|
Regulatory Committees
Standing Committee for Animal
Nutrition
Short report of
the meeting held on 28-29.09.2000
CHAIRMAN: W. Penning
All Member States, with the exception of Portugal,
were present.
Portugal has submitted a written delegation for the
vote to Spain
1.
Safeguard clause applied by Germany and Sweden as
regards the use of Dimetridazole belonging to the group of
coccidiostats and other medicinal substances communication
of the Commission services (SCAN opinion, CVMP
opinion)
A representative of the Commission has
briefly presented the SCAN (Scientific Committee for Animal
Nutrition) opinion expressed on 12 September 2000
(rejecting the conclusions drawn by Germany and Sweden) as
well as the minority opinions of two toxicologists of the
SCAN which are integrated in the SCAN opinion.
The French delegation has indicated that
a dossier has just been presented to France in the
framework of the re-evaluation procedure under of Article
9g paragraph 4 of Directive 70/524/EEC. This dossier in the
framework of the re-evaluation procedure under of Article
9g paragraph 4 of Directive 70/524/EEC is arrived at the
Commission on 28 of October 2000.
The Commission representative has
reminded that the CVMP (Committee for veterinary medicinal
products) concluded that as Dimetridazole is a genotoxic,
it should be banned.
Germany and Sweden have asked the
Commission to decide urgently on the safeguard
clauses.
2. Examination of the dossier dated May 2000 submitted
by Alpharma according to the provisions of article 2 of
Council Regulation (EC) N° 2821/98, which banned the use
of bacitracin zinc.
Article 2 of the Council Regulation
2821/98 foresees that the Commission shall re-examine the
provisions of the Regulation banning the use of bacitracin
in particular before 31 December 2000, on the basis of the
different investigations concerning the induction of
resistances by the use of bacitracin and the surveillance
programme of antimicrobial resistance in animals which have
received bacitracin, to be carried out by the responsible
for putting the additive into circulation.
As the previous rapporteur Member State
for bacitracin is not acting anymore as such, and as no
other Member State had volunteered to do so, the Commission
services have accepted, on the request of Alpharma, to be
exceptionally for this particular case the link between
Alpharma and the Member States.
The different points addressed by
Alpharma were presented to the Member States by the
Commission services. Some of the points were already in the
possession of the Member States and the Commission at the
end of 1998 (this means before the ban); others points were
known to the Commission and to the Member States
intervening in the Case T -70/99 in the Court of First
Instance of the European Communities of Alpharma against
the Council of the European Union, further points were new
elements. The result of the surveillance study in 6
European countries will however only be available by
November of 2000.
The Member States have been asked to
examine this dossier and to comment on this dossier.
3.
State of play by the rapporteur Member States on the
dossiers to be submitted not later than 30. September 2000
for a re-evaluation under article 9g paragraph 4 of
Directive 70/524/EEC.
The additives and additive uses which
fall under the scope of article 9g will be re-evaluated, as
provided for in paragraph 1 of article 9g. The Member
States were reminded that the concerned dossiers must be
sent by the persons responsible into circulation to the
rapporteur Member States no later than 30 September 2000.
The Commission representative asked the rapporteur Member
States to communicate to the Commission the list of
authorisations for which no dossiers was received by that
date. The Commission will adopt the necessary measures to
withdraw the authorisation(s) of the corresponding
product(s).
The Member States agreed to start the
evaluation according to the procedure described in article
4, paragraph 4 and 5 of Directive 70/5244/EEC, i.e. a 60
day period to check the compliance of the dossiers with
Directive 87/153/EEC, followed by a 30 day period to take a
decision on the dossier acceptability in the Standing
Committee. The Commission representative reminded the
Member States that, according to article 9g, paragraph 5
(b), a ruling regarding the company-bound product
authorisations must be taken within a maximum of 3 years,
i.e. no later than 1 October 2003.
4.
Coccidiostats and other medicinal substances: monensin -
"Coxidin" - Sintofarm - chicken for fattening, chicken
reared for laying, turkeys for fattening (end of the 60
days foreseen under article 4 paragraph 4: 25. September
2000) (rapporteur : IT)
As foreseen under article 4 paragraph 4,
several delegations have submitted comments in writing to
the Commission and to the other Member States, indicating
that the dossier has not been compiled in accordance with
Directive 87/153/EEC.
