SCHEDULE 13Authorisation of a preparation of 3-nitrooxypropanol (identification number 4c1) as a feed additive for ruminants for milk production and for reproduction

Regulation 3

The preparation of 3-nitrooxypropanol belonging to the additive category ‘zootechnical additives’ and to the functional group ‘substances which favourably affect the environment’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table.

Additive

3-nitrooxypropanol

Identification number

4c1

Authorisation holder

DSM Nutritional Products Ltd, Switzerland

Additive category

Zootechnical additives

Functional group

Substances which favourably affect the environment

Additive composition

Preparation of 3-nitrooxypropanol containing a minimum of 10% additive

Granular powder consisting of particles with a diameter < 50µm: 0.4%

Characterisation of the active substance(s)

3-nitrooxypropanol (C3H7NO4)

  • CAS no: 100502-66-7(1)

Analytical method(2)

For the quantification of 3-nitrooxypropanol in the feed additive, premixtures feed materials and compound feed:

  • Reversed phase high performance liquid chromatography with spectrophotometric detection (HPLC-UV)

Species or category of animal

  • Ruminants for milk production

  • Ruminants for reproduction

Maximum age

Not applicable

Content of 3-nitrooxypropanol (mg/kg of complete feed with a moisture content of 12%)

Minimum content

53 mg/kg

Maximum content

88 mg/kg

Other provisions

  1. 1

    The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture

  2. 2

    The additive must be incorporated into feed in the form of a premixture

(1)

This is a reference to the CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry.

(2)

Details of the analytical method is set out in the document referenced “Ares(2020)981992-15/02/2020” and last updated on 4th May 2020, available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-0057_en.