Commission Implementing Regulation (EU) 2025/973 of 23 May 2025 amending and correcting Implementing Regulation (EU) 2021/1165 authorising certain products and substances for use in organic production and establishing their lists
Date: 2025-05-23
Institutions: Directorate-General for Agriculture and Rural Development, European Commission
Subjects: animal feedingstuffs, animal welfare, decontamination, fertiliser, food additive, organic farming, organic product, plant health product, third country, wine




L_202500973EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/973


26.5.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/973
of 23 May 2025
         
amending and correcting Implementing Regulation (EU) 2021/1165 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) thereof,

Whereas:







(1)


Article 45(2) of Regulation (EU) 2018/848 empowers the Commission to grant specific authorisations for the use of products and substances in organic products originating from third countries and the outermost regions of the Union that are to be placed on the market in the Union. Article 10 of Commission Implementing Regulation (EU) 2021/1165 (2) sets out the procedure for granting such authorisations, but only in relation to third countries. It is therefore necessary to provide for the procedure for granting specific authorisations for the use of products and substances in organic products originating from the outermost regions of the Union. For reasons of clarity, the list of products and substances authorised in the outermost regions of the Union, once available, should be added in Annex VI to Implementing Regulation (EU) 2021/1165.












(2)


Commission Implementing Regulation (EU) 540/2011 (3) has been amended following the re-assessment of the active substances lavandulyl senecioate (4), potassium hydrogen carbonate (5), straight chain lepidopteran pheromones (acetates) (6), sheep fat (7) and quartz sand (8). In order to reflect these amendments, the entries for potassium hydrogen carbonate, sheep fat and quartz sand should be removed from point 4 of Annex I to Implementing Regulation (EU) 2021/1165 and the entries for lavandulyl senecioate, potassium hydrogen carbonate, straight chain lepidopteran pheromones (acetates), sheep fat and quartz sand should be included in point 2 of that Annex, which lists low-risk active substances.












(3)


In accordance with the procedure provided for in Article 24(7) of Regulation (EU) 2018/848, Member States have submitted dossiers on certain substances to the other Member States and the Commission, in view of their authorisation and inclusion in Annexes I, II, III and V to Implementing Regulation (EU) 2021/1165. Those dossiers have been examined by the Expert Group for Technical Advice on Organic Production (‘EGTOP’) and the Commission.












(4)


Based on the recent assessment of straight chain lepidopteran pheromones in Implementing Regulation (EU) 2022/1251 and the guidance document on semio-chemicals (9), pheromones and other semio-chemicals are applied via traps or dispensers, whether active or passive. Moreover, Article 24(3), point (c)(ii), of Regulation (EU) 2018/848 sets restrictions on the nature of the products that may be applied directly on the edible parts of the crops, and in the case of semio-chemicals, traps and dispensers are to prevent contact with the crop pursuant to Part I, point 1.10.3, of Annex II to that Regulation. It is therefore appropriate to remove the condition that pheromones and other semio-chemicals are to be used only in traps and dispensers in the table entry for ‘pheromones and other semio-chemicals’ in point 4 of Annex I to Implementing Regulation (EU) 2021/1165.












(5)


In accordance with Annex II to Implementing Regulation (EU) 2021/1165, products and by-products of plant origin may be used as fertilisers in organic production, but also as soil conditioners and nutrients under that Annex. The entry ‘products and by-products of plant origin for fertilisers’ should therefore be clarified and adapted accordingly.












(6)


Based on recommendations from EGTOP regarding greenhouses (10) and fertilisers (11), the entry concerning stone meal, clays and clay minerals in Annex II to Implementing Regulation (EU) 2021/1165 should be amended by adding further products. In addition, since stone meal, clays and clay minerals may be used as an inert medium in sprouted seeds production, such use should be included in that entry in accordance with the specific conditions set out in Part I, point 1.3(a), of Annex II to Regulation (EU) 2018/848.












(7)


Based on recommendations from EGTOP regarding greenhouses and fertilisers (12), the use of carbon dioxide should be allowed as a nutrient for the enrichment of water for algae production in closed systems on land, and the substance should be of food grade to avoid any contamination of water. Moreover, EGTOP has assessed and concluded positively on the use of carbon dioxide in organic greenhouse production (13). It is therefore appropriate to add an entry for carbon dioxide in Annex II to Implementing Regulation (EU) 2021/1165.












(8)


Based on recommendations from EGTOP regarding fertilisers (14), the use of calcium acetate should be authorised but only for foliar application on vegetables in greenhouses and on apple trees to prevent deficiency in calcium. Based on those recommendations, also the use of calcium phosphate should be authorised in organic production but only when derived from sewage sludge ash and only when contained in products complying with the requirements of Regulation (EU) 2019/1009 of the European Parliament and of the Council (15). Annex II to Implementing Regulation (EU) 2021/1165 should therefore be amended accordingly.












(9)


Based on recommendations from EGTOP regarding fertilisers (16), the use of plant fibre mats without any added fertilisers, soil conditioners or other nutrients should be allowed as an inert medium in the production of sprouted seeds in accordance with Part I, point 1.3(a), of Annex II to Regulation (EU) 2018/848. Moreover, on the basis of the dossier submitted, it is appropriate to require that such plant fibre mats be only mechanically manufactured with no use of additives or binders, and that the plant fibre used be of organic origin. Annex II to Implementing Regulation (EU) 2021/1165 should therefore be amended accordingly.












