Introduction on legal acts

Since 1 January 2022, Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 is the applicable legislative act, also known as the basic act, laying down the rules on organic production and labelling of organic products, repealing and replacing Council Regulation (EC) No 834/2007 of 28 June 2007. The new regulation provides for transitional periods for the implementation of certain new provisions, in particular on trade. Please refer to section 2 of Chapter IX of Regulation (EU) 2018/848, where provisions under previous Council Regulation (EC) No 834/2007 and Commission Regulation (EC) No 889/2008 may apply for a limited period.

It is on the basis of Regulation (EU) 2018/848 that the Commission adopts further detailed secondary legal acts.

The types of secondary legal acts are the following:

  • delegated acts, also known as Commission Delegated Regulations, which are acts of general application to supplement (“Commission Delegated Regulation supplementing”) or amend (“Commission Delegated Regulation amending”) certain non-essential (in the sense of complementary) elements of the legislative act;
  • implementing acts, also known as Commission Implementing Regulations, which are used where uniform conditions for implementation are needed.

Delegated acts amending the basic act are progressively incorporated into the so-called “consolidated” text of the legislative act and become part of it. Please note that the consolidated version of Regulation (EU) 2018/848 is made available only for informative purposes, but has no legal effect. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex.

The list of secondary acts concerning organic farming covers three main areas: production and labelling, controls and trade.

Production and labelling

The following secondary acts cover organic production and labelling of organic products.

Delegated regulations

Delegated Regulation (EU) 2020/427 of 13 January 2020 amending Annex II to Regulation (EU) 2018/848 on certain detailed production rules for organic products (OJ L 87, 23.3.2020)

Main content:

  • amending point 1.3 of Part I of Annex II to Regulation (EU) 2018/848 on derogations on the production of sprouted seeds;
  • amending point 1.9.6.2 of Part II of Annex II to Regulation (EU) 2018/848 on feeding bees in case of risk for survival;
  • adding Part III of Annex II to Regulation (EU) 2018/848 a new point 3.1.2.3. on aquaculture juvenile production;
  • amending point 3.1.3.3 by deletion of the maximum percentage of feed from plant origin in aquaculture.

Delegated Regulation (EU) 2020/1794 of 16 September 2020 amending Part I of Annex II to Regulation (EU) 2018/848 on the use of in-conversion and non-organic plant reproductive material (OJ L 402, 1.12.2020)

Main content:

  • amending point 1.8.5 of Part I of Annex II to Regulation (EU) 2018/848 with regards the use of in-conversion and organic plant reproductive material allowing the use of in-conversion plant reproductive material and setting conditions for use of non-organic plant reproductive material when organic material is not available.

Delegated Regulation (EU) 2021/642 of 30 October 2020 amending Annex III to Regulation (EU) 2018/848 on certain information to provide on the labelling of organic products (OJ L 133, 20.4.2021)

Main content:

  • amending point 2.1 of Annex III to add requirements on information to be provided on labelling of compound feed to be used in organic production and on labelling of mixtures of fodder seeds as plant reproductive material.

Delegated Regulation (EU) 2021/716 of 9 February 2021 amending Annex II to Regulation (EU) 2018/848 on organic production rules on sprouted seeds and chicory heads, on feed for certain aquaculture animals and on aquaculture parasite treatments (OJ L 151, 3.5.2021)

Main content:

  • replacing point 1.3 of Part I of Annex II to Regulation (EU) 2018/848 with detailed production rules for sprouted seeds and chicory heads;
  • amending Part III of Annex II to Regulation (EU) 2018/848, point 3.1.3.4 to allow use of organic cholesterol in the feed of penaeid shrimps and freshwater prawns;
  • replacing point 3.1.4.2 to amend requirements on frequency of parasite treatments for all species other than salmon and setting a maximum number of treatments for all aquaculture species.

Delegated Regulation (EU) 2020/2146 of 24 September 2020 supplementing Regulation (EU) 2018/848 on exceptional production rules in organic production (OJ L 428, 18.12.2020)

Main content:

  • supplementing Regulation (EU) 2018/848 as regards exceptional production rules on the recognition of catastrophic circumstances, conditions and types of derogations, which can be issued to operators by competent authorities in case of catastrophic events, and for their monitoring and reporting.

