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Directorate-General for Health and Food Safety
1. Adoption of the draft
agenda
The draft agenda was adopted.
2. Adoption of the draft minutes of the 2nd plenary meeting of the CSTEE held on 9.02.1998 in Brussels
The minutes were adopted with the following changes:
(i) The chairperson of the 'Chrysotile asbestos' Working Group pointed out that the text of the opinion annexed to the draft minutes did not correspond to the edited (by the CSTEE chairman) version. The edited version of the opinion on 'Chrysotile asbestos' adopted the 9 February 1998 should be included instead.
On point 4 of the draft minutes it was also requested to delete the reference to the fact that the chairperson of the WG, and other CSTEE members, might have commented on threshold levels.
(ii) The request was made to delete, in point 3 of the minutes, the reference to the presumed availability of an interim report by June 98 on the so-called NL study with human volunteers as it was considered that a guarantee of such availability could not be obtained. The sentence is to be replaced by one informing of the presumed conclusion of the study by September 1998.
(iii) Other, mainly editorial corrections, were suggested.
3. 'Phthalates in toys' - consideration of the draft final report for opinion
The CSTEE took account of the room documents (from refs. CSTEE/97/1-Adds. 82 to 86 of the list of documents) distributed just prior to the start of the meeting. Some minutes were spent analysing them.
Among the issues considered were: (i) what safety factor to use between exposure and the NOAEL values for the respective phthalates; (ii) relevance of peroxisome proliferation seen in rats (extrapolable to man or not); (iii) which additional safety factor to use in the absence of a NOAEL; (iv) how do SCF and CSTEE conclusions compare.
On (i) several comments were made on the validity of a safety factor lower than 100. One view was that, due to the lesser relevance of peroxisome proliferation for humans, a safety factor of 10 should be used. Others took the view that a safety factor of 100 was warranted. Some suggested that a safety factor of 50 should be used as a compromise. This view had some support but the final decision was that a safety factor of 100 should be chosen but with a clear explanation of the reasons why in the opinion.
On (ii) it was said that although it is currently generally accepted that peroxisome proliferation should not be an effect allowing for an extrapolation to humans, it was also acknowledged that this view is not consensual in the scientific community (particularly as increases in liver weight are statistically significant). It was also said that the effect should also be considered in immune cells and not only in the liver. This gave some weight to the opinion of those who thought that such an effect should not simply be ignored.
On (iii) an additional uncertainty factor of 5 was selected for DBP because of effects in the offspring, whereas a factor of 2 was selected for BBP because of slight organ weight effects.
On (iv), and with the presence of a member of the SCF, it was acknowledged that the specificity of the effect, plus the fact that some of the data on which the CSTEE had arrived at their conclusions were more recent than that used by the SCF, justified that the former could deviate from the conclusions of the latter.
Subsequently, and bearing in mind the information contained in all the documents made available, the chairperson of the 'Phthalates in toys' working group explained some important changes which were introduced into the model of calculation, i.e. a change from 12 to 6 hours exposure and that of the weight of the 'model' child from 5 to 8 Kg. These changes alter significantly the assessment. As a result DNOP came out of the range of concern (as defined by the model). The extractable amounts were calculated using the modelling techniques (DINP - 1.2mg, DNOP - 3.0mg, DEHP - 0.4mg, DIDP - 2.0mg, BBP - 6.8mg and DBP - 0.8mg) but such values do not take into account that children may have additional phthalate exposure via other sources.
Going through the results of the mentioned calculations the conclusions were that action is warranted on DINP because the exposure levels cause concern. As for DEHP it was acknowledged that the low margin of safety could give rise to concern. However, due to the nature of its critical effect (peroxisome proliferation), the CSTEE members were less concerned about exposure to this phthalate.
No new information was available on the study being carried out with human volunteers in the NL (study expected to be concluded in the autumn of 98). The CSTEE reiterated the view that the results of this study should be closely followed and that, in the light of the respective results, its opinion on 'Phthalates in toys' could be revised.
4. Water Framework Directive - consideration of the draft report of the working group with a view to the possible adoption of a final opinion
The main body of the opinion, particularly parts A and B was generally the object of a consensus. On part C there were few and mostly editorial comments on C1 to qualify the provisions of the directive dealing with pesticides. On C2 (Fish water directive), it was suggested that since comments were broader and applicable to the entire issue they should be moved to the Final Recommendations section. The importance of reference sites was emphasised. Regarding section E (presentation and classification of waters) a discussion on the classification about the different categories of waters also took place. There were only three in the terms of reference but some members suggested there should be five overall (with 'poor' and 'bad'). Others said that all that is possible at present is the classification of waters into 'good' and 'poor' and that a further change from 'bad' into 'fair' and 'bad' can be artificial (but can also contribute to harmonising the situation in M. States).The need for clarification on what the directive is intended to protect, particularly on the distinction between contamination/pollution and contaminant/pollutant, was also commented.
Regarding the procedure for the selection of priority substances with a view to establishing a list of Community priority substances, the representative of DG XI argued that, in their view, a 'monitoring based' selection process would probably be more realistic as opposed to the 'modelling based' process supported by the CSTEE Working Group. The members of the WG present gave the reasons why they thought that a 'modelling based' approach was preferable (basically due to the fact that monitoring is very much dependent upon the analytical capabilities of laboratories). Eventually it was agreed that a combined approach between the 'monitoring based' and the 'modelling based' selection process is desirable.
It was also said that the proposed directive has uncertainties since it is not clear what it is intended to protect. It was suggested that a clarification is necessary in the statement on how heavy metals should be addressed in the context of priority chemicals. DG XI has the intention of treating metals separately from micro-organic pollutants. They further informed the CSTEE that the ranking will be based on monitoring results. The selection of average concentrations and PNECs used for the ranking of metals will be made publicly available and openly discussed with experts including the CSTEE.
DG XI also informed that on 2/3 July 1998 experts of Member States, Industry and NGOs, as well as the chairperson of the CSTEE 'Water Framework Directive' Working Group will be invited by DG XI to a meeting to discuss the results of the COMMPS procedure.
The following course of action was agreed to speed up the adoption (by written procedure) of the draft opinion: (i) by the end of the following week (30 April), contributions of CSTEE members to be sent to the Working Group; (ii) Working Group to respond by the 8th of May; (iii) Working Group to integrate any subsequent comments by the 15th of May; (iv) Working Group meets the 18th of May and concludes final draft; (v) draft is circulated for adoption by written procedure with deadline for approval set at the 25th of May.
5. Information on matters not covered elsewhere in the agenda:
This point served the purpose of discussing the role to be played by the CSTEE on activities which, given the CSTEE brief, they should follow. The issue of electromagnetic radiation, was discussed and the creation of a provisional working group was decided. Another provisional working group on risk assessment was also created.
On the issue of possible future topics to be looked at by the CSTEE members were invited to reflect and propose new ones for the committee to address.
It was also decided that the next CSTEE plenary should take place over two working days (possibly one half day and a full working day). Given that the date of 15 June had already been decided for the next plenary it was decided that the plenary should take place over 15 and 16 of June in spite of this being an arrangement not convenient to everybody.
6. Presentation by DG III of opinion requests they have put forward:
(i) Tin, Arsenic and Cadmium and
(ii) Pentachlorophenol
DG III explained the context in which these opinion requests are being submitted to the CSTEE. Basically they are the result of the need that the Commission has of resolving the problem of the derogations that Sweden, Finland and Austria have in their Accession Treaties. The derogations cover, among others, Directive 76/769 on restrictions, marketing and use of Arsenic, Tin, Cadmium and Pentachlorophenol for a transitional period ending 1st January 1999.
The Commission agreed to review the legislation in question within the same period. It is possible that these countries may be forced to lower their standards and apply the existing directives. Because of the difficulties that this would pose, the review process is ranked very high politically.
The Accession Treaties require that the Commission review the directives in question by 31st December 1998. There is no engagement to change any legislation and all Member States (new and old) are required to apply this acquis (changed or unchanged) from 1st January 1999. The policy of the Commission to be followed in reviewing legislation is set out in the Communication "An Industrial Competitiveness Policy for the European Chemical Industry". In essence there are basically three requirements namely a risk assessment, a cost benefit analysis and a comparison with practice outside the EU.
The risk assessments have been carried out by external consultants who have produced, or are in the process of finalising, reports on the risks posed by the chemicals in question. The CSTEE is being asked to peer review such reports on the basis of the terms of reference submitted to them by DG III (already distributed to the CSTEE).
7. Tin, Arsenic and Cadmium - interim report presented by the Working Group chairperson
As two working group meetings had already taken place, one on Tin, Arsenic and Cadmium (16 March 1998) and another on Pentachlorophenol (30 March 1998) the chairperson of the respective working groups were asked to comment on any interim conclusions they might have had to the plenary. In the Working Group 'Tin, Arsenic & Cadmium' the decision had been taken to appoint a rapporteur per substance.
Tin - The rapporteur for this substance had prepared a draft preliminary report the main conclusions of which were that the degree of risk for both the aquatic environment and human health reported in the study of WS Atkins is sufficiently justified and also that in spite of the scarcity of available data and the budget limitations as well as the time constraints in the report, this might, provisionally, be deemed appropriate for decision taking. However the rapporteur stressed the limitations posed by the phraseology of the terms of reference as the scientific community is not used to making peer reviews of risk assessments bearing in mind any budget limitations.
Arsenic - the rapporteur for this substance highlighted the problems he had found with references. Very few of those mentioned in the report are published in standard scientific journals. Most are either reports to various organisations or published in proceedings of specialised conferences, both of which are not easily accessible. He requested from DG III and/or DG XXIV (CSTEE Secretariat) that the documents that are referenced should be made available in order to properly check the data. He subsequently provided a list of those thought to be the most relevant for the peer review of the document.
Cadmium - due to absence of the rapporteur for this particular substance no report could be made to the working group.
A meeting of the Working Group 'Tin, Arsenic & Cadmium' was scheduled for 29 May 1998.
8. Pentachlorophenol - interim report presented by the Working Group chairperson
The chairperson, and 'rapporteur' for this substance, reported to the CSTEE some of the interim conclusions arrived at by the Working Group. Basically the emphasis was put on the shortcomings of the report. Among those found he mentioned in particular confusing data and mistakes in units expressed in Table 3.3a (mg/kg, µg/kg, ng/kg) and also lack of compatibility of data in the table with that in the literature review.
Also in chapter 6 (on Exposure Assessment and Environment) there are also aspects which lack clarity with probable mistakes in expressed units of tables 6.3a and 6.3b. The chapter also lacks relevant PCP exposure data for a proper risk assessment.
Furthermore it was mentioned that the report deals essentially with steady emissions only, while it is a known fact that there are significant accidental releases of PCP against sapstaining of timber at outdoor or near outdoor facilities. Some data on such occurrences were reported orally by one of the WG members.
Finally it was also said that the report overlooks the more serious threats to man and the environment by releases of noncontained chlorophenol usage in timber. The characteristics of biodegradation of higher chlorinated dioxins/furans may mean dechlorination into more toxic substances and hence, in the long run, the human exposure to dioxins from PCP products released into the environment may rather increase than decrease regardless of whether emissions decrease or even remain stable.
A meeting of the 'Pentachlorophenol' Working Group was scheduled for 26 May 1998.
9. Strategies for dealing with additional chemicals (opinion requests to be submitted by DG III):
(i) Chrysotile asbestos
A presentation was made by DG III on the developments of the dossier since the last CSTEE plenary meeting. A meeting with M. States took place on the 3rd of March 98 where the opinion of the CSTEE was looked at. Since the CSTEE issued their opinion on this subject DG III have been trying to gather the information which the CSTEE suggested should be made available to fill the gaps in the ERM report. Basically there are still three sets of data which can be made available to the CSTEE: the so-called DE data (a series of studies), the FR data (which is a report from INSERM and is likely to be a very wide ranging report) and the UK data (a study carried out by the Leicester Institute of Environment and Health). It was also said that an epidemiological study from Canada should be forthcoming and would be made available to the CSTEE as soon as possible. The need to wait for the INSERM report was debated. It was suggested that a meeting with experts from INSERM should take place to explore the issue.
DG III presented the new terms of reference for the consultation of the CSTEE on the subject. Given the new questions asked to the CSTEE the Working Group chairperson expressed the view that in order to find answers to the questions, a wider participation and more time would be needed to address the problems of substitutes appropriately. In practice this should be taken to mean that no opinion should be expected by the CSTEE plenary in June.
It was finally agreed to organise a working group meeting in Paris (premises kindly made available by the INERIS) with the participation opened to participants from INSERM, IARC and an expert from Leicester University. The Working Group chairperson suggested a few experts to help the Working Group in the task and the CSTEE accepted. The Secretariat will check availability of the nominees.
DG III understood the time constraints but insisted that it was of the utmost importance for them to have an opinion of the CSTEE by its plenary meeting in September.
(ii) Creosotes
The presentation on this point was made by DG III. The context where the opinion of the CSTEE is being requested on this particular substance stems from the fact that there are in Directive 76/769 provisions on the marketing and use of Creosote, preparations containing Creosote and wood treated with Creosote. The restrictions laid down in Directive 76/769 are based on the fact that Creosote is classified in Directive 67/548 as carcinogenic but that such a classification need not apply below a given concentration (50 ppm) of a marker substance (benzo-[a]-pyrene). Certain M. States were of the opinion that the level of protection of human health laid down in Directive 76/769 was not sufficient and requested that their own, more restrictive, measures be accepted by the Commission, pursuant to Article 100a (4). The Commission requested that studies on the issue be produced by external consultants but such studies were inconclusive. They recommended to wait for the results of a new study carried out by the Fraunhoffer Institute, which should be properly analysed before proceeding with any risk management measures. The study has in the meantime been sent to European Chemicals Bureau in Ispra to allow them to organise the work in view of a possible revision of the classification of the substance under Directive 67/548/EEC.
The CSTEE is being asked here on whether there is a cancer risk to consumers from Creosote containing less than 50 ppm of the marker substance and/or from wood treated with such Creosote and the respective risk magnitude, if quantifiable.
In terms of timing DG III can wait for the CSTEE plenary meeting of September 1998 for an opinion to be adopted then. A working group was set up within the CSTEE to deal with this problem.
(iii) Chlorinated paraffins
It was acknowledged that before the CSTEE can look at these substances one should consider the risk assessments produced under the Existing Substances Regulation and what DG XI will do about it.
(iv) Azo dyes - The urgency of this subject is similar to that of Creosotes. A provisional working group was set up to deal with this subject when terms of reference are sent by DG III. The working group should meet before the summer break with a view to having an opinion adopted in September.
