70/524/EEC annex 1

COUNCIL DIRECTIVE (70/524/EEC)

of 23 November 1970

concerning additives in feeding-stuffs

(70/524/EEC)

List of other additives authorised on a provisional basis for no longer than four years or five years

in the case of additives which have been the subject of provisional authorisation before 1 April 1998

Micro-organisms (2)

N°
Additive Chemical formula, description Species or category of animal Maximum age Minimum content CFU/kg of complete feedingstuff Maximum content CFU/kg of complete feedingstuff
Other previsions
Period of authorization

10

Enterococcus faecium
NCIMB 10415

Preparation of Enterococcus faecium containing a minimum of:

Microencapsulated form:

1,0 * 10¹⁰ CFU/g additive
1,75 * 10¹⁰ CFU/g additive

Chickens for fattening

-

0,3 * 10⁹

2,8 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting.

May be used in compound feed containing the permitted coccidiostats: amprolium, amprolium/ethopabate, diclazuril, halofuginone, maduramicin ammonium, meticlorpindol, meticlorpindol / methylbenzoquate, monensin sodium, robenidine, salinomycin sodium.

30.6.2004 ^(I)(a)

Pigs for fattening

-

0,35 * 10⁹

1,5 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting.

30.6.2004 ^(I)(a)

Sows

-

0,2 * 10⁹

1,25 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting.

30.6.2004 ^(I)(a)

Cattle for fattening

-

0,25 * 10⁹

0,6 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting.

The quantity of Enterococcus faecium in the daily ration must not exceed 1 * 10⁹ CFU for 100 kg of body weight. Add 1 * 10⁹ CFU for each additional 100 kg of body weight.

30.6.2004 ^(I)(a)

Preparation of Enterococcus faecium containing a minimum of:

Microencapsulated form:

1,0 * 10¹⁰ CFU/g additive
1,75 * 10¹⁰ CFU/g additive

and

Granulated form:
3,5 * 10¹⁰ CFU/g additive

Piglets

Four months

0,3 * 10⁹

1,4 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting.

Granulated form to be used exclusively in milk replacers.

30.6.2004 ^(I)(a)

Calves

Six months

0,35 * 10⁹

6,6 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting.

Granulated form to be used exclusively in milk replacers.

30.6.2004 ^(I)(a)

11

Enterococcus faecium
DSM 5464

Preparation of Enterococcus faecium containing a minimum of:
5 * 10¹⁰ CFU/g additive

Piglets

Four months

0,5 * 10⁹

1 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting.

30.6.2004 ^(I)(a)

Chickens for fattening

-

0,5 * 10⁹

1 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting.

May be used in compound feed containing the permitted coccidiostats: amprolium, diclazuril, halofuginone, monensin-sodium, metilclorpindol, methylbenzoquate, nicarbazin.

1.4.2004 ^(I)(b)

Calves

Four months

0,5 * 10¹⁰

1 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting.

1.4.2004 ^(I)(b)

12

Lactobacillus farciminis
CNCM MA 67/4R

Preparation of Lactobacillus farciminis containing a minimum of:
1 * 10⁹ CFU/g additive

Piglets

Four months

1 * 10⁹

1 * 10¹⁰

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

30.6.2004 ^(I)(c)

13

Enteroccocus faecium
DSM 10 663/ NCIMB 10 415

Preparation of Enteroccocus faecium containing a minimum of:

Powder and granulated forms:
3,5 * 10¹⁰ CFU/g additive

Coated form:
2,0 * 10¹⁰ CFU/g additive

Liquid form:
1 * 10¹⁰ CFU/g additive

Piglets

Four months

1 * 10⁹

1 * 10¹⁰

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

30.6.2004 ^(I)(c)

Calves

6 months

1 * 10⁹

1 * 10¹⁰

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

26.7.2004 ^(I)(d)

Chickens for fattening

-

1 * 10⁹

1 * 10¹⁰

1. In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

2. May be used in compound feed containing the permitted coccidiostats: amprolium, amprolium/ethopabate, decoquinate, diclazuril, halofuginone, lasalocid sodium, maduramicin ammonium, meticlorpindol/ methylbenzoquate, monensin sodium, narasin, nicarbazin, robenidine, salinomycin sodium.

26.7.2004 ^(I)(d)

14

Saccharomyces cerevisiae
MUCL 39 885

Preparation of Saccharomyces cerevisiae containing a minimum of:

-Powder, spheric and oval granulated forms:
1 * 10⁹ CFU/g additive

Piglets

Four months

3 * 10⁹

3 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

30.6.2004 ^(I)(c)

Cattle for fattening

9 * 10⁹

9 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

The quantity of Saccharomyces cerevisiae in the daily ration must not exceed 1,6 * 10¹⁰ CFU per 100 kg/body weight. Add 3,2 * 10⁹ CFU for each additional 100 kg body weight.

30.6.2004 ^(I)(c)

15

Enteroccocus faecium
NCIMB 11181

Preparation of Enteroccocus faecium containing a minimum of:

Powder forms:
4 * 10¹¹ CFU/g additive

Coated form:
5 * 10¹⁰ CFU/g additive

Calves

6 months

5 * 10⁸

2 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

6.1.2004 ^(I)(e)

Piglets

4 months

5 * 10⁸

2 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

6.1.2004 ^(I)(e)

16

Enteroccocus faecium
DSM 7134

Lactobacillus rhamnosus
DSM 7133

Mixture of:

Enteroccocus faecium containing a minimum of: 7 * 10⁹ CFU/g

and of

Lactobacillus rhamnosus containing a minimum of: 3 * 10⁹ CFU/g

Calves

6 months

1 * 10⁹

6 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

6.1.2004 ^(I)(e)

Piglets

4 months

1 * 10⁹

5 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

6.1.2004 ^(I)(e)

17

Lactobacillus casei
NCIMB 30096

Enterococcus faecium
NCIMB 30098

Mixture of Lactobacillus casei and Enterococcus faecium containing a minimum of:

Lactobacillus casei
2 * 10⁹ CFU/g additive

and

Enterococcus faecium
6 * 10⁹ CFU/g additive

Calves

six months

Lactobacillus casei
0,5 * 10⁹

Enterococcus faecium
1,5 * 10⁹

Lactobacillus casei
1 * 10⁹

Enterococcus faecium
3 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

1.4.2004 ^(I)(b)

18

Enterococcus faecium
CECT 4515

Preparation of Enterococcus faecium containing a minimum of 1 * 10¹⁰ CFU/g additive

Piglets

Four months

1 * 10⁹

1 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

1.4.2004 ^(I)(b)

Calves

Six months

1 * 10⁹

1 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

1.4.2004 ^(I)(b)

19

Strepotococcus infantarius
CNCM I-841

Lactobacillus plantarum
CNCM I-840

Mixture of:
Strepotococcus infantarius and Lactobacillus plantarum containing a minimum of:

Strepotococcus infantarius
0,5 * 10⁹ CFU/g

and

Lactobacillus plantarum
2 * 10⁹ CFU/g

Calves

6 months

Strepotococcus infantarius
1 * 10⁹

Lactobacillus plantarum
0,5 * 10⁹

Strepotococcus infantarius
1 * 10⁹

Lactobacillus plantarum
0,5 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

17.7.2004 ^(I)(f)

20

Bacillus lecheniformis (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 CFU/g of each bacterium)

Sows

15 days pre partum and during lactation period

0,96 * 10⁹

1,92 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

23.11.2004 ^(I)(g)

Pigs for fattening

-

0,48 * 10⁹

1,28 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

23.11.2004 ^(I)(g)

Chickens for fattening

-

3,2 * 10⁹

3,2 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

May be used in compound feed containing the permitted coccidiostats: amprolium, ethopabate, diclazuril, halofuginone, methylbenzoquate/ meticlorpindol, monensin sodium, nicarbazine, robenidine and salinomycin sodium.

23.11.2004 ^(I)(g)

Turkeys for fattening

-

1,28 * 10⁹

3,2 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

May be used in compound feed containing the permitted coccidiostats: amprolium, ethopabate, diclazuril, halofuginone, methylbenzoquate/ meticlorpindol, monensin sodium, nifursol and robenidine.

