# L_2004243EN.01001001.xml

| 15.7.2004 | EN | Official Journal of the European Union | L 243/10 |
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15.7.2004

EN

Official Journal of the European Union

L 243/10

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COMMISSION REGULATION (EC) No 1288/2004

of 14 July 2004

concerning the permanent authorisation of certain additives and the provisional authorisation of a new use of an additive already authorised in feedingstuffs

(Text with EEA relevance)

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 (1), as last amended by Regulation (EC) No 1756/2002 (2) and in particular Article 3, and Articles 9d(1) and 9e(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. |
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(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 astaxanthin-rich Phaffia rhodozyma (ATCC 74219) as a colourant for salmon and trout has been provisionally authorised by Commission Regulation (EC) No 2316/98 (3). |
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(2)

The use of astaxanthin-rich Phaffia rhodozyma (ATCC 74219) as a colourant for salmon and trout has been provisionally authorised by Commission Regulation (EC) No 2316/98 (3).

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

New data were submitted in support of an application for an authorisation without a time limit for that colourant. The assessment shows that the conditions laid down in Directive 70/524/EEC for such an authorisation have been satisfied.

| (4) | The Scientific Panel on Additives and Products or Substances Used in Animal Feed of the European Food Safety Authority (EFSA) delivered a favourable opinion on 22 January 2003 on the efficacy of that additive when used in the animal category salmon and trout. In a second opinion adopted on 1 April 2004, the EFSA concluded that the yeast in that product is not a living organism and it is not expected to have any consequence on the environment, under the conditions of use set out in Annex I to this Regulation. |
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(4)

The Scientific Panel on Additives and Products or Substances Used in Animal Feed of the European Food Safety Authority (EFSA) delivered a favourable opinion on 22 January 2003 on the efficacy of that additive when used in the animal category salmon and trout. In a second opinion adopted on 1 April 2004, the EFSA concluded that the yeast in that product is not a living organism and it is not expected to have any consequence on the environment, under the conditions of use set out in Annex I to this Regulation.

| (5) | The use of the micro-organism preparation of Saccharomyces cerevisiae (NCYC Sc 47) has been provisionally authorised, for the first time, for sows by Commission Regulation (EC) No 1436/98 (4). |
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(5)

The use of the micro-organism preparation of Saccharomyces cerevisiae (NCYC Sc 47) has been provisionally authorised, for the first time, for sows by Commission Regulation (EC) No 1436/98 (4).

| (6) | The use of the micro-organism preparation of Saccharomyces cerevisiae (CBS 493.94) has been provisionally authorised, for the first time, for calves by Commission Regulation (EC) No 1436/98 and for cattle for fattening by Commission Regulation (EC) No 866/1999 (5). |
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(6)

The use of the micro-organism preparation of Saccharomyces cerevisiae (CBS 493.94) has been provisionally authorised, for the first time, for calves by Commission Regulation (EC) No 1436/98 and for cattle for fattening by Commission Regulation (EC) No 866/1999 (5).

| (7) | The use of the micro-organism preparation of Enterococcus faecium (NCIMB 10415) has been provisionally authorised, for the first time, for calves by Commission Regulation (EC) No 866/1999. |
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(7)

The use of the micro-organism preparation of Enterococcus faecium (NCIMB 10415) has been provisionally authorised, for the first time, for calves by Commission Regulation (EC) No 866/1999.

| (8) | The use of the micro-organism preparation of Enterococcus faecium (DSM 7134) and Lactobacillus rhamnosus (DSM 7133) has been provisionally authorised, for the first time, for calves by Commission Regulation (EC) No 2690/1999 (6). |
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(8)

The use of the micro-organism preparation of Enterococcus faecium (DSM 7134) and Lactobacillus rhamnosus (DSM 7133) has been provisionally authorised, for the first time, for calves by Commission Regulation (EC) No 2690/1999 (6).

| (9) | New data were submitted in support of applications for authorisation without a time limit for those micro-organisms. The assessment of those applications shows that the conditions laid down in Directive 70/524/EEC for such authorisations have been satisfied. |
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(9)

New data were submitted in support of applications for authorisation without a time limit for those micro-organisms. The assessment of those applications shows that the conditions laid down in Directive 70/524/EEC for such authorisations have been satisfied.

| (10) | Accordingly, the use of those additives without a time limit should be authorised. |
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(10)

Accordingly, the use of those additives without a time limit should be authorised.

