ANNEX ISupplementary provisions
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 –– 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: Endo-1,3(4)-beta-glucanase: 2 350 U ( 3 ) /g Endo-1,4-beta-glucanase: 4 000 U ( 4 ) /g Alpha-amylase: 400 U ( 5 ) /g Bacillolysin: 450 U ( 6 ) /g Endo-1,4-beta-xylanase: 20 000 U ( 7 ) /g Chickens for fattening –– Endo-1,3(4)-beta-glucanase: 587 U –– 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: 1 175 –2 350 U endo-1,4-beta-glucanase: 2 000 –4 000 U alpha-amylase: 200–400 U bacillolysin: 225–450 U endo-1,4-beta-xylanase: 10 000 –20 000 U 3. 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: 1 000 U –– Alpha-amylase: 100 U –– Bacillolysin: 112 U –– Endo-1,4-beta-xylanase: 5 000 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 : Endo-1,3(4)-beta-glucanase: 10 000 U ( 3 ) /g Endo-1,4-beta-glucanase: 120 000 U ( 4 ) /g Alpha-amylase: 400 U ( 5 ) /g Endo-1,4-beta-xylanase: 210 000 U ( 7 ) /g Chickens for fattening –– Endo-1,3(4)-beta-glucanase: 500 U –– 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: 1 000 –2 000 U endo-1,4-beta-glucanase: 12 000 –24 000 U alpha-amylase: 40–80 U endo-1,4-beta-xylanase: 21 000 –42 000 U 3. 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: 6 000 U –– Alpha-amylase: 20 U –– Endo-1,4-beta-xylanase: 10 500 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: 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.