# L_2023016EN.01002401.xml

| 18.1.2023 | EN | Official Journal of the European Union | L 16/24 |
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18.1.2023

EN

Official Journal of the European Union

L 16/24

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/121

of 17 January 2023

amending and correcting Implementing Regulation (EU) 2021/1165 authorising certain products and substances for use in organic production and establishing their lists

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (1), and in particular Article 24(9) thereof,

Whereas:

| (1) | In accordance with the procedure provided for in Article 24(7) of Regulation (EU) 2018/848, Member States have submitted dossiers on certain substances to the other Member States and the Commission, in view of their authorisation and inclusion in Annexes I, II, III and V to Commission Implementing Regulation (EU) 2021/1165 (2). Those dossiers have been examined by the Expert Group for Technical Advice on Organic Production (EGTOP) and the Commission. |
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(1)

In accordance with the procedure provided for in Article 24(7) of Regulation (EU) 2018/848, Member States have submitted dossiers on certain substances to the other Member States and the Commission, in view of their authorisation and inclusion in Annexes I, II, III and V to Commission Implementing Regulation (EU) 2021/1165 (2). Those dossiers have been examined by the Expert Group for Technical Advice on Organic Production (EGTOP) and the Commission.

| (2) | In its recommendations with regard to active substances contained in plant protection products (3), EGTOP recommended that the use of the substance Talc E553b be added to the basic substances allowed in organic production. EGTOP also recommended to add the following to the low risk active substances used in organic farming: (i) ABE-IT 56, provided that it is neither obtained from GMO strains nor by using growing media of GMO origin; (ii) ‘ferric pyrophosphate’ and (iii) ‘aqueous extract from the germinated seeds of sweet Lupinus albus’. Therefore, the use of those substances should be authorised. |
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(2)

In its recommendations with regard to active substances contained in plant protection products (3), EGTOP recommended that the use of the substance Talc E553b be added to the basic substances allowed in organic production. EGTOP also recommended to add the following to the low risk active substances used in organic farming: (i) ABE-IT 56, provided that it is neither obtained from GMO strains nor by using growing media of GMO origin; (ii) ‘ferric pyrophosphate’ and (iii) ‘aqueous extract from the germinated seeds of sweet Lupinus albus’. Therefore, the use of those substances should be authorised.

| (3) | EGTOP further recommended that deltamethrin in traps with specific attractants should be allowed to be used against Rhagoletis completa. Therefore, this use of deltamethrin should be authorised under its specific conditions and limits. |
| --- | --- |

(3)

EGTOP further recommended that deltamethrin in traps with specific attractants should be allowed to be used against Rhagoletis completa. Therefore, this use of deltamethrin should be authorised under its specific conditions and limits.

| (4) | Based on recommendations from EGTOP with regard to fertilisers, soil conditioners and nutrients (3), the use of the following substances should be authorised: (i) recovered struvite and precipitated phosphate salts, provided that they meet the requirements laid down in Regulation (EU) 2019/1009 of the European Parliament and of the Council (4) and that animal manure as source material is not of factory farming origin; (ii) potassium chloride (muriate of potash) of natural origin; and (iii) sodium nitrate used for algae production on land in closed systems. |
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(4)

Based on recommendations from EGTOP with regard to fertilisers, soil conditioners and nutrients (3), the use of the following substances should be authorised: (i) recovered struvite and precipitated phosphate salts, provided that they meet the requirements laid down in Regulation (EU) 2019/1009 of the European Parliament and of the Council (4) and that animal manure as source material is not of factory farming origin; (ii) potassium chloride (muriate of potash) of natural origin; and (iii) sodium nitrate used for algae production on land in closed systems.

