Commission Implementing Regulation (EU) 2020/1370 of 1 October 2020 concerning the authorisation of a preparation of lanthanide citrate as a feed additive for weaned piglets (holder of authorisation Treibacher Industrie AG) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1370
• 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

mg of additive/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters).

4d21

Treibacher Industrie AG

Lanthanide citrate

Additive composition

Preparation of lanthanide citrate containing:

Lanthanide citrate ≥ 65 %

Sodium 8-12 %

Chloride 8-12 %

Water < 10 %

Solid form

Weaned piglets

-

250

250

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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 skin, eyes and breathing protection.

22.10.2030

Characterisation of active substance

Lanthanide citrate

Lanthanum 8,5 ± 0,9 %

Chemical formula C 6 H 5 LaO 7

CAS-Number: 3002-52-6

Cerium 16,3 ± 1,6 %,

Chemical formula: C 6 H 5 CeO 7

CAS-Number: 512-24-3

Citrate 40 ± 5 %.

Chemical formula: C 6 H 5 O 7

CAS number: 126-44-3

-

Analytical method

( 1 )

For the quantification of citrate salts: Titration – European Pharmacopeia Monographs 0400 and 0412

For the quantification of total lanthanum and total cerium: Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports