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Directorate-General for Health and Food Safety
1. Adoption of the draft agenda
The draft agenda was adopted.
2. Adoption of the draft minutes of the 3rd plenary meeting of the CSTEE held on 24.04.1998 in Brussels
The draft minutes were adopted with the suggested corrections.
3. 'Phthalates in toys' - new set of questions to the CSTEE
The new set of questions to be answered by the CSTEE was read out. After a long debate the CSTEE adopted an answer whose main conclusions were:
a. On the basis of the Scientific Opinion of 24 April on phthalates in toys is it possible to say that there is serious and immediate risk?
The Committee considers that an answer to question 1 is dependent upon the definitions of 'immediate' and 'serious' as used by the Commission. The CSTEE considers that the risk it identified in the opinion it adopted at its 3rd plenary meeting is not sufficient to fall within the 'life-threatening' category. The present concerns are related to general long-term toxicity including liver and kidney damage. The induction of liver cancer in rodents by some phthalates is judged to be of little relevance for humans. The opinion adopted at the 3rd plenary meeting emphasised that an important area of uncertainty in assessing the risk was the quantification of exposure. The opinion noted that the Dutch study with adult human volunteers and its comparison with in vitro extraction methods should provide the basis for a standardised and validated in vitro test method on phthalate release. This should give more relevant data on human exposure. Should the Dutch study confirm the CSTEE's assessment, the CSTEE concludes that there is a health concern related to children's articles which can be put in the mouth, if the phthalate extractability is likely to exceed the proposed guideline values.
b. Does it exist at present a standardised, validated method to measure the maximum extracted amounts of phthalates in toys?
The answer to this question is No.
c. If such method does not exist how is it possible to implement the CSTEE recommendations on the guideline values for extractable amounts of phthalates in toys?
Any decision now, will have to be based on scientific judgement and assessments. The CSTEE followed a worst case approach founded on the available data recognising that, following clarification provided by the Dutch study the CSTEE approach might have to be revised.
d. How many methods to measure the maximum extracted amounts of phthalates in toys exist at present and how reliable are they? Which of the existing methods does give the greatest guarantees of reliability?
Currently there are a number of non-standardised and non-validated test methods whose quantification and relative quality is variable. The Committee expects to have the findings of the Dutch study available to it at its Plenary meeting in September. It will then be in a position to offer the Commission more conclusive advice.
4. Consideration of draft opinions with a view to their adoption by the CSTEE, on:
(i) Tin, Arsenic and Cadmium
(ii) Pentachlorophenol
As a general point the representative of the Commission service that requested the opinion informed the CSTEE that, in preparing the opinions, they could expand beyond the strict limits of the terms of reference.
The discussions on the chemicals under this agenda point were a trigger for a more general debate on how the CSTEE should address opinion requests of this kind. In general, problems were found with the quality of the reports (e.g. statements improperly referenced, assumptions that best practice is followed in all cases, etc.). This causes difficulties as the working group members have to look for the data themselves, something which may not be totally in line with the task initially anticipated. Some even suggested that the quality of contractors should be checked. DG III explained the difficulties both in terms of time and budget that they have to face when deciding on which is the best way to get a report for these targeted risk assessments. The suggestion was made that the IPCS format of reports should be followed. Another suggestion was that perhaps the CSTEE could prepare guidelines on how these reports should be produced.
The drafts available were then thoroughly discussed but no final opinions could be adopted given the nature of comments made which indicated the need for changes. The Commission service that had made the request, while acknowledging the effort put in by the working groups and the CSTEE, insisted on the urgency to have opinions adopted because of political commitments behind them (Accession treaty).
Arsenic
The rapporteur on this chemical made a detailed presentation pointing out that the bottom line of the working group's conclusions is that the Atkins report correctly identifies the main risks associated with wood preservation but that the justification could be better.
There appears to be a lot of arbitrary statements in their report. For instance in the introductory section the Atkins report states that their assumptions are based on the assumption of best current practice at all stages of the production, use and disposal of arsenic treated wood, but from the feedback given by the Commission service that requested the opinion it was apparently very difficult to obtain from M. States to what extent best practice is indeed followed.
The authors of the report assume that current specifications, whether they are derived from legislation or Industry guidelines, are strictly followed. The working group felt that to the extent that such rules are guided by law and imposed as such, these assumptions are correct and acceptable. On the other hand to the extent that this is not the case but a matter of voluntary agreements by Industry this assumption is a bit risky without backing it up and the report from Atkins does not confirm this. The problem with environmental data is that they are poor in this case and there is no real rational way to confirm that the best practice specifications are abided to.
In the report's section on environmental behaviour and chemistry of arsenic the working group's key point is that the chemistry is very complex and the complexity is not fully brought out in the report, specially the complexity of the processes that influence the speciation, the mobility and the bio-availability of arsenic in very widely differing environmental situations. This makes reliable predictions difficult and could have been brought out more clearly. The question on ecotoxicological effects is approached and the report identifies pnecs for various compartments; as far as the water compartment is concerned they identify effects on algae in low phosphate marine waters as being the most sensitive species and the pnecs are quite close to the actual background concentrations. There is very little room in general for additional exposures. In their calculation Atkins did not allow for an uncertainty factor (a factor which according to the TGD for Regulation 793/93 should be used to divide the NOAEL and whose magnitude depends on the degree of uncertainty allowed by the available data). In this case Atkins used an uncertainty factor of 1 based on the fact that the data that they had were derived from chronic exposures and field measurements in a number of species, in other words the uncertainty was limited. Had they used the uncertainty factor of 10 which is suggested as default in the TGD then the resulting PNECs would be below the actual background concentrations allowing for no room at all for antropogenic exposures. A number of other reports the working group had access to did actually come up with pnecs not very different from the ones of Atkins so it would seem that their option is acceptable. For a number of compartments, Atkins did not derive PNEC's but instead used guideline values taken from various reports or national legislation without giving any justification for doing so. For example, instead of deriving a PNEC for groundwater, a UK maximum loading limit was employed.
