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Directorate-General for Health and Food Safety
Introduction
1. Welcoming address, apologies for absence and declarations of interest
Apologies were received from Profs. Greim, Terracini and Utne-Skaare.
2. Adoption of the draft agenda
The draft agenda was adopted but with a change in the order of some agenda points. A new point was added at the request of members.
3. Adoption of the draft minutes of the 11th CSTEE plenary meeting held on the 27/28 September 1999 in Brussels
The adoption of the minutes was postponed pending clarification still needed on some minor points. The urgent need for this clarification was expressed by the CSTEE secretariat.
4. Information from the CSTEE secretariat
5. Draft Commission Decision prohibiting the placing on the market of toys and childcare articles containing six types of phthalates (DINP, DEHP, DBP, DIDP, DNOP and BBP)
The Chairman of the CSTEE and that of the Working Group on Phthalates informed about a personal letter sent by them on a private basis, due to the lack of opportunity to previously consult the Committee, and addressed to the Director of the directorate dealing with scientific opinions on health matters in Health and Consumer Protection Directorate General. It was explained that this unusual action was taken because of the urgency required. The letter proposed some changes in the Draft Decision Proposal in order to better reflect the previous opinions of the Committee on this issue. The Commission had responded positively.
In these opinions the CSTEE had only expressed concern about two of the phthalates, namely DEHP and DINP. No concerns had been identified for the other four phthalates. The Committee confirmed that this remained their view for DIDP, BBP and DNOP. For DBP there remained an issue of the size of the safety factor to be used as there was a LOAEL but not a NOAEL.
The Committee also clarified its view on the validity of the presently available test protocols to study migration. It was agreed that efforts to improve the predictability of the tests have resulted in major improvements. The CSTEE expected a valid test protocol will be available in the near future when the recommendations of the CSTEE have been met (see also item 6).
6. Discussion and possible adoption of a CSTEE position on two letters received from i) the UK LGC and ii) on behalf of the Dutch TNO contesting the CSTEE's conclusions on the reports respectively elaborated by those groups on the validation of the so-called "Dutch consensus Group study".
On this issue, three aspects were pointed out: (i)the lack of reproducibility found in the LGC method, (ii)the variability in the TNO method, and (iii)a recommendation to this last group to try to achieve a 9µgram/10 cm2/min level in their test. It was proposed to clarify why the CSTEE recommends 9µgram/10 cm2/min as a target level through making cross-references to previous Committee opinions.
About the reproducibility of both the TNO and LGC methods, it was stressed that the limit of 20 per cent, proposed by the CSTEE, is not set in the opinion as an absolute limit, but as a reasonable target. Cross-references to the previous opinions were proposed. Another aspect was raised in the letters from TNO and LGC regarding current EU harmonised standards for other substances having equal high variability. It was agreed that an appropriate answer to the question should be provided by the CSTEE once a data gathering exercise had been completed.
7. Progress reports and/or possible adoption of opinion related to the 'Water framework directive' on:
I) Report from a study on Technical specifications for classification and presentation of ecological status of surface waters (March 1999 ?) and
II) Report from a study on Technical specifications for monitoring of ecological status of surface waters (March 1999 ?)
The discussion of this issue was postponed to a forthcoming CSTEE plenary meeting.
8. Opinion request on a proposed Ready biodegradability approach to update detergent legislation - for opinion
The Working Group rapporteur presented the final draft opinion agreed in the last WG meeting. Some minor rewordings on the second paragraph of question 3 were proposed by the CSTEE in order to avoid possible misunderstandings. The opinion was adopted with these minor changes.
The Commission representative from DG ENTR expressed the satisfaction of his service for having the opinion in the time requested. He stressed the importance of this for the purpose of revising the existing legislation. He pointed out also that in his opinion the answers given by the Committee were clear and flexible enough to adopt them for the text of the legislation. He saw no necessity for further explanations by the CSTEE.
9. Evaluation of Technical Guidance Document in support of Directive 98/8/EC concerning the placing of biocidal products on the market - for opinion
The Chairperson of the working group informed the Committee about the progress made in its last meeting. It was expected to have a final draft opinion on the issue for next CSTEE plenary meeting.
The working group was concerned about the actual question posed to the CSTEE, since what was laid down in the Technical Guidance Document (TGD) was more aimed at dealing with hazard assessment than with risk assessment. It was informed that, subsequently, the WG members agreed with Commission representative from DG ENV to understand the question in the sense of advising the Commission on whether the TNsG proposed are or are not appropriate to carry out a proper hazard assessment.
The WG asked for the views of the CSTEE to their vision and positions on the issue. The CSTEE supported the position taken by the Working Group.
A concern about the terminological coherence among the technical documents produced by the Commission services was raised. There was the general agreement among CSTEE that the terminology used should be the same in all the documents and opinions.
10. Lead - Danish notification 595/98/DK
The Chairman of the WG presented the topic to the Committee. Two different questions were presented to the CSTEE for opinion. Question A is a broad one that refers to a general critical review of the human health effects of lead and also the environmental health effects of lead. The second set of questions relates to the Danish notification 98/595/DK, seeking a ban of lead on the grounds of both human and environmental health effects, and it is a much narrower one in scope. The WG has decided to concentrate on question B first and then look to see the extent to which they could address question A, bearing in mind the limited resources that the WG and the Committee has and the very general and broad scope of the question. Thus, whereas it is possible to answer question B in a relatively short time scale, it would take very much longer to produce a general review of the human health and also the environmental effects of lead.
The WG is trying to get more information on the Danish data on exposure. The next step will be to make a comparison with data from other member states, to see whether the Danish situation is worse than or comparable to that of other member states. The CSTEE members were asked to provide to the WG any information on the specific situation of their countries.
11. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
Reviewing of substances on the framework of Regulation 793/93 on existing chemical substances
The CSTEE secretariat informed the Committee about the imminent presentation of an opinion request on the risk assessments produced under Regulation 793/93 on existing chemical substances. Four of them had been already sent by e-mail to CSTEE members, who were asked to volunteer for this task. The CSTEE chairman explained that there were twelve chemicals to be reviewed by the CSTEE initially.
A Commission representative informed the CSTEE that there was a further group of 12 chemicals ready to be referred to the Committee. There were no deadlines set for the CSTEE, and it was proposed by the Committee to see the extent and size of the reports first and after that to decide on a timing for the task.
It was noted by the CSTEE that the Committee was being asked to evaluate in a short period of time a large amount of documents developed during many years of activity with some very experienced people involved in it.
A CSTEE member expressed his reservations about the sending by the CSTEE secretariat of a large amount of documentation by e-mail. The secretary explained that the sending of these documents regarding Regulation 793/93 was due to the necessity of giving the Committee as much time as possible to review the documents.
The CSTEE secretariat stressed the importance of both the time factor and overall work load. He also informed the Committee about a provisional understanding between DG SANCO and DG ENV, in what could be a regular task of the Committee in evaluating data provided by DG ENV on existing chemicals. A one-year trial period was proposed by the CSTEE, which will then be reviewed.
With regard to the kind of peer review that the responsible Commission services were asking for the CSTEE agreed that it was impracticable and unnecessary to conduct a very thorough check of every aspect, e.g. bibliography.
The representatives from Commission services supported this agreement. It was proposed that a first meeting be held with the presence of the chairpersons of the technical groups that had produced the risk assessment reports. The outcome of this meeting should be clear guidelines for the Working Groups. This was agreed.
A steering group was set up to decide the general strategy to deal with the issue and to co-ordinate the actual reviewing of the documents.
12. The use of measured exposure data in risk assessments - progress report
The chairman of the WG informed the Committee that the WG had not yet started working. A meeting was foreseen by the beginning of year 2000 with the European Environment Agency, which is also working on chemicals and monitoring of chemicals.
The CSTEE chairman informed the Committee that he had attended the Scientific Committee of the European Environment Agency to present the activities of the CSTEE and took the opportunity to look for future collaboration. He had made the proposal on behalf of the Committee that environmental exposure assessment would be a very relevant area for joint collaboration. The EEA had strongly supported this proposal. The CSTEE members agreed to this initiative.
13. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
The WG chairman informed that he had sent by e-mail to CSTEE members the final table of contents that had been agreed in the latest meeting of the WG. He informed the Committee of the dead lines expected: the end of the year for having a clear identification of the experts who were going to contribute to each chapter, the end of January 2000 for having a first draft for each chapter and March or April for the final draft.
Regarding classification, a meeting had been recently held in the ECB and classification for Terrestrial Environment was in progress, therefore opinions of CSTEE on the subject should be of interest. As regards biocides the WG needed to address the problem because of the lack of consistency.
CSTEE members were asked to circulate comments on it directly to the WG chairman. The chairman drew attention to the parallels of this document with the one already prepared by the CSTEE about endocrine disrupting chemicals, in the sense that both are very comprehensive and very important reviews. Due to this complexity he asked also for other CSTEE members to contribute if they could to the WG.
The WG chairman informed of some aspects where co-operation would be desirable, regarding monitoring and modelling data. Other points were expected to appear in the future, where other CSTEE members could be involved.
The WG was asked to highlight where its work fitted with the new concept of integrated risk assessment, which involves bringing together human and environmental risk assessment. On this issue, one CSTEE member informed of a draft report from IPCS currently being under discussion, and offered to send it to CSTEE members.
14. Feedback from the competent services of the Commission on the follow up to the opinions adopted previously by the CSTEE
The CSTEE secretariat informed that the only service that had transmitted comments to him had been the one responsible for the Water Framework Directive, comments that had already been incorporated in the annotated draft agenda of the meeting.
A representative from DG SANCO, unit A-4, informed about some divergent interpretations of the CSTEE recommendation for keeping open the list of priority substances within this directive and how to incorporate the concerns expressed by the CSTEE about new emerging high volume chemicals. The CSTEE chairman explained that the Committee concern was about situations where a chemical which is currently used at low level may suddenly be used at a high level as a result of a Commission approval and how the Commission proposes to deal with that sort of situation in the future. The concern was expressed also about some pesticides being used also as biocides or having other uses (veterinary products, for instance), and the mechanisms in place to ensure that human and environmental risk assessments covered the total amount of the chemical in use.
A representative from DG SANCO Unit A-4 informed on behalf of DG ENTR Unit C-4 of the follow up of a previous CSTEE opinion on chlorinated paraffins. A compromise was being elaborated in the sense that the Directive will propose the restrictions which follow on from the risk assessment reviewed by the Committee, but that further studies will be carried out on the emission from consumer products.
Regarding an inter-service consultation between DG ENV and DG SANCO for the list of priority substances for the Water Framework Directive, the CSTEE secretariat asked the representative from DG SANCO Unit A-4 if there was any new dead line for the process, the first one having been on the 19th of November, or any official answer being sent by DG SANCO. The answer was no.
15. Information related to:
a) The CSTEE opinion on Human and Wildlife Health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on Ecotoxicology Test Methods
b) Other information related to the subject "Endocrine disrupters"
The information was given that there were two validation committees (one on toxicology and another one on ecotoxicology) within the OECD, which were dealing with the validation of some new test for endocrine disruption.
The Committee was informed as well of contacts established by a WG member with the former chief editor of Critical Reviews in Toxicology, regarding the publication of the wildlife part of the CSTEE review. An answer was expected within one week.
Additional information was given on a meeting to be held in Japan, organised by the Japan Environment Agency, on December 9-11. The WG chairman had been invited to make a presentation of the issue on the EU, and also of the CSTEE report.
The publication of the report was not finished, and the CSTEE secretariat expressed his disappointment for that. The last information on the subject was that copies should be ready to be sent to CSTEE members within the first week of December.
16. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
The CSTEE chairman stated that the last meeting of the Scientific Steering Committee had only discussed the French ban on British beef.
