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Directorate-General for Health and Food Safety
1. Welcoming address, apologies for
absence and declarations of interest
Due to the absence of the Chairperson and the first and second vice Chairpersons of the CSTEE when the meeting was due to start, the meeting was opened and chaired during the morning session by the most senior CSTEE member present, Professor Benedetto Terracini. The afternoon session was chaired by the first vice Chairperson, Professor Helmut Greim.
Apologies were received from Professors: Bridges, Kyrtopoulos, Ladefoged, Rueff, Tarazona, Victorin and Vighi.
2. Adoption of the draft agenda
The draft agenda was adopted.
3. Adoption of the draft minutes of the 14th CSTEE plenary meeting held on the 11th of April 2000 in Brussels
The adoption was postponed among other reasons because of the significant number of CSTEE members absent.
4. Lead - Danish notification 595/98/DK - for opinion
The rapporteur presented the new draft of the opinion, which had been already distributed to CSTEE members; the draft was thoroughly discussed. Remarks were made, discussed and in some cases accepted in a detailed revision of the draft, which started with the answers to the questions posed, followed by the conclusions and finalising with the background for the conclusions.
Two points raised a particular concern for some CSTEE members: the one related to "Lead in soil" and the table on "no-risk lead blood levels" and "tolerable daily intake". In the first case the distinction in relation to the main sources of lead for forest and for agricultural soils was stressed. The relevant table was amended to make it more understandable.
One CSTEE member suggested that references to statements taken from different sources were needed to avoid possible confusions between what are the views of the Committee and what are citations from other documents. This issue was raised at different points during the discussion. Due to lack of time, however, a complete revision of the opinion to introduce all the necessary references was rejected. Nevertheless, the rapporteur was asked to revise the opinion and try to make as clear as possible which statements were CSTEE's and which ones were citations from other sources. For future CSTEE opinions this point was deemed an important one to be considered.
Subject to such editorial amendments, the opinion was unanimously adopted.
5. Regulation 793/93 on Existing substances (ESR):
The WG chairperson explained that some confusion was still present on the different versions of the drafts distributed previously to CSTEE members. The latest draft texts prepared by him were distributed to meeting participants as room documents. A representative from JRC-ECB requested clarification on the nature of changes made to the versions previously distributed and was informed that they were mainly editorial, with no real influence on the substance of the opinions.
A. Adoption of opinions on:
- Hydrogen Fluoride
The draft opinion was presented, discussed and approved, subject to some minor editorial changes.
Apart from some more specific remarks included in the final opinion, the CSTEE expressed its concern on the use in the report of some RIVM studies not published and not available, something which made it impossible to assess the respective validity. A sentence was included in the opinion to stress this.
Another point raised, in the specific comments on Human Health, was the use of an uncertainty factor of 100, even when human data had been considered. The Committee agreed that, even though a case by case approach is needed, in this particular case a safety factor of 10 should have been applied instead.
- Dimethyl sulphate
The draft opinion was discussed, amended and adopted. A significant discussion took place on the agreement of the CSTEE on the low concern of DMS for sediments and soil, due to some Committee members disagreeing on how fast the chemical is indeed, or not, hydrolysed.
- 4'4-Methylenedianiline
The draft opinion was approved with minor changes. Two paragraphs containing general and exposure information on the substance were taken off the opinion as they were not considered necessary. A discussion took place on the issue of aquatic environment, regarding mainly the instability of MDA in solution, something that compromises the use of aquatic toxicity data in the risk assessment. The respective paragraph was reworded and a new one added on the hepatotoxicity of DMA, under the subject of Mechanistic Considerations on human health effects of the substance.
- Cumene
The draft opinion was adopted. As it was the case with the previous one, the paragraphs on general and exposure information were deleted.
- Acrolein
The draft opinion was adopted. A CSTEE member expressed some concern about the recommendation to the effect that an irritation study should be conducted in humans. A representative from JRC-ECB commented on the recommendation of a transgenic mouse study by inhalation in order to better evaluate the potential of the substance to induce mutations in the respiratory system, pointing out that, to her knowledge, there was no previous experience of such a study in lung tissues.
B. State of play regarding the consultation of the CSTEE on other substances evaluated under the ESR:
i) Consultation of the CSTEE on the human health effects report of:
- Pentabromodiphenyl ether.
ii) Consultation of the CSTEE on the environmental effects report of:
- Octabromodiphenyl ether
- Decabromodiphenyl ether
iii) Other
A representative from JRC-ECB explained that the Risk Assessment Report on which a CSTEE opinion was more urgently needed was the one on Pentabromodiphenyl ether. The Committee considered feasible to have it adopted during the 16th plenary meeting of the CSTEE, scheduled for the 19th of June.
The same representative thanked the Committee, on behalf of Environment DG, for its efforts and adoption of the opinions on the other five substances within the deadlines set.
One CSTEE member expressed again his concern about the general way of dealing with such peer reviews. The CSTEE Secretary explained that after a test period of some six more months the system would be revised and corrective measures taken where necessary. The JRC-ECB representative on the other hand, insisted on the interest that both Environment DG and the ECB had in obtaining some informal input from the CSTEE before the reports reached their final stage.
6. Methylene chloride and certain Chemicals in Textiles - progress report
Due to the absence of the rapporteur for this opinion the discussion was postponed. Committee members were asked to send comments to the rapporteur and to the CSTEE secretariat.
7. Scientific experts in Toxicology, Ecotoxicology and Epidemiology for risk assessments, planning for the future - progress report
At the request of the Commission this point was dropped since it was believed that the right forum for raising such issues should be the Scientific Steering Committee.
8. The use of measured exposure data in risk assessments - progress report
For lack of time this point had to be postponed.
9. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
Due to the absence of the chairman of the working group, the progress report on this point was postponed until next plenary meeting of the CSTEE. The information was also given that in any case a WG meeting would take place before the next plenary.
10. Programme of procedures for the assessment of risks to health and the environment from cadmium in fertilisers - progress report
The first WG meeting is still to take place (on the 23rd of May). A progress report is hence expected for the next plenary.
11. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
The CSTEE secretariat informed the Committee about the upcoming submission of two opinion requests involving CSTEE participation. One on the subject of Endocrine Disrupting Chemicals (EDCs), more specifically on a report on a tentative list of substances to be assessed for their possible effects as EDCs (at that moment still pending an exchange of views between the requester Commission Service and the CSTEE secretariat and other DGs of the Commission on the final terms of reference to be submitted to the Committee). The second opinion request is on the subject of metabolites of plant protection products. Here the implication of the CSTEE is different as the WG is one of the Scientific Committee for Plants but the input/expertise of the CSTEE was deemed necessary a well. CSTEE members will receive more information and volunteers will be sought in view of integrating the mentioned working group.
12. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
The CSTEE secretary told the Committee that he had just been informed that the CSTEE Chairman would be invited to attend a session of the Environment Committee of the European Parliament to provide clarification on the issue of "Phthalates in childcare articles". No more specific information could be given.
13. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
Due to the absence of the CSTEE chairman this point was dropped.
14. Arrangements for the next meeting of the CSTEE
The next plenary meeting of the CSTEE is scheduled for 19/20 June, with 20 as the preferred day in case of a single day meeting. This would have to be changed however, as the SCIC ("Service Commun Interpretation Conférences") imposed on the CSTEE Secretariat that the meeting would have to take place on the 19th of June.
15. Any other business
A CSTEE member asked whether there were any news on developments on the Water Framework Directive. In the absence of a representative of the responsible Commission service, Environment DG, the CSTEE secretary informed the Committee that the now long outstanding study on inter-calibration needed by the Committee to answer the second part of the opinion request submitted by DG ENV, was indeed still outstanding.
