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Date: 2021-11-10 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Regulation (EU) 2021/1935 of 8 November 2021 amending Implementing Regulation (EU) 2019/723 as regards the information and data on organic production and labelling of organic products to be submitted by means of the standard model form (Text with EEA relevance)

Issued by European Commission · Directorate-General for Agriculture and Rural Development

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Executive Summary & Key Takeaways

Executive Summary: This regulation amends Implementing Regulation (EU) 2019/723 regarding the standard model form for annual reports on organic production and labeling. The changes account for new rules on organic production controls introduced by Regulation (EU) 2018/848, including internal control systems for groups of operators, reinspections, and national catalogues of measures for non-compliance. The regulation applies from September 1, 2022, for annual reports submitted by August 31, 2023, and subsequent reports. Key Points / Main Content: * **Amendment of Implementing Regulation (EU) 2019/723:** * Article 2 is replaced, specifying that Member States must submit information and data via the standard model form in the IMSOC system, except for Section 9 of Part II (organic production and labeling data), which must be submitted in OFIS. A confirmation in IMSOC is then required to indicate Section 9's submission in OFIS. * Section 9 of the standard model form in the Annex is replaced with updated text. * **Updated Standard Model Form (Section 9):** * Includes requirements for data related to competent authorities, control authorities, and control bodies. * Details the number of controls for registered operators and groups of operators, referencing Regulation (EU) 2018/848. * Requires reporting on types and numbers of major and critical non-compliances, along with measures taken. * Addresses supervision, audits, and activities of competent authorities related to control bodies, including delegation and withdrawal of control tasks. * Includes an individual form for supervision of control bodies. * Requires information on actions and measures taken by competent authorities to ensure effective official controls. Impact Analysis: * **Member States:** * *Impact:* Must use the updated standard model form, including OFIS for organic production data, for annual reports. * *Action Required:* Update reporting procedures to align with the amended regulation and utilize both IMSOC and OFIS as specified. * **Competent Authorities, Control Authorities, and Control Bodies:** * *Impact:* Subject to new reporting requirements regarding controls, non-compliances, and supervision activities. * *Action Required:* Implement revised data collection and reporting processes, including providing information for the new sections in the standard model form. * **Operators and Groups of Operators:** * *Impact:* Subject to controls and potential reinspections under the new rules, as well as measures outlined in national catalogues of measures for non-compliances. * *Action Required:* Ensure compliance with Regulation (EU) 2018/848, including internal control systems, and be prepared for potential reinspections and enforcement measures.

