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Commission Implementing Regulation (EU) 2021/1165 of 15 July 2021 authorising certain products and substances for use in organic production and establishing their lists (Text with EEA relevance)

In forceVersion 2021-07-15from 2021-08-05
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Contents
  1. Preamble
    1. Article 1 Active substances in plant protection products
    2. Article 2 Fertilisers, soil conditioners and nutrients
    3. Article 3 Non-organic feed material of plant, algal, animal or yeast origin or feed material of microbial or mineral origin
    4. Article 4 Feed additives and processing aids
    5. Article 5 Products for cleaning and disinfection
    6. Article 6 Food additives and processing aids
    7. Article 7 Non-organic agricultural ingredients to be used for the production of processed organic food
    8. Article 8 Processing aids for the production of yeast and yeast products
    9. Article 9 Products and substances for use in organic production of wine
    10. Article 10 Procedure to grant specific authorisations for the use of products and substances in certain areas of third countries
    11. Article 11 Repeal
    12. Article 12 Transitional provisions
    13. Article 13 Entry into force and application
  3. ANNEX
  4. 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
  5. ANNEX II Authorised fertilisers, soil conditioners and nutrients referred to in point (b) of Article 24(1) of Regulation (EU) 2018/848
  6. ANNEX III Authorised products and substances for use as feed or in feed production
  7. 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
  8. 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
  9. (1)
  10. (3)
  11. 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
  12. PART A Products for the cleaning and disinfection of ponds, cages, tanks, raceways, buildings or installations used for animal production
  13. PART B Products for the cleaning and disinfection of buildings and installations used for plant production, including for storage on an agricultural holding
  14. PART C Products for cleaning and disinfection in processing and storage facilities
  15. PART D Products referred to in Article 12(1) of this Regulation
  16. ANNEX V Authorised products and substances for use in the production of processed organic food and of yeast used as food or feed
  17. PART A Authorised food additives and processing aids referred to in point (a) of Article 24(2) of Regulation (EU) 2018/848
    1. SECTION A1 FOOD ADDITIVES, INCLUDING CARRIERS
    2. SECTION A2 PROCESSING AIDS AND OTHER PRODUCTS, WHICH MAY BE USED FOR PROCESSING OF INGREDIENTS OF AGRICULTURAL ORIGIN FROM ORGANIC PRODUCTION
  18. 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
  19. 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
  20. 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
  21. ANNEX VI

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007, and in particular Article 24(9) and point (a) of Article 39(2) thereof,

Whereas:

(1) Pursuant to Article 9(3) of Regulation (EU) 2018/848, only products and substances authorised under Article 24 of that Regulation may be used in organic production provided that their use in non-organic production has also been authorised in accordance with relevant provisions of Union law. The Commission has already evaluated the use of certain products and substances in organic production on the basis of the objectives and principles laid down in Council Regulation (EC) No 834/2007. The selected products and substances were consequently authorised under specific conditions by Commission Regulation (EC) No 889/2008 and listed in certain Annexes to that Regulation. The objectives and principles laid down in Regulation (EU) 2018/848 are similar to those in Regulation (EC) No 834/2007. As it is necessary to ensure the continuity of organic production, those products and substances should be included in the restrictive lists to be established on the basis of Regulation (EU) 2018/848.

(2) In addition, in accordance with Article 24(7) of Regulation (EU) 2018/848, Member States have submitted dossiers on certain products and substances to the Commission and to the other Member States, in view of their authorisation and inclusion in the lists to be established under that Regulation.

(3) Under certain circumstances and conditions set out, in particular, in point 1.10.2. of Part I of Annex II to Regulation (EU) 2018/848, certain authorised products and substances may be used to protect plants. For that purpose, the Commission should authorise active substances to be used in plant protection products as referred to in point (a) of Article 24(1) of Regulation (EU) 2018/848 and establish the list of those active substances.

(4) Under certain circumstances and conditions set out, in particular, in point 1.9.3 of Part I, points 1.9.1.2(b), 1.9.2.2(d), 1.9.3.2(b) and 1.9.5.2(a) of Part II and points 2.2.2(c) and 2.3.2 and the second indent of the fourth paragraph of point 3.1.5.3 of Part III of Annex II to Regulation (EU) 2018/848, certain fertilisers, soil conditioners and nutrients may be used for plant nutrition, litter improvement and enrichment, algae cultivation or husbandry environment of aquaculture animals. For that purpose, the Commission should authorise fertilisers, soil conditioners and nutrients as referred to in point (b) of Article 24(1) of Regulation (EU) 2018/848 and establish their list.

