Pancreatin of porcine pancreas glands

In the current application an authorisation is sought under Article 4 for pancreatin of porcine pancreas glands under the category/functional group 4(a) "zootechnical additives"/"digestibility enhancers" according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for dogs. According to the Applicant the feed additive contains various enzymes having proteolytic, lipolytic and amylolytic activities. The product complies with the purity criteria as laid down in the corresponding monograph for pancreas powder of the European Pharmacopoeia 01/2016:0350. In particular, 1 mg of the additive should contain not less than 1.0 Ph. Eur. U. of total proteolytic activity, 15 Ph. Eur. U. of lipolytic activity and 12 Ph. Eur. U. of amylolytic activity. Where, according to the Applicant: i) one unit of protease activity corresponds to the amount of enzyme that liberates per minute peptides with an absorption at 275 nm that is equivalent to the one of 1 micromole tyrosine, ii) one unit of lipase activity corresponds to the amount of enzyme that liberates under the conditions of the assay of pH 9.0 and 37 °C per minute one microequivalent of acid and iii) one unit of amylase activity corresponds to the amount of enzyme that splits starch under the conditions of the assay with an initial rate such that one microequivalent of glycosidic linkage is hydrolysed per minute. The feed additive is incorporated in wet food for dogs through complementary feed where the pancreatin content shall range between 10 and 40 % (w/w) and complemented by feed materials such as lactose, dextrose or maltodextrin. The Applicant recommended to include the feed additive in feed in order to obtain a maximum content for the feed additive of 6600 mg / kg feedingstuffs. For the determination of pancreatin of porcine pancreas glands in the feed additive, the Applicant submitted the analytical methods described in the European Pharmacopoeia monograph 0350 for pancreas powder. The monograph describes specific analytical methods for the quantification of the total proteolytic, lipolytic and amylolytic activities. Furthermore, in the frame of the homogeneity and stability studies the Applicant satisfactorily applied the above-mentioned methods to additive preparation formulated with the feed additive, lactose, dextrose and maltodextrin, thus confirming the suitability of these methods. The EURL recommends for official control the analytical methods described in the European Pharmacopoeia monograph 0350 for pancreas powder for the determination of pancreatin of porcine pancreas glands in the feed additive. The Applicant did not submit any analytical method or analytical data for the determination of pancreatin of porcine pancreas glands in feed. Therefore, the EURL cannot evaluate nor recommend any method for official control for the determination of pancreatin of porcine pancreas glands in feed. 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.