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Directorate-General for Health and Food Safety
1. Welcoming address, apologies for absence
and declarations of interest
Apologies were received from Profs. Lambré, Vos and Calow.
The CSTEE Secretary informed the Committee about the nomination of a new CSTEE member: Professor Peter Calow. Because of prior commitments he was unable to attend this plenary meeting however.
The issue of the declarations of interest was raised. The Chairman explained the necessity of being as clearer as possible about it, because of the importance and interest in the Committee's activities.
One of the CSTEE and Biocidal WG members reported funding of her institute by a company involved in biocides. The CSTEE chairman asked her to report this sort of interest at the beginning of every plenary and WG meetings on the point "declarations of interest".
2. Adoption of the draft agenda
The agenda was adopted with the only remark that points 8 and 9 should be postponed until the afternoon, due to the impossibility for some representatives from Enterprise and Environment DGs to attend the morning session.
A new point, now 7, was included to deal with a question raised by the rapporteur of the opinion on "Man Made Mineral Fibres classification - DE request for a derogation under Article 100a (4) - Maastricht Treaty".
3. Information from the CSTEE secretariat
The Secretary of the CSTEE informed about some documents sent recently to the Committee members by e-mail. He explained the contents of some of them: one on a new publication, "Chemical Awareness", now available to CSTEE members on Internet, and a second one regarding the possibility of accessing the databases of the European Chemicals Bureau (ECB).
4. Adoption of the draft minutes of the 12th CSTEE plenary meeting held on the 25th of November 1999 in Brussels
The minutes were not adopted because of a discussion raised regarding some aspects about them. A representative from Health and Consumer Protection DG pointed out the convenience of a harmonisation of the minutes of all the Scientific Committees within the DG. At the end there was a general agreement within the CSTEE that future minutes of Committee meetings should be shorter in order to allow them to be ready shortly after the meeting, and also to avoid possible misinterpretations. The secretariat took the task of re-wording the minutes of the November plenary meeting according to these new recommendations for adoption at the April plenary of the CSTEE.
Regarding the possible mentioning in the minutes of who had expressed a particular position it was decided to maintain the anonymity. Nevertheless, the CSTEE agreed that the information should be given on whether or not the decisions would have been unanimously adopted.
The Secretariat informed the Committee that the minutes of the 11th Plenary Meeting were approved by written procedure. A question was raised regarding the issue of Man Made Mineral Fibres discussed during that 11th Plenary Meeting. The Secretariat informed the CSTEE of some amendments that were proposed by Environment DG to a note prepared on that subject. The Secretariat, therefore, thought that it was necessary to consult the rapporteur of the opinion and only after obtaining agreement, incorporate the results of the discussion to the minutes of one of the Plenary Meetings of the CSTEE. The amendments were discussed during this 13th Plenary and a new version of the note adopted.
Some problems were reported to the CSTEE Secretariat regarding the documents received. The Secretariat explained that lists of documents made available to CSTEE members were prepared only for technical documents, and in principle not for information policy documents. Clarifications were asked about documents being sent both in electronic format via e-mail and in printed format via regular mail. The Secretary explained that as a general rule every technical document sent by e-mail is also sent afterwards in printed version, unless the time available for receiving some documents is too short before a meeting making it impossible to proceed to this latter sending in a timely manner.
5. Schedule of CSTEE plenary meetings for the year 2000
Dates were decided for the plenary meetings of this year. Members were asked to block in their agendas two days for each one, taking into account that probably most of them will be single day meetings. According to that a preferred day was decided for each of them. The dates were finally decided as follows: 10-11 April, with 11 as preferred day for a single day meeting; 19-20 June, 19 preferred day; 4-5 September, 4 preferred day; 9-10 October, preferred day 9; 2-3 November, preferred day 2.
Note: it was later realised after the meeting that 2 November being a holiday in Belgium the November plenary meeting will have to be rescheduled.
6. 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 presented the final draft opinion agreed at its last meeting. Some members of the WG made comments regarding the different treatment given in the Technical Notes for Guidance to the human health risk assessment compared to that given to the environment section. A certain concern was also raised about the possibility of setting criteria for waiving some tests on human toxicology.
The problem of the different versions of the Technical Notes for Guidance (TNsG) provided by Environment DG was also raised. One representative from that DG explained that the last document provided was in fact the final draft version of the TNsG.
A discussion was raised between one CSTEE member and those of the biocides WG on the issue of requirements for long term testing of products for carcinogenicity. In consequence, some rewordings were proposed and accepted for the paragraphs in question.
The problem of the terminology used, both in the Technical Notes for Guidance and in the draft opinion, was also discussed. A call for coherence in the terminology used was made. It was pointed out that what was in the TNsG did not allow the Committee to carry out a risk assessment but hazard or exposure assessment instead.
The opinion was adopted with the inclusion of some minor requests for changes proposed by CSTEE members.
7. Man Made Mineral Fibres classification - DE request for a derogation under Article 100a (4) - Maastricht Treaty
At the 11th Plenary Meeting of the CSTEE, held in Brussels, 27-28 September 1999, the necessity for further clarifying the position of the Committee on the mentioned issue was discussed. Afterwards, the CSTEE Secretariat received some comments on the subject from Environment DG. Due to the absence of the opinion rapporteur and WG chairman at the 12th Plenary Meeting, the question was postponed until this 13th plenary.
Environment DG had made three comments to a note prepared on the subject. The first one proposed a change in the first paragraph regarding the distinction for categories 2 and 3 for carcinogenicity in the note Q of the Directive 97/69/EC; this was rejected by the CSTEE. The second one, on paragraph 3, was accepted and therefore the respective sentence was corrected in the explanatory note; it refers to solubility as an indicator of the carcinogenicity of the man made mineral fibres, instead of "an indicator of their safety", as it read before. The third one was a comment on paragraph 4 of the mentioned note, regarding some advantages of the German proposal to better differentiate between category 3 for carcinogenicity and no classification; it was partially accepted and the sentence was, therefore, reworded.
A final version of the note, with these modifications included, was considered acceptable by the Committee.
8. Lead - Danish notification 595/98/DK - for opinion
Due to the fact that the Chairman of the WG had not been present in its last meeting one of the WG members presented a progress report on the issue. A WG meeting took place shortly before the plenary and the outcome of that meeting was presented to the CSTEE. Eight main points had been discussed during that meeting: the increase of soil concentration of lead; the effects in children in spite of lower blood lead levels; the reduction of lead impact accruing from its removal from gasoline; the blood lead levels in Europe; the possible correlation between soil contamination and blood lead levels; unusual lead exposures; lead contaminated soil and sewage sludge; and waste incineration.
Regarding the major sources of exposure to lead, WG members specially stressed the lack of correlation between blood lead levels and soil contamination. They pointed out also that there has been a constant decrease of blood lead levels in children since the late seventies, apparently due to the elimination of lead from gasoline.
A new WG meeting was deemed necessary and afterwards a draft opinion should be ready for consultation within the CSTEE by mid March. It was decided to have the opinion approved by written procedure and published no later than by the end of that month.
The CSTEE Secretary asked the Committee whether it considered or not the documentation submitted by Environment DG as sufficient to answer the terms of reference of the general question on lead. The CSTEE Chairman answered that the WG had to address again the issue of the huge amount of literature on the subject, which made necessary a thorough review of it. Adoption of an opinion on the general question was not, however, considered possible in the short term future for this reason.
A representative from Environment DG stressed the urgency of having an opinion adopted on the general question on lead as soon as possible
9. Regulation 793/93 on Existing substances (ESR):
A. Progress reports/opinions on:
The rapporteur for the report on the environmental part of Nonylphenol presented the draft opinion. He expressed the general satisfaction of the Working Group with the risk assessment report, which was considered to be based on a sufficient amount of information, the data being critically evaluated and, in general, being a well-elaborated risk assessment. Some minor comments were made on chapter 3 of the document (the section regarding degradation aspects): on predicted environmental concentration, on the use of this compound in pesticide formulation and on the effects in reproduction in fish, as well as some other minor points. The opinion was adopted.
The working party dealing with the environmental toxicology report on Pentabromodiphenyl ether also considered it a well-performed report. The rapporteur presented the opinion. The CSTEE made some minor remarks on different aspects of the study. A representative from JRC-ECB made some comments and gave explanations on the issues raised. The opinion was also adopted.
A CSTEE member asked about the origin of some figures present in the report with no reference to the source or sources of such information, e.g. volumes of a chemical produced or imported by the EU (they are present in all the reports). The same representative from JRC-ECB explained that, under the current regulation on existing chemicals, industry had the obligation to submit data on the volume produced or imported of a substance, including amounts in preparations. There may be additional sources of information (e.g. on imported articles) used in the risk assessment. The Committee asked for some references on the origin of these figures to be included in the reports.
A Committee member asked about who the author or authors of the reports were. The answer was given that the documents presented to the CSTEE were draft versions of the reports. The whole information about the origin and process will be included in the final document (e.g. member state and ministry or ministries involved in the preparation, discussion by competent group of technical experts, and, of course, the participation of the CSTEE in the peer review of the draft documents).
A question was raised about the validation of toxicity data on the reports. The information was given that such validations were carried out by the authors of the report, that the studies were usually done following standardised guidelines (e.g. OECD or similar) and where that would not be the case it should be indicated in the reports.
A representative from JRC-ECB informed the Committee that the reports on human health toxicology for Nonylphenol and Pentabromodiphenyl ether were already finished and they would be sent to the CSTEE within about two months, at the latest.
No CSTEE draft opinions were ready for the time being, regarding the environmental parts of the risk assessments for both Octabromodiphenyl ether and Decabromodiphenyl ether.