Additional information was given on the Harmonisation Risk Assessment group within the SSC. Three working parties were set within this working group: one on quantitative risk assessment, a second one on terminology and a third one on the interface between risk assessment and risk management.
17. Arrangements for the next meeting of the CSTEE/Schedule of CSTEE plenary meetings for the year 2000.
Due to the fact that some members of the Committee were not present in the meeting at the moment when this point was raised, it was agreed to deal with the subject of future meetings in the usual way, namely send to all the members of the CSTEE tables of availability, and depending on their response, arrange the most suitable dates both for plenary and for WG meetings. Because of lack of time and the absence of a few CSTEE members it was decided to fix the date of the 13th plenary meeting in this way. The secretary of the Committee made a call for co-operation on this aspect to all CSTEE members.
One CSTEE member asked the secretariat to arrange if possible WG meetings back to back to the plenary meeting.
18. Any other business
There was none.
SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE), 12th PLENARY MEETING, 25th of November 1999, 9H30, 232, rue Belliard, room 4/11, B-1040 Brussels, Belgium - AGENDA -
1. Welcoming address, apologies for absence and declarations of interest
2. Adoption of the draft agenda
3. Adoption of the draft minutes of the 11th CSTEE plenary meeting held on the 27/28 September 1999 in Brussels
4. Information from the CSTEE secretariat
5. Draft Commission Decision prohibiting the placing on the market of toys and childcare articles containing six types of phthalates (DINP, DEHP, DBP, DIDP, DNOP and BBP)
6. Discussion and possible adoption of a CSTEE position on two letters received from i) the UK LGC and ii) on behalf of the Dutch TNO contesting the CSTEE's conclusions on the reports respectively elaborated by those groups on the validation of the so-called "Dutch consensus Group study".
7. Progress reports and/or possible adoption of opinion related to the 'Water framework directive' on:
I) Report from a study on Technical specifications for classification and presentation of ecological status of surface waters (March 1999 ?) and
II) Report from a study on Technical specifications for monitoring of ecological status of surface waters (March 1999 ?)
8. Opinion request on a proposed Ready biodegradability approach to update detergent legislation - for opinion
9. Evaluation of Technical Guidance Document in support of Directive 98/8/EC concerning the placing of biocidal products on the market - for opinion
10. Lead - Danish notification 595/98/DK
11. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
12. The use of measured exposure data in risk assessments - progress report
13. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
14. Feedback from the competent services of the Commission on the follow up to the opinions adopted previously by the CSTEE
15. Information related to:
a) The CSTEE opinion on Human and Wildlife Health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on Ecotoxicology Test Methods
b) Other information related to the subject "Endocrine disrupters"
16. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
17. Arrangements for the next meeting of the CSTEE/ Schedule of CSTEE plenary meetings for the year 2000
18. Any other business
SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE), 12th PLENARY MEETING, 25th of November 1999, 9H30, 232, rue Belliard, room 4/11, B-1040 Brussels, Belgium
LIST OF PARTICIPANTS
CSTEE:
Prof. James W. BRIDGES, Prof. Erik DYBING, Prof. Bo JANSSON, Prof. Joseph VOS, Dr. Ole LADEFOGED, Prof. Dr. José RUEFF, Prof. Mirja SALKINOJA-SALONEN, Prof. Marco VIGHI, Prof. Joseph VOS, Dr. Claude LAMBRE, Prof. Katarina Victorin, Dr. Marc COSTELLO, Prof. Soterios KYRTOPOULOS, Dr. José TARAZONA, Prof. Robert WENNIG
External expert:
Dr Suresh RASTOGI
European Commission:
DG SANCO
Mr Michael WALSH, Mr. J. COSTA-DAVID, Mr Arpad SOMOGYI, Mrs A. FOKKEMA, Mrs Angelika WILHELM
DG ENTR
Mrs L. PERENIUS, Mr CANDA MORENO
DG ENV
Mrs. Ann VERMEERSCH, Mr. Paul HAYES, Mr. J. LEBSANFT
DG JRC
Mr Carl HAUX
1. Welcoming address, apologies for absence and declarations of interest
Apologies were received from Profs. Greim, Terracini and Utne-Skaare.
2. Adoption of the draft agenda
The draft agenda was adopted but with a change in the order of some agenda points. A new point was added at the request of members.
3. Adoption of the draft minutes of the 11th CSTEE plenary meeting held on the 27/28 September 1999 in Brussels
The adoption of the minutes was postponed pending clarification still needed on some minor points. The urgent need for this clarification was expressed by the CSTEE secretariat.
4. Information from the CSTEE secretariat
5. Draft Commission Decision prohibiting the placing on the market of toys and childcare articles containing six types of phthalates (DINP, DEHP, DBP, DIDP, DNOP and BBP)
The Chairman of the CSTEE and that of the Working Group on Phthalates informed about a personal letter sent by them on a private basis, due to the lack of opportunity to previously consult the Committee, and addressed to the Director of the directorate dealing with scientific opinions on health matters in Health and Consumer Protection Directorate General. It was explained that this unusual action was taken because of the urgency required. The letter proposed some changes in the Draft Decision Proposal in order to better reflect the previous opinions of the Committee on this issue. The Commission had responded positively.
In these opinions the CSTEE had only expressed concern about two of the phthalates, namely DEHP and DINP. No concerns had been identified for the other four phthalates. The Committee confirmed that this remained their view for DIDP, BBP and DNOP. For DBP there remained an issue of the size of the safety factor to be used as there was a LOAEL but not a NOAEL.
The Committee also clarified its view on the validity of the presently available test protocols to study migration. It was agreed that efforts to improve the predictability of the tests have resulted in major improvements. The CSTEE expected a valid test protocol will be available in the near future when the recommendations of the CSTEE have been met (see also item 6).
6. Discussion and possible adoption of a CSTEE position on two letters received from i) the UK LGC and ii) on behalf of the Dutch TNO contesting the CSTEE's conclusions on the reports respectively elaborated by those groups on the validation of the so-called "Dutch consensus Group study".
On this issue, three aspects were pointed out: (i)the lack of reproducibility found in the LGC method, (ii)the variability in the TNO method, and (iii)a recommendation to this last group to try to achieve a 9µgram/10 cm2/min level in their test. It was proposed to clarify why the CSTEE recommends 9µgram/10 cm2/min as a target level through making cross-references to previous Committee opinions.
About the reproducibility of both the TNO and LGC methods, it was stressed that the limit of 20 per cent, proposed by the CSTEE, is not set in the opinion as an absolute limit, but as a reasonable target. Cross-references to the previous opinions were proposed. Another aspect was raised in the letters from TNO and LGC regarding current EU harmonised standards for other substances having equal high variability. It was agreed that an appropriate answer to the question should be provided by the CSTEE once a data gathering exercise had been completed.
7. Progress reports and/or possible adoption of opinion related to the 'Water framework directive' on:
I) Report from a study on Technical specifications for classification and presentation of ecological status of surface waters (March 1999 ?) and
II) Report from a study on Technical specifications for monitoring of ecological status of surface waters (March 1999 ?)
The discussion of this issue was postponed to a forthcoming CSTEE plenary meeting.
8. Opinion request on a proposed Ready biodegradability approach to update detergent legislation - for opinion
The Working Group rapporteur presented the final draft opinion agreed in the last WG meeting. Some minor rewordings on the second paragraph of question 3 were proposed by the CSTEE in order to avoid possible misunderstandings. The opinion was adopted with these minor changes.
The Commission representative from DG ENTR expressed the satisfaction of his service for having the opinion in the time requested. He stressed the importance of this for the purpose of revising the existing legislation. He pointed out also that in his opinion the answers given by the Committee were clear and flexible enough to adopt them for the text of the legislation. He saw no necessity for further explanations by the CSTEE.
9. Evaluation of Technical Guidance Document in support of Directive 98/8/EC concerning the placing of biocidal products on the market - for opinion
The Chairperson of the working group informed the Committee about the progress made in its last meeting. It was expected to have a final draft opinion on the issue for next CSTEE plenary meeting.
