4. Products falling within the scope of Directive 82/471/EEC 4.1 L-Histidine monohydrochloride monohydrate

Transcription

1 The Standing Committee on Food Chain and Animal Health Section Animal Nutrition - which will take place on February 2005 (the meeting will be held in the CCAB, meeting room rue Froissart in Brussels. The meeting will begin 10.a.m. (local time). Standing committee 1. Discussion and possible request of opinion on a draft Commission Regulation concerning the permanent authorisation of an additive and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs 2. Feed additives 2.1. Applications under Regulation (EC) No 1831/ Directive 94/39/EC 3.1 Reduction of milk fever. Rapporteur: SE 3.2 Support of respiratory function in horses. 4. Products falling within the scope of Directive 82/471/EEC 4.1 L-Histidine monohydrochloride monohydrate 4.2 Vitalys liquid and Vitalys dry, l-lysine-sulphate (produced by fermentation with corynebacterium glutamicum).rapporteur DK 4.3 L- Arginine 5.- Legal status for creatine in animal nutrition. 6. Undesirable substances: a) Measures under discussion as regards - dioxins and dioxin-like PCBs - lead, cadmium and fluorine Discussion on the outcome of the consltation of the stakeholders b) Continuation of the discussions on the measures as regards deoxynivalenol, zearalenone and ochratoxin A EXPERT COMMITTEE 1. Feed additives 1.1. Microorganisms

2 1.1.1 MLB (Lactobacillus acidophilus DSM 13241). Application for provisional authorisation for the animal category: Cats. The evaluation period (clock 3 second part, art. 4 par. 6 of Dir. 70/524/EEC) re-started as from 7 September Rapporteur: DK. Annex Entry MLB (Lactobacillus acidophilus DSM 13241). Application for provisional authorisation for the animal category: Dogs. The evaluation period (clock 3 third part, art. 4 par. 6 of Dir. 70/524/EEC) re-started as from 27 September Rapporteur: DK. Annex Entry Pioneer PDFM (Enterococcus faecium ATCC Enterococcus faecium ATCC 55593). Application for permanent authorisation. Animal category: Chickens for fattening. The provisional authorisation will expire on 30 June Rapporteur: UK. Annex Entry Biosprint BCCM tm / MUCL (Saccharomyces cerevisiae BCCM tm / MUCL 39885). Application for permanent authorisation. Animal categories: Piglets and cattle for fattening. The provisional authorisation will expire on 30 June Rapporteur: IT Fecinor (Enteroccocus faecium CECT 4515). Application for permanent authorisation. Animal category: Piglets. The provisional authorisation expired on 1 April Rapporteur: ES Fecinor (Enteroccocus faecium CECT 4515). Application for extension of use. Animal category: chickens for fattening. The evaluation period (clock 3 as laid down in art. 4(6) of Directive 70/524/EEC) re-started as from 25 January Rapporteur: ES Levucell SC (Saccharomyces cerevisiae CNCM I-1077). Application for permanent authorisation for animal categories: dairy cows and cattle for fattening. The provisional authorisation will expire on 30 June Rapporteur: FR. Annex Entry Biosaf Sc 47 (Saccharomyces cerevisiae NCYC Sc 47). Application for permanent authorisation. For the animal category: Rabbits for fattening. The expiry date of provisional authorisation: 30 June 2004.Rapporteur : FR. Annex Entry Biosaf Sc 47 (Saccharomyces cerevisiae NCYC Sc 47).Application for permanent authorisation. For the animal category: Dairy cows. The expiry date of provisional authorisation: 31 May Rapporteur : FR Bactocell (Pediococcus acidilactici CNCM MA 18/5M). Application for permanent authorisation. For the animal category: Piglets, Pigs for fattening and Chickens for fattening.the expiry date of provisional authorisation: 30 June Rapporteur: FR BioPlus 2B (Bacillus licheniformis DSM 5749 Bacillus subtilis DSM 5750). Application for extension of product shelf life for all authorised animal categories. Rapporteur: DK Bioplus 2B (Bacillus licheniformis DSM 5749 Bacillus subtilis DSM 5750). Application for permanent authorisarion for the animal category: Turkeys for fattening.

