Date: 2023-11-30Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/2662 of 29 November 2023 amending Implementing Regulation (EU) 2017/447 as regards the terms of the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) for turkeys for fattening (holder of authorisation: Chr. Hansen A/S)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2023/2662 amends Implementing Regulation (EU) 2017/447, modifying the terms of authorisation for the feed additive Bacillus subtilis DSM 5750 and Bacillus licheniformis DSM 5749 when used for turkeys for fattening. The amendment addresses the additive's compatibility with formic acid and specific coccidiostats. The regulation came into force on the twentieth day following its publication in the Official Journal of the European Union, published on 30 November 2023.
Key Points / Main Content:
* **Amendment of Authorisation Terms:** Modifies the authorisation of Bacillus subtilis DSM 5750 and Bacillus licheniformis DSM 5749 for turkeys for fattening.
* **Compatibility with Additives:**
* Confirms compatibility with formic acid.
* Confirms compatibility with the coccidiostats semduramycin, maduramicin ammonium, diclazuril, and monensin sodium.
* Authorises simultaneous use with lasalocid sodium only with a maximum content of 90 mg/kg of complete feedingstuff (12% moisture).
* No conclusion was drawn regarding the coccidiostat robenidine hydrochloride, and in the absence of data, with the coccidiostat halofuginone.
* **Regulatory Basis:**
* Based on Article 5 of Regulation (EC) No 1831/2003, ensuring the additive still meets authorisation conditions.
* Takes into account the European Food Safety Authority (EFSA) opinion of 15 May 2019.
* **Implementing Regulation (EU) 2017/447 Amendment:** A new provision (point 6) is added to the "Other provisions" column of the Annex to Implementing Regulation (EU) 2017/447, formalising the compatibility conditions.
Impact Analysis:
European Commission:
* Impact: Responsible for ensuring the regulation is applied and followed by member states.
* Action Required: Oversee and enforce the implementation of the amended regulation.
Feed Manufacturers:
* Impact: Need to ensure that the use of Bacillus subtilis DSM 5750 and Bacillus licheniformis DSM 5749 in feed for turkeys for fattening complies with the updated authorisation terms, including compatibility with specific coccidiostats and formic acid.
* Action Required: Reformulate feed compositions as necessary to comply with the new rules, particularly concerning the use of lasalocid sodium, and ensure proper labelling.
Turkey Farmers:
* Impact: Must use feed that complies with the updated regulations to ensure the health and safety of their animals and to meet regulatory requirements.
* Action Required: Source feed from manufacturers that adhere to the updated regulations.
Chr. Hansen AS (Authorisation Holder):
* Impact: The company maintains authorisation, but under modified conditions for turkeys for fattening.
* Action Required: Ensure their product information and usage guidelines reflect the amended terms of authorisation, including the compatibility conditions.
Member States:
* Impact: Responsible for the correct application of the regulation within their territories.
* Action Required: Incorporate the changes into national regulations and ensure compliance.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
COMMISSION IMPLEMENTING REGULATION EU 2023/2662: A regulation of the European Union amending Implementing Regulation EU 2017/447 regarding the authorization of Bacillus subtilis DSM 5750 and Bacillus licheniformis DSM 5749 for turkeys.
Implementing Regulation EU 2017/447: A Commission Implementing Regulation authorizing the use of Bacillus subtilis DSM 5750 and Bacillus licheniformis DSM 5749 as a feed additive.
Bacillus subtilis DSM 5750: A strain of Bacillus subtilis used as a feed additive.
Bacillus licheniformis DSM 5749: A strain of Bacillus licheniformis used as a feed additive.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice on food-related risks.
Regulation EC No 1831/2003: Regulation of the European Parliament and of the Council on additives for use in animal nutrition.
Ursula VON DER LEYEN: The President of the European Commission.
Official Journal EN
of the European Union L series
2023/2662 30.11.2023
COMMISSION IMPLEMENTING REGULATION (EU) 2023/2662
of 29 November 2023
amending Implementing Regulation (EU) 2017/447 as regards the terms of the authorisation of the
preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) for turkeys for
fattening (holder of authorisation: Chr. Hansen A/S)
(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 2003on
additives for use in animal nutrition(1), and in particular Article 13(3) thereof,
Whereas:
(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 and modifying such authorisation.
(2) Commission Implementing Regulation (EU) 2017/447(2) authorised the use of the preparation of Bacillus subtilis
(DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for sows, weaned piglets, pigs for fattening,
calves for rearing and turkeys for fattening for a 10-year period.
