LegalizeCommission Regulation (EC) No 358/2005 of 2 March 2005 concerning the authorisations without a time limit of certain additives and the authorisation of new uses of additives already authorised in feedingstuffsText with EEA relevance
Article 1
The preparations belonging to the group ‘Enzymes’ as set out in Annex I are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in that Annex.
Article 2
The substances belonging to the group ‘Colourants, including pigments, other colourants’ as set out in Annex II are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in that Annex.
Article 3
The preparations belonging to the group ‘Enzymes’ as set out in Annex III are authorised provisionally for four years as additives in animal nutrition under the conditions laid down in that Annex.
Article 4
The preparation belonging to the group ‘Micro-organisms’, as set out in Annex IV is authorised provisionally for four years as additive in animal nutrition under the conditions laid down in that Annex.
Article 5
This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
| EC No | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| Units of activity/kg of complete feedingstuff | ||||||||
| Enzymes | ||||||||
| ————— | ||||||||
| ————— | ||||||||
| ————— | ||||||||
| ————— | ||||||||
| (1) 1 KNU is the amount of enzyme which liberates 672 micromoles of reducing sugars (glucose equivalent) from soluble starch per minute at pH 5,6 and 37 °C. (2) 1 FBG 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. (3) 1 U is the amount of enzyme which liberates 0,0056 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 7,5 and 30 °C. (4) 1 U is the amount of enzyme which liberates 0,0056 micromoles of reducing sugars (glucose equivalents) from carboxymethylcellulose per minute at pH 4,8 and 50 °C. (5) 1 U is the amount of enzyme which hydrolyses 1 micromole of glucosidic linkages from water insoluble cross-linked starch polymer per minute at pH 7,5 and 37 °C. (6) 1 U is the amount of enzyme which makes 1 microgram of azo-casein soluble in trichloracetic acid per minute at pH 7,5 and 37 °C. (7) 1 U is the amount of enzyme which liberates 0,0067 micromoles of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 5,3 and 50 °C. (8) 1 BGU is the amount of enzyme which liberates 0,278 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 3,5 and 40 °C. (9) 1 EXU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH 3,5 and 55 °C. |
ANNEX II
| EC No | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg/kg of complete feedingstuff | ||||||||
| Colourants, including pigments | ||||||||
| 2. Other colourants | ||||||||
| E 102 | Tartrazine | C16H9N4O9S2Na3 | Grain-eating ornamental birds | — | — | 150 | — | Without a time limit |
| Small rodents | — | — | 150 | — | Without a time limit | |||
| E 110 | Sunset yellow FCF | C16H10N2O7S2Na2 | Grain-eating ornamental birds | — | — | 150 | — | Without a time limit |
| Small rodents | — | — | 150 | — | Without a time limit | |||
| ————— | ||||||||
| ————— | ||||||||
ANNEX III
| EC No or No | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| Units of activity/kg of complete feedingstuff | ||||||||
| Enzymes | ||||||||
| 51 | Endo-1,4-beta-xylanase EC 3.2.1.8 | Preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis (LMG S-15136) having a minimum activity of: Solid and liquid form: 100 IU (1)/g or ml | Laying hens | — | 10 IU | — | 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 kg of complete feedingstuff: 10 IU 3. For use in compound feed rich in arabinoxylan, e.g. containing minimum 40 % wheat or barley. | 6 March 2009 |
| ————— | ||||||||
| (1) 1 IU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 4,5 and 30 °C. |
ANNEX IV
| EC No | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| CFU/kg of complete feedingstuff | ||||||||
| Micro-organisms | ||||||||
| 10 | Enterococcus faecium NCIMB 10415 | Preparation of Enterococcus faecium containing a minimum of microencapsulated form: 5 × 109 CFU/g | Dogs | — | 4,5 × 106 | 2 × 109 | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting | 6 March 2009 |
| Cats | — | 5 × 106 | 8 × 109 | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting | 6 March 2009 |
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