- General information enquiries
- Call 00 800 6 7 8 9 10 11
- E-mail your questions
Directorate-General for Health and Food Safety
1. Adoption of the draft agenda (copy
attached)
The draft agenda was adopted with a reordering of some of its points.
2. Adoption of the draft minutes of the 4th and 5th plenary meetings of the CSTEE held on 15/16 June 1998 and 14/15 September in Brussels
The CSTEE secretary presented the minutes of the June plenary meeting and requested comments from members on the preferred format, in particular on how detailed the information contained in them should be. Views were expressed and the consensus that emerged indicated that minutes should be brief (conclusions of discussions) although it would be helpful to have detailed accounts of important discussions. Some CSTEE members expressed the view that conclusions arrived at by working groups could be attached as annexes. Others still expressed the view that minutes should be simply about conclusions or sentences such as 'still under discussion'.
The adoption of the minutes was postponed. The CSTEE secretariat will send versions of the minutes drafted according to a format that will take as much as possible account of the comments made.
3. Adoption of the rules of procedure of the Scientific Committee on Toxicity, Ecotoxicity and the Environment
The draft rules of procedure previously distributed to the CSTEE members were commented upon. Clarification was sought and obtained on topics such as confidentiality, independence and others. The CSTEE strongly recommended that the rules on provision of information to the CSTEE and its working groups should be that they should be provided by the CSTEE Secretariat. The CSTEE were informed that the Commission services are working on a set of rules according to which information should indeed be provided via Commission services.
Other issues discussed were linked to confidentiality of membership of working groups as some members have been unexpectedly approached by third parties providing information and/or asking questions. Regarding occasional contacts with groups, Industry or other, the conclusion was that the rules of confidentiality should work both ways, i.e. that working group members would respect confidentiality of data provided by Industry but that Industry would be deemed not to disclose the identity of working group members to third parties.
Rules for membership of working groups were extensively discussed as some CSTEE members were of the opinion that the draft was not clear enough in that respect. On the issue of participation in working group meetings and what was meant by 'external expert' the view was expressed that a clear distinction was needed between regular members of working groups (who may not be CSTEE members) and occasional ad hoc representatives who may attend upon request and with the specific authorisation of the working group chairperson.
Deadlines for submission of documentation (the draft rules of procedure mentions that they should be made available to CSTEE members one week before the meeting) was also a subject of discussion as such a time frame is frequently not respected. The various means for submission of documents (e-mail, fax, other) was commented upon and the preferred one was considered to be still that of hard copies sent by regular mail, at least for documents larger than 10 pages (some suggested 20). However it was realised that some flexibility is necessary to this rule to compensate for a number of circumstances where it may not be totally feasible.
Pending minor changes to be made on a few of its points the draft rules of procedure were generally considered a good basis for work and adopted as such.
4. Setting of schedule of CSTEE meetings for 1999 and arrangements for the next meeting of the CSTEE
A short exchange of views took place on the anticipated work schedule for the CSTEE during 1999. Because of the forthcoming entry into force of the provisions of the Amsterdam Treaty an increase in the workload of the CSTEE stemming from opinion requests related to Directive 76/769/EEC is to be expected. A better clarification of the role to be played by the CSTEE on the work areas of DG XI is likely to change (increase) the workload picture somewhat.
With the proviso that they can be changed according to variations of the workload the following dates were agreed for plenary meetings in 1999:
18th January
4/5th March
6/7th May
1/2nd July
27/28th September
25/26th November
5. 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, with a view to their adoption by the CSTEE, on:
(i) Creosotes
The rapporteur presented the draft opinion that included comments on all the relevant data, in particular on the so-called Fraunhofer study. With some editorial changes the draft was adopted and its final conclusions were the following:
1. Given the genotoxicity of BaP and the outcome of the Fraunhofer skin painting study, there is sufficient scientific evidence to support the opinion that there is a cancer risk to consumers from Creosote containing less than 50 ppm BaP and/or from wood treated with such Creosote. BaP is a good indicator for the carcinogenic hazard of the Creosote preparation tested since there was a linear relationship between cancer incidence and BaP dose. However, the cancer potency of the Creosote preparation was 5 fold higher than judged from its BaP content.
2. On the basis of the available information, even taking into account the considerable uncertainties in assessing the risks for children coming into contact with Creosote-treated wood, the magnitude of the risk is judged to be low. In order to get a better estimate of the exposure situation, one would have to perform a real-life, mass-balance study in exposed children. In addition to being very complicated and resource intensive, to conduct such a study would raise ethical questions. The conclusion was that there is indeed a cancer risk to consumers from Creosote because of the presence of benzo-pyrene present in it at the levels indicated in the terms of reference, but that on the basis of the available information the magnitude of the risk cannot be stated.
(ii) Tin
The rapporteur presented the (fifth) version of the draft opinion on Tin, in particular following the changes, which were described, made during the last working group meeting of 23 October 1998. Most of the changes introduced were of an editorial nature. However other amendments were still proposed, namely on the issue of the PNEC value.
As would be the case with the report on Cadmium, here too the adequacy and general quality of the report as defined in the draft opinion still raised some question marks among some CSTEE members who were slightly reluctant to agree fully with such statements.
Again comments were made regarding the wording of the draft which needed more clarity. Examples given were: 'ought to be recommended' versus 'is recommended', 'may be deemed as appropriate for decision making' versus 'is appropriate' etc.
The requester Commission service emphasised again the limitations in terms of time and money they have when they set out to obtain these targeted risk assessments. Some CSTEE members had doubts as to whether they should comment on such factors as budget and timing.
Consequently it was considered that answering the second question in the terms of reference was actually outside the scope of the scientific judgement that is typical of a scientific committee as the CSTEE. Therefore the CSTEE expressed the view that it should explicitly decline to comment on constraints of budget and timing (particularly as data on budget and timing was not made available to it).
The view was also expressed that it should be made clear that the decision that the CSTEE recommended anybody to take should be based also on the CSTEE's estimation on not only on that of Atkins.
(iii) Cadmium
The draft opinion previously prepared was presented by the rapporteur. Severe criticisms were made by several CSTEE members for the disruption caused to the activities of the working group and the CSTEE by the several versions, and parts 1 and 2, of the Atkins report (to which members of the working group and of the CSTEE had access in different time frames). This was a source of confusion as it was realised that different members were expressing their views based on different versions of the Atkins report. As a consequence it had been necessary to revise several times the draft opinion previously prepared. The decision was taken to change substantially the format of the draft prepared after the working group meeting of 23 October 1998.
The wording of the draft was extensively commented upon, in particular some phraseology as the use of the words 'questionable', 'adequate/inadequate', 'acceptable/unacceptable', 'certain fractions of the population', etc., which in the overall draft could be prone to different interpretations by different readers given their intrinsic subjectivity. This will be even more of a problem when such an opinion is translated. In this respect it was reminded that the final objective of the peer review of the Atkins report by the CSTEE is to conclude whether the report is adequate for allowing risk management measures to be proposed based on it.
Comments were also made on the availability of other data on Cadmium, which were apparently not taken into consideration by Atkins, and its taking into consideration of probabilistic approaches and the use (or not) of safety factors versus relying on the 'technical guidance document'.
Some expressed the view that it is not the task of the CSTEE to improve the quality of reports such as the one under discussion here so many are its shortcomings. An explicit request was made by the CSTEE to the effect that such a statement should go to the minutes of 'this' plenary meeting.
Given the difficulties described the possibility was discussed to prepare first an 'interim' opinion, to be adopted by written procedure by mid December 1998. For this interim opinion it would have to be understood that the conclusions might not be based on the very last version of the Atkins report as not every working group member had access to it. Another working group meeting could take place in early January 1999 with a view to prepare a final draft opinion to be adopted at the CSTEE plenary meeting scheduled for the 18th of January 1999. The latter was specifically preferred by the requester service (DG III) given the sensitivity of the subject politically. The working group meeting will take place on the 11th of January 1999 in Brussels.
(iv) Pentachlorophenol
The rapporteur for this substance presented the draft opinion, in particular following the taking into consideration of comments of various sources, some in writing and some made previously at the CSTEE plenary meeting of September.
Again, as in the case of Cadmium, the previous evaluation had been made on a version of the report that was not the final one. This was only made available in mid September 1998. This final ERM version was to a certain extent a response by ERM to the previous version of the CSTEE draft opinion on its report. However it was the view of the rapporteur that the changes introduced by ERM were mainly formal and corrections of errors (e.g. PCP previously stated as cation and not as an anion which is what it is) and these have to be considered minor changes. The main conclusions of the final ERM report had to be considered as being the same.
The new draft CSTEE opinion contained an updated list of references and other changes, mainly of an editorial nature.
It was commented that since the new draft opinion basically comes up with a new risk assessment, it would be extremely helpful if the conclusion could be elaborated in order to be a balanced statement on which further decision making could be based.
