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Directorate-General for Health and Food Safety
1. Welcoming address, apologies for
absence, declarations of interest
Apologies were received from Professor Greim.
Regarding the issue of declarations of interest the CSTEE chairman reminded committee members that, for their reference, they might want to know that they could consider declarations of interest as being of possibly four types, i.e.: (i) personal and specific; (ii) personal and non-specific; (iii) non-personal and specific and (iv) non-personal and non-specific.
No declaration of interest was expressed by any CSTEE member.
2. Adoption of the draft agenda
The agenda was adopted with the only remark that, due to the early leaving of Professor Dybing, some points in which he was more directly involved should be discussed during the morning session.
A CSTEE member asked for a discussion on some aspects of the working procedures of the Committee that in his view, should cover a work plan and the setting of priorities. It was decided to devote part of the next CSTEE plenary meeting to discussing this topic.
3. Approval of the draft minutes of the 20th CSTEE plenary meeting
With some minor editorial corrections the minutes of the 20th CSTEE plenary meeting were approved.
4. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) Acrylonitrile
In the absence of the rapporteur, the draft opinion was presented by another CSTEE member. A question was raised on a sentence of the draft referring to the possible systemic effects of the substance under 20 ppm. Further consultation of the rapporteur was deemed necessary as it was not possible to find a specific reference to liver necrosis and increased haematopoesis at 20 ppm. The adoption of the draft opinion remained pending clarification on this point.
b) Anisidine
The draft opinion was adopted with a very minor change in the draft proposed by the rapporteur.
c) Acrylamide
A first draft was presented by the CSTEE rapporteur for this substance but with some comments yet missing relative to the environmental risk assessment. Due to the late availability of the text, the CSTEE agreed that it should evaluated in more detail and discussed at the occasion of the next plenary. Some committee members informed that they would be sending comments. The rapporteur agreed to prepare a new draft in the light of those. A cross-check with the CSTEE opinion on Acrylonitrile was deemed convenient to ensure consistency.
d) Methyl methacrylate
The CSTEE rapporteur for this substance presented the draft opinion. The CSTEE secretariat informed that Industry had sent, very late in the process, new data requesting that it be considered before the CSTEE opinion was adopted. The rapporteur analysed the new set of documentation before the meeting started but requested that he be given time to consider it in more detail. The CSTEE secretariat agreed to send this new data to the committee for their consideration. The rapporteur agreed to, if necessary, change the draft text in case he would deem this to be justified in which case the changes would be circulated to the CSTEE for comments. It was also agreed that, should this not be the case, the draft opinion presented at this 21st plenary should be considered adopted.
The ECB representative informed that in all likelihood the new set of data mentioned above should have had been considered by the ECB 'technical meeting' as discussions on this substance spanned over several meetings and Industry is invited to comment and contribute to the discussions as a matter of course.
B. Status report/opinion (Human health) on:
a) Nonylphenol and nonylphenol (branched) (human health only)
A draft opinion was presented by the rapporteur. In the light of the comments made he agreed to produce a new one in view of a possible adoption at the occasion of the next CSTEE plenary after the committee has been given an opportunity to consider it.
C. State of play regarding other substances evaluated under the ESR
The CSTEE asked what Regulation 793/93 substances were Commission's priorities for the short-term and for which a CSTEE opinion was more urgently needed. A representative from the ECB informed that the top priority one for the time being was MTBE. The CSTEE rapporteur for this substance promised to have a draft ready for the next CSTEE plenary in April 2001. The ECB representative also informed that the substances Acrylonitrile and Nonylphenol were also priorities as in principle all should be the object of an analysis during a risk reduction strategy meeting scheduled for late March 2001.
5. The use of exposure data in risk assessments - progress report
The chairman of the working group presented the latest progresses made. Some CSTEE members raised some points of concern, among them: (i) the document only refers to industrial chemicals and therefore a CSTEE member proposed to change the title into "The use of exposure data in risk assessment of industrial chemicals; (ii) a reference should be made to the Long Range Investigation (LRI) program, both of which were accepted.
The WG chairman agreed to prepare a new draft with a summary. The CSTEE would then have a chance of another round of comments. When the document will finally be agreed by the CSTEE it will be put onto the DG SANCO web-site for comments for a period of circa a month. After such comments are received they will be considered by the CSTEE at the occasion of the April 2001 CSTEE plenary meeting on 24/25 of that month in view of introducing any pertinent changes to it.
6. Proposed EU Water Framework Directive - Development of a specification for the intercalibration of biological monitoring methods - Final Draft (European Commission Directorate General XI), Report No: CO 4751/1 - October 1999 - for opinion
The chairman of the working group presented a draft opinion on the report (note: the report is a second part of the report Technical Specifications for Monitoring of Ecological Status of Surface Waters, NERI J. Nr 171/2-0079; it is not a separate study to be reviewed as such but rather to be seen as further specification on possibilities of ensuring comparability of monitoring results across regions and river basins).
The draft had been developed during the working group meeting that had taken place on 12 January 2001.
A CSTEE member expressed some concern about the issue of the election of the sites for the inter-calibration exercise, in his opinion and given the state of development of the legislative process, the opinion which the CSTEE was asked to provide might not be very useful, especially considering that two of the reports seemed to be quite outdated. Given the shortcomings found in the report a CSTEE member suggested that, in the future, it may be convenient to consult the CSTEE early in the process rather than late.
A representative from Environment DG agreed that the reports were not really up to date, but he considered nevertheless that the comments from the CSTEE came very timely, due to the ongoing developments in the process. He also expressed his gratefulness to the committee for them, and pointed out that they are consistent with previous CSTEE opinions on the subject. He presented the possible future follow up of the implementation of the directive.
With the usual editorial corrections the draft opinion was adopted as the CSTEE opinion.
7. Margins of safety - for opinion
It was initially pointed out that MOS was being considered as part of an effort to bring CSTEE opinions on the RARs produced under Regulation 793/93 into a more systematic framework where the CSTEE opinions would be more consistent vis à vis each other, regardless of the chemical, M. State rapporteur, CSTEE rapporteur, etc.
A CSTEE 'MOS' working group meeting had taken on 9 January 2001 and a new draft was produced by the CSTEE rapporteur. The new draft addressed terminology issues such as the possible use of the term 'concern' after considering options such as the qualifiers 'limited' and 'serious'. After hearing some committee members' comments they were initially changed into 'some' and 'clear' in order to avoid confusion with the Commission's interpretation of 'serious concern'. Alternatives such as 'less than protective' or 'not fully protective' were also considered for denoting a low MOS.
The draft also intended to be set in the context of the SSC´s report on 'Harmonisation of risk assessment procedures' and the new WHO/IPCS document 'Guidance document for the use of data in development of chemical-specific adjustment factors (CSAF) for inter-species differences and human variability in dose/concentration response assessment'.
The probabilistic methods in human and environmental risk assessment was also an area where it was proposed that the CSTEE should be proactive.
The CSTEE rapporteur agreed to produce a new draft in the light of comments made and/or yet to sent by other committee members. It is understood that this document is to be considered an 'evolving' paper, to be changes as and when data and developments so dictate.
8. Evaluation of sludge treatments for pathogen reduction - progress report
The working group chairman presented the issue. The report was considered to be very comprehensive but with significant weaknesses. A first draft was expected to be ready before the 22nd plenary of the Committee (scheduled for 6-7 March 2001) and a final one for adoption by April (24 and 25). A working group meeting will take place on 5 March 2001, on the eve of the next plenary, in view of putting, if possible, the finishing touches in the draft to be presented at the March 2001 CSTEE plenary.
The need a microbiologist expert in to the working group was expressed. Several committee members made proposals to fill in such a gap. The CSTEE secretariat is to follow this up and keep the CSTEE informed of any firm proposals that will be sent to it and will establish the necessary contacts with the experts indicated. It was also mentioned that expertise in the field of 'processing techniques' would be a useful input into the activities of the working group.
9. (i) Carcinogenic and non-carcinogenic effects of Cadmium, Nickel and Arsenic in ambient air - progress report
(ii) Derivation of limit values for PAH in ambient air - progress report
The CSTEE secretary presented the issue. He reminded the Committee about the members of the working group and the rapporteurs for each of the substances under discussion.
Representatives from Environment DG provided clarification on some particular points of the opinion request, as well as on their wished time schedule for the adoption of the opinion; they would like it to be adopted by the CSTEE March plenary, if possible.
A CSTEE member asked on whether the environmental aspects of the question should be addressed. The reply from Environment DG officials was that for the time being only human health would be covered.
A meeting of the CSTEE working group responsible for this opinion request was in the meantime scheduled for 5 March 2001.