10. Role of the CSTEE in the entry of chemicals under Directive 76/769
The main subjects of discussion on this particular point had taken place already in looking at the priorities of DG III to be submitted to the CSTEE (see above point 9). Generally the issues addressed under this directive have to do with the fact that harmonised restrictions on the marketing and use of dangerous substances and preparations require risk assessments and cost-benefit analyses. The process of introducing new restrictions is mostly triggered by a notification of national provisions under Directive 83/189. Following the need to react within a limited time, DG III is using independent consultants to carry out targeted risk assessments. Taking the time constraint into account as well as the committee's limited resources, the CSTEE agreed that an appropriate role for it is to check the scientific quality of the independent studies (peer-review).
In order to be able to meet the strict deadlines, the CSTEE wished to have a regular update on the issues in the pipeline in the framework of limitations on marketing and use. A report from DG III/C/4 every three months was agreed.
11. Endocrine disrupters - presentation by the Working Group chairperson of status report
The WG chairperson presented the outline of the draft report to be developed by the Working Group and adopted by the CSTEE. It includes the following chapters: (i)Introduction; (ii) Endocrine disrupting chemicals (EDCs) and human health; (iii) EDCs and ecological health; (iv) Ecotoxicology test protocols, and (v) Conclusion.
The CSTEE agreed in general with this approach. It was suggested that a section on prioritisation of chemicals should be included and this was accepted.
The content of each of the chapters was discussed. On the Introductory chapter a definition of what an endocrine disrupter is was considered necessary as this expression is still being used in a rather loose way.
In the chapter on human health the issue of declining of human semen quality is going to be covered as well as reproductive organ disorders, in particular testicular cancer.
The chapter on ecological health, presentations of case studies will help with the characterisation of the effects in the biota. The aquatic and terrestrial environments will be covered and a comparison between the situation in the EU and the USA will be made.
Regarding the ecotoxicolgy test protocols a special attention will be devoted to highlighting what is missing in the field of ecotoxicology tests for detecting EDC's. The logic corollary will be that recommendations for the adoption of guidelines with validated new test methods will be proposed.
The date of 15 May was scheduled for a meeting of the Working Group 'Endocrine disrupters'.
12. 'Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment' - discussion
It was agreed to revisit this agenda point at the occasion of the next CSTEE plenary as there was no time available for discussing it.
13. Arrangements for the next meeting of the CSTEE
Comments made as reflected in point 5 were restated given the growing number of opinion requests being submitted to the CSTEE and the obvious need of more time to discuss them in a proper manner (next plenary to take place over two working days). Given that the date previously chosen had been the 15th of June 1998, the decision to prolong it into the 16th of June 1998 was taken, in spite of the fact that at least two members could not make it into the second day.
14. Any other business
Without any, the meeting was closed at 6 p.m.
Annexes:
I - List of participants
II- Meeting agenda
LIST OF PARTICIPANTS
CSTEE:
Prof. Bridges, Prof. Dybing, Prof.Greim, Prof. Jansson, Prof. Kyrtopoulos, Dr. Ladefoged, Dr. Lambré, Prof. Rueff, Prof. Salkinoja-Salonen, Dr. Tarazona, Prof. Terracini, Prof. Vighi, Prof. Vos, Prof. Wennig
SCF:
Prof. Knaap
External expert:
Prof. P. Calow
Apologies:
Prof. Chambers
European Commission:
DG XXIV
Mrs de Solà, Mrs Brunko, Mr Costa-David, Mrs Gámez Moreno, Mrs Decamps, Mr M.-Magone
DG III
Mr Berend, Mr Burge, Mr Glynn, Mr Soro, Mr Rossi
DG XI
Mr Aichinger, Mr Brockett, Mrs Fidalgo, Mr Olsen, Mr Paquot
DG XII
Mr Nolan
Stagiaire:
Mrs Fischer
AGENDA -
1. Adoption of the draft agenda
2. Adoption of the draft minutes of the 2nd plenary meeting of the CSTEE held on 09.02.98 in Brussels
3. Phthalates in toys - consideration of the draft final report (for opinion)
4. Water Framework Directive:
(i)Practical implications of the proposed modification to the Water
Framework Directive (Annex V), and (ii)Procedure for selection of priority substances with a view to the establishing of a list of Community priority substances - consideration of the draft report with a view to the possible adoption of a final opinion
5. Information on matters not covered elsewhere in the agenda:
(i) Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee
(ii) Discussion on the brief of the CSTEE
(iii) Schedule of CSTEE meetings for 1998
6. Presentation by DG III of opinion requests they have put forward:
(i) Tin, Arsenic and Cadmium
(ii) Pentachlorophenol
7. Tin, Arsenic and Cadmium - interim report presented by the Working Group chairperson
8. Pentachlorophenol - interim report presented by the Working Group chairperson
9. Strategies for dealing with additional chemicals (opinion requests to be submitted by DG III):
(i) Chrysotile asbestos
(ii) Creosotes
(iii) Chlorinated paraffins
(iv) Azo dyes
(v) Other
10. Role of the CSTEE in the entry of chemicals under Directive 76/769
11. Endocrine disrupters - presentation by the Working Group chairperson of status report
12. 'Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment' - discussion
13. Arrangements for the next meeting of the CSTEE
14. Any other business
The draft agenda was adopted.