Key Entities Referenced

European Union: The political and economic union of European member states. European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations. Treaty on the Functioning of the European Union: One of the primary treaties of the European Union, outlining the scope of EU powers. European Parliament: The directly elected parliamentary body of the European Union with legislative, supervisory, and budgetary responsibilities. Commission Implementing Regulation EU 2021/1935: A regulation amending Implementing Regulation EU 2019/723 concerning information and data on organic production and labeling of organic products. Regulation EU 2017/625: Regulation on official controls and other official activities performed to ensure the application of food and feed law. Regulation EU 2018/848: Regulation of the European Parliament and of the Council on organic production and labeling of organic products. Organic Production Committee: A committee providing opinions on measures related to organic production.
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10.11.2021 EN Official Journal of the European Union L 396/17 COMMISSION IMPLEMENTING REGULATION (EU) 2021/1935 of 8 November 2021 amending Implementing Regulation (EU) 2019/723 as regards the information and data on organic production and labelling of organic products to be submitted by means of the standard model form (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation)(1), and in particular Article 25, first paragraph, point (a), Article 113(2), and Article 134, first paragraph, point (f), thereof, Whereas: (1) Commission Implementing Regulation (EU) 2019/723(2) establishes the standard model form to be used in the annual reports submitted by each Member State in accordance with Article 113(1) of Regulation (EU) 2017/625. (2) Section 9 of that standard model form requires Member States to report the organic data in accordance with the templates set out in Annex XIIIc to Commission Regulation (EC) No 889/2008(3). (3) Regulation (EU) 2018/848 of the European Parliament and of the Council(4) lays down new rules on controls of organic production and labelling of organic products, including the controls for the verification of the set-up and functioning of the internal control system of groups of operators, and the re-inspection of a minimum number of operators that are members of a group of operators. In addition, Member States will have to develop a national catalogue of measures to be taken in case of non-compliances, which includes the classification of non-compliances and the corresponding measures. Member States will have to report on the official controls that stem from those new rules and to provide information on the detected non-compliances and the enforcement of measures according to their national catalogue of measures. (4) In order to take into account those new rules and requirements in the annual report to be submitted in accordance with Article 113(1) of Regulation (EU) 2017/625, Section 9 of Part II of the standard model form needs to be updated. (5) Implementing Regulation (EU) 2019/723 should therefore be amended accordingly. (1) OJ L 95, 7.4.2017, p. 1. (2) Commission Implementing Regulation (EU) 2019/723 of 2 May 2019 laying down rules for the application of Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the standard model form to be used in the annual reports submitted by Member States (OJ L 124, 13.5.2019, p. 1). (3) Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control (OJ L 250 18.9.2008, p. 1). (4) Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).L 396/18 EN Official Journal of the European Union 10.11.2021 (6) The measures provided for in this Regulation are in accordance with the opinion of the Organic Production Committee, HAS ADOPTED THIS REGULATION: Article 1 Implementing Regulation (EU) 2019/723 is amended as follows: 1. Article 2 is replaced by the following: ‘Article 2 Standard model form Member States shall submit the information and data referred to in Article 113(1) of Regulation (EU) 2017/625 by means of the standard model form set out in the Annex to this Regulation. This shall be done using the electronic version of the standard model form provided in the computerised information management system for official controls (IMSOC). However, for the information and data on organic production and labelling of organic products referred to in Section 9 of Part II of that form, the Organic Farming Information System (OFIS) shall be used. Member States shall subsequently confirm in the electronic version of the standard model form in IMSOC that Section 9 of Part II of that form has been submitted in OFIS.’; 2. In the Annex, Section 9 of the standard model form is replaced by the text set out in the Annex to this Regulation. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 September 2022in respect of the annual reports to be submitted by 31 August 2023for 2022 and subsequent annual reports. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 8 November 2021. For the Commission The President Ursula VON DER LEYEN10.11.2021 EN Official Journal of the European Union L 396/19 ANNEX ‘9. Organic production and labelling of organic products 9.1. Overall conclusion on the level of compliance achieved 9.2. Organic data Identification of the Member State/competent authority that submits the annual report Data from Member State Number of competent authorities of which data have been Number of competent authorities integrated (A) Number of control authorities of which data have been integrated Number of control authorities (B) Number of control bodies of which data have been integrated Number of control bodies (C) Total number of authorities/bodies of which data have been Total number of authorities/bodies integrated (A) + (B) + (C) Reporting period YearTable 1 Number of controls for all competent authorities – control authorities – control bodies (all articles refer to Regulation (EU) 2018/848) 1. Registered operators in possession of a certificate per 31 December of the reporting year Code number Number of samples taken Article Number of Number of physical on-the-spot official controls carried out or name of 38(4)(c) verifications of competent Number of compliance authority/ Total number operators Article 38(3) Annual Additional risk Of which Number of control of controls Total number (physical and controls based Article un-announced samples with authority/ Article 38(3) & of samples non-physical) Article 38(3) 38(4)(b) Article 38(4)(a) detections control body 38(4)(b) Numbers for competent 1.a. authority/control authority/ control body 1 Numbers for competent 1.b. authority/control authority/ control body 2 Numbers for competent 1.c. authority/control authority/ control body 3 continue and list all authorities/ … bodies Total numbers for all competent authorities/control authorities/ control bodies [sum of (1.a.+1.b. +1.c.