Health
Scientific Committees
Scientific Committee on Food
Outcome of discussions
Minutes of the
122
nd meeting of the Scientific Committee on Food
held on 6/7 September 2000 in Brussels
ATTENDANCE LIST - LISTE DES
PARTICIPANTS - TEILNEHMERLISTE
Members/Membres/Mitglieder
Mme. S. BARLOW, MM. A. CARERE, D.
BOSKOU, I. ELMADFA (2
nd Vice-Chairman, Vice-President, Stellv.
Vorsitzender), Mme. A. FERRO-LUZZI, MM. A. FLYNN, R. FRIES,
W. GRUNOW, Mme. A. KNAAP (1
st Vice-Chairman, Vice-President, Stellv.
Vorsitzende), MM. I. KNUDSEN (Chairman, President,
Vorsitzender), B. MOSELEY, K-H. NAU (present on 6 September
only), A. PALOU, P. TOBBACK, P. Verger, J.-M. WAL, R.
WALKER
Experts
Mr. J. ALEXANDER (item 8)
Apologies for absences:
S. LINDGREN, W. SARIS
Commission/Kommission
Mrs H. Hoffmann (DG Health &
Consumer Protection), Mr. A. KLEPSCH (DG Health &
Consumer Protection), Mr. K MADSEN (DG Health &
Consumer Protection), Mrs K. Neubauer (DG Health &
Consumer Protection), Mr. L. ROSSI (DG Health &
Consumer Protection), Mr. B. MATHIOUDAKIS (DG Health &
Consumer Protection)
Secretariat/Secrétariat/Sekretariat
(DG Health & Consumer Protection)
Mr M. A. GRANERO ROSELL, Mr D. PETTAUER,
Mrs E. AGRO
1. Apologies for absence
The apologies for absence were
noted.
2. Adoption of the agenda
The draft agenda was adopted.
3. Declarations of interest
There were no interests declared.
4. Adoption of the minutes of the 121
st meeting
The draft minutes of the previous
plenary session, the 121
st meeting held on 20/21/22 June 2000 were
examined and agreed after a number of minor changes were
introduced.
5. Matters arising since last Plenary
5.1. Update of the opinion on crystalline beta
carotene from
Blakeslea trispora
The Committee had been made aware about
a lack of clarity regarding the strains of
Blakeslea trispora mentioned in the opinion on beta
carotene produced from this microorganism in the opinion
adopted by the Committee at the previous plenary session
(SCF/CS/ADD/COL/158 Final). The Working Group on
Microbiology and Hygiene had considered the matter and
recommended to correct the opinion accordingly. The
Committee agreed to this suggestion. The corrected opinion
appears as Annex I to these minutes and replaces the text
of the opinion as adopted at the previous plenary.
6. New requests of opinions
Consideration of a submission from the Italian
Authorities raising concerns for the safety of certain
products approved under the notification procedure of
Regulation (EC) No 258/97 on novel foods and novel food
ingredients
The Committee received an urgent request
from the Commission regarding the evaluation of the
scientific grounds provided by the Italian authorities when
adopting national legislation suspending the marketing of
certain novel foods and to invoke the safeguard clause laid
down in the Regulation on Novel Foods.
7. Novel Foods
7.1 Draft opinion on a request to consider a
submission from the Italian Authorities raising concerns
for the safety of certain products approved under the
notification procedure of Regulation (EC) 258/97 on novel
foods and novel food ingredients
The Committee was asked whether
information submitted by the Italian authorities provide
grounds, detailed or otherwise, for considering that the
use of the novel foods in question endangers public health.
This question was brought to the Committee as a matter of
urgency.
The documentation received by the
Commission consisted of opinions issued by the Italian
Health Council and the Italian Health Institute relating to
potential health effects of certain genetically modified
food products. These include products derived from four
maize lines and three rapeseed lines which had been
notified for placing on the market under the Novel Food
Regulation. These products had been evaluated previously
for their safety by the UK Advisory Committee on Novel
Foods and Processes. The Committee noted that both these
previous evaluations and the opinion of the Italian Health
Institute concluded that these products were safe for human
consumption. In its considerations the Committee needed to
clarify whether it was required to perform a full safety
evaluation of the products in question. It acknowledged
that the mandate was restricted to the consideration of the
scientific information submitted by the Italian
authorities. After a detailed discussion the Committee
adopted the opinion attached as Annex II to these
minutes.
7.2 Draft opinion regarding a request in relation to
the evaluation of toxicological information related to
the safety assessment of genetically modified
tomatoes
The Committee had discussed this issue
at the last plenary and had decided to refer the text
drafted ad hoc to the Working Group on Novel Foods for
revision. The new draft version was discussed and adopted
after introduction of further amendments.
The full text of this opinion appears as
Annex III to these minutes.
7.3 Draft opinion on bacterial dextrans
The rapporteur introduced the draft
prepared by the Working Group on Novel Foods. During the
discussion it became apparent that there were a number of
issues that required further explanation and clarification,
as well as a number of editorial and presentation
changes.
It was decided to continue the
discussion at the next meeting on the basis of a revised
draft.