(10)


Based on recommendations from EGTOP regarding fertilisers (17), the use of calcium and magnesium gluconate should be authorised, provided that it is obtained only from microbial fermentation and under strict limits. Annex II to Implementing Regulation (EU) 2021/1165 should therefore be amended accordingly.












(11)


Annex III to Implementing Regulation (EU) 2021/1165 allows the use of ‘calcium chloride’ and ‘propylene glycol’ (feed materials) as well as ‘iron dextran 10 %’ (nutritional additive) as feed intended for particular nutritional purposes. The specific conditions and limits for that use should be clarified to ensure a correct understanding of the relevant entries. In particular, reference should be made to the definition of ‘feed intended for particular nutritional purposes’ in Regulation (EC) No 767/2009 of the European Parliament and of the Council (18) and to the particular nutritional purpose of those substances under Commission Regulation (EU) 2020/354 (19).












(12)


Based on recommendations from EGTOP regarding feed (20) (21), single cell proteins from Trichoderma viride and Aspergillus oryyzae and products from Bacillus subtilis rich in protein used as feed materials, lecithins used as a feed additives in feed for all animals, and ethanol and papain used as processing aids should be authorised. Annex III to Implementing Regulation (EU) 2021/1165 should therefore be amended accordingly.












(13)


Commission Regulation (EC) No 2277/2003 (22) had authorised calcium stearate to be used as a feed additive in organic production. However, Commission Regulation (EU) No 892/2010 (23) listed calcium stearate among the products that are not feed additives. Consequently, in 2012, it was removed from the list of authorised feed additives in Commission Regulation (EC) No 889/2008 (24) by Commission Implementing Regulation (EU) No 505/2012 (25). Currently, calcium stearate is covered by the feed materials listed in the table in Part C, point 13, number 13.6.4, of the Annex to Commission Regulation (EU) No 68/2013 (26). Calcium stearate should therefore be authorised as a feed material for organic production. Annex III to Implementing Regulation (EU) 2021/1165 should be amended accordingly.












(14)


In Part B, point 1(a), of Annex III to Implementing Regulation (EU) 2021/1165, feed additives are identified by the European food additive number (E number). In accordance with Regulation (EC) No 1831/2003 of the European Parliament and of the Council (27), feed additives are to be identified by their functional group. For reasons of consistency, feed additives should also be identified by their functional group code in Implementing Regulation (EU) 2021/1165. Annex III to Implementing Regulation (EU) 2021/1165 should therefore be amended accordingly.












(15)


In its recommendations on the use of calcium propionate as a preservative and as feed intended for particular nutritional purposes20, EGTOP did not recommend its inclusion as a feed additive, with the justification that calcium chloride can be used for particular nutritional purposes and that calcium propionate is not to be used as a preservative. However, calcium propionate is absorbed more slowly than calcium chloride and will prevent the irritating effects when only using calcium chloride. In the table in Part B, entry ‘60’, of the Annex to Regulation (EU) 2020/354, calcium propionate is listed as feed intended for particular nutritional purposes. Pursuant to Commission Implementing Regulation (EU) 2022/415 (28), calcium propionate is a feed additive. Calcium propionate should therefore be listed as an authorised feed additive in Annex III to Implementing Regulation (EU) 2021/1165, provided that it is used only as feed intended for particular nutritional purposes.












(16)


In its recommendations on the use of iron(II) fumarate as a feed intended for particular nutritional purposes (29), EGTOP did not recommend the inclusion of iron(II) fumarate in Implementing Regulation (EU) 2021/1165 as it considered that the iron dextran authorised in that Implementing Regulation was the most effective product for iron deficiency. However, iron dextran and iron(II) fumarate are not alternatives but are both needed due to their different states, with iron dextran being liquid and iron(II) fumarate being solid. Iron(II) fumarate should therefore be listed as a feed additive in Annex III to Implementing Regulation (EU) 2021/1165.












(17)


Food additives and food processing aids used in the production of processed organic food are listed in two separate sections in Part A of Annex V to Implementing Regulation (EU) 2021/1165. The use of a product as a food additive or as a processing aid is to be determined in accordance with the definitions of food additive and processing aid in Article 3(2) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council (30). Depending on their technological function in the final product, certain products classified as processing aids should instead be classified as food additives and certain other products should be classified as food additives and as food processing aids according to their uses. For the sake of clarity, the lists of food additives and food processing aids in Part A, Sections A1 and A2, of Annex V to Implementing Regulation (EU) 2021/1165 should therefore be merged into a single list, and further specific conditions should be set for processing aids that can also be used as food additives.












(18)


In that merged list, the specific condition that the additive ‘calcium carbonate’ is not to be used for colouring or calcium enrichment should be deleted as the rules provided for in Part IV, points 2.2.2(c), (d) and (f), of Annex II to Regulation (EU) 2018/848 already contain that condition.












(19)


Based on recommendations from EGTOP regarding food (31), buffered vinegar should be included as a food additive in the list of authorised food additives and processing aids in Part A of Annex V to Implementing Regulation (EU) 2021/1165.












(20)


In the list of authorised food additives and processing aids in Part A of Annex V to Implementing Regulation (EU) 2021/1165, the maximum levels for sodium nitrite and potassium nitrate should be expressed as nitrite ion and nitrate ion, in line with the Acceptable Daily Intakes (ADIs) established by the European Food Safety Authority (32). For that purpose, a conversion factor between sodium nitrite and nitrite ion of 0,67 and a conversion factor between sodium nitrate and nitrate ion of 0,73 should be applied.












(21)


In Part A, section A1, of Annex V to Implementing Regulation (EU) 2021/1165, gellan gum is listed as an authorised food additive that is to be produced in accordance with organic production rules from 1 January 2026. Gellan gum production depends on maintaining specific and consistent raw material qualities for the microorganism. So far, attempts to manufacture gellan gum using organic agricultural raw materials have been unsuccessful. Gellan gum is used as an additive in organic processed food. To avoid disruption of the production of organic processed food, the use of non-organic gellan gum should continue to be authorised in organic production. This should be reflected in the entry for gellan gum in the merged list of authorised food additives and processing aids in Part A of Annex V to Implementing Regulation (EU) 2021/1165.












(22)


In Part A, section A1, of Annex V to Implementing Regulation (EU) 2021/1165, the use of hydrochloric acid, hydrogen peroxide and ammonium hydroxide is authorised for gelatine production under the condition that gelatine production complies with the rules for production of gelatine laid down in Regulation (EC) No 853/2004 of the European Parliament and of the Council (33). It is not necessary to repeat that specific condition in the merged list of authorised food additives and processing aids in Part A of Annex V to Implementing Regulation (EU) 2021/1165.












(23)


In its recommendations on yeast-based nutrients (34), EGTOP confirmed that nutrients corresponding to minerals, vitamins and amino acids were essential fermentation activators to assist yeast production. However, EGTOP concluded that the use of synthetic nutrients was not in line with the principles of organic production. EGTOP therefore recommended authorising the use of nutrients that derive exclusively from yeast extract or from autolysate to assist yeast production in a limited quantity of up to 5 % of the substrate concerned calculated in weight of dry matter. Fermentation activators consisting of nutrients from yeast extract or autolysate should therefore be listed in Part C of Annex V to Implementing Regulation (EU) 2021/1165 as authorised products, within the limit of 5 % of the substrate.












(24)


In accordance with Part VI, point 3.4, of Annex II to Regulation (EU) 2018/848, a Member State has submitted a dossier for an authorisation to use yeasts and lactic acid bacteria as acidity regulators in organic wine production. In accordance with Part D of Annex V to Implementing Regulation (EU) 2021/1165, yeasts for wine production and lactic acid bacteria are authorised as fermentation agents. These fermentation agents also exhibit acidity regulation properties. Since these fermentation agents are suitable alternatives to other acidity regulators already authorised for organic wine production, their use as acidity regulators should be authorised, and Part D of Annex V to Implementing Regulation (EU) 2021/1165 should be changed accordingly.












(25)


Based on recommendations from EGTOP regarding plant protection products (35), the use of ethylene for flower induction in pineapple and the use in organic crops of microorganisms that do not originate from genetically modified organisms, should be allowed for use in organic production in third countries as active substances contained in plant protection products. It is therefore appropriate to include those substances and the specific conditions and limits for their use in Annex VI to Implementing Regulation (EU) 2021/1165.












(26)


The basic substance ‘magnesium hydrogen metasilicate silicate mineral (Talc E 553b)’ is listed in the table in point 1 of Annex I to Implementing Regulation (EU) 2021/1165. However, the specific condition indicated in the column ‘specific conditions and limits’ is not an additional restriction on the use of that basic substance. This error should therefore be corrected.












(27)


Implementing Regulation (EU) 2021/1165 should therefore be amended and corrected accordingly.












(28)


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





HAS ADOPTED THIS REGULATION:



Article 1

Amendments to Implementing Regulation (EU) 2021/1165

Implementing Regulation (EU) 2021/1165 is amended as follows:






(1)


The following Article 10a is inserted:

‘Article 10a
Procedure to grant specific authorisation for the use of products and substances in the outermost regions of the Union

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


2.   The Commission shall publish any requests referred to in paragraph 1.


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 whole that:






(a)


such specific authorisation is justified in the outermost region concerned;










(b)


the product or substance described in the dossier complies with the principles laid down in Chapter II, the criteria set out in Article 24(3) and the condition set out in Article 24(5) of Regulation (EU) 2018/848; and










(c)


the use of the product or substance is in accordance with the relevant provisions of Union law, in particular, for active substances contained in plant protection products, with Regulation (EC) No 396/2005.
The authorised product or substance shall be included in Annex VI to this Regulation.






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 needs to be reassessed.’

;









(2)


Annex I is amended in accordance with Annex I to this Regulation;










(3)


Annex II is amended in accordance with Annex II to this Regulation;










(4)


Annex III is amended in accordance with Annex III to this Regulation;










(5)


Annex V is amended in accordance with Annex IV to this Regulation;










(6)


Annex VI is replaced by the text set out in Annex V to this Regulation.






Article 2

Correction of Implementing Regulation (EU) 2021/1165

In the table in point 1 of Annex I to Implementing Regulation (EU) 2021/1165, the entry ‘19C’ is replaced by the following:









‘19C


14807-96-6


Magnesium hydrogen metasilicate silicate mineral (Talc E 553b)’


 







Article 3

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 May 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 150, 14.6.2018, p. 1, ELI: http://data.europa.eu/eli/reg/2018/848/oj.

(2)  Commission Implementing Regulation (EU) 2021/1165 of 15 July 2021 authorising certain products and substances for use in organic production and establishing their lists (OJ L 253, 16.7.2021, p. 13, ELI: http://data.europa.eu/eli/reg_impl/2021/1165/oj).

(3)  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, ELI: http://data.europa.eu/eli/reg_impl/2011/540/oj).

(4)  Commission Implementing Regulation (EU) 2020/646 of 13 May 2020 approving the active substance Lavandulyl senecioate as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (OJ L 151, 14.5.2020, p. 3, ELI: http://data.europa.eu/eli/reg_impl/2020/646/oj).