3 The provisional authorisation will expire on 23 November Rapporteur: DK. Annex Entry BioPlus 2B (Bacillus licheniformis DSM 5749, Bacillus subtilis DSM 5750). For: calves. Application for permanent authorisation. The provisional authorisation expired on 28 February Rapporteur: DK. Annex Entry Yea Sacc (Saccharomyces cerevisiae, CBS ). Application for authorisation to change the concentration of the preparation. For all animal categories already authorised. Start of the evaluation period: Rapporteur: BE Oralin (Enterococcus faecium DSM NCIMB 10415). Application for permanent authorisation. For the animal category: Piglets. The expiry date of provisional authorisation: 30 June 2004.Rapporteur: DE Cylactin LBC (Enterococcus faecium NCIMB 10415). Application for permanent authorisation. Animal categories: Chickens for fattening. The provisional authorisation will expire on 30 June Rapporteur: DE Cylactin LBC (Enterococcus faecium NCIMB 10415). Application for permanent authorisation. Animal categories: Sows. The provisional authorisation will expire on 30 June Rapporteur: DE Cylactin LBC (Enterococcus faecium NCIMB10415). Application for permanent authorisation. Animal categories: Piglets. The provisional authorisation will expire on 30 June Rapporteur: DE Cylactin (Enterococcus faecium NCIMB 10415). Application for permanent authorisation. For the animal category: Pigs for fattening. The expiry date of provisional authorisation: 30 June 2004.Rapporteur: DE Reuteri (Lactobacillus reuteri ATCC 55148). For chickens for fattening. Application for provisional authorisation. Rapporteur: SE Toyocerin (Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012). Application for permanent authorisation for the animal category: Chickens for fattening. Provisional authorisation expires on 7 October Rapporteur: ES Toyocerin (Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012). Application for permanent authorisation for the animal category: Rabbits for fattening. Provisional authorisation expires on 7 October Rapporteur: ES Biacton (Lactobacillus farciminis CNCM MA 67/4R). Application for permanent authorisation. For the animal category: Piglets. The expiry date of provisional authorisation: 30 June 2004.Rapporteur : FR Biacton (Lactobacillus farciminis CNCM MA 67/4R). Application for extension of use. For the animal categories: Chickens for fattening, turkeys and laying hens.. The evaluation period (clock 3 first part, art. 4 par. 6 of Dir. 70/524/EEC) started as from 3 December Rapporteur: FR Turval B0399 (Kluyveromyces marxianus-fragilis B0399 ) Application for provisional authorisation. Animal category: Piglets. The evaluation period

4 (clock 3 third part, art. 4 par. 6 of Dir. 70/524/EEC) re-started as from 9 December Rapporteur: IT Coccidiostats Salinomax 120G Salinomycin sodium. Animal category: chickens for fattening. Rapporteur: B. Annex entry Clinacox 0.5% Active substance: Diclazuril (R064433) CAS Coccidiostat for rabbits for fattening and breeding. Request for permanent authorisation. Rapporteur: BE 1.3. Growth promoters Formi LHS, based on potassium diformate as grow promoters, solid form. Animal category: sows. Rapportuer: DK Formi LHS potassium diformate. Animal category: pigs for fattening, piglets Rapporteur: DK Application for permanent authorisation. The expiry date of temporary authorisation: Farmatan Active substance: Tannin. Request for permanent authorisation as grown promoter for rabbits and piglets. Rapporteur: AT 1.4. Vitamins Hy D (25-hydroxylcholecalciferol/25-hydroxy-pre-cholecalciferol). Animal categories: broilers, turkeys, laying hens. Rapp: ES 1.5 Colourants Astaxantin-rich (Aquasta) Active substance: Phaffia rhodozyma. Colourant for trout and salmon Request for permanent authorisation. Rapporteur: BE 1.6. Binders, anti-caking agents and coagulants Clinoptilolite of sedimentary origin, Animal category: pigs for fattening, chickens for fattening, turkeys for fattening, bovines, salmon. Rapportuer: LU Application for permanent authorisation. The expiry date of temporary authorisation: Sodium ferrocyanide, Animal category: all species or categories of animals Rapportuer: DE Application for permanent authorisation. The expiry date of temporary authorisation: Potassium ferrocyanide Animal category: all species or categories of animals

