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Commission Implementing Regulation (EU) 2018/338 of 7 March 2018 concerning the authorisation of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) as feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all other avian species (excluding laying birds) and weaned piglets (holder of the authorisation BASF SE) (Text with EEA relevance. )

Commission Implementing Regulation (EU) 2018/338 of 7 March 2018 concerning the authorisation of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) as feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all other avian species (excluding laying birds) and weaned piglets (holder of the authorisation BASF SE) (Text with EEA relevance. )

Implementing Regulation (EU) 2018/338 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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The 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 that Annex.

Article 2

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This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEXSupplementary provisions

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ANNEX Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method 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 with a moisture content of 12 % Category of zootechnical additives. Functional group: digestibility enhancers 4a27 BASF SE 6-phytase EC 3.1.3.26 Additive composition: Preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) with a minimum content of: Solid form: 5 000 FTU  ( 1 ) /g Liquid form: 5 000 FTU/g Characterisation of the active substance: 6-phytase produced by Aspergillus. niger (DSM 25770) Analytical method  ( 2 ) : For the quantification of phytase activity in the feed additive: — colorimetric method based on the enzymatic reaction of phytase on the phytate For the quantification of phytase activity in premixtures: — colorimetric method based on the enzymatic reaction of phytase on the phytate — VDLUFA 27.1.3 For the quantification of phytase activity in feedingstuffs: — colorimetric method based on the enzymatic reaction of phytase on the phytate — EN ISO 30024 Pigs for fattening Sows Minor porcine species for fattening or for reproduction — 100 FTU   1. 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 breathing protection. 3. For use in weaned piglets up to 35 kg. 28.3.2028 Weaned piglets 125 FTU Chickens for fattening Chickens reared for laying 750 FTU Turkeys for fattening Turkeys reared for breeding All other avian species (excluding laying birds) 125 FTU ( 1 )   1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5,5 and 37 °C ( 2 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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