Document ID: 32023R1173
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>16.6.2023&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 155/28</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2023/1173
of 15 June 2023
withdrawing from the market certain feed additives, amending Regulation (EC) No 1810/2005 and repealing Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 943/2005
(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 10(5) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EC) No&#160;1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. In particular, Article&#160;10(2) of that Regulation, provides rules for the re-evaluation of additives authorised pursuant to Council Directive&#160;70/524/EEC&#160;<a>(<span>2</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Article&#160;10(5) of Regulation (EC) No&#160;1831/2003 imposes an obligation on the Commission to adopt a Regulation withdrawing from the market feed additives for which no applications as required by Article&#160;10, paragraphs 2 and&#160;7 of Regulation (EC) No&#160;1831/2003 were submitted before the deadline provided for in those provisions, or for which an application was submitted but subsequently withdrawn.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Therefore, the feed additives as listed in the Annex should be withdrawn from the market.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In the case of feed additives for which applications have been submitted only for certain animal species or categories of animals, or applications have been withdrawn only for certain animal species or categories of animals, the withdrawal from the market should only concern the animal species and categories of animals for which no application has been submitted or for which the application has been withdrawn.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>As a consequence of the withdrawal from the market of the listed feed additives, it is appropriate to repeal the provisions authorising them. Consequently, Commission Regulation (EC) No&#160;1810/2005&#160;<a>(<span>3</span>)</a> should be amended accordingly and Commission Regulations (EC) No&#160;1453/2004&#160;<a>(<span>4</span>)</a>, (EC) No&#160;2148/2004&#160;<a>(<span>5</span>)</a> and (EC) No&#160;943/2005&#160;<a>(<span>6</span>)</a> should be repealed.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>It is appropriate to allow a transitional period within which existing stocks of the additives concerned, premixtures, feed materials and compound feed which have been produced with those additives may be used up, in order to allow interested parties to adapt to the withdrawal of those products from the market.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The withdrawal from the market of the products listed in the Annex does not prevent them from being authorised or from being subject to a measure concerning their status in accordance with Regulation (EC) No&#160;1831/2003.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Withdrawal from the market
The feed additives specified in the Annex shall be withdrawn from the market in respect of the animal species or categories of animals mentioned in that Annex.
Article 2
Transitional measures for the feed additives to be withdrawn from the market
1. Existing stocks of the feed additives listed in the Annex may continue to be placed on the market and used until 6 July 2024.
2. Premixtures produced with the additives referred to in paragraph 1 may continue to be placed on the market and used until 6 October 2024.
3. Compound feed and feed materials produced with the additives referred to in paragraph 1 or with the premixtures referred to in paragraph 2 may continue to be placed on the market and used until 6 July 2025.
Article 3
Amendment to Regulation (EC) No 1810/2005
Regulation (EC) No 1810/2005 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Article&#160;3 is deleted;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Annex III is deleted.</p></td></tr></tbody></table>
Article 4
Repeals
Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 943/2005 are repealed.
Article 5
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, 15 June 2023.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 268, 18.10.2003, p. 29 .
( 2 ) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs ( OJ L 270, 14.12.1970, p. 1 ).
( 3 ) Commission Regulation (EC) No 1810/2005 of 4 November 2005 concerning a new authorisation for 10 years of an additive in feedingstuffs, the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs ( OJ L 291, 5.11.2005, p. 5 ).
( 4 ) Commission Regulation (EC) No 1453/2004 of 16 August 2004 concerning the permanent authorisation of certain additives in feedingstuffs ( OJ L 269, 17.8.2004, p. 3 ).
( 5 ) Commission Regulation (EC) No 2148/2004 of 16 December 2004 concerning the permanent and provisional authorisations of certain additives and the authorisation of new uses of an additive already authorised in feedingstuffs ( OJ L 370, 17.12.2004, p. 24 ).
( 6 ) Commission Regulation (EC) No 943/2005 of 21 June 2005 concerning the permanent authorisation of additives in feedingstuffs ( OJ L 159, 22.6.2005, p. 6 ).