23.11.2004 ^(I)(g)

Calves

6 months

1,28 *10⁹

1,6 * 10⁹

In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

28.2.2005 ^(I)(h)

(I) Commission Regulation (EC) N° 2200/2001 of 17 October 2001 (OJ L 299, 15.11.2001)

(a) First authorisation Commission Regulation (EC) N° 866/1999 (OJ L 108, 27.4.1999)
(b) First authorisation Commission Regulation (EC) N° 654/2000 (OJ L 79, 30.3.2000)
(c) First authorisation Commission Regulation (EC) N° 1411/1999 (OJ L 164, 30.6.1999)
(d) First authorisation Commission Regulation (EC) N° 1636/1999 (OJ L 194, 27.7.1999)
(e) First authorisation Commission Regulation (EC) N° 2690/1999 (OJ L 326, 18.12.1999)
(f) First authorisation Commission Regulation (EC) N° 1353/2000 (OJ L 155, 28.6.2000)
(g) First authorisation Commission Regulation (EC) N° 2437/2000 (OJ L 280, 4.11.2000)
(h) First authorisation Commission Regulation (EC) N° 418/2001 (OJ L 62, 2.3.2001)

[back to Directive text]

N°	Additive	Chemical formula, description	Species or category of animal	Maximum age	Minimum content CFU/kg of complete feedingstuff	Maximum content CFU/kg of complete feedingstuff	Other previsions	Period of authorization

