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Commission Implementing Regulation (EU) 2021/1165 of 15 July 2021 authorising certain products and substances for use in organic production and establishing their lists (Text with EEA relevance)Text with EEA relevance
Konsolidēts teksts: Commission Implementing Regulation (EU) 2021/1165 of 15 July 2021 authorising certain products and substances for use in organic production and establishing their lists (Text with EEA relevance)Text with EEA relevance
Commission Implementing Regulation (EU) 2021/1165 of 15 July 2021 authorising certain products and substances for use in organic production and establishing their lists (Text with EEA relevance)Text with EEA relevance
ELI: http://data.europa.eu/eli/reg_impl/2021/1165/2023-11-15
02021R1165 — EN — 15.11.2023 — 002.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
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) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING REGULATION (EU) 2023/121 of 17 January 2023 |
L 16 |
24 |
18.1.2023 |
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COMMISSION IMPLEMENTING REGULATION (EU) 2023/2229 of 25 October 2023 |
L |
1 |
26.10.2023 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/1165
of 15 July 2021
authorising certain products and substances for use in organic production and establishing their lists
(Text with EEA relevance)
Article 1
Active substances in plant protection products
For the purposes of point (a) of Article 24(1) of Regulation (EU) 2018/848, only the active substances listed in Annex I to this Regulation may be contained in plant protection products used in organic production as set out in that Annex, provided that those plant protection products:
have been authorised pursuant to Regulation (EC) No 1107/2009 of the European Parliament and of the Council ( 1 );
are used in accordance with the conditions for use as specified in the authorisations of the products containing them, granted by the Member States; and
are used in compliance with the conditions set out in the Annex to Commission Implementing Regulation (EU) No 540/2011 ( 2 ).
Article 2
Fertilisers, soil conditioners and nutrients
For the purposes of point (b) of Article 24(1) of Regulation (EU) 2018/848, only the products and substances listed in Annex II to this Regulation may be used in organic production as fertilisers, soil conditioners and nutrients for plant nutrition, litter improvement and enrichment or algae cultivation or husbandry environment of aquaculture animals, provided that they are compliant with the relevant provisions of Union law, in particular with Regulation (EC) No 2003/2003 of the European Parliament and of the Council ( 3 ), the relevant applicable Articles of Regulation (EU) 2019/1009 of the European Parliament and of the Council ( 4 ), Regulation (EC) No 1069/2009 of the European Parliament and of the Council ( 5 ) and Commission Regulation (EU) No 142/2011 ( 6 ) and, where applicable, in accordance with national provisions based on Union law.
Article 3
Non-organic feed material of plant, algal, animal or yeast origin or feed material of microbial or mineral origin
For the purposes of point (c) of Article 24(1) of Regulation (EU) 2018/848, only the products and substances listed in Part A of Annex III to this Regulation may be used in organic production as non-organic feed material of plant, algal, animal or yeast origin or as feed material of microbial or mineral origin, provided that their use is in accordance with the relevant provisions of Union law, in particular Regulation (EC) No 767/2009 of the European Parliament and of the Council ( 7 ) and, where applicable, in accordance with national provisions based on Union law.
Article 4
Feed additives and processing aids
For the purposes of point (d) of Article 24(1) of Regulation (EU) 2018/848, only the products and substances listed in Part B of Annex III to this Regulation may be used in organic production as feed additives and processing aids used in animal nutrition, provided that their use is in accordance with the relevant provisions of Union law, in particular Regulation (EC) No 1831/2003 of the European Parliament and of the Council ( 8 ) and, where applicable, in accordance with national provisions based on Union law.
Article 5
Products for cleaning and disinfection
Article 6
Food additives and processing aids
For the purposes of point (a) of Article 24(2) of Regulation (EU) 2018/848, only the products and substances listed in Part A of Annex V to this Regulation may be used as food additives, including food enzymes to be used as food additives, and processing aids in the production of processed organic food, provided that their use is in accordance with the relevant provisions of Union law, in particular Regulation (EC) No 1333/2008 of the European Parliament and of the Council ( 9 ) and, where applicable, in accordance with national provisions based on Union law.
Article 7
Non-organic agricultural ingredients to be used for the production of processed organic food
For the purposes of point (b) of Article 24(2) of Regulation (EU) 2018/848, only the non-organic agricultural ingredients listed in Part B of Annex V to this Regulation may be used for the production of processed organic food, provided that their use is in accordance with the relevant provisions of Union law and, where applicable, in accordance with national provisions based on Union law.
The first paragraph is without prejudice to the detailed requirements for organic production of processed food provided in Section 2 of Part IV of Annex II to Regulation (EU) 2018/848. In particular, the first paragraph shall not apply to non-organic agricultural ingredients that are used as food additives, processing aids or products and substances referred to in point 2.2.2 of Part IV of Annex II to Regulation (EU) 2018/848.
Article 8
Processing aids for the production of yeast and yeast products
For the purposes of point (c) of Article 24(2) of Regulation (EU) 2018/848, only the products and substances listed in Part C of Annex V to this Regulation may be used as processing aids for the production of yeast and yeast products for food and feed, provided that their use is in accordance with the relevant provisions of Union law and, where applicable, in accordance with national provisions based on Union law.
Article 9
Products and substances for use in organic production of wine
For the purposes of point 2.2 of Part VI of Annex II to Regulation (EU) 2018/848, only the products and substances listed in Part D of Annex V to this Regulation may be used for the production and conservation of organic grapevine products as referred to in Part II of Annex VII to Regulation (EU) No 1308/2013, provided that their use is in accordance with the relevant provisions of Union law, in particular within the limits and conditions set out in Regulation (EU) No 1308/2013 and Commission Delegated Regulation (EU) 2019/934 ( 10 ) and, where applicable, in accordance with national provisions based on Union law.
Article 10
Procedure to grant specific authorisations for the use of products and substances in certain areas of third countries
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 wholethat:
such specific authorisation is justified in the area concerned;
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
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 of the European Parliament and of the Council ( 11 ).
The authorised product or substance shall be included in Annex VI to this Regulation.
Article 11
Repeal
Regulation (EC) No 889/2008 is repealed.
However, Annexes VII and IX shall continue to apply until 31 December 2023.
Article 12
Transitional provisions
Article 13
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.
It shall apply from 1 January 2022.
Article 5(1), (2) and (3) shall apply from 1 January 2026.
Article 7 shall apply from 1 January 2024.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
Active substances contained in plant protection products authorised for use in organic production as referred to in point (a) of Article 24(1) of Regulation (EU) 2018/848
The active substances listed in this Annex may be contained in plant protection products used in organic production as set out in this Annex, provided that these plant protection products are authorised pursuant to Regulation (EC) No 1107/2009. These plant protection products shall be used in compliance with the conditions set out in the Annex to Implementing Regulation (EU) No 540/2011 and in accordance with the conditions specified in the authorisations granted by the Member States where they are used. More restrictive conditions for use in organic production are specified in the last column of each table below.
In accordance with Article 9(3) of Regulation (EU) 2018/848, safeners, synergists and co-formulants as components of plant protection products, and adjuvants that are to be mixed with plant protection products shall be allowed for use in organic production, provided that they are authorised pursuant to Regulation (EC) No 1107/2009. The substances in this Annex may only be used for the control of pests as defined in Article 3(24) of Regulation (EU) 2018/848.
In accordance with point 1.10.2 of Part I of Annex II to Regulation (EU) 2018/848, these substances may only be used where plants cannot be adequately protected from pests by measures provided for in point 1.10.1 of that Part I, in particular by the use of biological control agents, such as beneficial insects, mites and nematodes complying with the provisions of Regulation (EU) No 1143/2014 of the European Parliament and of the Council ( 12 ).
For the purposes of this Annex, active substances are divided into following subcategories:
1. Basic substances
Basic substances listed in Part C of the Annex to Implementing Regulation (EU) No 540/2011, from plant or animal origin and based on food as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council ( 13 ) may be used for plant protection in organic production. Such basic substances are marked with an asterisk in the table below. They shall be used in accordance with the uses, conditions and restrictions set in the relevant review reports ( 14 ) and taking into account the additional restrictions, if any, in the last column of the table below.
Other basic substances listed in Part C of the Annex to Implementing Regulation (EU) No 540/2011 may be used for plant protection in organic production only when they are listed in the table below. Such basic substances shall be used in accordance with the uses, conditions and restrictions set in the relevant review reports3 and taking into account the additional restrictions, if any, in the right column of the table below.
Basic substances shall not be used as herbicides.
Number and Part of Annex (1) |
CAS |
Name |
Specific conditions and limits |
1C |
|
Equisetum arvense L.* |
|
2C |
70694-72-3 |
Chitosan hydrochloride (2) |
obtained from Aspergillus or organic aquaculture or from sustainable fisheries, as defined in Article 2 of Regulation (EU) No 1380/2013 of the European Parliament and of the Council (2) |
3C |
57-50-1 |
Sucrose* |
|
4C |
1305-62-0 |
Calcium Hydroxide |
|
5C |
90132-02-8 |
Vinegar* |
|
6C |
8002-43-5 |
Lecithins* |
|
7C |
- |
Salix spp. Cortex* |
|
8C |
57-48-7 |
Fructose* |
|
9C |
144-55-8 |
Sodium hydrogen carbonate |
|
10C |
92129-90-3 |
Whey* |
|
11C |
7783-28-0 |
Diammonium phosphate |
only in traps |
12C |
8001-21-6 |
Sunflower oil* |
|
14C |
84012-40-8 90131-83-2 |
Urtica spp. (Urtica dioica extract) (Urtica urens extract)* |
|
15C |
7722-84-1 |
Hydrogen peroxide |
|
16C |
7647-14-5 |
Sodium chloride |
|
17C |
8029-31-0 |
Beer* |
|
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 (3) |
20C |
8002-72-0 |
Onion oil* |
|
21C |
52-89-1 |
L-cysteine (E 920) |
|
22C |
8049-98-7 |
Cow milk* |
|
23C |
- |
Allium cepa* L. bulb extract |
|
|
|
Other basic substances from plant or animal origin and based on food* |
|
24C |
9012-76-4 |
Chitosan* |
obtained from Aspergillus or organic aquaculture or from sustainable fisheries, as defined in Article 2 of Regulation (EU) No 1380/2013 |
(1)
Listing according to Implementing Regulation (EU) No 540/2011, numbers and which category: Part A active substances deemed to have been approved under Regulation (EC) No 1107/2009, B, active substances approved under Regulation (EC) No 1107/2009, C basic substances, D low-risk active substances and E candidates for substitution.
(2)
Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22). |
2. Low risk active substances
Low risk active substances, other than micro-organisms, listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011 may be used for plant protection in organic production when they are listed in the table below or elsewhere in this Annex. Such low risk active substances shall be used in accordance with the uses, conditions and restrictions pursuant to Regulation (EC) No 1107/2009 and taking into account the additional restrictions, if any, in the last column of the table below.
Number and Part of Annex (1) |
CAS |
Name |
Specific conditions and limits |
2D |
|
COS-OGA |
|
3D |
|
Cerevisane and other products based on fragments of cells of micro-organisms |
Not from GMO origin |
5D |
10045-86-6 |
Ferric phosphate (iron (III) orthophosphate) |
|
12D |
9008-22-4 |
Laminarin |
Kelp shall be obtained from organic aquaculture or collected in a sustainable way in accordance with point 2.4 of Part III of Annex II to Regulation (EU) 2018/848 |
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 |
|
24D |
144-55-8 |
Sodium hydrogen carbonate |
|
28 D |
|
Aqueous extract from the germinated seeds of sweet Lupinus albus |
|
|
|
Other low risk substances from plant or animal origin * |
Herbicidal uses not allowed |
(1)
Listing according to Implementing Regulation (EU) No 540/2011, numbers and which category: Part A active substances deemed to have been approved under Regulation (EC) No 1107/2009, B, active substances approved under Regulation (EC) No 1107/2009, C basic substances, D low-risk active substances and E candidates for substitution. |
3. Micro-organisms
All micro-organisms listed in Parts A, B and D of the Annex to Implementing Regulation (EU) No 540/2011 may be used in organic production, provided that they are not from GMO origin and only when used in accordance with the uses, conditions and restrictions set in the relevant review reports3. Micro-organisms including viruses are biological control agents that are considered as active substances by Regulation (EC) No 1107/2009.
4. Active substances not included in any of the above categories
The active substances as approved pursuant to Regulation (EC) No 1107/2009 and listed in the table below may be used as plant protection products in organic production only when they are used in accordance with the uses, conditions and restrictions pursuant to Regulation (EC) No 1107/2009 and taking into account the additional restrictions, if any, in the right column of the table below.