The draft opinion was adopted by the CSTEE and its main conclusions are:
Due to an unsatisfactory literature review, to many inconsistencies between reported data and conclusions and to the unclear description of some aspects, the ERM studies cannot be considered adequate for a risk assessment of PCP.
The amount of information on PCP (including literature data not reported in the ERM studies) allow to conclude that:
In some areas, human exposure continued to occur even where PCP use has ceased. At some working situations, adverse health effects are sometimes observed. No adequate clean-up treatment has yet been found to remediate contaminated soil.
Risk for the aquatic environment from PCP and associated chemicals may occur, at least in "hot spots" areas, involving local PCP release to the environment. This is also demonstrated by some experimental monitoring data above the PNEC, reported in the ERM study.
Finally the decision was also made to make the same remark, as on other opinions previously discussed, to the effect that it was not appropriate for the CSTEE to comment on the constraints faced by the consultants in terms of budget and timing.
(v) Azo dyes
Due to the absence of the rapporteur the discussion on this agenda topic was postponed for the next plenary meeting (18th of January 1999).
6. Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment - Conclusions of the Workshop on Hazard identification systems and the development of classification criteria for the terrestrial environment (Madrid, 4-6 November 1998)
The Madrid meeting was essentially about hazard identification. Delegates from practically all M. States were present. A report on the meeting will be available by the end of the year and conclusions will be passed on to the Classification & Labelling group (Directive 67/548/EEC) that will meet at the end of January 1999.
Regarding the involvement of the CSTEE, it had been acknowledged by the former CSTE that this area is characterised by a lack of scientific knowledge. The CSTE had therefore suggested that the evidence should be validated by them. Such task has henceforth been passed to the current CSTEE. The task is about how to develop scientific methods for hazard identification for the terrestrial environment and particularly for the above soil compartment (there is a certain level of agreement for the soil compartment). A subsequent amendment/modification of the Classification and Labelling Directive will later be necessary. The involvement of the CSTEE needs to be established in terms of agreement between DG XI and DG XXIV. It was believed important to start as soon as possible with scientific issues (a working group established from within the CSTEE was set up). The activities of the working group should start yearly next year (1999). There are already a Nordic and a Spanish proposal that can be taken as a starting point for the activities of the CSTEE. The problem is also about criteria for risk assessment and not only on hazard identification.
7. 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)
A representative from DG XI gave an update on the status of development of the 'Water framework directive' starting with an acknowledgement of the work done by the CSTEE and the 'Water framework directive' working group on this subject. A detailed note will be sent to DG XXIV on what DG XI intends to do with each of the recommendations of the CSTEE. The DG XI representative said that the most important thing to do in terms of future participation of the CSTEE on developments of the Directive is to involve it in setting the so-called inter-calibration exercise. Terminological changes had also been proposed by the CSTEE and quite a few were already integrated.
On groundwater chemical status an interesting suggestion was made to include toxicity assessment as an additional parameter and DG XI supports this. However they have some concerns on the actual thresholds set out in the report which DG XI is consulting on at the moment with M. States and with the European Environment Agency.
As regards the presentation, precision and confidence of monitoring results, these are important areas but DG XI believes that they should be better dealt with by means of guidance because otherwise very detailed specifications may be necessary in practice and such a form makes it difficult for negotiating in a formal legal text, hence it may not be the best way forward.
Definitions of poor and bad status in addition to the three specified in the directive have been integrated in the latest Council text. Other provisions concern detailed guidance and monitoring, the inclusion of direct toxicity as a parameter for surface water in various situations and procedures for the establishment of site specific quality standards (there are provisions within the directive for adjusting the safety factors provided on the basis of more detailed site-specific data than M. States may have available).
M. States consider that the priorities are the inter-calibration exercise, the definition of heavily modified in artificial water bodies and the establishment of the concept of maximum ecological potential for those water bodies. This definition is something that will have a scientific content and the views of the CSTEE will be asked on this.
M. States were also consulted on the proposals for research priorities set out by the CSTEE and they thought that in spite of their validity there are short-term operational priorities which will probably have to take precedence. These will relate first of all to the inter-calibration and to the development of methods for assessing the fish and aquatic flora components of the ecosystem, secondly to the relation between surface and groundwater and thirdly to the causal relationship between distortion of hidromorphology and ecological distortion.
The draft Fraunhofer report on the combined modelling and monitoring priority setting was presented in July and comments on the database were requested from M. States. Monitoring data from all M. States will now be included and not just those of the twelve ones initially foreseen. On the basis of this a list of priority substances will be identified and subsequently sent for comments to various parties including the CSTEE. The time schedule for this is difficult to anticipate but it will probably not take place before March next year.
The timing is dependent on the negotiations of the Directive (it will be a co-decision text). The EP has postponed its opinion until February which means that the first reading will not be adopted until probably late February 1999, but the intention at a political level is to have discussions between the Council and the EP before the adoption of the EP opinion and the adoption of the Common position to try to bring the positions of the two institutions closer together. The priorities for implementation will come after these problems are settled as these negotiations will very likely absorb a lot of DG XI's activities.
DG XI will try to integrate the remaining concerns identified by the CSTEE in its opinion. These should be in the legislative proposal over the next few months and then, once the framework directive is adopted the remaining elements would follow. With luck adoption can take place under the German presidency in the June 99 Council and the implementation phase thereafter. The next consultation of the CSTEE should be on the first list of priority substances from March 99 onwards and the implementation from July 99 onwards.
The Chairman of the Committee expressed his appreciation of the warm co-operation developed between the CSTEE and the responsible Commission service in DG XI and expressed the hope that this would continue.
8. 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 accident was commented upon in that the problem is linked to the specific characteristics of the area. Regulation 793/93 does not have a good ecological risk assessment system for areas that should be protected at the ecological level because of their high ecological relevance or because of their high bio-diversity. The same system is applied to an Industry located in a normal area as in these very sensitive areas. Hence the proposal for a statement of the CSTEE to the effect that a method for the ecological risk assessment of these particularly relevant areas should be developed on a scientific basis. The statement need not necessarily be related to this particular accident and should be general. Agreement is needed on basic principles and on how to apply them to a local situation.
It was commented that the accident in question was basically related to the terrestrial environment and this links in with the activity mentioned previously under point 6 of these minutes.
A working group was set up to approach this general problem. If the CSTEE gets more members the work could be better split between all. People with an expertise in bio-diversity will be welcomed to the working group.
9. Phthalates in toys - discussion and possible adoption of a draft opinion on 'Phthalates migration from soft PVC and child-care articles - data made available since the 16th of June 1998'
The chairperson of the 'Phthalates in toys' working group presented the draft opinion which resulted from the working group meeting of 23 November 1998.
The new opinion was finally adopted. Its conclusions were the following:
(i). The evaluation of the data from the 'Dutch Consensus Group' volunteer study on the release of DINP from PVC toys as well as on child behaviour mouthing PVC toys, in conjunction with results from an Austrian volunteer study on DINP and DEHP, has led the CSTEE to revise its opinion of 24 April 1998 with respect to the exposure of children to these compounds and thereby the concern arising from such exposures.
It is estimated that children with average body weights of 8 kg being exposed for 3 hrs to PVC toys containing DINP and DEHP will have maximal daily intakes of 200 m g/kg for both substances. Newer data on the toxicity of DEHP have led the CSTEE to change its previous NOAEL designation to 3.7 mg/kg/day with testicular damage as the critical effect.
The revised margin of safety (MOS) values are 75 for DINP and 19 for DEHP, respectively. The MOS for DINP raises some concern as it is less than the previously recommended safety margin of at least 100. The MOS for DEHP raises clear concern. Exposure to DINP and DEHP from other sources than soft PVC toys will increase the concern, but the magnitude of such exposures is uncertain.
(ii). The CSTEE recommends that an inter-laboratory comparison exercise be carried out in order to document the reproducibility of the Dutch laboratory method to measure phthalate release from PVC toys. Studies performed in order to shed light on the issue of buccal absorption of phthalates should be carried out. The CSTEE further recommends that additional studies be carried out in order to gain more insight as to the total time children are mouthing PVC toys.
As a concluding remark it was again pointed out that some of the wording of the opinion is likely to pose problems, e.g. the expression 'some concern' which can be interpreted differently by different readers. However the CSTEE could not solve this problem fully.
10. Presentation to the CSTEE of the following terms of reference: 'Toxicological characteristics and risks of certain citrate esters/citric acid esters used as plasticisers in soft PVC products'
The CSTEE secretary introduced this point explaining that the initiative to consult the CSTEE on phthalates' substitutes is the logical corollary of the recommendation of the CSTEE in its opinion on phthalates in toys of 24 April 98, where it was said that the characteristics of candidates for phthalates substitution should be assessed before being put on the market. A draft document with provisional terms of reference was distributed to the CSTEE during the meeting for information. The CSTEE were informed that agreement still needed to be reached within the Commission before the final official version could be provided. In any case a consultation would take place soon.
On the other hand a delegation of the citrates Industry had paid a visit recently to DG XXIV. They tried to make the point that citrates are suitable candidates for replacing phthalates in the applications under consideration by the CSTEE. They had specifically pointed out that, from a toxicological point of view, citrates pose no threat to health.
CSTEE members made several comments such as that it was important to find out what chemicals are indeed candidates for substituting phthalates (some mentioned adipates as substitutes which should be looked at as well). The answers of the CSTEE to this problem will be of paramount importance if phthalates in the applications being considered are to be replaced by other substances.
The chairperson of the 'Phthalates in toys' working group expressed the wish to have available as soon as possible an indication of what would be the most likely substitutes before embarking on an analysis of specific groups of chemicals.
Information was also given from a meeting of the group of technical experts who met in mid November to discuss validation of testing methods in the ECB in Ispra. Apparently adipates and citrates are currently being used as substitutes and even in a number of countries phthalates are no longer used. This group suggested that a market study should be carried out to allow for a determination of what is being used as substitutes.
11. Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances. Consideration of draft opinions, as presented by the respective rapporteurs, with a view to their adoption by the CSTEE, on:
The provisional point was made that evaluating these risk assessment reports was a difficult task as the time given to the CSTEE to do it was scarce. In theory they should have followed the process from the beginning. However the CSTEE understood the limitations of the current circumstances. Unless time is given to them to follow the process of these risk assessments from the inception phase and the respective developments, the task requested is an extreme burden on the CSTEE and one which will result only with extreme difficulties in good peer reviews being generated. The CSTEE is also aware that risk assessments like this one are the result of a lot of negotiation involving M. States' regulatory authorities and Industry; this should mean that, during the process of producing conclusions, there are specific problems or even crucial aspects that need solving and it is these problems that perhaps the CSTEE could help sort out.
It was also mentioned that minutes of the ECB technical meetings are regularly available and that these can help identifying what the main issues are for particular chemicals. The CSTEE would therefore have an opportunity for reacting in case it would spot a difficulty.
It was also explained that the future role of the CSTEE on the peer reviewing of these risk assessments was being the subject of difficult negotiations between the involved DGs (XI and XXIV).
(i) 2-(2-butoxyethoxy)ethanol and
(ii) 2-(2-methoxyethoxy)ethanol
As for the reports on these first two substances the ones prepared by the rapporteur M. State were considered correct both in terms of conclusions on the human health and on the environment. However the problem is the use of data, especially in the case of workplace exposure which has not been done in the same professional way as the rest of the report. E.g. on 2-(2-methoxyethoxy)ethanol safe levels were derived in the workplace by using inhalation and dermal exposure. In the case of inhalative exposure the HBORV (Health Based Occupational Reference Values) is 46mg/m3. The Working Group could accept this value, it being in line with data available from different bodies. HBORV daily exposure calculated based on this value is 400mg /day. On the other hand tolerable limits for dermal exposure were also derived. Here one guinea pig study allowed for the conclusion of a total exposure of 28mg/day. This is in stark contrast with the conclusions on inhalation. According to these values toxicity by the dermal route would be more pronounced than by inhalation (10 times more pronounced). Obviously this cannot be true. These conclusions were only possible because of the use of uncertainty factors regardless of considerations on whether this is appropriate or not.
The ECB representative stated that the significance of the effects at low doses in the guinea pig study (marginal LOEL of 40 mg/kg bw/day) had been debated at length by the technical committee responsible for Regulation 793/93 and the final agreement had been to use the study in the risk assessment for dermal exposure, in the spirit of following the precautionary principle.
This was considered the major problem with the evaluation. The CSTEE suggested that this procedure should be re-evaluated. Should this procedure (use of uncertainty factors) be taken out of the risk assessment reports then the CSTEE can agree with its conclusions as well.
The ECB representative informed the CSTEE that the use of HBROVs was an approach used by one M. State, which had not been endorsed at the 793/93 technical committee meetings where it had been agreed to move the HBROVs out of the risk assessment report and into a separate annex. Thus the request of the CSTEE could be agreed to and, in effect, had already been addressed. The ECB representative also expressed the view that, the format of draft opinions (draft version distributed before and at the start of the meeting) was one they could accept for the Commission process of decision making. The draft opinions on 2-(2-butoxyethoxy)ethanol and 2-(2-methoxyethoxy)ethanol were therefore adopted.
(iii) Alkanes, C10-13, Chloro (SCCP)
The rapporteur for this chemical presented the draft opinion. It was mentioned that these compounds should be looked at as a group as they are among the most complex compounds today, a fact that makes risk assessments difficult. Overall the report was considered a good risk assessment.
The draft opinion on SCCP was therefore adopted pending some editorial changes and a slight rewording of the conclusions. It was suggested that these should be clearer in order to make the task of risk managers easier.
It was explained by the ECB representative that normally comments such as the ones that the CSTEE made on these chemicals would be chased up by the M. State rapporteur and they would be incorporated in the report. Given the late stage of involvement of the CSTEE on this occasion this could not be done.
The Commission representatives present, particularly DG III (responsible for Directive 76/769/EEC) commented briefly on the possible options for risk management for these chemicals.
(iv) Benzene, C10-13-Alkyl derivs
The rapporteur commented on the risk assessment report saying that this was also quite good and complete. Both on the environmental part and as regards human health the report is considered adequate for the purposes of risk assessment. There were only two major criticisms: the first one is related to some statements about the low volatility but this was considered as not being very relevant for risk assessment because it can be accepted that the risk via air pollution is negligible. The other aspect relates to the risk for the aquatic environment. It is correct to state that the risk on a regional scale is negligible because the compound is readily degradable and the risk assessment is correctly made. Nevertheless on a local basis and in the absence of a proper treatment facility a risk for the aquatic environment is likely to occur. It is probably a problem of labelling, and risk phrases for the aquatic environment are probably needed.
The ECB representative, acknowledging that indeed there was not a 100% connection rate to WWTP in Europe, explained that for this substance, all sites producing or processing the substance documented the use of WWTP, consequently a scenario accounting for the absence of adequate treatment facilities was not relevant in this particular instance, and editorial changes could be made to the risk assessment report to make this quite clear.
On the human health side the conclusions of the risk assessment were considered correct although some parts of the procedure were subject to minor comments by the WG rapporteur (some studies could have been more extensive and perhaps better conducted as well).
The draft opinions were adopted with minor editorial changes on Carcinogenicity and Man exposed indirectly via the environment.
12. Endocrine disrupters - (i) presentation by the working group chairperson of a status report being prepared by the 'Endocrine disrupters' working group (outcome of 'Endocrine disrupters' working group meeting of 13 November 98); (ii) presentation by other Commission services of developments on EDCs
The chairperson of the 'Endocrine disrupters' working group presented the latest version of the draft which, in spite of having reached a significant size, is not yet complete. Some sections are missing, namely the global conclusions and the recommendations. For the time being conclusions on the different chapters will be presented. An hand out from the presentation made by the working group chairperson in the Vienna conference in November was also distributed.
The draft report being prepared by the 'Endocrine disrupters' WG also addresses the following topics:
'Stress responses' - a statement will be made in the report to the effect that these will not be included in the report. On 'mechanisms' there will be a discussion on the species differences. On 'breast cancer' there is a possibility that a Danish study will be included. It apparently shows that there is a link with organo-chlorines. 'Central nervous system' and 'neuro-endocrine effects' will also be included. On 'exposure considerations' there will be some changes regarding the tables because relative potencies will come from different screening systems and that will have to be addressed. The view was expressed that what really matters is the retention in the actual tissue and the blood concentration does not say anything about the relative potency. Others said that it is the only way to make comparisons as estimates are necessary.
One conclusion arrived at was that the available data do not prove a causal link between endocrine disrupting chemicals so far investigated and adverse health effects in man. However this is not a 'black and white' situation and still remains an area of concern. There are associations but these have not been verified. As a general principle it was stated that concerns among the public should not influence the judgement of the CSTEE and this statement is certainly along these lines.
The 'Conclusions' chapter will reflect the main statement made in the meeting in Vienna. A final conclusion was suggested to the effect that an extra sentinel species should be added to the ecotoxicity testing. There is no test system for snails (imposex effect) so it might be considered whether snails could be included in the program and that could be mentioned in the recommendation.
A division between new and existing chemicals should be acknowledged. A recommendation should be made to test lower toner trigger in special cases. And OECD 407 should be upgraded in the future. For the existing chemicals the WG would like to recommend that the TGD should be updated to take account of the endocrine or fertility system.
The ecotoxicity tests should be enhanced and if they are not sufficient others should be developed. This should be done in the framework of the OECD, in particular in the area of ecotoxicity testing where there is a problem with the absence of hazard identification of the risk for endocrine disruption. For human risk assessment an update of 407 may be necessary.
The need to use the QSARs should also be looked at in order to detect potential EDCs.
