Commission Implementing Regulation (EU) 2025/973 of 23 May 2025 amending and correcting Implementing Regulation (EU) 2021/1165 authorising certain products and substances for use in organic production and establishing their lists

Amendments to Implementing Regulation (EU) 2021/1165

Article 1

Implementing Regulation (EU) 2021/1165 is amended as follows: (1) The following Article 10a is inserted: ‘Article 10a Procedure to grant specific authorisation for the use of products and substances in the outermost regions of the Union 1.   Where a Member State considers that a product or substance should be granted a specific authorisation for use in an outermost region of the Union due to the specific conditions set out in Article 45(2) of Regulation (EU) 2018/848, it may request the Commission to carry out an assessment. For that purpose, it shall notify the Commission of a dossier describing the product or substance concerned, giving the reasons for such specific authorisation due to the specific conditions set out in Article 45(2) of Regulation (EU) 2018/848 and explaining why the products and substances authorised under this Regulation are not adequate to be used due to the specific conditions in the outermost region concerned. It shall ensure that the dossier is fit to be made publicly available subject to Union and national legislation of the Member States on data protection. 2.   The Commission shall publish any requests referred to in paragraph 1. 3.   The Commission shall analyse the dossier referred to in paragraph 1. The Commission shall authorise the product or substance in the light of the specific conditions referred to in the dossier only if its analysis concludes, as a whole that: (a) such specific authorisation is justified in the outermost region concerned; (b) the product or substance described in the dossier complies with the principles laid down in Chapter II, the criteria set out in Article 24(3) and the condition set out in Article 24(5) of Regulation (EU) 2018/848; and (c) the use of the product or substance is in accordance with the relevant provisions of Union law, in particular, for active substances contained in plant protection products, with Regulation (EC) No 396/2005. The authorised product or substance shall be included in Annex VI to this Regulation. 4.   When the 2-year period referred to in Article 45(2) of Regulation (EU) 2018/848 expires, the authorisation shall be automatically renewed for another period of 2 years, provided that no new elements are available and no Member State or control authority or control body recognised under Article 46(1) of Regulation (EU) 2018/848 has objected, justifying that the conclusion by the Commission referred to in paragraph 3 needs to be reassessed.’ ; (2) Annex I is amended in accordance with Annex I to this Regulation; (3) Annex II is amended in accordance with Annex II to this Regulation; (4) Annex III is amended in accordance with Annex III to this Regulation; (5) Annex V is amended in accordance with Annex IV to this Regulation; (6) Annex VI is replaced by the text set out in Annex V to this Regulation.

Correction of Implementing Regulation (EU) 2021/1165

Article 2

In the table in point 1 of Annex I to Implementing Regulation (EU) 2021/1165, the entry ‘19C’ is replaced by the following: ‘19C 14807-96-6 Magnesium hydrogen metasilicate silicate mineral (Talc E 553b)’

Entry into force

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEX ISupplementary provisions

ANNEX I Annex I to Implementing Regulation (EU) 2021/1165 is amended as follows: (1) in point 2, the table is amended as follows: (a) the following entry is inserted between the entries ‘16D’ and ‘20D’: ‘19D 23960-07-8 Lavandulyl senecioate’   (b) the following entries are added after the entry for other low risk substances from plant or animal origin *: ‘32D 298-14-6 Potassium hydrogen carbonate   38D   Straight chain lepidopteran pheromones (acetates)   39D 98999-15-6 Sheep fat use as repellent by smell’ 44D 14808-60-7 and 7631-86-9 Quartz sand Silicon dioxide   (2) in point 4, the table is amended as follows: (a) the entries ‘244A’, ‘247A’, ‘249A’ and ‘255A and others’ are deleted; (b) the following entry is inserted between the entries ‘47B’ and ‘10E’: ‘153B and others   Pheromones and other semiochemicals’

