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)
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Address https://gelex.eu/eli/EU/regulation/2005/358@2005-03-02/en
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, and in particular Articles 3 and 9d(1) and 9e(1) thereof,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, and in particular Article 25 thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition in the European Union.
(2) Article 25 of Regulation (EC) No 1831/2003 lays down the transitional measures for applications for authorisation of feed additives submitted in accordance with Directive 70/524/EEC before the date of application of that Regulation.
(3) The applications for authorisation of additives listed in the annexes to this Regulation were submitted before the date of application of Regulation (EC) No 1831/2003.
(4) Initial comments by Member States on these applications were issued under Article 4(4) of Directive 70/524/EEC and have been forwarded to the Commission before the date of application of Regulation (EC) No 1831/2003. Such applications therefore shall continue to be treated in accordance with Article 4 of Directive 70/524/EEC.
(5) The use of the enzyme preparation of alpha-amylase and endo-1,3(4)-beta-glucanase produced by Bacillus amyloliquefaciens (DSM 9553) was provisionally authorised, for the first time, for chickens for fattening, by Commission Regulation (EC) No 654/2000.
(6) New data were submitted in support of the application for authorisation without a time limit of this enzyme preparation.
(7) The European Food Safety Authority (EFSA) delivered a favourable opinion on the toxin producing potential of the micro-organism producing this enzyme preparation dated 15 September 2004.
(8) The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied.
(9) The use of the enzyme preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) was provisionally authorised, for chickens for fattening, by Commission Regulation (EC) No 2437/2000.
(10) New data were submitted in support of the application for authorisation without a time limit of this enzyme preparation.
(11) The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied.
(12) The use of the enzyme preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) was provisionally authorised, for chickens for fattening, by Commission Regulation (EC) No 2437/2000.
(13) New data were submitted in support of the application for authorisation without a time limit of this enzyme preparation.
(14) The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied.
(15) The use of the enzyme preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CBS 357.94) was provisionally authorised for the first time for chickens for fattening, by Commission Regulation (EC) No 1436/98.
(16) New data were submitted in support of the application for authorisation without a time limit of this enzyme preparation.
(17) The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied.
(18) Accordingly, the use of those four enzyme preparations as specified in Annex I, should be authorised without a time limit.
(19) The use of the substance tartrazine was provisionally authorised, as colourant for grain-eating ornamental birds and small rodents, by Commission Regulation (EC) No 2697/2000.
(20) New data were submitted in support of the application for authorisation without a time limit of this colourant.
(21) The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied.
(22) The use of the substance sunset yellow FCF, was provisionally authorised, as colourant, for grain-eating ornamental birds and small rodents, by Regulation (EC) No 2697/2000.
(23) New data were submitted in support of the application for authorisation without a time limit of this colourant.
(24) The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied.
(25) The use of the substance patent blue V, was provisionally authorised, as colourant, for grain-eating ornamental birds and small rodents, by Regulation (EC) No 2697/2000.
(26) New data were submitted in support of the application for authorisation without a time limit of this colourant.
(27) The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied.
(28) The use of the substance chlorophyll copper complex was provisionally authorised as coulourant, for grain-eating ornamental birds and small rodents, by Regulation (EC) No 2697/2000.
(29) New data were submitted in support of the application for authorisation without a time limit of this colourant.
(30) The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied.
(31) Accordingly, the use of those four colourants as specified in Annex II, should be authorised without a time limit.
(32) The use of the enzyme preparation of endo-1(4)-beta- xylanase produced by Bacillus subtilis (LMG-15136) is authorised for chickens for fattening without a time limit by Commission Regulation (EC) No 1259/2004, and provisionally for piglets by Commission Regulation (EC) No 937/2001, for turkeys for fattening by Commission Regulation (EC) No 2188/2002, and for pigs for fattening by Commission Regulation (EC) No 261/2003.
(33) New data were submitted in support of an application to extend the authorisation of the use of this enzyme preparation to laying hens.
(34) The European Food Safety Authority (EFSA) has delivered an opinion on the use of this preparation which concludes that it does not present a risk for this additional animal category, under the conditions set out in Annex III to this Regulation.
(35) The assessment shows that the conditions laid down in Article 9e(1) of Directive 70/524/EEC for an authorisation of such preparation for that use have been satisfied.
(36) The use of the enzyme preparation of 3-phytase produced by Trichoderma reesei (CBS 528.94) is authorised for chickens for fattening by Commission Regulation (EC) No 418/2001.
(37) New data were submitted in support of an application to extend the authorisation of the use of this enzyme preparation to turkeys for fattening and sows.
(38) The European Food Safety Authority (EFSA) has delivered an opinion on the use of this preparation which concludes that it do not present a risk for these additional animal categories, under the conditions set out in Annex III to this Regulation.
(39) Accordingly, the use of these two enzyme preparations as specified in Annex III, should be provisionally authorised for four years.
(40) The use of the micro-organism preparation of Enterococcus faecium is authorised for calves without a time limit by Commission Regulation (EC) No 1288/2004 and provisionally until 30 June 2004, for chickens for fattening, piglets, pigs for fattening, sows, and cattle for fattening by Commission Regulation (EC) No 866/1999.
(41) New data were submitted in support of an application to extend the authorisation of the use of this micro-organism preparation to dogs and cats.
(42) The European Food Safety Authority (EFSA) has delivered an opinion on the use of this preparation which concludes that it does not present a risk for this additional animal category, under the conditions set out in Annex IV to this Regulation.
(43) The assessment shows that the conditions laid down in Article 9e(1) of Directive 70/524/EEC for an authorisation of such preparation for that use have been satisfied.
(44) Accordingly, the use of this micro-organism preparation as specified in Annex IV, should be provisionally authorised for four years.
(45) The assessment of these applications shows that certain procedures should be required to protect workers from exposure to the additives set out in the Annexes. 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.
(46) 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 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. Done at Brussels, 2 March 2005. For the Commission Markos Kyprianou Member of the Commission
ANNEX
(1) Alpha-amylase: 200 KNU/g (2) Endo-1,3(4)-beta-glucanase: 350 FBG/g (1) Coated form: (1) Alpha-amylase: 130 KNU/ml (2) Endo-1,3(4)-beta-glucanase: 225 FBG/ml (2) Liquid form: (3) alpha-amylase: 20–40 KNU (4) endo-1,3(4)-beta-glucanase: 35–70 FBG (5) Endo-1,3(4)-beta-glucanase: 2350 U/g (6) Endo-1,4-beta-glucanase: 4000 U/g (7) Alpha-amylase: 400 U/g (8) Bacillolysin: 450 U/g (9) Endo-1,4-beta-xylanase: 20000 U/g (10) endo-1,3(4)-beta-glucanase: 1175–2350 U (11) endo-1,4-beta-glucanase: 2000–4000 U (12) alpha-amylase: 200–400 U (13) bacillolysin: 225–450 U (14) endo-1,4-beta-xylanase: 10000–20000 U (15) Endo-1,3(4)-beta-glucanase: 10000 U/g (16) Endo-1,4-beta-glucanase: 120000 U/g (17) Alpha-amylase: 400 U/g (18) Endo-1,4-beta-xylanase: 210000 U/g (19) endo-1,3(4)-beta-glucanase: 1000–2000 U (20) endo-1,4-beta-glucanase: 12000–24000 U (21) alpha-amylase: 40–80 U (22) endo-1,4-beta-xylanase: 21000–42000 U (1) 6000 BGU/g (2) 8250 EXU/g (23) Granulated form: (1) 2000 BGU/ml (2) 2750 EXU/ml (24) Liquid form: (25) endo-1,3(4)-beta-glucanase: 500 BGU (26) endo-1,4-beta-xylanase: 680 EXU Anx. 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: Chickens for fattening –– alpha-amylase: 10 KNU –– In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: 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 –– E 1620 Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Endo-1,4-beta-glucanase EC 3.2.1.4 Alpha-amylase EC 3.2.1.1 Bacillolysin EC 3.4.24.28 Endo-1,4-beta-xylanase EC 3.2.1.8 Preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) having a minimum activity of: Chickens for fattening –– Endo-1,3(4)-beta-glucanase: 587 U –– In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 45 % wheat. Without a time limit Endo-1,4-beta-glucanase: 1000 U –– Alpha-amylase: 100 U –– Bacillolysin: 112 U –– Endo-1,4-beta-xylanase: 5000 U –– E 1621 Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Endo-1,4-beta-glucanase EC 3.2.1.4 Alpha-amylase EC 3.2.1.1 Endo-1,4-beta-xylanase EC 3.2.1.8 Preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (CBS 592.94) , alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) having a minimum activity of : Chickens for fattening –– Endo-1,3(4)-beta-glucanase: 500 U –– In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 45 % wheat. Without a time limit Endo-1,4-beta-glucanase: 6000 U –– Alpha-amylase: 20 U –– Endo-1,4-beta-xylanase: 10500 U –– 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: Chickens for fattening –– endo-1,3(4)-beta-glucanase: 500 BGU –– In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: 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 ––
ANNEX I 1.2.3.1.2.3.1.2.3.1.2.3.
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: Chickens for fattening –– alpha-amylase: 10 KNU –– In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: 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 –– E 1620 Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Endo-1,4-beta-glucanase EC 3.2.1.4 Alpha-amylase EC 3.2.1.1 Bacillolysin EC 3.4.24.28 Endo-1,4-beta-xylanase EC 3.2.1.8 Preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) having a minimum activity of: Chickens for fattening –– Endo-1,3(4)-beta-glucanase: 587 U –– In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 45 % wheat. Without a time limit Endo-1,4-beta-glucanase: 1000 U –– Alpha-amylase: 100 U –– Bacillolysin: 112 U –– Endo-1,4-beta-xylanase: 5000 U –– E 1621 Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Endo-1,4-beta-glucanase EC 3.2.1.4 Alpha-amylase EC 3.2.1.1 Endo-1,4-beta-xylanase EC 3.2.1.8 Preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (CBS 592.94) , alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) having a minimum activity of : Chickens for fattening –– Endo-1,3(4)-beta-glucanase: 500 U –– In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 45 % wheat. Without a time limit Endo-1,4-beta-glucanase: 6000 U –– Alpha-amylase: 20 U –– Endo-1,4-beta-xylanase: 10500 U –– 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: Chickens for fattening –– endo-1,3(4)-beta-glucanase: 500 BGU –– In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: 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) Alpha-amylase: 200 KNU/g (2) Endo-1,3(4)-beta-glucanase: 350 FBG/g (1) Coated form: (1) Alpha-amylase: 130 KNU/ml (2) Endo-1,3(4)-beta-glucanase: 225 FBG/ml (2) Liquid form: (3) alpha-amylase: 20–40 KNU (4) endo-1,3(4)-beta-glucanase: 35–70 FBG (5) Endo-1,3(4)-beta-glucanase: 2350 U/g (6) Endo-1,4-beta-glucanase: 4000 U/g (7) Alpha-amylase: 400 U/g (8) Bacillolysin: 450 U/g (9) Endo-1,4-beta-xylanase: 20000 U/g (10) endo-1,3(4)-beta-glucanase: 1175–2350 U (11) endo-1,4-beta-glucanase: 2000–4000 U (12) alpha-amylase: 200–400 U (13) bacillolysin: 225–450 U (14) endo-1,4-beta-xylanase: 10000–20000 U (15) Endo-1,3(4)-beta-glucanase: 10000 U/g (16) Endo-1,4-beta-glucanase: 120000 U/g (17) Alpha-amylase: 400 U/g (18) Endo-1,4-beta-xylanase: 210000 U/g (19) endo-1,3(4)-beta-glucanase: 1000–2000 U (20) endo-1,4-beta-glucanase: 12000–24000 U (21) alpha-amylase: 40–80 U (22) endo-1,4-beta-xylanase: 21000–42000 U (1) 6000 BGU/g (2) 8250 EXU/g (23) Granulated form: (1) 2000 BGU/ml (2) 2750 EXU/ml (24) Liquid form: (25) endo-1,3(4)-beta-glucanase: 500 BGU (26) endo-1,4-beta-xylanase: 680 EXU
Coated form: (1) Alpha-amylase: 200 KNU/g (2) Endo-1,3(4)-beta-glucanase: 350 FBG/g
Alpha-amylase: 200 KNU/g
Endo-1,3(4)-beta-glucanase: 350 FBG/g
Liquid form: (1) Alpha-amylase: 130 KNU/ml (2) Endo-1,3(4)-beta-glucanase: 225 FBG/ml
Alpha-amylase: 130 KNU/ml
Endo-1,3(4)-beta-glucanase: 225 FBG/ml
alpha-amylase: 20–40 KNU
endo-1,3(4)-beta-glucanase: 35–70 FBG
Endo-1,3(4)-beta-glucanase: 2350 U/g
Endo-1,4-beta-glucanase: 4000 U/g
Alpha-amylase: 400 U/g
Bacillolysin: 450 U/g
Endo-1,4-beta-xylanase: 20000 U/g
endo-1,3(4)-beta-glucanase: 1175–2350 U
endo-1,4-beta-glucanase: 2000–4000 U
alpha-amylase: 200–400 U
bacillolysin: 225–450 U
endo-1,4-beta-xylanase: 10000–20000 U
Endo-1,3(4)-beta-glucanase: 10000 U/g
Endo-1,4-beta-glucanase: 120000 U/g
Alpha-amylase: 400 U/g
Endo-1,4-beta-xylanase: 210000 U/g
endo-1,3(4)-beta-glucanase: 1000–2000 U
endo-1,4-beta-glucanase: 12000–24000 U
alpha-amylase: 40–80 U
endo-1,4-beta-xylanase: 21000–42000 U
Granulated form: (1) 6000 BGU/g (2) 8250 EXU/g
6000 BGU/g
8250 EXU/g
Liquid form: (1) 2000 BGU/ml (2) 2750 EXU/ml
2000 BGU/ml
2750 EXU/ml
endo-1,3(4)-beta-glucanase: 500 BGU
endo-1,4-beta-xylanase: 680 EXU
Anx_ii. 2. 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 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 E 131 Patent blue V Calcium salt of 5-Hydroxy-4′,4″-bis (diethylamino)-triphenyl-carbinol-2,4-disulfonic acid Grain-eating ornamental birds — — 150 — Without a time limit Small rodents — — 150 — Without a time limit E 141 Chlorophyll copper complex — Grain-eating ornamental birds — — 150 — Without a time limit Small rodents — — 150 — Without a time limit
ANNEX II 2.
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 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 E 131 Patent blue V Calcium salt of 5-Hydroxy-4′,4″-bis (diethylamino)-triphenyl-carbinol-2,4-disulfonic acid Grain-eating ornamental birds — — 150 — Without a time limit Small rodents — — 150 — Without a time limit E 141 Chlorophyll copper complex — Grain-eating ornamental birds — — 150 — Without a time limit Small rodents — — 150 — Without a time limit
(1) 100 IU/g or ml (2) Solid form: 5000 PPU/g (3) Liquid form: 1000 PPU/g Anx. 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: Laying hens — 10 IU — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: 10 IU 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: Turkeys for fattening — 250 PPU — In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: 250-1000 PPU For use in compound feed containing more than 0,22 % phytin bound phosphorus. 6 March 2009 Sows — 250 PPU — In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: 500-1000 PPU For use in compound feed containing more than 0,22 % phytin bound phosphorus. 6 March 2009
ANNEX III 1.2.3.1.2.3.1.2.3.
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: Laying hens — 10 IU — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kg of complete feedingstuff: 10 IU 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: Turkeys for fattening — 250 PPU — In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: 250-1000 PPU For use in compound feed containing more than 0,22 % phytin bound phosphorus. 6 March 2009 Sows — 250 PPU — In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: 500-1000 PPU For use in compound feed containing more than 0,22 % phytin bound phosphorus. 6 March 2009 (1) 100 IU/g or ml (2) Solid form: 5000 PPU/g (3) Liquid form: 1000 PPU/g
100 IU/g or ml
Solid form: 5000 PPU/g
Liquid form: 1000 PPU/g
Anx. 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
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
Versions
Cited by
- Commission Implementing Regulation (EU) 2021/758 of 7 May 2021 on the status of certain products as feed additives within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council and on the withdrawal from the market of certain feed additives (Text with EEA relevance) Regulation · Grade B
As a consequence of the withdrawal from the market of the feed additives, it is appropriate to repeal the provisions authorising them, where such provisions are still in force. Consequently, Commission Regulation (EC) No 358/2005 should be amended accordingly. In addition, Commission Regulation (EC) No 880/2004 should be repealed, as both entries in the Annex thereto are to be deleted as a result of the withdrawal from the market of beta-carotene for use for canaries as provided in Annex I, Chapter I.A, part 2, and as a result of the authorisation of canthaxanthin for use for ornamental birds
- Commission Implementing Regulation (EU) 2021/758 of 7 May 2021 on the status of certain products as feed additives within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council and on the withdrawal from the market of certain feed additives (Text with EEA relevance) Regulation · Grade B
In Annex II to Regulation (EC) No 358/2005, entry E 141 on chlorophyll copper complex is deleted.