Delegated Regulation (EU) 2021/1189 of 7 May 2021 supplementing Regulation (EU) 2018/848 on the production and marketing of plant reproductive material of organic heterogeneous material of particular genera or species (OJ L 258, 20.7.2021)

Main content:

  • supplementing Regulation (EU) 2018/848 as regards specific requirements for the production and marketing of organic heterogeneous material, in particular with respect to description, identity, sanitary quality, analytical purity and germination requirements, packaging and labelling, information to be kept by operators, maintenance and official controls.

Implementing regulations

Implementing Regulation (EU) 2020/464 of 26 March 2020 laying down certain rules for the application of Regulation (EU) 2018/848 on the documents needed for the retroactive recognition of periods for the purpose of conversion, the production of organic products and information to be provided by EU countries (OJ L 98, 31.3.2020)

Main content:

  • documents to be supplied in case of retroactive recognition of previous periods for the conversion to organic production;
  • production rules on livestock and aquaculture animals, processed food and feed with related transitional provisions;
  • information to be transmitted by EU countries concerning the availability on the market of organic and in-conversion plant reproductive material, organic animals and organic aquaculture juveniles.

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)

Main content:

  • conditions for the authorisation of substances and products for use in organic production;
  • procedure to grant specific authorisation for the use of products and substances in certain areas of third countries;
  • transitional measures for cleaning and disinfection of products and non-organic agricultural ingredients listed in relevant Annexes of Regulation (EC) No 889/2008;
  • transition period up to 31 December 2022 for the validity of documentary evidence under Article 68 of Regulation (EC) No 889/2008.

Controls

The following secondary acts cover controls in the organic sector.

Delegated regulations

Delegated Regulation (EU) 2021/715 of 20 January 2021 amending Regulation (EU) 2018/848 on the requirements for groups of operators (OJ L 151, 3.5.2021)

Main content:

  • amending Article 36 of Regulation (EU) 2018/848 in order to establish requirements for the geographical proximity of the members of a group of operators, the system for internal controls (ICS) and the responsibilities of the members of the group, of the ICS manager and ICS inspectors;
  • amending Article 36 of Regulation (EU) 2018/848 in order to establish a list of situations which can be considered deficiencies of the internal control system.

Delegated Regulation (EU) 2021/1006 of 12 April 2021 amending Regulation (EU) 2018/848 on the model of certificate attesting compliance with the rules on organic production (OJ L 222, 22.6.2021)

Main content:

  • replacing Annex VI to Regulation (EU) 2018/848 with a model for the certificate to operators and groups of operators as set under Article 35.

Delegated Regulation (EU) 2021/1691 of 22 September 2021 amending Annex II to Regulation (EU) 2018/848 on the requirements for records keeping from operators in organic production (OJ L 334, 22.9.2021)

Main content:

  • introduction of detailed record keeping requirements for operators and groups of operators applying specific organic production rules.

Delegated Regulation (EU) 2021/771 of 21 January 2021 supplementing Regulation (EU) 2018/848 laying down specific criteria and conditions for the checks of documentary accounts in the framework of official controls in organic production and the official controls of groups of operators (OJ L 165, 11.5.2021)

Main content:

  • supplementing basic act with rules on the traceability and mass balance checks during the official controls of operators and groups of operators;
  • additional requirements for the official controls of groups of operators.

Delegated Regulation (EU) 2021/2304 of 18 October 2021 supplementing Regulation (EU) 2018/848 with rules on the issuance of complementary certificates certifying the non-use of antibiotics in organic production of animal products for the purpose of export (OJ L 461, 27.12.2021)

Main content:

  • supplementing basic act with provisions and template for a complementary certificate for the non-use of antibiotics in organic production of animal products for the purpose of export.

Implementing regulations

Implementing Regulation (EU) 2021/279 of 22 February 2021 laying down detailed rules for implementation of Regulation (EU) 2018/848 on controls and other measures ensuring traceability and compliance in organic production and the labelling of organic products (OJ L 62, 23.2.2021)

Main content:

  • setting procedural steps to be followed by operators in case of a suspicion of non-compliance due to the presence of non-authorised products or substances;
  • establishing a methodology of official investigation in the event of the presence of non-authorised products or substances;
  • establishing detailed conditions for the reference to in-conversion and other indications on label of organic products;
  • setting composition requirements and maximum size of a group of operators;
  • setting requirements for documents and records for the purpose of the system of internal controls and for notifications from the managers of the system for internal controls, setting the minimum percentages of controls and sampling;
  • setting minimum requirements for the national catalogue of measures in case of established non-compliance as well as optional guidelines;
  • establishing the mandatory use from the competent authorities of the Organic Farming Information System (OFIS) for exchange of information with the Commission and other EU countries;
  • setting a transitional period up to 1 January 2023 for groups of operators in third countries with respect to compliance to maximum size of group.

Implementing Regulation (EU) 2021/1935 of 8 November 2021 amending Implementing Regulation (EU) 2019/723 on the information and data on organic production and labelling of organic products to be submitted by means of the standard model (OJ L 396, 10.11.2021, p. 17–26)

Main content:

  • establishing the use of the Organic Farming Information System for the submission of information and data on organic production and labelling of organic products in the framework of the annual reports;
  • providing the templates for the organic data in the annual reports.

Implementing Regulation (EU) 2021/2119 of 1 December 2021 on records and declarations required from operators and groups of operators and on the technical means for the issuance of certificates in accordance with Regulation (EU) 2018/848 and amending Implementing Regulation (EU) 2021/1378 of 19 August 2021 on the issuance of the certificate for operators, groups of operators and exporters in third countries (OJ L 430, 2.12.2021)

Main content:

  • detailed provisions on issuance of certificate under Article 35 in electronic form, on record keeping requirements by operators and groups of operators, on declarations and other communications to be made available to control authorities or control bodies.

Trade

The following secondary acts cover trade in the organic sector.

Delegated regulations

Delegated Regulation (EU) 2021/1697 of 13 July 2021 amending Regulation (EU) 2018/848 on the criteria for the recognition of control authorities and control bodies competent to carry out controls on organic products in third countries, and on the withdrawal of their recognition (OJ L 336, 23.9.2021)

Main content:

  • amending Article 46 of the basic act on the criteria for the recognition of control authorities and control bodies to carry out controls in third countries, including additional information and conditions required for the performance of their tasks, the capacity and competences of their staff as well as concerning their recognition;
  • additional criteria concerning the withdrawal of the recognition of control authorities and control bodies such as in case of failure to provide relevant information for their supervision or to take adequate corrective measures.

Delegated Regulation (EU) 2021/1698 of the 13 July 2021 supplementing Regulation (EU) 2018/848 with procedural requirements for the recognition of control authorities and control bodies that are competent to carry out controls on operators and groups of operators certified organic, and on organic products in third countries, and with rules on their supervision and the controls and other actions to be performed by those control authorities and control bodies (OJ L 336, 23.9.2021)

Main content:

  • setting procedures and requirements for the recognition of control authorities and control bodies in third countries;
  • details on technical dossier to be submitted to the Commission and request for extension of the scope of recognition;
  • general requirements for the supervision of control authorities and control bodies from the Commission, annual reports, spot examinations and audits, traceability checks, ad hoc requests by the Commission, list of high-risk products;
  • controls requirements in respect of operators and group of operators, checks for the certification, methods and techniques of control, sampling and selection of laboratories documented control procedures and records of controls;
  • specific control requirements for aquaculture;
  • verification of consignments intended for import into the Union, actions to be carried out by the control authorities and control bodies in terms of exchange of information, additional rules in case of non-compliance;
  • checks to be carried out and reporting for retroactive recognition of previous conversion periods;
  • reporting on authorisations for the use of non-organic plant reproductive material;
  • derogations for use of organic animals and aquaculture juveniles;
  • reporting of authorisations of use of non-organic ingredients;
  • recognition of catastrophic circumstances and conditions for derogations.

