EFSA unsure about efficacy of clay mineral

By Jane Byrne contact

- Last updated on GMT

© GettyImages
© GettyImages

Related tags: Efsa

EFSA has reiterated its previous conclusion that bentonite is safe for all animal species, the consumers and the environment when used at a maximum level of 20,000 mg/kg complete feed.

However, in an opinion published in late December​, the FEEDAP panel said that, due to data gaps, it could not conclude on the efficacy of the clay mineral for all animal species.

“The in vitro study showed that the di- and tri-octahedral smectites tested can adsorb aflatoxin B1 at different concentrations and at pH 5; however, no adequate in vivo studies were available. Therefore, the panel cannot draw conclusions on the additive's efficacy.”

The Commission asked EFSA’s panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to assess the safety and efficacy of bentonite when used as a technological feed additive - substances for reduction of the contamination of feed by mycotoxins - for all animal species. The applicant, the European Bentonite Association (EUBA), which represents six companies, submitted a technical dossier to EFSA in support.

The European Food Safety Authority (EFSA) experts said the results of a newly submitted genotoxicity study reinforced its previous conclusion in 2012 that smectites like bentonite are non-genotoxic.

The panel also restated that bentonite is not a skin irritant but might be mildly irritating to the eye. Based on a new study submitted, it said the additive is not a skin sensitizer. Owing to its silica content, the additive is a hazard by inhalation for the users.

The panel said it considers the safety and efficacy conclusions to apply equally to the di- and tri-octahedral smectites under assessment.

It also made some recommendations regarding the maximum content of other minerals in the additive, urging the retention of the limits for opal and feldspar and for quartz and calcite, as per Regulation (EU) No 1060/2013, should the additive be authorized.

In addition, in terms of the incompatibilities of the additive with other medicinal substances, the panel said other provisions in that legislation concerning the simultaneous oral use of bentonites with macrolides and, in poultry with robenidine, should be maintained.

The Panel remarked on the denomination of the additive and the current regulatory definition of Bentonite, arguing the term ‘smectites’ defines the additive better than the term ‘bentonites’; the latter often refers only to montmorillonite, a di-octahedral smectite.

Coccidiostat conclusions

Meanwhile, in another opinion published towards the end of December​, the FEEDAP panel said it could not conclude on the safety of a coccidiostat, Monimax, for the environment.

“The use of monensin sodium from Monimax in complete feed for turkeys for fattening does not pose a risk for the aquatic compartment and sediment, while a risk cannot be excluded for the terrestrial compartment.”

However, it said the product, which is produced by Huvepharma, has the potential to control coccidiosis in turkeys for fattening at a minimum concentration of 40 mg monensin sodium and 40 mg nicarbazin/kg complete feed.

The feed additive contains the active ingredients monensin and nicarbazin and is designed to be used in coccidiosis control.

The simultaneous use of Monimax and certain antibiotic drugs such as tiamulin is contraindicated, said the expert panel.

“Monensin has a selective antimicrobial activity against Gram-positive bacterial species while many Enterobacteriaceae are naturally resistant. Nicarbazin has no antimicrobial activity.”

The use of the additive at the highest proposed dose - 50 mg monensin sodium and 50 mg nicarbazin/kg complete feed - would not pose a risk to persons consuming animal products from treated turkeys, added EFSA.

Enzyme evaluation

The safety and efficacy of Kaesler Nutrition’s feed additive for monogastric production, Enzy Carboplus, a combination of xylanase and ß-glucanase, was also confirmed in a recent EFSA opinion​.

It is designed to improve feed conversion, and live weight gain in avian species, weaned piglets and minor weaned porcine species.

However, owing to the lack of data, the Authority said no conclusions could be drawn on the efficacy of the additive in laying hens.

The enzymes present in the product are produced by two genetically modified strains of Komagataella pastoris. EFSA said that species is suitable for the qualified presumption of safety (QPS) approach to establishing safety for the target animal, for consumers and the environment. The Authority said the production strains were identified and deemed safe.


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