The working group was concerned about the actual question posed to the CSTEE, since what was laid down in the Technical Guidance Document (TGD) was more aimed at dealing with hazard assessment than with risk assessment. It was informed that, subsequently, the WG members agreed with Commission representative from DG ENV to understand the question in the sense of advising the Commission on whether the TNsG proposed are or are not appropriate to carry out a proper hazard assessment.
The WG asked for the views of the CSTEE to their vision and positions on the issue. The CSTEE supported the position taken by the Working Group.
A concern about the terminological coherence among the technical documents produced by the Commission services was raised. There was the general agreement among CSTEE that the terminology used should be the same in all the documents and opinions.
10. Lead - Danish notification 595/98/DK
The Chairman of the WG presented the topic to the Committee. Two different questions were presented to the CSTEE for opinion. Question A is a broad one that refers to a general critical review of the human health effects of lead and also the environmental health effects of lead. The second set of questions relates to the Danish notification 98/595/DK, seeking a ban of lead on the grounds of both human and environmental health effects, and it is a much narrower one in scope. The WG has decided to concentrate on question B first and then look to see the extent to which they could address question A, bearing in mind the limited resources that the WG and the Committee has and the very general and broad scope of the question. Thus, whereas it is possible to answer question B in a relatively short time scale, it would take very much longer to produce a general review of the human health and also the environmental effects of lead.
The WG is trying to get more information on the Danish data on exposure. The next step will be to make a comparison with data from other member states, to see whether the Danish situation is worse than or comparable to that of other member states. The CSTEE members were asked to provide to the WG any information on the specific situation of their countries.
11. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
Reviewing of substances on the framework of Regulation 793/93 on existing chemical substances
The CSTEE secretariat informed the Committee about the imminent presentation of an opinion request on the risk assessments produced under Regulation 793/93 on existing chemical substances. Four of them had been already sent by e-mail to CSTEE members, who were asked to volunteer for this task. The CSTEE chairman explained that there were twelve chemicals to be reviewed by the CSTEE initially.
A Commission representative informed the CSTEE that there was a further group of 12 chemicals ready to be referred to the Committee. There were no deadlines set for the CSTEE, and it was proposed by the Committee to see the extent and size of the reports first and after that to decide on a timing for the task.
It was noted by the CSTEE that the Committee was being asked to evaluate in a short period of time a large amount of documents developed during many years of activity with some very experienced people involved in it.
A CSTEE member expressed his reservations about the sending by the CSTEE secretariat of a large amount of documentation by e-mail. The secretary explained that the sending of these documents regarding Regulation 793/93 was due to the necessity of giving the Committee as much time as possible to review the documents.
The CSTEE secretariat stressed the importance of both the time factor and overall work load. He also informed the Committee about a provisional understanding between DG SANCO and DG ENV, in what could be a regular task of the Committee in evaluating data provided by DG ENV on existing chemicals. A one-year trial period was proposed by the CSTEE, which will then be reviewed.
With regard to the kind of peer review that the responsible Commission services were asking for the CSTEE agreed that it was impracticable and unnecessary to conduct a very thorough check of every aspect, e.g. bibliography.
The representatives from Commission services supported this agreement. It was proposed that a first meeting be held with the presence of the chairpersons of the technical groups that had produced the risk assessment reports. The outcome of this meeting should be clear guidelines for the Working Groups. This was agreed.
A steering group was set up to decide the general strategy to deal with the issue and to co-ordinate the actual reviewing of the documents.
12. The use of measured exposure data in risk assessments - progress report
The chairman of the WG informed the Committee that the WG had not yet started working. A meeting was foreseen by the beginning of year 2000 with the European Environment Agency, which is also working on chemicals and monitoring of chemicals.
