Commission Implementing Regulation (EU) 2018/1568 of 18 October 2018 concerning the authorisation of a preparation of fumonisin esterase produced by Komagataella phaffii (DSM 32159) as a feed additive for all pigs and all poultry species (Text with EEA relevance.)

• CELEX: Implementing Regulation (EU) 2018/1568
• Articles: 3

Article 1

The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘substances for the reduction of the contamination of feed by mycotoxins’, is authorised as an additive in animal nutrition subject to the conditions laid down in the Annex.

Article 2

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 %

Technological additives: substances for reduction of the contamination of feed by mycotoxins: fumonisins

1m03i

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Fumonisin esterase EC 3.1.1.87

Additive composition

Preparation of fumonisin esterase produced by Komagataella phaffii (DSM 32159) containing a minimum of 3 000 U/g  ( 1 ) .

Characterisation of the active substance

Preparation of fumonisin esterase produced by Komagataella phaffii (DSM 32159)

Analytical method

( 2 )

For the determination of fumonisin esterase activity: High Performance Liquid Chromatography coupled with a tandem mass spectrometry.

(HPLC-MS/MS) method based on the quantification of the tricarballylic acid released from the action of the enzyme on fumonisin B1 at pH 8,0 and 30 °C.

All pigs

All poultry species

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10

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to pelleting shall be indicated.

2.

Recommended maximum dose: 300 U/kg of complete feedingstuff.

3.

The use of the additive is allowed in feedingstuffs complying with the European Union legislation on undesirable substances in animal feed.  ( 3 )

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks concerning 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 November 2028

( 1 )   1 U is the enzymatic activity that releases 1 μmol tricarballylic acid per minute from 100 μΜ fumonisin B1 in 20 mM Tris-Cl buffer pH 8,0 with 0,1 mg/ml bovine serum albumin at 30 °C.

( 2 )   Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

( 3 )   Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed ( OJ L 140, 30.5.2002, p. 10 ).