After consultation of the Standing
Committee as foreseen under paragraph 5, the Commission
reached the conclusion that some data are missing and that
their omission has not been justified.
It is deemed that the rules of
presentation of the dossier have not been complied with and
a representative of the Commission shall so notify the
applicant for authorisation to put into circulation and the
Member States. The evaluation of the application is stopped
at this stage.
5.
Coccidiostats and other medicinal substances :
salinomycin - "Poulcox" - Sintofarm - chicken for fattening
- (end of the 60 days foreseen under article 4 paragraph 4:
25. September 2000) (rapporteur : IT)
As foreseen under article 4 paragraph 4,
several delegations have submitted comments in writing to
the Commission and to the other Member States, indicating
that the dossier has not been compiled in accordance with
Directive 87/153/EEC.
After consultation of the Standing
Committee as foreseen under paragraph 5, the Commission
reached the conclusion that some data are missing and that
their omission has not been justified.
It is deemed that the rules of
presentation of the dossier have not been complied with and
a representative of the Commission shall so notify the
applicant for authorisation to put into circulation and the
Member States. The evaluation of the application is stopped
at this stage.
6.
Antibiotics: flavophospolipol - "Jivet" - Sintofarm -
laying hens; turkeys; other poultry excluding ducks, geese,
pigeons; piglets; pigs for fattening; animals bred for fur
excluding rabbits; calves; cattle for fattening - (end of
the 60 days foreseen under article 4 paragraph 4: 25.
September 2000) (rapporteur : IT)
As foreseen under article 4 paragraph 4,
several delegations have submitted comments in writing to
the Commission and to the other Member States, indicating
that the dossier has not been compiled in accordance with
Directive 87/153/EEC.
After consultation of the Standing
Committee as foreseen under paragraph 5, the Commission
reached the conclusion that some data are missing and that
their omission has not been justified.
It is deemed that the rules of
presentation of the dossier have not been complied with and
a representative of the Commission shall so notify the
applicant for authorisation to put into circulation and the
Member States. The evaluation of the application is stopped
at this stage.
7.
Anti-caking agents: sodiumferrocyanid - Verein für
Deutsche Salzindustrie e.V (end of the 60 days foreseen
under article 4 paragraph 4: 13. September 2000)
(rapporteur:
D)
The end of the 60 days period mentioned
under article 4, paragraph 4 of Directive 70/524/EEC,
during which the Member States check whether the dossier
has been compiled in accordance with Directive 87/153/EEC
expired on 13 September 2000.
The Commission, within the deadline,
received
no written comments from the Member States. However,
during the meeting three Member States explained that they
were not in the position to take a position on the
admissibility of the dossier due to the fact that the basic
dossier and the evaluation report are in German.
The Commission representative
acknowledged that the presentation of the dossier was in
accordance with the internal agreement on the languages to
be used (presentation of the dossier in an official
language of European Union and summary in English, French
and German). However, in order to allow a smooth evaluation
of the technical content of the dossier, Germany was
invited to make all possible efforts to make available
essential parts of the dossier in a language accessible to
all delegations
8.
Anti-caking agents: potassiumferrocyanid - Verein für
Deutsche Salzindustrie e.V (end of the 60 days foreseen
under article 4 paragraph 4: 13. September 2000)
(rapporteur: D)
The end of the 60 days period mentioned
under article 4, paragraph 4 of Directive 70/524/EEC,
during which the Member States check whether the dossier
has been compiled in accordance with Directive 87/153/EEC
expired on 13 September 2000.
The Commission, within the deadline,
received
no written comments from the Member States. However,
during the meeting three Member States explained that they
were not in the position to take a position on the
admissibility of the dossier due to the fact that the basic
dossier and the evaluation report are in German.
The Commission representative
acknowledged that the presentation of the dossier was in
accordance with the internal agreement on the languages to
be used (presentation of the dossier in an official
language of European Union and summary in English, French
and German). However, in order to allow a smooth evaluation
of the technical content of the dossier, Germany was
invited to make all possible efforts to make available
essential parts of the dossier in a language accessible to
all delegations
9.
