Document ID: 02021R0485-20220309
Language: ENG

02021R0485 — EN — 09.03.2022 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) 2021/485</p><p>of 22&#160;March 2021</p><p>concerning the authorisation as feed additives of ginger essential oil from<span>Zingiber officinale</span> Roscoe for all animal species, ginger oleoresin from<span>Zingiber officinale</span> Roscoe for chickens for fattening, laying hens, turkeys for fattening, piglets, pigs for fattening, sows, dairy cows, veal calves (milk replacers), cattle for fattening, sheep, goats, horses, rabbits, fish and pets and ginger tincture from<span>Zingiber officinale</span> Roscoe for horses and dogs</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 100 23.3.2021, p. 3)</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) 2022/385&#160;of 7&#160;March 2022</a></p></td><td><p>&#160;&#160;L&#160;78</p></td><td><p>21</p></td><td><p>8.3.2022</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2021/485
of 22 March 2021
concerning the authorisation as feed additives of ginger essential oil from Zingiber officinale Roscoe for all animal species, ginger oleoresin from Zingiber officinale Roscoe for chickens for fattening, laying hens, turkeys for fattening, piglets, pigs for fattening, sows, dairy cows, veal calves (milk replacers), cattle for fattening, sheep, goats, horses, rabbits, fish and pets and ginger tincture from Zingiber officinale Roscoe for horses and dogs
(Text with EEA relevance)
Article 1
Authorisation
The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
Use in water for drinking
The authorised substances specified in the Annex shall not be used in water for drinking.
Article 3
Transitional measures
1. The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 12 October 2021 in accordance with the rules applicable before 12 April 2021 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 12 April 2022 in accordance with the rules applicable before 12 April 2021 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 substances as specified in the Annex which are produced and labelled before 12 April 2023 in accordance with the rules applicable before 12 April 2021 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 4
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</span></p><p><span>Functional group: Flavouring compounds</span></p></td></tr><tr><td><p>2b489-eo</p></td><td><p>-</p></td><td><p>Ginger essential oil</p></td><td><p><span>Additive composition</span></p><p>Essential oil derived by steam distillation from the dried rhizomes of<span>Zingiber officinale</span> Roscoe.</p><p><span>Characterisation of the active substance</span></p><p>Essential oil derived by steam distillation from the dried rhizomes of<span>Zingiber officinale</span> Roscoe as defined by the Council of Europe&#160;<a>(<span>1</span>)</a>.</p><div><p>&#8212;&#160;&#945;-zingiberene: 29-40&#160;%</p></div><div><p>&#8212;&#160;&#946;-sesquiphellandrene: 8-14&#160;%</p></div><div><p>&#8212;&#160;ar-curcumene: 5-12&#160;%</p></div><div><p>&#8212;&#160;&#945;-farnesene: 4-10&#160;%</p></div><div><p>&#8212;&#160;camphene: 2-10&#160;%</p></div><div><p>&#8212;&#160;&#946;-bisabolene: 2-9&#160;%</p></div><p>CAS number: 8007-08-7</p><p>Einecs number: 283-634-2</p><p>FEMA number: 2522</p><p>CoE number: 489</p><p>Liquid form</p><p><span>Analytical method</span>&#160;<a>(<span>2</span>)</a></p><p>For the quantification of alpha-zingiberene, beta-sesquiphellandrene and ar-curcumene in the feed additive:</p><div><p>&#8212;&#160;Gas chromatography coupled to mass spectrometry (GC-MS) (full scan mode) using Retention Time Locking (RTL) methodology (or standard substances of the phytochemical markers) with (or without) gas chromatography coupled to flame ionisation detection (GC-FID) based on the ISO 11024 standard method.</p></div></td><td><p>All animal species</p></td><td><p>-</p></td><td><p>-</p></td><td><p>-</p></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;veal calves (milk replacer): 80 mg;</p></div><div><p>&#8212;&#160;other species or categories of animals: 20 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 ginger essential oil with other authorised additives obtained from<span>Zingiber officinale</span> Roscoe shall be 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 eye 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 breathing protection, safety glasses and gloves.</p></td><td><p>12.4.2031</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>