Discussion of human health effects is very limited. In particular, there is unacceptably scarce use of references from the open scientific literature, even on important issues like genotoxicity and dose-response relationships which are well covered by the available literature. The Atkins report identifies as important human effects the induction of lung cancer by inhalation and of non-cancer skin lesions by ingestion, but it does not mention the induction of skin cancer by ingestion which is an important effect. For risk estimation after inhalation they adopt linear extrapolation and the WHO unit risk, while for the oral induction of non-cancer effects they use a TDI of 2µg/kg also used by WHO.
For environmental effects the risks that the report identifies are related to with effects on the growth of algae in low phosphate marine waters; potential risks from unpredictable long term leaching in landfills in waste landfills; they identify marginally increased predicted lung cancer risks from controlled incineration, significantly increased predicted lung cancer risks from uncontrolled burning during home heating and significant predicted effects on the environment from uncontrolled burning and dumping. Even though they identify also some risks for children in playgrounds for some reason they do not carry over this in their conclusions. In the working group's discussion it was agreed that these are the main risks and that it should be pointed out that there are also potential risks in highly localised areas near CCA treated wood which should be borne in mind. Above all there is cause for concern arising from the high degree of uncertainty with which one can make predictions regarding the speciation of arsenic during long term storage and hence on how to predict its behaviour in migration and bio-availability.
The working group feels that it should make a recommendation to the effect that this should be addressed by research. In the meantime it would be advisable to exercise caution and to limit the use of arsenic based wood to those situations where it is absolutely necessary. As far as the quality of the report is concerned it should have been better justified and made better use of the available literature supporting its conclusions even though the methodology that was followed is basically correct and their main conclusions are fundamentally right. The report should have supported them better specially where it uses various guidelines whose choice should have been explained and what risks they're associated with so as to make their acceptance easier.
A few remarks/suggestions were made by some CSTEE members. One member informed the CSTEE about the existence and activities of an international expert group evaluating and concluding on the present knowledge as relates to health risks of arsenic. Their work should be on the verge on conclusion and maybe considering it is warranted before adopting a final opinion. Another member suggested that until the opposite is demonstrated some mention of skin cancer should be included in the opinion.
Still another member commented on the nature of the presentation as being a mixture of the conclusions of the report and the purported CSTEE's views.
It was decided that the proposed changes be introduced in the draft in view of a possible adoption by the CSTEE the following day, an intention that could not be confirmed as there was no time to revisit it.
5. Chrysotile asbestos - report by the WG chairman on the results of the 'Chrysotile asbestos' working group meeting in Paris, 9 June 1998
The 'Chrysotile asbestos' working group chairman presented this point. He made an oral account of the developments on this subject that took place in the Paris working group meeting of 9 June 1998. He described the composition of the working group, in particular who the external experts were and the kind of contribution that each made to the debate. He also described the documentation that the working group had received (all under the general reference CSTEE/97/2), in particular doc. CSTEE/97/2 - Add. 25, since it gave an overview of the situation in those countries where there is a more strict legislation than that generally in force in the EU.
The WG chairman also described the terms of reference for this particular opinion request as submitted by the requester Commission service (DG III/C/4) as well as the nature of the discussion on this and the reason why the terms of reference had been drafted in the chosen way.
These had been discussed between the various Commission services involved and the 'Chrysotile asbestos' Working Group and were the following:
'On the basis of the available data, do any of the following substitute fibres pose an equal or greater risk to human health than chrysotile asbestos?
- Cellulose fibres
- PVA fibres
- P-aramid fibres
Particular consideration should be given to the relative risk to para-occupational workers and other users of asbestos-containing products in comparison to non-asbestos products".
Another point under analysis was the consideration of "para-occupational" exposures in particular, but not exclusively, because this concept had initially been included in the terms of reference and triggered an uncomfortable reaction from the Commission services responsible for worker's protection (DG V). It was believed that occupational considerations, although they are probably not the first concern here, could still be addressed in the CSTEE's opinion as concentration limits of such agents in the workplace are relevant for comparisons. The terms of reference should not include them though. Furthermore it was reminded that DG V have a scientific committee on occupational exposure limits whose activities/conclusions should be of interest for the CSTEE to follow.
The WG chairman also explained the reasons for choosing to address the terms of reference as referring to "commercially available chrysotile" given the variable characteristics of this product depending on which market it is available from. He also commented on reactions from several sources to the first CSTEE opinion on this topic as adopted at the CSTEE plenary meeting of 9 February 1998.
Other elements described by the WG chairperson were various documents which were considered relevant for the forthcoming activities/conclusions of the CSTEE when it delivers its opinion on the subject (docs. from the Institute of Environmental Health, Leicester and from ISERM, Paris); the latter still subject to confidentiality at the time of the meeting.
The input provided by an academic representative from Spain, but that had to be considered as representing the views of the asbestos Industry sector, was described as well as the impact that its content had had on the "Chrysotile asbestos" WG members, some of which took on the task of commenting back.
The WG chairperson described the agreed working arrangements to follow this topic up. A working group meeting was scheduled for the 22nd of July 1998, with the 16th of July as deadline for submission of contribution to the WG chairperson in view of his preparing a draft paper to be discussed at the WG meeting. In principle no more WG meetings should be necessary to agree on a draft opinion that could be submitted to the CSTEE plenary meeting of September but in case of need another one can probably be accommodated shortly before that.
Finally the chairperson informed the plenary that he had been invited by the European Parliament social affairs committee to a meeting, the idea being to express his views as an expert in this field before the committee. The CSTEE chairman had been previously informed and given its agreement to it. The explanation was made to the committee that the WG chairperson was there on a personal basis and that the views expressed could not be taken to reflect the CSTEE's views on the subject.
A representative of the Commission service that requested the opinion expressed its gratitude for the work put in by the WG and the CSTEE on this and reiterated the importance to have an opinion on this subject adopted at the CSTEE plenary meeting of September 1998.
The representative of DG V of the Commission also commented on this activity. Its importance, in particular as Member States and the Council have recently expressed their interest when conclusions were adopted to the effect that the Commission should take rapid steps to have a look at the existing directives on asbestos worker's protection. DG V will do their best to try and follow closely the developments of the activity of this WG; if possible they will be present at the WG meeting of 22 July.
6. Accident at the Aznalcollar mine and the contamination of the Guadiamar river and the surroundings of the Doñana National Park - consideration of draft statement/opinion for possible adoption by the CSTEE
The suggestion was made that this kind of problems is taken care of properly already since there are EU legislative instruments to deal with them. This view was countered by some. A particular CSTEE member reacted saying that from the effects side, as in a specific case of an accident with an oil tanker off the coast of Wales, legislation was of no help whatsoever.
A draft statement was prepared by one CSTEE member and distributed. However, given the nature of the problem in question here and the fact that the CSTEE did not have the time to being properly informed on it, the decision was taken to prepare a more general statement on accidents of this kind to be presented in a future plenary meeting and endorsed by the CSTEE.
An ad hoc working group was set up from within the CSTEE to be activated as and when accidents of this kind would dictate in view of basically follow them up.
7. 'Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment' - discussion
This topic was included at the specific suggestion of one CSTEE member. The idea behind it was to have the CSTEE commenting on the best approach to pursue (e.g. based on soil organisms, holistic approach?) in trying to come up with a system suitable for hazard identification (classification) and risk assessment for effects on the terrestrial environment.
However, given that a workshop is scheduled to take place in Madrid in November where the issue will be thoroughly debated the decision was taken to wait for its results before a decision is taken on how the CSTEE should follow this one up.
8. Endocrine disrupters - presentation by the working group chairman of:
(i) status report being prepared by the 'Endocrine disrupters' working group;
(ii) oral report on his recent participation in an EDCs meeting in the USA
(i) The WG chairperson described the results of the working group meeting that had taken place in May where the outline of the report was again discussed. The content of the various chapters, i.e. Introduction, Human health, Ecological Health, Ecotoxicology test protocols and Conclusion were described.
As suggested by the CSTEE at its previous plenary meeting the issue of prioritisation of chemicals was accepted and it will be developed in the chapter on test protocols.
A working group meeting is foreseen for the 29th of June 1998 and contributions from the CSTEE and WG members are expected by the 23rd of June.
(ii) On the subject of his attending the meeting in Washington, a roundtable conference to prepare the implementation of the EC-US Science and Technology Co-operation Agreement that took place on the 8th and 9th of June 98, the WG chairperson gave some feedback commenting in particular on the differences of approach characterising the US and EU systems where the former relies very much on individual testing and the latter on test protocols.
Finally the information was also given that on 24-25-26 of June there will be a meeting of the IPCS/OECD steering committee to look at the state of science assessment.
9. Creosotes - consideration of the terms of reference and discussion on the approach to address this particular opinion request
A working group was formed to address this particular opinion request and the decision taken to have a working group meeting in Brussels on the 10th of August. In the meantime the requester Commission service would provide as much data as possible
10. Strategies to deal with additional chemicals (opinion requests to be submitted by DG III)
The DG III representative in the meeting informed the CSTEE of the possible forthcoming topics on which opinion requests could be submitted [Mercury (as contained in certain consumer products like thermometers, electrical equipment), new fertilisers, Azo dyes, chlorinated solvents and textile solvents, etc.].
The prioritisation has yet to be decided but the next opinion request is likely to be on Azo dyes.
11. Water framework directive - feedback from the responsible services of the Commission on the follow up to the opinion adopted by written procedure by the CSTEE (05.6.98)
The DG XI representative made a series of comments on the minutes of the previous CSTEE meting which were taken into consideration. Some aspects of the topic were revisited, in particular the issue of monitoring based and modelling based approaches as suggested by the CSTEE in its opinion, which should be seen as complementary and not mutually exclusive (monitoring based approaches only would not be appropriate as there are chemicals that have not been monitored); other issues debated were that of contamination versus pollution and the one on metals (which should be addressed separately from the organic micro-pollutants because of the peculiarities of the effects). The idea is to make a risk based prioritisation independent from the organic ones, to use solely monitoring data and finally decide what PNECs and what average concentrations should be used. The DG XI representative also informed the CSTEE that the data that will be used ranking the substances would be made publicly available and discussed in a Member States, Industry and NGOs meeting in July. The Water Framework Directive working group chairperson will be invited allowing for feedback to be given later to the CSTEE. The CSTEE will also be invited in due course to give its opinion to this scheme.