Final report on the « Guidelines on the assessment
of the efficacy of microorganisms in the animal categories
dogs, cats and horses » based on the result of the working
group « Requirements concerning the efficacy for
micro-organisms in animal categories dogs, cats and
horses.
A new draft of the "Guidelines on the
assessment of the efficacy of micro-
organisms in the animal categories dogs, cats and
horses" taking into account comments from Member States,
the Commission's Legal Service and the Institute of
Biometrics and Data Processing was presented and discussed.
The report will be on the agenda of the next meeting of the
Committee for formal agreement
10. Examination and possible opinion on a draft
Commission Decision amending Commission Decision
91/516/EEC establishing a list of ingredients whose use
is prohibited in compound feedingstuffs-(provisions
concerning the use oils and fats and their by-products in
feed).
The Commission representative presented
the draft Decision. The notification of this draft to the
World Trade Organisation did not generate any objection of
the third countries (exception made for the date of
application).
Some minor editorial modifications were
introduced to the proposed draft Commission
Decision.
The vote took place. The Committee
expressed a favourable opinion.
11.
Examination and possible opinion on a draft Commission
Regulation concerning the permanent authorisation of an
additive and the provisional authorisation of new additives
and new preparations in feedingstuffs
The draft Commission Regulation was
presented and discussed.
No objection was raised to the
proposal.
The vote took place. The Committee
expressed a favourable opinion by unanimity.
12. Examination and possible opinion on a draft
Commission Regulation concerning the provisional
authorisations of additives in feedingstuffs
The draft Commission Regulation
concerning the provisional authorisations of additives in
feedingstuffs was presented and discussed. The delegations
have welcomed the consolidation of the provisional
authorisations of additives in feedingstuffs into this
Regulation.
Some Member Sates had objections with
the extension of period of the provisional authorisations
of one antibiotic and one coccidiostat.
The vote took place. The Committee
expressed a favourable opinion.
13.
Organisation of a ring trial for the official control of
PCBs in feedingstuffs. Establishment of a list of
participating laboratories. Replies of the Member
States
A list of participating laboratories
(24) was distributed. Subject to some minor modifications
the Committee agreed with the list.
14.
Examination of a draft Commission Regulation (EC)
amending (EC) Regulation No 2439/1999 on the conditions for
the authorisation of additives belonging to the group
"binders, anti-caking agents and coagulants" in
feedingstuffs and repealing Commission Regulation (EC) No
739/2000
It has been observed that in addition to
the natural mixtures of steatites and chlorites, sepiolite
and sepiolitic clay (Commission Regulation No 739/2000,
sufficient monitoring data have been submitted indicating
that there is no problem concerning possible dioxin
contamination for sodium, potassium and calcium stearates,
silicic acid, colloidal silica, kieselgur, calcium
silicate, sodium aluminosilicate,
bentonite-montmorillonite, lignosulphonates, perlite and
clinoptilolite of volcanic origin.
Insufficient data have been submitted
for calcium sulphate dihydrate, vermiculite,
natrolite-phonolite, synthetic calcium aluminates and
clinoptilolite of sedimentary origin.
The Commission indicated to submit at
the next meeting a draft Regulation for approval, taking
into account the above-mentioned observations.
15.
Contamination by dioxins of a preparation of choline
chloride: Update of the situation.
Letter from the German delegation concerning the
classification of the preparation choline chloride
The Commission reported that guarantees
were received from the Spanish authorities that the current
production of choline chloride put on a carrier do not
contain significant levels of dioxins. No findings of
dioxin contamination on the current production have been
reported by other Member States.
The representative of the Commission
mentioned the intention to write to the Member States in
order to request to report extensively of the actions
undertaken, following the agreements made at previous
meetings of the Committee, to avoid that contaminated
choline chloride could enter the food and feed chain and
the measures taken for the safe disposal of the
contaminated batches.
Following the letter of the German
delegation, the choline chloride put on a carrier has to be
considered as a premixture. No remarks were made by the
Committee. The Commission will examine the issue in
detail.