5 Rapporteur: DE. Application for permanent autorisation. The expiry date of temporary authorisation: Enzymes Kemzyme W DRY. Preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS ), endo-1,4-beta-gluca-nase produced by Trichoderma longi-brachiatum (CBS ), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) and endo- 1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) (Enzyme No. 53). Extension of use for animal category: laying hens, turkeys for fattening. Rapp BE. Day O: Kemzyme W liquid, preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS ), endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (CBS ), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) (Enzyme No. 54). Request of provisional authorization (4 years) for animal category: laying hens (extension of use). Rapp BE. Day O: 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: chickens for fattening, turkeys. Rapp: FI 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 Belfeed B1100 MP/ML (Endo-1,4-beta-xylanase EC ) (solid/liquid form). Animal category: piglets Request for permanent authorization. Expiry of temporary authorisation Rapp: BE Avizyme 1300, Preparation of endo-1,4-beta-xylanase, EC , produced by Trichoderma longibrachiatum (ATCC 2105), and subtilisin, EC , produced by Bacillus subtilis (ATCC 2107) (Enzyme 37). Animal category: chickens for fattening. Request for permanent authorisation. The provisional authorisation expires on 26/07/2004. Rapp: UK Annex Entry

6 Avizyme SX, Preparation of endo-1,3(4) beta-glucanase, EC , from Trichoderma longibrachiatum (ATCC 2106) and endo-1,4 beta xylanase, EC , from Trichoderma longibrachiatum (IMI SD 135), (Enzyme 36). Animal category: chickens for fattening. Request for permanent authorization. Expiry of temporary authorisation 26 July Rapp UK Annex Entry Finase, Preparation of 3-Phytase, EC , from Trichoderma reesei (CBS ) (Enzyme 28). Animal category: piglets, pigs for fattening. Request for permanent authorization. Expiry of temporary authorisation 30 June Rapp FI Annex Entry Phytase SP 1002, preparation of 3-phytase, EC , produced by Hansenula polymorpha (DSM 15087). Request for permanent authorisation. Animal categories: piglets, pigs for fattening, sows, chickens for fattening, turkeys, laying hens. Rapp: BE. Day O Feedlyve AGL. Preparation of endo-1,3(4)-beta-glucanase, EC , produced by Aspergillus niger (MUCL 39199) (Enzyme 19). Animal category: chickens for fattening. Request for permanent authorization. Expiry of temporary authorisation 30 June Rapp FR Feedlyve AXC. Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (MUCL 39203) (Enzyme 21). Animal category: chickens for fattening. Request for permanent authorization. Expiry of temporary authorisation 30 June Rapp FR Roxazyme G2, Preparation of endo-1,4-beta-glucanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC ) (Enzyme 11).Animal category: turkeys for fattening. Request for permanent authorization. Expiry of temporary authorisation Rapp BE Rovabio Excel, Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-betaxylanase produced by Penicillium funiculosum (IMI SD 101 (Enzyme 30).Animal category: laying hens. Request for permanent authorization. Expiry of temporary authorisation Rapp UK Annex Entry Rovabio Excel. Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-betaxylanase produced by Penicillium funiculosum (IMI SD 101) (Enzyme 30).Animal category: turkeys for fattening. Request for permanent authorization. Expiry of temporary authorisation Rapp UK Annex Entry Avizyme Preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (ATCC 2106), endo-1,4-beta- xylanase produced by Trichoderma longibrachiatum (ATCC 2105) and subtilisin produced by Bacillus subtilis (ATCC 2107) (Enzyme 40). Animal category: chickens for fattening. Request for permanent authorisation:. Rapp UK Safizym X Preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (CNCM MA 6-10 W) (enzyme 23). Animal category: turkeys for fattening. Request for permanent authorization. Expiry of temporary authorisation Rapp FR Annex Entry Bio Feed Pro, proteinase EC Animal categories: chickens for fattening, piglets. Rapp: DK

