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Document 32019R0914
Commission Implementing Regulation (EU) 2019/914 of 29 May 2019 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying (holder of authorisation HuvePharma NV) (Text with EEA relevance.)
Commission Implementing Regulation (EU) 2019/914 of 29 May 2019 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying (holder of authorisation HuvePharma NV) (Text with EEA relevance.)
Commission Implementing Regulation (EU) 2019/914 of 29 May 2019 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying (holder of authorisation HuvePharma NV) (Text with EEA relevance.)
C/2019/3891
OJ L 146, 5.6.2019, p. 60–62
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
- Date of document:
- 29/05/2019; Date of adoption
- Date of effect:
- 25/06/2019; Entry into force Date pub. +20 See Art 2
- Date of end of validity:
- No end date
- Author:
- European Commission, Directorate-General for Health and Food Safety
- Responsible body:
- Directorate-General for Health and Food Safety, SANTE
- Form:
- Implementing regulation
- Additional information:
- EEA relevance
- Treaty:
- Treaty on the Functioning of the European Union
- Legal basis:
-
- 32003R1831 - A09P2
- Link
- Link
- Link
- Select all documents mentioning this document
- Instruments cited:
- Link
- EUROVOC descriptor:
- Subject matter:
- Directory code:
-
- 03.50.10.00 Agriculture / Approximation of laws and health measures / Animal feedingstuffs
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5.6.2019 |
EN |
Official Journal of the European Union |
L 146/60 |
COMMISSION IMPLEMENTING REGULATION (EU) 2019/914
of 29 May 2019
concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying (holder of authorisation HuvePharma NV)
(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 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 a preparation of Bacillus licheniformis DSM 28710. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. |
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(3) |
That application concerns the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying, to be classified in the additive category ‘zootechnical additives’. |
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(4) |
The preparation of Bacillus licheniformis DSM 28710, belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for chickens for fattening and chickens reared for laying by Commission Implementing Regulation (EU) 2017/1904 (2). |
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(5) |
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 November 2018 (3) that, under the proposed conditions of use, the preparation of Bacillus licheniformis DSM 28710 does not have an adverse effect on animal health or the environment. It also concluded that the additive is considered as a potential respiratory sensitiser and that no conclusion could be drawn on skin or eyes sensitisation or irritation by the additive. 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. The Authority also concluded that the additive has a potential to be efficacious in feed to gain ratio in turkeys for fattening at the recommended dose and that this conclusion can be extended to turkeys reared for breeding and to minor poultry species for fattening and those reared for laying. 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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(6) |
The assessment of the preparation of Bacillus licheniformis DSM 28710 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 preparation should be authorised as specified in the Annex to this Regulation. |
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(7) |
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 ‘gut flora stabilisers’, 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, 29 May 2019.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 268, 18.10.2003, p. 29.
(2) Commission Implementing Regulation (EU) 2017/1904 of 18 October 2017 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for chickens for fattening and chickens reared for laying (holder of authorisation Huvepharma NV) (OJ L 269, 19.10.2017, p. 27).
(3) EFSA Journal 2019;17(1):5536.
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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CFU/kg of complete feedingstuff with a moisture content of 12 % |
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Category of zootechnical additives. Functional group: gut flora stabilisers |
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4b1828 |
HuvePharma NV |
Bacillus licheniformis DSM 28710 |
Additive composition Preparation of Bacillus licheniformis DSM 28710 containing a minimum of 3,2 × 109 CFU/g of additive Solid form Characterisation of the active substance Viable spores of Bacillus licheniformis DSM 28710 Analytical method (1) For the enumeration of Bacillus licheniformis DSM 28710 in additive, premixture and feedingstuffs:
For the identification of Bacillus licheniformis DSM 28710:
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Turkeys for fattening Turkeys reared for breeding Minor poultry species for fattening or reared for laying |
— |
1,6 × 109 |
— |
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25 June 2029 |
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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