16.
Undesirable substances and products in feedingstuffs:
Further follow-up of contamination cases.
- Cadmium in zinc sulphate originating from China
- Lead in zinc oxide originating from China
- Dioxin in zinc oxide originating from Turkey
- Dioxin in copper oxide originating from Korea.
Very high levels of cadmium and lead
have been found in zinc sulphate and zinc oxide originating
from China. The maximum level of lead in zinc oxide is 600
ppm following the provisions of Council Directive 70/524.
No maximum level is established at Community level for
Cadmium.
The current available monitoring data
provide a very heterogeneous picture with regard to the
contamination level. Also increased levels of dioxin in
zinc oxide originating from Turkey and a very high level of
dioxins in copper oxide originating from Korea have been
reported. Further investigations have to be performed in
order to trace the unacceptable practices, which lead to
this contamination. These findings highlight the necessity
to set up a wider monitoring program for these kind of
additives in order to obtain a global overview of the
contamination situation. Contaminated batches cannot be
allowed to be used for feed or food purposes.
- Citrus pulp pellets originating from Brazil - update
of the situation
The finding of a slightly increased
level of dioxins in a batch of citrus pulp pellets
originating from Brazil could not be confirmed. In response
to the recommendations of the FVO-mission report, the
Brazilian authorities have submitted a report on their
internal control system to guarantee that current shipments
of citrus pulp pellets originating from Brazil comply with
the provisional maximum limit of 500 pg I-TEQ dioxins / kg
citrus pulp pellets.
- Green meal pellets: survey of drying techniques
The point has not been treated
- Other
The finding by Swiss researchers of
residues of mineral oil in animal feeds have been
discussed. The official communication of the Swiss
authorities as well a detailed report on the analysis were
available for discussion. It was concluded that still many
questions need to be solved in particular with regard to
the interpretation of the obtained analytical results and
that the issue needs to be further examined in detail in
order to be able to have a global view on the situation.
The development of an officially approved analytical method
is an important point in this context.
17.
Use of feed additives claiming a mycotoxin binding
action - Exchange of views.
Letter from the German delegation
Due to a lack of time, the point has not
been treated.
18.
Use of Hippozym
â
as a feed additive - Exchange of views.
Letter from the German delegation.
The Commission representative has
explained the reasons for the no acceptance of
Hippozym as a feed additive.
Furthermore, in case of authorisation as feed additive, the
requirements of Council Decision 1999/534/EC of 19 July
1999 has to be complied with the consequence that the heat
treatment at 133°C at 3 bar of the pancreatic extracts
would result in a destruction of the three enzymes.
Given the purpose of the product
(prophylactic effect) and the fact that the pancreatic
extracts are listed in the European Pharmacopae, this
product should be considered as a veterinary drug.
19. Use of glucosamine and chondroïtinesulfate in
petfoods - Exchange of views.
Letter from the Belgian delegation.
An exchange of views has taken place;
The Committee concluded that glucosamine and
chondroïtinesulfate cannot be considered as feed additives
(not listed in the Directive 70/524/EEC). As long as there
is no specific claim and depending on the amount of these
products in the feedingstuffs, these products can be put
into circulation as feed materials.
20. Exchange of views on a Draft of the European
Community position in response to a Codex circular letter
to member countries on lists established by different
governments to control the use of prohibited ingredients
and the presence of undesirable substances in
feedingstuffs or other approaches
The Commission has invited the
delegations to send comments:
- On the questionnaire concerning a list
of undesirable substances or prohibited ingredients by 15
October 2000.
- On the revised Code of Practice for
Good Animal Feeding by 30 October 2000.
21. Draft report of the working group on the revision
of Directive 70/524/EEC as regards to trace elements for
pets
The Commission has informed the Member
States on the organisation of a working group on trace
elements for pets. The report of the meeting will be
distributed to the delegations as soon as all the members
of the working group will have confirmed their agreement on
the report.
Other business
1.- Exchange of views on a change in the manufacturing
process of vitamin B2, a product authorised as a feed
additive under Directive 70/524/EEC (letter from D and
UK)
The exchange of views conducted to the
conclusion that the company must submit a dossier in
accordance with Commission Directive 87/153/EEC.
