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Directorate-General for Health and Food Safety
1. Welcoming address, apologies for
absence and declarations of interest
The CSTEE chairman welcomed the attendants to this first meeting after the summer break and reminded them that two more meetings were scheduled before the renewal of the committee: one in October and the last one in November 2000.
Apologies were received from Dr. Costello.
The committee discussed for a while the issue of declarations of interest. It was agreed that if some member of the CSTEE, or of any working party set up under it, had been advising his/her government on an issue submitted to the CSTEE as well, he or she should make this public even if there was no real personal interest on the subject. Afterwards it would be for the chairman of the committee, or of the WG as the case might be, to decide whether this declaration of interest entailed or not a conflict of interest. One CSTEE member proposed to clearly distinguish between scientific advice and regulatory advice and pointed out that he was involved in a process to scientifically advise his government on the regulation of chemicals, in general.
Prof. Jansson declared his participation in a meeting in the JRC on phthalates migration, where he was sent by the Swedish government but where he expressed only his personal scientific opinion on the subject and not representing any national or political opinion. He considered that there was no personal interest to be declared.
Dr. Rastogi declared that he had been advising the Danish EPA on analytical methods for phthalates and participated in meetings representing the Danish government. He also stressed the fact that, given that this could be seen as a conflict of interest, his participation had already been cancelled in those meetings.
2. Adoption of the draft agenda
Prof. Kyrtopoulos, rapporteur for the opinion on Methylene chloride, scheduled for discussion under the last point of the agenda (Any other business) explained he had to leave early in the afternoon, the point was therefore advanced to immediately after point 3.
Point 5 (List of priority substances for further evaluation of their role in Endocrine Disruption) was moved to the end of the agenda to allow for the finishing touches to be put on the draft opinion. This was due to the fact that the last WG meeting on that issue took place immediately before the plenary, from 8 to 10 in the morning.
Point 3 was modified to include also the approval of the minutes of the 15th plenary meeting.
3. Adoption of the draft minutes of the 15th and 16th CSTEE plenary meetings held on the 5th of May and the 19th of June 2000, respectively, in Brussels
The minutes of the 15th plenary meeting of the CSTEE had not been approved by written procedure during the summer because many members had not responded and therefore they were adopted during the 17th plenary.
The minutes of the 16th plenary meeting were approved with some amendments. Point 4 of the agenda (Endocrine disrupting chemicals) was amended as follows: A sentence on molecular mechanisms was deleted and two more were added: one on the difficulty to extrapolate in vitro testing to in vivo situations, and another on the fact that endocrine disruption is a descriptor of functional change that may lead to health effects and not a disease such as like e.g. cancer or allergy.
4. Methylene chloride and certain Chemicals in Textiles - for opinion
A CSTEE member expressed concern about the inclusion in the draft opinion of a sentence recommending a certain safe level of Methylene chloride in the air for the working place. In his opinion such a position conflicted with the activities of the SCOEL and the CSTEE should not propose such limits. Furthermore, he considered that the limit proposed had not been discussed at sufficient length by the committee and therefore it should not support such statements. Prior to such a decision, a thorough discussion on acceptable carcinogenic risks should take place.
It was proposed not to define what is acceptable or not, but just give the scientific basis for evaluation.
Two CSTEE members took responsibility for the rewording of the draft opinion, especially page 8, in a way that could be acceptable for the whole committee, taking account of the previous comments. This was done by changing some paragraphs to avoid proposing exposure limits and simply stating what the conclusions of the report were. After such a rewording the opinion was unanimously adopted by the CSTEE.
5. Programme for the validation of methodologies to test migration of plasticisers from toys and childcare articles - for opinion
The rapporteur for the opinion presented the draft. Three methods were under consideration: LGC mild horizontal shaking (with glass balls, at 37ºC), LGC stringent horizontal shaking (with relatively heavy metal balls, at 60ºC), TNO rotation method (dynamic extraction at 22ºC). He explained that the only method which at this stage can achieve the limit of 9microgram/10cm2/minute is the LGC stringent method. Asked about the reasons for the CSTEE to propose such a limit he explained that this was the worst limit observed in one in vivo experiment, therefore it should be the limit value chosen for the in vitro test. However this should not be taken to be the safe limit, which should be set at 6.7microgram/10cm2/minute.
Regarding the way of achieving that limit the rapporteur stated that a method which can guarantee non aggressive physiological-like conditions is highly desirable, which is not the case with the LGC stringent method. Furthermore, it should be necessary to ascertain the integrity of the material tested to ensure that it is migration what is being measured.
Another important point considered by the rapporteur was the possibility of using a correction factor to extrapolate from an in vitro study to in vivo conditions. This was more important due to the fact that the artificial saliva contained no proteins. Apparently the presence of proteins in the saliva can dramatically reduce the migration levels measured both in the in vivo test and in the in vitro ones. Consequently two different correction factors should be used: one to extrapolate from artificial to natural saliva containing proteins and a second one to extrapolate to the in vivo worst case of 9microgram/10cm2/min. It was explained that different correction factors should be established for the different compounds and this would only be possible after in vivo studies of these compounds.
Further explanations were requested about the number of laboratories needed for considering the acceptability of the method. The number of 15 laboratories implied in the validation process is based on international guidelines. Therefore a sentence in parenthesis was added to the draft opinion stating this. It was agreed that the method would be acceptable if 8 out of those 15 laboratories provide acceptable results.
Some CSTEE members asked for more and better in vivo studies, given that only one has been produced until now, in order for, for instance to include the role of particles extracted from the product. It was also suggested to ask for a better statistical stability of possible future in vivo studies. A representative from the JRC-ECB pointed out the difficulty to perform such studies and the difficulty in using animals in such tests.
A representative from Environment DG reminded the CSTEE about the context of the procedure. The validation of one or more testing methods for phthalate migration is a possible way out of a situation which is blocked politically. The possibility to extrapolate the results of the method on DINP to other phthalates was considered also.
After a thorough consideration of the opinion, page by page, and the introduction of some minor comments from different committee members, it was finally adopted by the CSTEE.
6. Endocrine disrupting chemicals:
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) - presentation and discussion of status report
Two working group meetings had taken place during the summer months: one on the 18 of August and another one immediately before the plenary. Drafts were prepared after each of them and distributed to the CSTEE members. The WG chairman and the rapporteur presented the last draft and compared it with the previous one. The main difference between these drafts was, apart from some minor points, the inclusion of 13 conclusions at the end of the document.
The WG chairman informed the committee about a discussion which was raised at the WG meeting in the morning on the eventual inclusion of plant protection products (PPP) in the priority list of substances for further evaluation. Some WG members had proposed to state clearly the strong opposition of the committee to that inclusion, given that they are being regulated under a different legal framework. The general opinion of the WG was that PPP should be considered together with the existing respective regulations.
A representative from Environment DG expressed concern about point 6 of the specific conclusions. In her opinion no substances were excluded from the exercise because of lack of scientific data. She also stressed that at the moment the list was not a list of substances with endocrine disruption effects but a list of substances for further evaluation. Some CSTEE members insisted on the fact that the importance of chemicals with data gaps had not been properly addressed in the report and on the validity of the specific conclusion 6.
The draft opinion was discussed and CSTEE members made some comments. After the inclusion of the changes described above the committee unanimously adopted the opinion.
7. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) 1,4 Dioxane
b) 1,4 Dichlorobenzene
c) 4-Chloro-2-Methylphenol
No drafts were ready for adoption on these substances. The rapporteur informed that they would most probably be ready for the 18th plenary, on the 9 October 2000.
B. State of play regarding other substances evaluated under the ESR
A representative from the JRC-ECB informed about new risk assessment reports which were about to be sent to the CSTEE secretariat, on the following chemicals: Acetonitrile, Methacrylic acid, Acrylonitrile and Anisidine.
8. The use of exposure data in risk assessments - progress report
The chairman of the working group informed the Committee on recent developments of the issue. A meeting had taken place in August and a first draft of chapters 1 and 2 was expected to be ready for the next one, scheduled for the 18 September.
9. Revision of Chapter 1, lines 412 to 449 of the Technical Notes for Guidance on Data requirements, version 4.3 December 1999, in support of Biocides Directive 98/8/EEC
The responsible CSTEE member for drafting this part of the original CSTEE opinion (4 February 2000) prepared a draft document on the issue. He considered that the changes introduced in the TNG were in conformity with the recommendations made by the CSTEE in its opinion. The committee endorsed his position.
It was agreed that no new opinion was needed to state this and that a reference to the endorsement by the committee of the revision of the document stated in the minutes should be sufficient. A representative from Environment DG considered that solution agreeable.
Therefore the revision of the Chapter 1, lines 412 to 449 of the Technical Notes for Guidance on Data requirements, version 4.3 December 1999, in support of Biocides Directive 98/8/EEC was considered unanimously acceptable by the CSTEE.
10. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - for opinion
The chairman of the working party presented the revision of the draft opinion, which included some comments from a WG meeting which had taken place in August, with some inputs from external experts specifically invited to attend. He explained that the draft could not be considered as a final one since some changes should still be introduced in it: it should rather be considered a pre-final one.
The main modifications vis a vis the previous version were: the introduction of a foreword clarifying the scope of the document, the first complete version of chapter 3 (yet to be discussed by the working group), some important changes in chapters 2 and 9, and, last but not least, the first draft of the final chapter, "Conclusions and Recommendations", probably, he said, the most important part of the whole document.
The time table for the approval of the opinion was quite tight, since a meeting in the ECB on classification and labelling would take place late in September and for that meeting some first conclusions of the document should be presented by the WG chairman.
The CSTEE chairman encouraged all committee members to send written comments to the WG chairman, to be considered in the final draft of the opinion, which should be ready for the October plenary meeting.
A question was raised, regarding the definition of "Hazard Identification" in page 33 of the draft, on whether the terminology and the process was the same for ecotoxicology and for human health toxicology. It was explained that there was an error in the term being defined, which should rather be "Hazard assessment" instead of "Hazard identification". One WG member stressed the fact that although the process and the terminology are similar in human health and ecotoxicology, the aim is different in both in that, while in human health it is to protect the individual, in ecotoxicology it is the protection of the ecosystem or the species which is aimed for.
A representative from JRC expressed their gratefulness to the WG members for the work they had done and considered the document to be useful both for the Classification and Labelling group and for the one revising the TGD.
11. Programme of procedures for the assessment of risks to health and the environment from cadmium in fertilisers - progress report/opinion
The Chairman of the working party and rapporteur for the opinion presented the draft. Some points of concern about the document had been considered by the working party, the most important being that there seems to be no practical available means to validate the calculations, algorithms and equations proposed in the report, since no real data appears to exist for most of them. Another concern of the working group was the fact that the report was a mixture of guidelines and background information. Some more specific remarks were made, among them: (i) health effects of Cadmium were not described in the report and should be; (ii) exposure to Cadmium through drinking water was almost not addressed; (iii) variation between European populations was not properly considered, etc. Therefore, the opinion of the WG was that the report needs to be improved before being fully acceptable to the CSTEE. The WG chairman also explained that a representative from Enterprise DG had provided the CSTEE chairman and himself during the plenary with a list of comments on the draft opinion, to be considered before its approval by the Committee.
The points raised by this representative from Enterprise DG related to the Committee's negative judgement on the report. Attention was drawn in particular to the very tight time schedule and some other restrictions on the actual situation on Europe, faced to the "ideal" scientific situation demanded by the committee (e.g. on the absence of a harmonised data base on Cadmium in the different Member States).
The view of the CSTEE members was that their brief is always to provide a scientific opinion. Therefore the committee has to stick to the scientific aspects of the issues, and other aspects of the problem are not within their mandate. The risk management is, of course, subject to those aspects but the risk assessment, in which it has to be based, should never be influenced by them.
Since the Committee refused to accept as a room document the list of comments presented by this representative from Enterprise DG, he orally presented before the plenary some of his comments. The CSTEE chairman considered that the members of the WG had properly addressed all those points at the meeting they had the day before the plenary and therefore no further discussion was needed. Specifically regarding the comments on chapter 3, the Committee stressed the fact that the question asked to the CSTEE was on the advisability of using the report as a basis for a risk assessment, not for an exposure assessment: consequently human health effects should have been considered and that was exactly what the opinion states. If the report's scope was that of covering only the algorithms for exposure assessment of Cadmium that should be the title of the report, not the current one, which apparently covers the whole risk assessment of the chemical. It was suggested to add a sentence to the opinion clarifying this.
The Committee realised that some of its conclusions may have been influenced by its initial understanding that the report was intended to be useful for a full risk assessment, however, the brief given to the consultant may have lead them to produce a report not totally in line with such an objective. The issue was raised as to whether the questions asked of the Committee had been the most appropriate ones.
The opinion was unanimously adopted pending some editorial aspects to be made by the rapporteur.
12. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
The CSTEE secretary informed the Committee of a possible future opinion request from Environment DG on contaminants in food. Further clarification on this was deemed necessary.
Dr. Tarazona informed the Committee on the follow up of the Water Framework Directive issue. New documents had been submitted by Environment DG and one or two more meetings of the working party should take place. Given the relevance of statistical approaches in the documents that had been submitted, the inclusion of an additional expert was deemed necessary.
A CSTEE member asked on whether or not the list of priority substances in the Water Framework Directive had been decided. No news on that issue could be provided, either by the WG chairman or by the CSTEE secretary, nevertheless, the later informed that a meeting of stakeholders was due to take place in September.
13. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
No other feedback was provided, apart from the information already given by a representative from Enterprise DG on Phthalates migration tests (see point 5 above).
14. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
The CSTEE chairman updated the Committee on the workings of the SSC. Regarding BSE he informed about a study on the disease being dormant in certain animal species, which had been carried out by the UK. With regard to harmonisation of risk assessment a first draft was likely to be presented to the SSC at its next meeting and a final draft to be presented in October. He asked CSTEE members to comment on it, due to the close involvement of the Committee in this area.
He also informed that the document on the shortage of experts on Toxicology, Ecotoxicology and Epidemiology, issue started at the CSTEE and afterwards transferred to the SSC, had been already approved by the SSC and passed to the Commission services for their response.
Another item on the SSC's agenda was the elaboration of a paper on emerging issues, addressing the health issues of the future, how to pick them up earlier and how to manage them.
15. Arrangements for the next meeting(s) of the CSTEE (October and November 2000)
The CSTEE confirmed the dates for the last two meetings of the current committee: the next one on the 9 October and the last one on the 8 November, back to back with the first meeting of the new CSTEE, on the 9 November.
16. Any other business
Taking into account some problems raised by different CSTEE members during the discussions of Risk Assessment Reports under regulation 793/93, the committee decided to set up a working party to prepare a draft document on the issue of margins of safety (MOS).
Professor Peter Calow asked about the state of the revision by Environment DG of the document on the future strategy for chemicals.
- DRAFT AGENDA (rev. 1)-
1. Welcoming address, apologies for absence and declarations of interest
2. Adoption of the draft agenda
3. Adoption of the draft minutes of the 15th and 16th CSTEE plenary meetings held on the 5th of May and the 19th of June 2000, respectively, in Brussels
4. Methylene chloride and certain Chemicals in Textiles - for opinion
5. Programme for the validation of methodologies to test migration of plasticisers from toys and childcare articles - for opinion
6. Endocrine disrupting chemicals:
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) - presentation and discussion of status report
7. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) 1,4 Dioxane
b) 1,4 Dichlorobenzene
c) 4-Chloro-2-Methylphenol
B. State of play regarding other substances evaluated under the ESR
8. The use of exposure data in risk assessments - progress report
9. Revision of Chapter 1, lines 412 to 449 of the Technical Notes for Guidance on Data requirements, version 4.3 December 1999, in support of Biocides Directive 98/8/EEC
10. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - for opinion
11. Programme of procedures for the assessment of risks to health and the environment from cadmium in fertilisers - progress report/opinion
12. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
13. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
14. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
15. Arrangements for the next meeting(s) of the CSTEE (October and November 2000)
16. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James BRIDGES, Prof. Peter CALOW, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Bo O. JANSSON, Prof. Soterios A. KYRTOKOPOULOS, 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. Katarina VICTORIN, Prof. M. VIGHI, Prof. Joseph G. VOS, Prof. Dr. Robert WENNIG.
Ad-hoc experts:
Dr. S. RASTOGI.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE, Mrs. Mercedes de SOLÀ.
ENTERPRISE DG:
Mr. Joachim EHRENBERG, Mrs. Lena PERENIUS.
ENVIRONMENT DG:
Mr. Walter CORTELLINI, Mrs. Kathryn TIERNEY.
JOINT RESEARCH CENTRE:
Mrs. Elke ANKLAM, Mr. Toralf KALAND.
The CSTEE chairman welcomed the attendants to this first meeting after the summer break and reminded them that two more meetings were scheduled before the renewal of the committee: one in October and the last one in November 2000.
Apologies were received from Dr. Costello.
The committee discussed for a while the issue of declarations of interest. It was agreed that if some member of the CSTEE, or of any working party set up under it, had been advising his/her government on an issue submitted to the CSTEE as well, he or she should make this public even if there was no real personal interest on the subject. Afterwards it would be for the chairman of the committee, or of the WG as the case might be, to decide whether this declaration of interest entailed or not a conflict of interest. One CSTEE member proposed to clearly distinguish between scientific advice and regulatory advice and pointed out that he was involved in a process to scientifically advise his government on the regulation of chemicals, in general.
Prof. Jansson declared his participation in a meeting in the JRC on phthalates migration, where he was sent by the Swedish government but where he expressed only his personal scientific opinion on the subject and not representing any national or political opinion. He considered that there was no personal interest to be declared.
Dr. Rastogi declared that he had been advising the Danish EPA on analytical methods for phthalates and participated in meetings representing the Danish government. He also stressed the fact that, given that this could be seen as a conflict of interest, his participation had already been cancelled in those meetings.
2. Adoption of the draft agenda
Prof. Kyrtopoulos, rapporteur for the opinion on Methylene chloride, scheduled for discussion under the last point of the agenda (Any other business) explained he had to leave early in the afternoon, the point was therefore advanced to immediately after point 3.
Point 5 (List of priority substances for further evaluation of their role in Endocrine Disruption) was moved to the end of the agenda to allow for the finishing touches to be put on the draft opinion. This was due to the fact that the last WG meeting on that issue took place immediately before the plenary, from 8 to 10 in the morning.
Point 3 was modified to include also the approval of the minutes of the 15th plenary meeting.
3. Adoption of the draft minutes of the 15th and 16th CSTEE plenary meetings held on the 5th of May and the 19th of June 2000, respectively, in Brussels
The minutes of the 15th plenary meeting of the CSTEE had not been approved by written procedure during the summer because many members had not responded and therefore they were adopted during the 17th plenary.
The minutes of the 16th plenary meeting were approved with some amendments. Point 4 of the agenda (Endocrine disrupting chemicals) was amended as follows: A sentence on molecular mechanisms was deleted and two more were added: one on the difficulty to extrapolate in vitro testing to in vivo situations, and another on the fact that endocrine disruption is a descriptor of functional change that may lead to health effects and not a disease such as like e.g. cancer or allergy.
4. Methylene chloride and certain Chemicals in Textiles - for opinion
A CSTEE member expressed concern about the inclusion in the draft opinion of a sentence recommending a certain safe level of Methylene chloride in the air for the working place. In his opinion such a position conflicted with the activities of the SCOEL and the CSTEE should not propose such limits. Furthermore, he considered that the limit proposed had not been discussed at sufficient length by the committee and therefore it should not support such statements. Prior to such a decision, a thorough discussion on acceptable carcinogenic risks should take place.
It was proposed not to define what is acceptable or not, but just give the scientific basis for evaluation.
Two CSTEE members took responsibility for the rewording of the draft opinion, especially page 8, in a way that could be acceptable for the whole committee, taking account of the previous comments. This was done by changing some paragraphs to avoid proposing exposure limits and simply stating what the conclusions of the report were. After such a rewording the opinion was unanimously adopted by the CSTEE.
5. Programme for the validation of methodologies to test migration of plasticisers from toys and childcare articles - for opinion
The rapporteur for the opinion presented the draft. Three methods were under consideration: LGC mild horizontal shaking (with glass balls, at 37ºC), LGC stringent horizontal shaking (with relatively heavy metal balls, at 60ºC), TNO rotation method (dynamic extraction at 22ºC). He explained that the only method which at this stage can achieve the limit of 9microgram/10cm2/minute is the LGC stringent method. Asked about the reasons for the CSTEE to propose such a limit he explained that this was the worst limit observed in one in vivo experiment, therefore it should be the limit value chosen for the in vitro test. However this should not be taken to be the safe limit, which should be set at 6.7microgram/10cm2/minute.
Regarding the way of achieving that limit the rapporteur stated that a method which can guarantee non aggressive physiological-like conditions is highly desirable, which is not the case with the LGC stringent method. Furthermore, it should be necessary to ascertain the integrity of the material tested to ensure that it is migration what is being measured.
Another important point considered by the rapporteur was the possibility of using a correction factor to extrapolate from an in vitro study to in vivo conditions. This was more important due to the fact that the artificial saliva contained no proteins. Apparently the presence of proteins in the saliva can dramatically reduce the migration levels measured both in the in vivo test and in the in vitro ones. Consequently two different correction factors should be used: one to extrapolate from artificial to natural saliva containing proteins and a second one to extrapolate to the in vivo worst case of 9microgram/10cm2/min. It was explained that different correction factors should be established for the different compounds and this would only be possible after in vivo studies of these compounds.
Further explanations were requested about the number of laboratories needed for considering the acceptability of the method. The number of 15 laboratories implied in the validation process is based on international guidelines. Therefore a sentence in parenthesis was added to the draft opinion stating this. It was agreed that the method would be acceptable if 8 out of those 15 laboratories provide acceptable results.
Some CSTEE members asked for more and better in vivo studies, given that only one has been produced until now, in order for, for instance to include the role of particles extracted from the product. It was also suggested to ask for a better statistical stability of possible future in vivo studies. A representative from the JRC-ECB pointed out the difficulty to perform such studies and the difficulty in using animals in such tests.
A representative from Environment DG reminded the CSTEE about the context of the procedure. The validation of one or more testing methods for phthalate migration is a possible way out of a situation which is blocked politically. The possibility to extrapolate the results of the method on DINP to other phthalates was considered also.
After a thorough consideration of the opinion, page by page, and the introduction of some minor comments from different committee members, it was finally adopted by the CSTEE.
6. Endocrine disrupting chemicals:
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) - presentation and discussion of status report
Two working group meetings had taken place during the summer months: one on the 18 of August and another one immediately before the plenary. Drafts were prepared after each of them and distributed to the CSTEE members. The WG chairman and the rapporteur presented the last draft and compared it with the previous one. The main difference between these drafts was, apart from some minor points, the inclusion of 13 conclusions at the end of the document.
The WG chairman informed the committee about a discussion which was raised at the WG meeting in the morning on the eventual inclusion of plant protection products (PPP) in the priority list of substances for further evaluation. Some WG members had proposed to state clearly the strong opposition of the committee to that inclusion, given that they are being regulated under a different legal framework. The general opinion of the WG was that PPP should be considered together with the existing respective regulations.
A representative from Environment DG expressed concern about point 6 of the specific conclusions. In her opinion no substances were excluded from the exercise because of lack of scientific data. She also stressed that at the moment the list was not a list of substances with endocrine disruption effects but a list of substances for further evaluation. Some CSTEE members insisted on the fact that the importance of chemicals with data gaps had not been properly addressed in the report and on the validity of the specific conclusion 6.
The draft opinion was discussed and CSTEE members made some comments. After the inclusion of the changes described above the committee unanimously adopted the opinion.
7. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) 1,4 Dioxane
b) 1,4 Dichlorobenzene
c) 4-Chloro-2-Methylphenol
No drafts were ready for adoption on these substances. The rapporteur informed that they would most probably be ready for the 18th plenary, on the 9 October 2000.
B. State of play regarding other substances evaluated under the ESR
A representative from the JRC-ECB informed about new risk assessment reports which were about to be sent to the CSTEE secretariat, on the following chemicals: Acetonitrile, Methacrylic acid, Acrylonitrile and Anisidine.
8. The use of exposure data in risk assessments - progress report
The chairman of the working group informed the Committee on recent developments of the issue. A meeting had taken place in August and a first draft of chapters 1 and 2 was expected to be ready for the next one, scheduled for the 18 September.
9. Revision of Chapter 1, lines 412 to 449 of the Technical Notes for Guidance on Data requirements, version 4.3 December 1999, in support of Biocides Directive 98/8/EEC
The responsible CSTEE member for drafting this part of the original CSTEE opinion (4 February 2000) prepared a draft document on the issue. He considered that the changes introduced in the TNG were in conformity with the recommendations made by the CSTEE in its opinion. The committee endorsed his position.
