Lactic acid

In the current application an authorisation is sought under Article 4(1) for lactic acid under the category/functional group 1(a) “preservatives”, according to the classification system of Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for all animal species other than ruminants with a non-functional rumen.
According to the Applicant, the feed additive contains a minimum of 72 % (w/w) of lactic acid, where different forms (D-, L- and D,L-) of lactic acid with varying content are considered by the Applicant as active substances.
The feed additive is to be used in premixtures and compound feed, with proposed maximum levels of 20000 mg or 5000 mg/kg compound feed depending on animal species.
For the determination of lactic acid (as total lactic acid) in the feed additive, premixtures and compound feed, the Applicant proposed and submitted the internationally recognised, ring-trial validated EN 17294 method based on ion chromatography coupled to conductivity detection (IC-CD). This method is designed for the determination of formic, lactic, propionic, citric, fumaric, malic and acetic acids and their salts (as total individual acids) in feed additives, premixtures, feed materials, compound feed and water.
Based on the performance characteristics presented and the scope of the method in terms of matrices, the EURL recommends for official control the ring-trial validated EN 17294 method based on ion chromatography coupled to conductivity detection (IC-CD) for the determination of lactic acid (as total lactic acid) in the feed additive, premixtures and compound feed.
For the determination of the stereochemical composition (D- and L- forms of lactic acid) in the feed additive, the Applicant submitted an in-house method based on gas chromatography (GC) coupled to flame ionisation detection (FID). The EURL considers this method fit-for-purpose for further characterisation of the feed additive.
Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary.