Carvacrol (Nimicoat) for weaned piglets rejected: two efficacy studies instead of the required three, studies with diarrhoea in up to 80 % of control animals excluded, removal of data from one room considered unjustified
Commission Implementing Regulation (EU) 2026/119, published on 21 January 2026, refuses authorisation of a carvacrol preparation (applicant: Techna France Nutrition) as an other zootechnical additive for weaned piglets. Regulation (EC) No 429/2008 and EFSA’s 2018 guidance require significant effects in three long-term efficacy studies, and the applicant provided two.
- Additive: at least 40 % carvacrol encapsulated with high-melting lipid (lipids from vegetable oils 30–35 %, amorphous silica E 551a 20–22 %, mono- and diglycerides of fatty acids 4–6 %); proposed level 250 mg/kg complete feed (previously 250–1 000 mg/kg). In its 2020 opinion EFSA found it safe for animals, consumers and the environment but corrosive to skin, eyes and the respiratory mucosae.
- Of the first four studies one showed efficacy at 250 mg/kg; the tolerance–efficacy trial at 1 000 mg/kg showed no significant improvement, and two studies were excluded because of diarrhoea (in one, up to 80 % of control animals were treated with antibiotics) and mortality (3.3 % and 5.8–10.9 %).
- In 2023 the applicant re-analysed two studies statistically, removing from one the data of animals from a room with high mortality — EFSA considered this unjustified, as no technical reason was given and mortality in that room was not significantly higher than in the others. A new study (270 piglets aged 27 days, average 7.1 kg, 18 pens of 15 animals, 9 replicates per group) showed a significant improvement — two positive studies in total.
- EFSA’s supplementary opinion of 31 January 2024 did not settle efficacy. On 10 April 2024 the Commission offered the applicant the chance to supplement the data; in its replies of 20 and 21 June 2024 the applicant disagreed with EFSA’s assessment and said it would neither provide additional information nor withdraw the application.