Commission Implementing Regulation (EU) 2023/1708 of 7 September 2023 concerning the renewal of the authorisation of urea as a feed additive for ruminants with a functional rumen and repealing Implementing Regulation (EU) No 839/2012 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/1708
• Articles: 4

Article 1 Renewal of authorisation

The authorisation of the substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘urea and its derivatives’, is renewed subject to the conditions laid down in that Annex.

Article 2 Repeal of Implementing Regulation (EU) No 839/2012

Implementing Regulation (EU) No 839/2012 is repealed.

Article 3 Entry into force

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

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 the additive/kg of complete feed with a moisture content of 12 %

Category: nutritional additives. Functional group: Urea and its derivatives

3d1

Urea

Additive composition

Urea content: minimum 97 %

Nitrogen content: 46 %

Solid form

Characterisation of the active substance

Diaminomethanone, CAS number 57-13-6, chemical formula: (NH 2 ) 2 CO

Analytical method

( 1 )

For the determination of the total nitrogen in the additive: Titrimetry (EN 15478)

For the determination of the biuret contribution to the total nitrogen in the additive: Spectrophotometry (EN 15479)

For the determination of urea in premixtures, compound feed and feed materials: Spectrophotometry (Annex III.D to Regulation (EC) No 152/2009)

Ruminants with a functional rumen

8 800

1.

In the directions for use of the additive and feed containing it, the following shall be indicated:

‘Urea shall only be fed to animals with a functional rumen. Feeding urea to the maximum level dose should be done gradually. The maximum content of urea should be fed only as part of diets rich in easily digestible carbohydrates and low in soluble nitrogen.

A maximum 30 % of total nitrogen in the daily ration should come from urea-N.’

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 by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.

28 September 2033

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en.