Document ID: 02022R0652-20230106
Language: ENG

02022R0652 — EN — 06.01.2023 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) 2022/652</p><p>of 20&#160;April 2022</p><p>concerning the authorisation of bitter orange extract as a feed additive for certain animal species</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 119 21.4.2022, p. 74)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#9658;M1</a></p></td><td><p><a>                              COMMISSION IMPLEMENTING REGULATION (EU) 2023/54&#160;of 4&#160;January 2023</a></p></td><td><p>&#160;&#160;L&#160;3</p></td><td><p>12</p></td><td><p>5.1.2023</p></td></tr></table>
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
(Text with EEA relevance)
Article 1
Authorisation
The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
Transitional measures
1. The substance specified in the Annex and premixtures containing this substance, which are produced and labelled before 11 November 2022 in accordance with the rules applicable before 11 May 2022 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 11 May 2023 in accordance with the rules applicable before 11 May 2022 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3. Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 11 May 2024 in accordance with the rules applicable before 11 May 2022 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article 3
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.
ANNEX
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Identification number of the additive</p></td><td><p>Name of the holder of authorisation</p></td><td><p>Additive</p></td><td><p>Composition, chemical formula, description, analytical method.</p></td><td><p>Species or category of animal</p></td><td><p>Maximum age</p></td><td><p>Minimum content</p></td><td><p>Maximum content</p></td><td><p>Other provisions</p></td><td><p>End of period of authorisation</p></td></tr><tr><td><p>mg active substance/kg of complete feed with a moisture content of 12&#160;%</p></td></tr><tr><td><p><span>Category: Sensory additives. Functional group: Flavouring compounds</span></p></td></tr><tr><td><p>2b136-ex</p></td><td><p>-</p></td><td><p>Bitter orange extract</p></td><td><p><span>Additive composition</span></p><p>Bitter orange extract from the fruit of<span>Citrus x aurantium</span> L.</p><p>Solid form</p><p><span>Characterisation of the active substance</span></p><p>Bitter orange extract from the fruit of<span>Citrus x aurantium</span> L. as defined by the Council of Europe&#160;<a>(<span>1</span>)</a>.</p><p>Flavonoids: 45-55&#160;% of which</p><div><p>&#8212;&#160;Naringin: 20-30&#160;%</p></div><div><p>&#8212;&#160;Neohesperidin: 10-20&#160;%</p></div><p>5- methoxypsoralen (also known as bergapten): &#8804;&#160;0,03&#160;%</p><p>(-)-Synephrine: &#8804;&#160;1&#160;%</p><p>CoE number: 136</p><p><span>Analytical method</span>&#160;<a>(<span>2</span>)</a></p><p>For the quantification of naringin (phytochemical marker) in the feed additive:</p><div><p>&#8212;&#160;High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection</p></div></td><td><p>Chickens for fattening</p><p>Laying hens</p><p>Turkeys for fattening</p><p>Piglets</p><p>Pigs for fattening</p><p>Sows</p><p>Dairy cows</p><p>Calves</p><p>Cattle for fattening</p><p>Sheep/goats</p><p>Horses</p><p>Rabbits</p><p>Salmonids</p><p>Ornamental fish</p><p>Dogs</p><p>Cats</p></td><td><p>-</p></td><td><p>-</p></td><td><p>&#160;</p><div/></td><td><p>1.&#160;&#160;The additive shall be incorporated into the feed in the form of a premixture.</p><p>2.&#160;&#160;In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.</p><p>3.&#160;&#160;On the label of the additive the following shall be indicated:</p><p>&#8216;Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12&#160;%:</p><div><p>&#8212;&#160;Chickens for fattening: 102 mg.</p></div><div><p>&#8212;&#160;Laying hens: 151 mg.</p></div><div><p>&#8212;&#160;Turkeys for fattening: 136 mg.</p></div><div><p>&#8212;&#160;Piglets: 182 mg.</p></div><div><p>&#8212;&#160;Pigs for fattening: 217 mg.</p></div><div><p>&#8212;&#160;Sows: 268 mg.</p></div><div><p>&#8212;&#160;Dairy cows: 259 mg.</p></div><div><p>&#8212;&#160;Calves (milk replacer), cattle for fattening, sheep/goats, horses, salmonids, dogs and ornamental fish: 400 mg.</p></div><div><p>&#8212;&#160;Cats: 80 mg.</p></div><div><p>&#8212;&#160;Rabbits: 161 mg.&#8217;.</p></div><p>4.&#160;&#160;The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.</p><p>5.&#160;&#160;The mixture of bitter orange extract from the fruit of<span>Citrus x aurantium</span> L with other authorised additives obtained from<span>Citrus aurantium</span> L. shall not be allowed in feedingstuffs.</p><p>6.&#160;&#160;For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational 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.</p></td><td><p>11&#160;May 2032</p></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>Natural sources of flavourings &#8211; Report No&#160;2 (2007)</p></div><div><a>(<span>2</span>)&#160;&#160;&#160;</a><p>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</p></div></td></tr></tbody></table>