# L_2021253EN.01001301.xml

| 16.7.2021 | EN | Official Journal of the European Union | L 253/13 |
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16.7.2021

EN

Official Journal of the European Union

L 253/13

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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)

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 (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 (2). The selected products and substances were consequently authorised under specific conditions by Commission Regulation (EC) No 889/2008 (3) 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. |
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(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 (2). The selected products and substances were consequently authorised under specific conditions by Commission Regulation (EC) No 889/2008 (3) 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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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 (4) and Regulation (EU) No 528/2012 of the European Parliament and of the Council (5) and with the organic criteria laid down in Chapter II and points (a) and (b) of Article 24(3) of Regulation (EU) 2018/848. |
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(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 (4) and Regulation (EU) No 528/2012 of the European Parliament and of the Council (5) 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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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 (6). For that purpose, the Commission should authorise such products and substances and establish their list. |
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(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 (6). 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. |
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(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. |
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(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. |
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(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. |
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(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, |
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(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 (7); |
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(a)

have been authorised pursuant to Regulation (EC) No 1107/2009 of the European Parliament and of the Council (7);

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| (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 |
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(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 (8). |
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(c)

are used in compliance with the conditions set out in the Annex to Commission Implementing Regulation (EU) No 540/2011 (8).

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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 (9), the relevant applicable Articles of Regulation (EU) 2019/1009 of the European Parliament and of the Council (10), Regulation (EC) No 1069/2009 of the European Parliament and of the Council (11) and Commission Regulation (EU) No 142/2011 (12) and, where applicable, in accordance with national provisions based on Union law.

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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 (13) and, where applicable, in accordance with national provisions based on Union law.

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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 (14) and, where applicable, in accordance with national provisions based on Union law.

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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 (15) and, where applicable, in accordance with national provisions based on Union law.

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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 (16) and, where applicable, in accordance with national provisions based on Union law.

16

Article 10

Procedure to grant specific authorisations for the use of products and substances in certain areas of third countries

1.   Where a control authority or control body recognised under Article 46(1) of Regulation (EU) 2018/848 considers that a product or substance should be granted a specific authorisation for use in a certain area outside the Union due to the specific conditions set out in Article 45(2) of that Regulation, it may request the Commission to carry out an assessment. For that purpose, it shall notify the Commission of a dossier describing the product or substance concerned, giving the reasons for such specific authorisation and explaining why the products and substances authorised under this Regulation are not adequate to be used due to the specific conditions in the relevant area. It shall ensure that the dossier is fit to be made publicly available subject to Union and national legislation of the Member States on data protection.

2.   The Commission shall forward the request referred to in paragraph 1 to the Member States and shall publish any such requests.

3.   The Commission shall analyse the dossier referred to in paragraph 1. The Commission shall authorise the product or substance in the light of the specific conditions referred to in the dossier only if its analysis concludes, as a wholethat:

| (a) | such specific authorisation is justified in the area concerned; |
| --- | --- |

(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 |
| --- | --- |

(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 (17). |
| --- | --- |

(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 (17).

The authorised product or substance shall be included in Annex VI to this Regulation.

4.   When the 2-year period referred to in Article 45(2) of Regulation (EU) 2018/848 expires, the authorisation shall be automatically renewed for another period of 2 years, provided that no new elements are available and no Member State or control authority or control body recognised under Article 46(1) of Regulation (EU) 2018/848 has objected, justifying that the conclusion by the Commission referred to in paragraph 3 need to be reassessed.

Article 11

Repeal

Regulation (EC) No 889/2008 is repealed.

However, Annexes VII and IX shall continue to apply until 31 December 2023.

Article 12

Transitional provisions

1.   For the purposes of Article 5(4) of this Regulation, the products for cleaning and disinfection listed in Annex VII to Regulation (EC) No 889/2008 may continue to be used until 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.

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

---

(1)  
  OJ L 150, 14.6.2018, p. 1.

1

(2)  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).

2

(3)  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).

3

(4)  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).

4

(5)  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).

5

(6)  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).

6

(7)  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).

7

(8)  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).

8

(9)  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).

9

(10)  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).

10

(11)  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).

11

(12)  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).

12

(13)  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).

13

(14)  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).

14

(15)  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).

15

(16)  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).

16

(17)  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).

17

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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 (1).

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 (2) 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 (3) 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 (4) | 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 (5) |
| 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* | |

Number and Part of Annex (4)

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 (5)

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 (6) | 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 |

Number and Part of Annex (6)

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 (7) | 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 |

Number and part of Annex (7)

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

---

(1)  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).

(2)  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).

