2004R1288 — EN — 25.11.2005 — 001.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B 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) (OJ L 243, 15.7.2004, p.10)

Amended by:









▼B

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. (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. (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 ). (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. (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. (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. (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. (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. (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, Whereas: 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









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 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 ▼M1 E 1704 Saccharomyces cerevisiae CBS 493.94 Preparation of Saccharomyces cerevisiae containing a minimum of 1 × 109 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 body weight. Add 1 × 108 CFU for each additional 100 kg of body weight. Without a time-limit ▼B 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 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









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 Coated form: 2,2 × 1010 CFU/g 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