(5) Under certain circumstances and conditions set out, in particular, in points 1.4.1(i) and 1.5.2.3 of Part II, point 3.1.3.1(d) of Part III and point 2.3 of Part V of Annex II to Regulation (EU) 2018/848, certain non-organic feed materials of plant, algal, animal or yeast origin, feed materials of microbial or mineral origin, feed additives and processing aids may be used for animal nutrition. For that purpose, the Commission should authorise non-organic feed materials of plant, algal, animal or yeast origin, feed materials of microbial or mineral origin and feed additives and processing aids as referred to in points (c) and (d) of Article 24(1) of Regulation (EU) 2018/848 and establish their lists.

(6) In addition, some non-organic feed materials are directly authorised in accordance with Regulation (EU) 2018/848. For the sake of clarity, those feed materials should also be listed together with the feed materials authorised by this Regulation, with a reference to the specific provisions of Regulation (EU) 2018/848.

(7) Under certain circumstances and conditions set out, in particular, in points 1.11 of Part I, points 1.5.1.6, 1.5.1.7 and 1.9.4.4(c) of Part II, point 3.1.4.1(f) of Part III, point 2.2.3 of Part IV, point 2.4 of Part V and point 1.4 of Part VII of Annex II and points 4.2 and 7.5 of Annex III to Regulation (EU) 2018/848, only certain products and substances may be used for cleaning and disinfection. For that purpose, the Commission should authorise products for cleaning and disinfection as referred to in points (e), (f) and (g) of Article 24(1) of Regulation (EU) 2018/848 and establish their lists.

(8) Certain products for cleaning and disinfection of buildings and installations for livestock, aquaculture animals and seaweed production have been evaluated and listed in Annex VII to Regulation (EC) No 889/2008. However, products for cleaning and disinfection of buildings and installations used for plant production and of processing and storage facilities are so far evaluated and authorised only by Member States. Before authorising those products in organic production, an evaluation should be done at Union level by the Commission assisted by the Expert Group for Technical Advice on Organic Production. That evaluation should include a revision of all existing authorised products and substances for cleaning and disinfection.

(9) For the sake of ensuring the continuity of organic production, the products listed in Annex VII to Regulation (EC) No 889/2008 and those authorised at Member States’ level should continue to be authorised until 31 December 2023 to allow the establishment of the lists of products for cleaning and disinfection in accordance with the provisions laid down in points (e), (f) and (g) of Article 24(1) of Regulation (EU) 2018/848. Nevertheless, those products must comply with the relevant requirements of Union law, in particular Regulation (EC) No 648/2004 of the European Parliament and of the Council and Regulation (EU) No 528/2012 of the European Parliament and of the Council and with the organic criteria laid down in Chapter II and points (a) and (b) of Article 24(3) of Regulation (EU) 2018/848.

(10) Under certain circumstances and conditions set out, in particular, in points 2.2.1 and 2.2.2(a) of Part IV of Annex II to Regulation (EU) 2018/848, certain food additives, including food enzymes to be used as food additives, and processing aids may be used in the production of processed organic food. For that purpose, the Commission should authorise food additives and processing aids as referred to in point (a) of Article 24(2) of Regulation (EU) 2018/848 and establish their list.

(11) Food additives and food processing aids used in the production of processed organic food were listed respectively in sections A, B and C of Annex VIII to Regulation (EC) No 889/2008. However, according to their uses and functions in the final product, certain of those products might be classified as additives and not as processing aids. This classification needs a specific and exhaustive analysis of those products in the production of processed organic food. Such analysis should be conducted on all products listed as processing aids in Regulation (EC) No 889/2008. That process will take time and cannot be completed before the date of application of Regulation (EU) 2018/848. Consequently, the products currently listed as processing aids in Regulation (EC) No 889/2008 will be listed as processing aids in this Regulation until a specific and exhaustive analysis has been carried out.

(12) Under certain circumstances and conditions set out, in particular, in point 2.2.1 of Part IV of Annex II to Regulation (EU) 2018/848, certain non-organic agricultural ingredients may be used for the production of processed organic food. For that purpose, the Commission should authorise such non-organic agricultural ingredients as referred to in point (b) of Article 24(2) of Regulation (EU) 2018/848 and establish their list. The dossiers on non-organic agricultural ingredients to be used for the production of processed organic food that have been submitted by Member States in accordance with Article 24(7) of Regulation (EU) 2018/848 were evaluated within the Committee on Organic Production. The selected products and substances that comply with the objectives and principles laid down in Regulation (EU) 2018/848 should be included in the restrictive list to be established by this Regulation, where necessary under specific conditions.