10. Health effects of Radio Frequency and Electromagnetic fields - progress report
The CSTEE secretary informed that for the time being and due to the considerable workload of the Committee, the starting of the CSTEE's involvement on this subject had to be postponed. In any case the intention is to start this activity soon. It was confirmed that the contribution of Profs. Silano and Klein from the SSC had been ensured.
11. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission
A. Assessment of the risks to human health posed by azo colorants in toys, writing inks and paper products, and analysis of the advantages and drawbacks of restrictions on their marketing and use - LGC report ETD/99/502495
The CSTEE rapporteur responsible for this opinion request expressed the view that, from a first look at the report, it seemed to be a good one. No great difficulties were expected to draft the opinion. He would inform the committee and its secretariat about the need for a working group meeting and would prepare a first draft at a forthcoming opportunity.
B. The availability of substitutes for soft PVC containing phthalates in certain toys and childcare articles - RPA final report ETD/99/502498
The rapporteur for this opinion informed the committee about his first impressions on the report presented for peer review; he noted in particular the lack of information on exposure.
One CSTEE member insisted on the need to consider the environmental aspects of the issue. Another one volunteered to be a new member of the WG.
The rapporteur agreed to prepare a draft at the earliest opportunity. He would also inform the CSTEE and its secretariat about the need to organise a working group meeting.
The Secretary of the Committee reminded the members on two aspects: the fact that the CSTEE should expect to receive relatively soon the RARs (under Regulation 793/93) on other phthalates, particularly DINP, and the ongoing validation exercise, under the co-ordination of the JRC, of a migration test for DINP.
Some committee members expressed the view that it would be preferable, if possible, that all these issues be dealt with by the committee in parallel given the obvious links between them.
A representative from the ECB informed the committee that it was expected that most phthalates RARs should be sent to evaluation by the CSTEE during February. The one on DBP had been already sent and DEHP and DINP should be sent soon.
C. Other
A representative from Environment DG presented a new opinion request on the issue of the Bathing water directive, for which a draft proposal was about to be implemented.
After the presentation by the ENV DG representative some CSTEE members requested more clarification on some aspects of the issue, e.g.: (i) enteroviruses, (ii) water quality in small lakes, (iii) chemical contamination of water, covered in the project through ecological quality standards, (iv) whether or not there is a general study on pathogens, used for the election of some of them in the project, etc.
The representative from Environment DG informed the committee about a meeting which would take place on 24-26 April on the issue and expressed the wish that a CSTEE opinion be adopted on the questions presented before that date, if possible.
A tentative working party to deal with the issue was set up and a chairman/rapporteur chosen.
12. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
No Commission service covered by this agenda item was present to provide feedback, however the CSTEE secretary informed the committee that with reference to the CSTEE opinion on the Danish notification 98/595/DK on lead, adopted by the committee at its 15th plenary meeting on 5 May 2000, he had been informed by DG Enterprise that a ban on lead was about to be implemented by the Danish authorities; no other information on this issue was however available.
13. Update on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
The CSTEE chairman provided a brief overview on the latest SSC's discussions, namely on the subject of BSE.
One Committee member asked him whether the endocrine disrupting chemicals issue had been presented to the SSC for consideration. The CSTEE chairman replied that it was scheduled for the next SSC plenary.
14. Arrangements for the next (22nd) plenary meeting of the CSTEE
The CSTEE secretary informed that bearing in mind the growing number of subjects submitted to the CSTEE for opinion, at least a one and a half-day meeting would be necessary for the next CSTEE plenary. The 22nd plenary meeting of the CSTEE was scheduled to take place in Brussels on 6 March (whole day) and 7 March (morning session only) 2001.
15. Any other business
The CSTEE secretary reminded committee members that, in line with a request made some time before, the CSTEE secretariat was still waiting that each committee member send to the secretariat a two-page CV for publication in the DG SANCO web-site.
The secretariat informed the committee about the impending departure of Mr. Crespo-Arce. The Committee thanked him for his collaboration during his term in the secretariat.
- DRAFT AGENDA -
1. Welcoming address, apologies for absence, declarations of interest
2. Adoption of the draft agenda
3. Approval of the draft minutes of the 20th CSTEE plenary meeting
4. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) Acrylonitrile
b) Anisidine
c) Acrylamide
d) Methyl methacrylate
B. Status report/opinion (Human health) on:
a) Nonylphenol and nonylphenol (branched) (human health only)
C. State of play regarding other substances evaluated under the ESR
5. The use of exposure data in risk assessments - progress report
6. Proposed EU Water Framework Directive - Development of a specification for the intercalibration of biological monitoring methods - Final Draft (European Commission Directorate General XI), Report No: CO 4751/1 - October 1999 - for opinion
7. Margins of safety - for opinion
8. Evaluation of sludge treatments for pathogen reduction - progress report
9. (i) Carcinogenic and non-carcinogenic effects of Cadmium, Nickel and Arsenic in ambient air - progress report
(ii) Derivation of limit values for PAH in ambient air - progress report
10. Health effects of Radio Frequency and Electromagnetic fields - progress report
11. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission
A. Assessment of the risks to human health posed by azo colorants in toys, writing inks and paper products, and analysis of the advantages and drawbacks of restrictions on their marketing and use - LGC report ETD/99/502495
B. The availability of substitutes for soft PVC containing phthalates in certain toys and childcare articles - RPA final report ETD/99/502498
C. Other
12. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
13. Update on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
14. Arrangements for the next (22nd) plenary meeting of the CSTEE
15. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James BRIDGES, Prof. Peter CALOW, Prof. Giorgio CANTELLI FORTI, Prof. Wolfgang DEKANT, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Colin JANSSEN, Prof. Bo O. JANSSON, Prof. Soterios A. KYRTOPOULOS, Dr. Claude LAMBRÉ, Prof. Amadeu SOARES, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, Prof. Janneche UTNE-SKÅRE, Prof. Cornelis Van LEEUWEN, Prof. Katarina VICTORIN, Prof. Marco VIGHI, Prof. Joseph G. VOS.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE.
ENVIRONMENT DG:
Mrs. Maria José CARROQUINO, Mr. Bert van MAELE, Mr. Brian BRANGAN, Mr. Asger OLSEN.
RESEARCH DG:
Mr. Jean-François JUNGER.
EMPLOYMENT AND SOCIAL AFFAIRS DG:
Mrs. Kyriakoula ZIEGLER-SKYLAKAKIS.
JOINT RESEARCH CENTRE:
Mrs. Sharon MUNN.
Apologies were received from Professor Greim.
Regarding the issue of declarations of interest the CSTEE chairman reminded committee members that, for their reference, they might want to know that they could consider declarations of interest as being of possibly four types, i.e.: (i) personal and specific; (ii) personal and non-specific; (iii) non-personal and specific and (iv) non-personal and non-specific.
No declaration of interest was expressed by any CSTEE member.
2. Adoption of the draft agenda
The agenda was adopted with the only remark that, due to the early leaving of Professor Dybing, some points in which he was more directly involved should be discussed during the morning session.
A CSTEE member asked for a discussion on some aspects of the working procedures of the Committee that in his view, should cover a work plan and the setting of priorities. It was decided to devote part of the next CSTEE plenary meeting to discussing this topic.
3. Approval of the draft minutes of the 20th CSTEE plenary meeting
With some minor editorial corrections the minutes of the 20th CSTEE plenary meeting were approved.
4. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) Acrylonitrile
In the absence of the rapporteur, the draft opinion was presented by another CSTEE member. A question was raised on a sentence of the draft referring to the possible systemic effects of the substance under 20 ppm. Further consultation of the rapporteur was deemed necessary as it was not possible to find a specific reference to liver necrosis and increased haematopoesis at 20 ppm. The adoption of the draft opinion remained pending clarification on this point.
b) Anisidine
The draft opinion was adopted with a very minor change in the draft proposed by the rapporteur.
c) Acrylamide
A first draft was presented by the CSTEE rapporteur for this substance but with some comments yet missing relative to the environmental risk assessment. Due to the late availability of the text, the CSTEE agreed that it should evaluated in more detail and discussed at the occasion of the next plenary. Some committee members informed that they would be sending comments. The rapporteur agreed to prepare a new draft in the light of those. A cross-check with the CSTEE opinion on Acrylonitrile was deemed convenient to ensure consistency.
d) Methyl methacrylate
The CSTEE rapporteur for this substance presented the draft opinion. The CSTEE secretariat informed that Industry had sent, very late in the process, new data requesting that it be considered before the CSTEE opinion was adopted. The rapporteur analysed the new set of documentation before the meeting started but requested that he be given time to consider it in more detail. The CSTEE secretariat agreed to send this new data to the committee for their consideration. The rapporteur agreed to, if necessary, change the draft text in case he would deem this to be justified in which case the changes would be circulated to the CSTEE for comments. It was also agreed that, should this not be the case, the draft opinion presented at this 21st plenary should be considered adopted.