12. Information on matters not covered elsewhere in the agenda:
(i) Update by the CSTEE chairman on the latest meetings of the SSC
The chairman informed the CSTEE of developments taking place under the SSC, in particular he commented on the topics BSE, GMOs and antibiotic resistance. He is also gathering contributions from other scientific committee members to the activity on risk assessment.
(ii) Discussion on the brief of the CSTEE
The brief of the CSTEE was discussed. It was unanimously accepted that the committee should be deemed responsible for subjects under the general heading 'Environment', including sub-subjects as Water, Atmospheric emissions, Waste and Chemicals in general. The main reason behind this has to do with the principle that sustainability is intrinsically linked to human health and that, for all intents and purposes, in any of those subjects chemicals are in question in one way or another. However the practical means to achieve this were still being negotiated by the Commission Directorates General concerned (XI and XXIV).
(iii) Directive 67/548/EEC and Regulation 793/93/EEC
A DG XI official had kindly accepted to come to the meeting and make a general presentation on the legal instruments mentioned. He did so using in a very effective manner transparencies, depicting the essential features of the system. It allowed the CSTEE to better understand how some of the opinion requests that have been submitted to them (particularly those stemming so far from Directive 76/769/EEC) fit into the overall picture of chemicals legislation in the EU.
This was also an opportunity for a first exchange of impressions on how the CSTEE could be directly involved in possible opinion requests stemming directly from those two legal instruments.
(iv) New subjects to be addressed by the CSTEE - CSTEE proposals
Among the various ideas that were suggested the more interesting ones were perhaps particulate matter/indoor and/or outdoor pollution and Dioxins. The opportunity to take this up will be decided depending on the CSTEE workload. It was acknowledged that this is probably not the moment to do it.
(v) Schedule of CSTEE meetings for 1998 (update)
Apart from the working group meetings that were decided under previous agenda items the plenary meetings previously foreseen were confirmed, i.e. 14/15 September and 26/27 November 1998 with a possible exceptional one in case of need scheduled for the 21st of December 1998.
13. Arrangements for the next meeting of the CSTEE and planning of timetable of meetings
This agenda point was partially dealt with under agenda point 12(v). No other timetable of meetings was discussed.
14. Any other business
There was none. The meeting was closed at 14H00.
SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE)
4th PLENARY MEETING, Brussels - 15 June 1998, 2 p.m., 16 June 1998, 9 a.m. - AGENDA -
1. Adoption of the draft agenda
2. Adoption of the draft minutes of the 3rd plenary meeting of the CSTEE held on 24.4.98 in Brussels
3. Phthalates in toys - feedback from the responsible services of the Commission on the follow up to the opinion adopted by the CSTEE at its 3rd plenary meeting (24.4.98). New set of questions to the CSTEE.
4. Consideration of draft opinions with a view to their adoption by the CSTEE, on:
(i) Tin, Arsenic and Cadmium
(ii) Pentachlorophenol
5. Chrysotile asbestos - report by the WG chairman on the results of the 'Chrysotile asbestos' working group meeting in Paris, 9 June 1998
6. Accident at the Aznalcollar mine and the contamination of the Guadiamar river and the surroundings of the Doñana National Park - consideration of draft statement/opinion for possible adoption by the CSTEE
7. 'Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment' - discussion
8. Endocrine disrupters - presentation by the working group chairman of:
(i) status report being prepared by the 'Endocrine disrupters' working group; (ii) oral report on his recent participation in EDC's meeting in the USA
9. Creosotes - consideration of the terms of reference and discussion on the approach to address this particular opinion request
10. Strategies for dealing with additional chemicals (opinion requests to be submitted by DG III):
(i) Chlorinated paraffins
(ii) Azo dyes
(iii) New fertilisers
(iv) Other
11. Water Framework Directive - feedback from the responsible services of the Commission on the follow up to the opinion adopted by written procedure by the CSTEE (05.6.98)
12. Information on matters not covered elsewhere in the agenda:
(i) Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee
(ii) Discussion on the brief of the CSTEE
(iii) Directive 67/548/ECC (Classification, Packaging and Labelling of Dangerous Chemical Substances) and Regulation 793/93/EEC (Evaluation and Control of Existing Substances)
(iv) New subjects to be addressed by the CSTEE - CSTEE proposals
(v) Schedule of CSTEE meetings for 1998 (update)
13. Arrangements for the next meeting of the CSTEE and planning of timetable of meetings.
14. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James W. Bridges, Prof. Philip L. Chambers, Prof. Erik Dybing, Prof. Dr. Helmut Greim, Prof. Bo O. Jansson, Prof. Soterios Kyrtopoulos, Dr. Ole Ladefoged, Dr. Claude Lambré, Prof. Dr. José Rueff (15/6), Prof. Mirja Salkinoja-Salonen, Dr. José V. Tarazona, Prof. Benedetto Terracini, Prof. Marco Vighi (15/6), Prof. Joseph Vos, Prof. Dr. Robert Wennig
European Commission:
DG XXIV
Mrs. M. de Solà, Mr. J. Costa-David, Mr. B. Delogu, Mr. W. De Klerck, Mr. T. Daskaleros
DG III
Mr. K. Berend
DG XI
Mr. M. Fidalgo, Mr. A. Paquot
DG V
Mr. A.M. Halsberghe
The draft agenda was adopted.
2. Adoption of the draft minutes of the 3rd plenary meeting of the CSTEE held on 24.04.1998 in Brussels
The draft minutes were adopted with the suggested corrections.
3. 'Phthalates in toys' - new set of questions to the CSTEE
The new set of questions to be answered by the CSTEE was read out. After a long debate the CSTEE adopted an answer whose main conclusions were:
a. On the basis of the Scientific Opinion of 24 April on phthalates in toys is it possible to say that there is serious and immediate risk?
The Committee considers that an answer to question 1 is dependent upon the definitions of 'immediate' and 'serious' as used by the Commission. The CSTEE considers that the risk it identified in the opinion it adopted at its 3rd plenary meeting is not sufficient to fall within the 'life-threatening' category. The present concerns are related to general long-term toxicity including liver and kidney damage. The induction of liver cancer in rodents by some phthalates is judged to be of little relevance for humans. The opinion adopted at the 3rd plenary meeting emphasised that an important area of uncertainty in assessing the risk was the quantification of exposure. The opinion noted that the Dutch study with adult human volunteers and its comparison with in vitro extraction methods should provide the basis for a standardised and validated in vitro test method on phthalate release. This should give more relevant data on human exposure. Should the Dutch study confirm the CSTEE's assessment, the CSTEE concludes that there is a health concern related to children's articles which can be put in the mouth, if the phthalate extractability is likely to exceed the proposed guideline values.
b. Does it exist at present a standardised, validated method to measure the maximum extracted amounts of phthalates in toys?
The answer to this question is No.
c. If such method does not exist how is it possible to implement the CSTEE recommendations on the guideline values for extractable amounts of phthalates in toys?
Any decision now, will have to be based on scientific judgement and assessments. The CSTEE followed a worst case approach founded on the available data recognising that, following clarification provided by the Dutch study the CSTEE approach might have to be revised.
d. How many methods to measure the maximum extracted amounts of phthalates in toys exist at present and how reliable are they? Which of the existing methods does give the greatest guarantees of reliability?
Currently there are a number of non-standardised and non-validated test methods whose quantification and relative quality is variable. The Committee expects to have the findings of the Dutch study available to it at its Plenary meeting in September. It will then be in a position to offer the Commission more conclusive advice.
4. Consideration of draft opinions with a view to their adoption by the CSTEE, on:
(i) Tin, Arsenic and Cadmium
(ii) Pentachlorophenol
As a general point the representative of the Commission service that requested the opinion informed the CSTEE that, in preparing the opinions, they could expand beyond the strict limits of the terms of reference.
The discussions on the chemicals under this agenda point were a trigger for a more general debate on how the CSTEE should address opinion requests of this kind. In general, problems were found with the quality of the reports (e.g. statements improperly referenced, assumptions that best practice is followed in all cases, etc.). This causes difficulties as the working group members have to look for the data themselves, something which may not be totally in line with the task initially anticipated. Some even suggested that the quality of contractors should be checked. DG III explained the difficulties both in terms of time and budget that they have to face when deciding on which is the best way to get a report for these targeted risk assessments. The suggestion was made that the IPCS format of reports should be followed. Another suggestion was that perhaps the CSTEE could prepare guidelines on how these reports should be produced.
The drafts available were then thoroughly discussed but no final opinions could be adopted given the nature of comments made which indicated the need for changes. The Commission service that had made the request, while acknowledging the effort put in by the working groups and the CSTEE, insisted on the urgency to have opinions adopted because of political commitments behind them (Accession treaty).
Arsenic
The rapporteur on this chemical made a detailed presentation pointing out that the bottom line of the working group's conclusions is that the Atkins report correctly identifies the main risks associated with wood preservation but that the justification could be better.
There appears to be a lot of arbitrary statements in their report. For instance in the introductory section the Atkins report states that their assumptions are based on the assumption of best current practice at all stages of the production, use and disposal of arsenic treated wood, but from the feedback given by the Commission service that requested the opinion it was apparently very difficult to obtain from M. States to what extent best practice is indeed followed.
The authors of the report assume that current specifications, whether they are derived from legislation or Industry guidelines, are strictly followed. The working group felt that to the extent that such rules are guided by law and imposed as such, these assumptions are correct and acceptable. On the other hand to the extent that this is not the case but a matter of voluntary agreements by Industry this assumption is a bit risky without backing it up and the report from Atkins does not confirm this. The problem with environmental data is that they are poor in this case and there is no real rational way to confirm that the best practice specifications are abided to.
In the report's section on environmental behaviour and chemistry of arsenic the working group's key point is that the chemistry is very complex and the complexity is not fully brought out in the report, specially the complexity of the processes that influence the speciation, the mobility and the bio-availability of arsenic in very widely differing environmental situations. This makes reliable predictions difficult and could have been brought out more clearly. The question on ecotoxicological effects is approached and the report identifies pnecs for various compartments; as far as the water compartment is concerned they identify effects on algae in low phosphate marine waters as being the most sensitive species and the pnecs are quite close to the actual background concentrations. There is very little room in general for additional exposures. In their calculation Atkins did not allow for an uncertainty factor (a factor which according to the TGD for Regulation 793/93 should be used to divide the NOAEL and whose magnitude depends on the degree of uncertainty allowed by the available data). In this case Atkins used an uncertainty factor of 1 based on the fact that the data that they had were derived from chronic exposures and field measurements in a number of species, in other words the uncertainty was limited. Had they used the uncertainty factor of 10 which is suggested as default in the TGD then the resulting PNECs would be below the actual background concentrations allowing for no room at all for antropogenic exposures. A number of other reports the working group had access to did actually come up with pnecs not very different from the ones of Atkins so it would seem that their option is acceptable. For a number of compartments, Atkins did not derive PNEC's but instead used guideline values taken from various reports or national legislation without giving any justification for doing so. For example, instead of deriving a PNEC for groundwater, a UK maximum loading limit was employed.
Discussion of human health effects is very limited. In particular, there is unacceptably scarce use of references from the open scientific literature, even on important issues like genotoxicity and dose-response relationships which are well covered by the available literature. The Atkins report identifies as important human effects the induction of lung cancer by inhalation and of non-cancer skin lesions by ingestion, but it does not mention the induction of skin cancer by ingestion which is an important effect. For risk estimation after inhalation they adopt linear extrapolation and the WHO unit risk, while for the oral induction of non-cancer effects they use a TDI of 2µg/kg also used by WHO.
For environmental effects the risks that the report identifies are related to with effects on the growth of algae in low phosphate marine waters; potential risks from unpredictable long term leaching in landfills in waste landfills; they identify marginally increased predicted lung cancer risks from controlled incineration, significantly increased predicted lung cancer risks from uncontrolled burning during home heating and significant predicted effects on the environment from uncontrolled burning and dumping. Even though they identify also some risks for children in playgrounds for some reason they do not carry over this in their conclusions. In the working group's discussion it was agreed that these are the main risks and that it should be pointed out that there are also potential risks in highly localised areas near CCA treated wood which should be borne in mind. Above all there is cause for concern arising from the high degree of uncertainty with which one can make predictions regarding the speciation of arsenic during long term storage and hence on how to predict its behaviour in migration and bio-availability.
The working group feels that it should make a recommendation to the effect that this should be addressed by research. In the meantime it would be advisable to exercise caution and to limit the use of arsenic based wood to those situations where it is absolutely necessary. As far as the quality of the report is concerned it should have been better justified and made better use of the available literature supporting its conclusions even though the methodology that was followed is basically correct and their main conclusions are fundamentally right. The report should have supported them better specially where it uses various guidelines whose choice should have been explained and what risks they're associated with so as to make their acceptance easier.
A few remarks/suggestions were made by some CSTEE members. One member informed the CSTEE about the existence and activities of an international expert group evaluating and concluding on the present knowledge as relates to health risks of arsenic. Their work should be on the verge on conclusion and maybe considering it is warranted before adopting a final opinion. Another member suggested that until the opposite is demonstrated some mention of skin cancer should be included in the opinion.
Still another member commented on the nature of the presentation as being a mixture of the conclusions of the report and the purported CSTEE's views.
It was decided that the proposed changes be introduced in the draft in view of a possible adoption by the CSTEE the following day, an intention that could not be confirmed as there was no time to revisit it.
5. Chrysotile asbestos - report by the WG chairman on the results of the 'Chrysotile asbestos' working group meeting in Paris, 9 June 1998
The 'Chrysotile asbestos' working group chairman presented this point. He made an oral account of the developments on this subject that took place in the Paris working group meeting of 9 June 1998. He described the composition of the working group, in particular who the external experts were and the kind of contribution that each made to the debate. He also described the documentation that the working group had received (all under the general reference CSTEE/97/2), in particular doc. CSTEE/97/2 - Add. 25, since it gave an overview of the situation in those countries where there is a more strict legislation than that generally in force in the EU.
The WG chairman also described the terms of reference for this particular opinion request as submitted by the requester Commission service (DG III/C/4) as well as the nature of the discussion on this and the reason why the terms of reference had been drafted in the chosen way.
These had been discussed between the various Commission services involved and the 'Chrysotile asbestos' Working Group and were the following:
'On the basis of the available data, do any of the following substitute fibres pose an equal or greater risk to human health than chrysotile asbestos?
- Cellulose fibres
- PVA fibres
- P-aramid fibres
Particular consideration should be given to the relative risk to para-occupational workers and other users of asbestos-containing products in comparison to non-asbestos products".
Another point under analysis was the consideration of "para-occupational" exposures in particular, but not exclusively, because this concept had initially been included in the terms of reference and triggered an uncomfortable reaction from the Commission services responsible for worker's protection (DG V). It was believed that occupational considerations, although they are probably not the first concern here, could still be addressed in the CSTEE's opinion as concentration limits of such agents in the workplace are relevant for comparisons. The terms of reference should not include them though. Furthermore it was reminded that DG V have a scientific committee on occupational exposure limits whose activities/conclusions should be of interest for the CSTEE to follow.
The WG chairman also explained the reasons for choosing to address the terms of reference as referring to "commercially available chrysotile" given the variable characteristics of this product depending on which market it is available from. He also commented on reactions from several sources to the first CSTEE opinion on this topic as adopted at the CSTEE plenary meeting of 9 February 1998.
Other elements described by the WG chairperson were various documents which were considered relevant for the forthcoming activities/conclusions of the CSTEE when it delivers its opinion on the subject (docs. from the Institute of Environmental Health, Leicester and from ISERM, Paris); the latter still subject to confidentiality at the time of the meeting.
The input provided by an academic representative from Spain, but that had to be considered as representing the views of the asbestos Industry sector, was described as well as the impact that its content had had on the "Chrysotile asbestos" WG members, some of which took on the task of commenting back.
The WG chairperson described the agreed working arrangements to follow this topic up. A working group meeting was scheduled for the 22nd of July 1998, with the 16th of July as deadline for submission of contribution to the WG chairperson in view of his preparing a draft paper to be discussed at the WG meeting. In principle no more WG meetings should be necessary to agree on a draft opinion that could be submitted to the CSTEE plenary meeting of September but in case of need another one can probably be accommodated shortly before that.
Finally the chairperson informed the plenary that he had been invited by the European Parliament social affairs committee to a meeting, the idea being to express his views as an expert in this field before the committee. The CSTEE chairman had been previously informed and given its agreement to it. The explanation was made to the committee that the WG chairperson was there on a personal basis and that the views expressed could not be taken to reflect the CSTEE's views on the subject.
A representative of the Commission service that requested the opinion expressed its gratitude for the work put in by the WG and the CSTEE on this and reiterated the importance to have an opinion on this subject adopted at the CSTEE plenary meeting of September 1998.
The representative of DG V of the Commission also commented on this activity. Its importance, in particular as Member States and the Council have recently expressed their interest when conclusions were adopted to the effect that the Commission should take rapid steps to have a look at the existing directives on asbestos worker's protection. DG V will do their best to try and follow closely the developments of the activity of this WG; if possible they will be present at the WG meeting of 22 July.
6. Accident at the Aznalcollar mine and the contamination of the Guadiamar river and the surroundings of the Doñana National Park - consideration of draft statement/opinion for possible adoption by the CSTEE
The suggestion was made that this kind of problems is taken care of properly already since there are EU legislative instruments to deal with them. This view was countered by some. A particular CSTEE member reacted saying that from the effects side, as in a specific case of an accident with an oil tanker off the coast of Wales, legislation was of no help whatsoever.
A draft statement was prepared by one CSTEE member and distributed. However, given the nature of the problem in question here and the fact that the CSTEE did not have the time to being properly informed on it, the decision was taken to prepare a more general statement on accidents of this kind to be presented in a future plenary meeting and endorsed by the CSTEE.
An ad hoc working group was set up from within the CSTEE to be activated as and when accidents of this kind would dictate in view of basically follow them up.
7. 'Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment' - discussion
This topic was included at the specific suggestion of one CSTEE member. The idea behind it was to have the CSTEE commenting on the best approach to pursue (e.g. based on soil organisms, holistic approach?) in trying to come up with a system suitable for hazard identification (classification) and risk assessment for effects on the terrestrial environment.
However, given that a workshop is scheduled to take place in Madrid in November where the issue will be thoroughly debated the decision was taken to wait for its results before a decision is taken on how the CSTEE should follow this one up.
8. Endocrine disrupters - presentation by the working group chairman of:
(i) status report being prepared by the 'Endocrine disrupters' working group;
(ii) oral report on his recent participation in an EDCs meeting in the USA
(i) The WG chairperson described the results of the working group meeting that had taken place in May where the outline of the report was again discussed. The content of the various chapters, i.e. Introduction, Human health, Ecological Health, Ecotoxicology test protocols and Conclusion were described.
As suggested by the CSTEE at its previous plenary meeting the issue of prioritisation of chemicals was accepted and it will be developed in the chapter on test protocols.
A working group meeting is foreseen for the 29th of June 1998 and contributions from the CSTEE and WG members are expected by the 23rd of June.
(ii) On the subject of his attending the meeting in Washington, a roundtable conference to prepare the implementation of the EC-US Science and Technology Co-operation Agreement that took place on the 8th and 9th of June 98, the WG chairperson gave some feedback commenting in particular on the differences of approach characterising the US and EU systems where the former relies very much on individual testing and the latter on test protocols.
Finally the information was also given that on 24-25-26 of June there will be a meeting of the IPCS/OECD steering committee to look at the state of science assessment.
9. Creosotes - consideration of the terms of reference and discussion on the approach to address this particular opinion request
A working group was formed to address this particular opinion request and the decision taken to have a working group meeting in Brussels on the 10th of August. In the meantime the requester Commission service would provide as much data as possible
10. Strategies to deal with additional chemicals (opinion requests to be submitted by DG III)
The DG III representative in the meeting informed the CSTEE of the possible forthcoming topics on which opinion requests could be submitted [Mercury (as contained in certain consumer products like thermometers, electrical equipment), new fertilisers, Azo dyes, chlorinated solvents and textile solvents, etc.].
The prioritisation has yet to be decided but the next opinion request is likely to be on Azo dyes.
11. Water framework directive - feedback from the responsible services of the Commission on the follow up to the opinion adopted by written procedure by the CSTEE (05.6.98)
The DG XI representative made a series of comments on the minutes of the previous CSTEE meting which were taken into consideration. Some aspects of the topic were revisited, in particular the issue of monitoring based and modelling based approaches as suggested by the CSTEE in its opinion, which should be seen as complementary and not mutually exclusive (monitoring based approaches only would not be appropriate as there are chemicals that have not been monitored); other issues debated were that of contamination versus pollution and the one on metals (which should be addressed separately from the organic micro-pollutants because of the peculiarities of the effects). The idea is to make a risk based prioritisation independent from the organic ones, to use solely monitoring data and finally decide what PNECs and what average concentrations should be used. The DG XI representative also informed the CSTEE that the data that will be used ranking the substances would be made publicly available and discussed in a Member States, Industry and NGOs meeting in July. The Water Framework Directive working group chairperson will be invited allowing for feedback to be given later to the CSTEE. The CSTEE will also be invited in due course to give its opinion to this scheme.