(13) However, in order to give enough time to operators to adapt to the new restrictive list of authorised non-organic agricultural ingredients and, in particular, to find a source of agricultural ingredients that have been produced in accordance with Regulation (EU) 2018/848, it is appropriate that the list of non-organic agricultural ingredients authorised for use in processing of organic food by this Regulation applies from 1 January 2024.

(14) Given the composition of certain non-organic agricultural ingredients, some of their uses in processed organic food may correspond to uses as food additives, food processing aids or products and substances referred to in point 2.2.2 of Part IV of Annex II to Regulation (EU) 2018/848. Those uses require a specific authorisation in accordance with point 2.2 of Part IV of Annex II to Regulation (EU) 2018/848 and such uses should not be allowed via the authorisation of non-organic agricultural ingredients.

(15) Under certain circumstances and conditions set out, in particular, in point 1.3(a) of Part VII of Annex II to Regulation (EU) 2018/848, certain processing aids may be used for the production of yeast and yeast products. For that purpose, the Commission should authorise processing aids for the production of yeast and yeast products as referred to in point (c) of Article 24(2) of Regulation (EU) 2018/848 and establish their list.

(16) In accordance with point 2.2 of Part VI of Annex II to Regulation (EU) 2018/848, only products and substances authorised pursuant to Article 24 of that Regulation for use in organic production may be used for the making of products of the wine sector as referred to point (l) of Article 1(2) of Regulation (EU) No 1308/2013 of the European Parliament and of the Council. For that purpose, the Commission should authorise such products and substances and establish their list.

(17) Article 45(2) of Regulation (EU) 2018/848 empowers the Commission to grant specific authorisations for the use of products and substances in third countries and in the outermost regions of the Union. How to initiate the procedure to be followed by Member States in respect of the outermost regions of the Union is set out in Article 24(7) of that Regulation. However, the procedure to be followed for such authorisations in respect of third countries is not detailed in Regulation (EU) 2018/848. Therefore, it is appropriate to establish that procedure in this Regulation, in line with the procedure to be followed to authorise products and substances for use in organic production in the Union, as set out in Article 24 of Regulation (EU) 2018/848. As those authorisations may be granted for a renewable period of 2 years, it is appropriate, in order to avoid confusion with products and substances authorised without time limitation, to list the relevant products and substances in a dedicated Annex.

(18) In the interest of clarity and legal certainty, Regulation (EC) No 889/2008 should be repealed. However, as the lists of products for cleaning and disinfection will not be established before 1 January 2024, Annex VII to Regulation (EC) No 889/2008 should continue to apply until 31 December 2023. In that context, it is appropriate to specify that products listed in that Annex which are not authorised pursuant to Regulation (EU) No 528/2012, cannot be used as biocidal products. Furthermore, the list of non-organic agricultural ingredients to be used for the production of processed organic food established by this Regulation will only apply from 1 January 2024. Therefore, it is appropriate to provide that processed organic food that has been produced before 1 January 2024 with non-organic agricultural ingredients listed in Annex IX to Regulation (EC) No 889/2008 may be placed on the market after that date until the stocks are exhausted.

(19) The certificate to be issued to operators by the competent authorities, or, where appropriate, the control authorities or control bodies in accordance with Article 35(1) of Regulation (EU) 2018/848 can be issued from 1 January 2022. However, it will not be provided to all operators concerned on that day. For the sake of ensuring the continuity of organic production and by way of derogation from Article 35(2) of Regulation (EU) 2018/848, the documentary evidence issued to operators by the control authorities or control bodies in accordance with Article 68 of Regulation (EC) No 889/2008 before 1 January 2022 should remain valid until the end of the validity period. However, as pursuant to Article 38(3) of Regulation (EU) 2018/848 operators are to be subject to a verification of compliance at least once a year and, in accordance with Article 38(5) of that Regulation, the delivery of the certificate is to be based on the results of that verification, the validity should not go beyond 31 December 2022.

(20) In the interest of clarity and legal certainty, this Regulation should apply from the date of application of Regulation (EU) 2018/848. However, for the reasons set out in recital 18 of this Regulation, the provisions referring to the lists of products for cleaning and disinfection and to the list of non-organic agricultural ingredients to be used for the production of processed organic food should apply from 1 January 2024.

(21) The measures provided for in this Regulation are in accordance with the opinion of the Committee on Organic Production,

HAS ADOPTED THIS REGULATION:

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;

(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.

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, the relevant applicable Articles of Regulation (EU) 2019/1009 of the European Parliament and of the Council, Regulation (EC) No 1069/2009 of the European Parliament and of the Council and Commission Regulation (EU) No 142/2011 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 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 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 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 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: The authorised product or substance shall be included in Annex VI to this Regulation.

