# Official Journal L 186/2021

| | ISSN 1977-0677 |
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| Official Journal
  of the European Union | L 186 |
| | |
| English edition | Legislation | Volume 6427 May 2021 |

ISSN 1977-0677

Official Journal

of the European Union

L 186

English edition

Legislation

Volume 6427 May 2021

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| Contents | | I   Legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Regulation (EU) 2021/840 of the European Parliament and of the Council of 20 May 2021 establishing an exchange, assistance and training programme for the protection of the euro against counterfeiting for the period 2021-2027 (the Pericles IV programme), and repealing Regulation (EU) No 331/2014 | 1 |

Contents

I   Legislative acts

page

REGULATIONS

*

Regulation (EU) 2021/840 of the European Parliament and of the Council of 20 May 2021 establishing an exchange, assistance and training programme for the protection of the euro against counterfeiting for the period 2021-2027 (the Pericles IV programme), and repealing Regulation (EU) No 331/2014

1

| | | II   Non-legislative acts |
| --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2021/841 of 19 February 2021 amending Delegated Regulation (EU) No 640/2014 as regards the rules on non-compliances in relation to the system for the identification and registration for bovine, ovine and caprine animals and on the calculation of the level of administrative penalties in respect of declared animals under animal aid schemes or animal-related support measures | 12 |
| | * | Commission Implementing Regulation (EU) 2021/842 of 26 May 2021 amending Implementing Regulation (EU) No 307/2012 as regards transparency and confidentiality requirements for the EU risk assessment of substances under scrutiny (
  1
  ) | 16 |
| | * | Commission Implementing Regulation (EU) 2021/843 of 26 May 2021 renewing the approval of the active substance cyazofamid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (
  1
  ) | 20 |
| | | DECISIONS |
| | * | Commission Implementing Decision (EU) 2021/844 of 26 May 2021 terminating the anti-subsidy proceeding concerning imports of certain hot-rolled flat products of iron, non-alloy or other alloy steel originating in Turkey | 26 |
| | * | Commission Implementing Decision (EU) 2021/845 of 26 May 2021 amending Implementing Decision (EU) 2019/1202 as regards determination of the spontaneous ignition behaviour of dust accumulations | 28 |

II   Non-legislative acts

REGULATIONS

*

Commission Delegated Regulation (EU) 2021/841 of 19 February 2021 amending Delegated Regulation (EU) No 640/2014 as regards the rules on non-compliances in relation to the system for the identification and registration for bovine, ovine and caprine animals and on the calculation of the level of administrative penalties in respect of declared animals under animal aid schemes or animal-related support measures

12

*

Commission Implementing Regulation (EU) 2021/842 of 26 May 2021 amending Implementing Regulation (EU) No 307/2012 as regards transparency and confidentiality requirements for the EU risk assessment of substances under scrutiny (
  1
  )

1

16

*

Commission Implementing Regulation (EU) 2021/843 of 26 May 2021 renewing the approval of the active substance cyazofamid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (
  1
  )

1

20

DECISIONS

*

Commission Implementing Decision (EU) 2021/844 of 26 May 2021 terminating the anti-subsidy proceeding concerning imports of certain hot-rolled flat products of iron, non-alloy or other alloy steel originating in Turkey

26

*

Commission Implementing Decision (EU) 2021/845 of 26 May 2021 amending Implementing Decision (EU) 2019/1202 as regards determination of the spontaneous ignition behaviour of dust accumulations

28

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to to Commission Implementing Regulation (EU) 2019/238 of 8 February 2019 amending Regulation (EU) No 37/2010 to classify the substance ovotransferrin as regards its maximum residue limit ( OJ L 39, 11.2.2019 ) | 32 |
| | * | Corrigendum to Commission Implementing Regulation (EU) 2021/810 of 20 May 2021 amending Implementing Regulation (EU) 2021/2021/808 as regards transitional provisions for certain substances listed in Annex II to Decision 2002/657/EC ( OJ L 180, 21.5.2021 ) | 33 |

Corrigenda

*

Corrigendum to to Commission Implementing Regulation (EU) 2019/238 of 8 February 2019 amending Regulation (EU) No 37/2010 to classify the substance ovotransferrin as regards its maximum residue limit ( OJ L 39, 11.2.2019 )

( OJ L 39, 11.2.2019 )

32

*

Corrigendum to Commission Implementing Regulation (EU) 2021/810 of 20 May 2021 amending Implementing Regulation (EU) 2021/2021/808 as regards transitional provisions for certain substances listed in Annex II to Decision 2002/657/EC ( OJ L 180, 21.5.2021 )

( OJ L 180, 21.5.2021 )

33

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| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
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EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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I Legislative acts

REGULATIONS

| 27.5.2021 | EN | Official Journal of the European Union | L 186/1 |
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27.5.2021

EN

Official Journal of the European Union

L 186/1

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REGULATION (EU) 2021/840 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 20 May 2021

establishing an exchange, assistance and training programme for the protection of the euro against counterfeiting for the period 2021-2027 (the ‘Pericles IV’ programme), and repealing Regulation (EU) No 331/2014

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 133 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Central Bank (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

| (1) | The Union and Member States have set themselves the objective of laying down the measures necessary for the use of the euro as a single currency. Those measures include protecting the euro against counterfeiting and related fraud to ensure the effectiveness of the Union’s economy and secure the sustainability of public finances. |
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(1)

The Union and Member States have set themselves the objective of laying down the measures necessary for the use of the euro as a single currency. Those measures include protecting the euro against counterfeiting and related fraud to ensure the effectiveness of the Union’s economy and secure the sustainability of public finances.

| (2) | Council Regulation (EC) No 1338/2001 (3) provides for exchanges of information, cooperation and mutual assistance, thereby establishing a harmonised framework for the protection of the euro. The effects of that Regulation were extended by Council Regulation (EC) No 1339/2001 (4) to those Member States which have not adopted the euro as their single currency, so as to provide an equivalent level of protection for the euro throughout the Union. |
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(2)

Council Regulation (EC) No 1338/2001 (3) provides for exchanges of information, cooperation and mutual assistance, thereby establishing a harmonised framework for the protection of the euro. The effects of that Regulation were extended by Council Regulation (EC) No 1339/2001 (4) to those Member States which have not adopted the euro as their single currency, so as to provide an equivalent level of protection for the euro throughout the Union.

| (3) | Actions with the aim of promoting exchanges of information and staff, technical and scientific assistance and specialised training help significantly to protect the Union’s single currency against counterfeiting and related fraud and therefore to attain a high and equivalent level of protection across the Union, whilst demonstrating the Union’s ability to tackle serious organised crime. Such actions could also help addressing the common challenges to combat organised crime, including money laundering. |
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(3)

Actions with the aim of promoting exchanges of information and staff, technical and scientific assistance and specialised training help significantly to protect the Union’s single currency against counterfeiting and related fraud and therefore to attain a high and equivalent level of protection across the Union, whilst demonstrating the Union’s ability to tackle serious organised crime. Such actions could also help addressing the common challenges to combat organised crime, including money laundering.

| (4) | A programme for the protection of the euro against counterfeiting contributes to raising the awareness of Union citizens, increasing their confidence in that currency and improving the protection of the euro, especially through the constant dissemination of results of actions supported by that programme. |
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(4)

A programme for the protection of the euro against counterfeiting contributes to raising the awareness of Union citizens, increasing their confidence in that currency and improving the protection of the euro, especially through the constant dissemination of results of actions supported by that programme.

| (5) | Sound protection of the euro against counterfeiting is a key component of a secure and competitive Union economy, and directly linked to the Union objective of improving the efficient functioning of the economic and monetary union. |
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(5)

Sound protection of the euro against counterfeiting is a key component of a secure and competitive Union economy, and directly linked to the Union objective of improving the efficient functioning of the economic and monetary union.

| (6) | Past support for such actions, through Council Decisions 2001/923/EC (5) and 2001/924/EC (6), which were subsequently amended and extended by Council Decisions 2006/75/EC (7), 2006/76/EC (8), 2006/849/EC (9) and 2006/850/EC (10) and Regulation (EU) No 331/2014 of the European Parliament and of the Council (11), has made it possible to enhance the actions of the Union and the Member States in the field of the protection of the euro against counterfeiting. The objectives of the programme for the protection of the euro against counterfeiting for the preceding periods have been successfully achieved. |
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(6)

Past support for such actions, through Council Decisions 2001/923/EC (5) and 2001/924/EC (6), which were subsequently amended and extended by Council Decisions 2006/75/EC (7), 2006/76/EC (8), 2006/849/EC (9) and 2006/850/EC (10) and Regulation (EU) No 331/2014 of the European Parliament and of the Council (11), has made it possible to enhance the actions of the Union and the Member States in the field of the protection of the euro against counterfeiting. The objectives of the programme for the protection of the euro against counterfeiting for the preceding periods have been successfully achieved.

| (7) | In 2017, the Commission carried out a mid-term evaluation of the multiannual action programme established by Regulation (EU) No 331/2014 (the ‘Pericles 2020’ programme), supported by an independent report. The report was generally positive about the Pericles 2020 programme but it expressed concerns about the limited number of competent authorities applying for the implementation of actions under the Pericles 2020 programme and the quality of the key performance indicators used for measuring the results of the Pericles 2020 programme. In its Communication to the European Parliament and to the Council on the mid-term evaluation of the Pericles 2020 programme and its ex ante evaluation in the form of a Staff Working Document accompanying its proposal, the Commission concluded, taking into consideration the conclusions and recommendations of the mid-term evaluation, that the continuation of the Pericles 2020 programme beyond 2020 should be supported, given its Union added value, its long-term impact and the sustainability of its actions as well as its contribution to combating organised crime. |
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(7)

In 2017, the Commission carried out a mid-term evaluation of the multiannual action programme established by Regulation (EU) No 331/2014 (the ‘Pericles 2020’ programme), supported by an independent report. The report was generally positive about the Pericles 2020 programme but it expressed concerns about the limited number of competent authorities applying for the implementation of actions under the Pericles 2020 programme and the quality of the key performance indicators used for measuring the results of the Pericles 2020 programme. In its Communication to the European Parliament and to the Council on the mid-term evaluation of the Pericles 2020 programme and its ex ante evaluation in the form of a Staff Working Document accompanying its proposal, the Commission concluded, taking into consideration the conclusions and recommendations of the mid-term evaluation, that the continuation of the Pericles 2020 programme beyond 2020 should be supported, given its Union added value, its long-term impact and the sustainability of its actions as well as its contribution to combating organised crime.

| (8) | The advice contained in the mid-term evaluation was that actions financed under the Pericles 2020 programme should be continued, while addressing the need to simplify the submission of applications, to encourage differentiation of beneficiaries and the participation of a maximum number of competent authorities from various countries in the activities of the Pericles 2020 programme, to continue focusing on emerging and recurrent counterfeiting threats, and to streamline the key performance indicators. |
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(8)

The advice contained in the mid-term evaluation was that actions financed under the Pericles 2020 programme should be continued, while addressing the need to simplify the submission of applications, to encourage differentiation of beneficiaries and the participation of a maximum number of competent authorities from various countries in the activities of the Pericles 2020 programme, to continue focusing on emerging and recurrent counterfeiting threats, and to streamline the key performance indicators.

| (9) | Counterfeiting hotspots have been detected in third countries and counterfeiting of the euro is acquiring a growing international dimension. Capacity building and training activities involving the competent authorities of third countries should therefore be considered essential to achieve the effective protection of the euro and should be further encouraged in the context of the continuation of the Pericles 2020 programme. |
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(9)

Counterfeiting hotspots have been detected in third countries and counterfeiting of the euro is acquiring a growing international dimension. Capacity building and training activities involving the competent authorities of third countries should therefore be considered essential to achieve the effective protection of the euro and should be further encouraged in the context of the continuation of the Pericles 2020 programme.

| (10) | A new programme for the period 2021-2027 (the ‘Pericles IV’ programme) should be adopted. It should be ensured that the Pericles IV programme is consistent with, and complementary to, other relevant programmes and actions. The Commission should therefore carry out all the necessary consultations with regard to evaluating needs for the protection of the euro with the principal parties involved, in particular the competent national authorities designated by Member States, the European Central Bank (ECB) and Europol, within the committee referred to in Regulation (EC) No 1338/2001, particularly as regards exchanges, assistance and training, for the purpose of the application of the Pericles IV programme. Moreover, the Commission should draw on the vast experience of the ECB in relation to the conduct of training and the provision of information on counterfeit euro banknotes when implementing the Pericles IV programme. |
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(10)

A new programme for the period 2021-2027 (the ‘Pericles IV’ programme) should be adopted. It should be ensured that the Pericles IV programme is consistent with, and complementary to, other relevant programmes and actions. The Commission should therefore carry out all the necessary consultations with regard to evaluating needs for the protection of the euro with the principal parties involved, in particular the competent national authorities designated by Member States, the European Central Bank (ECB) and Europol, within the committee referred to in Regulation (EC) No 1338/2001, particularly as regards exchanges, assistance and training, for the purpose of the application of the Pericles IV programme. Moreover, the Commission should draw on the vast experience of the ECB in relation to the conduct of training and the provision of information on counterfeit euro banknotes when implementing the Pericles IV programme.

| (11) | Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 of the Treaty on the Functioning of the European Union (TFEU) apply to this Regulation. Those rules are laid down in Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (12) (the ‘Financial Regulation’) and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes, indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union’s budget. |
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(11)

Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 of the Treaty on the Functioning of the European Union (TFEU) apply to this Regulation. Those rules are laid down in Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (12) (the ‘Financial Regulation’) and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes, indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union’s budget.

| (12) | Since the objectives of this Regulation, namely to facilitate cooperation among Member States and between the Commission and Member States in order to protect the euro against counterfeiting, without impinging on Member States’ responsibilities, and using resources more efficiently than could be done at national level, to assist Member States in collectively protecting the euro and to encourage the use of common Union structures to increase cooperation and the timely and comprehensive exchange of information between competent authorities, cannot be sufficiently achieved by the Member States, but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. |
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(12)

Since the objectives of this Regulation, namely to facilitate cooperation among Member States and between the Commission and Member States in order to protect the euro against counterfeiting, without impinging on Member States’ responsibilities, and using resources more efficiently than could be done at national level, to assist Member States in collectively protecting the euro and to encourage the use of common Union structures to increase cooperation and the timely and comprehensive exchange of information between competent authorities, cannot be sufficiently achieved by the Member States, but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

| (13) | The Pericles IV programme should be implemented in accordance with the multiannual financial framework laid down in Council Regulation (EU, Euratom) 2020/2093 (13). |
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(13)

The Pericles IV programme should be implemented in accordance with the multiannual financial framework laid down in Council Regulation (EU, Euratom) 2020/2093 (13).

| (14) | In order to ensure uniform conditions for the implementation of the Pericles IV programme, implementing powers should be conferred on the Commission. The Commission should adopt annual work programmes setting out the priorities, the budget breakdown and the evaluation criteria for the grants for actions. The exceptional and duly justified cases, in which an increase in the co-financing rate is necessary in order to give the Member States greater economic flexibility, thus enabling them to carry out and complete projects to protect and safeguard the euro in a satisfactory manner, should be part of the annual work programmes. |
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(14)

In order to ensure uniform conditions for the implementation of the Pericles IV programme, implementing powers should be conferred on the Commission. The Commission should adopt annual work programmes setting out the priorities, the budget breakdown and the evaluation criteria for the grants for actions. The exceptional and duly justified cases, in which an increase in the co-financing rate is necessary in order to give the Member States greater economic flexibility, thus enabling them to carry out and complete projects to protect and safeguard the euro in a satisfactory manner, should be part of the annual work programmes.

| (15) | This Regulation lays down a financial envelope for the Pericles IV programme which is to constitute the prime reference amount, within the meaning of Point 18 of the Interinstitutional Agreement of 16 December 2020 (14), for the European Parliament and for the Council during the annual budgetary procedure. |
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(15)

This Regulation lays down a financial envelope for the Pericles IV programme which is to constitute the prime reference amount, within the meaning of Point 18 of the Interinstitutional Agreement of 16 December 2020 (14), for the European Parliament and for the Council during the annual budgetary procedure.

| (16) | To ensure the effective assessment of progress of the Pericles IV programme towards the achievement of its objectives, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the Annex with regard to the indicators where considered necessary for the purposes of evaluation, as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (15). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. |
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(16)

To ensure the effective assessment of progress of the Pericles IV programme towards the achievement of its objectives, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the Annex with regard to the indicators where considered necessary for the purposes of evaluation, as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (15). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

| (17) | In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (16) and Council Regulations (EC, Euratom) No 2988/95 (17), (Euratom, EC) No 2185/96 (18) and (EU) 2017/1939 (19), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union.
  The European Public Prosecutor’s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union, as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (20). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. |
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(17)

In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (16) and Council Regulations (EC, Euratom) No 2988/95 (17), (Euratom, EC) No 2185/96 (18) and (EU) 2017/1939 (19), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union.

The European Public Prosecutor’s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union, as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (20). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights.

| (18) | The Commission should present to the European Parliament and to the Council a mid-term evaluation report on the implementation of the Pericles IV programme and a final evaluation report on the achievement of its objectives. Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, the Pericles IV programme should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the Pericles IV programme on the ground. |
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(18)

The Commission should present to the European Parliament and to the Council a mid-term evaluation report on the implementation of the Pericles IV programme and a final evaluation report on the achievement of its objectives. Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, the Pericles IV programme should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the Pericles IV programme on the ground.

| (19) | Regulation (EU) No 331/2014 should therefore be repealed. |
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(19)

Regulation (EU) No 331/2014 should therefore be repealed.

| (20) | In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the multi-annual financial framework 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021, |
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(20)

In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the multi-annual financial framework 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

This Regulation establishes an exchange, assistance and training programme for the protection of the euro against counterfeiting (the ‘Pericles IV’ programme), for the period from 1 January 2021 to 31 December 2027.

It lays down the objectives of the Pericles IV programme, the budget for the period 2021-2027, the forms of Union funding and the rules for providing such funding.

Article 2

Programme objectives

1.   The general objective of the Pericles IV programme shall be to prevent and combat counterfeiting and related fraud and preserve the integrity of the euro banknotes and coins, thus strengthening the trust of citizens and business in the genuineness of these banknotes and coins and therefore enhancing the trust in the Union’s economy, while securing the sustainability of public finances.

2.   The specific objective of the Pericles IV programme shall be to protect euro banknotes and coins against counterfeiting and related fraud, by supporting and supplementing the measures undertaken by Member States and assisting the competent national and Union authorities in their efforts to develop among themselves and with the Commission a close and regular cooperation and an exchange of best practice, where appropriate including third countries and international organisations.

Article 3

Budget

1.   The financial envelope for the implementation of the Pericles IV programme for the period from 1 January 2021 to 31 December 2027 shall be EUR 6 193 284 in current prices.

2.   The annual appropriations shall be authorised by the European Parliament and by the Council within the limits of the multiannual financial framework.

3.   The amount referred to in paragraph 1 may be used for technical and administrative assistance for the implementation of the Pericles IV programme, such as preparatory, monitoring, control, audit and evaluation activities, including corporate information technology systems.

Article 4

Implementation and forms of Union funding

1.   The Pericles IV programme shall be implemented under direct management in accordance with the Financial Regulation.

2.   The Pericles IV programme shall be implemented by the Commission in cooperation with the Member States, through regular consultations at different stages of the implementation of the Pericles IV programme, whilst ensuring consistency and avoiding unnecessary duplication with relevant measures undertaken by other competent entities, in particular the ECB and Europol. To that effect, when preparing the work programmes pursuant to Article 10, the Commission shall take into account existing and planned ECB activities and Europol activities against euro counterfeiting and related fraud.

3.   Financial support under the Pericles IV programme for eligible actions listed in Article 6 shall take the form of either grants or public procurement.

Article 5

Joint actions

1.   Actions under the Pericles IV programme may be organised jointly by the Commission and other partners having relevant expertise, such as:

| (a) | the national central banks and the ECB; |
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(a)

the national central banks and the ECB;

| (b) | the National Analysis Centres and the Coin National Analysis Centres; |
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(b)

the National Analysis Centres and the Coin National Analysis Centres;

| (c) | the European Technical and Scientific Centre and the mints; |
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(c)

the European Technical and Scientific Centre and the mints;

| (d) | Europol, Eurojust and Interpol; |
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(d)

Europol, Eurojust and Interpol;

| (e) | the national central anti-counterfeiting offices provided for in Article 12 of the International Convention for the Suppression of Counterfeiting Currency signed at Geneva on 20 April 1929 (21) and other agencies specialising in prevention, detection and law-enforcement in connection with counterfeiting; |
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(e)

the national central anti-counterfeiting offices provided for in Article 12 of the International Convention for the Suppression of Counterfeiting Currency signed at Geneva on 20 April 1929 (21) and other agencies specialising in prevention, detection and law-enforcement in connection with counterfeiting;

| (f) | specialist bodies concerned in the field of duplication and certification technologies, printers and engravers; |
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(f)

specialist bodies concerned in the field of duplication and certification technologies, printers and engravers;

| (g) | bodies other than those referred to in points (a) to (f) offering specific expertise, including, where appropriate, such bodies from third countries and in particular from acceding States and candidate countries; and |
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(g)

bodies other than those referred to in points (a) to (f) offering specific expertise, including, where appropriate, such bodies from third countries and in particular from acceding States and candidate countries; and

| (h) | private entities that have developed and provided evidence of technical knowledge and teams specialising in detecting counterfeit banknotes and coins. |
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(h)

private entities that have developed and provided evidence of technical knowledge and teams specialising in detecting counterfeit banknotes and coins.

2.   Where eligible actions are organised jointly by the Commission and the ECB, Eurojust, Europol or Interpol, the ensuing expenses shall be divided among them. In any event, each of them shall bear the travel and accommodation costs of its own guest speakers.

