LegalizeCommission Implementing Regulation (EU) 2022/565 of 7 April 2022 concerning the authorisation of a preparation of 3-nitrooxypropanol as a feed additive for dairy cows and cows for reproduction (holder of the authorisation: DSM Nutritional Products Ltd, represented in the Union by DSM Nutritional Products Sp. z o.o.) (Text with EEA relevance)
Article 1
The preparation specified in the Annex, 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 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
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 active substance/kg of complete feed with moisture content 12 % | |||||||||
| Category: zootechnical additives. Functional group: substances which favourably affect the environment. (reduction of enteric methane production) | |||||||||
| 4c1 | dsm-firmenich Switzerland Ltd. represented in the EU by dsm-firmenich Austria GmbH | 3-nitrooxypropanol | Additive composition Preparation with a minimum of 10 % of 3- nitrooxypropanol Particles < 50 μm: below 0,5 % Particles < 10 μm: 0 % Granular powder | Dairy cows and cows for reproduction | - | 53 | 80 | 1. The additive shall be incorporated into feed in the form of a premixture. 2. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including eyes, skin and breathing protection. | 28 April 2032 |
| Characterisation of the active substance 3- nitrooxypropanol (Propan-1,3-diol-mononitrate) Chemical formula: C3H7NO4 CAS number: 100502-66-7 | |||||||||
| Analytical method (1) 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) | |||||||||
| (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 |
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