- General information enquiries
- Call 00 800 6 7 8 9 10 11
- E-mail your questions
Directorate-General for Health and Food Safety
1. Welcoming address, apologies for
absence. Presentation of the CSTEE secretariat
staff
The Head of Unit C-2 in the Health and Consumer Protection Directorate General, service responsible for the CSTEE, Mrs. Mercedes de Solà, chaired the session at its beginning, until the election of the chairperson and two vice chairpersons had been accomplished.
She welcomed the CSTEE members and congratulated them for their nomination as CSTEE members. She explained the process of renewal and stressed the important role that transparency played in it.
She expressed the gratefulness of the Commission to all the re-appointed members of the Committee and especially to its former chairman, Professor James Bridges, for the excellent work they had performed during the previous three years.
She also welcomed the six new appointed members, and encouraged them to act as a source of new ideas and constructive criticism.
The secretariat staff of the CSTEE was presented.
Apologies were received from Professors Calow, Kyrtopoulos and Vighi.
2. Adoption of the draft agenda
The agenda was adopted.
3. Introduction of members of the CSTEE
Election of its chairperson and of the two vice-chairpersons
The initial chairperson of the session read for the information of CSTEE members the paragraphs of the CSTEE Rules of Procedure related to the election of the chairperson and the two vice chairpersons of the Committee. Afterwards, all the CSTEE members introduced themselves in a "tour de table". For the information of those present the scientific secretary of the CSTEE described the expertise of the three Committee members who were not present at the meeting: Profs. Calow, Kyrtopoulos and Vighi.
The only candidate proposed (by Professor E. Dybing) for chairperson of the Committee was Professor James W. Bridges. Professor Helmut Greim and Doctor Tarazona seconded the proposal. The candidate proposed expressed his willingness to accept the obligations of being the chairman of the CSTEE, should he obtain the support of the majority of the members. Following the rules of procedure of the CSTEE the requirement for secrecy of the election was waived by unanimity of the Committee. Therefore the election took place by raising hands. Professor James W. Bridges was elected chairman of the CSTEE by 15 votes in favour and one abstention.
The same process occurred for the election of the two vice chairpersons. Professor Helmut A. Greim (proposed by Prof. Dybing, seconded by Dr. Tarazona) was elected first vice chairperson and Doctor José Vicente Tarazona was elected second vice chairperson (proposed by Prof. Bridges, seconded by Prof. Dybing). The former was elected by 14 votes in favour and two abstentions while the latter by 15 votes in favour and 1 abstention.
4. Information on the previous Scientific Committee on Toxicity, Ecotoxicity and the Environment. Rules of procedure of the CSTEE. Declarations of interest. Confidentiality. Modalities of payment. Other rules governing the functioning of the activities of the CSTEE
The Head of Unit C2 in Health and Consumer Protection DG, responsible for the CSTEE, introduced herself. She briefly talked about some key points of the rules of procedure of the CSTEE; such an explanation was especially aimed to inform the new members of the Committee but also a reminder to all the others.
Another key point she stressed was the need for transparency and the importance of being as accurate as possible in the declarations of interests of CSTEE members, both in the annual general one as well as in the ones in individual meetings, which could concern some particular issues. She pointed out that any declaration of interest will be reflected in the minutes of the respective meeting and, therefore, published on Internet.
The counterpart to transparency is confidentiality. Only the CSTEE members, Commission officials and invitees are allowed to attend CSTEE meetings, in order to preserve the privacy of the debates, making sure that they are strictly scientific, to assure the independence of the Committee and its opinions and to guarantee that those data which require it are kept confidential. For the same reasons Committee members are asked to sign a declaration of confidentiality.
She informed the Committee that the decision had been taken of publishing in the Internet web site of Health and Consumer Protection DG a short version of the CVs of each Committee member. She therefore asked them to send a copy of a two page CV at their best opportunity.
Finally she also stressed the importance of keeping the independence both of the Committee as a body as well as of each of its members. The meaning of that being that no instructions should be accepted by any Committee member, nor from external instances (such as MSs) neither from any Commission service or official.
The CSTEE secretary shortly presented a set of documents provided to all Committee members for them to be properly informed about certain aspects of the functioning of the Committee (Rules of Procedure, reimbursement of expenses, Commission decisions setting up the Scientific Committees, nomination of experts, etc.) The Rules of Procedure of the former CSTEE were endorsed by this 'new' CSTEE.
Mrs. S. Clarke, from Health and Consumer Protection DG, Unit C-2, explained to all Committee members the procedures for reimbursement of expenses as well as the amount of the indemnities paid by the Commission to experts attending meetings of the Scientific Committees.
Mrs. De Solà offered all the support of the Unit staff and more specifically of the CSTEE secretariat on any need that the members could have. She also explained that the working language of the Committee was English, it had been a decision of the former CSTEE and so it would continue to be in the future. The opinions of the Committee are published only in that language.
Finally she took the opportunity of the meeting to announce that she was leaving Health and Consumer Protection DG for a new post in a different Commission service. She wished all the best to the CSTEE and thanked their members for the joint work performed in the past three years. The elected chairman of the CSTEE thanked her for the support she had provided the Committee during the time she had been in charge of the Unit, pointing out that this was all the more relevant as the committee had gone through some difficult moments during its previous mandate.
From this point on it was the elected chairman of the Committee who chaired the session.
5. Schedule of CSTEE activities/plenary meetings for the remainder of the year 2000 and for the year 2001
The secretary stressed the importance of deciding on the dates for plenary meetings of the Committee, since the setting up of the Scientific Steering Committee meetings schedule depends on those of the other eight scientific committees.
It was agreed that the CSTEE should hold eight plenary meetings during the year 2001 and the dates were set as follows:
21st Plenary: 30 January 2001
22nd Plenary: 6 and 7 March 2001
23rd Plenary: 24 and 25 April 2001
24th Plenary: 12 and 13 June 2001
25th Plenary: 20 July 2001
26th Plenary: 10 and 11 September 2001
27th Plenary: 29 and 30 October 2001
28th Plenary: 6 and 7 December.
The preferred day in case only a single day meeting will be necessary were the following ones: 6 March, 24 April, 12 June, 11 September, 30 October and 7 December.
The CSTEE secretary explained shortly the system of the so-called 'tables of unavailable dates', used by the CSTEE secretariat to set dates for working group meetings and encouraged the CSTEE members to reply as quickly as possible to the demands of the secretariat on this aspect.
6. Regulation 793/93 on Existing substances (ESR):
As an initial remark on that point, the CSTEE chairman proposed not to adopt any of the reports that might have been prepared (on the RAR on Acrylonitrile and Anisidine) for the sake of not presenting the new members with a 'fait accompli'. Because an adoption at the occasion of the following plenary would not pose an unsurmountable problem to the DG requester service (DG Environment) the new members should be given an opportunity to comment on them before the 21st plenary meeting of the Committee, scheduled for the 30 January 2001. The CSTEE accepted this proposal
A. Status reports/opinions (Human health & Environment) on:
a) Acrylonitrile
The rapporteur presented the draft opinion. He considered the Risk Assessment Report (RAR) to be an excellent one and the conclusions as being correct. Some points of concern were signalled such as: the NOAEL proposed upon inhalation studies, and the risk characterisation. Some other minor points were also mentioned.
One CSTEE member asked whether or not the CSTEE should ask for more studies on respiratory sensitisation of the compound. The rapporteur pointed out that the substance is a carcinogen and that this fact implies the need for reduction of exposure to the minimum possible level. Therefore the need for inhalation studies cannot be considered a priority. He proposed, as a consequence, not to make any strong such request.
One CSTEE member highlighted an inconsistency in the draft opinion in stating that the report is an excellent while making also a strong criticism to some important aspects (such as the derivation of NOAEL to 4 ppm). The answer of the rapporteur was that the overall evaluation of the report has to be that it is a good one, although there can be disagreement in some points.
b) Anisidine
The rapporteur presented the draft report and stressed that he would welcome more comments from other CSTEE members. In general he considered the report of good quality. He reminded that the CSTEE had previously expressed an opinion on Azo dyes, relevant, obviously, to this one.
Some comments on the report reflected the need for a control of the products from third countries containing the substance. He, nevertheless, questioned whether this was a point to be considered in a RAR or a risk management issue.
Among other comments on the different aspects of the report, he pointed out that, in the effects assessment section, in the IARC classification of Anisidine references are only made to an IARC evaluation of 1982, while a new one had been issued in 1999 (during the risk assessment process, therefore) reaching different conclusions regarding the genotoxic effects.
One CSTEE member expressed concern on the conclusions on reproductive toxicity (conclusion 1 instead of conclusion 2), not in line, from his point of view, with the recommendations of the Technical Guidance Document (in support of regulation 793/93 - TGD), following the studies available.
Some concern was also expressed on the use of a factor of 10 for the NOEC, based on a long-term toxicity test on the most sensitive species, Daphnia magna. He considered that not to be in agreement with the TGD (where many other tests are required for applying a factor of 10). The rapporteur considered that the combination of short-term toxicity studies for each trophic level with a long-term toxicity study for the most sensitive species allows for the use of a factor of 10. Further consideration by the CSTEE to this point was deemed necessary.
Other comments were made on certain aspects of the report, such as downstream use of the product.
B. State of play regarding other substances evaluated under the ESR
The secretary informed on the next RARs to be evaluated by the CSTEE: Nonylphenol and Nonylphenol (branched), human health part. The RARs were received by the secretariat too late to have paper copies of them prepared and sent to members before this plenary. Two other RARs were also to be received shortly: on Acrylamide and Methyl methacrylate and these will also be sent shortly to all CSTEE members.
For information of the new members the secretariat distributed copies of the minutes of the working group meeting where rules were decided on the working procedure to deal with these RARs. The CSTEE secretary described the document and the mentioned rules. The CSTEE chairman explained that a revision of the rules of procedure for this particular working group was expected for January 2001, as part of the activities of the Working Group on Margins of Safety (MOS).
A representative from Environment DG expressed its gratefulness for the co-operation of the CSTEE and informed that a procedure was being set up to get feedback from the ECB on the 793/93 RARs peer reviewed by the Committee. He also informed that the ECB was going to put the RAR reports on a public web site, sometimes both the draft before and after being reviewed by the CSTEE. Therefore the intervention of the Committee would be made transparent to everybody.
He anticipated another 20 RARs to be finalised within a couple of months, all to be referred to the Committee for opinion. He welcomed any general comments from the CSTEE, and assured that all of them would be taken into account at the technical meetings, although not all of them would be necessarily accepted. The Committee was also informed of the follow up given to the opinions on some RARs already adopted by the CSTEE (on brominated flame retardants, PentaBromo Diphenyl Ether, Cumene, Dimethyl Sulphate, Methylene Dianiline, Acrylaldehyde, Hydrogen Fluoride and on the environmental part of Nonylphenol).
7. The use of exposure data in risk assessments - progress report
The chairman of the working party explained the background and origins of the CSTEE initiative on this subject. The explanation was mainly aimed to inform the new CSTEE members. The CSTEE felt the necessity of taking some action on exposure data when it realised that the weakest part in most of the RARs peer reviewed by the CSTEE was the one on exposure. The main target of the document, he explained, was the revision of the Technical Guidance Document (TGD) which is the basis for the RARs. He asked all CSTEE members, new and old ones, to send comments on the draft presented and distributed at the occasion of this 20th plenary meeting, to allow the working party to present a final draft for adoption of the Committee at the 21st plenary meeting, in January 2001.
The WG chairman asked the secretariat to distribute the draft to the new members for their information as soon as possible. The secretary explained that the decision had been taken by him not to overflow new CSTEE members with tons of paper sending them all the documents on all the issues in one single package, but to do it gradually as the necessity for a particular set of documents would be felt.
One CSTEE member asked about two aspects of the draft opinion: whether some reports from ECETOC on monitoring data of high production volume chemicals (HPVC) had been taken into account, and on the relative importance given in the document to the estimation of emissions. He offered to collaborate with the working group in this latter aspect and provide them with some documentation from the OECD-TRI group on the issue.
The WG chairman was also asked to include a paragraph on population sub-groups and another one on environmental accidents. The answer was that for the first one a short chapter would be included in the next version of the draft, while no reference will be made to accidents.
8. 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
The Chairman of the working party introduced the subject. Two opinions were adopted in the past by the CSTEE on the Water Framework Directive and a list of priority chemicals. The question now presented to the Committee refers particularly to intercalibration of tests for assessing the ecological quality of European waters.
He asked all the new members, some of them with an expertise on ecotoxicology, to join the group, which was expected to have a meeting by mid January 2001.
A representative from Environment DG presented the overall context for the inter-calibration process. He stressed the importance of this step within the whole Water Framework Directive, both scientifically and politically. Regarding the timetable he explained that the EP had shortened the deadline by one year, which means that the Directive must be in place by 2006. He presented the different tasks and steps implied in the setting up of the Directive, pointing out the aspects where the advice of the Committee would be more welcomed or more necessary.
On the basis of these explanations, the WG chairman considered feasible to have a draft opinion ready for approval at the 21st plenary meeting of the CSTEE, on 30 January 2001. Two of the new CSTEE members expressed their willingness to participate in the working group. The secretariat was asked to speed up the process (sending of documentation, organising a WG meeting, etc.) given the tight time schedule for the adoption of the opinion.
9. Margins of safety - progress report
For information of the new members, the CSTEE chairman shortly explained the origins and background of this CSTEE initiative. The chairperson of the WG presented afterwards a draft document containing the conclusions of the two meetings held until that moment by the WG; she called it an interim position paper.
One of the main problems experienced by the CSTEE members when peer reviewing the RARs produced under Regulation 793/93 was the interpretation of the standard conclusion sentences, always subject to personal interpretation. In the case of Dichlorobenzene this issue became critical because the recommendation was "No need for further risk reduction measures", although there was a very small margin of safety (MOS) between the NOAEL and the exposure measures actually observed. That lead the CSTEE to question (i)how the reviews should been done by the Committee and (ii)the limits between purely scientific evaluations of the RARs and the field of risk management.
The Committee was worried about the possible different interpretations that different persons could give to the expressions of concern in the CSTEE opinions on the acceptability of risks for the substances under evaluation.
The WG chairperson explained that the work of the CSTEE on that issue was attentively followed by representatives of the European Chemicals Bureau (ECB) working in the revision of the Technical Guidance Document (TGD) in support of Regulation 793/93 on existing substances and Directive 93/67 on new substances. The actual way to give body to that co-operation was still to be decided.
A different question also considered in the draft opinion was the consistency of the CSTEE in writing its opinions about RARs under Regulation 793/93. The WG chairperson had prepared, and presented to the last WG meeting and then to the plenary, a table where it was showed that the CSTEE opinions on 793/93 RARs lacked consistency in some respects. Other points of interest reflected by the chairperson in the "Interim position paper" were: risks for possible sensitive sub-groups of the population (not commented on in any of the opinions) and the use of Structure Activity Relationships in them. Finally some comments were made in the document on probabilistic methods in risk assessment and on the use of a default MOS of 100 based on animal tests. All these aspects were presented by the rapporteur as key points for discussion both within the working group and within the whole CSTEE. The idea was to review the whole process of peer reviewing the RARs by the Committee.
Regarding the appropriateness of using probabilistic methods in RA one CSTEE member expressed his strong position in favour of taking a proactive initiative on that, because of the importance that these methods are gaining both in Europe and in the USA, both in environmental and in human health risk assessments. The CSTEE chairman pointed out that the report on the SSC on harmonisation of risk assessment (to be published shortly on the Internet) also stressed the importance of probabilistic methods in risk assessment.
A CSTEE member asked whether or not the "Interim position paper" would be published on the Internet as such. The answer was given that at that moment the paper was only an internal document of the CSTEE, to be developed by the WG as a draft opinion of the Committee. He therefore suggested to avoid in the title the term Margins of Safety as the document might be a much more general one. He also commented on some aspects of the paper: QSARs, population sub-groups implicitly mentioned in some of the opinions and the role of the so-called "progress chasers".
A CSTEE member stressed the importance of deriving from the exercise some sort of guidelines, to assure the consistency of the CSTEE opinions on the RARs under Regulation 793/93. He also expressed the view that the Committee should consider carefully whether it should be proactive in the area, since, he reminded, there was an on-going process of revision of the Technical Guidance Document (TGD) conducted by the European Chemicals Bureau and therefore he considered best not to interfere with that revision process.
Besides the comments mentioned on the consistency of the CSTEE opinions, a member suggested to include comments on the consistency of the RARs themselves.
Regarding the above-mentioned on-going revision of the TGD a CSTEE member proposed that consideration should be given on what would be the best possible attitude to take by the Committee: whether to try to scientifically "interfere" with the process or to wait and see what the results of the process are and react afterwards. The secretary reminded the whole Committee that the preferences expressed in the past by some ECB representatives were to receive the comments of the CSTEE in order for these to be considered during the revision process, not afterwards. Some CSTEE members supported this view, which was, also, considered the correct one by the desk official responsible in Environment DG for Regulation 793/93.
One member stressed the importance of some statements contained in the paper, among them (i) the need of a good exposure assessment, (ii) the default factor of 100 for the MOS, (iii) the need to harmonise the opinions.
10. Evaluation of sludge treatments for pathogen reduction - progress report
The CSTEE secretary presented the background of the question. It had been already introduced to the Committee at the occasion of the previous plenary meeting but nothing had been done since the previous had been the final plenary of the CSTEE with the former constitution. In the absence of the appointed WG chairman, he explained that one of the former CSTEE members, not re-appointed to be a member of the current Committee was going to be contacted in order to keep its WG membership. Both he and the CSTEE chairman made a request to Committee members to participate in the WG. Given that the question was mainly focused in microbial contamination, rather than chemical contamination some ad-hoc possible experts were suggested.
11. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
A. (i) Carcinogenic and non-carcinogenic effects of Cadmium, Nickel and Arsenic in ambient air. (ii) Derivation of limit values for PAH in ambient air
A representative from Environment DG introduced the two questions presented to the CSTEE. She informed the Committee about the different formats in which the documentation was going to be submitted to the CSTEE secretariat (paper copies, electronic versions or even Internet addresses) and asked the Committee to have the opinion adopted during the 22nd plenary meeting, scheduled for early March.
She shortly explained the background of the questions presented. The Air Quality Framework Directive required the Commission to develop ambient air levels by December 1999. The Commission set up a working group on Nickel, Cadmium and Arsenic and a working paper was issued from it. The Committee was being asked an opinion on some controversial points raised. The deadline for a proposal on limit values both for metals and for polyaromatic hydrocarbons (PAH) was the beginning of the summer and therefore she urged the Committee to answer the questions as soon as possible. She afterwards presented individually each of the questions proposed to the Committee. One CSTEE member, who participated in the elaboration of a Swedish report mentioned during the presentation, made some remarks and clarifications on it. She also pointed out that unfortunately the mentioned report had never been published. A representative from Environment DG offered to provide the Committee with the report, made available to them by the Swedish authorities.
The CSTEE chairman considered the questions a real challenge for the Committee, both in terms of time schedule and of complexity of the issue. He suggested to set up an 'umbrella' working group, with some sub-working groups within it devoted to each of the substances under consideration. CSTEE members were appointed to be responsible for each of them. Some ad-hoc experts were also suggested and more were expected to be proposed once the documentation would have been looked at by the CSTEE. The proposed chairman for the overall WG asked for the support of another epidemiologist, a proposal which was supported by some Committee members.
A CSTEE member raised the issue of sensitisation, not mentioned in the questions. Some concern was also expressed by some CSTEE members on the tight time schedule and they expressed the view that it was a non-realistic one. A representative from Environment DG explained the reasons for this time pressure. Environment DG wanted to consider the CSTEE opinion from the beginning of the legislative process, scheduled for early May.
B. Health effects of Radio Frequency and Electromagnetic fields.
A representative from Health and Consumer Protection DG, Directorate G, responsible for non-ionising radiation protection, introduced the issue. The origin of the question was the adoption by the Council in July 1999 of a Recommendation limiting the exposure of the general public to electromagnetic fields, based on guidelines established by the International Commission on non-ionising protection radiation, endorsed in June 1998 by the Scientific Steering Committee. The CSTEE was requested to update that SSC opinion, in the light of new technologies that might have appeared since its adoption. The Commission is obliged, he explained, to present to the European Parliament in July 2001 an implementation report to the Council Recommendation. For the end of 2001 new legislative measures were envisaged. The deadline for the adoption of an opinion by the CSTEE would be before July 2001.
A tentative working group was proposed. Additional external co-operation was deemed necessary, and some names were proposed.
C. Other
A representative from Enterprise DG presented the Committee two more opinion requests and announced that an official note containing them would be sent very soon to the CSTEE secretariat.
One of the questions was on Azo dyes. She explained that a proposal to ban the use of these compounds in leather materials and textiles was expected to be in force by the beginning of 2002 (and the CSTEE had already expressed its opinion on the subject). The question proposed here was on the use of Azo dyes in other materials than leather and textiles. A study had been carried out (on azo dyes in toys, writing inks and paper products) and was being presented to the Committee for peer review. She informed that no especial urgency was put on it, however, but of course, the sooner the CSTEE will adopt an opinion, the better that wiould be for Environment DG.
The second question regarded phthalates. The same Enterprise DG representative explained very shortly the background and antecedents on the banning of certain phthalates in toys and childcare articles. The study then presented to the Committee regards the possible substitutes to phthalates and their risks. She asked the CSTEE to give priority to this subject, given the time pressure under which Enterprise DG was.
The chairman of the WG on phthalates expressed some concern about the increasingly amount of questions to which the Committee has to give priority and the risk of a break down should this trend continue.
12. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
A CSTEE member asked a representative from Research DG on the 5th Framework Program and, particularly, on the issue of Endocrine Disrupting Chemicals. The DG Research representative explained that a dedicated call for proposals on the issue would be published shortly and explained briefly the project (timetable, objectives, etc.) He offered to act as a contact point for any question related to that issue.
13. Update on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
The CSTEE chairman updated the Committee on the last meeting of the SSC, mainly dedicated to BSE. Besides that he commented on the report on Harmonisation of Risk Assessment, which would be published on the Internet the week after the CSTEE plenary. He encouraged the CSTEE to take initiatives in this field, especially on probabilistic and integrated risk assessments.
He also raised the attention of the CSTEE to the document on Emerging Issues, also prepared by the SSC.
14. Arrangements for the next (21st) plenary meeting of the CSTEE
As indicated in point 5 of these minutes the 21st plenary meeting was scheduled for 30 January 2001.
15. Any other business
A CSTEE member expressed some concern on an opinion of the Scientific Committee on Food, expressing its views on the acceptable levels of dioxin and dioxin like PCB in food. Other CSTEE members expressed similar concern. The Chairman proposed to raise the question in the Scientific Steering Committee, proposing to set up a cross working group lead by the CSTEE, because of the environmental implications of such chemicals.
DRAFT AGENDA -
1. Welcoming address, apologies for absence. Presentation of the CSTEE secretariat staff
2. Adoption of the draft agenda
3. Introduction of members of the CSTEE
Election of its chairperson and of the two vice-chairpersons
4. Information on the previous Scientific Committee on Toxicity, Ecotoxicity and the Environment. Rules of procedure of the CSTEE. Declarations of interest. Confidentiality. Modalities of payment. Other rules governing the functioning of the activities of the CSTEE
5. Schedule of CSTEE activities/plenary meetings for the remainder of the year 2000 and for the year 2001
6. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) Acrylonitrile
b) Anisidine
B. State of play regarding other substances evaluated under the ESR
7. The use of exposure data in risk assessments - progress report
8. 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
9. Margins of safety - progress report
10. Evaluation of sludge treatments for pathogen reduction - progress report
11. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
A. (i) Carcinogenic and non-carcinogenic effects of Cadmium, Nickel and Arsenic in ambient air. (ii) Derivation of limit values for PAH in ambient air
B. Health effects of Radio Frequency and Electromagnetic fields.
C. Other
12. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
13. Update on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
14. Arrangements for the next (21st) plenary meeting of the CSTEE
15. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James BRIDGES, Prof. Giorgio CANTELLI FORTI, Prof. Wolfgang DEKANT, Prof. José L. DOMINGO, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Colin JANSSEN, Prof. Bo O. JANSSON, Dr. Claude LAMBRÉ, Prof. Amadeu SOARES, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, Prof. Janneche UTNE-SKÅRE, Prof. Cornelis Van LEEUWEN, Prof. Katarina VICTORIN, Prof. Joseph G. VOS.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mr. Soeren ABILGAARD, Mrs. Stella CLARKE, Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE, Mrs. Mercedes de SOLÀ, Mr. Panagiotis DASKALEROS, Mr. Marc SEGUINOT, Mrs. Angelika WILHELM.
ENVIRONMENT DG:
Mrs. Maria José CARROQUINO, Mr. Paul HAYES, Mr. Asger OLSEN.
ENTERPRISE DG:
Mrs. Lena PERENIUS, Mr. Francesco G.G. ZINGALES.
RESEARCH DG:
Mr. Laurent BONTOUX, Mrs. Kirsi HAAVISTO, Mr. Jean-François JUNGER.