Delegated Regulation (EU) 2021/1342 of 27 May 2021 supplementing Regulation (EU) 2018/848 with rules on the information to be sent by third countries and by control authorities and control bodies for the purpose of supervision of their recognition under Article 33(2) and (3) of Regulation (EC) No 834/2007 of 28 June 2007 for imported organic products and the measures to be taken in the exercise of that supervision (OJ L 292, 16.8.2021)

Main content:

  • provisions concerning the supervision of third countries under equivalence recognition until 31 December 2026 for exporting organic products to the EU;
  • provisions concerning the supervision of control authorities and control bodies under equivalence recognition until 31 December 2024 including information to be provided, on the spot examination, notifications and follow up on cases of irregularities;
  • provisions concerning rules for the review of the recognition of third countries, control authorities and control bodies.

Delegated Regulation (EU) 2021/2305 of 21 October 2021 supplementing Regulation (EU) 2017/625 with rules on the cases where and conditions under which organic products and in-conversion products are exempted from official controls at border control posts, the place of official controls for such products and amending Commission Delegated Regulations (EU) 2019/2023 and (EU) 2019/2124 (OJ L 461, 27.12.2021)

Main content:

  • supplementing Regulation (EU) 2017/625 as regards the conditions under which certain organic and in-conversion products entering the EU and posing a low risk or no specific risk to human, animal or plant health, animal welfare or to the environment, are exempted from official controls at border control posts performed for the verification of compliance with the rules on organic production and labelling of organic products and the place where the official controls for such products intended to be placed on the EU market are to be carried out;
  • amending Delegated Regulations (EU) 2019/2123 and (EU) 2019/2124. The amendment ensures that Regulations (EU) 2019/2123 and (EU) 2019/2124 apply to plants, plant products and other objects currently under their scope, including where such goods are organic products or in-conversion products subject to official controls at border control posts pursuant to Article 45(5) of Regulation (EU) 2018/848.

Delegated Regulation (EU) 2021/2306 of 21 October supplementing Regulation (EU) 2018/848 with rules on the official controls in respect of consignments of organic products and in-conversion products intended for import into the EU and on the certificate of inspection (OJ L 461, 27.12.2021)

Main content:

  • supplementing the basic act as regards the certificate of inspection and the official controls carried out by EU countries before the release for free circulation into the EU of the organic products originating in third countries;
  • the provisions regarding the information to be provided by a competent authority, control authority or control body in a third country on cases of non-compliances on consignments intended for import into the EU.

Implementing regulations

Implementing Regulation (EU) 2021/1378 of 19 August 2021 laying down certain rules in accordance with Regulation (EU) 2018/848 concerning the certificate issued to operators, groups of operators and exporters in third countries involved in the imports of organic and in-conversion products into the EU and establishing the list of recognised control authorities and control bodies for the purpose of compliance (OJ L 297, 20.8.2021)

Please note that this act was amended by above-mentioned Commission Implementing Regulation (EU) 2021/2119.

Main content:

  • setting provisions and the model of the certificate issued to operators, groups of operators and exporters in third countries and the list of recognised control authorities and control bodies in third countries in accordance with Article 46 of the basic act.

Implementing Regulation (EU) 2021/2307 of 21 October 2021 on documents and notifications required for organic and in-conversion products intended for import into the EU (OJ L 461, 27.12.2021)

Main content:

  • provisions concerning the declarations and communications by importers, operators responsible for the consignments, first consignees and consignees for the import of products from third countries for the purpose of placing those products on the market within the EU as organic products or in-conversion products;
  • provisions on the notification by the competent authorities of suspected or established non-compliance of consignments.

Implementing Regulation (EU) 2021/2325 of 16 December 2021 establishing, pursuant to Regulation (EU) 2018/848 the list of third countries and the list of control authorities and control bodies that have been recognised under Article 33(2) and (3) of Regulation (EC) No 834/2007 for the purpose of importing organic products into the EU (OJ L 465, 29.12.2021)

Main content:

  • lists of third countries recognised for the purpose of equivalence and information concerning their recognition including the specific product categories;
  • lists of control authorities and control bodies recognised for the purpose of equivalence and information on the countries and product categories for which they are recognised.

In addition, please refer to specific information concerning trade on organic products covered by specific agreements with Chile, Switzerland and the UK.