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Food Safety

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.

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Regulatory Committees Standing Committee for Animal Nutrition
FOOD SAFETY | PUBLIC HEALTH | CONSUMER PROTECTION | DIRECTORATE GENERAL "HEALTH & CONSUMER PROTECTION"

 
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