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Directorate-General for Health and Food Safety
1. Welcoming address, apologies for
absence and declarations of interest
The chairman of the CSTEE welcomed all attendants to the plenary and in particular those invited specially to the meeting.
Apologies were received from Professors/Doctors Marco Vighi, Peter Calow, Katarina Victorin, Marc Costello and Soterios Kyrtopoulos.
2. Adoption of the draft agenda
The agenda was amended as follows. Former point 10 (Programme of procedures for the assessment of risks to health and the environment from cadmium in fertilisers) was moved to just before point 5. Points 6 (Regulation 793/93 on Existing substances), 7 (Methylene chloride and certain Chemicals in Textiles), 12 (Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission) and 13 (Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE) were postponed to the afternoon session. With those changes, the agenda was adopted.
3. Adoption of the draft minutes of the 14th and 15th CSTEE plenary meetings held on the 11th of April and 5th of May 2000 in Brussels respectively.
Two corrections were made to the draft minutes of the 14th plenary: Dr. Tarazona asked for a sentence to be added to his former declaration of interest stating that he decided not to take further part in the discussions, due to his interest in the subject; Prof. Vos asked to substitute the word "genotoxicity" in point 5 line 5 by "ecotoxicity". With this changes the minutes of the 14th plenary meeting of the CSTEE were adopted.
Some subjects related to the minutes, although not included in the agenda for that meeting, were raised. A timetable for the renewal of the Committee was presented to the CSTEE by its chairman. The CSTEE secretary provided information about the opinion on the Danish notification on lead, which had been already published on the Internet. Regarding the question of the future of Toxicology, Ecotoxicology and Epidemiology in Europe the chairman explained that this issue had been transferred for strategic reasons to the Scientific Steering Committee. Nevertheless he expressed his opinion that a working party should exist within the CSTEE to deal with some points more specifically related to toxicology, ecotoxicology and epidemiology, even if the general subject should be discussed within the framework of the SSC. The Committee supported this position.
It was agreed to approve the minutes of the 15th plenary meeting by written procedure during the summer break.
4. Endocrine disrupting chemicals:
A. 2nd presentation by representatives of the Fraunhofer-Institut für Umweltchemie und Oekotoxikologie, Schmallenberg, Germany, of their ongoing research project relating to the development and validation of a test method for the identification of endocrine disrupting chemicals (the first presentation took place at the 9th CSTEE plenary meeting, 5th of May 1999).
Two representatives from the Fraunhofer Institut presented a status report on the project. They explained that the aim of the project was to develop a test protocol to screen EDCs to elucidate the molecular mechanism and assess the impact both at individual and at the population level. A four-step battery of assays was established: screening in transactivation assays, molecular mechanisms in cell culture, effects in intact mammals and effects on reproduction of fishes.
Three properties of compounds were considered important for environmental risk assessment: potency of molecular interaction, relation of relevant endocrine effect concentration to acute toxicity and persistence and environmental findings.
In-vitro and in-vivo assays were proposed to elucidate de estrogenic potential of compounds. A short-term uterotrophic assay would be used to confirm the estrogenicity in mammal. Finally, long-term in-vivo studies in zebra fishes would be useful to include all stages of development and reproduction.
After the presentation some CSTEE members expressed their views on the project. Some points of concern were raised, among them: i) the difficulty to extrapolate to field tests the results of laboratory testing; ii)the difficulty of extrapolation of in vitro results to the in vivo situation; iii) the problems derived from focussing the study on the estrogenic effects of the chemicals, when there are other important points when studying EDCs; iv) the advantages of this test compared to others, etc.
One CSTEE member asked about the role of the CSTEE at the present stage of development of the project and whether the Committee was being asked to express its opinion on it. The answer was given that the presentation was made only for information of the Committee and no formal opinion on it was being requested.
B. Request for an Opinion of the CSTEE on the study report entitled "Towards the Establishment of a Priority List of Substances for further evaluation of their role in Endocrine Disruption", carried out by BKH Consulting Engineers (NL).
A representative from Environment Directorate-General presented the background of the consultation. A Communication from the Commission on the subject (of December 1999) was followed in March 2000 by the conclusions of the Council of Environment Ministers, endorsing the list of priority substances for further evaluation of their role in endocrine disruption. She stressed the fact that the Commission is not proposing to the Committee a list of chemicals with endocrine disruption activity, but a list of substances for further evaluation. The program is organised in two consecutive steps: first of all, a study had been launched to look at the information available, and afterwards a consultation period should start, in which all the expert groups related to the issue would be contacted. Step 1 was about to be finalised and the report was expected to be ready within a week and distributed to CSTEE members. The Committee was being consulted about two aspects: whether the source material, methodology and selection criteria used to establish the list of chemicals were logical and scientifically relevant, and on the methodology used for establishing the priority list of substances.
Two representatives from BKH Consulting Engineers presented the results of the study. The aim of the study was to identify those man-made chemicals which may have endocrine disruption effects, both to human health and wildlife. Those produced to intentionally interfere with the endocrine system were not considered. The process to establish a priority list of substances for further evaluation as endocrine disrupters was explained. The process started with the review of existing lists of substances. From the list obtained, highly persisting chemicals and high production volume chemicals were selected and, after an evaluation of scientific evidence of endocrine disruption and of exposure on human and wildlife, a candidate list of priority substance was obtained. The result is a list divided in three categories: high, medium and low concern substances, which was being proposed to the CSTEE for its opinion. It was remarked that most probably the terms used would be changed from high, medium and low concern substances to clear, potential and unknown concern.
Some CSTEE members were concerned about the fact that dose-response relationships in connection with critical effects of the chemicals were not used as a criterion for selecting the substances of the priority list. Relation to PEC/PNEC was also suggested as a desirable criterion towards the same objective. It was also stressed that endocrine disruption is not a disease outcome like cancer or allergy but a descriptor of functional change that may lead to health effects, e.g. on reproduction.
Some CSTEE members expressed their agreement with the title of the study. Because of the difficult definition of the effects of endocrine disrupters it was considered a good approach to the question to establish a list of substances for further evaluation instead of a list endocrine disrupting chemicals. Nevertheless, a CSTEE member asked for some explanations about the "further evaluation" mentioned in the title. He was concerned both with what kind of evaluation would be carried out and with who would perform it. One representative from Environment DG explained that a priority list would be used to identify substances for testing once agreed test methods are available (not before two years), to identify substances already subject to regulatory measures not necessarily related to endocrine disruption, to help guide future research and monitoring efforts and to initiate some further studies on the priority substances. Another CSTEE member pointed out that it was important to verify prior to the adoption of a final list whether the criteria used were the appropriate ones.
The CSTEE secretary explained that the comments already made in the plenary could be considered as part of the answers to the questions proposed. Regarding the time table for the adoption of the opinion, he considered that while the September plenary was not a realistic one for adoption, the October one should be.
The CSTEE chairman thanked the two BKH representatives for their interesting presentation of the report.
5. Consideration of a document on the Minimum Data Set for CSTEE to express an opinion on a chemical.
The CSTEE chairman presented the background of the issue. While discussing a question proposed to the Committee, the members of that working group realised that the lack of relevant information made it impossible to adopt an opinion. Therefore they considered the possibility of preparing a guideline on the minimum data set that the CSTEE needs in order to perform a risk assessment for a chemical. He stressed the importance of the word "minimum". Professor Dybing was appointed as rapporteur for the human part of the document and Dr Tarazona for the ecotoxicological aspects.
Both rapporteurs presented the draft document, and afterwards different CSTEE members made some comments. Finally the two mentioned CSTEE members took the charge of rewriting the draft considering the comments and remarks made during that plenary meeting in order to present it during the September plenary meeting of the Committee for discussion and eventual adoption.
6. Regulation 793/93 on Existing substances (ESR):
Following a suggestion of Environment DG, it was decided to add a standard note, in the form of a footnote, to all the CSTEE opinions on risk assessments elaborated under Regulation 793/93, setting out the legal framework under which the opinions are expressed.