(5)  Commission Implementing Regulation (EU) 2021/1452 of 3 September 2021 renewing the approval of the active substance potassium hydrogen carbonate as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 313, 6.9.2021, p. 30, ELI: http://data.europa.eu/eli/reg_impl/2021/1452/oj).

(6)  Commission Implementing Regulation (EU) 2022/1251 of 19 July 2022 renewing the approval of the active substances Straight Chain Lepidopteran Pheromones (acetates) as low-risk active substances, and Straight Chain Lepidopteran Pheromones (aldehydes and alcohols) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 191, 20.7.2022, p. 35, ELI: http://data.europa.eu/eli/reg_impl/2022/1251/oj).

(7)  Commission Implementing Regulation (EU) 2022/1474 of 6 September 2022 renewing the approval of the low-risk active substance sheep fat in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 232, 7.9.2022, p. 3, ELI: http://data.europa.eu/eli/reg_impl/2022/1474/oj).

(8)  Commission Implementing Regulation (EU) 2023/1488 of 6 July 2023 renewing the approval of the low-risk active substance quartz sand in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 (OJ L 183, 20.7.2023, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2023/1488/oj).

(9)  European Commission: Directorate-General for Health and Food Safety, ‘Guidance document on semiochemical active substances and plant protection products’, SANTE/12815/2014 rev. 11, January 2024, https://food.ec.europa.eu/document/download/ae787d28-356b-4e42-8c15-89ed8c91faf2_en?filename=pesticides_ppp_app-proc_guide_doss_semiochemicals_202401.pdf.

(10)  EGTOP, ‘Final report on Greenhouses’, 19 June 2016, https://agriculture.ec.europa.eu/document/download/7ae7f682-cf88-4c1e-8686-afd5617ec7ae_en?filename=final-report-etop-greenhouse-production.pdf.

(11)  EGTOP, ‘Final report on Plant Protection (X) and Fertilisers (VII)’, 3 May 2024, https://agriculture.ec.europa.eu/document/download/57c18571-67ba-4e28-b9df-139f2ac36b91_en?filename=egtop-report-ppp-10_and_fertilisers-7_en.pdf.

(12)  EGTOP, ‘Final report on Greenhouses’, 19 June 2016, https://agriculture.ec.europa.eu/document/download/7ae7f682-cf88-4c1e-8686-afd5617ec7ae_en?filename=final-report-etop-greenhouse-production.pdf; EGTOP, ‘Final report on Fertilisers (VI) and Plant Protection Products (VIII)’, 28 August 2023, https://agriculture.ec.europa.eu/document/download/a4561074-266c-40dd-881b-c27f150e3d8a_en?filename=egtop-report-fertilisers-vi-and-ppp-viii_en.pdf.

(13)  EGTOP, ‘Final report on Greenhouses’, 19 June 2016, https://agriculture.ec.europa.eu/document/download/7ae7f682-cf88-4c1e-8686-afd5617ec7ae_en?filename=final-report-etop-greenhouse-production.pdf.

(14)  EGTOP, ‘Final report on Plant Protection (X) and Fertilisers (VII)’, 3 May 2024, https://agriculture.ec.europa.eu/document/download/57c18571-67ba-4e28-b9df-139f2ac36b91_en?filename=egtop-report-ppp-10_and_fertilisers-7_en.pdf.

(15)  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, ELI: http://data.europa.eu/eli/reg/2019/1009/oj).

(16)  EGTOP, ‘Final report on Fertilisers (VI) and Plant Protection Products (VIII)’, 28 August 2023, https://agriculture.ec.europa.eu/document/download/a4561074-266c-40dd-881b-c27f150e3d8a_en?filename=egtop-report-fertilisers-vi-and-ppp-viii_en.pdf.

(17)  EGTOP, ‘Final report on Plant Protection (X) and Fertilisers (VII)’, 3 May 2024, https://agriculture.ec.europa.eu/document/download/57c18571-67ba-4e28-b9df-139f2ac36b91_en?filename=egtop-report-ppp-10_and_fertilisers-7_en.pdf.

(18)  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, ELI: http://data.europa.eu/eli/reg/2009/767/oj).

(19)  Commission Regulation (EU) 2020/354 of 4 March 2020 establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC (OJ L 67, 5.3.2020, p. 1, ELI: http://data.europa.eu/eli/reg/2020/354/oj).

(20)  EGTOP, ‘Final report on Feed (VII) and Pet Food (II)’, 16 March 2023, https://agriculture.ec.europa.eu/document/download/46e56928-5332-4ae5-919e-c5c108422537_en?filename=egtop-report-feed-vii-and-petfood-ii_en.pdf.

(21)  EGTOP, ‘Final report on Feed (VIII) and Food (IX)’, 1 July 2024, https://agriculture.ec.europa.eu/document/download/88317fd1-c9d2-4dca-bbc3-64521f806d09_en?filename=egtop-report-feed-viii_and_food-ix_en.pdf.

(22)  Commission Regulation (EC) No 2277/2003 of 22 December 2003 amending Annexes I and II to Council Regulation (EEC) No 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs (OJ L 336, 23.12.2003, p. 68, ELI: http://data.europa.eu/eli/reg/2003/2277/oj).

(23)  Commission Regulation (EU) No 892/2010 of 8 October 2010 on the status of certain products with regard to feed additives within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council (OJ L 266, 9.10.2010, p. 6, ELI: http://data.europa.eu/eli/reg/2010/892/oj).

