Commission Implementing Regulation (EU) 2016/1833 of 17 October 2016 concerning the authorisation of a preparation of kidney bean lectins (Phaseolus vulgaris lectins) as a feed additive for suckling piglets (holder of authorisation Biolek Sp. z o.o.) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2016/1833
• Articles: 3

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 .

Schedules & Appendices

ANNEX

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