Commission Implementing Regulation (EU) 2023/1698 of 6 September 2023 concerning the renewal of the authorisation of a preparation of potassium diformate as a feed additive for sows (holder of the authorisation: ADDCON Europe GmbH) and repealing Regulation (EU) No 104/2010 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/1698
• Articles: 5

Article 1 Renewal of the authorisation

The authorisation of the preparation of potassium diformate, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives (improvement of performance parameters)’, is renewed subject to the conditions laid down in the Annex.

Article 2 Repeal of Regulation (EU) No 104/2010

Regulation (EU) No 104/2010 is repealed.

Article 3 Transitional measures

1.   The preparation specified in the Annex and premixtures containing this substance, which are produced and labelled before 27 March 2024 in accordance with the rules applicable before 27 September 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 27 September 2024 in accordance with the rules applicable before 27 September 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

mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)

4d800

ADDCON Europe GmbH

Potassium diformate

Additive composition

Preparation of potassium diformate, min. 98 %

Silicate max. 1,5 %

Water max. 0,5 %

Solid form

Characterisation of active substance

Potassium diformate, solid

KH(COOH) 2

CAS No 20642-05-1

Analytical method

( 1 )

For the determination of potassium

diformate (as total formic acid) in the feed additive, premixtures and compound feeds: ion chromatography with conductivity detection (IC-CD) – EN 17294.

For the determination of total potassium in the feed additive:

—

atomic absorption spectrometry (AAS) – EN ISO 6869; or

—

inductively coupled plasma-atomic emission spectrometry (ICP-AES) – EN 15510.

Sows

—

10 000  ( 2 )

12 000  ( 3 )

1.

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

2.

The maximum content of potassium diformate shall be 12 000 mg/kg of complete feedingstuff with a moisture content of 12 % for sows, whether used alone as a zootechnical additive or used in combination with other sources of potassium diformate.

3.

The mixture of different sources of formic acid shall not exceed the permitted maximum level of 10 000 mg formic acid/kg of complete feedingstuff with a moisture content of 12 %.

4.

The additive shall be incorporated in feed in form of a premixture.

5.

In the directions for use of the additive, premixture and feedingstuff the following shall be indicated: ‘The simultaneous use of different organic acids or their salts is contraindicated where one or more of them is used at or near the maximum permitted content’.

6.

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 by such procedures and measures, the additive and premixtures shall be used with personal eye protective equipment.

27 September 2033

( 1 )   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.

( 2 )   10 000 mg/kg potassium diformate equals 6993 mg/kg as formic acid.

( 3 )   12 000 mg/kg potassium diformate equals 8391 mg/kg as formic acid.