The DG XI representative also gave an account of the state of play of the drafting of the EDC policy paper whose preparation they are co-ordinating. It was acknowledged that the input of the CSTEE on the type of tests that are being proposed at the OECD is useful. However they expressed surprise at the fact that the issue of low dose effects are not being looked at in the CSTEE report as these seem to be one area of particular concern and a reference to this aspect in the CSTEE report would be useful. The EDC WG chairperson thought that this aspect was somewhat out of the scope of the document. DG XI insisted that it would be worthwhile to have an explicit statement on this aspect.
Some CSTEE members expressed the view that it would be not useful to introduce non-scientific aspects in a scientific document. They expressed the view that many people are trying to prove low dose effects but they have failed. It was agreed that the dose-response curve aspect should be acknowledged and this will be covered in a general comment.
On the side of the procedural adoption of the final version of the report questions were asked about the right procedure to be followed given the potential problems posed by its intrinsic size. It was proposed that the focus should be on the conclusions and recommendations. These could be used within the EU and the OECD. Discussing it in detail during a meeting would be out of the question. Several options as to how it should be disseminated publicly and in particular among the scientific community were considered.
It was also said that the scope of the document could be useful in the framework of the revision of the EU chemicals policy. One of the issues which has recently come up is this one (EDCs). Since the legislation currently in force does not acknowledge this sort of effect, perhaps the conclusions of the report could have an impact on the review of the chemicals policy. One practical possibility is organising a workshop together with DGs III and XI to see what conclusions could be drawn from this report that should be taken into account when the reviewing of the chemicals legislation is carried out.
The DG XI representative also said that, in parallel, the policy paper is being finalised (by early next year). Informal consultations with NGOs and Industry will take place soon and then the aim will be to have it adopted by the Commission in March. The role of independent advice is clearly stated there but the need to communicate to the public is also important. According to the DG XI representative the adoption by the Commission will then be discussed with the Council and if the CSTEE report is ready too both can go together.
It was suggested that for the policy paper of the Commission at least the conclusions and recommendations should be included in case the CSTEE report may not be finalised.
The proposal was made that the EDC working group should meet once more. The date of 7 January was provisionally scheduled for that purpose.
13. Strategies for dealing with additional chemicals (opinion requests submitted by other DGs of the Commission):
a) Polyvinylpyrrolidone in fish food - opinion request from DG VI
The CSTEE secretary presented this point together with the secretary of the Scientific Committee on Animal Nutrition (SCAN). It was explained that DG VI (Agriculture) of the Commission had initially sent to DG XXIV a request for the consultation of the CSTEE under the following terms of reference:
"Does polyvinylpyrrolidone, if administered to salmon at the level of 40000 mg/kg of complete feedingstuff, adversely affect the environment?".
The idea of addressing the opinion request to the CSTEE was a recognition of the fact that the expertise needed to answer the questions was more likely to exist within it. Subsequently, however, there was agreement that because of the subject matter of the request, the working group which needed to be set up should be chaired by a member of SCAN with extra input from several CSTEE members. A working group was therefore set up under those terms (four CSTEE members, one of which for information + 2 members of SCAN).
The SCAN secretariat will ensure the secretarial support of any meetings of this WG.
14. 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 CSTEE chairman gave a brief account of the latest activities of the SSC which have for the most part concentrated on BSE issues.
(ii) Developments on the subject of the brief of the CSTEE:
- Foreseeable future CSTEE workload following the Commission's new obligations under the provisions of the Amsterdam Treaty
The CSTEE chairman commented briefly on this problem. Basically the new provisions of the Amsterdam treaty mean that the CSTEE can expect more opinion requests to be submitted to it for adoption within shorter timeframes. It is difficult to anticipate quantitatively what increase in the workload this will mean in practice. However, if anything, this proves the point that reinforcement of the resources available to the CSTEE and its secretariat are even more needed.
- Resources available to the CSTEE (Secretariat and appointment of CSTEE members)
The information was given that more staff should be available to the CSTEE secretariat soon. This will take place either by means of redeployment of existing staff or by recruitment of new staff.
The information was also given that a proposal is being made to the effect that the CSTEE gets the extra four members to which it is entitled. Should this prospect be confirmed, in principle the expertise that will be brought in will be in the area of Ecotoxicology and/or Environment (possibly three people) and another with an expertise in the area of Human toxicology or a mixed one. In this exercise the Commission is somewhat limited by the (still) available candidates which have applied when the recruitment of members of scientific committees took place last year.
15. Any other business
The question of what kind of links would/could be established between the CSTEE and the European Chemicals Bureau was put. The answer was that this was to be seen in the context of an agreement between DG XXIV and XI, something that is still being discussed.
Information was given on the future involvement of the CSTEE on the general subject 'air quality'. Proposals on limit values on benzene and carbon monoxide have been put forward and the involvement on the CSTEE was considered. Due to political constraints a referral of the specific proposal to the CSTEE could not take place, but an agreement to the effect that air quality directives will be submitted to the CSTEE for opinion has been reached and the upcoming proposal on ozone will be the first one to be the object of scrutiny by the CSTEE.
A full review of the entire air quality policy is coming up where all the limit values that have been set so far or that are now being set will be subject to much more fundamental review as well as any interactions between them.
A working group was therefore set up within the CSTEE to tackle the general subject 'air quality'.
The question was asked of whether the CSTEE would be involved on issues such as 'radiation' and 'noise'. The answer was that, given that we are expecting comparatively few opinion requests on these areas and that there are no people in the list to choose from with that sort of expertise, when such opinion requests arrive the problem will be solved by means of resorting to external experts.
Without any other business, the meeting was closed at 13H10.
AGENDA
1. Adoption of the draft agenda
2. Adoption of the draft minutes of the 4th and 5th plenary meetings of the CSTEE held on 15/16 June 98 and on 14/15 September 1998 in Brussels
3. Adoption of the rules of procedure of the Scientific Committee on Toxicity, Ecotoxicity and the Environment
4. Setting of schedule of CSTEE meetings for 1999 and arrangements for the next meeting of the CSTEE
5. 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, with a view to their adoption by the CSTEE, on:
(i) Creosotes
(ii) Tin
(iii) Cadmium
(iv) Pentachlorophenol
(v) Azo dyes
6. Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment - Conclusions of the Workshop on Hazard identification systems and the development of classification criteria for the terrestrial environment (Madrid, 4-6 November 1998)
7. 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)
8. 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
9. Phthalates in toys - discussion and possible adoption of a draft opinion on 'Phthalates migration from soft PVC and child-care articles - data made available since the 16th of June 1998'
10. Presentation to the CSTEE of the following terms of reference: 'Toxicological characteristics and risks of certain citrate esters/citric acid esters used as plasticisers in soft PVC products'
11. Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances. Consideration of draft opinions, as presented by the respective rapporteurs, with a view to their adoption by the CSTEE, on:
(i) 2-(2-Butoxyethoxy)ethanol
(ii) 2-(2-methoxyethoxy)ethanol
(iii) alkanes, C10-13, Chloro
(iv) Benzene, C10-13-Alkyl derivs
12. Endocrine disrupters - (i) presentation by the working group chairperson of a status report being prepared by the 'Endocrine disrupters' working group (outcome of 'Endocrine disrupters' working group meeting of 13 November 98); (ii) presentation by other Commission services of developments on EDCs
13. Strategies for dealing with additional chemicals (opinion requests submitted by other DGs of the Commission):
a) Polyvinylpyrrolidone in fish food - opinion request from DG VI
b) other
14. 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:
- Foreseeable future CSTEE workload following the Commission's new obligations under the provisions of the Amsterdam Treaty
- Resources available to the CSTEE (Secretariat and appointment of CSTEE members)
15. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James W. BRIDGES, Prof. Philip L. CHAMBERS, Prof. Erik DYBING, Prof. Dr. Helmut GREIM, Prof. Bo O. JANSSON, Dr. Ole LADEFOGED, Dr. Claude LAMBRÉ, Prof. Dr. José RUEFF, Prof. Mirja SALKINOJA-SALONEN, Dr. José V. TARAZONA (26/11), Prof. Benedetto TERRACINI (26/11), Prof. Marco VIGHI, Prof. Joseph VOS, Prof. Dr. Robert WENNIG
APOLOGIES
Prof. Benedetto TERRACINI 27th November 1998, Dr. José V. TARAZONA 27th November 1998, Prof. Soterios KYRTOPOULOS
European Commission:
DG XXIV
Mrs M. de SOLÀ, Mr. J. COSTA-DAVID, Mr. T. DASKALEROS, Mrs A. FOKKEMA, Mr. L. BAY
DG III
Mrs. L. PERENIUS, Mrs. PAKALIN, Mr. TAMINIAUX, Mr. SORO, Mr. G.A. RITTER,
DG XI
Mrs K. TIERNEY, Mr. M. MORETTINI, Mr. S. BROCKETT, JRC-ECB, Mr. S. MOON
The draft agenda was adopted with a reordering of some of its points.
