SUMMARY MINUTES OF THE MEETING OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH Animal Nutrition Section

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1 SUMMARY MINUTES OF THE MEETING OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH Animal Nutrition Section Brussels, 26 & 27 May 2004 STANDING COMMITTEE 1. Discussion and possible request for opinion on a draft Commission Regulation concerning the permanent authorisation of certain additives already authorised in feedingstuffs (SANCO/1208/2004). This draft Regulation concerned the authorisations without time limit for six additives for chickens for fattening. The additives concerned were: the micro-organism preparation of Enteroccocus faecium DSM 10663/NCIMB 10415, trade name Oralin ; the enzyme preparation of endo-1,4-beta-glucanase, EC , Endo- 1,3(4)-beta-glucanase, EC , and endo-1,4-beta-xylanase, EC , produced by Trichoderma longibrachiatum (ATCC ), trade name Roxazyme G2 ; the enzyme preparation of endo-1,3(4)-beta-glucanase, EC , produced by Aspergillus aculeatus (CBS ), trade name "Energex CT and L ; the enzyme preparation of endo-1,3(4)-beta glucanase EC , and endo-1,4-beta-xylanase EC produced by Penicillium funiculosum (IMI SD101), trade name Rovabio Excel LC & AP ; the enzyme preparation of endo-1,4-beta xylanase, EC , produced by Aspergillus niger (CBS ), trade name Allzyme PT ; and the enzyme preparation of endo-1,4-beta-xylanase, EC , produced by Bacillus subtilis (LMG S 15136), trade name Belfeed B1100 MP/ML. The vote on the draft was taken and it was adopted with 24 Member States in favour and one abstention. 2. Discussion and possible request for opinion on a draft Commission Regulation concerning the authorisation for ten years of the additive Deccox in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances (SANCO/867/2004).

2 The vote was taken and the Committee adopted, by a qualified majority, an opinion in favour of a Regulation on authorising for ten years the additive Deccox, Decoquinate, (E 156) as a coccidiostat for chickens for fattening and linked Alpharma. The following declaration was made by the French delegation: Au cour de la réévaluation, selon l'article 9g de la directive 70/524, de l'additif decoquinate (Deccox) destiné aux poulets à l'engrais, le pétitionnaire n'a pas répondu de façon satisfaisante aux questions des experts français sur l'efficacité de ce produit. N'étant pas convaincue de l'intérêt du décoquinate en tant que coccidiostatique pour les poulets à l'engrais, la France ne peut voter en faveur du texte proposé par la Commission. En revanche, le pétitionnaire ayant amené les preuves de son innocuité, la France s'abstient. 3. Discussion and possible request for opinion on a draft Commission Regulation concerning the permanent authorisation of a colorant and the provisional and permanent authorisations of certain micro-organisms (SANCO/1552/2004). This draft Regulation concerned authorisations without time limit for the following additives: the colourant Astaxantin-rich Phaffia Rhodozyma ATCC for salmon and trout; the micro-organism preparation of Saccharomyces cerevisiae NCYC Sc 47 for sows, trade name Biosaf SC 47 ; the micro-organism preparation of Saccharomyces cerevisiae CBS for calves and cattle for fattening, trade name Yea-Sacc ; the micro-organism preparation of Enterococcus faecium NCIMB for calves, trade name Cylactin ; the micro-organism preparation of Enterococcus faecium DSM 7134 and Lactobacillus rhamnosus DSM 7133 for calves, trade name Provita LE. This draft Regulation also concerned provisional authorisation for a new use of the micro-organism preparation of Enterococcus faecium DSM /NCIMB for dogs, trade name Oralin. The vote was taken and the Committee adopted, by qualified majority, an opinion in favour of the draft Regulation.

