Organic Production Regulation

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Article 29 Measures to be taken in the event of the presence of non-authorised products or substances 1. Where the competent authority, or, where appropriate, the control authority or control body, receives substantiated information about the presence of products or substances that are not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production, or has been informed by an operator in accordance with point (d) of Article 28(2), or detects such products or substances in an organic or an in-conversion product: (a) it shall immediately carry out an official investigation in accordance with Regulation (EU) 2017/625 with a view to determining the source and the cause in order to verify compliance with the first subparagraph of Article 9(3) and with Article 28(1); such investigation shall be completed as soon as possible, within a reasonable period, and shall take into account the durability of the product and the complexity of the case; (b) it shall provisionally prohibit both the placing on the market of the products concerned as organic or in-conversion products and their use in organic production pending the results of the investigation referred to in point (a). 2. The product concerned shall not be marketed as an organic or in-conversion product or used in organic production where the competent authority, or, where appropriate, the control authority or control body, has established that the operator concerned: (a) has used products or substances not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production; (b) has not taken the precautionary measures referred to in Article 28(1); or (c) has not taken measures in response to relevant previous requests from the competent authorities, control authorities or control bodies. 3. The operator concerned shall be given an opportunity to comment on the results of the investigation referred to in point (a) of paragraph 1. The competent authority, or, where appropriate, the control authority or control body, shall keep records of the investigation it has carried out. Where required, the operator concerned shall take such corrective measures as necessary to avoid future contamination. 4. By 31 December 2024, 2025, the Commission shall present a report to the European Parliament and the Council on the implementation of this Article, on the presence of products and substances not authorised pursuant to the first subparagraph of Article 9(3) for use in organic … 463 unchanged words … well as the volume and nature of products contaminated. This information shall be collected by the Commission through the computer system made available by the Commission and shall be used to facilitate the formulation of best practices for avoiding contamination.

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Article 30 Use of terms referring to organic production 1. For the purposes of this Regulation, a product shall be regarded as bearing terms referring to organic production where, in the labelling, advertising material or commercial documents, such a product, its ingredients … 438 unchanged words … are organic, and provided that those ingredients comply with the production rules set out in this Regulation; and (ii) the processed food complies with the production rules set out in points 1.5, 2.1(a), 2.1(b) and 2.2.1 of Part IV of Annex II II, with the exception of the rules on restricted use of non-organic agricultural ingredients set out in point 2.2.1 of Part IV of Annex II, and with the rules laid down in accordance with Article 16(3); (c) in the sales description and in the list of ingredients, provided that: (i) the main ingredient is a product of hunting or fishing; (ii) the term referred to in paragraph 1 is clearly related in the sales description to another ingredient which is organic and different from the main ingredient; (iii) all other agricultural ingredients are organic; and (iv) the processed food complies with the production rules set out in points 1.5, 2.1(a), 2.1(b) and 2.2.1 of Part IV of Annex II II, with the exception of the rules on restricted use of non-organic agricultural ingredients set out in point 2.2.1 of Part IV of Annex II, and with the rules laid down in accordance with Article 16(3). The list of ingredients referred to in points (a), (b) and (c) of the first subparagraph shall indicate which ingredients are organic. The references to organic production may only appear in relation to the organic ingredients. The list of ingredients referred to in points (b) and (c) of the first subparagraph shall include an indication of the total percentage of organic ingredients in proportion to the total quantity of agricultural ingredients. The terms referred to in paragraph 1, when used in the list of ingredients referred to in points (a), (b), and (c) of the first subparagraph of this paragraph, and the indication of the percentage referred to in the third subparagraph of this paragraph shall appear in the same colour, identical size and style of lettering as the other indications in the list of ingredients. 6. For processed feed, the terms referred to in paragraph 1 may be used in the sales description and in the list of ingredients, provided that: (a) the processed feed complies with the production rules set out in Parts II, III and V of Annex II and with the specific rules laid down in accordance with Article 16(3); 17(3); (b) all of the ingredients of agricultural origin that are contained in the processed feed are organic; and (c) at least 95 % of the dry matter of the product are organic. 7. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending: (a) this Article by adding further rules on the labelling of products listed in Annex I, or by amending those added rules; and (b) the list of terms set out in Annex IV, taking into account linguistic developments within the Member States. 8. The Commission may adopt implementing acts to set detailed requirements for the application of paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

