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Directorate-General for Health and Food Safety
1. Welcoming address, apologies for
absence and declarations of interest
The Chairman of the CSTEE welcomed all the participants and reminded them that this was the penultimate meeting of the current committee.
Apologies were received from Professor R. Wennig and Doctor M. Costello
Doctor J. Tarazona declared his involvement in the elaboration of the Risk Assessment Report (RAR) on Acetonitrile on behalf of the Spanish authorities (Spain was the rapporteur Member State for this substance), to be discussed under point 5A of the agenda. Therefore he declined to participate in the discussions.
2. Adoption of the draft agenda
The agenda was adopted. Agenda item 7 was agreed to be discussed after the 9th.
3. Adoption of the draft minutes of the 17th CSTEE plenary meeting held on the 5th of September 2000 in Brussels
The minutes of the 17th plenary meeting were discussed. Some modifications were requested. Apart from some very minor editorial considerations, the main remarks related to point 5 of the agenda (Validation of test methods for phthalate migration), on the temperature for the LGC stringent horizontal shaking method and on the need for further in vivo studies in order to obtain conversion factors for the different compounds. A note on the setting up of a working party on Margins of Safety (MOS), decided at the 17th plenary meeting, as well as a reference to a question on the revision of the paper on Chemicals Strategy by Environment DG, was included also in the minutes.
With those changes the minutes were adopted by the CSTEE.
4. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - for opinion
The chairman of the working party updated the committee on the issue. A pre-final draft had been distributed during the 17th plenary meeting of the committee and comments on it had been sent by CSTEE members. He informed about some of them, e.g. the homogeneity between the media, and the differences between terrestrial and aquatic environments, both in terms of distribution and in terms of routes of intake. The CSTEE decided that a new point should be added to the draft opinion to cover that particular issue.
A CSTEE member commented on the paragraph of the draft opinion on hazard identification and toxicity tests (pages 143-144 of the draft). There were no references to endocrine disruption, while in the previous CSTEE opinion on the issue (March 1999) it had been said that in some cases toxicity tests cannot be sufficient. The WG chairman proposed to include some sentences filling in such a gap in the report and requested forms of words. He considered that a final draft would be surely ready for consideration at the last plenary meeting of the current CSTEE, scheduled for 9 November 2000.
The WG chairman informed also that the draft opinion had been presented at the meeting of the working group on classification and labelling held in Ispra in late September 2000. The document was well received there. The chapters on biomagnification and bioacummulation were considered of great importance for the group revising the Technical Guidance Document in support of Reg. 793/93. Once approved the CSTEE opinion should be included as a basic document of that working area.
The CSTEE chairman expressed the view that the document was a very important one and congratulated the WG members for the extraordinary work they had done. He also asked for an appropriate dissemination of the document of the same kind as that given to the opinion on Endocrine Disruption (March 1999). An additional possibility considered by the WG members was to extract some specific parts of the document to be sent for publication in scientific peer-reviewed literature.
5. Regulation 793/93 on Existing substances (ESR):
A representative from JRC-ECB informed the committee that a risk reduction strategy meeting previously foreseen for November of the current year had been cancelled. Therefore, there was no particular priority regarding the adoption of any RAR related opinion above another during the 18th plenary meeting of the CSTEE.
The rapporteur for the documents on the first three substances mentioned below (1,4 Dioxane, 1,4 Dichlorobenzene and 4-Chloro-2-Methylphenol) explained that comments had been received from different CSTEE members and included in the drafts distributed as room documents during the meeting. He informed that he had requested a WG meeting, now scheduled for the 24 October 2000. Confirmation of this should be provided by the secretariat to the WG members.
A. Status reports/opinions (Human health & Environment) on:
a) 1,4 Dioxane
The rapporteur explained that in general the RAR was a good one and acceptable to the CSTEE. The main problem regarded the difficulty in evaluating it. Confidential annexes had not been provided to the committee and therefore it had to rely on the data included in the report.
A CSTEE member expressed certain concern, supported by some other members, because of the classification of the product as a "possible carcinogen", category 2B of the IARC (International Agency for Research on Cancer), not mentioned in the report. He offered to draft a text reflecting this, to be included in the opinion.
Regarding the exposure part of the report, one CSTEE member was surprised by the fact that the emissions from products had been neglected; since Dioxane is widely used as a solvent, e.g. in paints and glues, emissions should be considered. Accordingly, Comments had already been sent to the rapporteur.
Another CSTEE member took the task of preparing some comments on Dioxane in water for the rapporteur to consider, together with the previous ones, and prepare a final draft for the next plenary meeting.
b) 1,4 Dichlorobenzene
The rapporteur pointed out that there was quite a big number of concerns on the risk assessment report, e.g. risks from its presence in the atmospheric compartment, accumulation in plants and classification as ready biodegradable (this one stated in the report but questionable). A CSTEE member stressed the fact that Dichlorobenzene accumulates in sludge and lake sediments. Regarding biodegradability she warned the committee about the fact that the study mentioned in the report bases the biodegradability of the chemical on oxygen consumption, a criterion which for this particular one is not acceptable, it should instead be based on carbon dioxide evolution.