It was agreed that no new opinion was needed to state this and that a reference to the endorsement by the committee of the revision of the document stated in the minutes should be sufficient. A representative from Environment DG considered that solution agreeable.
Therefore the revision of the Chapter 1, lines 412 to 449 of the Technical Notes for Guidance on Data requirements, version 4.3 December 1999, in support of Biocides Directive 98/8/EEC was considered unanimously acceptable by the CSTEE.
10. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - for opinion
The chairman of the working party presented the revision of the draft opinion, which included some comments from a WG meeting which had taken place in August, with some inputs from external experts specifically invited to attend. He explained that the draft could not be considered as a final one since some changes should still be introduced in it: it should rather be considered a pre-final one.
The main modifications vis a vis the previous version were: the introduction of a foreword clarifying the scope of the document, the first complete version of chapter 3 (yet to be discussed by the working group), some important changes in chapters 2 and 9, and, last but not least, the first draft of the final chapter, "Conclusions and Recommendations", probably, he said, the most important part of the whole document.
The time table for the approval of the opinion was quite tight, since a meeting in the ECB on classification and labelling would take place late in September and for that meeting some first conclusions of the document should be presented by the WG chairman.
The CSTEE chairman encouraged all committee members to send written comments to the WG chairman, to be considered in the final draft of the opinion, which should be ready for the October plenary meeting.
A question was raised, regarding the definition of "Hazard Identification" in page 33 of the draft, on whether the terminology and the process was the same for ecotoxicology and for human health toxicology. It was explained that there was an error in the term being defined, which should rather be "Hazard assessment" instead of "Hazard identification". One WG member stressed the fact that although the process and the terminology are similar in human health and ecotoxicology, the aim is different in both in that, while in human health it is to protect the individual, in ecotoxicology it is the protection of the ecosystem or the species which is aimed for.
A representative from JRC expressed their gratefulness to the WG members for the work they had done and considered the document to be useful both for the Classification and Labelling group and for the one revising the TGD.
11. Programme of procedures for the assessment of risks to health and the environment from cadmium in fertilisers - progress report/opinion
The Chairman of the working party and rapporteur for the opinion presented the draft. Some points of concern about the document had been considered by the working party, the most important being that there seems to be no practical available means to validate the calculations, algorithms and equations proposed in the report, since no real data appears to exist for most of them. Another concern of the working group was the fact that the report was a mixture of guidelines and background information. Some more specific remarks were made, among them: (i) health effects of Cadmium were not described in the report and should be; (ii) exposure to Cadmium through drinking water was almost not addressed; (iii) variation between European populations was not properly considered, etc. Therefore, the opinion of the WG was that the report needs to be improved before being fully acceptable to the CSTEE. The WG chairman also explained that a representative from Enterprise DG had provided the CSTEE chairman and himself during the plenary with a list of comments on the draft opinion, to be considered before its approval by the Committee.
The points raised by this representative from Enterprise DG related to the Committee's negative judgement on the report. Attention was drawn in particular to the very tight time schedule and some other restrictions on the actual situation on Europe, faced to the "ideal" scientific situation demanded by the committee (e.g. on the absence of a harmonised data base on Cadmium in the different Member States).
The view of the CSTEE members was that their brief is always to provide a scientific opinion. Therefore the committee has to stick to the scientific aspects of the issues, and other aspects of the problem are not within their mandate. The risk management is, of course, subject to those aspects but the risk assessment, in which it has to be based, should never be influenced by them.
Since the Committee refused to accept as a room document the list of comments presented by this representative from Enterprise DG, he orally presented before the plenary some of his comments. The CSTEE chairman considered that the members of the WG had properly addressed all those points at the meeting they had the day before the plenary and therefore no further discussion was needed. Specifically regarding the comments on chapter 3, the Committee stressed the fact that the question asked to the CSTEE was on the advisability of using the report as a basis for a risk assessment, not for an exposure assessment: consequently human health effects should have been considered and that was exactly what the opinion states. If the report's scope was that of covering only the algorithms for exposure assessment of Cadmium that should be the title of the report, not the current one, which apparently covers the whole risk assessment of the chemical. It was suggested to add a sentence to the opinion clarifying this.