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Article 41 Additional rules on actions in case the event of non-compliance suspected and established non-compliance, and common catalogue of measures 1. Subject to Article 29, where a competent authority, or, where appropriate, a control authority or control body, suspects or receives substantiated information, including information from other competent authorities, or, where appropriate, from other control authorities or control bodies, that an operator intends to use or to place on the market a product which may not be in compliance with this Regulation but which bears terms referring to the organic production, or where such competent authority, control authority or control body has been informed by an operator of a suspicion of non-compliance in accordance with Article 27: (a) it shall immediately carry out an official investigation in accordance with Regulation (EU) 2017/625 with a view to verifying compliance with this Regulation; such investigation shall be completed as soon as possible, within a reasonable period, and shall take into account the durability of the product and the complexity of the case; (b) it shall provisionally prohibit both the placing on the market of the products concerned as organic or in-conversion products and their use in organic production pending the results of the investigation referred to in point (a). Before taking such a decision, the competent authority, or, where appropriate, the control authority or control body, shall give the operator an opportunity to comment. 2. In the event that the results of the investigation referred to in point (a) of paragraph 1 do not show any non-compliance affecting the integrity of organic or in-conversion products, the operator shall be allowed to use the products concerned or to place them on the market as organic or in-conversion products. 3. Member States shall take any measures, and provide for any necessary sanctions, to prevent fraudulent use of the indications referred to in Chapter IV of this Regulation. 4. Competent authorities shall provide a common catalogue of measures for cases of suspected non-compliance and established non-compliance to be applied in their territory, including by control authorities and control bodies. 5. The Commission may adopt implementing acts to specify uniform arrangements for the cases where competent authorities are to take measures in relation to suspected or established non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

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Article 42 Additional rules on measures in the event of non-compliance affecting integrity 1. In the event of non-compliance affecting the integrity of organic or in-conversion products throughout any of the stages of production, preparation and distribution, for example as result of the use of non-authorised products, substances or techniques, or commingling with non-organic products, competent authorities, and, where appropriate, control authorities and control bodies, shall ensure, in addition to the measures to be taken in accordance with Article 138 of Regulation (EU) 2017/625, that no reference is made to organic production in the labelling and advertising of the entire lot or production run concerned. 2. In the event of serious, or repetitive or continued non-compliance, competent authorities, and, where appropriate, control authorities and control bodies, shall ensure that the operators or the groups of operators concerned, in addition to the measures laid down in paragraph 1 and any appropriate measures taken in particular in accordance with Article 138 of Regulation (EU) 2017/625, are prohibited from marketing products which refer to organic production for a given period, and that their certificate referred to in Article 35 be suspended or withdrawn, as appropriate.

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Article 48 Equivalence under Regulation (EC) No 834/2007 1. A recognised third country referred to in point (b)(iii) of Article 45(1) is a third country which has been recognised for the purposes of equivalence under Article 33(2) of Regulation (EC) No 834/2007, including those recognised under the transitional measure provided for in Article 58 of this Regulation. That recognition shall expire on 31 December 2025. 2026. 2. On the basis of annual reports to be sent to the Commission, by 31 March of each year, by the third countries referred to in paragraph 1 regarding the implementation and enforcement of the control measures established by them, and in the light of any other information received, the Commission shall ensure appropriate supervision of the recognised third countries by regularly reviewing their recognition. For this purpose, the Commission may request the assistance of Member States. The nature of the supervision shall be determined on the basis of an assessment of the likelihood of non-compliance, taking into account in particular the volume of exports to the Union from the third country concerned, the results of the monitoring and supervisory activities carried out by the competent authority and the results of previous controls. The Commission shall regularly report to the European Parliament and the Council on the outcome of its review. 3. The Commission shall, by means of an implementing act, establish a list of the third countries referred to in paragraph 1 and may amend that list by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). 4. The Commission is empowered to adopt delegated acts in accordance with Article 54 supplementing this Regulation as regards the information to be sent by the third countries listed in accordance with paragraph 3 of this Article which is necessary for the supervision of their recognition by the Commission, as well as the exercise of that supervision by the Commission, including through on-the-spot examination. 5. The Commission may adopt implementing acts to ensure the application of measures in relation to cases of suspected or established non-compliance, in particular those affecting the integrity of organic or in-conversion products imported from third countries referred to in this Article. Such measures may consist in particular in the verification of the integrity of organic or in-conversion products before placing the products on the market within the Union and, where appropriate, in the suspension of the authorisation for the placing on the market of such products within the Union as organic products or in-conversion products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

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Article 49 Report from the Commission on the application of Articles 47 and 48 By 31 December 2021, 2022, the Commission shall present a report to the European Parliament and the Council on the state of application of Articles 47 and 48, in particular as regards the recognition of third countries for the purpose of equivalence.

