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Document 32023R1173

    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)

    C/2023/3795

    OJ L 155, 16.6.2023, p. 28–32 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    Legal status of the document In force: This act has been changed. Current consolidated version: 31/07/2024

    ELI: http://data.europa.eu/eli/reg_impl/2023/1173/oj

    Date of document:
    15/06/2023; Date of adoption
    Date of effect:
    06/07/2023; Entry into force Date pub. +20 See Art 5
    Deadline:
    06/07/2024; See Art 2.1
    Deadline:
    06/10/2024; See Art 2.2
    Deadline:
    06/07/2025; See Art 2.3
    Date of end of validity:
    No end date
    Author:
    European Commission, Directorate-General for Health and Food Safety
    Responsible body:
    Directorate-General for Health and Food Safety, SANTE
    Form:
    Implementing regulation
    Additional information:
    EEA relevance
    Treaty:
    Treaty on the Functioning of the European Union
    Legal basis:
    Link
    Link
    Link
    Select all documents mentioning this document
    Modifies:
    Relation Act Comment Subdivision concerned From To
    Repeal 32004R1453
    Repeal 32004R2148 06/07/2023
    Repeal 32005R0943 06/07/2023
    Modifies 32005R1810 Deletion annex III 06/07/2023
    Modifies 32005R1810 Deletion article 3 06/07/2023
    Implicit repeal 32005R1980 Partial repeal article 1 point 2 06/07/2023
    Implicit repeal 32011R0361 Partial repeal article 2 06/07/2023
    Implicit repeal 32012R1018 Partial repeal article 9 06/07/2023
    Implicit repeal 32014R0290 Partial repeal article 3 06/07/2023
    Implicit repeal 32015R1043 Partial repeal article 2 06/07/2023
    Implicit repeal 32015R1399 Partial repeal article 4 06/07/2023
    Implicit repeal 32015R2305 Partial repeal article 2 06/07/2023
    Implicit repeal 32017R0447 Partial repeal article 2 06/07/2023
    Implicit repeal 32017R0447 Partial repeal article 3 06/07/2023
    Implicit repeal 32017R1145 Partial repeal article 11 06/07/2023
    Implicit repeal 32017R1145 Partial repeal article 12 06/07/2023
    Implicit repeal 32017R1145 Partial repeal article 17 06/07/2023
    Implicit repeal 32018R1566 Partial repeal article 2 06/07/2023
    Implicit repeal 32019R0011 Partial repeal article 3 06/07/2023
    Implicit repeal 32020R0147 Partial repeal article 2 06/07/2023
    Modified by:
    Relation Act Comment Subdivision concerned From To
    Modified by 32024R2039 Deletion annex part 1 Text 31/07/2024
    Instruments cited:
    Link

    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).

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