LegalizeCommission 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:
- (a) have been authorised pursuant to Regulation (EC) No 1107/2009 of the European Parliament and of the Council ([^E0001]);
- (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 ([^E0002]).
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 ([^E0003]), the relevant applicable Articles of Regulation (EU) 2019/1009 of the European Parliament and of the Council ([^E0004]), Regulation (EC) No 1069/2009 of the European Parliament and of the Council ([^E0005]) and Commission Regulation (EU) No 142/2011 ([^E0006]) 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 ([^E0007]) 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 ([^E0008]) and, where applicable, in accordance with national provisions based on Union law.
Article 5
Products for cleaning and disinfection
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.
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.
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.
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 ([^E0009]) 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 ([^E0010]) 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
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.
The Commission shall forward the request referred to in paragraph 1 to the Member States and shall publish any such requests.
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 ([^E0011]).
The authorised product or substance shall be included in Annex VI to this Regulation.
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 10a
Procedure to grant specific authorisation for the use of products and substances in the outermost regions of the Union
Where a Member State considers that a product or substance should be granted a specific authorisation for use in an outermost region of the Union due to the specific conditions set out in Article 45(2) of Regulation (EU) 2018/848, it may request the Commission to carry out an assessment. For that purpose, it shall notify the Commission of a dossier describing the product or substance concerned, giving the reasons for such specific authorisation due to the specific conditions set out in Article 45(2) of Regulation (EU) 2018/848 and explaining why the products and substances authorised under this Regulation are not adequate to be used due to the specific conditions in the outermost region concerned. It shall ensure that the dossier is fit to be made publicly available subject to Union and national legislation of the Member States on data protection.
The Commission shall publish any requests referred to in paragraph 1.
The Commission shall analyse the dossier referred to in paragraph 1. The Commission shall authorise the product or substance in the light of the specific conditions referred to in the dossier only if its analysis concludes, as a whole that:
- (a) such specific authorisation is justified in the outermost region concerned;
- (b) the product or substance described in the dossier complies with the principles laid down in Chapter II, the criteria set out in Article 24(3) and the condition set out in Article 24(5) of Regulation (EU) 2018/848; and
- (c) the use of the product or substance is in accordance with the relevant provisions of Union law, in particular, for active substances contained in plant protection products, with Regulation (EC) No 396/2005. The authorised product or substance shall be included in Annex VI to this Regulation.
When the 2-year period referred to in Article 45(2) of Regulation (EU) 2018/848 expires, the authorisation shall be automatically renewed for another period of 2 years, provided that no new elements are available and no Member State or control authority or control body recognised under Article 46(1) of Regulation (EU) 2018/848 has objected, justifying that the conclusion by the Commission referred to in paragraph 3 needs to be reassessed.
Article 11
Repeal
Regulation (EC) No 889/2008 is repealed.
However, Annex VII shall continue to apply until 31 December 2027 and Annex IX shall continue to apply until 31 December 2023.
Article 12
Transitional provisions
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 31 December 2027 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.
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.
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 2028.
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 ([^E0012]).
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 ([^E0013]) 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 ([^E0014]) 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 [^E0015] | CAS | Name | Specific conditions and limits |
|---|---|---|---|
| 1C | Equisetum arvense L.* | ||
| 2C | 70694-72-3 | Chitosan hydrochloride [^E0016] | 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 [^E0016] |
| 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 E 553b) | |
| 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 |
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.
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).
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 [^E0018] | 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 |
| 19D | 23960-07-8 | Lavandulyl senecioate | |
| 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 | ||
| 32D | 298-14-6 | Potassium hydrogen carbonate | |
| 38D | Straight chain lepidopteran pheromones (acetates) | ||
| 39D | 98999-15-6 | Sheep fat | use as repellent by smell |
| 44D | 14808-60-7 and 7631-86-9 | Quartz sand Silicon dioxide | |
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 [^E0019] | 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 | ||
| ————— | ————— | ————— | ————— | |
| 220A | 1332-58-7 | Aluminium silicate (kaolin) | ||
| 236A | 61790-53-2 | Kieselgur (diatomaceous earth) | ||
| ————— | ————— | ————— | ————— | |
| 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 | ||
| 153B and others | Pheromones and other semiochemicals | |||
| 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 | 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 | 1317-39-1 | Copper oxide | 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 | 8011-63-0 | Bordeaux mixture | 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 | 12527-76-3 | Tribasic copper sulphate | 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 | |
| 40A | 52918-63-5 | Deltamethrin | 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 | 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 |
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 ([^E0020]) 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 [^E0022]) | 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 | 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, sand of natural origin, clays and clay minerals | e.g., perlite, sand and vermiculite, including when heat treated, perlite, sand and vermiculite, including when heat treated, may also be used for sprouted seeds production as an inert medium as referred to in Part I, point 1.3(a), of Annex II to Regulation (EU) 2018/848 |
| 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 [^E0021] 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 |
| Carbon dioxide | use for enrichment of water for algae production on land in closed systems; in this case, carbon dioxide shall be of food grade when available, carbon dioxide shall be obtained as a by-product of other processes or from renewable sources pursuant to Directive (EU) 2018/2001 of the European Parliament and of the Council [^E0023] may also be used in greenhouse production |
| Calcium acetate | only for foliar application on vegetables in greenhouses and on apple trees to prevent deficiency in calcium obtained from calcium carbonate of natural origin |
| Calcium phosphate | only when derived from sewage sludge ash only products complying with the requirements of Regulation (EU) 2019/1009 |
| Plant fibre mats | plant-based fibres, such as hemp fibre, flax fibre, coconut fibre with no addition of any fertiliser, soil conditioner or nutrient nor additives or binders, only mechanically manufactured only for sprouted seeds production as an inert medium referred to in Part I, point 1.3(a), of Annex II to Regulation (EU) 2018/848 when available, materials from organic production shall be used |
| Calcium and magnesium gluconate | derived from microbial fermentation |
Here ‘organic’ is used in the sense of organic chemistry, not organic farming
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).
Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82, ELI: http://data.europa.eu/eli/dir/2018/2001/oj).
ANNEX III
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 [^E0024] | 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 | may only be used as ‘feed intended for particular nutritional purposes’ defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for the reduction of the risk of milk fever and subclinical hypocalcaemia in accordance with Part B, table entry ‘60’, of the Annex to Commission Regulation (EU) 2020/354 [^E0025], including bolus formulation calcium chloride when purified from naturally occurring brine, if available only for dairy cows in need and for a limited period |
| 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 |
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).
Commission Regulation (EU) 2020/354 of 4 March 2020 establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC (OJ L 67, 5.3.2020, p. 1, ELI: http://data.europa.eu/eli/reg/2020/354/oj).
(2) OTHER FEED MATERIALS
| Number In feed catalogue [^E0026] | 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 |
| ex 12.1.9 | Single cell proteins from Trichoderma viride and Aspergillus oryzae | only from non-GM strain and culture media not obtained from substrates with synthetic nitrogen sources obtained from substrates coming from organic production when used for ruminants and other herbivores when used, antifoaming agents shall be authorised for organic production |
| 12.1.10 | Products from Bacillus subtilis rich in protein | only from non-GM strain and culture media not obtained from substrates with synthetic nitrogen sources obtained from substrates coming from organic production when used for ruminants and other herbivores when used, antifoaming agents shall be authorised for organic production |
| 12.1.12 | Yeast products | when not available from organic production |
| ex 13.6.4 | Calcium stearate | |
| 13.11.1 | Propylene glycol; [1,2-propanediol]; [propane-1,2-diol] | may only be used as ‘feed intended for particular nutritional purposes’ defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for the reduction of the risk of ketosis in accordance with Part B, table entry ‘61’, of the Annex to Regulation (EU) 2020/354, including bolus formulation only for dairy cows, ewes and goats in need and for a limited period |
| 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 |
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 |
|---|---|---|
| 1a200 | Sorbic acid | |
| 1k236 | Formic acid | |
| 1k237i | Sodium formate | |
| 1a260 | Acetic acid | |
| 1a270 1a270i | Lactic acids | |
| 1k280 | Propionic acid | |
| 1a282 | Calcium propionate | may only be used as ‘feed intended for particular nutritional purposes’ defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for the reduction of the risk of milk fever and subclinical hypocalcaemia in accordance with Part B, table entry ‘60’, of the Annex to Regulation (EU) 2020/354, including bolus formulation only for dairy cows in need and for a limited period |
| 1a330 | Citric acid |
(b) 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 | derived from organic raw material from 1 January 2027, only from organic production |
| 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 | only authorised to ensure adequate fermentation |
| 1k237 | Sodium formate | only authorised to ensure adequate fermentation |
| 1k280 | Propionic acid | only authorised to ensure adequate fermentation |
| 1k281 | Sodium propionate | only authorised to ensure adequate fermentation |
(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 | |
| 3b105 | Iron(II) fumarate | may only be used as ‘feed intended for particular nutritional purposes’ defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for compensation of insufficient iron availability after birth in accordance with Part B, table entry ‘64’, of the Annex to Regulation (EU) 2020/354 only for suckling piglets in need and for a limited period |
| 3b107 | Iron (II) chelate of protein hydrolysates | from organic soy production, if available |
| 3b110 | Iron dextran 10 % | may only be used as ‘feed intended for particular nutritional purposes’ defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for compensation of insufficient iron availability after birth in accordance with Part B, table entry ‘64’, of the Annex to Regulation (EU) 2020/354 growing medium for the fermentation process for dextran shall be of non-GMO origin only for suckling piglets in need and for a limited period |
| 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 |
(5) PROCESSING AIDS
For processing aids as defined in Article 2(2), point (h), of Regulation (EC) No 1831/2003, the specific conditions and limits set out in the following table shall apply.
| Name | Specific conditions and limits |
|---|---|
| Ethanol | to be used only as extraction solvent for the production of protein meals and only when protein meals from mechanical extraction are not available in sufficient quantities only from fermentation if available only from organic production if available |
| Papain | only for the production of flavouring innards for the manufacture of pet food that are defined in point 18 of Annex I to Regulation (EU) No 142/2011 provided that the enzyme is inactivated during the process and therefore is not present as such in the resulting flavouring innards and does not have any technological effect on the product from 1 January 2027, only from organic raw material |
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 Article 24(2), point (a), of Regulation (EU) 2018/848, including carriers and other substances used in the same way and with the same purpose as processing aids
The organic foodstuffs to which food additives may be added are within the limit of authorisations given in accordance with Regulation (EC) No 1333/2008.
The specific conditions and limits set out in the table below shall apply in addition to the conditions of the authorisations under Regulation (EC) No 1333/2008.
The use as food additives or as processing aids shall be attributed on a case-by-case basis in accordance with Regulation (EC) No 1333/2008 and national legislation on processing aids.
For the purpose of the calculation of the percentages referred to in Article 30(5) of Regulation (EU) 2018/848, food additives marked with an asterisk in the column “E-number or Einecs, or both” shall be calculated as ingredients of agricultural origin.
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