The Committee expressed its wish for dealing with both parts of the reports (i.e. human health and environmental toxicology) together rather than with each of them separately.
B. State of play regarding the consultation of the CSTEE on other substances evaluated under the ESR.
The CSTEE Secretary informed the Committee that four additional reports on substances for peer review by the Committee had been received and that the documents had already been sent to all Committee members. The WG Chairman explained that the Committee expected to receive during the year 2000 around forty reports on substances to be peer reviewed.
The proposed strategy to deal with such reports was to set up four Sub Working Groups for each of them to tackle a different group of substances. The suggestion was to concentrate in particular issues (e.g. inconsistencies based on structure activity relationship or physico-chemical properties, inconsistencies between human and environmental sections, endocrine disruption, terrestrial ecosystems, etc.) It was also proposed that in addition to the working group efforts, individual CSTEE members with special expertise in some precise issues should look at each chemical from that key perspective (e.g. carcinogenicity). Four categories were proposed: simple aliphatics, simple aromatics and heterocyclics, acroleins and phthalates, and long chain aliphatics and environmentally persistent chemicals.
The CSTEE was informed about a letter sent by the CEPAD - Conseil Européen des Phénols Alkylés et Derivés / European Council for Alkylphenols and Derivates (a CEFIC sector group) to the Secretariat and received the day before the meeting, asking for a delay on the adoption of the opinion on Nonylphenol. The Secretary explained that the answer to this letter was to consider that request unacceptable. A representative from Environment DG asked for stating clearly in the minutes the strongest refusal by the Committee to these kind of procedures. The CSTEE agreed with that position. The CSTEE Secretary pointed out that in the rules of procedure of the Committee it is clearly stated that the Committee adopts opinions at the request of Commission services and according to terms of references provided by them. The representative of JRC-ECB confirmed that discussions within the Ispra technical meetings on Regulation 793/93 substances had been quite exhaustive and that industry representatives had contributed to the exercise on Nonylphenol.
10. The use of measured exposure data in risk assessments - progress report
The Chairman of the Working Group informed about the possible co-operation between the CSTEE and the European Environment Agency (EEA). As informed in the 12th plenary meeting of the CSTEE the EEA was interested in some sort of co-operation, but the WG Chairman pointed out that, due to budgetary problems in the Agency, nothing had been done.
The CSTEE Chairman informed the Committee about the setting up of a sub-working group within the Harmonisation Risk Assessment Working Group of the Scientific Steering Committee to deal with Exposure Assessment. He suggested a direct contact between both Chairpersons, that of the CSTEE WG and that of the SSC sub-WG.
11. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
The WG Chairman explained that a first draft should be ready by the end of February 2000 and a WG meeting was expected by that time.
He also informed of a meeting of the ECB in Vienna held during the previous week on hazard identification for classification and labelling. A new meeting on the subject was scheduled for September, and by then the CSTEE opinion on terrestrial ecosystems should be already adopted and published.
The CSTEE was also informed about a workshop on risk assessment of pesticides under Directive 91/414/CEE on plant protection products, regarding the subject of beneficial arthropods.
The WG Chairman expressed the wish of the WG to invite someone from the Scientific Committee on Plants to join the CSTEE working group. The CSTEE Chairman suggested an informal contact with the Chairman of the SCP and afterwards more formal consultations.
12. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
The CSTEE Secretary provided the Committee with information about the issues expected to be presented to them in the next few months. Four forthcoming issues were already announced to the Committee.
Environment DG had announced a list of priority substances for assessment as potential endocrine disrupters to be sent to the Committee for opinion within three months after the meeting.
A representative from Enterprise DG informed the Committee of two forthcoming issues. The first one was a report on Methylene chloride carried out by the Dutch TNO. This representative informed about the background for launching the study, under Directive 76/769. The second report was an assessment on dyes in textiles, performed by WS Atkins.
With regard to the issue of drinking water the CSTEE secretariat gave the information about two possible forthcoming opinion requests: one on relevant pesticides metabolites in drinking water and another on construction products in contact with drinking water.
13. 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
The printed version of the opinion was presented. The information was given that five copies of it had been already sent to each member of the CSTEE and a copy to all the Commission officials with an interest on the subject and some other third parties.
b) Other information related to the subject "Endocrine disrupters"
A representative from Environment DG distributed for information a "Communication from the Commission to the Council and the European Parliament -Community strategy for endocrine disrupters- A range of substances suspected of interfering with the hormone systems of humans and wildlife".
14. Feedback from the competent services of the Commission on the follow up to the opinions adopted previously by the CSTEE
A representative from Enterprise DG gave information about three upcoming Commission Proposals for banning the following substances under Directive 76/769: Phthalates, Carcinogenic Azo Dyes and Short chained chlorinated parafins. The first two proposals were already adopted by the Commission and at the moment were being discussed within the Council, the European Parliament and the Economic and Social Committee. For the third one she informed that a draft proposal had been prepared by Enterprise DG and sent for consultation to other DGs.
