2025/708

14.4.2025

COMMISSION IMPLEMENTING REGULATION (EU) 2025/708

of 11 April 2025

concerning the authorisation of sodium ferrocyanide and potassium ferrocyanide as feed additives for all animal species and repealing Regulation (EC) No 1810/2005

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2) Sodium ferrocyanide and potassium ferrocyanide were authorised without a time limit by Commission Regulation (EC) No 1810/2005 (3), in accordance with Directive 70/524/EEC, as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products belonging to the group of binders, anti-caking agents and coagulants, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.

(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of sodium ferrocyanide and potassium ferrocyanide as feed additives for all animal species. The applicant requested the additives to be classified in the additive category ‘technological additives’ and in the functional group ‘anticaking agents’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 21 March 2023 (4) and 4 June 2024 (5) that the use of sodium ferrocyanide and potassium ferrocyanide was safe for animals, when added to sodium chloride at the maximum contents further specified in the opinions and that, under the proposed conditions of use, they were of no concern to consumer safety. The Authority also concluded that sodium ferrocyanide and potassium ferrocyanide were neither skin and eye irritants nor skin sensitisers. However, owing to the presence of nickel, sodium ferrocyanide was considered a dermal and respiratory sensitiser. No conclusions could be reached on safety for the user exposed via inhalation to potassium ferrocyanide. The use of sodium ferrocyanide and potassium ferrocyanide as feed additives was considered safe for the environment. Sodium ferrocyanide and potassium ferrocyanide were considered to be efficacious as anticaking agents when included in sodium chloride at the proposed use levels. The Authority also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5) In view of the above, the Commission considers that sodium ferrocyanide and potassium ferrocyanide satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of those additives.

(6) As there are no safety issues that require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

The substances specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘anticaking agents’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Repeal of Regulation (EC) No 1810/2005

Regulation (EC) No 1810/2005 is repealed.

Article 3

Transitional measures

1. The feed additives sodium ferrocyanide and potassium ferrocyanide, as authorised pursuant to Commission Regulation (EC) No 1810/2005, and premixtures containing those additives, which are produced and labelled before 4 November 2025 in accordance with the rules applicable before 4 May 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.

2. Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 4 May 2026 in accordance with the rules applicable before 4 May 2025 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals.

3. Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 4 May 2027 in accordance with the rules applicable before 4 May 2025 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals.

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 11 April 2025.

For the Commission

The President

Ursula VON DER LEYEN

(1)

OJ L 268, 18.10.2003, p. 29

, ELI:

http://data.europa.eu/eli/reg/2003/1831/oj

(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs

(

OJ L 270, 14.12.1970, p. 1

, ELI:

http://data.europa.eu/eli/dir/1970/524/oj

(3) Commission Regulation (EC) No 1810/2005 of 4 November 2005 concerning a new authorisation for 10 years of an additive in feedingstuffs, the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs (

OJ L 291, 5.11.2005, p. 5

, ELI:

http://data.europa.eu/eli/reg/2005/1810/oj

(4)

EFSA Journal

2023;21(4):7960.

https://doi.org/10.2903/j.efsa.2023.7960

(5)

EFSA Journal

2024.22(7):e8851.

https://doi.org/10.2903/j.efsa.2024.8851

ANNEX

Identification number of the feed additive

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 sodium ferrocyanide (calculated as ferrocyanide ion) / kg NaCl

Category: technological additives. Functional group: anticaking agents

1i535

Sodium ferrocyanide

Additive composition

Sodium ferrocyanide ≥ 99 %

Solid form

_____________________________

Turkeys for fattening and turkeys reared for breeding

Laying hens

Minor poultry for laying or breeding

Porcine species

Ruminants

Camelids

Rabbits

Equines

Fin fish

Dogs

Cats

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

2.	The additive shall only be used in sodium chloride.

3.	On the label of the additive the following shall be indicated: ‘Sodium ferrocyanide shall not be mixed with strong acids’(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 by such procedures and measures, the additive and premixtures shall be used with personal skin and breathing protective equipment.

4 May 2035

Characterisation of the active substance

Sodium ferrocyanide produced by chemical synthesis

CAS number: 13601-19-9

Chemical formula:

Na4[Fe(CN)6] 10H2O

Moisture ≤ 1 %

Water-insoluble matter ≤ 0,03 %

Chloride ion (Cl-) ≤ 0,2 %

Sulphate (SO4) ≤ 0,1 %

Free cyanide not detectable

Ferricyanide not detectable

_____________________________

Analytical method (1)

For the characterisation of sodium ferrocyanide in the feed additive:

—	FAO JECFA monograph ‘Ferrocyanides of calcium, potassium and sodium’

For the determination of ferrocyanide in sodium chloride:

—	spectrophotometry at 700 nm

All other animal species

Identification number of the feed additive

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 potassium ferrocyanide (calculated as ferrocyanide ion) / kg NaCl

Category: technological additives. Functional group: anticaking agents

1i536

Potassium ferrocyanide

Additive composition

Potassium ferrocyanide ≥ 99 %

Solid form

_____________________________

Turkeys for fattening and turkeys reared for breeding

Laying hens

Minor poultry for laying and breeding

Porcine species

Ruminants

Camelids

Rabbits

Equines

Fin fish

Dogs

Cats

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

2.	The additive shall only be used in sodium chloride.

3.	On the label of the additive the following shall be indicated: ‘Potassium ferrocyanide shall not be mixed with strong acids’(4).

4 May 2035

Characterisation of the active substance

Potassium ferrocyanide produced by chemical synthesis

CAS number: 14459-95-1

Chemical formula:

K4[Fe(CN)6] 3H2O

Moisture ≤ 1 %

Water-insoluble matter ≤ 0,03 %

Chloride ion (Cl-) ≤ 0,2 %

Sulphate (SO4) ≤ 0,1 %

Free cyanide not detectable

Ferricyanide not detectable

____________________________

Analytical method (3)

For the characterisation of potassium ferrocyanide in the feed additive:

—	FAO JECFA monograph ‘Ferrocyanides of calcium, potassium and sodium’

For the determination of ferrocyanide in sodium chloride:

—	spectrophotometry at 700 nm

All other animal species

(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) Strong acids: acids with pKa < -2 in water

(3) 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

(4) Strong acids: acids with pKa < -2 in water

ELI: http://data.europa.eu/eli/reg_impl/2025/708/oj

ISSN 1977-0677 (electronic edition)