SUMMARY RECORD OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH HELD ON DECEMBER 2009 IN BRUSSELS (Section Animal Nutrition)

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EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL D(2009)411967 SUMMARY RECORD OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH HELD ON 17-18 DECEMBER 2009 IN BRUSSELS (Section Animal Nutrition) President : Mr Willem PENNING 1. Feed Additives 1.1. Applications under Regulation (EC) No 1831/2003 Art. 4 1.1.1. New applications New applications have been presented to the Member States. 1.2. Applications under Regulation (EC) No 1831/2003 Art. 9 1.2.1. Discussion on EFSA scientific opinion on the safety and efficacy of Finase EC (6-phytase) as feed additive for chickens for fattening and reared for laying, laying hens, turkeys for fattening and reared for breeding, ducks and other minor species, piglets (weaned), pigs for fattening and sows A discussion took place. The Commission will submit a draft Regulation to the vote for some species. The company will be asked for information on the missing parts. 1.2.2. Discussion on EFSA scientific opinion on the safety and efficacy of Bonvital (Enterococcus faecium) as a feed additive for dogs A discussion took place. The company will be asked for further information. 1.2.3. Discussion on the EFSA scientific opinion on the safety of a copper chelate of hydroxy analogue of methionine as feed additive for all species

A discussion took place. A draft Annex entry will be prepared for the next meeting. 1.2.4. Discussion on the EFSA scientific opinion on the safety of a zinc chelate of hydroxy analogue of methionine as feed additive for all species A discussion took place. A draft Annex entry will be prepared for the next meeting. 1.3. Applications under Regulation (EC) No 1831/2003 Art. 25 1.3.1. Endo-1,3(4)-betaglucanase (EC 3.2.1.6), Endo-1,4-beta-glucanase (EC 3.2.1.4), Alpha-amylase (EC 3.2.1.1.), and Endo-1,4-beta-xylanase (EC 3.2.1.8) (enzyme 54) laying hens. Application for permanent authorisation. Rapp. : BE The Belgian representative presented the new dossier. 1.4. Re-evaluation Article 10 (2) A review of the status of the re-evaluation process took place. The Commission announced its intention to send a second reminding letter to notifiers of existing products of the notification process of 2004 requesting information about the intentions to submit applications for re-evaluations. The text of the letter was made available to Member States' delegations. EFSA presented its activities regarding the re-evaluation process. An exchange of views took place exploring several ways in which Member States could help the Commission and EFSA at particular stages of the process. It was considered desirable to pursue further discussions to clearly establish activities where this possible collaboration could take place within the framework foreseen in Regulations (EC) N 1831/2003 and 178/2002. 1.5. The use of unauthorised feed additives in animal trials Upon request of one Member State on the interpretation of Article 3 (2) of Regulation (EC) N 1831/2003 concerning the possibility for granting authorisation by Member States for additives not authorised at the level of the Union, it was the common understanding of all Member States and the Commission's representative that these authorisations are meant to be 'ad personam' decisions for the purpose mentioned in the said article. 2. Implementing measures of Regulation (EC) N 767/2009 2.1. Borderline between feed materials and feed additives (Article 7)

A discussion on the borderline issue took place based on a working paper with concrete products to be classified as feed materials with reference to Article 7(2) of the new Regulation. A majority of delegations supported the initiative to clarify the situation in the interest of a harmonisation of the common market and many of them explicitly were in favour of a phasing out of a double listing of products in the feed additive register and the list of feed materials. On the concrete substances, modifications were suggested and wishes for further product descriptions were expressed. The Commission services will revise the list in the light of the discussion and will present an updated version in one of the next meetings. 2.2. Community catalogue of feed materials A discussion took place on the working document and the adoption of the draft Regulation will probably be scheduled for February 2010. 2.3. Establishment of a transitional period concerning the labelling (Article 32 (4)) A Commission representative presented a draft Regulation on transitional measures concerning the labelling provisions which was supported by all delegations. The draft will be presented for a vote in the next Committee. 2.4. Update of Annex III of Regulation (EC) N 767/2009 A discussion took place on the working document and the draft Regulation will be scheduled for adoption probably in February 2010. 2.5. Revision of Annex IV for analytical tolerances Based on the discussions of the respective expert group in October and the working documents sent out by the Commission in November, concrete proposals for modifications of Annex IV have been elaborated. In particular, the exchange of views on the changes for the parameters in paragraphs 2a-2c consequently to the application of the statistical data on measurement uncertainties lead to further adjustments covering as well the issues of pet food and moist feed. A revised version of Annex IV will be presented in one of the next Committees. 3. Issues related to undesirable substances in feed 3.1. Discussion on a draft Commission Regulation defining acceptability criteria for detoxification processes in application of Article 8 of Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed It was clarified that the scope of the proposed draft Regulation defining acceptability criteria for detoxification processes is limited to the undesirable substances falling within the scope of Directive 2002/32/EC, which means e.g. that microbial contamination is outside the scope, whereas Fusarium-toxins are within the scope. The provisions of the Regulation do no apply to physical detoxification processes consisting of only mechanical actions (cleaning, sorting, de-hulling, ).