(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.

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 31 December 2023 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. However, Article 5(1), (2) and (3) and Article 7 shall apply from 1 January 2024.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 15 July 2021. For the Commission The President Ursula von der Leyen

ANNEX

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. 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 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 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 CAS Name Specific conditions and limits 1C Equisetum arvense L.* 2C 9012-76-4 Chitosan hydrochloride* 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 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* 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*

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 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

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 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 and Ceratitis capitata 5E 91465-08-6 Lambda-cyhalothrin only in traps with specific attractants against Bactrocera oleae and Ceratitis capitata

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 listed in this Annex may be used in organic production, provided that they are compliant with In accordance with point 1.9.6 of Part I of Annex II to Regulation (EU) 2018/848, preparations of micro-organisms may be used to improve the overall condition of the soil or to improve the availability of nutrients in the soil or in the crops. They may only be used according to the specifications and restrictions of use of those respective Union and national legislations. More restrictive conditions for use in organic production are specified in the right column of the tables. Name Compound products or products containing only materials listed hereunder Description, specific conditions and limits Farmyard manure product comprising a mixture of animal excrements and vegetable matter (animal bedding and feed material) factory farming origin forbidden Dried farmyard manure and dehydrated poultry manure factory farming origin forbidden Composted animal excrements, including poultry manure and composted farmyard manure included factory farming origin forbidden Liquid animal excrements use after controlled fermentation and/or appropriate dilution factory farming origin forbidden Composted or fermented mixture of household waste product obtained from source separated household waste, which has been submitted to composting or to anaerobic fermentation for biogas production only vegetable and animal household 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: 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: 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): particle size: 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): particle size: 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): or 10 % P2O5 phosphorus expressed as phosphorus pentoxide soluble in 2 % citric acid particle size: 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): 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): calcium and sulphur expressed as total CaO + SO3 fineness of grind: 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 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

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.

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

(i) physical processes including dehydration, freezing and grinding

(ii) extraction with water or aqueous acid and/or alkaline solution

(iii) fermentation

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

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

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)

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

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

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

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

25 % CaO

35 % SO3

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

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 Name Specific conditions and limits 11.1.1 Calcium carbonate 11.1.2 Calcareous marine shells 11.1.4 Maerl 11.1.5 Lithothamn 11.1.13 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 11.3.3 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 11.4.1 Sodium chloride 11.4.2 Sodium bicarbonate 11.4.4 Sodium carbonate 11.4.6 Sodium sulphate 11.5.1 Potassium chloride

(2) OTHER FEED MATERIALS Number In feed catalogue Name Specific conditions and limits 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 ex 12.1.5 Yeasts yeast obtained from Saccharomyces cerevisiae or Saccharomyces carlsbergensis, inactivated resulting in absence of live micro-organisms when not available from organic production ex 12.1.12 Yeast products fermentation product obtained from Saccharomyces cerevisiae, Saccharomyces carlsbergensis, inactivated resulting in absence of live micro-organisms and containing yeast parts when not available from organic production 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: Molasses in accordance with point (e)(iv) of Article 24(3) of Regulation (EU) 2018/848, in particular: 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: 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

when not available in organic form

produced/prepared without chemical solvents

maximum 1 % in the feed ration

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

when not available in organic form

produced/prepared without chemical solvents

maximum 1 % in the feed ration

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

(1)

(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

(d) Binders and anti-caking agents ID number or functional group Name Specific conditions and limits E 412 Guar gum 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 566 Natrolite-Phonolite 1g568 Clinoptilolite of sedimentary origin E 599 Perlite

(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

(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

(3)

(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: 3a920 Betaine anhydrous only for monogastric animals from organic production; if not available, from natural origin

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

(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 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 3b409 Dicopper chloride trihydroxide 3b502 Manganese (II) oxide 3b503 Manganous sulfate, monohydrate 3b603 Zinc oxide 3b604 Zinc sulphate heptahydrate 3b605 Zinc sulphate monohydrate 3b609 Zinc chloride hydroxide monohydrate 3b701 Sodium molybdate dihydrate 3b801 Sodium selenite 3b802 3b803 Coated granulated sodium selenite Sodium selenate 3b810 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

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 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 milk products 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 E 336 Potassium tartrates products of plant origin 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 2023 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 herbs and spices in dried powdered form, flavourings propolis E 553b Talc sausages based on meat 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 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

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 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 sugar only for antimicrobial purposes from organic production, if available Pine rosin extract sugar 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 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)

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

Versions

  1. 2021-07-15

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