CHAPTER II

ELIGIBILITY

Article 6

Eligible actions

1.   The Pericles IV programme shall provide, under the conditions set out in the annual work programmes referred to in Article 10, financial support for the following actions:

| (a) | exchange and dissemination of information, in particular through organising workshops, meetings and seminars, including training, targeted placements and exchanges of staff of competent national authorities and other similar actions. The exchange of information shall, among others, be targeted at:






  — | best practices in preventing counterfeiting and fraud relating to the euro, |
| --- | --- | --- |

(a)

exchange and dissemination of information, in particular through organising workshops, meetings and seminars, including training, targeted placements and exchanges of staff of competent national authorities and other similar actions. The exchange of information shall, among others, be targeted at:

—

best practices in preventing counterfeiting and fraud relating to the euro,

| — | methodologies for monitoring and analysing the economic and financial impact of counterfeiting, |
| --- | --- |

—

methodologies for monitoring and analysing the economic and financial impact of counterfeiting,

| — | operation of databases and early warning systems, |
| --- | --- |

—

operation of databases and early warning systems,

| — | use of detection tools, including with computer back-up, |
| --- | --- |

—

use of detection tools, including with computer back-up,

| — | enquiry and investigation methods, |
| --- | --- |

—

enquiry and investigation methods,

| — | scientific assistance, including monitoring of new developments, |
| --- | --- |

—

scientific assistance, including monitoring of new developments,

| — | protection of the euro outside the Union, |
| --- | --- |

—

protection of the euro outside the Union,

| — | research actions, |
| --- | --- |

—

research actions,

| — | provision of specific operational expertise; |
| --- | --- |

—

provision of specific operational expertise;

| (b) | technical, scientific and operational assistance, as appears necessary as part of the Pericles IV programme, including in particular:






  — | any appropriate measure which establishes teaching resources at Union level, such as a handbook of Union legislation, information bulletins, practical manuals, glossaries and lexicons, databases, especially in the area of scientific assistance or technology watch, or computer support applications, such as software, |
| --- | --- | --- |

(b)

technical, scientific and operational assistance, as appears necessary as part of the Pericles IV programme, including in particular:

—

any appropriate measure which establishes teaching resources at Union level, such as a handbook of Union legislation, information bulletins, practical manuals, glossaries and lexicons, databases, especially in the area of scientific assistance or technology watch, or computer support applications, such as software,

| — | relevant studies with a multidisciplinary and transnational dimension, including research on innovative security features, |
| --- | --- |

—

relevant studies with a multidisciplinary and transnational dimension, including research on innovative security features,

| — | development of technical support instruments and methods to facilitate detection actions at Union level, |
| --- | --- |

—

development of technical support instruments and methods to facilitate detection actions at Union level,

| — | support for cooperation in operations involving at least two countries when such support cannot be made available from other programmes of Union institutions and bodies; |
| --- | --- |

—

support for cooperation in operations involving at least two countries when such support cannot be made available from other programmes of Union institutions and bodies;

| (c) | the purchase of equipment to be used by specialised anti-counterfeiting authorities of third countries for protecting the euro against counterfeiting, in compliance with Article 7(2). |
| --- | --- |

(c)

the purchase of equipment to be used by specialised anti-counterfeiting authorities of third countries for protecting the euro against counterfeiting, in compliance with Article 7(2).

2.   The Pericles IV programme shall take into account the transnational and multidisciplinary aspects of the fight against counterfeiting by targeting the participation of the following groups:

| (a) | staff of agencies engaged in detecting and combating counterfeiting, in particular police forces, customs and financial administrations, depending on their specific functions at national level; |
| --- | --- |

(a)

staff of agencies engaged in detecting and combating counterfeiting, in particular police forces, customs and financial administrations, depending on their specific functions at national level;

| (b) | intelligence personnel; |
| --- | --- |

(b)

intelligence personnel;

| (c) | representatives of the national central banks, the mints, commercial banks and other financial intermediaries, in particular as regards the obligations of financial institutions; |
| --- | --- |

(c)

representatives of the national central banks, the mints, commercial banks and other financial intermediaries, in particular as regards the obligations of financial institutions;

| (d) | judicial officers, specialist lawyers and members of the judiciary in this field; |
| --- | --- |

(d)

judicial officers, specialist lawyers and members of the judiciary in this field;

| (e) | any other group of specialists concerned, such as chambers of commerce and industry or comparable structures capable of providing access to small and medium-sized enterprises, retailers and cash-in-transit companies. |
| --- | --- |

(e)

any other group of specialists concerned, such as chambers of commerce and industry or comparable structures capable of providing access to small and medium-sized enterprises, retailers and cash-in-transit companies.

3.   The groups referred to in paragraph 2 may include participants from third countries.

CHAPTER III

GRANTS

Article 7

Grants

1.   Grants under the Pericles IV programme shall be awarded and managed in accordance with Title VIII of the Financial Regulation.

2.   For actions implemented through grants, the purchase of equipment shall not be the sole component of the grant agreement.

Article 8

Co-financing rates

The co-financing rate for grants awarded under the Pericles IV programme shall not exceed 75 % of the eligible costs. In exceptional and duly justified cases, defined in the annual work programmes referred to in Article 10, the co-financing rate shall not exceed 90 % of the eligible costs.

Article 9

Eligible entities

Entities eligible for funding under the Pericles IV programme shall be the competent national authorities as defined in point (b) of Article 2 of Regulation (EC) No 1338/2001.

CHAPTER IV

PROGRAMMING, MONITORING AND EVALUATION

Article 10

Work programmes

1.   In order to implement the Pericles IV programme, the Commission shall adopt work programmes as referred to in Article 110 of the Financial Regulation.

2.   For grants, in addition to the requirements laid down in Article 110 of the Financial Regulation, the work programme shall specify the essential selection and award criteria and the maximum possible rate of co-financing.

Article 11

Exercise of delegation

1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.   The power to adopt delegated acts referred to in Article 12(2) shall be conferred on the Commission from 1 January 2021 until 31 December 2027.

3.   The delegation of power referred to in Article 12(2), may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.   Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.   A delegated act adopted pursuant to Article 12(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.

Article 12

Monitoring

1.   Indicators to report on progress of the Pericles IV programme towards the achievement of the specific objective laid down in Article 2 are set out in the Annex.

2.   To ensure the effective assessment of progress of the Pericles IV programme towards the achievement of its objectives, the Commission is empowered to adopt delegated acts, in accordance with Article 11, to amend the Annex with regard to the indicators where considered necessary for the purposes of evaluation, as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework.

3.   The Commission shall provide annual information on the results of the Pericles IV programme to the European Parliament, to the Council and to the ECB, taking into account the quantitative and qualitative indicators set out in the Annex.

4.   The participating countries and other beneficiaries shall provide the Commission with all the data and information necessary to permit the monitoring and evaluation of the Pericles IV programme.

Article 13

Evaluation

1.   An independent mid-term evaluation of the Pericles IV programme shall be carried out once there is sufficient information available about the implementation of the Pericles IV programme, but no later than four years after the start of the programme implementation.

2.   At the end of the implementation of the Pericles IV programme, but no later than two years after the end of the period specified in Article 1, a final evaluation of the Pericles IV programme shall be carried out by the Commission.

3.   The Commission shall communicate the conclusions of the evaluations accompanied by its observations, to the European Parliament, to the Council and to the ECB.

CHAPTER V

TRANSITIONAL AND FINAL PROVISIONS

Article 14

Information, communication and visibility

1.   The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public.

2.   The Commission shall implement information and communication actions relating to the Pericles IV programme, and to actions taken pursuant to the Pericles IV programme and to the results obtained.

3.   Financial resources allocated to the Pericles IV programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as these priorities are related to the objectives referred to in Article 2.

Article 15

Repeal

Regulation (EU) No 331/2014 is repealed with effect from 1 January 2021.

Article 16

Transitional provisions

1.   This Regulation shall not affect the continuation or modification of actions initiated pursuant to Regulation (EU) No 331/2014, which shall continue to apply to these actions until their closure.

2.   The financial envelope for the Pericles IV programme may also cover the technical and administrative assistance expenses necessary to ensure the transition between the Pericles IV programme and the measures adopted pursuant to Regulation (EU) No 331/2014.

Article 17

Entry into force and application

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

It shall apply from 1 January 2021.

This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.

Done at Brussels, 20 May 2021.

For the European Parliament

The President

D. M. SASSOLI

For the Council

The President

A. P. ZACARIAS

---

(1)  OJ C 378, 19.10.2018, p. 2.

1

(2)  Position of the European Parliament of 13 February 2019 (not yet published in the Official Journal) and position of the Council at first reading of 13 April 2021 (not yet published in the Official Journal). Position of the European Parliament of 18 May 2021 (not yet published in the Official Journal).

2

(3)  Council Regulation (EC) No 1338/2001 of 28 June 2001 laying down measures necessary for the protection of the euro against counterfeiting (OJ L 181, 4.7.2001, p. 6).

3

(4)  Council Regulation (EC) No 1339/2001 of 28 June 2001 extending the effects of Regulation (EC) No 1338/2001 laying down measures necessary for the protection of the euro against counterfeiting to those Member States which have not adopted the euro as their single currency (OJ L 181, 4.7.2001, p. 11).

4

(5)  Council Decision 2001/923/EC of 17 December 2001 establishing an exchange, assistance and training programme for the protection of the euro against counterfeiting (the ‘Pericles’ programme) (OJ L 339, 21.12.2001, p. 50).

5

(6)  Council Decision 2001/924/EC of 17 December 2001 extending the effects of the Decision establishing an exchange, assistance and training programme for the protection of the euro against counterfeiting (‘Pericles’ programme) to the Member States which have not adopted the euro as the single currency (OJ L 339, 21.12.2001, p. 55).

6

(7)  Council Decision 2006/75/EC of 30 January 2006 amending and extending Decision 2001/923/EC establishing an exchange, assistance and training programme for the protection of the euro against counterfeiting (the ‘Pericles’ programme) (OJ L 36, 8.2.2006, p. 40).

7

(8)  Council Decision 2006/76/EC of 30 January 2006 extending to the non-participating Member States the application of Decision 2006/75/EC amending and extending Decision 2001/923/EC establishing an exchange, assistance and training programme for the protection of the euro against counterfeiting (the ‘Pericles’ programme) (OJ L 36, 8.2.2006, p. 42).

8

(9)  Council Decision 2006/849/EC of 20 November 2006 amending and extending Decision 2001/923/EC establishing an exchange, assistance and training programme for the protection of the euro against counterfeiting (the Pericles programme) (OJ L 330, 28.11.2006, p. 28).

9

(10)  Council Decision 2006/850/EC of 20 November 2006 extending to the non-participating Member States the application of Decision 2006/849/EC amending and extending Decision 2001/923/EC establishing an exchange, assistance and training programme for the protection of the euro against counterfeiting (the Pericles programme) (OJ L 330, 28.11.2006, p. 30).

10

(11)  Regulation (EU) No 331/2014 of the European Parliament and of the Council of 11 March 2014 establishing an exchange, assistance and training programme for the protection of the euro against counterfeiting (the ‘Pericles 2020’ programme) and repealing Council Decisions 2001/923/EC, 2001/924/EC, 2006/75/EC, 2006/76/EC, 2006/849/EC and 2006/850/EC (OJ L 103, 5.4.2014, p. 1).

11

(12)  Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).

12

(13)  Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, p. 11).

13

(14)  Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (OJ L 433 I, 22.12.2020, p. 28).

14

(15)  OJ L 123, 12.5.2016, p. 1.

15

(16)  Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999, (OJ L 248, 18.9.2013, p. 1).

16

(17)  Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1).

17

(18)  Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2).

18

(19)  Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283, 31.10.2017, p. 1).

19

(20)  Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union’s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29).

20

(21)  League of Nations Treaty Series No 2623 (1931), p. 372.

21

---

ANNEX

INDICATORS FOR THE EVALUATION OF THE PERICLES IV PROGRAMME

The Pericles IV programme will be monitored closely on the basis of a set of indicators intended to measure, at minimal administrative burdens and costs, the extent to which the general and specific objectives of the Pericles IV programme have been achieved. To that end, data will be collected as regards the following set of key indicators:

| (a) | the number of counterfeit euros detected; |
| --- | --- |

(a)

the number of counterfeit euros detected;

| (b) | the number of illegal workshops dismantled; |
| --- | --- |

(b)

the number of illegal workshops dismantled;

| (c) | the number of competent authorities applying to the Pericles IV programme; |
| --- | --- |

(c)

the number of competent authorities applying to the Pericles IV programme;

| (d) | the satisfaction rate of participants in the actions financed by the Pericles IV programme; and |
| --- | --- |

(d)

the satisfaction rate of participants in the actions financed by the Pericles IV programme; and

| (e) | the feedback of participants that have already taken part in previous Pericles actions on the impact of the Pericles IV programme on their activities in protecting the euro against counterfeiting. |
| --- | --- |

(e)

the feedback of participants that have already taken part in previous Pericles actions on the impact of the Pericles IV programme on their activities in protecting the euro against counterfeiting.

The data and information for the key performance indicators shall be collected annually by the Commission and the beneficiaries of the Pericles IV programme, as follows:

| — | the Commission shall collect the data for the number of counterfeit euro coins and banknotes; |
| --- | --- |

—

the Commission shall collect the data for the number of counterfeit euro coins and banknotes;

| — | the Commission shall collect the data for the number of illegal workshops dismantled; |
| --- | --- |

—

the Commission shall collect the data for the number of illegal workshops dismantled;

| — | the Commission shall collect the data for the number of competent authorities applying to the Pericles IV programme; |
| --- | --- |

—

the Commission shall collect the data for the number of competent authorities applying to the Pericles IV programme;

| — | the Commission and the beneficiaries of the Pericles IV programme shall collect the data for the satisfaction rate of participants in the actions financed by the Pericles IV programme; |
| --- | --- |

—

the Commission and the beneficiaries of the Pericles IV programme shall collect the data for the satisfaction rate of participants in the actions financed by the Pericles IV programme;

| — | the Commission and the beneficiaries of the Pericles IV programme shall collect the data for the feedback of participants that have already taken part in previous Pericles actions on the impact of the Pericles IV programme on their activities in protecting the euro against counterfeiting. |
| --- | --- |

—

the Commission and the beneficiaries of the Pericles IV programme shall collect the data for the feedback of participants that have already taken part in previous Pericles actions on the impact of the Pericles IV programme on their activities in protecting the euro against counterfeiting.

---

II Non-legislative acts

REGULATIONS

| 27.5.2021 | EN | Official Journal of the European Union | L 186/12 |
| --- | --- | --- | --- |

27.5.2021

EN

Official Journal of the European Union

L 186/12

---

COMMISSION DELEGATED REGULATION (EU) 2021/841

of 19 February 2021

amending Delegated Regulation (EU) No 640/2014 as regards the rules on non-compliances in relation to the system for the identification and registration for bovine, ovine and caprine animals and on the calculation of the level of administrative penalties in respect of declared animals under animal aid schemes or animal-related support measures

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (1), and in particular Articles 63(4), 64(6) and 77(7) thereof,

Whereas:

| (1) | Article 30 of Commission Delegated Regulation (EU) No 640/2014 (2) contains rules to establish the number of determined animals for the purposes of voluntary coupled support based on livestock aid applications under animal aid schemes or rural development support based on payment claims under animal-related support measures. In particular, it sets out rules for cases of non-compliances with regard to the system for the identification and registration for bovine animals and for ovine and caprine animals. Council Regulation (EC) No 21/2004 (3) provides that the Member States are to establish a system for the identification and registration of ovine and caprine animals. Since that identification and registration system contains requirements similar to those of the identification and registration system for bovine animals as laid down in Regulation (EC) No 1760/2000 of the European Parliament and of the Council (4), it is appropriate to align the rules for taking into account non-compliances related to the system of identification and registration of those three animal categories. In that context, it is appropriate to replace the reference to ‘ear tags’ by a reference to ‘means of identification’ in line with those two Regulations. |
| --- | --- |

(1)

Article 30 of Commission Delegated Regulation (EU) No 640/2014 (2) contains rules to establish the number of determined animals for the purposes of voluntary coupled support based on livestock aid applications under animal aid schemes or rural development support based on payment claims under animal-related support measures. In particular, it sets out rules for cases of non-compliances with regard to the system for the identification and registration for bovine animals and for ovine and caprine animals. Council Regulation (EC) No 21/2004 (3) provides that the Member States are to establish a system for the identification and registration of ovine and caprine animals. Since that identification and registration system contains requirements similar to those of the identification and registration system for bovine animals as laid down in Regulation (EC) No 1760/2000 of the European Parliament and of the Council (4), it is appropriate to align the rules for taking into account non-compliances related to the system of identification and registration of those three animal categories. In that context, it is appropriate to replace the reference to ‘ear tags’ by a reference to ‘means of identification’ in line with those two Regulations.

| (2) | Taking into account the evolution of the integrated administration and control system and for reasons of simplification, it is appropriate to adapt the administrative penalties in respect of animal aid schemes and animal-related support measures laid down in Article 31 of Delegated Regulation (EU) No 640/2014 by exempting up to three animals found non-determined from the application of administrative penalties as long they can be individually identified by means of identification or supporting documentation, and by adjusting the level of penalties to be applied if more than three animals are found non-determined. |
| --- | --- |

(2)

Taking into account the evolution of the integrated administration and control system and for reasons of simplification, it is appropriate to adapt the administrative penalties in respect of animal aid schemes and animal-related support measures laid down in Article 31 of Delegated Regulation (EU) No 640/2014 by exempting up to three animals found non-determined from the application of administrative penalties as long they can be individually identified by means of identification or supporting documentation, and by adjusting the level of penalties to be applied if more than three animals are found non-determined.

| (3) | In accordance with Article 53(4) of Commission Delegated Regulation (EU) No 639/2014 (5), where the coupled support measure concerns bovine animals and/or sheep and goats, Member States have to define as an eligibility condition for the support, the requirements to identify and register animals provided for in Regulation (EC) No 1760/2000 or Regulation (EC) No 21/2004, respectively. Furthermore, in accordance with those Regulations, animal events such as births, deaths and movements are to be notified to the computerised database within certain time limits. Non-respect of those time limits is considered as a non-compliance in respect of the animal concerned. However, in order to ensure proportionality and without prejudice to other eligibility conditions fixed by the Member State, bovine, ovine and caprine animals should be considered as eligible for aid or support without application of administrative penalties as long as a late notification of an animal event took place before the start of a retention period or before a given reference date, as established by the Member State in accordance with Article 53(4) of Delegated Regulation (EU) No 639/2014. |
| --- | --- |

(3)

In accordance with Article 53(4) of Commission Delegated Regulation (EU) No 639/2014 (5), where the coupled support measure concerns bovine animals and/or sheep and goats, Member States have to define as an eligibility condition for the support, the requirements to identify and register animals provided for in Regulation (EC) No 1760/2000 or Regulation (EC) No 21/2004, respectively. Furthermore, in accordance with those Regulations, animal events such as births, deaths and movements are to be notified to the computerised database within certain time limits. Non-respect of those time limits is considered as a non-compliance in respect of the animal concerned. However, in order to ensure proportionality and without prejudice to other eligibility conditions fixed by the Member State, bovine, ovine and caprine animals should be considered as eligible for aid or support without application of administrative penalties as long as a late notification of an animal event took place before the start of a retention period or before a given reference date, as established by the Member State in accordance with Article 53(4) of Delegated Regulation (EU) No 639/2014.

| (4) | For reasons of clarity and simplification, the wording of Article 31(3) of Delegated Regulation (EU) No 640/2014 should be aligned between the claim based and claimless system. |
| --- | --- |

(4)

For reasons of clarity and simplification, the wording of Article 31(3) of Delegated Regulation (EU) No 640/2014 should be aligned between the claim based and claimless system.

| (5) | Delegated Regulation (EU) No 640/2014 should therefore be amended accordingly. |
| --- | --- |

(5)

Delegated Regulation (EU) No 640/2014 should therefore be amended accordingly.

| (6) | In order to allow Member States sufficient time to adjust their systems to implement the amended rules, this Regulation should apply in relation to aid applications, applications for support and payment claims submitted for claim years or premium periods starting as from 1 January 2021, |
| --- | --- |

(6)

In order to allow Member States sufficient time to adjust their systems to implement the amended rules, this Regulation should apply in relation to aid applications, applications for support and payment claims submitted for claim years or premium periods starting as from 1 January 2021,

HAS ADOPTED THIS REGULATION:

Article 1

Delegated Regulation (EU) No 640/2014 is amended as follows:

| (1) | Article 30 is amended as follows:






  (a) | paragraph 4 is replaced by the following:

  ‘4.   Where cases of non-compliances with regard to the system for the identification and registration for bovine, ovine and caprine animals are found, the following shall apply:






  (a) | a bovine animal present on the holding which has lost one of the two means of identification shall be considered as determined provided that it is clearly and individually identified by the other elements of the system for the identification and registration of bovine animals referred to in points (b), (c) and (d) of the first paragraph of Article 3 of Regulation (EC) No 1760/2000; |
| --- | --- | --- | --- |

(1)

Article 30 is amended as follows:

(a)

paragraph 4 is replaced by the following:

‘4.   Where cases of non-compliances with regard to the system for the identification and registration for bovine, ovine and caprine animals are found, the following shall apply:

(a)

a bovine animal present on the holding which has lost one of the two means of identification shall be considered as determined provided that it is clearly and individually identified by the other elements of the system for the identification and registration of bovine animals referred to in points (b), (c) and (d) of the first paragraph of Article 3 of Regulation (EC) No 1760/2000;

| (b) | an ovine or caprine animal present on the holding which has lost one of the two means of identification means shall be considered as determined provided that the animal can still be identified by a first means of identification in accordance with Article 4(2)(a) of Regulation (EC) No 21/2004 and provided that all other requirements of the system for the identification and registration of ovine and caprine animals are fulfilled; |
| --- | --- |

(b)

an ovine or caprine animal present on the holding which has lost one of the two means of identification means shall be considered as determined provided that the animal can still be identified by a first means of identification in accordance with Article 4(2)(a) of Regulation (EC) No 21/2004 and provided that all other requirements of the system for the identification and registration of ovine and caprine animals are fulfilled;

| (c) | where one single bovine, ovine or caprine animal present on the holding has lost two means of identification, it shall be considered as determined provided that the animal can still be individually identified by the register, animal passport, where relevant, database or other means laid down in Regulation (EC) No 1760/2000 or Regulation (EC) No 21/2004, respectively, and provided that the animal keeper can provide evidence that he has already taken action to remedy the situation before the announcement of the on-the-spot check; |
| --- | --- |

(c)

where one single bovine, ovine or caprine animal present on the holding has lost two means of identification, it shall be considered as determined provided that the animal can still be individually identified by the register, animal passport, where relevant, database or other means laid down in Regulation (EC) No 1760/2000 or Regulation (EC) No 21/2004, respectively, and provided that the animal keeper can provide evidence that he has already taken action to remedy the situation before the announcement of the on-the-spot check;

| (d) | where the non-compliances found relate to incorrect entries in the register, the animal passports or the computerised database for animals, but are not of relevance for the verification of the respect of the eligibility conditions other than that referred to in Article 53(4) of Delegated Regulation (EU) No 639/2014 under the aid scheme or support measure concerned, the animal concerned shall only be considered as not determined if such incorrect entries are found during at least two checks within a period of 24 months. In all other cases the animals concerned shall be considered as not determined after the first finding; |
| --- | --- |

(d)

where the non-compliances found relate to incorrect entries in the register, the animal passports or the computerised database for animals, but are not of relevance for the verification of the respect of the eligibility conditions other than that referred to in Article 53(4) of Delegated Regulation (EU) No 639/2014 under the aid scheme or support measure concerned, the animal concerned shall only be considered as not determined if such incorrect entries are found during at least two checks within a period of 24 months. In all other cases the animals concerned shall be considered as not determined after the first finding;

| (e) | where the non-compliances found relate to late notifications of animal events to the computerised database, the animal concerned shall be considered as determined if the notification has taken place before the start of the retention period or before the reference date established in accordance with Article 53(4) of Delegated Regulation (EU) No 639/2014. |
| --- | --- |

(e)

where the non-compliances found relate to late notifications of animal events to the computerised database, the animal concerned shall be considered as determined if the notification has taken place before the start of the retention period or before the reference date established in accordance with Article 53(4) of Delegated Regulation (EU) No 639/2014.