| (11) | In addition, Directive 70/524/EEC provides for the authorisation on a provisional basis of a new use of an additive already authorised to be granted for a period not exceeding four years, subject to certain conditions. |
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(11)

In addition, Directive 70/524/EEC provides for the authorisation on a provisional basis of a new use of an additive already authorised to be granted for a period not exceeding four years, subject to certain conditions.

| (12) | The use of the micro-organism preparation of Enterococcus faecium (DSM 10663/NCIMB 10415) has been provisionally authorised, for the first time, for piglets by Commission Regulation (EC) No 1411/1999 (7), for calves and chickens for fattening by Commission Regulation (EC) No 1636/1999 (8) and for turkeys for fattening by Commission Regulation (EC) No 1801/2003 (9). |
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(12)

The use of the micro-organism preparation of Enterococcus faecium (DSM 10663/NCIMB 10415) has been provisionally authorised, for the first time, for piglets by Commission Regulation (EC) No 1411/1999 (7), for calves and chickens for fattening by Commission Regulation (EC) No 1636/1999 (8) and for turkeys for fattening by Commission Regulation (EC) No 1801/2003 (9).

| (13) | New data were submitted in support of an application to extend the authorisation of the use of that additive to dogs. The assessment shows that the conditions laid down in Directive 70/524/EEC for such an authorisation have been satisfied. |
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(13)

New data were submitted in support of an application to extend the authorisation of the use of that additive to dogs. The assessment shows that the conditions laid down in Directive 70/524/EEC for such an authorisation have been satisfied.

| (14) | The EFSA delivered a favourable opinion on 15 April 2004 on the safety of that additive when used in the animal category dogs, under the conditions of use set out in Annex II to this Regulation. |
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(14)

The EFSA delivered a favourable opinion on 15 April 2004 on the safety of that additive when used in the animal category dogs, under the conditions of use set out in Annex II to this Regulation.

| (15) | Accordingly, the use of the Enterococcus faecium, as specified in Annex II, should be authorised for a period not exceeding four years. |
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(15)

Accordingly, the use of the Enterococcus faecium, as specified in Annex II, should be authorised for a period not exceeding four years.

| (16) | The assessment of the applications shows that certain procedures should be required to protect workers from exposure to the additives set out in Annexes I and II to this Regulation. 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 (10). |
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(16)

The assessment of the applications shows that certain procedures should be required to protect workers from exposure to the additives set out in Annexes I and II to this Regulation. 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 (10).

| (17) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(17)

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 group ‘Colourants, including pigments’ and ‘Micro-organisms’, as set out in Annex I, are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in that Annex.

Article 2

The preparation belonging to the group ‘micro-organisms’, as set out in Annex II, is provisionally authorised for use as an additive in animal nutrition under the conditions laid down in that Annex.

Article 3

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, 14 July 2004.

For the Commission

David BYRNE

Member of the Commission

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(1)  
  OJ L 270, 14.12.1970, p. 1.

1

(2)  
  OJ L 265, 3.10.2002, p. 1.

2

(3)  
  OJ L 289, 28.10.1998, p. 4.

3

(4)  
  OJ L 191, 7.7.1998, p. 15.

4

(5)  
  OJ L 108, 27.4.1999, p. 21.

5

(6)  
  OJ L 326, 18.12.1999, p. 33.

6

(7)  
  OJ L 164, 30.6.1999, p. 56.

7

(8)  
  OJ L 194, 27.7.1999, p. 17.

8

(9)  
  OJ L 264, 15.10.2003, p. 16.

9

(10)  
  OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p 1).

10

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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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg/kg of complete feedingstuff |
| Colourants, including pigments |
| 1.   Carotenoids and xanthophylls |
| E 161(z) | Astaxanthin-rich Phaffia Rhodozyma

  (ATCC 74219) | Concentrated biomass of the yeast Phaffia rhodozyma (ATCC 74219), killed, containing at least 4,0 g astaxanthin per kilogram of additive and having a maximum ethoxyquin content of 2 000  mg/kg | Salmon | — | — | 100 | The maximum content is expressed as astaxanthin
  Use permitted only from the age of six months onwards
  The mixture of the additive with canthaxanthin is allowed provided that the total concentration of astaxanthin and canthaxanthin does not exceed 100 mg/kg in the complete feedingstuff
  Ethoxyquin content to be declared | Without a time limit |
| Trout | — | — | 100 | The maximum content is expressed as astaxanthin
  Use permitted only from the age of six months onwards
  The mixture of the additive with canthaxanthin is allowed provided that the total concentration of astaxanthin and canthaxanthin does not exceed 100 mg/kg in the complete feedingstuff
  Ethoxyquin content to be declared | Without a time limit |