3 2. Setting Timetable for Additives 2.1 Levucell SC (Saccharomyces cerevisiae CNCM I-1077). Application for permanent authorisarion for animal categories: dairy cows and cattle for fattening. The provisional authorisation will expire on 30 June Rapporteur: FR. 2.2 Fecinor (Enteroccocus faecium CECT 4515).Application for extension of use. Animal category: Chickens for fattening. (Day 0: 20 April End of the sixty-day period, as laid down in Article 4 (4) of Directive 70/524/EEC: 19 June 2004). Rapporteur: ES. 2.3 Duddingtonia flagrans (Duddingtonia Flagrans, strain: Troll A CBS ). Application for provisional authorisation. Animal category: calves. (Day 0: 5 May End of the sixty-day period, as laid down in Article 4 (4) of Directive 70/524/EEC: 4 July 2004). Rapporteur: IE Econase Wheat Plus, Endo-1, 4-beta-xylanase (EC ) from Trichoderma reesei CBS and endo-1, 3(4)-beta-glucanase (EC ) from Trichoderma reesei CBS Animal categories: broilers, turkeys. Rapporteur: FI. The evaluation period was restarted on 26/05/ Econase BG and Barley P700, Endo-1, 3(4)-beta-glucanase, EC , from Trichoderma reesei (CBS ). Enzyme 26. Animal categories: chickens for fattening, piglets. Request for permanent authorization. Expiry of temporary authorisation Rapporteur: FI Porzyme xylanase dry and liquid, preparation of Endo -1,4 beta xylanase, EC , from Trichoderma longibrachiatum (ATCC 2105). (Enzyme 33) Animal category: piglets. Request for permanent authorization. Expiry of temporary authorisation Rapp UK Porzyme xylanase dry and liquid, preparation of Endo -1,4 beta xylanase, EC , from Trichoderma longibrachiatum (ATCC 2105). (Enzyme 33) Animal category: pigs for fattening. Request for permanent authorization. Expiry of temporary authorisation Rapp UK 2.7. Belfeed B1100 MP/ML (Endo-1,4-beta-xylanase EC ) Animal category: piglets (solid/liquid form). Request for permanent authorisation. Expiry of temporary authorisation Rapporteur: BE Formi LHS, based on potassium diformate as grow promoters, solid form. Animal category: sows Rapporteur: DK. The period of formal check according to Directive 87/153 is finished on 22 May The clock 3 starts on 26 May Belfeed B1100 MP/ML (Endo-1,4-beta-xylanase EC ) Extension of use for the animal category: laying hens (solid/liquid form) Clock restarted on 19/2/ Rapporteur: BE. The evaluation period was stopped on 27/05/2004.

4 Bio Feed Phytase L, Preparation of 6-Phytase, EC , from Aspergillus orizae strain (DSM 14223). Animal category: salmonids. Request for permanent authorisation. Rapporteur: DK. Day 0 of start of full evaluation: The evaluation period was stopped on Exchange of views on implementation of Council and European Parliament Regulation on feed additives 1831/2003. Agenda of Working Group meeting. The Commission (JRC) distributed CD ROM copies of the report of the workshop held on 26 April. The Commission announced that a Working Group meeting on feed additives implementation of the new Regulation 1831/2003 was scheduled to take place on 21 June. The issues to be discussed would be those already discussed at the earlier working group meeting on the same subject plus some additional items indicated by the Commission and some Delegations. 5. Implementation of Regulation (EC) No 1829/2003 on GM food and feed: operation of the 0.9 % labelling threshold (request from BE). The interpretation of Article 24(2) of Regulation (EC) No 1829/2003 was discussed. Article 24(2) read as follows: This section shall not apply to feed containing material which contains, consists of or it is produced from GMOs in a proportion no higher than 0.9% per cent of the feed and of each feed of which it is composed, provided that his presence is adventitious or technically unavoidable. Two cases were raised: 1) Feed material. E.g. a non-genetically modified maize which contained a genetically modified soya in the form of an impurity. Directive 96/25/EC allowed for a level of 5% of botanical impurities (referred to the weight of the product as such). It regarded soya as a botanical impurity of maize. The feed was composed of only one feed which was maize and labelled as maize. The soya could not be regarded as a feed in accordance with the definition of feed laid down in Regulation (EC) No 178/2002 because it was not intended to be used for oral feeding, it was present as an impurity.

