Commission Implementing Regulation (EU) 2023/1342 of 30 June 2023 concerning the renewal of the authorisation of a preparation of 6-phytase produced by Aspergillus oryzae DSM 33699 as a feed additive for poultry, pigs for fattening, weaned piglets and sows (holder of authorisation: DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.) and repealing Implementing Regulation (EU) No 837/2012 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/1342
• Articles: 5

Article 1 Renewal of the authorisation

The authorisation of the preparation of 6-phytase produced by Aspergillus oryzae DSM 33699, 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 Repeal of Implementing Regulation (EU) No 837/2012

Implementing Regulation (EU) No 837/2012 is repealed.

Article 3 Transitional measures

1.   The preparation specified in the Annex and premixtures containing that preparation, which are produced and labelled before 23 January 2024 in accordance with the rules applicable before 23 July 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the preparation specified in the Annex, which are produced and labelled before 23 July 2024 in accordance with the rules applicable before 23 July 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4 Entry into force

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 feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a18i

DSM Nutritional Products Ltd., represented by DSM Nutritional Products Sp. z o.o.

6-phytase (EC 3.1.3.26)

Additive composition

Preparation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae DSM 33699 with a minimum activity of:

10 000 FYT  ( 1 ) /g in solid form,

20 000 FYT/g in liquid form

Characterisation of the active substance

6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae DSM 33699

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 – VDLUFA 27.1.4;

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 compound feeds: colorimetric method based on the enzymatic reaction of phytase on the phytate – EN ISO 30024.

Poultry

Piglets (weaned)

Pigs for fattening

Sows

—

500 FYT

—

1.

In the directions for use of the additive and premixture, the storage temperature, storage life, 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 by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

23 July 2033

( 1 )   1 FYT is the amount of enzyme which liberates 1 μmol of inorganic phosphate from phytate per minute under reaction conditions with a phytate concentration of 5,0 mM at pH 5,5 and 37 °C.

( 2 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en.