Guanidinoacetic acid (GAA)

In the current application an authorisation is sought under Article 4(1) for guanidinoacetic acid (GAA), under the category/functional group 4(d) “zootechnical additives”/“other zootechnical additives” according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for chickens for fattening, chickens reared for laying and breeding, turkeys for fattening, and turkeys reared for laying and breeding.
According to the Applicant, the feed additive (guanidinoacetic acid) is to be marketed as two formulations with a minimum purity of 96 and 98 % (w/w, based on dry matter). Guanidinoacetic acid is the active substance of the additive, which is produced by a chemical synthesis.
The feed additive is intended to be added to premixtures, compound feed and water for drinking. The Applicant proposed minimum and maximum levels of GAA in compound feed and water, ranging from 600 mg to 1200 mg/kg and from 300 and 600 mg/L, respectively.
For the determination of guanidinoacetic acid (GAA) in the feed additive, premixtures, compound feed and water the Applicant proposed and submitted a single-laboratory validated and further verified method based on ion-exchange chromatography coupled to a spectrophotometric detection (IC-UV).
In addition, the Applicant demonstrated the applicability of the IC-UV method in the stability studies of the feed additive, premixtures, compound feed and water. Also, in the frame of the homogeneity studies the Applicant applied the IC-UV method demonstrating its fitness-for-purpose for premixtures and compound feed, containing the feed additive.
Based on the performance characteristics and overall available data, the EURL recommends for official control the single-laboratory validated and further verified method based on ion-exchange chromatography coupled to a spectrophotometric detection (IC-UV) for the determination of guanidinoacetic acid (GAA) in the feed additive, premixtures, compound feed and water.
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.