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Directorate-General for Health and Food Safety
1. Welcoming address, apologies for
absence, declarations of interest
No declarations of interest relative to the agenda points of this 22nd CSTEE plenary were submitted by any CSTEE member.
Apologies were received from Profs. Soares and Janneche Utne Skaare. Profs. Terracini and Victorin had previously informed that they would be able to attend only during the 1st day of the meeting.
2. Adoption of the draft agenda
The draft agenda was adopted. It was requested however by two different CSTEE members that the subjects 'The future of the EU chemicals policy' and the role of the CSTEE in the establishment of the priority setting of substances (Water policy) be discussed.
3. Approval of the draft minutes of the 21st CSTEE plenary meeting
The draft minutes were approved.
4. CSTEE working procedures
A long discussion took place on this agenda point. The chairman, who had submitted a short paper for discussion on this agenda point, reminded the committee about the significance and importance of the principles of transparency and independence.
The increase in the workload of the committee was noted and it was stated that the high quality demanded in the opinions of the committee was difficult to reconcile with this.
The proactive role typically played by the committee on a few selected subjects with a view to producing papers of a reference nature was also difficult to reconcile with the increase in the workload. However CSTEE members generally believed that such a proactive role should remain a feature of the CSTEE's activities. One way to achieve this could be by means of the setting of priorities by the committee and a fair balance between reactive/proactive activities should be achieved although most committee members expressed the view that the current balance was about right. In this regard the cross-committees collaboration was also believed to be an essential aspect of the CSTEE's activities.
The proactive involvement of the CSTEE on emerging issues was also to be seen in the light of its responsibilities as defined recently by the SSC.
A routine agenda point on workload and prioritisation was suggested by some. It should be put up front in the agenda. However it was also suggested that the Commission's priorities had to be addressed and as such this needed to be taken into account as well.
The chairman asked whether the CSTEE should produce guidelines on working procedures. One reply was that this might be difficult to achieve given that the remit of the CSTEE is not focussed enough. Some CSTEE members have not missed them so far. The conclusion was that setting guidelines is currently not a priority for the CSTEE.
Regarding the difficulties with organising WG meetings and how these should tie in with plenary meetings, some CSTEE members expressed the view that if possible WG meetings should take place in the morning of the day of a plenary meeting, which should start in the afternoon and possibly continue the day after if necessary.
Some CSTEE members expressed the view that given that members come from sometimes very distant parts of Europe (transportation/trips take an undue long time), conference calls should be a means of coping with this, especially regarding subjects for which the discussions can be very short. Some members commented on their positive experience with videoconferences.
Regarding the specific subject of the CSTEE involvement on the peer review of Regulation 793/93 RARs, a committee member expressed the view that this ought to be reviewed. The CSTEE secretary said that this could happen anyway given the necessary review of the interservices operations manual in the field of chemicals, due to take place in May 2001.
This agenda point was also the opportunity for the 2nd vice-chairman to comment on his involvement on the exercise, for which DG Environment is responsible, of setting up of priority chemicals in the field of water policy. The CSTEE secretary took the task of checking with the mentioned Commission service how to deal with this in practice.
5. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) Acrylamide
The draft CSTEE opinion on Acrylamide was adopted with some minor changes. It is available in:
http://ec.europa.eu/food/fs/sc/sct/outcome_en.html
b) Dibutyl Phthalate
A draft text was presented for discussion. It was commented that an overestimation of risk had been used in the RAR and that minimal MOS had also been used extensively in it. Some committee members commented on the fact that the environmental effects of this chemical seem to be a cause for concern.
The need was expressed to enlarge the existing 'Phthalates' working group in order to deal with this opinion request and other related ones, i.e. i)JRC report on validation of test methods to determine migration of DINP, ii)phthalates substitutes and iii)other RARs on other phthalates to be submitted to the CSTEE in the near future. The composition of the working group was therefore reviewed and some CSTEE members, not previously members of this working group, were included in it.
The working group chairman accepted to review the draft text, also in the light of comments to be sent on the environmental part which was the bit in more need of completion. The human health part was generally accepted.
c) Acrylonitrile
The draft opinion had already been discussed at the occasion of the previous CSTEE plenary and the CSTEE had agreed to endorse it as the CSTEE opinion. However there was an outstanding issue, i.e. the rapporteur was not able to find a specific reference to liver necrosis and increased haematopoesis at 20 ppm. This was in the meantime clarified and therefore the draft was adopted as the CSTEE opinion.
It is available in: http://ec.europa.eu/food/fs/sc/sct/outcome_en.html
d) Methyl methacrylate
The CSTEE rapporteur for MMA had prepared a new draft that was sent to the committee by the CSTEE secretariat together with the documentation submitted by Industry and that was at the origin at the changes made to the draft. The evidence submitted was taken on board by the rapporteur and he acknowledged that regarding skin sensitisation the Nyquist et al. (1958) study might not be an adequate study to reveal the human skin irritation potential of MMA. However, MMA was still considered clearly skin irritating in animal tests.
Regarding NOAEL for systemic effects: Since the dose spacing in the Rohm and Haas study was 100 and 400 ppm, and the very similar NTP study determined a NOAEL of 250 ppm and a LOAEL of 500 ppm for growth retardation in female rats, the rapporteur agreed to the use of 250 ppm as the NOAEL for systemic effects. However it was greed that such a NOEL does not substantially affect the risk assessment and its conclusions. A MOS of 7.5 rather than 3 (3 x 250/100) should still be judged to be too low to be protective with respect to systemic effects, even for an occupational workforce. The draft on Methyl methacrylate was adopted as the CSTEE opinion. It is available in: http://ec.europa.eu/food/fs/sc/sct/outcome_en.html
B. Status report/opinion (Environment) on:
Methyl-tert-Butyl Ether
A discussion took place on the draft CSTEE opinion but this related only to the environmental part. It was agreed to have a more in depth discussion once a draft report on the human health part would be available.
C. Status report/opinion (Human health) on:
Nonylphenol and nonylphenol (branched) (human health only)
The draft on this chemical (human health part only) was adopted as the CSTEE opinion with some minor editorial corrections. It is available in: http://ec.europa.eu/food/fs/sc/sct/outcome_en.html
D. State of play regarding other substances evaluated under the ESR
The CSTEE took note of the incoming RARs on Acrylic acid, Toluene, Methyl oxirane and Naphthalene. The rapporteurs/contributors to the elaboration of the CSTEE opinions on each were nominated.
E. Input of the CSTEE into the revision of the 'Technical Guidance Document' in support of Regulation 793/93
This agenda point was discussed with interventions from CSTEE members, its secretariat and of a representative of the ECB. The CSTEE secretary gave an account of his participation in the recently held Competent Authorities meeting in Paris (12-14 February 2001) where he gave his views on the CSTEE involvement in the peer-review of 793/93 RARs and requested M.S's comments on the experience so far.
The ECB representative described a room document distributed during this plenary which indicated the status quo of work of 793/93 Regulation RARs.
A more general discussion took place on the possible changes in the CSTEE peer review process particularly in the light of possible changes to be introduced to the EU chemicals regulatory framework once measures tentatively described in the 'White paper on the future of the EU chemicals policy' will start being implemented. Aspects such as 'fast tracking' (its definition), TGD development, completeness of databases of High Production Volume Chemicals, data needed to start a RA, etc. were discussed.
6. Margins of safety
The draft report sent by the rapporteur was adopted. A debate took place on its status. This being an own initiative CSTEE report the committee finally concluded that, given its scope and interest it was preferable that it should for the time being be circulated among Commission services only. These may want to consider its usefulness as input to the revision of the so-called Technical Guidance Document. The CSTEE should however keep a sort of 'watching brief' and update it as and when appropriate. Referral to the 'Harmonisation of risk assessment procedures' SSC WG was another proposed use.
7. Exposure data in risk assessments of industrial organic chemicals - final paper
The rapporteur presented the paper and drew the CSTEE's attention to the fact that an 'executive summary' had been added. The editorial changes made relative to the draft previously distributed to the CSTEE were described. The attention of the ECB TGD working groups in particular should be drawn to this report so that they may give it proper consideration in their TGD revision work.
Some late comments sent by one CSTEE member were presented/discussed and the draft changed accordingly.
The CSTEE reiterated its endorsement to the idea that this report should be put on the DG SANCO website, with a request for public comments ('public' here meaning in principle the scientific community specialised in this field). The CSTEE secretary informed that he would take action to have this done and that, in line with the practice of other scientific committees of the Commission when requesting public comments, the document would be in the DG SANCO website for a period of about a month.
8. Evaluation of sludge treatments for pathogen reduction - for opinion
The rapporteur presented the most recent draft. The possible involvement of further experts in the activities of the working group was considered. The draft text had reached an advanced stage and the working group chairman informed that, in his view, pending the submission of any further comments, he considered the draft opinion practically finalised.
The WG chairman recognised that there might still be a need for a further working group meeting though, again, such a prospect would be dependent upon any comments and the respective nature. The WG chairman suggested that any comments that any CSTEE member might still want to make should be sent within the subsequent couple of weeks after the plenary.
The CSTEE secretariat took the task of organising a WG meeting if necessary.
9. The availability of substitutes for soft PVC containing phthalates in certain toys and childcare articles (RPA final report ETD/99/502498) - for opinion
The draft prepared by the rapporteur had been sent by the CSTEE secretariat by e-mail prior to the meeting. Only concurring comments had been received. A contribution from the SCF representative in the CSTEE phthalates working group was noted. This too was a concurring comment. The draft was adopted as the CSTEE opinion. It is available in:
http://ec.europa.eu/food/fs/sc/sct/outcome_en.html#opinions
10. (i) Carcinogenic and non-carcinogenic effects of Cadmium, Nickel and Arsenic in ambient air - progress report
Two working group meetings had taken place, one on 13 February 2001 and another one on 5 March 2001. The individual rapporteurs responsible for each presented the respective drafts. Only the one on Nickel would be adopted as a CSTEE opinion. It was suggested by one CSTEE member, and this was agreed, that a disclaimer should be included in all to say:
Following the terms of reference, this opinion focuses on specific questions related to human health issues and does not cover ecosystems protection.
(ii) Derivation of limit values for PAH in ambient air - progress report
The draft prepared by the rapporteur was discussed but the nature of the debate did not allow for an adoption at this plenary. The need for some tables was expressed, one of which on toxic equivalent factors, and the rapporteur undertook to provide these. The CSTEE chairman suggested that the committee should have access to the so-called Swedish report. The rapporteur provided a copy, which the CSTEE secretariat undertook to distribute to the CSTEE.
11. Proposed standards for a revised bathing water directive - progress report
The composition of the working group was revised. The WG chairman informed that input from one or more microbiologists was necessary. The CSTEE secretary informed that this sort of expertise was already in principle available. A starter WG meeting was felt needed and the CSTEE secretary took the task of arranging this once the WG composition would be finalised. The need to establish a link with the 'Water Framework Directive' WG was also expressed and here too the CSTEE secretary informed that this had been ensured.
12. Health effects of Radio Frequency and Electromagnetic fields - progress report
The need to proceed with the finalisation of the composition of the working group was also underlined and the need to involve statisticians and biophysicists was mentioned. It was noted that a working group meeting also needed to be organised soon. The CSTEE secretary informed the committee that this subject is one on which the secretariat is being literally inundated with calls with information requests on the scope of the CSTEE involvement, mandate, conclusions that the committee might have reached so far, etc.
13. 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) - progress report
Given the burden of work regarding his contribution to the 'Cadmium in the air' WG, which has proved greater than anticipated, the rapporteur for this opinion request was unable to have a preliminary draft ready for this plenary. An oral account was made however. He highlighted in particular the shortcomings of the report on the 'exposure' side. A working group was set up to deal with this issue and the rapporteur undertook to write a draft.
14. Participation of the CSTEE in activities/working groups of other scientific committees of the Commission
a) Toxicity of minerals such as Cu and Zn in animal feed regarding the possible environmental impact of these minerals - activity of the SCAN
The secretary of the SCAN presented the issue. The opinion request involves two questions, one on Cu and another on Zn. In principle other 'trace' elements will be addressed also later. A WG will be soon set up within the SCAN to tackle this and they would like two CSTEE members to join the 'horizontal' group. The main objective is the harmonisation of the addressing of this subject. The objective is also to seek a harmonised position between different opinions adopted between different 'vertical' groups.
Two CSTEE members were appointed to be involved in this activity. One of them commented on the difficulties posed by the SCAN approach. The SCAN secretary explained that these are due to the specificity of the submission of dossiers under legislation that goes back to the early eighties and this legislation is limited in the obligation it imposes which make them relatively 'week' by modern standards.
The CSTEE members expressed the wish to receive documentation as soon as possible. Others said that the CSTEE should be kept regularly informed of the appointed CSTEE member's involvement in this exercise. A third CSTEE member (absent in this plenary) had also expressed interest in being also involved actively.
b) Other
There was no other active involvement on the part of any CSTEE member to report on.
15. Strategies for dealing with emerging issues identified by the SSC and for which the CSTEE is the 'lead' committee:
a) Endocrine disruption (Human health)
The WG chairman 'revisited' the WG composition. Several names were suggested as possible future participants, particularly given that the CSTEE should now address namely the 'human health effects' part (as opposed to the environmental one that had been the main focus of its own initiative report/opinion on 'Human and Wildlife Health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on a Ecotoxicology Test Methods' expressed at the 8th CSTEE plenary meeting, Brussels, 4 March 1999,).
The CSTEE secretary undertook the task of drafting a mandate to the CSTEE, for formalising its involvement on this own initiative opinion. It was reminded that this was also an area on which the SSC had recently suggested (at the occasion of a recent Scientific Steering Committee plenary meeting) that the CSTEE should be made 'chef de file' given the still emerging nature of the problem.
It was suggested that the working group should include members of the SCP, the SCAN and the SCVMPH. The former two committees had already nominated the respective representatives.
b) Indoor pollution
This is a subject on which the CSTEE had long ago expressed the view that it deserved a CSTEE own initiative report. Apparently others outside the committee also agree that it is a relevant subject in its own right. This subject was also deemed by the SSC to be one of the three mentioned emerging issues for which the CSTEE should be made responsible.
The composition of the WG was discussed and some committee members volunteered. A CSTEE member undertook to draft a mandate for the committee. The general expertise needed was discussed and some CSTEE members undertook also to inform the CSTEE secretary of external experts who could contribute to this activity in the light of the identified areas where expertise might be lacking in the committee.
16. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission
a) Draft CPMP discussion paper on environmental risk assessment of medicinal products - document from the London EMEA
A fax was received from the London EMEA, requesting the CSTEE's views on a draft CPMP paper on the 'Environmental risk assessment of medicinal products'. Some CSTEE members welcomed this opinion request as, they said, it is a critical issue. Some CSTEE members wondered whether this could not be a good opportunity to develop the subject further. One CSTEE member said that information on concentration of pharmaceutical products in the environment was necessary. The CSTEE secretary informed that the EMEA needed the opinion before the end of July 2001 at the latest.
A tentative working group was formed and the appointed chairman/rapporteur undertook to prepare a draft on the subject.
b) Other
There was none.
17. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
No Commission service was represented for this agenda point but the CSTEE secretary gave an overview of the so-called 'Lead problem' (the CSTEE has still outstanding an opinion request on lead to which it should respond once a general report allowing the committee to carry out its peer review will be available). At the recently held meetings of the competent authorities (CAs) responsible for Regulation 793/93 and Directive 67/548 in Paris an Industry proposal (EUROMETAUX) on a voluntary risk assessment of lead was described. EUROMETAUX recalled that these actions had been initiated further to a formal letter from DG ENV to CEFIC asking for more commitment from Industry in the initial hazard assessment conducted under the ICCA initiative. DG ENV asked at that time to start assessing the substances, which were included on the EU Working List. EUROMETAUX expressed the need for guidance from the CAs and for a peer review of the reports. At the CA's meeting the CSTEE secretary underlined the urgency for lead risk assessment in relation to the Danish notification and also that there is a general opinion request on Lead submitted to the CSTEE the tackling of which by the committee is still outstanding. The understanding is that the committee would address the subject once a comprehensive risk assessment report would be available for peer-review.
Commenting on the initiative one CSTEE member wondered why was this necessary since there is already a quite good OECD document on the subject.
18. Update on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
a) Harmonisation of Risk Assessment Task Force and Working groups
The CSTEE chairman provided an update of the most recent activities. Regarding the 'harmonisation of risk assessment' exercise, and following a 1st report, the activity should now proceed. Each scientific committee was invited to have a member representing the respective committee. Note was taken of who would be the CSTEE representatives. The next meeting of the WG was scheduled for 12 March 2001. The activities would proceed by means of working groups of which there are two for the moment, i.e. 'Chemicals' and 'Environment'. The chairman informed committee members that volunteers would be welcomed to participate in the exercise. The 'Chemicals' working group should devote a particular attention to quantitative risk assessment. The SSC agreed to further the initiative on 'probabilistic risk assessment', an area which has implications to several Commission services.
Regarding the 'Environment' working group there was a 'specialisation' on quantitative risk assessment as well. Working procedures within the various groups have yet to be approved and the time scale is very long since the timeframe foreseen is of about three years.
One committee member expressed the view that since there is an enormous amount of information available a convergence of approaches is necessary. Another member suggested that this activity should wait for the finalisation of the TGD revision underway under the auspices of the ECB to which the CSTEE chairman replied that, while this would be a good idea, the fact is that the TGD finalisation is essentially relevant for the CSTEE's areas of work whereas the SSC activity is of concern to all Commission scientific committees.
Another committee member wondered whether the EC has a budget for carrying out literature reviews since these are necessary upfront before such an exercise starts. The answer to this was that this aspect of the problem should be raised at a SSC meeting. This proposal met the agreement of the CSTEE.
b) Cross committee's collaboration
Subjects such as the involvement of the CSTEE on the Dioxin's issue, currently being evaluated by the SCF, were discussed. A CSTEE member was appointed to represent the CSTEE in the SCFs meetings where the subject will continue to be discussed.
The 2nd vice-chairman of the CSTEE suggested that the CSTEE should be involved in the peer-review of a guideline document for the risk assessment of pesticides.
19. Arrangements for the next (23rd) plenary meeting of the CSTEE
As was the case with this one, the 23rd plenary should also be a one and a half-day meeting, scheduled for 24/25 April 2001 (Note: because of difficulties of various natures, namely the difficulty that some CSTEE members had in finding hotel rooms in Brussels or its vicinity, the meting would finally be a one day one only, held on 24 April 2001).
20. Any other business
The 2nd vice-chairman expressed the view that Commission services and the CSTEE secretariat should agree on terms of reference for interim opinions and final opinions relative to the subjects 'Water Framework Directive' and ''TGD'.
A Commission official (representing DG SANCO/B) informed the committee of the possible forthcoming submission of an opinion request on TBTs. This is an issue for which other Commission services are also responsible, given that each addresses this group of chemicals from a different standpoint (i)TBTs in ships hulls paints and ii)in baby nappies). The concern of course is also that these chemicals may contaminate the food chain. In principle draft terms of reference will be sent o the CSTEE secretariat soon.
Another opinion request is likely to be submitted to the committee soon on two major studies carried out in Europe, concerning the subject of 'drinking water quality'.
Finally one CSTEE member gave an oral account of a meeting recently held in London concerning the subject of 'Expert consultation on statistical extrapolation techniques for environmental effects assessment'.
AGENDA -
1. Welcoming address, apologies for absence, declarations of interest
2. Adoption of the draft agenda
3. Approval of the draft minutes of the 21st CSTEE plenary meeting
4. CSTEE working procedures
5. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) Acrylamide
b) Dibutyl Phthalate
c) Acrylonitrile
d) Methyl methacrylate
B. Status report/opinion (Environment) on:
Methyl-tert-Butyl Ether
C. Status report/opinion (Human health) on:
Nonylphenol and nonylphenol (branched) (human health only)
D. State of play regarding other substances evaluated under the ESR
E. Input of the CSTEE into the revision of the 'Technical Guidance Document' in support of Regulation 793/93
6. Margins of safety - for opinion
7. The use of exposure data in risk assessments - final paper
8. Evaluation of sludge treatments for pathogen reduction - for opinion
9. The availability of substitutes for soft PVC containing phthalates in certain toys and childcare articles (RPA final report ETD/99/502498) - for opinion
10. (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
11. Proposed standards for a revised bathing water directive - progress report
12. Health effects of Radio Frequency and Electromagnetic fields - progress report
13. 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) - progress report
14. Participation of the CSTEE in activities/working groups of other scientific committees of the Commission
a) Toxicity of minerals such as Cu and Zn in animal feed regarding the possible environmental impact of these minerals - activity of the SCAN
b) Other
15. Strategies for dealing with emerging issues identified by the SSC and for which the CSTEE is the 'lead' committee:
a) Endocrine disruption (Human health)
b) Indoor pollution
16. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission
a) Draft CPMP discussion paper on environmental risk assessment of medicinal products - document from the London EMEA
b) Other
17. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
18. Update on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
a) Harmonisation of Risk Assessment Task Force and Working groups
b) Cross committee's collaboration
19. Arrangements for the next (23rd) plenary meeting of the CSTEE
20. 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, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, 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
JOINT RESEARCH CENTRE:
Mrs. Sharon MUNN
No declarations of interest relative to the agenda points of this 22nd CSTEE plenary were submitted by any CSTEE member.
Apologies were received from Profs. Soares and Janneche Utne Skaare. Profs. Terracini and Victorin had previously informed that they would be able to attend only during the 1st day of the meeting.
2. Adoption of the draft agenda
The draft agenda was adopted. It was requested however by two different CSTEE members that the subjects 'The future of the EU chemicals policy' and the role of the CSTEE in the establishment of the priority setting of substances (Water policy) be discussed.
3. Approval of the draft minutes of the 21st CSTEE plenary meeting
The draft minutes were approved.
4. CSTEE working procedures
A long discussion took place on this agenda point. The chairman, who had submitted a short paper for discussion on this agenda point, reminded the committee about the significance and importance of the principles of transparency and independence.
The increase in the workload of the committee was noted and it was stated that the high quality demanded in the opinions of the committee was difficult to reconcile with this.
The proactive role typically played by the committee on a few selected subjects with a view to producing papers of a reference nature was also difficult to reconcile with the increase in the workload. However CSTEE members generally believed that such a proactive role should remain a feature of the CSTEE's activities. One way to achieve this could be by means of the setting of priorities by the committee and a fair balance between reactive/proactive activities should be achieved although most committee members expressed the view that the current balance was about right. In this regard the cross-committees collaboration was also believed to be an essential aspect of the CSTEE's activities.
The proactive involvement of the CSTEE on emerging issues was also to be seen in the light of its responsibilities as defined recently by the SSC.
A routine agenda point on workload and prioritisation was suggested by some. It should be put up front in the agenda. However it was also suggested that the Commission's priorities had to be addressed and as such this needed to be taken into account as well.
The chairman asked whether the CSTEE should produce guidelines on working procedures. One reply was that this might be difficult to achieve given that the remit of the CSTEE is not focussed enough. Some CSTEE members have not missed them so far. The conclusion was that setting guidelines is currently not a priority for the CSTEE.
Regarding the difficulties with organising WG meetings and how these should tie in with plenary meetings, some CSTEE members expressed the view that if possible WG meetings should take place in the morning of the day of a plenary meeting, which should start in the afternoon and possibly continue the day after if necessary.
Some CSTEE members expressed the view that given that members come from sometimes very distant parts of Europe (transportation/trips take an undue long time), conference calls should be a means of coping with this, especially regarding subjects for which the discussions can be very short. Some members commented on their positive experience with videoconferences.
Regarding the specific subject of the CSTEE involvement on the peer review of Regulation 793/93 RARs, a committee member expressed the view that this ought to be reviewed. The CSTEE secretary said that this could happen anyway given the necessary review of the interservices operations manual in the field of chemicals, due to take place in May 2001.
This agenda point was also the opportunity for the 2nd vice-chairman to comment on his involvement on the exercise, for which DG Environment is responsible, of setting up of priority chemicals in the field of water policy. The CSTEE secretary took the task of checking with the mentioned Commission service how to deal with this in practice.
5. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) Acrylamide
The draft CSTEE opinion on Acrylamide was adopted with some minor changes. It is available in:
http://ec.europa.eu/food/fs/sc/sct/outcome_en.html
b) Dibutyl Phthalate
A draft text was presented for discussion. It was commented that an overestimation of risk had been used in the RAR and that minimal MOS had also been used extensively in it. Some committee members commented on the fact that the environmental effects of this chemical seem to be a cause for concern.
The need was expressed to enlarge the existing 'Phthalates' working group in order to deal with this opinion request and other related ones, i.e. i)JRC report on validation of test methods to determine migration of DINP, ii)phthalates substitutes and iii)other RARs on other phthalates to be submitted to the CSTEE in the near future. The composition of the working group was therefore reviewed and some CSTEE members, not previously members of this working group, were included in it.
The working group chairman accepted to review the draft text, also in the light of comments to be sent on the environmental part which was the bit in more need of completion. The human health part was generally accepted.
c) Acrylonitrile
The draft opinion had already been discussed at the occasion of the previous CSTEE plenary and the CSTEE had agreed to endorse it as the CSTEE opinion. However there was an outstanding issue, i.e. the rapporteur was not able to find a specific reference to liver necrosis and increased haematopoesis at 20 ppm. This was in the meantime clarified and therefore the draft was adopted as the CSTEE opinion.
It is available in: http://ec.europa.eu/food/fs/sc/sct/outcome_en.html
d) Methyl methacrylate
The CSTEE rapporteur for MMA had prepared a new draft that was sent to the committee by the CSTEE secretariat together with the documentation submitted by Industry and that was at the origin at the changes made to the draft. The evidence submitted was taken on board by the rapporteur and he acknowledged that regarding skin sensitisation the Nyquist et al. (1958) study might not be an adequate study to reveal the human skin irritation potential of MMA. However, MMA was still considered clearly skin irritating in animal tests.
Regarding NOAEL for systemic effects: Since the dose spacing in the Rohm and Haas study was 100 and 400 ppm, and the very similar NTP study determined a NOAEL of 250 ppm and a LOAEL of 500 ppm for growth retardation in female rats, the rapporteur agreed to the use of 250 ppm as the NOAEL for systemic effects. However it was greed that such a NOEL does not substantially affect the risk assessment and its conclusions. A MOS of 7.5 rather than 3 (3 x 250/100) should still be judged to be too low to be protective with respect to systemic effects, even for an occupational workforce. The draft on Methyl methacrylate was adopted as the CSTEE opinion. It is available in: http://ec.europa.eu/food/fs/sc/sct/outcome_en.html
B. Status report/opinion (Environment) on:
Methyl-tert-Butyl Ether
A discussion took place on the draft CSTEE opinion but this related only to the environmental part. It was agreed to have a more in depth discussion once a draft report on the human health part would be available.
C. Status report/opinion (Human health) on:
Nonylphenol and nonylphenol (branched) (human health only)
The draft on this chemical (human health part only) was adopted as the CSTEE opinion with some minor editorial corrections. It is available in: http://ec.europa.eu/food/fs/sc/sct/outcome_en.html
D. State of play regarding other substances evaluated under the ESR
The CSTEE took note of the incoming RARs on Acrylic acid, Toluene, Methyl oxirane and Naphthalene. The rapporteurs/contributors to the elaboration of the CSTEE opinions on each were nominated.
E. Input of the CSTEE into the revision of the 'Technical Guidance Document' in support of Regulation 793/93
This agenda point was discussed with interventions from CSTEE members, its secretariat and of a representative of the ECB. The CSTEE secretary gave an account of his participation in the recently held Competent Authorities meeting in Paris (12-14 February 2001) where he gave his views on the CSTEE involvement in the peer-review of 793/93 RARs and requested M.S's comments on the experience so far.
The ECB representative described a room document distributed during this plenary which indicated the status quo of work of 793/93 Regulation RARs.
A more general discussion took place on the possible changes in the CSTEE peer review process particularly in the light of possible changes to be introduced to the EU chemicals regulatory framework once measures tentatively described in the 'White paper on the future of the EU chemicals policy' will start being implemented. Aspects such as 'fast tracking' (its definition), TGD development, completeness of databases of High Production Volume Chemicals, data needed to start a RA, etc. were discussed.
6. Margins of safety
The draft report sent by the rapporteur was adopted. A debate took place on its status. This being an own initiative CSTEE report the committee finally concluded that, given its scope and interest it was preferable that it should for the time being be circulated among Commission services only. These may want to consider its usefulness as input to the revision of the so-called Technical Guidance Document. The CSTEE should however keep a sort of 'watching brief' and update it as and when appropriate. Referral to the 'Harmonisation of risk assessment procedures' SSC WG was another proposed use.
7. Exposure data in risk assessments of industrial organic chemicals - final paper
The rapporteur presented the paper and drew the CSTEE's attention to the fact that an 'executive summary' had been added. The editorial changes made relative to the draft previously distributed to the CSTEE were described. The attention of the ECB TGD working groups in particular should be drawn to this report so that they may give it proper consideration in their TGD revision work.
Some late comments sent by one CSTEE member were presented/discussed and the draft changed accordingly.
The CSTEE reiterated its endorsement to the idea that this report should be put on the DG SANCO website, with a request for public comments ('public' here meaning in principle the scientific community specialised in this field). The CSTEE secretary informed that he would take action to have this done and that, in line with the practice of other scientific committees of the Commission when requesting public comments, the document would be in the DG SANCO website for a period of about a month.
8. Evaluation of sludge treatments for pathogen reduction - for opinion
The rapporteur presented the most recent draft. The possible involvement of further experts in the activities of the working group was considered. The draft text had reached an advanced stage and the working group chairman informed that, in his view, pending the submission of any further comments, he considered the draft opinion practically finalised.
The WG chairman recognised that there might still be a need for a further working group meeting though, again, such a prospect would be dependent upon any comments and the respective nature. The WG chairman suggested that any comments that any CSTEE member might still want to make should be sent within the subsequent couple of weeks after the plenary.
The CSTEE secretariat took the task of organising a WG meeting if necessary.
9. The availability of substitutes for soft PVC containing phthalates in certain toys and childcare articles (RPA final report ETD/99/502498) - for opinion
The draft prepared by the rapporteur had been sent by the CSTEE secretariat by e-mail prior to the meeting. Only concurring comments had been received. A contribution from the SCF representative in the CSTEE phthalates working group was noted. This too was a concurring comment. The draft was adopted as the CSTEE opinion. It is available in:
http://ec.europa.eu/food/fs/sc/sct/outcome_en.html#opinions
10. (i) Carcinogenic and non-carcinogenic effects of Cadmium, Nickel and Arsenic in ambient air - progress report
Two working group meetings had taken place, one on 13 February 2001 and another one on 5 March 2001. The individual rapporteurs responsible for each presented the respective drafts. Only the one on Nickel would be adopted as a CSTEE opinion. It was suggested by one CSTEE member, and this was agreed, that a disclaimer should be included in all to say:
Following the terms of reference, this opinion focuses on specific questions related to human health issues and does not cover ecosystems protection.
(ii) Derivation of limit values for PAH in ambient air - progress report
The draft prepared by the rapporteur was discussed but the nature of the debate did not allow for an adoption at this plenary. The need for some tables was expressed, one of which on toxic equivalent factors, and the rapporteur undertook to provide these. The CSTEE chairman suggested that the committee should have access to the so-called Swedish report. The rapporteur provided a copy, which the CSTEE secretariat undertook to distribute to the CSTEE.
11. Proposed standards for a revised bathing water directive - progress report
The composition of the working group was revised. The WG chairman informed that input from one or more microbiologists was necessary. The CSTEE secretary informed that this sort of expertise was already in principle available. A starter WG meeting was felt needed and the CSTEE secretary took the task of arranging this once the WG composition would be finalised. The need to establish a link with the 'Water Framework Directive' WG was also expressed and here too the CSTEE secretary informed that this had been ensured.
12. Health effects of Radio Frequency and Electromagnetic fields - progress report
The need to proceed with the finalisation of the composition of the working group was also underlined and the need to involve statisticians and biophysicists was mentioned. It was noted that a working group meeting also needed to be organised soon. The CSTEE secretary informed the committee that this subject is one on which the secretariat is being literally inundated with calls with information requests on the scope of the CSTEE involvement, mandate, conclusions that the committee might have reached so far, etc.
13. 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) - progress report
Given the burden of work regarding his contribution to the 'Cadmium in the air' WG, which has proved greater than anticipated, the rapporteur for this opinion request was unable to have a preliminary draft ready for this plenary. An oral account was made however. He highlighted in particular the shortcomings of the report on the 'exposure' side. A working group was set up to deal with this issue and the rapporteur undertook to write a draft.
14. Participation of the CSTEE in activities/working groups of other scientific committees of the Commission
a) Toxicity of minerals such as Cu and Zn in animal feed regarding the possible environmental impact of these minerals - activity of the SCAN
The secretary of the SCAN presented the issue. The opinion request involves two questions, one on Cu and another on Zn. In principle other 'trace' elements will be addressed also later. A WG will be soon set up within the SCAN to tackle this and they would like two CSTEE members to join the 'horizontal' group. The main objective is the harmonisation of the addressing of this subject. The objective is also to seek a harmonised position between different opinions adopted between different 'vertical' groups.
Two CSTEE members were appointed to be involved in this activity. One of them commented on the difficulties posed by the SCAN approach. The SCAN secretary explained that these are due to the specificity of the submission of dossiers under legislation that goes back to the early eighties and this legislation is limited in the obligation it imposes which make them relatively 'week' by modern standards.
The CSTEE members expressed the wish to receive documentation as soon as possible. Others said that the CSTEE should be kept regularly informed of the appointed CSTEE member's involvement in this exercise. A third CSTEE member (absent in this plenary) had also expressed interest in being also involved actively.
b) Other
There was no other active involvement on the part of any CSTEE member to report on.
15. Strategies for dealing with emerging issues identified by the SSC and for which the CSTEE is the 'lead' committee:
a) Endocrine disruption (Human health)
The WG chairman 'revisited' the WG composition. Several names were suggested as possible future participants, particularly given that the CSTEE should now address namely the 'human health effects' part (as opposed to the environmental one that had been the main focus of its own initiative report/opinion on 'Human and Wildlife Health Effects of Endocrine Disrupting Chemicals, with Emphasis on Wildlife and on a Ecotoxicology Test Methods' expressed at the 8th CSTEE plenary meeting, Brussels, 4 March 1999,).
The CSTEE secretary undertook the task of drafting a mandate to the CSTEE, for formalising its involvement on this own initiative opinion. It was reminded that this was also an area on which the SSC had recently suggested (at the occasion of a recent Scientific Steering Committee plenary meeting) that the CSTEE should be made 'chef de file' given the still emerging nature of the problem.
It was suggested that the working group should include members of the SCP, the SCAN and the SCVMPH. The former two committees had already nominated the respective representatives.
b) Indoor pollution
This is a subject on which the CSTEE had long ago expressed the view that it deserved a CSTEE own initiative report. Apparently others outside the committee also agree that it is a relevant subject in its own right. This subject was also deemed by the SSC to be one of the three mentioned emerging issues for which the CSTEE should be made responsible.
The composition of the WG was discussed and some committee members volunteered. A CSTEE member undertook to draft a mandate for the committee. The general expertise needed was discussed and some CSTEE members undertook also to inform the CSTEE secretary of external experts who could contribute to this activity in the light of the identified areas where expertise might be lacking in the committee.
16. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission
a) Draft CPMP discussion paper on environmental risk assessment of medicinal products - document from the London EMEA
A fax was received from the London EMEA, requesting the CSTEE's views on a draft CPMP paper on the 'Environmental risk assessment of medicinal products'. Some CSTEE members welcomed this opinion request as, they said, it is a critical issue. Some CSTEE members wondered whether this could not be a good opportunity to develop the subject further. One CSTEE member said that information on concentration of pharmaceutical products in the environment was necessary. The CSTEE secretary informed that the EMEA needed the opinion before the end of July 2001 at the latest.
A tentative working group was formed and the appointed chairman/rapporteur undertook to prepare a draft on the subject.
b) Other
There was none.
17. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
No Commission service was represented for this agenda point but the CSTEE secretary gave an overview of the so-called 'Lead problem' (the CSTEE has still outstanding an opinion request on lead to which it should respond once a general report allowing the committee to carry out its peer review will be available). At the recently held meetings of the competent authorities (CAs) responsible for Regulation 793/93 and Directive 67/548 in Paris an Industry proposal (EUROMETAUX) on a voluntary risk assessment of lead was described. EUROMETAUX recalled that these actions had been initiated further to a formal letter from DG ENV to CEFIC asking for more commitment from Industry in the initial hazard assessment conducted under the ICCA initiative. DG ENV asked at that time to start assessing the substances, which were included on the EU Working List. EUROMETAUX expressed the need for guidance from the CAs and for a peer review of the reports. At the CA's meeting the CSTEE secretary underlined the urgency for lead risk assessment in relation to the Danish notification and also that there is a general opinion request on Lead submitted to the CSTEE the tackling of which by the committee is still outstanding. The understanding is that the committee would address the subject once a comprehensive risk assessment report would be available for peer-review.
