# L_2023155EN.01002801.xml

| 16.6.2023 | EN | Official Journal of the European Union | L 155/28 |
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16.6.2023

EN

Official Journal of the European Union

L 155/28

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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). |
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(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before the deadline provided for in those provisions, or for which an application was submitted but subsequently withdrawn. |
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(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before the deadline provided for in those provisions, or for which an application was submitted but subsequently withdrawn.

| (3) | Therefore, the feed additives as listed in the Annex should be withdrawn from the market. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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, |
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(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; |
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(1)

Article 3 is deleted;

| (2) | Annex III is deleted. |
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(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.

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

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(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).

3

(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).

4

(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).

5

(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).

6

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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 |

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 |

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

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(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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