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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 4th plenary meeting of the CSTEE held on 14/15.6.98 in Brussels
The draft minutes were not available. Agreement still needs to be reached on its ideal format (how detailed the information contained in it should be, etc.).
3. Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations. Consideration of draft opinions/reports, as presented by the respective rapporteurs/chairmen, with a view to their adoption by the CSTEE, on:
(i) Creosotes,
The rapporteur for this opinion request started off by describing the terms of reference submitted by the requester Commission service (DG III). An oral account was given of the main conclusions of the 'Creosotes' working group that met on the 10th of August 1998. They were that the study is correct and that on the basis of available information the magnitude of the carcinogenic risk to the general population cannot be quantified. The conclusions also supported the view that the products under consideration have a carcinogenic potential but specially that the potency of a certain exposure in an experiment with mice and its relevance for human exposure cannot be estimated as there is only very scant information available.
The existence of reports on exposure was acknowledged but the assumptions they contain are such that they do not allow for a good quantitative estimation of risk. This is one of the reasons why the conclusions were what they were.
The requester service (DG III) welcomed the conclusions but the adoption of the opinion was postponed till the next CSTEE plenary meeting given that the draft still needs some work done before it can be considered finalised.
Suggestions were made in order to simplify the activity of the CSTEE in the future in cases of opinion requests such as this one. It was pointed out that the approach to choose on how each opinion request should be tackled depends very much on the case at hand.
(ii) Chrysotile asbestos
The Working Group (WG) chairperson presented the draft opinion that resulted from the last 'Chrysotile asbestos' WG meeting (22 July 1998). He started off describing the new terms of reference as decided at the WG meeting in Paris (9 June 1998) emphasising the fact that the CSTEE had not been asked to provide a risk assessment on Chrysotile but only to come up with a comparative evaluation between it and a specific set of fibres (Cellulose fibres, PVA fibres and p-aramid fibres) in terms of the risks they pose as compared with Chrysotile.
The representative of the requester service (DG III) pointed out that, in this case as well as in others, they would welcome the CSTEE to make comments that would go beyond the confines of any terms of reference submitted to it.
The text of the draft opinion was subsequently analysed in detail and adopted with minor amendments. Its main conclusions were the following:
'A major concern with fibres is their carcinogenic potential. There is sufficient evidence that all forms of asbestos, including Chrysotile, are carcinogenic to man. No evidence of fibre-caused cancer occurrence in man is available for any of the three candidate substitutes. Admittedly, for cellulose fibres, this may reflect limitations in the design of the underlying studies, whereas the lack of epidemiological studies on PVA and p-aramid may be due to the relatively short time elapsed since the onset of industrial uses of these materials.
Lung fibrosis is a well-known consequence of Chrysotile exposure, but to-date no case has been reported in workers exposed to any of the three candidate substitute fibres.
Chrysotile is an established experimental carcinogen in laboratory animals. Of the candidate substitutes, only p-aramid has been tested in adequately designed long-term inhalation experimental studies, which did not provide evidence of carcinogenicity.
Overall, acute and sub-acute toxicity data on the three substitute fibres are very meagre and do not allow for a proper comparison with Chrysotile, with the possible exception of p-aramid, which in a series of experiments in rats was shown to cause less inflammation and cellular proliferation than Chrysotile given at similar doses. In vitro, the ability of cellulose to induce certain inflammation-related changes seems greater than that of Chrysotile.
Fibre characteristics, such as size, respirability, biopersistence and fragmentability, indirectly provide elements for an overall comparison of potential effects between different types of fibres. Current knowledge on the mechanisms of long-term toxicity of fibrous materials in humans based on such characteristics is consistent with the inference that substitutes are less harmful than commercial Chrysotile.
On the basis of the above, in the opinion of the CSTEE the ability of Cellulose, PVA or p-aramid fibres to induce cancer or fibrosis of the lung in man is likely to be lower than that of Chrysotile.
The limited amount of toxicological studies on the three candidate substitutes leaves wider margins of uncertainty in order to predict their ability to produce effects other than cancer and lung fibrosis. Nevertheless, the available data on current levels of exposure and fibre characteristics suggest that the amount of fibres of critical size and shape reaching the human pulmonary alveoli is very limited.
Thus, both for the induction of lung and pleural cancer and lung fibrosis - i.e. the end point conditions investigated to a greater extent - and for other effects, it is unlikely that either Cellulose, PVA or p-aramid fibres pose an equal or greater risk than Chrysotile asbestos. With regard to carcinogenesis and induction of lung fibrosis, the CSTEE has reached a consensus that the risk is likely to be lower.
The CSTEE recommends these conclusions not to be interpreted in the sense that environmental control of the workplaces where the substitute fibres are produced or used can be relaxed. Finally the CSTEE strongly recommends expansion of research in the areas of toxicology and epidemiology of the substitute fibres as well as in the technology of development of new, thicker (less respirable) fibres'.
Finally, in order to clarify some doubts that had been expressed by the asbestos Industry on whether all the documentation submitted to the CSTEE via its Secretariat had been considered, the rapporteur commented on a specific set of documents coming from Spain (CSTEE/97/2-Adds. 19, 20, 21, 22, 24, 34, 35, 36 and 37). The WG chairperson also informed the CSTEE that he had had access to a confidential report, and as such only provided to him, on 'Description of an on-going epidemiological study on workers exposed to asbestos in Spain'. The chairperson confirmed that this confidential document did not add anything to the evaluation of the WG. He confirmed also that the other documents had indeed been analysed by the WG but that the WG did not consider them as being relevant in terms of the questions that had been asked to the CSTEE. The WG chairperson/rapporteur also confirmed that the so-called Canadian criticisms had also been considered.
Again the requester service expressed thanks for the work done by the CSTEE. The representative of DG V said that the opinion of the CSTEE will be examined in detail in order to derive any conclusions that may be useful in the context of legislation on workers protection for which they are responsible.
(iii) Tin
The rapporteur presented an update of the draft opinion. The (minor) differences vis à vis the previous version were described, i.e. basically references to the EPA report, to toxicity studies on the effects of Tin on human thymocytes. Since a WG meeting will take place on the 23rd of October 98 to address basically the 'Cadmium' issue, that will be an opportunity to have a last look at the draft. The issue of the recommended ADI was also debated, not in terms of the conclusion but in the phraseology chosen, e.g. 'should be recommended/is recommended/ought to be recommended'. Given also the need to introduce some editorial corrections, the formal adoption was postponed for the next CSTEE plenary meeting .
(iv) Arsenic
An opinion was finally adopted on this one after consideration was given to the various comments/suggestions made during the previous CSTEE plenary meeting. Its main conclusions were:
The following unacceptable risks were identified in the Atkins Report:
a) effects on aquatic organisms in low-phosphate marine waters, arising from arsenic leaching from CCA-treated wood;
b) marginally increased lung cancer risks from controlled incineration of CCA-treated wood;
c) significantly increased lung cancer risks from uncontrolled use of CCA-treated wood for home heating;
d) significant effects on the environment from uncontrolled burning and disposal of CCA-treated wood.
e) potential risks from the unpredictable long-term leaching behaviour of arsenic in special waste landfills;
In addition, a risk for children arising from skin contact with CCA-treated wood in playgrounds, is identified in the body of the Report, but it is not included in the Conclusions Section.
The CSTEE considers that overall the Report identifies correctly most of the main risks associated with arsenic-based wood preservation, which are derived primarily from the disposal of CCA-treated wood. In addition to the risks identified in the Report, the CSTEE notes that further risks may exist:
a) for children through the ingestion or inhalation of sand particles in playground sandpits, and
b) for soil, aquatic or sediment-inhabiting biota growing in close proximity to CCA-treated wood.
Finally, a potential risk not discussed in the Report, is that of skin cancer by ingestion of arsenic, known to be significant in areas where arsenic levels in drinking water are naturally high.
The CSTEE wishes to underline that a major source of concern regarding the use of arsenic-containing wood preservatives relates to the high degree of uncertainty regarding the speciation of arsenic during its long-term storage in landfills (the major points of arsenic accumulation), making reliable quantitative predictions about its migration and bioavailability extremely difficult. This is a serious knowledge gap which the CSTEE recommends should be addressed by further research. In the meantime, it would be advisable to exercise caution by limiting the use of arsenic-based wood preservation to those situations where it is absolutely necessary.
Answers to the questions posed to the CSTEE:
a) The Report correctly identifies the main risks associated with arsenic-based wood preservation. Additional risks, not identified in the Report, exist for children playing in sandpits with arsenic-treated wood and for soil, aquatic or sediment-inhabiting biota growing in close proximity to CCA-treated wood. Finally; the uncertainty of predictions of the long-term behaviour of arsenic in landfills are higher than implied in the Report.
b) While the risk assessment methodology employed in the Report is broadly correct, the quality of documentation and justification contained is not considered adequate: Much of the important bibliography on the environmental chemistry and toxicology of arsenic appears to have been ignored. Furthermore, the use of "best current practice" hypothesis, while largely imposed by the lack of adequate data, should have been better justified, as should have been the adoption of various environmental guidelines developed by various agencies.
(v) Cadmium
The importance of having an opinion adopted soon was emphasised again by the requester service, in particular bearing in mind their schedule of meetings with M. States.
However, in the course of the debate it was realised that the adoption of the opinion had still some way to go. The WG 'Tin, Arsenic, Cadmium' will meet again on the 23rd of October 1998 to try and settle some issues still needing clarification, in particular with regard to environmental risk assessment (PNEC's, safety factors, etc.). These difficulties were partly due to the fact that new versions of the so called Atkins report on which the CSTEE was asked to express an opinion seem to be popping up all the time. It was agreed that the WG should base its opinion on the documents it has at hand and that asking for updates to the authors of the report is not advisable. Depending on progress made at the next WG meeting, the opinion can either be adopted by written procedure or adoption deferred till the next CSTEE plenary meeting (26/27 November 1998); the first option was preferred by the requester service.
(vi) Pentachlorophenol
A new draft opinion was presented and discussed. However, given that the text had not been looked at before by CSTEE members (draft was only finalised just before the discussion) the decision was taken to ask the rapporteur to take account of some comments made during the meeting (some members expressed reservations in connection with issues such as environmental effects characterisation, reliability of some of the data, confusion in the proposed text between concepts of danger/hazard and risk, etc.). The rapporteur is to rewrite the draft with a view to its possible adoption by written procedure (adoption by early October 1998 envisaged).
(vii) Azo dyes
The rapporteur for this particular opinion request presented the draft opinion. It is an assessment of the report by the Laboratory for the Government Chemist (LGC) - UK. LGC addressed the risk of cancer caused by textiles and other goods coloured with azo dyes. It reviewed the toxicology and the use of azo dyes and the conclusions are that the associated cancer risks from the mentioned uses cause concern, even though the consumer exposure is very low. Based on these conclusions a number of recommendations are made. Some aromatic amines are recommended to be eliminated or its use restricted. Some other aromatic amines (eight) are classified by MAK as category 2 carcinogens. For these LGC suggest that additional data should be generated to assess their mutagenic potential.
