Regulation 3(1)

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

Authorisation

1.  The preparation 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.

Table

Column 1Column 2
Additive3-nitrooxypropanol
Identification number4c1
Authorisation holderDSM Nutritional Products Ltd., Switzerland
Additive categoryZootechnical additives
Functional groupSubstances 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 (C 3H7NO4)
  • CAS No: 100502-66-7(1)

Analytical methods(2)For 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 ageNo maximum
Content of 3-nitrooxypropanol (mg/kg of complete feed with a moisture content of 12%)Minimum content53 mg/kg
Maximum content88 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

(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. The document is available at the following address: https://joint-research-centre.ec.europa.eu/publications/fad-2019-0057_en.