Biodegradability of the compound was considered a key point for various CSTEE members. One of them asked also for the actual documentation on which the statements of the report were based. A committee member pointed out that one of the referenced documents, Calamari 1982, was aimed more at assessing the toxicity of the compound rather than at biodegradation.
Another CSTEE member expressed serious concern about the issue of hepatocarcinogenicity of the product. He had drafted a paragraph about it to be sent to the rapporteur for inclusion in the draft opinion. He pointed out also some inconsistencies in the presentation of the document, making it less than reliable. A representative from JRC-ECB asked for more clear indications on the part or parts of the documents to which such references were made. On the other hand a CSTEE member considered that the exposure part was excellent. The atmospheric part was also considered acceptable by the committee, but not the conclusion, which is not in conformity with the evaluation of the report. Therefore the committee's opinion should recommend changing the conclusion.
Some CSTEE members considered that the leaching potential of the compound should be mentioned in the report due to its potential action for the contamination of ground water. That applies not only to Dichlorobenzene but to Dioxane and Methacrylic acid as well.
A CSTEE member pointed out a possible problem in the relation PEC/PNEC. If the biodegradability of the product is in the order of 10 to 20 days then a multiplying factor of 4 should be applied and, therefore, the ratio PEC/PNEC will be above 1; this implies clear concern.
The committee was also concerned about the very low margins of safety (MoS), well below 100, considered acceptable by the report. The committee agreed that very good scientific reasons are needed to use margins of safety below 100 if health protection is to be guaranteed.
Concern was also raised on sensitisation and carcinogenic properties. The original documents referenced in the report on those effects should be checked and comments sent to the CSTEE member rapporteur for the opinion. A final draft should be ready for consideration at the 19th plenary meeting.
c) 4-Chloro-2-Methylphenol
No draft was yet ready for discussion. The rapporteur presented a very preliminary view on the report. Some foreseen problems were mentioned, for instance, accumulation on vegetables.
One member asked for more consideration on the potential of the chemical as endocrine disrupter. Should that be the case it would entail very important changes in the evaluation of the product, whose PNEC is based on chronic toxicity on fish, relying only on short term toxicity studies, and that should be changed if potential for endocrine disruption were proved.
d) Acetonitrile
The rapporteur for that substance presented a first oral account. He made a short explanation of the human health part of the product. Another CSTEE member took the responsibility of drafting the environment part and sending it to him for inclusion in the draft opinion.
e) Methacrylic acid
The rapporteur described the characteristics of the product under study. Some CSTEE members commented on different aspects that should be taken into account in the drafting of the opinion, among them chronic effects and accumulation.
B. State of play regarding other substances evaluated under the ESR
A representative from the JRC-ECB informed about the status of RARs on substances recently sent or about to be sent to the CSTEE. The reports on Anisidine and Acrylonitrile had been already received by the secretariat. The human health part of the RAR on Nonylphenol should be soon ready to be sent. The list for informal consultation had been completely changed because some of the reports had been completed since the previous list was sent.
The RAR on the human health part of Nonylphenol was described a priority for an opinion.
The CSTEE secretary informed about a meeting organised by the Commission and attended by Member States representatives that had taken place the week before the plenary on the process to evaluate substances under regulation 793/93. During the meeting proposals for improving the Regulation 793/93 process were presented. This could affect in one way or another the involvement of the CSTEE in the RAR evaluations. In the CSTEE chairman's view the so-called "informal consultation" could be a way for improving the process. A representative from the ECB expressed her support to that initiative. The CSTEE secretary expressed a certain concern on how this could affect the committee, especially in terms of workload.
6. The use of exposure data in risk assessments - progress report
The chairman of the WG reported to the committee on the latest progress made by the party. First drafts for the first two chapters of the document had already been prepared and the contents list had been revised. New drafts were expected shortly and the idea was to have a final draft of the document ready by Christmas 2000.
The CSTEE chairman considered that the document once finalised would be a very important one and encouraged all WG members to try and have some draft ready by December or January. He also expressed his view that the proposed SSC document on harmonisation of risk assessment most probably would state that exposure assessment is one of the weaknesses of the process. Therefore the CSTEE document would be even more important.
7. 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 - progress report/for opinion
The chairman of the respective working party updated the committee on the latest developments. Two different questions on the issue had been presented in the past: a first one on a priority list of substances and another one on ecological quality.
Two meetings on the priority list had been scheduled, back to back, for late September by the responsible Commission service. Member States representatives were invited, but stakeholders were so only to the second one. The chairman of the WG, acting as a representative of the CSTEE, was invited to the second day, something he considered not to be in conformity of the status of the CSTEE and therefore he did not attend the meeting. He was also invited to submit written comments on the document already distributed by Environment DG, but he did not considered appropriate to express his position in writing on the issue without a previous endorsement of the committee.
