Language selector

  • Current language:en
 
left
  slide
right
transtrans
 

en

Food Safety

Regulatory Committees Standing Committee for Animal Nutrition

Short report of the meeting held on 6 April 2000

CHAIRMAN : J. THIBEAUX

1. Examination of the safeguard clause introduced by Sweden on antibiotics in feedingstuffs (avilamycin, salinomycin sodium, monensin sodium, flavophospholipol).

Avilamycin

The Commission reminds the different actions underway:

· the SCAN is analysing the question of the Commission and it could be that it adopts its opinion at the Plenary of 28-29 April,

· the firm developing everninomycin has not the answered yet as regards its development,

· not all Ministers of Health have answered yet the letter of Commissioner Byrne, in spite of the reminder to the Heads of Delegation of the Standing Committee on Feedingstuffs. It is essential that the Commission is aware of the trials underway in the different Member States, in complement to the elements given on this subject by the Company itself. The Member States, which have not answered, will ensure that they will do it,

· the UK informs that the clinical trials with everninomycin have stopped in UK because of a problem. The Commission has been made aware of "unexpected results", directly from the company itself, which will keep the Commission informed.

· the study on MIC done by Eli Lilly in different human enteric bacteria has been presented by the rapporteur.

2. Application for authorisation of formaldehyde as a preservative under Directive 70/524/EEC.

The Commission reminds the content of the letter of Mr. Coleman to the Permanent Representations concerning in particular formaldehyde's use under Directive 70/524/EEC. The UK presents its reaction to this letter. First of all, the company will answer the questions of the SCAN. Secondly, according to the UK, the use of formaldehyde could be considered to be a technological aid. The Commission reminds that there was an application for authorisation as an additive. It reminds also, that the use of technological aids may result in residues, which should not present any health risk.

Several delegations stated that formaldehyde has many uses, in particular as a decontamination agent of salmonella contaminated fishmeal or it could fall under national rules before the biocides Directive is in place. The Commission will check with the relevant services and ask this to be discussed in the Standing Veterinary Committee.

3. Examination of applications for authorisation of certain additives as foreseen under article 4 paragraph 4 of Council Directive 70/524/EC:

Some delegations would like that the detailed rules proposed by the Commission as regards article 4 paragraph 4 to 6 be incorporated in a legislative text. However, before this can be done in the next proposal of amendment of the Directive, it seems more appropriate to be flexible and agree on these common rules.

3.1. Coccidiostat and other medicinal substances : salinomycin 120 G - "Koksican" - KRKA - chickens for fattening

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.

3.2 Coccidiostats and other medicinal substances : salinomycin 120G- "BIO-COX 120G"- Roche Vitamins Europe- chickens for fattening

As foreseen under article 4 paragraph 4, a delegation has 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.

3.3 Acidity regulator of the urine : ammonium chloride - ovines

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.

3.4 Preservatives : sodium benzoate (E 211), propionic acid (E280), sodium propionate (E281) - "KOFA GRAIN pH 5"- pigs- dairy cows, cattle for fattening

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 but that their omission has been justified by the company, which is acceptable at this stage of the formal check of the dossier.

It is deemed that the rules of presentation of the dossier have been complied with.

As foreseen under paragraph 6, the Commission shall ensure that a decision is taken on the application for authorisation, within 320 days following its inclusion on the agenda of the Standing Committee of today.

The requests of the Member States for additional information should be communicated within the next 3 to 4 months, if possible.

The Commission asks the rapporteur to ensure that the dossier is sent as a matter of urgency to all SCAN members.

3.5. Enzyme: Endo-1,4- ß -xylanase produced by Bacillus subtilis LMG S-15136 "Belfeed", laying hens.

As foreseen under article 4 paragraph 4, several delegations have submitted comments in writing to the Commission and to the other Member States, regarding the acceptability of the data, in accordance with Directive 87/153/EEC.

After consultation of the Standing Committee, according to paragraph 5 of article 4, the Commission reached the conclusion that the rules of presentation of the dossier have been complied with.

The first day of the 320 days period mentioned in article 4 paragraph 6 is thus: 4 April 2000.

The rapporteur is of the opinion that the data on efficacy allows to envisage a provisional authorisation only . The SCAN will thus not be consulted on the efficacy part of the dossier.

4. Examination of application for authorisation of certain additives as foreseen under article 4, paragraph 6 of Council Directive 70/524/EC:

4.1. Enzyme: Endo-1,4 ß xylanase produced by Trichoderma longibrachiatum CNCM MA 6-10W "Safizym X", laying hens, turkeys.

