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Document 32023R0054
Commission Implementing Regulation (EU) 2023/54 of 4 January 2023 correcting Implementing Regulation (EU) 2022/652 concerning the authorisation of bitter orange extract as a feed additive for certain animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2023/54 of 4 January 2023 correcting Implementing Regulation (EU) 2022/652 concerning the authorisation of bitter orange extract as a feed additive for certain animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2023/54 of 4 January 2023 correcting Implementing Regulation (EU) 2022/652 concerning the authorisation of bitter orange extract as a feed additive for certain animal species (Text with EEA relevance)
C/2023/22
OJ L 3, 5.1.2023, p. 12–15
(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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5.1.2023 |
EN |
Official Journal of the European Union |
L 3/12 |
COMMISSION IMPLEMENTING REGULATION (EU) 2023/54
of 4 January 2023
correcting Implementing Regulation (EU) 2022/652 concerning the authorisation of bitter orange extract as a feed additive for certain animal species
(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) |
The use of the bitter orange extract as a feed additive was authorised for certain animal species by Commission Implementing Regulation (EU) 2022/652 (2). |
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(2) |
Bitter orange extract is known to contain 10 to 20 % neohesperidin, as detailed in the column ‘Composition, chemical formula, description, analytical method’ in the Annex to Implementing Regulation (EU) 2022/652. |
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(3) |
An incorrect presumption of a relationship between neohesperidin, identified with CAS number 13241-33-3, and neohesperidin dihydrochalcone, identified with CAS number 20702-77-6, which has a similar name, but is a distinct substance, resulted in point 3 of the column ‘Other provisions’ in the Annex to Implementing Regulation (EU) 2022/652, which mistakenly provides for the exclusion of the use of bitter orange extract in combination with neohesperidin dihydrochalcone. |
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(4) |
Theopinion of the European Food Safety Authority of 23 June 2021 on the safety of bitter orange extract (3) does not mention any risk as regards the use of bitter orange extract in combination with neohesperidin dihydrochalcone. |
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(5) |
It is therefore necessary to correct the Annex to Implementing Regulation (EU) 2022/652 by deleting point 3 of the column ‘Other provisions’ in that Annex. For the sake of clarity, it is appropriate to replace the whole Annex to that Implementing Regulation. |
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(6) |
In the interest of preventing disruptions to the placing of the feed additive in the market due to the error in Implementing Regulation (EU) 2022/652, this Regulation should enter into force as a matter of urgency. |
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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 Annex to Implementing Regulation (EU) 2022/652 is replaced by the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the 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, 4 January 2023.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 268, 18.10.2003, p. 29.
(2) Commission Implementing Regulation (EU) 2022/652 of 20 April 2022 concerning the authorisation of bitter orange extract as a feed additive for certain animal species (OJ L 119, 21.4.2022, p. 74).
(3) EFSA Journal 2021;19(7):6709.
ANNEX
‘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 a moisture content of 12 % |
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Category: Sensory additives. Functional group: Flavouring compounds |
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2b136-ex |
- |
Bitter orange extract |
Additive composition Bitter orange extract from the fruit of Citrus x aurantium L. Solid form Characterisation of the active substance Bitter orange extract from the fruit of Citrus x aurantium L. as defined by the Council of Europe (1). Flavonoids: 45-55 % of which
5- methoxypsoralen (also known as bergapten): ≤ 0,03 % (-)-Synephrine: ≤ 1 % CoE number: 136 Analytical method (2) For the quantification of naringin (phytochemical marker) in the feed additive:
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Chickens for fattening Laying hens Turkeys for fattening Piglets Pigs for fattening Sows Dairy cows Calves Cattle for fattening Sheep/goats Horses Rabbits Salmonids Ornamental fish Dogs Cats |
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- |
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11 May 2032 |
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(1) Natural sources of flavourings – Report No 2 (2007)
(2) 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’