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Food Safety

Regulatory Committees Standing Committee for Animal Nutrition

Short report of the meeting held on 12-13 July 2000

CHAIRMAN: D.André for points 3, 4, and 5
A. Rodriguez for point 7
F. Verstraete for points 8, 9 and 10
J. Thibeaux for all the other points

1. 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 derivatives in feed).

This item has not been treated

2. Final report on the «Requirements concerning the efficacy for micro-organisms in animal categories dogs, cats and horses». Discussion and conclusion.

The report on the « Requirements concerning the efficacy for micro-organisms in animal categories dogs, cats and horses » was discussed. Several Member States commented on the report. In order to prepare a new draft the Commission asked the Member States to send their comments in writing as soon as possible.

3. Examination of an application for authorisation of sodium benzoate (E 211), propionic acid (E280), sodium propionate (E281) (group of preservatives) - "KOFA GRAIN pH 5"- pigs- dairy cows, cattle for fattening (Rapporteur: D) as foreseen under article 4 paragraph 6 of Council Directive 70/524/EEC: interruption of the evaluation period

As foreseen under article 4 paragraph 6 of Directive 70/524/EEC, the time limit is interrupted where a request is made for additional information. This is the case as several delegations have submitted comments in writing to the Commission and Austria has asked orally in the meeting for a tolerance study in target species. The evaluation is thus stopped on the 13 th of July, which is the day 98 of the 320 days evaluation period.

The Ad hoc group of the SCAN will establish the list of possible questions in its meeting on the 17 th of July and the Commission will forward these questions to the rapporteur.

When the supplementary dossier concerning the questions raised by Member States and possibly by the SCAN will be provided by the company, the evaluation of the product will start again at the next Standing Committee meeting taking place 15 days after the dispatch date of the complementary dossier.

4. 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)

The Commission representative informs the Member States of the state of play of the evaluation of these safeguard clauses by the SCAN and by the CVMP.

The SCAN has discussed extensively a draft opinion in the plenary of 21-23 June. The main conclusion is that DMZ is a non genotoxic tumorigen and that when the withdrawal time is respected, the residues are of no concern for the consumer. Two members of the SCAN could not agree with these conclusions for reasons they have explained and which will be recorded in the opinion. These reasons are in fact very similar to the CVMP position of 8 December 1999 under particular consideration genotoxicity and carcinogenicity on the use of Dimetridazole (this document has been presented briefly). Some calculations on the residues of Dimetridazole in different tissues have to be reviewed before the draft can be put into written procedure for adoption during the summer.

The Member States will be receiving the SCAN opinion when available and it is reminded that SCAN opinions can be found on the internet site of DG Health and Consumer Protection.

The Commission will then take the necessary legislative measures. In the present case, it appears that there is scientific uncertainty. The Commission draws the attention to the fact that an important factor for future Commission measures will be whether a dossier is submitted by the company not later than 30 September 2000 for the re-evaluation as foreseen under article 9g paragraph 4 of Directive 70/524/EEC.

5. State of play by the rapporteur Member States on the dossiers to be submitted for a re-evaluation under article 9g paragraph 4 of Directive 70/524/EEC.

Article 9 g paragraph 4 of Directive 70/524/EEC prescribes that the rapporteur shall ensure that the person responsible for putting an additive as referred to in paragraph 1 submits, as provided for in article 4 and no later than 30 September 2000, the dossier with a view to re-evaluation.

The status on the 13 th of July of the evaluation by the respective rapporteurs (UK: 9 dossiers, F: 6 dossiers and B: 1 dossier) of the dossiers for the re-evaluation of the authorisations of 2 antibiotic uses and of 12 coccidiostats and other medicinal substances uses has been discussed.

Several dossiers have been deemed by the rapporteur to have been compiled in accordance with Directive 87/153/EEC and will be distributed soon to the Member States and to the Commission, some others are still being evaluated by the rapporteur but should be in accordance with the guidelines in time, some have just arrived and 3 are still not submitted to the rapporteur. The different rapporteurs are reminded by the Commission representative to proceed in a harmonised way in this matter.

6.1 Examination of 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. Minor errors were identified in the annexes and corrected. The Commission representative explained that, for procedural reasons, the draft Regulation couldn't be proposed for a vote in July. The vote will take place at the September meeting of the Standing Committee.

