# L_2021162EN.01000501.xml

| 10.5.2021 | EN | Official Journal of the European Union | L 162/5 |
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10.5.2021

EN

Official Journal of the European Union

L 162/5

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COMMISSION IMPLEMENTING REGULATION (EU) 2021/758

of 7 May 2021

on the status of certain products as feed additives within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council and on the withdrawal from the market of certain feed additives

(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 Articles 2(3) and 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), in conjunction with Article 10(7) of that Regulation provides for specific procedures for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2) and Council Directive 82/471/EEC (3). |
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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), in conjunction with Article 10(7) of that Regulation provides for specific procedures for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2) and Council Directive 82/471/EEC (3).

| (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 notification referred to in Article 10(1)(a) of that Regulation was supplied within a specified period. The same obligation applies to feed additives for which no applications in accordance with Article 10(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before the deadline provided for in those provisions, or for which an application was submitted but subsequently withdrawn.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 notification referred to in Article 10(1)(a) of that Regulation was supplied within a specified period. The same obligation applies to feed additives for which no applications in accordance with Article 10(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, such feed additives should be withdrawn from the market. As Article 10(5) of Regulation (EC) No 1831/2003 does not differentiate between authorisations issued with a time limit and authorisations without a time limit, for clarity reasons it is appropriate to provide for the withdrawal from the market of feed additives whose limited authorisation periods pursuant to Directive 70/524/EEC have already expired. |
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(3)

Therefore, such feed additives should be withdrawn from the market. As Article 10(5) of Regulation (EC) No 1831/2003 does not differentiate between authorisations issued with a time limit and authorisations without a time limit, for clarity reasons it is appropriate to provide for the withdrawal from the market of feed additives whose limited authorisation periods pursuant to Directive 70/524/EEC have already expired.

| (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 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 the application has been withdrawn.

| (5) | As a consequence of the withdrawal from the market of the feed additives, it is appropriate to repeal the provisions authorising them, where such provisions are still in force. Consequently, Commission Regulation (EC) No 358/2005 (4) should be amended accordingly. In addition, Commission Regulation (EC) No 880/2004 (5) should be repealed, as both entries in the Annex thereto are to be deleted as a result of the withdrawal from the market of beta-carotene for use for canaries as provided in Annex I, Chapter I.A, part 2, and as a result of the authorisation of canthaxanthin for use for ornamental birds in Commission Implementing Regulation (EU) 2015/1486 (6). Furthermore, as a consequence of both the authorisation of canthaxanthin by Implementing Regulation (EU) 2015/1486 and the withdrawal from the market of that additive for non-authorised species and uses by Commission Implementing Regulation (EU) 2017/1145 (7), it is appropriate to repeal Commission Regulation (EC) No 775/2008 (8) which established maximum residue limits for canthaxanthin. |
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(5)

As a consequence of the withdrawal from the market of the feed additives, it is appropriate to repeal the provisions authorising them, where such provisions are still in force. Consequently, Commission Regulation (EC) No 358/2005 (4) should be amended accordingly. In addition, Commission Regulation (EC) No 880/2004 (5) should be repealed, as both entries in the Annex thereto are to be deleted as a result of the withdrawal from the market of beta-carotene for use for canaries as provided in Annex I, Chapter I.A, part 2, and as a result of the authorisation of canthaxanthin for use for ornamental birds in Commission Implementing Regulation (EU) 2015/1486 (6). Furthermore, as a consequence of both the authorisation of canthaxanthin by Implementing Regulation (EU) 2015/1486 and the withdrawal from the market of that additive for non-authorised species and uses by Commission Implementing Regulation (EU) 2017/1145 (7), it is appropriate to repeal Commission Regulation (EC) No 775/2008 (8) which established maximum residue limits for canthaxanthin.

| (6) | As regards feed additives whose authorisation did not expire until the date of entry into force of this Regulation, it is appropriate to allow a transitional period for interested parties, 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, taking account of the shelf-life of certain feed containing the additives in question. |
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(6)

As regards feed additives whose authorisation did not expire until the date of entry into force of this Regulation, it is appropriate to allow a transitional period for interested parties, 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, taking account of the shelf-life of certain feed containing the additives in question.

| (7) | The withdrawal from the market of the products listed in Annex I does not prevent them from being authorised or 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 Annex I does not prevent them from being authorised or subject to a measure concerning their status in accordance with Regulation (EC) No 1831/2003.

| (8) | For several substances, micro-organisms or preparations (referred to as ‘products’), there is uncertainty whether they are feed additives within the scope of Regulation (EC) No 1831/2003. This uncertainty may result from the inclusion of certain products both in the Register of feed additives referred to in Article 17 of Regulation (EC) No 1831/2003 and in the Catalogue of feed materials established in accordance with Article 24 of Regulation (EC) No 767/2009 of the European Parliament and of the Council (9). The uncertainty may also derive from various doubts or questions expressed by national competent authorities responsible for official controls or by economic operators concerning the classification of certain products, taking into account in particular the guidelines established by Commission Recommendation 2011/25/EU (10). |
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(8)

For several substances, micro-organisms or preparations (referred to as ‘products’), there is uncertainty whether they are feed additives within the scope of Regulation (EC) No 1831/2003. This uncertainty may result from the inclusion of certain products both in the Register of feed additives referred to in Article 17 of Regulation (EC) No 1831/2003 and in the Catalogue of feed materials established in accordance with Article 24 of Regulation (EC) No 767/2009 of the European Parliament and of the Council (9). The uncertainty may also derive from various doubts or questions expressed by national competent authorities responsible for official controls or by economic operators concerning the classification of certain products, taking into account in particular the guidelines established by Commission Recommendation 2011/25/EU (10).

| (9) | Such uncertainty about the status of certain products with regard to feed additives within the scope of Regulation (EC) No 1831/2003 may jeopardise the marketing of feed products throughout the Union, since the distinction between feed additives and other feed products has implications for the conditions of their placing on the market, depending on the relevant applicable legislation. |
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(9)

Such uncertainty about the status of certain products with regard to feed additives within the scope of Regulation (EC) No 1831/2003 may jeopardise the marketing of feed products throughout the Union, since the distinction between feed additives and other feed products has implications for the conditions of their placing on the market, depending on the relevant applicable legislation.

| (10) | In order to allay the uncertainty regarding the status as feed additives of certain products, it is appropriate to adopt relevant measures under Regulation (EC) No 1831/2003, clarifying that status. Such measures would bring consistency in the treatment of the products concerned and would facilitate the work of the national competent authorities responsible for official controls, while helping the interested economic operators to act in a framework providing for an appropriate level of legal certainty. |
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(10)

In order to allay the uncertainty regarding the status as feed additives of certain products, it is appropriate to adopt relevant measures under Regulation (EC) No 1831/2003, clarifying that status. Such measures would bring consistency in the treatment of the products concerned and would facilitate the work of the national competent authorities responsible for official controls, while helping the interested economic operators to act in a framework providing for an appropriate level of legal certainty.

| (11) | To determine whether products are feed additives within the scope of Regulation (EC) No 1831/2003, it is appropriate to refer to the guidelines for the distinction between feed additives, feed materials and other products, established by Recommendation 2011/25/EU. In particular, those guidelines provide for several criteria to be simultaneously considered in a case-by-case evaluation in order to create a profile of each specific product, taking into account all its characteristics. Useful criteria for the differentiation between feed additives and feed materials include the production and processing method, the chemical definition and the level of standardisation or purification, the safety conditions and mode of use, the functionality of the product concerned. In addition, for the sake of consistency, products with similar properties should be classified by analogy. |
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(11)

To determine whether products are feed additives within the scope of Regulation (EC) No 1831/2003, it is appropriate to refer to the guidelines for the distinction between feed additives, feed materials and other products, established by Recommendation 2011/25/EU. In particular, those guidelines provide for several criteria to be simultaneously considered in a case-by-case evaluation in order to create a profile of each specific product, taking into account all its characteristics. Useful criteria for the differentiation between feed additives and feed materials include the production and processing method, the chemical definition and the level of standardisation or purification, the safety conditions and mode of use, the functionality of the product concerned. In addition, for the sake of consistency, products with similar properties should be classified by analogy.

| (12) | The products sodium citrates, potassium citrates, sorbitol, mannitol and calcium hydroxide are included in the Register of feed additives as existing products for which no applications in accordance with Article 10(2) of Regulation (EC) No 1831/2003 were submitted before the deadline prescribed by that provision. They have also been included in the Catalogue of feed materials by Commission Regulation (EU) No 575/2011 (11). However, a re-examination of the profile of those products with regard to the criteria proposed in Recommendation 2011/25/EU led to the conclusion that they should be considered as feed additives within the scope of Regulation (EC) No 1831/2003. In particular, they are defined by their specific functions referred to in the Register of feed additives and their feed additives status allows improved scope for an effective management thereof in terms of safety and mode of use. In addition, account is taken of their classification as additives for use in food. |
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(12)

