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)
Date: 2023-06-15
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, enzyme, food additive, market approval, microorganism, vitamin, withdrawal from the market




L_2023155EN.01002801.xml










16.6.2023   


EN


Official Journal of the European Union


L 155/28








            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:







(1)


Regulation (EC) No 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 10(2) of that Regulation, provides rules for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).












(2)


Article 10(5) of Regulation (EC) No 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 10, paragraphs 2 and 7 of Regulation (EC) No 1831/2003 were submitted before the deadline provided for in those provisions, or for which an application was submitted but subsequently withdrawn.












(3)


Therefore, the feed additives as listed in the Annex should be withdrawn from the market.












(4)


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applications have been submitted only for certain animal species or categories of animals, or applications have been withdrawn only for certain animal species or categories of animals, the withdrawal from the market should only concern the animal species and categories of animals for which no application has been submitted or for which the application has been withdrawn.












(5)


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 1810/2005 (3) should be amended accordingly and Commission Regulations (EC) No 1453/2004 (4), (EC) No 2148/2004 (5) and (EC) No 943/2005 (6) should be repealed.












(6)


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.












(7)


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 1831/2003.












(8)


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

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:






(1)


Article 3 is deleted;










(2)


Annex III is deleted.






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








Identification Number


Additive


Species or category of animals





Emulsifying and stabilising agents, thickeners and gelling agents





E 433


Polyoxyethylene(20)-sorbitan monooleate


All species




E 413


Tragacanth


All species





Binders, anti-caking agents and coagulants





E 561


Vermiculite


All species




E 599


Perlite


All species





Vitamins, provitamins and chemically well-defined substances having similar effect





 


Vitamin B12 or Cyanocobalamin. All forms with the exception of the preparation of cyanocobalamin produced by Ensifer adhaerens CNCM I-5541 containing ≤ 1 % of cyanocobalamin, solid form [3a835] (1).


All species





Silage additives






Microorganisms





 



Lactobacillus casei NBRC 3425 (ATCC 7469)


All species




 



Saccharomyces cerevisiae NBRC 0203 (IFO 0203)


All species





Enzymes





 


Alpha-amylase EC 3.2.1.1 from Aspergillus oryzae CBS 585.94


All species





Colourants, including pigments






Other colourants





E 150b, E 150c and E 150d


Caramel colours as colouring agents authorised for colouring foodstuffs by Community rules


All species





Flavouring and appetising substances






Natural products – botanically defined





 



Abies alba Mill., A. sibirica Ledeb.: Pine needle oil CAS 8021-29-2 FEMA 2905 CoE 5 Einecs 294-351-9


All species




 



Eleutherococcus senticosus Rupr. et Maxim. = Acanthopanax s. Harms: Taiga root extract (solvent-based)


All species




 



Helianthus annuus L.: Sunflower absolute/Sunflower oil/Sunflower tincture


All species




 



Origanum heracleoticum L.: Greek oregano extract/oleoresin/Greek oregano oil


All species




 



Origanum heracleoticum L.: Oregano oil


All species




 



Petroselinum sativum Hoffm. = P. crispum Mill. = P. hortense 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


All species




 



Trachyspermum ammi (L.) Sprag. et Turr.: Ajowan oil


All species




 



Bupleurum rotundifolium L.: Hare’s ear tincture


All species




 



Boswellia serrata Roxb. ex Colebr.: Olibanum tincture


All species




 



Bambusa sp.: tincture


All species




 



Pimenta dioica L. Merr. = P. officinalis Lind L.: Allspice oil
CAS 8006-77-7 FEMA 2018 CoE 335 Einecs 284-540-4


All species





Natural products and corresponding synthetic products





 


CAS No 13678-67-6/Difurfuryl Sulfide/Flavis No 13.056


All species




 


CAS No 29606-79-9/Isopulegone/Flavis No 07.067


All species




 


CAS No 43052-87-5/alpha-Damascone/Flavis No 07.134


All species




 


CAS No 4437-22-3/Difurfuryl ether/Flavis No 13.061


All species




 


CAS No 623-15-4/4-(2-Furyl)but-3-en-2-one/Flavis No 13.044


All species




PART 2

Feed additives to be withdrawn from the market for certain species or categories of animals








Identification Number


Additive


Species and category of animals





Preservatives





E 250


Sodium nitrite


Dogs; Cats





Emulsifying and stabilising agents, thickeners and gelling agents





E 406


Agar


Pets and other non-food producing animals





Binders, anti-caking agents and coagulants





E 567


Clinoptilolite of volcanic origin


Pigs, Poultry





Silage additives






Substances





 


Hexamethylene tetramine


Bovines; Ovines; Pigs; Poultry; Rabbits; Horses; Goats





Enzymes





E 1613


Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10 W)


Laying hens; Turkeys for fattening; Chickens for fattening





Colourants, including pigments






Other colourants





E 127


Erythrosine as colouring agent authorised for colouring foodstuffs by Community rules


Reptiles; Cats




E 127


Erythrosine
[functional group 2 a (iii)]


Ornamental fish





Flavouring and appetising substances






Natural products – botanically defined





 



Humulus lupulus L. flos: Hop extract (strobiles) rich in beta acids


All animal species with the exception of weaned piglets, pigs for fattening and minor porcine species weaned and for fattening




 



Natural products and corresponding synthetic products



 




 


CAS No 3188-00-9/4,5-Dihydro-2-methylfuran-3(2H)-one/Flavis No 13.042


All animal species with the exception of pets




 


CAS No 3658-77-3/4-Hydroxy-2,5-dimethylfuran-3(2H)-one/Flavis No 13.010


All animal species with the exception of pets




 


CAS No 4180-23-8/1-Methoxy-4-(prop- 1(trans)-enyl)benzene/Flavis No 04.010


Poultry and fish




 


CAS No 97-53-0/Eugenol/Flavis No 04.003


Poultry





Vitamins, provitamins and chemically well-defined substances having similar effect





 



Omega-6 Essential Unsaturated Fatty acids (as octadecadienoic acid)


Sows for reproduction; Sows, in order to have benefit in piglets; Cows for reproduction






(1)  This form of vitamin B12 or cyanocobalamin has been authorised by Commission Implementing Regulation (EU) 2022/1249 of 19 July 2022 concerning the authorisation of vitamin B12 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).