EC No

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg/kg of complete feedingstuff

Colourants, including pigments

Carotenoids and xanthophylls

E 161(z)

Astaxanthin-rich Phaffia Rhodozyma

(ATCC 74219)

Concentrated biomass of the yeast Phaffia rhodozyma (ATCC 74219), killed, containing at least 4,0 g astaxanthin per kilogram of additive and having a maximum ethoxyquin content of 2 000  mg/kg

Salmon

—

—

100

The maximum content is expressed as astaxanthin

Use permitted only from the age of six months onwards

The mixture of the additive with canthaxanthin is allowed provided that the total concentration of astaxanthin and canthaxanthin does not exceed 100 mg/kg in the complete feedingstuff

Ethoxyquin content to be declared

Without a time limit

Trout

—

—

100

The maximum content is expressed as astaxanthin

Use permitted only from the age of six months onwards

The mixture of the additive with canthaxanthin is allowed provided that the total concentration of astaxanthin and canthaxanthin does not exceed 100 mg/kg in the complete feedingstuff

Ethoxyquin content to be declared

Without a time limit

| 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 1702 | Saccharomyces cerevisiae

  NCYC Sc 47 | Preparation of Saccharomyces cerevisiae containing a minimum of 5 × 109 CFU/g additive | Sows | — | 5 × 109 | 1 × 1010 | 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 1704 | Saccharomyces cerevisiae

  CBS 493.94 | Preparation of Saccharomyces cerevisiae containing a minimum of 1 × 108 CFU/g additive | Calves | 6 months | 2 × 108 | 2 × 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 |
| Cattle for fattening | — | 1,7 × 108 | 1,7 × 108 | In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting
  The quantity of Saccharomyces cerevisiae in the daily ration must not exceed 7,5 × 108 CFU for 100 kg of body weight
  Add 1 × 108 CFU for each additional 100 kg body weight | Without a time limit |
| E 1705 | Enterococcus faecium

  NCIMB 10415 | Preparation of Enterococcus faecium containing a minimum of | Microencapsulated form:
  1 × 1010 CFU/g additive |

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 1702

Saccharomyces cerevisiae

NCYC Sc 47

Preparation of Saccharomyces cerevisiae containing a minimum of 5 × 109 CFU/g additive

Sows

—

5 × 109

1 × 1010

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 1704

Saccharomyces cerevisiae

CBS 493.94

Preparation of Saccharomyces cerevisiae containing a minimum of 1 × 108 CFU/g additive

Calves

6 months

2 × 108

2 × 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

Cattle for fattening

—

1,7 × 108

1,7 × 108

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

The quantity of Saccharomyces cerevisiae in the daily ration must not exceed 7,5 × 108 CFU for 100 kg of body weight

Add 1 × 108 CFU for each additional 100 kg body weight

Without a time limit

E 1705

Enterococcus faecium

NCIMB 10415

Preparation of Enterococcus faecium containing a minimum of

Microencapsulated form:

1 × 1010 CFU/g additive

| | Granulated form:
  3,5 × 1010 CFU/g additive |
| --- | --- |

Granulated form:

3,5 × 1010 CFU/g additive

Calves

6 months

1 × 109

6,6 × 109

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

Granulated form to be used exclusively in milk replacers

Without a time limit

E 1706

Enterococcus faecium

DSM 7134

Mixture of:

Enterococcus faecium containing a minimum of: 7 × 109 CFU/g

Calves

4 months

1 × 109

5 × 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

Lactobacillus rhamnosus

DSM 7133

and of

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

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ANNEX II

| 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 |
| 13 | Enterococcus faecium

  DSM10663/NCIMB 10415 | Preparation of Enterococcus faecium containing a minimum of: | Powder and granulated form:
  3,5 × 1010 CFU/g of additive |

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

13

Enterococcus faecium

DSM10663/NCIMB 10415

Preparation of Enterococcus faecium containing a minimum of:

Powder and granulated form:

3,5 × 1010 CFU/g of additive

| | Coated form:
  2,2 × 1010 CFU/g of additive |
| --- | --- |

Coated form:

2,2 × 1010 CFU/g of additive

| | Liquid form:
  1 × 1010 CFU/ml of additive |
| --- | --- |

Liquid form:

1 × 1010 CFU/ml of additive

Dogs

—

1 × 109

1 × 1010

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

17 July 2008

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