Number and part of Annex (1) |
CAS |
Name |
Specific conditions and limits |
139A |
131929-60-7 131929-63-0 |
Spinosad |
|
225A |
124-38-9 |
Carbon dioxide |
|
227A |
74-85-1 |
Ethylene |
only on bananas and potatoes; however, it may also be used on citrus as part of a strategy for the prevention of fruit fly damage |
230A |
i.a. 67701-09-1 |
Fatty acids |
all uses authorised, except herbicide |
231A |
8008-99-9 |
Garlic extract (Allium sativum) |
|
234A |
CAS No not allocated CIPAC No 901 |
Hydrolysed proteins excluding gelatine |
|
244A |
298-14-6 |
Potassium hydrogen carbonate |
|
249A |
98999-15-6 |
Repellents by smell of animal or plant origin/sheep fat |
|
255A and others |
|
Pheromones and other semiochemicals |
only in traps and dispensers |
220A |
1332-58-7 |
Aluminium silicate (kaolin) |
|
236A |
61790-53-2 |
Kieselgur (diatomaceous earth) |
|
247A |
14808-60-7 7637-86-9 |
Quartz sand |
|
343A |
11141-17-6 84696-25-3 |
Azadirachtin (Margosa extract) |
extracted from Neem tree seeds (Azadirachta indica) |
240A |
8000-29-1 |
Citronella oil |
all uses authorised, except herbicide |
241A |
84961-50-2 |
Clove oil |
all uses authorised, except herbicide |
242A |
8002-13-9 |
Rape seed oil |
all uses authorised, except herbicide |
243A |
8008-79-5 |
Spearmint oil |
all uses authorised, except herbicide |
56A |
8028-48-6 5989-27-5 |
Orange oil |
all uses authorised, except herbicide |
228A |
68647-73-4 |
Tea tree oil |
all uses authorised, except herbicide |
246A |
8003-34-7 |
Pyrethrins extracted from plants |
|
292A |
7704-34-9 |
Sulphur |
|
294A 295A |
64742-46-7 72623-86-0 97862-82-3 8042-47-5 |
Paraffin oils |
|
345A |
1344-81-6 |
Lime sulphur (calcium polysulphide) |
|
44B |
9050-36-6 |
Maltodextrin |
|
45B |
97-53-0 |
Eugenol |
|
46B |
106-24-1 |
Geraniol |
|
47B |
89-83-8 |
Thymol |
|
10E |
20427-59-2 |
Copper hydroxide |
in accordance with Implementing Regulation (EU) No 540/2011 only uses resulting in a total application of maximum 28 kg of copper per hectare over a period of 7 years may be authorised |
10E |
1332-65-6 1332-40-7 |
Copper oxychloride |
|
10E |
1317-39-1 |
Copper oxide |
|
10E |
8011-63-0 |
Bordeaux mixture |
|
10E |
12527-76-3 |
Tribasic copper sulphate |
|
40A |
52918-63-5 |
Deltamethrin |
only in traps with specific attractants against Bactrocera oleae, Ceratitis capitata and Rhagoletis completa |
5E |
91465-08-6 |
Lambda-cyhalothrin |
only in traps with specific attractants against Bactrocera oleae and Ceratitis capitata |
(1)
Listing according to Implementing Regulation (EU) No 540/2011, numbers and which category: Part A active substances deemed to have been approved under Regulation (EC) No 1107/2009, B, active substances approved under Regulation (EC) No 1107/2009, C basic substances, D low-risk active substances and E candidates for substitution. |
ANNEX II
Authorised fertilisers, soil conditioners and nutrients referred to in point (b) of Article 24(1) of Regulation (EU) 2018/848
Fertilisers, soil conditioners and nutrients ( 15 ) listed in this Annex may be used in organic production, provided that they are compliant with
In accordance with point 1.9.6 of Part I of Annex II to Regulation (EU) 2018/848, preparations of micro-organisms may be used to improve the overall condition of the soil or to improve the availability of nutrients in the soil or in the crops.
They may only be used according to the specifications and restrictions of use of those respective Union and national legislations. More restrictive conditions for use in organic production are specified in the right column of the tables.
Name Compound products or products containing only materials listed hereunder |
Description, specific conditions and limits |
Farmyard manure |
product comprising a mixture of animal excrements and vegetable matter (animal bedding and feed material) factory farming origin forbidden |
Dried farmyard manure and dehydrated poultry manure |
factory farming origin forbidden |
Composted animal excrements, including poultry manure and composted farmyard manure included |
factory farming origin forbidden |
Liquid animal excrements |
use after controlled fermentation and/or appropriate dilution factory farming origin forbidden |
Composted or fermented bio-waste (Directive 2008/98/EC of the European Parliament and of the Council (2)) |
product obtained from separate bio-waste collection at source, which has been submitted to composting or to anaerobic fermentation for biogas production only vegetable and animal bio-waste only when produced in a closed and monitored collection system, accepted by the Member State maximum concentrations in mg/kg of dry matter: cadmium: 0,7; copper: 70; nickel: 25; lead: 45; zinc: 200; mercury: 0,4; chromium (total): 70; chromium (VI): not detectable |
Peat |
use limited to horticulture (market gardening, floriculture, arboriculture, nursery) |
Mushroom culture wastes |
the initial composition of the substrate shall be limited to products of this Annex |
Dejecta of worms (vermicompost) and insect frass-substrate mixture |
where relevant in accordance with Regulation (EC) No 1069/2009 |
Guano |
|
Composted or fermented mixture of vegetable matter |
product obtained from mixtures of vegetable matter, which have been submitted to composting or to anaerobic fermentation for biogas production |
Biogas digestate containing animal by-products co-digested with material of plant or animal origin as listed in this Annex |
animal by-products (including by-products of wild animals) of category 3 and digestive tract content of category 2 (categories as defined in Regulation (EC) No 1069/2009) factory farming origin forbidden the processes have to be in accordance with Regulation (EU) No 142/2011 not to be applied to edible parts of the crop |
Products or by-products of animal origin as below: Blood meal Hoof meal Horn meal Bone meal or degelatinised bone meal Fish meal Meat meal Feather, hair and skin meal (‘chiquette’) Wool Fur (1) Hair Dairy products Hydrolysed proteins (2) |
(1) Maximum concentration in mg/kg of dry matter of chromium (VI): not detectable (2) Not to be applied to edible parts of the crop |
Products and by-products of plant origin for fertilisers |
e.g.: oilseed cake meal, cocoa husks, malt culms |
Hydrolysed proteins of plant origin |
|
Algae and algae products |
as far as directly obtained by: (i) physical processes including dehydration, freezing and grinding (ii) extraction with water or aqueous acid and/or alkaline solution (iii) fermentation only from organic or collected in a sustainable way in accordance with point 2.4 of Part III of Annex II to Regulation (EU) 2018/848 |
Sawdust and wood chips |
wood not chemically treated after felling |
Composted bark |
wood not chemically treated after felling |
Wood ash |
from wood not chemically treated after felling |
Soft ground rock phosphate |
product obtained by grinding soft mineral phosphates and containing tricalcium phosphate and calcium carbonate as essential ingredients minimum content of nutrients (percentage by weight): 25 % P2O5 phosphorus expressed as P2O5 soluble in mineral acids, at least 55 % of the declared content of P2O5 being soluble in 2 % formic acid particle size: — at least 90 % by weight able to pass through a sieve with a mesh of 0,063 mm — at least 99 % by weight able to pass through a sieve with a mesh of 0,125 mm until 15 July 2022, cadmium content less than or equal to 90 mg/kg of P2O5; from 16 July 2022, the relevant limits for contaminants set in Regulation (EU) 2019/1009 apply |
Aluminium-calcium phosphate |
product obtained in amorphous form by heat treatment and grinding, containing aluminium and calcium phosphates as essential ingredients minimum content of nutrients (percentage by weight): 30 % P2O5 phosphorus expressed as P2O5 soluble in mineral acids, at least 75 % of the declared content of P2O5 being soluble in alkaline ammonium citrate (Joulie) particle size: — at least 90 % by weight able to pass through a sieve with a mesh of 0,160 mm — at least 98 % by weight able to pass through a sieve with a mesh of 0,630 mm until 15 July 2022, cadmium content less than or equal to 90 mg/kg of P2O5; from 16 July 2022, the relevant limits for contaminants set in Regulation (EU) 2019/1009 apply use limited to basic soils (pH > 7,5) |
Basic slag (Thomas phosphates or Thomas slag) |
product obtained in iron-smelting by treatment of the phosphorus melts and containing calcium silicophosphates as its essential ingredients minimum content of nutrients (percentage by weight): 12 % P2O5 phosphorus expressed as phosphorus pentoxide soluble in mineral acids, at least 75 % of the declared content of phosphorus pentoxide being soluble in 2 % citric acid or 10 % P2O5 phosphorus expressed as phosphorus pentoxide soluble in 2 % citric acid particle size: — at least 75 % able to pass through a sieve with a mesh of 0,160 mm — at least 96 % able to pass through a sieve with a mesh of 0,630 mm from 16 July 2022, the relevant limits for contaminants set in Regulation (EU) 2019/1009 apply |
Crude potassium salt |
product obtained from crude potassium salts minimum content of nutrients (percentage by weight): 9 % K2O potassium expressed as water- soluble K2O 2 % MgO magnesium in the form of water- soluble salts, expressed as magnesium oxide from 16 July 2022, the relevant limits for contaminants set in Regulation (EU) 2019/1009 apply |
Potassium sulphate, possibly containing magnesium salt |
product obtained from crude potassium salt by a physical extraction process, containing possibly also magnesium salts |
Stillage and stillage extract |
ammonium stillage excluded |
Calcium carbonate, for instance: chalk, marl, ground limestone, Breton ameliorant (maerl), phosphate chalk |
only of natural origin |
Mollusc waste |
only from organic aquaculture or from sustainable fisheries, in accordance with Article 2 of Regulation (EU) No 1380/2013 |
Egg shells |
factory farming origin forbidden |
Magnesium and calcium carbonate |
only of natural origin e.g. magnesian chalk, ground magnesium, limestone |
Magnesium sulphate (kieserite) |
only of natural origin |
Calcium chloride solution |
only for foliar treatment of apple trees, to prevent deficit of calcium |
Calcium sulphate (gypsum) |
product of natural origin containing calcium sulphate at various degrees of hydration minimum content of nutrients (percentage per weight): 25 % CaO 35 % SO3 calcium and sulphur expressed as total CaO + SO3 fineness of grind: — at least 80 % to pass through a sieve with a 2 mm mesh width, — at least 99 % to pass through a sieve with a 10 mm mesh width from 16 July 2022, the relevant limits for contaminants set in Regulation (EU) 2019/1009 apply |
Industrial lime from sugar production |
by-product of sugar production from sugar beet and sugar cane |
Industrial lime from vacuum salt production |
by-product of the vacuum salt production from brine found in mountains |
Elemental sulphur |
until 15 July 2022: as listed in accordance with Part D of Annex I to Regulation (EC) No 2003/2003 from 16 July 2022, the relevant limits for contaminants set in Regulation (EU) 2019/1009 apply |
Inorganic Micronutrient Fertilisers |
until 15 July 2022: as listed in accordance with Part E of Annex I to Regulation (EC) No 2003/2003; from 16 July 2022, the relevant limits for contaminants set in Regulation (EU) 2019/1009 apply |
Sodium chloride |
|
Stone meal, clays and clay minerals |
|
Leonardite (Raw organic sediment rich in humic acids) |
only if obtained as a by-product of mining activities |
Humic and fulvic acids |
only if obtained by inorganic salts/solutions excluding ammonium salts; or obtained from drinking water purification |
Xylite |
only if obtained as a by-product of mining activities (e.g. by-product of brown coal mining) |
Chitin (Polysaccharide obtained from the shell of crustaceans) |
obtained from organic aquaculture or from sustainable fisheries, in accordance with Article 2 of Regulation (EU) No 1380/2013 |
Organic (1) rich sediment from fresh water bodies formed under exclusion of oxygen (e.g. sapropel) |
only organic sediments that are by-products of fresh water body management or extracted from former freshwater areas when applicable, extraction should be done in a way to cause minimal impact on the aquatic system only sediments derived from sources free from contaminations of pesticides, persistent organic pollutants and petrol like substances until 15 July 2022: maximum concentrations in mg/kg of dry matter: cadmium: 0,7; copper: 70; nickel: 25; lead: 45; zinc: 200; mercury: 0,4; chromium (total): 70; chromium (VI): not detectable from 16 July 2022, the relevant limits for contaminants set in Regulation (EU) 2019/1009 apply |
Biochar – pyrolysis product made from a wide variety of organic materials of plant origin and applied as a soil conditioner |
only from plant materials, when treated after harvest only with products included in Annex I until 15 July 2022: maximum value of 4 mg polycyclic aromatic hydro-carbons (PAHs) per kg dry matter (DM) from 16 July 2022, the relevant limits for contaminants set in Regulation (EU) 2019/1009 apply |
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 |
Selenium salts |
only in case of deficiency in the soils used for animal rearing, and/or grazing or for the production of feed crops |
(1)
Here ‘organic’ is used in the sense of organic chemistry, not organic farming
(2)
Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3). |
ANNEX III
Authorised products and substances for use as feed or in feed production
PART A
Authorised non-organic feed material of plant, algal, animal or yeast origin or feed material of microbial or mineral origin referred to in point (c) of Article 24(1) of Regulation (EU) 2018/848
(1) FEED MATERIALS OF MINERAL ORIGIN
Number in feed catalogue (1) |
Name |
Specific conditions and limits |
11.1.1 |
Calcium carbonate |
|
11.1.2 |
Calcareous marine shells |
|
11.1.4 |
Maerl |
|
11.1.5 |
Lithothamn |
|
11.1.6 |
Calcium chloride |
restricted to use in accordance with Commission Regulation (EU) 2020/354 (2) as feed intended for particular nutritional purposes: reduction of the risk of milk fever and subclinical hypocalcaemia on dairy cows use restricted as selective application(only for individual animals in need and for a limited period) calcium chloride when purified from naturally occurring brine, if available |
11.1.13 |
Calcium gluconate |
|
11.2.1 |
Magnesium oxide |
|
11.2.4 |
Magnesium sulphate anhydrous |
|
11.2.6 |
Magnesium chloride |
|
11.2.7 |
Magnesium carbonate |
|
11.3.1 |
Dicalcium phosphate |
|
11.3.2 |
Monodicalcium phosphate |
|
11.3.3 |
Monocalcium phosphate |
|
11.3.5 |
Calcium-magnesium phosphate |
|
11.3.8 |
Magnesium phosphate |
|
11.3.10 |
Monosodium phosphate |
|
11.3.16 |
Calcium sodium phosphate |
|
11.3.17 |
Monoammonium phosphate (Ammonium dihydrogen orthophosphate) |
only for aquaculture |
11.3.19 |
Pentasodium triphosphate (STPP) |
only for pet food |
11.3.27 |
Disodium dihydrogen diphosphate (SAPP) |
only for pet food |
11.4.1 |
Sodium chloride |
|
11.4.2 |
Sodium bicarbonate |
|
11.4.4 |
Sodium carbonate |
|
11.4.6 |
Sodium sulphate |
|
11.5.1 |
Potassium chloride |
|
(1)
In accordance with Commission Regulation (EU) No 68/2013 of 16 January 2013 on the Catalogue of feed materials (OJ L 29, 30.1.2013, p. 1).