The products sodium citrates, potassium citrates, sorbitol, mannitol and calcium hydroxide are included in the Register of feed additives as existing products for which no applications in accordance with Article 10(2) of Regulation (EC) No 1831/2003 were submitted before the deadline prescribed by that provision. They have also been included in the Catalogue of feed materials by Commission Regulation (EU) No 575/2011 (11). However, a re-examination of the profile of those products with regard to the criteria proposed in Recommendation 2011/25/EU led to the conclusion that they should be considered as feed additives within the scope of Regulation (EC) No 1831/2003. In particular, they are defined by their specific functions referred to in the Register of feed additives and their feed additives status allows improved scope for an effective management thereof in terms of safety and mode of use. In addition, account is taken of their classification as additives for use in food.

| (13) | The feed additives status of the products sodium citrates, potassium citrates, sorbitol, mannitol and calcium hydroxide makes it necessary to withdraw them from the market as provided for by Article 10(5) of Regulation (EC) No 1831/2003. However, a longer transitional period should be allowed for the withdrawal from the market of those additives and of feed containing them, in order to take account of the legal uncertainty about their classification, allowing interested parties to submit a new application for authorisation of those feed additives under the procedures set out in Regulation (EC) No 1831/2003. |
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(13)

The feed additives status of the products sodium citrates, potassium citrates, sorbitol, mannitol and calcium hydroxide makes it necessary to withdraw them from the market as provided for by Article 10(5) of Regulation (EC) No 1831/2003. However, a longer transitional period should be allowed for the withdrawal from the market of those additives and of feed containing them, in order to take account of the legal uncertainty about their classification, allowing interested parties to submit a new application for authorisation of those feed additives under the procedures set out in Regulation (EC) No 1831/2003.

| (14) | Most of the products listed in Annex II are included in the Catalogue of feed materials established by Commission Regulation (EU) No 68/2013 (12). However, they are all, in addition, either listed in the Register of feed additives or have been subject to a withdrawal from the market as feed additives under Article 10(5) of Regulation (EC) No 1831/2003. In order to provide legal certainty concerning the status of those products, their respective profiles were examined in the light of the criteria proposed in Recommendation 2011/25/EU, leading to the conclusion that they should no longer be considered as feed additives within the scope of Regulation (EC) No 1831/2003. |
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(14)

Most of the products listed in Annex II are included in the Catalogue of feed materials established by Commission Regulation (EU) No 68/2013 (12). However, they are all, in addition, either listed in the Register of feed additives or have been subject to a withdrawal from the market as feed additives under Article 10(5) of Regulation (EC) No 1831/2003. In order to provide legal certainty concerning the status of those products, their respective profiles were examined in the light of the criteria proposed in Recommendation 2011/25/EU, leading to the conclusion that they should no longer be considered as feed additives within the scope of Regulation (EC) No 1831/2003.

| (15) | As regards the labelling of the products listed in Annex II which are still allowed on the market as feed additives, and the labelling of premixtures, feed materials and compound feed containing those products, a transitional period should be provided for to allow feed business operators to adapt. Furthermore, those products should be deleted from the Register of feed additives. |
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(15)

As regards the labelling of the products listed in Annex II which are still allowed on the market as feed additives, and the labelling of premixtures, feed materials and compound feed containing those products, a transitional period should be provided for to allow feed business operators to adapt. Furthermore, those products should be deleted from the Register of feed additives.

| (16) | The products xylitol, ammonium lactate and ammonium acetate are included in the Catalogue of feed materials established by Regulation (EU) No 68/2013. However, some doubts have been expressed notably by national competent authorities responsible for official controls as to their legal status, which led to an examination of their respective profiles based on the criteria proposed in Recommendation 2011/25/EU. Based on that examination, it has been concluded that those products should be considered as feed additives within the scope of Regulation (EC) No 1831/2003. In particular, the characteristics of xylitol are very similar to those of mannitol and sorbitol, which are considered as feed additives, and the classification of xylitol as a feed additive by analogy would bring consistency in the treatment of those similar products. In addition, account is taken of the classification of xylitol as additive for use in food. As regards ammonium lactate and ammonium acetate, they are chemically well-defined substances that are purified and exerting a specific function defined in Article 5(3) of Regulation (EC) No 1831/2003 and their feed additives status allows improved scope for an effective management thereof in terms of safety and mode of use. Moreover, a classification of ammonium lactate and ammonium acetate as feed additives would bring consistency with other similar products considered as feed additives, such as ammonium propionate or ammonium formate. |
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(16)