10	Enterococcus faecium NCIMB 10415	Preparation of Enterococcus faecium containing a minimum of: Microencapsulated form: 1,0 * 10¹⁰ CFU/g additive 1,75 * 10¹⁰ CFU/g additive	Chickens for fattening	-	0,3 * 10⁹	2,8 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting. May be used in compound feed containing the permitted coccidiostats: amprolium, amprolium/ethopabate, diclazuril, halofuginone, maduramicin ammonium, meticlorpindol, meticlorpindol / methylbenzoquate, monensin sodium, robenidine, salinomycin sodium.	30.6.2004 ^(I)(a)
			Pigs for fattening	-	0,35 * 10⁹	1,5 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting.	30.6.2004 ^(I)(a)
			Sows	-	0,2 * 10⁹	1,25 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting.	30.6.2004 ^(I)(a)
			Cattle for fattening	-	0,25 * 10⁹	0,6 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting. The quantity of Enterococcus faecium in the daily ration must not exceed 1 * 10⁹ CFU for 100 kg of body weight. Add 1 * 10⁹ CFU for each additional 100 kg of body weight.	30.6.2004 ^(I)(a)
		Preparation of Enterococcus faecium containing a minimum of: Microencapsulated form: 1,0 * 10¹⁰ CFU/g additive 1,75 * 10¹⁰ CFU/g additive and Granulated form: 3,5 * 10¹⁰ CFU/g additive	Piglets	Four months	0,3 * 10⁹	1,4 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting. Granulated form to be used exclusively in milk replacers.	30.6.2004 ^(I)(a)
			Calves	Six months	0,35 * 10⁹	6,6 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting. Granulated form to be used exclusively in milk replacers.	30.6.2004 ^(I)(a)
11	Enterococcus faecium DSM 5464	Preparation of Enterococcus faecium containing a minimum of: 5 * 10¹⁰ CFU/g additive	Piglets	Four months	0,5 * 10⁹	1 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting.	30.6.2004 ^(I)(a)
			Chickens for fattening	-	0,5 * 10⁹	1 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting. May be used in compound feed containing the permitted coccidiostats: amprolium, diclazuril, halofuginone, monensin-sodium, metilclorpindol, methylbenzoquate, nicarbazin.	1.4.2004 ^(I)(b)
			Calves	Four months	0,5 * 10¹⁰	1 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life, and stability to pelleting.	1.4.2004 ^(I)(b)
12	Lactobacillus farciminis CNCM MA 67/4R	Preparation of Lactobacillus farciminis containing a minimum of: 1 * 10⁹ CFU/g additive	Piglets	Four months	1 * 10⁹	1 * 10¹⁰	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	30.6.2004 ^(I)(c)
13	Enteroccocus faecium DSM 10 663/ NCIMB 10 415	Preparation of Enteroccocus faecium containing a minimum of: Powder and granulated forms: 3,5 * 10¹⁰ CFU/g additive Coated form: 2,0 * 10¹⁰ CFU/g additive Liquid form: 1 * 10¹⁰ CFU/g additive	Piglets	Four months	1 * 10⁹	1 * 10¹⁰	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	30.6.2004 ^(I)(c)
			Calves	6 months	1 * 10⁹	1 * 10¹⁰	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	26.7.2004 ^(I)(d)
			Chickens for fattening	-	1 * 10⁹	1 * 10¹⁰	1. In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting. 2. May be used in compound feed containing the permitted coccidiostats: amprolium, amprolium/ethopabate, decoquinate, diclazuril, halofuginone, lasalocid sodium, maduramicin ammonium, meticlorpindol/ methylbenzoquate, monensin sodium, narasin, nicarbazin, robenidine, salinomycin sodium.	26.7.2004 ^(I)(d)
14	Saccharomyces cerevisiae MUCL 39 885	Preparation of Saccharomyces cerevisiae containing a minimum of: -Powder, spheric and oval granulated forms: 1 * 10⁹ CFU/g additive	Piglets	Four months	3 * 10⁹	3 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	30.6.2004 ^(I)(c)
14	Saccharomyces cerevisiae MUCL 39 885		Cattle for fattening		9 * 10⁹	9 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting. The quantity of Saccharomyces cerevisiae in the daily ration must not exceed 1,6 * 10¹⁰ CFU per 100 kg/body weight. Add 3,2 * 10⁹ CFU for each additional 100 kg body weight.	30.6.2004 ^(I)(c)
15	Enteroccocus faecium NCIMB 11181	Preparation of Enteroccocus faecium containing a minimum of: Powder forms: 4 * 10¹¹ CFU/g additive Coated form: 5 * 10¹⁰ CFU/g additive	Calves	6 months	5 * 10⁸	2 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	6.1.2004 ^(I)(e)
15	Enteroccocus faecium NCIMB 11181		Piglets	4 months	5 * 10⁸	2 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	6.1.2004 ^(I)(e)
16	Enteroccocus faecium DSM 7134 Lactobacillus rhamnosus DSM 7133	Mixture of: Enteroccocus faecium containing a minimum of: 7 * 10⁹ CFU/g and of Lactobacillus rhamnosus containing a minimum of: 3 * 10⁹ CFU/g	Calves	6 months	1 * 10⁹	6 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	6.1.2004 ^(I)(e)
16			Piglets	4 months	1 * 10⁹	5 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	6.1.2004 ^(I)(e)
17	Lactobacillus casei NCIMB 30096 Enterococcus faecium NCIMB 30098	Mixture of Lactobacillus casei and Enterococcus faecium containing a minimum of: Lactobacillus casei 2 * 10⁹ CFU/g additive and Enterococcus faecium 6 * 10⁹ CFU/g additive	Calves	six months	Lactobacillus casei 0,5 * 10⁹ Enterococcus faecium 1,5 * 10⁹	Lactobacillus casei 1 * 10⁹ Enterococcus faecium 3 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	1.4.2004 ^(I)(b)
18	Enterococcus faecium CECT 4515	Preparation of Enterococcus faecium containing a minimum of 1 * 10¹⁰ CFU/g additive	Piglets	Four months	1 * 10⁹	1 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	1.4.2004 ^(I)(b)
18	Enterococcus faecium CECT 4515		Calves	Six months	1 * 10⁹	1 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	1.4.2004 ^(I)(b)
19	Strepotococcus infantarius CNCM I-841 Lactobacillus plantarum CNCM I-840	Mixture of: Strepotococcus infantarius and Lactobacillus plantarum containing a minimum of: Strepotococcus infantarius 0,5 * 10⁹ CFU/g and Lactobacillus plantarum 2 * 10⁹ CFU/g	Calves	6 months	Strepotococcus infantarius 1 * 10⁹ Lactobacillus plantarum 0,5 * 10⁹	Strepotococcus infantarius 1 * 10⁹ Lactobacillus plantarum 0,5 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	17.7.2004 ^(I)(f)
20	Bacillus lecheniformis (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 CFU/g of each bacterium)	Sows	15 days pre partum and during lactation period	0,96 * 10⁹	1,92 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	23.11.2004 ^(I)(g)
			Pigs for fattening	-	0,48 * 10⁹	1,28 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	23.11.2004 ^(I)(g)
			Chickens for fattening	-	3,2 * 10⁹	3,2 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting. May be used in compound feed containing the permitted coccidiostats: amprolium, ethopabate, diclazuril, halofuginone, methylbenzoquate/ meticlorpindol, monensin sodium, nicarbazine, robenidine and salinomycin sodium.	23.11.2004 ^(I)(g)
			Turkeys for fattening	-	1,28 * 10⁹	3,2 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting. May be used in compound feed containing the permitted coccidiostats: amprolium, ethopabate, diclazuril, halofuginone, methylbenzoquate/ meticlorpindol, monensin sodium, nifursol and robenidine.	23.11.2004 ^(I)(g)
			Calves	6 months	1,28 *10⁹	1,6 * 10⁹	In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.	28.2.2005 ^(I)(h)