12. Information on matters not covered elsewhere in the agenda:
(i) Update by the CSTEE chairman on the latest meetings of the SSC
The chairman informed the CSTEE of developments taking place under the SSC, in particular he commented on the topics BSE, GMOs and antibiotic resistance. He is also gathering contributions from other scientific committee members to the activity on risk assessment.
(ii) Discussion on the brief of the CSTEE
The brief of the CSTEE was discussed. It was unanimously accepted that the committee should be deemed responsible for subjects under the general heading 'Environment', including sub-subjects as Water, Atmospheric emissions, Waste and Chemicals in general. The main reason behind this has to do with the principle that sustainability is intrinsically linked to human health and that, for all intents and purposes, in any of those subjects chemicals are in question in one way or another. However the practical means to achieve this were still being negotiated by the Commission Directorates General concerned (XI and XXIV).
(iii) Directive 67/548/EEC and Regulation 793/93/EEC
A DG XI official had kindly accepted to come to the meeting and make a general presentation on the legal instruments mentioned. He did so using in a very effective manner transparencies, depicting the essential features of the system. It allowed the CSTEE to better understand how some of the opinion requests that have been submitted to them (particularly those stemming so far from Directive 76/769/EEC) fit into the overall picture of chemicals legislation in the EU.
This was also an opportunity for a first exchange of impressions on how the CSTEE could be directly involved in possible opinion requests stemming directly from those two legal instruments.
(iv) New subjects to be addressed by the CSTEE - CSTEE proposals
Among the various ideas that were suggested the more interesting ones were perhaps particulate matter/indoor and/or outdoor pollution and Dioxins. The opportunity to take this up will be decided depending on the CSTEE workload. It was acknowledged that this is probably not the moment to do it.
(v) Schedule of CSTEE meetings for 1998 (update)
Apart from the working group meetings that were decided under previous agenda items the plenary meetings previously foreseen were confirmed, i.e. 14/15 September and 26/27 November 1998 with a possible exceptional one in case of need scheduled for the 21st of December 1998.
13. Arrangements for the next meeting of the CSTEE and planning of timetable of meetings
This agenda point was partially dealt with under agenda point 12(v). No other timetable of meetings was discussed.
14. Any other business
There was none. The meeting was closed at 14H00.
SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE)
4th PLENARY MEETING, Brussels - 15 June 1998, 2 p.m., 16 June 1998, 9 a.m. - AGENDA -
1. Adoption of the draft agenda
2. Adoption of the draft minutes of the 3rd plenary meeting of the CSTEE held on 24.4.98 in Brussels
3. Phthalates in toys - feedback from the responsible services of the Commission on the follow up to the opinion adopted by the CSTEE at its 3rd plenary meeting (24.4.98). New set of questions to the CSTEE.
4. Consideration of draft opinions with a view to their adoption by the CSTEE, on:
(i) Tin, Arsenic and Cadmium
(ii) Pentachlorophenol
5. Chrysotile asbestos - report by the WG chairman on the results of the 'Chrysotile asbestos' working group meeting in Paris, 9 June 1998
6. Accident at the Aznalcollar mine and the contamination of the Guadiamar river and the surroundings of the Doñana National Park - consideration of draft statement/opinion for possible adoption by the CSTEE
7. 'Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment' - discussion
8. Endocrine disrupters - presentation by the working group chairman of:
(i) status report being prepared by the 'Endocrine disrupters' working group; (ii) oral report on his recent participation in EDC's meeting in the USA
9. Creosotes - consideration of the terms of reference and discussion on the approach to address this particular opinion request
10. Strategies for dealing with additional chemicals (opinion requests to be submitted by DG III):
(i) Chlorinated paraffins
(ii) Azo dyes
(iii) New fertilisers
(iv) Other
11. Water Framework Directive - feedback from the responsible services of the Commission on the follow up to the opinion adopted by written procedure by the CSTEE (05.6.98)
12. Information on matters not covered elsewhere in the agenda:
(i) Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee
(ii) Discussion on the brief of the CSTEE
(iii) Directive 67/548/ECC (Classification, Packaging and Labelling of Dangerous Chemical Substances) and Regulation 793/93/EEC (Evaluation and Control of Existing Substances)
(iv) New subjects to be addressed by the CSTEE - CSTEE proposals
(v) Schedule of CSTEE meetings for 1998 (update)
13. Arrangements for the next meeting of the CSTEE and planning of timetable of meetings.
14. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James W. Bridges, Prof. Philip L. Chambers, Prof. Erik Dybing, Prof. Dr. Helmut Greim, Prof. Bo O. Jansson, Prof. Soterios Kyrtopoulos, Dr. Ole Ladefoged, Dr. Claude Lambré, Prof. Dr. José Rueff (15/6), Prof. Mirja Salkinoja-Salonen, Dr. José V. Tarazona, Prof. Benedetto Terracini, Prof. Marco Vighi (15/6), Prof. Joseph Vos, Prof. Dr. Robert Wennig
European Commission:
DG XXIV
Mrs. M. de Solà, Mr. J. Costa-David, Mr. B. Delogu, Mr. W. De Klerck, Mr. T. Daskaleros
DG III
Mr. K. Berend
DG XI
Mr. M. Fidalgo, Mr. A. Paquot
DG V
Mr. A.M. Halsberghe
