1. Welcoming address, apologies for
absence and declarations of interest
The CSTEE chairman welcomed the attendants to
this last plenary meeting of the committee
before its renewal. All the committee members
were present.
Doctor José Tarazona renewed his declaration
of involvement in the elaboration of the Risk
Assessment Report (RAR) on Acetonitrile
(Regulation 793/93 on existing substances) on
behalf of the Spanish authorities (Spain was
the rapporteur MS for this substance). He had
already made a declaration on such an
involvement at the occasion of the 18th
plenary meeting of the CSTEE. The RAR on
Acetonitrile was scheduled to be discussed
under point 5A of the agenda. He, therefore,
declined to take part in the discussions.
2. Adoption of the draft agenda
The agenda was adopted with no changes.
3. Adoption of the draft minutes of the
18th CSTEE plenary meeting held on the 9th of
October 2000 in Brussels
Some minor comments, mainly editorial, were
made to the draft minutes previously
distributed to the meeting participants. The
minutes thus corrected were adopted by the
committee.
4. Available scientific approaches to
assess the potential effects and risks of
chemical substances on terrestrial ecosystems
- for opinion
The WG chairman presented the final draft
opinion on the issue, which had been
distributed to the Committee members prior to
the plenary meeting. He also informed that
finally no chapters would be included on the
risk assessment for areas of high ecological
value and on the risk assessment and
management of environmental catastrophes. Some
recommendations would be made, in any case, on
these two issues.
The CSTEE secretary commented on suggestions
received by the secretariat from third parties
asking for the publication of the draft
opinion in Internet to get comments on it
before its adoption by the committee. Such an
option was not considered adequate by the
CSTEE, specially bearing in mind the urgency
of its adoption before the renewal of the
committee and therefore during this 19th
plenary meeting. The WG chairman reminded the
CSTEE that the group revising the Technical
Guidance Document in support of Regulation
793/93 on existing chemicals was waiting for
the document to be adopted as soon as
possible. He reminded also that it would be
published on Internet after its adoption
following the usual procedure. He therefore
considered that any comment or remark on it
could be included in a possible future
revision of the opinion by the new CSTEE.
The CSTEE secretary informed that he had
requested the publication of the opinion by
the Publications Office of the Commission.
That would facilitate a better distribution
and use of the document within the scientific
community. Both the CSTEE and the WG chairmen
considered it useful to select certain parts
of the document to be sent for publication in
peer reviewed scientific journals as had been
previously done with the CSTEE opinion on
Human and Wildlife Health Effects of Endocrine
Disrupting Chemicals, with Emphasis on
Wildlife and on Ecotoxicology Test Methods.
The committee chairman asked about the
possible follow up of hypothetical
recommendations of the CSTEE for further
research in this area. Two ways of action were
seemingly possible, i.e. JRC or DG SANCO to
send proposals to DG RESEARCH. The CSTEE
secretariat informed that a procedure exists
whereby DG RESEARCH requests from other
Commission services opinions on what research
to foster. The CSTEE secretariat also
suggested three actions to be taken: (i) state
in the minutes this need, (ii) inform the
Scientific Steering Committee of it and (iii)
an official note to be sent by the Director in
SANCO's Directorate C proposing further
research in the area. The Head of Unit in
SANCO C-2 expressed her satisfaction and
congratulated both the committee and the
working party for the excellent work they had
made. She also proposed to release a press
note on the issue as soon as the opinion would
be ready for publication. The WG chairman
accepted the responsibility of drafting such a
note.
Some CSTEE members commented on different
sections of the document, among them on the
use of expressions like teratogenicity,
genotoxicity and carcinogenicity, as well as
on the endpoints to be considered. Another
committee member provided the WG chairman with
a paper copy of the opinion including some
comments on it. The WG chairman promised to
consider attentively all of them.
The CSTEE chairman asked both the WG chairman
and the CSTEE secretary about a possible
deadline for having the opinion ready for
publication on the Internet. Bearing in mind
the considerable size of the document,
implying the need for quite a big number of
editorial corrections, both considered the end
of the year to be a reasonable date to aim
for.
The opinion was unanimously adopted by the
CSTEE, subject to the above mentioned
editorial corrections.
5. Regulation 793/93 on Existing substances
(ESR):
A. Status reports/opinions (Human health &
Environment) on:
a) 1,4 Dioxane
The rapporteur for this substance presented
the draft opinion. Some CSTEE members
commented on the point of the classification
of the chemical as a carcinogen Cat 3 in the
EU legislation and in the group 2B by the IARC
(International Agency for Research on Cancer).
One of the concerns was the possible
misinterpretation of the CSTEE opinion as
criticising the IARC classification. Some
sentences were reworded to better reflect
those comments.
Another CSTEE member requested a correction in
a sentence on the ready biodegradability of
the compound. The proposal was to substitute
the expression "1,4-Dioxane seems not to be
readily biodegradable" by the stronger one
"1,4-Dioxane is not readily biodegradable".
The correction was accepted.
Subject to those minor changes the opinion was
unanimously adopted.
b) 1,4 Dichlorobenzene
The draft opinion on this substance presented
at the 18th plenary meeting had been revised
and the rapporteur explained the changes.
Some concern was expressed about the issue of
the biodegradability of the compound, already
raised at the occasion of the 18th CSTEE
plenary. A CSTEE member explained that the
conclusions on the issue of the literature
mentioned in the RAR was exactly the opposite
of the one expressed in it.
The committee decided to delete a sentence on
the situation of the chemical in Sweden,
considering it inadequate.
With some other minor editorial changes the
opinion was adopted.
c) 4-Chloro-2-Methylphenol
The rapporteur presented the revised draft
opinion and it was approved by the Committee.
d) Acetonitrile
A first version of a draft opinion was
presented and discussed.
e) Methacrylic acid
A first version of a draft opinion was
presented and discussed.
f) Acrylonitrile
The appointed rapporteur for the RAR on this
substance briefly presented it. It was
considered a very good report. A discussion
was deemed necessary on the NOAEL and on
carcinogenicity. He also demanded some
information on the ecotoxicology part. The
CSTEE secretary reminded the committee about
the members appointed as "progress chasers"
for particular endpoints in the peer review of
RAR under regulation 793/93
g) Anisidine
No draft text was available at the time of the
meeting for discussion and this was postponed.
B. State of play regarding other substances
evaluated under the ESR
The CSTEE secretariat informed the Committee
that a fourth priority list had recently been
adopted by the Commission. Copies of it in the
Official Journal of the EU were made available
as room documents.
6. The use of exposure data in risk
assessments - progress report
The chairman of the Working Group presented a
draft on the subject and explained that in
principle it should be ready for adoption by
the CSTEE by the end of the year provided
input from CSTEE members would be sent by mid
December. The CSTEE chairman pointed out the
obvious relations between this CSTEE opinion
and the document on Harmonisation of Risk
Assessment already adopted by the Scientific
Steering Committee. A CSTEE member asked the
WG chairman about the issue of food as an
exposure source, especially in the case of
fisheries, shellfisheries, etc. The reply was
that this issue was being kept out of the
document because food related issues are in
principle the province of the Scientific
Committee for Food.
7. Proposed EU Water Framework Directive -
Development of a specification for the
intercalibration of biological monitoring
methods - Final Draft (European Commission
Directorate General XI), Report No: CO 4751/1
- October 1999 - progress report/for opinion
The CSTEE secretary informed the Committee
that regarding the WG meeting scheduled for
the 29 November 2000, due to the unexpected
unavailability of most of the members, it had
to be postponed. Considering the difficulties
and the absence of an urgent deadline from the
requesting Commission service, the WG chairman
proposed to leave the final decision to be
made on this point to the new CSTEE, whose
first meeting was scheduled for 5 December
2000. The Committee accepted the suggestion.
8. Margins of safety - progress report
A meeting of the working party had taken place
the very same morning of the plenary, from
8h00 to 10h00, and the WG chairperson
presented its outcome.
