European Food Safety Authority reaffirms safety of neohesperidine dihydrochalcone in animal feed
EFSA also confirmed the safety and efficacy of two additional feed additives, but warned against resultant skin and respiratory irritation.
EUROPE – In a scientific opinion published on April 10, 2025, EFSA’s Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) confirmed that NHDC, used as a sweetener and flavouring agent, poses no safety concerns for target animals, consumers, or the environment when used as authorised.
The ruling follows a request from the European Commission to assess the renewal of the additive’s authorisation for use in piglets, pigs for fattening, calves, sheep, fish and dogs.
The additive is already approved under category 2b959 with a maximum content of 35 mg/kg in complete feed. The current renewal application did not seek any modifications to its usage conditions, prompting EFSA to focus solely on safety reassessment.
The applicant submitted evidence that NHDC on the market remains compliant with previously established production standards and conditions.
To support the renewal, the applicant conducted an extensive literature review spanning 2011 to 2024, examining 67 potentially relevant publications across databases such as PubMed, Web of Science, and LIVIVO.
No new information was found that would alter earlier safety conclusions. Additionally, no adverse effect reports had been filed since the last authorisation.
EFSA’s evaluation also referenced a 2022 opinion by the Panel on Food Additives and Flavourings (FAF), which confirmed NHDC’s systemic absorption in animals and humans without genotoxic risk.
Toxicological studies in rodents showed no adverse effects, and a new acceptable daily intake (ADI) of 20 mg/kg body weight was established, higher than the previous 5 mg/kg limit set in 1989.
Regarding user safety, while NHDC is not irritating to skin or eyes and is not a dermal sensitiser, exposure via inhalation remains likely due to the additive’s dusting potential.
Safety equipment, including gloves, safety glasses and breathing protection, continues to be recommended during handling.
As the renewal application did not propose changes affecting efficacy, EFSA stated there was no need to reassess the additive’s functional performance.
The FEEDAP Panel concluded that NHDC meets safety requirements under its existing authorisation, securing its continued use in animal nutrition across the European Union.
EFSA greenlights two other feed additives
EFSA also confirmed the safety and efficacy of two additional feed additives: capsaicin and Sepiolitic clay.
Capsaicin, assessed for use as a flavouring compound in all animal species, was found to be safe at a maximum of 6.5 mg/kg of feed for most species. A slightly lower level of 5.3 mg/kg was recommended for cats and unclassified species.
While effective as a flavouring additive, capsaicin was identified as a skin and respiratory irritant and likely an eye irritant, though not a dermal sensitiser. User exposure remains a concern, warranting caution during handling.
Additionally, sepiolitic clay, evaluated as a binder and anticaking agent, was confirmed safe for all animal species at up to 20,000 mg/kg of complete feed.
Previous limitations on particular species were resolved through new tolerance studies in chickens, trout, piglets, and dairy cows.
While not irritating to skin or eyes, Sepiolitic clay is a known respiratory and dermal sensitiser due to its dusting potential and silica content.
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