The delegations were of the opinion that some provisions of the draft Regulation should be modified in order to minimise the administrative burden for authorities. The Commission representative indicated to take these comments into account, to adapt the text accordingly and to send the draft as working document for comments to the stakeholder organisations. 3.2. Discussion on possible provisions as regards discussion on non-dioxin like PCBs in feed A short discussion took place. Member States were asked to check the suggested maximum levels as regards the achievability taking into account nationally available data. The Committee was informed of the concerns expressed by an organisation as regards the suggested levels for fish oil and fish meal. 3.3. Discussion on the review of the provisions on dioxins and dioxin-like PCBs in feed and the influence of using the new TEF 2005 A short discussion took place. Member States were asked to check the suggested maximum and action levels, using the new TEF2005, as regards the achievability taking into account nationally available data. The Commission representative indicated that at next meeting a discussion will also take place on the need to keep the concept of "target level". 3.4. Replacement of the current annex to Directive 2002/32/EC on undesirable substances in feed integrating all amendments since 2002 The Committee was informed on the outcome of the questionnaire as regards the extraction method to be used for the determination of lead (Pb), cadmium (Cd), mercury (Hg), Arsenic (As) and fluorine (F). Based on the comments received, following proposal was made to change the footnotes as follows: - for lead and cadmium: Maximum levels refer to an analytical determination of lead/cadmium, whereby extraction is performed following the extraction procedure described in the European standard EN 15550 "Animal feedingstuffs Determination of cadmium and lead by graphite furnace atomic absorption spectrometry (GF-AAS) after pressure digestion". Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency. - for fluorine Maximum levels refer to an analytical determination of fluorine, whereby extraction is performed with hydrochloric acid 1 N for 20 minutes at ambient temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency (= the current footnote) -for arsenic and mercury: Maximum levels refer to an analytical determination of arsenic/mercury, whereby extraction is performed with 65% HNO 3 and 30% H 2 O 2, applying pressure digestion. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency.

The Commission representative questioned furthermore the appropriateness to keep the current footnotes mentioning that maximum levels should be reviewed with the aim of reducing the maximum level and this for certain provisions on lead, cadmium, fluorine and camphechlor. A specific request on this will be addressed by email to the delegations. The Commission representative informed the meeting to present at the next meeting an updated annex to Directive 2002/32/EC for discussion 3.5. Assessment of the current provisions as regards mycotoxins in feed Given that no concrete proposal was elaborated, taking into account the discussions at the last meting, no discussion took place on this agenda item. 4. Sampling of feed Discussion on the sampling provisions provided for in Annex I of Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed. Agreement on the general orientations for possible amendment, to be technically worked out by a working group. Delegations welcomed the resumption of this activity and highlighted the importance and urgency of it. Most delegations were in favour of a review of the current sampling provisions in particular to adapt to recent developments in the way feed is currently produced, stored, transported and marketed and to pay particular attention to sampling provisions for silage, for feed in silo's, for very large lots stored in warehouses or transported. The review of the sampling provisions will be prepared in a small working group. Delegations are requested to appoint experts to participate in a small working group on sampling. 5. Exchange of views on the electronic Working Group relating to future work on animal feeding in Codex Alimentarius A quick overview of the replies sent by participants after the proposals by the chair took place. 6. A.O.B. An overview of recent RASFF notifications on undesirable substances in feed was given: arsenic in di-calcium phosphate from China, aflatoxins in maize from Italy and the Netherlands, aflatoxins in groundnuts from Argentina, dioxins in sunflower seed from Italy, dioxins in bentonite from Spain, lead in zinc oxide from India. France updated the Committee on their investigations of the presence of dioxins in sulphur. The Commission representative clarified that sulfur is not an

authorised feed additive in the EU. The French authorities were requested to investigate the intended use of the sulfur added to the feed by the feed business operator and to report back to the Committee. Status of fishing baits In response to a question raised by the Belgian delegation, a Commission representative indicated that it was not the intention of the legislator to exclude fishing baits from the concept of "feed", as covered by Regulation (EC) No 767/2009, taking into account : - the definitions provided for in Regulation (EC) No 767/2009, and in particular the definition of "feed materials" which is drafted in sufficiently broad terms; - the need of consistency of Community legislation, considering the reference made in Article 18 of Regulation (EC) No 1069/2009 to maggots and worms for fishing bait in a context of animal feeding. Interpretation of Article 24(6) of Regulation (EC) No 767/2009 Further to a question raised by the Belgian delegation, a Commission representative confirmed that the term "for the first time" concerns the person who places a feed material on the market that is not listed in the Catalogue, considering in particular the objective of transparency pursued by the legislator. Bernard Van Goethem, Director (signed)