The products xylitol, ammonium lactate and ammonium acetate are included in the Catalogue of feed materials established by Regulation (EU) No 68/2013. However, some doubts have been expressed notably by national competent authorities responsible for official controls as to their legal status, which led to an examination of their respective profiles based on the criteria proposed in Recommendation 2011/25/EU. Based on that examination, it has been concluded that those products should be considered as feed additives within the scope of Regulation (EC) No 1831/2003. In particular, the characteristics of xylitol are very similar to those of mannitol and sorbitol, which are considered as feed additives, and the classification of xylitol as a feed additive by analogy would bring consistency in the treatment of those similar products. In addition, account is taken of the classification of xylitol as additive for use in food. As regards ammonium lactate and ammonium acetate, they are chemically well-defined substances that are purified and exerting a specific function defined in Article 5(3) of Regulation (EC) No 1831/2003 and their feed additives status allows improved scope for an effective management thereof in terms of safety and mode of use. Moreover, a classification of ammonium lactate and ammonium acetate as feed additives would bring consistency with other similar products considered as feed additives, such as ammonium propionate or ammonium formate.

| (17) | As a result of the classification of xylitol, ammonium lactate and ammonium acetate as feed additives within the scope of Regulation (EC) No 1831/2003, it is appropriate to provide for a transitional period which would allow interested parties to adapt to the new status of those products, including the submission of an application for authorisation, and the further processing thereof, under the procedures set out in Regulation (EC) No 1831/2003. |
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(17)

As a result of the classification of xylitol, ammonium lactate and ammonium acetate as feed additives within the scope of Regulation (EC) No 1831/2003, it is appropriate to provide for a transitional period which would allow interested parties to adapt to the new status of those products, including the submission of an application for authorisation, and the further processing thereof, under the procedures set out in Regulation (EC) No 1831/2003.

| (18) | 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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(18)

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 Annex I shall be withdrawn from the market in respect of the animal species or categories of animals as specified 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 Chapters I.A and I.C of Annex I may continue to be placed on the market and used until 30 May 2022.

2.   Premixtures produced with the additives referred to in paragraph 1 may continue to be placed on the market and used until 30 August 2022.

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 30 May 2023.

4.   By way of derogation from paragraphs 1, 2 and 3, the feed additives sodium citrates, potassium citrates, sorbitol, mannitol and calcium hydroxide listed in Chapter I.A of Annex I, and feed produced with those additives, may continue to be placed on the market and used until 30 May 2028.

Article 3

Amendment to Regulation (EC) No 358/2005

In Annex II to Regulation (EC) No 358/2005, entry E 141 on chlorophyll copper complex is deleted.

Article 4

Repeals

Regulations (EC) No 880/2004 and (EC) No 775/2008 are repealed.

Article 5

Products not considered as feed additives within the scope of Regulation (EC) No 1831/2003

1.   The substances, micro-organisms or preparations (referred to as ‘products’) set out in Annex II are not feed additives within the scope of Regulation (EC) No 1831/2003.

2.   Products referred to in paragraph 1 which are lawfully on the market and are labelled as feed additives and premixtures before 30 May 2024 may continue to be placed on the market until stocks are exhausted. The same applies to feed materials or compound feed which refer to those products in their labelling as feed additives in accordance with Regulation (EC) No 767/2009.

Article 6

Products considered as feed additives within the scope of Regulation (EC) No 1831/2003

1.   The substances, micro-organisms or preparations (referred to as ‘products’) set out in Annex III are feed additives within the scope of Regulation (EC) No 1831/2003.

2.   Products referred to in paragraph 1 may continue to be placed on the market and used until 30 May 2028.

Article 7

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, 7 May 2021.

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)  Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (OJ L 213, 21.7.1982, p. 8).

3

(4)  Commission Regulation (EC) No 358/2005 of 2 March 2005 concerning the authorisation without a time limit of certain additives and the authorisation of new uses of additives already authorised in feedingstuffs (OJ L 57, 3.3.2005, p. 3).

4

(5)  Commission Regulation (EC) No 880/2004 of 29 April 2004 authorising without time limit the use of beta carotene and canthaxanthin as additives in feedingstuffs belonging to the group of colouring matters including pigments (OJ L 162, 30.4.2004, p. 68).

5

(6)  Commission Implementing Regulation (EU) 2015/1486 of 2 September 2015 concerning the authorisation of canthaxanthin as feed additive for certain categories of poultry, ornamental fish and ornamental birds (OJ L 229, 3.9.2015, p. 5).

6

(7)  Commission Implementing Regulation (EU) 2017/1145 of 8 June 2017 on the withdrawal from the market of certain feed additives authorised pursuant to Council Directives 70/524/EEC and 82/471/EEC and repealing the obsolete provisions authorising those feed additives (OJ L 166, 29.6.2017, p. 1).