2. Adoption of the draft minutes of the 4th and 5th plenary meetings of the CSTEE held on 15/16 June 1998 and 14/15 September in Brussels
The CSTEE secretary presented the minutes of the June plenary meeting and requested comments from members on the preferred format, in particular on how detailed the information contained in them should be. Views were expressed and the consensus that emerged indicated that minutes should be brief (conclusions of discussions) although it would be helpful to have detailed accounts of important discussions. Some CSTEE members expressed the view that conclusions arrived at by working groups could be attached as annexes. Others still expressed the view that minutes should be simply about conclusions or sentences such as 'still under discussion'.
The adoption of the minutes was postponed. The CSTEE secretariat will send versions of the minutes drafted according to a format that will take as much as possible account of the comments made.
3. Adoption of the rules of procedure of the Scientific Committee on Toxicity, Ecotoxicity and the Environment
The draft rules of procedure previously distributed to the CSTEE members were commented upon. Clarification was sought and obtained on topics such as confidentiality, independence and others. The CSTEE strongly recommended that the rules on provision of information to the CSTEE and its working groups should be that they should be provided by the CSTEE Secretariat. The CSTEE were informed that the Commission services are working on a set of rules according to which information should indeed be provided via Commission services.
Other issues discussed were linked to confidentiality of membership of working groups as some members have been unexpectedly approached by third parties providing information and/or asking questions. Regarding occasional contacts with groups, Industry or other, the conclusion was that the rules of confidentiality should work both ways, i.e. that working group members would respect confidentiality of data provided by Industry but that Industry would be deemed not to disclose the identity of working group members to third parties.
Rules for membership of working groups were extensively discussed as some CSTEE members were of the opinion that the draft was not clear enough in that respect. On the issue of participation in working group meetings and what was meant by 'external expert' the view was expressed that a clear distinction was needed between regular members of working groups (who may not be CSTEE members) and occasional ad hoc representatives who may attend upon request and with the specific authorisation of the working group chairperson.
Deadlines for submission of documentation (the draft rules of procedure mentions that they should be made available to CSTEE members one week before the meeting) was also a subject of discussion as such a time frame is frequently not respected. The various means for submission of documents (e-mail, fax, other) was commented upon and the preferred one was considered to be still that of hard copies sent by regular mail, at least for documents larger than 10 pages (some suggested 20). However it was realised that some flexibility is necessary to this rule to compensate for a number of circumstances where it may not be totally feasible.
Pending minor changes to be made on a few of its points the draft rules of procedure were generally considered a good basis for work and adopted as such.
4. Setting of schedule of CSTEE meetings for 1999 and arrangements for the next meeting of the CSTEE
A short exchange of views took place on the anticipated work schedule for the CSTEE during 1999. Because of the forthcoming entry into force of the provisions of the Amsterdam Treaty an increase in the workload of the CSTEE stemming from opinion requests related to Directive 76/769/EEC is to be expected. A better clarification of the role to be played by the CSTEE on the work areas of DG XI is likely to change (increase) the workload picture somewhat.
With the proviso that they can be changed according to variations of the workload the following dates were agreed for plenary meetings in 1999:
18th January
4/5th March
6/7th May
1/2nd July
27/28th September
25/26th November
5. 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, with a view to their adoption by the CSTEE, on:
(i) Creosotes
The rapporteur presented the draft opinion that included comments on all the relevant data, in particular on the so-called Fraunhofer study. With some editorial changes the draft was adopted and its final conclusions were the following:
1. Given the genotoxicity of BaP and the outcome of the Fraunhofer skin painting study, there is sufficient scientific evidence to support the opinion that there is a cancer risk to consumers from Creosote containing less than 50 ppm BaP and/or from wood treated with such Creosote. BaP is a good indicator for the carcinogenic hazard of the Creosote preparation tested since there was a linear relationship between cancer incidence and BaP dose. However, the cancer potency of the Creosote preparation was 5 fold higher than judged from its BaP content.
2. On the basis of the available information, even taking into account the considerable uncertainties in assessing the risks for children coming into contact with Creosote-treated wood, the magnitude of the risk is judged to be low. In order to get a better estimate of the exposure situation, one would have to perform a real-life, mass-balance study in exposed children. In addition to being very complicated and resource intensive, to conduct such a study would raise ethical questions. The conclusion was that there is indeed a cancer risk to consumers from Creosote because of the presence of benzo-pyrene present in it at the levels indicated in the terms of reference, but that on the basis of the available information the magnitude of the risk cannot be stated.
(ii) Tin
The rapporteur presented the (fifth) version of the draft opinion on Tin, in particular following the changes, which were described, made during the last working group meeting of 23 October 1998. Most of the changes introduced were of an editorial nature. However other amendments were still proposed, namely on the issue of the PNEC value.
As would be the case with the report on Cadmium, here too the adequacy and general quality of the report as defined in the draft opinion still raised some question marks among some CSTEE members who were slightly reluctant to agree fully with such statements.
Again comments were made regarding the wording of the draft which needed more clarity. Examples given were: 'ought to be recommended' versus 'is recommended', 'may be deemed as appropriate for decision making' versus 'is appropriate' etc.
The requester Commission service emphasised again the limitations in terms of time and money they have when they set out to obtain these targeted risk assessments. Some CSTEE members had doubts as to whether they should comment on such factors as budget and timing.
Consequently it was considered that answering the second question in the terms of reference was actually outside the scope of the scientific judgement that is typical of a scientific committee as the CSTEE. Therefore the CSTEE expressed the view that it should explicitly decline to comment on constraints of budget and timing (particularly as data on budget and timing was not made available to it).
The view was also expressed that it should be made clear that the decision that the CSTEE recommended anybody to take should be based also on the CSTEE's estimation on not only on that of Atkins.
(iii) Cadmium
The draft opinion previously prepared was presented by the rapporteur. Severe criticisms were made by several CSTEE members for the disruption caused to the activities of the working group and the CSTEE by the several versions, and parts 1 and 2, of the Atkins report (to which members of the working group and of the CSTEE had access in different time frames). This was a source of confusion as it was realised that different members were expressing their views based on different versions of the Atkins report. As a consequence it had been necessary to revise several times the draft opinion previously prepared. The decision was taken to change substantially the format of the draft prepared after the working group meeting of 23 October 1998.
The wording of the draft was extensively commented upon, in particular some phraseology as the use of the words 'questionable', 'adequate/inadequate', 'acceptable/unacceptable', 'certain fractions of the population', etc., which in the overall draft could be prone to different interpretations by different readers given their intrinsic subjectivity. This will be even more of a problem when such an opinion is translated. In this respect it was reminded that the final objective of the peer review of the Atkins report by the CSTEE is to conclude whether the report is adequate for allowing risk management measures to be proposed based on it.
Comments were also made on the availability of other data on Cadmium, which were apparently not taken into consideration by Atkins, and its taking into consideration of probabilistic approaches and the use (or not) of safety factors versus relying on the 'technical guidance document'.
Some expressed the view that it is not the task of the CSTEE to improve the quality of reports such as the one under discussion here so many are its shortcomings. An explicit request was made by the CSTEE to the effect that such a statement should go to the minutes of 'this' plenary meeting.
Given the difficulties described the possibility was discussed to prepare first an 'interim' opinion, to be adopted by written procedure by mid December 1998. For this interim opinion it would have to be understood that the conclusions might not be based on the very last version of the Atkins report as not every working group member had access to it. Another working group meeting could take place in early January 1999 with a view to prepare a final draft opinion to be adopted at the CSTEE plenary meeting scheduled for the 18th of January 1999. The latter was specifically preferred by the requester service (DG III) given the sensitivity of the subject politically. The working group meeting will take place on the 11th of January 1999 in Brussels.
(iv) Pentachlorophenol
The rapporteur for this substance presented the draft opinion, in particular following the taking into consideration of comments of various sources, some in writing and some made previously at the CSTEE plenary meeting of September.
Again, as in the case of Cadmium, the previous evaluation had been made on a version of the report that was not the final one. This was only made available in mid September 1998. This final ERM version was to a certain extent a response by ERM to the previous version of the CSTEE draft opinion on its report. However it was the view of the rapporteur that the changes introduced by ERM were mainly formal and corrections of errors (e.g. PCP previously stated as cation and not as an anion which is what it is) and these have to be considered minor changes. The main conclusions of the final ERM report had to be considered as being the same.
The new draft CSTEE opinion contained an updated list of references and other changes, mainly of an editorial nature.
It was commented that since the new draft opinion basically comes up with a new risk assessment, it would be extremely helpful if the conclusion could be elaborated in order to be a balanced statement on which further decision making could be based.
The draft opinion was adopted by the CSTEE and its main conclusions are:
Due to an unsatisfactory literature review, to many inconsistencies between reported data and conclusions and to the unclear description of some aspects, the ERM studies cannot be considered adequate for a risk assessment of PCP.
