Commission Implementing Regulation (EU) 2021/982 of 17 June 2021 concerning the renewal of the authorisation of a preparation of 6-phytase produced by Trichoderma reesei CBS 122001 as a feed additive for pigs and poultry (holder of the authorisation: Roal Oy), and repealing Regulations (EU) No 277/2010, (EU) No 891/2010 and Implementing Regulation (EU) No 886/2011 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/982
• Articles: 5

Article 1

The authorisation of the preparation of 6-phytase produced by Trichoderma reesei CBS 122001 specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’ is renewed subject to the conditions laid down in the Annex.

Article 2

1.   The preparation of 6-phytase produced by Trichoderma reesei CBS 122001 and premixtures containing it, which are produced and labelled before 8 January 2022 in accordance with the rules applicable before 8 July 2021 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the preparation referred to in point 1, which are produced and labelled before 8 July 2022 in accordance with the rules applicable before 8 July 2021 may continue to be placed on the market and used until the existing stocks are exhausted, where they are intended for food-producing animals.

Article 3

Regulations (EU) No 277/2010, (EU) No 891/2010 and Implementing Regulation (EU) No 886/2011 are repealed.

Article 4

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

Units of activity/kg of complete feed with a moisture content of 12 %

Category: zootechnical additives. Functional group: digestibility enhancers.

4a12

Roal Oy

6-Phytase

(EC 3.1.3.26)

Additive composition

Preparation of 6-phytase (EC 3.1.3.26) produced by Trichoderma reesei CBS 122001 with a minimum content of

Solid form: 40 000 PPU  ( 1 ) /g

Liquid form: 10 000 PPU/g

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Characterisation of active substance

6-phytase (EC 3.1.3.26) produced by Trichoderma reesei (CBS 122001)

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Analytical method

( 2 )

Colorimetric method quantifying the activity of 6-phytase by measuring released inorganic phosphate from sodium phytate by analysing the colour formed by reduction of a phosphomolybdate complex.

Poultry for fattening and breeding

Pigs

-

250 PPU

-

1.

In the directions for use of the additive and premixture, 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.

8 July 2031

Poultry for laying

125 PPU

( 1 )   1 PPU is the amount of enzyme which liberates 1 μmol of inorganic phosphate from sodium phytate per minute at pH = 5,0 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