7

(8)  Commission Regulation (EC) No 775/2008 of 4 August 2008 establishing maximum residue limits for the feed additive canthaxanthin in addition to the conditions provided for in Directive 2003/7/EC (OJ L 207, 5.8.2008, p. 5).

8

(9)  Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (OJ L 229, 1.9.2009, p. 1).

9

(10)  Commission Recommendation 2011/25/EU of 14 January 2011 establishing guidelines for the distinction between feed materials, feed additives, biocidal products and veterinary medicinal products (OJ L 11, 15.1.2011, p. 75).

10

(11)  Commission Regulation (EU) No 575/2011 of 16 June 2011 on the Catalogue of feed materials (OJ L 159, 17.6.2011, p. 25).

11

(12)  Commission Regulation (EU) No 68/2013 of 16 January 2013 on the Catalogue of feed materials (OJ L 29, 30.1.2013, p. 1).

12

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ANNEX I

Feed additives to be withdrawn from the market, as referred to in Article 1

CHAPTER I.A.

Feed additives which were authorised without a time limit

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 |
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| Preservatives |
| E 331 | Sodium citrates | All species |
| E 332 | Potassium citrates | All species |
| E 325 | Sodium lactate | All species |
| E 326 | Potassium lactate | All species |
| Emulsifying and stabilising agents, thickeners and gelling agents |
| E 420 | Sorbitol | All species |
| E 421 | Mannitol | All species |
| Binders, anti-caking agents and coagulants |
| E 558 | Bentonite-montmorillonite | All species |
| Vitamins, provitamins and chemically well-defined substances having similar effect |
| | Riboflavin or Vitamin B2. All forms with the exception of:






  — | Riboflavin solid form produced by Ashbya gossypii DSM 23096 (1) [3a825i]; |

Identification Number

Additive

Species or category of animals

Preservatives

E 331

Sodium citrates

All species

E 332

Potassium citrates

All species

E 325

Sodium lactate

All species

E 326

Potassium lactate

All species

Emulsifying and stabilising agents, thickeners and gelling agents

E 420

Sorbitol

All species

E 421

Mannitol

All species

Binders, anti-caking agents and coagulants

E 558

Bentonite-montmorillonite

All species

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

Riboflavin or Vitamin B2. All forms with the exception of:

—

Riboflavin solid form produced by Ashbya gossypii DSM 23096 (1) [3a825i];

| — | Riboflavin solid form produced by Bacillus subtilis DSM 17339 and/or DSM 23984 (1) [3a825ii]; |
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—

Riboflavin solid form produced by Bacillus subtilis DSM 17339 and/or DSM 23984 (1) [3a825ii];

| — | Riboflavin 5'-phosphate ester monosodium salt solid form produced after phosphorylation of riboflavin 98 % produced by Bacillus subtilis DSM 17339 and/or DSM 23984 (1) [3a826]; |
| --- | --- |

—

Riboflavin 5'-phosphate ester monosodium salt solid form produced after phosphorylation of riboflavin 98 % produced by Bacillus subtilis DSM 17339 and/or DSM 23984 (1) [3a826];

| — | Riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 (2). |
| --- | --- |

—

Riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 (2).

All species

E 160 a

Beta-carotene. All forms with the exception of beta-carotene authorised by Commission Implementing Regulation (EU) 2015/1103 (3) [3a160(a)]

All species

Silage additives

Microorganisms

Enterococcus faecium CNCM I-3236/ATCC 19434

All species

Bacillus subtilis MBS-BS-01

All species

Lactobacillus plantarum DSM 11520

All species

Colourants, including pigments

Other colourants

E 153

Carbon black as a colouring agent authorised for colouring foodstuffs by Community rules

All species

Flavouring and appetising substances

Natural products – botanically defined

Allium cepa L.: Onion concentrate CoE 24

All species

Allium sativum L.: Garlic extract (water-based)

All species

Amyris balsamifera L.: Amyris oil CoE 33

All species

Anacardium occidentale L.: Cashew oil CoE 34

All species

Anethum graveolens L.: Dill seed extract CAS 8006-75-5 CoE 42 Einecs 289-790-8

All species

Apium graveolens L.: Celery seed extract CAS 89997-35-3 FEMA 2270 CoE 52 Einecs 289-668-4

All species

Artemisia absinthium L.: Wormwood oil CAS 8008-93-3 FEMA 3116 CoE 61 Einecs 284-503-2

All species

Artemisia annua L.: Annual mugwort extract (water-based)/Annual mugwort oil

All species

Artemisia pallens Wall.: Davana oil CAS 8016-03-3 FEMA 2359 CoE 69 Einecs 295-155-6

All species

Bacopa monnieri (L.) Pennell: Thyme leaved gratiola tincture

All species

Carum carvi L. = Apium carvi L.: Caraway seed extract/Caraway oleoresin CAS 8000-42-8 CoE 112 Einecs 288-921-6

All species

Cimicifuga simplex (Wormsk. ex DC.) Ledeb.

= C. racemosa (L.) Nutt.: Sarashina shoma extract

All species

Cinnamomum aromaticum Nees, C. cassia Nees ex Blume: Cassia bark extract CAS 84961-46-6 FEMA 2257 CoE 131 Einecs 284-635-0

All species

Cinnamomum zeylanicum Bl., C. verum J.S. Presl: Cinnamon bark oleoresin CAS 84961-46-6 FEMA 2290 CoE 133 Einecs 283-479-0

All species

Citrus aurantium L.: Neroli bigarade oil CAS 8016-38-4 FEMA 2771 CoE 136 Einecs 277-143-2/Petitgrain bigarade absolute CAS 8014-17-3 CoE 136 Einecs 283-881-6

All species

Citrus reticulata Blanco: Mandarin, Tangerine terpenes CoE 142

All species

Citrus x paradisi Macfad.: Grapefruit oil expressed CAS 8016-20-4 FEMA 2530 CoE 140 Einecs 289-904-6/Grapefruit extract CoE 140

All species

Glycyrrhiza glabra L.: Licorice extract (solvent-based) CAS 97676-23-8 FEMA 2628 CoE 218 Einecs 272-837-1

All species

Juniperus communis L.: Juniper berry extract CAS 84603-69-0 CoE 249 Einecs 283-268-3

All species

Laurus nobilis L.: Laurel leaves extract/Laurel leaves oleoresin CAS 84603-73-6 FEMA 2613 CoE 255 Einecs 283-272-5

All species

Lavandula latifolia Medik.: Spike lavender oil CoE 256

All species

Lepidium meyenii Walp.: Maca extract

All species

Leptospermum scoparium J. R. et G. Forst.: Broom teatree oil

All species

Macleaya cordata (Willd.) R. Br.: Plume poppy absolute/Plume poppy extract/Plume poppy oil/Plume poppy tincture

All species

Mallotus philippinensis (Lam.) Muell. Arg.: Kamala extract CoE 535

All species

Malpighia glabra L.: Acerola extract

All species

Malus sylvestris Mill.: Apple concentrate CoE 386

All species

Medicago sativa L.: Alfalfa tincture CoE 274

All species

Melissa officinalis L.: Melissa oil CoE 280

All species

Mentha pulegium L.: Pennyroyal oil CAS 8013-99-8 FEMA 2839 CoE 283 Einecs 290-061-1

All species

Myristica fragrans Houtt.: Mace oil CAS 8007-12-3 FEMA 2653 CoE 296 Einecs 282-013-3/Nutmeg oleoresin CAS 8408268-8 CoE 296 Einecs 282-013-3

All species

Myroxylon balsamum (L.) Harms: Tolu balsam extract (solvent-based) CAS 9000-64-0 FEMA 3069 CoE 297 Einecs 232-550-4

All species

Myroxylon balsamum (L.) Harms var. Pereirae: Balsam peru extract (solvent-based) CAS 8007-00-9 FEMA 2117, 2116 CoE 298 Einecs 232-352-8

All species

Ocimum basilicum L.: Basil oil CAS 801573-4 FEMA 2119 CoE 308 Einecs 283-900-8

All species

Opopanax chironium (L.) Koch, Commiphora erythrea Engler: Opoponax oil CAS 8021- 36-1 CoE 313 Einecs 232-558-8

All species

Passiflora edulis Sims. = P. incarnata L.: Passionfruit extract (water-based) CoE 321

All species

Pelargonium asperum Her. ex Spreng.: Geranium oil

All species

Peumus boldus Mol.: Boldo extract CoE 328/Boldo tincture CoE 328

All species

Pinus pinaster Soland.: Pine oil

All species

Pimenta racemosa (Mill.) J.W.Moore: Bay oil CAS 8006-78-8 CoE 334

All species

Piper methysticum G. Forst.: Kawa-kawa tincture

All species

Quillaja saponaria Molina: Quillaia extract (solvent-based) CoE 391/Quillaia concentrate

All species

Ribes nigrum L.: Black currant extract CoE 399

All species

Satureja hortensis L.: Savory summer oil CAS 8016-68-0 FEMA 3013 CoE 425 Einecs 283-922-8

All species

Sophora japonica L.: Pagoda tree oil

All species

Styrax benzoin Dryand., S. tonkinensis (Pierre) Craib ex Hartwich: Benzoin resinoid CAS 9000 -05-9 FEMA 2133 CoE 439 Einecs 232-523-7

All species

Tagetes erecta L., T. glandulifera Schrank., T. minuta L. e.a.: Tagetes oil CAS 8016- 84-0 FEMA 3040 CoE 443/494 Einecs 294-862-7

All species

Thea sinensis L. = Camellia thea Link. = Camellia sinensis (L.) O. Kuntze: Tea tincture CoE 451

All species

Uncaria tomentosa L. = Ourouparia guianensis Aubl.: Cat’s claw extract

All species

Valeriana officinalis L.: Valerian root tincture CoE 473

All species

Vetiveria zizanoides (L.) Nash.: Vetiver oil CAS 8016-96-4 CoE 479 Einecs 282-490-8

All species

Vitis vinifera L.: Cognac oil green CAS 8016-21-5 FEMA 2331 CoE 485 Einecs 232-403-4/Cognac oil white CAS 801621-5 FEMA 2332 CoE 485 Einecs 232-403-4

All species

Vitis vinifera L.: Grape seed extract CoE 485

All species

Yucca mohavensis Sarg. = Y. schidigera Roezl ex Ortgies: Mojave yucca extract (solvent-based) CAS 90147-57-2 FEMA 3121 Einecs 290-449-0/Yucca concentrate/Yucca residuals

All species

Zingiber officinale Rosc.: Ginger extract CAS 84696-15-1 FEMA 2521 CoE 489 Einecs 283-634-2

All species

Natural products and corresponding synthetic products

CAS No 1128 -08-1/3-Methyl-2-pentylcyclopent-2-en-1-one/Flavis No 07.140

All species

CAS No 352195-40-5/Disodium Inosine-5-Mono-phosphate (IMP)

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 |
| --- | --- | --- |
| Trace elements |
| E 7 | Molybdenum – Mo, Sodium molybdate | All animal species and categories with the exception of sheep |
| Acidity regulators |
| E 503 (i) | Ammonium carbonate | Cats; Dogs |
| E 503 (ii) | Ammonium hydrogen carbonate | Cats; Dogs |
| E 525 | Potassium hydroxide | Cats; Dogs |
| E 526 | Calcium hydroxide | Cats; Dogs |
| Colourants, including pigments |
| Carotenoids and xanthophylls |
| E 160 a | Beta-carotene | Canaries |
| Other colourants |
| E 141 | Chlorophyllin copper complex as a colouring agent authorised for colouring foodstuffs by Community rules | All animal species and categories with the exception of dogs and cats |
| E 141 | Chlorophyll copper complex as a colouring agent
  [functional group 2 a (iii)] | Grain-eating ornamental birds; Small rodents; Ornamental fish |
| E 153 | Carbon black as a colouring agent
  [functional group 2 a (iii)] | Ornamental fish |
| E 172 | Iron Oxide Red, Black & Yellow as colouring agent authorised for colouring foodstuffs by Community rules | Horses |
| Flavouring and appetising substances |
| Natural products – botanically defined |
| | Helianthus annuus L.: Sunflower extract | Cats; Dogs |
| | Hyssopus officinalis L. = H. decumbens Jord. & Fourr.: Hyssop Oil CAS 8006-83-5 FEMA 2591 CoE 235 Einecs 283-266-3 | Cats; Dogs |
| | Sus scrofa (extract from defatted porcine pancreatic glands) | Cats and dogs and other carnivorous and omnivorous companion animals such as ferrets |
| Amino acids, their salts and analogues |
| 3.2.7. | Mixtures of:






  (a) | L-lysine-monohydrochloride, technically pure and, |

Identification Number

Additive

Species and category of animals

Trace elements

E 7

Molybdenum – Mo, Sodium molybdate

All animal species and categories with the exception of sheep

Acidity regulators

E 503 (i)

Ammonium carbonate

Cats; Dogs

E 503 (ii)

Ammonium hydrogen carbonate

Cats; Dogs

E 525

Potassium hydroxide

Cats; Dogs

E 526

Calcium hydroxide

Cats; Dogs

Colourants, including pigments

Carotenoids and xanthophylls

E 160 a

Beta-carotene

Canaries

Other colourants

E 141

Chlorophyllin copper complex as a colouring agent authorised for colouring foodstuffs by Community rules

All animal species and categories with the exception of dogs and cats

E 141

Chlorophyll copper complex as a colouring agent

[functional group 2 a (iii)]

Grain-eating ornamental birds; Small rodents; Ornamental fish

E 153

Carbon black as a colouring agent

[functional group 2 a (iii)]

Ornamental fish

E 172

Iron Oxide Red, Black & Yellow as colouring agent authorised for colouring foodstuffs by Community rules

Horses

Flavouring and appetising substances

Natural products – botanically defined

Helianthus annuus L.: Sunflower extract

Cats; Dogs

Hyssopus officinalis L. = H. decumbens Jord. & Fourr.: Hyssop Oil CAS 8006-83-5 FEMA 2591 CoE 235 Einecs 283-266-3

Cats; Dogs

Sus scrofa (extract from defatted porcine pancreatic glands)

Cats and dogs and other carnivorous and omnivorous companion animals such as ferrets

Amino acids, their salts and analogues

3.2.7.