The amount of information on PCP (including literature data not reported in the ERM studies) allow to conclude that:
In some areas, human exposure continued to occur even where PCP use has ceased. At some working situations, adverse health effects are sometimes observed. No adequate clean-up treatment has yet been found to remediate contaminated soil.
Risk for the aquatic environment from PCP and associated chemicals may occur, at least in "hot spots" areas, involving local PCP release to the environment. This is also demonstrated by some experimental monitoring data above the PNEC, reported in the ERM study.
Finally the decision was also made to make the same remark, as on other opinions previously discussed, to the effect that it was not appropriate for the CSTEE to comment on the constraints faced by the consultants in terms of budget and timing.
(v) Azo dyes
Due to the absence of the rapporteur the discussion on this agenda topic was postponed for the next plenary meeting (18th of January 1999).
6. Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment - Conclusions of the Workshop on Hazard identification systems and the development of classification criteria for the terrestrial environment (Madrid, 4-6 November 1998)
The Madrid meeting was essentially about hazard identification. Delegates from practically all M. States were present. A report on the meeting will be available by the end of the year and conclusions will be passed on to the Classification & Labelling group (Directive 67/548/EEC) that will meet at the end of January 1999.
Regarding the involvement of the CSTEE, it had been acknowledged by the former CSTE that this area is characterised by a lack of scientific knowledge. The CSTE had therefore suggested that the evidence should be validated by them. Such task has henceforth been passed to the current CSTEE. The task is about how to develop scientific methods for hazard identification for the terrestrial environment and particularly for the above soil compartment (there is a certain level of agreement for the soil compartment). A subsequent amendment/modification of the Classification and Labelling Directive will later be necessary. The involvement of the CSTEE needs to be established in terms of agreement between DG XI and DG XXIV. It was believed important to start as soon as possible with scientific issues (a working group established from within the CSTEE was set up). The activities of the working group should start yearly next year (1999). There are already a Nordic and a Spanish proposal that can be taken as a starting point for the activities of the CSTEE. The problem is also about criteria for risk assessment and not only on hazard identification.
7. 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)
A representative from DG XI gave an update on the status of development of the 'Water framework directive' starting with an acknowledgement of the work done by the CSTEE and the 'Water framework directive' working group on this subject. A detailed note will be sent to DG XXIV on what DG XI intends to do with each of the recommendations of the CSTEE. The DG XI representative said that the most important thing to do in terms of future participation of the CSTEE on developments of the Directive is to involve it in setting the so-called inter-calibration exercise. Terminological changes had also been proposed by the CSTEE and quite a few were already integrated.
On groundwater chemical status an interesting suggestion was made to include toxicity assessment as an additional parameter and DG XI supports this. However they have some concerns on the actual thresholds set out in the report which DG XI is consulting on at the moment with M. States and with the European Environment Agency.
As regards the presentation, precision and confidence of monitoring results, these are important areas but DG XI believes that they should be better dealt with by means of guidance because otherwise very detailed specifications may be necessary in practice and such a form makes it difficult for negotiating in a formal legal text, hence it may not be the best way forward.
Definitions of poor and bad status in addition to the three specified in the directive have been integrated in the latest Council text. Other provisions concern detailed guidance and monitoring, the inclusion of direct toxicity as a parameter for surface water in various situations and procedures for the establishment of site specific quality standards (there are provisions within the directive for adjusting the safety factors provided on the basis of more detailed site-specific data than M. States may have available).
M. States consider that the priorities are the inter-calibration exercise, the definition of heavily modified in artificial water bodies and the establishment of the concept of maximum ecological potential for those water bodies. This definition is something that will have a scientific content and the views of the CSTEE will be asked on this.
M. States were also consulted on the proposals for research priorities set out by the CSTEE and they thought that in spite of their validity there are short-term operational priorities which will probably have to take precedence. These will relate first of all to the inter-calibration and to the development of methods for assessing the fish and aquatic flora components of the ecosystem, secondly to the relation between surface and groundwater and thirdly to the causal relationship between distortion of hidromorphology and ecological distortion.
The draft Fraunhofer report on the combined modelling and monitoring priority setting was presented in July and comments on the database were requested from M. States. Monitoring data from all M. States will now be included and not just those of the twelve ones initially foreseen. On the basis of this a list of priority substances will be identified and subsequently sent for comments to various parties including the CSTEE. The time schedule for this is difficult to anticipate but it will probably not take place before March next year.
The timing is dependent on the negotiations of the Directive (it will be a co-decision text). The EP has postponed its opinion until February which means that the first reading will not be adopted until probably late February 1999, but the intention at a political level is to have discussions between the Council and the EP before the adoption of the EP opinion and the adoption of the Common position to try to bring the positions of the two institutions closer together. The priorities for implementation will come after these problems are settled as these negotiations will very likely absorb a lot of DG XI's activities.
DG XI will try to integrate the remaining concerns identified by the CSTEE in its opinion. These should be in the legislative proposal over the next few months and then, once the framework directive is adopted the remaining elements would follow. With luck adoption can take place under the German presidency in the June 99 Council and the implementation phase thereafter. The next consultation of the CSTEE should be on the first list of priority substances from March 99 onwards and the implementation from July 99 onwards.
The Chairman of the Committee expressed his appreciation of the warm co-operation developed between the CSTEE and the responsible Commission service in DG XI and expressed the hope that this would continue.
8. 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 accident was commented upon in that the problem is linked to the specific characteristics of the area. Regulation 793/93 does not have a good ecological risk assessment system for areas that should be protected at the ecological level because of their high ecological relevance or because of their high bio-diversity. The same system is applied to an Industry located in a normal area as in these very sensitive areas. Hence the proposal for a statement of the CSTEE to the effect that a method for the ecological risk assessment of these particularly relevant areas should be developed on a scientific basis. The statement need not necessarily be related to this particular accident and should be general. Agreement is needed on basic principles and on how to apply them to a local situation.
It was commented that the accident in question was basically related to the terrestrial environment and this links in with the activity mentioned previously under point 6 of these minutes.
A working group was set up to approach this general problem. If the CSTEE gets more members the work could be better split between all. People with an expertise in bio-diversity will be welcomed to the working group.
9. Phthalates in toys - discussion and possible adoption of a draft opinion on 'Phthalates migration from soft PVC and child-care articles - data made available since the 16th of June 1998'
The chairperson of the 'Phthalates in toys' working group presented the draft opinion which resulted from the working group meeting of 23 November 1998.
The new opinion was finally adopted. Its conclusions were the following:
(i). The evaluation of the data from the 'Dutch Consensus Group' volunteer study on the release of DINP from PVC toys as well as on child behaviour mouthing PVC toys, in conjunction with results from an Austrian volunteer study on DINP and DEHP, has led the CSTEE to revise its opinion of 24 April 1998 with respect to the exposure of children to these compounds and thereby the concern arising from such exposures.
It is estimated that children with average body weights of 8 kg being exposed for 3 hrs to PVC toys containing DINP and DEHP will have maximal daily intakes of 200 m g/kg for both substances. Newer data on the toxicity of DEHP have led the CSTEE to change its previous NOAEL designation to 3.7 mg/kg/day with testicular damage as the critical effect.
The revised margin of safety (MOS) values are 75 for DINP and 19 for DEHP, respectively. The MOS for DINP raises some concern as it is less than the previously recommended safety margin of at least 100. The MOS for DEHP raises clear concern. Exposure to DINP and DEHP from other sources than soft PVC toys will increase the concern, but the magnitude of such exposures is uncertain.
(ii). The CSTEE recommends that an inter-laboratory comparison exercise be carried out in order to document the reproducibility of the Dutch laboratory method to measure phthalate release from PVC toys. Studies performed in order to shed light on the issue of buccal absorption of phthalates should be carried out. The CSTEE further recommends that additional studies be carried out in order to gain more insight as to the total time children are mouthing PVC toys.
As a concluding remark it was again pointed out that some of the wording of the opinion is likely to pose problems, e.g. the expression 'some concern' which can be interpreted differently by different readers. However the CSTEE could not solve this problem fully.
10. Presentation to the CSTEE of the following terms of reference: 'Toxicological characteristics and risks of certain citrate esters/citric acid esters used as plasticisers in soft PVC products'
The CSTEE secretary introduced this point explaining that the initiative to consult the CSTEE on phthalates' substitutes is the logical corollary of the recommendation of the CSTEE in its opinion on phthalates in toys of 24 April 98, where it was said that the characteristics of candidates for phthalates substitution should be assessed before being put on the market. A draft document with provisional terms of reference was distributed to the CSTEE during the meeting for information. The CSTEE were informed that agreement still needed to be reached within the Commission before the final official version could be provided. In any case a consultation would take place soon.
