LegalizeCommission Regulation (EC) No 418/2001 of 1 March 2001 concerning the authorisations of new additives and uses of additives in feedingstuffs (Text with EEA relevance)
Article 1
The preparations belonging to the group ‘Micro-organisms’ listed in Annex I to the present Regulation are authorised for use as additives in animal nutrition under the conditions laid down in that Annex.
Article 2
The preparations belonging to the group ‘Enzymes’ listed in Annex II to the present Regulation are authorised for use as additives in animal nutrition under the conditions laid down in that Annex.
Article 3
The additive belonging to the group ‘Coccidiostats and other medicinal substances’ listed in Annex III to the present Regulation is authorised for use as additive in animal nutrition under the conditions laid down in that Annex.
Article 4
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Communities.
It shall apply from 1 March 2001.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
| No (or EC No) | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | Period of authorisation |
|---|---|---|---|---|---|---|---|---|
| CFU/kg of complete feedingstuff | CFU/kg of complete feedingstuff | |||||||
| 20 | Bacillus licheniformis DSM 5749 Bacillus subtilis DSM 5750 (In a 1/1 ratio) | Mixture of Bacillus licheniformis and Bacillus subtilis containing a minimum of 3,2 × 109 CFU/g of the additive (1,6 × 109 UFC/g of each bacterium) | Calves | 6 month | 1,28 × 109 | 1,6 × 109 | In the directions for use of the additive and premixture, indicate the storage temeprature, storage life, and stability to pelleting. | 28.2.2005 |
| 21 | Enterococcus faecium DSM 3530 | Preparation of Enterococcus faecium containing a minimum of 2,5 × 109 CFU/g | Calves | 6 months | 1 × 109 | 1 × 109 | In the directions for use of the additive and premixture, indicate the storage temeprature, storage life, and stability to pelleting | 28.2.2005 |
ANNEX II
| No (or EC No) | Additive | Chemical formula, decription | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | Period of authorisation |
|---|---|---|---|---|---|---|---|---|
| Units of activity/kg complete feedingstuff | Units of activity/kg complete feedingstuff | |||||||
| 23 | Endo-1,4-beta-xylanase EC 3.2.1.8 | Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10W) having a minimum of activity of: Solid form: 70 000 IFP (1)/g Liquid form: 7 000 IFP/ml | Turkeys for fattening | — | 700 IFP | — | 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting 2. Recommended dose per kilogram of complete feedingstuff: 1 400 IFP 3. For use in compound feed rich in non- starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheat | 28.2.2005 |
| Laying hens | — | 840 IFP | — | 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting 2. Recommended dose per kilogram of complete feedingstuff: 840 IFP 3. For use in compound feed rich in non- starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheat | 28.2.2005 | |||
| 27 | Endo-1,4-beta-xylanase EC 3.2.1.8 Endo-1,3(4)-beta-glucanase EC 3.2.1.6 | Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 529.94) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (CBS 526.94) having a minimum activity of: Solid form: 200 000 BXU (2)/g 200 000 BU (3)/g Liquid form: 30 000 BXU/g 30 000 BU/g | Piglets | 2 months | 7 500 BXU | — | 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting 2. Recommended dose per kilogram of complete feedingstuff: 7 500 to 15 000 BXU 7 500 to 15 000 BU 3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 50 % wheat | 28.2.2005 |
| 7 500 BU | — | |||||||
