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Food Safety

Regulatory Committees Standing Committee for Animal Nutrition

Summary minutes of the meeting held on 26-27 March 2001

CHAIRMAN:  W. Penning

STANDING COMMITTEE

1. Exchange of views on the scientific basis for the safety assessment of novel feeds for animals (Task Force for the Safety of Novel Foods and Feeds-OECD-)

A document including comments from the European Commission on nutritional assessment of novel foods and feeds had been sent to the OECD and distributed before the meeting.

A Commission representative thanked those delegations which had submitted comments and informed the delegations that the comments from the Commission had been drafted in collaboration with the relevant Commission departments.

At the request of the German delegation, the Commission distributed information on the meeting of the Task Force for the Safety of Foods and Feeds that would take place in Paris on 21-23 May.

2. Products under Article 9g: consultation of the Standing Committee on the acceptability of dossiers that came under the scope of Article 9g of Directive 70/524/EEC

2.1 Discussion on the following dossiers, the evaluation of which started on 29/01/01, the date of the last meeting of the Standing Committee (Clock 3: Date 0 = 29 January 2001; Article 4, paragraph 6)

The meeting of the Standing Committee for Animal Nutrition on 29 January 2001 marked the start of the first evaluation period for the dossiers Flavomycin 40 & 60, Romensin (Rapporteur UK), Deccox, Stenorol, Elancoban, Monteban, Sacox 120 micro Granulate, Cycostat 66G (Rapporteur UK) and Avatec 15% (Rapporteur F). The Commission asked the Rapporteur Member States to provide their expert reports as soon as possible.

According to the timetable, it had been agreed to end the first evaluation period at the Standing Committee meeting scheduled for 7/8 June 2001. The Member States were asked to send their comments one week in advance of the meeting.

2.2 Koffogran â (nicarbazin): discussion on the dossier's acceptability, taking into consideration the supplementary data sent by the petitioner

In view of the supplementary information provided by the petitioner, the Member States agreed to postpone the decision regarding the dossier's compliance with the existing guidelines until further details were provided regarding the remaining gaps.

2.3 Proposal for a Commission Regulation amending Council Directive 70/524/EEC concerning additives in feedingstuffs, as regards the withdrawal of the authorisation of certain additives belonging to the group coccidiostats and other medicinal substances
Preliminary position of the Member States, with a view to the adoption of the proposal at the next meeting of the Standing Committee

The draft Commission Regulation was circulated and discussed. Most members of the Standing Committee approved the document, pending a final ruling on the above-mentioned product and clarification on another dossier, where the petitioner had given incomplete answers regarding the identified deficiencies.

3. Micro-organisms: - new dossier - "CALFMIX"- Lactobacillus fermentum DSM 12476, - Lactobacillus fermentum DSM 12477 - Valio Ltd - calves - timetable,
(clock 1, day 0: 30 January 2001; end of sixty-day period for formal check in accordance with Article 4, paragraph 4: 31 March 2001) Rapporteur: FIN

In accordance with Article 4, paragraph 4, of Directive 70/524/EEC, the Member States have a period of sixty days to check whether the dossier has been complied compiled in accordance with Directive 87/153/EEC). According to the timetable the end of the sixty-day period was 31 March 2001.

4. Micro-organisms: "ORALIN"- Enterococcus faecium - extension of use for turkeys - timetable, (clock 1, day 0: 2 February 2001; end of sixty-day period for formal check in accordance with Article 4, paragraph 4: 3 April 2001) Rapporteur: D

In accordance with Article 4, paragraph 4, of Directive 70/524/EEC the Member States have a period of sixty days to check whether the dossier has been complied compiled in accordance with Directive 87/153/EEC). According to the timetable the end of the sixty-day period was 3 April 2001. The expert report should be provided no later than the beginning of the evaluation period.

