02005R0600 — EN — 04.04.2017 — 008.001


This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

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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)

(OJ L 099 19.4.2005, p. 5)

Amended by:

 

 

Official Journal

  No

page

date

 M1

COMMISSION REGULATION (EC) No 2028/2006 of 18 December 2006

  L 414

26

30.12.2006

►M2

COMMISSION REGULATION (EC) No 496/2007 of 4 May 2007

  L 117

9

5.5.2007

 M3

COMMISSION REGULATION (EC) No 202/2009 of 16 March 2009

  L 71

8

17.3.2009

 M4

COMMISSION IMPLEMENTING REGULATION (EU) No 516/2011 of 25 May 2011

  L 138

43

26.5.2011

 M5

COMMISSION IMPLEMENTING REGULATION (EU) No 118/2012 of 10 February 2012

  L 38

36

11.2.2012

►M6

COMMISSION IMPLEMENTING REGULATION (EU) No 334/2012 of 19 April 2012

  L 108

6

20.4.2012

►M7

COMMISSION IMPLEMENTING REGULATION (EU) No 1014/2013 of 22 October 2013

  L 281

1

23.10.2013

►M8

COMMISSION IMPLEMENTING REGULATION (EU) 2017/447 of 14 March 2017

  L 69

18

15.3.2017




▼B

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)



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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

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ANNEX I



Registration number of additive

Name and registration number of person responsible for putting 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

Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin

mg of active substance/kg of complete feedingstuff

Coccidiostats and other medicinal substances

‘E 766

►M7  Zoetis Belgium SA ◄

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, C42H69O11Na,

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 one day 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 contraindicated”

22.4.2015

5 μg of Salinomycin/kg for all wet tissues’

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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 × 1011 CFU/g additive

Dogs

—

6 × 109

2 × 1010

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 × 109

2 × 1010

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



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 × 108 CFU/g additive.

(i.e. a minimum of 1 × 108 CFU/g of each bacterium)

Chickens for fattening

—

1 × 108

1 × 108

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

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