| 28 | 3-Phytase EC 3.1.3.8 | Preparation of 3-phytase produced by Trichoderma reesei (CBS 528.94) having a minimum activity of Solid form: 5 000 PPU (4)/g Liquid form: 1 000 PPU/g | Chickens for fattening | — | 500 PPU | — | 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting 2. Recommended dose per kilogram of complete feedingstuff: 500 to 750 PPU 3. For use in compound feed containing more than 0,22 % phytin bound phosphorus | 28.2.2005 |
| 30 | Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Endo-1,-beta-xylanase EC 3.2.1.8 | Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Penicillium funiculosum (IMI SD 101) having a minimum activity of: Powder form: Endo-1,3(4)-beta-glucanase: 2 000 U (5)/g Endo-1,4-beta-xylanase: 1 400 U/g (6)/g Liquid form: Endo-1,3(4)-beta-glucanase: 500 U/ml Endo-1,4-beta-xylanase: 350 U/ml | Turkeys for fattening | — | Endo-1,3(4)-beta-glucanase: 100 U | — | 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting 2. Recommended dose per kilogram of complete feedingstuff: endo-1,3(4)-beta-glucanase: 100 U endo-1,4-beta-xylanase: 70 U 3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 50 % wheat | 28.2.2005 |
| Endo-1,4-beta-xylanase: 70 U | — | |||||||
| Laying hens | — | Endo-1,3(4)-beta-glucanase: 100 U | — | 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stabiltiy to pelleting 2. Recommended dose per kilogram of complete feedingstuff: endo-1,3(4)-beta-glucanase: 100 U endo-1,4-beta-xylanase: 70 U 3. For use in compound feed rich in non-starch polysaccharides (mainly beta- glucans and arabinoxylans), e.g. continaing more than 60 % barley or 30 % wheat | 28.2.2005 | |||
| Endo-1,4-beta-xylanase: 70 U | — | |||||||
| Pigs for fattening | — | Endo-1,3(4)-beta-glucanase: 100 U | — | 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. Recommended dose per kilogram of complete feedingstuff: endo-1,3(4)-beta-glucanase: 100 U endo-1,4-beta-xylanase: 70 U 3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 50 % barley or 60 % wheat | 28.2.2005 | |||
| Endo-1,4-beta-xylanase: 70 U | — | |||||||
| 59 | Endo-1,4-beta-xylanase EC 3.2.1.8 | 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 589.94) having a minimum activity of: Endo-1,4-beta-xylanase: 300 U (7)/g Endo-1,3(4)-beta-glucanase: 150 U (8)/g Subtilisin: 4 000 U (9)/g Alpha-amylase: 400 U (10)/g Polygalacturonase: 25 U (11)/g | Chickens for fattening | — | Endo-1,4-beta-xylanase: 300 U | — | 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stbility to pelleting 2. Recommended dose per kilogram of complete feedingstuff: endo-1,4-beta-xylanase: 300 U endo-1,3(4)-beta-glucanase: 150 U subtilisin: 4 000 U alpha-amylase: 400 U polygalacturonase: 25 U 3. For use in compound feed rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40 % maize | 28.2.2005 |
| Endo-1,3(4)-beta-glucanase EC 3.2.1.6 | Endo-1,3(4)-beta-glucanase: 150 U | — | ||||||
| Subtilisin EC 3.4.21.62 | Subtilisin: 4 000 U | — | ||||||
| Alpha-amylase EC 3.2.1.1 | Alpha-amylase: 400 U | — | ||||||
| Polygalacturonase EC 3.2.1.15 | Polygalacturonase: 25 U | — | ||||||
| 60 | Endo-1,4-beta-xylanase EC 3.2.1.8 | Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105), endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (ATCC 2106) having a minimum activitiy of: Endo-1,4-beta-xylanase: 5 000 U (7)/g Endo-1,3(4)-beta-glucanase: 50 U (8)/g | Chickens for fattening | — | Endo-1,4-beta-xylanase: 500 U | — | 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. 2. Recommended dose per kilogram of complete feedingstuff: endo-1,4-beta-xylanase: 500 to 2 500 U endo-1,3(4)-beta-glucanase: 5 to 25 U 3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 20 % barley and 40 % wheat | 28.2.2005 |
| Endo-1,3(4)-beta-glucanase EC 3.2.1.6 | Endo-1,3(4)-beta-glucanase: 5 U | — | ||||||
| 61 | Endo-1,4-beta-xylanase EC 3.2.1.8 | Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 526.94) having a minimum activity of: Powder form: Endo-1,(4)-beta-xylanase: 17 000 BXU (2)/g Endo-1,3(4)-beta-xylanase: 11 000 BU/ (3)/g Liquid form: Endo-1,4-beta-xylanase: 22 000 U/ml Endo-1,3(4)-beta-glucanase: 15 000 U/ml | Chickens for fattening | — | Endo-1,4-beta-xylanase: 17 000 BXU | — | 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting 2. Recommended dose per kilogram of complete feedingstuff: endo-1,4-beta-xylanase: 17 000 BXU endo-1,3(4)-beta-glucanase: 11 000 BU 3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 40 % barley or 55 % wheat | 28.2.2005 |
| Endo-1,3(4)-beta-glucanase EC 3.2.1.6 | Endo-1,3(4)-beta-glucanase: 11 000 BU | — | ||||||
| (1) 1 IFP is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat xylan per minute at pH 4,8 and 50°C. (2) 1 BXU is the amount of enzyme which liberates 0,06 micromoles of reducing sugars (xylose equivalents) from birch xylan per minute at pH 5,3 and 50 °C. (3) 1 BU is the amount of enzyme which liberates 0,06 micromoles of reducing sugars (glucose equivalents) from barley-glucan per minute at pH 4,8 and 50 °C. (4) 1 PPU is the amount of enzyme which liberates 1 micromole of inorganic phosphate from sodium phytate per minute at pH 5,0 and 37 °C. (5) 1 U is the amount of enzyme which liberates 5,55 micromoles of reducing sugars (maltose equivalents) from barley beta-glucan per minute at pH 5,0 and 50 °C. (6) 1 U is the amount of enzyme which liberates 4,00 micromoles of reducing sugars (maltose equivalents) from birchwood xylan per minute at pH 5,5 and 50 °C. (7) 1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 5,3 and 50 °C. (8) 1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 5,0 and 30 °C. (9) 1 U is the amount of enzyme which liberates 1 micromole of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40 °C. (10) 1 U is the amount of enzyme which liberates 1 micromole of glucosidic linkages from a water insoluble cross-linked starch polymer substrate per minute at pH 6,5 and 37 °C. (11) 1 U is the amount of enzyme which liberates 1 micromole of reducing material (galacturonic acid equivalents) from a poly D-galacturonic substrate per minute at pH 5,0 and 40 °C. |
ANNEX III
| Registration number of additive | Name and registration number of person responsible for putting additive into circulation | Additive (trade name) | Composition, chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation | Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin |
|---|---|---|---|---|---|---|---|---|---|---|
| mg of active substance/kg of complete feedingstuff | ||||||||||
| Coccidiostats and other medicinal substances | ||||||||||
| E 771 | Janssen Pharmaceutica nv | Diclazuril 0,5 g/100 g (Clinacox 0,5 % Premix) Diclazuril 0,2 g/100 g (Clinacox 0,2 % Premix) | Additive composition: Diclazuril: 0,5 g/100 g Soybean meal: 99,25 g/100 g Polyvidone K 30: 0,2 g/100 g Sodium hydroxide: 0,0538 g/100 g Diclazuril: 0,2 g/100 g Soybean meal: 39,7 g/100 g Polyvidone K 30: 0,08 g/100 g Sodium hydroxide: 0,0215 g/100 g Wheat middling: 60 g/100 g Active substance: Diclazuril C17H9Cl3N4O2, (±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile, CAS number: 101831-37-2 Related impurities: Degradation compound (R064318): ≤ 0,2 % Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually Total impurities: ≤ 1,5 % | Turkeys for fattening | 12 weeks | 1 | 1 | — | 28.2.2011 | 1 500 μg diclazuril/kg of wet liver 1 000 μg diclazuril/kg of wet kidney 500 μg diclazuril/kg of wet muscle 500 μg diclazuril/kg of wet skin/fat |
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