ANNEX IISupplementary provisions

ANNEX II Annex II to Implementing Regulation (EU) 2021/1165 is amended as follows: (1) in the table, the entry ‘products and by-products of plant origin for fertilisers’ is replaced by the following: ‘Products and by-products of plant origin e.g., oilseed cake meal, cocoa husks, malt culms’ (2) in the table, the entry ‘stone meal, clays and clay minerals’ is replaced by the following: ‘Stone meal, sand of natural origin, clays and clay minerals e.g., perlite, sand and vermiculite, including when heat treated, perlite, sand and vermiculite, including when heat treated, may also be used for sprouted seeds production as an inert medium as referred to in Part I, point 1.3(a), of Annex II to Regulation (EU) 2018/848’ (3) in the table, the following entries are added after the entry ‘selenium salts’: ‘Carbon dioxide use for enrichment of water for algae production on land in closed systems; in this case, carbon dioxide shall be of food grade when available, carbon dioxide shall be obtained as a by-product of other processes or from renewable sources pursuant to Directive (EU) 2018/2001 of the European Parliament and of the Council  ( *1 ) may also be used in greenhouse production Calcium acetate only for foliar application on vegetables in greenhouses and on apple trees to prevent deficiency in calcium obtained from calcium carbonate of natural origin Calcium phosphate only when derived from sewage sludge ash only products complying with the requirements of Regulation (EU) 2019/1009 Plant fibre mats plant-based fibres, such as hemp fibre, flax fibre, coconut fibre with no addition of any fertiliser, soil conditioner or nutrient nor additives or binders, only mechanically manufactured only for sprouted seeds production as an inert medium referred to in Part I, point 1.3(a), of Annex II to Regulation (EU) 2018/848 when available, materials from organic production shall be used Calcium and magnesium gluconate derived from microbial fermentation ( *1 )   Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources ( OJ L 328, 21.12.2018, p. 82 , ELI: http://data.europa.eu/eli/dir/2018/2001/oj ).’.

ANNEX IIISupplementary provisions

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), in the table, the entry ‘11.1.6’ is replaced by the following: ‘11.1.6 Calcium chloride may only be used as “feed intended for particular nutritional purposes” defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for the reduction of the risk of milk fever and subclinical hypocalcaemia in accordance with Part B, table entry “60”, of the Annex to Commission Regulation (EU) 2020/354  ( *1 ) , including bolus formulation calcium chloride when purified from naturally occurring brine, if available only for dairy cows in need and for a limited period (b) in point (2), the table is amended as follows: (i) the following entries are inserted between the entries ‘12.1.5’ and ‘12.1.12’: ‘ex 12.1.9 Single cell proteins from Trichoderma viride and Aspergillus oryzae only from non-GM strain and culture media not obtained from substrates with synthetic nitrogen sources obtained from substrates coming from organic production when used for ruminants and other herbivores when used, antifoaming agents shall be authorised for organic production 12.1.10 Products from Bacillus subtilis rich in protein only from non-GM strain and culture media not obtained from substrates with synthetic nitrogen sources obtained from substrates coming from organic production when used for ruminants and other herbivores when used, antifoaming agents shall be authorised for organic production’ (ii) the following entry is inserted between the entries ‘12.1.12’ and ‘13.11.1’: ‘ex 13.6.4 Calcium stearate’   (iii) the entry ‘13.11.1’ is replaced by the following: ‘13.11.1 Propylene glycol; [1,2-propanediol]; [propane-1,2-diol] may only be used as “feed intended for particular nutritional purposes” defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for the reduction of the risk of ketosis in accordance with Part B, table entry “61”, of the Annex to Regulation (EU) 2020/354, including bolus formulation only for dairy cows, ewes and goats in need and for a limited period’ (2) Part B is amended as follows: (a) in point (1)(a), the table is replaced by the following: ‘ID number or functional group Name Specific conditions and limits 1a200 Sorbic acid   1k236 Formic acid   1k237i Sodium formate   1a260 Acetic acid   1a270 1a270i Lactic acids   1k280 Propionic acid   1a282 Calcium propionate may only be used as “feed intended for particular nutritional purposes” defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for the reduction of the risk of milk fever and subclinical hypocalcaemia in accordance with Part B, table entry “60”, of the Annex to Regulation (EU) 2020/354, including bolus formulation only for dairy cows in need and for a limited period’ 1a330 Citric acid   (b) in point (1)(c), in the table, the entry ‘1c322, 1c322i’ is replaced by the following: ‘1c322, 1c322i Lecithins derived from organic raw material from 1 January 2027, only from organic production’ (c) in point (3)(b), the table is amended as follows: (i) the following entry is inserted between the entries ‘3b104’ and ‘3b107’: ‘3b105 Iron(II) fumarate may only be used as “feed intended for particular nutritional purposes” defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for compensation of insufficient iron availability after birth in accordance with Part B, table entry “64”, of the Annex to Regulation (EU) 2020/354 only for suckling piglets in need and for a limited period’ (ii) the entry ‘3b110’ is replaced by the following: ‘3b110 Iron dextran 10 % may only be used as “feed intended for particular nutritional purposes” defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for compensation of insufficient iron availability after birth in accordance with Part B, table entry “64”, of the Annex to Regulation (EU) 2020/354 growing medium for the fermentation process for dextran shall be of non-GMO origin only for suckling piglets in need and for a limited period’ (d) the following point is added: ‘(5) PROCESSING AIDS For processing aids as defined in Article 2(2), point (h), of Regulation (EC) No 1831/2003, the specific conditions and limits set out in the following table shall apply. Name Specific conditions and limits Ethanol to be used only as extraction solvent for the production of protein meals and only when protein meals from mechanical extraction are not available in sufficient quantities only from fermentation if available only from organic production if available Papain only for the production of flavouring innards for the manufacture of pet food that are defined in point 18 of Annex I to Regulation (EU) No 142/2011 provided that the enzyme is inactivated during the process and therefore is not present as such in the resulting flavouring innards and does not have any technological effect on the product from 1 January 2027, only from organic raw material’ ( *1 )   Commission Regulation (EU) 2020/354 of 4 March 2020 establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC ( OJ L 67, 5.3.2020, p. 1 , ELI: http://data.europa.eu/eli/reg/2020/354/oj ).’.