The CSTEE secretary informed the Committee about a Competent Authorities meeting for Regulation 793/93 which had taken place in Lisbon the week before the plenary and where he explained the role and participation of the CSTEE in the process of elaboration of risk assessments on substances under Regulation 793/93.
One CSTEE member asked the secretary whether the Committee would receive the revised versions of the Technical Guidance Document for opinion. The reply was that it was forseen that the CSTEE would be involved in the process in reviewing it.
One CSTEE member stressed the value of this participation, specially regarding metals.
A. Adoption of opinions on:
i) Human health effects report of Pentabromodiphenyl ether.
The rapporteur presented the draft opinion. Some CSTEE members expressed a certain degree of concern about the paragraph on "Studies in animals" under the point on "Effects of repeated exposure". Therefore, this part was reworded to better reflect such points of view. One CSTEE member asked for further clarification on the statement on the exposure to consumers from PeBDE to be negligible. It was explained that the main point of concern was the apparent contradiction between the levels of PeBDE in human breast milk increasing over the period 1972 to 1997 while the levels in the environment stayed stable or even decreased. Given these facts and the possible existence of other routes of exposure, a representative from Environment DG provided the committee with the information that industry reported no other uses of PeBDE apart from those already known, and that further studies were being conducted to determine whether or not Octabromodiphenyl ether or Decabromodiphenyl ether degrade to PeBDE. The opinion was then unanimously adopted.
ii) Environmental effects report of:
a) Octabromodiphenyl ether
The rapporteur presented the draft. The section on the terrestrial compartment was completed with a text drafted by a different CSTEE member. The opinion was unanimously adopted.
b) Decabromodiphenyl ether
The rapporteur presented the opinion. Some minor comments were proposed and accepted, mainly on the section of the opinion regarding the terrestrial compartment. The opinion was finally unanimously adopted.
B. State of play regarding other substances evaluated under the ESR
Due to the absence of a representative from JRC, it was one from Environment DG who updated the Committee. Reports on three substances had been prepared and submitted for opinion of the CSTEE: 1,4 Dichlorobenzene, 1,4 Dioxane and 4 Chloro 2 Methylphenol.
Reports on Acrylonitrile and Metacrylic acid would be submitted in the near future. During the second part of the year some other reports would be submitted.
7. Methylene chloride and certain Chemicals in Textiles - for opinion
Due to the absence of the rapporteur for these two opinions, it was one of the working group members who made the respective presentation.
A working group meeting had taken place two weeks before the plenary and the need for revision of the draft, specially on the issues of toxico-kinetics, carcinogenicity and mutagenicity, was identified. A sub WG was created to deal with them and its conclusions were already in the draft presented to the plenary.
Some CSTEE members expressed concern about the table on page 3 of the draft opinion on Methylene chloride. Other inconsistencies and inaccuracies were pointed out in both draft opinions. Since the rapporteur for these two opinions was not present, it was decided that CSTEE members would send him their comments on both documents and to adopt the opinions by written procedure.
8. The use of exposure data in risk assessments - progress report
The working group had met two days before the plenary and the WG chairman informed the Committee about it. A new draft table of contents was produced after that meeting, which was presented to the plenary. Comments from CSTEE members on that were requested.
The chairman of this working group also informed the committee about a meeting of a related working group on Harmonisation of Risk Assessment set up under the Scientific Steering Committee, of which he is a member. A report on that meeting was distributed to the CSTEE.
9. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
A first draft of the opinion was presented to the committee. The chairman of the working group explained that this was not a final one. It included only eight of the ten chapters expected to be in the opinion. A meeting of the working group had taken place two days before the plenary and therefore no comments from that meeting were yet reflected in the document being presented to CSTEE members. A new meeting was scheduled for mid August to try and prepare a pre-final draft for presentation to the 17th CSTEE plenary meeting in September. Contributions were asked from all CSTEE members.
10. Programme of procedures for the assessment of risks to health and the environment from cadmium in fertilisers - progress report
The chairman presented the members of this new working group and informed the committee about a future meeting of it, scheduled to take place on 4 September, just before the plenary.