The entries in, and notifications to, the system for the identification and registration of bovine, ovine and caprine animals may be adjusted at any time in cases of obvious errors recognised by the competent authority.’;

| (b) | paragraph 5 is deleted; |
| --- | --- |

(b)

paragraph 5 is deleted;

| (2) | Article 31 is replaced by the following:

  ‘Article 31
  Administrative penalties in respect of animals under the animal aid schemes or animal-related support measures

  1.   The total amount of aid or support to which the beneficiary is entitled under an animal aid scheme or animal-related support measure or type of operation under such support measure for the claim year concerned shall be paid based on the number of animals determined in accordance with Article 30(3), provided that following administrative checks or on the spot checks:






  (a) | no more than three animals are found non-determined; and |
| --- | --- | --- |

(2)

Article 31 is replaced by the following:

‘Article 31

Administrative penalties in respect of animals under the animal aid schemes or animal-related support measures

1.   The total amount of aid or support to which the beneficiary is entitled under an animal aid scheme or animal-related support measure or type of operation under such support measure for the claim year concerned shall be paid based on the number of animals determined in accordance with Article 30(3), provided that following administrative checks or on the spot checks:

(a)

no more than three animals are found non-determined; and

| (b) | non-determined animals can be individually identified by any means laid down in Regulation (EC) No 1760/2000 or (EC) No 21/2004. |
| --- | --- |

(b)

non-determined animals can be individually identified by any means laid down in Regulation (EC) No 1760/2000 or (EC) No 21/2004.

2.   If more than three animals are non-determined, the total amount of aid or support to which the beneficiary is entitled under the aid scheme or support measure or type of operation under such support measure referred to in paragraph 1 for the claim year concerned shall be reduced by:

| (a) | the percentage to be established in accordance with paragraph 3, if it is not more than 20 %; |
| --- | --- |

(a)

the percentage to be established in accordance with paragraph 3, if it is not more than 20 %;

| (b) | twice the percentage to be established in accordance with paragraph 3, if it is more than 20 % but not more than 30 %. |
| --- | --- |

(b)

twice the percentage to be established in accordance with paragraph 3, if it is more than 20 % but not more than 30 %.

If the percentage established in accordance with paragraph 3 is more than 30 %, no aid or support to which the beneficiary would have been entitled pursuant to Article 30(3) shall be granted under the aid scheme or support measure or type of operation under such support measure for the claim year concerned.

If the percentage established in accordance with paragraph 3 is more than 50 %, no aid or support to which the beneficiary would have been entitled pursuant to Article 30(3) shall be granted under the aid scheme or support measure or type of operation under such support measure for the claim year concerned. Moreover, the beneficiary shall be subject to an additional penalty of an amount equal to the amount corresponding to the difference between the number of animals declared and the number of animals determined in accordance with Article 30(3). If that amount cannot be fully off-set in the course of the three calendar years following the calendar year of the finding, in accordance with Article 28 of Implementing Regulation (EU) No 908/2014, the outstanding balance shall be cancelled.

For other species than those referred to in Article 30(4) of this Regulation, Member States may decide to determine a number of animals different from the threshold of three animals provided for in paragraphs 1 and 2 of this Article. When determining that number, Member States shall ensure that it is equivalent in substance to that threshold, by, inter alia, taking into account the livestock units and/or the amount of aid or support granted.

3.   In order to establish the percentages referred to in paragraph 2, the number of animals of an aid scheme or support measure or type of operation found to be non-determined shall be divided by the number of animals determined for that aid scheme or support measure or type of operation under such support measure for the claim year concerned.

4.   Where the calculation of the total amount of aid or support to which the beneficiary is entitled under an aid scheme or support measure or type of operation under such support measure for the claim year concerned is based on the number of days the animals fulfilling the eligibility conditions are present on the holding, the calculation of the number of animals found to be non-determined as referred to in paragraph 2 shall also be based on the number of days those animals are present on the holding.’.

Article 2

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 in relation to aid applications, applications for support and payment claims submitted for claim years or premium periods starting as from 1 January 2021.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 19 February 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 347, 20.12.2013, p. 549.

1

(2)  Commission Delegated Regulation (EU) No 640/2014 of 11 March 2014 supplementing Regulation (EU) No 1306/2013 of the European Parliament and of the Council with regard to the integrated administration and control system and conditions for refusal or withdrawal of payments and administrative penalties applicable to direct payments, rural development support and cross compliance (OJ L 181,20.6.2014, p. 48).

2

(3)  Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identification and registration of ovine and caprine animals and amending Regulation (EC) No 1782/2003 and Directives 92/102/EEC and 64/432/EEC (OJ L 5, 9.1.2004, p. 8).

3

(4)  Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 (OJ L 204, 11.8.2000, p. 1).

4

(5)  Commission Delegated Regulation (EU) No 639/2014 of 11 March 2014 supplementing Regulation (EU) No 1307/2013 of the European Parliament and of the Council establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and amending Annex X to that Regulation (OJ L 181, 20.6.2014, p. 1).

5

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| 27.5.2021 | EN | Official Journal of the European Union | L 186/16 |
| --- | --- | --- | --- |

27.5.2021

EN

Official Journal of the European Union

L 186/16

---

COMMISSION IMPLEMENTING REGULATION (EU) 2021/842

of 26 May 2021

amending Implementing Regulation (EU) No 307/2012 as regards transparency and confidentiality requirements for the EU risk assessment of substances under scrutiny

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (1), and in particular Article 8(6) thereof,

Whereas:

| (1) | Regulation (EC) No 1925/2006 harmonises the national rules in Member States on the addition of vitamins and minerals and of certain other substances to foods. |
| --- | --- |

(1)

Regulation (EC) No 1925/2006 harmonises the national rules in Member States on the addition of vitamins and minerals and of certain other substances to foods.

| (2) | Commission Implementing Regulation (EU) No 307/2012 (2) lays down, in particular, implementing rules for the application of the procedure referred to in Article 8(4) and (5) of Regulation (EC) No 1925/2006 concerning the safety assessment by the European Food Safety Authority (‘the Authority’) of the substances under scrutiny listed in Part C of Annex III thereto. |
| --- | --- |

(2)

Commission Implementing Regulation (EU) No 307/2012 (2) lays down, in particular, implementing rules for the application of the procedure referred to in Article 8(4) and (5) of Regulation (EC) No 1925/2006 concerning the safety assessment by the European Food Safety Authority (‘the Authority’) of the substances under scrutiny listed in Part C of Annex III thereto.

| (3) | Regulation (EU) 2019/1381 of the European Parliament and the Council (3) amended Regulation (EC) No 178/2002 of the European Parliament and of the Council (4). Those amendments are aimed at strengthening the transparency and the sustainability of the EU risk assessment in all areas of the food chain where the Authority delivers a scientific risk assessment. |
| --- | --- |

(3)

Regulation (EU) 2019/1381 of the European Parliament and the Council (3) amended Regulation (EC) No 178/2002 of the European Parliament and of the Council (4). Those amendments are aimed at strengthening the transparency and the sustainability of the EU risk assessment in all areas of the food chain where the Authority delivers a scientific risk assessment.

| (4) | The amendments to Regulation (EC) No 178/2002 introduced new provisions concerning, amongst others, general pre-submission advice by the staff of the Authority at the request of a potential applicant and the obligation to notify studies commissioned or carried out by business operators to support an application and the consequences in case of non-compliance with that obligation. The amendments also introduced provisions on the public disclosure, by the Authority, of all scientific data, studies and other information supporting applications, with the exception of duly justified confidential information, early on in the risk assessment process, followed up by a consultation of third parties. |
| --- | --- |

(4)

The amendments to Regulation (EC) No 178/2002 introduced new provisions concerning, amongst others, general pre-submission advice by the staff of the Authority at the request of a potential applicant and the obligation to notify studies commissioned or carried out by business operators to support an application and the consequences in case of non-compliance with that obligation. The amendments also introduced provisions on the public disclosure, by the Authority, of all scientific data, studies and other information supporting applications, with the exception of duly justified confidential information, early on in the risk assessment process, followed up by a consultation of third parties.

| (5) | Although Regulation (EU) 2019/1381 does not contain any provisions concerning the risk assessment of substances or ingredients, which had been listed to Annex III to Regulation (EC) No 1925/2006, its provisions are of direct relevance to that procedure, as outlined in Article 8(4) and (5) of Regulation (EC) No 1925/2006. These provisions concern the pre-submission phase, as regards pre-submission advice and the notification of commissioned studies, as well as the risk assessment phase, as regards transparency and confidentiality requirements and public consultations. They govern mainly application-based processes initiated by food business operators. |
| --- | --- |

(5)

Although Regulation (EU) 2019/1381 does not contain any provisions concerning the risk assessment of substances or ingredients, which had been listed to Annex III to Regulation (EC) No 1925/2006, its provisions are of direct relevance to that procedure, as outlined in Article 8(4) and (5) of Regulation (EC) No 1925/2006. These provisions concern the pre-submission phase, as regards pre-submission advice and the notification of commissioned studies, as well as the risk assessment phase, as regards transparency and confidentiality requirements and public consultations. They govern mainly application-based processes initiated by food business operators.

| (6) | Regulation (EC) No 1925/2006 gives an important role in demonstrating the safety of a particular substance under scrutiny listed in Part C of Annex III thereto not only to food business operators, but also to other interested parties, such as industry or consumer organisations. Therefore, the evaluation of a substance under scrutiny does not require the submission of an application by a designated applicant, but all interested business operators and other interested parties may submit data and information to that end. |
| --- | --- |

(6)

Regulation (EC) No 1925/2006 gives an important role in demonstrating the safety of a particular substance under scrutiny listed in Part C of Annex III thereto not only to food business operators, but also to other interested parties, such as industry or consumer organisations. Therefore, the evaluation of a substance under scrutiny does not require the submission of an application by a designated applicant, but all interested business operators and other interested parties may submit data and information to that end.

| (7) | It is necessary to ensure that the procedure for the safety assessment of the substance under scrutiny listed in Part C of Annex III to Regulation (EC) No 1925/2006 is governed by provisions comparable to those in Regulation (EU) 2019/1381 both for the pre-submission and the risk assessment phases. |
| --- | --- |

(7)

It is necessary to ensure that the procedure for the safety assessment of the substance under scrutiny listed in Part C of Annex III to Regulation (EC) No 1925/2006 is governed by provisions comparable to those in Regulation (EU) 2019/1381 both for the pre-submission and the risk assessment phases.

| (8) | In view of the above, Implementing Regulation (EU) No 307/2012 should be aligned with the amendments to Regulation (EC) No 178/2002 introduced by Regulation (EU) 2019/1381, in particular as regards (i) the possibility, provided for in Article 32a, to request pre-submission advice from the staff of the Authority, whenever the Authority is required or requested to provide an opinion; (ii) the obligation, set out in Article 32b, to notify relevant studies to the Authority; (iii) the obligation of the Authority to consult third parties set out in Article 32c, (iv) the obligations as regards the form of the submissions set out in Article 39f, and (v) the confidentiality rules provided for in Article 39. |
| --- | --- |

(8)

