Fermentation-produced citric acid using Aspergillus niger strain CGMCC 6.466
In a significant development for the animal feed industry, a new method for determining citric acid in feed additives, premixtures, compound feed, and water has been endorsed by the European Union Reference Laboratory (EURL). The method, known as EN 17294, has been validated through a ring-trial and is suitable for the determination of not only citric acid but also formic, lactic, propionic, fumaric, malic, and acetic acids and their salts.
According to Regulation (EC) No 1831/2003, which governs the use of feed additives in the EU, applicants are required to propose robust and validated analytical methods for the detection and quantification of additives. The EURL typically evaluates the proposed methods, ensuring they are fit for purpose and comply with legal and scientific standards.
The ring-trial validated method EN 17294 is designed for the determination of citric acid in feed additives, premixtures, feed materials, compound feed, and water. The European Commission authorisation is sought for all animal species. The product, intended to be added directly into compound feed or through premixtures, complementary feed, and water, has a maximum inclusion level of 15000 mg/kg compound feed or 5000 mg/L water.
The application seeks authorisation for Citric acid produced by fermentation with Aspergillus niger CGMCC 6.466 under the categories "technological additives," "preservatives," and "acidity regulators." The minimum purity of the monohydrate form of the product is 92%, while the minimum purity of the monohydrate form of the other organic acids is not specified in the application.
While the method is suitable for the determination of multiple organic acids, no additional information about further testing or validation of other methods is provided. The EURL recommends EN 17294 based on IC-CD for official control, making it the only method proposed for the determination of multiple organic acids in the scope of the application.
In terms of analysis, samples of feed additives, premixtures, compound feed, or water should be prepared according to the nature of the matrix. Commonly recommended techniques include High Performance Liquid Chromatography (HPLC), Enzymatic Methods, and Ion Chromatography (IC). The method must be validated for accuracy, precision, specificity, robustness, and detection/quantification limits.
Detailed documentation, including sample preparation, analytical procedures, raw data, calibration curves, and method validation reports, must be provided by the applicant. Analytical standards for citric acid must be available and used for calibration and quality control.
It is worth noting that no information about the intended use of the other organic acids (as technological additives, preservatives, or acidity regulators) is provided in the application. The minimum purity of the anhydrous form of the product is 99.5%, and the maximum inclusion level of the other organic acids in compound feed or water has not been stated in the application.
The applicant does not propose any new methods for the determination of other organic acids in the feed additive, premixtures, feed materials, compound feed, and water. No additional information about further testing or validation of other methods for determining organic acids besides citric acid is provided in the application. The application also does not mention any specific animal species for the use of the other organic acids.
[1] EU reference laboratories confirm the availability of analytical standards, ensuring reliable quantification.
The new method EN 17294, endorsed by the European Union Reference Laboratory (EURL), not only determines citric acid but also other organic acids such as formic, lactic, propionic, fumaric, malic, and acetic acids and their salts in health-and-wellness related areas like nutrition for various animal species. In accordance with Regulation (EC) No 1831/2003, this method is being considered for official control, advocated by the EURL, due to its suitability and compliance with legal and scientific standards.