A table had been prepared that included all
the opinions previously adopted by the CSTEE
on the RARs of substances evaluated under
Regulation 793/93. The table allowed for the
conclusion that some inconsistencies existed
in the approaches followed by the CSTEE for
each chemical. While recognising that RARs
have to be dealt with on a case by case basis,
the CSTEE chairman insisted in the need of,
were possible, being consistent in future
Committee opinions.
It was decided to prepare a document on the
acceptance of a margin of safety of 100 as a
general rule, and on whether under what
conditions it can be reduced or increased.
9. Evaluation of sludge treatments for
pathogen reduction - progress report
Given that apparently there was no special
urgency to adopt this opinion, the CSTEE
decided to postpone any decision on it until
the first meeting of the Committee with its
new members, on 5 December 2000.
10. Strategies for dealing with possible
additional opinion requests submitted by other
DGs of the Commission
A representative from the European Chemicals
Bureau (ECB) informed that at least two more
RARs on substances evaluated under Regulation
793/93 were about to be sent to the Committee
for peer review.
The CSTEE secretary informed that the
Committee would shortly receive from
Environment DG the terms of reference for a
new opinion request on 'Nickel, Cadmium,
Arsenic and PAHs in ambient air'.
11. Feedback from the relevant services of
the Commission on the follow up to the
opinions adopted previously by the CSTEE
The Committee asked the Environment DG
representative about the strategy for future
EU Chemicals Policy currently being developed
by the Commission. He informed the Committee
about the current draft timetable, the main
milestone being the adoption of the White
Paper by the Commission by the end of the
year. However, due to the complexity of the
subject matter under discussion there was a
strong possibility of delays. The role of the
CSTEE in respect of any future legislation on
chemicals had been considered and was assured,
although the precise detail would depend on
the outcome of the strategy.
A CSTEE member asked about the revision of
Regulation 793/93. The CSTEE secretary
informed that changes with a view to
simplifying procedures are still being
discussed between Commission services and
Member States.
Some CSTEE members had requested access to the
original reference documents mentioned in the
RARs peer reviewed by the Committee. A
representative from the ECB considered that
the best way to deal with that issue should be
by means of a direct contact between the
chairman of the respective WG and herself.
The CSTEE secretary presented the conclusions
of a meeting that had taken place in Ispra the
30 October 2000 on the validation of migration
test methods for phthalates. It became
apparent that the whole validation exercise
was already delayed by about one month. The
tests with sample discs would start
immediately and continue during November and
December, until the Christmas break. Only in
January would the tests with actual toys
start, with samples already distributed to the
participant laboratories. The results of the
validation will be submitted for evaluation to
the CSTEE.
The Committee secretary also informed about a
Commission's inter-service meeting on EDCs
which had taken place the day before the
plenary. ON the other hand the chairman of the
working party dealing with that issue within
the CSTEE provided the Committee with
information on a meeting that had taken place
in 10-12 October 2000, where some interesting
question had been discussed, such as low-dose
EDCs and the question of new test
methodologies being developed by the OECD.
12. Update by the CSTEE chairman on the
latest meetings of the Scientific Steering
Committee on matters of interest to the CSTEE
The CSTEE chairman updated the Committee on
the latest meeting of the SSC. Apart from the
issue of BSE two more points had been
considered of interest to the Committee. The
first one being the document on Emerging
Issues already adopted. He asked all CSTEE
members to read those sections of special
interest for each one and comment on them.
The second document adopted by the SSC was the
one on Harmonisation of Risk Assessment. It is
the first one of a series on this subject and
the CSTEE chairman encouraged Committee
members to comment on it.
13. Arrangements for the next (20th)
meeting of the CSTEE (5th of December 2000).