| (5) | Based on recommendations from EGTOP with regard to feed (5), the use of the following substances should be authorised: (i) monodicalcium phosphate used as feed material of mineral origin; (ii) in addition to the ones obtained from Saccharomyces cerevisiae or Saccharomyces carlsbergensis, all authorised yeast and yeast products used as feed materials; (iii) xanthan gum used as technological feed additive within the functional group ‘emulsifiers, stabilisers, thickeners and gelling agents’; (iv) illite-montmorillonite-kaolinite and sepiolitic clay used as technological feed additives within the functional group ‘binders and anti-caking agents’; and (v) bentonite used as technological feed additive within a new functional group ‘substances for reduction of the contamination of feed by mycotoxins’. |
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(5)

Based on recommendations from EGTOP with regard to feed (5), the use of the following substances should be authorised: (i) monodicalcium phosphate used as feed material of mineral origin; (ii) in addition to the ones obtained from Saccharomyces cerevisiae or Saccharomyces carlsbergensis, all authorised yeast and yeast products used as feed materials; (iii) xanthan gum used as technological feed additive within the functional group ‘emulsifiers, stabilisers, thickeners and gelling agents’; (iv) illite-montmorillonite-kaolinite and sepiolitic clay used as technological feed additives within the functional group ‘binders and anti-caking agents’; and (v) bentonite used as technological feed additive within a new functional group ‘substances for reduction of the contamination of feed by mycotoxins’.

| (6) | Based on further recommendation from EGTOP with regard to feed (6), betaine anhydrous is currently authorised only for monogastric animals in Implementing Regulation (EU) 2021/1165. However, the recommendation from EGTOP was based on a file for betaine anhydrous used as nutritional additive for poultry, pigs and fish. Therefore, the authorisation of betaine anhydrous should also be granted for feeding fish. |
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(6)

Based on further recommendation from EGTOP with regard to feed (6), betaine anhydrous is currently authorised only for monogastric animals in Implementing Regulation (EU) 2021/1165. However, the recommendation from EGTOP was based on a file for betaine anhydrous used as nutritional additive for poultry, pigs and fish. Therefore, the authorisation of betaine anhydrous should also be granted for feeding fish.

| (7) | Based on recommendations from EGTOP with regard to pet food (5), the use of the following substances should be authorised: (i) pentasodium triphosphate (STPP) and disodium dihydrogen diphosphate (SAPP) used as feed material of mineral origin; (ii) carrageenan; (iii) locust bean gum (carob gum), provided that locust bean gum is obtained through a roasting process (iv) acacia (gum arabic), used as gelling agents and/or emulsifiers; (v) taurine used as nutritional additive for cats and dogs; and (vi) ammonium chloride used as zootechnical additive for cats. |
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(7)

Based on recommendations from EGTOP with regard to pet food (5), the use of the following substances should be authorised: (i) pentasodium triphosphate (STPP) and disodium dihydrogen diphosphate (SAPP) used as feed material of mineral origin; (ii) carrageenan; (iii) locust bean gum (carob gum), provided that locust bean gum is obtained through a roasting process (iv) acacia (gum arabic), used as gelling agents and/or emulsifiers; (v) taurine used as nutritional additive for cats and dogs; and (vi) ammonium chloride used as zootechnical additive for cats.

| (8) | Based on recommendations from EGTOP with regard to food (5), the use of the following substances should be authorised: (i) silicon dioxide used as anti-caking agent for cocoa powder in automated drinks dispensing machines; and (ii) pine rosin extract and hop extract as antimicrobials in the production of food of plant origin. |
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(8)

Based on recommendations from EGTOP with regard to food (5), the use of the following substances should be authorised: (i) silicon dioxide used as anti-caking agent for cocoa powder in automated drinks dispensing machines; and (ii) pine rosin extract and hop extract as antimicrobials in the production of food of plant origin.

| (9) | Regulation (EU) 2021/1165 provides that gellan gum is authorised from 1 January 2023 only if it is from organic production. However, there is no sufficient quantity of gellan gum from organic production available. In order to allow operators to continue their food production, the application of that requirement should be postponed. |
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(9)