7 Bio feed Combi, preparation of endo-1,3(4)-beta-glucanase, EC , produced by Aspergillus aculeatus (CBS ) and xylanase, EC , produced by Aspergillus oryzae (DSM 10287), coated and liquid forms. Request for provisional authorisation for animal categories: chickens for fattening, piglets. Rapp. DK Day O: Phyzyme XP. Preparation of 6-Phytase, EC , produced by Schizosaccharomyces pombe (ATCC 38399). Animal category: chickens for fattening. Request of permanent authorisation. Rapp UK. Day O: Avizyme Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105), endo-1,3(4)-beta-glucanase and alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), subtilisin produced by Bacillus subtilis (ATCC 2107), polygalacturonase produced by Aspergillus aculeatus (CBS ) (Enzyme 59). Animal category: turkeys for fattening. Request of extension of use. Rapp UK. Day O: End of the sixty-days period: Avizyme Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105), endo-1,3(4)-beta-glucanase and alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), subtilisin produced by Bacillus subtilis (ATCC 2107), polygalacturonase produced by Aspergillus aculeatus (CBS ) (Enzyme 59). Animal category: laying hens. Request of extension of use. Rapp UK. Day O: Avizyme Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105) and subtilisin produced by Bacillus subtilis (ATCC 2107 (Enzyme 37). Animal category: ducks. Request of extension of use. Rapp UK. Day O: Avizyme Endo-1, 4-beta-xylanase (EC ) from Trichoderma longibrachiatum (ATC 2105), endo-1, 3(4)-beta-glucanase (EC ) and alpha-amylase, EC , from Bacillus amyloliquefaciens (DSM 9553), subtilisin (EC ) produced by Bacillus subtilis (ATCC 2107), and polygalacturonase (EC ) produced by Aspergillus aculeatus (CBS ). Extension of use for animal category: Ducks. Rapp: UK "Double concentration": "Porzyme 9100 Double Strength ", preparation of endo-1,3(4)-beta-glucanase EC ; and endo-1,4-beta-xylanase, EC Animal category : pigs for fattening. Rapporteur: UK "Porzyme 9300 Double Strength ", preparation of endo-1,4-beta-xylanase EC Animal category : pigs for fattening, piglets. Rapporteur: UK "Avizyme 1200 Double Strength ", preparation of endo-1,3(4)-beta-glucanase, EC ; endo-1,4-beta-xylanase, EC ; and subtilisin, E.C ,. Animal category : chickens for fattening, laying hens. Rapporteur: UK "Avizyme 1300 Double Strength ", preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105) and subtilisin produced by Bacillus subtilis (ATCC 2107) (Enzyme 37). Animal categories: chicken for fattening, turkeys. Request for authorisation at double strength. Rapp UK

8 Porzyme 9100 Preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (ATCC 2106) and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105) (Enzyme 39). Extension of use for piglets. Rapp UK. Day O: Bio feed Wheat, preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10287) (Enzyme 5). Extension of use pigs for fattening, ducks for fattening. Rapp DK. Day O: Grindazym GP, preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS ). Extension of formulation: granulate form. Animal categories: chickens for fattening, turkeys for fattening, piglets. Rapp DK. Day O: Grindazym GP, preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS ). Extension of use for animal category ducks for fattening. Rapp DK. Day O: Energex, preparation of endo- 1,3(4)-beta-glucanase, EC (Enzyme No 6 & E 1603) Animal category piglets. Request for permanent authorisation. Expiration of temporary authorisation: Rapp. DK Rovabio Excel. Preparation of endo-1,3(4)-betaglucanase, EC , endo-1,4-betaxylanase, EC , produced from Penicillium funiculosum (IMI SD101).(Enzyme 50) Animal category: pigs for fattening, Request for permanent authorisation. Expiration of temporary authorisation: Rapp UK Finase, Preparation of 3-Phytase, EC , from Trichoderma reesei (CBS ) (Enzyme 28). Animal category: chickens for fattening. Request for permanent authorization. Expiry of temporary authorisation Rapp FI Safizym X, preparation of endo-1,3(4)-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10 W) (Enzyme 23 and E 1613). Animal category: laying hens. Request for permanent authorisation. Expiry of temporary authorisation Rapp FR Natuphos FTU 11, preparation of 3-phytase produced by Aspergillus niger (CBS ). Animal categories: Ducks, geese, salmonidae, channel catfish. Rapp NL Natugrain Wheat+ G and L. Preparation of Endo-1,4-beta-xylanase, EC , produced by Aspergillus niger (CBS ). Animal category: chickens for fattening". Rapp: NL Avizyme 1210 Preparation of endo-1,4-beta-xylanase, EC , produced by Trichoderma longibrachiatum (ATCC 2105), endo-1,3(4)-beta-glucanase, EC produced by Trichoderma longibrachiatum (ATCC 2106) (Enzyme 60).Dry form Extension of use Animal category: turkeys for fattening. Rap UK Avizyme Beta-glucanase, preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (ATCC 2106) (enzyme 32). Animal category: chickens for

9 fattening. Request for permanent authorization. Expiry of temporary authorisation Rapp UK. 1.8 Trace elements Chelated forms of the trace elements iron, copper, manganese and zinc with chemically synthesised aminoacids: request for authorisation under Article 4 of Directive 70/524/EEC. Rapporteur: UK Iodine in animal nutrition