ANNEX IVSupplementary provisions

ANNEX IV Annex V to Implementing Regulation (EU) 2021/1165 is amended as follows: (1) Part A is replaced by the following: ‘PART A Authorised food additives and processing aids referred to in Article 24(2), point (a), of Regulation (EU) 2018/848, including carriers and other substances used in the same way and with the same purpose as processing aids The organic foodstuffs to which food additives may be added are within the limit of authorisations given in accordance with Regulation (EC) No 1333/2008. The specific conditions and limits set out in the table below shall apply in addition to the conditions of the authorisations under Regulation (EC) No 1333/2008. The use as food additives or as processing aids shall be attributed on a case-by-case basis in accordance with Regulation (EC) No 1333/2008 and national legislation on processing aids. For the purpose of the calculation of the percentages referred to in Article 30(5) of Regulation (EU) 2018/848, food additives marked with an asterisk in the column “E-number or Einecs, or both” shall be calculated as ingredients of agricultural origin. E-number or Einecs  ( + ) , or both Name Organic foodstuffs in which the additive or processing aid may be used and specific conditions and limits Use as an additive Use as a processing aid E 153 Vegetable carbon edible cheese rind of ashy goat cheese   Morbier cheese   E 160b(i)* Annatto bixin Red Leicester cheese   Double Gloucester cheese   Cheddar   Mimolette cheese   E 160b(ii)* Annatto norbixin Red Leicester cheese   Double Gloucester cheese   Cheddar   Mimolette cheese   E 170/207-439-9 and 215-279-6 Calcium carbonate products of plant and animal origin products of plant origin E 220 Sulphur dioxide fruit wines (wine made from fruits other than grapes, including cider and perry) and mead with and without added sugar 100 mg/l (maximum levels available from all sources, expressed as SO 2 in mg/l)   E 223 Sodium metabisulphite crustaceans   E 224 Potassium metabisulphite fruit wines (wine made from fruits other than grapes, including cider and perry) and mead with and without added sugar 100 mg/l (maximum levels available from all sources, expressed as SO 2 in mg/l)   E 250 Sodium nitrite meat products may only be used, if it has been demonstrated to the satisfaction of the competent authority that no technological alternative, giving the same guarantees and/or allowing to maintain the specific features of the product, is available not in combination with E252 maximum amount that may be added during the manufacturing expressed as NO 2 ion: 50 mg/kg maximum residual amount from all sources for the product ready for marketing throughout the shelf life of the product expressed as NO 2 ion: 30 mg/kg   E252 Potassium nitrate meat products may only be used, if it has been demonstrated to the satisfaction of the competent authority that no technological alternative, giving the same guarantees and/or allowing to maintain the specific features of the product, is available not in combination with E250 maximum amount that may be added during the manufacturing expressed as NO 3 ion: 55 mg/kg maximum residual amount from all sources for the product ready for marketing throughout the shelf life of the product expressed as NO 3 ion: 35 mg/kg   E 267* Buffered vinegar products of plant and animal origin only from organic production   E 270/200-018-0 Lactic acid products of plant and animal origin cheese for the regulation of pH of the brine bath in cheese production E 290/204-696-9 Carbon dioxide products of plant and animal origin products of plant and animal origin E 296 Malic acid products of plant origin   E 300 Ascorbic acid products of plant origin meat products (category 08,3  ( ++ ) ) and meat preparations (category 08,2  ( ++ ) ) to which other ingredients than additives or salt have been added   E 301 Sodium ascorbate meat products may only be used in connection with nitrates and nitrites   E 306* Tocopherol-rich extract products of plant and animal origin only as antioxidant   E 322* Lecithins products of plant and animal origin only from organic production   E 325 Sodium lactate products of plant origin   milk-based products   meat products   E 330/201-069-1 Citric acid products of plant and animal origin products of plant and animal origin E 331 Sodium citrates products of plant and animal origin   E 333 Calcium citrates products of plant origin   E 334 Tartaric acid (L(+)-) products of plant origin mead   E 335* Sodium tartrates products of plant origin from 1 January 2027, only from organic production   E 336* Potassium tartrates products of plant origin from 1 January 2027, only from organic production   E 337* Potassium sodium tartrate products of plant origin from 1 January 2027, only from organic production   E 341(i) Monocalcium phosphate self-raising flour only as raising agent   E 392* Extracts of rosemary products of plant and animal origin only from organic production   E 400 Alginic acid products of plant origin   milk products   E 401 Sodium alginate products of plant origin   milk products   sausages based on meat   E 402 Potassium alginate products of plant origin   milk-based products   E 406 Agar products of plant origin   milk-based products   meat products   E 407 Carrageenan products of plant origin   milk-based products   E 410* Locust bean gum products of plant and animal origin only from organic production   E 412* Guar gum products of plant and animal origin only from organic production   E 414* Arabic gum products of plant and animal origin only from organic production   E 415 Xanthan gum products of plant and animal origin   E 417* Tara gum products of plant and animal origin only from organic production only as thickener   E 418* Gellan gum products of plant and animal origin from organic production, if available only high-acyl form   E 422* Glycerol plant extracts and flavourings only from plant origin only from organic production as solvent and carrier as humectant in gel capsules as surface coating of tablets   E 440(i)* Pectin products of plant origin   milk-based products E 460/232-674-9 Cellulose gelatine gelatine products of plant origin E 464 Hydroxypropyl methyl cellulose products of plant and animal origin only as encapsulation material for capsules   E 500/207-838-8, 205-633-8, 208-580-9 Sodium carbonates products of plant and animal origin products of plant and animal origin E 501/209-529-3, 206-059-0 Potassium carbonates products of plant origin grapes only as drying agent to produce dried grapes E 503 Ammonium carbonates products of plant origin   E 504 Magnesium carbonates products of plant origin   E 509/233-140-8 Calcium chloride products of plant origin only to induce coagulation products of plant origin only as clarifying/flocculating agent milk-based products only as stabiliser sausages based on meat only to induce coagulation to form casing E 511/232-094-6 Magnesium chloride products of plant origin only to induce coagulation products of plant origin only as clarifying/flocculating agent E 516/231-900-3 Calcium sulphate products of plant origin only as carrier or to induce coagulation products of plant origin only as clarifying/flocculating agent E 524/215-185-5 Sodium hydroxide surface-treated Laugengebäck only as surface treatment sugar(s) flavourings only as acidity regulator oil from plant origin excluding olive oil plant protein extracts E 551/231-545-4 Silicon dioxide cocoa only as anticaking agent for use in automated dispensing machines products of plant origin herbs and spices in dried powdered form flavourings propolis E 553b Talc products of plant origin products of plant origin sausages based on meat only as surface treatment E 901*/232-383-7 Beeswax confectionery only from organic production only as glazing agent products of plant origin only from organic production only as releasing agent E 903*/232-399-4 Carnauba wax confectionery only from organic production only as glazing agent products of plant origin only from organic production only as releasing agent citrus fruit only from organic production only as mitigating method for mandatory extreme cold treatment of fruit against harmful organisms in accordance with Commission Implementing Regulation (EU) 2019/2072  ( +++ ) E 938 Argon products of plant and animal origin   E 939 Helium products of plant and animal origin   E 941/231-783-9 Nitrogen products of plant and animal origin products of plant and animal origin E 948 Oxygen products of plant and animal origin   E 968* Erythritol products of plant and animal origin only from organic production without using ion exchange technology   -/200-578-6 Ethanol   products of plant and animal origin only as solvent on crystallization primers for the production of sugar and/or extraction solvent -/200-580-7 Acetic acid   products of plant origin from organic production, if available fish from organic production, if available -/215-108-5 Bentonite   products of plant origin mead only as sticking agent -/215-137-3 Calcium hydroxide   products of plant origin -/231-595-7 Hydrochloric acid   gelatine Gouda, Edam and Maasdammer cheeses, Boerenkaas, Friese and Leidse Nagelkaas only as regulation of the pH of the brine bath in the processing of cheeses -/231-639-5 Sulphuric acid   gelatine sugar(s) -/231-765-0 Hydrogen peroxide   gelatine -/232-554-6 Gelatine   products of plant origin -/232-555-1 Casein   products of plant origin -/293-292-6 Isinglass   products of plant origin -/931-328-0 Activated carbon   products of plant and animal origin   Ammonium hydroxide   gelatine   Diammonium phosphate   fruit wines, cider, perry and mead   L(+)lactic acid from fermentation   plant protein extracts   Thiamin hydrochloride   fruit wines, cider, perry and mead   Diatomaceous earth   products of plant origin gelatine   Egg white albumin   products of plant origin   Hop extract   products of plant origin from organic production, if available only for antimicrobial purposes   Hazelnut shells   products of plant origin   Perlite   products of plant origin gelatine   Pine rosin extract   products of plant origin from organic production, if available only for antimicrobial purposes   Rice meal   products of plant origin   Tannic acid   products of plant origin only as filtration aid   Vegetable oils   products of plant and animal origin only from organic production only as greasing, releasing or antifoaming agent   Vinegar   products of plant origin only from organic production fish only from organic production   Water   products of plant and animal origin water intended for human consumption within the meaning of Directive (EU) 2020/2184 of the European Parliament and of the Council  ( ++++ )   Wood fibre   products of plant and animal origin the source of timber shall be restricted to certified, sustainably harvested wood wood used shall not contain toxic components (post-harvest treatment, naturally occurring toxins or toxins from microorganisms) (2) in Part C, in the table, the following entry is added after the entry ‘vegetable oils’: ‘Fermentation activators X   nutrients from yeast extract or autolysate up to 5 % of the substrate calculated in weight of dry matter’ (3) in Part D, the table is amended as follows: (a) the entry ‘yeasts for wine production’ is replaced by the following: ‘Yeasts for wine production   Part A, Table 2, point 1.11 Part A, Table 2, point 9.1 for the individual yeast strains, organic if available’ (b) the entry ‘lactic acid bacteria’ is replaced by the following: ‘Lactic acid bacteria   Part A, Table 2, point 1.12 Part A, Table 2, point 9.2’   ( + )   European Inventory of Existing Commercial Chemical Substances ( OJ C 146, 15.6.1990, p. 4 ). ( ++ )   Food categories in Part D of Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives ( OJ L 354, 31.12.2008, p. 16 , ELI: http://data.europa.eu/eli/reg/2008/1333/oj ). ( +++ )   Commission Implementing Regulation (EU) 2019/2072 of 28 November 2019 establishing uniform conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament and the Council, as regards protective measures against pests of plants, and repealing Commission Regulation (EC) No 690/2008 and amending Commission Implementing Regulation (EU) 2018/2019 ( OJ L 319, 10.12.2019, p. 1 , ELI: http://data.europa.eu/eli/reg_impl/2019/2072/oj ). ( ++++ )   Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption ( OJ L 435, 23.12.2020, p. 1 , ELI: http://data.europa.eu/eli/dir/2020/2184/oj ).’;

ANNEX VSupplementary provisions

ANNEX V ‘ANNEX VI Products and substances authorised for use in organic production in third countries and in the outermost regions of the Union pursuant to Article 45(2) of Regulation (EU) 2018/848 PART A PRODUCTS AND SUBSTANCES AUTHORISED FOR USE IN ORGANIC PRODUCTION IN THIRD COUNTRIES Active substances to be used in plant protection products Active substances listed in the table below may be used in organic production in third countries, provided that they comply with the relevant third country legislation, are exempted from maximum residue levels in accordance with Codex Alimentarius guidelines CXG 97-2022  ( *1 ) , are included in Annex IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council  ( *2 ) , or specific maximum residue levels have been set in that Regulation. They are subject to the corresponding specific conditions and limits set out in that table. CAS number Name of the active substance Specific conditions and limits   Microorganisms including viruses, when used as biological control agents not from GMO origin not produced by using growing media of GMO origin 74-85-1 Ethylene for flower induction in pineapple PART B PRODUCTS AND SUBSTANCES AUTHORISED FOR USE IN ORGANIC PRODUCTION IN THE OUTERMOST REGIONS OF THE UNION Active substances to be used in plant protection products Active substances listed in the table below may be used in organic production in the outermost regions of the Union, provided that they comply with the relevant provisions of Union law and, where applicable, with national provisions based on Union law. . ( *1 )    https://www.fao.org/fao-who-codexalimentarius/codex-texts/guidelines/en . ( *2 )   Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ( OJ L 70, 16.3.2005, p. 1 , ELI: http://data.europa.eu/eli/reg/2005/396/oj ).’