# Assessment of the feed additive consisting of coated granulated cobalt(II) carbonate for ruminants with functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals for the renewal of its authorisation (Dox‐al Italia SpA)

**Authors:** Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López‐Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona, Katerina Theodoridou, Alberto Mantovani, Jürgen Gropp, Ruud Woursten, Orsolya Holczknecht, Jaume Galobart, Eleni Gkimprixi, Fabiola Pizzo, Maria Vittoria Vettori, Alberto Navarro‐Villa

PMC · DOI: 10.2903/j.efsa.2026.9924 · EFSA Journal · 2026-02-23

## TL;DR

This paper assesses the safety and efficacy of a cobalt additive for various animals, confirming its effectiveness but raising concerns about some coating agents.

## Contribution

The paper evaluates a modified manufacturing process for a cobalt additive and its safety implications.

## Key findings

- The cobalt component is safe for target species and the environment.
- The additive is effective as a cobalt source for the specified animals.
- Safety of coating agents remains uncertain due to insufficient data.

## Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of coated granulated cobalt(II) carbonate as nutritional feed additive for ruminants with functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals. The additive is already authorised for use for these animal species. The applicant has provided evidence that, in essence, the additives under assessment comply with the conditions of the authorisation. In addition, a modification in the manufacturing process (i.e. addition of 0.2% sepiolite) is proposed. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the cobalt component from the additive (cobalt(II) carbonate) remains safe for the target species and the environment. However, due to the absence of adequate data on some of the coating agents used in the manufacture of the additive, the Panel cannot conclude on the safety of coated granulated cobalt(II) carbonate for the target species and the environment. Due to the lack of adequate cobalt deposition data and information on the safety of some of the coating agents listed by the applicant, the FEEDAP Panel cannot conclude on the safety for the consumer. With regards to the safety for the users, the additive should be considered as irritant to the skin and eyes and a dermal and respiratory sensitiser. Any exposure is considered a risk and should be minimised. The FEEDAP Panel concludes that the additive is an efficacious source of cobalt in feeds for ruminants with functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals.

## Linked entities

- **Chemicals:** cobalt(II) carbonate (PubChem CID 10565), sepiolite (PubChem CID 155804690)
- **Species:** Equidae (taxon 9788)

## Full-text entities

- **Diseases:** carcinogenic (MESH:D011230), cobalt deficiency (MESH:D007153), polycythaemia (MESH:C548016), allergic dermatitis (MESH:D017449), DM (MESH:D009223), OEL (MESH:D009784), ECHA (MESH:D004675)
- **Chemicals:** maltodextrin (MESH:C008315), PCBs (MESH:D011078), furans (MESH:D005663), calcium carbonate (MESH:D002119), 3b302 (-), PCDDs (MESH:D000072317), dioxin (MESH:D004147), Carbonate (MESH:D002254), polyethyleneglycol 300 (MESH:C000595211), nickel (MESH:D009532), polyethyleneglycol (MESH:D011092), polychlorinated dibenzofurans (MESH:D000072338), water (MESH:D014867), sorbitol (MESH:D013012), octanol (MESH:D000442), Co (MESH:D003035), sepiolite (MESH:C001671), E432 (MESH:D011136), calcium magnesium carbonate (MESH:C028042)
- **Species:** Homo sapiens (human, species) [taxon 9606], Equus caballus (domestic horse, species) [taxon 9796], Bos taurus (bovine, species) [taxon 9913], Oryctolagus cuniculus (domestic rabbit, species) [taxon 9986]

## Full text

_Full body text omitted from this summary view._ Fetch the complete paper as Markdown: https://tomesphere.com/paper/PMC12928048/full.md

## References

10 references — full list in the complete paper: https://tomesphere.com/paper/PMC12928048/full.md

---
Source: https://tomesphere.com/paper/PMC12928048