Commission Regulation (EC) No 1453/2004 of 16 August 2004 concerning the permanent authorisation of certain additives in feedingstuffs (Text with EEA relevance)

In forceVersion 2004-08-16from 2004-08-20

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Contents

Preamble
1. Article 1
2. Article 2
ANNEX
ANNEX I
ANNEX II 1.2.3.1.2.3.1.2.3.4.1.2.3.1.2.3.1.2.3.4.1.2.3.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs, and in particular Article 3 and Article 9d(1) thereof,

Whereas:

(1) Directive 70/524/EEC provides for the authorisation of additives to be used in the Community. The additives referred to in Part II of Annex C to that Directive may be authorised without a time limit subject to certain conditions being satisfied.

(2) The use of the micro-organism preparation of Bacillus licheniformis (DSM 5749) and Bacillus subtilis (DSM 5750) was provisionally authorised, for the first time, for sows, by Commission Regulation (EC) No 2437/2000.

(3) New data were submitted in support of the application for authorisation without a time limit of that preparation. The assessment shows that the conditions laid down in Directive 70/524/EEC for such authorisation are satisfied.

(4) Accordingly, the use of that preparation for sows, as specified in the Annex I, should be authorised without a time limit.

(5) The use of the micro-organism preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I–1012) was provisionally authorised, for the first time, for pigs for fattening by Commission Directive 94/17/EC.

(6) The Scientific Committee on Animal Nutrition (SCAN), in its report on Bacillus cereus var. toyoi (NCIMB 40112/CNCM I–1012) adopted on 5 December 2001, confirmed that preparation, when used in the animal categories piglets, pigs for fattening and sows, satisfies the conditions of Article 3a(b) of Directive 70/524/EEC. The SCAN report also concluded favourably on the efficacy of that preparation when used in the animal categories piglets to two months and sows.

(7) New data were submitted in support of the application for authorisation without a time limit of that preparation.

(8) The European Food Safety Authority (EFSA) was asked to issue on opinion on the efficacy of that preparation when used as feed additive for pigs for fattening. In its opinion adopted on 7 May 2004, the EFSA concluded favourably on the efficacy regarding that preparation and the whole assessment shows that the conditions laid down in Directive 70/524/EEC for such authorisation are satisfied.

(9) Accordingly, the use of that preparation for pigs for fattening, as specified in Annex I, should be authorised without a time limit.

(10) The use of the enzyme preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 600.94) set out in the first row of Annex II was provisionally authorised, for the first time, for chickens for fattening, turkeys for fattening and piglets by Commission Regulation (EC) No 654/2000.

(11) The use of the enzyme preparation of endo-1,4-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 600.94) set out in the second row of Annex II was provisionally authorised, for the first time, for chickens for fattening, by Commission Regulation (EC) No 654/2000.

(12) The use of the enzyme preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (ATCC 2106) and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (IMI SD 135) and polygalacturonase produced by Aspergillus aculeatus (CBS 589.94) was provisionally authorised, for the first time, for pigs for fattening by Commission Regulation (EC) No 2690/1999.

(13) The use of the enzyme preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (phoenicis) (NRRL 25541) and of alpha-amylase produced by Aspergillus oryzae (ATCC 66222) was provisionally authorised, for the first time, for piglets by Commission Regulation (EC) No 1636/1999.

(14) The use of the enzyme preparation of endo-1,4-beta-xylanase, produced from Trichoderma longibrachiatum (CNCM MA 6–10W) was provisionally authorised, for the first time, for chickens for fattening by Commission Regulation (EC) No 1436/98.

(15) New data were submitted in support of the application for authorisation without a time limit of those five enzyme preparations. The assessment shows that the conditions laid down in Directive 70/524/EEC for such authorisation are satisfied.

(16) Accordingly, the use of those five enzyme preparations as specified in Annex II, should be authorised without a time limit.

(17) The assessment of those seven applications shows that certain procedures should be required to protect workers from exposure to the additives set out in the Annexes. Such protection should be assured by the application of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work.

(18) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

The preparations belonging to the groups Micro-organisms and Enzymes, as set out in Annexes I and II are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in those Annexes.

