# Assessment of the feed additive beta‐carotene (3a160(a)) for all animal species for the renewal of its authorisation (BASF SE, DSM Nutritional Products Ltd., Europe‐Asia GmbH, JYB Europe BV, NHU Europe GmbH)

**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, Ilen Röhe, Katerina Theodoridou, Maria Bastos, Paul Brantom, Jürgen Gropp, Kettil Svensson, Maria Dulak‐Lis, Jaume Galobart, Orsolya Holczknecht, Laura Iancu, Paola Manini, Fabiola Pizzo, Maria Vittoria Vettori, Eleni Gkimprixi

PMC · DOI: 10.2903/j.efsa.2025.9549 · EFSA Journal · 2025-07-31

## TL;DR

This paper assesses the safety and efficacy of beta-carotene as a feed additive for all animal species, confirming its safety for animals, consumers, and the environment.

## Contribution

The study confirms the continued safety of beta-carotene in animal feed under approved conditions for renewal of its authorisation.

## Key findings

- Beta-carotene is safe for target species, consumers, and the environment.
- It is not a skin or eye irritant and not a skin sensitiser.
- No efficacy assessment is needed for renewal of its authorisation.

## Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of beta‐carotene (3a160(a)) for the renewal of its authorisation as a nutritional additive for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of beta‐carotene in animal nutrition under the approved conditions remains safe for target species, consumers and the environment. Regarding user safety, the FEEDAP Panel concludes that beta‐carotene is not a skin and eye irritant and not a skin sensitiser. One preparation containing 10% beta‐carotene was shown not to be a skin sensitiser. However, no conclusions on the safety for the user can be done on any other preparations. The Panel concluded there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

## Linked entities

- **Chemicals:** beta-carotene (PubChem CID 5280489)

## Full-text entities

- **Diseases:** lung cancer (MESH:D008175), irritation (MESH:D001523), eye irritation (MESH:D005128), skin (MESH:D012871), phototoxic reactions (MESH:D017484), DM (MESH:D009223)
- **Chemicals:** 3a160 (-), PCBs (MESH:D011078), tocopherol (MESH:D024505), alpha-tocopherol (MESH:D024502), chrysin (MESH:C043561), bemotrizinol (MESH:C439083), calcium lignosulfonate (MESH:C000353), fat (MESH:D005223), silicic acid (MESH:D012824), tricalcium phosphate (MESH:C018392), vitamin A (MESH:D014801), furans (MESH:D005663), pro (MESH:D011392), apigenin (MESH:D047310), sodium ascorbate (MESH:D001205), TPPO (MESH:C063888), ethoxyquin (MESH:D005015), dioxin (MESH:D004147), BHT (MESH:D002084), Beta-carotene (MESH:D019207), ascorbyl palmitate (MESH:C031226), TPP (MESH:C061896), carotenoids (MESH:D002338), carbohydrates (MESH:D002241)
- **Species:** Cavia porcellus (domestic guinea pig, species) [taxon 10141], Felis catus (cat, species) [taxon 9685], Sus scrofa (pig, species) [taxon 9823], Oryctolagus cuniculus (domestic rabbit, species) [taxon 9986], Canis lupus familiaris (dog, subspecies) [taxon 9615], Mammalia (mammals, class) [taxon 40674], Homo sapiens (human, species) [taxon 9606], Ovis aries (domestic sheep, species) [taxon 9940], Daucus carota (carrot, species) [taxon 4039], Equus caballus (domestic horse, species) [taxon 9796], Meleagris gallopavo (common turkey, species) [taxon 9103], Gallus gallus (bantam, species) [taxon 9031], Bos taurus (bovine, species) [taxon 9913], Spinacia oleracea (spinach, species) [taxon 3562], Blakeslea trispora (species) [taxon 4850]

## Full text

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## References

10 references — full list in the complete paper: https://tomesphere.com/paper/PMC12312207/full.md

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Source: https://tomesphere.com/paper/PMC12312207