(24)  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, ELI: http://data.europa.eu/eli/reg/2008/889/oj).

(25)  Commission Implementing Regulation (EU) No 505/2012 of 14 June 2012 amending and correcting Regulation (EC) No 889/2008 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 154, 15.6.2012, p. 12, ELI: http://data.europa.eu/eli/reg_impl/2012/505/oj).

(26)  Commission Regulation (EU) No 68/2013 of 16 January 2013 on the Catalogue of feed materials (OJ L 29, 30.1.2013, p. 1, ELI: http://data.europa.eu/eli/reg/2013/68/oj).

(27)  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, ELI: http://data.europa.eu/eli/reg/2003/1831/oj).

(28)  Commission Implementing Regulation (EU) 2022/415 of 11 March 2022 concerning the authorisation of malic acid, citric acid produced by Aspergillus niger DSM 25794 or CGMCC 4513/CGMCC 5751 or CICC 40347/CGMCC 5343, sorbic acid and potassium sorbate, acetic acid, sodium diacetate and calcium acetate, propionic acid, sodium propionate, calcium propionate and ammonium propionate, formic acid, sodium formate, calcium formate and ammonium formate, and lactic acid produced by Bacillus coagulans (LMG S-26145 or DSM 23965), or Bacillus smithii (LMG S-27890) or Bacillus subtilis (LMG S-27889) and calcium lactate as feed additives for certain animal species (OJ L 85, 14.3.2022, p. 6, ELI: http://data.europa.eu/eli/reg_impl/2022/415/oj).

(29)  EGTOP, ‘Final report on Feed (VII) and Pet Food (II)’, 16 March 2023, https://agriculture.ec.europa.eu/document/download/46e56928-5332-4ae5-919e-c5c108422537_en?filename=egtop-report-feed-vii-and-petfood-ii_en.pdf.

(30)  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, ELI: http://data.europa.eu/eli/reg/2008/1333/oj).

(31)  EGTOP, ‘Final report on Feed (VIII) and Food (IX)’, 1 July 2024, https://agriculture.ec.europa.eu/document/download/88317fd1-c9d2-4dca-bbc3-64521f806d09_en?filename=egtop-report-feed-viii_and_food-ix_en.pdf.

(32)  EFSA, Re-evaluation of potassium nitrite (E 249) and sodium nitrite (E 250) as food additives, EFSA Journal 2017;15(6):4786, https://doi.org/10.2903/j.efsa.2017.4786.

(33)  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, ELI: http://data.europa.eu/eli/reg/2004/853/oj).

(34)  EGTOP, ‘Final report on Food (X)’, 31 January 2025, https://agriculture.ec.europa.eu/document/download/c4cef8da-34a4-48f7-9f5d-2c97f86f2a15_en?filename=egtop-report-food-x_en.pdf.

(35)  EGTOP, ‘Final report on Fertilisers (VI) and Plant Protection Products (VIII)’, 28 August 2023, https://agriculture.ec.europa.eu/document/download/a4561074-266c-40dd-881b-c27f150e3d8a_en?filename=egtop-report-fertilisers-vi-and-ppp-viii_en.pdf; EGTOP, ‘Final report on Plant Protection (IX)’, 14 December 2023, https://agriculture.ec.europa.eu/document/download/5a183a99-2e86-4add-a0ae-27fc519e5c11_en?filename=egtop-report-ppp-ix_en.pdf.




ANNEX I
Annex I to Implementing Regulation (EU) 2021/1165 is amended as follows:






(1)


in point 2, the table is amended as follows:






(a)


the following entry is inserted between the entries ‘16D’ and ‘20D’:








‘19D


23960-07-8


Lavandulyl senecioate’


 














(b)


the following entries are added after the entry for other low risk substances from plant or animal origin *:








‘32D


298-14-6


Potassium hydrogen carbonate


 




38D


 


Straight chain lepidopteran pheromones (acetates)


 




39D


98999-15-6


Sheep fat


use as repellent by smell’




44D


14808-60-7 and
7631-86-9


Quartz sand
Silicon dioxide


 


















(2)


in point 4, the table is amended as follows:






(a)


the entries ‘244A’, ‘247A’, ‘249A’ and ‘255A and others’ are deleted;










(b)


the following entry is inserted between the entries ‘47B’ and ‘10E’:








‘153B and others


 


Pheromones and other semiochemicals’


 

















ANNEX II
Annex II to Implementing Regulation (EU) 2021/1165 is amended as follows:






(1)


in the table, the entry ‘products and by-products of plant origin for fertilisers’ is replaced by the following:






‘Products and by-products of plant origin


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














(2)


in the table, the entry ‘stone meal, clays and clay minerals’ is replaced by the following:






‘Stone meal, sand of natural origin, clays and clay minerals


e.g., perlite, sand and vermiculite, including when heat treated,
perlite, sand and vermiculite, including when heat treated, may also be used for sprouted seeds production as an inert medium as referred to in Part I, point 1.3(a), of Annex II to Regulation (EU) 2018/848’














(3)


in the table, the following entries are added after the entry ‘selenium salts’:






‘Carbon dioxide


use for enrichment of water for algae production on land in closed systems; in this case, carbon dioxide shall be of food grade
when available, carbon dioxide shall be obtained as a by-product of other processes or from renewable sources pursuant to Directive (EU) 2018/2001 of the European Parliament and of the Council (*1)

may also be used in greenhouse production




Calcium acetate


only for foliar application on vegetables in greenhouses and on apple trees to prevent deficiency in calcium
obtained from calcium carbonate of natural origin




Calcium phosphate


only when derived from sewage sludge ash
only products complying with the requirements of Regulation (EU) 2019/1009




Plant fibre mats


plant-based fibres, such as hemp fibre, flax fibre, coconut fibre
with no addition of any fertiliser, soil conditioner or nutrient nor additives or binders, only mechanically manufactured
only for sprouted seeds production as an inert medium referred to in Part I, point 1.3(a), of Annex II to Regulation (EU) 2018/848
when available, materials from organic production shall be used




Calcium and magnesium gluconate


derived from microbial fermentation










(*1)  Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82, ELI: http://data.europa.eu/eli/dir/2018/2001/oj).’.





