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Document 32022R0565
Commission 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)
Commission 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)
Commission 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)
C/2022/2100
OJ L 109, 8.4.2022, p. 32–34
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
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8.4.2022 |
EN |
Official Journal of the European Union |
L 109/32 |
COMMISSION 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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
Whereas:
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(1) |
Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. |
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(2) |
In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of 3-nitrooxypropanol. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(3) |
The application concerns the authorisation of a preparation of 3-nitrooxypropanol as a feed additive for dairy cows and cows for reproduction to be classified in the additive category ‘zootechnical additives’ and functional group ‘substances which favourably affect the environment’. |
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(4) |
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 September 2021 (2) that, under the proposed conditions of use, 3-nitrooxypropanol does not have an adverse effect on the health of dairy cows and cows for reproduction, consumer safety or the environment. The Authority concluded that the additive should be considered an irritant to eyes and skin, and 3-NOP may be harmful if inhaled with a potential risk due to exposure by inhalation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. Moreover, the risk of inhalation should be addressed by placing the additive granulated on the market with a negligible percentage of inhalable particles. The Authority concluded that the additive has the potential to reduce enteric methane production in dairy cows and cows for reproduction. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
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(5) |
The assessment of 3-nitrooxypropanol shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation. |
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(6) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
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.
Done at Brussels, 7 April 2022.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2021;19(11):6905.
ANNEX
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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 |
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mg active substance/kg of complete feed with moisture content 12 % |
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Category: zootechnical additives. Functional group: substances which favourably affect the environment. (reduction of enteric methane production) |
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4c1 |
DSM Nutritional Products Ltd represented in the Union by DSM Nutritional Products Sp. z o.o. |
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 |
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28 April 2032 |
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Characterisation of the active substance 3- nitrooxypropanol (Propan-1,3-diol-mononitrate) Chemical formula: C3H7NO4 CAS number: 100502-66-7 |
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Analytical method (1) For the quantification of 3-nitrooxypropanol in the feed additive, premixtures and compound feed:
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(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