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

Official Journal EN of the European Union L series 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 2003on 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.

(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.

ELI: http://data.europa.eu/eli/reg_impl/2025/708/oj 1/5EN OJ L, 14.4.2025

(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 2025in accordance with the rules applicable before 4 May 2025may 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 2026in accordance with the rules applicable before 4 May 2025may 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 2027in accordance with the rules applicable before 4 May 2025may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals.

2/5 ELI: http://data.europa.eu/eli/reg_impl/2025/708/ojEN OJ L, 14.4.2025 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

ELI: http://data.europa.eu/eli/reg_impl/2025/708/oj 3/5ANNEX Mini­ Maximum mum content Identifica­ content Species or tion number Composition, chemical formula, description, Maximum End of period of Additive category of Other provisions of the feed analytical method age mg of sodium authorisation animal additive ferrocyanide (calculated as ferrocyanide ion) / kg NaCl

Category: technological additives. Functional group: anticaking agents 1i535 Sodium Additive composition Turkeys for - - 80 1. In the directions for use of the 4 May 2035 ferrocya­ fattening and additive and premixtures, the Sodium ferrocyanide ≥ 99 % nide turkeys reared storage conditions and Solid form for breeding stability to heat treatment shall _____________________________ be indicated.

Laying hens

2. The additive shall only be used Characterisation of the active substance Minor poultry in sodium chloride.

Sodium ferrocyanide produced by chemical for laying or 3. On the label of the additive the

synthesis breeding following shall be indicated:

CAS number: 13601-19-9 ‘Sodium ferrocyanide shall not Porcine species

Chemical formula: be mixed with strong acids’(2).

Na [Fe(CN) ] 10H O Ruminants 4. For users of the additive and 4 6 2 Moisture ≤ 1 % premixtures, feed business Camelids Water-insoluble matter ≤ 0,03 % operators shall establish Chloride ion (Cl-) ≤ 0,2 % Rabbits operational procedures and Sulphate (SO ) ≤ 0,1 % organisational measures to Free cyanide n4 ot detectable Equines address potential risks Ferricyanide not detectable Fin fish resulting from their use.

_____________________________ Where those risks cannot be Dogs eliminated by such procedures Analytical method(1) Cats and measures, the additive and premixtures shall be used with For the characterisation of sodium ferrocyanide personal skin and breathing

in the feed additive: protective equipment. — FAO JECFA monograph ‘Ferrocyanides of calcium, potassium and sodium’ All other - - 60 For the determination of ferrocyanide in sodium animal species

chloride: — spectrophotometry at 700 nm

(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 4/5

ELI:

http://data.europa.eu/eli/reg_impl/2025/708/oj EN OJ L,

14.4.2025Minimum Maximum Identifica­ content content Species or tion number Composition, chemical formula, description, Maximum End of period of Additive category of Other provisions of the feed analytical method age mg of potassium authorisation animal additive ferrocyanide (calculated as ferrocyanide ion) / kg NaCl

Category: technological additives. Functional group: anticaking agents 1i536 Potassium Additive composition Turkeys for - - 80 1. In the directions for use of 4 May 2035 ferrocyanide fattening and the additive and Potassium ferrocyanide ≥ 99 % turkeys reared premixtures, the storage Solid form for breeding conditions and stability to _____________________________ heat treatment shall be Laying hens Characterisation of the active substance indicated.

Minor poultry 2. The additive shall only be Potassium ferrocyanide produced by chemical for laying and used in sodium chloride. synthesis breeding 3. On the label of the additive

CAS number: 14459-95-1 the following shall be

Chemical formula: Porcine species

indicated: ‘Potassium K [Fe(CN) ] 3H O 4 6 2 Ruminants ferrocyanide shall not be Moisture ≤ 1 % mixed with strong acids’(2).

Water-insoluble matter ≤ 0,03 % Camelids

4. For users of the additive and Chloride ion (Cl-) ≤ 0,2 % Rabbits premixtures, feed business Sulphate (SO ) ≤ 0,1 % 4 operators shall establish Free cyanide not detectable Equines operational procedures and Ferricyanide not detectable Fin fish organisational measures to ____________________________ address potential risks Analytical method(1) Dogs resulting from their use.

Where those risks cannot be Cats For the characterisation of potassium eliminated by such

ferrocyanide in the feed additive: All other - - 60 procedures and measures, animal species the additive and premixtures — FAO JECFA monograph ‘Ferrocyanides of shall be used with personal calcium, potassium and sodium’ skin and breathing For the determination of ferrocyanide in protective equipment.

sodium chloride: — spectrophotometry at 700 nm

(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

ELI:

http://data.europa.eu/eli/reg_impl/2025/708/oj 5/5 OJ L,

14.4.2025 EN