In view of the above, Implementing Regulation (EU) No 307/2012 should be aligned with the amendments to Regulation (EC) No 178/2002 introduced by Regulation (EU) 2019/1381, in particular as regards (i) the possibility, provided for in Article 32a, to request pre-submission advice from the staff of the Authority, whenever the Authority is required or requested to provide an opinion; (ii) the obligation, set out in Article 32b, to notify relevant studies to the Authority; (iii) the obligation of the Authority to consult third parties set out in Article 32c, (iv) the obligations as regards the form of the submissions set out in Article 39f, and (v) the confidentiality rules provided for in Article 39.

| (9) | The provision by the Authority, upon request, of pre-submission advice on the rules applicable to, and the content required for the submission of the files demonstrating the safety of a substance under scrutiny, listed in Part C of Annex III to Regulation (EC) No 1925/2006, can improve the quality of the submissions, and thus provide support to the safety assessment. However, food business operators and any other interested parties may not be able to make full use of the pre-submission advice due to the deadline for the submission of their files. In the interest of the improved quality of the scientific assessment, food business operators and other interested parties should be able to request pre-submission advice for a potential submission from the day of the adoption of an opinion by the Authority under Article 8(2)(b) of Regulation (EC) No 1925/2006, which identifies the possibility of harmful effects on health associated with the intake of a substance, but acknowledges that scientific uncertainty persists. |
| --- | --- |

(9)

The provision by the Authority, upon request, of pre-submission advice on the rules applicable to, and the content required for the submission of the files demonstrating the safety of a substance under scrutiny, listed in Part C of Annex III to Regulation (EC) No 1925/2006, can improve the quality of the submissions, and thus provide support to the safety assessment. However, food business operators and any other interested parties may not be able to make full use of the pre-submission advice due to the deadline for the submission of their files. In the interest of the improved quality of the scientific assessment, food business operators and other interested parties should be able to request pre-submission advice for a potential submission from the day of the adoption of an opinion by the Authority under Article 8(2)(b) of Regulation (EC) No 1925/2006, which identifies the possibility of harmful effects on health associated with the intake of a substance, but acknowledges that scientific uncertainty persists.

| (10) | The studies required to prove the safety of a substance under scrutiny, listed in Part C to Annex III to Regulation (EC) No 1925/2006, take in account a number of factors and therefore may vary significantly. Extending the period for food business operators or interested parties to submit files from 18 to 24 months from the date on which a substance has been listed in Part C of Annex III to Regulation (EC) No 1925/2006 can facilitate the preparation and submission of files, and therefore provide support to the safety assessment. |
| --- | --- |

(10)

The studies required to prove the safety of a substance under scrutiny, listed in Part C to Annex III to Regulation (EC) No 1925/2006, take in account a number of factors and therefore may vary significantly. Extending the period for food business operators or interested parties to submit files from 18 to 24 months from the date on which a substance has been listed in Part C of Annex III to Regulation (EC) No 1925/2006 can facilitate the preparation and submission of files, and therefore provide support to the safety assessment.

| (11) | The obligation to notify relevant studies set out in Article 32b of Regulation (EC) No 178/2002 should apply also to food business operators or interested parties who intend to submit for evaluation the file as defined in Article 2 of Implementing Regulation (EU) No 307/2012. A further adaptation to the procedure of Article 32b of Regulation (EC) No 178/2002 is however, required. The procedural consequences provided for by Article 32b of Regulation (EC) No 178/2002 in case of non-compliance with its provisions result in delays in the assessment of the file. However, given the imperative time limit of 4 years prescribed by Article 8(5) of Regulation (EC) No 1925/2006 delays in the evaluation could mean that the prescribed time limit would not be respected. Therefore, those procedural consequences are not appropriate in the context of the evaluation procedure for substances placed in part C of Annex III to Regulation (EC) No 1925/2006 and should not be provided for. In order to allow the Commission to take a decision concerning a substance under scrutiny listed in Part C of Annex III to Regulation (EC) No 1925/2006 within the required deadline, only files submitted within 24 months from the date on which a substance has been listed in that Annex should be taken into consideration. |
| --- | --- |

(11)

The obligation to notify relevant studies set out in Article 32b of Regulation (EC) No 178/2002 should apply also to food business operators or interested parties who intend to submit for evaluation the file as defined in Article 2 of Implementing Regulation (EU) No 307/2012. A further adaptation to the procedure of Article 32b of Regulation (EC) No 178/2002 is however, required. The procedural consequences provided for by Article 32b of Regulation (EC) No 178/2002 in case of non-compliance with its provisions result in delays in the assessment of the file. However, given the imperative time limit of 4 years prescribed by Article 8(5) of Regulation (EC) No 1925/2006 delays in the evaluation could mean that the prescribed time limit would not be respected. Therefore, those procedural consequences are not appropriate in the context of the evaluation procedure for substances placed in part C of Annex III to Regulation (EC) No 1925/2006 and should not be provided for. In order to allow the Commission to take a decision concerning a substance under scrutiny listed in Part C of Annex III to Regulation (EC) No 1925/2006 within the required deadline, only files submitted within 24 months from the date on which a substance has been listed in that Annex should be taken into consideration.

| (12) | Regulation (EU) 2019/1381 shall apply from 27 March 2021. Therefore, in order to ensure legal certainty and clarity with regard to transparency requirements for procedure under Article 8(4) of Regulation (EC) No 1925/2006 and to allow for uniform implementation of the transparency and confidentiality requirements for the EU risk assessment for all concerned sectors, it is necessary that this Regulation enters into force on the third day following that of its publication. For the reasons of legal certainty this Regulation should apply to the files submitted to the Authority from that date onwards. |
| --- | --- |

(12)

Regulation (EU) 2019/1381 shall apply from 27 March 2021. Therefore, in order to ensure legal certainty and clarity with regard to transparency requirements for procedure under Article 8(4) of Regulation (EC) No 1925/2006 and to allow for uniform implementation of the transparency and confidentiality requirements for the EU risk assessment for all concerned sectors, it is necessary that this Regulation enters into force on the third day following that of its publication. For the reasons of legal certainty this Regulation should apply to the files submitted to the Authority from that date onwards.

| (13) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(13)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Amendments to Implementing Regulation (EU) No 307/2012

Implementing Regulation (EU) No 307/2012 is amended as follows:

| (1) | Article 5 is replaced by the following:

  ‘Article 5
  Substance listed in Part C of Annex III to Regulation (EC) No 1925/2006

  1.   Until the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the Authority shall only consider valid a file, presented in an electronic format, which allows downloading, printing and searching of documents.
  After the adoption of standard data formats, the file shall be presented in accordance with those standard data formats to be considered valid.
  Where the Authority considers a file not valid, it shall inform the food business operator or interested party that has submitted the file and the Commission of the reasons why it considers that file not valid.


  2.   The Authority shall only take into consideration, for the purposes of the decision referred to in Article 8(5) of Regulation (EC) No 1925/2006, files submitted within 24 months from the entry into force of a decision listing a substance in Part C of Annex III to that Regulation, pursuant to Article 8(2) thereof.’; |
| --- | --- |

(1)

Article 5 is replaced by the following:

‘Article 5

Substance listed in Part C of Annex III to Regulation (EC) No 1925/2006

1.   Until the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the Authority shall only consider valid a file, presented in an electronic format, which allows downloading, printing and searching of documents.

After the adoption of standard data formats, the file shall be presented in accordance with those standard data formats to be considered valid.

Where the Authority considers a file not valid, it shall inform the food business operator or interested party that has submitted the file and the Commission of the reasons why it considers that file not valid.

2.   The Authority shall only take into consideration, for the purposes of the decision referred to in Article 8(5) of Regulation (EC) No 1925/2006, files submitted within 24 months from the entry into force of a decision listing a substance in Part C of Annex III to that Regulation, pursuant to Article 8(2) thereof.’;

| (2) | the following Articles are inserted:

  ‘Article 5a
  Pre-submission advice
  At the request of a food business operator or any other interested party, the staff of the Authority shall provide advice on the rules applicable to, and the content required for, the submission of a file containing the scientific data aiming to demonstrate the safety of a substance listed in Part C of Annex III to Regulation (EC) No 1925/2006.
  Food business operators and other interested parties may request pre-submission advice for a potential submission from the day of the adoption of an opinion by the Authority under Article 8(2) of Regulation (EC) No 1925/2006, which identifies the possibility of harmful effects on health associated with the intake of a substance.
  Such pre-submission advice shall be provided in accordance with Article 32a of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.


  Article 5b
  Notification of studies

  1.   Food business operators and other interested parties shall notify to the Authority, without delay, the title, the scope, and the starting and planned completion dates of any study commissioned or carried out by them to demonstrate the safety of a substance listed in Part C of Annex III to Regulation (EC) No 1925/2006, as well as the laboratory or testing facility located in the Union carrying out that study.


  2.   Laboratories and other testing facilities located in the Union shall also, without delay, notify the Authority of the title and the scope of any study commissioned by food business operators and other interested parties, carried out by such laboratories or other testing facilities to demonstrate the safety of a substance listed in Part C of Annex III to Regulation (EC) No 1925/2006, its starting and planned completion dates, as well as the name of the food business operator or interested party who has commissioned that study.


  3.   Studies notified in accordance with this article shall be included by the Authority in the database referred to in Article 32b(1) of Regulation (EC) No 178/2002.



  Article 5c
  Transparency
  Where the Authority is to deliver an opinion on a substance under scrutiny listed in Part C of Annex III to Regulation (EC) No 1925/2006, on the basis of a valid file, it shall:






  (a) | make public the data submitted in that file in accordance with Article 38(1)(c) of Regulation (EC) No 178/2002, which shall apply mutatis mutandis; |
| --- | --- | --- |

(2)

the following Articles are inserted:

‘Article 5a

Pre-submission advice

At the request of a food business operator or any other interested party, the staff of the Authority shall provide advice on the rules applicable to, and the content required for, the submission of a file containing the scientific data aiming to demonstrate the safety of a substance listed in Part C of Annex III to Regulation (EC) No 1925/2006.

Food business operators and other interested parties may request pre-submission advice for a potential submission from the day of the adoption of an opinion by the Authority under Article 8(2) of Regulation (EC) No 1925/2006, which identifies the possibility of harmful effects on health associated with the intake of a substance.

Such pre-submission advice shall be provided in accordance with Article 32a of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.

Article 5b

Notification of studies

1.   Food business operators and other interested parties shall notify to the Authority, without delay, the title, the scope, and the starting and planned completion dates of any study commissioned or carried out by them to demonstrate the safety of a substance listed in Part C of Annex III to Regulation (EC) No 1925/2006, as well as the laboratory or testing facility located in the Union carrying out that study.

2.   Laboratories and other testing facilities located in the Union shall also, without delay, notify the Authority of the title and the scope of any study commissioned by food business operators and other interested parties, carried out by such laboratories or other testing facilities to demonstrate the safety of a substance listed in Part C of Annex III to Regulation (EC) No 1925/2006, its starting and planned completion dates, as well as the name of the food business operator or interested party who has commissioned that study.

3.   Studies notified in accordance with this article shall be included by the Authority in the database referred to in Article 32b(1) of Regulation (EC) No 178/2002.

Article 5c

Transparency

Where the Authority is to deliver an opinion on a substance under scrutiny listed in Part C of Annex III to Regulation (EC) No 1925/2006, on the basis of a valid file, it shall:

(a)

make public the data submitted in that file in accordance with Article 38(1)(c) of Regulation (EC) No 178/2002, which shall apply mutatis mutandis;

| (b) | consult stakeholders and the public, pursuant to Article 32c(2) of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, on the basis of the non-confidential version of the data submitted in accordance with this Regulation. |
| --- | --- |

(b)

consult stakeholders and the public, pursuant to Article 32c(2) of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, on the basis of the non-confidential version of the data submitted in accordance with this Regulation.