The ECB representative informed that in all likelihood the new set of data mentioned above should have had been considered by the ECB 'technical meeting' as discussions on this substance spanned over several meetings and Industry is invited to comment and contribute to the discussions as a matter of course.
B. Status report/opinion (Human health) on:
a) Nonylphenol and nonylphenol (branched) (human health only)
A draft opinion was presented by the rapporteur. In the light of the comments made he agreed to produce a new one in view of a possible adoption at the occasion of the next CSTEE plenary after the committee has been given an opportunity to consider it.
C. State of play regarding other substances evaluated under the ESR
The CSTEE asked what Regulation 793/93 substances were Commission's priorities for the short-term and for which a CSTEE opinion was more urgently needed. A representative from the ECB informed that the top priority one for the time being was MTBE. The CSTEE rapporteur for this substance promised to have a draft ready for the next CSTEE plenary in April 2001. The ECB representative also informed that the substances Acrylonitrile and Nonylphenol were also priorities as in principle all should be the object of an analysis during a risk reduction strategy meeting scheduled for late March 2001.
5. The use of exposure data in risk assessments - progress report
The chairman of the working group presented the latest progresses made. Some CSTEE members raised some points of concern, among them: (i) the document only refers to industrial chemicals and therefore a CSTEE member proposed to change the title into "The use of exposure data in risk assessment of industrial chemicals; (ii) a reference should be made to the Long Range Investigation (LRI) program, both of which were accepted.
The WG chairman agreed to prepare a new draft with a summary. The CSTEE would then have a chance of another round of comments. When the document will finally be agreed by the CSTEE it will be put onto the DG SANCO web-site for comments for a period of circa a month. After such comments are received they will be considered by the CSTEE at the occasion of the April 2001 CSTEE plenary meeting on 24/25 of that month in view of introducing any pertinent changes to it.
6. Proposed EU Water Framework Directive - Development of a specification for the intercalibration of biological monitoring methods - Final Draft (European Commission Directorate General XI), Report No: CO 4751/1 - October 1999 - for opinion
The chairman of the working group presented a draft opinion on the report (note: the report is a second part of the report Technical Specifications for Monitoring of Ecological Status of Surface Waters, NERI J. Nr 171/2-0079; it is not a separate study to be reviewed as such but rather to be seen as further specification on possibilities of ensuring comparability of monitoring results across regions and river basins).
The draft had been developed during the working group meeting that had taken place on 12 January 2001.
A CSTEE member expressed some concern about the issue of the election of the sites for the inter-calibration exercise, in his opinion and given the state of development of the legislative process, the opinion which the CSTEE was asked to provide might not be very useful, especially considering that two of the reports seemed to be quite outdated. Given the shortcomings found in the report a CSTEE member suggested that, in the future, it may be convenient to consult the CSTEE early in the process rather than late.
A representative from Environment DG agreed that the reports were not really up to date, but he considered nevertheless that the comments from the CSTEE came very timely, due to the ongoing developments in the process. He also expressed his gratefulness to the committee for them, and pointed out that they are consistent with previous CSTEE opinions on the subject. He presented the possible future follow up of the implementation of the directive.
With the usual editorial corrections the draft opinion was adopted as the CSTEE opinion.
7. Margins of safety - for opinion
It was initially pointed out that MOS was being considered as part of an effort to bring CSTEE opinions on the RARs produced under Regulation 793/93 into a more systematic framework where the CSTEE opinions would be more consistent vis à vis each other, regardless of the chemical, M. State rapporteur, CSTEE rapporteur, etc.
A CSTEE 'MOS' working group meeting had taken on 9 January 2001 and a new draft was produced by the CSTEE rapporteur. The new draft addressed terminology issues such as the possible use of the term 'concern' after considering options such as the qualifiers 'limited' and 'serious'. After hearing some committee members' comments they were initially changed into 'some' and 'clear' in order to avoid confusion with the Commission's interpretation of 'serious concern'. Alternatives such as 'less than protective' or 'not fully protective' were also considered for denoting a low MOS.
