ANNEXSupplementary provisions
ANNEX Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation Units of activity animal/day Category of zootechnical additives. Functional group: other zootechnical additives (performance enhancer in weaned piglets) 4d13 Biolek Sp. z o.o. Kidney bean lectins Additive composition Preparation of kidney bean lectins ( Phaseolus vulgaris lectins), having a minimum of activity: 1 280 HAU/g ( 1 ) Characterisation of the active substance Mixture of phytohaemagglutinin (PHA) isoforms: PHA-E 4 , PHA-E 3 L, PHA-E 2 L 2 , PHA-EL 3 , PHA-L 4 CAS (PHA-L) 9008-97-3 Analytical methods ( 2 ) For the quantification of the kidney bean lectin in the additive: Haemagglutination assay Suckling piglets 14 days 220 HAU 660 HAU 1. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. 2. The additive shall be fed only via a complementary feed to suckling piglets from 10 th to 14 th day of age with the maximum dose of: — 220 HAU/suckling piglet/day for 3 days or — 660 HAU/suckling piglet (in one day). 3. On the label of the additive, the instructions for use via complementary feed shall be indicated. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. 7 November 2026 ( 1 ) 1 HAU (Haemagglutination Activity Units) is the amount of material (1 mg/ml) in the last dilution giving 50 % agglutination (clumping) of the red blood cells. ( 2 ) Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports