02004R2148 — EN — 04.04.2017 — 005.001
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COMMISSION REGULATION (EC) No 2148/2004 of 16 December 2004 concerning the permanent and provisional authorisations of certain additives and the authorisation of new uses of an additive already authorised in feedingstuffs (OJ L 370 17.12.2004, p. 24) |
Amended by:
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Official Journal |
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No |
page |
date |
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L 318 |
3 |
6.12.2005 |
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COMMISSION IMPLEMENTING REGULATION (EU) No 1018/2012 of 5 November 2012 |
L 307 |
56 |
7.11.2012 |
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COMMISSION IMPLEMENTING REGULATION (EU) 2015/1043 of 30 June 2015 |
L 167 |
63 |
1.7.2015 |
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COMMISSION IMPLEMENTING REGULATION (EU) 2015/2305 of 10 December 2015 |
L 326 |
43 |
11.12.2015 |
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COMMISSION IMPLEMENTING REGULATION (EU) 2017/447 of 14 March 2017 |
L 69 |
18 |
15.3.2017 |
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COMMISSION REGULATION (EC) No 2148/2004
of 16 December 2004
concerning the permanent and provisional authorisations of certain additives and the authorisation of new uses of an additive already authorised in feedingstuffs
(Text with EEA relevance)
Article 1
The preparation belonging to the group ‘Binders, anti-caking agents and coagulants’, is authorised for use without a time limit as additive in animal nutrition under the conditions laid down in Annex I.
Article 2
The preparations belonging to the group ‘Micro-organisms’, are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in Annex II.
Article 3
The preparation belonging to the group ‘Micro-organisms’, is authorised provisionally for four years as additive in animal nutrition under the conditions laid down in Annex III.
Article 4
The preparations belonging to the group ‘Enzymes’, are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in Annex IV.
Article 5
The preparation belonging to the group ‘Enzymes’, is authorised provisionally for four years as additive in animal nutrition under the conditions laid down in Annex V.
Article 6
This Regulation shall enter into force on the third day following that of 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
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EC No |
Additive |
Chemical formula, description |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
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mg/kg of complete feedingstuff |
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Binders, anti-caking agents and coagulants |
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E 567 |
Clinoptilolite of volcanic origin |
Calcium hydrated aluminosilicate of volcanic origin containing a minimum of 85 % of clinoptilolite and a maximum of 15 % of feldspar, micas and clays free of fibres and quartz
►M1
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Pigs |
— |
— |
20 000 |
All feedingstuffs |
Without a time limit |
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Rabbits |
— |
— |
20 000 |
All feedingstuffs |
Without a time limit |
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Poultry |
— |
— |
20 000 |
All feedingstuffs |
Without a time limit |
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ANNEX II
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EC No |
Additive |
Chemical formula, description |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
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CFU/kg of complete feedingstuff |
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Micro-organisms |
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▼M5 ————— |
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E 1702 |
Saccharomyces cerevisiae NCYC Sc 47 |
Preparation of Saccharomyces cerevisiae containing a minimum of: 5 × 109 CFU/g additive |
Piglets (weaned) |
— |
5 × 109 |
►M2 1 × 10 ◄ |
In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. For use in weaned piglets until approximately 35 kg. |
Without a time limit |
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E 1706 |
Enterococcus faecium DSM 7134 Lactobacillus rhamnosus DSM 7133 |
Mixture of: Enterococcus faecium containing a minimum of: 7 × 109 CFU/g and of Lactobacillus rhamnosus containing a minimum of: 3 × 109 CFU/g |
Piglets (weaned) |
— |
2,5 × 109 |
5 × 109 |
In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. For use in weaned piglets until approximately 35 kg. |
Without a time limit |
ANNEX III
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No (or EC No) |
Additive |
Chemical formula, description |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
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CFU/kg of complete feedingstuff |
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Micro-organisms |
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24 |
Kluyveromyces marxianus var. lactisK1 BCCM/MUCL 39434 |
Preparation of Kluyveromyces marxianus var. lactisK1 having a minimum activity of: 1,0 × 108 CFU/g |
Dairy cows |
— |
0,25 × 106 |
1,0 × 106 |
In directions for use of the additive and premixture, indicate the storage temperature and storage life. Do not use in pelleted premixture and feedingstuffs. Use in dairy cows, in particular when they are reaching the maximum of daily milk production, for minimum period of 14 days. The amount of daily ration administered to each cow is 1,0 × 107 CFU. |
20 December 2008 |
ANNEX IV
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EC No |
Additive |
Chemical formula, description |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
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Units of activity/kg of complete feedingstuff |
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Enzymes |
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E 1615 |
Endo-1,3(4)-beta-glucanase EC 3.2.1.6 |
Preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (CNCM MA 6-10 W) having a minimum activity of: Solid form: 70 000 BGN (1)/g Liquid form: 14 000 BGN/ml |
Chickens for fattening |
— |
1 050 BGN |
— |
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: 2 800 BGN. 3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans), e.g. containing more than 35 % barley. |
Without a time limit |
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▼M4 ————— |
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▼M3 ————— |
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(1) 1 BGN is the amount of enzyme which liberates 1 micromole of reducing sugar (glucose equivalents) from barley beta-glucan per minute at pH 4,8 and 50 °C. |
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ANNEX V
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No (or EC No) |
Additive |
Chemical formula, description |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
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Units of activity/kg of complete feedingstuff |
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Enzymes |
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30 (or E 1604) |
Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Endo-1,4-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: Liquid form: Endo-1,3(4)-beta-glucanase: 500 U/ml Endo-1,4-beta-xylanase: 350 U/ml |
Piglets (weaned) |
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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 kg 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-glucan and arabinoxylans), e.g. containing more than 30 % barley or 20 % wheat. 4. For weaned piglets up to approximately 35 kg. |
20.12.2008 |
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endo-1,4-beta-xylanase: 70 U |
— |
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Ducks 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 kg 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-glucan and arabinoxylans), e.g. containing more than 50 % barley or 60 % wheat. |
20.12.2008 |
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endo-1,4-beta-xylanase: 70 U |
— |
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(1) 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. (2) 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. |
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