Commenting on the initiative one CSTEE member wondered why was this necessary since there is already a quite good OECD document on the subject.
18. Update on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
a) Harmonisation of Risk Assessment Task Force and Working groups
The CSTEE chairman provided an update of the most recent activities. Regarding the 'harmonisation of risk assessment' exercise, and following a 1st report, the activity should now proceed. Each scientific committee was invited to have a member representing the respective committee. Note was taken of who would be the CSTEE representatives. The next meeting of the WG was scheduled for 12 March 2001. The activities would proceed by means of working groups of which there are two for the moment, i.e. 'Chemicals' and 'Environment'. The chairman informed committee members that volunteers would be welcomed to participate in the exercise. The 'Chemicals' working group should devote a particular attention to quantitative risk assessment. The SSC agreed to further the initiative on 'probabilistic risk assessment', an area which has implications to several Commission services.
Regarding the 'Environment' working group there was a 'specialisation' on quantitative risk assessment as well. Working procedures within the various groups have yet to be approved and the time scale is very long since the timeframe foreseen is of about three years.
One committee member expressed the view that since there is an enormous amount of information available a convergence of approaches is necessary. Another member suggested that this activity should wait for the finalisation of the TGD revision underway under the auspices of the ECB to which the CSTEE chairman replied that, while this would be a good idea, the fact is that the TGD finalisation is essentially relevant for the CSTEE's areas of work whereas the SSC activity is of concern to all Commission scientific committees.
Another committee member wondered whether the EC has a budget for carrying out literature reviews since these are necessary upfront before such an exercise starts. The answer to this was that this aspect of the problem should be raised at a SSC meeting. This proposal met the agreement of the CSTEE.
b) Cross committee's collaboration
Subjects such as the involvement of the CSTEE on the Dioxin's issue, currently being evaluated by the SCF, were discussed. A CSTEE member was appointed to represent the CSTEE in the SCFs meetings where the subject will continue to be discussed.
The 2nd vice-chairman of the CSTEE suggested that the CSTEE should be involved in the peer-review of a guideline document for the risk assessment of pesticides.
19. Arrangements for the next (23rd) plenary meeting of the CSTEE
As was the case with this one, the 23rd plenary should also be a one and a half-day meeting, scheduled for 24/25 April 2001 (Note: because of difficulties of various natures, namely the difficulty that some CSTEE members had in finding hotel rooms in Brussels or its vicinity, the meting would finally be a one day one only, held on 24 April 2001).
20. Any other business
The 2nd vice-chairman expressed the view that Commission services and the CSTEE secretariat should agree on terms of reference for interim opinions and final opinions relative to the subjects 'Water Framework Directive' and ''TGD'.
A Commission official (representing DG SANCO/B) informed the committee of the possible forthcoming submission of an opinion request on TBTs. This is an issue for which other Commission services are also responsible, given that each addresses this group of chemicals from a different standpoint (i)TBTs in ships hulls paints and ii)in baby nappies). The concern of course is also that these chemicals may contaminate the food chain. In principle draft terms of reference will be sent o the CSTEE secretariat soon.
Another opinion request is likely to be submitted to the committee soon on two major studies carried out in Europe, concerning the subject of 'drinking water quality'.
Finally one CSTEE member gave an oral account of a meeting recently held in London concerning the subject of 'Expert consultation on statistical extrapolation techniques for environmental effects assessment'.
AGENDA -
1. Welcoming address, apologies for absence, declarations of interest
2. Adoption of the draft agenda
3. Approval of the draft minutes of the 21st CSTEE plenary meeting
4. CSTEE working procedures
5. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) Acrylamide
b) Dibutyl Phthalate
c) Acrylonitrile
d) Methyl methacrylate
B. Status report/opinion (Environment) on:
Methyl-tert-Butyl Ether
C. Status report/opinion (Human health) on:
Nonylphenol and nonylphenol (branched) (human health only)
D. State of play regarding other substances evaluated under the ESR
E. Input of the CSTEE into the revision of the 'Technical Guidance Document' in support of Regulation 793/93
6. Margins of safety - for opinion
7. The use of exposure data in risk assessments - final paper
8. Evaluation of sludge treatments for pathogen reduction - for opinion
9. The availability of substitutes for soft PVC containing phthalates in certain toys and childcare articles (RPA final report ETD/99/502498) - for opinion
10. (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
11. Proposed standards for a revised bathing water directive - progress report
12. Health effects of Radio Frequency and Electromagnetic fields - progress report
13. 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) - progress report
14. Participation of the CSTEE in activities/working groups of other scientific committees of the Commission
a) Toxicity of minerals such as Cu and Zn in animal feed regarding the possible environmental impact of these minerals - activity of the SCAN
b) Other
15. Strategies for dealing with emerging issues identified by the SSC and for which the CSTEE is the 'lead' committee:
a) Endocrine disruption (Human health)
b) Indoor pollution
16. Strategies for dealing with additional opinion requests submitted by other DGs of the Commission
a) Draft CPMP discussion paper on environmental risk assessment of medicinal products - document from the London EMEA
b) Other
17. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
18. Update on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
a) Harmonisation of Risk Assessment Task Force and Working groups
b) Cross committee's collaboration
19. Arrangements for the next (23rd) plenary meeting of the CSTEE
20. 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, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, 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
JOINT RESEARCH CENTRE:
Mrs. Sharon MUNN