11. Water Framework Directive -progress report
The WG chairman informed the Committee about a meeting with member states on the list of priority substances to which he had been invited and in which the previous opinions of the CSTEE on the subject had been considered.
The WG was still waiting for some documentation on the issue to be provided by the competent Commission service to resume its work.
12. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
a) Validation of testing methods for phthalates migration
The background and the terms of reference for the CSTEE to express an opinion on the above mentioned issue was presented to the committee. Copies of the document presented to the Committee were distributed.
b) Development of a general opinion on human and environmental effects of lead and its compounds
A representative from Enterprise DG presented the general situation of the issue. A study would be launched shortly on the effects of lead in general on human health and environmental effects of lead. The CSTEE should be asked afterwards to express its opinion on that study.
c) any other
The CSTEE secretary informed the Committee about a possible future opinion request from Environment DG on waste related issues.
13. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
A representative from Enterprise DG informed the Committee that the report on Pentabromodiphenyl ether was ready to be discussed at the working group meeting to decide what kind of follow up would be taken.
14. Renewal of the Scientific Committees
The head of unit C-2 of Health and Consumer Protection DG updated the Committee on the last news about the renewal of the Committees. The general procedure and the deadlines for this renewal were explained.
She also expressed the gratitude of the Commission for the excellent work performed by the CSTEE in the last three years.
15. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
There were no updates to be presented to the committee.
16. Arrangements for the next meeting of the CSTEE
The secretary proposed the CSTEE to consider the possibility of having a two day or at least a one and a half day meeting, due to important issues to be discussed and possibly also some WG meetings back to back with the plenary.
17. Any other business
There was none.
- 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 14th and 15th CSTEE plenary meetings held on the 11th of April and 5th of May 2000 in Brussels respectively.
4. Endocrine disrupting chemicals:
A. 2nd presentation by representatives of the Fraunhofer-Institut für Umweltchemie und Oekotoxikologie, Schmallenberg, Germany, of their ongoing research project relating to the development and validation of a test method for the identification of endocrine disrupting chemicals (the first presentation took place at the 9th CSTEE plenary meeting, 5th of May 1999).
B. Request for an Opinion of the CSTEE on the study report entitled "Towards the Establishment of a Priority List of Substances for further evaluation of their role in Endocrine Disruption", carried out by BKH Consulting Engineers (NL).
5. Consideration of a document on the Minimum Data Set for CSTEE to express an opinion on a chemical.
6. Regulation 793/93 on Existing substances (ESR):
A. Adoption of opinions on:
i) Human health effects report of Pentabromodiphenyl ether.
ii) Environmental effects report of:
a) Octabromodiphenyl ether
b) Decabromodiphenyl ether
B. State of play regarding other substances evaluated under the ESR
7. Methylene chloride and certain Chemicals in Textiles - for opinion
8. The use of exposure data in risk assessments - progress report
9. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
10. Programme of procedures for the assessment of risks to health and the environment from cadmium in fertilisers - progress report
11. Water Framework Directive -progress report
12. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
a) Validation of testing methods for phthalates migration
b) Development of a general opinion on human and environmental effects of lead and its compounds
c) any other
13. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
14. Renewal of the Scientific Committee
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
LIST OF PARTICIPANTS
CSTEE:
Prof. James BRIDGES, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Bo O. JANSSON, Dr. Ole LADEFOGED, Dr. Claude LAMBRÉ, Dr. José RUEFF, Prof. Mirja S. SALKINOJA-SALONEN, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, Prof. Janneche UTNE-SKÅRE, Prof. Joseph G. VOS, Prof. Dr. Robert WENNIG.
Ad-hoc experts:
Dr. P.C. OKKERMAN, Dr. Christoph SCHÄFERS, Dr. I. VAN DER PUTTE, Dr. Andrea WENZEL.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE, Mr. Panagiotis DASKALEROS, Mrs. Mercedes de SOLÀ, Mrs. Angelika WILHELM.
ENTERPRISE DG:
Mr. Joachim EHRENBERG, Mr. Wolfgang HEHN, Mr. Vincenzo GENTE, Mrs. Lena PERENIUS.
ENVIRONMENT DG:
Mr. Paul HAYES, Mrs. Kathryn TIERNEY.