2.- Use of colourants in feedingstuffs for fish - Letter
of the Belgian delegation.
An exchange of view has concluded that
it is necessary to introduce a dossier for the extension of
the authorisation of canthaxanthin and astaxanthin for fish
other than salmon, trout and ornamental fish.
3.- Implementation of Commission Decision 2000/285/EC
of 5.4.2000 - Letter from the German delegation (on
sewage sludge)
This item has not been treated and will
be examined in the next meeting in October.
4.- Transmission of the overall report of the
Commission on the results of inspections carried out at
Community level- Article 22 of Directive 95/53/EC -
Request of the German delegation
The Commission representation indicated
that it is not possible for the Commission services to make
the report by October 2000. The Standing Committee for
animal nutrition will be informed on this issue in a next
meeting.
5.- Consolidation of the list of authorised additives
in feedingstuffs in accordance with Article 9 t point b)
of Directive 70/524/EEC
The Commission services will submit this
list in English to all the delegations for the next
Standing Committee in October.
6.- Period of authorisation for Halofuginone - Request
of the German delegation
The Commission representative indicated
that a corrigendum would be done for the German text
(authorisation of the additive Halofuginone hydrobromide
for chickens for laying until 30.9.2009 instead of
30.9.2000).
7. The national PCB and dioxins levels in certain
feed materials and feedingstuffs from Belgium and the
orientation values from Germany for Deoxynivalenol and
zearalenone in certain feedingstuffs have been raised by
delegations but have not been discussed due to a lack of
time.
8. Enzyme feed-additives:
8.1 Kemzyme W liquid
â
, turkeys: end of the 60 days foreseen
under article 4, paragraph 4. (Rapporteur : B)
As foreseen under article 4 paragraph 4,
Member States were asked if the Kemzyme W liquid
â
dossier extension to turkeys was compiled
in accordance with Directive 87/153/EEC. Several delegations
had already expressed their opinion in writing. No objection
was raised to the dossier acceptability. The assessment
procedure will therefore be conducted according to article 4,
paragraph 5.
8.2 Kemzyme W dry
â
, turkeys: end of the 60 days foreseen
under article 4, paragraph 4. (Rapporteur : B)
As foreseen under article 4 paragraph 4,
Member States were asked if the Kemzyme W dry
â
dossier extension to turkeys was compiled
in accordance with Directive 87/153/EEC. Several delegations
had already expressed their opinion in writing. No objection
was raised to the dossier acceptability. The assessment
procedure will therefore be conducted according to article 4,
paragraph 5.
8.3 Safizym Z
â
, laying hens and turkeys: evaluation
procedure according to article 4, paragraph 6. (Rapporteur
: F)
The Commission representative informed
the Member States that the answers to the questions raised
during the first phase of the evaluation period had been
sent by the rapporteur to the Member States and to the
Commission. Therefore, the second phase of the evaluation
procedure will start at the next meeting of the Standing
Committee.
9. Micro-organism feed-additives:
9.1 Biosaf SC 47
â
, dairy cows: evaluation procedure
according to article 4, paragraph 6. (Rapporteur :
F)
The Commission representative informed the
Member States that the first period of the evaluation of the
Biosaf SC 47
â
dossier extension to dairy cows is now
completed. Therefore, the 320 day period mentioned in article
4, paragraph 6 is now interrupted. The evaluation will resume
when answers are given to all questions raised by the Member
States.
9.2 Bioplus 2B
â
, calves. (Rapporteur: DK)
The requested complementary data have been
provided. No further objection was raised regarding to the
authorisation of the use of Bioplus 2B
â
in calves. Therefore, the Member States
were informed that the dossier evaluation of the Bioplus
2B
â
extension dossier to calves is now
completed.
Regulatory Committees
Standing Committee for Animal
Nutrition
FOOD SAFETY |
PUBLIC
HEALTH |
CONSUMER
PROTECTION |
DIRECTORATE
GENERAL "HEALTH & CONSUMER PROTECTION"
| 