+….] L 396/20 EN Official Journal of the European Union 10.11.20212. Groups of operators (GoO) in possession of a certificate per 31 December of the reporting year Code number or name of competent Total number of Total number of Number of re- Inspections in which Identification of authority/control Number of groups operators that are official controls on inspections to at least 1 sample the group authority/control member of groups groups members of groups was taken body Total numbers for all groups of 2. operators for all competent authorities/ control authorities/control bodies 2.a. Numbers for competent authority/ control authority/control body 1 2.a.1 Group of operators a.1 2.a.2 Group of operators a.2 2.a. Group of operators a. Numbers for competent authority/ 2.b. control authority/control body 2 2.b.1 Group of operators b.1 2.b.2 Group of operators b.2 2.b. Group of operators b continue and list all groups of operators per 2.c competent authority/control authority/ control body 2.c Group of operators … 10.11.2021 EN Official Journal of the European Union L 396/21Table 2 NON-COMPLIANCES Data per competent authority/control authority/control body 1. Type and number of cases of major and critical non-compliance established Type of cases per type of non-compliances established during official controls performed Name or code number of Non- competent authority/control General Specific authorised Documents Rules for authority/control body produc-tion produc-tion substances or Deroga-tions and records GoO Labelling Other rules rules products 1. Established cases of non- compliance – TOTAL 1.a. Established cases for competent authority/control authority/control body 1 1.b. Established cases for competent authority/control authority/control body 2 1.c. Established cases for competent authority/control authority/control body 3 … continue and list all authorities/bodies 2. Measures taken for established cases of major and critical non-compliances Measures taken for established cases of non-compliances Number of Improvement of No reference to organic Prohibition of placing the established implementation of production in the labelling affected product(s) on the New Limitation of Suspension Withdrawal Corrective cases of non- precautionary measures and and advertising of the entire market with reference to conversion the scope of of the of the measure still Other compliance controls put in place by lot or production run organic production, for a period the certificate certificate certificate to be decided operator concerned given period (A) (B1) (B2) (B3) (B4) (B5) (B6) (B7) (B8) (B9) L 396/22 EN Official Journal of the European Union 10.11.2021Table 3 Supervision & Audits Activities of the competent authority related to — control bodies to whom it has delegated certain tasks — the supervision of such control bodies — the withdrawal of delegations to such control bodies — audit of control authorities 1. New control bodies to whom the competent authority has delegated control tasks/control bodies of which delegation has been withdrawn Number of control bodies Comments where necessary Number at the start of the reporting year (1 January of year N) (A) New control bodies during year N (B) Control bodies for which delegation has been withdrawn during year N (C) Number at the end of reporting year (31 December of year N) (D) 2. Supervision of control bodies by the competent authority 2.a. Total numbers on supervision of control bodies Number of supervision audits of Coverage of control bodies by Number of control bodies at end of reporting control bodies carried out by the supervision audit of competent Comment where necessary year competent authority during authority reporting year (D) (E) (F) = (E)/(D) Number of control bodies - Number of supervision audits during reporting year – coverage 10.11.2021 EN Official Journal of the European Union L 396/23The total number of Approved Control Bodies (D) should correspond to the number reported under section 1 2.b. Detail of supervision per control body Indicate reference number Number of operator Number of GoO files List all control bodies Audit carried out by Coverage of number Coverage of number of individual form files reviewed in reviewed in the under supervision of Number of competent authority of operator files of GoO files completed for the control Number of GoO supervision audit course of the audit the competent operators during reporting reviewed versus total reviewed versus total body (template "individual during reporting during reporting authority year yes = 1/no = 0 number of operators number of GoO form for control body" year year attached) Code number (G) (H) (I) (J) (K) = (J)/(G) (L) (M)= (L)/(H) (N) 3. Audit activities carried out by the competent authority on control authorities (only relevant if the competent authority delegates control tasks to control authorities) Number of control authorities to Number of audits carried out on Coverage of control authorities whom the competent authority has control authorities by the competent audited by competent authority Comment where necessary delegated control tasks authority during reporting year (K) (L) (M) = (L)/(K) During reporting year L 396/24 EN Official Journal of the European Union 10.11.202110.11.2021 EN Official Journal of the European Union L 396/25 Table 4 INDIVIDUAL FORM ON SUPERVISION OF CONTROL BODY (Form may be completed by competent authority for each control body that was subject to a supervision audit during the reporting year (optional)) Form reference number to be copied into supervision audit table – data-field K Reporting year Competent authority in charge of supervision Supervision audit report Reference: Date: Identification of control body Code number SUMMARY OF MAIN FINDINGS OF THE SUPERVISION AUDIT 1. Conditions for approval of the control body and delegation of control tasks Please insert text 2. Findings related to compliance with minimum control requirements Please insert text 3. Findings related to risk assessment of operators Please insert text 4. Findings related to compliance with national catalogue of measures Please insert text 5. Findings related to exchange of information with competent authority Please insert text 6. Other findings Please insert text 7. Overall conclusion Please insert text+A1:C24L 396/26 EN Official Journal of the European Union 10.11.2021 Table 5 Actions and measures undertaken by competent authority during the reporting year to ensure effectiveness of official controls by control authorities/control bodies Data from Member State Period Year 1. National legislation Please insert text 2. New, updated or revised control procedures Please insert text 3. Training activities Please insert text 4. Provision of additional resources or reallocation of existing resources following review of priorities Please insert text 5. Special control initiatives Please insert text 6. Changes to the organisation or management of competent authorities Please insert text 7. Other Please insert text’

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