6.2 Examination of an application for the new use of an additive, as foreseen under article 4 paragraph 6 of Council Directive 70/524/EEC:

endo-1,4- b xylanase produced by Bacillus subtilis LMG S-15136, Belfeed â , in piglets.

A brief summary of the outstanding questions related to the Belfeed â extension dossier to piglets was circulated to the Member States. The representative of the Commission asked if Member States intended to ask additional questions. Two of them indicated that they would send a letter related to the extension dossier before 31 July 2000. According to article 4, paragraph 6 of Directive 70/524/EEC, and with due consideration to the internal agreement on the periods of evaluation, it was therefore decided to interrupt the present phase of evaluation on 6 August 2000. The dossier evaluation will resume when answers to all questions are addressed.

7. 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.

An exchange of views has taken place. The Member States generally welcomed the working document. Several amendments were proposed. The discussion will be continued at the next meeting of the Committee.

8. Organisation of a ring trial for the official control of PCBs in feedingstuffs. Discussion and establishment of a list of participating laboratories (cf. multifax to the Member States - to follow).

The Committee was informed of the organisation of a proficiency trial to evaluate the performance and comparability at EU level of the analysis of PCBs in feedingstuffs. 30 laboratories, appointed by the competent authorities can participate. Three poultry feed samples, spiked with different levels of PCBs, and a fish meal sample will be prepared for this trial. Each laboratory can use its own method and the laboratories which are able to analyse the PCB content with the simplified GC/MS method developed by the Joint Research Centre of the EC can do this in addition. A multifax in order to request competent authorities to appoint the laboratories will be sent.

9. Contamination by dioxins of a preparation of choline chloride: Update of the situation.

The contamination of the choline chloride by dioxin has been discussed extensively.

The information provided by the Spanish authorities indicate clearly that the pure choline chloride (78%) originating from Belgium is not contaminated. The contamination finds its origin in the carrier, more in particular and mainly in the pentachlorophenol treated pine sawdust used as a component for 25 % in the carrier indicated as "corn cob meal". The eventual role of the use of contaminated rice husks as potential additional source of contamination needs further clarification.

Therefore, following the provisions of Commission Decision 91/516/EC of 9 September 1991 establishing a list of ingredients whose use is prohibited in compound feedingstuffs, the use of "wood, sawdust and other materials derived from wood treated with wood protection products" is prohibited in compound feedingstuffs.

The use of sawdust contaminated with pentachlorophenol (PCP) can be detected through the very specific congener pattern. The Committee agreed that levels of dioxin found above 0.5 ng/kg with the specific PCP-congener pattern is an indication that PCP-treated sawdust is used, which is not in conformity with the provisions of the above-mentioned Commission Decision 91/516/EC.

The Committee agreed upon the measures to undertake urgently, in so far not yet done, to avoid that contaminated preparation of choline chloride and premixtures containing contaminated choline chloride can enter the feed chain.

The Committee was informed of the actions already undertaken by the different Member States and Member States were requested to inform further the Commission and the other Member States of the measures taken, the results of the analysis and the way of disposal of the quantities of contaminated preparation choline chloride and contaminated premixtures containing choline chloride.

At the request of a Member State the Committee agreed that choline chloride put on a carrier has to be considered as a feed additive (preparation) and is not a premixture.

10. Undesirable substances and products in feedingstuffs: Further follow-up of recent contamination cases.

Dioxins and PCBs in feed materials and compound feedingstuffs (including fish feed)

At the request of Denmark, the application by the Netherlands and Germany of maximum permitted levels of dioxins in fish oil and fish feed respectively has been discussed under this agenda item and the following was clarified in the Committee:

- As the consequence of the Belgian dioxin crisis, the Dutch authorities notified, in accordance with article 9 of Council Directive 1999/29/EC of 22 April 1999 on the undesirable substances and products in animal nutrition, on 20 July 1999 to the Commission the application of a maximum limit of 6 ng WHO-TEQ dioxins kg fat for feed materials and feedingstuffs. This notification was presented at the meeting of the Standing Committee for Feedingstuffs of 14-15 September 1999.