ANNEX
Feed additives to be withdrawn from the market, as referred to in Article 1
PART 1
Feed additives to be withdrawn from the market for all species and categories of animals
<table><col/><col/><col/><tbody><tr><td><p>Identification Number</p></td><td><p>Additive</p></td><td><p>Species or category of animals</p></td></tr><tr><td><p><span>Emulsifying and stabilising agents, thickeners and gelling agents</span></p></td></tr><tr><td><p>E 433</p></td><td><p>Polyoxyethylene(20)-sorbitan monooleate</p></td><td><p>All species</p></td></tr><tr><td><p>E 413</p></td><td><p>Tragacanth</p></td><td><p>All species</p></td></tr><tr><td><p><span>Binders, anti-caking agents and coagulants</span></p></td></tr><tr><td><p>E 561</p></td><td><p>Vermiculite</p></td><td><p>All species</p></td></tr><tr><td><p>E 599</p></td><td><p>Perlite</p></td><td><p>All species</p></td></tr><tr><td><p><span>Vitamins, provitamins and chemically well-defined substances having similar effect</span></p></td></tr><tr><td><p>&#160;</p></td><td><p>Vitamin B<span>12</span> or Cyanocobalamin. All forms<span>with the exception of</span> the preparation of cyanocobalamin produced by<span>Ensifer adhaerens</span> CNCM I-5541 containing &#8804;&#160;1&#160;% of cyanocobalamin, solid form [3a835]<a>&#160;(<span>1</span>)</a>.</p></td><td><p>All species</p></td></tr><tr><td><p><span>Silage additives</span></p></td></tr><tr><td><p><span>Microorganisms</span></p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Lactobacillus casei</span> NBRC 3425 (ATCC 7469)</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Saccharomyces cerevisiae</span> NBRC 0203 (IFO 0203)</p></td><td><p>All species</p></td></tr><tr><td><p><span>Enzymes</span></p></td></tr><tr><td><p>&#160;</p></td><td><p>Alpha-amylase EC 3.2.1.1 from<span>Aspergillus oryzae</span> CBS 585.94</p></td><td><p>All species</p></td></tr><tr><td><p><span>Colourants, including pigments</span></p></td></tr><tr><td><p><span>Other colourants</span></p></td></tr><tr><td><p>E 150b, E 150c and E 150d</p></td><td><p>Caramel colours as colouring agents authorised for colouring foodstuffs by Community rules</p></td><td><p>All species</p></td></tr><tr><td><p><span>Flavouring and appetising substances</span></p></td></tr><tr><td><p><span>Natural products &#8211; botanically defined</span></p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Abies alba</span> Mill.,<span>A. sibirica</span> Ledeb.: Pine needle oil CAS 8021-29-2 FEMA 2905 CoE 5 Einecs 294-351-9</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Eleutherococcus senticosus</span> Rupr. et Maxim. =<span>Acanthopanax s</span>. Harms: Taiga root extract (solvent-based)</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Helianthus annuus</span> L.: Sunflower&#160;absolute/Sunflower oil/Sunflower tincture</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Origanum heracleoticum</span> L.: Greek oregano extract/oleoresin/Greek oregano oil</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Origanum heracleoticum</span> L.: Oregano oil</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Petroselinum sativum</span> Hoffm. =<span>P. crispum</span> Mill. =<span>P. hortense</span> L.: Parsley leaf oil CAS 8000-68-8 FEMA 2836 CoE 326 Einecs 281-677-1/Parsley seed oil CAS 8000-68-8 CoE 326 Einecs 281-677-1</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Trachyspermum ammi</span> (L.) Sprag. et Turr.: Ajowan oil</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Bupleurum rotundifolium</span> L.: Hare&#8217;s ear tincture</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Boswellia serrata</span> Roxb. ex Colebr.: Olibanum tincture</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Bambusa</span> sp.: tincture</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Pimenta dioica</span> L. Merr. =<span>P. officinalis</span> Lind L.: Allspice oil</p><p>CAS 8006-77-7 FEMA 2018 CoE 335 Einecs 284-540-4</p></td><td><p>All species</p></td></tr><tr><td><p><span>Natural products and corresponding synthetic products</span></p></td></tr><tr><td><p>&#160;</p></td><td><p>CAS No&#160;13678-67-6/Difurfuryl&#160;Sulfide/Flavis No&#160;13.056</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p>CAS No&#160;29606-79-9/Isopulegone/Flavis No&#160;07.067</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p>CAS No&#160;43052-87-5/alpha-Damascone/Flavis No&#160;07.134</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p>CAS No&#160;4437-22-3/Difurfuryl&#160;ether/Flavis No&#160;13.061</p></td><td><p>All species</p></td></tr><tr><td><p>&#160;</p></td><td><p>CAS No&#160;623-15-4/4-(2-Furyl)but-3-en-2-one/Flavis No&#160;13.044</p></td><td><p>All species</p></td></tr></tbody></table>