Article 2

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. Done at Brussels, 16 August 2004. For the Commission David Byrne Member of the Commission

ANNEX

Anx. 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 CFU/kg of complete feedingstuff Micro-organisms E 1700 Bacillus licheniformis DSM 5749 Bacillus subtilis DSM 5750 (In 1/1 ratio) Mixture of Bacillus licheniformis and Bacillus subtilis containing a minimum of: 3,2 × 109 CFU/g additive (1,6 × 109 CFU/g additive of each bacterium) Sows — 1,28 × 109 1,28 × 109 In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. For sows two weeks before farrowing and during the lactation. Without a time limit E 1701 Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012 Preparation of Bacillus cereus var. toyoi containing a minimum of 1 × 1010 CFU/g additive Piglets From two to four months 0,5 × 109 1 × 109 In the directions for use of the additive and premixture indicate the storage temperature, storage life and stability to pelleting. Without a time limit Pigs for fattening From four months until slaughter 0,2 × 109 1 × 109 In the directions for use of the additive and premixture indicate the storage temperature, storage life and stability to pelleting. Without a time limit

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 CFU/kg of complete feedingstuff Micro-organisms E 1700 Bacillus licheniformis DSM 5749 Bacillus subtilis DSM 5750 (In 1/1 ratio) Mixture of Bacillus licheniformis and Bacillus subtilis containing a minimum of: 3,2 × 109 CFU/g additive (1,6 × 109 CFU/g additive of each bacterium) Sows — 1,28 × 109 1,28 × 109 In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. For sows two weeks before farrowing and during the lactation. Without a time limit E 1701 Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012 Preparation of Bacillus cereus var. toyoi containing a minimum of 1 × 1010 CFU/g additive Piglets From two to four months 0,5 × 109 1 × 109 In the directions for use of the additive and premixture indicate the storage temperature, storage life and stability to pelleting. Without a time limit Pigs for fattening From four months until slaughter 0,2 × 109 1 × 109 In the directions for use of the additive and premixture indicate the storage temperature, storage life and stability to pelleting. Without a time limit

