1. Welcoming address, apologies for absence
and declarations of interest
Apologies were received from Profs. Lambré,
Vos and Calow.
The CSTEE Secretary informed the Committee
about the nomination of a new CSTEE member:
Professor Peter Calow. Because of prior
commitments he was unable to attend this
plenary meeting however.
The issue of the declarations of interest was
raised. The Chairman explained the necessity
of being as clearer as possible about it,
because of the importance and interest in the
Committee's activities.
One of the CSTEE and Biocidal WG members
reported funding of her institute by a company
involved in biocides. The CSTEE chairman asked
her to report this sort of interest at the
beginning of every plenary and WG meetings on
the point "declarations of interest".
2. Adoption of the draft agenda
The agenda was adopted with the only remark
that points 8 and 9 should be postponed until
the afternoon, due to the impossibility for
some representatives from Enterprise and
Environment DGs to attend the morning session.
A new point, now 7, was included to deal with
a question raised by the rapporteur of the
opinion on "Man Made Mineral Fibres
classification - DE request for a derogation
under Article 100a (4) - Maastricht Treaty".
3. Information from the CSTEE secretariat
The Secretary of the CSTEE informed about some
documents sent recently to the Committee
members by e-mail. He explained the contents
of some of them: one on a new publication,
"Chemical Awareness", now available to CSTEE
members on Internet, and a second one
regarding the possibility of accessing the
databases of the European Chemicals Bureau (ECB).
4. Adoption of the draft minutes of the 12th
CSTEE plenary meeting held on the 25th of
November 1999 in Brussels
The minutes were not adopted because of a
discussion raised regarding some aspects about
them. A representative from Health and
Consumer Protection DG pointed out the
convenience of a harmonisation of the minutes
of all the Scientific Committees within the
DG. At the end there was a general agreement
within the CSTEE that future minutes of
Committee meetings should be shorter in order
to allow them to be ready shortly after the
meeting, and also to avoid possible
misinterpretations. The secretariat took the
task of re-wording the minutes of the November
plenary meeting according to these new
recommendations for adoption at the April
plenary of the CSTEE.
Regarding the possible mentioning in the
minutes of who had expressed a particular
position it was decided to maintain the
anonymity. Nevertheless, the CSTEE agreed that
the information should be given on whether or
not the decisions would have been unanimously
adopted.
The Secretariat informed the Committee that
the minutes of the 11th Plenary Meeting were
approved by written procedure. A question was
raised regarding the issue of Man Made Mineral
Fibres discussed during that 11th Plenary
Meeting. The Secretariat informed the CSTEE of
some amendments that were proposed by
Environment DG to a note prepared on that
subject. The Secretariat, therefore, thought
that it was necessary to consult the
rapporteur of the opinion and only after
obtaining agreement, incorporate the results
of the discussion to the minutes of one of the
Plenary Meetings of the CSTEE. The amendments
were discussed during this 13th Plenary and a
new version of the note adopted.
Some problems were reported to the CSTEE
Secretariat regarding the documents received.
The Secretariat explained that lists of
documents made available to CSTEE members were
prepared only for technical documents, and in
principle not for information policy
documents. Clarifications were asked about
documents being sent both in electronic format
via e-mail and in printed format via regular
mail. The Secretary explained that as a
general rule every technical document sent by
e-mail is also sent afterwards in printed
version, unless the time available for
receiving some documents is too short before a
meeting making it impossible to proceed to
this latter sending in a timely manner.
5. Schedule of CSTEE plenary meetings for the
year 2000
Dates were decided for the plenary meetings of
this year. Members were asked to block in
their agendas two days for each one, taking
into account that probably most of them will
be single day meetings. According to that a
preferred day was decided for each of them.
The dates were finally decided as follows:
10-11 April, with 11 as preferred day for a
single day meeting; 19-20 June, 19 preferred
day; 4-5 September, 4 preferred day; 9-10
October, preferred day 9; 2-3 November,
preferred day 2.
Note: it was later realised after the meeting
that 2 November being a holiday in Belgium the
November plenary meeting will have to be
rescheduled.
6. Evaluation of Technical Guidance Document
in support of Directive 98/8/EC concerning the
placing of biocidal products on the market -
for opinion
The Chairperson of the Working Group presented
the final draft opinion agreed at its last
meeting. Some members of the WG made comments
regarding the different treatment given in the
Technical Notes for Guidance to the human
health risk assessment compared to that given
to the environment section. A certain concern
was also raised about the possibility of
setting criteria for waiving some tests on
human toxicology.
The problem of the different versions of the
Technical Notes for Guidance (TNsG) provided
by Environment DG was also raised. One
representative from that DG explained that the
last document provided was in fact the final
draft version of the TNsG.
A discussion was raised between one CSTEE
member and those of the biocides WG on the
issue of requirements for long term testing of
products for carcinogenicity. In consequence,
some rewordings were proposed and accepted for
the paragraphs in question.
The problem of the terminology used, both in
the Technical Notes for Guidance and in the
draft opinion, was also discussed. A call for
coherence in the terminology used was made. It
was pointed out that what was in the TNsG did
not allow the Committee to carry out a risk
assessment but hazard or exposure assessment
instead.
The opinion was adopted with the inclusion of
some minor requests for changes proposed by
CSTEE members.
7. Man Made Mineral Fibres classification - DE
request for a derogation under Article 100a
(4) - Maastricht Treaty
At the 11th Plenary Meeting of the CSTEE, held
in Brussels, 27-28 September 1999, the
necessity for further clarifying the position
of the Committee on the mentioned issue was
discussed. Afterwards, the CSTEE Secretariat
received some comments on the subject from
Environment DG. Due to the absence of the
opinion rapporteur and WG chairman at the 12th
Plenary Meeting, the question was postponed
until this 13th plenary.
Environment DG had made three comments to a
note prepared on the subject. The first one
proposed a change in the first paragraph
regarding the distinction for categories 2 and
3 for carcinogenicity in the note Q of the
Directive 97/69/EC; this was rejected by the
CSTEE. The second one, on paragraph 3, was
accepted and therefore the respective sentence
was corrected in the explanatory note; it
refers to solubility as an indicator of the
carcinogenicity of the man made mineral fibres,
instead of "an indicator of their safety", as
it read before. The third one was a comment on
paragraph 4 of the mentioned note, regarding
some advantages of the German proposal to
better differentiate between category 3 for
carcinogenicity and no classification; it was
partially accepted and the sentence was,
therefore, reworded.
A final version of the note, with these
modifications included, was considered
acceptable by the Committee.
8. Lead - Danish notification 595/98/DK - for
opinion
Due to the fact that the Chairman of the WG
had not been present in its last meeting one
of the WG members presented a progress report
on the issue. A WG meeting took place shortly
before the plenary and the outcome of that
meeting was presented to the CSTEE. Eight main
points had been discussed during that meeting:
the increase of soil concentration of lead;
the effects in children in spite of lower
blood lead levels; the reduction of lead
impact accruing from its removal from
gasoline; the blood lead levels in Europe; the
possible correlation between soil
contamination and blood lead levels; unusual
lead exposures; lead contaminated soil and
sewage sludge; and waste incineration.
Regarding the major sources of exposure to
lead, WG members specially stressed the lack
of correlation between blood lead levels and
soil contamination. They pointed out also that
there has been a constant decrease of blood
lead levels in children since the late
seventies, apparently due to the elimination
of lead from gasoline.
A new WG meeting was deemed necessary and
afterwards a draft opinion should be ready for
consultation within the CSTEE by mid March. It
was decided to have the opinion approved by
written procedure and published no later than
by the end of that month.
The CSTEE Secretary asked the Committee
whether it considered or not the documentation
submitted by Environment DG as sufficient to
answer the terms of reference of the general
question on lead. The CSTEE Chairman answered
that the WG had to address again the issue of
the huge amount of literature on the subject,
which made necessary a thorough review of it.
Adoption of an opinion on the general question
was not, however, considered possible in the
short term future for this reason.
A representative from Environment DG stressed
the urgency of having an opinion adopted on
the general question on lead as soon as
possible
9. Regulation 793/93 on Existing substances (ESR):
A. Progress reports/opinions on:
SUBSTANCE |
CAS RN |
Nonylphenol
straight and
branched chain |
84852-15-3,
25154-52-3 |
Pentabromodiphenyl
ether |
32534-81-9 |
Octabromodiphenyl ether |
32536-52-0 |
Decabromodiphenyl ether |
1163-19-5 |
The rapporteur for the report on the
environmental part of Nonylphenol presented
the draft opinion. He expressed the general
satisfaction of the Working Group with the
risk assessment report, which was considered
to be based on a sufficient amount of
information, the data being critically
evaluated and, in general, being a
well-elaborated risk assessment. Some minor
comments were made on chapter 3 of the
document (the section regarding degradation
aspects): on predicted environmental
concentration, on the use of this compound in
pesticide formulation and on the effects in
reproduction in fish, as well as some other
minor points. The opinion was adopted.