- The Belgian delegation informed the Standing Committee for feedingstuffs on 28-29 February 2000 of the draft national measures they intend to take concerning the establishment of maximum limits for dioxins and PCBs in certain feed materials and feedingstuffs. These national measures have been adopted in May 2000

- The Committee agreed respectively in the meeting of 14-15 September 1999 and in the meeting of 28-29 February 2000 to examine these national measures in detail simultaneously with the discussion on the Community measures concerning the same subject. As long as no Community decision has been taken concerning the acceptance of the measures, The Netherlands and Belgium can maintain their national measures

- At the meeting of the Committee on 20 June 2000, the delegation of Germany informed the Standing Committee for feedingstuffs of the finding of dioxins at a level of 2,59 ng ITEQ/kg dry matter in a fish feed originating from Denmark. The German authorities informed the Committee that they are of the opinion that fish feed at that level of contamination cannot be considered as being of "sound, genuine and of merchantable quality" as required by the EU legislation. Therefore the lot had been seized and the marketing and the use thereof had been prohibited.

The Commission indicated at that meeting that the finding of such a level is not unusual if the fish feed is made of feed materials originating from certain regions . However in the absence of any Community measures, it is up to the Member States individually to define the level above which a feed material and feedingstuff can no longer be considered as "sound, genuine and of merchantable quality".

- However, if a certain maximum level for an undesirable substance for which no Community level exists is applied by a competent authority in a systematic way, the Commission stated that the authorities in question have to notify their measures to the Commission and the other Member States, in accordance with the provisions of Article 8 of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and in accordance with the provisions of Article 9 of Council Directive 1999/29/EC of 22 April 1999 on the undesirable substances and products in animal nutrition.

- At this occasion the Committee was informed of three other notifications by the Netherlands concerning draft measures

- proposing to lay down maximum limits of PCBs for animal and vegetable oils and fats, fish oil compound feed, including fish feed.

- proposing to lay down maximum limits of deoxynivalenol (DON) for feed materials based on wheat and for compound feedingstuffs

- proposing separation of production lines to avoid cross contamination of ruminant feed by meat and bone meal.

In the above cases the Commission has asked further clarification and/or justifcation of the measures. In the meantime the Netherlands cannot take the measures.

Possible high levels of cadmium in zinc sulphate originating from China

The issue of possible high levels of cadmium in zinc sulphate originating from China, mentioned at previous meeting, has been raised. No new information was available.

11. Surveillance program of dioxins in binders, anti-caking agents and coagulants: update of the situation and outcome of the discussions of the ad hoc working group. Conclusions and further follow up.

On the basis of the report of an ad-hoc working group discussed at the previous meeting of the Committee, a proposal for amending Commission Regulation 739/2000 of 7 April 2000 amending Regulation (EC) No 2439/1999 on the conditions for authorisation of additives belonging to the group of 'binders, anti-caking agents and coagulants' in feedingstuffs will be presented at the next meeting for opinion.

12. Directive 94/39/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes: Reduction of Accumulation of Dental Plaque and Calculus (Tartar)": Letter from the Belgian authorities dd. 19.05.2000.

An exchange of views has been taken place.

13 (ev.) Commission Decision 2000/285/EC of 5 April 2000 amending Decision 91/516/EEC establishing a list of ingredients whose use is prohibited in compound feedingstuffs. Letter from the German authorities (to follow).

The point has not been treated.

14. Other points

The Commission representative presents the letters of two companies (KRKA , Alpharma) to the Commission as regards the decision, which was taken in the Standing Committee meeting of 6. April 2000 for their applications (respectively salinomycin 120G - "Koksican"-chickens for fattening and salinomycin 120G- "BIO-COX 120G "- chickens for fattening), decision which was followed by letters sent by the Commission to those firms informing that the evaluation of these applications was stopped at this stage and highlighting the deficiencies in the dossier. After an in depth discussion in the Committee, the Commission and the Member States agreed on the elements which will be given in the answer of the Commission to both companies (which will be copied to the Member States for information).

A request was made by a delegation to know the current situation concerning the control measures applied to guarantee that citrus pulp pellets originating from Brazil are in compliance with the maximum limit of 0.5 ng TEQ/ kg product. The Commission informed that there is nothing new but the Brazilian authorities have still to submit their annual report for 1999 concerning the application of the national monitoring system. The Commission will insist to receive this report in order to be able to judge if the recommendations of the mission reports have been implemented.

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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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