5. Emulsifiers: - new dossier "EMULBESTO 3000" - Acetylated hydrolysed lecithin- SKW Biosystems - timetable, (clock 1, day 0: 16 February 2001; end of sixty-day period for formal check in accordance with Article 4, paragraph 4: 17 April 2001) Rapporteur: F

In accordance with Article 4, paragraph 4, of Directive 70/524/EEC the Member States have a period of sixty days to check whether the dossier has been complied compiled in accordance with Directive 87/153/EEC). According to the timetable the end of the sixty-day period was 17 April 2001. The expert report should be provided no later than the beginning of the evaluation period.

6. Examination and possible opinion on the draft proposal for a Commission recommendation concerning coordinated inspection programmes in the feed sector

Doc. SANCO 4301/01 rev. 2 was presented and briefly discussed. Most delegations agreed with the approach proposed for the coordinated inspection programme, which would take into account the following issues:

- Monitoring of contamination by dioxins, PCBs and heavy metals of certain products to be used in animal nutrition.

- Monitoring Salmonella contamination of proteins of vegetable origin.

- Monitoring of the possible use of additives for which the authorisation has been suspended or withdrawn, and additives for which maximum limits have been set.

- Monitoring of compliance with the feed ban concerning certain proteins of animal origin.

Most delegations said they had no problem with the proposal, as the issues were already part of current control programmes.

The Commission representatives agreed to amend a number of minor points in the proposal in order to present it to the next meeting of the Standing Committee for a formal opinion.

7. Working paper concerning the definition and limitation of animal categories (pigs, poultry, ruminants), the duration of efficacy trials, and new proposals for an annex entry based on the findings of the working group "Animal categories listed in the Annex to Directive 70/524/EEC"

The working paper concerning the definition and limitation of animal categories (pigs, poultry, ruminants), the duration of efficacy trials and new proposals for an annex entry based on the findings of the working group "Animal categories listed in the Annex to Directive 70/524/EEC" was presented. The objective was to simplify the Annex. Instead of using the maximum age as a limitation, a link between the animal category and the feedingstuff or the weight of the animal at the end of the period in which the additive was given to the animal might be a more practical approach for some groups of additives. Concerning the efficacy trials, a minimum duration for the tests should be fixed depending on the animal category.

The working paper would be distributed to FEFANA for comment. Member States were asked to comment by the end of April.

8. Examination and possible opinion on a draft Commission Regulation (EC) amending Regulation (EC) No 2439/1999 of 17 November 1999 on the conditions for the authorisation of additives belonging to the group "binders, anti-caking agents and coagulants" in feedingstuffs

As very high levels of dioxins had been found in kaolinitic clays, urgent measures had been taken to prevent an unacceptable degree of contamination of feedingstuffs. Pending the results of the monitoring programme and risk assessment, the acceptable level of dioxins in kaolinitic clays had been provisionally restricted, as a precaution, to the analytical limit of determination.

In the meantime the scientific risk assessment had become available, and possible measures to limit the presence of dioxins in feedingstuffs, including binders, were being discussed. It was therefore appropriate to await the further outcome of these discussions in order to establish definitive measures in relation to binders, anti-caking agents and coagulants used as feed additives.

9. Exchange of views and discussion on legislative measures to reduce the presence of dioxins in feedingstuffs

A first exchange of views had taken place concerning possible measures to be taken in order to reduce the presence of dioxins in feedingstuffs. The proposed measures were based on the conclusions and recommendations in the opinion of the Scientific Committee on Animal Nutrition on "dioxin contamination of feedingstuffs and their contribution to the contamination of food of animal origin", adopted on 06 November 2000.

The proposed measures were part of a comprehensive strategy with the objective of reducing the presence and release of dioxins and dioxin-like PCBs into the environment, feed and food.

The aim of the measures discussed was to protect public health by ensuring a pro-active approach to further reducing the presence of dioxins in food and feed, thereby accelerating the ongoing decreasing trend.

The presented approach was generally welcomed, and the measures will be discussed in more detail at a future meeting.

10. Exchange of views on a draft standardisation mandate addressed to the CEN in the field of feedingstuffs analysis methods

The proposed mandate was welcomed, as it would avoid the overlapping of activities and efforts in the field of the standardisation of feedingstuffs analysis methods . This should result in a more complete and up-to-date set of standardised methods of analysis and sampling, conducive to the uniform application of Community legislation.

Certain provisions in the proposed mandate needed further discussion in detail, and it was therefore agreed to discuss it again at a future meeting before concluding the matter.

11. Commission multifax of 12.3.2001 : "not permitted additive in a milk replacer"

Members States informed the Standing Committee that additive was not used in feed materials and that the origin of this issue was the use of a wrong and incorrect technical information sheet

12.1 Anti-caking agents: sodiumferrocyanid - evaluation of the dossier (day 0 : 29. September 2000; (clock 3: end of the first part of the evaluation period as foreseen under article 4 paragraph 6 of Council Directive 70/524/EEC) (rapporteur: D)

The rapporteur was asked to send all the questions made by the Member States experts to the applicant company. The evaluation period was formally stopped on the 27 March 2001 and the evaluation will be resumed after receiving the answers.

12.2 Anti-caking agents: potassiumferrocyanid - evaluation of the dossier - Article 4 paragraph 6 (day 0 : 29. September 2000; (clock 3: end of the first part of the evaluation period as foreseen under article 4 paragraph 6 of Council Directive 70/524/EEC)) (rapporteur: D)

The rapporteur was asked to send all the questions made by the Member States experts to the applicant company. The evaluation period was formally stopped on the 27 March 2001 and the evaluation will be resumed after receiving the answers.

12.3. Preservatives: "KOFA GRAIN pH 5"- sodium benzoate (E 211), propionic acid (E280), sodium propionate (E281) - (clock 3: start of the second part of the evaluation period as foreseen under article 4 paragraph 6 of Council Directive 70/524/EEC) (rapporteur: D)

The rapporteur explained that a report addressing the questions made by the Member States experts was sent on 25 March 2001. The evaluation period will be resumed at the next standing committee.

13. Cocciodiostat: "Sacox 12 microGranulate" application for a permanent (10 year)

authorisation - animal category: rabbits for fattening - timetable - (rapporteur UK)

The Commission informed the Member States about the current status of the product. The provisional authorisation expired on 20 March 2001. As there were no outstanding questions, the Commission proposed to add this product to the proposal for a new regulation which would be on the agenda for the next Standing Committee meeting for adoption. (see item 3 Expert Committee).

14. Expiry of the provisional authorisation 2001

14. 1 Expiry of the provisional authorisation for coccidiostats:

- Sacox 120 (salinomycin-natrium - Intervet - animal category: chickens reared for laying - rapporteur: UK)

- Cygro 1% (maduramicin-ammonium-alpha - Alpharma AS - animal category: turkeys - rapporteur: UK)

14. 2. Expiry of the provisional authorisation for the radionuclide binder:

- Ferric (III) ammonium hexacyanoferrate (II) for the animal categories:

- Ruminants (domestic and wild)

- Calves prior to the start of rumination

- Lambs prior to the start of rumination

- Kids prior to the start of rumination

- Pigs (domestic and wild)

(rapporteur: NOR)

The Rapporteur Member States were asked to contact the companies in order to clarify the outstanding questions, which had to be answered before transition to permanent authorisation.

The Commission would send a letter to the companies requesting a supplementary dossier at least 6 months prior to the expiry date of the provisional authorisation.

15. Other business

expert committee

3. Draft Commission Regulation concerning the authorisation of new additives and uses of additives, and the extension of the provisional authorisation of an additive

The draft Commission Regulation was presented and discussed. Following the opinion of the SCAN regarding the absence of toxin production by Bacillus cereus NCIMB 40112 [Toyocerin â ], adopted at the plenary meeting of the SCAN on 21 March 2001, the Commission representative drew the attention of the Member States to the reintroduction of the provisional authorisations for Toyocerin â , which had expired on 20.2.2001, pending the outcome of the safety reassessment of the strain with regard to the production of toxins, as provided for in Commission Regulation No 2697/2000.

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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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