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 , as last amended by Regulation (EC) No 1756/2002 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)
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 .
(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 .
(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 .
(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 , for calves and chickens for fattening by Commission Regulation (EC) No 1636/1999 and for turkeys for fattening by Commission Regulation (EC) No 1801/2003 .
(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 .
(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
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
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 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
OJ L 270, 14.12.1970, p. 1.
OJ L 265, 3.10.2002, p. 1.
OJ L 289, 28.10.1998, p. 4.
OJ L 191, 7.7.1998, p. 15.
OJ L 108, 27.4.1999, p. 21.
OJ L 326, 18.12.1999, p. 33.
OJ L 164, 30.6.1999, p. 56.
OJ L 194, 27.7.1999, p. 17.
OJ L 264, 15.10.2003, p. 16.
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).
Deleted by Commission Implementing Regulation (EU) 2017/1145 of 8 June 2017 on the withdrawal from the market of certain feed additives authorised pursuant to Council Directives 70/524/EEC and 82/471/EEC and repealing the obsolete provisions authorising those feed additives (Text with EEA relevance).
Deleted by Commission Implementing Regulation (EU) 2020/147 of 3 February 2020 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for weaned piglets, sows (in order to have a benefit for suckling piglets) and dairy cows and amending Regulations (EC) No 2148/2004, (EC) No 1288/2004 and (EC) No 1811/2005 (holder of authorisation S.I. Lesaffre) (Text with EEA relevance).
Deleted by Commission Implementing Regulation (EU) No 1109/2014 of 20 October 2014 concerning the authorisation of the preparation of Saccharomyces cerevisiae CBS 493.94 as a feed additive for cattle for fattening, minor ruminant species for fattening, dairy cows and minor dairy ruminant species and amending Regulations (EC) No 1288/2004 and (EC) No 1811/2005 (holder of authorisation Alltech France) (Text with EEA relevance).
Deleted by Commission Implementing Regulation (EU) No 1061/2013 of 29 October 2013 concerning the authorisation of a preparation of Enterococcus faecium NCIMB 10415 as a feed additive for calves, kids, cats and dogs and amending Regulation (EC) No 1288/2004 (holder of the authorisation DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o) (Text with EEA relevance).
Deleted by Commission Implementing Regulation (EU) No 1101/2013 of 6 November 2013 concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 and Lactobacillus rhamnosus DSM 7133 as a feed additive for calves for rearing and amending Regulation (EC) No 1288/2004 (holder of authorisation Lactosan GmbH & CoKG) (Text with EEA relevance).