ANNEX III
Annex III to Implementing Regulation (EU) 2021/1165 is amended as follows:






(1)


Part A is amended as follows:






(a)


in point (1), in the table, the entry ‘11.1.6’ is replaced by the following:







‘11.1.6


Calcium chloride


may only be used as “feed intended for particular nutritional purposes” defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for the reduction of the risk of milk fever and subclinical hypocalcaemia in accordance with Part B, table entry “60”, of the Annex to Commission Regulation (EU) 2020/354 (*1), including bolus formulation
calcium chloride when purified from naturally occurring brine, if available
only for dairy cows in need and for a limited period














(b)


in point (2), the table is amended as follows:






(i)


the following entries are inserted between the entries ‘12.1.5’ and ‘12.1.12’:







‘ex 12.1.9


Single cell proteins from Trichoderma viride and Aspergillus oryzae



only from non-GM strain and culture media
not obtained from substrates with synthetic nitrogen sources
obtained from substrates coming from organic production when used for ruminants and other herbivores
when used, antifoaming agents shall be authorised for organic production




12.1.10


Products from Bacillus subtilis rich in protein


only from non-GM strain and culture media
not obtained from substrates with synthetic nitrogen sources
obtained from substrates coming from organic production when used for ruminants and other herbivores
when used, antifoaming agents shall be authorised for organic production’














(ii)


the following entry is inserted between the entries ‘12.1.12’ and ‘13.11.1’:







‘ex 13.6.4


Calcium stearate’


 














(iii)


the entry ‘13.11.1’ is replaced by the following:







‘13.11.1


Propylene glycol; [1,2-propanediol]; [propane-1,2-diol]


may only be used as “feed intended for particular nutritional purposes” defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for the reduction of the risk of ketosis in accordance with Part B, table entry “61”, of the Annex to Regulation (EU) 2020/354, including bolus formulation
only for dairy cows, ewes and goats in need and for a limited period’






















(2)


Part B is amended as follows:






(a)


in point (1)(a), the table is replaced by the following:







‘ID number or functional group


Name


Specific conditions and limits




1a200


Sorbic acid


 




1k236


Formic acid


 




1k237i


Sodium formate


 




1a260


Acetic acid


 




1a270 1a270i


Lactic acids


 




1k280


Propionic acid


 




1a282


Calcium propionate


may only be used as “feed intended for particular nutritional purposes” defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for the reduction of the risk of milk fever and subclinical hypocalcaemia in accordance with Part B, table entry “60”, of the Annex to Regulation (EU) 2020/354, including bolus formulation
only for dairy cows in need and for a limited period’




1a330


Citric acid


 














(b)


in point (1)(c), in the table, the entry ‘1c322, 1c322i’ is replaced by the following:







‘1c322,
1c322i


Lecithins


derived from organic raw material
from 1 January 2027, only from organic production’














(c)


in point (3)(b), the table is amended as follows:






(i)


the following entry is inserted between the entries ‘3b104’ and ‘3b107’:







‘3b105


Iron(II) fumarate


may only be used as “feed intended for particular nutritional purposes” defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for compensation of insufficient iron availability after birth in accordance with Part B, table entry “64”, of the Annex to Regulation (EU) 2020/354
only for suckling piglets in need and for a limited period’














(ii)


the entry ‘3b110’ is replaced by the following:







‘3b110


Iron dextran 10 %


may only be used as “feed intended for particular nutritional purposes” defined in Article 3(2), point (o), of Regulation (EC) No 767/2009 for compensation of insufficient iron availability after birth in accordance with Part B, table entry “64”, of the Annex to Regulation (EU) 2020/354
growing medium for the fermentation process for dextran shall be of non-GMO origin
only for suckling piglets in need and for a limited period’


















(d)


the following point is added:






‘(5)


PROCESSING AIDS




For processing aids as defined in Article 2(2), point (h), of Regulation (EC) No 1831/2003, the specific conditions and limits set out in the following table shall apply.






Name


Specific conditions and limits




Ethanol


to be used only as extraction solvent for the production of protein meals and only when protein meals from mechanical extraction are not available in sufficient quantities
only from fermentation if available
only from organic production if available




Papain


only for the production of flavouring innards for the manufacture of pet food that are defined in point 18 of Annex I to Regulation (EU) No 142/2011
provided that the enzyme is inactivated during the process and therefore is not present as such in the resulting flavouring innards and does not have any technological effect on the product
from 1 January 2027, only from organic raw material’














(*1)  Commission Regulation (EU) 2020/354 of 4 March 2020 establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC (OJ L 67, 5.3.2020, p. 1, ELI: http://data.europa.eu/eli/reg/2020/354/oj).’.





