
Article 1 
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 17 October 2016.
For the Commission
The President
Jean-Claude JUNCKER
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 
Preparation of kidney bean lectins (Phaseolus vulgaris lectins), having a minimum of activity: 1 280 HAU/g

Mixture of phytohaemagglutinin (PHA) isoforms: PHA-E4, PHA-E3L, PHA-E2L2, PHA-EL3, PHA-L4

CAS (PHA-L) 9008-97-3

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 10th to 14th 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

