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Directorate-General for Health and Food Safety
Introduction
The meeting started with a general presentation of CSTEE members and Commission staff.
1. Adoption of the draft agenda
The revised draft agenda was adopted.
2. Adoption of the draft minutes of the 1st plenary meeting of the CSTEE held on 17.11.1997 in Brussels
The minutes were adopted.
3. (i) Adoption of the draft minutes of the 1st and 2nd meetings of the ad hoc working group 'Phthalates in toys'
With the agreement of the CSTEE members included in the working group and that of Dr Rastogi (who had given his agreement by e-mail) the minutes of both meetings of the ad hoc working group on 'Phthalates in toys' were adopted (with the correction introduced to point 7 of the latter, where the margin of safety for DEHP was changed from 1.9 to 21).
(ii) Status report - possible adoption of an opinion
The chairman of the 'Phthalates in toys' working group started his presentation by explaining the steps involved in the risk assessment procedure for this agenda item which included (i)exposure assessment, (ii)effects assessment, (iii)risk management and (iv)guidance values for maximum extractable amounts.
The CSTEE were informed about a consensus meeting with consumers that had recently taken place in NL. A study is being carried out with human volunteers and the conclusion of the study is expected by September 98. It will allow for the development of in vitro tests on the effects of phthalates on human health and the respective calibration. It is expected that the study will be concluded by the autumn of 98. This information was welcomed by some of the CSTEE members as it will presumably allow for a better characterisation of the effects of these substances on human health and on the development of an vitro test, something which the 'Phthalates in toys' working group felt was needed in order to better answer the mandate given on the subject of phthalate effects on human health.
It was agreed that the issue of additional exposure still requires further clarification.
Going through the data on each of the individual phthalates the conclusions were that action was probably warranted on DINP because the exposure levels cause concern. As for DEHP it was acknowledged that this is a very prevalent compound, a very widely used plasticiser, and hence action should also be warranted. As for DNOP, in spite of the scarcity of data it should also be the object of action.
Whilst recognising that the terms of reference had not been fully answered, the CSTEE then endorsed a position opinion (Annex III) on the subject of phthalates in toys. The NL study whose results will be available by the autumn will provide the kind of insight that will help the CSTEE address the problem more fully. On the other hand it is expected that the issues of additional exposure can also be better characterised.
4. ERM report on 'Recent assessments of the hazards and risks posed by asbestos and substitute fibres, and recent regulation of fibres world-wide' - for opinion
A draft opinion document was presented. DG III explained the context in which the opinion had been requested. Some Member States have made their preference for an asbestos banning very clear. DG had tried this in 1994 but a consensus had not been possible then because only four M. States were in favour of that option. Since then that number rose to eight with twelve now having made clear that they could accept such a solution.
Given the lack of information available and also that of resources in DG III, they decided to publish a call for proposals and chose ERM to do, not a fundamental research on asbestos, but to assess the available data on the subject. ERM then produced the report the CSTEE was asked to peer review.
A brief description was also made of the situation as regards the legislation still in force (14 categories of chrysotile asbestos have been banned). It was also reminded that, on the issue of workplace concerns, the 1st workplace directive dates from 1983 with an amendment in 1991.
Environmental risks were also commented on by the CSTEE, given the impact on other species where carcinogenicity may be an issue.
The CSTEE required clarification on the urgency of the request: is it due to political pressures or to health incidence rates? Are there data that would allow for a calculation on the number of lives saved for instance?
Other question asked was whether the Commission would be willing to accept some fluctuations in legislation across Member States. This was answered commenting on the so-called article 100 (a), whereby Members States can request for temporary derogation measures if they can prove that circumstances in their territories are such that derogations are warranted.
The chairman of the 'ERM study' working group then spelt out some of the weaknesses which had been highlighted in the draft paper to be the basis of the CSTEE opinion. The general view was that the ERM should have addressed exposure to chrysotile more properly. Para-occupational exposure was also felt to be a problem.
In the end the CSTEE endorsed a text (position plus detailed comments on the ERM study, see Annex IV) as its official opinion. It includes a list of points in the ERM report that the CSTEE would like to see improved upon.
5. Practical implications of the proposed modification to the Water Framework Directive elaborating the technical specifications for the monitoring and presentation of good status for surface water and ground water (Annex V of the Directive) - discussion and formation of a Working Group.