- 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) Regulation · Grade B
Annex I to Regulation (EC) No 358/2005 is amended as follows:
- Commission Regulation (EU) No 1270/2009 of 21 December 2009 concerning the permanent authorisations of certain additives in feedingstuffs (Text with EEA relevance) Regulation · Grade B
The use of the enzyme preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589,94), endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (CBS 592,94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) was provisionally authorised for piglets by Commission Regulation (EC) No 2200/2001. It was provisionally authorised for turkeys for fattening by Commission Regulation (EC) No 252/2006. It was authorised
- Commission Regulation (EC) No 1458/2005 of 8 September 2005 concerning the permanent and provisional authorisations of certain additives in feedingstuffs and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs (Text with EEA relevance) Regulation · Grade B
The use of the enzyme preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) is authorised for chickens for fattening without a time limit by Commission Regulation (EC) No 358/2005, and provisionally for turkeys for fattening by Commission Regulation (EC) No 2013/2001. New data were submitted in support of an application to extend the authoris
- Commission Regulation (EC) No 252/2006 of 14 February 2006 concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisations of new uses of certain additives already authorised in feedingstuffs (Text with EEA relevance) Regulation · Grade B
The use of the enzyme preparation of 3-phytase produced by Trichoderma reesei (CBS 528.94) was provisionally authorised for the first time for sows and turkeys for fattening by Commission Regulation (EC) No 358/2005. It was authorised without a time-limit for pigs for fattening and piglets by Commission Regulation (EC) No 943/2005. New data were submitted in support of an application to extend the authorisation of the use of this enzyme preparation to laying hens. The European Food Safety Authority (EFSA) has delivered an opinion on the use of this preparation which concludes that it does not
- Commission Regulation (EC) No 252/2006 of 14 February 2006 concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisations of new uses of certain additives already authorised in feedingstuffs (Text with EEA relevance) Regulation · Grade B
The use of the enzyme preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) was provisionally authorised for the first time for piglets by Commission Regulation (EC) No 2437/2000. It was authorised without a time-limit for chickens for fattening by Regulation (EC) No 358/2005. Ne
- Commission Implementing Regulation (EU) 2025/2575 of 18 December 2025 withdrawing from the market certain feed additives (Text with EEA relevance) Regulation · Grade B
As a consequence of the withdrawal from the market of the feed additives concerned, it is appropriate to amend and repeal the provisions authorising them, where such provisions are still in force. Consequently, Commission Regulation (EC) No 358/2005 should be amended accordingly. In addition, Commission Regulations (EC) No 316/2003, (EC) No 1811/2005 and (EC) No 1876/2006 should be repealed.
- Commission Implementing Regulation (EU) 2025/2575 of 18 December 2025 withdrawing from the market certain feed additives (Text with EEA relevance) Regulation · Grade B
In Annex III to Regulation (EC) No 358/2005, entry 28 on 3-Phytase EC 3.1.3.8 is deleted.
- Commission Regulation (EC) No 322/2009 of 20 April 2009 concerning the permanent authorisations of certain additives in feedingstuffs (Text with EEA relevance) Regulation · Grade B
The use of the enzyme preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis (LMG S-15136) was provisionally authorised for laying hens by Commission Regulation (EC) No 358/2005. It was authorised without a time limit for chickens for fattening by Commission Regulation (EC) No 1259/2004, for piglets (weaned) by Commission Regulation (EC) No 1206/2005, for pigs for fattening and turkeys for fattening by Commission Regulation (EC) No 516/2007 and for 10 years for ducks by Commission Regulation (EC) No 242/2007. New data were submitted in support of an application for authorisation w
- Commission Regulation (EU) No 516/2010 of 15 June 2010 concerning the permanent authorisation of an additive in feedingstuffs (Text with EEA relevance) Regulation · Grade B
The use of the enzyme preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) was provisionally authorised for laying hens by Commission Regulation (EC) No 1458/2005. It was authorised without a time limit for chickens for fattening by Commission Regulation (EC) No 358/2005 and for turkeys for fattening by Commission Regulation (EC) No 1284/200
- Commission Implementing Regulation (EU) 2023/1712 of 7 September 2023 concerning the authorisation of Sunset Yellow FCF as a feed additive for cats, dogs, ornamental fish, grain-eating ornamental birds and small rodents (Text with EEA relevance) Regulation · Grade B
Sunset Yellow FCF was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for ornamental fish belonging to the group colourants, including pigments under the heading other colourants and for dogs and cats under the heading other colourants – colouring agents authorised for colouring foodstuffs by Community rules. Under the same Directive, it was authorised without a time limit for all species or categories of animals, with the exception of cats and dogs, in animal feedingstuffs only in products processed from: (i) waste products of foodstuffs; (ii) other
- Commission Regulation (EC) No 102/2009 of 3 February 2009 concerning the permanent authorisation of an additive in feedingstuffs (Text with EEA relevance) Regulation · Grade B
The use of the micro-organism preparation of Enterococcus faecium NCIMB 10415 was provisionally authorised for dogs and cats by Commission Regulation (EC) No 358/2005. It was authorised without a time limit for calves by Commission Regulation (EC) No 1288/2004, for chickens for fattening and pigs for fattening by Commission Regulation (EC) No 943/2005, for sows by Commission Regulation (EC) No 1200/2005 and for piglets by Commission Regulation (EC) No 252/2006.
- Commission Implementing Regulation (EU) 2017/963 of 7 June 2017 concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatinus (formerly classified as Aspergillus aculeatus) (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma reesei (formerly classified as Trichoderma longibrachiatum) (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP4842) and bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) as a feed additive for all avian species and weaned piglets and amending Regulations (EC) No 358/2005 and (EU) No 1270/2009 (holder of the authorisation Kemin Europa NV) (Text with EEA relevance) Regulation · Grade B
The preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatinus (formerly classified as Aspergillus aculeatus) (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma reesei (formerly classified as Trichoderma longibrachiatum) (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP4842) and bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for chickens for fattening by Commi
- Commission Implementing Regulation (EU) 2017/963 of 7 June 2017 concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatinus (formerly classified as Aspergillus aculeatus) (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma reesei (formerly classified as Trichoderma longibrachiatum) (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP4842) and bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) as a feed additive for all avian species and weaned piglets and amending Regulations (EC) No 358/2005 and (EU) No 1270/2009 (holder of the authorisation Kemin Europa NV) (Text with EEA relevance) Regulation · Grade B
In Annex I to Regulation (EC) No 358/2005 entry E 1620 on endo-1,3(4)-beta-glucanase EC 3.2.1.6, endo-1,4-beta-glucanase EC 3.2.1.4, alpha-amylase EC 3.2.1.1, bacillolysin EC 3.4.24.28 and endo-1,4-beta-xylanase EC 3.2.1.8 is deleted.
- Commission Implementing Regulation (EU) No 643/2013 of 4 July 2013 concerning the authorisation of Patent Blue V as a feed additive for non-food producing animals and amending Regulation (EC) No 358/2005 (Text with EEA relevance) Regulation · Grade B
Patent Blue V was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for certain feed materials on all animals and in feedingstuffs intended for cats and dogs by Commission Directive 74/181/EEC, and in feedingstuffs intended for use in grain eating ornamental birds and small rodents by Commission Regulation (EC) No 358/2005. That product was subsequently entered in the European Union Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
- Commission Implementing Regulation (EU) No 643/2013 of 4 July 2013 concerning the authorisation of Patent Blue V as a feed additive for non-food producing animals and amending Regulation (EC) No 358/2005 (Text with EEA relevance) Regulation · Grade B
As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulation (EC) No 358/2005 should therefore be amended accordingly.
- Commission Implementing Regulation (EU) No 643/2013 of 4 July 2013 concerning the authorisation of Patent Blue V as a feed additive for non-food producing animals and amending Regulation (EC) No 358/2005 (Text with EEA relevance) Regulation · Grade B
Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for the disposal of existing stocks of the additive, pre-mixtures and compound feed containing it, as authorised by Directive 74/181/EEC and Regulation (EC) No 358/2005.
- Commission Implementing Regulation (EU) No 643/2013 of 4 July 2013 concerning the authorisation of Patent Blue V as a feed additive for non-food producing animals and amending Regulation (EC) No 358/2005 (Text with EEA relevance) Regulation · Grade B
In Annex II to Regulation (EC) No 358/2005 the entry of the row E 131 is deleted.
- Commission Regulation (EC) No 1140/2007 of 1 October 2007 concerning the provisional authorisation of a new use of an additive already authorised in feedingstuffs (Text with EEA relevance) Regulation · Grade B
The use of the enzyme preparation endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) was authorised without a time limit for chickens for fattening by Commission Regulation (EC) No 358/2005.