5 The presence of the genetically modified material in the feed should, therefore, be calculated in relation to the feed which was the maize, in this example was a feed material. Therefore, if for example there were 100kg of non-gm maize containing 0.9 kg of GM soya as an impurity, the threshold in this case was 0.9 % of the feed, and therefore labelling was not required. If the level of soya was, for example, 0.91 kg, then the soya should be labelled according to Regulation (EC) No 1829/2003. The threshold was calculated in relation to the feed material which was the maize. 2) A compound feed. E.g. a compound feed with three ingredients: non-gm maize (contaminated with GM soya) + non-gm colza + non-gm soya. In this case there were two ways of calculating the threshold: 1. If the soya was an ingredient of the compound feed, the threshold for the GM soya contained as an impurity in the maize should be calculated in relation to the total quantity of soya in the feed (in this case a compound feed) regardless of whether such soya was contained as an impurity of the maize or as a feed material. 2. The GM soya contained in the compound feed as an impurity of the maize should not be viewed as an ingredient but as an impurity in the compound feed, therefore, the threshold should be calculated not on the basis of the soya added as an ingredient, but on the basis of the total feed. (Belgian position) Regulation (EC) No 1829/2003 provided no indication about how to express the results on GM presence. The results could be expressed by weight, but other ways were also possible. For example, the Committee on the Release of GMOs into the Environment had expressed an opinion on 24 May 2004 on a Commission Recommendation on technical guidance for sampling and detecting genetically modified organisms and material produced from GMOs as or in products in the context of Regulation (EC) No 1830/2003. According to this Recommendation, the results of quantitative analysis should be expressed the percentage of the number of target DNA sequences per target taxon specific sequences calculated in terms of haploid genomes. A similar approach could be followed in the context of Regulation (EC) No 1829/2003. The delegations and the Commission indicated that: This issue needed further discussion. Each result should be examined on a case-by-case basis taking into account not only the results of an analysis but also the information included in the documentation for the purpose of traceability. The examination of feed materials was very important. The information on the label should not mislead the user and should be in line with the requirements of the Regulation. The threshold only applied when the presence of GM material was adventitious or technically unavoidable.

6 At the request of one delegation, a Commission representative explained that additives which do not need to be indicated on the label of compound feedingstuffs in accordance with Directive 70/524/EEC must be indicated on the label in accordance with the provisions laid down in Articles 24 and 25 of Regulation (EC) No 1829/2003, if those additives fell within the scope of such Regulation. 6 Legal status for high-concentration calcium products used in the last days of gestation. These products were modern oil and paste formulations of high-concentrated calcium which were used before and after calving for a short period of time to prevent milk fever. Some of these products were regarded as medicinal products while others were deemed to be complementary feed. The delegations agreed that these types of product should be carefully examined on a case-by-case basis in the context of Directive 93/74/EEC on feedingstuffs intended for particular nutritional purposes. This would make it possible to check whether these products might fall within the Directive s scope. 7 Undesirable substances in animal feed- Update and exchange of views on several items under discussion. Update on discussions on undesirable substances in feed by the Panel on Contaminants (CONTAN Panel) in EFSA The Committee was informed that the scientific opinions on lead and cadmium were expected to be adopted and to become available shortly. Once the opinions were available, the current provisions on maximum lead and cadmium in the Annex to Directive 2002/32/EC on undesirable substances in animal feed would be reconsidered and if necessary modified. The discussions on a scientific opinion on deoxynivalenol and zearalenone in animal feed were ongoing within EFSA and the adoption of an opinion was expected possibly within one month. Aflatoxin B1. It was noted that aflatoxin B1 had been included in the coordinated inspection programme for 2004 (Commission Recommendation 2004/163/EC of 17 February 2004 on the coordinated inspection programme in the field of animal nutrition for 2004 in accordance with Council Directive 95/53/EC). Monitoring should focus as far as possible on feed materials at risk and compound feedingstuffs intended for dairy animals. Particular attention should be paid to compound feedingstuffs intended for dairy animals other than dairy cattle.

7 With regard to possibly setting action levels for aflatoxin B1, several delegations expressed some reservation on this point, while other delegations were of the opinion that setting action levels for aflatoxin B1 was appropriate. The Commission said that at the next meeting it would be asking the delegations for their view on the appropriateness of setting action levels before possibly initiating any discussions on possible levels. Residues of prohibited pesticides Commission Directive 2004/61/EC of 26 April 2004 as regards maximum residue levels for certain pesticides prohibited for use in the European Community established maximum residue levels for prohibited pesticides at the lower limit of analytical determination. Given the fact that compound feedingstuffs were complex matrices with possible analytical interferences it was important that a discussion took place on the lower limit of analytical determination in the case of animal feed. One delegation mentioned also the importance of considering the issue of carry-over so that the maximum residue levels set for food of animal origin could be complied with. A specific working group would be established to consider these issues in detail. A delegation mentioned that the abovementioned Directive established a maximum residue level for mercury compounds, in cereals for example, which was different from the maximum level established for mercury in Directive 2002/32/EC on undesirable substances in animal feed. The Commission indicated that the maximum residue level established in Commission Directive 2004/61/EC only took into account the prohibited use of pesticides based on mercury compounds while the maximum level in Directive 2002/32/EC also took into account the environmental sources of mercury contamination. From a legal point of view the maximum level established in Directive 2002/32/EC for mercury in animal feed took precedence over provisions in Commission Directive 2004/61/EC. 8. EFSA opinion on Avatec in accordance with Art.9g Dir. 70/524. A Commission representative presented a short summary of the European Food Safety Authority s opinion on Avatec 15% and the position on this coccidiostat being re-evaluated according to Article 9g of Directive (EEC) No 70/524. The Committee was informed that the company Alpharma had been requested to supply the missing data as soon as possible in order to fully clarify the questions about safety. The EFSA was asked to issue an opinion on the new data in order to complete the procedures. 9. State of play on implementation of Directive 2002/2/EC The Belgian, Austrian, Swedish and Czech delegations indicated that their authorities had decided to be flexible in cases where non-compliance with the national measures transposing the Directive was established.

8 The German delegation informed the Committee that an administrative court of the Land of North Rhine-Westphalia had provisionally suspended application of the controversial measures for the operator who had lodged the appeal but only regarding specific products. It also indicated that an appeal was pending in two other Länder. Addendum: Results of the coordinated inspection programme in the field of animal nutrition for 2003 in accordance with Council Directive 95/53/EC, as laid down in Commission Recommendation 2003/91/EC The Commission representative presented a summary of checks concerning feeding restrictions for feed of animal origin in accordance with Annex I of Commission Recommendation 2003/91/EC on the coordinated inspection programme for Data regarding controls laid down in this Recommendation as well as national reports on the results of other official controls carried out during 2003 should have been submitted to the Commission before April Although some Member States had already presented their data, several Member States had not done so yet. Member States were requested to send the missing data by 30 June Any other business - The chairman clarified the status of the following additives awaiting a permanent authorisation: *The dossier on the enzyme preparation of endo-1,3(4)-beta-glucanase, EC , produced by Aspergillus aculeatus (CBS ), trade name Energex: this enzyme was included in the draft Regulation submitted during this meeting to the Committee with a request for opinion under Point 1 (document SANCO/1208/2004). *The dossiers on the enzyme preparation of endo-1,4-beta-xylanase EC and endo-1,4-beta-glucanase EC produced by Humicola insolens (strain DSM 10442), trade name Bio-Feed Plus, and the enzyme preparation of endo-1,4-beta-xylanase, EC produced by Aspergillus oryzae, trade name Bio-Feed Wheat: after completion of the Commission interdepartmental consultation it was planned to request the Committee s opinion on on a draft Regulation on permanent authorisation of these enzymes. * The dossier on the enzyme preparation Alpha-amylase EC and endo-1,3(4)-beta-glucanase EC , trade name Bio-Feed Alpha: EFSA s opinion on this enzyme was awaited. If the opinion were favourable, a draft Regulation on permanent authorisation would be prepared. *The dossier on the enzyme preparation 6-Phytase, EC , from Aspergillus orizae, change of strain from DSM to DSM 14223, trade name Bio-Feed Phytase: EFSA s opinion on this enzyme was expected soon. If the opinion were favourable, a draft Regulation on permanent authorisation would be prepared. In addition, Article 46(5) of Regulation (EC) No 1829/2003, implemented by Article 8 of Regulation (EC) No 641/2004, applied to this enzyme which was a product falling under the scope of

9 Regulation 1829/2003. This meant that a separate application for authorisation had to be submitted in accordance with Article 17 of Regulation (EC) No 1829/2003 with a view to placing the additive on the market. As regards the strain of the enzyme currently mentioned in the existing authorisation, this could be notified as an existing product according to Article 20 of Regulation (EC) No 1829/2003 but it would need a permanent authorisation further to the legislation on additives in order to be allowed on the market after the expiry of the current provisional authorisation. * The dossier on the micro-organism preparation of Enterococcus faecium NCIMB 11181, trade name Lactiferm : after receipt of additional studies expected by mid-june 2004, this micro-organism would be the subject of a draft Regulation on permanent authorisation for piglets and calves to be submitted to the Committee as soon as possible for a request for opinion. - At the Chairman s request the Belgian delegation briefly reported on the PCBcontamination of eggs derived from free-ranging animals. It informed the Committee that the originating farm had been identified and that the authorities now had the situation under control and were further investigating the precise source of the contamination while awaiting the results of ongoing dioxin analysis. - An updated list containing contact details for Heads of Delegation and contact points for handling dossiers on feed additives and bioproteins was circulated with the request that it be added to and updated as necessary.