ANNEX IV
Annex V to Implementing Regulation (EU) 2021/1165 is amended as follows:






(1)


Part A is replaced by the following:

                                 ‘PART A

Authorised food additives and processing aids referred to in Article 24(2), point (a), of Regulation (EU) 2018/848, including carriers and other substances used in the same way and with the same purpose as processing aids

The organic foodstuffs to which food additives may be added are within the limit of authorisations given in accordance with Regulation (EC) No 1333/2008.
The specific conditions and limits set out in the table below shall apply in addition to the conditions of the authorisations under Regulation (EC) No 1333/2008.
The use as food additives or as processing aids shall be attributed on a case-by-case basis in accordance with Regulation (EC) No 1333/2008 and national legislation on processing aids.
For the purpose of the calculation of the percentages referred to in Article 30(5) of Regulation (EU) 2018/848, food additives marked with an asterisk in the column “E-number or Einecs, or both” shall be calculated as ingredients of agricultural origin.








E-number or Einecs (+), or both


Name


Organic foodstuffs in which the additive or processing aid may be used and specific conditions and limits




Use as an additive


Use as a processing aid




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 170/207-439-9 and 215-279-6


Calcium carbonate


products of plant and animal origin


products of plant origin




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)


 




E 250


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 amount that may be added during the manufacturing expressed as NO2 ion: 50 mg/kg
maximum residual amount from all sources for the product ready for marketing throughout the shelf life of the product expressed as NO2 ion: 30 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 amount that may be added during the manufacturing expressed as NO3 ion: 55 mg/kg
maximum residual amount from all sources for the product ready for marketing throughout the shelf life of the product expressed as NO3 ion: 35 mg/kg


 




E 267*


Buffered vinegar


products of plant and animal origin
only from organic production


 




E 270/200-018-0


Lactic acid


products of plant and animal origin


cheese
for the regulation of pH of the brine bath in cheese production




E 290/204-696-9


Carbon dioxide


products of plant and animal origin


products of plant and animal origin




E 296


Malic acid


products of plant origin


 




E 300


Ascorbic acid


products of plant origin
meat products (category 08,3 (++)) and meat preparations (category 08,2 (++)) to which other ingredients than additives or salt have been added


 




E 301


Sodium ascorbate


meat products
may only be used in connection with nitrates and nitrites


 




E 306*


Tocopherol-rich extract


products of plant and animal origin
only as antioxidant


 




E 322*


Lecithins


products of plant and animal origin
only from organic production


 




E 325


Sodium lactate


products of plant origin


 




milk-based products


 




meat products


 




E 330/201-069-1


Citric acid


products of plant and animal origin


products of plant and animal origin




E 331


Sodium citrates


products of plant and animal origin


 




E 333


Calcium citrates


products of plant origin


 




E 334


Tartaric acid (L(+)-)


products of plant origin
mead


 




E 335*


Sodium tartrates


products of plant origin
from 1 January 2027, only from organic production


 




E 336*


Potassium tartrates


products of plant origin
from 1 January 2027, only from organic production


 




E 337*


Potassium sodium tartrate


products of plant origin
from 1 January 2027, only from organic production


 




E 341(i)


Monocalcium phosphate


self-raising flour
only as 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


 




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
only from organic production
only as thickener


 




E 418*


Gellan gum


products of plant and animal origin
from organic production, if available
only high-acyl form


 




E 422*


Glycerol


plant extracts and flavourings
only from plant origin
only from organic production
as solvent and carrier
as humectant in gel capsules
as surface coating of tablets


 




E 440(i)*


Pectin


products of plant origin


 




milk-based products




E 460/232-674-9


Cellulose


gelatine


gelatine




products of plant origin




E 464


Hydroxypropyl methyl cellulose


products of plant and animal origin
only as encapsulation material for capsules


 




E 500/207-838-8, 205-633-8, 208-580-9


Sodium carbonates


products of plant and animal origin


products of plant and animal origin




E 501/209-529-3, 206-059-0


Potassium carbonates


products of plant origin


grapes
only as drying agent to produce dried grapes




E 503


Ammonium carbonates


products of plant origin


 




E 504


Magnesium carbonates


products of plant origin


 




E 509/233-140-8


Calcium chloride


products of plant origin
only to induce coagulation


products of plant origin
only as clarifying/flocculating agent




milk-based products
only as stabiliser




sausages based on meat
only to induce coagulation to form casing




E 511/232-094-6


Magnesium chloride


products of plant origin
only to induce coagulation


products of plant origin
only as clarifying/flocculating agent




E 516/231-900-3


Calcium sulphate


products of plant origin
only as carrier or to induce coagulation


products of plant origin
only as clarifying/flocculating agent




E 524/215-185-5


Sodium hydroxide


surface-treated Laugengebäck

only as surface treatment


sugar(s)




flavourings
only as acidity regulator


oil from plant origin excluding olive oil




plant protein extracts




E 551/231-545-4


Silicon dioxide


cocoa
only as anticaking agent for use in automated dispensing machines


products of plant origin




herbs and spices in dried powdered form




flavourings




propolis




E 553b


Talc


products of plant origin


products of plant origin




sausages based on meat
only as surface treatment




E 901*/232-383-7


Beeswax


confectionery
only from organic production
only as glazing agent


products of plant origin
only from organic production
only as releasing agent




E 903*/232-399-4


Carnauba wax


confectionery
only from organic production
only as glazing agent


products of plant origin
only from organic production
only as releasing agent




citrus fruit
only from organic production
only as mitigating method for mandatory extreme cold treatment of fruit against harmful organisms in accordance with Commission Implementing Regulation (EU) 2019/2072 (+++)





E 938


Argon


products of plant and animal origin


 




E 939


Helium


products of plant and animal origin


 