The extension dossier of Safizym X Ò to laying hens and turkeys was assessed by the Member States. At this stage, all Member States who wished to ask additional information have done so in writing. It is therefore proposed to stop the evaluation period in order to allow the company to answer the questions of the Member States. The proposal was accepted .

4.2. Enzyme: Endo-1,4 ß xylanase and Endo-1,3(4) ß-glucanase produced by Aspergillus niger CNCM I-1517 "Quatrazyme", laying hens

At the 28 February meeting of the Standing Committee, the Member States agreed to consider that the extension dossier of Quatrazyme Ò was compiled in accordance with Directive 87/153/EEC on the condition that the additional data requested by Sweden are sent to the Member States and to the Commission within 3 weeks following the date of the meeting. Since no complementary dossier has been received, it is proposed to reverse the conditional position adopted on 28 February, and to consider that the dossier is not compiled in accordance with Directive 87/153/EEC. All Member States accepted the proposal.

5. Administration of additives in liquid form (letter from DK January 17, 2000)

In reply to the questions put by Denmark concerning the possibility of using additives in liquid form, the Commission replied that :

- additives could be placed on the market in liquid form; authorisations had already been granted in the past;

- under Article 9k(1) of Directive 70/524/CEE, additives in liquid form could be used only if they were incorporated in feedingstuffs, which ruled out the administration of vitamins and trace elements, for example, in drinking water, by sprinkling them on feed, in the form of individual doses, etc.;

- Article 9k(2) provided that 'additives belonging to groups other than "antibiotics", "coccidiostats and other medicinal substances", and growth promoters may be used if administered by a method other than incorporation in feedingstuffs, on condition that that method is provided for in the authorisation regulation'.
To date, no derogation had been granted on the basis of Article 9k(2);

- under Article 13(5) Finland and Sweden were authorised, on certain conditions and until 1 July 2000, to allow premixtures of vitamins and provitamins to be supplied to stock farmers for direct addition to feed materials of vegetable origin.

6. Examination of the draft Commission Regulation authorising new additives and new additives uses in feedingstuffs (Working Document SANCO/0429/2000).

The working document SANCO/0429/2000 concerning the permanent authorisation of an additive and the provisional authorisation of new additives, new additive uses and new preparations in feedingstuffs was examined. No particular remark was made on the document, except for the maximum age of piglets in the proposed conditions of use of the two phytase products. The Commission explained that this modification takes into account the SCAN recommendation on the age limit of this particular animal category.

The representative of the Commission informed the members of the Standing Committee that, for administrative reasons, the vote on the draft Regulation will only take place at the May meeting of the Standing Committee.

7. Communication of the services of the Commission on the revision of the maximum ages of the animal categories indicated in the annexes to directive 70/524/EEC.

(Ref.: Annex to the "Report of the Scientific Committee on Animal Nutrition on the assessment under directive 87/153/EEC of the efficacy of micro-organisms used as feed additives").

The services of the Commission informed the members of the Standing Committee that, following the above mentioned SCAN opinion on the assessment of the efficacy of the micro-organisms used as feed additives, it intends to establish a working group composed of national experts to review the age limits of the different animal categories mentioned in the annexes of Directive 70/524/EEC. The objective is to adapt the animal categories to the present rearing practices and to modify the categories and age limits accordingly, when appropriate.

The Standing Committee will then be asked to adopt a position on the modifications which need to be done to the current animal categories.

8. Surveillance program dioxins in binders, anti-caking agents and coagulants : update of the monitoring results-Establishment of the working group.

The Commission indicated that following the discussions in the last Committee a working group should be established to examine the results of the surveillance program. The examination will involve the comparability of the results and the determination of those binders, anti-caking agents and coagulants for which there is no problem of dioxin contamination following the results of the surveillance program. Member states are requested to designate experts to participate in this working group.

9. Dioxins in green meal pellets; survey of the results of the investigations performed by Member States on the drying methods and burning material used for drying feed materials and their influence on the dioxin content of the dried feed material.

The Commission informed the Committee that only a few Member States have replied to the request of the Commission to examine the different drying methods and burning material used for drying feed materials and their influence on the dioxin content of the dried feed material and to inform the Commission thereof. A reminder of this request will be done in writing.

10. Other business

Top

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

 
lefttranspright

 

  Print  
Public HealthFood SafetyConsumer Affairs