Commission Implementing Regulation (EU) 2018/1566 of 18 October 2018 concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No 1453/2004 (holder of authorisation Andrès Pintaluba S.A.) (Text with EEA relevance.)
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  • Corrigendum to Commission Implementing Regulation (EU) 2018/1566 of 18 October 2018 concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No 1453/2004 (holder of authorisation Andrès Pintaluba S.A.), 32018R1566R(01), August 7, 2020
Commission Implementing Regulation (EU) 2018/1566of 18 October 2018concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus orizae (ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No 1453/2004 (holder of authorisation Andrès Pintaluba S.A.)(Text with EEA relevance)
Article 1AuthorisationThe preparation specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "digestibility enhancers", is authorised as an additive in animal nutrition, subject to the conditions laid down in the Annex.
Article 2Amendment to Regulation (EC) No 1453/2004In Annex II to Regulation (EC) No 1453/2004 entry E 1612 on the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase and alpha-amylase is deleted.
Article 3Transitional measuresThe preparation specified in the Annex, and feed containing that preparation, which are produced and labelled before 8 May 2019 in accordance with the rules applicable before 8 November 2018 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 4Entry into forceThis Regulation shall enter into force on the twentieth 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
1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,0 and 30 °C.1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from rye arabinoxylan per minute at pH 4,0 and 30 °C.1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from wheat starch per minute at pH 5,0 and 30 °C.Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reportsCategory of zootechnical additives. Functional group: digestibility enhancers
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff with a moisture content of 12 %
4a1612iAndrés Pintaluba S.A.Endo-1,3(4)-beta-glucanaseEC 3.2.1.6Endo-1,4-beta-xylanaseEC 3.2.1.8Alpha-amylaseEC 3.2.1.1Additive compositionPreparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus orizae (ATCC66222) having respectively a minimum activity of.Endo-1,3(4)-beta-glucanase 900 U/g;Endo-1,4-beta-xylanase 1000 U/g;Alpha-amylase 3000 U/gSolid formCharacterisation of the active substanceendo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus orizae (ATCC66222)Analytical methodsDetermination in the feed additive of:endo-1,3(4)-beta glucanase: colorimetric method based on the enzymatic reaction of glucanase on barley betaglucan substrate in the presence of 3,5-dinitrosalicylic acid (DNS) at pH 4,0 and 30 °C;endo-1,4-β-xylanase in the feed additive: colorimetric method based on the enzymatic reaction of xylanase on rye arabinoxylan substrate in the presence of DNS at pH 4,0 and 30 °C;alpha-amylase: colorimetric method based on the enzymatic reaction of amylase on wheat starch substrate in the presence of DNS at pH 5,0 and 30 °C.Determination of the active substances in premixtures and feedingstuffs:Colorimetric method measuring depolymerised soluble fragments released by action of glucanase on azo-barley-glucan;Colorimetric method measuring depolymerised soluble fragments released by action of endo-1,4-β-xylanase on azo-xylan;Colorimetric method measuring depolymerised soluble fragments released by action of amylase on p-nitrophenylmaltoheptaoside.Weaned pigletsMinor porcine species(weaned)endo-1,3(4)-beta-glucanase450 Ubeta-xylanase500 Ualpha-amylase1500 U1.In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment including skin, eyes and breathing protections.3.For use in weaned piglets until approximately 35 kg.8 November 2028
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