The CSTEE secretary informed that in principle
the meeting scheduled for the 5 December 2000
should take place in the usual venue: the CCAB.
He also informed briefly about the state of
the renewal process. The final Commission
Decision should be taken by the last week of
November and therefore there should be no
problems in organising the meeting at the
scheduled date.
14. Any other business
One committee member raised the point
(supported in general by the Committee) of the
workload and time pressures that the CSTEE
members were suffering to produce opinions,
which too often have demanded brinkmanship. He
was also concerned about the manner of
reimbursement for attendance at meetings,
meaning that minimal time can be devoted to
CSTEE work by committee members unless
somebody else is paying for such time (i.e.
their employer). From his point of view this
could compromise their independence since they
are accountable to the respective employers
(e.g. universities and institutes that receive
funding from industry, and government agencies
that may support a particular national stance
on an issue). He pointed out the inconsistency
of the amount of reimbursement to CSTEE
members being less than what is paid to the
ones co-operating with Research DG, while the
CSTEE has more highly qualified experts.
DRAFT AGENDA -
1. Welcoming address, apologies for absence
and declarations of interest
2. Adoption of the draft agenda
3. Adoption of the draft minutes of the 18th
CSTEE plenary meeting held on the 9th of
October 2000 in Brussels
4. Available scientific approaches to assess
the potential effects and risks of chemical
substances on terrestrial ecosystems - for
opinion
5. Regulation 793/93 on Existing substances (ESR):
A. Status reports/opinions (Human health &
Environment) on:
a) 1,4 Dioxane
b) 1,4 Dichlorobenzene
c) 4-Chloro-2-Methylphenol
d) Acetonitrile
e) Methacrylic acid
f) Acrylonitrile
g) Anisidine
B. State of play regarding other substances
evaluated under the ESR
6. The use of exposure data in risk
assessments - progress report
7. Proposed EU Water Framework Directive -
Development of a specification for the
intercalibration of biological monitoring
methods - Final Draft (European Commission
Directorate General XI), Report No: CO 4751/1
- October 1999 - progress report/for opinion
8. Margins of safety - progress report
9. Evaluation of sludge treatments for
pathogen reduction - progress report
10. Strategies for dealing with possible
additional opinion requests submitted by other
DGs of the Commission
11. Feedback from the relevant services of the
Commission on the follow up to the opinions
adopted previously by the CSTEE
12. Update by the CSTEE chairman on the latest
meetings of the Scientific Steering Committee
on matters of interest to the CSTEE
13. Arrangements for the next (20th) meeting
of the CSTEE (5th of December 2000); note:
this will be the first meeting of the CSTEE
following appointment of CSTEE members after
completion of the selection process in
conformity with provisions of call for
expression of interest to be a member of a
scientific committee (OJ series C, 2000/C,
142/17 of 20.5.2000, p. 46).
14. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James BRIDGES, Prof. Peter CALOW, Dr.
Mark J. COSTELLO, Prof. Erik DYBING, Prof.
Helmut A. GREIM, Prof. Bo O. JANSSON, Prof.
Soterios A. KYRTOKOPOULOS, Dr. Ole LADEFOGED,
Dr. Claude LAMBRÉ, Dr. José RUEFF, Prof. Mirja
S. SALKINOJA-SALONEN, Dr. José V. TARAZONA,
Prof. Benedetto TERRACINI, Prof. Janneche
UTNE-SKÅRE, Prof. Katarina VICTORIN, Prof. M.
VIGHI, Prof. Joseph G. VOS, Prof. Robert
WENNIG.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mrs. Silvia BERNAL-BLANCO, Mr. Jorge
COSTA-DAVID, Mr. Juan B. CRESPO ARCE, Mrs.
Mercedes de SOLÀ.
ENVIRONMENT DG:
Mr. Paul HAYES.
JOINT RESEARCH CENTRE:
Mrs. Sharon MUNN.