The LGC report also includes an annex which contains the conclusions of an European study (project called European Inspection of the Notification of New Substances). This includes a questionnaire addressed to a number of manufacturers to determine how well the notification of new chemicals legislation is applied. From it, it turns out that a substantial fraction of new chemicals appear not to be notified in accordance to EU regulations.
LGC reviews briefly but adequately the toxicology and the use of azo dyes in the colouring of textiles and leather goods. They reviewed non-cancer end points but did not go into details. They pointed out that the main cancer risks derive from the ability of azo dyes to undergo reductive cleavage to aromatic amines that are carcinogenic. This is assumed to be the main mechanism giving rise to the cancer risk. The main routes of exposure considered are oral ingestion primarily concerning children which suck textiles, dermal absorption (the main route of concern for consumers - clothes coming into contact with skin) and risk to workers in dyes production; for the latter group there is also an inhalation route which causes concern.
The workplace exposures are immediately taken care of in the report by assuming that best practice is applied and hence that regulations do not permit exposures of concern.
Estimation of exposure is based on a number of studies carried out by the Ecological and Toxicological Association of Dyes and Organic Pigment Manufacturers; it seems that there are no other studies. The conclusion of these studies is that in most cases the leaching rate is low with one or two exceptions.
Calculations were also made regarding the exposure of children. The risk here would be much higher as the model included oral absorption as well.
Altogether it would look as if the assumptions are justified.
Other CSTEE members commented relatively favourably on the LGC report (in spite of some shortcomings such as the references) and on the draft opinion prepared by the rapporteur. Some suggestions to change the format of the latter were made.
The relative potency of the 22 amines being considered in the LGC report was discussed but the picture in terms of the concern caused did not change appreciably regardless of which one was being considered.
Other issues addressed had to do with the fate of textiles and their environmental impact as there are indications that a lot of clothes we use have a very short life span. They therefore can enter the aquatic ecosystem where we take our food from (fish); they can also go to sludges and this is a cause for concern as these are used in many European countries to be spread on land and therefore they would come in direct food contact. In waste-water there are considerable amounts of azo dyes as these are leached from washing machines and although we are not drinking waste water we put it in our crop fields.
The information was also given that azo dyes are being looked at under Regulation 793/93. However there are problems linked to the availability of confidential data on new chemicals which means that passing these on to the CSTEE cannot be considered an automatic process.
A potential solution to this was suggested: reports could be prepared with just some figures, not indicating the names of the chemicals but the levels of human exposure through the different routes, making it possible to check how relevant this could be.
It was proposed to the rapporteur to revise the draft opinion in the light of the various comments made by the CSTEE. A new draft should be ready for adoption at the next CSTEE plenary.
4. Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances. Presentation by DG XI of the Commission of the terms of reference for consulting the CSTEE on the results of the risk evaluation of:
(i) 2-(2-butoxyethoxy)ethanol (NL)
(ii) 2-(2-methoxyethoxy)ethanol (NL)
(iii) Alkanes, C10-13, Chloro (UK)
(iv) Benzene, C10-13-Alkyl derivs (IT)
The point was presented by two representatives of the European Chemicals Bureau (ECB) responsible for ensuring the running of the technical meetings under Council Regulation 793/93 in the ECB in Ispra.
The functioning of the Regulation was described starting off with a chronological description of its implementation. As a piece of legislation it is based in Article 100a of the Treaty and therefore it is basically intended at ensuring the free movement of goods in the Community and a high level of protection of man and the environment. The ultimate objective of the Regulation is to propose risk reduction strategies, themselves based on the risk assessments. The exercise implies compromises, the reason being that decisions must be made within a limited timeframe and that puts difficult requirements on science since decisions have to be made even when science may not be totally clear. The risk assessments have to be specific on where there are certainties and where these are non existent.
The whole process involves data collection (on about 2600 chemicals). The purpose of data collection is to select those substances that seem to be of highest concern and make them undergo immediate attention (risk assessment needed quickly). Rankings follow this step and based on it the M. States and the Commission select chemicals ending up with the drawing up of priority lists (currently they include about 110 chemicals overall). M. States then volunteer to carry out risk assessments of specific chemicals. Conclusions of risk assessments are basically of three kinds: either more information is needed, no concern exists or risk reduction measures are needed.
The framework for risk assessments is laid down in Regulation 1488/94/EC. This was not seen as sufficient and therefore Technical Guidance Documents were developed with the support of M. States and the Commission. These are now available through the Office of Publications in Luxembourg (note: a few copies were made available to some CSTEE members during the meeting).
Industry provides the data they have available in order to allow the risk assessments to be carried out. Where there are data gaps Industry is required to perform the testing until a complete set of end points is available. Industry is also supposed to provide emission and exposure information to the rapporteur in order to allow for as complete a risk assessment as possible.
The overall role of the ECB is to provide scientific support to the legislator (the Commission - DG XI) who are politically responsible for Regulation 793/93. They do this as previously stated by organising technical meetings. When the risk assessment report is considered finalised risk management measures are proposed. These form the basis of the Commission recommendation for a particular chemical.
The process is a lengthy one also because of the number of stakeholders that participate in the exercise.
The presentation ended up with a description of what both the ECB and DG XI expect from the CSTEE. DG XXIV stated that following the reform of the entire system of scientific advice at Community level the Risk Assessment reports produced under regulation 793/93 will have to be presented to the CSTEE for peer-review. The ECB commented that if this was the case then the CSTEE will be seeing a substantial increase in the number of risk assessment reports for which comments by the CSTEE would be requested.
In terms of deadlines the opinions of the CSTEE on those four chemicals are important for reports that are being drawn up on the implementation of Regulation 793/93 (and Directive 67/548). An Environment Council foreseen for the 8th of December 1998 would be the ideal opportunity to present the conclusions of the risk assessments and proposed risk reduction measures as adopted by the Commission on the four substances. The schedule ahead for this, considering all its steps, means that the opinion of the CSTEE will have to be delivered by the 10th of November 1998.
The conclusions of the risk assessments mentioned above were then briefly presented by another ECB representative who also described the main uses of each chemical. The CSTEE will receive the final risk assessment reports and it is these documents that they will be asked to peer review with a view to confirm whether the conclusions arrived at by the rapporteur M. States are correct/justified.
The terms of reference, submitted by DG XI to DG XXIV, for the consultation of the CSTEE on the risk assessment reports mentioned were the following:
The CSTEE, on the basis of the examination of the results of the Risk Assessments carried out on the four substances, supported by the relevant scientific bibliography, which will all be made available to CSTEE members, is to answer the following two questions:
(1) Are the conclusions of the four Risk Assessment reports justified?
(2) Are the Risk Assessment reports presented by the Member States rapporteurs of good quality?
Finally DG XXIV provided some clarification on the reasons and rationale for the involvement of the CSTEE in the process as well as how some of the foreseeable difficulties, mainly logistic, may be solved in practice.
DG XXIV added that it was considered crucial that, for the future, a proper planning and well thought out involvement of the CSTEE from the early stages of development of the risk assessments is necessary as these risk assessment reports, once finished, represent several man-years of work. The principle of the peer review by the CSTEE of the Regulation 793/93 risk assessment reports was, however, considered a correct one by the committee itself.
Consideration should also be given to the consequences of the CSTEE opinions. A debate ensued and various scenarios were analysed. Possibilities for ensuring in the future a proper follow up by the CSTEE of various pieces of EU legislation covering the mandate of the CSTEE, were also considered.
Concerning practical arrangements for involving the CSTEE and keeping it informed of developments, the possibilities discussed were, among others: (i) those of creating working groups specifically to look at issues under Regulation 793/93 and Directive 67/548; (ii) resorting to external expertise where it may be felt that this is not available within the CSTEE; (iii) distributing minutes of ECB meetings to CSTEE members.
The mentioned minutes are very detailed and henceforth informative and would very likely be a good means of keeping the CSTEE informed of the state of technical discussions. This would allow them to react in case they saw a problem in the course of events in the ECB working group meetings.
New appointments to the CSTEE to fill the four vacancies still available in it is still a possibility which the Commission services are working on. When this is done the extra manpower available will mean an easier tackling of opinion submissions such as this one.
Concrete solutions to tackle this consultation were discussed and the principle to look at the conclusions rather than at the supporting documents was agreed. Several CSTEE members volunteered to look at the four substances and the agreement was that the various rapporteurs should transmit the conclusions to the CSTEE Secretariat as soon as possible but certainly before the end of October 98.
5. Endocrine disrupters
(i) presentation by the working group chairman of a status report being prepared by the 'Endocrine disrupters' working group (outcome of 'Endocrine disrupters' working group meeting of 8 September 98)
The EDC WG chairman presented the latest draft available from the 8th of September 98 EDC WG meeting. The intention is to finally produce a report that covers human health and environmental effects of EDCs. The basic idea presiding at the elaboration of this report/opinion is that it should not cover in detail human health effects (the general feeling of the WG is that the human part is not the most problematic one), rather it should focus on areas where knowledge is scarce.
A major focus of the report will be on the health of ecosystems and therefore the utility of ecotoxicity testing for ecosystems protection will be included in a separate chapter. There are a limited number of papers on non-existing ecotoxicity testing. EDCs and wildlife health effects will also be covered. These will focus on the European situation. It looks as if there is significant evidence of endocrine disruption in wildlife; this is based not only on wildlife studies but also on semi-field conditions or laboratory studies.
On the specific side of human health effects those on the immune system need being considered (although strictly speaking these are probably not endocrine but can be endocrine mediated). For most chemicals the mechanisms are unknown.
Another major area of the report, and a sensitive one at that, is the chapter on the regulatory guidelines. The ones that exist will be described, in particular the ecotoxicology ones. It is likely that the conclusions in the EDC report on ecotoxicity testing will be that at present they are deficient (as the OECD and CEFIC have also pointed out). There have also been suggestions from the USA to include batteries of in vitro test systems as a pre-screening to pick up endocrine disruption. It is not sure whether the WG will follow this approach as this will bring about false negatives as well as false positives (since not all endocrine disruption effects will be mediated through an effect on the receptor). In the USA system they use three receptors: (i)an androgen receptor, (ii)a steroid receptor and (iii)a thyroid receptor, but these don't cover everything. Besides that it is also a very costly approach.
Another chapter of the report will review the EU testing strategy for new chemicals including exposure considerations, (partly dependent on the tonnage of chemicals), and what type of testing is necessary. Possibly one of the CSTEE's conclusions will be that endocrine disruption for the human health assessment is poorly done, e.g. in the sub acute toxicity testing, but that it is much better in the area of reproduction toxicity (the limitation still remains that these tests are only done when you have high tonnage compounds). This is an area which needs some thinking in the sense that perhaps the criteria should be changed to include other, low tonnage, chemicals. For ecotoxicity testing the WG will come up with recommendations to include target organ toxicology in, e.g., fish toxicity testing, because the current end points such as mortality and others, don't say anything about possible targets of the endocrine system.
Conclusions and recommendations will end the report. At least two more WG meetings are foreseen with a view to have a draft report available for the meeting of 26/27 November 1998.
A short table with chemicals and indications of their potency will probably be produced but no listing of chemicals is foreseen. Natural products will in principle not be covered by the report.