Regulation (EU) 2021/1165 provides that gellan gum is authorised from 1 January 2023 only if it is from organic production. However, there is no sufficient quantity of gellan gum from organic production available. In order to allow operators to continue their food production, the application of that requirement should be postponed.

| (10) | Guar gum E 412 is listed in Part B of Annex III to Implementing Regulation (EU) 2021/1165 as a binder and anti-caking agent within technological additives. However, in the European Union Register of feed additives, it is listed under emulsifying and stabilising agents, thickeners and gelling agents. That error needs to be corrected. |
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(10)

Guar gum E 412 is listed in Part B of Annex III to Implementing Regulation (EU) 2021/1165 as a binder and anti-caking agent within technological additives. However, in the European Union Register of feed additives, it is listed under emulsifying and stabilising agents, thickeners and gelling agents. That error needs to be corrected.

| (11) | Talc E 553b was authorised as a food additive in foodstuffs of plant origin by Commission Regulation (EC) No 889/2008 (7). This use was not included in Annex V to Implementing Regulation (EU) 2021/1165. That error needs to be corrected. |
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(11)

Talc E 553b was authorised as a food additive in foodstuffs of plant origin by Commission Regulation (EC) No 889/2008 (7). This use was not included in Annex V to Implementing Regulation (EU) 2021/1165. That error needs to be corrected.

| (12) | Implementing Regulation (EU) 2021/1165 should therefore be amended and corrected accordingly. |
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(12)

Implementing Regulation (EU) 2021/1165 should therefore be amended and corrected accordingly.

| (13) | The inclusion of talc E 553b as a food additive was erroneously limited and some organic operators may have continued to use it as a food additive in foodstuffs of plant origin. That error should therefore be corrected retroactively from the date of entry into force of Implementing Regulation (EU) 2021/1165. |
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(13)

The inclusion of talc E 553b as a food additive was erroneously limited and some organic operators may have continued to use it as a food additive in foodstuffs of plant origin. That error should therefore be corrected retroactively from the date of entry into force of Implementing Regulation (EU) 2021/1165.

| (14) | The measures provided for in this Regulation are in accordance with the opinion of the Organic Production Committee, |
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(14)

The measures provided for in this Regulation are in accordance with the opinion of the Organic Production Committee,

HAS ADOPTED THIS REGULATION:

Article 1

Amendments to Implementing Regulation (EU) 2021/1165

Implementing Regulation (EU) 2021/1165 is amended as follows:

| (1) | Annex I is amended in accordance with Annex I to this Regulation; |
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(1)

Annex I is amended in accordance with Annex I to this Regulation;

| (2) | Annex II is amended in accordance with Annex II to this Regulation; |
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(2)

Annex II is amended in accordance with Annex II to this Regulation;

| (3) | Annex III is amended in accordance with Annex III to this Regulation; |
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(3)

Annex III is amended in accordance with Annex III to this Regulation;

| (4) | Annex V is amended in accordance with Annex IV to this Regulation. |
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(4)

Annex V is amended in accordance with Annex IV to this Regulation.

Article 2

Corrections to Implementing Regulation (EU) 2021/1165

Implementing Regulation (EU) 2021/1165 is corrected as follows:

| (1) | point (1) (Technological additives) of Part B of Annex III is corrected as follows:






  (a) | in point (c), the following entry is added:







  ‘E412 | Guar gum’ | |
| --- | --- | --- | --- | --- |

(1)

point (1) (Technological additives) of Part B of Annex III is corrected as follows:

(a)

in point (c), the following entry is added:

‘E412

Guar gum’

| (b) | in point (d), the entry for ‘E 412 Guar gum’ is deleted; |
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(b)

in point (d), the entry for ‘E 412 Guar gum’ is deleted;

| (2) | in Section A1 (Food additives, including carriers) of Part A in Annex V, the entry for ‘E 553b Talc’ is replaced by the following:








  E 553b | Talc | | products of plant origin |
| --- | --- | --- | --- | --- |

(2)

in Section A1 (Food additives, including carriers) of Part A in Annex V, the entry for ‘E 553b Talc’ is replaced by the following:

E 553b

Talc

products of plant origin

| | sausages based on meat |
| --- | --- |

sausages based on meat

For sausages based on meat, only surface treatment

Article 3

Entry into force and application

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

Article 2(2) shall apply from 5 August 2021.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 17 January 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 150, 14.6.2018, p. 1.

