Commission Implementing Regulation (EU) 2020/172 of 6 February 2020 concerning the renewal of the authorisation of 3-phytase produced by Aspergillus niger (CBS 101.672) as a feed additive for piglets (weaned), pigs for fattening, sows, chickens for fattening, turkeys for fattening, laying hens, ducks and all other minor avian species, ornamental birds and the new authorisation for chickens reared for laying or for breeding purposes, turkeys reared for breeding or breeding hens and suckling piglets and repealing Regulations (EC) No 243/2007, (EC) No 1142/2007, (EC) No 165/2008, (EC) No 505/2008 and (EU) No 327/2010 (holder of authorisation BASF SE) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/172
• Articles: 4

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’ is authorised and renewed as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Regulations (EC) No 243/2007, (EC) No 1142/2007, (EC) No 165/2008, (EC) No 505/2008 and (EU) No 327/2010 are repealed.

Article 3

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

Schedules & Appendices

ANNEX

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

Unit of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a1600

BASF SE

3-phytase

EC 3.1.3.8

Additive composition

3-phytase produced

by Aspergillus niger (CBS 101.672)

having a minimum activity of:

Solid form: 5 000 FTU  ( 1 ) /g

Liquid form: 5 000 FTU/ml

Characterisation of the active substance

3-phytase produced

by Aspergillus niger (CBS 101.672)

Analytical method

( 2 )

Colorimetric method measuring inorganic phosphate released by the enzyme from phytate substrate.

Piglets

(suckling and weaned)

Sows

-

500 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 its 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 and skin protection.

27.2.2030

Pigs for fattening

-

100 FTU

Chickens for fattening

Chickens reared for laying/breeding

-

375 FTU

Laying hens

Turkeys for fattening

Turkeys reared for breeding and breeding hens

Ornamental birds and all minor avian species, other than ducks

-

250 FTU

Ducks

-

300 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