The CSTEE secretary explained that he had received information from Environment DG in the sense that the invitation to the CSTEE WG chairman only to the second day had been a mistake caused by time constraints.
Regarding the second opinion request, the chairman informed the committee that some documents for which the WG had been waiting for a long time had been finally received and two meetings were scheduled, respectively for the 10 and the 30 October 2000. It was uncertain whether a draft opinion would be ready for adoption at the plenary meeting of 9 November.
8. Margins of safety - progress report
The chairperson of the working party explained about its setting up, decided at the 17th plenary meeting of the CSTEE when she commented on the low MoS accepted in the risk assessment report for Dichlorobenzene.
She reported on the WG meeting that had taken place from 8h00 to 10h00 the very same day of the 18th plenary meeting. After a discussion on some issues (e.g. uncertainty factors, the revision of the TGD for the RA of chemicals and a paper from an IPCS meeting) the main part of the meeting was aimed at defining how deeply should the committee go in its opinions and the borderline between risk assessment and risk management. The majority of the WG supported the idea that it was the role of the committee to comment on the reliability of the MoS and the NOAELs and exposure assessment part.
Regarding the future activities of the party, the CSTEE secretary was asked to discuss with the ECB on how to co-operate with them on the revision of the TGD. It was considered also useful to prepare a document on the standard factor of 100 for the MoS and on under what circumstances lower margins could be acceptable. A review of the previous CSTEE opinions was deemed necessary as a first step, to check on whether the committee had been consistent. The chairperson of the working party took the responsibility of that task.
The CSTEE secretariat was asked to provide the WG with a copy of the standard terms of reference for the CSTEE opinions on the RARs under regulation 793/93. This was deemed crucial for steering the group.
A WG member expressed his opinion in the sense that three different areas can be defined in the process: (i) the framework, (ii) the extrapolation and (iii) the uncertainty. It is on this third one that judgements are required and where more careful attention is needed to distinguish between science and management. In his opinion no definite and clear rules can be set on that.
A CSTEE member asked for the way or ways in which other committees, such as the Scientific Committee for Food, deal with this issue.
Another CSTEE member suggested considering also the question of the heterogeneity of susceptibility in human populations.
The question on how in certain cases the committee could avoid considering the general conclusions of the reports was also raised. For instance, when it agrees with the risk assessment, but not with the consequences extracted from them and expressed in the RAR.
Another member expressed the view that stick to the science means to ask always for the whole set of information needed for the evaluation of any chemical, regardless of any regulatory obligation. Another member considered that he agreed with that but that a pragmatic approach has to be taken into account. For instance, given the need for speeding up the evaluation of existing chemicals.
Some committee members expressed the view that the committee could always recommend the adoption of risk reduction measures, when the committee would considered that needed, but not necessarily recommending a particular measure or orienting the manager in one way or another.
The CSTEE secretary informed the committee about the conclusions of an OECD workshop on risk communication, which had taken place in Berlin some weeks before the plenary. It is clear that limits between risk assessment and risk management are not always easy, but for the sake of a proper risk communication involvement in each others fields is sometimes necessary.
9. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
A. Evaluation of sludge treatments for pathogen reduction
A representative from Environment DG introduced the issue. He briefly presented the legislative frame for the treatment of sewage sludge, with special attention to Directive 86/278. One of the aims of the revision of the directive is to better define what is meant by the term "treated sludge", which currently is defined in a broad and perhaps vague way, and to set clear parameters to determine it. The final objective is to reduce the possibility of spreading pathogens, metals, etc. together with the sludge. He explained that in the past some cases of contamination, e.g. of cattle, had been produced because of use of untreated sludge in pastures.
About one half of the sludge produced in Europe, he said, is used in agriculture. Furthermore, a substantial increase in the production of it at European level was expected due to the implementation of directive 91/271 on urban wastewater treatment.
The revision intents to regulate all kind of sludge, not only sewage sludge but also e.g. food production sludge, and any kind of spreading in soil, apart from agricultural land.
The study on which the committee was being invited to express an opinion would be used by the Commission to regulate the use of sludge, in terms of better defining what is meant by "treatment" and tightening the rules on the use of untreated sludge. A representative from WRc, the consultants that produced the report, presented it and some questions on it were asked to him, among them on: (i) pathogens resistant to heat and chlorinated treatments; (ii) wildlife; (iii) metals; (iv) spores, etc. Replies were given both by the WRc representative and by the Environment DG representative.
The representative from Environment DG stressed the importance of the distinction proposed in the report between advanced treated sludge and conventionally treated sludge. The rules for spreading it would be much more restrictive for the conventional than for the advanced one. He also explained that metals were not considered at all in the report because this was only intended to cover pathogens in sludge. He, nevertheless, asked the committee to highlight in its opinion all the gaps that it may observe in the program.
One CSTEE member pointed out the absence in the report of any reference to the potential wash-off of sludge into the aquatic environment, and also to the interface between impacts on wildlife and human health.
A CSTEE member asked the Environment DG representative about the possibility of harmonising or creating a general framework on the whole use of sludge and other related matters, e.g. animal manure or nitrogen, and their use in soil. The answer was that the revision of the directive intends only to control the use of sludge. He recognised, nevertheless, that it is an important gap, given that sludge represents a minimal part of the products used in agriculture, compared to manure.
The same CSTEE member reminded that in European legislation there are criteria for water and air quality but not for soil quality and asked on whether some harmonisation on that was foreseen, at least for heavy metals. The representative from Environment DG explained that, although the actual question asked to the CSTEE only addresses pathogens in sludge, another aspect of the revision of the directive envisages the control of heavy metals in sludge. Much more difficult would be to control the risks posed by the presence of heavy metals in soil.
The CSTEE secretary commented on the terms of reference of the opinion request agreed between the secretariat and Environment DG. A tentative working group was set up to deal with this opinion request and its chairman was chosen. It was strongly recommended to have some external co-operation from other scientific committees being managed by the Health and Consumer Protection DG. Some specific names were suggested. It was also suggested to integrate in it an expert on parasitology.
B. Other
A representative from Environment DG explained briefly that an opinion could be sent in the near future to the CSTEE on the issue of metals in air. She also explained that some controversy had been raised about Nickel and certain effect levels interpreted alternatively as NOAELs or LOAELs. Other questions could be possible on Arsenic and Cadmium. A short explanation was given to her on the way the committee works, time schedule, etc.
10. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
The CSTEE secretary informed shortly about the follow up of the opinion on Cadmium in fertilisers, expressed at the 17th plenary meeting of the CSTEE and on the revision of a paragraph of the Technical Notes for Guidance for the Directive on biocides, expressed also in the previous plenary of the committee.
11. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
Regarding the BSE issue, the CSTEE chairman informed about the latest developments on it.
Apart from that, three other areas of interest were signaled. One was a paper being prepared by the SSC on GMOs, to be adopted by the end of October. The second one was a list of emerging issues which can be expected for the future. The last one was the "harmonisation of risk assessment" report. On this last issue a first list of recommendations was distributed during the meeting for members' comments.
12. Arrangements for the next (last) meeting of the current CSTEE (9th of November 2000) and the 1st meeting of the next CSTEE
The CSTEE secretary informed the committee about the impossibility of organising the two meetings in the originally scheduled way. It was decided to schedule the first meeting of the new CSTEE for the 5th December 2000.
A CSTEE member requested a change in the date for the last meeting of the current CSTEE, from the 8th to the 9th November 2000. This change was considered agreeable by all the CSTEE members.
The CSTEE secretariat confirmed the dates for the following WG meetings: two for the one on the Water Framework Directive, on 10 and 30 October 2000, and one of the steering group on Regulation 793/93 for the 24 October.
13. Any other business
One committee member asked for the state of the document on the insufficient resources on Toxicology, Ecotoxicology and Epidemiology in Europe. The CSTEE chairman explained that a document on that had already been sent from the SSC to the competent Commission services and a response was awaited. The issue was also included in the harmonisation of risk assessment report.
A representative from JRC-ECB asked on whether or not some measures were envisaged from Health and Consumer Protection DG on the limits of Cadmium in food. The reply was that the competent committee for that was the Scientific Committee for Food. The CSTEE chairman offered to consult the SCF one on the issue.
- AGENDA -
1. Welcoming address, apologies for absence and declarations of interest
2. Adoption of the draft agenda
3. Adoption of the draft minutes of the 17th CSTEE plenary meeting held on the 5th of September 2000 in Brussels
4. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - for opinion
5. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) 1,4 Dioxane
b) 1,4 Dichlorobenzene
c) 4-Chloro-2-Methylphenol
d) Acetonitrile
e) Methacrylic acid
B. State of play regarding other substances evaluated under the ESR
6. The use of exposure data in risk assessments - progress report
7. 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 - progress report/for opinion
8. Margins of safety - progress report
9. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
A. Evaluation of sludge treatments for pathogen reduction
B. Other
10. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
11. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
12. Arrangements for the next (last) meeting(s) of the current CSTEE (8th of November 2000) back to back with 1st meeting of the next CSTEE (9th of November 2000)
13. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James BRIDGES, Prof. Peter CALOW, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Bo O. JANSSON, Prof. Soterios A. KYRTOKOPOULOS, Dr. Ole LADEFOGED, Dr. Claude LAMBRÉ, Dr. José RUEFF, Prof. Mirja S. SALKINOJA-SALONEN, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, Prof. Janneche UTNE-SKÅRE, Prof. Katarina VICTORIN, Prof. M. VIGHI, Prof. Joseph G. VOS.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mrs. Silvia BERNAL-BLANCO, Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE, Mrs. Mercedes de SOLÀ, Mrs. Angelika WILHELM.
ENVIRONMENT DG:
Mrs. María José CARROQUINO, Mr. Luca MARMO.
JOINT RESEARCH CENTRE:
Mrs. Sharon MUNN.
