1. Welcoming address, apologies for
absence and declarations of interest
Due to the late arrival of the Chairman of the
CSTEE, it was the first Vice Chairman who
opened the session and chaired it during first
30 minutes (while discussing points 1 to 3 of
the Agenda).
Professor Peter Calow, new member of the CSTEE
was introduced to the Committee.
Apologies were received from Prof. Wennig.
Dr Tarazona expressed a declaration of
interest on the point of Cumene (substance
evaluated under the Existing Substances
Regulation 793/93/EC). He explained that he
participated in the preparation of the Risk
Assessment Report on behalf of the Spanish
authorities (Spain was the rapporteur Member
State for this substance) and took no further
part in the discussion.
2. Adoption of the draft agenda
The draft agenda was adopted, with the
agreement of the CSTEE that point 8 would be
the first one to be discussed in the
afternoon.
3. Adoption of the draft minutes of the
12th and 13th CSTEE plenary meetings held
respectively on the 25th of November 1999 and
on the 4th of February 2000 in Brussels
The minutes of the 12th and 13th plenary
meetings of the CSTEE were adopted.
4. Change in the schedule of CSTEE plenary
meetings for the year 2000
Due to the impossibility for adopting some
important opinions during the meeting, an
additional extraordinary one was decided for 5
May 2000.
The plenary meeting of November 2000 was
rescheduled for the 8-9 November 2000 with the
8 as the preferred date in case of a one-day
meeting. The preferred dates for the June and
September plenary meetings were changed to be
20 June and 5 September respectively.
5. Presentation by representatives of the
Rijkinstituut voor Volksgezondheid en Milieu (RIVM),
Nederland, of their ongoing research project
relating to the development and validation of
a test method for the identification of
endocrine disrupting chemicals
Representatives from RIVM made a presentation
which was followed by a detailed discussion.
An important element of the RIVM project was
agreed by members to be the fish atlas,
designed to offer material for the normal
histology and toxicological pathology with
emphasis on effects of endocrine disruption.
It expected to find application in the
screening for ecotoxicity. One CSTEE member
expressed some concern about the importance
given to histology in the study with
insufficient evidence given to the relation
between histological change and reproductive
effects;. A question was also raised about the
possibility of testing the relation between
laboratory and ecosystem behaviour by choosing
a species which could be examined in both
situations. Committee members were assured
that the atlas will be developed further as
and when new data becomes available. The
project is on course to deliver on time (in
which the OECD seems to be very interested).
6. Lead - Danish notification 595/98/DK -
for opinion
The draft was extensively discussed. Many
CSTEE members commented on different points of
the draft opinion. Because of the nature of
some of these comments (which strictly could
not be considered only editorial) it was
decided that the CSTEE members with
reservations should send them to the WG
chairman, to the editor of the opinion, and to
the CSTEE secretariat. Under these
circumstances the opinion could not, at that
stage, be considered finally adopted. Since an
extraordinary plenary meeting was already
scheduled for 5 May this was considered a good
opportunity to sort out the few areas of
concern and to adopt the opinion then.
7. Regulation 793/93 on Existing substances
(ESR):
Prior to the discussion on the actual drafts,
the CSTEE chairman initiated a discussion on
where it was felt that the CSTEE could best
contribute to the proposed general strategy to
deal with each report, and the necessity of
harmonising the style of presentation of the
opinions.
The CSTEE Secretary informed the Committee
about a meeting, held the week before the
plenary, between Health and Consumer
Protection DG and Environment DG to discuss
the possibility of submitting to the CSTEE the
so called "informal consultations" on the
reports while they are still under discussion
in the technical meetings in the JRC-ECB,
prior, therefore, to their final stage. He
explained the advantages and problems of this
approach and some CSTEE members expressed
their views on this.
A representative from Environment DG gave a
general view of what would be the follow up of
the opinions expressed by CSTEE. They would be
submitted to the JRC to be considered for
revision of the Risk Assessment Reports in the
Technical Meetings. They would be considered,
as well, in any Risk Reduction Strategy to be
adopted in the future. Finally he asked the
Committee for any comments on methodology, in
the framework of the previous mentioned
informal consultation, and to point out any
particular question that should be taken into
account by Commission Services.
Some CSTEE members asked about the
acknowledgement given to the advice provided
by the Committee, whether it was accepted by
the Commission Services involved or not. From
their point of view that would show clearly
the transparency and independence of the
Committees.
A. Progress reports/opinions on:
- Hydrogen Fluoride
- Dimethyl sulphate
- 4'4-Methylenedianiline
- Cumene
- Acrolein
The drafts were presented and discussed. As
was the case with point 6 of the Agenda, here
too, reservations of various sorts prevented
the CSTEE from the final adoption of these
opinions. The adoptions were postponed until
the extraordinary Plenary Meeting of 5 May.
