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Document 02005R0358-20170628

    Consolidated text: Commission Regulation (EC) No 358/2005 of 2 March 2005 concerning the authorisations without a time limit of certain additives and the authorisation of new uses of additives already authorised in feedingstuffs (Text with EEA relevance)

    ELI: http://data.europa.eu/eli/reg/2005/358/2017-06-28

    02005R0358 — EN — 28.06.2017 — 003.001


    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

    ►B

    COMMISSION REGULATION (EC) No 358/2005

    of 2 March 2005

    concerning the authorisations without a time limit of certain additives and the authorisation of new uses of additives already authorised in feedingstuffs

    (Text with EEA relevance)

    (OJ L 057 3.3.2005, p. 3)

    Amended by:

     

     

    Official Journal

      No

    page

    date

    ►M1

    COMMISSION IMPLEMENTING REGULATION (EU) No 643/2013 of 4 July 2013

      L 186

    7

    5.7.2013

    ►M2

    COMMISSION IMPLEMENTING REGULATION (EU) 2017/429 of 10 March 2017

      L 66

    4

    11.3.2017

    ►M3

    COMMISSION IMPLEMENTING REGULATION (EU) 2017/963 of 7 June 2017

      L 145

    18

    8.6.2017




    ▼B

    COMMISSION REGULATION (EC) No 358/2005

    of 2 March 2005

    concerning the authorisations without a time limit of certain additives and the authorisation of new uses of additives already authorised in feedingstuffs

    (Text with EEA relevance)



    Article 1

    The preparations belonging to the group ‘Enzymes’ 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 substances belonging to the group ‘Colourants, including pigments, other colourants’ as set out in Annex II are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in that Annex.

    Article 3

    The preparations belonging to the group ‘Enzymes’ as set out in Annex III are authorised provisionally for four years as additives in animal nutrition under the conditions laid down in that Annex.

    Article 4

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

    Article 5

    This Regulation shall enter into force on the third day following 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

    Units of activity/kg of complete feedingstuff

    Enzymes

    E 1619

    Alpha-amylase EC 3.2.1.1

    Endo-1,3(4)-beta-glucanase EC 3.2.1.6

    Preparation of alpha-amylase and endo-1,3(4)-beta-glucanase produced by Bacillus amyloliquefaciens (DSM 9553) having minimum activities of:

    Coated form:

    Alpha-amylase: 200 KNU (1)/g

    Endo-1,3(4)-beta-glucanase: 350 FBG (2)/g

    Liquid form:

    Alpha-amylase: 130 KNU/ml

    Endo-1,3(4)-beta-glucanase: 225 FBG/ml

    Chickens for fattening

    ––

    alpha-amylase: 10 KNU

    ––

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

    2.  Recommended dose per kg of complete feedingstuff:

    alpha-amylase: 20–40 KNU

    endo-1,3(4)-beta-glucanase: 35–70 FBG

    3.  For use in compound feed rich in starch and beta glucans, e.g. containing more than 40 % cereals (e.g. barley, oats, wheat, rye, triticale, or maize).

    Without a time limit

    endo-1,3(4)-beta –glucanase: 17 FBG

    ––

    ▼M3 —————

    ▼M2 —————

    ▼B

    E 1622

    Endo-1,3(4)-beta-glucanase EC 3.2.1.6

    Endo-1,4-beta-xylanase EC 3.2.1.8

    Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CBS 357.94) having a minimum activity of:

    Granulated form:

    6 000  BGU (8)/g

    8 250  EXU (9)/g

    Liquid form:

    2 000  BGU/ml

    2 750  EXU/ml

    Chickens for fattening

    ––

    endo-1,3(4)-beta-glucanase: 500 BGU

    ––

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

    2.  Recommended dose per kg of complete feedingstuff:

    endo-1,3(4)-beta-glucanase: 500 BGU

    endo-1,4-beta-xylanase: 680 EXU

    3.  For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 30 % wheat and 30 % barley, or 20 % rye.

    Without a time limit

    endo-1,4-beta-xylanase: 680 EXU

    ––

    (1)   1 KNU is the amount of enzyme which liberates 672 micromoles of reducing sugars (glucose equivalent) from soluble starch per minute at pH 5,6 and 37 °C.

    (2)   1 FBG is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 5,0 and 30 °C.

    (3)   1 U is the amount of enzyme which liberates 0,0056 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 7,5 and 30 °C.

    (4)   1 U is the amount of enzyme which liberates 0,0056 micromoles of reducing sugars (glucose equivalents) from carboxymethylcellulose per minute at pH 4,8 and 50 °C.

    (5)   1 U is the amount of enzyme which hydrolyses 1 micromole of glucosidic linkages from water insoluble cross-linked starch polymer per minute at pH 7,5 and 37 °C.

    (6)   1 U is the amount of enzyme which makes 1 microgram of azo-casein soluble in trichloracetic acid per minute at pH 7,5 and 37 °C.

    (7)   1 U is the amount of enzyme which liberates 0,0067 micromoles of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 5,3 and 50 °C.

    (8)   1 BGU is the amount of enzyme which liberates 0,278 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 3,5 and 40 °C.

    (9)   1 EXU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH 3,5 and 55 °C.




    ANNEX II



    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

    2.  Other colourants

    E 102

    Tartrazine

    C16H9N4O9S2Na3

    Grain-eating ornamental birds

    150

    Without a time limit

    Small rodents

    150

    Without a time limit

    E 110

    Sunset yellow FCF

    C16H10N2O7S2Na2

    Grain-eating ornamental birds

    150

    Without a time limit

    Small rodents

    150

    Without a time limit

    ▼M1 —————

    ▼B

    E 141

    Chlorophyll copper complex

    Grain-eating ornamental birds

    150

    Without a time limit

    Small rodents

    150

    Without a time limit




    ANNEX III



    EC No or No

    Additive

    Chemical formula, description

    Species or category of animal

    Maximum age

    Minimum content

    Maximum content

    Other provisions

    End of period of authorisation

    Units of activity/kg of complete feedingstuff

    Enzymes

    51

    Endo-1,4-beta-xylanase EC 3.2.1.8

    Preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis (LMG S-15136) having a minimum activity of:

    Solid and liquid form:

    100 IU (1)/g or ml

    Laying hens

    10 IU

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

    2.  Recommended dose per kg of complete feedingstuff: 10 IU

    3.  For use in compound feed rich in arabinoxylan, e.g. containing minimum 40 % wheat or barley.

    6 March 2009

    28

    3-Phytase EC 3.1.3.8

    Preparation of 3-phytase produced by Trichoderma reesei (CBS 528.94) having a minimum activity of:

    Solid form: 5 000 PPU (2)/g

    Liquid form: 1 000 PPU/g

    Turkeys for fattening

    250 PPU

    1.  In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

    2.  Recommended dose per kg of complete feedingstuff: 250-1 000 PPU

    3.  For use in compound feed containing more than 0,22 % phytin bound phosphorus.

    6 March 2009

    Sows

    250 PPU

    1.  In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.

    2.  Recommended dose per kg of complete feedingstuff: 500-1 000 PPU

    3.  For use in compound feed containing more than 0,22 % phytin bound phosphorus.

    6 March 2009

    (1)   1 IU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 4,5 and 30 °C.

    (2)   1 PPU is the amount of enzyme which liberates 1 micromole of inorganic phosphate from sodium phytate per minute at pH 5 and 37 °C.




    ANNEX IV



    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

    10

    Enterococcus faecium NCIMB 10415

    Preparation of Enterococcus faecium containing a minimum of microencapsulated form: 5 × 109 CFU/g

    Dogs

    4,5 × 106

    2 × 109

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

    6 March 2009

    Cats

    5 × 106

    8 × 109

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

    6 March 2009

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