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1、 JRC.DG.D.6/CvH/SB/ag/ARES(2011)480045 EURL Evaluation Report on the Analytical Methods submitted in connection with the Application for Authorisation of a Feed Additive according to Regulation (EC) No 1831/2003 Dossier related to: FAD-2010-0056 CRL/ 100047 Name of Feed Additive: L-Tryptophan Active
2、 Agent (s): L-Tryptophan Rapporteur Laboratory: European Union Reference Laboratory for Feed Additives (EURL-FA) Geel, Belgium Report prepared by: Stefano Bellorini (EURL-FA) Report checked by: Date: Piotr Robouch (EURL-FA) 03/05/2011 Report approved by: Date: Christoph von Holst 03/05/2011 EUROPEAN
3、 COMMISSION JOINT RESEARCH CENTRE Institute for Reference Materials and Measurements European Union Reference Laboratory for Feed Additives EURL Evaluation Report L-Tryptophan 2/7 EXECUTIVE SUMMARY In the current application authorisation is sought for L-Tryptophan under Articles 4(1) and 10(2), cat
4、egory nutritional additives and functional group 3(c) amino acids, their salts and analogues according to Annex I of Regulation (EC) No 1831/2003. Specifically, authorisation is sought for the use of L-Tryptophan for all animal species and categories. The feed additive is intended to be mixed either
5、 in premixtures or added directly to complete feedingstuffs or water. The Applicant suggested no minimum or maximum L-Tryptophan concentrations in premixtures, feedingstuffs and water. For the determination of L-Tryptophan in premixtures and feedingstuffs the Applicant submitted the ring-trial valid
6、ated Community method (Commission Regulation (EC) No 152/2009). The method applies for the determination of free (synthetic and natural) and total (peptide-bound and free) amino acid, using High Performance Liquid Chromatography (HPLC) equipment. The following performance characteristics are reporte
7、d: * For free L-Tryptophan: - a relative standard deviation for repeatability (RSDr) of 1.3%; - a relative standard deviation for reproducibility (RSDR) ranging from 4.7 to 5.1%. * For total L-Tryptophan: - a relative standard deviation for repeatability (RSDr) ranging from 0.8 to 1.9%; - a relative
8、 standard deviation for reproducibility (RSDR) ranging from 1.5 to 6.3%. Based on the performance characteristics presented, the EURL recommends for official control the ring-trial validated Community method, based on reversed phase HPLC with fluorescence detection, to determine L-Tryptophan in prem
9、ixtures and feedingstuffs. For the determination of the active substance in the feed additive the Applicant submitted the above-mentioned ring trial validated Community method designed for the analysis of premixtures and feedingstuffs. Nevertheless the EURL identified, for the determination of the a
10、mino acid in the feed additive, a titrimetric method among the internationally recognised European Pharmacopoeia methods. No performance characteristics of this method are provided. However, the EURL considers this method suitable to be used within the frame of official control. The Applicant provid
11、ed neither experimental data nor experimental method for the determination of L-Tryptophan in water. Therefore, the EURL cannot evaluate nor recommend a method for the official control to determine L-Tryptophan in water. EURL Evaluation Report L-Tryptophan 3/7 Further testing or validation of the me
12、thods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005) is not considered necessary. KEYWORDS L-Tryptophan, nutritional additives, amino acids, all animal species and categories. 1. BACKGROUND In the current
13、application authorisation is sought for L-Tryptophan under Articles 4(1) (new use in water) and 10(2) (already authorised as feed additive without any restrictions under Commission Directive 88/485/EEC 1), category of nutritional additives functional group 3(c) amino acids, their salts and analogues
14、 according to Annex I of Regulation (EC) No 1831/2003 2. According to the Applicant L-Tryptophan is produced through fermentation process using a strain of Escherichia coli K-12 or alternatively with a strain of Corynebacterium Glutamicum 3. The feed additive is white/yellow/light grey crystalline p
15、owder with a minimum purity of 98% of the active substance 4, 5. Specifically, authorisation is sought for the use of L-Tryptophan for all animal species and categories. The feed additive is intended to be mixed either in premixtures or added directly to complete feedingstuffs or water 6. The Applic
16、ants suggested no minimum or maximum L- Tryptophan concentrations in premixtures, feedingstuffs and water 7. 2. TERMS OF REFERENCE In accordance with Article 5 of Regulation (EC) No 378/2005, as last amended by Regulation (EC) No 885/2009, on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and the tasks of the European Union Reference Lab
