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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 nutritionnote, 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 2026note 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.
(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 1Authorisation#
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 2Entry 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.
| Identification number of the additive | Name of the holder of authorisation | Name of the 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 additive/kg sugar-based feed with a moisture content of 30 % | |||||||||
| Category: zootechnical additives. Functional group: physiological condition stabilisers (improvement of winter survival rate) | |||||||||
| 4e2 | Oligofeed SAS | Molybdenum chelate of EDTA | Additive compositionMolybdenum in form of a chelate of EDTAnote having a molybdenum content of 27–31 %.Solid form.Characterisation of the active substanceChelate of molybdenum in the form of [Mo2O4]2+ and an organic ligand EDTA4 – in a form of sodium salt.Na2[Mo2O4(EDTA)](H2O)x(NaCl)y, with x = 0–5 and y = 0–0,5.CAS number 3075057-08-5Analytical methodsnoteFor the determination of total molybdenum in the feed additive: inductively coupled plasma-atomic emission spectrometry (ICP-AES) – EN 15510For the determination of total sodium in the feed additive:Inductively coupled plasma-atomic emission spectrometry (ICP-AES) – EN 15510 orInductively coupled plasma-atomic emission spectrometry (ICP-AES) – EN 15621 orAtomic absorption spectrometry (AAS) – ISO 6869For the determination of total molybdenum in compound feed: inductively coupled plasma-mass spectrometry (ICP-MS) – EN 17053For the qualitative proving of the chelate structure between molybdate and EDTA in the feed additive: Fourier transformed infrared spectroscopy (FTIR) | Honeybees | — | 2,9note | 2,9note | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2. The additive shall be fed to honeybees via a sugar-based feed at the minimum and maximum dose of 8 mg additive per hive per feeding.3. Indicate in the directions for use of the additive, premixtures and sugar-based feed: The additive shall not be used when the honey supers are on, nor in the 2-month period preceding the honey collection.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 respiratory and skin protective equipment. | 1 October 2036 |
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