<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</span></p><p><span>Functional group: Flavouring compounds</span></p></td></tr><tr><td><p>2b489-or</p></td><td><p>-</p></td><td><p>Ginger oleoresin</p></td><td><p><span>Additive composition</span></p><p>Ginger oleoresin obtained by steam distillation and solvent extraction of dried rhizomes of<span>Zingiber officinale</span> Roscoe.</p><p><span>Characterisation of the active substance</span></p><p>Ginger oleoresin obtained by steam distillation and solvent extraction of dried rhizomes of<span>Zingiber officinale</span> Roscoe as defined by the Council of Europe&#160;<a>(<span>1</span>)</a>.</p><p>Essential oil: 25-30 (w/w)</p><p>Total gingerols: 0,5-8&#160;% (w/w)</p><div><p>&#8212;&#160;6-Gingerol</p></div><div><p>&#8212;&#160;8-Gingerol</p></div><div><p>&#8212;&#160;10-Gingerol</p></div><p>Total shogaols: 3-6&#160;% (w/w)</p><div><p>&#8212;&#160;6-Shogaol</p></div><div><p>&#8212;&#160;8-Shogaol</p></div><p>Humidity and volatiles: 25-30 (w/w)</p><p>CoE number: 489</p><p>Liquid form</p><p><span>Analytical method</span>&#160;<a>(<span>2</span>)</a></p><p>For the quantification of the phytochemical markers: total gingerols and total shogaols in the feed additive (ginger oleoresin):</p><div><p>&#8212;&#160;High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection &#8211; ISO 13685</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>Veal calves (milk replacers)</p><p>Cattle for fattening</p><p>Sheep and goats</p><p>Horses</p><p>Rabbits</p><p>Fish</p><p>Pets</p></td><td><p>-</p></td><td><p>-</p></td><td><p>-</p></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;% and for milk replacers with a moisture content of 5,5&#160;%:</p><div><p>&#8212;&#160;chickens for fattening: 5 mg;</p></div><div><p>&#8212;&#160;laying hens and rabbits: 7 mg;</p></div><div><p>&#8212;&#160;turkeys for fattening: 6 mg;</p></div><div><p>&#8212;&#160;piglets: 8 mg;</p></div><div><p>&#8212;&#160;pigs for fattening: 10 mg;</p></div><div><p>&#8212;&#160;sows: 13 mg;</p></div><div><p>&#8212;&#160;dairy cows: 12 mg;</p></div><div><p>&#8212;&#160;veal calves (milk replacers): 21 mg;</p></div><div><p>&#8212;&#160;cattle for fattening: 19 mg;</p></div><div><p>&#8212;&#160;sheep, goats, horses and fish: 20 mg;</p></div><div><p>&#8212;&#160;pets: 1 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 ginger oleoresin with other authorised additives obtained from<span>Zingiber officinale</span> Roscoe shall be 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 eye 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 breathing protection, safety glasses and gloves.</p></td><td><p>12.4.2031</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>
<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</span></p><p><span>Functional group: Flavouring compounds</span></p></td></tr><tr><td><p>2b489-t</p></td><td><p>-</p></td><td><p>Ginger tincture</p></td><td><p><span>Additive composition</span></p><p>Ginger tincture obtained by extraction of ground dried rhizomes of<span>Zingiber officinale</span> Roscoe using an ethanol/water mixture.</p><p><span>Characterisation of the active substance</span></p><p>Ginger tincture is obtained by extraction of ground dried rhizomes of<span>Zingiber officinale</span> Roscoe using an ethanol/water mixture as defined by the Council of Europe&#160;<a>(<span>1</span>)</a>.</p><p>Solvent (ethanol/water, 90/10): 97-98&#160;% (w/w)</p><p>Dry matter: 2-3&#160;% (w/w)</p><p>Total gingerols: 0,14-0,11&#160;% (w/w)</p><div><p>&#8212;&#160;6-Gingerol</p></div><div><p>&#8212;&#160;8-Gingerol</p></div><div><p>&#8212;&#160;10-Gingerol</p></div><p>Total shogaols: 0,043-0,031&#160;% (w/w)</p><div><p>&#8212;&#160;6 Shogaol</p></div><div><p>&#8212;&#160;8-Shogaol</p></div><p><span>Analytical method</span>&#160;<a>(<span>2</span>)</a></p><p>For the quantification of the phytochemical markers: total gingerols and total shogaols in the feed additive (ginger tincture):</p><div><p>&#8212;&#160;High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection &#8211; ISO 13685</p></div></td><td><p>Horses</p><p>Dogs</p></td><td><p>-</p></td><td><p>-</p></td><td><p>-</p></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;Horses 1,58 mL</p></div><div><p>&#8212;&#160;Dogs 1,81 mL&#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 ginger tincture with other authorised additives obtained from<span>Zingiber officinale</span> Roscoe shall be 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 eye 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 breathing protection, safety glasses and gloves.</p></td><td><p>12.4.2031</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>