Mixtures of:

(a)

L-lysine-monohydrochloride, technically pure and,

| (b) | DL-methionine, technically pure |
| --- | --- |

(b)

DL-methionine, technically pure

protected with copolymer vinyl-pyridine/styrene

Dairy cows

CHAPTER I.B.

Feed additives which were authorised for a limited period

| Identification Number | Additive | Species or category of animals |
| --- | --- | --- |
| Coccidiostats and other medicinal substances |
| E 758 | Robenidine hydrochloride 66 g/kg (holder of the authorisation Zoetis Belgium SA) | Turkeys |
| E 770 | Maduramicin ammonium alpha 1 g/100 g (holder of the authorisation Zoetis Belgium SA) | Turkeys |

Identification Number

Additive

Species or category of animals

Coccidiostats and other medicinal substances

E 758

Robenidine hydrochloride 66 g/kg (holder of the authorisation Zoetis Belgium SA)

Turkeys

E 770

Maduramicin ammonium alpha 1 g/100 g (holder of the authorisation Zoetis Belgium SA)

Turkeys

CHAPTER I.C.

Feed additives for which a notification referred to in Article 10(1)(a) of Regulation (EC) No 1831/2003 was not submitted

| Identification Number | Additive | Species or category of animals |
| --- | --- | --- |
| Amino acids, their salts and analogues |
| 3.2.6. | L-lysine phosphate and its by-products produced by fermentation with Brevibacterium lactofermentum NRRL B-11470 | Poultry; Pigs |

Identification Number

Additive

Species or category of animals

Amino acids, their salts and analogues

3.2.6.

L-lysine phosphate and its by-products produced by fermentation with Brevibacterium lactofermentum NRRL B-11470

Poultry; Pigs

---

(1)  Those forms of riboflavin have been authorised by Commission Implementing Regulation (EU) 2019/901 of 29 May 2019 concerning the authorisation of riboflavin produced by Ashbya gossypii (DSM 23096), riboflavin produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) and riboflavin 5′-phosphate sodium salt produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) (sources of vitamin B2) as feed additives for all animal species (OJ L 144, 3.6.2019, p. 41).

(2)  This form of riboflavin has been the subject of a denial of authorisation by Commission Implementing Regulation (EU) 2018/1254 of 19 September 2018 concerning the denial of authorisation of riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 as a feed additive belonging to the functional group of vitamins, pro-vitamins and chemically well-defined substances having similar effect (OJ L 237, 20.9.2018, p. 5).

(3)  Commission Implementing Regulation (EU) 2015/1103 of 8 July 2015 concerning the authorisation of beta-carotene as a feed additive for all animal species (OJ L 181, 9.7.2015, p. 57).

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ANNEX II

Products which are not feed additives within the scope of Regulation (EC) No 1831/2003, as referred to in Article 5(1)

1.

Tamarind seed flour

2.

Potassium dihydrogen orthophosphate

3.

Dipotassium hydrogen orthophosphate

4.

Tripotassium orthophosphate

5.

Ammonium dihydrogen orthophosphate

6.

Diammonium hydrogen orthophosphate

7.

Disodium dihydrogen diphosphate

8.

Tetrapotassium diphosphate

9.

Pentapotassium triphosphate

10.

Sodium sesquicarbonate

11.

Potassium hydrogen carbonate

12.

Calcium oxide

13.

Sucrose esters of fatty acids (esters of saccharose and edible fatty acids)

14.

Sucroglycerides (mixture of esters of saccharose and mono- and di-glycerides of edible fatty acids)

15.

Polyglycerol esters of non-polymerised edible fatty acids

16.

Mono-esters of propane-1,2-diol (propyleneglycol) and edible fatty acids, alone or in mixtures with diesters

17.

Merluccius capensis, Galeorhinus australis e.a.,/Cartilage

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ANNEX III

Products which are feed additives within the scope of Regulation (EC) No 1831/2003, as referred to in Article 6(1)

1.

Xylitol

2.

Ammonium lactate

3.

Ammonium acetate

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