Safety and efficacy of Nimicoat® (carvacrol) as a zootechnical additive for weaned piglets

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy Nimicoat^® (carvacrol), as a zootechnical additive for weaned piglets. The additive is composed by carvacrol (≥  40 %) as an active substance encapsulated with high‐melting lipids. Nimicoat^® is intended to be used in feed for weaned piglets at a minimum recommended dose of 250 mg/kg complete feed and at a maximum recommended dose of 1,000 mg/kg complete feed corresponding to a minimum and maximum of 100 and 400 mg carvacrol/kg complete feed, respectively. Based on a tolerance study, the FEEDAP Panel concluded that the use of Nimicoat^® in feed for weaned piglet at the maximum recommended dose of 1,000 mg/kg feed is safe for the target animal; however, a precise figure for the margin of safety cannot be defined. Nimicoat^® used in feed for weaned piglets at the maximum recommended concentration does not pose a safety concern for consumers. The additive is corrosive to eyes, skin and the respiratory mucosae. Concerning safety for the environment a Phase II was required; taking into consideration the data provided, the FEEDAP Panel concluded that the additive does not pose any risk to the terrestrial and aquatic compartments and that bioaccumulation potential for carvacrol is low and risk for secondary poisoning for worm/fish eating birds and mammals is not likely to occur. Only one study positively supporting efficacy of the additive was available; therefore, the FEEDAP Panel is not in a position to conclude on the efficacy of Nimicoat^®.