Article 5d

Confidentiality

Upon the submission of a file, the food business operator or other interested party may request the treatment as confidential of certain parts of the information or data submitted.

Such a confidentiality request shall be accompanied by a verifiable justification that demonstrates that the disclosure of such information or data significantly harms the interests of the requestor, within the meaning of Article 39(2) and (3) of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.’

Article 2

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 to the files submitted to the Authority from that date.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 26 May 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 404, 30.12.2006, p. 26.

1

(2)  Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods (OJ L 102, 12.4.2012, p. 2).

2

(3)  Regulation (EU)_2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and the sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (OJ L 231, 6.9.2019, p. 1).

3

(4)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

4

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| 27.5.2021 | EN | Official Journal of the European Union | L 186/20 |
| --- | --- | --- | --- |

27.5.2021

EN

Official Journal of the European Union

L 186/20

---

COMMISSION IMPLEMENTING REGULATION (EU) 2021/843

of 26 May 2021

renewing the approval of the active substance cyazofamid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) thereof,

Whereas:

| (1) | Commission Directive 2003/23/EC (2) included cyazofamid as an active substance in Annex I to Council Directive 91/414/EEC (3). |
| --- | --- |

(1)

Commission Directive 2003/23/EC (2) included cyazofamid as an active substance in Annex I to Council Directive 91/414/EEC (3).

| (2) | Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4). |
| --- | --- |

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

| (3) | The approval of the active substance cyazofamid, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2021. |
| --- | --- |

(3)

The approval of the active substance cyazofamid, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2021.

| (4) | An application for the renewal of the approval of cyazofamid was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article. |
| --- | --- |

(4)

An application for the renewal of the approval of cyazofamid was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

| (5) | The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State. |
| --- | --- |

(5)

The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

| (6) | The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 23 June 2015. |
| --- | --- |

(6)

The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 23 June 2015.

| (7) | The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission. |
| --- | --- |

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

| (8) | On 23 May 2016, the Authority communicated to the Commission its conclusion (6) on whether cyazofamid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. Following a mandate from the Commission due to uncertainties related to non-target arthropods, the Authority updated its conclusion on 28 July 2020 (7). The Commission presented a renewal report regarding cyazofamid to the Standing Committee on Plants, Animals, Food and Feed on 3 December 2020 and a draft Regulation on 26 January 2021. |
| --- | --- |

(8)

On 23 May 2016, the Authority communicated to the Commission its conclusion (6) on whether cyazofamid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. Following a mandate from the Commission due to uncertainties related to non-target arthropods, the Authority updated its conclusion on 28 July 2020 (7). The Commission presented a renewal report regarding cyazofamid to the Standing Committee on Plants, Animals, Food and Feed on 3 December 2020 and a draft Regulation on 26 January 2021.

| (9) | As regards the criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (8), the conclusion of the Authority indicates that, based on the scientific evidence, it is highly unlikely that cyazofamid is an endocrine disrupter via the estrogenic, androgenic, thyroidogenic or steroidogenic modalities. Based on the available data and current knowledge summarised in the conclusion of the Authority no adverse effects that could be related to an endocrine disruptor mode of action were observed. Therefore, the Commission concludes that cyazofamid is not to be considered as having endocrine disrupting properties. |
| --- | --- |

(9)

As regards the criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (8), the conclusion of the Authority indicates that, based on the scientific evidence, it is highly unlikely that cyazofamid is an endocrine disrupter via the estrogenic, androgenic, thyroidogenic or steroidogenic modalities. Based on the available data and current knowledge summarised in the conclusion of the Authority no adverse effects that could be related to an endocrine disruptor mode of action were observed. Therefore, the Commission concludes that cyazofamid is not to be considered as having endocrine disrupting properties.

| (10) | The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the renewal reports. The applicant submitted its comments, which have been carefully examined. |
| --- | --- |

(10)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the renewal reports. The applicant submitted its comments, which have been carefully examined.

| (11) | It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance cyazofamid that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. |
| --- | --- |

(11)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance cyazofamid that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

| (12) | The risk assessment for the renewal of the approval of cyazofamid is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing cyazofamid may be authorised. It is therefore appropriate not to maintain the restriction to use as a fungicide. |
| --- | --- |

(12)

The risk assessment for the renewal of the approval of cyazofamid is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing cyazofamid may be authorised. It is therefore appropriate not to maintain the restriction to use as a fungicide.

| (13) | It is therefore appropriate to renew the approval of cyazofamid. |
| --- | --- |

(13)

It is therefore appropriate to renew the approval of cyazofamid.

| (14) | In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to provide for certain conditions. It is, in particular, appropriate to require further confirmatory information. |
| --- | --- |

(14)

In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to provide for certain conditions. It is, in particular, appropriate to require further confirmatory information.

| (15) | In order to increase the confidence in the conclusion that cyazofamid does not have endocrine disrupting properties, the applicant should provide an updated assessment, in accordance with point 2.2(b) of Annex II to Regulation (EC) No 1107/2009, of the criteria laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, and in accordance with the guidance for the identification of endocrine disruptors (9). |
| --- | --- |

(15)

In order to increase the confidence in the conclusion that cyazofamid does not have endocrine disrupting properties, the applicant should provide an updated assessment, in accordance with point 2.2(b) of Annex II to Regulation (EC) No 1107/2009, of the criteria laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, and in accordance with the guidance for the identification of endocrine disruptors (9).

| (16) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
| --- | --- |

(16)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (17) | Commission Implementing Regulation (EU) 2020/869 (10) extended the approval period of cyazofamid to 31 July 2021 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. As the date of entry into force of this Regulation would be close to the date of expiry of the approval of cyazofamid this Regulation should apply from the day after the date of expiry of the approval of cyazofamid. |
| --- | --- |

(17)

Commission Implementing Regulation (EU) 2020/869 (10) extended the approval period of cyazofamid to 31 July 2021 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. As the date of entry into force of this Regulation would be close to the date of expiry of the approval of cyazofamid this Regulation should apply from the day after the date of expiry of the approval of cyazofamid.

| (18) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(18)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Renewal of the approval of the active substance

The approval of the active substance cyazofamid, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3

Entry into force and date of application

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 August 2021.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 26 May 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 309, 24.11.2009, p. 1.

1

(2)  Commission Directive 2003/23/EC of 25 March 2003 amending Council Directive 91/414/EEC to include imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid as active substances (OJ L 81, 28.3.2003, p. 39).

2

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

3

(4)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

4

(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

5

(6)  EFSA Journal 2016;14(6):4503 [24 pp.]. Available online:www.efsa.europa.eu

6

EFSA Journal

(7)  Updated peer review of the pesticide risk assessment of the active substance cyazofamid; EFSA Journal 2020;18(9):6232.

7

EFSA Journal

(8)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. (OJ L 101, 20.4.2018, p. 33).

8

(9)  ECHA (European Chemicals Agency) and EFSA (European Food Safety Authority) with the technical support of the Joint Research Centre (JRC), Andersson N, Arena M, Auteri D, Barmaz S, Grignard E, Kienzler A, Lepper P, Lostia AM, Munn S, Parra Morte JM, Pellizzato F, Tarazona J, Terron A and Van der Linden S, 2018. Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311, 135 pp.

9

EFSA Journal

(10)  Commission Implementing Regulation (EU) 2020/869 of 24 June 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, cyazofamid, dimethomorph, ethephon, etoxazole, famoxadone, fenamiphos, flumioxazine, fluoxastrobin, folpet, formetanate, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole and S-metolachlor (OJ L 201, 25.6.2020, p. 7).

10

Paecilomyces lilacinus

---

ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity  (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Cyazofamid
  CAS No: 120116-88-3
  CIPAC No: 653 | 4-chloro-2-cyano-N,N-dimethyl-5-p-tolylimidazole-1-sulfonamide | ≥ 935 g/kg | 1.8.2021 | 31.7.2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on cyazofamid, and in particular Appendices I and II thereto, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  (a) | the specification of the technical material as commercially manufactured; |

Common Name, Identification Numbers

IUPAC Name

Purity  (1)

Date of approval

Expiration of approval

Specific provisions

Cyazofamid

CAS No: 120116-88-3

CIPAC No: 653

4-chloro-2-cyano-N,N-dimethyl-5-p-tolylimidazole-1-sulfonamide

≥ 935 g/kg

1.8.2021

31.7.2036

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on cyazofamid, and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(a)

the specification of the technical material as commercially manufactured;

| (b) | the impact of processing on the consumer risk assessment; |
| --- | --- |

(b)

the impact of processing on the consumer risk assessment;

| (c) | the protection of non-target arthropods and earthworms. |
| --- | --- |

(c)

the protection of non-target arthropods and earthworms.

The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

| 1. | the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water; |
| --- | --- |

1.

the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water;

| 2. | points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605. |
| --- | --- |

2.

points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605.

The applicant shall submit the requested information referred to in point 1 within two years from the date of publication by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

As regards point 2, the applicant shall provide an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of endocrine activity by 16 June 2023.

---

(1)  Further details on the identity and the specification of the active substance are provided in the renewal report.

---

ANNEX II

The Annex to Commission Implementing Regulation (EU) No 540/2011 is amended as follows:

| (1) | in Part A, entry 46 on cyazofamid is deleted; |
| --- | --- |

(1)

in Part A, entry 46 on cyazofamid is deleted;

| (2) | in Part B, the following entry is added:












  No | Common Name, Identification Numbers | IUPAC Name | Purity  (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‘146 | Cyazofamid
  CAS No: 120116-88-3
  CIPAC No: 653 | 4-chloro-2-cyano-N,N-dimethyl-5-p-tolylimidazole-1-sulfonamide | ≥ 935 g/kg | 01/08/2021 | 31/07/2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on cyazofamid, and in particular Appendices I and II thereto, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  (a) | the specification of the technical material as commercially manufactured; |

(2)

in Part B, the following entry is added:

No

Common Name, Identification Numbers

IUPAC Name

Purity  (1)

Date of approval

Expiration of approval

Specific provisions

‘146

Cyazofamid

CAS No: 120116-88-3

CIPAC No: 653

4-chloro-2-cyano-N,N-dimethyl-5-p-tolylimidazole-1-sulfonamide

≥ 935 g/kg

01/08/2021

31/07/2036

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on cyazofamid, and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(a)

the specification of the technical material as commercially manufactured;

| (b) | the impact of processing on the consumer risk assessment; |
| --- | --- |

(b)

the impact of processing on the consumer risk assessment;

| (c) | the protection of non-target arthropods and earthworms. |
| --- | --- |

(c)

the protection of non-target arthropods and earthworms.

The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

| 1. | the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water; |
| --- | --- |

1.

the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water;

| 2. | points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605. |
| --- | --- |

2.

points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605.

The applicant shall submit the requested information referred to in point 1 within two years from the date of publication by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

As regards point 2 the applicant shall provide an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of endocrine activity by 16 June 2023’

---

(1)  Further details on the identity and the specification of the active substance are provided in the renewal report.