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Article 53 Derogations, authorisations and report 1. The derogations from the use of organic plant reproductive material and from the use of organic animals provided in points 1.8.5 of Part I of Annex II and points 1.3.4.3 and 1.3.4.4 of Part II of Annex II, with the exception of point 1.3.4.4.2 of Part II of Annex II, shall expire on 31 December 2035. 2036. 2. From 1 January 2028, 2029, based on the conclusions as regards availability of organic plant reproductive material and animals presented in the report provided for in paragraph 7 of this Article, the Commission shall be empowered to adopt delegated acts in accordance with Article 54 amending this Regulation by: (a) ending the derogations referred to in point 1.8.5 of Part I of Annex II and in points 1.3.4.3 and 1.3.4.4 of Part II of Annex II, with the exception of point 1.3.4.4.2 of Part II of Annex II, at an earlier date than 31 December 2035 2036 or extending them beyond that date; or (b) ending the derogation referred to in point 1.3.4.4.2 of Part II of Annex II. 3. From 1 January 2026, 2027, the Commission shall be empowered to adopt delegated acts in accordance with Article 54 amending point (b) of Article 26(2) to extend the scope of the information system referred to in Article 26(2) to pullets and point 1.3.4.3 of Part II of Annex II to base the derogations concerning pullets on the data collected in accordance with this system. 4. From 1 January 2025, 2026, the Commission shall be empowered to adopt delegated acts in accordance with Article 54, based on the information as regards availability of organic protein feed for poultry and porcine animals made available by Member States in accordance with paragraph 6 of this Article or presented in the report referred to in paragraph 7 of this Article, ending the authorisations to use non-organic protein feed in the nutrition of poultry and porcine animals referred to in points 1.9.3.1(c) and 1.9.4.2(c) of Part II of Annex II at an earlier date than 31 December 2025 2026 or extending them beyond that date. 5. When extending the derogations or authorisations referred to in paragraphs 2, 3 and 4, the Commission shall do so only for as long as it has information, in particular information provided by Member States in accordance with paragraph 6, that confirms the unavailability on the Union market of the plant reproductive material, animal or feed concerned. 6. By 30 June of each year, Member States shall make available to the Commission and to the other Member States: (a) information provided in the database referred to in Article 26(1) and in the systems referred to in Article 26(2) and, if relevant, in the systems referred to in Article 26(3); (b) information on the derogations granted in accordance with point 1.8.5 of Part I of Annex II and points 1.3.4.3 and 1.3.4.4 of Part II of Annex II; and (c) information on the availability on the Union market of organic protein feed for poultry and porcine animals and on the authorisations granted in accordance with points 1.9.3.1(c) and 1.9.4.2(c) of Part II of Annex II. 7. By 31 December 2025, 2026, the Commission shall present a report to the European Parliament and the Council on the availability on the Union market of and, if relevant, on the causes of limited access to: (a) organic plant reproductive material; (b) organic animals covered by the derogations referred to in points 1.3.4.3 and 1.3.4.4 of Part II of Annex II; (c) organic protein feed intended for the nutrition of poultry and porcine animals subject to the authorisations referred to in points 1.9.3.1(c) and 1.9.4.2(c) of Part II of Annex II. In drawing up that report, the Commission shall take into account, in particular, the data collected in accordance with Article 26 and the information relating to the derogations and the authorisations referred to in paragraph 6 of this Article.

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Article 57 Transitional measures relating to control authorities and control bodies recognised under Article 33(3) of Regulation (EC) No 834/2007 1. The recognition of control authorities and control bodies granted under Article 33(3) of Regulation (EC) No 834/2007 shall expire by 31 December 2023 2024 at the latest. 2. The Commission shall, by means of an implementing act, establish a list of the control authorities and control bodies recognised under Article 33(3) of Regulation (EC) No 834/2007, and may amend that list by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). 3. The Commission is empowered to adopt delegated acts in accordance with Article 54 supplementing this Regulation as regards the information to be sent by the control authorities and control bodies referred to in paragraph 2 of this Article which is necessary for the purpose of the supervision of their recognition by the Commission, as well as the exercise of that supervision by the Commission, including through on-the-spot examination.

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Article 60 Transitional measures for stocks of organic products produced in accordance with Regulation (EC) No 834/2007 Products produced in accordance with Regulation (EC) No 834/2007 before 1 January 2021 2022 may be placed on the market after that date until stocks are exhausted.