1

(2)  Commission Implementing Regulation (EU) 2021/1165 of 15 July 2021 authorising certain products and substances for use in organic production and establishing their lists (OJ L 253, 16.7.2021, p. 13).

2

(3)  EGTOP final report on Fertilisers IV and Plant Protection Products VI and EGTOP final report on Plant Protection Products VII and Fertilisers V: https://agriculture.ec.europa.eu/farming/organic-farming/co-operation-and-expert-advice/egtop-reports_en.

3

(4)  Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, p. 1).

4

(5)  EGTOP final report on Food VII – Feed V and EGTOP final report on Feed VI and pet Food I: https://agriculture.ec.europa.eu/farming/organic-farming/co-operation-and-expert-advice/egtop-reports_en.

5

(6)  EGTOP final report on Feed III – Food V: https://agriculture.ec.europa.eu/farming/organic-farming/co-operation-and-expert-advice/egtop-reports_en.

6

(7)  Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control (OJ L 250, 18.9.2008, p. 1).

7

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ANNEX I

Annex I to Implementing Regulation (EU) 2021/1165 is amended as follows:

| (1) | in point 1 (Basic substances) the following entry is inserted after the entry ‘18C mustard seeds powder *’:








  ‘19C | 14807-96-6 | Magnesium hydrogen metasilicate
  silicate mineral
  (Talc E553b) | food grade in conformity with Commission Regulation (EU) No 231/2012 (*1) |
| --- | --- | --- | --- | --- |

(1)

in point 1 (Basic substances) the following entry is inserted after the entry ‘18C mustard seeds powder *’:

‘19C

14807-96-6

Magnesium hydrogen metasilicate

silicate mineral

(Talc E553b)

food grade in conformity with Commission Regulation (EU) No 231/2012 (*1)

| (2) | in point 2 (Low risk active substances) the following entries are added:








  ‘16D | CAS not allocated | ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) | not from GMO origin
  not produced by using growing media of GMO origin’ |
| --- | --- | --- | --- | --- |
| 20 D | 10058-44-3 | Ferric pyrophosphate | |
| 28 D | | Aqueous extract from the germinated seeds of sweet Lupinus albus | |

(2)

in point 2 (Low risk active substances) the following entries are added:

‘16D

CAS not allocated

ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

not from GMO origin

not produced by using growing media of GMO origin’

20 D

10058-44-3

Ferric pyrophosphate

28 D

Aqueous extract from the germinated seeds of sweet Lupinus albus

| (3) | in point 4 (Active substances not included in any of the above categories) the entry for ‘40A Deltamethrin’ is replaced by the following:








  ‘40A | 52918-63-5 | Deltamethrin | only in traps with specific attractants against Bactrocera oleae, Ceratitis capitata and Rhagoletis completa’ |
| --- | --- | --- | --- | --- |

(3)

in point 4 (Active substances not included in any of the above categories) the entry for ‘40A Deltamethrin’ is replaced by the following:

‘40A

52918-63-5

Deltamethrin

only in traps with specific attractants against Bactrocera oleae, Ceratitis capitata and Rhagoletis completa’

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(*1)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).’;