The question was raised on the acceptability
or not of the use of certain uncertainty
factors in the Margins of Safety (MOS) to
compensate gaps in the database. Some of the
CSTEE members expressed their concern about
that, especially due to the danger of
accepting that as a consequence there will be
no necessity to fill in these gaps. A
representative of JRC-ECB explained that the
same concerns were already expressed in their
technical meetings, and asked the Committee
for suggestions on possible alternatives to
the use of these uncertainty factors.
Regarding the report on Hydrogen Fluoride, one
CSTEE member considered that the question of
marine effects was not adequately addressed in
the report. He was invited to draft a text on
that, in the context that this is a general
issue affecting many chemicals and not only
this particular one.
During the discussion of the report on
Dimethyl sulphate a concern was expressed
among CSTEE members on the meaning of the term
"worst case scenario", used sometimes even
when there are not enough data to define it. A
further written explanation on this important
issue was deemed necessary.
B. State of play regarding the consultation
of the CSTEE on other substances evaluated
under the ESR:
Consultation of the CSTEE on the human health
effects report of:
- Pentabromodiphenyl ether.
DG Environment confirmed that they can wait
till the June plenary for the adoption of the
human effects part of this Report (the CSTEE
had already adopted the opinion on the
environmental part).
Consultation of the CSTEE on the environmental
effects report of:
- Octabromodiphenyl ether
- Decabromodiphenyl ether
These two were also not considered urgent by
Environment DG (the Commission service
responsible for them), and they were postponed
for adoption to the June meeting,.
8. Consultation of the CSTEE on the
following reports on Methylene chloride and
certain Chemicals in Textiles" submitted by DG
Enterprise:
A - "Methylene chloride: Advantages and
Drawbacks of Possible Market Restrictions in
the EU" - TNO (Dr. Tukker & Ir. L.Ph. Simons -
NL) report STB-99-53 Final - November 1999 (CSTEE/2000/5
- Add. 1).
B - "Assessment of the Risks to Human Health
Posed by Certain Chemicals in Textiles and of
the Advantages and Drawbacks of Restrictions
on their Marketing and Use" - Final Report -
July 1999 - WS Atkins International Ltd (UK) -
(CSTEE/2000/5 - Add. 2).
A draft opinion was presented. The rapporteur
explained that one of the major problems found
in the report was that the chemicals were
referred to only by the name of the Colour
Index, not by the formula or Chemical Abstract
Service number (CAS Number). The report limits
its references to two aspects: sensitisation
and carcinogenicity. Some weaknesses of the
report were pointed out on both aspects.
Regarding the occupational and consumer
exposure, the document only deals with dermal
exposure. From the point of view of the
rapporteur at least oral exposure should have
been considered for consumers, because of the
possibility of children being exposed to very
high doses of dyes through chewing and sucking
textiles. It was also pointed out that there
was a lack of toxicity information for many of
the dyes.
A representative from Enterprise DG was
requested to explain the background of the
reports both on dyes and on Methylene
chloride.
It was considered very important to identify
the structure of each of the chemicals under
consideration (azo dyes and anthraquinone
dyes), in order to look at their structure
activity relationship. Therefore, before the
opinion could be considered ready for adoption
at least a meeting of the working party was
deemed necessary. Enterprise DG, the
responsible service for that dossier, accepted
the delay in adoption to probably the June
Plenary meeting.
9. Scientific experts in Toxicology,
Ecotoxicology and Epidemiology for risk
assessments - planning for the future
Prof. Bridges presented a draft document
prepared by him and Profs. Greim and Dybing.
Attention is drawn in this document to the
gradually loss of high level expertise in
those disciplines in Europe. The proposal was
agreed that CSTEE, as the Scientific Committee
with the greatest involvement in each of these
areas would develop the document as an Opinion
to be submitted to the Commission. A working
group was set up to further refine the draft.
10. The use of measured exposure data in
risk assessments - progress report
No time was available to discuss this in
depth. The chairman of the working group had
prepared a draft table of contents for the
report to be adopted by the CSTEE. A meeting
of the working group would take place soon.
11. Available scientific approaches to
assess the potential effects and risks of
chemical substances on terrestrial ecosystems
- progress report
A new draft text was available but a new
working group meeting was expected to take
place on 8 May for making progress.
12. Strategies for dealing with possible
additional opinion requests submitted by other
DGs of the Commission
a) "Programme of procedures for the assessment
of risks to health and the environment from
cadmium in fertilisers"
The setting up of a WG was decided to tackle
this opinion request. A WG meeting was deemed
necessary and, therefore, would be soon
organised.
b) Other
The CSTEE secretariat informed the committee
about the upcoming consultation on Endocrine
Disrupting Chemicals (priority list of
substances that are suspected of having ED
properties). The submission would take place
in June and the opinion would be necessary for
the October 2000 plenary at the latest.
