# C_2021507EN.01000101.xml

| 16.12.2021 | EN | Official Journal of the European Union | C 507/1 |
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16.12.2021

EN

Official Journal of the European Union

C 507/1

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Commission Notice on a guidance document on how to fill in section 9 of the standard model form in the Annex to Commission Implementing Regulation (EU) 2019/723

(2021/C 507/01)

Table of contents

| 1. | Purpose of the guidance document | 2 |
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1.

| 2. | Point 9.1 ‘Overall conclusion on the level of compliance achieved’ | 2 |
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2.

| 3. | Point 9.2 ‘Identification of the member state/competent authority that submits the annual report’ | 2 |
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3.

| 4. | Table 1: Number of controls for all competent authorities-control authorities -control bodies | 2 |
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4.

| 1.1. | Registered operators in possession of a certificate per 31 December of the reporting year | 3 |
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1.1.

| 1.2. | Groups of operators (GoO) in possession of a certificate per 31 December of the reporting year | 4 |
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1.2.

| 5. | Table 2: Non-compliances | 4 |
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5.

| 2.1. | Number of cases of non-compliance established | 4 |
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2.1.

| 2.2. | Measures taken for established cases of major and critical non-compliances | 5 |
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2.2.

| 6. | Table 3: Supervision & audits | 5 |
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6.

| 3.1. | New control bodies to whom the competent authority has delegated control tasks/ control bodies whose delegation has been withdrawn | 5 |
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3.1.

| 3.2. | Supervision of control bodies by the competent authority (only relevant if the competent authority delegates controls tasks to control bodies) | 5 |
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3.2.

| 3.3. | Audit activities carried out by the competent authority on control authorities (only relevant if the competent authority confers control tasks to control authorities) | 5 |
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3.3.

| 7. | Table 4. Individual form in supervision of control body | 6 |
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7.

| 8. | Table 5. Actions and measures undertaken by competent authority during the reporting year to ensure effectiveness of official controls by control authorities/control bodies | 6 |
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8.

1.   Purpose of the guidance document

The purpose of this guidance document is to assist the Member States in submitting the information and data on organic production and labelling of organic products in their annual report on the implementation of their multi-annual national control plans (MANCP) in section 9 of part II of annex of Commission Implementing Regulation (EU) 2019/723 (1), as amended by Commission Implementing Regulation (EU) 2021/1935 of 8 November 2021 (2).

This guidance document is intended to be additional to the Commission Notice on a guidance document on how to fill in the standard model form in the Annex to Commission Implementing Regulation (EU) 2019/723 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 (3).

In this regard, the definitions in Section 4 of Commission Notice 2021/C 71/01 also apply to the organic sector.

Only the Court of Justice of the European Union is competent to authoritatively interpret Union law.

2.   Point 9.1 ‘Overall conclusion on the level of compliance achieved’

This information is presented in a text box, for free text.

Member States should take into account the guidance in Section A.1 of Part II of Commission Notice 2021/C 71/01.

3.   Point 9.2 ‘Identification of the member state/competent authority that submits the annual report’

This information is presented in a form template.

Member States shall provide the following identification information:

| — | data from: the name of Member State and the name of the competent authority that submits the report; |
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data from: the name of Member State and the name of the competent authority that submits the report;

| — | number of competent authorities whose data has been integrated (A): the total number of competent authorities, as defined in Article 3, point (3), of Regulation (EU) 2017/625, including at the national, regional or local level if applicable; |
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number of competent authorities whose data has been integrated (A): the total number of competent authorities, as defined in Article 3, point (3), of Regulation (EU) 2017/625, including at the national, regional or local level if applicable;

| — | number of control authorities whose data has been integrated (B): the total number of control authorities, as defined in point (55) of Article 3 of Regulation (EU) 2018/848, including at the national, regional or local level if applicable; |
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number of control authorities whose data has been integrated (B): the total number of control authorities, as defined in point (55) of Article 3 of Regulation (EU) 2018/848, including at the national, regional or local level if applicable;

| — | number of control bodies whose data has been integrated (C): the total number of control bodies, as defined in point (56) of Article 3 of Regulation (EU) 2018/848 (4); |
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number of control bodies whose data has been integrated (C): the total number of control bodies, as defined in point (56) of Article 3 of Regulation (EU) 2018/848 (4);

| — | total number of authorities / bodies whose data has been integrated (A) + (B) + (C): the sum of A, B and C; |
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total number of authorities / bodies whose data has been integrated (A) + (B) + (C): the sum of A, B and C;

| — | reporting period: Member States should take into account the guidance in Section 6 of Commission Notice 2021/C 71/01. |
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reporting period: Member States should take into account the guidance in Section 6 of Commission Notice 2021/C 71/01.

4.   Table 1: Number of controls for all competent authorities/control authorities/control bodies

This information is presented in two tables 1.1 and 1.2.

1.1.   Registered operators in possession of a certificate per 31 December of the reporting year

For each line of table 1.1 (1.a, 1.b ...), Member States should provide in the corresponding columns the following information:

| — | code number or name of competent authority/control authority/control body: |
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code number or name of competent authority/control authority/control body:

for delegated bodies, this refers to the code number assigned to them by the competent authority in accordance with Article 28 (2) of Regulation (EU) 2017/625;

for control authorities, this refers either to the name or the code number or both of the control authorities;

for competent authorities, this refers to the name of the competent authorities.

| — | number of operators: |
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number of operators:

for competent authorities: the number of operators directly controlled and certified by the competent authorities that appear in the list of operators referred to in Article 34(6) of Regulation (EU) 2018/848 as at 31 December of the reporting year;

for control authorities and control bodies: the number of operators controlled and certified by the control authorities/control bodies that appear in the list of operators referred to in Article 34(6) of Regulation (EU) 2018/848 as at 31 December of the reporting year.

‘Suspended’ and ‘withdrawn’ operators should not be counted when the suspension or withdrawal of their certificate took place during the reporting year. The same applies for ‘operators whose certification is still pending’.

| — | number of verifications of compliance referred to in Article 38(3) of Regulation (EU) 2018/848 (physical and non-physical): |
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number of verifications of compliance referred to in Article 38(3) of Regulation (EU) 2018/848 (physical and non-physical):

this number refers to the total number of verifications of compliance that took place in the reporting year, regardless of whether they include physical on-the-spot inspections.

| — | number of physical on-the-spot inspections carried out. This refers to controls that included physical on-the-spot inspections under the following cases:






  — | annual controls for the delivery or renewal of certificate as referred to in Article 38(5) of Regulation (EU) 2018/848; |
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number of physical on-the-spot inspections carried out. This refers to controls that included physical on-the-spot inspections under the following cases:

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annual controls for the delivery or renewal of certificate as referred to in Article 38(5) of Regulation (EU) 2018/848;

| — | the additional risk based controls as referred to in Article 38(4), point (b), of Regulation (EU) 2018/848; |
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the additional risk based controls as referred to in Article 38(4), point (b), of Regulation (EU) 2018/848;

| — | the sum of ‘annual controls’ and ‘additional risk based controls’; and |
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the sum of ‘annual controls’ and ‘additional risk based controls’; and

| — | the sum of ‘annual controls’ and ‘additional risk based controls’ that were carried out without prior notice as referred to in Article 38 (4), point (a), of Regulation (EU) 2018/848. |
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the sum of ‘annual controls’ and ‘additional risk based controls’ that were carried out without prior notice as referred to in Article 38 (4), point (a), of Regulation (EU) 2018/848.

Member States should also take into account the guidance by referring to the text in Section 4, point (a), of Commission Notice 2021/C 71/01 (How to count official controls).

| — | number of samples taken according to Article 38(4), point (c), of Regulation (EU) 2018/848 |
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number of samples taken according to Article 38(4), point (c), of Regulation (EU) 2018/848

Member States should provide the number of samples taken during all official controls (annual, additional risk based, unannounced) as following:

the total number of samples taken and analysed; and

the number of samples with detections of products and substances not authorised for use in organic production.

When multiple samples are taken from the same product lot from one operator on a single occasion, Member States should report them as one sample.

However, when multiple samples are taken from several lots/products from one operator on a single occasion, Member States should report each of them.