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ANNEX II

In the table in Annex II to Implementing Regulation (EU) 2021/1165, the following entries are added:

| ‘Recovered struvite and precipitated phosphate salts | products must meet the requirements laid down in Regulation (EU) 2019/1009
  animal manure as source material cannot have factory farming origin |
| --- | --- |
| Sodium nitrate | only for algae production on land in closed systems |
| Potassium chloride (muriate of potash) | only of natural origin’ |

‘Recovered struvite and precipitated phosphate salts

products must meet the requirements laid down in Regulation (EU) 2019/1009

animal manure as source material cannot have factory farming origin

Sodium nitrate

only for algae production on land in closed systems

Potassium chloride (muriate of potash)

only of natural origin’

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ANNEX III

Annex III to Implementing Regulation (EU) 2021/1165 is amended as follows:

| (1) | Part A is amended as follows:






  (a) | in point (1), after the entry ‘11.3.1 Dicalcium phosphate’, the following entry is inserted:







  ‘11.3.2 | Monodicalcium phosphate’ | |
| --- | --- | --- | --- | --- |

(1)

Part A is amended as follows:

(a)

in point (1), after the entry ‘11.3.1 Dicalcium phosphate’, the following entry is inserted:

‘11.3.2

Monodicalcium phosphate’

| (b) | in point (1), after the entry ‘11.3.17 Monoammonium phosphate’, the following entries are inserted:







  ‘11.3.19 | Pentasodium triphosphate (STPP) | only for pet food |
| --- | --- | --- | --- |
| 11.3.27 | Disodium dihydrogen diphosphate (SAPP) | only for pet food’ |

(b)

in point (1), after the entry ‘11.3.17 Monoammonium phosphate’, the following entries are inserted:

‘11.3.19

Pentasodium triphosphate (STPP)

only for pet food

11.3.27

Disodium dihydrogen diphosphate (SAPP)

only for pet food’

| (c) | in point (2), the entries for ‘ex 12.1.5 Yeasts’ and ‘ex 12.1.12 Yeast products’ are replaced by the following:







  ‘12.1.5 | Yeasts | when not available from organic production |
| --- | --- | --- | --- |
| 12.1.12 | Yeast products | when not available from organic production’ |

(c)

in point (2), the entries for ‘ex 12.1.5 Yeasts’ and ‘ex 12.1.12 Yeast products’ are replaced by the following:

‘12.1.5

Yeasts

when not available from organic production

12.1.12

Yeast products

when not available from organic production’

| (2) | Part B is amended as follows:






  (a) | in point (1)(c) (Emulsifiers, stabilisers, thickeners and gelling agents), the following entries are added:







  ‘E 407 | Carrageenan | only for pet food |
| --- | --- | --- | --- | --- |
| E 410 | Locust bean gum (Carob gum) | only for pet food
  obtained only from a roasting process
  from organic production if available |
| E 414 | Acacia (Gum arabic) | only for pet food
  from organic production if available’ |
| E 415 | Xanthan gum | |

(2)

Part B is amended as follows:

(a)

in point (1)(c) (Emulsifiers, stabilisers, thickeners and gelling agents), the following entries are added:

‘E 407

Carrageenan

only for pet food

E 410

Locust bean gum (Carob gum)

only for pet food

obtained only from a roasting process

from organic production if available

E 414

Acacia (Gum arabic)

only for pet food

from organic production if available’

E 415

Xanthan gum

| (b) | in point (1)(d) (Binders and anti-caking agents) the following entries are inserted in the order of the numbers of the codes:







  ‘E 563 | Sepiolitic clay | |
| --- | --- | --- | --- |
| 1g599 | Illite-montmorillonite-kaolinite’ | |

(b)

in point (1)(d) (Binders and anti-caking agents) the following entries are inserted in the order of the numbers of the codes:

‘E 563

Sepiolitic clay

1g599

Illite-montmorillonite-kaolinite’

| (c) | in point (1), a new point (f) and the following entry are added:






  ‘(f) | substances for reduction of the contamination of feed by mycotoxins








  ID number or functional group | Name | Specific conditions and limits |
| --- | --- | --- | --- | --- |
| 1m558 | Bentonite’ | |

