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

Commission Implementing Regulation (EU) 2021/1165 of 15 July 2021 authorising certain products and substances for use in organic production and establishing their lists (Text with EEA relevance) 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 OJ L 150, 14.6.2018, p. 1. , 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 Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ L 189, 20.7.2007, p. 1). . The selected products and substances were consequently authorised under specific conditions by Commission Regulation (EC) No 889/2008 Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control (OJ L 250, 18.9.2008, p. 1). 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 Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1).

and Regulation (EU) No 528/2012 of the European Parliament and of the Council Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1). 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 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671). . 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 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market (OJ L 309, 24.11.2009, p. 1). ; (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 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1). .

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 Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers (OJ L 304, 21.11.2003, p. 1). , the relevant applicable Articles of Regulation (EU) 2019/1009 of the European Parliament and of the Council Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L 170 25.6.2019, p. 1). , Regulation (EC) No 1069/2009 of the European Parliament and of the Council Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (OJ L 300, 14.11.2009, p. 1). and Commission Regulation (EU) No 142/2011 Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1). 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 Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (OJ L 229, 1.9.2009, p. 1). 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

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29). 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 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16).

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 Commission Delegated Regulation (EU) 2019/934 of 12 March 2019 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards wine-growing areas where the alcoholic strength may be increased, authorised oenological practices and restrictions applicable to the production and conservation of grapevine products, the minimum percentage of alcohol for by-products and their disposal, and publication of OIV files (OJ L 149, 7.6.2019, p. 1). 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.

1. The Commission shall forward the request referred to in paragraph 1 to the Member States and shall publish any such requests.
2. 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 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1). . The authorised product or substance shall be included in Annex VI to this Regulation.
3. 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 Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on the prevention and management of the introduction and spread of invasive alien species (OJ L 317, 4.11.2014, p. 35). . 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 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). 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

Available in the Pesticides Database: https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=search.as 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. 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). Number and Part of AnnexCASNameSpecific conditions and limits1CEquisetum arvense L.2C9012-76-4Chitosan hydrochlorideobtained 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 3C57-50-1Sucrose4C1305-62-0Calcium Hydroxide5C90132-02-8Vinegar6C8002-43-5Lecithins7C-Salix spp. Cortex8C57-48-7Fructose9C144-55-8Sodium hydrogen carbonate10C92129-90-3Whey11C7783-28-0Diammonium phosphateonly in traps12C8001-21-6Sunflower oil14C 84012-40-8 90131-83-2 Urtica spp. (Urtica dioica extract) (Urtica urens extract)15C7722-84-1Hydrogen peroxide16C7647-14-5Sodium chloride17C8029-31-0Beer18C-Mustard seeds powder20C8002-72-0Onion oil21C52-89-1L-cysteine (E 920)22C8049-98-7Cow milk23C-Allium cepa L. bulb extractOther 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. 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.

Number and Part of AnnexCASNameSpecific conditions and limits2DCOS-OGA3DCerevisane and other products based on fragments of cells of micro-organismsNot from GMO origin 5D10045-86-6Ferric phosphate (iron (III) orthophosphate)12D9008-22-4LaminarinKelp 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. 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. Number and part of AnnexCASNameSpecific conditions and limits139A 131929-60-7 131929-63-0 Spinosad225A124-38-9Carbon dioxide227A74-85-1Ethyleneonly on bananas and potatoes; however, it may also be used on citrus as part of a strategy for the prevention of fruit fly damage230Ai.a. 67701-09-1Fatty acidsall uses authorised, except herbicide231A8008-99-9Garlic extract (Allium sativum)234A CAS No not allocated CIPAC No 901 Hydrolysed proteins excluding gelatine244A298-14-6Potassium hydrogen carbonate249A98999-15-6Repellents by smell of animal or plant origin/sheep fat255A and othersPheromones and other semiochemicalsonly in traps and dispensers220A1332-58-7Aluminium silicate (kaolin)236A61790-53-2Kieselgur (diatomaceous earth) 247A 14808-60-7 7637-86-9 Quartz sand343A 11141-17-6 84696-25-3 Azadirachtin (Margosa extract)extracted from Neem tree seeds (Azadirachta indica)240A8000-29-1Citronella oilall uses authorised, except herbicide241A84961-50-2Clove oilall uses authorised, except herbicide242A8002-13-9Rape seed oilall uses authorised, except herbicide243A8008-79-5Spearmint oilall uses authorised, except herbicide56A 8028-48-6 5989-27-5 Orange oilall uses authorised, except herbicide228A68647-73-4Tea tree oilall uses authorised, except herbicide246A8003-34-7Pyrethrins extracted from plants292A7704-34-9Sulphur294A 295A 64742-46-7 72623-86-0

97862-82-3 8042-47-5 Paraffin oils345A1344-81-6Lime sulphur (calcium polysulphide)44B9050-36-6Maltodextrin45B97-53-0Eugenol46B106-24-1Geraniol47B89-83-8Thymol10E20427-59-2Copper hydroxidein 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 authorised10E 1332-65-6 1332-40-7 Copper oxychloride10E1317-39-1Copper oxide10E8011-63-0Bordeaux mixture10E12527-76-3Tribasic copper sulphate40A52918-63-5Deltamethrin,only in traps with specific attractants against Bactrocera oleae and Ceratitis capitata5E91465-08-6Lambda-cyhalothrinonly in traps with specific attractants against Bactrocera oleae and Ceratitis capitata

Annex

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 Covering in particular all the product function categories listed in Part I of Annex I to Regulation (EU) 2019/1009. 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. Here organic is used in the sense of organic chemistry, not organic farming Name Compound products or products containing only materials listed hereunder Description, specific conditions and limitsFarmyard 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 manurefactory farming origin forbiddenComposted animal excrements, including poultry manure and composted farmyard manure includedfactory farming origin forbiddenLiquid 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

Peatuse limited to horticulture (market gardening, floriculture, arboriculture, nursery)Mushroom culture wastesthe initial composition of the substrate shall be limited to products of this AnnexDejecta of worms (vermicompost) and insect frass-substrate mixturewhere relevant in accordance with Regulation (EC) No 1069/2009GuanoComposted or fermented mixture of vegetable matterproduct obtained from mixtures of vegetable matter, which have been submitted to composting or to anaerobic fermentation for biogas production Biogas digestate containing animal by-products co-digested with material of plant or animal origin as listed in this Annex animal by-products (including by-products of wild animals) of category 3 and digestive tract content of category 2 (categories as defined in Regulation (EC) No 1069/2009) factory farming origin forbidden the processes have to be in accordance with Regulation (EU) No 142/2011 not to be applied to edible parts of the crop Products or by-products of animal origin as below: Blood meal Hoof meal Horn meal Bone meal or degelatinised bone meal Fish meal Meat meal Feather, hair and skin meal (chiquette) Wool Fur (1) Hair Dairy products Hydrolysed proteins (2) (1) Maximum concentration in mg/kg of dry matter of chromium (VI): not detectable (2) Not to be applied to edible parts of the crop Products and by-products of plant origin for fertiliserse.g.: oilseed cake meal, cocoa husks, malt culmsHydrolysed proteins of plant originAlgae 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 chipswood not chemically treated after fellingComposted barkwood not chemically treated after fellingWood ashfrom wood not chemically treated after fellingSoft 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 saltproduct obtained from crude potassium salt by a physical extraction process, containing possibly also magnesium saltsStillage and stillage extractammonium stillage excluded Calcium carbonate, for instance: chalk, marl, ground limestone, Breton ameliorant (maerl), phosphate chalkonly of natural originMollusc wasteonly from organic aquaculture or from sustainable fisheries, in accordance with Article 2 of Regulation (EU) No 1380/2013Egg shellsfactory farming origin forbiddenMagnesium and calcium carbonate only of natural origin e.g. magnesian chalk, ground magnesium, limestone Magnesium sulphate (kieserite)only of natural originCalcium chloride solutiononly for foliar treatment of apple trees, to prevent deficit of calciumCalcium 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 productionby-product of sugar production from sugar beet and sugar caneIndustrial lime from vacuum salt productionby-product of the vacuum salt production from brine found in mountainsElemental 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 chlorideStone meal, clays and clay mineralsLeonardite (Raw organic sediment rich in humic acids)only if obtained as a by-product of mining activitiesHumic and fulvic acidsonly if obtained by inorganic salts/solutions excluding ammonium salts; or obtained from drinking water purificationXyliteonly 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

Annex

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 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). Number in feed catalogueNameSpecific conditions and limits11.1.1Calcium carbonate11.1.2Calcareous marine shells11.1.4Maerl11.1.5Lithothamn11.1.13Calcium gluconate11.2.1Magnesium oxide11.2.4Magnesium sulphate anhydrous11.2.6Magnesium chloride11.2.7Magnesium carbonate11.3.1Dicalcium phosphate11.3.3Monocalcium phosphate11.3.5Calcium-magnesium phosphate11.3.8Magnesium phosphate11.3.10Monosodium phosphate11.3.16Calcium sodium phosphate11.3.17Monoammonium phosphate (Ammonium dihydrogen orthophosphate)only for aquaculture11.4.1Sodium chloride11.4.2Sodium bicarbonate11.4.4Sodium carbonate11.4.6Sodium sulphate11.5.1Potassium chloride

(2) OTHER FEED MATERIALS In accordance with Regulation (EU) No 68/2013. Number In feed catalogueNameSpecific conditions and limits10Meal, 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 10Meal, 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 10Fishmeal 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 12.1.5Yeasts yeast obtained from Saccharomyces cerevisiae or Saccharomyces carlsbergensis, inactivated resulting in absence of live micro-organisms when not available from organic production ex 12.1.12Yeast 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: 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 zooplanktononly in the larval rearing of organic juvenilesspecific 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 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 groupNameSpecific conditions and limitsE 200Sorbic acidE 236Formic acidE 237Sodium formate E 260Acetic acidE 270Lactic acidE 280Propionic acidE 330Citric acid (b) Antioxidants ID number or functional groupNameSpecific conditions and limits1b306(i)Tocopherol extracts from vegetable oils1b306(ii)Tocopherol-rich extracts from vegetable oils (delta rich) (c) Emulsifiers, stabilisers, thickeners and gelling agents ID number or functional groupNameSpecific conditions and limits1c322, 1c322iLecithins only when derived from organic raw material use restricted to aquaculture animal feed (d) Binders and anti-caking agents ID number or functional groupNameSpecific conditions and limitsE 412Guar gumE 535Sodium ferrocyanidemaximum content: 20 mg/kg NaCl calculated as ferrocyanide anionE 551bColloidal silicaE 551cKieselgur (diatomaceous earth, purified)1m558iBentoniteE 559Kaolinitic clays, free of asbestosE 560Natural mixtures of steatites and chloriteE 561VermiculiteE 562SepioliteE 566Natrolite-Phonolite1g568Clinoptilolite of sedimentary originE 599Perlite (e) Silage additives ID number or functional groupNameSpecific conditions and limits1kEnzymes, micro-organismsonly authorised to ensure adequate fermentation1k236Formic acid1k237Sodium formate1k280Propionic acid1k281Sodium propionate (2) SENSORY ADDITIVES ID number or functional groupNameSpecific conditions and limitsex2aAstaxanthin 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 ex2bFlavouring compoundsonly 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 groupNameSpecific conditions and limitsex3aVitamins 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 3a920Betaine anhydrous only for monogastric animals from organic production; if not available, from natural origin (b) Compounds of trace elements ID number or functional groupNameSpecific conditions and limits3b101Iron(II) carbonate (siderite)3b103Iron(II) sulphate monohydrate3b104Iron(II) sulphate heptahydrate3b201Potassium iodide3b202Calcium iodate, anhydrous3b203Coated granulated calcium iodate anhydrous3b301Cobalt(II) acetate tetrahydrate3b302Cobalt(II) carbonate3b303Cobalt(II) carbonate hydroxide (2:3) monohydrate3b304Coated granulated cobalt(II) carbonate3b305Cobalt(II) sulphate heptahydrate3b402Copper(II) carbonate dihydroxy monohydrate3b404Copper (II) oxide3b405Copper(II) sulphate pentahydrate3b409Dicopper chloride trihydroxide3b502Manganese (II) oxide3b503Manganous sulfate, monohydrate3b603Zinc oxide3b604Zinc sulphate heptahydrate3b605Zinc sulphate monohydrate3b609Zinc chloride hydroxide monohydrate3b701Sodium molybdate dihydrate3b801Sodium selenite 3b802 3b803 Coated granulated sodium selenite Sodium selenate 3b810Selenised yeast, Saccharomyces cerevisiae CNCM I-3060, inactivated3b811Selenised yeast, Saccharomyces cerevisiae NCYC R397, inactivated3b812Selenised yeast, Saccharomyces cerevisiae CNCM I-3399, inactivated3b813Selenised yeast, Saccharomyces cerevisiae NCYC R646, inactivated3b817Selenised yeast, Saccharomyces cerevisiae NCYC R645 inactivated (c) Amino acids, their salts and analogues ID number or functional groupNameSpecific conditions and limits3c3.5.1 and 3c352L-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 groupNameSpecific conditions and limits4a, 4b, 4c and 4dEnzymes and microorganism

Annex

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

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. Commission Implementing Directive (EU) 2017/1279 of 14 July 2017 amending Annexes I to V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 184, 15.7.2017, p. 33). CodeNameOrganic foodstuffs to which it may be addedSpecific conditions and limitsE 153Vegetable 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 170Calcium carbonateproducts of plant and animal originshall not be used for colouring or calcium enrichment of productsE 220Sulphur dioxidefruit wines (wine made from fruits other than grapes, including cider and perry) and mead with and without added sugar100 mg/l (maximum levels available from all sources, expressed as SO2 in mg/l)E 223Sodium metabisulphitecrustaceansE 224Potassium metabisulphitefruit wines (wine made from fruits other than grapes, including cider and perry) and mead with and without added sugar100 mg/l (maximum levels available from all sources, expressed as SO2 in mg/l)E250Sodium nitritemeat 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 E252Potassium nitratemeat 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 270Lactic acidproducts of plant and animal originE 290Carbon dioxideproducts of plant and animal originE 296Malic acidproducts of plant originE 300Ascorbic acid products of plant origin meat products E 301Sodium ascorbatemeat productsmay only be used in connection with nitrates and nitritesE 306 Tocopherol-rich extract products of plant and animal originantioxidantE 322Lecithins products of plant origin milk products only from organic productionE 325Sodium lactate products of plant origin milk-based and meat products E 330Citric acidproducts of plant and animal originE 331Sodium citratesproducts of plant and animal originE 333Calcium citratesproducts of plant originE 334 Tartaric acid (L(+)-) products of plant origin mead E 335Sodium tartratesproducts of plant originE 336Potassium tartratesproducts of plant originE 341(i)Monocalcium phosphateself-raising flourraising agentE 392Extracts of Rosemaryproducts of plant and animal originonly from organic production E 400Alginic acid products of plant origin milk products E 401Sodium alginate products of plant origin milk products sausages based on meat E 402Potassium alginate products of plant origin milk-based products E 406Agar products of plant origin milk-based products and meat products E 407Carrageenan products of plant origin milk-based products E 410Locust bean gumproducts of plant and animal originonly from organic productionE 412Guar gumproducts of plant and animal originonly from organic productionE 414Arabic gumproducts of plant and animal originonly from organic productionE 415Xanthan gumproducts of plant and animal originE 417Tara gumproducts of plant and animal origin thickener only from organic production E 418Gellan gumproducts of plant and animal origin high-acyl form only only from organic production, applicable as of 1 January 2023 E 422Glycerol 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 460CellulosegelatineE 464Hydroxypropyl methyl celluloseproducts of plant and animal originencapsulation material for capsulesE 500Sodium carbonatesproducts of plant and animal originE 501Potassium carbonatesproducts of plant originE 503Ammonium carbonatesproducts of plant originE 504Magnesium carbonatesproducts of plant originE 509Calcium chlorideMilk-based productscoagulation agent

E 516Calcium sulphateproducts of plant origincarrierE 524Sodium hydroxide Laugengebäck flavourings surface treatment acidity regulator E 551Silicon dioxide herbs and spices in dried powdered form, flavourings propolis E 553bTalcsausages based on meatsurface treatmentE 901Beeswaxconfectionery glazing agent only from organic production E 903Carnauba 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 938Argonproducts of plant and animal originE 939Heliumproducts of plant and animal originE 941Nitrogenproducts of plant and animal originE 948Oxygenproducts of plant and animal originE 968Erythritolproducts of plant and animal originonly 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. Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32). Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55) NameOnly authorised for the processing of the following organic foodstuffsSpecific conditions and limitsWaterproducts of plant and animal origindrinking water within the meaning of Council Directive 98/83/ECCalcium chloride products of plant origin sausages based on meat coagulation agentCalcium carbonateproducts of plant originCalcium hydroxideproducts of plant origin Calcium sulfateproducts of plant origincoagulation agentMagnesium chloride (or nigari)products of plant origincoagulation agentPotassium carbonateGrapesdrying agentSodium carbonateproducts of plant and animal originLactic acidCheesefor the regulation of the pH of the brine bath in cheese productionL(+)lactic acid from fermentationplant protein extractsCitric acidproducts of plant and animal originSodium hydroxide Sugar(s) oil from plant origin excluding olive oil plant protein extracts Sulphuric acid gelatine sugar(s) Hop extractsugar only for antimicrobial purposes from organic production, if available Pine rosin extractsugar 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 hydroxideGelatinegelatine production in compliance with Regulation (EC) No 853/2004Hydrogen peroxideGelatinegelatine production in compliance with Regulation (EC) No 853/2004Carbon dioxideproducts of plant and animal originNitrogenproducts of plant and animal originEthanolproducts of plant and animal originsolventTannic acidproducts of plant originfiltration aidEgg white albuminproducts of plant originCaseinproducts of plant originGelatinproducts of plant originIsinglassproducts of plant origin

Vegetable oilsproducts of plant and animal origingreasing, releasing or antifoaming agent only from organic productionSilicon dioxide gel or colloidal solutionproducts of plant origin Activated carbon (CAS-7440-44-0) products of plant and animal originTalcproducts of plant originin compliance with the specific purity criteria for food additive E 553bBentonite products of plant origin mead sticking agent for meadCellulose products of plant origin gelatine Diatomaceous earth products of plant origin gelatine Perlite products of plant origin gelatine Hazelnut shellsproducts of plant originRice mealproducts of plant originBeeswaxproducts of plant origin releasing agent only from organic production Carnauba waxproducts 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 hydrochloridefruit wines, cider, perry and meadDiammonium phosphatefruit wines, cider, perry and meadWood fibreproducts 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 NameSpecific conditions and limitsAlga Arame (Eisenia bicyclis), unprocessed as well as products of first-stage processing directly related to this algaAlga Hijiki (Hizikia fusiforme), unprocessed as well as products of first-stage processing directly related to this algaBark of the Pau d’arco tree Handroanthus impetiginosus (lapacho)only for use in Kombucha and tea mixturesCasingsfrom natural raw materials of animal or from plant origin materialGelatinfrom other sources than porcineMilk mineral powder/liquidonly when used for its sensory function to replace wholly or partly sodium chlorideWild 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 NamePrimary yeastYeast production/confection/formulationSpecific conditions and limitsCalcium chlorideXCarbon dioxideXXCitric acidXfor the regulation of the pH in yeast productionLactic acidXfor the regulation of the pH in yeast productionNitrogenXXOxygenXXPotato starchXX for filtering only from organic production Sodium carbonateXXfor the regulation of the pHVegetable oilsXX