The CSTEE chairman informed the Committee that he had attended the Scientific Committee of the European Environment Agency to present the activities of the CSTEE and took the opportunity to look for future collaboration. He had made the proposal on behalf of the Committee that environmental exposure assessment would be a very relevant area for joint collaboration. The EEA had strongly supported this proposal. The CSTEE members agreed to this initiative.
13. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
The WG chairman informed that he had sent by e-mail to CSTEE members the final table of contents that had been agreed in the latest meeting of the WG. He informed the Committee of the dead lines expected: the end of the year for having a clear identification of the experts who were going to contribute to each chapter, the end of January 2000 for having a first draft for each chapter and March or April for the final draft.
Regarding classification, a meeting had been recently held in the ECB and classification for Terrestrial Environment was in progress, therefore opinions of CSTEE on the subject should be of interest. As regards biocides the WG needed to address the problem because of the lack of consistency.
CSTEE members were asked to circulate comments on it directly to the WG chairman. The chairman drew attention to the parallels of this document with the one already prepared by the CSTEE about endocrine disrupting chemicals, in the sense that both are very comprehensive and very important reviews. Due to this complexity he asked also for other CSTEE members to contribute if they could to the WG.
The WG chairman informed of some aspects where co-operation would be desirable, regarding monitoring and modelling data. Other points were expected to appear in the future, where other CSTEE members could be involved.
The WG was asked to highlight where its work fitted with the new concept of integrated risk assessment, which involves bringing together human and environmental risk assessment. On this issue, one CSTEE member informed of a draft report from IPCS currently being under discussion, and offered to send it to CSTEE members.
14. Feedback from the competent services of the Commission on the follow up to the opinions adopted previously by the CSTEE
The CSTEE secretariat informed that the only service that had transmitted comments to him had been the one responsible for the Water Framework Directive, comments that had already been incorporated in the annotated draft agenda of the meeting.
A representative from DG SANCO, unit A-4, informed about some divergent interpretations of the CSTEE recommendation for keeping open the list of priority substances within this directive and how to incorporate the concerns expressed by the CSTEE about new emerging high volume chemicals. The CSTEE chairman explained that the Committee concern was about situations where a chemical which is currently used at low level may suddenly be used at a high level as a result of a Commission approval and how the Commission proposes to deal with that sort of situation in the future. The concern was expressed also about some pesticides being used also as biocides or having other uses (veterinary products, for instance), and the mechanisms in place to ensure that human and environmental risk assessments covered the total amount of the chemical in use.
A representative from DG SANCO Unit A-4 informed on behalf of DG ENTR Unit C-4 of the follow up of a previous CSTEE opinion on chlorinated paraffins. A compromise was being elaborated in the sense that the Directive will propose the restrictions which follow on from the risk assessment reviewed by the Committee, but that further studies will be carried out on the emission from consumer products.
Regarding an inter-service consultation between DG ENV and DG SANCO for the list of priority substances for the Water Framework Directive, the CSTEE secretariat asked the representative from DG SANCO Unit A-4 if there was any new dead line for the process, the first one having been on the 19th of November, or any official answer being sent by DG SANCO. The answer was no.
15. Information related to:
a) The CSTEE opinion on Human and Wildlife Health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on Ecotoxicology Test Methods
b) Other information related to the subject "Endocrine disrupters"
The information was given that there were two validation committees (one on toxicology and another one on ecotoxicology) within the OECD, which were dealing with the validation of some new test for endocrine disruption.
The Committee was informed as well of contacts established by a WG member with the former chief editor of Critical Reviews in Toxicology, regarding the publication of the wildlife part of the CSTEE review. An answer was expected within one week.
Additional information was given on a meeting to be held in Japan, organised by the Japan Environment Agency, on December 9-11. The WG chairman had been invited to make a presentation of the issue on the EU, and also of the CSTEE report.
The publication of the report was not finished, and the CSTEE secretariat expressed his disappointment for that. The last information on the subject was that copies should be ready to be sent to CSTEE members within the first week of December.
16. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
The CSTEE chairman stated that the last meeting of the Scientific Steering Committee had only discussed the French ban on British beef.