(c)

in point (1), a new point (f) and the following entry are added:

‘(f)

substances for reduction of the contamination of feed by mycotoxins

ID number or functional group

Name

Specific conditions and limits

1m558

Bentonite’

| (d) | point (3)(a) (Vitamins, pro-vitamins and chemically well-defined substances having similar effect) is amended as follows:






  (i) | the following entry is inserted after the entry for ‘ex3a Vitamins and Provitamins’:







  ‘3a370 | Taurine | only for cats and dogs
  not from synthetic origin, if available’ |
| --- | --- | --- | --- | --- |

(d)

point (3)(a) (Vitamins, pro-vitamins and chemically well-defined substances having similar effect) is amended as follows:

(i)

the following entry is inserted after the entry for ‘ex3a Vitamins and Provitamins’:

‘3a370

Taurine

only for cats and dogs

not from synthetic origin, if available’

| (ii) | the entry for ‘3a920 Betaine anhydrous’ is replaced by the following:







  ‘3a920 | Betaine anhydrous | only for monogastric animals and fish
  from organic production; if not available, from natural origin’ |
| --- | --- | --- | --- |

(ii)

the entry for ‘3a920 Betaine anhydrous’ is replaced by the following:

‘3a920

Betaine anhydrous

only for monogastric animals and fish

from organic production; if not available, from natural origin’

| (e) | in point (4) (Zootechnical additives) the following entry is added:







  ‘4d7 and 4d8 | Ammonium chloride | only for cats’ |
| --- | --- | --- | --- |

(e)

in point (4) (Zootechnical additives) the following entry is added:

‘4d7 and 4d8

Ammonium chloride

only for cats’

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ANNEX IV

Part A of Annex V to Implementing Regulation (EU) 2021/1165 is amended as follows:

| (1) | Section A1 (Food additives, including carriers) is amended as follows:






  (a) | the entry for ‘E 418 Gellan gum’ is replaced by the following:








  ‘E 418 | Gellan gum | products of plant and animal origin | high-acyl form only
  only from organic production, applicable as of 1 January 2026’ |
| --- | --- | --- | --- | --- | --- |

(1)

Section A1 (Food additives, including carriers) is amended as follows:

(a)

the entry for ‘E 418 Gellan gum’ is replaced by the following:

‘E 418

Gellan gum

products of plant and animal origin

high-acyl form only

only from organic production, applicable as of 1 January 2026’

| (b) | the entry for ‘E 551 – Silicon dioxide’ is replaced by the following:








  ‘E 551 | Silicon dioxide | cocoa, herbs and spices in dried powdered form
  flavourings
  propolis | for cocoa, only for use in automated dispensing machines’ |
| --- | --- | --- | --- | --- |

(b)

the entry for ‘E 551 – Silicon dioxide’ is replaced by the following:

‘E 551

Silicon dioxide

cocoa, herbs and spices in dried powdered form

flavourings

propolis

for cocoa, only for use in automated dispensing machines’

| (2) | in Section A2 (Processing aids and other products, which may be used for processing of ingredients of agricultural origin from organic production), the entries for hop extract and pine rosin extract are replaced by the following:







  ‘Hop extract | products of plant origin | only for antimicrobial purposes
  from organic production, if available’ |
| --- | --- | --- | --- |

(2)

in Section A2 (Processing aids and other products, which may be used for processing of ingredients of agricultural origin from organic production), the entries for hop extract and pine rosin extract are replaced by the following:

‘Hop extract

products of plant origin

only for antimicrobial purposes

from organic production, if available’

| ‘Pine rosin extract | products of plant origin | only for antimicrobial purposes
  from organic production, if available’ |
| --- | --- | --- |

‘Pine rosin extract

products of plant origin

only for antimicrobial purposes

from organic production, if available’

---