2. Adoption of the draft minutes of the 2nd plenary meeting of the CSTEE held on 9.02.1998 in Brussels
The minutes were adopted with the following changes:
(i) The chairperson of the 'Chrysotile asbestos' Working Group pointed out that the text of the opinion annexed to the draft minutes did not correspond to the edited (by the CSTEE chairman) version. The edited version of the opinion on 'Chrysotile asbestos' adopted the 9 February 1998 should be included instead.
On point 4 of the draft minutes it was also requested to delete the reference to the fact that the chairperson of the WG, and other CSTEE members, might have commented on threshold levels.
(ii) The request was made to delete, in point 3 of the minutes, the reference to the presumed availability of an interim report by June 98 on the so-called NL study with human volunteers as it was considered that a guarantee of such availability could not be obtained. The sentence is to be replaced by one informing of the presumed conclusion of the study by September 1998.
(iii) Other, mainly editorial corrections, were suggested.
3. 'Phthalates in toys' - consideration of the draft final report for opinion
The CSTEE took account of the room documents (from refs. CSTEE/97/1-Adds. 82 to 86 of the list of documents) distributed just prior to the start of the meeting. Some minutes were spent analysing them.
Among the issues considered were: (i) what safety factor to use between exposure and the NOAEL values for the respective phthalates; (ii) relevance of peroxisome proliferation seen in rats (extrapolable to man or not); (iii) which additional safety factor to use in the absence of a NOAEL; (iv) how do SCF and CSTEE conclusions compare.
On (i) several comments were made on the validity of a safety factor lower than 100. One view was that, due to the lesser relevance of peroxisome proliferation for humans, a safety factor of 10 should be used. Others took the view that a safety factor of 100 was warranted. Some suggested that a safety factor of 50 should be used as a compromise. This view had some support but the final decision was that a safety factor of 100 should be chosen but with a clear explanation of the reasons why in the opinion.
On (ii) it was said that although it is currently generally accepted that peroxisome proliferation should not be an effect allowing for an extrapolation to humans, it was also acknowledged that this view is not consensual in the scientific community (particularly as increases in liver weight are statistically significant). It was also said that the effect should also be considered in immune cells and not only in the liver. This gave some weight to the opinion of those who thought that such an effect should not simply be ignored.
On (iii) an additional uncertainty factor of 5 was selected for DBP because of effects in the offspring, whereas a factor of 2 was selected for BBP because of slight organ weight effects.
On (iv), and with the presence of a member of the SCF, it was acknowledged that the specificity of the effect, plus the fact that some of the data on which the CSTEE had arrived at their conclusions were more recent than that used by the SCF, justified that the former could deviate from the conclusions of the latter.
Subsequently, and bearing in mind the information contained in all the documents made available, the chairperson of the 'Phthalates in toys' working group explained some important changes which were introduced into the model of calculation, i.e. a change from 12 to 6 hours exposure and that of the weight of the 'model' child from 5 to 8 Kg. These changes alter significantly the assessment. As a result DNOP came out of the range of concern (as defined by the model). The extractable amounts were calculated using the modelling techniques (DINP - 1.2mg, DNOP - 3.0mg, DEHP - 0.4mg, DIDP - 2.0mg, BBP - 6.8mg and DBP - 0.8mg) but such values do not take into account that children may have additional phthalate exposure via other sources.
Going through the results of the mentioned calculations the conclusions were that action is warranted on DINP because the exposure levels cause concern. As for DEHP it was acknowledged that the low margin of safety could give rise to concern. However, due to the nature of its critical effect (peroxisome proliferation), the CSTEE members were less concerned about exposure to this phthalate.
No new information was available on the study being carried out with human volunteers in the NL (study expected to be concluded in the autumn of 98). The CSTEE reiterated the view that the results of this study should be closely followed and that, in the light of the respective results, its opinion on 'Phthalates in toys' could be revised.
4. Water Framework Directive - consideration of the draft report of the working group with a view to the possible adoption of a final opinion
The main body of the opinion, particularly parts A and B was generally the object of a consensus. On part C there were few and mostly editorial comments on C1 to qualify the provisions of the directive dealing with pesticides. On C2 (Fish water directive), it was suggested that since comments were broader and applicable to the entire issue they should be moved to the Final Recommendations section. The importance of reference sites was emphasised. Regarding section E (presentation and classification of waters) a discussion on the classification about the different categories of waters also took place. There were only three in the terms of reference but some members suggested there should be five overall (with 'poor' and 'bad'). Others said that all that is possible at present is the classification of waters into 'good' and 'poor' and that a further change from 'bad' into 'fair' and 'bad' can be artificial (but can also contribute to harmonising the situation in M. States).The need for clarification on what the directive is intended to protect, particularly on the distinction between contamination/pollution and contaminant/pollutant, was also commented.
Regarding the procedure for the selection of priority substances with a view to establishing a list of Community priority substances, the representative of DG XI argued that, in their view, a 'monitoring based' selection process would probably be more realistic as opposed to the 'modelling based' process supported by the CSTEE Working Group. The members of the WG present gave the reasons why they thought that a 'modelling based' approach was preferable (basically due to the fact that monitoring is very much dependent upon the analytical capabilities of laboratories). Eventually it was agreed that a combined approach between the 'monitoring based' and the 'modelling based' selection process is desirable.
It was also said that the proposed directive has uncertainties since it is not clear what it is intended to protect. It was suggested that a clarification is necessary in the statement on how heavy metals should be addressed in the context of priority chemicals. DG XI has the intention of treating metals separately from micro-organic pollutants. They further informed the CSTEE that the ranking will be based on monitoring results. The selection of average concentrations and PNECs used for the ranking of metals will be made publicly available and openly discussed with experts including the CSTEE.
DG XI also informed that on 2/3 July 1998 experts of Member States, Industry and NGOs, as well as the chairperson of the CSTEE 'Water Framework Directive' Working Group will be invited by DG XI to a meeting to discuss the results of the COMMPS procedure.
The following course of action was agreed to speed up the adoption (by written procedure) of the draft opinion: (i) by the end of the following week (30 April), contributions of CSTEE members to be sent to the Working Group; (ii) Working Group to respond by the 8th of May; (iii) Working Group to integrate any subsequent comments by the 15th of May; (iv) Working Group meets the 18th of May and concludes final draft; (v) draft is circulated for adoption by written procedure with deadline for approval set at the 25th of May.
5. Information on matters not covered elsewhere in the agenda:
This point served the purpose of discussing the role to be played by the CSTEE on activities which, given the CSTEE brief, they should follow. The issue of electromagnetic radiation, was discussed and the creation of a provisional working group was decided. Another provisional working group on risk assessment was also created.
On the issue of possible future topics to be looked at by the CSTEE members were invited to reflect and propose new ones for the committee to address.
It was also decided that the next CSTEE plenary should take place over two working days (possibly one half day and a full working day). Given that the date of 15 June had already been decided for the next plenary it was decided that the plenary should take place over 15 and 16 of June in spite of this being an arrangement not convenient to everybody.
6. Presentation by DG III of opinion requests they have put forward:
(i) Tin, Arsenic and Cadmium and
(ii) Pentachlorophenol
DG III explained the context in which these opinion requests are being submitted to the CSTEE. Basically they are the result of the need that the Commission has of resolving the problem of the derogations that Sweden, Finland and Austria have in their Accession Treaties. The derogations cover, among others, Directive 76/769 on restrictions, marketing and use of Arsenic, Tin, Cadmium and Pentachlorophenol for a transitional period ending 1st January 1999.
The Commission agreed to review the legislation in question within the same period. It is possible that these countries may be forced to lower their standards and apply the existing directives. Because of the difficulties that this would pose, the review process is ranked very high politically.
The Accession Treaties require that the Commission review the directives in question by 31st December 1998. There is no engagement to change any legislation and all Member States (new and old) are required to apply this acquis (changed or unchanged) from 1st January 1999. The policy of the Commission to be followed in reviewing legislation is set out in the Communication "An Industrial Competitiveness Policy for the European Chemical Industry". In essence there are basically three requirements namely a risk assessment, a cost benefit analysis and a comparison with practice outside the EU.
The risk assessments have been carried out by external consultants who have produced, or are in the process of finalising, reports on the risks posed by the chemicals in question. The CSTEE is being asked to peer review such reports on the basis of the terms of reference submitted to them by DG III (already distributed to the CSTEE).
7. Tin, Arsenic and Cadmium - interim report presented by the Working Group chairperson
As two working group meetings had already taken place, one on Tin, Arsenic and Cadmium (16 March 1998) and another on Pentachlorophenol (30 March 1998) the chairperson of the respective working groups were asked to comment on any interim conclusions they might have had to the plenary. In the Working Group 'Tin, Arsenic & Cadmium' the decision had been taken to appoint a rapporteur per substance.
Tin - The rapporteur for this substance had prepared a draft preliminary report the main conclusions of which were that the degree of risk for both the aquatic environment and human health reported in the study of WS Atkins is sufficiently justified and also that in spite of the scarcity of available data and the budget limitations as well as the time constraints in the report, this might, provisionally, be deemed appropriate for decision taking. However the rapporteur stressed the limitations posed by the phraseology of the terms of reference as the scientific community is not used to making peer reviews of risk assessments bearing in mind any budget limitations.
Arsenic - the rapporteur for this substance highlighted the problems he had found with references. Very few of those mentioned in the report are published in standard scientific journals. Most are either reports to various organisations or published in proceedings of specialised conferences, both of which are not easily accessible. He requested from DG III and/or DG XXIV (CSTEE Secretariat) that the documents that are referenced should be made available in order to properly check the data. He subsequently provided a list of those thought to be the most relevant for the peer review of the document.
Cadmium - due to absence of the rapporteur for this particular substance no report could be made to the working group.
A meeting of the Working Group 'Tin, Arsenic & Cadmium' was scheduled for 29 May 1998.