The chairman of the CSTEE welcomed all attendants to the plenary and in particular those invited specially to the meeting.
Apologies were received from Professors/Doctors Marco Vighi, Peter Calow, Katarina Victorin, Marc Costello and Soterios Kyrtopoulos.
2. Adoption of the draft agenda
The agenda was amended as follows. Former point 10 (Programme of procedures for the assessment of risks to health and the environment from cadmium in fertilisers) was moved to just before point 5. Points 6 (Regulation 793/93 on Existing substances), 7 (Methylene chloride and certain Chemicals in Textiles), 12 (Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission) and 13 (Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE) were postponed to the afternoon session. With those changes, the agenda was adopted.
3. Adoption of the draft minutes of the 14th and 15th CSTEE plenary meetings held on the 11th of April and 5th of May 2000 in Brussels respectively.
Two corrections were made to the draft minutes of the 14th plenary: Dr. Tarazona asked for a sentence to be added to his former declaration of interest stating that he decided not to take further part in the discussions, due to his interest in the subject; Prof. Vos asked to substitute the word "genotoxicity" in point 5 line 5 by "ecotoxicity". With this changes the minutes of the 14th plenary meeting of the CSTEE were adopted.
Some subjects related to the minutes, although not included in the agenda for that meeting, were raised. A timetable for the renewal of the Committee was presented to the CSTEE by its chairman. The CSTEE secretary provided information about the opinion on the Danish notification on lead, which had been already published on the Internet. Regarding the question of the future of Toxicology, Ecotoxicology and Epidemiology in Europe the chairman explained that this issue had been transferred for strategic reasons to the Scientific Steering Committee. Nevertheless he expressed his opinion that a working party should exist within the CSTEE to deal with some points more specifically related to toxicology, ecotoxicology and epidemiology, even if the general subject should be discussed within the framework of the SSC. The Committee supported this position.
It was agreed to approve the minutes of the 15th plenary meeting by written procedure during the summer break.
4. Endocrine disrupting chemicals:
A. 2nd presentation by representatives of the Fraunhofer-Institut für Umweltchemie und Oekotoxikologie, Schmallenberg, Germany, of their ongoing research project relating to the development and validation of a test method for the identification of endocrine disrupting chemicals (the first presentation took place at the 9th CSTEE plenary meeting, 5th of May 1999).
Two representatives from the Fraunhofer Institut presented a status report on the project. They explained that the aim of the project was to develop a test protocol to screen EDCs to elucidate the molecular mechanism and assess the impact both at individual and at the population level. A four-step battery of assays was established: screening in transactivation assays, molecular mechanisms in cell culture, effects in intact mammals and effects on reproduction of fishes.
Three properties of compounds were considered important for environmental risk assessment: potency of molecular interaction, relation of relevant endocrine effect concentration to acute toxicity and persistence and environmental findings.
In-vitro and in-vivo assays were proposed to elucidate de estrogenic potential of compounds. A short-term uterotrophic assay would be used to confirm the estrogenicity in mammal. Finally, long-term in-vivo studies in zebra fishes would be useful to include all stages of development and reproduction.
After the presentation some CSTEE members expressed their views on the project. Some points of concern were raised, among them: i) the difficulty to extrapolate to field tests the results of laboratory testing; ii)the difficulty of extrapolation of in vitro results to the in vivo situation; iii) the problems derived from focussing the study on the estrogenic effects of the chemicals, when there are other important points when studying EDCs; iv) the advantages of this test compared to others, etc.
One CSTEE member asked about the role of the CSTEE at the present stage of development of the project and whether the Committee was being asked to express its opinion on it. The answer was given that the presentation was made only for information of the Committee and no formal opinion on it was being requested.
B. Request for an Opinion of the CSTEE on the study report entitled "Towards the Establishment of a Priority List of Substances for further evaluation of their role in Endocrine Disruption", carried out by BKH Consulting Engineers (NL).