PART 2
Feed additives to be withdrawn from the market for certain species or categories of animals
<table><col/><col/><col/><tbody><tr><td><p>Identification Number</p></td><td><p>Additive</p></td><td><p>Species and category of animals</p></td></tr><tr><td><p><span>Preservatives</span></p></td></tr><tr><td><p>E 250</p></td><td><p>Sodium nitrite</p></td><td><p>Dogs; Cats</p></td></tr><tr><td><p><span>Emulsifying and stabilising agents, thickeners and gelling agents</span></p></td></tr><tr><td><p>E 406</p></td><td><p>Agar</p></td><td><p>Pets and other non-food producing animals</p></td></tr><tr><td><p><span>Binders, anti-caking agents and coagulants</span></p></td></tr><tr><td><p>E 567</p></td><td><p>Clinoptilolite of volcanic origin</p></td><td><p>Pigs, Poultry</p></td></tr><tr><td><p><span>Silage additives</span></p></td></tr><tr><td><p><span>Substances</span></p></td></tr><tr><td><p>&#160;</p></td><td><p>Hexamethylene tetramine</p></td><td><p>Bovines; Ovines; Pigs; Poultry; Rabbits; Horses; Goats</p></td></tr><tr><td><p><span>Enzymes</span></p></td></tr><tr><td><p>E 1613</p></td><td><p>Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by<span>Trichoderma longibrachiatum</span> (CNCM MA 6-10 W)</p></td><td><p>Laying hens; Turkeys for fattening; Chickens for fattening</p></td></tr><tr><td><p><span>Colourants, including pigments</span></p></td></tr><tr><td><p><span>Other colourants</span></p></td></tr><tr><td><p>E 127</p></td><td><p>Erythrosine as colouring agent authorised for colouring foodstuffs by Community rules</p></td><td><p>Reptiles; Cats</p></td></tr><tr><td><p>E 127</p></td><td><p>Erythrosine</p><p>[functional group 2 a (iii)]</p></td><td><p>Ornamental fish</p></td></tr><tr><td><p><span>Flavouring and appetising substances</span></p></td></tr><tr><td><p><span>Natural products &#8211; botanically defined</span></p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Humulus lupulu</span>s L. flos: Hop extract (strobiles) rich in beta acids</p></td><td><p>All animal species with the exception of weaned piglets, pigs for fattening and minor porcine species weaned and for fattening</p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Natural products and corresponding synthetic products</span></p></td><td><p>&#160;</p></td></tr><tr><td><p>&#160;</p></td><td><p>CAS No&#160;3188-00-9/4,5-Dihydro-2-methylfuran-3(2H)-one/Flavis No&#160;13.042</p></td><td><p>All animal species with the exception of pets</p></td></tr><tr><td><p>&#160;</p></td><td><p>CAS No&#160;3658-77-3/4-Hydroxy-2,5-dimethylfuran-3(2H)-one/Flavis No&#160;13.010</p></td><td><p>All animal species with the exception of pets</p></td></tr><tr><td><p>&#160;</p></td><td><p>CAS No&#160;4180-23-8/1-Methoxy-4-(prop- 1(trans)-enyl)benzene/Flavis No&#160;04.010</p></td><td><p>Poultry and fish</p></td></tr><tr><td><p>&#160;</p></td><td><p>CAS No&#160;97-53-0/Eugenol/Flavis No&#160;04.003</p></td><td><p>Poultry</p></td></tr><tr><td><p><span>Vitamins, provitamins and chemically well-defined substances having similar effect</span></p></td></tr><tr><td><p>&#160;</p></td><td><p><span>Omega-6 Essential Unsaturated Fatty acids</span> (as octadecadienoic acid)</p></td><td><p>Sows for reproduction; Sows, in order to have benefit in piglets; Cows for reproduction</p></td></tr></tbody></table>
<note>
( 1 ) This form of vitamin B 12 or cyanocobalamin has been authorised by Commission Implementing Regulation (EU) 2022/1249 of 19 July 2022 concerning the authorisation of vitamin B 12 in the form of cyanocobalamin produced by Ensifer adhaerens CNCM I-5541 as a feed additive for all animal species ( OJ L 191, 20.7.2022, p. 10 ).
</note>