The Head of Unit C-2 in the Health and Consumer Protection Directorate General, service responsible for the CSTEE, Mrs. Mercedes de Solà, chaired the session at its beginning, until the election of the chairperson and two vice chairpersons had been accomplished.
She welcomed the CSTEE members and congratulated them for their nomination as CSTEE members. She explained the process of renewal and stressed the important role that transparency played in it.
She expressed the gratefulness of the Commission to all the re-appointed members of the Committee and especially to its former chairman, Professor James Bridges, for the excellent work they had performed during the previous three years.
She also welcomed the six new appointed members, and encouraged them to act as a source of new ideas and constructive criticism.
The secretariat staff of the CSTEE was presented.
Apologies were received from Professors Calow, Kyrtopoulos and Vighi.
2. Adoption of the draft agenda
The agenda was adopted.
3. Introduction of members of the CSTEE
Election of its chairperson and of the two vice-chairpersons
The initial chairperson of the session read for the information of CSTEE members the paragraphs of the CSTEE Rules of Procedure related to the election of the chairperson and the two vice chairpersons of the Committee. Afterwards, all the CSTEE members introduced themselves in a "tour de table". For the information of those present the scientific secretary of the CSTEE described the expertise of the three Committee members who were not present at the meeting: Profs. Calow, Kyrtopoulos and Vighi.
The only candidate proposed (by Professor E. Dybing) for chairperson of the Committee was Professor James W. Bridges. Professor Helmut Greim and Doctor Tarazona seconded the proposal. The candidate proposed expressed his willingness to accept the obligations of being the chairman of the CSTEE, should he obtain the support of the majority of the members. Following the rules of procedure of the CSTEE the requirement for secrecy of the election was waived by unanimity of the Committee. Therefore the election took place by raising hands. Professor James W. Bridges was elected chairman of the CSTEE by 15 votes in favour and one abstention.
The same process occurred for the election of the two vice chairpersons. Professor Helmut A. Greim (proposed by Prof. Dybing, seconded by Dr. Tarazona) was elected first vice chairperson and Doctor José Vicente Tarazona was elected second vice chairperson (proposed by Prof. Bridges, seconded by Prof. Dybing). The former was elected by 14 votes in favour and two abstentions while the latter by 15 votes in favour and 1 abstention.
4. Information on the previous Scientific Committee on Toxicity, Ecotoxicity and the Environment. Rules of procedure of the CSTEE. Declarations of interest. Confidentiality. Modalities of payment. Other rules governing the functioning of the activities of the CSTEE
The Head of Unit C2 in Health and Consumer Protection DG, responsible for the CSTEE, introduced herself. She briefly talked about some key points of the rules of procedure of the CSTEE; such an explanation was especially aimed to inform the new members of the Committee but also a reminder to all the others.
Another key point she stressed was the need for transparency and the importance of being as accurate as possible in the declarations of interests of CSTEE members, both in the annual general one as well as in the ones in individual meetings, which could concern some particular issues. She pointed out that any declaration of interest will be reflected in the minutes of the respective meeting and, therefore, published on Internet.
The counterpart to transparency is confidentiality. Only the CSTEE members, Commission officials and invitees are allowed to attend CSTEE meetings, in order to preserve the privacy of the debates, making sure that they are strictly scientific, to assure the independence of the Committee and its opinions and to guarantee that those data which require it are kept confidential. For the same reasons Committee members are asked to sign a declaration of confidentiality.
She informed the Committee that the decision had been taken of publishing in the Internet web site of Health and Consumer Protection DG a short version of the CVs of each Committee member. She therefore asked them to send a copy of a two page CV at their best opportunity.
Finally she also stressed the importance of keeping the independence both of the Committee as a body as well as of each of its members. The meaning of that being that no instructions should be accepted by any Committee member, nor from external instances (such as MSs) neither from any Commission service or official.
The CSTEE secretary shortly presented a set of documents provided to all Committee members for them to be properly informed about certain aspects of the functioning of the Committee (Rules of Procedure, reimbursement of expenses, Commission decisions setting up the Scientific Committees, nomination of experts, etc.) The Rules of Procedure of the former CSTEE were endorsed by this 'new' CSTEE.
Mrs. S. Clarke, from Health and Consumer Protection DG, Unit C-2, explained to all Committee members the procedures for reimbursement of expenses as well as the amount of the indemnities paid by the Commission to experts attending meetings of the Scientific Committees.
Mrs. De Solà offered all the support of the Unit staff and more specifically of the CSTEE secretariat on any need that the members could have. She also explained that the working language of the Committee was English, it had been a decision of the former CSTEE and so it would continue to be in the future. The opinions of the Committee are published only in that language.
Finally she took the opportunity of the meeting to announce that she was leaving Health and Consumer Protection DG for a new post in a different Commission service. She wished all the best to the CSTEE and thanked their members for the joint work performed in the past three years. The elected chairman of the CSTEE thanked her for the support she had provided the Committee during the time she had been in charge of the Unit, pointing out that this was all the more relevant as the committee had gone through some difficult moments during its previous mandate.
From this point on it was the elected chairman of the Committee who chaired the session.
5. Schedule of CSTEE activities/plenary meetings for the remainder of the year 2000 and for the year 2001
The secretary stressed the importance of deciding on the dates for plenary meetings of the Committee, since the setting up of the Scientific Steering Committee meetings schedule depends on those of the other eight scientific committees.
It was agreed that the CSTEE should hold eight plenary meetings during the year 2001 and the dates were set as follows:
21st Plenary: 30 January 2001
22nd Plenary: 6 and 7 March 2001
23rd Plenary: 24 and 25 April 2001
24th Plenary: 12 and 13 June 2001
25th Plenary: 20 July 2001
26th Plenary: 10 and 11 September 2001
27th Plenary: 29 and 30 October 2001
28th Plenary: 6 and 7 December.
The preferred day in case only a single day meeting will be necessary were the following ones: 6 March, 24 April, 12 June, 11 September, 30 October and 7 December.
The CSTEE secretary explained shortly the system of the so-called 'tables of unavailable dates', used by the CSTEE secretariat to set dates for working group meetings and encouraged the CSTEE members to reply as quickly as possible to the demands of the secretariat on this aspect.
6. Regulation 793/93 on Existing substances (ESR):
As an initial remark on that point, the CSTEE chairman proposed not to adopt any of the reports that might have been prepared (on the RAR on Acrylonitrile and Anisidine) for the sake of not presenting the new members with a 'fait accompli'. Because an adoption at the occasion of the following plenary would not pose an unsurmountable problem to the DG requester service (DG Environment) the new members should be given an opportunity to comment on them before the 21st plenary meeting of the Committee, scheduled for the 30 January 2001. The CSTEE accepted this proposal
A. Status reports/opinions (Human health & Environment) on:
a) Acrylonitrile
The rapporteur presented the draft opinion. He considered the Risk Assessment Report (RAR) to be an excellent one and the conclusions as being correct. Some points of concern were signalled such as: the NOAEL proposed upon inhalation studies, and the risk characterisation. Some other minor points were also mentioned.
One CSTEE member asked whether or not the CSTEE should ask for more studies on respiratory sensitisation of the compound. The rapporteur pointed out that the substance is a carcinogen and that this fact implies the need for reduction of exposure to the minimum possible level. Therefore the need for inhalation studies cannot be considered a priority. He proposed, as a consequence, not to make any strong such request.
One CSTEE member highlighted an inconsistency in the draft opinion in stating that the report is an excellent while making also a strong criticism to some important aspects (such as the derivation of NOAEL to 4 ppm). The answer of the rapporteur was that the overall evaluation of the report has to be that it is a good one, although there can be disagreement in some points.
b) Anisidine
The rapporteur presented the draft report and stressed that he would welcome more comments from other CSTEE members. In general he considered the report of good quality. He reminded that the CSTEE had previously expressed an opinion on Azo dyes, relevant, obviously, to this one.
Some comments on the report reflected the need for a control of the products from third countries containing the substance. He, nevertheless, questioned whether this was a point to be considered in a RAR or a risk management issue.
Among other comments on the different aspects of the report, he pointed out that, in the effects assessment section, in the IARC classification of Anisidine references are only made to an IARC evaluation of 1982, while a new one had been issued in 1999 (during the risk assessment process, therefore) reaching different conclusions regarding the genotoxic effects.
One CSTEE member expressed concern on the conclusions on reproductive toxicity (conclusion 1 instead of conclusion 2), not in line, from his point of view, with the recommendations of the Technical Guidance Document (in support of regulation 793/93 - TGD), following the studies available.
Some concern was also expressed on the use of a factor of 10 for the NOEC, based on a long-term toxicity test on the most sensitive species, Daphnia magna. He considered that not to be in agreement with the TGD (where many other tests are required for applying a factor of 10). The rapporteur considered that the combination of short-term toxicity studies for each trophic level with a long-term toxicity study for the most sensitive species allows for the use of a factor of 10. Further consideration by the CSTEE to this point was deemed necessary.
Other comments were made on certain aspects of the report, such as downstream use of the product.
B. State of play regarding other substances evaluated under the ESR
The secretary informed on the next RARs to be evaluated by the CSTEE: Nonylphenol and Nonylphenol (branched), human health part. The RARs were received by the secretariat too late to have paper copies of them prepared and sent to members before this plenary. Two other RARs were also to be received shortly: on Acrylamide and Methyl methacrylate and these will also be sent shortly to all CSTEE members.
For information of the new members the secretariat distributed copies of the minutes of the working group meeting where rules were decided on the working procedure to deal with these RARs. The CSTEE secretary described the document and the mentioned rules. The CSTEE chairman explained that a revision of the rules of procedure for this particular working group was expected for January 2001, as part of the activities of the Working Group on Margins of Safety (MOS).
A representative from Environment DG expressed its gratefulness for the co-operation of the CSTEE and informed that a procedure was being set up to get feedback from the ECB on the 793/93 RARs peer reviewed by the Committee. He also informed that the ECB was going to put the RAR reports on a public web site, sometimes both the draft before and after being reviewed by the CSTEE. Therefore the intervention of the Committee would be made transparent to everybody.
He anticipated another 20 RARs to be finalised within a couple of months, all to be referred to the Committee for opinion. He welcomed any general comments from the CSTEE, and assured that all of them would be taken into account at the technical meetings, although not all of them would be necessarily accepted. The Committee was also informed of the follow up given to the opinions on some RARs already adopted by the CSTEE (on brominated flame retardants, PentaBromo Diphenyl Ether, Cumene, Dimethyl Sulphate, Methylene Dianiline, Acrylaldehyde, Hydrogen Fluoride and on the environmental part of Nonylphenol).
7. The use of exposure data in risk assessments - progress report
The chairman of the working party explained the background and origins of the CSTEE initiative on this subject. The explanation was mainly aimed to inform the new CSTEE members. The CSTEE felt the necessity of taking some action on exposure data when it realised that the weakest part in most of the RARs peer reviewed by the CSTEE was the one on exposure. The main target of the document, he explained, was the revision of the Technical Guidance Document (TGD) which is the basis for the RARs. He asked all CSTEE members, new and old ones, to send comments on the draft presented and distributed at the occasion of this 20th plenary meeting, to allow the working party to present a final draft for adoption of the Committee at the 21st plenary meeting, in January 2001.
The WG chairman asked the secretariat to distribute the draft to the new members for their information as soon as possible. The secretary explained that the decision had been taken by him not to overflow new CSTEE members with tons of paper sending them all the documents on all the issues in one single package, but to do it gradually as the necessity for a particular set of documents would be felt.
One CSTEE member asked about two aspects of the draft opinion: whether some reports from ECETOC on monitoring data of high production volume chemicals (HPVC) had been taken into account, and on the relative importance given in the document to the estimation of emissions. He offered to collaborate with the working group in this latter aspect and provide them with some documentation from the OECD-TRI group on the issue.
The WG chairman was also asked to include a paragraph on population sub-groups and another one on environmental accidents. The answer was that for the first one a short chapter would be included in the next version of the draft, while no reference will be made to accidents.
8. 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
The Chairman of the working party introduced the subject. Two opinions were adopted in the past by the CSTEE on the Water Framework Directive and a list of priority chemicals. The question now presented to the Committee refers particularly to intercalibration of tests for assessing the ecological quality of European waters.
He asked all the new members, some of them with an expertise on ecotoxicology, to join the group, which was expected to have a meeting by mid January 2001.
A representative from Environment DG presented the overall context for the inter-calibration process. He stressed the importance of this step within the whole Water Framework Directive, both scientifically and politically. Regarding the timetable he explained that the EP had shortened the deadline by one year, which means that the Directive must be in place by 2006. He presented the different tasks and steps implied in the setting up of the Directive, pointing out the aspects where the advice of the Committee would be more welcomed or more necessary.