From the political side of things all that could be said was that discussions at EP and Council level were still ongoing and no conclusions on the final format/content of the directive had been reached yet.
The secretary also gave information on a start-off meeting held in the JRC in Ispra on Phthalates Migration Tests.
CSTEE/00/plen.age.05.05.00
- 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 CSTEE plenary meeting held on the 11th of April 2000 in Brussels
4. Lead - Danish notification 595/98/DK - for opinion
5. Regulation 793/93 on Existing substances (ESR):
A. Adoption of opinions on:
- Hydrogen Fluoride
- Dimethyl sulphate
- 4'4-Methylenedianiline
- Cumene
- Acrolein
B. State of play regarding the consultation of the CSTEE on other substances evaluated under the ESR:
i) Consultation of the CSTEE on the human health effects report of:
- Pentabromodiphenyl ether.
ii) Consultation of the CSTEE on the environmental effects report of:
- Octabromodiphenyl ether
- Decabromodiphenyl ether
iii) Other
6. Methylene chloride and certain Chemicals in Textiles - progress report
7. Scientific experts in Toxicology, Ecotoxicology and Epidemiology for risk assessments, planning for the future - progress report
8. The use of measured 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. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
12. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
13. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
14. Arrangements for the next meeting of the CSTEE
15. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. Peter CALOW, Dr. Mark J. COSTELLO, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Bo O. JANSSON, Dr. Claude LAMBRÉ, Prof. Mirja S. SALKINOJA-SALONEN, Prof. Benedetto TERRACINI, Prof. Janneche UTNE-SKÅRE, Prof. Joseph G. VOS, Prof. Dr. Robert WENNIG.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE, Mr. Panagiotis DASKALEROS, Mrs. Mercedes de SOLÀ.
ENTERPRISE DG:
Mrs. Lena PERENIUS.
ENVIRONMENT DG:
Mr. Alexandre PAQUOT.
JOINT RESEARCH CENTRE:
Mrs. Sharon MUNN
Due to the absence of the Chairperson and the first and second vice Chairpersons of the CSTEE when the meeting was due to start, the meeting was opened and chaired during the morning session by the most senior CSTEE member present, Professor Benedetto Terracini. The afternoon session was chaired by the first vice Chairperson, Professor Helmut Greim.
Apologies were received from Professors: Bridges, Kyrtopoulos, Ladefoged, Rueff, Tarazona, Victorin and Vighi.
2. Adoption of the draft agenda
The draft agenda was adopted.
3. Adoption of the draft minutes of the 14th CSTEE plenary meeting held on the 11th of April 2000 in Brussels
The adoption was postponed among other reasons because of the significant number of CSTEE members absent.
4. Lead - Danish notification 595/98/DK - for opinion
The rapporteur presented the new draft of the opinion, which had been already distributed to CSTEE members; the draft was thoroughly discussed. Remarks were made, discussed and in some cases accepted in a detailed revision of the draft, which started with the answers to the questions posed, followed by the conclusions and finalising with the background for the conclusions.
Two points raised a particular concern for some CSTEE members: the one related to "Lead in soil" and the table on "no-risk lead blood levels" and "tolerable daily intake". In the first case the distinction in relation to the main sources of lead for forest and for agricultural soils was stressed. The relevant table was amended to make it more understandable.
One CSTEE member suggested that references to statements taken from different sources were needed to avoid possible confusions between what are the views of the Committee and what are citations from other documents. This issue was raised at different points during the discussion. Due to lack of time, however, a complete revision of the opinion to introduce all the necessary references was rejected. Nevertheless, the rapporteur was asked to revise the opinion and try to make as clear as possible which statements were CSTEE's and which ones were citations from other sources. For future CSTEE opinions this point was deemed an important one to be considered.
Subject to such editorial amendments, the opinion was unanimously adopted.