E 941/231-783-9


Nitrogen


products of plant and animal origin


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


 




-/200-578-6


Ethanol


 


products of plant and animal origin
only as solvent on crystallization primers for the production of sugar and/or extraction solvent




-/200-580-7


Acetic acid


 


products of plant origin
from organic production, if available




fish
from organic production, if available




-/215-108-5


Bentonite


 


products of plant origin




mead
only as sticking agent




-/215-137-3


Calcium hydroxide


 


products of plant origin




-/231-595-7


Hydrochloric acid


 


gelatine




Gouda, Edam and Maasdammer cheeses, Boerenkaas, Friese and Leidse Nagelkaas
only as regulation of the pH of the brine bath in the processing of cheeses




-/231-639-5


Sulphuric acid


 


gelatine




sugar(s)




-/231-765-0


Hydrogen peroxide


 


gelatine




-/232-554-6


Gelatine


 


products of plant origin




-/232-555-1


Casein


 


products of plant origin




-/293-292-6


Isinglass


 


products of plant origin




-/931-328-0


Activated carbon


 


products of plant and animal origin




 


Ammonium hydroxide


 


gelatine




 


Diammonium phosphate


 


fruit wines, cider, perry and mead




 


L(+)lactic acid from fermentation


 


plant protein extracts




 


Thiamin hydrochloride


 


fruit wines, cider, perry and mead




 


Diatomaceous earth


 


products of plant origin




gelatine




 


Egg white albumin


 


products of plant origin




 


Hop extract


 


products of plant origin
from organic production, if available
only for antimicrobial purposes




 


Hazelnut shells


 


products of plant origin




 


Perlite


 


products of plant origin




gelatine




 


Pine rosin extract


 


products of plant origin
from organic production, if available
only for antimicrobial purposes




 


Rice meal


 


products of plant origin




 


Tannic acid


 


products of plant origin
only as filtration aid




 


Vegetable oils


 


products of plant and animal origin
only from organic production
only as greasing, releasing or antifoaming agent




 


Vinegar


 


products of plant origin
only from organic production




fish
only from
organic production




 


Water


 


products of plant and animal origin
water intended for human consumption within the meaning of Directive (EU) 2020/2184 of the European Parliament and of the Council (++++)





 


Wood fibre


 


products of plant and animal origin
the source of timber shall be restricted to certified, sustainably harvested wood
wood used shall not contain toxic components (post-harvest treatment, naturally occurring toxins or toxins from microorganisms)














(2)


in Part C, in the table, the following entry is added after the entry ‘vegetable oils’:








‘Fermentation activators


X


 


nutrients from yeast extract or autolysate
up to 5 % of the substrate calculated in weight of dry matter’














(3)


in Part D, the table is amended as follows:






(a)


the entry ‘yeasts for wine production’ is replaced by the following:








‘Yeasts for wine production


 


Part A, Table 2, point 1.11
Part A, Table 2, point 9.1


for the individual yeast strains, organic if available’














(b)


the entry ‘lactic acid bacteria’ is replaced by the following:








‘Lactic acid bacteria


 


Part A, Table 2, point 1.12
Part A, Table 2, point 9.2’


 














(+)  European Inventory of Existing Commercial Chemical Substances (OJ C 146, 15.6.1990, p. 4).

(++)  Food categories in Part D of Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16, ELI: http://data.europa.eu/eli/reg/2008/1333/oj).

(+++)  Commission Implementing Regulation (EU) 2019/2072 of 28 November 2019 establishing uniform conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament and the Council, as regards protective measures against pests of plants, and repealing Commission Regulation (EC) No 690/2008 and amending Commission Implementing Regulation (EU) 2018/2019 (OJ L 319, 10.12.2019, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2019/2072/oj).

(++++)  Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (OJ L 435, 23.12.2020, p. 1, ELI: http://data.europa.eu/eli/dir/2020/2184/oj).’;





ANNEX V



‘ANNEX VI
Products and substances authorised for use in organic production in third countries and in the outermost regions of the Union pursuant to Article 45(2) of Regulation (EU) 2018/848
PART A

PRODUCTS AND SUBSTANCES AUTHORISED FOR USE IN ORGANIC PRODUCTION IN THIRD COUNTRIES


Active substances to be used in plant protection products

Active substances listed in the table below may be used in organic production in third countries, provided that they comply with the relevant third country legislation, are exempted from maximum residue levels in accordance with Codex Alimentarius guidelines CXG 97-2022 (*1), are included in Annex IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council (*2), or specific maximum residue levels have been set in that Regulation. They are subject to the corresponding specific conditions and limits set out in that table.







CAS number


Name of the active substance


Specific conditions and limits




 


Microorganisms including viruses, when used as biological control agents


not from GMO origin
not produced by using growing media of GMO origin




74-85-1


Ethylene


for flower induction in pineapple




PART B

PRODUCTS AND SUBSTANCES AUTHORISED FOR USE IN ORGANIC PRODUCTION IN THE OUTERMOST REGIONS OF THE UNION


Active substances to be used in plant protection products

Active substances listed in the table below may be used in organic production in the outermost regions of the Union, provided that they comply with the relevant provisions of Union law and, where applicable, with national provisions based on Union law.


            .


(*1)  
            https://www.fao.org/fao-who-codexalimentarius/codex-texts/guidelines/en.

(*2)  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, ELI: http://data.europa.eu/eli/reg/2005/396/oj).’



ELI: http://data.europa.eu/eli/reg_impl/2025/973/oj
ISSN 1977-0677 (electronic edition)