13. Feedback from the relevant services of
the Commission on the follow up to the
opinions adopted previously by the CSTEE
The CSTEE secretary informed the committee
about a meeting that took place the week
before in Ispra on the development/validation
of a test method for determining phthalate
migration. The meeting was a difficult one in
the sense that participants agreed that the
technical difficulties of such an exercise are
significant. The ECB will produce a report
soon. In principle the CSTEE will be asked an
opinion on some methodological aspects on
which clarification is still needed before the
further development of the method itself is
pursued.
14. Update by the CSTEE chairman on the
latest meetings of the Scientific Steering
Committee on matters of interest to the CSTEE
No feed back was possible on this for lack of
time.
15. Arrangements for the next meeting of
the CSTEE
The decision was taken to have an
extraordinary meeting on 5 May 2000,
essentially to solve the problem of the
outstanding adoption of the opinions on
substances under the Existing Substances
Regulation 793/93/EC, but other outstanding
agenda items could be sorted out as well
during that meeting.
16. Any other business
The chairman of the working group on
phthalates presented his conclusions on very
recent data on the change in the
classification of DEHP for carcinogenic
effects. A possible future change in the MOS
(Margin Of Safety) of 100 for DEHP (may have
to take place because once data is available
it no longer makes sense to establish
arbitrary uncertainty factors such as the one
of 100 chosen for DEHP); this may lead to a
change in the level of concern for this
chemical.
- 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 12th
and 13th CSTEE plenary meetings held
respectively on the 25th of November 1999 and
on the 4th of February 2000 in Brussels
4. Change in the schedule of CSTEE plenary
meetings for the year 2000
5. Presentation by representatives of the
Rijkinstituut voor Volksgezondheid en Milieu (RIVM),
Nederland, of their ongoing research project
relating to the development and validation of
a test method for the identification of
endocrine disrupting chemicals
6. Lead - Danish notification 595/98/DK - for
opinion
7. Regulation 793/93 on Existing substances (ESR):
A. Progress reports/opinions on:
- Hydrogen Fluoride
- Dimethyl sulphate
- 4'4-Methylenedianiline
- Cumene
- Acrolein
B. State of play regarding the consultation of
the CSTEE on other substances evaluated under
the ESR:
Consultation of the CSTEE on the human health
effects report of:
- Pentabromodiphenyl ether.
Consultation of the CSTEE on the environmental
effects report of:
- Octabromodiphenyl ether
- Decabromodiphenyl ether
8. Consultation of the CSTEE on the following
reports on Methylene chloride and certain
Chemicals in Textiles" submitted by DG
Enterprise:
A - "Methylene chloride: Advantages and
Drawbacks of Possible Market Restrictions in
the EU" - TNO (Dr. Tukker & Ir. L.Ph. Simons -
NL) report STB-99-53 Final - November 1999 (CSTEE/2000/5
- Add. 1).
B - "Assessment of the Risks to Human Health
Posed by Certain Chemicals in Textiles and of
the Advantages and Drawbacks of Restrictions
on their Marketing and Use" - Final Report -
July 1999 - WS Atkins International Ltd (UK) -
(CSTEE/2000/5 - Add. 2).
9. The use of measured exposure data in risk
assessments - progress report
10. Available scientific approaches to assess
the potential effects and risks of chemical
substances on terrestrial ecosystems -
progress report
11. Strategies for dealing with possible
additional opinion requests submitted by other
DGs of the Commission
12. Feedback from the relevant services of the
Commission on the follow up to the opinions
adopted previously by the CSTEE
13. Update by the CSTEE chairman on the latest
meetings of the Scientific Steering Committee
on matters of interest to the CSTEE
14. Arrangements for the next meeting of the
CSTEE
15. Any other business
LIST OF PARTICIPANTS
CSTEE:
Prof. James W. BRIDGES, Prof. Peter Calow, Dr.
Mark J. COSTELLO, Prof. Erik DYBING, Prof.
Helmut A. GREIM, Prof. Bo O. JANSSON, Prof.
Soterios A. KYRTOPOULOS, Prof. Ole LADEFOGED,
Dr. Claude Lambré, 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.
Ad-Hoc Experts:
Dr. Peter WESTER, Dr. van de VEN.
European Commission:
HEALTH AND CONSUMER PROTECTION DG:
Mr. Jorge COSTA-DAVID, Mr. Juan B. CRESPO ARCE,
Mr. Panagiotis DASKALEROS, Mrs. Mercedes de
SOLÀ.
ENTERPRISE DG:
Mr. Joachim EHRENBERG, Mr. Vincenzo GENTE,
Mrs. Lena PERENIUS.
ENVIRONMENT DG:
Mr. Peter DREW, Mr. Paul HAYES, Mr. Alexandre
PAQUOT, Mrs. Birgit van TONGELEN.
RESEARCH DG:
Mrs. Kirsi HAAVISTO.
JOINT RESEARCH CENTRE:
Mrs. Sharon MUNN