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

Regulation 3(1)

The preparation of 3-nitrooxypropanol specified in the table, 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 subject to the conditions set out in the 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; particles with a diameter < 50 µm: 0.4%

Characterisation of the active substance(s)

3-nitrooxypropanol (C3H7NO4)

  • CAS number: 100502-66-7(1)
Analytical methods(2)

For the quantification of 3-nitrooxypropanol in the feed additive, premixtures 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

None

Minimum content(3)

53 mg/kg

Maximum content(3)

88 mg/kg

Other provisions

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

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

(1)

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

(2)

Details of the analytical methods are set out in the document referenced “Ares(2020)981992-15/02/2020” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 4 May 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-0057_en.

(3)

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