(3)  Available in the Pesticides Database: https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=search.as

(4)  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.

(5)  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).

(6)  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.

(7)  Listing according to Implementing Regulation (EU) No 540/2011, numbers and which category: Part A active substances deemed to have been approved under Regulation (EC) No 1107/2009, B, active substances approved under Regulation (EC) No 1107/2009, C basic substances, D low-risk active substances and E candidates for substitution.

---

ANNEX II

Authorised fertilisers, soil conditioners and nutrients referred to in point (b) of Article 24(1) of Regulation (EU) 2018/848

Fertilisers, soil conditioners and nutrients (1) 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 |
| --- | --- |

—

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. |
| --- | --- |

—

Union legislation on animal by-products, in particular Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011, in particular Annexes V and XI.

In accordance with point 1.9.6 of Part I of Annex II to Regulation (EU) 2018/848, preparations of micro-organisms may be used to improve the overall condition of the soil or to improve the availability of nutrients in the soil or in the crops.

They may only be used according to the specifications and restrictions of use of those respective Union and national legislations. More restrictive conditions for use in organic production are specified in the right column of the tables.

| Name
  Compound products or products containing only materials listed hereunder | Description, specific conditions and limits |
| --- | --- |
| Farmyard manure | product comprising a mixture of animal excrements and vegetable matter (animal bedding and feed material)
  factory farming origin forbidden |
| Dried farmyard manure and dehydrated poultry manure | factory farming origin forbidden |
| Composted animal excrements, including poultry manure and composted farmyard manure included | factory farming origin forbidden |
| Liquid animal excrements | use after controlled fermentation and/or appropriate dilution
  factory farming origin forbidden |
| Composted or fermented 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: | Blood meal |

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:

Blood meal

| | Hoof meal |
| --- | --- |

Hoof meal

| | Horn meal |
| --- | --- |

Horn meal

| | Bone meal or degelatinised bone meal |
| --- | --- |

Bone meal or degelatinised bone meal

| | Fish meal |
| --- | --- |

Fish meal

| | Meat meal |
| --- | --- |

Meat meal

| | Feather, hair and skin meal (‘chiquette’) |
| --- | --- |

Feather, hair and skin meal (‘chiquette’)

| | Wool |
| --- | --- |

Wool

| | Fur (1) |
| --- | --- |

Fur (1)

| | Hair |
| --- | --- |

Hair

| | Dairy products |
| --- | --- |

Dairy products

| | Hydrolysed proteins (2) |
| --- | --- |

Hydrolysed proteins (2)

| (1) | Maximum concentration in mg/kg of dry matter of chromium (VI): not detectable |
| --- | --- |

(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 |
| --- | --- |

(2)

Not to be applied to edible parts of the crop

Products and by-products of plant origin for fertilisers

e.g.: oilseed cake meal, cocoa husks, malt culms

Hydrolysed proteins of plant origin

Algae and algae products

as far as directly obtained by:

| (i) | physical processes including dehydration, freezing and grinding |
| --- | --- |

(i)

physical processes including dehydration, freezing and grinding

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

(ii)

extraction with water or aqueous acid and/or alkaline solution

| (iii) | fermentation |
| --- | --- |

(iii)

fermentation

only from organic or collected in a sustainable way in accordance with point 2.4 of Part III of Annex II to Regulation (EU) 2018/848

Sawdust and wood chips

wood not chemically treated after felling

Composted bark

wood not chemically treated after felling

Wood ash

from wood not chemically treated after felling

Soft ground rock phosphate

product obtained by grinding soft mineral phosphates and containing tricalcium phosphate and calcium carbonate as essential ingredients

minimum content of nutrients (percentage by weight):

| | 25 % P2O5 |
| --- | --- |

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 |
| --- | --- |

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 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 |
| --- | --- |

—

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 |
| --- | --- |

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) |
| --- | --- |

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 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 |
| --- | --- |

—

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 |
| --- | --- |

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 |
| --- | --- |

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 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 |
| --- | --- |

—

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 |
| --- | --- |

9 % K2O

| | potassium expressed as water- soluble K2O |
| --- | --- |

potassium expressed as water- soluble K2O

| | 2 % MgO |
| --- | --- |

2 % MgO

| | magnesium in the form of water- soluble salts, expressed as magnesium oxide |
| --- | --- |

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 |
| --- | --- |

from 16 July 2022, the relevant limits for contaminants set in Regulation (EU) 2019/1009 apply

Potassium sulphate, possibly containing magnesium salt

product obtained from crude potassium salt by a physical extraction process, containing possibly also magnesium salts

Stillage and stillage extract

ammonium stillage excluded

Calcium carbonate, for instance: chalk, marl, ground limestone, Breton ameliorant (maerl), phosphate chalk

only of natural origin

Mollusc waste

only from organic aquaculture or from sustainable fisheries, in accordance with Article 2 of Regulation (EU) No 1380/2013

Egg shells

factory farming origin forbidden

Magnesium and calcium carbonate

only of natural origin

e.g. magnesian chalk, ground magnesium, limestone

Magnesium sulphate (kieserite)

only of natural origin

Calcium chloride solution

only for foliar treatment of apple trees, to prevent deficit of calcium

Calcium sulphate (gypsum)

product of natural origin containing calcium sulphate at various degrees of hydration

minimum content of nutrients (percentage per weight):

| | 25 % CaO |
| --- | --- |

25 % CaO

| | 35 % SO3 |
| --- | --- |

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 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 |
| --- | --- |

—

at least 99 % to pass through a sieve with a 10 mm mesh width

from 16 July 2022, the relevant limits for contaminants set in Regulation (EU) 2019/1009 apply

Industrial lime from sugar production

by-product of sugar production from sugar beet and sugar cane

Industrial lime from vacuum salt production

by-product of the vacuum salt production from brine found in mountains

Elemental sulphur

until 15 July 2022: as listed in accordance with Part D of Annex I to Regulation (EC) No 2003/2003

from 16 July 2022, the relevant limits for contaminants set in Regulation (EU) 2019/1009 apply

Inorganic Micronutrient Fertilisers

until 15 July 2022: as listed in accordance with Part E of Annex I to Regulation (EC) No 2003/2003;

from 16 July 2022, the relevant limits for contaminants set in Regulation (EU) 2019/1009 apply

Sodium chloride

Stone meal, clays and clay minerals

Leonardite (Raw organic sediment rich in humic acids)

only if obtained as a by-product of mining activities

Humic and fulvic acids

only if obtained by inorganic salts/solutions excluding ammonium salts; or obtained from drinking water purification

Xylite

only if obtained as a by-product of mining activities (e.g. by-product of brown coal mining)

Chitin (Polysaccharide obtained from the shell of crustaceans)

obtained from organic aquaculture or from sustainable fisheries, in accordance with Article 2 of Regulation (EU) No 1380/2013

Organic (2) 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

---

(1)  Covering in particular all the product function categories listed in Part I of Annex I to Regulation (EU) 2019/1009.

(2)  Here ‘organic’ is used in the sense of organic chemistry, not organic farming

---

ANNEX III

Authorised products and substances for use as feed or in feed production

PART A

Authorised non-organic feed material of plant, algal, animal or yeast origin or feed material of microbial or mineral origin referred to in point (c) of Article 24(1) of Regulation (EU) 2018/848

(1)   FEED MATERIALS OF MINERAL ORIGIN

| Number in feed catalogue (1) | Name | Specific conditions and limits |
| --- | --- | --- |
| 11.1.1 | Calcium carbonate | |
| 11.1.2 | Calcareous marine shells | |
| 11.1.4 | Maerl | |
| 11.1.5 | Lithothamn | |
| 11.1.13 | 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 | |

Number in feed catalogue (1)

Name

Specific conditions and limits

11.1.1

Calcium carbonate

11.1.2

Calcareous marine shells

11.1.4

Maerl

11.1.5

Lithothamn

11.1.13

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 (2) | 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:






  — | when not available in organic form |

Number In feed catalogue (2)

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:

—

when not available in organic form

| — | produced/prepared without chemical solvents |
| --- | --- |

—

produced/prepared without chemical solvents

| — | maximum 1 % in the feed ration |
| --- | --- |

—

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 |
| --- | --- |

—

when not available in organic form

| — | produced/prepared without chemical solvents |
| --- | --- |

—

produced/prepared without chemical solvents

| — | maximum 1 % in the feed ration |
| --- | --- |

—

maximum 1 % in the feed ration

Phytoplankton and zooplankton

only in the larval rearing of organic juveniles

specific protein compounds

In accordance with point 1.9.3.1(c) and 1.9.4.2(c) of Regulation (EU) 2018/848, in particular:

| — | until 31 December 2026, |
| --- | --- |

—

until 31 December 2026,

| — | when not available in organic form, |
| --- | --- |

—

when not available in organic form,

| — | produced/prepared without chemical solvents, |
| --- | --- |

—

produced/prepared without chemical solvents,

| — | for feeding piglets of up to 35 kg or young poultry, |
| --- | --- |

—

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 |
| --- | --- |

—

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 |
| --- | --- |

—

when not available in organic form

| — | produced/prepared without chemical solvents |
| --- | --- |

—

produced/prepared without chemical solvents

| — | maximum 1 % in the feed ration |
| --- | --- |

—

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 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 | |

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) | |

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 |

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 | |

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 |

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.) |

ID number or functional group

Name

Specific conditions and limits

ex2a

Astaxanthin

only when derived from organic sources, such as organic crustacean shells

only in the feed ration for salmon and trout within the limit of their physiological needs

if no astaxanthin derived from organic sources are available, astaxanthin from natural sources may be used such as Astaxanthin-rich Phaffia rhodozyma

ex2b

Flavouring compounds

only extracts from agricultural products, including Chestnut extract (Castanea sativa Mill.)

(3)   NUTRITIONAL ADDITIVES

(a)   Vitamins, pro-vitamins and chemically well-defined substances having similar effect

| ID number or functional group | Name | Specific conditions and limits |
| --- | --- | --- |
| ex3a | Vitamins and Provitamins | derived from agricultural products
  if not available from agricultural products:






  — | derived synthetically, only those identical to vitamins derived from agricultural products may be used for monogastric animals and aquaculture animals |

ID number or functional group

Name

Specific conditions and limits

ex3a

Vitamins and Provitamins

derived from agricultural products

if not available from agricultural products:

—

derived synthetically, only those identical to vitamins derived from agricultural products may be used for monogastric animals and aquaculture animals

| — | derived synthetically, only vitamins A, D and E identical to vitamins derived from agricultural products may be used for ruminants; the use is subject to prior authorisation of the Member States based on the assessment of the possibility for organic ruminants to obtain the necessary quantities of the said vitamins through their feed rations |
| --- | --- |

—

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

3a920

Betaine anhydrous

only for monogastric animals

from organic production; if not available, from natural origin

(b)   Compounds of trace elements

| ID number or functional group | Name | Specific conditions and limits |
| --- | --- | --- |
| 3b101 | Iron(II) carbonate (siderite) | |
| 3b103 | Iron(II) sulphate monohydrate | |
| 3b104 | Iron(II) sulphate heptahydrate | |
| 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 | |

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 |

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 | |

ID number or functional group

Name

Specific conditions and limits

4a, 4b, 4c and 4d

Enzymes and microorganism

---

(1)  In accordance with Commission Regulation (EU) No 68/2013 of 16 January 2013 on the Catalogue of feed materials (OJ L 29, 30.1.2013, p. 1).

(2)  In accordance with Regulation (EU) No 68/2013.

---

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 soda;

| — | caustic potash; |
| --- | --- |

—

caustic potash;

| — | oxalic acid; |
| --- | --- |

—

oxalic acid;

| — | natural essences of plants with the exception of linseed oil, lavender oil and peppermint oil; |
| --- | --- |

—

natural essences of plants with the exception of linseed oil, lavender oil and peppermint oil;

| — | nitric acid; |
| --- | --- |

—

nitric acid;

| — | phosporic acid; |
| --- | --- |

—

phosporic acid;

| — | sodium carbonate; |
| --- | --- |

—

sodium carbonate;

| — | copper sulphate; |
| --- | --- |

—

copper sulphate;

| — | potassium permanganate; |
| --- | --- |

—

potassium permanganate;

| — | tea seed cake made of natural camelia seed; |
| --- | --- |

—

tea seed cake made of natural camelia seed;

| — | humic acid; |
| --- | --- |

—

humic acid;

| — | peroxyacetic acids with the exception of peracetic 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 (1)

  only from organic production |
| E 938 | Argon | products of plant and animal origin | |
| E 939 | Helium | products of plant and animal origin | |
| E 941 | Nitrogen | products of plant and animal origin | |
| E 948 | Oxygen | products of plant and animal origin | |
| E 968 | Erythritol | products of plant and animal origin | only from organic production without using ion exchange technology |

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 (1)

only from organic production

E 938

Argon

products of plant and animal origin

E 939

Helium

products of plant and animal origin

E 941

Nitrogen

products of plant and animal origin

E 948

Oxygen

products of plant and animal origin

E 968

Erythritol

products of plant and animal origin

only from organic production without using ion exchange technology

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 (2) |
| 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 (3)

  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) |

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 (2)

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 (3)

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 |

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 |

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 |

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

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(1)  Commission Implementing Directive (EU) 2017/1279 of 14 July 2017 amending Annexes I to V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 184, 15.7.2017, p. 33).

(2)  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).

(3)  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)

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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

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