On the basis of these explanations, the WG chairman considered feasible to have a draft opinion ready for approval at the 21st plenary meeting of the CSTEE, on 30 January 2001. Two of the new CSTEE members expressed their willingness to participate in the working group. The secretariat was asked to speed up the process (sending of documentation, organising a WG meeting, etc.) given the tight time schedule for the adoption of the opinion.
9. Margins of safety - progress report
For information of the new members, the CSTEE chairman shortly explained the origins and background of this CSTEE initiative. The chairperson of the WG presented afterwards a draft document containing the conclusions of the two meetings held until that moment by the WG; she called it an interim position paper.
One of the main problems experienced by the CSTEE members when peer reviewing the RARs produced under Regulation 793/93 was the interpretation of the standard conclusion sentences, always subject to personal interpretation. In the case of Dichlorobenzene this issue became critical because the recommendation was "No need for further risk reduction measures", although there was a very small margin of safety (MOS) between the NOAEL and the exposure measures actually observed. That lead the CSTEE to question (i)how the reviews should been done by the Committee and (ii)the limits between purely scientific evaluations of the RARs and the field of risk management.
The Committee was worried about the possible different interpretations that different persons could give to the expressions of concern in the CSTEE opinions on the acceptability of risks for the substances under evaluation.
The WG chairperson explained that the work of the CSTEE on that issue was attentively followed by representatives of the European Chemicals Bureau (ECB) working in the revision of the Technical Guidance Document (TGD) in support of Regulation 793/93 on existing substances and Directive 93/67 on new substances. The actual way to give body to that co-operation was still to be decided.
A different question also considered in the draft opinion was the consistency of the CSTEE in writing its opinions about RARs under Regulation 793/93. The WG chairperson had prepared, and presented to the last WG meeting and then to the plenary, a table where it was showed that the CSTEE opinions on 793/93 RARs lacked consistency in some respects. Other points of interest reflected by the chairperson in the "Interim position paper" were: risks for possible sensitive sub-groups of the population (not commented on in any of the opinions) and the use of Structure Activity Relationships in them. Finally some comments were made in the document on probabilistic methods in risk assessment and on the use of a default MOS of 100 based on animal tests. All these aspects were presented by the rapporteur as key points for discussion both within the working group and within the whole CSTEE. The idea was to review the whole process of peer reviewing the RARs by the Committee.
Regarding the appropriateness of using probabilistic methods in RA one CSTEE member expressed his strong position in favour of taking a proactive initiative on that, because of the importance that these methods are gaining both in Europe and in the USA, both in environmental and in human health risk assessments. The CSTEE chairman pointed out that the report on the SSC on harmonisation of risk assessment (to be published shortly on the Internet) also stressed the importance of probabilistic methods in risk assessment.
A CSTEE member asked whether or not the "Interim position paper" would be published on the Internet as such. The answer was given that at that moment the paper was only an internal document of the CSTEE, to be developed by the WG as a draft opinion of the Committee. He therefore suggested to avoid in the title the term Margins of Safety as the document might be a much more general one. He also commented on some aspects of the paper: QSARs, population sub-groups implicitly mentioned in some of the opinions and the role of the so-called "progress chasers".
A CSTEE member stressed the importance of deriving from the exercise some sort of guidelines, to assure the consistency of the CSTEE opinions on the RARs under Regulation 793/93. He also expressed the view that the Committee should consider carefully whether it should be proactive in the area, since, he reminded, there was an on-going process of revision of the Technical Guidance Document (TGD) conducted by the European Chemicals Bureau and therefore he considered best not to interfere with that revision process.
Besides the comments mentioned on the consistency of the CSTEE opinions, a member suggested to include comments on the consistency of the RARs themselves.
Regarding the above-mentioned on-going revision of the TGD a CSTEE member proposed that consideration should be given on what would be the best possible attitude to take by the Committee: whether to try to scientifically "interfere" with the process or to wait and see what the results of the process are and react afterwards. The secretary reminded the whole Committee that the preferences expressed in the past by some ECB representatives were to receive the comments of the CSTEE in order for these to be considered during the revision process, not afterwards. Some CSTEE members supported this view, which was, also, considered the correct one by the desk official responsible in Environment DG for Regulation 793/93.
One member stressed the importance of some statements contained in the paper, among them (i) the need of a good exposure assessment, (ii) the default factor of 100 for the MOS, (iii) the need to harmonise the opinions.
10. Evaluation of sludge treatments for pathogen reduction - progress report
The CSTEE secretary presented the background of the question. It had been already introduced to the Committee at the occasion of the previous plenary meeting but nothing had been done since the previous had been the final plenary of the CSTEE with the former constitution. In the absence of the appointed WG chairman, he explained that one of the former CSTEE members, not re-appointed to be a member of the current Committee was going to be contacted in order to keep its WG membership. Both he and the CSTEE chairman made a request to Committee members to participate in the WG. Given that the question was mainly focused in microbial contamination, rather than chemical contamination some ad-hoc possible experts were suggested.
11. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
A. (i) Carcinogenic and non-carcinogenic effects of Cadmium, Nickel and Arsenic in ambient air. (ii) Derivation of limit values for PAH in ambient air
A representative from Environment DG introduced the two questions presented to the CSTEE. She informed the Committee about the different formats in which the documentation was going to be submitted to the CSTEE secretariat (paper copies, electronic versions or even Internet addresses) and asked the Committee to have the opinion adopted during the 22nd plenary meeting, scheduled for early March.
She shortly explained the background of the questions presented. The Air Quality Framework Directive required the Commission to develop ambient air levels by December 1999. The Commission set up a working group on Nickel, Cadmium and Arsenic and a working paper was issued from it. The Committee was being asked an opinion on some controversial points raised. The deadline for a proposal on limit values both for metals and for polyaromatic hydrocarbons (PAH) was the beginning of the summer and therefore she urged the Committee to answer the questions as soon as possible. She afterwards presented individually each of the questions proposed to the Committee. One CSTEE member, who participated in the elaboration of a Swedish report mentioned during the presentation, made some remarks and clarifications on it. She also pointed out that unfortunately the mentioned report had never been published. A representative from Environment DG offered to provide the Committee with the report, made available to them by the Swedish authorities.
The CSTEE chairman considered the questions a real challenge for the Committee, both in terms of time schedule and of complexity of the issue. He suggested to set up an 'umbrella' working group, with some sub-working groups within it devoted to each of the substances under consideration. CSTEE members were appointed to be responsible for each of them. Some ad-hoc experts were also suggested and more were expected to be proposed once the documentation would have been looked at by the CSTEE. The proposed chairman for the overall WG asked for the support of another epidemiologist, a proposal which was supported by some Committee members.