1.2.   Groups of operators (GoO) in possession of a certificate per 31 December of the reporting year

For each line of table 1.2 (2.a, 2.b ...), the Member States shall insert in the corresponding columns the following information:

| — | code number or name of competent authority/control authority/control body; |
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code number or name of competent authority/control authority/control body;

| — | number of groups. |
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number of groups.

| — | This refers to the total number of groups of operators controlled and certified by each competent authority/control authority/control body; |
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This refers to the total number of groups of operators controlled and certified by each competent authority/control authority/control body;

| — | identification of the group. This refers to the name or other identification for each group of operators; |
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identification of the group. This refers to the name or other identification for each group of operators;

| — | total number of operators that are member of groups. This refers to the total number of members for each group of operators; |
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total number of operators that are member of groups. This refers to the total number of members for each group of operators;

| — | total number of official controls on groups. This refers to the total number of official controls on each group of operators as following: |
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total number of official controls on groups. This refers to the total number of official controls on each group of operators as following:

annual verification of the set-up and functioning of the internal control system regardless if it includes a physical on-the-spot inspection as referred to in Article 38(1), point (d), of Regulation (EU) 2018/848;

re-inspections of members of the groups, as referred to in Article 38(4), point (d), of Regulation (EU) 2018/848 and in Article 7 of Regulation (EU) 2021/279;

witness audits, as referred to in Article 2(5) of Regulation (EU) 2021/771; and

additional risk-based inspections as referred to in Article 38(4), point (b), of Regulation (EU) 2018/848.

| — | number of re- inspections of members of groups. This refers to the re-inspections of members carried out by the competent authority/control authority/control body for each group of operators; and |
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number of re- inspections of members of groups. This refers to the re-inspections of members carried out by the competent authority/control authority/control body for each group of operators; and

| — | inspections in which at least one sample was taken. |
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inspections in which at least one sample was taken.

5.   Table 2: Non-compliances

This information is presented in two tables 2.1 and 2.2.

2.1.   Number of cases of non-compliance established

For each line of table 2.1 (1.a, 1.b ...), the Member States should provide in the corresponding columns the following information:

| — | name or code number of competent authority/control authority/control body; |
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name or code number of competent authority/control authority/control body;

| — | general production rules. This refers to established major and critical non-compliances that concern the general production rules referred to in Articles 9, 10 and 11 of Regulation (EU) 2018/848 and corresponding secondary legislation; |
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general production rules. This refers to established major and critical non-compliances that concern the general production rules referred to in Articles 9, 10 and 11 of Regulation (EU) 2018/848 and corresponding secondary legislation;

| — | specific production rules. This refers to established major and critical non-compliances that concern the specific production rules referred to in Articles 12 to 21 and in Annex II to Regulation (EU) 2018/848 and in Regulations (EU) 2020/464 and (EU) 2021/1189; |
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specific production rules. This refers to established major and critical non-compliances that concern the specific production rules referred to in Articles 12 to 21 and in Annex II to Regulation (EU) 2018/848 and in Regulations (EU) 2020/464 and (EU) 2021/1189;

| — | non-authorised substances or products. This refers to established major and critical non-compliances that concern presence of products and substances non-authorised for organic production; |
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non-authorised substances or products. This refers to established major and critical non-compliances that concern presence of products and substances non-authorised for organic production;

| — | derogations. This refers to established major and critical non-compliances that concern the derogations referred to in Article 22 of Regulation (EU) 2018/848 and in Regulation (EU) 2020/1691 |
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derogations. This refers to established major and critical non-compliances that concern the derogations referred to in Article 22 of Regulation (EU) 2018/848 and in Regulation (EU) 2020/1691

| — | documents and records. This refers to established major and critical non-compliances that concern the documents and records referred to in Article 39 of Regulation (EU) 2018/848 and in Regulation (EU) 2021/1691; |
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documents and records. This refers to established major and critical non-compliances that concern the documents and records referred to in Article 39 of Regulation (EU) 2018/848 and in Regulation (EU) 2021/1691;

| — | rules for GoO. This refers to established major and critical non-compliances that concern the rules on GoO referred to in Article 36 of Regulation (EU) 2018/848 and in Articles 4 to 7 of Regulation (EU) 2021/279, and Article 2 of Regulation (EU) 2021/771; |
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rules for GoO. This refers to established major and critical non-compliances that concern the rules on GoO referred to in Article 36 of Regulation (EU) 2018/848 and in Articles 4 to 7 of Regulation (EU) 2021/279, and Article 2 of Regulation (EU) 2021/771;

| — | labelling. This refers to established major and critical non-compliances that concern the rules on labelling referred to in Articles 30 to 33 of Regulation (EU) 2018/848 and Article 3 of Regulation (EU) 2021/279; and |
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labelling. This refers to established major and critical non-compliances that concern the rules on labelling referred to in Articles 30 to 33 of Regulation (EU) 2018/848 and Article 3 of Regulation (EU) 2021/279; and

| — | other. This refers to established major and critical non-compliances that concern any other rules not mentioned above. |
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other. This refers to established major and critical non-compliances that concern any other rules not mentioned above.