8. Upper levels for vitamins and minerals. Progress
report
8.1. Discussion on an upper level for selenium
8.2. Discussion on an upper level for manganese
8.3. discussion on an upper level on beta carotene
The Committee examined the drafts
prepared by the rapporteurs and discussed thoroughly by the
Task Force. Members expressed satisfaction about the
progress in this area. As regards the discussion on
selenium it was decided that a number of sections should be
made more clear, as well as the reasoning for deriving
upper levels. In the case of the report on manganese there
was an overall agreement on it subject to a number of small
changes. As regards the paper on the upper level on beta
carotene, the Committee decided to look first on the
general paper on beta carotene from all dietary sources
(see below). The draft on upper level for beta carotene
required some further changes that were highlighted during
the discussions.
As a conclusion, the Committee decided
to reserve the adoption of all the papers on upper levels
for the different nutrients that were sufficiently
discussed at the level of the Task Force at the next
meeting to ensure overall consistency and homogeneous
approach and presentation among all the nutrients
evaluated.
9. Beta carotene
Discussion on beta carotene from all dietary
sources
The Committee had had at the previous
meeting a thorough discussion on the issue already.
Following the discussions the remaining issues had been
addressed by the rapporteur at the different Working
Groups. It was considered that the new draft reflected
these points adequately. Following this discussion a number
of changes were introduced and agreed.
The text of the full opinion appears as
annex IV to these minutes.
10. Additives
10.1. Draft opinion on sucralose
As agreed at the previous plenary, the
Committee was presented with a new draft that incorporated
the evaluation of the latest studies submitted and the
discussions at the plenary. The Committee was now satisfied
with the overall evaluation of the safety in use of this
substance requested as new sweetener, as laid down in the
draft opinion. The full opinion appears as Annex V to these
minutes.
11. Safety of creatine supplementation
The paper on the safety of creatine
supplementation incorporating the changes discussed at
Working Group level was discussed and agreed.
The full text of this opinion appears as
annex VI to these minutes.
12.
Contaminants: Progress report from the Task Force on
dioxins
The Chair of the Task Force on Dioxins
reported that good progress had been made in the Task
Force. A final meeting was scheduled for 14/15 September
and a draft opinion will be presented at the next plenary
meeting.
13. Revision of schedule of SCF meetings
- Schedule for 2000
The Committee discussed the consequences
that the next plenary meeting might be the last meeting
under the current mandate of its members. Taking into
account the heavy workload of the Committee and the likely
high number of matters of substantial content to be dealt
with at this meeting, the members agreed to extend the
duration of the next meeting to 3 days and a half (16 to 19
October).
The Secretariat informed the Committee
that a possible first meeting of the new membership of the
SCF had been provisionally scheduled for 21 and 22
November. The final schedule will depend on progress with
the renewal procedure of the mandates of scientific
committee members.
14. Work programme of the SCF
The Secretariat reported about the
status of dossiers pending finalisation. The Committee
noted that opinions on a large number of requests
(approximately 125) are pending and that this situation was
unlikely to change in the near future due to the limited
capacity of the Committee. An informal exchange of views on
possible ways of increasing the efficiency of the Committee
followed.
15. General information from the Commission
services
The Secretariat reported about the
current status of the renewal process of the scientific
committees and in particular the Scientific Steering
Committee.
16. Progress reports from Working Groups
Due to the lack of time no detailed
progress reports were made.
17. Any other business
17.1. Statement on D-
a
- tocopheryl acid succinate
(TAS)
The Committee evaluated a number of
substances, including D-
a
- tocopheryl acid succinate (TAS),
intended to be used in the manufacture of foods for
particular nutritional purposes (PARNUTS) in May 1999
(SCF/CS/ADD/NUT/20 final, opinion expressed on
12/5/99).
In the case of TAS, the Committee
considered it temporarily acceptable, pending submission of
additional information within one year of publication of
the opinion to clarify the extent of hydrolysis of TAS in
the gut and, consequently, whether any unhydrolysed TAS is
available for absorption.
The Committee has received additional
information but this was not sufficient to clarify the
extent of hydrolysis of TAS. The Committee is therefore
requesting further clarification on this issue from the
petitioner.
In the meantime, in the light of the
long history of use of TAS as a human medicine and studies
in humans showing that tocopherol is bioavailable when TAS
is ingested (though not the extent of bioavailability), the
Committee agrees to extend its temporary acceptance of TAS
for a further 2 years with the proviso that the requested
information be submitted to the Committee within one year
from now.
18. Adoption of these minutes
These minutes were adopted at the 123
rd Meeting of the SCF, held on 16-19 October
2000 in Brussels.
ANNEXES
(The text of the opinions adopted in
these annexes appear in the section outcome/opinions of the
webpages of the SCF on the Internet).
ANNEX I
Opinion on ß-carotene from
Blakeslea trispora (corrected) (SCF/CS/ADD/COL/158
correction)
ANNEX II
Opinion concerning a submission from the
Italian authorities raising concerns for the safety of
certain products approved under the notification procedure
of Regulation (EC) 258/97. (CS/NF/DOS/11 ADD 4 REV 2
Final)
ANNEX III
Opinion on the evaluation of
toxicological information related to the safety assessment
of genetically modified tomatoes (CS/NF/TOM/8 ADD 1 REV 3
Final)
ANNEX IV
Opinion on the safety of use of beta
carotene from all dietary sources (SCF/CS/ADD/COL/159
Final)
ANNEX V
Opinion on sucralose
(SCF/CS/ADDS/EDUL/190 Final)
ANNEX VI
Opinion on safety aspects of creatine
supplementation (SCF/CS/NUT/SPORT/9 Final)
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