(3) In accordance with Article 13(3) of Regulation (EC) No 1831/2003, an application was submitted on 19 April 2018
for the modification of the terms of the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus
licheniformis (DSM 5749) as regards turkeys for fattening. That application concerns the compatibility of the use of
that preparation with the preservative formic acid and several coccidiostats and was accompanied by the relevant
data supporting the request for the change.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 15 May 2019(3)that the proposed
modification in the conditions of the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus
licheniformis (DSM 5749) would not modify the conclusions previously drawn regarding the safety of the additive. It
also stated that the conclusions on the compatibility of the additive with several coccidiostats and the preservative
formic acid which were drawn for chickens for fattening in its opinions of 22 October 2008(4) and 6 January
2011(5) apply also to turkeys for fattening provided that the maximum authorised concentrations of the
coccidiostats semduramycin, maduramicin ammonium, lasalocid sodium and the preservative formic acid (when
maximum authorised concentrations exist) are equal or lower than those for chickens for fattening. In addition, the
Authority concluded that the use of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM
5749) is also compatible with the coccidiostats diclazuril and monensin sodium. Based on the available data, no
conclusion could be drawn by the Authority on the compatibility of the use of that preparation with the
coccidiostat robenidine hydrochloride and, in the absence of data, with the coccidiostat halofuginone.
(1) OJ L 268, 18.10.2003, p. 29.
(2) Commission Implementing Regulation (EU) 2017/447 of 14 March 2017 concerning the authorisation of the preparation of Bacillus
subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for sows, weaned piglets, pigs for fattening, calves for
rearing and turkeys for fattening and amending Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 (holder
of authorisation Chr. Hansen A/S) (OJ L 69, 15.3.2017, p. 18).
(3) EFSA Journal 2019;17(6):5726.
(4) EFSA Journal (2008) 841, 1-7
(5) EFSA Journal 2011;9(1):1953.
ELI: http://data.europa.eu/eli/reg_impl/2023/2662/oj 1/2EN
OJ L, 30.11.2023
(5) The coccidiostat lasalocid sodium is authorised, in accordance with Commission Implementing Regulation
(EU) 2023/1172(6), for chickens for fattening with a maximum content of 90 mg of active substance/kg of
complete feedingstuff with a moisture content of 12 %. In order to fully take into account the conclusions of the
Authority’s opinion of 15 May 2019, the simultaneous use for turkeys for fattening of the preparation of Bacillus
subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) and of lasalocid sodium should therefore be authorised
only where the maximum content of lasalocid sodium is 90 mg of active substance/kg of complete feedingstuff
with a moisture content of 12 %.
(6) In view of the above, the Commission considers that the authorisation of the preparation of Bacillus subtilis (DSM
5750) and Bacillus licheniformis (DSM 5749) still meets the conditions provided for in Article 5 of Regulation (EC)
No 1831/2003 when modifying the terms thereof as regards turkeys for fattening, by specifying the compatibility
of the use of that preparation with formic acid and, where authorised as feed additives for the same animal species
and category, the coccidiostats semduramycin, maduramicin ammonium, diclazuril, monensin sodium and
lasalocid sodium with a maximum content of 90 mg of lasalocid sodium/kg of complete feedingstuff with a
moisture content of 12 %. Implementing Regulation (EU) 2017/447 should therefore be amended accordingly.
(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
Amendment to Implementing Regulation (EU) 2017/447
The following provision is added in the column ‘Other provisions’ of the Annex to Implementing Regulation
(EU) 2017/447:
‘6. The additive may be used in turkeys for fattening in compound feed containing formic acid, or containing the following
coccidiostats, where authorised as feed additives for the same animal species and category: semduramycin,
maduramicin ammonium, diclazuril, monensin sodium and lasalocid sodium with a maximum content of 90 mg of
lasalocid sodium/kg of complete feedingstuff with a moisture content of 12 %.’
Article 2
Entry into force
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 November 2023.
For the Commission
The President
Ursula VON DER LEYEN
(6) Commission Implementing Regulation (EU) 2023/1172 of 15 June 2023 concerning the authorisation of a preparation of lasalocid A
sodium (Avatec 150 G) as a feed additive for chickens for fattening, the denial of authorisation of a preparation of lasalocid A sodium
(Avatec 150 G) as a feed additive for chickens reared for laying, the withdrawal from the market of a preparation of lasalocid A
sodium (Avatec 15 % cc) as a feed additive for chickens for fattening and chickens reared for laying and repealing Regulation (EC)
No 1455/2004 and Implementing Regulation (EU) 2021/932 (holder of authorisation: Zoetis Belgium S.A.) (OJ L 155, 16.6.2023,
p. 22).
2/2 ELI: http://data.europa.eu/eli/reg_impl/2023/2662/oj