2.2.   Measures taken for established cases of major and critical non-compliances

The Member States should provide both the total number of measures taken by the competent authorities/control authorities/control bodies to restore compliance and the number of measures under columns B1-B9 of table 2.2.

When providing such information, the Member States should take into account that competent authorities/control authorities/control bodies may take more than one measure for some cases of established non-compliances and thus the total number of established non-compliances and the total number of measures may be different.

6.   Table 3: Supervision & audits

This information is presented in three tables 3.1, 3.2 and 3.3

3.1.   New control bodies to whom the competent authority has delegated control tasks/ control bodies whose delegation has been withdrawn

The Member States should indicate the number of new bodies to whom the competent authority has delegated control tasks during the reporting year (line B) and the number of control bodies whose delegation has been withdrawn during the reporting year (line C).

In order to ensure consistency of the data, the Member States should also provide the number of delegated bodies at the beginning (line A) and the end of the reporting year (line D).

The Member States may also provide some comments if it is necessary to clarify a situation.

3.2.   Supervision of control bodies by the competent authority (only relevant if the competent authority delegates controls tasks to control bodies)

This table has two parts 3.2.a and 3.2.b.

The Member States should provide the overall information on supervision of control bodies in the first part 3.2.a. as indicated in columns D, E, and F of the table.

The ‘supervision audits’ in column E refer to the audits or inspections referred to in point (a) of Article 33 of Regulation (EU) 2017/625.

The Member States may use the ‘comments’ column to provide explanations when the coverage is less than 100 % or more than 100 % if the Member State has more than one competent authority performing supervision.

In the second part 3.2.b of the table, the Member States should provide detailed information on the supervision of each control bodies as indicated in columns G to M of the table.

The ‘review of operators’ files’ in column J of the table refers to the review of control files of operators certified by the control body concerned either during the office audit or during on-the-spot physical inspection of the operator. The latter inspection may be carried out either directly by the staff of the competent authority or by the inspectors of the control body (witness audit).

Similarly, the ‘review of GoO files’ in column L of the table refers to the review of control files of groups of operators certified by the control body concerned and it may concern verifications of the set up and functioning of the Internal Control System (ICS), or re-inspections of members of the groups or witness audits.

The Member States should fill in column N of the table only if they also fill in the optional table 4. In such a case, they should provide the reference number of the ‘individual form’ for each control body.

3.3.   Audit activities carried out by the competent authority on control authorities (only relevant if the competent authority confers control tasks to control authorities)

The Member States should provide information on the audits of organic control authorities carried out in accordance with Article 6 of Regulation (EU) 2017/625 as indicated in columns K to M of table 3.3.

7.   Table 4. Individual form in supervision of control body

This information in table 4 is optional.

When Member States choose to fill in this table, they should create one individual form for each control body under their supervision and create one reference number for each individual form.

The Member States should provide summary text information on the main findings of the supervision audits under the five pre-defined categories of table 4. They may also add text information on other findings, which are not covered by the five pre-defined categories.

The Member States should indicate, in the conclusion, text information on the actions taken by the competent authority in order to restore conformity.

8.   Table 5. Actions and measures undertaken by competent authority during the reporting year to ensure effectiveness of official controls by control authorities/control bodies

This information is the same as the one requested under part I of Annex of Regulation (EU) 2019/723. By completing this table in the Organic Farming Information System (OFIS), the Member States do not need to fill in part I in the special module for the submission of annual reports of the computerised information management system for official controls (Annual Reporting on Official Controls).

The Member States should provide text information on the actions taken to ensure effectiveness of the national organic system of controls under the six pre-defined categories of text and may add other initiatives not pre-defined in table 5.

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(1)  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).

(2)  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 (OJ L 396, 10.11.2021, p. 17).

(3)  OJ C 71, 1.3.2021, 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).

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