The Chairman of the CSTEE welcomed all the participants and reminded them that this was the penultimate meeting of the current committee.
Apologies were received from Professor R. Wennig and Doctor M. Costello
Doctor J. Tarazona declared his involvement in the elaboration of the Risk Assessment Report (RAR) on Acetonitrile on behalf of the Spanish authorities (Spain was the rapporteur Member State for this substance), to be discussed under point 5A of the agenda. Therefore he declined to participate in the discussions.
2. Adoption of the draft agenda
The agenda was adopted. Agenda item 7 was agreed to be discussed after the 9th.
3. Adoption of the draft minutes of the 17th CSTEE plenary meeting held on the 5th of September 2000 in Brussels
The minutes of the 17th plenary meeting were discussed. Some modifications were requested. Apart from some very minor editorial considerations, the main remarks related to point 5 of the agenda (Validation of test methods for phthalate migration), on the temperature for the LGC stringent horizontal shaking method and on the need for further in vivo studies in order to obtain conversion factors for the different compounds. A note on the setting up of a working party on Margins of Safety (MOS), decided at the 17th plenary meeting, as well as a reference to a question on the revision of the paper on Chemicals Strategy by Environment DG, was included also in the minutes.
With those changes the minutes were adopted by the CSTEE.
4. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - for opinion
The chairman of the working party updated the committee on the issue. A pre-final draft had been distributed during the 17th plenary meeting of the committee and comments on it had been sent by CSTEE members. He informed about some of them, e.g. the homogeneity between the media, and the differences between terrestrial and aquatic environments, both in terms of distribution and in terms of routes of intake. The CSTEE decided that a new point should be added to the draft opinion to cover that particular issue.
A CSTEE member commented on the paragraph of the draft opinion on hazard identification and toxicity tests (pages 143-144 of the draft). There were no references to endocrine disruption, while in the previous CSTEE opinion on the issue (March 1999) it had been said that in some cases toxicity tests cannot be sufficient. The WG chairman proposed to include some sentences filling in such a gap in the report and requested forms of words. He considered that a final draft would be surely ready for consideration at the last plenary meeting of the current CSTEE, scheduled for 9 November 2000.
The WG chairman informed also that the draft opinion had been presented at the meeting of the working group on classification and labelling held in Ispra in late September 2000. The document was well received there. The chapters on biomagnification and bioacummulation were considered of great importance for the group revising the Technical Guidance Document in support of Reg. 793/93. Once approved the CSTEE opinion should be included as a basic document of that working area.
The CSTEE chairman expressed the view that the document was a very important one and congratulated the WG members for the extraordinary work they had done. He also asked for an appropriate dissemination of the document of the same kind as that given to the opinion on Endocrine Disruption (March 1999). An additional possibility considered by the WG members was to extract some specific parts of the document to be sent for publication in scientific peer-reviewed literature.
5. Regulation 793/93 on Existing substances (ESR):
A representative from JRC-ECB informed the committee that a risk reduction strategy meeting previously foreseen for November of the current year had been cancelled. Therefore, there was no particular priority regarding the adoption of any RAR related opinion above another during the 18th plenary meeting of the CSTEE.
The rapporteur for the documents on the first three substances mentioned below (1,4 Dioxane, 1,4 Dichlorobenzene and 4-Chloro-2-Methylphenol) explained that comments had been received from different CSTEE members and included in the drafts distributed as room documents during the meeting. He informed that he had requested a WG meeting, now scheduled for the 24 October 2000. Confirmation of this should be provided by the secretariat to the WG members.
A. Status reports/opinions (Human health & Environment) on:
a) 1,4 Dioxane
The rapporteur explained that in general the RAR was a good one and acceptable to the CSTEE. The main problem regarded the difficulty in evaluating it. Confidential annexes had not been provided to the committee and therefore it had to rely on the data included in the report.
A CSTEE member expressed certain concern, supported by some other members, because of the classification of the product as a "possible carcinogen", category 2B of the IARC (International Agency for Research on Cancer), not mentioned in the report. He offered to draft a text reflecting this, to be included in the opinion.
Regarding the exposure part of the report, one CSTEE member was surprised by the fact that the emissions from products had been neglected; since Dioxane is widely used as a solvent, e.g. in paints and glues, emissions should be considered. Accordingly, Comments had already been sent to the rapporteur.
Another CSTEE member took the task of preparing some comments on Dioxane in water for the rapporteur to consider, together with the previous ones, and prepare a final draft for the next plenary meeting.
b) 1,4 Dichlorobenzene
The rapporteur pointed out that there was quite a big number of concerns on the risk assessment report, e.g. risks from its presence in the atmospheric compartment, accumulation in plants and classification as ready biodegradable (this one stated in the report but questionable). A CSTEE member stressed the fact that Dichlorobenzene accumulates in sludge and lake sediments. Regarding biodegradability she warned the committee about the fact that the study mentioned in the report bases the biodegradability of the chemical on oxygen consumption, a criterion which for this particular one is not acceptable, it should instead be based on carbon dioxide evolution.