The draft also intended to be set in the context of the SSC´s report on 'Harmonisation of risk assessment procedures' and the new WHO/IPCS document 'Guidance document for the use of data in development of chemical-specific adjustment factors (CSAF) for inter-species differences and human variability in dose/concentration response assessment'.
The probabilistic methods in human and environmental risk assessment was also an area where it was proposed that the CSTEE should be proactive.
The CSTEE rapporteur agreed to produce a new draft in the light of comments made and/or yet to sent by other committee members. It is understood that this document is to be considered an 'evolving' paper, to be changes as and when data and developments so dictate.
8. Evaluation of sludge treatments for pathogen reduction - progress report
The working group chairman presented the issue. The report was considered to be very comprehensive but with significant weaknesses. A first draft was expected to be ready before the 22nd plenary of the Committee (scheduled for 6-7 March 2001) and a final one for adoption by April (24 and 25). A working group meeting will take place on 5 March 2001, on the eve of the next plenary, in view of putting, if possible, the finishing touches in the draft to be presented at the March 2001 CSTEE plenary.
The need a microbiologist expert in to the working group was expressed. Several committee members made proposals to fill in such a gap. The CSTEE secretariat is to follow this up and keep the CSTEE informed of any firm proposals that will be sent to it and will establish the necessary contacts with the experts indicated. It was also mentioned that expertise in the field of 'processing techniques' would be a useful input into the activities of the working group.
9. (i) Carcinogenic and non-carcinogenic effects of Cadmium, Nickel and Arsenic in ambient air - progress report
(ii) Derivation of limit values for PAH in ambient air - progress report
The CSTEE secretary presented the issue. He reminded the Committee about the members of the working group and the rapporteurs for each of the substances under discussion.
Representatives from Environment DG provided clarification on some particular points of the opinion request, as well as on their wished time schedule for the adoption of the opinion; they would like it to be adopted by the CSTEE March plenary, if possible.
A CSTEE member asked on whether the environmental aspects of the question should be addressed. The reply from Environment DG officials was that for the time being only human health would be covered.
A meeting of the CSTEE working group responsible for this opinion request was in the meantime scheduled for 5 March 2001.
10. Health effects of Radio Frequency and Electromagnetic fields - progress report
The CSTEE secretary informed that for the time being and due to the considerable workload of the Committee, the starting of the CSTEE's involvement on this subject had to be postponed. In any case the intention is to start this activity soon. It was confirmed that the contribution of Profs. Silano and Klein from the SSC had been ensured.
11. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission
A. Assessment of the risks to human health posed by azo colorants in toys, writing inks and paper products, and analysis of the advantages and drawbacks of restrictions on their marketing and use - LGC report ETD/99/502495
The CSTEE rapporteur responsible for this opinion request expressed the view that, from a first look at the report, it seemed to be a good one. No great difficulties were expected to draft the opinion. He would inform the committee and its secretariat about the need for a working group meeting and would prepare a first draft at a forthcoming opportunity.
B. The availability of substitutes for soft PVC containing phthalates in certain toys and childcare articles - RPA final report ETD/99/502498
The rapporteur for this opinion informed the committee about his first impressions on the report presented for peer review; he noted in particular the lack of information on exposure.
One CSTEE member insisted on the need to consider the environmental aspects of the issue. Another one volunteered to be a new member of the WG.
The rapporteur agreed to prepare a draft at the earliest opportunity. He would also inform the CSTEE and its secretariat about the need to organise a working group meeting.
The Secretary of the Committee reminded the members on two aspects: the fact that the CSTEE should expect to receive relatively soon the RARs (under Regulation 793/93) on other phthalates, particularly DINP, and the ongoing validation exercise, under the co-ordination of the JRC, of a migration test for DINP.
Some committee members expressed the view that it would be preferable, if possible, that all these issues be dealt with by the committee in parallel given the obvious links between them.
A representative from the ECB informed the committee that it was expected that most phthalates RARs should be sent to evaluation by the CSTEE during February. The one on DBP had been already sent and DEHP and DINP should be sent soon.
C. Other
A representative from Environment DG presented a new opinion request on the issue of the Bathing water directive, for which a draft proposal was about to be implemented.
After the presentation by the ENV DG representative some CSTEE members requested more clarification on some aspects of the issue, e.g.: (i) enteroviruses, (ii) water quality in small lakes, (iii) chemical contamination of water, covered in the project through ecological quality standards, (iv) whether or not there is a general study on pathogens, used for the election of some of them in the project, etc.
The representative from Environment DG informed the committee about a meeting which would take place on 24-26 April on the issue and expressed the wish that a CSTEE opinion be adopted on the questions presented before that date, if possible.
A tentative working party to deal with the issue was set up and a chairman/rapporteur chosen.
12. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
No Commission service covered by this agenda item was present to provide feedback, however the CSTEE secretary informed the committee that with reference to the CSTEE opinion on the Danish notification 98/595/DK on lead, adopted by the committee at its 15th plenary meeting on 5 May 2000, he had been informed by DG Enterprise that a ban on lead was about to be implemented by the Danish authorities; no other information on this issue was however available.
13. Update on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
The CSTEE chairman provided a brief overview on the latest SSC's discussions, namely on the subject of BSE.
One Committee member asked him whether the endocrine disrupting chemicals issue had been presented to the SSC for consideration. The CSTEE chairman replied that it was scheduled for the next SSC plenary.
14. Arrangements for the next (22nd) plenary meeting of the CSTEE
The CSTEE secretary informed that bearing in mind the growing number of subjects submitted to the CSTEE for opinion, at least a one and a half-day meeting would be necessary for the next CSTEE plenary. The 22nd plenary meeting of the CSTEE was scheduled to take place in Brussels on 6 March (whole day) and 7 March (morning session only) 2001.
15. Any other business
The CSTEE secretary reminded committee members that, in line with a request made some time before, the CSTEE secretariat was still waiting that each committee member send to the secretariat a two-page CV for publication in the DG SANCO web-site.
The secretariat informed the committee about the impending departure of Mr. Crespo-Arce. The Committee thanked him for his collaboration during his term in the secretariat.
- DRAFT AGENDA -
1. Welcoming address, apologies for absence, declarations of interest
2. Adoption of the draft agenda
3. Approval of the draft minutes of the 20th CSTEE plenary meeting
4. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) Acrylonitrile
b) Anisidine
c) Acrylamide
d) Methyl methacrylate
B. Status report/opinion (Human health) on:
a) Nonylphenol and nonylphenol (branched) (human health only)
C. State of play regarding other substances evaluated under the ESR
5. The use of exposure data in risk assessments - progress report
6. Proposed EU Water Framework Directive - Development of a specification for the intercalibration of biological monitoring methods - Final Draft (European Commission Directorate General XI), Report No: CO 4751/1 - October 1999 - for opinion
7. Margins of safety - for opinion
8. Evaluation of sludge treatments for pathogen reduction - progress report
9. (i) Carcinogenic and non-carcinogenic effects of Cadmium, Nickel and Arsenic in ambient air - progress report
(ii) Derivation of limit values for PAH in ambient air - progress report
10. Health effects of Radio Frequency and Electromagnetic fields - progress report
11. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission
A. Assessment of the risks to human health posed by azo colorants in toys, writing inks and paper products, and analysis of the advantages and drawbacks of restrictions on their marketing and use - LGC report ETD/99/502495
B. The availability of substitutes for soft PVC containing phthalates in certain toys and childcare articles - RPA final report ETD/99/502498
C. Other
12. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
13. Update on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
14. Arrangements for the next (22nd) plenary meeting of the CSTEE
15. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James BRIDGES, Prof. Peter CALOW, Prof. Giorgio CANTELLI FORTI, Prof. Wolfgang DEKANT, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Colin JANSSEN, Prof. Bo O. JANSSON, Prof. Soterios A. KYRTOPOULOS, Dr. Claude LAMBRÉ, Prof. Amadeu SOARES, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, Prof. Janneche UTNE-SKÅRE, Prof. Cornelis Van LEEUWEN, Prof. Katarina VICTORIN, Prof. Marco VIGHI, Prof. Joseph G. VOS.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE.
ENVIRONMENT DG:
Mrs. Maria José CARROQUINO, Mr. Bert van MAELE, Mr. Brian BRANGAN, Mr. Asger OLSEN.
RESEARCH DG:
Mr. Jean-François JUNGER.
EMPLOYMENT AND SOCIAL AFFAIRS DG:
Mrs. Kyriakoula ZIEGLER-SKYLAKAKIS.
JOINT RESEARCH CENTRE:
Mrs. Sharon MUNN.
