# L_2021396EN.01001701.xml

| 10.11.2021 | EN | Official Journal of the European Union | L 396/17 |
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10.11.2021

EN

Official Journal of the European Union

L 396/17

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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 2017 on 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. |
| --- | --- |

(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). |
| --- | --- |

(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. |
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(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. |
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(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. |
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(5)

Implementing Regulation (EU) 2019/723 should therefore be amended accordingly.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Organic Production Committee, |
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(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.’; |
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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. |
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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 2022 in respect of the annual reports to be submitted by 31 August 2023 for 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 LEYEN

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(1)  
  OJ L 95, 7.4.2017, p. 1.

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).

2

(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).

3

(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).

4

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ANNEX

‘9.   Organic production and labelling of organic products

| 9.1. | Overall conclusion on the level of compliance achieved |
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9.1.

| 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 integrated
  (A) | Number of competent authorities |
| Number of control authorities of which data have been integrated
  (B) | Number of control authorities |
| Number of control bodies of which data have been integrated
  (C) | Number of control bodies |
| Total number of authorities/bodies of which data have been integrated
  (A) + (B) + (C) | Total number of authorities/bodies |
| Reporting period | Year |

9.2.

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 integrated

(A)

Number of competent authorities

Number of control authorities of which data have been integrated

(B)

Number of control authorities

Number of control bodies of which data have been integrated

(C)

Number of control bodies

Total number of authorities/bodies of which data have been integrated

(A) + (B) + (C)

Total number of authorities/bodies

Reporting period

Year

Table 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 or name of competent authority/control authority/control body | Number of operators | Number of verifications of compliance Article 38(3)
  (physical and non-physical) | Number of physical on-the-spot official controls carried out | Number of samples taken Article 38(4)(c) |
| --- | --- | --- | --- | --- | --- |
| Annual controls Article 38(3) | Additional risk based Article 38(4)(b) | Total number of controls Article 38(3) & 38(4)(b) | Of which un-announced Article 38(4)(a) | Total number of samples | Number of samples with detections |
| 1.a. | Numbers for competent authority/control authority/control body 1 | | | | | | | | | |
| 1.b. | Numbers for competent authority/control authority/control body 2 | | | | | | | | | |
| 1.c. | Numbers for competent 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.+....] | | | | | | | | | |

Code number or name of competent authority/control authority/control body

Number of operators

Number of verifications of compliance Article 38(3)

(physical and non-physical)

Number of physical on-the-spot official controls carried out

Number of samples taken Article 38(4)(c)

Annual controls Article 38(3)

Additional risk based Article 38(4)(b)

Total number of controls Article 38(3) & 38(4)(b)

Of which un-announced Article 38(4)(a)

Total number of samples

Number of samples with detections

1.a.

Numbers for competent authority/control authority/control body 1

1.b.

Numbers for competent authority/control authority/control body 2

1.c.

Numbers for competent 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.+....]

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

| | Code number or name of competent authority/control authority/control body | Number of groups | Identification of the group | Total number of operators that are member of groups | Total number of official controls on groups | Number of re- inspections to members of groups | Inspections in which at least 1 sample was taken |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2. | Total numbers for all groups of 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. | | | | | | | |
| 2.b. | Numbers for competent authority/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 | | | | | | | |
| 2.c | continue and list all groups of operators per competent authority/control authority/control body | | | | | | | |
| 2.c | Group of operators ... | | | | | | | |

Code number or name of competent authority/control authority/control body

Number of groups

Identification of the group

Total number of operators that are member of groups

Total number of official controls on groups

Number of re- inspections to members of groups

Inspections in which at least 1 sample was taken

2.

Total numbers for all groups of 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.

2.b.

Numbers for competent authority/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

2.c

continue and list all groups of operators per competent authority/control authority/control body

2.c

Group of operators ...

Table 2

NON-COMPLIANCES

Data per competent authority/control authority/control body

1.   Type and number of cases of major and critical non-compliance established

| | Name or code number of competent authority/control authority/control body | Type of cases per type of non-compliances established during official controls performed |
| --- | --- | --- |
| General produc-tion rules | Specific produc-tion rules | Non-authorised substances or products | Deroga-tions | Documents and records | Rules for GoO | Labelling | Other |
| 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 | | | | | | | | | |

Name or code number of competent authority/control authority/control body

Type of cases per type of non-compliances established during official controls performed

General produc-tion rules

Specific produc-tion rules

Non-authorised substances or products

Deroga-tions

Documents and records

Rules for GoO

Labelling

Other

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

| Number of established cases of non-compliance | Measures taken for established cases of non-compliances |
| --- | --- |
| Improvement of implementation of precautionary measures and controls put in place by operator | No reference to organic production in the labelling and advertising of the entire lot or production run concerned | Prohibition of placing the affected product(s) on the market with reference to organic production, for a given period | New conversion period | Limitation of the scope of the certificate | Suspension of the certificate | Withdrawal of the certificate | Corrective measure still to be decided | Other |
| (A) | (B1) | (B2) | (B3) | (B4) | (B5) | (B6) | (B7) | (B8) | (B9) |
| | | | | | | | | | |

Number of established cases of non-compliance

Measures taken for established cases of non-compliances

Improvement of implementation of precautionary measures and controls put in place by operator

No reference to organic production in the labelling and advertising of the entire lot or production run concerned

Prohibition of placing the affected product(s) on the market with reference to organic production, for a given period

New conversion period

Limitation of the scope of the certificate

Suspension of the certificate

Withdrawal of the certificate

Corrective measure still to be decided

Other

(A)

(B1)

(B2)

(B3)

(B4)

(B5)

(B6)

(B7)

(B8)

(B9)

Table 3

Supervision & Audits

Activities of the competent authority related to

| — | control bodies to whom it has delegated certain tasks |
| --- | --- |

—

control bodies to whom it has delegated certain tasks

| — | the supervision of such control bodies |
| --- | --- |

—

the supervision of such control bodies

| — | the withdrawal of delegations to such control bodies |
| --- | --- |

—

the withdrawal of delegations to such control bodies

| — | audit of control authorities |
| --- | --- |

—

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) | | |

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 control bodies at end of reporting year | Number of supervision audits of control bodies carried out by the competent authority during reporting year | Coverage of control bodies by supervision audit of competent authority | Comment where necessary |
| --- | --- | --- | --- | --- |
| (D) | (E) | (F) = (E)/(D) | |
| Number of control bodies - Number of supervision audits during reporting year – coverage | | | | |

Number of control bodies at end of reporting year

Number of supervision audits of control bodies carried out by the competent authority during reporting year

Coverage of control bodies by supervision audit of competent authority

Comment where necessary

(D)

(E)

(F) = (E)/(D)

Number of control bodies - Number of supervision audits during reporting year – coverage

The total number of Approved Control Bodies (D) should correspond to the number reported under section 1

2.b.   Detail of supervision per control body

| List all control bodies under supervision of the competent authority | Number of operators | Number of GoO | Audit carried out by competent authority during reporting year yes = 1/no = 0 | Number of operator files reviewed in supervision audit during reporting year | Coverage of number of operator files reviewed versus total number of operators | Number of GoO files reviewed in the course of the audit during reporting year | Coverage of number of GoO files reviewed versus total number of GoO | Indicate reference number of individual form completed for the control body (template "individual form for control body" attached) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Code number | (G) | (H) | (I) | (J) | (K) = (J)/(G) | (L) | (M)= (L)/(H) | (N) |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |

List all control bodies under supervision of the competent authority

Number of operators

Number of GoO

Audit carried out by competent authority during reporting year yes = 1/no = 0

Number of operator files reviewed in supervision audit during reporting year

Coverage of number of operator files reviewed versus total number of operators

Number of GoO files reviewed in the course of the audit during reporting year

Coverage of number of GoO files reviewed versus total number of GoO

Indicate reference number of individual form completed for the control body (template "individual form for control body" 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 whom the competent authority has delegated control tasks | Number of audits carried out on control authorities by the competent authority | Coverage of control authorities audited by competent authority during reporting year | Comment where necessary |
| --- | --- | --- | --- | --- |
| (K) | (L) | (M) = (L)/(K) | |
| During reporting year | | | | |

Number of control authorities to whom the competent authority has delegated control tasks

Number of audits carried out on control authorities by the competent authority

Coverage of control authorities audited by competent authority during reporting year

Comment where necessary

(K)

(L)

(M) = (L)/(K)

During reporting year

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 |

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 |
| --- | --- |

2.

Findings related to compliance with minimum control requirements

Please insert text

| 3. | Findings related to risk assessment of operators |
| --- | --- |

3.

Findings related to risk assessment of operators

Please insert text

| 4. | Findings related to compliance with national catalogue of measures |
| --- | --- |

4.

Findings related to compliance with national catalogue of measures

Please insert text

| 5. | Findings related to exchange of information with competent authority |
| --- | --- |

5.

Findings related to exchange of information with competent authority

Please insert text

| 6. | Other findings |
| --- | --- |

6.

Other findings

Please insert text

| 7. | Overall conclusion |
| --- | --- |

7.

Overall conclusion

Please insert text+A1:C24

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 |

Data from

Member State

Period

Year

1.

National legislation

Please insert text

| 2. | New, updated or revised control procedures |
| --- | --- |

2.

New, updated or revised control procedures

Please insert text

| 3. | Training activities |
| --- | --- |

3.

Training activities

Please insert text

| 4. | Provision of additional resources or reallocation of existing resources following review of priorities |
| --- | --- |

4.

Provision of additional resources or reallocation of existing resources following review of priorities

Please insert text

| 5. | Special control initiatives |
| --- | --- |

5.

Special control initiatives

Please insert text

| 6. | Changes to the organisation or management of competent authorities |
| --- | --- |

6.

Changes to the organisation or management of competent authorities

Please insert text

| 7. | Other |
| --- | --- |

7.

Other

Please insert text’

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