The working party dealing with the
environmental toxicology report on
Pentabromodiphenyl ether also considered it a
well-performed report. The rapporteur
presented the opinion. The CSTEE made some
minor remarks on different aspects of the
study. A representative from JRC-ECB made some
comments and gave explanations on the issues
raised. The opinion was also adopted.
A CSTEE member asked about the origin of some
figures present in the report with no
reference to the source or sources of such
information, e.g. volumes of a chemical
produced or imported by the EU (they are
present in all the reports). The same
representative from JRC-ECB explained that,
under the current regulation on existing
chemicals, industry had the obligation to
submit data on the volume produced or imported
of a substance, including amounts in
preparations. There may be additional sources
of information (e.g. on imported articles)
used in the risk assessment. The Committee
asked for some references on the origin of
these figures to be included in the reports.
A Committee member asked about who the author
or authors of the reports were. The answer was
given that the documents presented to the
CSTEE were draft versions of the reports. The
whole information about the origin and process
will be included in the final document (e.g.
member state and ministry or ministries
involved in the preparation, discussion by
competent group of technical experts, and, of
course, the participation of the CSTEE in the
peer review of the draft documents).
A question was raised about the validation of
toxicity data on the reports. The information
was given that such validations were carried
out by the authors of the report, that the
studies were usually done following
standardised guidelines (e.g. OECD or similar)
and where that would not be the case it should
be indicated in the reports.
A representative from JRC-ECB informed the
Committee that the reports on human health
toxicology for Nonylphenol and
Pentabromodiphenyl ether were already finished
and they would be sent to the CSTEE within
about two months, at the latest.
No CSTEE draft opinions were ready for the
time being, regarding the environmental parts
of the risk assessments for both
Octabromodiphenyl ether and Decabromodiphenyl
ether.
The Committee expressed its wish for dealing
with both parts of the reports (i.e. human
health and environmental toxicology) together
rather than with each of them separately.
B. State of play regarding the consultation of
the CSTEE on other substances evaluated under
the ESR.
The CSTEE Secretary informed the Committee
that four additional reports on substances for
peer review by the Committee had been received
and that the documents had already been sent
to all Committee members. The WG Chairman
explained that the Committee expected to
receive during the year 2000 around forty
reports on substances to be peer reviewed.
The proposed strategy to deal with such
reports was to set up four Sub Working Groups
for each of them to tackle a different group
of substances. The suggestion was to
concentrate in particular issues (e.g.
inconsistencies based on structure activity
relationship or physico-chemical properties,
inconsistencies between human and
environmental sections, endocrine disruption,
terrestrial ecosystems, etc.) It was also
proposed that in addition to the working group
efforts, individual CSTEE members with special
expertise in some precise issues should look
at each chemical from that key perspective
(e.g. carcinogenicity). Four categories were
proposed: simple aliphatics, simple aromatics
and heterocyclics, acroleins and phthalates,
and long chain aliphatics and environmentally
persistent chemicals.
The CSTEE was informed about a letter sent by
the CEPAD - Conseil Européen des Phénols
Alkylés et Derivés / European Council for
Alkylphenols and Derivates (a CEFIC sector
group) to the Secretariat and received the day
before the meeting, asking for a delay on the
adoption of the opinion on Nonylphenol. The
Secretary explained that the answer to this
letter was to consider that request
unacceptable. A representative from
Environment DG asked for stating clearly in
the minutes the strongest refusal by the
Committee to these kind of procedures. The
CSTEE agreed with that position. The CSTEE
Secretary pointed out that in the rules of
procedure of the Committee it is clearly
stated that the Committee adopts opinions at
the request of Commission services and
according to terms of references provided by
them. The representative of JRC-ECB confirmed
that discussions within the Ispra technical
meetings on Regulation 793/93 substances had
been quite exhaustive and that industry
representatives had contributed to the
exercise on Nonylphenol.
10. The use of measured exposure data in risk
assessments - progress report
The Chairman of the Working Group informed
about the possible co-operation between the
CSTEE and the European Environment Agency (EEA).
As informed in the 12th plenary meeting of the
CSTEE the EEA was interested in some sort of
co-operation, but the WG Chairman pointed out
that, due to budgetary problems in the Agency,
nothing had been done.
The CSTEE Chairman informed the Committee
about the setting up of a sub-working group
within the Harmonisation Risk Assessment
Working Group of the Scientific Steering
Committee to deal with Exposure Assessment. He
suggested a direct contact between both
Chairpersons, that of the CSTEE WG and that of
the SSC sub-WG.