The CSTEE Secretary presented this point. Given the clear implications of water policy on the health of the consumer, it was DG XXIV's view that the CSTEE should be consulted on the general water policy framework.
Subsequently DG XI made a presentation of their approach. In particular they emphasised that there are currently about 25 directives dealing with water from different perspectives. Co-ordinating its various elements are part of the difficulty in managing this work area.
It was pointed out that the focus of changes is currently being put on Annex V. DG XI expressed the view that tight parameters are what should be looked at to quantify water quality. There are chemicals and other criteria, including biota, but NOAEL's may not be a good indicator of water quality.
A fundamental principle of the approach being pursued is that all EU water pools cannot be qualified in the same way. There may be a need for individual normative definitions for lakes, rivers, estuaries and coastal areas.
The terms 'significantly', 'slightly modified' are soft expressions which are probably closer to what is feasible in Europe given the wide variability of water pools across Europe. As part of the process Member States were asked to identify individual ecosystems.
Water pools need to be subdivided in categories. Member States were asked to identify water pools of high and of good status and to characterise which species live there in order to allow for comparability to be possible.
In order to ensure objectivity the directive will also allow Member States to propose their own criteria. DG XI believes this is an improvement vis-à-vis the former fish and shell fish directives.
Finally the time factor pressures were described in order to give the CSTEE an overview of the deadlines involved. The EP Environment committee will likely meet in mid March and in mid April with a view to adopt their position.
Several CSTEE members commented on the task ahead. Most expressed concern with the time pressure factors.
Finally a working group was formed to address an as yet to be defined mandate/terms of reference. In this respect the CSTEE Secretary said that all parties involved would have to participate in the definition. DG XI could produce draft terms of reference but both DG XXIV, the CSTEE and the 'Water framework directive' working group should also be allowed to comment and contribute to defining the terms of reference.
The working group 'Water framework directive' is to be chaired by Dr Tarazona. From within the CSTEE, Profs. Vighi and Greim both accepted to participate. It was agreed that two more external experts should be nominated. The chairman would check and suggest later to the Secretariat two suitable names and alternatives, should the nominees not be able to accept. [Note: within a few days Dr. Tarazona suggested the names of Prof. Calow (UK) and Dr Canton (NL) who, after being contacted by the Secretariat, both accepted their nomination as members of the 'Water framework directive' working group]. Subsequently Dr Lambré from the CSTEE also volunteered to be member of the WG. The CSTEE Secretariat accepted.
6. Endocrine disrupters. Collaboration of the CSTEE
The CSTEE Secretary pointed out that this subject had been endorsed by the former CSTE as one that the new CSTEE should follow with attention. Given the clear implications of endocrine disrupters on consumers' health the CSTEE and its Secretariat could not but enthusiastically endorse this proposal. The prompt volunteering characterising the formation of a working group to tackle this subject (see below) is also an indication of the interest that the subject met within the CSTEE.
The secretary also informed the CSTEE that DG XXIV/B may eventually have available, under management credits B6-792, a fund which can be used to publish a call for tender in the Official Journal of the European Union for a research project on endocrine disruption. Ways of involving the CSTEE on the follow up of the project will be explored. In the first instance the 'Endocrine disruption' working group (see below) will be involved.
Then Mr Canice Nolan (DG XII) made a presentation on the subject. He gave an overview of the international developments that took place since 1994 and in which DG XII and other Commission services have been involved.
Basically Mr Nolan pointed out that there are still quite a lot of grey areas characterising the subject and as such research is needed before one can jump into cause/effect conclusions. He distributed an outline summary of the most relevant and recent international activities also indicating that the pace of developments is such at present that at any rate the document will become outdated very quickly.
The working group 'Endocrine disruption' is to be made up of: Profs. Vos (chairman), Dybing, Greim, Drs Tarazona, Lambré and Ladefoged. Subsequently Prof. Vos suggested also Dr Dick Vethaak from the Dutch National Institute or Coastal and Marine management and the proposal was accepted by the Secretariat.
7. 'Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment' (submitted by Dr. J. Tarazona) - discussion
Its author presented this point. He pointed out that under the current EU classification system, chemicals, which have intrinsic properties as dangerous to the environment, are not classifiable as such. He emphasised that, before criteria for classification as dangerous to the terrestrial environment are adopted (Classification and Labelling Directive, 67/548/EEC) it is important that they be looked at by the CSTEE. He requested feed back on how the CSTEE should be involved. Most said that it was important that more information was made available to the CSTEE before they could embark on a task of this kind, in particular information on research being carried out in this area, documents included in Dr Tarazona's references and also others mainly on risk assessment (OECD).
8. Schedule of CSTEE meetings for 1998 - work programme of the CSTEE
The CSTEE secretary informed the plenary that essentially the committee's work programme would have to be characterised by some flexibility. Apart from the agenda items included in the agenda of the present meeting, and which will continue to be the object of developments, there will be others. In particular Directorate General III (Industry) of the Commission provided a list of their likely subjects for CSTEE consultation (Annex V, Doc. CSTEE/98/3). One DG III representative gave a brief outline of DG III normal procedure on outside advice they get from consultants and, more specifically, on the nature of the problems to be tackled by the CSTEE as described in the Doc. CSTEE/98/3.
Going through the DG III work programme three working groups were created to address some pressing issues: one on Creosote [Profs. Greim (chairman), Dybing, Terracini and Jansson], another on Cadmium and Arsenic/Tin [Profs. Chambers (chairman), Rueff and Kyrtopoulos] and finally one on PCP [Profs. Vighi (chairman), Bridges and Salkinoja-Salonen).
On the other hand, given the significant body of EU legislation on environmental related subjects, and the competence of the CSTEE, it is expected that its consultation on environmental related issues will grow significantly.
The CSTEE were also informed that, contrary to the indication given by the Secretariat in point 7 of the draft minutes of the 1st plenary meeting of the CSTEE, the date of the 3rd plenary meeting remains unchanged as the SSC revised again its schedule and they are not having a meeting on the 24th of April 98.
9. Rules of procedure
Declarations of interest (annual statement)
Confidentiality
This agenda point was not discussed due to lack of time. The secretary informed the CSTEE that members still had time, if they so wished, to comment on document CSTE/98/2 intended to serve as a common basis of the rules of procedure that would apply to all scientific committees operating under DG XXIV management.
10. Any other business
Without any other business, the meeting was closed at 18H00.
Annexes:
I - List of participants
II- Meeting agenda
LIST OF PARTICIPANTS
CSTEE:
Prof. Bridges, Prof. Chambers, Prof. Dybing, Prof.Greim, Prof. Jansson, Prof. Kyrtopoulos, Dr. Ladefoged, Dr. Lambré, Prof. Rueff, Prof. Salkinoja-Salonen, Dr. Tarazona, Prof. Terracini, Prof. Vighi, Prof. Vos
European Commission:
DG XXIV
Mrs de Solà, Mrs Brunko, Mr Costa-David, Mrs Gamez-Moreno
DG III
Mr Berend, Mr Burge, Mr Glynn
DG XI
Mr Brockett, Mrs Fidalgo, Mr Olsen, Mr Paquot
DG XII
Mr Nolan
AGENDA -
1. Adoption of the draft agenda
2. Adoption of the draft minutes of the 1st plenary meeting of the CSTEE held on 17.11.97 in Brussels
3. Phthalates in toys (docs. CSTEE/97/1 and Adds. 1 to 58) - (i) adoption of the draft minutes of the 1st and 2nd meetings of the working group 'Phthalates in toys'; (ii) status report - possible adoption of an opinion
4. ERM report on 'Recent assessments of the hazards and risks posed by asbestos and substitute fibres, and recent regulation of fibres world-wide' (docs. CSTEE/97/2 and Adds. 1 to 4) - for opinion
5. Practical implications of the proposed modification to the Water Framework Directive elaborating the technical specifications for the monitoring and presentation of good status for surface water and ground water (Annex V of the Directive) - discussion and formation of a Working Group.
6. Endocrine disrupters. Collaboration of the CSTEE
7. 'Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment' (submitted by Dr. J. Tarazona) - discussion
8. Schedule of CSTEE meetings for 1998 - work programme of the CSTEE
9. Rules of procedure
Declarations of interest (annual statement)
Confidentiality
10. Any other business
The meeting started with a general presentation of CSTEE members and Commission staff.
1. Adoption of the draft agenda
The revised draft agenda was adopted.
2. Adoption of the draft minutes of the 1st plenary meeting of the CSTEE held on 17.11.1997 in Brussels
The minutes were adopted.
3. (i) Adoption of the draft minutes of the 1st and 2nd meetings of the ad hoc working group 'Phthalates in toys'
With the agreement of the CSTEE members included in the working group and that of Dr Rastogi (who had given his agreement by e-mail) the minutes of both meetings of the ad hoc working group on 'Phthalates in toys' were adopted (with the correction introduced to point 7 of the latter, where the margin of safety for DEHP was changed from 1.9 to 21).
(ii) Status report - possible adoption of an opinion
The chairman of the 'Phthalates in toys' working group started his presentation by explaining the steps involved in the risk assessment procedure for this agenda item which included (i)exposure assessment, (ii)effects assessment, (iii)risk management and (iv)guidance values for maximum extractable amounts.
The CSTEE were informed about a consensus meeting with consumers that had recently taken place in NL. A study is being carried out with human volunteers and the conclusion of the study is expected by September 98. It will allow for the development of in vitro tests on the effects of phthalates on human health and the respective calibration. It is expected that the study will be concluded by the autumn of 98. This information was welcomed by some of the CSTEE members as it will presumably allow for a better characterisation of the effects of these substances on human health and on the development of an vitro test, something which the 'Phthalates in toys' working group felt was needed in order to better answer the mandate given on the subject of phthalate effects on human health.
It was agreed that the issue of additional exposure still requires further clarification.
Going through the data on each of the individual phthalates the conclusions were that action was probably warranted on DINP because the exposure levels cause concern. As for DEHP it was acknowledged that this is a very prevalent compound, a very widely used plasticiser, and hence action should also be warranted. As for DNOP, in spite of the scarcity of data it should also be the object of action.
Whilst recognising that the terms of reference had not been fully answered, the CSTEE then endorsed a position opinion (Annex III) on the subject of phthalates in toys. The NL study whose results will be available by the autumn will provide the kind of insight that will help the CSTEE address the problem more fully. On the other hand it is expected that the issues of additional exposure can also be better characterised.
4. ERM report on 'Recent assessments of the hazards and risks posed by asbestos and substitute fibres, and recent regulation of fibres world-wide' - for opinion
A draft opinion document was presented. DG III explained the context in which the opinion had been requested. Some Member States have made their preference for an asbestos banning very clear. DG had tried this in 1994 but a consensus had not been possible then because only four M. States were in favour of that option. Since then that number rose to eight with twelve now having made clear that they could accept such a solution.
Given the lack of information available and also that of resources in DG III, they decided to publish a call for proposals and chose ERM to do, not a fundamental research on asbestos, but to assess the available data on the subject. ERM then produced the report the CSTEE was asked to peer review.
A brief description was also made of the situation as regards the legislation still in force (14 categories of chrysotile asbestos have been banned). It was also reminded that, on the issue of workplace concerns, the 1st workplace directive dates from 1983 with an amendment in 1991.
Environmental risks were also commented on by the CSTEE, given the impact on other species where carcinogenicity may be an issue.
The CSTEE required clarification on the urgency of the request: is it due to political pressures or to health incidence rates? Are there data that would allow for a calculation on the number of lives saved for instance?
Other question asked was whether the Commission would be willing to accept some fluctuations in legislation across Member States. This was answered commenting on the so-called article 100 (a), whereby Members States can request for temporary derogation measures if they can prove that circumstances in their territories are such that derogations are warranted.
The chairman of the 'ERM study' working group then spelt out some of the weaknesses which had been highlighted in the draft paper to be the basis of the CSTEE opinion. The general view was that the ERM should have addressed exposure to chrysotile more properly. Para-occupational exposure was also felt to be a problem.
In the end the CSTEE endorsed a text (position plus detailed comments on the ERM study, see Annex IV) as its official opinion. It includes a list of points in the ERM report that the CSTEE would like to see improved upon.
5. Practical implications of the proposed modification to the Water Framework Directive elaborating the technical specifications for the monitoring and presentation of good status for surface water and ground water (Annex V of the Directive) - discussion and formation of a Working Group.
The CSTEE Secretary presented this point. Given the clear implications of water policy on the health of the consumer, it was DG XXIV's view that the CSTEE should be consulted on the general water policy framework.
Subsequently DG XI made a presentation of their approach. In particular they emphasised that there are currently about 25 directives dealing with water from different perspectives. Co-ordinating its various elements are part of the difficulty in managing this work area.
It was pointed out that the focus of changes is currently being put on Annex V. DG XI expressed the view that tight parameters are what should be looked at to quantify water quality. There are chemicals and other criteria, including biota, but NOAEL's may not be a good indicator of water quality.
A fundamental principle of the approach being pursued is that all EU water pools cannot be qualified in the same way. There may be a need for individual normative definitions for lakes, rivers, estuaries and coastal areas.
The terms 'significantly', 'slightly modified' are soft expressions which are probably closer to what is feasible in Europe given the wide variability of water pools across Europe. As part of the process Member States were asked to identify individual ecosystems.
Water pools need to be subdivided in categories. Member States were asked to identify water pools of high and of good status and to characterise which species live there in order to allow for comparability to be possible.
In order to ensure objectivity the directive will also allow Member States to propose their own criteria. DG XI believes this is an improvement vis-à-vis the former fish and shell fish directives.
Finally the time factor pressures were described in order to give the CSTEE an overview of the deadlines involved. The EP Environment committee will likely meet in mid March and in mid April with a view to adopt their position.
Several CSTEE members commented on the task ahead. Most expressed concern with the time pressure factors.
Finally a working group was formed to address an as yet to be defined mandate/terms of reference. In this respect the CSTEE Secretary said that all parties involved would have to participate in the definition. DG XI could produce draft terms of reference but both DG XXIV, the CSTEE and the 'Water framework directive' working group should also be allowed to comment and contribute to defining the terms of reference.
The working group 'Water framework directive' is to be chaired by Dr Tarazona. From within the CSTEE, Profs. Vighi and Greim both accepted to participate. It was agreed that two more external experts should be nominated. The chairman would check and suggest later to the Secretariat two suitable names and alternatives, should the nominees not be able to accept. [Note: within a few days Dr. Tarazona suggested the names of Prof. Calow (UK) and Dr Canton (NL) who, after being contacted by the Secretariat, both accepted their nomination as members of the 'Water framework directive' working group]. Subsequently Dr Lambré from the CSTEE also volunteered to be member of the WG. The CSTEE Secretariat accepted.
6. Endocrine disrupters. Collaboration of the CSTEE
The CSTEE Secretary pointed out that this subject had been endorsed by the former CSTE as one that the new CSTEE should follow with attention. Given the clear implications of endocrine disrupters on consumers' health the CSTEE and its Secretariat could not but enthusiastically endorse this proposal. The prompt volunteering characterising the formation of a working group to tackle this subject (see below) is also an indication of the interest that the subject met within the CSTEE.
The secretary also informed the CSTEE that DG XXIV/B may eventually have available, under management credits B6-792, a fund which can be used to publish a call for tender in the Official Journal of the European Union for a research project on endocrine disruption. Ways of involving the CSTEE on the follow up of the project will be explored. In the first instance the 'Endocrine disruption' working group (see below) will be involved.
Then Mr Canice Nolan (DG XII) made a presentation on the subject. He gave an overview of the international developments that took place since 1994 and in which DG XII and other Commission services have been involved.
Basically Mr Nolan pointed out that there are still quite a lot of grey areas characterising the subject and as such research is needed before one can jump into cause/effect conclusions. He distributed an outline summary of the most relevant and recent international activities also indicating that the pace of developments is such at present that at any rate the document will become outdated very quickly.
The working group 'Endocrine disruption' is to be made up of: Profs. Vos (chairman), Dybing, Greim, Drs Tarazona, Lambré and Ladefoged. Subsequently Prof. Vos suggested also Dr Dick Vethaak from the Dutch National Institute or Coastal and Marine management and the proposal was accepted by the Secretariat.
7. 'Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment' (submitted by Dr. J. Tarazona) - discussion
Its author presented this point. He pointed out that under the current EU classification system, chemicals, which have intrinsic properties as dangerous to the environment, are not classifiable as such. He emphasised that, before criteria for classification as dangerous to the terrestrial environment are adopted (Classification and Labelling Directive, 67/548/EEC) it is important that they be looked at by the CSTEE. He requested feed back on how the CSTEE should be involved. Most said that it was important that more information was made available to the CSTEE before they could embark on a task of this kind, in particular information on research being carried out in this area, documents included in Dr Tarazona's references and also others mainly on risk assessment (OECD).
8. Schedule of CSTEE meetings for 1998 - work programme of the CSTEE
The CSTEE secretary informed the plenary that essentially the committee's work programme would have to be characterised by some flexibility. Apart from the agenda items included in the agenda of the present meeting, and which will continue to be the object of developments, there will be others. In particular Directorate General III (Industry) of the Commission provided a list of their likely subjects for CSTEE consultation (Annex V, Doc. CSTEE/98/3). One DG III representative gave a brief outline of DG III normal procedure on outside advice they get from consultants and, more specifically, on the nature of the problems to be tackled by the CSTEE as described in the Doc. CSTEE/98/3.
Going through the DG III work programme three working groups were created to address some pressing issues: one on Creosote [Profs. Greim (chairman), Dybing, Terracini and Jansson], another on Cadmium and Arsenic/Tin [Profs. Chambers (chairman), Rueff and Kyrtopoulos] and finally one on PCP [Profs. Vighi (chairman), Bridges and Salkinoja-Salonen).
On the other hand, given the significant body of EU legislation on environmental related subjects, and the competence of the CSTEE, it is expected that its consultation on environmental related issues will grow significantly.
The CSTEE were also informed that, contrary to the indication given by the Secretariat in point 7 of the draft minutes of the 1st plenary meeting of the CSTEE, the date of the 3rd plenary meeting remains unchanged as the SSC revised again its schedule and they are not having a meeting on the 24th of April 98.
9. Rules of procedure
Declarations of interest (annual statement)
Confidentiality
This agenda point was not discussed due to lack of time. The secretary informed the CSTEE that members still had time, if they so wished, to comment on document CSTE/98/2 intended to serve as a common basis of the rules of procedure that would apply to all scientific committees operating under DG XXIV management.
10. Any other business
Without any other business, the meeting was closed at 18H00.
Annexes:
I - List of participants
II- Meeting agenda
LIST OF PARTICIPANTS
CSTEE:
Prof. Bridges, Prof. Chambers, Prof. Dybing, Prof.Greim, Prof. Jansson, Prof. Kyrtopoulos, Dr. Ladefoged, Dr. Lambré, Prof. Rueff, Prof. Salkinoja-Salonen, Dr. Tarazona, Prof. Terracini, Prof. Vighi, Prof. Vos
European Commission:
DG XXIV
Mrs de Solà, Mrs Brunko, Mr Costa-David, Mrs Gamez-Moreno
DG III
Mr Berend, Mr Burge, Mr Glynn
DG XI
Mr Brockett, Mrs Fidalgo, Mr Olsen, Mr Paquot
DG XII
Mr Nolan
AGENDA -
1. Adoption of the draft agenda
2. Adoption of the draft minutes of the 1st plenary meeting of the CSTEE held on 17.11.97 in Brussels
3. Phthalates in toys (docs. CSTEE/97/1 and Adds. 1 to 58) - (i) adoption of the draft minutes of the 1st and 2nd meetings of the working group 'Phthalates in toys'; (ii) status report - possible adoption of an opinion
4. ERM report on 'Recent assessments of the hazards and risks posed by asbestos and substitute fibres, and recent regulation of fibres world-wide' (docs. CSTEE/97/2 and Adds. 1 to 4) - for opinion
5. Practical implications of the proposed modification to the Water Framework Directive elaborating the technical specifications for the monitoring and presentation of good status for surface water and ground water (Annex V of the Directive) - discussion and formation of a Working Group.
6. Endocrine disrupters. Collaboration of the CSTEE
7. 'Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment' (submitted by Dr. J. Tarazona) - discussion
8. Schedule of CSTEE meetings for 1998 - work programme of the CSTEE
9. Rules of procedure
Declarations of interest (annual statement)
Confidentiality
10. Any other business