(1) Endo-1,4-beta-xylanase: 36000 FXU/g (2) Endo-1,4-beta-glucanase: 15000 BGU/g (1) Coated form: (1) Endo-1,4-beta-xylanase: 36000 FXU/ml (2) Endo-1,4-beta-glucanase: 15000 BGU/ml (2) Liquid form: (1) Endo-1,4-beta-xylanase: 36000 FXU/g (2) Endo-1,4-beta-glucanase: 15000 BGU/g (3) Solid form: (4) 4860–6000 FXU (5) 2025–2500 BGU. (6) 6000 FXU (7) 2500 BGU. (1) Endo-1,4-beta-glucanase: 10000 BGU/g (2) Endo-1,4-beta-xylanase: 4000 FXU/g (8) Coated form: (1) Endo-1,4-beta-glucanase: 20000 BGU/ml (2) Endo-1,4-beta-xylanase: 8000 FXU/ml (9) Liquid form: (1) Endo-1,4-beta-glucanase: 20000 BGU/g (2) Endo-1,4-beta-xylanase: 8000 FXU/g (10) Solid form: (11) 5000–10000 BGU (12) 2000–4000 FXU. (13) Endo-1,3(4)-beta-glucanase: 400 U/g (14) Endo-1,4-beta-xylanase: 400 U/g (15) Polygalacturonase: 50 U/g (16) endo-1,3(4)-beta-glucanase: 400 U (17) endo-1,4-beta-xylanase: 400 U (18) polygalacturonase: 50 U. (19) Endo-1,3(4)-beta-glucanase: 275 U/g (20) Endo-1,4-beta-xylanase: 400 U/g (21) Alpha-amylase: 3100 U/g (22) endo-1,3(4)-beta-glucanase: 138 U (23) endo-1,4-beta-xylanase: 200 U (24) alpha-amylase: 1550 U (25) Powder form: 70000 IFP/g (26) Liquid form: 7000 IFP/ml Anx. 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 Units of activity/kg of complete feedingstuff Enzymes E 1609 Endo-1,4-beta-xylanase EC 3.2.1.8 Endo-1,4-beta-glucanase EC 3.2.1.4 Preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 600.94) having minimum activities of: Chickens for fattening — 4860 FXU — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: For use in compound feed rich in non-starch polysaccharides (mainly arabino-xylans and beta-glucans), e.g. containing more than 35 % barley and 20 % wheat. Without a time limit 2025 BGU — Turkeys for fattening — 6000 FXU — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: 6000 FXU 2500 BGU. For use in compound feed rich in non-starch polysaccharides (mainly arabino-xylans and beta-glucans), e.g. containing more than 40 % wheat. Without a time limit 2500 BGU — Piglets (weaned) — 6000 FXU — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: For use in compound feed rich in non-starch polysaccharides (mainly arabino-xylans and beta-glucans), e.g. containing more than 30 % wheat and 30 % barley. For use in weaned piglets until approximately 35 kg. Without a time limit 2500 BGU — E 1610 Endo-1,4-beta-glucanase EC 3.2.1.4 Endo-1,4-beta-xylanase EC 3.2.1.8 Preparation of endo-1,4-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 600.94) having minimum activities of: Chickens for fattening — 5000 BGU — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: For use in compound feed rich in non-starch polysaccharides (mainly arabino-xylans and beta-glucans), e.g. containing more than 60 % barley. Without a time limit 2000 FXU — E 1611 Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Endo-1,4-beta-xylanase EC 3.2.1.8 Polygalacturonase EC 3.2.1.15 Preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (ATCC 2106) and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (IMI SD 135) and polygalacturonase produced by Aspergillus aculeatus (CBS 589.94) having a minimum activity of: Pigs for fattening — endo-1,3(4)-beta-glucanase: 400 U — In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: For use in compound feed containing cereals rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40 % barley. Without a time limit endo-1,4-beta-xylanase: 400 U — polygalacturonase: 50 U — E 1612 Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Endo-1,4-beta-xylanase EC 3.2.1.8 Alpha-amylase EC 3.2.1.1 Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (phoenicis) (NRRL 25541) and of alpha-amylase produced by Aspergillus oryzae (ATCC 66222) having a minimum activity of: Piglets (weaned) — endo-1,3(4)-beta-glucanase: 138 U — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: For use in compound feeds rich in starch and non-starch polysaccharides, for example mixed diets containing barley, maize, wheat. For use in weaned piglets until approximately 35 kg. Without a time limit endo-1,4-beta-xylanase: 200 U — alpha-amylase: 1550 U — E 1613 Endo-1,4-beta-xylanase EC 3.2.1.8 Preparation of endo-1,4-beta-xylanase, produced from Trichoderma longibrachiatum (CNCM MA 6 - 10W), having a minimum activity of: Chickens for fattening — 1050 IFP — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: 1400 IFP. For use in compound feeds rich in non-starch polysaccharides (mainly arabinoxylans), for example more than 40 % wheat. Without a time limit

ANNEX II 1.2.3.1.2.3.1.2.3.4.1.2.3.1.2.3.1.2.3.4.1.2.3.