(2)
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). |
(2) OTHER FEED MATERIALS
Number In feed catalogue (1) |
Name |
Specific conditions and limits |
ex 7.1.4 |
Algal oil |
oil obtained by extraction from microalgae through fermentation growing medium for the fermentation process must not be of GMO origin and should be from organic raw materials, if available |
10 |
Meal, oil and other feed materials of fish or other aquatic animals origin |
provided that they are obtained from fisheries that have been certified as sustainable under a scheme recognised by the competent authority in line with the principles laid down in Regulation (EU) No 1380/2013 provided that they are produced or prepared without chemically synthesised solvents their use is authorised only to non-herbivores livestock the use of fish protein hydrolysate is authorised only for young non-herbivores livestock |
10 |
Meal, oil and other feed materials of fish, mollusc or crustacean origin |
for carnivorous aquaculture animals from fisheries that have been certified as sustainable under a scheme recognised by the competent authority in line with the principles laid down in Regulation (EU) No 1380/2013, in accordance with point 3.1.3.1(c) of Part III of Annex II to Regulation (EU) 2018/848 derived from trimmings of fish, crustaceans or molluscs already caught for human consumption in accordance with point 3.1.3.3(c) of Part III of Annex II to Regulation (EU) 2018/848, or derived from whole fish, crustaceans or molluscs caught and not used for human consumption in accordance with point 3.1.3.3(d) of Part III of Annex II to Regulation (EU) 2018/848 |
10 |
Fishmeal and fish oil |
in the grow-out phase, for fish in inland waters, penaeid shrimps and freshwater prawns and tropical freshwater fish from fisheries that have been certified as sustainable under a scheme recognised by the competent authority in line with the principles laid down in Regulation (EU) No 1380/2013, in accordance with point 3.1.3.1(c) of Part III of Annex II to Regulation (EU) 2018/848 only where natural feed in ponds and lake is not available in sufficient quantities, maximum 25 % of fishmeal and 10 % of fish oil in the feed ration of penaeid shrimps and freshwater prawns (Macrobrachium spp.) and maximum 10 % of fishmeal or fish oil in the feed ration of siamese catfish (Pangasius spp.), in accordance with point 3.1.3.4(c)(i) and (ii) of Part III of Annex II to Regulation (EU) 2018/848 |
12.1.5 |
Yeasts |
when not available from organic production |
12.1.12 |
Yeast products |
when not available from organic production |
13.11.1 |
Propylene glycol; [1,2-propanediol]; [propane-1,2-diol] |
restricted to use in accordance with Commission Regulation (EU) 2020/354 as feed intended for particular nutritional purposes: reduction of the risk of ketosis on dairy cows, ewes and goats use restricted to selective application (only to individual animals in need and for a limited period) |
|
Cholesterol |
product obtained from wool grease (lanolin) by saponification, separations and crystallisation, from shellfish or other sources to secure the quantitative dietary needs of penaeid shrimps and freshwater prawns (Macrobrachium spp.) in the grow-out stage and in earlier life stages in nurseries and hatcheries when not available from organic production |
|
Herbs |
in accordance with point (e)(iv) of Article 24(3) of Regulation (EU) 2018/848, in particular: — when not available in organic form — produced/prepared without chemical solvents — maximum 1 % in the feed ration |
|
Molasses |
in accordance with point (e)(iv) of Article 24(3) of Regulation (EU) 2018/848, in particular: — when not available in organic form — produced/prepared without chemical solvents — maximum 1 % in the feed ration |
|
Phytoplankton and zooplankton |
only in the larval rearing of organic juveniles |
|
specific protein compounds |
In accordance with point 1.9.3.1(c) and 1.9.4.2(c) of Regulation (EU) 2018/848, in particular: — until 31 December 2026, — when not available in organic form, — produced/prepared without chemical solvents, — for feeding piglets of up to 35 kg or young poultry, — maximum 5 % of the dry matter of feed from agricultural origin per period of 12 months |
|
Spices |
in accordance with point (e)(iv) of Article 24(3) of Regulation (EU) 2018/848, in particular: — when not available in organic form — produced/prepared without chemical solvents — maximum 1 % in the feed ration |
(1)
In accordance with Regulation (EU) No 68/2013. |
PART B
Authorised feed additives and processing aids used in animal nutrition referred to in point (d) of Article 24(1) of Regulation (EU) 2018/848
Feed additives listed in this Part must be authorised under Regulation (EC) No 1831/2003.
The specific conditions set out here are to be applied in addition to the conditions of the authorisations under Regulation (EC) No 1831/2003.
(1) TECHNOLOGICAL ADDITIVES
(a) Preservatives
ID number or functional group |
Name |
Specific conditions and limits |
E 200 |
Sorbic acid |
|
E 236 |
Formic acid |
|
E 237 |
Sodium formate |
|
E 260 |
Acetic acid |
|
E 270 |
Lactic acid |
|
E 280 |
Propionic acid |
|
E 330 |
Citric acid |
|
(b) Antioxidants
ID number or functional group |
Name |
Specific conditions and limits |
1b306(i) |
Tocopherol extracts from vegetable oils |
|
1b306(ii) |
Tocopherol-rich extracts from vegetable oils (delta rich) |
|
(c) Emulsifiers, stabilisers, thickeners and gelling agents
ID number or functional group |
Name |
Specific conditions and limits |
1c322, 1c322i |
Lecithins |
only when derived from organic raw material use restricted to aquaculture animal feed |
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 |
|
E 412 |
Guar gum |
|
(d) Binders and anti-caking agents
ID number or functional group |
Name |
Specific conditions and limits |
▼M1 ————— |
||
E 535 |
Sodium ferrocyanide |
maximum content: 20 mg/kg NaCl calculated as ferrocyanide anion |
E 551b |
Colloidal silica |
|
E 551c |
Kieselgur (diatomaceous earth, purified) |
|
1m558i |
Bentonite |
|
E 559 |
Kaolinitic clays, free of asbestos |
|
E 560 |
Natural mixtures of steatites and chlorite |
|
E 561 |
Vermiculite |
|
E 562 |
Sepiolite |
|
E 563 |
Sepiolitic clay |
|
E 566 |
Natrolite-Phonolite |
|
1g568 |
Clinoptilolite of sedimentary origin |
|
E 599 |
Perlite |
|
1g599 |
Illite-montmorillonite-kaolinite |
|
(e) Silage additives
ID number or functional group |
Name |
Specific conditions and limits |
1k |
Enzymes, micro-organisms |
only authorised to ensure adequate fermentation |
1k236 |
Formic acid |
|
1k237 |
Sodium formate |
|
1k280 |
Propionic acid |
|
1k281 |
Sodium propionate |
(f) substances for reduction of the contamination of feed by mycotoxins
ID number or functional group |
Name |
Specific conditions and limits |
1m558 |
Bentonite |
|
(2) SENSORY ADDITIVES
ID number or functional group |
Name |
Specific conditions and limits |
ex2a |
Astaxanthin |
only when derived from organic sources, such as organic crustacean shells only in the feed ration for salmon and trout within the limit of their physiological needs if no astaxanthin derived from organic sources are available, astaxanthin from natural sources may be used such as Astaxanthin-rich Phaffia rhodozyma |
ex2b |
Flavouring compounds |
only extracts from agricultural products, including Chestnut extract (Castanea sativa Mill.) |
(3) NUTRITIONAL ADDITIVES
(a) Vitamins, pro-vitamins and chemically well-defined substances having similar effect
ID number or functional group |
Name |
Specific conditions and limits |
ex3a |
Vitamins and Provitamins |
derived from agricultural products if not available from agricultural products: — derived synthetically, only those identical to vitamins derived from agricultural products may be used for monogastric animals and aquaculture animals — derived synthetically, only vitamins A, D and E identical to vitamins derived from agricultural products may be used for ruminants; the use is subject to prior authorisation of the Member States based on the assessment of the possibility for organic ruminants to obtain the necessary quantities of the said vitamins through their feed rations |
3a370 |
Taurine |
only for cats and dogs not from synthetic origin, if available |
3a920 |
Betaine anhydrous |
only for monogastric animals and fish from organic production; if not available, from natural origin |
(b) Compounds of trace elements
ID number or functional group |
Name |
Specific conditions and limits |
3b101 |
Iron(II) carbonate (siderite) |
|
3b103 |
Iron(II) sulphate monohydrate |
|
3b104 |
Iron(II) sulphate heptahydrate |
|
3b107 |
Iron (II) chelate of protein hydrolysates |
from organic soy production, if available |
3b110 |
Iron dextran 10 % |
restricted to use in accordance with Commission Regulation (EU) 2020/354 as feed intended for particular nutritional purposes: compensation for insufficient iron availability after birth only for suckling piglets growing medium for the fermentation process for dextran must be of non-GMO origin use restricted to selective application (only for piglets in need and for a limited period) |
3b201 |
Potassium iodide |
|
3b202 |
Calcium iodate, anhydrous |
|
3b203 |
Coated granulated calcium iodate anhydrous |
|
3b301 |
Cobalt(II) acetate tetrahydrate |
|
3b302 |
Cobalt(II) carbonate |
|
3b303 |
Cobalt(II) carbonate hydroxide (2:3) monohydrate |
|
3b304 |
Coated granulated cobalt(II) carbonate |
|
3b305 |
Cobalt(II) sulphate heptahydrate |
|
3b402 |
Copper(II) carbonate dihydroxy monohydrate |
|
3b404 |
Copper (II) oxide |
|
3b405 |
Copper(II) sulphate pentahydrate |
|
3b407 |
Copper (II) chelate of protein hydrolysates |
from organic soy production, if available |
3b409 |
Dicopper chloride trihydroxide |
|
3b502 |
Manganese (II) oxide |
|
3b503 |
Manganous sulfate, monohydrate |
|
3b505 |
Manganese chelates of protein hydrolysates |
from organic soy production, if available |
3b603 |
Zinc oxide |
|
3b604 |
Zinc sulphate heptahydrate |
|
3b605 |
Zinc sulphate monohydrate |
|
3b609 |
Zinc chloride hydroxide monohydrate |
|
3b612 |
Zinc chelate of protein hydrolysates |
from organic soy production, if available |
3b701 |
Sodium molybdate dihydrate |
|
3b801 |
Sodium selenite |
|
3b802 3b803 |
Coated granulated sodium selenite Sodium selenate |
|
3b810 |
Selenised yeast, Saccharomyces cerevisiae CNCM I-3060, inactivated |
|
3b810i |
Selenised yeast Saccharomyces cerevisiae CNCM I-3060, inactivated |
|
3b811 |
Selenised yeast, Saccharomyces cerevisiae NCYC R397, inactivated |
|
3b812 |
Selenised yeast, Saccharomyces cerevisiae CNCM I-3399, inactivated |
|
3b813 |
Selenised yeast, Saccharomyces cerevisiae NCYC R646, inactivated |
|
3b817 |
Selenised yeast, Saccharomyces cerevisiae NCYC R645 inactivated |
|
(c) Amino acids, their salts and analogues
ID number or functional group |
Name |
Specific conditions and limits |
3c3.5.1 and 3c352 |
L-histidine monohydrochloride monohydrate |
produced through fermentation may be used in the feed ration for salmonids when the feed sources listed in point 3.1.3.3 of Part II of Annex II to Regulation (EU) 2018/848, do not provide a sufficient amount of histidine to meet the dietary needs of the fish |
(4) ZOOTECHNICAL ADDITIVES
ANNEX IV
Authorised products for cleaning and disinfection referred to in points (e), (f) and (g) of Article 24(1) of Regulation (EU) 2018/848
PART A
Products for the cleaning and disinfection of ponds, cages, tanks, raceways, buildings or installations used for animal production
PART B
Products for the cleaning and disinfection of buildings and installations used for plant production, including for storage on an agricultural holding
PART C
Products for cleaning and disinfection in processing and storage facilities
PART D
Products referred to in Article 12(1) of this Regulation
The following products or products containing the following active substances as listed in Annex VII to Regulation (EC) No 889/2008 cannot be used as biocidal products:
ANNEX V
Authorised products and substances for use in the production of processed organic food and of yeast used as food or feed
PART A
Authorised food additives and processing aids referred to in point (a) of Article 24(2) of Regulation (EU) 2018/848
SECTION A1 – FOOD ADDITIVES, INCLUDING CARRIERS
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 restrictions set out here are to be applied in addition to the conditions of the authorisations under Regulation (EC) No 1333/2008.
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 of the code number shall be calculated as ingredients of agricultural origin.
Code |
Name |
Organic foodstuffs to which it may be added |
Specific conditions and limits |
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 |
Calcium carbonate |
products of plant and animal origin |
shall not be used for colouring or calcium enrichment of products |
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 SO2 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 SO2 in mg/l) |
E250 |
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 ingoing amount expressed as NaNO2: 80 mg/kg, maximum residual amount expressed as NaNO2: 50 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 ingoing amount expressed as NaNO3: 80 mg/kg, maximum residual amount expressed as NaNO3: 50 mg/kg |
E 270 |
Lactic acid |
products of plant and animal origin |
|
E 290 |
Carbon dioxide |
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 (2)) and meat preparations (category 08.2 (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 |
antioxidant |
E 322* |
Lecithins |
products of plant origin products of animal origin |
only from organic production |
E 325 |
Sodium lactate |
products of plant origin milk-based and meat products |
|
E 330 |
Citric acid |
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 |
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 and 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 |
thickener only from organic production |
E 418 |
Gellan gum |
products of plant and animal origin |
high-acyl form only only from organic production, applicable as of 1 January 2026 |
E 422 |
Glycerol |
plant extracts flavourings |
only from plant origin solvent and carrier in plant extracts and flavourings humectant in gel capsules surface coating of tablets only from organic production |
E 440(i)* |
Pectin |
products of plant origin milk-based products |
|
E 460 |
Cellulose |
gelatine |
|
E 464 |
Hydroxypropyl methyl cellulose |
products of plant and animal origin |
encapsulation material for capsules |
E 500 |
Sodium carbonates |
products of plant and animal origin |
|
E 501 |
Potassium carbonates |
products of plant origin |
|
E 503 |
Ammonium carbonates |
products of plant origin |
|
E 504 |
Magnesium carbonates |
products of plant origin |
|
E 509 |
Calcium chloride |
Milk-based products |
coagulation agent |
E 516 |
Calcium sulphate |
products of plant origin |
carrier |
E 524 |
Sodium hydroxide |
‘Laugengebäck’ flavourings |
surface treatment acidity regulator |
E 551 |
Silicon dioxide |
cocoa, herbs and spices in dried powdered form flavourings propolis |
for cocoa, only for use in automated dispensing machines |
E 553b |
Talc |
products of plant origin sausages based on meat |
For sausages based on meat, only surface treatment |
E 901 |
Beeswax |
confectionery |
glazing agent only from organic production |
E 903 |
Carnauba wax |
confectionery citrus fruit |
glazing agent mitigating method for mandatory extreme cold treatment of fruit as a mandatory quarantine measure against harmful organisms in accordance with Commission Implementing Directive (EU) 2017/1279 (1) only from organic production |
E 938 |
Argon |
products of plant and animal origin |
|
E 939 |
Helium |
products of plant and animal origin |
|
E 941 |
Nitrogen |
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 |
(1)
Commission Implementing Directive (EU) 2017/1279 of 14 July 2017 amending Annexes I to V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 184, 15.7.2017, p. 33).
(2)
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). |
SECTION A2 – PROCESSING AIDS AND OTHER PRODUCTS, WHICH MAY BE USED FOR PROCESSING OF INGREDIENTS OF AGRICULTURAL ORIGIN FROM ORGANIC PRODUCTION
The specific conditions and restrictions set out here are to be applied in addition to the conditions of the authorisations under Regulation (EC) No 1333/2008.
Name |
Only authorised for the processing of the following organic foodstuffs |
Specific conditions and limits |
Water |
products of plant and animal origin |
drinking water within the meaning of Council Directive 98/83/EC (1) |
Calcium chloride |
products of plant origin sausages based on meat |
coagulation agent |
Calcium carbonate |
products of plant origin |
|
Calcium hydroxide |
products of plant origin |
|
Calcium sulfate |
products of plant origin |
coagulation agent |
Magnesium chloride (or nigari) |
products of plant origin |
coagulation agent |
Potassium carbonate |
Grapes |
drying agent |
Sodium carbonate |
products of plant and animal origin |
|
Lactic acid |
Cheese |
for the regulation of the pH of the brine bath in cheese production |
L(+)lactic acid from fermentation |
plant protein extracts |
|
Citric acid |
products of plant and animal origin |
|
Sodium hydroxide |
Sugar(s) oil from plant origin excluding olive oil plant protein extracts |
|
Sulphuric acid |
gelatine sugar(s) |
|
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 |
Hydrochloric acid |
gelatine Gouda-, Edam and Maasdammer cheeses, Boerenkaas, Friese and Leidse Nagelkaas |
gelatine production in compliance with Regulation (EC) No 853/2004 of the European Parliament and of the Council (2) for the regulation of the pH of the brine bath in the processing of cheeses |
Ammonium hydroxide |
Gelatine |
gelatine production in compliance with Regulation (EC) No 853/2004 |
Hydrogen peroxide |
Gelatine |
gelatine production in compliance with Regulation (EC) No 853/2004 |
Carbon dioxide |
products of plant and animal origin |
|
Nitrogen |
products of plant and animal origin |
|
Ethanol |
products of plant and animal origin |
solvent |
Tannic acid |
products of plant origin |
filtration aid |
Egg white albumin |
products of plant origin |
|
Casein |
products of plant origin |
|
Gelatin |
products of plant origin |
|
Isinglass |
products of plant origin |
|
Vegetable oils |
products of plant and animal origin |
greasing, releasing or antifoaming agent only from organic production |
Silicon dioxide gel or colloidal solution |
products of plant origin |
|
Activated carbon (CAS-7440-44-0) |
products of plant and animal origin |
|
Talc |
products of plant origin |
in compliance with the specific purity criteria for food additive E 553b |
Bentonite |
products of plant origin mead |
sticking agent for mead |
Cellulose |
products of plant origin gelatine |
|
Diatomaceous earth |
products of plant origin gelatine |
|
Perlite |
products of plant origin gelatine |
|
Hazelnut shells |
products of plant origin |
|
Rice meal |
products of plant origin |
|
Beeswax |
products of plant origin |
releasing agent only from organic production |
Carnauba wax |
products of plant origin |
releasing agent only from organic production |
Acetic acid/vinegar |
products of plant origin; fish |
only from organic production from natural fermentation |
Thiamin hydrochloride |
fruit wines, cider, perry and mead |
|
Diammonium phosphate |
fruit wines, cider, perry and mead |
|
Wood fibre |
products of plant and animal origin |
the source of timber should be restricted to certified, sustainably harvested wood wood used must not contain toxic components (post-harvest treatment, naturally occurring toxins or toxins from micro-organisms) |
(1)
Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32).
(2)
Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55) |
PART B
Authorised non-organic agricultural ingredients to be used for the production of processed organic food referred to in point (b) of Article 24(2) of Regulation (EU) 2018/848
Name |
Specific conditions and limits |
Alga Arame (Eisenia bicyclis), unprocessed as well as products of first-stage processing directly related to this alga |
|
Alga Hijiki (Hizikia fusiforme), unprocessed as well as products of first-stage processing directly related to this alga |
|
Bark of the Pau d’arco tree Handroanthus impetiginosus (‘lapacho’) |
only for use in Kombucha and tea mixtures |
Casings |
from natural raw materials of animal or from plant origin material |
Gelatin |
from other sources than porcine |
Milk mineral powder/liquid |
only when used for its sensory function to replace wholly or partly sodium chloride |
Wild fishes and wild aquatic animals, unprocessed as well as products derived therefrom by processes |
only from fisheries that have been certified as sustainable under a scheme recognised by the competent authority in line with the principles laid down in Regulation (EU) No 1380/2013, in accordance with point 3.1.3.1(c) of Part III of Annex II to Regulation (EU) 2018/848 only when not available in organic aquaculture |
PART C
Authorised processing aids and other products for the production of yeast and yeast products referred to in point (c) of Article 24(2) of Regulation (EU) 2018/848
Name |
Primary yeast |
Yeast production/confection/formulation |
Specific conditions and limits |
Calcium chloride |
X |
|
|
Carbon dioxide |
X |
X |
|
Citric acid |
X |
|
for the regulation of the pH in yeast production |
Lactic acid |
X |
|
for the regulation of the pH in yeast production |
Nitrogen |
X |
X |
|
Oxygen |
X |
X |
|
Potato starch |
X |
X |
for filtering only from organic production |
Sodium carbonate |
X |
X |
for the regulation of the pH |
Vegetable oils |
X |
X |
greasing, releasing or anti-foaming agent only from organic production |
PART D
Authorised products and substances for the production and conservation of organic grapevine products of the wine sector referred to in point 2.2 of Part VI of Annex II to Regulation (EU) 2018/848
Name |
ID numbers |
References in Annex I to Delegated Regulation (EU) 2019/934 |
Specific conditions and limits |
Air |
|
Part A, Table 1, points 1 and 8 |
|
Gaseous oxygen |
E 948 CAS 17778- 80-2 |
Part A, Table 1, point 1 Part A, Table 2, point 8.4 |
|
Argon |
E 938 CAS 7440-37-1 |
Part A, Table 1, point 4 Part A, Table 2, point 8.1 |
may not be used for bubbling |
Nitrogen |
E 941 CAS 7727-37-9 |
Part A, Table 1, points 4, 7 and 8 Part A, Table 2, point 8.2 |
|
Carbon dioxide |
E 290 CAS 124-38-9 |
Part A, Table 1, points 4 and 8 Part A, Table 2, point 8.3 |
|
Pieces of oak wood |
|
Part A, Table 1, point 11 |
|
Tartaric acid (L(+)-) |
E 334 CAS 87-69-4 |
Part A, Table 2, point 1.1 |
|
Lactic acid |
E 270 |
Part A, Table 2, point 1.3 |
|
Potassium L(+)-tartrate |
E 336(ii) CAS 921- 53-9 |
Part A, Table 2, point 1.4 |
|
Potassium bicarbonate |
E 501(ii) CAS 298- 14-6 |
Part A, Table 2, point 1.5 |
|
Calcium carbonate |
E 170 CAS 471-34-1 |
Part A, Table 2, point 1.6 |
|
Calcium sulphate |
E 516 |
Part A, Table 2, point 1.8 |
|
Sulphur dioxide |
E 220 CAS 7446-09-5 |
Part A, Table 2, point 2.1 |
the maximum sulphur dioxide content shall not exceed 100 milligrams per litre for red wines as referred to in point A.1.(a) of Part B of Annex I to Delegated Regulation (EU) 2019/934 and with a residual sugar level lower than 2 grams per litre the maximum sulphur dioxide content shall not exceed 150 milligrams per litre for white and rosé wines as referred to in point A.1.(b) of Part B of Annex I to Delegated Regulation (EU) 2019/934 and with a residual sugar level lower than 2 grams per litre for all other wines, the maximum sulphur dioxide content applied in accordance with Part B of Annex I to Delegated Regulation (EU) 2019/934 shall be reduced by 30 milligrams per litre |
Potassium bisulphite |
E 228 CAS 7773-03-7 |
Part A, Table 2, point 2.2 |
|
Potassium metabisulphite |
E 224 CAS 16731-55-8 |
Part A, Table 2, point 2.3 |
|
L ascorbic acid |
E 300 |
Part A, Table 2, point 2.6 |
|
Charcoal for oenological use |
|
Part A, Table 2, point 3.1 |
|
Diammonium hydrogen phosphate |
E 342/CAS 7783-28-0 |
Part A, Table 2, point 4.2 |
|
Thiamine hydrochloride |
CAS 67-03-8 |
Part A, Table 2, point 4.5 |
|
Yeast autolysates |
|
Part A, Table 2, point 4.6 |
|
Yeast cell walls |
|
Part A, Table 2, point 4.7 |
|
Inactivated yeasts |
|
Part A, Table 2, point 4.8 Part A, Table 2, point 10.5 Part A, Table 2, point 11.5 |
|
Edible gelatine |
CAS 9000-70-8 |
Part A, Table 2, point 5.1 |
derived from organic raw material if available |
Wheat protein |
|
Part A, Table 2, point 5.2 |
derived from organic raw material if available |
Peas protein |
|
Part A, Table 2, point 5.3 |
derived from organic raw material if available |
Potatoes protein |
|
Part A, Table 2, point 5.4 |
derived from organic raw material if available |
Isinglass |
|
Part A, Table 2, point 5.5 |
derived from organic raw material if available |
Casein |
CAS 9005-43-0 |
Part A, Table 2, point 5.6 |
derived from organic raw material if available |
Potassium caseinates |
CAS 68131-54-4 |
Part A, Table 2, point 5.7 |
|
Egg albumin |
CAS 9006-59-1 |
Part A, Table 2, point 5.8 |
derived from organic raw material if available |
Bentonite |
E 558 |
Part A, Table 2, point 5.9 |
|
Silicon dioxide (gel or colloidal solution) |
E 551 |
Part A, Table 2, point 5.10 |
|
Tannins |
|
Part A, Table 2, point 5.12 Part A, Table 2, point 6.4 |
derived from organic raw material if available |
Chitosan derived from Aspergillus niger |
CAS 9012-76-4 |
Part A, Table 2, point 5.13 Part A, Table 2, point 10.3 |
|
Yeast protein extracts |
|
Part A, Table 2, point 5.15 |
derived from organic raw material if available |
Potassium alginate |
E 402/CAS 9005-36-1 |
Part A, Table 2, point 5.18 |
|
Potassium hydrogen tartrate |
E336(i)/CAS 868-14-4 |
Part A, Table 2, point 6.1 |
|
Citric acid |
E 330 |
Part A, Table 2, point 6.3 |
|
Metatartaric acid |
E 353 |
Part A, Table 2, point 6.7 |
|
Gum arabic |
E 414/CAS 9000-01-5 |
Part A, Table 2, point 6.8 |
derived from organic raw material if available |
Yeast mannoproteins |
|
Part A, Table 2, point 6.10 |
|
Pectin lyases |
EC 4.2.2.10 |
Part A, Table 2, point 7.2 |
only for oenological purposes in clarification |
Pectin methylesterase |
EC 3.1.1.11 |
Part A, Table 2, point 7.3 |
only for oenological purposes in clarification |
Polygalacturonase |
EC 3.2.1.15 |
Part A, Table 2, point 7.4 |
only for oenological purposes in clarification |
Hemicellulase |
EC 3.2.1.78 |
Part A, Table 2, point 7.5 |
only for oenological purposes in clarification |
Cellulase |
EC 3.2.1.4 |
Part A, Table 2, point 7.6 |
only for oenological purposes in clarification |
Yeasts for wine production |
|
Part A, Table 2, point 9.1 |
for the individual yeast strains, organic if available |
Lactic acid bacteria |
|
Part A, Table 2, point 9.2 |
|
Copper citrate |
CAS 866-82-0 |
Part A, Table 2, point 10.2 |
|
Aleppo pine resin |
|
Part A, Table 2, point 11.1 |
|
Fresh lees |
|
Part A, Table 2, point 11.2 |
only from organic production |
ANNEX VI
Products and substances authorised for use in organic production in certain areas of third countries pursuant to Article 45(2) of Regulation (EU) 2018/848
( 1 ) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market (OJ L 309, 24.11.2009, p. 1).
( 2 ) Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).
( 3 ) Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers (OJ L 304, 21.11.2003, p. 1).
( 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).
( 5 ) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (OJ L 300, 14.11.2009, p. 1).
( 6 ) Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).
( 7 ) 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).
( 8 ) Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).
( 9 ) 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).
( 10 ) Commission Delegated Regulation (EU) 2019/934 of 12 March 2019 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards wine-growing areas where the alcoholic strength may be increased, authorised oenological practices and restrictions applicable to the production and conservation of grapevine products, the minimum percentage of alcohol for by-products and their disposal, and publication of OIV files (OJ L 149, 7.6.2019, p. 1).
( 11 ) 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).
( 12 ) Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on the prevention and management of the introduction and spread of invasive alien species (OJ L 317, 4.11.2014, p. 35).
( 13 ) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
( 14 ) Available in the Pesticides Database: https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=search.as
( 15 ) Covering in particular all the product function categories listed in Part I of Annex I to Regulation (EU) 2019/1009.