8. Pentachlorophenol - interim report presented by the Working Group chairperson
The chairperson, and 'rapporteur' for this substance, reported to the CSTEE some of the interim conclusions arrived at by the Working Group. Basically the emphasis was put on the shortcomings of the report. Among those found he mentioned in particular confusing data and mistakes in units expressed in Table 3.3a (mg/kg, µg/kg, ng/kg) and also lack of compatibility of data in the table with that in the literature review.
Also in chapter 6 (on Exposure Assessment and Environment) there are also aspects which lack clarity with probable mistakes in expressed units of tables 6.3a and 6.3b. The chapter also lacks relevant PCP exposure data for a proper risk assessment.
Furthermore it was mentioned that the report deals essentially with steady emissions only, while it is a known fact that there are significant accidental releases of PCP against sapstaining of timber at outdoor or near outdoor facilities. Some data on such occurrences were reported orally by one of the WG members.
Finally it was also said that the report overlooks the more serious threats to man and the environment by releases of noncontained chlorophenol usage in timber. The characteristics of biodegradation of higher chlorinated dioxins/furans may mean dechlorination into more toxic substances and hence, in the long run, the human exposure to dioxins from PCP products released into the environment may rather increase than decrease regardless of whether emissions decrease or even remain stable.
A meeting of the 'Pentachlorophenol' Working Group was scheduled for 26 May 1998.
9. Strategies for dealing with additional chemicals (opinion requests to be submitted by DG III):
(i) Chrysotile asbestos
A presentation was made by DG III on the developments of the dossier since the last CSTEE plenary meeting. A meeting with M. States took place on the 3rd of March 98 where the opinion of the CSTEE was looked at. Since the CSTEE issued their opinion on this subject DG III have been trying to gather the information which the CSTEE suggested should be made available to fill the gaps in the ERM report. Basically there are still three sets of data which can be made available to the CSTEE: the so-called DE data (a series of studies), the FR data (which is a report from INSERM and is likely to be a very wide ranging report) and the UK data (a study carried out by the Leicester Institute of Environment and Health). It was also said that an epidemiological study from Canada should be forthcoming and would be made available to the CSTEE as soon as possible. The need to wait for the INSERM report was debated. It was suggested that a meeting with experts from INSERM should take place to explore the issue.
DG III presented the new terms of reference for the consultation of the CSTEE on the subject. Given the new questions asked to the CSTEE the Working Group chairperson expressed the view that in order to find answers to the questions, a wider participation and more time would be needed to address the problems of substitutes appropriately. In practice this should be taken to mean that no opinion should be expected by the CSTEE plenary in June.
It was finally agreed to organise a working group meeting in Paris (premises kindly made available by the INERIS) with the participation opened to participants from INSERM, IARC and an expert from Leicester University. The Working Group chairperson suggested a few experts to help the Working Group in the task and the CSTEE accepted. The Secretariat will check availability of the nominees.
DG III understood the time constraints but insisted that it was of the utmost importance for them to have an opinion of the CSTEE by its plenary meeting in September.
(ii) Creosotes
The presentation on this point was made by DG III. The context where the opinion of the CSTEE is being requested on this particular substance stems from the fact that there are in Directive 76/769 provisions on the marketing and use of Creosote, preparations containing Creosote and wood treated with Creosote. The restrictions laid down in Directive 76/769 are based on the fact that Creosote is classified in Directive 67/548 as carcinogenic but that such a classification need not apply below a given concentration (50 ppm) of a marker substance (benzo-[a]-pyrene). Certain M. States were of the opinion that the level of protection of human health laid down in Directive 76/769 was not sufficient and requested that their own, more restrictive, measures be accepted by the Commission, pursuant to Article 100a (4). The Commission requested that studies on the issue be produced by external consultants but such studies were inconclusive. They recommended to wait for the results of a new study carried out by the Fraunhoffer Institute, which should be properly analysed before proceeding with any risk management measures. The study has in the meantime been sent to European Chemicals Bureau in Ispra to allow them to organise the work in view of a possible revision of the classification of the substance under Directive 67/548/EEC.
The CSTEE is being asked here on whether there is a cancer risk to consumers from Creosote containing less than 50 ppm of the marker substance and/or from wood treated with such Creosote and the respective risk magnitude, if quantifiable.
In terms of timing DG III can wait for the CSTEE plenary meeting of September 1998 for an opinion to be adopted then. A working group was set up within the CSTEE to deal with this problem.
(iii) Chlorinated paraffins
It was acknowledged that before the CSTEE can look at these substances one should consider the risk assessments produced under the Existing Substances Regulation and what DG XI will do about it.
(iv) Azo dyes - The urgency of this subject is similar to that of Creosotes. A provisional working group was set up to deal with this subject when terms of reference are sent by DG III. The working group should meet before the summer break with a view to having an opinion adopted in September.