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 E 1609 Endo-1,4-beta-xylanase EC 3.2.1.8 Endo-1,4-beta-glucanase EC 3.2.1.4 Preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 600.94) having minimum activities of: Chickens for fattening — 4860 FXU — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: For use in compound feed rich in non-starch polysaccharides (mainly arabino-xylans and beta-glucans), e.g. containing more than 35 % barley and 20 % wheat. Without a time limit 2025 BGU — Turkeys for fattening — 6000 FXU — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: 6000 FXU 2500 BGU. For use in compound feed rich in non-starch polysaccharides (mainly arabino-xylans and beta-glucans), e.g. containing more than 40 % wheat. Without a time limit 2500 BGU — Piglets (weaned) — 6000 FXU — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: For use in compound feed rich in non-starch polysaccharides (mainly arabino-xylans and beta-glucans), e.g. containing more than 30 % wheat and 30 % barley. For use in weaned piglets until approximately 35 kg. Without a time limit 2500 BGU — E 1610 Endo-1,4-beta-glucanase EC 3.2.1.4 Endo-1,4-beta-xylanase EC 3.2.1.8 Preparation of endo-1,4-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 600.94) having minimum activities of: Chickens for fattening — 5000 BGU — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: For use in compound feed rich in non-starch polysaccharides (mainly arabino-xylans and beta-glucans), e.g. containing more than 60 % barley. Without a time limit 2000 FXU — E 1611 Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Endo-1,4-beta-xylanase EC 3.2.1.8 Polygalacturonase EC 3.2.1.15 Preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (ATCC 2106) and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (IMI SD 135) and polygalacturonase produced by Aspergillus aculeatus (CBS 589.94) having a minimum activity of: Pigs for fattening — endo-1,3(4)-beta-glucanase: 400 U — In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: For use in compound feed containing cereals rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40 % barley. Without a time limit endo-1,4-beta-xylanase: 400 U — polygalacturonase: 50 U — E 1612 Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Endo-1,4-beta-xylanase EC 3.2.1.8 Alpha-amylase EC 3.2.1.1 Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (phoenicis) (NRRL 25541) and of alpha-amylase produced by Aspergillus oryzae (ATCC 66222) having a minimum activity of: Piglets (weaned) — endo-1,3(4)-beta-glucanase: 138 U — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: For use in compound feeds rich in starch and non-starch polysaccharides, for example mixed diets containing barley, maize, wheat. For use in weaned piglets until approximately 35 kg. Without a time limit endo-1,4-beta-xylanase: 200 U — alpha-amylase: 1550 U — E 1613 Endo-1,4-beta-xylanase EC 3.2.1.8 Preparation of endo-1,4-beta-xylanase, produced from Trichoderma longibrachiatum (CNCM MA 6 - 10W), having a minimum activity of: Chickens for fattening — 1050 IFP — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: 1400 IFP. For use in compound feeds rich in non-starch polysaccharides (mainly arabinoxylans), for example more than 40 % wheat. Without a time limit (1) Endo-1,4-beta-xylanase: 36000 FXU/g (2) Endo-1,4-beta-glucanase: 15000 BGU/g (1) Coated form: (1) Endo-1,4-beta-xylanase: 36000 FXU/ml (2) Endo-1,4-beta-glucanase: 15000 BGU/ml (2) Liquid form: (1) Endo-1,4-beta-xylanase: 36000 FXU/g (2) Endo-1,4-beta-glucanase: 15000 BGU/g (3) Solid form: (4) 4860–6000 FXU (5) 2025–2500 BGU. (6) 6000 FXU (7) 2500 BGU. (1) Endo-1,4-beta-glucanase: 10000 BGU/g (2) Endo-1,4-beta-xylanase: 4000 FXU/g (8) Coated form: (1) Endo-1,4-beta-glucanase: 20000 BGU/ml (2) Endo-1,4-beta-xylanase: 8000 FXU/ml (9) Liquid form: (1) Endo-1,4-beta-glucanase: 20000 BGU/g (2) Endo-1,4-beta-xylanase: 8000 FXU/g (10) Solid form: (11) 5000–10000 BGU (12) 2000–4000 FXU. (13) Endo-1,3(4)-beta-glucanase: 400 U/g (14) Endo-1,4-beta-xylanase: 400 U/g (15) Polygalacturonase: 50 U/g (16) endo-1,3(4)-beta-glucanase: 400 U (17) endo-1,4-beta-xylanase: 400 U (18) polygalacturonase: 50 U. (19) Endo-1,3(4)-beta-glucanase: 275 U/g (20) Endo-1,4-beta-xylanase: 400 U/g (21) Alpha-amylase: 3100 U/g (22) endo-1,3(4)-beta-glucanase: 138 U (23) endo-1,4-beta-xylanase: 200 U (24) alpha-amylase: 1550 U (25) Powder form: 70000 IFP/g (26) Liquid form: 7000 IFP/ml

Coated form: (1) Endo-1,4-beta-xylanase: 36000 FXU/g (2) Endo-1,4-beta-glucanase: 15000 BGU/g

Endo-1,4-beta-xylanase: 36000 FXU/g

Endo-1,4-beta-glucanase: 15000 BGU/g

Liquid form: (1) Endo-1,4-beta-xylanase: 36000 FXU/ml (2) Endo-1,4-beta-glucanase: 15000 BGU/ml

Endo-1,4-beta-xylanase: 36000 FXU/ml

Endo-1,4-beta-glucanase: 15000 BGU/ml

Solid form: (1) Endo-1,4-beta-xylanase: 36000 FXU/g (2) Endo-1,4-beta-glucanase: 15000 BGU/g

Endo-1,4-beta-xylanase: 36000 FXU/g

Endo-1,4-beta-glucanase: 15000 BGU/g

4860–6000 FXU

2025–2500 BGU.