The same official informed about two future issues to be proposed for opinion of the CSTEE. The first one, about possible substitutes for Phthalates as plasticisers, was expected to be presented before the summer break. The second one on Cadmium would arrive later.
A representative from Environment DG informed about the follow up of the first four opinions adopted by the CSTEE on risk assessment reports produced under Regulation 793/93, those related to 2-(2-butoxyethoxye)ethanol, 2-(2-methoxyethoxy)ethanol, Alkanes C10-13 chloro, and Benzene C10-13-alkyl derivs. A Commission Recommendation on the issue had been adopted on 12 October 1999 (publication in the Official Journal on 13 November 1999).
The CSTEE Secretary informed the Committee that unexpected delays were preventing the finalisation of the outstanding reports needed to allow the CSTEE to continue its analysis of part A of the opinion request on the Water Framework Directive.
15. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
The CSTEE chairman informed the Committee about the last meeting of the Scientific Steering Committee where almost the only issue they dealt with was Bovine Spongiform Encephalopaty (BSE). Other major issues treated were the geographical risk assessment, storage of risk materials and early detection and new tests to be applied.
He explained that the SSC was trying to predict future issues to be treated by them and asked for co-operation of CSTEE members on that point.
Finally he informed about the SSC working party on Harmonisation of Risk Assessment. The WG had been broken up into four sub-WG: quantitative risk assessment, risk terminology, the interfaces between risk assessors and risk managers, and exposure assessment.
16. Arrangements for the next meeting of the CSTEE
The CSTEE Secretary reminded the Committee that the next plenary meeting would be on 10-11 April 2000, with 11 as preferred day for a single day meeting.
17. Any other business
The Committee expressed its concern about the future of the toxicology in Europe. A report on the situation of toxicology in Germany was presented to the Committee. The Chairman proposed to set up a working group to take an initiative in order to identify the key actions to be taken as a way to stimulate the Commission to address the issue. One CSTEE member proposed also a co-operation with the European section of the International Epidemiological Association, which was discussing the same problem.
Some Committee members reminded that co-operation with Research DG had been proposed to influence the orientation of future research programs. A CSTEE member, also member of an Expert Advisory Group of Research DG proposed himself to act as an interface between the two parts. This idea was endorsed by the CSTEE.
Without any other business the meeting was closed at 17h 00.
SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE), 13th PLENARY MEETING, 4th of February 2000, 10H00, Centre A. Borschette, rue Froissart, B-1040 Brussels, Belgium - AGENDA -
1. Welcoming address, apologies for absence and declarations of interest
2. Adoption of the draft agenda
3. Information from the CSTEE secretariat
4. Adoption of the draft minutes of the 12th CSTEE plenary meeting held on the 25th of November 1999 in Brussels
5. Schedule of CSTEE plenary meetings for the year 2000
6. Evaluation of Technical Guidance Document in support of Directive 98/8/EC concerning the placing of biocidal products on the market - for opinion
7. Man Made Mineral Fibres
8. Lead - Danish notification 595/98/DK - for opinion
9. Regulation 793/93 on Existing substances (ESR):
A. Progress reports/opinions on:
B. State of play regarding the consultation of the CSTEE on other substances evaluated under the ESR.
10. The use of measured exposure data in risk assessments - progress report
11. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
12. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
13. 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"
14. Feedback from the competent services of the Commission on the follow up to the opinions adopted previously by the CSTEE
15. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
16. Arrangements for the next meeting of the CSTEE
17. Any other business
SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE), 13th PLENARY MEETING, 4th of February 2000, 10H00, Centre A. Borschette, rue Froissart, B-1040 Brussels, Belgium
LIST OF PARTICIPANTS
CSTEE:
Prof. James W. BRIDGES, Dr. Mark J. COSTELLO, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Bo O. JANSSON, Prof. Soterios A. KYRTOPOULOS, Prof. Ole LADEFOGED, Prof. Dr. José RUEFF, Prof. Mirja S. SALKINOJA-SALONEN, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, Prof. Janneche UTNE-SKÅRE, Prof. Katarina VICTORIN, Prof. Marco VIGHI, Prof. Dr. Robert WENNIG.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE, Mrs. Mercedes de SOLÀ.
ENTERPRISE DG:
Mrs. Lena PERENIUS.
ENVIRONMENT DG:
Mr. Walter CORTELLINI, Mr. Lars FOCK, Mr. Paul HAYES, Mrs. Birgit van TONGELEN.
JOINT RESEARCH CENTRE:
Mrs. Sharon MUNN
Apologies were received from Profs. Lambré, Vos and Calow.
The CSTEE Secretary informed the Committee about the nomination of a new CSTEE member: Professor Peter Calow. Because of prior commitments he was unable to attend this plenary meeting however.