Biodegradability of the compound was considered a key point for various CSTEE members. One of them asked also for the actual documentation on which the statements of the report were based. A committee member pointed out that one of the referenced documents, Calamari 1982, was aimed more at assessing the toxicity of the compound rather than at biodegradation.
Another CSTEE member expressed serious concern about the issue of hepatocarcinogenicity of the product. He had drafted a paragraph about it to be sent to the rapporteur for inclusion in the draft opinion. He pointed out also some inconsistencies in the presentation of the document, making it less than reliable. A representative from JRC-ECB asked for more clear indications on the part or parts of the documents to which such references were made. On the other hand a CSTEE member considered that the exposure part was excellent. The atmospheric part was also considered acceptable by the committee, but not the conclusion, which is not in conformity with the evaluation of the report. Therefore the committee's opinion should recommend changing the conclusion.
Some CSTEE members considered that the leaching potential of the compound should be mentioned in the report due to its potential action for the contamination of ground water. That applies not only to Dichlorobenzene but to Dioxane and Methacrylic acid as well.
A CSTEE member pointed out a possible problem in the relation PEC/PNEC. If the biodegradability of the product is in the order of 10 to 20 days then a multiplying factor of 4 should be applied and, therefore, the ratio PEC/PNEC will be above 1; this implies clear concern.
The committee was also concerned about the very low margins of safety (MoS), well below 100, considered acceptable by the report. The committee agreed that very good scientific reasons are needed to use margins of safety below 100 if health protection is to be guaranteed.
Concern was also raised on sensitisation and carcinogenic properties. The original documents referenced in the report on those effects should be checked and comments sent to the CSTEE member rapporteur for the opinion. A final draft should be ready for consideration at the 19th plenary meeting.
c) 4-Chloro-2-Methylphenol
No draft was yet ready for discussion. The rapporteur presented a very preliminary view on the report. Some foreseen problems were mentioned, for instance, accumulation on vegetables.
One member asked for more consideration on the potential of the chemical as endocrine disrupter. Should that be the case it would entail very important changes in the evaluation of the product, whose PNEC is based on chronic toxicity on fish, relying only on short term toxicity studies, and that should be changed if potential for endocrine disruption were proved.
d) Acetonitrile
The rapporteur for that substance presented a first oral account. He made a short explanation of the human health part of the product. Another CSTEE member took the responsibility of drafting the environment part and sending it to him for inclusion in the draft opinion.
e) Methacrylic acid
The rapporteur described the characteristics of the product under study. Some CSTEE members commented on different aspects that should be taken into account in the drafting of the opinion, among them chronic effects and accumulation.
B. State of play regarding other substances evaluated under the ESR
A representative from the JRC-ECB informed about the status of RARs on substances recently sent or about to be sent to the CSTEE. The reports on Anisidine and Acrylonitrile had been already received by the secretariat. The human health part of the RAR on Nonylphenol should be soon ready to be sent. The list for informal consultation had been completely changed because some of the reports had been completed since the previous list was sent.
The RAR on the human health part of Nonylphenol was described a priority for an opinion.
The CSTEE secretary informed about a meeting organised by the Commission and attended by Member States representatives that had taken place the week before the plenary on the process to evaluate substances under regulation 793/93. During the meeting proposals for improving the Regulation 793/93 process were presented. This could affect in one way or another the involvement of the CSTEE in the RAR evaluations. In the CSTEE chairman's view the so-called "informal consultation" could be a way for improving the process. A representative from the ECB expressed her support to that initiative. The CSTEE secretary expressed a certain concern on how this could affect the committee, especially in terms of workload.
6. The use of exposure data in risk assessments - progress report
The chairman of the WG reported to the committee on the latest progress made by the party. First drafts for the first two chapters of the document had already been prepared and the contents list had been revised. New drafts were expected shortly and the idea was to have a final draft of the document ready by Christmas 2000.
The CSTEE chairman considered that the document once finalised would be a very important one and encouraged all WG members to try and have some draft ready by December or January. He also expressed his view that the proposed SSC document on harmonisation of risk assessment most probably would state that exposure assessment is one of the weaknesses of the process. Therefore the CSTEE document would be even more important.
7. 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 - progress report/for opinion
The chairman of the respective working party updated the committee on the latest developments. Two different questions on the issue had been presented in the past: a first one on a priority list of substances and another one on ecological quality.
Two meetings on the priority list had been scheduled, back to back, for late September by the responsible Commission service. Member States representatives were invited, but stakeholders were so only to the second one. The chairman of the WG, acting as a representative of the CSTEE, was invited to the second day, something he considered not to be in conformity of the status of the CSTEE and therefore he did not attend the meeting. He was also invited to submit written comments on the document already distributed by Environment DG, but he did not considered appropriate to express his position in writing on the issue without a previous endorsement of the committee.
The CSTEE secretary explained that he had received information from Environment DG in the sense that the invitation to the CSTEE WG chairman only to the second day had been a mistake caused by time constraints.