6000 FXU

2500 BGU.

Coated form: (1) Endo-1,4-beta-glucanase: 10000 BGU/g (2) Endo-1,4-beta-xylanase: 4000 FXU/g

Endo-1,4-beta-glucanase: 10000 BGU/g

Endo-1,4-beta-xylanase: 4000 FXU/g

Liquid form: (1) Endo-1,4-beta-glucanase: 20000 BGU/ml (2) Endo-1,4-beta-xylanase: 8000 FXU/ml

Endo-1,4-beta-glucanase: 20000 BGU/ml

Endo-1,4-beta-xylanase: 8000 FXU/ml

Solid form: (1) Endo-1,4-beta-glucanase: 20000 BGU/g (2) Endo-1,4-beta-xylanase: 8000 FXU/g

Endo-1,4-beta-glucanase: 20000 BGU/g

Endo-1,4-beta-xylanase: 8000 FXU/g

5000–10000 BGU

2000–4000 FXU.

Endo-1,3(4)-beta-glucanase: 400 U/g

Endo-1,4-beta-xylanase: 400 U/g

Polygalacturonase: 50 U/g

endo-1,3(4)-beta-glucanase: 400 U

endo-1,4-beta-xylanase: 400 U

polygalacturonase: 50 U.

Endo-1,3(4)-beta-glucanase: 275 U/g

Endo-1,4-beta-xylanase: 400 U/g

Alpha-amylase: 3100 U/g

endo-1,3(4)-beta-glucanase: 138 U

endo-1,4-beta-xylanase: 200 U

alpha-amylase: 1550 U

Powder form: 70000 IFP/g

Liquid form: 7000 IFP/ml

Versions

2004-08-16

Cited by

Commission Implementing Regulation (EU) 2017/1145 of 8 June 2017 on the withdrawal from the market of certain feed additives authorised pursuant to Council Directives 70/524/EEC and 82/471/EEC and repealing the obsolete provisions authorising those feed additives (Text with EEA relevance) Regulation · Grade B
Annex II to Regulation (EC) No 1453/2004 is amended as follows:
Commission Regulation (EC) No 202/2009 of 16 March 2009 amending Regulation (EC) No 600/2005 as regards the use of the preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 in compound feed containing lasalocid sodium (Text with EEA relevance) Regulation · Grade B
The preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750, belonging to the group of micro-organisms, was authorised without a time limit in accordance with Council Directive 70/524/EEC as a feed additive for use in sows by Commission Regulation (EC) No 1453/2004, for use in turkeys for fattening and calves up to three months by Commission Regulation (EC) No 600/2005 which was subsequently amended by Regulation (EC) No 2028/2006, for use in pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004. This additive was subsequently entered in the Community
Commission Regulation (EC) No 497/2007 of 4 May 2007 concerning the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 (Safizym X) as a feed additive (Text with EEA relevance) Regulation · Grade B
The use of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10) was authorised without a time limit for chickens for fattening by Commission Regulation (EC) No 1453/2004, without a time limit for turkeys for fattening by Commission Regulation (EC) No 943/2005 and without a time limit for laying hens by Commission Regulation (EC) No 1810/2005.
Commission Implementing Regulation (EU) No 288/2013 of 25 March 2013 concerning the suspension of the authorisations of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as provided for by Regulations (EC) No 256/2002, (EC) No 1453/2004, (EC) No 255/2005, (EC) No 1200/2005, (EC) No 166/2008 and (EC) No 378/2009 (Text with EEA relevance) Regulation · Grade B
The preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use for piglets under two months and sows by Commission Regulation (EC) No 256/2002, for piglets from two to four months and pigs for fattening by Commission Regulation (EC) No 1453/2004, for cattle for fattening by Commission Regulation (EC) No 255/2005 and for rabbits for fattening and chickens for fattening by Commission Regulation (EC) No 1200/2005. The preparation was subsequently entered in the European Union Register o
Commission Implementing Regulation (EU) No 288/2013 of 25 March 2013 concerning the suspension of the authorisations of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as provided for by Regulations (EC) No 256/2002, (EC) No 1453/2004, (EC) No 255/2005, (EC) No 1200/2005, (EC) No 166/2008 and (EC) No 378/2009 (Text with EEA relevance) Regulation · Grade B
The authorisation provided for by Regulation (EC) No 1453/2004 concerning the preparation specified in entry E 1701 of Annex I to that Regulation is suspended.
Commission Implementing Regulation (EU) No 516/2011 of 25 May 2011 amending Regulation (EC) No 600/2005 as regards the use of the preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 in feed containing formic acid (Text with EEA relevance) Regulation · Grade B
The preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750, belonging to the group of micro-organisms, was authorised, without a time limit, in accordance with Council Directive 70/524/EEC as a feed additive for use on sows by Commission Regulation (EC) No 1453/2004, for use on turkeys for fattening and calves up to 3 months by Commission Regulation (EC) No 600/2005 and for use on pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004.
Commission Regulation (EC) No 1501/2007 of 18 December 2007 concerning the authorisation of a new use of endo-1,4-beta-xylanase EC 3.2.1.8 (Safizym X) as a feed additive (Text with EEA relevance) Regulation · Grade B
The use of the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10) was authorised without a time limit for chickens for fattening by Commission Regulation (EC) No 1453/2004, without a time limit for turkeys for fattening by Commission Regulation (EC) No 943/2005, without a time limit for laying hens by Commission Regulation (EC) No 1810/2005 and for ten years for piglets (weaned) by Commission Regulation (EC) No 497/2007.
Commission Regulation (EC) No 2028/2006 of 18 December 2006 amending Regulation (EC) No 600/2005 as regards the authorisation of the feed additive preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750, belonging to the group of microorganisms (Text with EEA relevance) Regulation · Grade B
The preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750, belonging to the group of microorganisms, was authorised without a time limit in accordance with Council Directive 70/524/EEC as a feed additive for use in sows by Commission Regulation (EC) No 1453/2004, for use in turkeys for fattening and calves up to three months by Commission Regulation (EC) No 600/2005, for use in pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004. This additive was subsequently entered in the Community Register of Feed Additives as an existing product, in accordance
Commission Implementing Regulation (EU) 2018/1566 of 18 October 2018 concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No 1453/2004 (holder of authorisation Andrès Pintaluba S.A.) (Text with EEA relevance) Regulation · Grade B
The preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) was authorised in accordance with Directive 70/524/EEC without a time limit as a feed additive for weaned piglets by Commission Regulation (EC) No 1453/2004. That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.
Commission Implementing Regulation (EU) 2018/1566 of 18 October 2018 concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No 1453/2004 (holder of authorisation Andrès Pintaluba S.A.) (Text with EEA relevance) Regulation · Grade B
As a consequence of granting the authorisation for the preparation Regulation (EC) No 1453/2004 should be amended accordingly.
Commission Implementing Regulation (EU) 2018/1566 of 18 October 2018 concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No 1453/2004 (holder of authorisation Andrès Pintaluba S.A.) (Text with EEA relevance) Regulation · Grade B
In Annex II to Regulation (EC) No 1453/2004 entry E 1612 on the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase and alpha-amylase is deleted.
Commission Regulation (EC) No 773/2006 of 22 May 2006 concerning the provisional and permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs (Text with EEA relevance) Regulation · Grade B
The use of the enzyme preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 600.94) is authorised without a time limit for chickens for fattening, turkeys for fattening and piglets, as enzyme E1609 in coated, liquid and solid forms by Commission Regulation (EC) No 1453/2004. New data were submitted in support of an application to extend the authorisation of the use of this enzyme preparation to ducks and to include in the authorisation for this animal species a granulate form. EFSA delivered an opinion on 30 November 2005 on the use of this prepar
Commission Regulation (EC) No 166/2008 of 22 February 2008 concerning the authorisation of a new use of the preparation of Bacillus cereus var. toyoi (Toyocerin) as a feed additive (Text with EEA relevance) Regulation · Grade B
The use of that microorganism preparation was permanently authorised for piglets under 2 months and sows by Commission Regulation (EC) No 256/2002, piglets and pigs for fattening by Commission Regulation (EC) No 1453/2004, cattle for fattening by Commission Regulation (EC) No 255/2005 and rabbits for fattening and chickens for fattening by Commission Regulation (EC) No 1200/2005.
Commission Regulation (EC) No 378/2009 of 8 May 2009 concerning the authorisation of a new use of the preparation of Bacillus cereus var. toyoi as a feed additive for rabbits breeding does (holder of the authorisation Rubinum S.A.) (Text with EEA relevance) Regulation · Grade B
The use of that microorganism preparation was permanently authorised for piglets under two months and sows by Commission Regulation (EC) No 256/2002, for piglets and pigs for fattening by Commission Regulation (EC) No 1453/2004, for cattle for fattening by Commission Regulation (EC) No 255/2005, for rabbits for fattening and chickens for fattening by Commission Regulation (EC) No 1200/2005, for piglets (two months) and sows by Commission Regulation (EC) No 1143/2007 and for 10 years by Commission Regulation (EC) No 166/2008 for turkeys for fattening.
Commission Implementing Regulation (EU) 2017/447 of 14 March 2017 concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for sows, weaned piglets, pigs for fattening, calves for rearing and turkeys for fattening and amending Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance) Regulation · Grade B
The preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for sows by Commission Regulation (EC) No 1453/2004, for pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004, for turkeys for fattening and calves by Commission Regulation (EC) No 600/2005. That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
Commission Implementing Regulation (EU) 2017/447 of 14 March 2017 concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for sows, weaned piglets, pigs for fattening, calves for rearing and turkeys for fattening and amending Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance) Regulation · Grade B
Annex I to Regulation (EC) No 1453/2004 is deleted.
Commission Implementing Regulation (EU) 2015/1399 of 17 August 2015 concerning the denial of authorisation of the preparation of Bacillus toyonensis (NCIMB 14858T) (formerly Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012) as a feed additive for cattle for fattening, rabbits for fattening, chickens for fattening, piglets (weaned), pigs for fattening, sows for reproduction and calves for rearing and the revocation of the authorisations of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as a feed additive for turkeys for fattening and rabbit breeding does, amending Regulations (EC) No 256/2002, (EC) No 1453/2004, (EC) No 255/2005 and (EC) No 1200/2005 and repealing Regulations (EC) No 166/2008, (EC) No 378/2009 and Implementing Regulation (EU) No 288/2013 (Text with EEA relevance) Regulation · Grade B
The preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for piglets under 2 months and sows by Commission Regulation (EC) No 256/2002, for piglets from 2 to 4 months and pigs for fattening by Commission Regulation (EC) No 1453/2004, for cattle for fattening by Commission Regulation (EC) No 255/2005 and for rabbits for fattening and chickens for fattening by Commission Regulation (EC) No 1200/2005. The preparation was subsequently entered in the Register of feed additives as an existin
Commission Implementing Regulation (EU) 2015/1399 of 17 August 2015 concerning the denial of authorisation of the preparation of Bacillus toyonensis (NCIMB 14858T) (formerly Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012) as a feed additive for cattle for fattening, rabbits for fattening, chickens for fattening, piglets (weaned), pigs for fattening, sows for reproduction and calves for rearing and the revocation of the authorisations of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as a feed additive for turkeys for fattening and rabbit breeding does, amending Regulations (EC) No 256/2002, (EC) No 1453/2004, (EC) No 255/2005 and (EC) No 1200/2005 and repealing Regulations (EC) No 166/2008, (EC) No 378/2009 and Implementing Regulation (EU) No 288/2013 (Text with EEA relevance) Regulation · Grade B
In Annex I to Regulation (EC) No 1453/2004, the entry E 1701, Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012, is deleted.