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 NameID numbersReferences in Annex I to Delegated Regulation (EU) 2019/934Specific conditions and limitsAirPart A, Table 1, points 1 and 8Gaseous 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 bubblingNitrogen 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 woodPart A, Table 1, point 11Tartaric acid (L(+)-) E 334 CAS 87-69-4 Part A, Table 2, point 1.1Lactic acidE 270Part A, Table 2, point 1.3Potassium L(+)-tartrate E 336(ii) CAS 921- 53-9 Part A, Table 2, point 1.4Potassium bicarbonate E 501(ii) CAS 298- 14-6 Part A, Table 2, point 1.5Calcium carbonate E 170 CAS 471-34-1 Part A, Table 2, point 1.6Calcium sulphateE 516Part A, Table 2, point 1.8Sulphur 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 2.2Potassium metabisulphite E 224 CAS 16731-55-8 Part A, Table 2, point 2.3 L ascorbic acidE 300Part A, Table 2, point 2.6Charcoal for oenological usePart A, Table 2, point 3.1Diammonium hydrogen phosphateE 342/CAS 7783-28-0Part A, Table 2, point 4.2Thiamine hydrochlorideCAS 67-03-8Part A, Table 2, point 4.5Yeast autolysatesPart A, Table 2, point 4.6Yeast cell wallsPart A, Table 2, point 4.7Inactivated yeasts Part A, Table 2, point 4.8 Part A, Table 2, point 10.5 Part A, Table 2, point 11.5 Edible gelatineCAS 9000-70-8Part A, Table 2, point 5.1derived from organic raw material if availableWheat proteinPart A, Table 2, point 5.2derived from organic raw material if availablePeas proteinPart A, Table 2, point 5.3derived from organic raw material if availablePotatoes proteinPart A, Table 2, point 5.4derived from organic raw material if availableIsinglassPart A, Table 2, point 5.5derived from organic raw material if availableCaseinCAS 9005-43-0Part A, Table 2, point 5.6derived from organic raw material if availablePotassium caseinatesCAS 68131-54-4Part A, Table 2, point 5.7Egg albuminCAS 9006-59-1Part A, Table 2, point 5.8derived from organic raw material if available

BentoniteE 558Part A, Table 2, point 5.9Silicon dioxide (gel or colloidal solution)E 551Part A, Table 2, point 5.10Tannins Part A, Table 2, point 5.12 Part A, Table 2, point 6.4 derived from organic raw material if availableChitosan derived from Aspergillus nigerCAS 9012-76-4 Part A, Table 2, point 5.13 Part A, Table 2, point 10.3 Yeast protein extractsPart A, Table 2, point 5.15derived from organic raw material if availablePotassium alginateE 402/CAS 9005-36-1Part A, Table 2, point 5.18Potassium hydrogen tartrateE336(i)/CAS 868-14-4Part A, Table 2, point 6.1Citric acidE 330Part A, Table 2, point 6.3Metatartaric acidE 353Part A, Table 2, point 6.7Gum arabicE 414/CAS 9000-01-5Part A, Table 2, point 6.8derived from organic raw material if availableYeast mannoproteinsPart A, Table 2, point 6.10Pectin lyasesEC 4.2.2.10Part A, Table 2, point 7.2only for oenological purposes in clarificationPectin methylesteraseEC 3.1.1.11Part A, Table 2, point 7.3only for oenological purposes in clarificationPolygalacturonaseEC 3.2.1.15Part A, Table 2, point 7.4only for oenological purposes in clarificationHemicellulaseEC 3.2.1.78Part A, Table 2, point 7.5only for oenological purposes in clarificationCellulaseEC 3.2.1.4Part A, Table 2, point 7.6only for oenological purposes in clarificationYeasts for wine productionPart A, Table 2, point 9.1for the individual yeast strains, organic if availableLactic acid bacteriaPart A, Table 2, point 9.2Copper citrateCAS 866-82-0Part A, Table 2, point 10.2Aleppo pine resinPart A, Table 2, point 11.1Fresh leesPart A, Table 2, point 11.2only from organic production

Annex

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