Commission Implementing Regulation (EU) 2026/2027 of 10 September 2026 concerning the authorisation of molybdenum chelate of EDTA as a feed additive for honeybees (holder of authorisation: Oligofeed SAS)

Official Journal EN of the European Union L series 2026/2027 11.9.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/2027 of 10 September 2026 concerning the authorisation of molybdenum chelate of EDTA as a feed additive for honeybees (holder of authorisation: Oligofeed SAS) (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.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of molybdenum chelate of EDTA. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of molybdenum chelate of EDTA as a feed additive for honeybees and bumblebees, requesting that additive to be classified in the category ‘nutritional additives’, in the functional group ‘compounds of trace elements’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2026(2) that molybdenum chelate of EDTA is safe for the target species, as well as for consumers and the environment, when used at the maximum recommended use level of 8 mg/hive per feeding. The Authority also concluded that molybdenum chelate of EDTA should be considered a skin and respiratory sensitiser, that inhalation and dermal exposure are considered a risk and should be minimised, while the additive is not irritant to skin nor to eyes. It could not conclude on the efficacy of molybdenum chelate of EDTA as a nutritional additive in honeybees and bumblebees but concluded that the supplementation of the additive at 8 mg/hive has the potential to be efficacious as a zootechnical additive for honeybees. However, no conclusion could be reached on the efficacy of molybdenum chelate of EDTA when supplemented to bumblebees. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5) On 2 March 2026, the applicant withdrew the application for the authorisation of molybdenum chelate of EDTA for bumblebees, and on 12 May 2026 it requested molybdenum chelate of EDTA to be reclassified in the category ‘zootechnical additives’ and in the functional group ‘physiological condition stabilisers’.

(6) In view of the above, the Commission considers that molybdenum chelate of EDTA satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised for honeybees. Considering that molybdenum chelate of EDTA is to be fed to honeybees via sugar-based feed, it is appropriate to prohibit the use of the additive when the honey supers are on, and in the 2-month period preceding the honey collection, to avoid honey adulteration. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) EFSA Journal2026;24:e9918, https://doi.org/10.2903/j.efsa.2026.9918.

ELI: http://data.europa.eu/eli/reg_impl/2026/2027/oj 1/4EN OJ L, 11.9.2026

(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 substance specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘physiological condition stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 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, 10 September 2026.

For the Commission The President Ursula VON DER LEYEN 2/4 ELI: http://data.europa.eu/eli/reg_impl/2026/2027/ojANNEX Minimum Maximum content content Identification Name of the Species or End of period Name of the Composition, chemical formula, number of holder of category of Maximum age Other provisions of additive description, analytical method mg additive/kg sugar-based the additive authorisation animal authorisation feed with a moisture content of 30 %

Category: zootechnical additives. Functional group: physiological condition stabilisers (improvement of winter survival rate) 4e2 Oligofeed SAS Molybdenum Additive composition Honeybees — 2,9(3) 2,9(3) 1. In the directions for use of 1 October chelate of Molybdenum in form of a chelate the additive and 2036 EDTA of EDTA(1)having a molybdenum premixture, the storage content of 27–31 %. conditions and stability to Solid form. heat treatment shall be indicated.

Characterisation of the active substance

2. The additive shall be fed Chelate of molybdenum in the to honeybees via a sugar- form of [Mo O ]2+and an organic 2 4 based feed at the ligand EDTA4 –in a form of sodium minimum and maximum salt. dose of 8 mg additive per Na [Mo O (EDTA)](H O)(NaCl), 2 2 4 2 x y hive per feeding.

with x =0–5 and y =0–0,5.

CAS number 3075057-08-5

3. Indicate in the directions Analytical methods(2) for use of the additive, For the determination of total premixtures and sugar-

molybdenum in the feed additive: based feed: inductively coupled plasma-atomic ‘The additive shall not be emission spectrometry (ICP-AES) – used when the honey supers are on, nor in the EN 15510 2-month period For the determination of total preceding the honey

sodium in the feed additive: collection.’ — Inductively coupled plasma- atomic emission spectrometry 4. For users of the additive (ICP-AES) – EN 15510 or and premixtures, feed — Inductively coupled plasma- business operators shall atomic emission spectrometry establish operational (ICP-AES) – EN 15621 or procedures and — Atomic absorption organisational measures spectrometry (AAS) – ISO to address potential risks 6869 resulting from their use.

ELI:

http://data.europa.eu/eli/reg_impl/2026/2027/oj 3/4 OJ L,

11.9.2026 ENMinimum Maximum content content Identification Name of the Species or End of period Name of the Composition, chemical formula, number of holder of category of Maximum age Other provisions of additive description, analytical method mg additive/kg sugar-based the additive authorisation animal authorisation feed with a moisture content of 30 % For the determination of total Where those risks cannot

molybdenum in compound feed: be eliminated by such inductively coupled plasma-mass procedures and spectrometry (ICP-MS) – EN measures, the additive 17053 and premixtures shall be used with personal For the qualitative proving of the respiratory and skin chelate structure between protective equipment.

molybdate and EDTA in the feed

additive: Fourier transformed infrared spectroscopy (FTIR)

(1) Ethylenediaminetetraacetic acid.

(2) 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.

(3) Corresponding to the feeding of a hive with 2 litres sugar syrup containing 4 mg additive/litre (1 litre sugar syrup with a moisture content of 30 % = 1,4 kg).

4/4

ELI:

http://data.europa.eu/eli/reg_impl/2026/2027/oj EN OJ L,

11.9.2026