After the presentation some CSTEE members made comments/suggestions such as a specific recommendation to the effect that the predictive value of QSARs (in other words relationship between molecular structure and toxicological effects) could be developed to address this type of effect. The rationale would be to compensate for the fact that there are probably a lot of different toxicological mechanisms involved on endocrine disruption and that for the time being there are not enough tools to evaluate if a chemical is an EDC or not. Therefore this should be stressed in the recommendations.
The REU representative asked the following questions: (i)whether there is evidence pointing to an EDC effect in the decreased mean male sperm count or whether this is due to the methodology used and (ii)whether there is any suitable experimental animal model which could be used to study the phenomenon of endocrine disruption as an explanatory factor in testicular cancer.
Regarding (i) the state of the art on sperm quality it was pointed out that this will be summarised in the draft report. The so-called Carlsson meta-analysis has been checked very thoroughly and criticised as it had various sources of bias and confounding. After that one, several studies have been carried out but four of those stand out as having a much better quality than that of Carlsson. Two of them have observed a decline in sperm concentration, one found no change and another found an increase. As regards (ii) (testicular cancer) the answer seems to be that there is no adequate animal model for testicular germinal cancer.
It was also explained that rodent models are used particularly when you use the so-called 90 days study and here the endocrine system is taken into account. Of course this could be bettered and there are proposals to improve the 407 OECD type study to include more parameters. Basically when a whole series of toxicity tests is carried out endocrine disruption is picked up. The wildlife situation is different mainly because of the big and variable number of species at stake.
These elements are included in the latest version of the EDC WG draft report.
Other questions asked centred on how much attention in the report will be devoted to the methodological issues of the epidemiological studies. The answer was that the title of the draft report points out that the focus is on ecosystem effects and particularly in identified blank areas on how to improve ecotoxicology test methods. It will not be a lengthy discussion on the epidemiology methodology used since there are other reports that cover that. The WG did not feel as being its charge to give an authoritative review on epidemiological issues. They would like to present only a summary statement and not any other detailed review.
It was pointed out that it would certainly be useful if DG XI could consider this report for their purposes as they are also involved in the EDC debate, particularly as they are co-ordinating the drafting of a Commission EDC strategy paper. The role played by the CSTEE on this issue will be stated in the strategy paper.
It was reminded that a meeting will take place in Vienna (18/19 November); DG XI is involved and the EDC WG chairman has been invited to make a presentation on EDCs and wildlife. Obviously the aim of the EC is to co-ordinate all these efforts and the CSTEE has a pivotal role to play in gathering scientific information and giving advice.
(ii) presentation by other Commission services of developments on EDCs
No other Commission services made presentations on their respective involvement on this topic.
6. Phthalates in toys - presentation by RIVM and others of the first results of the so-called 'Dutch study' on standardisation of measurement of phthalate release
A delegation from the so-called Dutch Consensus Group (Mrs Steenbekkers, Mr Konemann and Mrs Braybrook) presented the conclusions of their study on phthalate release from soft PVC toys. The information was given that the conclusions presented today would have to be considered confidential till at least Monday of the following week (21 September 98).
A question time period followed the presentation. They addressed issues such as (i) Test specimens (toys) used during the experiment. (ii) Prospects of inter-laboratory comparison exercises - Not considered by the Group as it was outside the remit of the exercise; necessary funding not available, perhaps dependent on a leading role by the Commission. (iii) Had problems with particles been covered? - Yes, samples were rinsed before using them, particularly considering that a cut surface can have particles. (iv) The chewing experiment - A coarse filter was used but this does not remove any fine particles left. (v) Were the experiments conducted with samples representative of a worst case situation or with the best quality articles available? - It is difficult to say which toy has the highest release rate; the point of the exercise was not that of addressing a worst case scenario but only to come up with a realistic assessment; however the data seems to indicate that the Dutch Consensus Group Study is near to a worst-case scenario. (vi) Is the material produced for the experiment available in large amounts? - The Industrial R&D laboratory that produced the material is able to provide samples, so in theory the answer is yes. (vii) What extrapolations to other EU children can we make from the conclusions of the study bearing in mind that the experiment was conducted with 'typical Dutch children'? How were they selected and how representative are they of the Dutch society? - The answer is 'don't know', but presumably, given that there was some variation in the results, other EU children should provide similar results; on the other hand there are no signs that societal factors influence sucking behaviour and one assumes that these factors would not influence the final results. (viii) What was the DINP content in samples - The sample produced had 38% but toys used had 43%. (ix) Where did children experiments take place? At home? At day care centres? - Children were observed at home by their parents; it was not possible to say whether children at day care centres would behave differently. (x) How were toys used representative of the toys available to the average consumer? - Difficult to answer as the range of articles is very high in terms of composition, size, shape, etc.. (xi) What is the likely reproducibility of in vitro test? - The reproducibility of the test will have to be determined by an inter-laboratory exercise, other views would be speculating, but the indications so far are promising if we compare this experiment with other methods used before. (xii) Is there a relation between the release and the initial concentration of the phthalate in the toy? - The answer seems to be that there is no relation with total phthalate content. (xiii) All tests having been conducted with new material what is the likelihood that when 'hold' material is used a similar level of release would be reached? - The concentrations of DINP are so high that lesser availability of the chemical is not expected; however there are no final data on this. (xiv) What about differences in the amount of muccins between children and adults? How does this influence results? - It was decided to move away from the use of muccin within the saliva simulant; the salt concentration in the saliva is as important and it was considered as probably not desirable in a standardised test. The protein content in the saliva seems to have no effect in the DINP release.
Other factors contributing to the conclusions of the Dutch Consensus Group Study were a not normal distribution and the use of sophisticated statistical techniques (something which does not live well with the reporting of standard deviations - a somewhat misleading element).
The great variability in the data available had led to CSTEE to use a worst case approach. With the data available from the Dutch Consensus Group, changes in the concern with DINP can be substantial with MOS changing accordingly. It was pointed out that additional exposures had not been incorporated in the previously determined MOS. If one considers these now to be, e.g. in the region of 50%, this can lead to changes in the MOS as well. Calculations have to be carried out however.
The extrapolation of the representativness of DINP results to other phthalates is speculation, so the correct assumption is that results with other phthalates would be different (because of differences in molecular weight and other physical/chemical properties). Using a very similar test to the one used in the Dutch Consensus Group study, data on DEHP release showed a release rate twice that of DINP, which seems to prove the point that there will be variations in terms of phthalate release.
The Dutch study seems to be a much better basis to make a decision from a scientific standpoint. The representativeness of the test specimen and the inter-laboratory exercise remain as weaknesses needing resolving. On the other the Austrian investigation seems to corroborate the Dutch conclusions. Therefore the CSTEE held the view that the Dutch data, with its limitations, is a good basis for reconsidering the previous calculations in its previous opinion of the 24th of April 98.
It was judged important to give the CSTEE time to reflect on the Dutch study before jumping to conclusions, particularly as, at the time of the meeting, the Dutch data is still under embargo. The decision was finally made not to release a final statement from the CSTEE as long as the Dutch Consensus Group Study becomes public. Given that a press release will take place a CSTEE statement was considered necessary. Some CSTEE members agreed that a series of provisos need to be considered in any statement. The problem of reproducibility is particularly relevant and the final Dutch Consensus Group report should make it clear that this is a limitation.
The 'Phthalates in toys' WG chairperson will prepare a draft statement to be sent by e-mail/fax to all CSTEE members for comments. Once agreed this will be submitted to the Commission. The limitations of endorsing a statement, basically on the Dutch Consensus Group study, without it having been taken out from embargo were again highlighted.
The ECB representative reminded that under the existing substances regulation phthalates are being evaluated and these will be looked at, at the next technical meeting by the end of September, with the full risk assessment report being first discussed at their December meeting.
Finally, the CSTEE were informed of the sending late last week of still another study from the Spanish IAJU (Spanish toys Industry). Copies will be submitted to the CSTEE very soon.
7. Accident at the Aznalcollar mine and the contamination of the Guadiamar river and the surroundings of the Doñana National Park - consideration of a draft general statement for possible adoption by the CSTEE
The discussion on this agenda item was postponed to the next CSTEE plenary meeting.
8. Strategies for dealing with additional chemicals (opinion requests to be submitted by other DGs of the Commission):
(i) Chlorinated paraffins
It was pointed out that these chemicals had just been discussed under Regulation 793/93 and, given the link between it and those on Directive 76/769, there is not as yet a clear picture of when a consultation of the CSTEE on these chemicals should take place. This is due to the fact that the risk assessment conclusions and risk reduction recommendations under 793/93 have yet to be endorsed. A CSTEE member pointed out that the risk assessment of the chlorinated paraffins being carried out under Regulation 793/93 only covers the short chain ones and there are two more groups, the medium length and the long chain groups. The DG III representative explained that this group will be tackled stepwise and priority is being given to the short chain ones as these are recognised as being the most toxic and posing the biggest risks.
(ii) New fertilisers
New questions on these are not foreseeable in the near future. Contrary to what the requester Commission service believed a few months ago it has turned out that there are no issues raised on EC fertilisers for the moment. This means that a consultation of the CSTEE is not foreseen for the near future.
(iii) Other
(i) There is work ongoing on mercury and a consultation on it is likely to be submitted to the CSTEE in the near future, perhaps next Autumn.
(ii) DG III has just launched a study to look at further dyes in textiles (the sensitising dyes - not all of them are azo dyes but most are). The study will not be concluded before some eight months so that is when a consultation of the CSTEE is likely, the report will be one similar to the LGC study on which the CSTEE's opinion was asked.
9. Water Framework Directive - feedback from the responsible services of the Commission on the follow up to the opinion adopted by written procedure by the CSTEE (05.6.98)
The chairman of the Water Framework Directive made a presentation on the Member States meeting, organised by DG XI, in which he participated on 2/3 July (the minutes of the meeting were circulated as a room document). Some important issues were raised during that meeting such as the basis for prioritisation of chemicals. Following the July meeting mentioned above, the Fraunhofer Institute produced a final report with a reviewed position that takes account of a number of remarks made by experts at the meeting (which resulted in some modifications in the ranked list).
So far, only the methodology and not individual substances were discussed with experts. At the meeting, experts were also asked for written comments, in particular to the database and to the monitoring data used by the consultant. Currently the Fraunhofer-Institute is working on a revised study, the outcome of which will be a list of substances to be discussed at expert level (including, of course, the CSTEE).
In any case there are two different aspects that perhaps the CSTEE could consider (dependent upon terms of reference to be submitted/discussed by/with DG XI). These are that the new report includes (i)some specific chemicals that have been identified as the potential priority ones, and (ii) a specific expert judgement by the Fraunhofer Institute with their opinion on whether these chemicals should or not be in the priority list. These are issues that the CSTEE could address as it has not discussed these points yet. The CSTEE has discussed the method and not specific chemicals and now these are being proposed. A rapid look at them shows some strange things such as the fact that mercury is not included at all even though there is a lot of information to the effect that the risk it poses should be higher than 1 in the PNEC calculation. This proves the point that this problem needs to be looked at very carefully.