Regarding the second opinion request, the chairman informed the committee that some documents for which the WG had been waiting for a long time had been finally received and two meetings were scheduled, respectively for the 10 and the 30 October 2000. It was uncertain whether a draft opinion would be ready for adoption at the plenary meeting of 9 November.
8. Margins of safety - progress report
The chairperson of the working party explained about its setting up, decided at the 17th plenary meeting of the CSTEE when she commented on the low MoS accepted in the risk assessment report for Dichlorobenzene.
She reported on the WG meeting that had taken place from 8h00 to 10h00 the very same day of the 18th plenary meeting. After a discussion on some issues (e.g. uncertainty factors, the revision of the TGD for the RA of chemicals and a paper from an IPCS meeting) the main part of the meeting was aimed at defining how deeply should the committee go in its opinions and the borderline between risk assessment and risk management. The majority of the WG supported the idea that it was the role of the committee to comment on the reliability of the MoS and the NOAELs and exposure assessment part.
Regarding the future activities of the party, the CSTEE secretary was asked to discuss with the ECB on how to co-operate with them on the revision of the TGD. It was considered also useful to prepare a document on the standard factor of 100 for the MoS and on under what circumstances lower margins could be acceptable. A review of the previous CSTEE opinions was deemed necessary as a first step, to check on whether the committee had been consistent. The chairperson of the working party took the responsibility of that task.
The CSTEE secretariat was asked to provide the WG with a copy of the standard terms of reference for the CSTEE opinions on the RARs under regulation 793/93. This was deemed crucial for steering the group.
A WG member expressed his opinion in the sense that three different areas can be defined in the process: (i) the framework, (ii) the extrapolation and (iii) the uncertainty. It is on this third one that judgements are required and where more careful attention is needed to distinguish between science and management. In his opinion no definite and clear rules can be set on that.
A CSTEE member asked for the way or ways in which other committees, such as the Scientific Committee for Food, deal with this issue.
Another CSTEE member suggested considering also the question of the heterogeneity of susceptibility in human populations.
The question on how in certain cases the committee could avoid considering the general conclusions of the reports was also raised. For instance, when it agrees with the risk assessment, but not with the consequences extracted from them and expressed in the RAR.
Another member expressed the view that stick to the science means to ask always for the whole set of information needed for the evaluation of any chemical, regardless of any regulatory obligation. Another member considered that he agreed with that but that a pragmatic approach has to be taken into account. For instance, given the need for speeding up the evaluation of existing chemicals.
Some committee members expressed the view that the committee could always recommend the adoption of risk reduction measures, when the committee would considered that needed, but not necessarily recommending a particular measure or orienting the manager in one way or another.
The CSTEE secretary informed the committee about the conclusions of an OECD workshop on risk communication, which had taken place in Berlin some weeks before the plenary. It is clear that limits between risk assessment and risk management are not always easy, but for the sake of a proper risk communication involvement in each others fields is sometimes necessary.
9. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
A. Evaluation of sludge treatments for pathogen reduction
A representative from Environment DG introduced the issue. He briefly presented the legislative frame for the treatment of sewage sludge, with special attention to Directive 86/278. One of the aims of the revision of the directive is to better define what is meant by the term "treated sludge", which currently is defined in a broad and perhaps vague way, and to set clear parameters to determine it. The final objective is to reduce the possibility of spreading pathogens, metals, etc. together with the sludge. He explained that in the past some cases of contamination, e.g. of cattle, had been produced because of use of untreated sludge in pastures.
About one half of the sludge produced in Europe, he said, is used in agriculture. Furthermore, a substantial increase in the production of it at European level was expected due to the implementation of directive 91/271 on urban wastewater treatment.
The revision intents to regulate all kind of sludge, not only sewage sludge but also e.g. food production sludge, and any kind of spreading in soil, apart from agricultural land.
The study on which the committee was being invited to express an opinion would be used by the Commission to regulate the use of sludge, in terms of better defining what is meant by "treatment" and tightening the rules on the use of untreated sludge. A representative from WRc, the consultants that produced the report, presented it and some questions on it were asked to him, among them on: (i) pathogens resistant to heat and chlorinated treatments; (ii) wildlife; (iii) metals; (iv) spores, etc. Replies were given both by the WRc representative and by the Environment DG representative.
The representative from Environment DG stressed the importance of the distinction proposed in the report between advanced treated sludge and conventionally treated sludge. The rules for spreading it would be much more restrictive for the conventional than for the advanced one. He also explained that metals were not considered at all in the report because this was only intended to cover pathogens in sludge. He, nevertheless, asked the committee to highlight in its opinion all the gaps that it may observe in the program.
One CSTEE member pointed out the absence in the report of any reference to the potential wash-off of sludge into the aquatic environment, and also to the interface between impacts on wildlife and human health.
A CSTEE member asked the Environment DG representative about the possibility of harmonising or creating a general framework on the whole use of sludge and other related matters, e.g. animal manure or nitrogen, and their use in soil. The answer was that the revision of the directive intends only to control the use of sludge. He recognised, nevertheless, that it is an important gap, given that sludge represents a minimal part of the products used in agriculture, compared to manure.
The same CSTEE member reminded that in European legislation there are criteria for water and air quality but not for soil quality and asked on whether some harmonisation on that was foreseen, at least for heavy metals. The representative from Environment DG explained that, although the actual question asked to the CSTEE only addresses pathogens in sludge, another aspect of the revision of the directive envisages the control of heavy metals in sludge. Much more difficult would be to control the risks posed by the presence of heavy metals in soil.
The CSTEE secretary commented on the terms of reference of the opinion request agreed between the secretariat and Environment DG. A tentative working group was set up to deal with this opinion request and its chairman was chosen. It was strongly recommended to have some external co-operation from other scientific committees being managed by the Health and Consumer Protection DG. Some specific names were suggested. It was also suggested to integrate in it an expert on parasitology.
B. Other
A representative from Environment DG explained briefly that an opinion could be sent in the near future to the CSTEE on the issue of metals in air. She also explained that some controversy had been raised about Nickel and certain effect levels interpreted alternatively as NOAELs or LOAELs. Other questions could be possible on Arsenic and Cadmium. A short explanation was given to her on the way the committee works, time schedule, etc.
10. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
The CSTEE secretary informed shortly about the follow up of the opinion on Cadmium in fertilisers, expressed at the 17th plenary meeting of the CSTEE and on the revision of a paragraph of the Technical Notes for Guidance for the Directive on biocides, expressed also in the previous plenary of the committee.
11. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
Regarding the BSE issue, the CSTEE chairman informed about the latest developments on it.
Apart from that, three other areas of interest were signaled. One was a paper being prepared by the SSC on GMOs, to be adopted by the end of October. The second one was a list of emerging issues which can be expected for the future. The last one was the "harmonisation of risk assessment" report. On this last issue a first list of recommendations was distributed during the meeting for members' comments.
12. Arrangements for the next (last) meeting of the current CSTEE (9th of November 2000) and the 1st meeting of the next CSTEE
The CSTEE secretary informed the committee about the impossibility of organising the two meetings in the originally scheduled way. It was decided to schedule the first meeting of the new CSTEE for the 5th December 2000.
A CSTEE member requested a change in the date for the last meeting of the current CSTEE, from the 8th to the 9th November 2000. This change was considered agreeable by all the CSTEE members.
The CSTEE secretariat confirmed the dates for the following WG meetings: two for the one on the Water Framework Directive, on 10 and 30 October 2000, and one of the steering group on Regulation 793/93 for the 24 October.
13. Any other business
One committee member asked for the state of the document on the insufficient resources on Toxicology, Ecotoxicology and Epidemiology in Europe. The CSTEE chairman explained that a document on that had already been sent from the SSC to the competent Commission services and a response was awaited. The issue was also included in the harmonisation of risk assessment report.
A representative from JRC-ECB asked on whether or not some measures were envisaged from Health and Consumer Protection DG on the limits of Cadmium in food. The reply was that the competent committee for that was the Scientific Committee for Food. The CSTEE chairman offered to consult the SCF one on the issue.
- AGENDA -
1. Welcoming address, apologies for absence and declarations of interest
2. Adoption of the draft agenda
3. Adoption of the draft minutes of the 17th CSTEE plenary meeting held on the 5th of September 2000 in Brussels
4. Available scientific approaches to assess the potential effects and risks of chemical substances on terrestrial ecosystems - for opinion
5. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) 1,4 Dioxane
b) 1,4 Dichlorobenzene
c) 4-Chloro-2-Methylphenol
d) Acetonitrile
e) Methacrylic acid
B. State of play regarding other substances evaluated under the ESR
6. The use of exposure data in risk assessments - progress report
7. 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 - progress report/for opinion
8. Margins of safety - progress report
9. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
A. Evaluation of sludge treatments for pathogen reduction
B. Other
10. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
11. Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
12. Arrangements for the next (last) meeting(s) of the current CSTEE (8th of November 2000) back to back with 1st meeting of the next CSTEE (9th of November 2000)
13. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James BRIDGES, Prof. Peter CALOW, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Bo O. JANSSON, Prof. Soterios A. KYRTOKOPOULOS, Dr. Ole LADEFOGED, Dr. Claude LAMBRÉ, Dr. José RUEFF, Prof. Mirja S. SALKINOJA-SALONEN, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, Prof. Janneche UTNE-SKÅRE, Prof. Katarina VICTORIN, Prof. M. VIGHI, Prof. Joseph G. VOS.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mrs. Silvia BERNAL-BLANCO, Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE, Mrs. Mercedes de SOLÀ, Mrs. Angelika WILHELM.
ENVIRONMENT DG:
Mrs. María José CARROQUINO, Mr. Luca MARMO.
JOINT RESEARCH CENTRE:
Mrs. Sharon MUNN.