Additional information was given on the Harmonisation Risk Assessment group within the SSC. Three working parties were set within this working group: one on quantitative risk assessment, a second one on terminology and a third one on the interface between risk assessment and risk management.
17. Arrangements for the next meeting of the CSTEE/Schedule of CSTEE plenary meetings for the year 2000.
Due to the fact that some members of the Committee were not present in the meeting at the moment when this point was raised, it was agreed to deal with the subject of future meetings in the usual way, namely send to all the members of the CSTEE tables of availability, and depending on their response, arrange the most suitable dates both for plenary and for WG meetings. Because of lack of time and the absence of a few CSTEE members it was decided to fix the date of the 13th plenary meeting in this way. The secretary of the Committee made a call for co-operation on this aspect to all CSTEE members.
One CSTEE member asked the secretariat to arrange if possible WG meetings back to back to the plenary meeting.
18. Any other business
There was none.
SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE), 12th PLENARY MEETING, 25th of November 1999, 9H30, 232, rue Belliard, room 4/11, B-1040 Brussels, Belgium - AGENDA -
1. Welcoming address, apologies for absence and declarations of interest
2. Adoption of the draft agenda
3. Adoption of the draft minutes of the 11th CSTEE plenary meeting held on the 27/28 September 1999 in Brussels
4. Information from the CSTEE secretariat
5. Draft Commission Decision prohibiting the placing on the market of toys and childcare articles containing six types of phthalates (DINP, DEHP, DBP, DIDP, DNOP and BBP)
6. Discussion and possible adoption of a CSTEE position on two letters received from i) the UK LGC and ii) on behalf of the Dutch TNO contesting the CSTEE's conclusions on the reports respectively elaborated by those groups on the validation of the so-called "Dutch consensus Group study".
7. Progress reports and/or possible adoption of opinion related to the 'Water framework directive' on:
I) Report from a study on Technical specifications for classification and presentation of ecological status of surface waters (March 1999 ?) and
II) Report from a study on Technical specifications for monitoring of ecological status of surface waters (March 1999 ?)
8. Opinion request on a proposed Ready biodegradability approach to update detergent legislation - for opinion
9. Evaluation of Technical Guidance Document in support of Directive 98/8/EC concerning the placing of biocidal products on the market - for opinion
10. Lead - Danish notification 595/98/DK
11. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
12. The use of measured exposure data in risk assessments - progress report
13. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
14. Feedback from the competent services of the Commission on the follow up to the opinions adopted previously by the CSTEE
15. Information related to:
a) The CSTEE opinion on Human and Wildlife Health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on Ecotoxicology Test Methods
b) Other information related to the subject "Endocrine disrupters"
16. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
17. Arrangements for the next meeting of the CSTEE/ Schedule of CSTEE plenary meetings for the year 2000
18. Any other business
SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE), 12th PLENARY MEETING, 25th of November 1999, 9H30, 232, rue Belliard, room 4/11, B-1040 Brussels, Belgium
LIST OF PARTICIPANTS
CSTEE:
Prof. James W. BRIDGES, Prof. Erik DYBING, Prof. Bo JANSSON, Prof. Joseph VOS, Dr. Ole LADEFOGED, Prof. Dr. José RUEFF, Prof. Mirja SALKINOJA-SALONEN, Prof. Marco VIGHI, Prof. Joseph VOS, Dr. Claude LAMBRE, Prof. Katarina Victorin, Dr. Marc COSTELLO, Prof. Soterios KYRTOPOULOS, Dr. José TARAZONA, Prof. Robert WENNIG
External expert:
Dr Suresh RASTOGI
European Commission:
DG SANCO
Mr Michael WALSH, Mr. J. COSTA-DAVID, Mr Arpad SOMOGYI, Mrs A. FOKKEMA, Mrs Angelika WILHELM
DG ENTR
Mrs L. PERENIUS, Mr CANDA MORENO
DG ENV
Mrs. Ann VERMEERSCH, Mr. Paul HAYES, Mr. J. LEBSANFT
DG JRC
Mr Carl HAUX