The issue of the declarations of interest was raised. The Chairman explained the necessity of being as clearer as possible about it, because of the importance and interest in the Committee's activities.
One of the CSTEE and Biocidal WG members reported funding of her institute by a company involved in biocides. The CSTEE chairman asked her to report this sort of interest at the beginning of every plenary and WG meetings on the point "declarations of interest".
2. Adoption of the draft agenda
The agenda was adopted with the only remark that points 8 and 9 should be postponed until the afternoon, due to the impossibility for some representatives from Enterprise and Environment DGs to attend the morning session.
A new point, now 7, was included to deal with a question raised by the rapporteur of the opinion on "Man Made Mineral Fibres classification - DE request for a derogation under Article 100a (4) - Maastricht Treaty".
3. Information from the CSTEE secretariat
The Secretary of the CSTEE informed about some documents sent recently to the Committee members by e-mail. He explained the contents of some of them: one on a new publication, "Chemical Awareness", now available to CSTEE members on Internet, and a second one regarding the possibility of accessing the databases of the European Chemicals Bureau (ECB).
4. Adoption of the draft minutes of the 12th CSTEE plenary meeting held on the 25th of November 1999 in Brussels
The minutes were not adopted because of a discussion raised regarding some aspects about them. A representative from Health and Consumer Protection DG pointed out the convenience of a harmonisation of the minutes of all the Scientific Committees within the DG. At the end there was a general agreement within the CSTEE that future minutes of Committee meetings should be shorter in order to allow them to be ready shortly after the meeting, and also to avoid possible misinterpretations. The secretariat took the task of re-wording the minutes of the November plenary meeting according to these new recommendations for adoption at the April plenary of the CSTEE.
Regarding the possible mentioning in the minutes of who had expressed a particular position it was decided to maintain the anonymity. Nevertheless, the CSTEE agreed that the information should be given on whether or not the decisions would have been unanimously adopted.
The Secretariat informed the Committee that the minutes of the 11th Plenary Meeting were approved by written procedure. A question was raised regarding the issue of Man Made Mineral Fibres discussed during that 11th Plenary Meeting. The Secretariat informed the CSTEE of some amendments that were proposed by Environment DG to a note prepared on that subject. The Secretariat, therefore, thought that it was necessary to consult the rapporteur of the opinion and only after obtaining agreement, incorporate the results of the discussion to the minutes of one of the Plenary Meetings of the CSTEE. The amendments were discussed during this 13th Plenary and a new version of the note adopted.
Some problems were reported to the CSTEE Secretariat regarding the documents received. The Secretariat explained that lists of documents made available to CSTEE members were prepared only for technical documents, and in principle not for information policy documents. Clarifications were asked about documents being sent both in electronic format via e-mail and in printed format via regular mail. The Secretary explained that as a general rule every technical document sent by e-mail is also sent afterwards in printed version, unless the time available for receiving some documents is too short before a meeting making it impossible to proceed to this latter sending in a timely manner.
5. Schedule of CSTEE plenary meetings for the year 2000
Dates were decided for the plenary meetings of this year. Members were asked to block in their agendas two days for each one, taking into account that probably most of them will be single day meetings. According to that a preferred day was decided for each of them. The dates were finally decided as follows: 10-11 April, with 11 as preferred day for a single day meeting; 19-20 June, 19 preferred day; 4-5 September, 4 preferred day; 9-10 October, preferred day 9; 2-3 November, preferred day 2.
Note: it was later realised after the meeting that 2 November being a holiday in Belgium the November plenary meeting will have to be rescheduled.
6. 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 presented the final draft opinion agreed at its last meeting. Some members of the WG made comments regarding the different treatment given in the Technical Notes for Guidance to the human health risk assessment compared to that given to the environment section. A certain concern was also raised about the possibility of setting criteria for waiving some tests on human toxicology.
The problem of the different versions of the Technical Notes for Guidance (TNsG) provided by Environment DG was also raised. One representative from that DG explained that the last document provided was in fact the final draft version of the TNsG.
A discussion was raised between one CSTEE member and those of the biocides WG on the issue of requirements for long term testing of products for carcinogenicity. In consequence, some rewordings were proposed and accepted for the paragraphs in question.
The problem of the terminology used, both in the Technical Notes for Guidance and in the draft opinion, was also discussed. A call for coherence in the terminology used was made. It was pointed out that what was in the TNsG did not allow the Committee to carry out a risk assessment but hazard or exposure assessment instead.
The opinion was adopted with the inclusion of some minor requests for changes proposed by CSTEE members.
7. Man Made Mineral Fibres classification - DE request for a derogation under Article 100a (4) - Maastricht Treaty
At the 11th Plenary Meeting of the CSTEE, held in Brussels, 27-28 September 1999, the necessity for further clarifying the position of the Committee on the mentioned issue was discussed. Afterwards, the CSTEE Secretariat received some comments on the subject from Environment DG. Due to the absence of the opinion rapporteur and WG chairman at the 12th Plenary Meeting, the question was postponed until this 13th plenary.