A CSTEE member raised the issue of sensitisation, not mentioned in the questions. Some concern was also expressed by some CSTEE members on the tight time schedule and they expressed the view that it was a non-realistic one. A representative from Environment DG explained the reasons for this time pressure. Environment DG wanted to consider the CSTEE opinion from the beginning of the legislative process, scheduled for early May.
B. Health effects of Radio Frequency and Electromagnetic fields.
A representative from Health and Consumer Protection DG, Directorate G, responsible for non-ionising radiation protection, introduced the issue. The origin of the question was the adoption by the Council in July 1999 of a Recommendation limiting the exposure of the general public to electromagnetic fields, based on guidelines established by the International Commission on non-ionising protection radiation, endorsed in June 1998 by the Scientific Steering Committee. The CSTEE was requested to update that SSC opinion, in the light of new technologies that might have appeared since its adoption. The Commission is obliged, he explained, to present to the European Parliament in July 2001 an implementation report to the Council Recommendation. For the end of 2001 new legislative measures were envisaged. The deadline for the adoption of an opinion by the CSTEE would be before July 2001.
A tentative working group was proposed. Additional external co-operation was deemed necessary, and some names were proposed.
C. Other
A representative from Enterprise DG presented the Committee two more opinion requests and announced that an official note containing them would be sent very soon to the CSTEE secretariat.
One of the questions was on Azo dyes. She explained that a proposal to ban the use of these compounds in leather materials and textiles was expected to be in force by the beginning of 2002 (and the CSTEE had already expressed its opinion on the subject). The question proposed here was on the use of Azo dyes in other materials than leather and textiles. A study had been carried out (on azo dyes in toys, writing inks and paper products) and was being presented to the Committee for peer review. She informed that no especial urgency was put on it, however, but of course, the sooner the CSTEE will adopt an opinion, the better that wiould be for Environment DG.
The second question regarded phthalates. The same Enterprise DG representative explained very shortly the background and antecedents on the banning of certain phthalates in toys and childcare articles. The study then presented to the Committee regards the possible substitutes to phthalates and their risks. She asked the CSTEE to give priority to this subject, given the time pressure under which Enterprise DG was.
The chairman of the WG on phthalates expressed some concern about the increasingly amount of questions to which the Committee has to give priority and the risk of a break down should this trend continue.
12. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
A CSTEE member asked a representative from Research DG on the 5th Framework Program and, particularly, on the issue of Endocrine Disrupting Chemicals. The DG Research representative explained that a dedicated call for proposals on the issue would be published shortly and explained briefly the project (timetable, objectives, etc.) He offered to act as a contact point for any question related to that issue.
13. Update on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
The CSTEE chairman updated the Committee on the last meeting of the SSC, mainly dedicated to BSE. Besides that he commented on the report on Harmonisation of Risk Assessment, which would be published on the Internet the week after the CSTEE plenary. He encouraged the CSTEE to take initiatives in this field, especially on probabilistic and integrated risk assessments.
He also raised the attention of the CSTEE to the document on Emerging Issues, also prepared by the SSC.
14. Arrangements for the next (21st) plenary meeting of the CSTEE
As indicated in point 5 of these minutes the 21st plenary meeting was scheduled for 30 January 2001.
15. Any other business
A CSTEE member expressed some concern on an opinion of the Scientific Committee on Food, expressing its views on the acceptable levels of dioxin and dioxin like PCB in food. Other CSTEE members expressed similar concern. The Chairman proposed to raise the question in the Scientific Steering Committee, proposing to set up a cross working group lead by the CSTEE, because of the environmental implications of such chemicals.
DRAFT AGENDA -
1. Welcoming address, apologies for absence. Presentation of the CSTEE secretariat staff
2. Adoption of the draft agenda
3. Introduction of members of the CSTEE
Election of its chairperson and of the two vice-chairpersons
4. Information on the previous Scientific Committee on Toxicity, Ecotoxicity and the Environment. Rules of procedure of the CSTEE. Declarations of interest. Confidentiality. Modalities of payment. Other rules governing the functioning of the activities of the CSTEE
5. Schedule of CSTEE activities/plenary meetings for the remainder of the year 2000 and for the year 2001
6. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health & Environment) on:
a) Acrylonitrile
b) Anisidine
B. State of play regarding other substances evaluated under the ESR
7. The use of exposure data in risk assessments - progress report
8. 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
9. Margins of safety - progress report
10. Evaluation of sludge treatments for pathogen reduction - progress report
11. Strategies for dealing with possible additional opinion requests submitted by other DGs of the Commission
A. (i) Carcinogenic and non-carcinogenic effects of Cadmium, Nickel and Arsenic in ambient air. (ii) Derivation of limit values for PAH in ambient air
B. Health effects of Radio Frequency and Electromagnetic fields.
C. Other
12. Feedback from the relevant services of the Commission on the follow up to the opinions adopted previously by the CSTEE
13. Update on the latest meetings of the Scientific Steering Committee on matters of interest to the CSTEE
14. Arrangements for the next (21st) plenary meeting of the CSTEE
15. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James BRIDGES, Prof. Giorgio CANTELLI FORTI, Prof. Wolfgang DEKANT, Prof. José L. DOMINGO, Prof. Erik DYBING, Prof. Helmut A. GREIM, Prof. Colin JANSSEN, Prof. Bo O. JANSSON, Dr. Claude LAMBRÉ, Prof. Amadeu SOARES, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, Prof. Janneche UTNE-SKÅRE, Prof. Cornelis Van LEEUWEN, Prof. Katarina VICTORIN, Prof. Joseph G. VOS.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mr. Soeren ABILGAARD, Mrs. Stella CLARKE, Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE, Mrs. Mercedes de SOLÀ, Mr. Panagiotis DASKALEROS, Mr. Marc SEGUINOT, Mrs. Angelika WILHELM.
ENVIRONMENT DG:
Mrs. Maria José CARROQUINO, Mr. Paul HAYES, Mr. Asger OLSEN.
ENTERPRISE DG:
Mrs. Lena PERENIUS, Mr. Francesco G.G. ZINGALES.
RESEARCH DG:
Mr. Laurent BONTOUX, Mrs. Kirsi HAAVISTO, Mr. Jean-François JUNGER.
