The European Food Safety Authority (EFSA) has concluded that Huvepharma N.V.'s feed additive NICACOX®, containing nicarbazin, is safe and effective for chickens for fattening and chickens reared for laying when used at up to 80 mg/kg complete feed during the first 21 days of life, provided a 5-day withdrawal period is observed. In a scientific opinion adopted on 1 July 2026 and published on 3 August 2026, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) found the additive safe for target animals and consumers, with no risk to the terrestrial or aquatic environment, groundwater, or secondary poisoning. However, the panel could not conclude on user safety due to missing data on the final additive, and it confirmed efficacy at 75 mg/kg feed in preventing coccidiosis during the specified period.
The opinion responds to a European Commission request under Regulation (EC) No 1831/2003, following Huvepharma's application submitted on 19 April 2021 and deemed valid by EFSA on 4 August 2021. NICACOX® is not currently authorised in the EU, but the same active substance from the same applicant is approved in combination with monensin sodium as Monimax® for turkeys and chickens. The FEEDAP Panel's assessment builds on earlier opinions on related nicarbazin-containing additives from Huvepharma, including Monimax® for turkeys (2017, 2019) and chickens (2018, 2019), and Coxar® for turkeys (2018, 2021, 2022). Maximum residue limits for nicarbazin in chicken tissues are already in force, with the marker residue dinitrocarbanilide (DNC) set at 15,000 μg/kg in liver, 6,000 μg/kg in kidney, and 4,000 μg/kg in muscle and skin+fat.
The additive is specified to contain 250 g/kg nicarbazin, with batch analyses showing compliance on impurities such as heavy metals, dioxins, and mycotoxins. The active substance nicarbazin is an equimolar complex of DNC and HDP, and the panel noted that residual solvent levels are below VICH limits. The European Union Reference Laboratory confirmed that previous analytical methods for controlling nicarbazin in feed and tissue residues remain valid for this application.
The opinion marks a step toward potential EU authorisation of NICACOX® as a coccidiostat, a category of feed additives used to prevent coccidiosis, a parasitic disease that can cause significant economic losses in poultry production. For poultry farmers, the additive offers a new tool to manage the disease, but the mandatory 5-day withdrawal period before slaughter adds a management constraint. For consumers, the safety assessment and MRLs provide assurance that residues in chicken tissues remain within acceptable limits. For Huvepharma, a positive EFSA opinion is a prerequisite for market access, though the final authorisation decision rests with the European Commission, which will consider the opinion alongside the regulatory framework. The inability to conclude on user safety means that workers handling the additive may face unresolved exposure risks until further data are provided, potentially delaying full approval or requiring additional protective measures. The Commission will now weigh these findings in deciding whether to grant authorisation, a process that typically involves a draft regulation and scrutiny by member states.