Environment DG had made three comments to a note prepared on the subject. The first one proposed a change in the first paragraph regarding the distinction for categories 2 and 3 for carcinogenicity in the note Q of the Directive 97/69/EC; this was rejected by the CSTEE. The second one, on paragraph 3, was accepted and therefore the respective sentence was corrected in the explanatory note; it refers to solubility as an indicator of the carcinogenicity of the man made mineral fibres, instead of "an indicator of their safety", as it read before. The third one was a comment on paragraph 4 of the mentioned note, regarding some advantages of the German proposal to better differentiate between category 3 for carcinogenicity and no classification; it was partially accepted and the sentence was, therefore, reworded.
A final version of the note, with these modifications included, was considered acceptable by the Committee.
8. Lead - Danish notification 595/98/DK - for opinion
Due to the fact that the Chairman of the WG had not been present in its last meeting one of the WG members presented a progress report on the issue. A WG meeting took place shortly before the plenary and the outcome of that meeting was presented to the CSTEE. Eight main points had been discussed during that meeting: the increase of soil concentration of lead; the effects in children in spite of lower blood lead levels; the reduction of lead impact accruing from its removal from gasoline; the blood lead levels in Europe; the possible correlation between soil contamination and blood lead levels; unusual lead exposures; lead contaminated soil and sewage sludge; and waste incineration.
Regarding the major sources of exposure to lead, WG members specially stressed the lack of correlation between blood lead levels and soil contamination. They pointed out also that there has been a constant decrease of blood lead levels in children since the late seventies, apparently due to the elimination of lead from gasoline.
A new WG meeting was deemed necessary and afterwards a draft opinion should be ready for consultation within the CSTEE by mid March. It was decided to have the opinion approved by written procedure and published no later than by the end of that month.
The CSTEE Secretary asked the Committee whether it considered or not the documentation submitted by Environment DG as sufficient to answer the terms of reference of the general question on lead. The CSTEE Chairman answered that the WG had to address again the issue of the huge amount of literature on the subject, which made necessary a thorough review of it. Adoption of an opinion on the general question was not, however, considered possible in the short term future for this reason.
A representative from Environment DG stressed the urgency of having an opinion adopted on the general question on lead as soon as possible
9. Regulation 793/93 on Existing substances (ESR):
A. Progress reports/opinions on:
| SUBSTANCE | CAS RN |
|
Nonylphenol
straight and branched chain |
84852-15-3, 25154-52-3 |
| Pentabromodiphenyl ether | 32534-81-9 |
| Octabromodiphenyl ether | 32536-52-0 |
| Decabromodiphenyl ether | 1163-19-5 |
The rapporteur for the report on the environmental part of Nonylphenol presented the draft opinion. He expressed the general satisfaction of the Working Group with the risk assessment report, which was considered to be based on a sufficient amount of information, the data being critically evaluated and, in general, being a well-elaborated risk assessment. Some minor comments were made on chapter 3 of the document (the section regarding degradation aspects): on predicted environmental concentration, on the use of this compound in pesticide formulation and on the effects in reproduction in fish, as well as some other minor points. The opinion was adopted.
The working party dealing with the environmental toxicology report on Pentabromodiphenyl ether also considered it a well-performed report. The rapporteur presented the opinion. The CSTEE made some minor remarks on different aspects of the study. A representative from JRC-ECB made some comments and gave explanations on the issues raised. The opinion was also adopted.
A CSTEE member asked about the origin of some figures present in the report with no reference to the source or sources of such information, e.g. volumes of a chemical produced or imported by the EU (they are present in all the reports). The same representative from JRC-ECB explained that, under the current regulation on existing chemicals, industry had the obligation to submit data on the volume produced or imported of a substance, including amounts in preparations. There may be additional sources of information (e.g. on imported articles) used in the risk assessment. The Committee asked for some references on the origin of these figures to be included in the reports.
A Committee member asked about who the author or authors of the reports were. The answer was given that the documents presented to the CSTEE were draft versions of the reports. The whole information about the origin and process will be included in the final document (e.g. member state and ministry or ministries involved in the preparation, discussion by competent group of technical experts, and, of course, the participation of the CSTEE in the peer review of the draft documents).
A question was raised about the validation of toxicity data on the reports. The information was given that such validations were carried out by the authors of the report, that the studies were usually done following standardised guidelines (e.g. OECD or similar) and where that would not be the case it should be indicated in the reports.
A representative from JRC-ECB informed the Committee that the reports on human health toxicology for Nonylphenol and Pentabromodiphenyl ether were already finished and they would be sent to the CSTEE within about two months, at the latest.
No CSTEE draft opinions were ready for the time being, regarding the environmental parts of the risk assessments for both Octabromodiphenyl ether and Decabromodiphenyl ether.