A representative from Environment Directorate-General presented the background of the consultation. A Communication from the Commission on the subject (of December 1999) was followed in March 2000 by the conclusions of the Council of Environment Ministers, endorsing the list of priority substances for further evaluation of their role in endocrine disruption. She stressed the fact that the Commission is not proposing to the Committee a list of chemicals with endocrine disruption activity, but a list of substances for further evaluation. The program is organised in two consecutive steps: first of all, a study had been launched to look at the information available, and afterwards a consultation period should start, in which all the expert groups related to the issue would be contacted. Step 1 was about to be finalised and the report was expected to be ready within a week and distributed to CSTEE members. The Committee was being consulted about two aspects: whether the source material, methodology and selection criteria used to establish the list of chemicals were logical and scientifically relevant, and on the methodology used for establishing the priority list of substances.
Two representatives from BKH Consulting Engineers presented the results of the study. The aim of the study was to identify those man-made chemicals which may have endocrine disruption effects, both to human health and wildlife. Those produced to intentionally interfere with the endocrine system were not considered. The process to establish a priority list of substances for further evaluation as endocrine disrupters was explained. The process started with the review of existing lists of substances. From the list obtained, highly persisting chemicals and high production volume chemicals were selected and, after an evaluation of scientific evidence of endocrine disruption and of exposure on human and wildlife, a candidate list of priority substance was obtained. The result is a list divided in three categories: high, medium and low concern substances, which was being proposed to the CSTEE for its opinion. It was remarked that most probably the terms used would be changed from high, medium and low concern substances to clear, potential and unknown concern.
Some CSTEE members were concerned about the fact that dose-response relationships in connection with critical effects of the chemicals were not used as a criterion for selecting the substances of the priority list. Relation to PEC/PNEC was also suggested as a desirable criterion towards the same objective. It was also stressed that endocrine disruption is not a disease outcome like cancer or allergy but a descriptor of functional change that may lead to health effects, e.g. on reproduction.
Some CSTEE members expressed their agreement with the title of the study. Because of the difficult definition of the effects of endocrine disrupters it was considered a good approach to the question to establish a list of substances for further evaluation instead of a list endocrine disrupting chemicals. Nevertheless, a CSTEE member asked for some explanations about the "further evaluation" mentioned in the title. He was concerned both with what kind of evaluation would be carried out and with who would perform it. One representative from Environment DG explained that a priority list would be used to identify substances for testing once agreed test methods are available (not before two years), to identify substances already subject to regulatory measures not necessarily related to endocrine disruption, to help guide future research and monitoring efforts and to initiate some further studies on the priority substances. Another CSTEE member pointed out that it was important to verify prior to the adoption of a final list whether the criteria used were the appropriate ones.
The CSTEE secretary explained that the comments already made in the plenary could be considered as part of the answers to the questions proposed. Regarding the time table for the adoption of the opinion, he considered that while the September plenary was not a realistic one for adoption, the October one should be.
The CSTEE chairman thanked the two BKH representatives for their interesting presentation of the report.
5. Consideration of a document on the Minimum Data Set for CSTEE to express an opinion on a chemical.
The CSTEE chairman presented the background of the issue. While discussing a question proposed to the Committee, the members of that working group realised that the lack of relevant information made it impossible to adopt an opinion. Therefore they considered the possibility of preparing a guideline on the minimum data set that the CSTEE needs in order to perform a risk assessment for a chemical. He stressed the importance of the word "minimum". Professor Dybing was appointed as rapporteur for the human part of the document and Dr Tarazona for the ecotoxicological aspects.
Both rapporteurs presented the draft document, and afterwards different CSTEE members made some comments. Finally the two mentioned CSTEE members took the charge of rewriting the draft considering the comments and remarks made during that plenary meeting in order to present it during the September plenary meeting of the Committee for discussion and eventual adoption.
6. Regulation 793/93 on Existing substances (ESR):
Following a suggestion of Environment DG, it was decided to add a standard note, in the form of a footnote, to all the CSTEE opinions on risk assessments elaborated under Regulation 793/93, setting out the legal framework under which the opinions are expressed.
The CSTEE secretary informed the Committee about a Competent Authorities meeting for Regulation 793/93 which had taken place in Lisbon the week before the plenary and where he explained the role and participation of the CSTEE in the process of elaboration of risk assessments on substances under Regulation 793/93.
One CSTEE member asked the secretary whether the Committee would receive the revised versions of the Technical Guidance Document for opinion. The reply was that it was forseen that the CSTEE would be involved in the process in reviewing it.
One CSTEE member stressed the value of this participation, specially regarding metals.
A. Adoption of opinions on:
i) Human health effects report of Pentabromodiphenyl ether.
The rapporteur presented the draft opinion. Some CSTEE members expressed a certain degree of concern about the paragraph on "Studies in animals" under the point on "Effects of repeated exposure". Therefore, this part was reworded to better reflect such points of view. One CSTEE member asked for further clarification on the statement on the exposure to consumers from PeBDE to be negligible. It was explained that the main point of concern was the apparent contradiction between the levels of PeBDE in human breast milk increasing over the period 1972 to 1997 while the levels in the environment stayed stable or even decreased. Given these facts and the possible existence of other routes of exposure, a representative from Environment DG provided the committee with the information that industry reported no other uses of PeBDE apart from those already known, and that further studies were being conducted to determine whether or not Octabromodiphenyl ether or Decabromodiphenyl ether degrade to PeBDE. The opinion was then unanimously adopted.
ii) Environmental effects report of:
a) Octabromodiphenyl ether
The rapporteur presented the draft. The section on the terrestrial compartment was completed with a text drafted by a different CSTEE member. The opinion was unanimously adopted.
b) Decabromodiphenyl ether
The rapporteur presented the opinion. Some minor comments were proposed and accepted, mainly on the section of the opinion regarding the terrestrial compartment. The opinion was finally unanimously adopted.
B. State of play regarding other substances evaluated under the ESR
Due to the absence of a representative from JRC, it was one from Environment DG who updated the Committee. Reports on three substances had been prepared and submitted for opinion of the CSTEE: 1,4 Dichlorobenzene, 1,4 Dioxane and 4 Chloro 2 Methylphenol.
Reports on Acrylonitrile and Metacrylic acid would be submitted in the near future. During the second part of the year some other reports would be submitted.
7. Methylene chloride and certain Chemicals in Textiles - for opinion
Due to the absence of the rapporteur for these two opinions, it was one of the working group members who made the respective presentation.
A working group meeting had taken place two weeks before the plenary and the need for revision of the draft, specially on the issues of toxico-kinetics, carcinogenicity and mutagenicity, was identified. A sub WG was created to deal with them and its conclusions were already in the draft presented to the plenary.
Some CSTEE members expressed concern about the table on page 3 of the draft opinion on Methylene chloride. Other inconsistencies and inaccuracies were pointed out in both draft opinions. Since the rapporteur for these two opinions was not present, it was decided that CSTEE members would send him their comments on both documents and to adopt the opinions by written procedure.
8. The use of exposure data in risk assessments - progress report
The working group had met two days before the plenary and the WG chairman informed the Committee about it. A new draft table of contents was produced after that meeting, which was presented to the plenary. Comments from CSTEE members on that were requested.
The chairman of this working group also informed the committee about a meeting of a related working group on Harmonisation of Risk Assessment set up under the Scientific Steering Committee, of which he is a member. A report on that meeting was distributed to the CSTEE.
9. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
A first draft of the opinion was presented to the committee. The chairman of the working group explained that this was not a final one. It included only eight of the ten chapters expected to be in the opinion. A meeting of the working group had taken place two days before the plenary and therefore no comments from that meeting were yet reflected in the document being presented to CSTEE members. A new meeting was scheduled for mid August to try and prepare a pre-final draft for presentation to the 17th CSTEE plenary meeting in September. Contributions were asked from all CSTEE members.
10. Programme of procedures for the assessment of risks to health and the environment from cadmium in fertilisers - progress report
The chairman presented the members of this new working group and informed the committee about a future meeting of it, scheduled to take place on 4 September, just before the plenary.
11. Water Framework Directive -progress report
The WG chairman informed the Committee about a meeting with member states on the list of priority substances to which he had been invited and in which the previous opinions of the CSTEE on the subject had been considered.
