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

• CELEX: Implementing Regulation (EU) 2025/973
• Articles: 8

Article 1 Amendments to Implementing Regulation (EU) 2021/1165

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.

Article 2 Correction of Implementing Regulation (EU) 2021/1165

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)’

Article 3 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 .

Schedules & Appendices

ANNEX I

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 II

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 III

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 IV

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 V

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 ).’