At the meeting of 2/3 July 1998, some experts also expressed their surprise that mercury does not rank within the first 5 top metals ranked on the basis of exposure values derived from monitoring data. In order to find out possible reasons the Commission asked Member States to provide additional information on monitoring data, including detailed information on the sampling conditions and on results/estimates of the total vs. soluble concentrations of metals. As said above, the information received by DG XI is currently being assessed but the outcome is not yet known.
As soon as the revised Fraunhofer study is available, it will be distributed to experts (including the CSTEE).
It was pointed out that DG XI had accepted to take on board the conclusions of the CSTEE in their developing of the Water Framework Directive. Besides that the DG XI representatives that participated in the CSTEE meetings where the opinion on the Water Framework Directive was discussed and adopted, made the explicit statement to the effect that the CSTEE would be involved in the developments of the Water Framework Directive and that applies to the choice of substances for prioritisation.
The CSTEE Secretary informed the committee that some national authorities have been sending documents relevant for the activities on the development of the Water Framework Directive directly to the CSTEE Secretariat. However, given that there is no new opinion request pending on the subject, the Secretariat has refrained from sending them to CSTEE members. This will be done when such a new consultation is launched.
10. Information on matters not covered elsewhere in the agenda:
(i) Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee
The last SSC meeting took place in July and its focus was again on BSE. The SSC has now formally set up a small group to look at risk assessment and the CSTEE chairperson is one of its members. The CSTEE will be kept regularly informed. In case the activity will include the creation of working groups other CSTEE members will likely be involved. At the moment the intention is to harmonise risk assessment and look at various ways in which harmonisation might be approached. A meeting of this working group is scheduled for the 23rd of September 98.
(ii) Developments on the subject of the brief of the CSTEE
The CSTEE was asked whether there were any topics on which it should be pro-active. (i) The view was expressed that, based on the examples of phthalates and azo dyes, two groups of chemicals with some significant toxicological effects, it is striking that they can reach the consumer market without a proper legislative framework that will enforce adequate testing or examination of all these aspects beforehand. This includes things such as adequate testing of leaching of hazardous chemicals from products as a fundamental requirement prior to them being put on the market. Other examples could be mentioned. The idea was put forward to set up a small group to set a framework on what the CSTEE should look at in terms of exposure.
In this respect it was pointed out that enforcing the labelling of articles directly available to the consumer (an extention of the so-called 6th amendment of Directive 67/548) could solve the problem somewhat.
The ECB representative pointed out that an ECB working group on consumer exposure had been set up with a view to look at all the available models, assess them and feed in information. Details on its activities will be sent to the CSTEE Secretariat.
(ii) Indoor climate/pollution was again mentioned as an area the CSTEE should look at as a priority. Phthalates and chlorinated paraffins were quoted as examples of products that can contaminate the indoor environment.
(iii) Particulate matter and criteria for estimating its importance had been mentioned previously in a CSTEE plenary meeting and this again was raised as an area of interest. However the information was given that a meeting had been arranged between the SSC and various DGs, including DG XI, and the initial message to the SSC was to stay away from being involved.
The CSTEE were informed by its Secretary of the fact that the DG XI Unit responsible for air quality is taking seriously the point of information of the CSTEE and as such they have been sending information in various forms to its Secretariat. However it was recognised that the CSTEE is currently overloaded and therefore perhaps its involvement on this and other issues should be postponed. Before deciding on how to involve the CSTEE on issues to do with air quality it was felt that perhaps for the time being the CSTEE should refrain from being too pro-active.
(iii) Directive 67/548/EEC (Classification, Packaging and Labelling of Dangerous Chemical Substances)
Its Secretary informed the CSTEE about the lack of progress on clarification of the role to be played by the CSTEE on this legislative piece. The strategy of keeping the CSTEE informed is still being pursued as the regular sending of information to the CSTEE in connection with this topic shows.
Related to this topic, questions were asked about the possible involvement of the CSTEE on the new Preparations Directive (that includes environmental classification). The answer was that it is expected that DG III asks the opinion of the CSTEE on all legislative proposals with a potential bearing on consumer health and that includes the Preparations Directive. Concern was expressed at the prospect that, as was the case with the four chemicals under Regulation 793/93, on which the involvement of the CSTEE took place very late in the process, the same might happen with the Preparations Directive.
The suggestion was made that an explicit note should be endorsed by the CSTEE drawing the attention of the Commission to the various topics that the CSTEE believes should be the object of its closer scientific peer review/scrutiny.
Another issue raised in connection with Directive 67/548 was that of the definition, since the 7th amendment, of reproduction within it. This seems to have been severely criticised by the scientific community. However, since the Commission is participating in an exercise of international harmonisation of chemical classification systems, including addressing the issue of reproduction, perhaps the CSTEE involvement on this issue should take that into account as well.
Pka was also mentioned as an area of concern and one CSTEE member volunteered to produce a note stating the nature of the problem and making suggestions.
One CSTEE member asked what was the situation on the possible consultation of the committee on the classification of Nickel Chloride, a prospect that seemed likely a couple of months before. The response was that DG XI had decided to ask the views of the main Classification & Labelling working group (health effects) on whether the CSTEE should be consulted on this or not and if so how. The information recently received from DG XI was that, at their last meeting, the Classification & Labelling working group did not have time to discuss the issue.
It was suggested, however, that the issues submitted for opinion of the Specialised Experts group under Directive 67/548, should also be looked at by the CSTEE (this had been the case of nickel chloride).
(iv) Developments on future subjects to be addressed by the CSTEE - CSTEE proposals:
- Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment
Dr Tarazona informed the CSTEE about the forthcoming workshop due to take place in Madrid, from 4 to 6 November 1998. The draft agenda is still waiting formal approval from the ECB, which is also involved in the workshop's organisation along with the Spanish authorities. All CSTEE members will receive the agenda as soon as this is available. The ECB will publish the proceedings and these will also be made available to the CSTEE.
Several room documents will be available and these can be sent to CSTEE members upon request. All CSTEE members are being considered by the organising committee as potential participants.
There are various classification proposals for the terrestrial environment already in the pipeline, from Spain, ECETOC, the Nordic countries and apparently CONCAWE may have one too. The Spanish proposal covers endocrine disrupters with three levels of hazard, (i)highly toxic, (ii)toxic and (iii)harmful and potential long term or widely distributed effects. The possibility of having the EDC working group represented by its chairman was discussed.
(v) Schedule of CSTEE meetings for 1998 (update)
The schedule was revisited and the next plenary meeting confirmed for the 26/27 November 1998. The 21st of December 1998 remains as a provisional date for a CSTEE plenary meeting in case of need. The CSTEE chairman suggested for one of the next plenary meetings an item on review of working procedures. Another item suggested for discussion was whether individual members should have watching briefs in certain areas, in order to inform the CSTEE on what's going on in the wide world and avoid, so to speak, reinventing the wheel and, at another level, contributing to warn early the CSTEE of issues that are likely to come to its attention. The chairman will prepare a paper suggesting how the CSTEE should work during the forthcoming year.
11. Arrangements for the next meeting of the CSTEE
No particular arrangements were needed apart from the setting of the starting time (at 10 a.m. on 26 November) and finishing time (at 1 p.m. on the 27th of November).
12. Any other business
Prof. Greim distributed a paper prepared by a subcommittee of the German MAK commission, on the classification of carcinogens. So far all classification schemes for carcinogenicity have three categories. The problem seems to be that neither mechanistic data nor exposure data are included in the classification. The new German scheme is already being used and it is based on the use of two new categories, (i) One for carcinogens for which a threshold can be established (the concept is based on an identification of risk based on the likelihood of exposures above or below the identified threshold). (ii) The other category is for genotoxic agents for which the establishment of a threshold is unlikely. The reactions so far to the new DE scheme have been positive. The approach described has already been explained to the SCOEL.
The point was made that this input should be forwarded to the international instances responsible for the exercise of harmonisation of classification and labelling schemes. Some members supported the paper as the IARC scheme of classification is believed to have some limitations .
Without any other business, the meeting was closed at 13H00.
AGENDA
1. Adoption of the draft agenda
2. Adoption of the draft minutes of the 4th plenary meeting of the CSTEE held on 14/15.6.98 in Brussels
3. Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations. Consideration of draft opinions/reports, as presented by the respective rapporteurs/chairmen, with a view to their adoption by the CSTEE, on:
(i) Creosotes,
(ii) Chrysotile asbestos,
(iii) Tin,
(iv) Arsenic,
(v) Cadmium,
(vi) Pentachlorophenol,
(vii) Azo dyes
4. Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances. Presentation by DG XI of the Commission of the terms of reference for consulting the CSTEE on the results of the risk evaluation of:
(i) 2-(2-Butoxyethoxy)ethanol
(ii) 2-(2-methoxyethoxy)ethanol
(iii) alkanes, C10-13, Chloro
(iv) Benzene, C10-13-Alkyl derivs
5. Endocrine disrupters - (i) presentation by the working group chairman of a status report being prepared by the 'Endocrine disrupters' working group (outcome of 'Endocrine disrupters' working group meeting of 8 September 98). (ii) presentation by other Commission services of developments on EDCs
6. Phthalates in toys - presentation by RIVM and others of the first results of the so called 'Dutch study' on standardisation of measurement of phthalate release
(Note: this agenda point will start the 2nd day of the meeting)
7. Accident at the Aznalcollar mine and the contamination of the Guadiamar river and the surroundings of the Doñana National Park - consideration of a draft general statement for possible adoption by the CSTEE
8. Strategies for dealing with additional chemicals (opinion requests to be submitted by other DGs of the Commission):
(i) Chlorinated paraffins
(ii) New fertilisers
(iii) Other
9. Water Framework Directive - feedback from the responsible services of the Commission on the follow up to the opinion adopted by written procedure by the CSTEE (05.6.98)
10. 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) Developments on the subject of the brief of the CSTEE
(iii) Directive 67/548/ECC (Classification, Packaging and Labelling of Dangerous Chemical Substances)
(iv) Developments on future subjects to be addressed by the CSTEE - CSTEE proposals:
- Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment
(v) Schedule of CSTEE meetings for 1998 (update)
11. Arrangements for the next meeting of the CSTEE
12. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James W. BRIDGES, Prof. Philip L. CHAMBERS, Prof. Erik DYBING, Prof. Dr. Helmut GREIM (14/9), Prof. Bo O. JANSSON, Prof. Soterios KYRTOPOULOS, Dr. Claude LAMBRÉ, Prof. Dr. José RUEFF, Prof. Mirja SALKINOJA-SALONEN, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, Prof. Marco VIGHI, Prof. Joseph VOS, Prof. Dr. Robert WENNIG
AD HOC EXPERTS (15/9)
Dr. W.H. KÖNEMANN (R.I.V.M.)
Mw. B. STEENBEKKERS (Landbouwuniversiteit Wageningen)
Dr. Julian BRAYBROOK (Laboratory of the Government Chemist)
European Commission:
DG XXIV
Mrs M. de SOLÀ, Mr. J. COSTA-DAVID, Mr. T. DASKALEROS
DG III
Mrs L. PERENIUS, Mr. P. GLYNN, DG JRC/ECB, Mr. B. HANSEN, Mr. S. MUNN
The draft agenda was adopted.