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Article 61 Entry into force and application This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. 2022.

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ANNEX II DETAILED PRODUCTION RULES REFERRED TO IN CHAPTER III Part I: Plant production rules In addition to the production rules laid down in Articles 9 to 12, the rules set out in this Part shall apply to organic plant production. 1. General requirements 1.1. Organic crops, except those which are naturally grown in water, shall be produced in living soil, or in living soil mixed or fertilised with materials and products allowed in organic production, in connection with the subsoil and bedrock. 1.2. Hydroponic production, which is a method of growing plants which do not naturally grow in water with their roots in a nutrient solution only or in an inert medium to which a nutrient solution is added, is prohibited. 1.3. By way of derogation from point 1.1, the production of sprouts by moistening of seeds and the obtaining of chicory heads including by dipping in clear water shall be allowed. 1.4. By way of derogation from point 1.1, the following practices shall be allowed: (a) growing plants for the production of ornamentals and herbs in pots to be sold together with the pot to the final consumer; (b) growing seedlings or transplants in containers for further transplanting. 1.5. By way of derogation from point 1.1, growing crops in demarcated beds shall only be allowed for the surfaces that have been certified as organic for that practice before 28 June 2017 in Finland, Sweden and Denmark. No extension of those surfaces shall be permitted. That derogation shall expire on 31 December 2030. 2031. By 31 December 2025, 2026, the Commission shall present a report to the European Parliament and the Council on the use of demarcated beds in organic agriculture. That report may be accompanied, where appropriate, by a legislative proposal on the use of demarcated beds in … 5,574 unchanged words … feed is not available, shall be produced in cooperation with other organic or in-conversion production units and feed operators using feed and feed material from the same region. This percentage shall be raised to 70 % as from 1 January 2023; 2024; (b) animals shall have access to pasturage for grazing whenever conditions allow; (c) notwithstanding point (b), male bovine animals over one year old shall have access to pasturage or an open air area; (d) where animals have access to pasturage during the … 353 unchanged words … feed is not available, shall be produced in cooperation with other organic or in-conversion production units and feed operators using feed and feed material from the same region. This percentage shall be raised to 70 % as from 1 January 2023; 2024; (b) animals shall have access to pasturage for grazing whenever conditions allow; (c) where animals have access to pasturage during the grazing period and where the winter housing system allows the animals to move freely, the obligation to provide open air … 436 unchanged words … the daily ration; (c) where farmers are unable to obtain protein feed exclusively from organic production, and the competent authority has confirmed that organic protein feed is not available in sufficient quantity, non-organic protein feed may be used until 31 December 2025 2026 provided that the following conditions are fulfilled: (i) it is not available in organic form; (ii) it is produced or prepared without chemical solvents; (iii) its use is limited to the feeding of piglets of up to 35 kg with specific protein compounds; … 468 unchanged words … where farmers are unable to obtain protein feed exclusively from organic production for poultry species, and the competent authority has confirmed that organic protein feed is not available in sufficient quantity, non-organic protein feed may be used until 31 December 2025, 2026, provided that the following conditions are fulfilled: (i) it is not available in organic form; (ii) it is produced or prepared without chemical solvents; (iii) its use is limited to the feeding of young poultry with specific protein compounds; and (iv) the maximum percentage … 3,110 unchanged words … from point (a), Member States may authorise the introduction for on-growing purposes on an organic production unit of a maximum of 50 % of non-organic juveniles of species that were not developed as organic in the Union by 1 January 2021, 2022, provided that at least the latter two thirds of the duration of the production cycle are managed under organic management. Such derogation may be granted for a maximum period of two years and shall not be renewable. For aquaculture holdings situated … 4,916 unchanged words … 19, the rules laid down in this Part shall apply to the organic production of yeast used as food or feed. 1. General requirements 1.1. For the production of organic yeast, only organically produced substrates shall be used. However, until 31 December 2023, 2024, the addition of up to 5 % non-organic yeast extract or autolysate to the substrate (calculated in weight of dry matter) is allowed for the production of organic yeast where operators are unable to obtain yeast extract or autolysate from organic production. 1.2. Organic yeast shall not be present in organic food or feed together with non-organic yeast. 1.3. The following products and substances may be used in the production, confection and formulation of organic yeast: (a) processing aids authorised pursuant to Article 24 for use in organic production; (b) products and substances referred to in points (a), (b) and (e) of point 2.2.2 of Part IV. 1.4. Only the products for cleaning and disinfection authorised pursuant to Article 24 for use in processing shall be used for that purpose.