The Committee expressed its wish for dealing with both parts of the reports (i.e. human health and environmental toxicology) together rather than with each of them separately.
B. State of play regarding the consultation of the CSTEE on other substances evaluated under the ESR.
The CSTEE Secretary informed the Committee that four additional reports on substances for peer review by the Committee had been received and that the documents had already been sent to all Committee members. The WG Chairman explained that the Committee expected to receive during the year 2000 around forty reports on substances to be peer reviewed.
The proposed strategy to deal with such reports was to set up four Sub Working Groups for each of them to tackle a different group of substances. The suggestion was to concentrate in particular issues (e.g. inconsistencies based on structure activity relationship or physico-chemical properties, inconsistencies between human and environmental sections, endocrine disruption, terrestrial ecosystems, etc.) It was also proposed that in addition to the working group efforts, individual CSTEE members with special expertise in some precise issues should look at each chemical from that key perspective (e.g. carcinogenicity). Four categories were proposed: simple aliphatics, simple aromatics and heterocyclics, acroleins and phthalates, and long chain aliphatics and environmentally persistent chemicals.
The CSTEE was informed about a letter sent by the CEPAD - Conseil Européen des Phénols Alkylés et Derivés / European Council for Alkylphenols and Derivates (a CEFIC sector group) to the Secretariat and received the day before the meeting, asking for a delay on the adoption of the opinion on Nonylphenol. The Secretary explained that the answer to this letter was to consider that request unacceptable. A representative from Environment DG asked for stating clearly in the minutes the strongest refusal by the Committee to these kind of procedures. The CSTEE agreed with that position. The CSTEE Secretary pointed out that in the rules of procedure of the Committee it is clearly stated that the Committee adopts opinions at the request of Commission services and according to terms of references provided by them. The representative of JRC-ECB confirmed that discussions within the Ispra technical meetings on Regulation 793/93 substances had been quite exhaustive and that industry representatives had contributed to the exercise on Nonylphenol.
10. The use of measured exposure data in risk assessments - progress report
The Chairman of the Working Group informed about the possible co-operation between the CSTEE and the European Environment Agency (EEA). As informed in the 12th plenary meeting of the CSTEE the EEA was interested in some sort of co-operation, but the WG Chairman pointed out that, due to budgetary problems in the Agency, nothing had been done.
The CSTEE Chairman informed the Committee about the setting up of a sub-working group within the Harmonisation Risk Assessment Working Group of the Scientific Steering Committee to deal with Exposure Assessment. He suggested a direct contact between both Chairpersons, that of the CSTEE WG and that of the SSC sub-WG.
11. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
The WG Chairman explained that a first draft should be ready by the end of February 2000 and a WG meeting was expected by that time.
He also informed of a meeting of the ECB in Vienna held during the previous week on hazard identification for classification and labelling. A new meeting on the subject was scheduled for September, and by then the CSTEE opinion on terrestrial ecosystems should be already adopted and published.
The CSTEE was also informed about a workshop on risk assessment of pesticides under Directive 91/414/CEE on plant protection products, regarding the subject of beneficial arthropods.
The WG Chairman expressed the wish of the WG to invite someone from the Scientific Committee on Plants to join the CSTEE working group. The CSTEE Chairman suggested an informal contact with the Chairman of the SCP and afterwards more formal consultations.
12. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
The CSTEE Secretary provided the Committee with information about the issues expected to be presented to them in the next few months. Four forthcoming issues were already announced to the Committee.
Environment DG had announced a list of priority substances for assessment as potential endocrine disrupters to be sent to the Committee for opinion within three months after the meeting.
A representative from Enterprise DG informed the Committee of two forthcoming issues. The first one was a report on Methylene chloride carried out by the Dutch TNO. This representative informed about the background for launching the study, under Directive 76/769. The second report was an assessment on dyes in textiles, performed by WS Atkins.
With regard to the issue of drinking water the CSTEE secretariat gave the information about two possible forthcoming opinion requests: one on relevant pesticides metabolites in drinking water and another on construction products in contact with drinking water.
13. 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
The printed version of the opinion was presented. The information was given that five copies of it had been already sent to each member of the CSTEE and a copy to all the Commission officials with an interest on the subject and some other third parties.
b) Other information related to the subject "Endocrine disrupters"
A representative from Environment DG distributed for information a "Communication from the Commission to the Council and the European Parliament -Community strategy for endocrine disrupters- A range of substances suspected of interfering with the hormone systems of humans and wildlife".
14. Feedback from the competent services of the Commission on the follow up to the opinions adopted previously by the CSTEE
A representative from Enterprise DG gave information about three upcoming Commission Proposals for banning the following substances under Directive 76/769: Phthalates, Carcinogenic Azo Dyes and Short chained chlorinated parafins. The first two proposals were already adopted by the Commission and at the moment were being discussed within the Council, the European Parliament and the Economic and Social Committee. For the third one she informed that a draft proposal had been prepared by Enterprise DG and sent for consultation to other DGs.