The WG was still waiting for some documentation on the issue to be provided by the competent Commission service to resume its work.
12. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
a) Validation of testing methods for phthalates migration
The background and the terms of reference for the CSTEE to express an opinion on the above mentioned issue was presented to the committee. Copies of the document presented to the Committee were distributed.
b) Development of a general opinion on human and environmental effects of lead and its compounds
A representative from Enterprise DG presented the general situation of the issue. A study would be launched shortly on the effects of lead in general on human health and environmental effects of lead. The CSTEE should be asked afterwards to express its opinion on that study.
c) any other
The CSTEE secretary informed the Committee about a possible future opinion request from Environment DG on waste related issues.
13. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
A representative from Enterprise DG informed the Committee that the report on Pentabromodiphenyl ether was ready to be discussed at the working group meeting to decide what kind of follow up would be taken.
14. Renewal of the Scientific Committees
The head of unit C-2 of Health and Consumer Protection DG updated the Committee on the last news about the renewal of the Committees. The general procedure and the deadlines for this renewal were explained.
She also expressed the gratitude of the Commission for the excellent work performed by the CSTEE in the last three years.
15. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
There were no updates to be presented to the committee.
16. Arrangements for the next meeting of the CSTEE
The secretary proposed the CSTEE to consider the possibility of having a two day or at least a one and a half day meeting, due to important issues to be discussed and possibly also some WG meetings back to back with the plenary.
17. Any other business
There was none.
- 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 14th and 15th CSTEE plenary meetings held on the 11th of April and 5th of May 2000 in Brussels respectively.
4. Endocrine disrupting chemicals:
A. 2nd presentation by representatives of the Fraunhofer-Institut für Umweltchemie und Oekotoxikologie, Schmallenberg, Germany, of their ongoing research project relating to the development and validation of a test method for the identification of endocrine disrupting chemicals (the first presentation took place at the 9th CSTEE plenary meeting, 5th of May 1999).
B. Request for an Opinion of the CSTEE on the study report entitled "Towards the Establishment of a Priority List of Substances for further evaluation of their role in Endocrine Disruption", carried out by BKH Consulting Engineers (NL).
5. Consideration of a document on the Minimum Data Set for CSTEE to express an opinion on a chemical.
6. Regulation 793/93 on Existing substances (ESR):
A. Adoption of opinions on:
i) Human health effects report of Pentabromodiphenyl ether.
ii) Environmental effects report of:
a) Octabromodiphenyl ether
b) Decabromodiphenyl ether
B. State of play regarding other substances evaluated under the ESR
7. Methylene chloride and certain Chemicals in Textiles - for opinion
8. The use of exposure data in risk assessments - progress report
9. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
10. Programme of procedures for the assessment of risks to health and the environment from cadmium in fertilisers - progress report
11. Water Framework Directive -progress report
12. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
a) Validation of testing methods for phthalates migration
b) Development of a general opinion on human and environmental effects of lead and its compounds
c) any other
13. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
14. Renewal of the Scientific Committee
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
LIST OF PARTICIPANTS
CSTEE:
Prof. James BRIDGES, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Bo O. JANSSON, Dr. Ole LADEFOGED, Dr. Claude LAMBRÉ, Dr. José RUEFF, Prof. Mirja S. SALKINOJA-SALONEN, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, Prof. Janneche UTNE-SKÅRE, Prof. Joseph G. VOS, Prof. Dr. Robert WENNIG.
Ad-hoc experts:
Dr. P.C. OKKERMAN, Dr. Christoph SCHÄFERS, Dr. I. VAN DER PUTTE, Dr. Andrea WENZEL.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE, Mr. Panagiotis DASKALEROS, Mrs. Mercedes de SOLÀ, Mrs. Angelika WILHELM.
ENTERPRISE DG:
Mr. Joachim EHRENBERG, Mr. Wolfgang HEHN, Mr. Vincenzo GENTE, Mrs. Lena PERENIUS.
ENVIRONMENT DG:
Mr. Paul HAYES, Mrs. Kathryn TIERNEY.
