Date: 2023-01-05Category: Not ApplicableState: Union GovernmentCountry: Europe
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)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2023/54 corrects Implementing Regulation (EU) 2022/652 regarding the authorization of bitter orange extract as a feed additive for certain animal species. The correction removes an incorrect provision that excluded the use of bitter orange extract in combination with neohesperidin dihydrochalcone. This regulation entered into force on the day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Correction of Implementing Regulation (EU) 2022/652:**
* The Annex to Implementing Regulation (EU) 2022/652 is replaced in its entirety.
* Point 3 of the "Other provisions" column in the Annex to Implementing Regulation (EU) 2022/652 is deleted.
* **Specifications for Bitter Orange Extract as a Feed Additive:**
* Additive composition: Bitter orange extract from the fruit of Citrus x aurantium L.
* Species and Maximum content are defined for: Chickens, Laying hens, Turkeys, Piglets, Pigs, Sows, Dairy cows, Calves, Cattle, Sheep/goats, Horses, Rabbits, Salmonids, Dogs, Ornamental fish and Cats.
* Functional Group: Flavouring compounds.
* **Usage and Labeling Requirements:**
* The additive must be incorporated into feed as a premixture.
* Directions for use of the additive and premixtures must include storage conditions and stability to heat treatment.
* The label of the additive must include: Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%, The functional group, the identification number, the name and the added amount of the active substance.
* **Restrictions and Safety Measures:**
* Mixing bitter orange extract with other authorized additives from Citrus aurantium L. in feedingstuffs is prohibited.
* Feed business operators must establish operational procedures and organizational measures to address potential inhalation, dermal contact, or eye contact risks.
* Personal protective equipment (skin, eye, and breathing protection) must be used if risks cannot be eliminated or minimized.
Impact Analysis:
Feed Business Operators and Users of the Additive and Premixtures:
* Impact: Need to comply with the corrected specifications and updated usage/labeling requirements for bitter orange extract.
* Action Required: Update procedures and labels to reflect the removal of the restriction on combining bitter orange extract with neohesperidin dihydrochalcone. Establish operational procedures and measures to address potential risks by inhalation, dermal contact or eyes contact and provide personal protective equipment where needed.
Member States:
* Impact: Required to apply the regulation directly.
* Action Required: Ensure the regulation is enforced within their jurisdiction.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the day-to-day business of the EU.
Regulation EC No 1831/2003: A European Parliament and Council regulation on additives for use in animal nutrition.
Commission Implementing Regulation EU 2022/652: A Commission Implementing Regulation concerning the authorisation of bitter orange extract as a feed additive for certain animal species.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Standing Committee on Plants, Animals, Food and Feed: A committee that provides opinions on measures proposed by the European Commission related to plant health, animal health, food and feed safety.
Ursula VON DER LEYEN: The President of the European Commission.
Brussels: The de facto capital city of the European Union, located in Belgium, where the regulation was adopted.
L 3/12 EN Official Journal of the European Union 5.1.2023
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 2003on
additives for use in animal nutrition(1), and in particular Article 9(2) thereof,
Whereas:
(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).
(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.
(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.
(4) Theopinion of the European Food Safety Authority of 23 June 2021on 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.
(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.
(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.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
(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):6709.5.1.2023 EN Official Journal of the European Union L 3/13
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 LEYENANNEX
‘ANNEX
Mini- Maxi-
mum mum
Name content content
Identifica- of the End of
Maxi-
tion holder Composition, chemical formula, Species or category of period of
Additive mum Other provisions
number of of description, analytical method. animal mg active authorisa-
age
the additive author- substance/kg of tion
isation complete feed with
a moisture content
of 12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b136-ex - Bitter Additive composition Chickens for - - 1. The additive shall be incorporated into 11 May
orange fattening the feed in the form of a premixture. 2032
Bitter orange extract from the fruit of
extract 2. In the directions for use of the additive
Citrus x aurantium L. Laying hens and premixtures, the storage conditions
Turkeys for fattening and stability to heat treatment shall be
Solid form
indicated.
Piglets
Characterisation of the active substance 3. On the label of the additive the follow
Bitter orange extract from the fruit of Pigs for fattening ing shall be indicated:
Citrus x aurantium L. as defined by the ‘Recommended maximum content of
Council of Europe(1). Sows the active substance per kg of complete
feedingstuff with a moisture content of
Flavonoids: 45-55 % of which Dairy cows 12 %:
— Naringin: 20-30 % — Chickens for fattening: 102 mg.
— Neohesperidin: 10-20 % Calves — Laying hens: 151 mg.
— Turkeys for fattening: 136 mg.
5- methoxypsoralen (also known as Cattle for fattening
— Piglets: 182 mg.
bergapten): ≤ 0,03 %
— Pigs for fattening: 217 mg.
Sheep/goats
(-)-Synephrine: ≤ 1 %
— Sows: 268 mg.
Horses — Dairy cows: 259 mg.
CoE number: 136 — Calves (milk replacer), cattle for fat
Analytical method(2) Rabbits tening, sheep/goats, horses, salmo
For the quantification of naringin nids, dogs and ornamental fish:
(phytochemical marker) in the feed Salmonids 400 mg.
additive: — Cats: 80 mg.
— High performance liquid chro Ornamental fish — Rabbits: 161 mg.’.
matography (HPLC) with spec
Dogs
trophotometric (UV) detection
Cats
L
3/14
EN
Official
Journal
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5.1.20234. The functional group, the identification
number, the name and the added
amount of the active substance shall
be indicated on the label of the premix
ture where the use level on the label of
the premixture would result in exceed
ing the level referred to in point 3.
5. The mixture of bitter orange extract
from the fruit of Citrus x aurantium L
with other authorised additives ob
tained from Citrus aurantium L. shall
not be allowed in feedingstuffs.
6. For users of the additive and premix
tures, feed business operators shall es
tablish operational procedures and or
ganisational measures to address
potential risks by inhalation, dermal
contact or eyes contact. Where those
risks cannot be eliminated or reduced
to a minimum by such procedures and
measures, the additive and premixtures
shall be used with personal protective
equipment, including skin, eye and
breathing protection.
(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’
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