Commission Implementing Regulation (EU) 2025/708of 11 April 2025concerning 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)

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 OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. , 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 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). . (2) Sodium ferrocyanide and potassium ferrocyanide were authorised without a time limit by Commission Regulation (EC) No 1810/2005 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). , 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 EFSA Journal 2023;21(4):7960. https://doi.org/10.2903/j.efsa.2023.7960. and 4 June 2024 EFSA Journal 2024.22(7):e8851. https://doi.org/10.2903/j.efsa.2024.8851. 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

Annex

ANNEX 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.

Strong acids: acids with pKa < -2 in water Identification number of the feed additiveAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg of sodium ferrocyanide (calculated as ferrocyanide ion) / kg NaClCategory: technological additives. Functional group: anticaking agents1i535Sodium 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 --80

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.
4. 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 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--60 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. Strong acids: acids with pKa < -2 in water Identification number of the feed additiveAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg of potassium ferrocyanide (calculated as ferrocyanide ion) / kg NaClCategory: technological additives. Functional group: anticaking agents1i536Potassium 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 --80

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

1. The additive shall only be used in sodium chloride.
2. On the label of the additive the following shall be indicated: Potassium ferrocyanide shall not be mixed with strong acids.
3. 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 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 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--60