5. Regulation 793/93 on Existing substances (ESR):
The WG chairperson explained that some confusion was still present on the different versions of the drafts distributed previously to CSTEE members. The latest draft texts prepared by him were distributed to meeting participants as room documents. A representative from JRC-ECB requested clarification on the nature of changes made to the versions previously distributed and was informed that they were mainly editorial, with no real influence on the substance of the opinions.
A. Adoption of opinions on:
- Hydrogen Fluoride
The draft opinion was presented, discussed and approved, subject to some minor editorial changes.
Apart from some more specific remarks included in the final opinion, the CSTEE expressed its concern on the use in the report of some RIVM studies not published and not available, something which made it impossible to assess the respective validity. A sentence was included in the opinion to stress this.
Another point raised, in the specific comments on Human Health, was the use of an uncertainty factor of 100, even when human data had been considered. The Committee agreed that, even though a case by case approach is needed, in this particular case a safety factor of 10 should have been applied instead.
- Dimethyl sulphate
The draft opinion was discussed, amended and adopted. A significant discussion took place on the agreement of the CSTEE on the low concern of DMS for sediments and soil, due to some Committee members disagreeing on how fast the chemical is indeed, or not, hydrolysed.
- 4'4-Methylenedianiline
The draft opinion was approved with minor changes. Two paragraphs containing general and exposure information on the substance were taken off the opinion as they were not considered necessary. A discussion took place on the issue of aquatic environment, regarding mainly the instability of MDA in solution, something that compromises the use of aquatic toxicity data in the risk assessment. The respective paragraph was reworded and a new one added on the hepatotoxicity of DMA, under the subject of Mechanistic Considerations on human health effects of the substance.
- Cumene
The draft opinion was adopted. As it was the case with the previous one, the paragraphs on general and exposure information were deleted.
- Acrolein
The draft opinion was adopted. A CSTEE member expressed some concern about the recommendation to the effect that an irritation study should be conducted in humans. A representative from JRC-ECB commented on the recommendation of a transgenic mouse study by inhalation in order to better evaluate the potential of the substance to induce mutations in the respiratory system, pointing out that, to her knowledge, there was no previous experience of such a study in lung tissues.
B. State of play regarding the consultation of the CSTEE on other substances evaluated under the ESR:
i) Consultation of the CSTEE on the human health effects report of:
- Pentabromodiphenyl ether.
ii) Consultation of the CSTEE on the environmental effects report of:
- Octabromodiphenyl ether
- Decabromodiphenyl ether
iii) Other
A representative from JRC-ECB explained that the Risk Assessment Report on which a CSTEE opinion was more urgently needed was the one on Pentabromodiphenyl ether. The Committee considered feasible to have it adopted during the 16th plenary meeting of the CSTEE, scheduled for the 19th of June.
The same representative thanked the Committee, on behalf of Environment DG, for its efforts and adoption of the opinions on the other five substances within the deadlines set.
One CSTEE member expressed again his concern about the general way of dealing with such peer reviews. The CSTEE Secretary explained that after a test period of some six more months the system would be revised and corrective measures taken where necessary. The JRC-ECB representative on the other hand, insisted on the interest that both Environment DG and the ECB had in obtaining some informal input from the CSTEE before the reports reached their final stage.
6. Methylene chloride and certain Chemicals in Textiles - progress report
Due to the absence of the rapporteur for this opinion the discussion was postponed. Committee members were asked to send comments to the rapporteur and to the CSTEE secretariat.
7. Scientific experts in Toxicology, Ecotoxicology and Epidemiology for risk assessments, planning for the future - progress report
At the request of the Commission this point was dropped since it was believed that the right forum for raising such issues should be the Scientific Steering Committee.
8. The use of measured exposure data in risk assessments - progress report
For lack of time this point had to be postponed.
9. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - progress report
Due to the absence of the chairman of the working group, the progress report on this point was postponed until next plenary meeting of the CSTEE. The information was also given that in any case a WG meeting would take place before the next plenary.
10. Programme of procedures for the assessment of risks to health and the environment from cadmium in fertilisers - progress report
The first WG meeting is still to take place (on the 23rd of May). A progress report is hence expected for the next plenary.
11. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
The CSTEE secretariat informed the Committee about the upcoming submission of two opinion requests involving CSTEE participation. One on the subject of Endocrine Disrupting Chemicals (EDCs), more specifically on a report on a tentative list of substances to be assessed for their possible effects as EDCs (at that moment still pending an exchange of views between the requester Commission Service and the CSTEE secretariat and other DGs of the Commission on the final terms of reference to be submitted to the Committee). The second opinion request is on the subject of metabolites of plant protection products. Here the implication of the CSTEE is different as the WG is one of the Scientific Committee for Plants but the input/expertise of the CSTEE was deemed necessary a well. CSTEE members will receive more information and volunteers will be sought in view of integrating the mentioned working group.
12. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
The CSTEE secretary told the Committee that he had just been informed that the CSTEE Chairman would be invited to attend a session of the Environment Committee of the European Parliament to provide clarification on the issue of "Phthalates in childcare articles". No more specific information could be given.
13. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
Due to the absence of the CSTEE chairman this point was dropped.
14. Arrangements for the next meeting of the CSTEE
The next plenary meeting of the CSTEE is scheduled for 19/20 June, with 20 as the preferred day in case of a single day meeting. This would have to be changed however, as the SCIC ("Service Commun Interpretation Conférences") imposed on the CSTEE Secretariat that the meeting would have to take place on the 19th of June.
15. Any other business
A CSTEE member asked whether there were any news on developments on the Water Framework Directive. In the absence of a representative of the responsible Commission service, Environment DG, the CSTEE secretary informed the Committee that the now long outstanding study on inter-calibration needed by the Committee to answer the second part of the opinion request submitted by DG ENV, was indeed still outstanding.
From the political side of things all that could be said was that discussions at EP and Council level were still ongoing and no conclusions on the final format/content of the directive had been reached yet.
The secretary also gave information on a start-off meeting held in the JRC in Ispra on Phthalates Migration Tests.
CSTEE/00/plen.age.05.05.00
- 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 CSTEE plenary meeting held on the 11th of April 2000 in Brussels
4. Lead - Danish notification 595/98/DK - for opinion
5. Regulation 793/93 on Existing substances (ESR):
A. Adoption of opinions on:
- Hydrogen Fluoride
- Dimethyl sulphate
- 4'4-Methylenedianiline
- Cumene
- Acrolein
B. State of play regarding the consultation of the CSTEE on other substances evaluated under the ESR:
i) Consultation of the CSTEE on the human health effects report of:
- Pentabromodiphenyl ether.
ii) Consultation of the CSTEE on the environmental effects report of:
- Octabromodiphenyl ether
- Decabromodiphenyl ether
iii) Other
6. Methylene chloride and certain Chemicals in Textiles - progress report
7. Scientific experts in Toxicology, Ecotoxicology and Epidemiology for risk assessments, planning for the future - progress report
8. The use of measured 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. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
12. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
13. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
14. Arrangements for the next meeting of the CSTEE
15. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. Peter CALOW, Dr. Mark J. COSTELLO, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Bo O. JANSSON, Dr. Claude LAMBRÉ, Prof. Mirja S. SALKINOJA-SALONEN, Prof. Benedetto TERRACINI, Prof. Janneche UTNE-SKÅRE, Prof. Joseph G. VOS, Prof. Dr. Robert WENNIG.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE, Mr. Panagiotis DASKALEROS, Mrs. Mercedes de SOLÀ.
ENTERPRISE DG:
Mrs. Lena PERENIUS.
ENVIRONMENT DG:
Mr. Alexandre PAQUOT.
JOINT RESEARCH CENTRE:
Mrs. Sharon MUNN
