Fumaric acid in feed renewed only for terrestrial animals: as a preservative determined by ion chromatography with conductivity detection according to EN 17294, as a flavouring — by GC-MS-RTL; for aquatic animals only the former flavouring authorisation remains
Commission Implementing Regulation (EU) 2026/171, published on 27 January 2026, renews until 16 February 2036 the authorisation of fumaric acid (≥ 99.5 %, chemical synthesis) as a preservative and flavouring in feed for terrestrial animals, repeals Regulation 1078/2013 and amends Regulation 2017/56 so that the former flavouring authorisation now covers only aquatic species. EFSA could not conclude on safety for aquatic animals, and the applicant withdrew the request for them and for the new use as an acidity regulator.
- Methods in the annex: fumaric acid as a preservative (total fumaric acid) in the additive, premixtures and compound feed is determined by ion chromatography with conductivity detection (IC-CD) according to EN 17294; as a flavouring in the additive and flavouring premixtures — by gas chromatography-mass spectrometry with retention time locking (GC-MS-RTL). The reference laboratory considered its earlier evaluation of the methods still valid.
- Maximum contents for the preservative: poultry and pigs other than those fed milk replacers 20 000 mg/kg complete feed; young mammals fed milk replacers 10 000 mg/kg of milk replacer (94.5 % dry matter). As a flavouring the recommended maximum is 5 mg/kg, and combination with other sources of fumaric acid is allowed only below the level resulting from the maximum or recommended content.
- EFSA data (e9019): three manufacturers supplied results for 15 batches (five each), averaging 99.7 % fumaric acid; cadmium, lead, mercury, arsenic and nickel were below the limit of quantification in all batches but one, in which nickel was 0.3 mg/kg — hence the additive was considered a skin and respiratory sensitiser. Fumaric acid is obtained by isomerisation of maleic acid; EFSA considered the levels of dioxins and PCBs in nine batches of no concern.
- For aquatic animals EFSA had two studies with limitations (no overdose, short duration, no blood analysis or histopathology), so it could not assess safety. The instructions for food-producing animals warn against simultaneous use of several organic acids at or close to the maximum content. Additive and premixtures made under the old rules before 16 August 2026, feed for food-producing animals before 16 February 2027 and other feed before 16 February 2028 may be used until stocks are exhausted.