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Food Safety

Regulatory Committees Standing Committee for Animal Nutrition

Short report of the meeting held on 15-16 May 2000

CHAIRMAN :

Mr. Thibeaux for points 1, 4, 7 and 8
D. André for point 2 and 3
F. Verstraete for points 5 and 6

1.1 Examination and possible opinion on a draft Commission Regulation concerning the permanent authorisation of an additive and the provisional authorisation of new additives, new additive uses and new preparations in feedingstuffs.

The final draft Commission Regulation was discussed. One delegation expressed reservations on the modification of the age limit of one animal category (piglets), in the proposed authorisation without a time limit of the 3-phytase EC 3.2.1.8 . In its view, for enzymes and micro-organisms, age limits should be based exclusively on safety concerns.

The representative of the Commission reminded this delegation that the modification of the age limit was introduced in order to take into account the opinion of the Scientific Committee on Animal Nutrition (SCAN) on the efficacy of the 3-phytase, for which an authorisation without a time limit is envisaged.

The Committee was informed that a working- group would meet shortly to address the problem of the age limits of the different animal categories, which concerns the authorisations of all feed-additives. The objective is to update the age limits, taking into account current rearing and breeding practices, and to reach a common position of the Standing Committee in the near future.

The delegation that objected to the age limit questioned the composition of the probiotic for which a provisional authorisation is envisaged, since the ratio of the two micro-organisms which are the active components of the product varies in the different columns of the annex. The representative of the Commission reminded the German delegation of the different stability of the two micro-organism strains, which belong to two different species.

A vote took place.

Result of the vote: favourable opinion by qualified majority.

1.2 Conformity with Directive 87/153/EEC, according to article 4, paragraph 4 of Directive 70/524/EEC: Feed additive Saccharomyces cerevisiae NCYC Sc 47, Biosaf â , extension of use to dairy cows.

The end of the 60 day 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 10 April 2000. The Member States which expressed an opinion, orally or in writing, concluded that the extension dossier was compiled in accordance with Directive 87/153/EEC. At the meeting, all Member States confirmed this opinion. The first day of the 320 days period mentioned in article 4 paragraph 6 is thus: 15 May 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.

2. Examination of the safeguard clause introduced by Sweden on antibiotics in feedingstuffs

The Commission services presented the opinion on avilamycin of the Scientific committee for animal nutrition (SCAN) which was adopted on 28.April 2000 and informed the Member States that Schering Plough had, according to a press release of 5 May 2000, stopped the development and use of everninomycin (ziracin) as a human medicine. The Commission has asked the company to receive this information more officially. The consequence of this is that avilamycin has not anymore a human equivalent which is being developed. For such kind of antibiotics, the opinion of the Scientific Steering Committee is to phase them out. The Commission services remind action 19 foreseen in the White Paper on Food Safety which is a proposal of amendment of Directive 70/524/EEC on additives in feedingstuffs and which will address in particular antibiotics in feedingstuffs.

3 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

A presentation is made by a Member State as regards a change in the manufacturing process of vitamin B2 (riboflavin) authorised as a feed additive. As the modification is a change in the production strain in particular through genetic modification, this will in accordance with Directive 87/153/EEC fixing guidelines for the assessment of additives in animal nutrition, necessitate the submission of documentation suitable for a new assessment The other Member States are invited to indicate which data they would request in order to give guidance to the company who has notified the change and who is elaborating a dossier. The reactions are expected for the next meeting. A rapporteur Member State still has to be found by the Company.

4 Examination and exchange of views on a Draft Commission Regulation amending Directive 70/524/EEC concerning additives in feedingstuffs as regards to trace elements.

The group has examined the draft Commission Regulation amending Directive 70/524/EEC concerning additives in feedingstuffs as regards to trace elements. This Regulation has as objective to reduce the maximum contents of trace elements authorised in feedingstuffs, taken into account the physiological necessities of the animals and excluding growing promoter effects. These provisions shall conduct to minimise soil contamination in particular for copper and zinc.

The group agreed in some technical amendments and drafting points. The Commission indicated that the text might be discussed again where the Scientific Committee on Feedingstuffs gives its opinion as regards to the use of copper as growing promoter and to the physiological requirements for copper.

The Commission agreed to organise a group of experts to study the physiological requirements for pets. S, E, F, D and UK would designate experts for this purpose.

5 Surveillance program of dioxins in binders , anti-caking agents and coagulants : update of the situation.

Commission Regulation (EC) No 739/2000 of 7 April 2000 amending Regulation (EC) No 2439/1999 on the conditions for the authorisation of additives belonging to the group 'binders, anti-caking agents and coagulants" in feedingstuffs did prolong the measures until 15 October as the investigations and the monitoring programme are still ongoing. Sufficient monitoring data on the presence of dioxins had been provided for in natural mixtures of steatites and chlorites, sepiolite and sepiolitic clay. These data indicated that these additives are not contaminated with dioxins or contain levels of dioxins below the threshold of the analytical method to provide a determination. It was therefore appropriate that the footnote requiring monitoring should no longer apply to these additives.

In the meantime more data have been provided and it was decided to create a working group to examine the provided data in more detail. The working group was also asked to examine in detail the way the data were reported especially with regard the quality of the data provided and the reporting as "upperbound" and "lowerbound".

The Committee was informed that the working group was established and would meet within short notice. Member States were requested to submit the data which are in the "pipeline" as soon as possible in order to enable the working group to include them in their evaluation.

6 CEMA : information on the ongoing activities.

The Committee was informed on the ongoing discussions in the Expert Committee "methods of Analysis - Feedingstuffs"

- Analysis of PCBs in feedingstuffs: PCBs are analysed in the majority Member States by determining the content of the 7 indicator PCBs (PCB congeners IUPAC No. 28, 52, 101, 118, 138, 153, 180) by GC-MS or GC-ECD. Both methods provide reliable results. The JRC has worked out a simplified method for the determination of polychlorinated biphenyls (PCBs) for feedingstuffs by GC/MS.

It was found appropriate to organise a ringtest (proficiency testing) for the analysis of PCBs in feedingstuffs (compound feed and a fishmeal) between the official control laboratories.

- Analysis of dioxins in feed materials and feedingstuffs. The document containing minimum requirements for the method of analysis to be used for official control was referred to the ad-hoc working group dealing with the methods of analysis for dioxins in feedingstuffs.

- Methods of analysis to be used for official control: official method of analysis, routine method, screening method, reference method. An exchange of views on a harmonised approach with regard the use of methods of analysis for official control has taken place.

- Relationship with ISO/CEN: Draft terms of reference for co-operation between Standing Committee for Feedingstuffs and CEN are being finalised.

7. Other points

The Member States were informed of the opinion of the SCAN on diclazuril for rabbits adopted on 28.April 2000. The rapporteur will transmit this information to the company.

8. Information on inspection activities carried out in 1999 pursuant Art 22 of Council Directive 95/53/EC

The representative of the Commission made reference to a fax of 22 March 2000 sent to all delegations on their obligation to made available the result of the activities carried out in 1999 to verify compliance with the relevant community legislation on animal nutrition.

The information should have been made available, at the latest, by 1 April 2000. So far only four Member States provided the reports to the Commission services. The other delegations were asked to provide details on the situation. Five delegations stated that the report was made and was either already sent or on the way to be sent. Five delegations stated that the will provide the report as soon as possible and in any case by June 2000.One delegation was absent.

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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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