On the other hand a delegation of the citrates Industry had paid a visit recently to DG XXIV. They tried to make the point that citrates are suitable candidates for replacing phthalates in the applications under consideration by the CSTEE. They had specifically pointed out that, from a toxicological point of view, citrates pose no threat to health.
CSTEE members made several comments such as that it was important to find out what chemicals are indeed candidates for substituting phthalates (some mentioned adipates as substitutes which should be looked at as well). The answers of the CSTEE to this problem will be of paramount importance if phthalates in the applications being considered are to be replaced by other substances.
The chairperson of the 'Phthalates in toys' working group expressed the wish to have available as soon as possible an indication of what would be the most likely substitutes before embarking on an analysis of specific groups of chemicals.
Information was also given from a meeting of the group of technical experts who met in mid November to discuss validation of testing methods in the ECB in Ispra. Apparently adipates and citrates are currently being used as substitutes and even in a number of countries phthalates are no longer used. This group suggested that a market study should be carried out to allow for a determination of what is being used as substitutes.
11. Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances. Consideration of draft opinions, as presented by the respective rapporteurs, with a view to their adoption by the CSTEE, on:
The provisional point was made that evaluating these risk assessment reports was a difficult task as the time given to the CSTEE to do it was scarce. In theory they should have followed the process from the beginning. However the CSTEE understood the limitations of the current circumstances. Unless time is given to them to follow the process of these risk assessments from the inception phase and the respective developments, the task requested is an extreme burden on the CSTEE and one which will result only with extreme difficulties in good peer reviews being generated. The CSTEE is also aware that risk assessments like this one are the result of a lot of negotiation involving M. States' regulatory authorities and Industry; this should mean that, during the process of producing conclusions, there are specific problems or even crucial aspects that need solving and it is these problems that perhaps the CSTEE could help sort out.
It was also mentioned that minutes of the ECB technical meetings are regularly available and that these can help identifying what the main issues are for particular chemicals. The CSTEE would therefore have an opportunity for reacting in case it would spot a difficulty.
It was also explained that the future role of the CSTEE on the peer reviewing of these risk assessments was being the subject of difficult negotiations between the involved DGs (XI and XXIV).
(i) 2-(2-butoxyethoxy)ethanol and
(ii) 2-(2-methoxyethoxy)ethanol
As for the reports on these first two substances the ones prepared by the rapporteur M. State were considered correct both in terms of conclusions on the human health and on the environment. However the problem is the use of data, especially in the case of workplace exposure which has not been done in the same professional way as the rest of the report. E.g. on 2-(2-methoxyethoxy)ethanol safe levels were derived in the workplace by using inhalation and dermal exposure. In the case of inhalative exposure the HBORV (Health Based Occupational Reference Values) is 46mg/m3. The Working Group could accept this value, it being in line with data available from different bodies. HBORV daily exposure calculated based on this value is 400mg /day. On the other hand tolerable limits for dermal exposure were also derived. Here one guinea pig study allowed for the conclusion of a total exposure of 28mg/day. This is in stark contrast with the conclusions on inhalation. According to these values toxicity by the dermal route would be more pronounced than by inhalation (10 times more pronounced). Obviously this cannot be true. These conclusions were only possible because of the use of uncertainty factors regardless of considerations on whether this is appropriate or not.
The ECB representative stated that the significance of the effects at low doses in the guinea pig study (marginal LOEL of 40 mg/kg bw/day) had been debated at length by the technical committee responsible for Regulation 793/93 and the final agreement had been to use the study in the risk assessment for dermal exposure, in the spirit of following the precautionary principle.
This was considered the major problem with the evaluation. The CSTEE suggested that this procedure should be re-evaluated. Should this procedure (use of uncertainty factors) be taken out of the risk assessment reports then the CSTEE can agree with its conclusions as well.
The ECB representative informed the CSTEE that the use of HBROVs was an approach used by one M. State, which had not been endorsed at the 793/93 technical committee meetings where it had been agreed to move the HBROVs out of the risk assessment report and into a separate annex. Thus the request of the CSTEE could be agreed to and, in effect, had already been addressed. The ECB representative also expressed the view that, the format of draft opinions (draft version distributed before and at the start of the meeting) was one they could accept for the Commission process of decision making. The draft opinions on 2-(2-butoxyethoxy)ethanol and 2-(2-methoxyethoxy)ethanol were therefore adopted.
(iii) Alkanes, C10-13, Chloro (SCCP)
The rapporteur for this chemical presented the draft opinion. It was mentioned that these compounds should be looked at as a group as they are among the most complex compounds today, a fact that makes risk assessments difficult. Overall the report was considered a good risk assessment.
The draft opinion on SCCP was therefore adopted pending some editorial changes and a slight rewording of the conclusions. It was suggested that these should be clearer in order to make the task of risk managers easier.
It was explained by the ECB representative that normally comments such as the ones that the CSTEE made on these chemicals would be chased up by the M. State rapporteur and they would be incorporated in the report. Given the late stage of involvement of the CSTEE on this occasion this could not be done.
The Commission representatives present, particularly DG III (responsible for Directive 76/769/EEC) commented briefly on the possible options for risk management for these chemicals.
(iv) Benzene, C10-13-Alkyl derivs
The rapporteur commented on the risk assessment report saying that this was also quite good and complete. Both on the environmental part and as regards human health the report is considered adequate for the purposes of risk assessment. There were only two major criticisms: the first one is related to some statements about the low volatility but this was considered as not being very relevant for risk assessment because it can be accepted that the risk via air pollution is negligible. The other aspect relates to the risk for the aquatic environment. It is correct to state that the risk on a regional scale is negligible because the compound is readily degradable and the risk assessment is correctly made. Nevertheless on a local basis and in the absence of a proper treatment facility a risk for the aquatic environment is likely to occur. It is probably a problem of labelling, and risk phrases for the aquatic environment are probably needed.
The ECB representative, acknowledging that indeed there was not a 100% connection rate to WWTP in Europe, explained that for this substance, all sites producing or processing the substance documented the use of WWTP, consequently a scenario accounting for the absence of adequate treatment facilities was not relevant in this particular instance, and editorial changes could be made to the risk assessment report to make this quite clear.
On the human health side the conclusions of the risk assessment were considered correct although some parts of the procedure were subject to minor comments by the WG rapporteur (some studies could have been more extensive and perhaps better conducted as well).
The draft opinions were adopted with minor editorial changes on Carcinogenicity and Man exposed indirectly via the environment.
12. Endocrine disrupters - (i) presentation by the working group chairperson of a status report being prepared by the 'Endocrine disrupters' working group (outcome of 'Endocrine disrupters' working group meeting of 13 November 98); (ii) presentation by other Commission services of developments on EDCs
The chairperson of the 'Endocrine disrupters' working group presented the latest version of the draft which, in spite of having reached a significant size, is not yet complete. Some sections are missing, namely the global conclusions and the recommendations. For the time being conclusions on the different chapters will be presented. An hand out from the presentation made by the working group chairperson in the Vienna conference in November was also distributed.
The draft report being prepared by the 'Endocrine disrupters' WG also addresses the following topics:
'Stress responses' - a statement will be made in the report to the effect that these will not be included in the report. On 'mechanisms' there will be a discussion on the species differences. On 'breast cancer' there is a possibility that a Danish study will be included. It apparently shows that there is a link with organo-chlorines. 'Central nervous system' and 'neuro-endocrine effects' will also be included. On 'exposure considerations' there will be some changes regarding the tables because relative potencies will come from different screening systems and that will have to be addressed. The view was expressed that what really matters is the retention in the actual tissue and the blood concentration does not say anything about the relative potency. Others said that it is the only way to make comparisons as estimates are necessary.
One conclusion arrived at was that the available data do not prove a causal link between endocrine disrupting chemicals so far investigated and adverse health effects in man. However this is not a 'black and white' situation and still remains an area of concern. There are associations but these have not been verified. As a general principle it was stated that concerns among the public should not influence the judgement of the CSTEE and this statement is certainly along these lines.
The 'Conclusions' chapter will reflect the main statement made in the meeting in Vienna. A final conclusion was suggested to the effect that an extra sentinel species should be added to the ecotoxicity testing. There is no test system for snails (imposex effect) so it might be considered whether snails could be included in the program and that could be mentioned in the recommendation.
A division between new and existing chemicals should be acknowledged. A recommendation should be made to test lower toner trigger in special cases. And OECD 407 should be upgraded in the future. For the existing chemicals the WG would like to recommend that the TGD should be updated to take account of the endocrine or fertility system.
The ecotoxicity tests should be enhanced and if they are not sufficient others should be developed. This should be done in the framework of the OECD, in particular in the area of ecotoxicity testing where there is a problem with the absence of hazard identification of the risk for endocrine disruption. For human risk assessment an update of 407 may be necessary.
The need to use the QSARs should also be looked at in order to detect potential EDCs.