11. Available scientific approaches to assess
the potential effects and risks of chemical
substances on terrestrial ecosystems -
progress report
The WG Chairman explained that a first draft
should be ready by the end of February 2000
and a WG meeting was expected by that time.
He also informed of a meeting of the ECB in
Vienna held during the previous week on hazard
identification for classification and
labelling. A new meeting on the subject was
scheduled for September, and by then the CSTEE
opinion on terrestrial ecosystems should be
already adopted and published.
The CSTEE was also informed about a workshop
on risk assessment of pesticides under
Directive 91/414/CEE on plant protection
products, regarding the subject of beneficial
arthropods.
The WG Chairman expressed the wish of the WG
to invite someone from the Scientific
Committee on Plants to join the CSTEE working
group. The CSTEE Chairman suggested an
informal contact with the Chairman of the SCP
and afterwards more formal consultations.
12. Strategies for dealing with possible
additional opinion requests submitted by other
DGs of the Commission
The CSTEE Secretary provided the Committee
with information about the issues expected to
be presented to them in the next few months.
Four forthcoming issues were already announced
to the Committee.
Environment DG had announced a list of
priority substances for assessment as
potential endocrine disrupters to be sent to
the Committee for opinion within three months
after the meeting.
A representative from Enterprise DG informed
the Committee of two forthcoming issues. The
first one was a report on Methylene chloride
carried out by the Dutch TNO. This
representative informed about the background
for launching the study, under Directive
76/769. The second report was an assessment on
dyes in textiles, performed by WS Atkins.
With regard to the issue of drinking water the
CSTEE secretariat gave the information about
two possible forthcoming opinion requests: one
on relevant pesticides metabolites in drinking
water and another on construction products in
contact with drinking water.
13. Information related to:
a) The CSTEE opinion on Human and Wildlife
Health Effects of Endocrine Disrupting
Chemicals, with Emphasis on Wildlife and on
Ecotoxicology Test Methods
The printed version of the opinion was
presented. The information was given that five
copies of it had been already sent to each
member of the CSTEE and a copy to all the
Commission officials with an interest on the
subject and some other third parties.
b) Other information related to the subject
"Endocrine disrupters"
A representative from Environment DG
distributed for information a "Communication
from the Commission to the Council and the
European Parliament -Community strategy for
endocrine disrupters- A range of substances
suspected of interfering with the hormone
systems of humans and wildlife".
14. Feedback from the competent services of
the Commission on the follow up to the
opinions adopted previously by the CSTEE
A representative from Enterprise DG gave
information about three upcoming Commission
Proposals for banning the following substances
under Directive 76/769: Phthalates,
Carcinogenic Azo Dyes and Short chained
chlorinated parafins. The first two proposals
were already adopted by the Commission and at
the moment were being discussed within the
Council, the European Parliament and the
Economic and Social Committee. For the third
one she informed that a draft proposal had
been prepared by Enterprise DG and sent for
consultation to other DGs.
The same official informed about two future
issues to be proposed for opinion of the CSTEE.
The first one, about possible substitutes for
Phthalates as plasticisers, was expected to be
presented before the summer break. The second
one on Cadmium would arrive later.
A representative from Environment DG informed
about the follow up of the first four opinions
adopted by the CSTEE on risk assessment
reports produced under Regulation 793/93,
those related to 2-(2-butoxyethoxye)ethanol,
2-(2-methoxyethoxy)ethanol, Alkanes C10-13
chloro, and Benzene C10-13-alkyl derivs. A
Commission Recommendation on the issue had
been adopted on 12 October 1999 (publication
in the Official Journal on 13 November 1999).
The CSTEE Secretary informed the Committee
that unexpected delays were preventing the
finalisation of the outstanding reports needed
to allow the CSTEE to continue its analysis of
part A of the opinion request on the Water
Framework Directive.
15. Update by the CSTEE chairman on the latest
meetings of the Scientific Steering Committee
on matters of interest to the CSTEE
The CSTEE chairman informed the Committee
about the last meeting of the Scientific
Steering Committee where almost the only issue
they dealt with was Bovine Spongiform
Encephalopaty (BSE). Other major issues
treated were the geographical risk assessment,
storage of risk materials and early detection
and new tests to be applied.
He explained that the SSC was trying to
predict future issues to be treated by them
and asked for co-operation of CSTEE members on
that point.
Finally he informed about the SSC working
party on Harmonisation of Risk Assessment. The
WG had been broken up into four sub-WG:
quantitative risk assessment, risk
terminology, the interfaces between risk
assessors and risk managers, and exposure
assessment.
16. Arrangements for the next meeting of the
CSTEE
The CSTEE Secretary reminded the Committee
that the next plenary meeting would be on
10-11 April 2000, with 11 as preferred day for
a single day meeting.
17. Any other business
The Committee expressed its concern about the
future of the toxicology in Europe. A report
on the situation of toxicology in Germany was
presented to the Committee. The Chairman
proposed to set up a working group to take an
initiative in order to identify the key
actions to be taken as a way to stimulate the
Commission to address the issue. One CSTEE
member proposed also a co-operation with the
European section of the International
Epidemiological Association, which was
discussing the same problem.
Some Committee members reminded that
co-operation with Research DG had been
proposed to influence the orientation of
future research programs. A CSTEE member, also
member of an Expert Advisory Group of Research
DG proposed himself to act as an interface
between the two parts. This idea was endorsed
by the CSTEE.
Without any other business the meeting was
closed at 17h 00.
SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY
AND THE ENVIRONMENT (CSTEE), 13th PLENARY
MEETING, 4th of February 2000, 10H00, Centre
A. Borschette, rue Froissart, B-1040 Brussels,
Belgium
- AGENDA -
1. Welcoming address, apologies for absence
and declarations of interest
2. Adoption of the draft agenda
3. Information from the CSTEE secretariat
4. Adoption of the draft minutes of the 12th
CSTEE plenary meeting held on the 25th of
November 1999 in Brussels
5. Schedule of CSTEE plenary meetings for the
year 2000
6. Evaluation of Technical Guidance Document
in support of Directive 98/8/EC concerning the
placing of biocidal products on the market -
for opinion
7. Man Made Mineral Fibres
8. Lead - Danish notification 595/98/DK - for
opinion
9. Regulation 793/93 on Existing substances (ESR):
A. Progress reports/opinions on:
SUBSTANCE |
CAS RN |
Nonylphenol
straight and
branched chain |
84852-15-3,
25154-52-3 |
Pentabromodiphenyl
ether |
32534-81-9 |
Octabromodiphenyl ether |
32536-52-0 |
Decabromodiphenyl ether |
1163-19-5 |
B. State of play regarding the consultation of
the CSTEE on other substances evaluated under
the ESR.
10. The use of measured exposure data in risk
assessments - progress report
11. Available scientific approaches to assess
the potential effects and risks of chemical
substances on terrestrial ecosystems -
progress report
12. Strategies for dealing with possible
additional opinion requests submitted by other
DGs of the Commission
13. Information related to:
a) The CSTEE opinion on Human and Wildlife
Health Effects of Endocrine Disrupting
Chemicals, with Emphasis on Wildlife and on
Ecotoxicology Test Methods
b) Other information related to the subject
"Endocrine disrupters"
14. Feedback from the competent services of
the Commission on the follow up to the
opinions adopted previously by the CSTEE
15. Update by the CSTEE chairman on the latest
meetings of the Scientific Steering Committee
on matters of interest to the CSTEE
16. Arrangements for the next meeting of the
CSTEE
17. Any other business
SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY
AND THE ENVIRONMENT (CSTEE), 13th PLENARY
MEETING, 4th of February 2000, 10H00, Centre
A. Borschette, rue Froissart, B-1040 Brussels,
Belgium
LIST OF PARTICIPANTS
CSTEE:
Prof. James W. BRIDGES, Dr. Mark J. COSTELLO,
Prof. Erik DYBING, Prof. Helmut A. GREIM,
Prof. Bo O. JANSSON, Prof. Soterios A.
KYRTOPOULOS, Prof. Ole LADEFOGED, Prof. Dr.
José RUEFF, Prof. Mirja S. SALKINOJA-SALONEN,
Dr. José V. TARAZONA, Prof. Benedetto
TERRACINI, Prof. Janneche UTNE-SKÅRE, Prof.
Katarina VICTORIN, Prof. Marco VIGHI, Prof.
Dr. Robert WENNIG.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE,
Mrs. Mercedes de SOLÀ.
ENTERPRISE DG:
Mrs. Lena PERENIUS.
ENVIRONMENT DG:
Mr. Walter CORTELLINI, Mr. Lars FOCK, Mr. Paul
HAYES, Mrs. Birgit van TONGELEN.
JOINT RESEARCH CENTRE:
Mrs. Sharon MUNN