The same official informed about two future issues to be proposed for opinion of the CSTEE. The first one, about possible substitutes for Phthalates as plasticisers, was expected to be presented before the summer break. The second one on Cadmium would arrive later.
A representative from Environment DG informed about the follow up of the first four opinions adopted by the CSTEE on risk assessment reports produced under Regulation 793/93, those related to 2-(2-butoxyethoxye)ethanol, 2-(2-methoxyethoxy)ethanol, Alkanes C10-13 chloro, and Benzene C10-13-alkyl derivs. A Commission Recommendation on the issue had been adopted on 12 October 1999 (publication in the Official Journal on 13 November 1999).
The CSTEE Secretary informed the Committee that unexpected delays were preventing the finalisation of the outstanding reports needed to allow the CSTEE to continue its analysis of part A of the opinion request on the Water Framework Directive.
15. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
The CSTEE chairman informed the Committee about the last meeting of the Scientific Steering Committee where almost the only issue they dealt with was Bovine Spongiform Encephalopaty (BSE). Other major issues treated were the geographical risk assessment, storage of risk materials and early detection and new tests to be applied.
He explained that the SSC was trying to predict future issues to be treated by them and asked for co-operation of CSTEE members on that point.
Finally he informed about the SSC working party on Harmonisation of Risk Assessment. The WG had been broken up into four sub-WG: quantitative risk assessment, risk terminology, the interfaces between risk assessors and risk managers, and exposure assessment.
16. Arrangements for the next meeting of the CSTEE
The CSTEE Secretary reminded the Committee that the next plenary meeting would be on 10-11 April 2000, with 11 as preferred day for a single day meeting.
17. Any other business
The Committee expressed its concern about the future of the toxicology in Europe. A report on the situation of toxicology in Germany was presented to the Committee. The Chairman proposed to set up a working group to take an initiative in order to identify the key actions to be taken as a way to stimulate the Commission to address the issue. One CSTEE member proposed also a co-operation with the European section of the International Epidemiological Association, which was discussing the same problem.
Some Committee members reminded that co-operation with Research DG had been proposed to influence the orientation of future research programs. A CSTEE member, also member of an Expert Advisory Group of Research DG proposed himself to act as an interface between the two parts. This idea was endorsed by the CSTEE.
Without any other business the meeting was closed at 17h 00.
SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE), 13th PLENARY MEETING, 4th of February 2000, 10H00, Centre A. Borschette, rue Froissart, B-1040 Brussels, Belgium - AGENDA -
1. Welcoming address, apologies for absence and declarations of interest
2. Adoption of the draft agenda
3. Information from the CSTEE secretariat
4. Adoption of the draft minutes of the 12th CSTEE plenary meeting held on the 25th of November 1999 in Brussels
5. Schedule of CSTEE plenary meetings for the year 2000
6. Evaluation of Technical Guidance Document in support of Directive 98/8/EC concerning the placing of biocidal products on the market - for opinion
7. Man Made Mineral Fibres
8. Lead - Danish notification 595/98/DK - for opinion
9. Regulation 793/93 on Existing substances (ESR):
A. Progress reports/opinions on:
| SUBSTANCE | CAS RN |
|
Nonylphenol
straight and branched chain |
84852-15-3, 25154-52-3 |
| Pentabromodiphenyl ether | 32534-81-9 |
| Octabromodiphenyl ether | 32536-52-0 |
| Decabromodiphenyl ether | 1163-19-5 |
B. State of play regarding the consultation of the CSTEE on other substances evaluated under the ESR.
10. The use of measured exposure data in risk assessments - progress report
11. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
12. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
13. 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"
14. Feedback from the competent services of the Commission on the follow up to the opinions adopted previously by the CSTEE
15. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
16. Arrangements for the next meeting of the CSTEE
17. Any other business
SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE), 13th PLENARY MEETING, 4th of February 2000, 10H00, Centre A. Borschette, rue Froissart, B-1040 Brussels, Belgium
LIST OF PARTICIPANTS
CSTEE:
Prof. James W. BRIDGES, Dr. Mark J. COSTELLO, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Bo O. JANSSON, Prof. Soterios A. KYRTOPOULOS, Prof. Ole LADEFOGED, Prof. Dr. José RUEFF, Prof. Mirja S. SALKINOJA-SALONEN, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, Prof. Janneche UTNE-SKÅRE, Prof. Katarina VICTORIN, Prof. Marco VIGHI, Prof. Dr. Robert WENNIG.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE, Mrs. Mercedes de SOLÀ.
ENTERPRISE DG:
Mrs. Lena PERENIUS.
ENVIRONMENT DG:
Mr. Walter CORTELLINI, Mr. Lars FOCK, Mr. Paul HAYES, Mrs. Birgit van TONGELEN.
JOINT RESEARCH CENTRE:
Mrs. Sharon MUNN
