Commission Regulation (EC) No 600/2005 of 18 April 2005 concerning a new authorisation for 10 years of a coccidiostat as an additive in feedingstuffs, the provisional authorisation of an additive and the permanent authorisation of certain additives in feedingstuffs (Text with EEA relevance)

• CELEX: Regulation (EC) No 600/2005
• Articles: 7

Article 1

The preparation belonging to the group ‘Coccidiostats and other medicinal substances’, as specified in Annex I, is authorised for use for 10 years as additive in animal nutrition under the conditions laid down in that Annex.

Article 2

The preparation belonging to the group ‘Micro-organisms’, as specified in Annex II, is authorised provisionally for four years as an additive in animal nutrition under the conditions laid down in that Annex.

Article 3

The preparations belonging to the group ‘Micro-organisms’, as specified in Annex III, are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in that Annex.

Article 4

This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX I

ANNEX I

Registration number of additive

Name and registration number of person responsible for putting the 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

mg of active substance/kg of complete feedingstuff

Coccidiostats and other medicinal substances

‘E 766

Alpharma (Belgium) BVBA

Salinomycin sodium 120 g/kg

(Salinomax 120G)

Additive composition:

Salinomycin sodium 120 g/kg

Calcium lignosulfonate: 40 g/kg

Calcium sulphate dihydrate to 1 000  g/kg

Active substance:

Salinomycin sodium,

C 42 H 69 O 11 Na,

Sodium salt of a polyether monocarboxylic acid produced by fermentation of Streptomyces albus (ATCC 21838/US 9401-06),

CAS No: 55 721-31-8

Related impurities:

< 42 mg elaiophylin/kg salinomycin sodium.

< 40 g 17-epi-20 desoxysalinomycin /kg salinomycin sodium

Chickens for fattening

—

50

70

Use prohibited at least 5 days before slaughter.

Indicate in the instructions for use:

“Dangerous for equines and turkeys”

“This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g.tiamulin) can be contra-indicated”

22.4.2015’

ANNEX II

ANNEX II

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

CFU/kg of complete feedingstuff

Micro-organisms

‘25

Lactobacillus acidophilus DSM 13241

Preparation of Lactobacillus acidophilus containing a minimum of:

1 × 10 11  CFU/g additive

Dogs

—

6 × 10 9

2 × 10 10

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

For use in dry feed with a water content at or below 2 %.

22.4.2009

Cats

—

3 × 10 9

2 × 10 10

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

For use in dry feed with a water content at or below 2 %.

22.4.2009’

ANNEX III

ANNEX III

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 1709

Enterococcus faecium ATCC 53519

Enterococcus faecium ATCC 55593

(In a 1/1 ratio)

Mixture of encapsulated Enterococcus faecium and Enterococcus faecium containing a minimum of 2 × 10 8 CFU/g additive.

(i.e. a minimum of 1 × 10 8 CFU/g of each bacterium)

Chickens for fattening

—

1 × 10 8

1 × 10 8

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

May be used in compounded feed containing coccidiostats: decoquinate, halofuginone, lasalocid sodium, maduramicin ammonium, monensin sodium, narasin, narasin/nicarbazin, and salinomycin sodium.

Without a time limit

E 1700

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 × 10 9 CFU/g additive (1,6 × 10 9 of each bacterium)

Turkeys for fattening

—

1,28 × 10 9

1,28 × 10 9

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

May be used in compounded feed containing coccidiostats: diclazuril, halofuginone, monensin sodium and robenidine.

Without a time limit

Calves

3 months

1,28 × 10 9

1,28 × 10 9

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

Without a time limit

E 1702

Saccharomyces cerevisiae

NCYC Sc 47

Preparation of Saccharomyces cerevisiae containing 5 × 10 9 CFU/g additive

Rabbits for fattening

—

2,5 × 10 9

7,5 × 10 9

In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting

Without a time limit’