2. Adoption of the draft minutes of the 4th plenary meeting of the CSTEE held on 14/15.6.98 in Brussels
The draft minutes were not available. Agreement still needs to be reached on its ideal format (how detailed the information contained in it should be, etc.).
3. Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations. Consideration of draft opinions/reports, as presented by the respective rapporteurs/chairmen, with a view to their adoption by the CSTEE, on:
(i) Creosotes,
The rapporteur for this opinion request started off by describing the terms of reference submitted by the requester Commission service (DG III). An oral account was given of the main conclusions of the 'Creosotes' working group that met on the 10th of August 1998. They were that the study is correct and that on the basis of available information the magnitude of the carcinogenic risk to the general population cannot be quantified. The conclusions also supported the view that the products under consideration have a carcinogenic potential but specially that the potency of a certain exposure in an experiment with mice and its relevance for human exposure cannot be estimated as there is only very scant information available.
The existence of reports on exposure was acknowledged but the assumptions they contain are such that they do not allow for a good quantitative estimation of risk. This is one of the reasons why the conclusions were what they were.
The requester service (DG III) welcomed the conclusions but the adoption of the opinion was postponed till the next CSTEE plenary meeting given that the draft still needs some work done before it can be considered finalised.
Suggestions were made in order to simplify the activity of the CSTEE in the future in cases of opinion requests such as this one. It was pointed out that the approach to choose on how each opinion request should be tackled depends very much on the case at hand.
(ii) Chrysotile asbestos
The Working Group (WG) chairperson presented the draft opinion that resulted from the last 'Chrysotile asbestos' WG meeting (22 July 1998). He started off describing the new terms of reference as decided at the WG meeting in Paris (9 June 1998) emphasising the fact that the CSTEE had not been asked to provide a risk assessment on Chrysotile but only to come up with a comparative evaluation between it and a specific set of fibres (Cellulose fibres, PVA fibres and p-aramid fibres) in terms of the risks they pose as compared with Chrysotile.
The representative of the requester service (DG III) pointed out that, in this case as well as in others, they would welcome the CSTEE to make comments that would go beyond the confines of any terms of reference submitted to it.
The text of the draft opinion was subsequently analysed in detail and adopted with minor amendments. Its main conclusions were the following:
'A major concern with fibres is their carcinogenic potential. There is sufficient evidence that all forms of asbestos, including Chrysotile, are carcinogenic to man. No evidence of fibre-caused cancer occurrence in man is available for any of the three candidate substitutes. Admittedly, for cellulose fibres, this may reflect limitations in the design of the underlying studies, whereas the lack of epidemiological studies on PVA and p-aramid may be due to the relatively short time elapsed since the onset of industrial uses of these materials.
Lung fibrosis is a well-known consequence of Chrysotile exposure, but to-date no case has been reported in workers exposed to any of the three candidate substitute fibres.
Chrysotile is an established experimental carcinogen in laboratory animals. Of the candidate substitutes, only p-aramid has been tested in adequately designed long-term inhalation experimental studies, which did not provide evidence of carcinogenicity.
Overall, acute and sub-acute toxicity data on the three substitute fibres are very meagre and do not allow for a proper comparison with Chrysotile, with the possible exception of p-aramid, which in a series of experiments in rats was shown to cause less inflammation and cellular proliferation than Chrysotile given at similar doses. In vitro, the ability of cellulose to induce certain inflammation-related changes seems greater than that of Chrysotile.
Fibre characteristics, such as size, respirability, biopersistence and fragmentability, indirectly provide elements for an overall comparison of potential effects between different types of fibres. Current knowledge on the mechanisms of long-term toxicity of fibrous materials in humans based on such characteristics is consistent with the inference that substitutes are less harmful than commercial Chrysotile.
On the basis of the above, in the opinion of the CSTEE the ability of Cellulose, PVA or p-aramid fibres to induce cancer or fibrosis of the lung in man is likely to be lower than that of Chrysotile.
The limited amount of toxicological studies on the three candidate substitutes leaves wider margins of uncertainty in order to predict their ability to produce effects other than cancer and lung fibrosis. Nevertheless, the available data on current levels of exposure and fibre characteristics suggest that the amount of fibres of critical size and shape reaching the human pulmonary alveoli is very limited.
Thus, both for the induction of lung and pleural cancer and lung fibrosis - i.e. the end point conditions investigated to a greater extent - and for other effects, it is unlikely that either Cellulose, PVA or p-aramid fibres pose an equal or greater risk than Chrysotile asbestos. With regard to carcinogenesis and induction of lung fibrosis, the CSTEE has reached a consensus that the risk is likely to be lower.
The CSTEE recommends these conclusions not to be interpreted in the sense that environmental control of the workplaces where the substitute fibres are produced or used can be relaxed. Finally the CSTEE strongly recommends expansion of research in the areas of toxicology and epidemiology of the substitute fibres as well as in the technology of development of new, thicker (less respirable) fibres'.
Finally, in order to clarify some doubts that had been expressed by the asbestos Industry on whether all the documentation submitted to the CSTEE via its Secretariat had been considered, the rapporteur commented on a specific set of documents coming from Spain (CSTEE/97/2-Adds. 19, 20, 21, 22, 24, 34, 35, 36 and 37). The WG chairperson also informed the CSTEE that he had had access to a confidential report, and as such only provided to him, on 'Description of an on-going epidemiological study on workers exposed to asbestos in Spain'. The chairperson confirmed that this confidential document did not add anything to the evaluation of the WG. He confirmed also that the other documents had indeed been analysed by the WG but that the WG did not consider them as being relevant in terms of the questions that had been asked to the CSTEE. The WG chairperson/rapporteur also confirmed that the so-called Canadian criticisms had also been considered.
Again the requester service expressed thanks for the work done by the CSTEE. The representative of DG V said that the opinion of the CSTEE will be examined in detail in order to derive any conclusions that may be useful in the context of legislation on workers protection for which they are responsible.
(iii) Tin
The rapporteur presented an update of the draft opinion. The (minor) differences vis à vis the previous version were described, i.e. basically references to the EPA report, to toxicity studies on the effects of Tin on human thymocytes. Since a WG meeting will take place on the 23rd of October 98 to address basically the 'Cadmium' issue, that will be an opportunity to have a last look at the draft. The issue of the recommended ADI was also debated, not in terms of the conclusion but in the phraseology chosen, e.g. 'should be recommended/is recommended/ought to be recommended'. Given also the need to introduce some editorial corrections, the formal adoption was postponed for the next CSTEE plenary meeting .
(iv) Arsenic
An opinion was finally adopted on this one after consideration was given to the various comments/suggestions made during the previous CSTEE plenary meeting. Its main conclusions were:
The following unacceptable risks were identified in the Atkins Report:
a) effects on aquatic organisms in low-phosphate marine waters, arising from arsenic leaching from CCA-treated wood;
b) marginally increased lung cancer risks from controlled incineration of CCA-treated wood;
c) significantly increased lung cancer risks from uncontrolled use of CCA-treated wood for home heating;
d) significant effects on the environment from uncontrolled burning and disposal of CCA-treated wood.
e) potential risks from the unpredictable long-term leaching behaviour of arsenic in special waste landfills;
In addition, a risk for children arising from skin contact with CCA-treated wood in playgrounds, is identified in the body of the Report, but it is not included in the Conclusions Section.
The CSTEE considers that overall the Report identifies correctly most of the main risks associated with arsenic-based wood preservation, which are derived primarily from the disposal of CCA-treated wood. In addition to the risks identified in the Report, the CSTEE notes that further risks may exist:
a) for children through the ingestion or inhalation of sand particles in playground sandpits, and
b) for soil, aquatic or sediment-inhabiting biota growing in close proximity to CCA-treated wood.
Finally, a potential risk not discussed in the Report, is that of skin cancer by ingestion of arsenic, known to be significant in areas where arsenic levels in drinking water are naturally high.
The CSTEE wishes to underline that a major source of concern regarding the use of arsenic-containing wood preservatives relates to the high degree of uncertainty regarding the speciation of arsenic during its long-term storage in landfills (the major points of arsenic accumulation), making reliable quantitative predictions about its migration and bioavailability extremely difficult. This is a serious knowledge gap which the CSTEE recommends should be addressed by further research. In the meantime, it would be advisable to exercise caution by limiting the use of arsenic-based wood preservation to those situations where it is absolutely necessary.
Answers to the questions posed to the CSTEE:
a) The Report correctly identifies the main risks associated with arsenic-based wood preservation. Additional risks, not identified in the Report, exist for children playing in sandpits with arsenic-treated wood and for soil, aquatic or sediment-inhabiting biota growing in close proximity to CCA-treated wood. Finally; the uncertainty of predictions of the long-term behaviour of arsenic in landfills are higher than implied in the Report.
b) While the risk assessment methodology employed in the Report is broadly correct, the quality of documentation and justification contained is not considered adequate: Much of the important bibliography on the environmental chemistry and toxicology of arsenic appears to have been ignored. Furthermore, the use of "best current practice" hypothesis, while largely imposed by the lack of adequate data, should have been better justified, as should have been the adoption of various environmental guidelines developed by various agencies.
(v) Cadmium
The importance of having an opinion adopted soon was emphasised again by the requester service, in particular bearing in mind their schedule of meetings with M. States.
However, in the course of the debate it was realised that the adoption of the opinion had still some way to go. The WG 'Tin, Arsenic, Cadmium' will meet again on the 23rd of October 1998 to try and settle some issues still needing clarification, in particular with regard to environmental risk assessment (PNEC's, safety factors, etc.). These difficulties were partly due to the fact that new versions of the so called Atkins report on which the CSTEE was asked to express an opinion seem to be popping up all the time. It was agreed that the WG should base its opinion on the documents it has at hand and that asking for updates to the authors of the report is not advisable. Depending on progress made at the next WG meeting, the opinion can either be adopted by written procedure or adoption deferred till the next CSTEE plenary meeting (26/27 November 1998); the first option was preferred by the requester service.
(vi) Pentachlorophenol
A new draft opinion was presented and discussed. However, given that the text had not been looked at before by CSTEE members (draft was only finalised just before the discussion) the decision was taken to ask the rapporteur to take account of some comments made during the meeting (some members expressed reservations in connection with issues such as environmental effects characterisation, reliability of some of the data, confusion in the proposed text between concepts of danger/hazard and risk, etc.). The rapporteur is to rewrite the draft with a view to its possible adoption by written procedure (adoption by early October 1998 envisaged).
(vii) Azo dyes
The rapporteur for this particular opinion request presented the draft opinion. It is an assessment of the report by the Laboratory for the Government Chemist (LGC) - UK. LGC addressed the risk of cancer caused by textiles and other goods coloured with azo dyes. It reviewed the toxicology and the use of azo dyes and the conclusions are that the associated cancer risks from the mentioned uses cause concern, even though the consumer exposure is very low. Based on these conclusions a number of recommendations are made. Some aromatic amines are recommended to be eliminated or its use restricted. Some other aromatic amines (eight) are classified by MAK as category 2 carcinogens. For these LGC suggest that additional data should be generated to assess their mutagenic potential.
The LGC report also includes an annex which contains the conclusions of an European study (project called European Inspection of the Notification of New Substances). This includes a questionnaire addressed to a number of manufacturers to determine how well the notification of new chemicals legislation is applied. From it, it turns out that a substantial fraction of new chemicals appear not to be notified in accordance to EU regulations.
LGC reviews briefly but adequately the toxicology and the use of azo dyes in the colouring of textiles and leather goods. They reviewed non-cancer end points but did not go into details. They pointed out that the main cancer risks derive from the ability of azo dyes to undergo reductive cleavage to aromatic amines that are carcinogenic. This is assumed to be the main mechanism giving rise to the cancer risk. The main routes of exposure considered are oral ingestion primarily concerning children which suck textiles, dermal absorption (the main route of concern for consumers - clothes coming into contact with skin) and risk to workers in dyes production; for the latter group there is also an inhalation route which causes concern.
The workplace exposures are immediately taken care of in the report by assuming that best practice is applied and hence that regulations do not permit exposures of concern.
Estimation of exposure is based on a number of studies carried out by the Ecological and Toxicological Association of Dyes and Organic Pigment Manufacturers; it seems that there are no other studies. The conclusion of these studies is that in most cases the leaching rate is low with one or two exceptions.
Calculations were also made regarding the exposure of children. The risk here would be much higher as the model included oral absorption as well.
Altogether it would look as if the assumptions are justified.
Other CSTEE members commented relatively favourably on the LGC report (in spite of some shortcomings such as the references) and on the draft opinion prepared by the rapporteur. Some suggestions to change the format of the latter were made.
The relative potency of the 22 amines being considered in the LGC report was discussed but the picture in terms of the concern caused did not change appreciably regardless of which one was being considered.
Other issues addressed had to do with the fate of textiles and their environmental impact as there are indications that a lot of clothes we use have a very short life span. They therefore can enter the aquatic ecosystem where we take our food from (fish); they can also go to sludges and this is a cause for concern as these are used in many European countries to be spread on land and therefore they would come in direct food contact. In waste-water there are considerable amounts of azo dyes as these are leached from washing machines and although we are not drinking waste water we put it in our crop fields.
The information was also given that azo dyes are being looked at under Regulation 793/93. However there are problems linked to the availability of confidential data on new chemicals which means that passing these on to the CSTEE cannot be considered an automatic process.
A potential solution to this was suggested: reports could be prepared with just some figures, not indicating the names of the chemicals but the levels of human exposure through the different routes, making it possible to check how relevant this could be.
It was proposed to the rapporteur to revise the draft opinion in the light of the various comments made by the CSTEE. A new draft should be ready for adoption at the next CSTEE plenary.
4. Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances. Presentation by DG XI of the Commission of the terms of reference for consulting the CSTEE on the results of the risk evaluation of:
(i) 2-(2-butoxyethoxy)ethanol (NL)
(ii) 2-(2-methoxyethoxy)ethanol (NL)
(iii) Alkanes, C10-13, Chloro (UK)
(iv) Benzene, C10-13-Alkyl derivs (IT)
The point was presented by two representatives of the European Chemicals Bureau (ECB) responsible for ensuring the running of the technical meetings under Council Regulation 793/93 in the ECB in Ispra.
The functioning of the Regulation was described starting off with a chronological description of its implementation. As a piece of legislation it is based in Article 100a of the Treaty and therefore it is basically intended at ensuring the free movement of goods in the Community and a high level of protection of man and the environment. The ultimate objective of the Regulation is to propose risk reduction strategies, themselves based on the risk assessments. The exercise implies compromises, the reason being that decisions must be made within a limited timeframe and that puts difficult requirements on science since decisions have to be made even when science may not be totally clear. The risk assessments have to be specific on where there are certainties and where these are non existent.
The whole process involves data collection (on about 2600 chemicals). The purpose of data collection is to select those substances that seem to be of highest concern and make them undergo immediate attention (risk assessment needed quickly). Rankings follow this step and based on it the M. States and the Commission select chemicals ending up with the drawing up of priority lists (currently they include about 110 chemicals overall). M. States then volunteer to carry out risk assessments of specific chemicals. Conclusions of risk assessments are basically of three kinds: either more information is needed, no concern exists or risk reduction measures are needed.
The framework for risk assessments is laid down in Regulation 1488/94/EC. This was not seen as sufficient and therefore Technical Guidance Documents were developed with the support of M. States and the Commission. These are now available through the Office of Publications in Luxembourg (note: a few copies were made available to some CSTEE members during the meeting).
Industry provides the data they have available in order to allow the risk assessments to be carried out. Where there are data gaps Industry is required to perform the testing until a complete set of end points is available. Industry is also supposed to provide emission and exposure information to the rapporteur in order to allow for as complete a risk assessment as possible.
The overall role of the ECB is to provide scientific support to the legislator (the Commission - DG XI) who are politically responsible for Regulation 793/93. They do this as previously stated by organising technical meetings. When the risk assessment report is considered finalised risk management measures are proposed. These form the basis of the Commission recommendation for a particular chemical.
The process is a lengthy one also because of the number of stakeholders that participate in the exercise.
The presentation ended up with a description of what both the ECB and DG XI expect from the CSTEE. DG XXIV stated that following the reform of the entire system of scientific advice at Community level the Risk Assessment reports produced under regulation 793/93 will have to be presented to the CSTEE for peer-review. The ECB commented that if this was the case then the CSTEE will be seeing a substantial increase in the number of risk assessment reports for which comments by the CSTEE would be requested.
In terms of deadlines the opinions of the CSTEE on those four chemicals are important for reports that are being drawn up on the implementation of Regulation 793/93 (and Directive 67/548). An Environment Council foreseen for the 8th of December 1998 would be the ideal opportunity to present the conclusions of the risk assessments and proposed risk reduction measures as adopted by the Commission on the four substances. The schedule ahead for this, considering all its steps, means that the opinion of the CSTEE will have to be delivered by the 10th of November 1998.
The conclusions of the risk assessments mentioned above were then briefly presented by another ECB representative who also described the main uses of each chemical. The CSTEE will receive the final risk assessment reports and it is these documents that they will be asked to peer review with a view to confirm whether the conclusions arrived at by the rapporteur M. States are correct/justified.
The terms of reference, submitted by DG XI to DG XXIV, for the consultation of the CSTEE on the risk assessment reports mentioned were the following:
The CSTEE, on the basis of the examination of the results of the Risk Assessments carried out on the four substances, supported by the relevant scientific bibliography, which will all be made available to CSTEE members, is to answer the following two questions:
(1) Are the conclusions of the four Risk Assessment reports justified?
(2) Are the Risk Assessment reports presented by the Member States rapporteurs of good quality?
Finally DG XXIV provided some clarification on the reasons and rationale for the involvement of the CSTEE in the process as well as how some of the foreseeable difficulties, mainly logistic, may be solved in practice.
DG XXIV added that it was considered crucial that, for the future, a proper planning and well thought out involvement of the CSTEE from the early stages of development of the risk assessments is necessary as these risk assessment reports, once finished, represent several man-years of work. The principle of the peer review by the CSTEE of the Regulation 793/93 risk assessment reports was, however, considered a correct one by the committee itself.
Consideration should also be given to the consequences of the CSTEE opinions. A debate ensued and various scenarios were analysed. Possibilities for ensuring in the future a proper follow up by the CSTEE of various pieces of EU legislation covering the mandate of the CSTEE, were also considered.
Concerning practical arrangements for involving the CSTEE and keeping it informed of developments, the possibilities discussed were, among others: (i) those of creating working groups specifically to look at issues under Regulation 793/93 and Directive 67/548; (ii) resorting to external expertise where it may be felt that this is not available within the CSTEE; (iii) distributing minutes of ECB meetings to CSTEE members.
The mentioned minutes are very detailed and henceforth informative and would very likely be a good means of keeping the CSTEE informed of the state of technical discussions. This would allow them to react in case they saw a problem in the course of events in the ECB working group meetings.
New appointments to the CSTEE to fill the four vacancies still available in it is still a possibility which the Commission services are working on. When this is done the extra manpower available will mean an easier tackling of opinion submissions such as this one.
Concrete solutions to tackle this consultation were discussed and the principle to look at the conclusions rather than at the supporting documents was agreed. Several CSTEE members volunteered to look at the four substances and the agreement was that the various rapporteurs should transmit the conclusions to the CSTEE Secretariat as soon as possible but certainly before the end of October 98.
5. Endocrine disrupters
(i) presentation by the working group chairman of a status report being prepared by the 'Endocrine disrupters' working group (outcome of 'Endocrine disrupters' working group meeting of 8 September 98)
The EDC WG chairman presented the latest draft available from the 8th of September 98 EDC WG meeting. The intention is to finally produce a report that covers human health and environmental effects of EDCs. The basic idea presiding at the elaboration of this report/opinion is that it should not cover in detail human health effects (the general feeling of the WG is that the human part is not the most problematic one), rather it should focus on areas where knowledge is scarce.
A major focus of the report will be on the health of ecosystems and therefore the utility of ecotoxicity testing for ecosystems protection will be included in a separate chapter. There are a limited number of papers on non-existing ecotoxicity testing. EDCs and wildlife health effects will also be covered. These will focus on the European situation. It looks as if there is significant evidence of endocrine disruption in wildlife; this is based not only on wildlife studies but also on semi-field conditions or laboratory studies.
On the specific side of human health effects those on the immune system need being considered (although strictly speaking these are probably not endocrine but can be endocrine mediated). For most chemicals the mechanisms are unknown.
Another major area of the report, and a sensitive one at that, is the chapter on the regulatory guidelines. The ones that exist will be described, in particular the ecotoxicology ones. It is likely that the conclusions in the EDC report on ecotoxicity testing will be that at present they are deficient (as the OECD and CEFIC have also pointed out). There have also been suggestions from the USA to include batteries of in vitro test systems as a pre-screening to pick up endocrine disruption. It is not sure whether the WG will follow this approach as this will bring about false negatives as well as false positives (since not all endocrine disruption effects will be mediated through an effect on the receptor). In the USA system they use three receptors: (i)an androgen receptor, (ii)a steroid receptor and (iii)a thyroid receptor, but these don't cover everything. Besides that it is also a very costly approach.
Another chapter of the report will review the EU testing strategy for new chemicals including exposure considerations, (partly dependent on the tonnage of chemicals), and what type of testing is necessary. Possibly one of the CSTEE's conclusions will be that endocrine disruption for the human health assessment is poorly done, e.g. in the sub acute toxicity testing, but that it is much better in the area of reproduction toxicity (the limitation still remains that these tests are only done when you have high tonnage compounds). This is an area which needs some thinking in the sense that perhaps the criteria should be changed to include other, low tonnage, chemicals. For ecotoxicity testing the WG will come up with recommendations to include target organ toxicology in, e.g., fish toxicity testing, because the current end points such as mortality and others, don't say anything about possible targets of the endocrine system.
Conclusions and recommendations will end the report. At least two more WG meetings are foreseen with a view to have a draft report available for the meeting of 26/27 November 1998.
A short table with chemicals and indications of their potency will probably be produced but no listing of chemicals is foreseen. Natural products will in principle not be covered by the report.
After the presentation some CSTEE members made comments/suggestions such as a specific recommendation to the effect that the predictive value of QSARs (in other words relationship between molecular structure and toxicological effects) could be developed to address this type of effect. The rationale would be to compensate for the fact that there are probably a lot of different toxicological mechanisms involved on endocrine disruption and that for the time being there are not enough tools to evaluate if a chemical is an EDC or not. Therefore this should be stressed in the recommendations.
The REU representative asked the following questions: (i)whether there is evidence pointing to an EDC effect in the decreased mean male sperm count or whether this is due to the methodology used and (ii)whether there is any suitable experimental animal model which could be used to study the phenomenon of endocrine disruption as an explanatory factor in testicular cancer.
Regarding (i) the state of the art on sperm quality it was pointed out that this will be summarised in the draft report. The so-called Carlsson meta-analysis has been checked very thoroughly and criticised as it had various sources of bias and confounding. After that one, several studies have been carried out but four of those stand out as having a much better quality than that of Carlsson. Two of them have observed a decline in sperm concentration, one found no change and another found an increase. As regards (ii) (testicular cancer) the answer seems to be that there is no adequate animal model for testicular germinal cancer.
It was also explained that rodent models are used particularly when you use the so-called 90 days study and here the endocrine system is taken into account. Of course this could be bettered and there are proposals to improve the 407 OECD type study to include more parameters. Basically when a whole series of toxicity tests is carried out endocrine disruption is picked up. The wildlife situation is different mainly because of the big and variable number of species at stake.
These elements are included in the latest version of the EDC WG draft report.
Other questions asked centred on how much attention in the report will be devoted to the methodological issues of the epidemiological studies. The answer was that the title of the draft report points out that the focus is on ecosystem effects and particularly in identified blank areas on how to improve ecotoxicology test methods. It will not be a lengthy discussion on the epidemiology methodology used since there are other reports that cover that. The WG did not feel as being its charge to give an authoritative review on epidemiological issues. They would like to present only a summary statement and not any other detailed review.
It was pointed out that it would certainly be useful if DG XI could consider this report for their purposes as they are also involved in the EDC debate, particularly as they are co-ordinating the drafting of a Commission EDC strategy paper. The role played by the CSTEE on this issue will be stated in the strategy paper.
It was reminded that a meeting will take place in Vienna (18/19 November); DG XI is involved and the EDC WG chairman has been invited to make a presentation on EDCs and wildlife. Obviously the aim of the EC is to co-ordinate all these efforts and the CSTEE has a pivotal role to play in gathering scientific information and giving advice.
(ii) presentation by other Commission services of developments on EDCs
No other Commission services made presentations on their respective involvement on this topic.
6. Phthalates in toys - presentation by RIVM and others of the first results of the so-called 'Dutch study' on standardisation of measurement of phthalate release
A delegation from the so-called Dutch Consensus Group (Mrs Steenbekkers, Mr Konemann and Mrs Braybrook) presented the conclusions of their study on phthalate release from soft PVC toys. The information was given that the conclusions presented today would have to be considered confidential till at least Monday of the following week (21 September 98).
A question time period followed the presentation. They addressed issues such as (i) Test specimens (toys) used during the experiment. (ii) Prospects of inter-laboratory comparison exercises - Not considered by the Group as it was outside the remit of the exercise; necessary funding not available, perhaps dependent on a leading role by the Commission. (iii) Had problems with particles been covered? - Yes, samples were rinsed before using them, particularly considering that a cut surface can have particles. (iv) The chewing experiment - A coarse filter was used but this does not remove any fine particles left. (v) Were the experiments conducted with samples representative of a worst case situation or with the best quality articles available? - It is difficult to say which toy has the highest release rate; the point of the exercise was not that of addressing a worst case scenario but only to come up with a realistic assessment; however the data seems to indicate that the Dutch Consensus Group Study is near to a worst-case scenario. (vi) Is the material produced for the experiment available in large amounts? - The Industrial R&D laboratory that produced the material is able to provide samples, so in theory the answer is yes. (vii) What extrapolations to other EU children can we make from the conclusions of the study bearing in mind that the experiment was conducted with 'typical Dutch children'? How were they selected and how representative are they of the Dutch society? - The answer is 'don't know', but presumably, given that there was some variation in the results, other EU children should provide similar results; on the other hand there are no signs that societal factors influence sucking behaviour and one assumes that these factors would not influence the final results. (viii) What was the DINP content in samples - The sample produced had 38% but toys used had 43%. (ix) Where did children experiments take place? At home? At day care centres? - Children were observed at home by their parents; it was not possible to say whether children at day care centres would behave differently. (x) How were toys used representative of the toys available to the average consumer? - Difficult to answer as the range of articles is very high in terms of composition, size, shape, etc.. (xi) What is the likely reproducibility of in vitro test? - The reproducibility of the test will have to be determined by an inter-laboratory exercise, other views would be speculating, but the indications so far are promising if we compare this experiment with other methods used before. (xii) Is there a relation between the release and the initial concentration of the phthalate in the toy? - The answer seems to be that there is no relation with total phthalate content. (xiii) All tests having been conducted with new material what is the likelihood that when 'hold' material is used a similar level of release would be reached? - The concentrations of DINP are so high that lesser availability of the chemical is not expected; however there are no final data on this. (xiv) What about differences in the amount of muccins between children and adults? How does this influence results? - It was decided to move away from the use of muccin within the saliva simulant; the salt concentration in the saliva is as important and it was considered as probably not desirable in a standardised test. The protein content in the saliva seems to have no effect in the DINP release.
Other factors contributing to the conclusions of the Dutch Consensus Group Study were a not normal distribution and the use of sophisticated statistical techniques (something which does not live well with the reporting of standard deviations - a somewhat misleading element).
The great variability in the data available had led to CSTEE to use a worst case approach. With the data available from the Dutch Consensus Group, changes in the concern with DINP can be substantial with MOS changing accordingly. It was pointed out that additional exposures had not been incorporated in the previously determined MOS. If one considers these now to be, e.g. in the region of 50%, this can lead to changes in the MOS as well. Calculations have to be carried out however.
The extrapolation of the representativness of DINP results to other phthalates is speculation, so the correct assumption is that results with other phthalates would be different (because of differences in molecular weight and other physical/chemical properties). Using a very similar test to the one used in the Dutch Consensus Group study, data on DEHP release showed a release rate twice that of DINP, which seems to prove the point that there will be variations in terms of phthalate release.
The Dutch study seems to be a much better basis to make a decision from a scientific standpoint. The representativeness of the test specimen and the inter-laboratory exercise remain as weaknesses needing resolving. On the other the Austrian investigation seems to corroborate the Dutch conclusions. Therefore the CSTEE held the view that the Dutch data, with its limitations, is a good basis for reconsidering the previous calculations in its previous opinion of the 24th of April 98.
It was judged important to give the CSTEE time to reflect on the Dutch study before jumping to conclusions, particularly as, at the time of the meeting, the Dutch data is still under embargo. The decision was finally made not to release a final statement from the CSTEE as long as the Dutch Consensus Group Study becomes public. Given that a press release will take place a CSTEE statement was considered necessary. Some CSTEE members agreed that a series of provisos need to be considered in any statement. The problem of reproducibility is particularly relevant and the final Dutch Consensus Group report should make it clear that this is a limitation.
The 'Phthalates in toys' WG chairperson will prepare a draft statement to be sent by e-mail/fax to all CSTEE members for comments. Once agreed this will be submitted to the Commission. The limitations of endorsing a statement, basically on the Dutch Consensus Group study, without it having been taken out from embargo were again highlighted.
The ECB representative reminded that under the existing substances regulation phthalates are being evaluated and these will be looked at, at the next technical meeting by the end of September, with the full risk assessment report being first discussed at their December meeting.
Finally, the CSTEE were informed of the sending late last week of still another study from the Spanish IAJU (Spanish toys Industry). Copies will be submitted to the CSTEE very soon.
7. Accident at the Aznalcollar mine and the contamination of the Guadiamar river and the surroundings of the Doñana National Park - consideration of a draft general statement for possible adoption by the CSTEE
The discussion on this agenda item was postponed to the next CSTEE plenary meeting.
8. Strategies for dealing with additional chemicals (opinion requests to be submitted by other DGs of the Commission):
(i) Chlorinated paraffins
It was pointed out that these chemicals had just been discussed under Regulation 793/93 and, given the link between it and those on Directive 76/769, there is not as yet a clear picture of when a consultation of the CSTEE on these chemicals should take place. This is due to the fact that the risk assessment conclusions and risk reduction recommendations under 793/93 have yet to be endorsed. A CSTEE member pointed out that the risk assessment of the chlorinated paraffins being carried out under Regulation 793/93 only covers the short chain ones and there are two more groups, the medium length and the long chain groups. The DG III representative explained that this group will be tackled stepwise and priority is being given to the short chain ones as these are recognised as being the most toxic and posing the biggest risks.
(ii) New fertilisers
New questions on these are not foreseeable in the near future. Contrary to what the requester Commission service believed a few months ago it has turned out that there are no issues raised on EC fertilisers for the moment. This means that a consultation of the CSTEE is not foreseen for the near future.
(iii) Other
(i) There is work ongoing on mercury and a consultation on it is likely to be submitted to the CSTEE in the near future, perhaps next Autumn.
(ii) DG III has just launched a study to look at further dyes in textiles (the sensitising dyes - not all of them are azo dyes but most are). The study will not be concluded before some eight months so that is when a consultation of the CSTEE is likely, the report will be one similar to the LGC study on which the CSTEE's opinion was asked.
9. Water Framework Directive - feedback from the responsible services of the Commission on the follow up to the opinion adopted by written procedure by the CSTEE (05.6.98)
The chairman of the Water Framework Directive made a presentation on the Member States meeting, organised by DG XI, in which he participated on 2/3 July (the minutes of the meeting were circulated as a room document). Some important issues were raised during that meeting such as the basis for prioritisation of chemicals. Following the July meeting mentioned above, the Fraunhofer Institute produced a final report with a reviewed position that takes account of a number of remarks made by experts at the meeting (which resulted in some modifications in the ranked list).
So far, only the methodology and not individual substances were discussed with experts. At the meeting, experts were also asked for written comments, in particular to the database and to the monitoring data used by the consultant. Currently the Fraunhofer-Institute is working on a revised study, the outcome of which will be a list of substances to be discussed at expert level (including, of course, the CSTEE).
In any case there are two different aspects that perhaps the CSTEE could consider (dependent upon terms of reference to be submitted/discussed by/with DG XI). These are that the new report includes (i)some specific chemicals that have been identified as the potential priority ones, and (ii) a specific expert judgement by the Fraunhofer Institute with their opinion on whether these chemicals should or not be in the priority list. These are issues that the CSTEE could address as it has not discussed these points yet. The CSTEE has discussed the method and not specific chemicals and now these are being proposed. A rapid look at them shows some strange things such as the fact that mercury is not included at all even though there is a lot of information to the effect that the risk it poses should be higher than 1 in the PNEC calculation. This proves the point that this problem needs to be looked at very carefully.