The DG XI representative also gave an account of the state of play of the drafting of the EDC policy paper whose preparation they are co-ordinating. It was acknowledged that the input of the CSTEE on the type of tests that are being proposed at the OECD is useful. However they expressed surprise at the fact that the issue of low dose effects are not being looked at in the CSTEE report as these seem to be one area of particular concern and a reference to this aspect in the CSTEE report would be useful. The EDC WG chairperson thought that this aspect was somewhat out of the scope of the document. DG XI insisted that it would be worthwhile to have an explicit statement on this aspect.
Some CSTEE members expressed the view that it would be not useful to introduce non-scientific aspects in a scientific document. They expressed the view that many people are trying to prove low dose effects but they have failed. It was agreed that the dose-response curve aspect should be acknowledged and this will be covered in a general comment.
On the side of the procedural adoption of the final version of the report questions were asked about the right procedure to be followed given the potential problems posed by its intrinsic size. It was proposed that the focus should be on the conclusions and recommendations. These could be used within the EU and the OECD. Discussing it in detail during a meeting would be out of the question. Several options as to how it should be disseminated publicly and in particular among the scientific community were considered.
It was also said that the scope of the document could be useful in the framework of the revision of the EU chemicals policy. One of the issues which has recently come up is this one (EDCs). Since the legislation currently in force does not acknowledge this sort of effect, perhaps the conclusions of the report could have an impact on the review of the chemicals policy. One practical possibility is organising a workshop together with DGs III and XI to see what conclusions could be drawn from this report that should be taken into account when the reviewing of the chemicals legislation is carried out.
The DG XI representative also said that, in parallel, the policy paper is being finalised (by early next year). Informal consultations with NGOs and Industry will take place soon and then the aim will be to have it adopted by the Commission in March. The role of independent advice is clearly stated there but the need to communicate to the public is also important. According to the DG XI representative the adoption by the Commission will then be discussed with the Council and if the CSTEE report is ready too both can go together.
It was suggested that for the policy paper of the Commission at least the conclusions and recommendations should be included in case the CSTEE report may not be finalised.
The proposal was made that the EDC working group should meet once more. The date of 7 January was provisionally scheduled for that purpose.
13. Strategies for dealing with additional chemicals (opinion requests submitted by other DGs of the Commission):
a) Polyvinylpyrrolidone in fish food - opinion request from DG VI
The CSTEE secretary presented this point together with the secretary of the Scientific Committee on Animal Nutrition (SCAN). It was explained that DG VI (Agriculture) of the Commission had initially sent to DG XXIV a request for the consultation of the CSTEE under the following terms of reference:
"Does polyvinylpyrrolidone, if administered to salmon at the level of 40000 mg/kg of complete feedingstuff, adversely affect the environment?".
The idea of addressing the opinion request to the CSTEE was a recognition of the fact that the expertise needed to answer the questions was more likely to exist within it. Subsequently, however, there was agreement that because of the subject matter of the request, the working group which needed to be set up should be chaired by a member of SCAN with extra input from several CSTEE members. A working group was therefore set up under those terms (four CSTEE members, one of which for information + 2 members of SCAN).
The SCAN secretariat will ensure the secretarial support of any meetings of this WG.
14. 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 CSTEE chairman gave a brief account of the latest activities of the SSC which have for the most part concentrated on BSE issues.
(ii) Developments on the subject of the brief of the CSTEE:
- Foreseeable future CSTEE workload following the Commission's new obligations under the provisions of the Amsterdam Treaty
The CSTEE chairman commented briefly on this problem. Basically the new provisions of the Amsterdam treaty mean that the CSTEE can expect more opinion requests to be submitted to it for adoption within shorter timeframes. It is difficult to anticipate quantitatively what increase in the workload this will mean in practice. However, if anything, this proves the point that reinforcement of the resources available to the CSTEE and its secretariat are even more needed.
- Resources available to the CSTEE (Secretariat and appointment of CSTEE members)
The information was given that more staff should be available to the CSTEE secretariat soon. This will take place either by means of redeployment of existing staff or by recruitment of new staff.
The information was also given that a proposal is being made to the effect that the CSTEE gets the extra four members to which it is entitled. Should this prospect be confirmed, in principle the expertise that will be brought in will be in the area of Ecotoxicology and/or Environment (possibly three people) and another with an expertise in the area of Human toxicology or a mixed one. In this exercise the Commission is somewhat limited by the (still) available candidates which have applied when the recruitment of members of scientific committees took place last year.
15. Any other business
The question of what kind of links would/could be established between the CSTEE and the European Chemicals Bureau was put. The answer was that this was to be seen in the context of an agreement between DG XXIV and XI, something that is still being discussed.
Information was given on the future involvement of the CSTEE on the general subject 'air quality'. Proposals on limit values on benzene and carbon monoxide have been put forward and the involvement on the CSTEE was considered. Due to political constraints a referral of the specific proposal to the CSTEE could not take place, but an agreement to the effect that air quality directives will be submitted to the CSTEE for opinion has been reached and the upcoming proposal on ozone will be the first one to be the object of scrutiny by the CSTEE.
A full review of the entire air quality policy is coming up where all the limit values that have been set so far or that are now being set will be subject to much more fundamental review as well as any interactions between them.
A working group was therefore set up within the CSTEE to tackle the general subject 'air quality'.
The question was asked of whether the CSTEE would be involved on issues such as 'radiation' and 'noise'. The answer was that, given that we are expecting comparatively few opinion requests on these areas and that there are no people in the list to choose from with that sort of expertise, when such opinion requests arrive the problem will be solved by means of resorting to external experts.
Without any other business, the meeting was closed at 13H10.
AGENDA
1. Adoption of the draft agenda
2. Adoption of the draft minutes of the 4th and 5th plenary meetings of the CSTEE held on 15/16 June 98 and on 14/15 September 1998 in Brussels
3. Adoption of the rules of procedure of the Scientific Committee on Toxicity, Ecotoxicity and the Environment
4. Setting of schedule of CSTEE meetings for 1999 and arrangements for the next meeting of the CSTEE
5. 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, with a view to their adoption by the CSTEE, on:
(i) Creosotes
(ii) Tin
(iii) Cadmium
(iv) Pentachlorophenol
(v) Azo dyes
6. Scientific basis for the hazard and risk assessment of chemical substances for the terrestrial environment - Conclusions of the Workshop on Hazard identification systems and the development of classification criteria for the terrestrial environment (Madrid, 4-6 November 1998)
7. 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)
8. 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
9. Phthalates in toys - discussion and possible adoption of a draft opinion on 'Phthalates migration from soft PVC and child-care articles - data made available since the 16th of June 1998'
10. Presentation to the CSTEE of the following terms of reference: 'Toxicological characteristics and risks of certain citrate esters/citric acid esters used as plasticisers in soft PVC products'
11. Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances. Consideration of draft opinions, as presented by the respective rapporteurs, with a view to their adoption by the CSTEE, on:
(i) 2-(2-Butoxyethoxy)ethanol
(ii) 2-(2-methoxyethoxy)ethanol
(iii) alkanes, C10-13, Chloro
(iv) Benzene, C10-13-Alkyl derivs
12. Endocrine disrupters - (i) presentation by the working group chairperson of a status report being prepared by the 'Endocrine disrupters' working group (outcome of 'Endocrine disrupters' working group meeting of 13 November 98); (ii) presentation by other Commission services of developments on EDCs
13. Strategies for dealing with additional chemicals (opinion requests submitted by other DGs of the Commission):
a) Polyvinylpyrrolidone in fish food - opinion request from DG VI
b) other
14. 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:
- Foreseeable future CSTEE workload following the Commission's new obligations under the provisions of the Amsterdam Treaty
- Resources available to the CSTEE (Secretariat and appointment of CSTEE members)
15. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James W. BRIDGES, Prof. Philip L. CHAMBERS, Prof. Erik DYBING, Prof. Dr. Helmut GREIM, Prof. Bo O. JANSSON, Dr. Ole LADEFOGED, Dr. Claude LAMBRÉ, Prof. Dr. José RUEFF, Prof. Mirja SALKINOJA-SALONEN, Dr. José V. TARAZONA (26/11), Prof. Benedetto TERRACINI (26/11), Prof. Marco VIGHI, Prof. Joseph VOS, Prof. Dr. Robert WENNIG
APOLOGIES
Prof. Benedetto TERRACINI 27th November 1998, Dr. José V. TARAZONA 27th November 1998, Prof. Soterios KYRTOPOULOS
European Commission:
DG XXIV
Mrs M. de SOLÀ, Mr. J. COSTA-DAVID, Mr. T. DASKALEROS, Mrs A. FOKKEMA, Mr. L. BAY
DG III
Mrs. L. PERENIUS, Mrs. PAKALIN, Mr. TAMINIAUX, Mr. SORO, Mr. G.A. RITTER,
DG XI
Mrs K. TIERNEY, Mr. M. MORETTINI, Mr. S. BROCKETT, JRC-ECB, Mr. S. MOON