The Committee realised that some of its conclusions may have been influenced by its initial understanding that the report was intended to be useful for a full risk assessment, however, the brief given to the consultant may have lead them to produce a report not totally in line with such an objective. The issue was raised as to whether the questions asked of the Committee had been the most appropriate ones.
The opinion was unanimously adopted pending some editorial aspects to be made by the rapporteur.
12. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
The CSTEE secretary informed the Committee of a possible future opinion request from Environment DG on contaminants in food. Further clarification on this was deemed necessary.
Dr. Tarazona informed the Committee on the follow up of the Water Framework Directive issue. New documents had been submitted by Environment DG and one or two more meetings of the working party should take place. Given the relevance of statistical approaches in the documents that had been submitted, the inclusion of an additional expert was deemed necessary.
A CSTEE member asked on whether or not the list of priority substances in the Water Framework Directive had been decided. No news on that issue could be provided, either by the WG chairman or by the CSTEE secretary, nevertheless, the later informed that a meeting of stakeholders was due to take place in September.
13. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
No other feedback was provided, apart from the information already given by a representative from Enterprise DG on Phthalates migration tests (see point 5 above).
14. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
The CSTEE chairman updated the Committee on the workings of the SSC. Regarding BSE he informed about a study on the disease being dormant in certain animal species, which had been carried out by the UK. With regard to harmonisation of risk assessment a first draft was likely to be presented to the SSC at its next meeting and a final draft to be presented in October. He asked CSTEE members to comment on it, due to the close involvement of the Committee in this area.
He also informed that the document on the shortage of experts on Toxicology, Ecotoxicology and Epidemiology, issue started at the CSTEE and afterwards transferred to the SSC, had been already approved by the SSC and passed to the Commission services for their response.
Another item on the SSC's agenda was the elaboration of a paper on emerging issues, addressing the health issues of the future, how to pick them up earlier and how to manage them.
15. Arrangements for the next meeting(s) of the CSTEE (October and November 2000)
The CSTEE confirmed the dates for the last two meetings of the current committee: the next one on the 9 October and the last one on the 8 November, back to back with the first meeting of the new CSTEE, on the 9 November.
16. Any other business
Taking into account some problems raised by different CSTEE members during the discussions of Risk Assessment Reports under regulation 793/93, the committee decided to set up a working party to prepare a draft document on the issue of margins of safety (MOS).
Professor Peter Calow asked about the state of the revision by Environment DG of the document on the future strategy for chemicals.
- DRAFT AGENDA (rev. 1)-
1. Welcoming address, apologies for absence and declarations of interest
2. Adoption of the draft agenda
3. Adoption of the draft minutes of the 15th and 16th CSTEE plenary meetings held on the 5th of May and the 19th of June 2000, respectively, in Brussels
4. Methylene chloride and certain Chemicals in Textiles - for opinion
5. Programme for the validation of methodologies to test migration of plasticisers from toys and childcare articles - for opinion
6. Endocrine disrupting chemicals:
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) - presentation and discussion of status report
7. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) 1,4 Dioxane
b) 1,4 Dichlorobenzene
c) 4-Chloro-2-Methylphenol
B. State of play regarding other substances evaluated under the ESR
8. The use of exposure data in risk assessments - progress report
9. Revision of Chapter 1, lines 412 to 449 of the Technical Notes for Guidance on Data requirements, version 4.3 December 1999, in support of Biocides Directive 98/8/EEC
10. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - for opinion
11. Programme of procedures for the assessment of risks to health and the environment from cadmium in fertilisers - progress report/opinion
12. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
13. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
14. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
15. Arrangements for the next meeting(s) of the CSTEE (October and November 2000)
16. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James BRIDGES, Prof. Peter CALOW, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Bo O. JANSSON, Prof. Soterios A. KYRTOKOPOULOS, 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. Katarina VICTORIN, Prof. M. VIGHI, Prof. Joseph G. VOS, Prof. Dr. Robert WENNIG.
Ad-hoc experts:
Dr. S. RASTOGI.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE, Mrs. Mercedes de SOLÀ.
ENTERPRISE DG:
Mr. Joachim EHRENBERG, Mrs. Lena PERENIUS.
ENVIRONMENT DG:
Mr. Walter CORTELLINI, Mrs. Kathryn TIERNEY.
JOINT RESEARCH CENTRE:
Mrs. Elke ANKLAM, Mr. Toralf KALAND.