10. Role of the CSTEE in the entry of chemicals under Directive 76/769
The main subjects of discussion on this particular point had taken place already in looking at the priorities of DG III to be submitted to the CSTEE (see above point 9). Generally the issues addressed under this directive have to do with the fact that harmonised restrictions on the marketing and use of dangerous substances and preparations require risk assessments and cost-benefit analyses. The process of introducing new restrictions is mostly triggered by a notification of national provisions under Directive 83/189. Following the need to react within a limited time, DG III is using independent consultants to carry out targeted risk assessments. Taking the time constraint into account as well as the committee's limited resources, the CSTEE agreed that an appropriate role for it is to check the scientific quality of the independent studies (peer-review).
In order to be able to meet the strict deadlines, the CSTEE wished to have a regular update on the issues in the pipeline in the framework of limitations on marketing and use. A report from DG III/C/4 every three months was agreed.
11. Endocrine disrupters - presentation by the Working Group chairperson of status report
The WG chairperson presented the outline of the draft report to be developed by the Working Group and adopted by the CSTEE. It includes the following chapters: (i)Introduction; (ii) Endocrine disrupting chemicals (EDCs) and human health; (iii) EDCs and ecological health; (iv) Ecotoxicology test protocols, and (v) Conclusion.
The CSTEE agreed in general with this approach. It was suggested that a section on prioritisation of chemicals should be included and this was accepted.
The content of each of the chapters was discussed. On the Introductory chapter a definition of what an endocrine disrupter is was considered necessary as this expression is still being used in a rather loose way.
In the chapter on human health the issue of declining of human semen quality is going to be covered as well as reproductive organ disorders, in particular testicular cancer.
The chapter on ecological health, presentations of case studies will help with the characterisation of the effects in the biota. The aquatic and terrestrial environments will be covered and a comparison between the situation in the EU and the USA will be made.
Regarding the ecotoxicolgy test protocols a special attention will be devoted to highlighting what is missing in the field of ecotoxicology tests for detecting EDC's. The logic corollary will be that recommendations for the adoption of guidelines with validated new test methods will be proposed.
The date of 15 May was scheduled for a meeting of the Working Group 'Endocrine disrupters'.
12. 'Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment' - discussion
It was agreed to revisit this agenda point at the occasion of the next CSTEE plenary as there was no time available for discussing it.
13. Arrangements for the next meeting of the CSTEE
Comments made as reflected in point 5 were restated given the growing number of opinion requests being submitted to the CSTEE and the obvious need of more time to discuss them in a proper manner (next plenary to take place over two working days). Given that the date previously chosen had been the 15th of June 1998, the decision to prolong it into the 16th of June 1998 was taken, in spite of the fact that at least two members could not make it into the second day.
14. Any other business
Without any, the meeting was closed at 6 p.m.
Annexes:
I - List of participants
II- Meeting agenda
LIST OF PARTICIPANTS
CSTEE:
Prof. Bridges, Prof. Dybing, Prof.Greim, Prof. Jansson, Prof. Kyrtopoulos, Dr. Ladefoged, Dr. Lambré, Prof. Rueff, Prof. Salkinoja-Salonen, Dr. Tarazona, Prof. Terracini, Prof. Vighi, Prof. Vos, Prof. Wennig
SCF:
Prof. Knaap
External expert:
Prof. P. Calow
Apologies:
Prof. Chambers
European Commission:
DG XXIV
Mrs de Solà, Mrs Brunko, Mr Costa-David, Mrs Gámez Moreno, Mrs Decamps, Mr M.-Magone
DG III
Mr Berend, Mr Burge, Mr Glynn, Mr Soro, Mr Rossi
DG XI
Mr Aichinger, Mr Brockett, Mrs Fidalgo, Mr Olsen, Mr Paquot
DG XII
Mr Nolan
Stagiaire:
Mrs Fischer
AGENDA -
1. Adoption of the draft agenda
2. Adoption of the draft minutes of the 2nd plenary meeting of the CSTEE held on 09.02.98 in Brussels
3. Phthalates in toys - consideration of the draft final report (for opinion)
4. Water Framework Directive:
(i)Practical implications of the proposed modification to the Water
Framework Directive (Annex V), and (ii)Procedure for selection of priority substances with a view to the establishing of a list of Community priority substances - consideration of the draft report with a view to the possible adoption of a final opinion
5. Information on matters not covered elsewhere in the agenda:
(i) Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee
(ii) Discussion on the brief of the CSTEE
(iii) Schedule of CSTEE meetings for 1998
6. Presentation by DG III of opinion requests they have put forward:
(i) Tin, Arsenic and Cadmium
(ii) Pentachlorophenol
7. Tin, Arsenic and Cadmium - interim report presented by the Working Group chairperson
8. Pentachlorophenol - interim report presented by the Working Group chairperson
9. Strategies for dealing with additional chemicals (opinion requests to be submitted by DG III):
(i) Chrysotile asbestos
(ii) Creosotes
(iii) Chlorinated paraffins
(iv) Azo dyes
(v) Other
10. Role of the CSTEE in the entry of chemicals under Directive 76/769
11. Endocrine disrupters - presentation by the Working Group chairperson of status report
12. 'Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment' - discussion
13. Arrangements for the next meeting of the CSTEE
14. Any other business