At the meeting of 2/3 July 1998, some experts also expressed their surprise that mercury does not rank within the first 5 top metals ranked on the basis of exposure values derived from monitoring data. In order to find out possible reasons the Commission asked Member States to provide additional information on monitoring data, including detailed information on the sampling conditions and on results/estimates of the total vs. soluble concentrations of metals. As said above, the information received by DG XI is currently being assessed but the outcome is not yet known.
As soon as the revised Fraunhofer study is available, it will be distributed to experts (including the CSTEE).
It was pointed out that DG XI had accepted to take on board the conclusions of the CSTEE in their developing of the Water Framework Directive. Besides that the DG XI representatives that participated in the CSTEE meetings where the opinion on the Water Framework Directive was discussed and adopted, made the explicit statement to the effect that the CSTEE would be involved in the developments of the Water Framework Directive and that applies to the choice of substances for prioritisation.
The CSTEE Secretary informed the committee that some national authorities have been sending documents relevant for the activities on the development of the Water Framework Directive directly to the CSTEE Secretariat. However, given that there is no new opinion request pending on the subject, the Secretariat has refrained from sending them to CSTEE members. This will be done when such a new consultation is launched.
10. Information on matters not covered elsewhere in the agenda:
(i) Update by the CSTEE chairman on the latest meetings of the Scientific Steering Committee
The last SSC meeting took place in July and its focus was again on BSE. The SSC has now formally set up a small group to look at risk assessment and the CSTEE chairperson is one of its members. The CSTEE will be kept regularly informed. In case the activity will include the creation of working groups other CSTEE members will likely be involved. At the moment the intention is to harmonise risk assessment and look at various ways in which harmonisation might be approached. A meeting of this working group is scheduled for the 23rd of September 98.
(ii) Developments on the subject of the brief of the CSTEE
The CSTEE was asked whether there were any topics on which it should be pro-active. (i) The view was expressed that, based on the examples of phthalates and azo dyes, two groups of chemicals with some significant toxicological effects, it is striking that they can reach the consumer market without a proper legislative framework that will enforce adequate testing or examination of all these aspects beforehand. This includes things such as adequate testing of leaching of hazardous chemicals from products as a fundamental requirement prior to them being put on the market. Other examples could be mentioned. The idea was put forward to set up a small group to set a framework on what the CSTEE should look at in terms of exposure.
In this respect it was pointed out that enforcing the labelling of articles directly available to the consumer (an extention of the so-called 6th amendment of Directive 67/548) could solve the problem somewhat.
The ECB representative pointed out that an ECB working group on consumer exposure had been set up with a view to look at all the available models, assess them and feed in information. Details on its activities will be sent to the CSTEE Secretariat.
(ii) Indoor climate/pollution was again mentioned as an area the CSTEE should look at as a priority. Phthalates and chlorinated paraffins were quoted as examples of products that can contaminate the indoor environment.
(iii) Particulate matter and criteria for estimating its importance had been mentioned previously in a CSTEE plenary meeting and this again was raised as an area of interest. However the information was given that a meeting had been arranged between the SSC and various DGs, including DG XI, and the initial message to the SSC was to stay away from being involved.
The CSTEE were informed by its Secretary of the fact that the DG XI Unit responsible for air quality is taking seriously the point of information of the CSTEE and as such they have been sending information in various forms to its Secretariat. However it was recognised that the CSTEE is currently overloaded and therefore perhaps its involvement on this and other issues should be postponed. Before deciding on how to involve the CSTEE on issues to do with air quality it was felt that perhaps for the time being the CSTEE should refrain from being too pro-active.
(iii) Directive 67/548/EEC (Classification, Packaging and Labelling of Dangerous Chemical Substances)
Its Secretary informed the CSTEE about the lack of progress on clarification of the role to be played by the CSTEE on this legislative piece. The strategy of keeping the CSTEE informed is still being pursued as the regular sending of information to the CSTEE in connection with this topic shows.
Related to this topic, questions were asked about the possible involvement of the CSTEE on the new Preparations Directive (that includes environmental classification). The answer was that it is expected that DG III asks the opinion of the CSTEE on all legislative proposals with a potential bearing on consumer health and that includes the Preparations Directive. Concern was expressed at the prospect that, as was the case with the four chemicals under Regulation 793/93, on which the involvement of the CSTEE took place very late in the process, the same might happen with the Preparations Directive.
The suggestion was made that an explicit note should be endorsed by the CSTEE drawing the attention of the Commission to the various topics that the CSTEE believes should be the object of its closer scientific peer review/scrutiny.
Another issue raised in connection with Directive 67/548 was that of the definition, since the 7th amendment, of reproduction within it. This seems to have been severely criticised by the scientific community. However, since the Commission is participating in an exercise of international harmonisation of chemical classification systems, including addressing the issue of reproduction, perhaps the CSTEE involvement on this issue should take that into account as well.
Pka was also mentioned as an area of concern and one CSTEE member volunteered to produce a note stating the nature of the problem and making suggestions.
One CSTEE member asked what was the situation on the possible consultation of the committee on the classification of Nickel Chloride, a prospect that seemed likely a couple of months before. The response was that DG XI had decided to ask the views of the main Classification & Labelling working group (health effects) on whether the CSTEE should be consulted on this or not and if so how. The information recently received from DG XI was that, at their last meeting, the Classification & Labelling working group did not have time to discuss the issue.
It was suggested, however, that the issues submitted for opinion of the Specialised Experts group under Directive 67/548, should also be looked at by the CSTEE (this had been the case of nickel chloride).
(iv) Developments on future subjects to be addressed by the CSTEE - CSTEE proposals:
- Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment
Dr Tarazona informed the CSTEE about the forthcoming workshop due to take place in Madrid, from 4 to 6 November 1998. The draft agenda is still waiting formal approval from the ECB, which is also involved in the workshop's organisation along with the Spanish authorities. All CSTEE members will receive the agenda as soon as this is available. The ECB will publish the proceedings and these will also be made available to the CSTEE.
Several room documents will be available and these can be sent to CSTEE members upon request. All CSTEE members are being considered by the organising committee as potential participants.
There are various classification proposals for the terrestrial environment already in the pipeline, from Spain, ECETOC, the Nordic countries and apparently CONCAWE may have one too. The Spanish proposal covers endocrine disrupters with three levels of hazard, (i)highly toxic, (ii)toxic and (iii)harmful and potential long term or widely distributed effects. The possibility of having the EDC working group represented by its chairman was discussed.
(v) Schedule of CSTEE meetings for 1998 (update)
The schedule was revisited and the next plenary meeting confirmed for the 26/27 November 1998. The 21st of December 1998 remains as a provisional date for a CSTEE plenary meeting in case of need. The CSTEE chairman suggested for one of the next plenary meetings an item on review of working procedures. Another item suggested for discussion was whether individual members should have watching briefs in certain areas, in order to inform the CSTEE on what's going on in the wide world and avoid, so to speak, reinventing the wheel and, at another level, contributing to warn early the CSTEE of issues that are likely to come to its attention. The chairman will prepare a paper suggesting how the CSTEE should work during the forthcoming year.
11. Arrangements for the next meeting of the CSTEE
No particular arrangements were needed apart from the setting of the starting time (at 10 a.m. on 26 November) and finishing time (at 1 p.m. on the 27th of November).
12. Any other business
Prof. Greim distributed a paper prepared by a subcommittee of the German MAK commission, on the classification of carcinogens. So far all classification schemes for carcinogenicity have three categories. The problem seems to be that neither mechanistic data nor exposure data are included in the classification. The new German scheme is already being used and it is based on the use of two new categories, (i) One for carcinogens for which a threshold can be established (the concept is based on an identification of risk based on the likelihood of exposures above or below the identified threshold). (ii) The other category is for genotoxic agents for which the establishment of a threshold is unlikely. The reactions so far to the new DE scheme have been positive. The approach described has already been explained to the SCOEL.
The point was made that this input should be forwarded to the international instances responsible for the exercise of harmonisation of classification and labelling schemes. Some members supported the paper as the IARC scheme of classification is believed to have some limitations .
Without any other business, the meeting was closed at 13H00.
AGENDA
1. Adoption of the draft agenda
2. Adoption of the draft minutes of the 4th plenary meeting of the CSTEE held on 14/15.6.98 in Brussels
3. Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations. Consideration of draft opinions/reports, as presented by the respective rapporteurs/chairmen, with a view to their adoption by the CSTEE, on:
(i) Creosotes,
(ii) Chrysotile asbestos,
(iii) Tin,
(iv) Arsenic,
(v) Cadmium,
(vi) Pentachlorophenol,
(vii) Azo dyes
4. Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances. Presentation by DG XI of the Commission of the terms of reference for consulting the CSTEE on the results of the risk evaluation of:
(i) 2-(2-Butoxyethoxy)ethanol
(ii) 2-(2-methoxyethoxy)ethanol
(iii) alkanes, C10-13, Chloro
(iv) Benzene, C10-13-Alkyl derivs
5. Endocrine disrupters - (i) presentation by the working group chairman of a status report being prepared by the 'Endocrine disrupters' working group (outcome of 'Endocrine disrupters' working group meeting of 8 September 98). (ii) presentation by other Commission services of developments on EDCs
6. Phthalates in toys - presentation by RIVM and others of the first results of the so called 'Dutch study' on standardisation of measurement of phthalate release
(Note: this agenda point will start the 2nd day of the meeting)
7. Accident at the Aznalcollar mine and the contamination of the Guadiamar river and the surroundings of the Doñana National Park - consideration of a draft general statement for possible adoption by the CSTEE
8. Strategies for dealing with additional chemicals (opinion requests to be submitted by other DGs of the Commission):
(i) Chlorinated paraffins
(ii) New fertilisers
(iii) Other
9. Water Framework Directive - feedback from the responsible services of the Commission on the follow up to the opinion adopted by written procedure by the CSTEE (05.6.98)
10. 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) Developments on the subject of the brief of the CSTEE
(iii) Directive 67/548/ECC (Classification, Packaging and Labelling of Dangerous Chemical Substances)
(iv) Developments on future subjects to be addressed by the CSTEE - CSTEE proposals:
- Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment
(v) Schedule of CSTEE meetings for 1998 (update)
11. Arrangements for the next meeting of the CSTEE
12. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James W. BRIDGES, Prof. Philip L. CHAMBERS, Prof. Erik DYBING, Prof. Dr. Helmut GREIM (14/9), Prof. Bo O. JANSSON, Prof. Soterios KYRTOPOULOS, Dr. Claude LAMBRÉ, Prof. Dr. José RUEFF, Prof. Mirja SALKINOJA-SALONEN, Dr. José V. TARAZONA, Prof. Benedetto TERRACINI, Prof. Marco VIGHI, Prof. Joseph VOS, Prof. Dr. Robert WENNIG
AD HOC EXPERTS (15/9)
Dr. W.H. KÖNEMANN (R.I.V.M.)
Mw. B. STEENBEKKERS (Landbouwuniversiteit Wageningen)
Dr. Julian BRAYBROOK (Laboratory of the Government Chemist)
European Commission:
DG XXIV
Mrs M. de SOLÀ, Mr. J. COSTA-DAVID, Mr. T. DASKALEROS
DG III
Mrs L. PERENIUS, Mr. P. GLYNN, DG JRC/ECB, Mr. B. HANSEN, Mr. S. MUNN
