paper and enquiring on whether it would be possible to receive from the Cadmium WG chairperson guidance on what work was needed to clarify the remaining uncertainties from the previous Cadmium Risk assessment and to recommend who best to be commissioned to carry it out. The WG chairperson had declined to answer because he thought it would be incorrect to do so without consulting the CSTEE first.
The CSTEE secretary confirmed that attempts have been made in the past to give out this sort of information to whoever approaches CSTEE members individually. The CSTEE were reminded that in similar circumstances all they should be saying is that contacts should be established either at the level of the CSTEE secretariat or the Commission service responsible for the particular opinion request at stake. This approach was endorsed by the CSTEE explicitly and they called on the Commission to produce a code of conduct for lobbyists as soon as possible.
Given the current prospects in terms of workload, the July plenary meeting of the CSTEE will in principle be a one-day meeting. The CSTEE secretary will check whether the necessary authorisation for it to take place in Oslo after the Eurotox meeting can be obtained. The chairman of the Eurotox congress, member of the CSTEE, pointed out that it is important to decide, in case the July plenary meeting takes effectively place in Oslo, whether it will be a one or two day one as those who are planning to participate in the congress should register ASAP to get the low registration fee.
Annexes: I - Draft agenda
Scientific committee on Toxicity, Ecotoxicity and the Environment (CSTEE) - 8th plenary meeting - Brussels - 4th march 1999, 9h30a.m. - agenda -
1. Adoption of the draft agenda
2. Declarations of interest
3. Adoption of the draft minutes of the 7th CSTEE plenary meeting held on the 18th of January 1999
4. Endocrine disrupters -
(i) presentation and possible adoption of a draft report being prepared by the 'Endocrine disrupters' working group;
(ii) presentation by other Commission services of developments on EDCs
5. Tropospheric ozone - progress report on the draft opinion
6. 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
7. Possible revision of the opinion on Creosote containing less than 50 ppm benzo-[a]-pyrene
8. Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment - information concerning the mandate for a working group and possible presentation and discussion of working paper
9. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission
10. Feedback from the competent services of the Commission on the follow up to the opinions adopted by the CSTEE on:
(i) Water Framework Directive
(ii) Council Regulation (EEC) 793/93:
- 2-(2-butoxyethoxy)ethanol
- 2-(2-methoxyethoxy)ethanol
- Alkanes, C10-13, Chloro
- Benzene, C10-13-Alkyl derivs
(iii) Phthalates in toys
(iv) Directive 76/769 (EEC):
- Chrysotile asbestos and substitute fibres
- Cadmium
- Tin
- Pentachlorophenol
- Azo dyes
11. Information on matters not covered elsewhere in the agenda:
(i) Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
(ii) Developments on the subject of the brief of the CSTEE
12. Arrangements for the next meeting of the CSTEE
13. Any other business
List of participants
CSTEE:
Prof. Philip L. CHAMBERS, Prof. Erik DYBING, Prof. Bo O. JANSSON, Prof. S. KYRTOPOULOS, Dr. Claude LAMBRÉ, Prof. Dr. José RUEFF, Prof. Mirja SALKINOJA-SALONEN, Dr. José V. TARAZONA, Prof. Marco VIGHI, Prof. Joseph VOS,
European Commission:
DG XXIV: Mrs M. de SOLÀ, Mr. J. COSTA-DAVID, Mrs. M. LAURIDSEN, Mrs A. FOKKEMA
DG III: Mrs. L. PERENIUS, Mr. SORO
DG XI: Mr. T. PETRIE, Mrs. H. NOVER
DG XII: Mr. L. BONTOUX
