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.

• (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.

• (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’.

• (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.

• (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.

• (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.

• (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.

• (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;

• (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;

• (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:

• (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:

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.

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

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 *’:

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

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

ANNEX II

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

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:

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

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

• (2) Part B is amended as follows:

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

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

• (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’

• (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’

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:

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

• (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: