HomeReg. 848/2018 (Non EU Countries)Impl. Reg. 2021-1165
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Stefanos T. Billas
President, A CERT
Company presentation

how can we help you?

Contact us at the A CERT office nearest to you or submit a business inquiry online.

CONTACT A CERT

Having values, we offer strictly professional services and through the recognition and reputation of the A CERT, our associated companies and structures and strategic collaborators, we add value to the products, services, institutes and organizations giving them a competitive advantage and making them capable of achieving a dominant position in national and international level.

Stefanos T. Billas
President, A CERT

Commission Implementing Regulation (EU) 2021/1165

of 15 July 2021

authorising certain products and substances for use in organic production and establishing their lists

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:

(a) have been authorised pursuant to Regulation (EC) No 1107/2009 of the European Parliament and of the Council ( 1 );
(b) 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
(c) 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

1.  For the purposes of point (e) of Article 24(1) of Regulation (EU) 2018/848, only the products listed in Part A of Annex IV to this Regulation may be used for the cleaning and disinfection of ponds, cages, tanks, raceways, buildings or installations used for animal production, provided that those products comply with the provisions of Union law, in particular Regulation (EC) No 648/2004 and Regulation (EU) No 528/2012 and, where applicable, in accordance with national provisions based on Union law.
2.  For the purposes of point (f) of Article 24(1) of Regulation (EU) 2018/848, only the products listed in Part B of Annex IV to this Regulation may be used for the cleaning and disinfection of buildings and installations used for plant production, including for storage on an agricultural holding, provided that those products comply with the provisions of Union law, in particular Regulation (EC) No 648/2004 and Regulation (EU) No 528/2012 and, where applicable, in accordance with national provisions based on Union law.
3.  For the purposes of point (g) of Article 24(1) of Regulation (EU) 2018/848, only the products listed in Part C of Annex IV to this Regulation may be used for cleaning and disinfection in processing and storage facilities, provided that those products comply with the provisions of Union law, in particular Regulation (EC) No 648/2004 and Regulation (EU) No 528/2012 and, where applicable, in accordance with national provisions based on Union law.
4.  Pending their inclusion in Part A, B or C of Annex IV to this Regulation, products for cleaning and disinfection referred to in points (e), (f) and (g) of Article 24(1) of Regulation (EU) 2018/848 that were authorised for use in organic production under Regulation (EC) No 834/2007 or under national law prior to the date of application of Regulation (EU) 2018/848 may continue to be used if they comply with the relevant provisions of Union law, in particular Regulation (EC) No 648/2004 and Regulation (EU) No 528/2012 and, where applicable, in accordance with national provisions based on Union law.

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

1.  Where a control authority or control body recognised under Article 46(1) of Regulation (EU) 2018/848 considers that a product or substance should be granted a specific authorisation for use in a certain area outside the Union due to the specific conditions set out in Article 45(2) of that Regulation, 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 and explaining why the products and substances authorised under this Regulation are not adequate to be used due to the specific conditions in the relevant area. 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 forward the request referred to in paragraph 1 to the Member States and shall publish any such requests.
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 wholethat:

(a) such specific authorisation is justified in the area 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 of the European Parliament and of the Council ( 11 ).

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 need to be reassessed.

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

1.  For the purposes of Article 5(4) of this Regulation, the products for cleaning and disinfection listed in Annex VII to Regulation (EC) No 889/2008 may continue to be used until December 2025 for the cleaning and disinfection of ponds, cages, tanks, raceways, buildings or installations used for animal production, subject to Part D of Annex IV to this Regulation.
2.  For the purposes of point (b) of Article 24(2) of Regulation (EU) 2018/848, the non-organic agricultural ingredients listed in Annex IX to Regulation (EC) No 889/2008 may continue to be used for the production of processed organic food until 31 December 2023. Processed organic food that has been produced before 1 January 2024 with those non-organic agricultural ingredients may be placed on the market after that date until the stocks are exhausted.
3.  Documentary evidence issued in accordance with Article 68 of Regulation (EC) No 889/2008 prior to 1 January 2022 shall remain valid until the end of its validity period but not beyond 31 December 2022.

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).

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

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

— the relevant Union and national legislations on fertilising products, in particular, where applicable, Regulation (EC) No 2003/2003 and Regulation (EU) 2019/1009; and
— Union legislation on animal by-products, in particular Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011, in particular Annexes V and XI.

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

—————
 

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

ID number or functional group

Name

Specific conditions and limits

4a, 4b, 4c and 4d

Enzymes and microorganism

 

 
 

4d7 and 4d8

Ammonium chloride

only for cats
 

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:

— caustic soda;
— caustic potash;
— oxalic acid;
— natural essences of plants with the exception of linseed oil, lavender oil and peppermint oil;
— nitric acid;
— phosporic acid;
— sodium carbonate;
— copper sulphate;
— potassium permanganate;
— tea seed cake made of natural camelia seed;
— humic acid;
— peroxyacetic acids with the exception of peracetic acid.

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

Applications Documents

Council Regulation

Council Regulation (EC) No. 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No. 2092/91

This regulation establishes the legal framework for all levels of production, distribution, control and labeling of organic products which may be offered and traded in the EU. It determines the continued development of organic production through the provision of clearly defined goals and principles. General production, control and labeling guidelines were established by the Council Regulation and can therefore only be changed by the European Council of Agricultural Ministers. The previous Regulation (EEC) No. 2092/91 is simultaneously repealed.

The new labeling regulations in connection with the obligatory use of the EU organic logo were postponed until 1 July 2010 by an amendment to the Council Regulation.

Area of applicability

The Council Regulation applies to the following agricultural products, including aquaculture and yeast:

  • Living or unprocessed products
  • Processed foods
  • Animal feed
  • Seeds and propagating material

Collection of wild plants and seaweed is also included in the scope of this Regulation
Not included in its scope:

  • Products from hunting and fishing of wild animals.

Commission Regulations

The following Commission Regulations have been adopted thus far:

In Commission Regulation (EC) No. 889/2008 all levels of plant and animal production are regulated, from the cultivation of land and keeping of animals to the processing and distribution of organic foods and their control. They go into great technical detail and are, for the most part, an extension of the original organic Regulation, except where this was regulated differently in the Council Regulation.

Multiple Annexes are attached to the Commission Regulation. Within these one can find the following:

  • Products permitted in organic farming, such as fertilisers, soil ameliorants and pesticides
  • Minimum requirements on the size of housing and exercise areas including pastures for organic livestock, depending on animal species and development stage.
  • Non-organic animal feed, feed additives and processing aids for the production of compound feed and premixtures permitted in organic farming.
  • Non-organic ingredients, additives and processing aids permitted in organic food production (including yeast production).
  • Requirements on the Community logo.

These Annexes and other parts of this Commission Regulation can be supplemented by the Commission so as to keep them up to date in regard to continuing developments in technology, science and the organic market.

In order to facilitate the implementation of the new rules and to incorporate some expiring exemptions of the previous organic Regulation, transitional measures were laid down.

In addition to EU legislation on organic farming and organic production, organically operating farmers and processors must also adhere to generally applicable rules on agricultural production and processing of agricultural products. That means that all generally applicable rules on the regulation of the production, processing, marketing, labeling and control of agricultural products also apply to organic foods.