---

DECISIONS

| 27.5.2021 | EN | Official Journal of the European Union | L 186/26 |
| --- | --- | --- | --- |

27.5.2021

EN

Official Journal of the European Union

L 186/26

---

COMMISSION IMPLEMENTING DECISION (EU) 2021/844

of 26 May 2021

terminating the anti-subsidy proceeding concerning imports of certain hot-rolled flat products of iron, non-alloy or other alloy steel originating in Turkey

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (1), and in particular Article 14(1) thereof,

Whereas:

1.   PROCEDURE

| (1) | On 12 June 2020, the European Commission (‘the Commission’) initiated an anti-subsidy investigation with regard to imports of certain hot-rolled flat products of iron, non-alloy or other alloy steel (‘the product under investigation’) originating in Turkey. The Commission published a Notice of Initiation in the Official Journal of the European Union (‘Notice of Initiation’) (2). |
| --- | --- |

(1)

On 12 June 2020, the European Commission (‘the Commission’) initiated an anti-subsidy investigation with regard to imports of certain hot-rolled flat products of iron, non-alloy or other alloy steel (‘the product under investigation’) originating in Turkey. The Commission published a Notice of Initiation in the Official Journal of the European Union (‘Notice of Initiation’) (2).

| (2) | The product under investigation is certain flat-rolled products of iron, non-alloy steel or other alloy steel, whether or not in coils (including ‘cut-to-length’ and ‘narrow strip’ products), not further worked than hot-rolled, not clad, plated or coated, originating in Turkey.
  The following products are not covered by this investigation:






  — | products of stainless steel and grain-oriented silicon electrical steel; |
| --- | --- | --- |

(2)

The product under investigation is certain flat-rolled products of iron, non-alloy steel or other alloy steel, whether or not in coils (including ‘cut-to-length’ and ‘narrow strip’ products), not further worked than hot-rolled, not clad, plated or coated, originating in Turkey.

The following products are not covered by this investigation:

—

products of stainless steel and grain-oriented silicon electrical steel;

| — | products of tool steel and high-speed steel; |
| --- | --- |

—

products of tool steel and high-speed steel;

| — | products, not in coils, without patterns in relief, of a thickness exceeding 10 mm and of a width of 600 mm or more; and |
| --- | --- |

—

products, not in coils, without patterns in relief, of a thickness exceeding 10 mm and of a width of 600 mm or more; and

| — | products, not in coils, without patterns in relief, of a thickness of 4,75 mm or more but not exceeding 10 mm and of a width of 2 050 mm or more. |
| --- | --- |

—

products, not in coils, without patterns in relief, of a thickness of 4,75 mm or more but not exceeding 10 mm and of a width of 2 050 mm or more.

| (3) | The investigation was initiated following a complaint lodged by the European Steel Association (‘Eurofer’ or ‘the complainant’) on behalf of producers representing more than 25 % of the total Union production of the product under investigation. The complaint contained sufficient evidence of subsidisation and of a resulting injury to justify the initiation of the investigation. |
| --- | --- |

(3)

The investigation was initiated following a complaint lodged by the European Steel Association (‘Eurofer’ or ‘the complainant’) on behalf of producers representing more than 25 % of the total Union production of the product under investigation. The complaint contained sufficient evidence of subsidisation and of a resulting injury to justify the initiation of the investigation.

| (4) | In the Notice of Initiation, the Commission invited interested parties to contact it in order to participate in the investigation. In addition, the Commission specifically informed the complainants, other known Union producers, the known exporting producers and the Turkish authorities, known importers, suppliers and users, traders, as well as associations known to be concerned about the initiation of the investigation and invited them to participate. |
| --- | --- |

(4)

In the Notice of Initiation, the Commission invited interested parties to contact it in order to participate in the investigation. In addition, the Commission specifically informed the complainants, other known Union producers, the known exporting producers and the Turkish authorities, known importers, suppliers and users, traders, as well as associations known to be concerned about the initiation of the investigation and invited them to participate.

| (5) | All interested parties had an opportunity to comment on the initiation of the investigation and to request a hearing with the Commission and/or the Hearing Officer in trade proceedings within the time limit set in the Notice of Initiation. |
| --- | --- |

(5)

All interested parties had an opportunity to comment on the initiation of the investigation and to request a hearing with the Commission and/or the Hearing Officer in trade proceedings within the time limit set in the Notice of Initiation.

2.   WITHDRAWAL OF THE COMPLAINT AND TERMINATION OF THE PROCEEDING

| (6) | On 24 March 2021, the complainant informed the Commission that it withdrew the complaint. |
| --- | --- |

(6)

On 24 March 2021, the complainant informed the Commission that it withdrew the complaint.

| (7) | Under Article 14(1) of Regulation (EU) 2016/1037, proceedings may be terminated where the complaint is withdrawn, unless such termination would not be in the Union interest. |
| --- | --- |

(7)

Under Article 14(1) of Regulation (EU) 2016/1037, proceedings may be terminated where the complaint is withdrawn, unless such termination would not be in the Union interest.

| (8) | The investigation had not brought to light any considerations showing that a continuation of the case would be in the Union interest. |
| --- | --- |

(8)

The investigation had not brought to light any considerations showing that a continuation of the case would be in the Union interest.

| (9) | The Commission therefore concluded that anti-subsidy proceding concerning imports of certain hot-rolled flat products of iron, non-alloy or other alloy steel originating in Turkey should be terminated without the imposition of measures. |
| --- | --- |

(9)

The Commission therefore concluded that anti-subsidy proceding concerning imports of certain hot-rolled flat products of iron, non-alloy or other alloy steel originating in Turkey should be terminated without the imposition of measures.

| (10) | Interested parties were informed accordingly and were given an opportunity to comment. No comments were received. |
| --- | --- |

(10)

Interested parties were informed accordingly and were given an opportunity to comment. No comments were received.

| (11) | The Decision is in accordance with the opinion of the Committee established by Article 15(1) of Regulation (EU) 2016/1036 of the European Parliament and of the Council (3), |
| --- | --- |

(11)

The Decision is in accordance with the opinion of the Committee established by Article 15(1) of Regulation (EU) 2016/1036 of the European Parliament and of the Council (3),

HAS ADOPTED THIS DECISION:

Article 1

The anti-subsidy proceding concerning imports of flat-rolled products of iron, non-alloy steel or other alloy steel, whether or not in coils (including ‘cut-to-length’ and ‘narrow strip’ products), not further worked than hot-rolled, not clad, plated or coated, currently falling under CN codes 7208 10 00, 7208 25 00, 7208 26 00, 7208 27 00, 7208 36 00, 7208 37 00, 7208 38 00, 7208 39 00, 7208 40 00, 7208 52 10, 7208 52 99, 7208 53 10, 7208 53 90, 7208 54 00, 7211 13 00, 7211 14 00, 7211 19 00, ex 7225 19 10 (TARIC code 7225191090), 7225 30 90, ex 7225 40 60 (TARIC code 7225406090), 7225 40 90, ex 7226 19 10 (TARIC code 7226191090), 7226 91 91 and 7226 91 99, originating in Turkey, is terminated.

Article 2

This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.

Done at Brussels, 26 May 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 176, 30.6.2016, p. 55.

1

(2)  Notice of initiation of an anti-subsidy proceeding concerning imports of certain hot-rolled flat products of iron, non-alloy or other alloy steel originating in Turkey (OJ C 197, 12.6.2020, p. 4).

2

(3)  Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (OJ L 176, 30.6.2016, p. 21).

3

---

| 27.5.2021 | EN | Official Journal of the European Union | L 186/28 |
| --- | --- | --- | --- |

27.5.2021

EN

Official Journal of the European Union

L 186/28

---

COMMISSION IMPLEMENTING DECISION (EU) 2021/845

of 26 May 2021

amending Implementing Decision (EU) 2019/1202 as regards determination of the spontaneous ignition behaviour of dust accumulations

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (1), and in particular Article 10(6) thereof,

Whereas:

| (1) | In accordance with Article 12 of Directive 2014/34/EU of the European Parliament and of the Council (2), products which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the essential health and safety requirements set out in Annex II to that Directive covered by those standards or parts thereof. |
| --- | --- |

(1)

In accordance with Article 12 of Directive 2014/34/EU of the European Parliament and of the Council (2), products which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the essential health and safety requirements set out in Annex II to that Directive covered by those standards or parts thereof.

| (2) | By letter BC/CEN/46-92 – BC/CLC/05-92 of 12 December 1994, the Commission made a request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) for the drafting and revision of harmonised standards in support of Directive 94/9/EC of the European Parliament and of the Council (3). That Directive was replaced by Directive 2014/34/EU without changing the essential health and safety requirements set out in Annex II to Directive 94/9/EC. |
| --- | --- |

(2)

By letter BC/CEN/46-92 – BC/CLC/05-92 of 12 December 1994, the Commission made a request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) for the drafting and revision of harmonised standards in support of Directive 94/9/EC of the European Parliament and of the Council (3). That Directive was replaced by Directive 2014/34/EU without changing the essential health and safety requirements set out in Annex II to Directive 94/9/EC.

| (3) | In particular, CEN and Cenelec were requested to draft a standard on the design and testing of equipment for use in potentially explosive atmospheres as indicated in Chapter I of the standardisation programme agreed between CEN and Cenelec and the Commission and attached to request BC/CEN/46-92 – BC/CLC/05-92. CEN and Cenelec were also requested to revise the existing standards with a view to aligning them to the essential health and safety requirements of Directive 94/9/EC. |
| --- | --- |

(3)

In particular, CEN and Cenelec were requested to draft a standard on the design and testing of equipment for use in potentially explosive atmospheres as indicated in Chapter I of the standardisation programme agreed between CEN and Cenelec and the Commission and attached to request BC/CEN/46-92 – BC/CLC/05-92. CEN and Cenelec were also requested to revise the existing standards with a view to aligning them to the essential health and safety requirements of Directive 94/9/EC.

| (4) | On the basis of the request BC/CEN/46-92 – BC/CLC/05-92, CEN revised standard EN 15188:2007 on determination of the spontaneous ignition behaviour of dust accumulations. As a result of that revision CEN submitted to the Commission standard EN 15188:2020. |
| --- | --- |

(4)

On the basis of the request BC/CEN/46-92 – BC/CLC/05-92, CEN revised standard EN 15188:2007 on determination of the spontaneous ignition behaviour of dust accumulations. As a result of that revision CEN submitted to the Commission standard EN 15188:2020.

| (5) | The Commission together with CEN has assessed whether the standard EN 15188:2020 drafted by CEN complies with the request BC/CEN/46-92 – BC/CLC/05-92. |
| --- | --- |

(5)

The Commission together with CEN has assessed whether the standard EN 15188:2020 drafted by CEN complies with the request BC/CEN/46-92 – BC/CLC/05-92.

| (6) | The standard EN 15188:2020 satisfies the requirements which it aims to cover and which are set out in Annex II to Directive 2014/34/EU. It is therefore appropriate to publish the reference of that standard in the Official Journal of the European Union. |
| --- | --- |

(6)

The standard EN 15188:2020 satisfies the requirements which it aims to cover and which are set out in Annex II to Directive 2014/34/EU. It is therefore appropriate to publish the reference of that standard in the Official Journal of the European Union.

| (7) | Standard EN 15188:2020 replaces standard EN 15188:2007. It is therefore necessary to withdraw from the Official Journal of the European Union the reference of standard EN 15188:2007. |
| --- | --- |

(7)

Standard EN 15188:2020 replaces standard EN 15188:2007. It is therefore necessary to withdraw from the Official Journal of the European Union the reference of standard EN 15188:2007.

| (8) | In order to provide manufacturers with sufficient time to adapt their products to the revised version of standard EN 15188:2007, it is necessary to defer the withdrawal of the reference to that standard. |
| --- | --- |

(8)

In order to provide manufacturers with sufficient time to adapt their products to the revised version of standard EN 15188:2007, it is necessary to defer the withdrawal of the reference to that standard.

| (9) | References of harmonised standards drafted in support of Directive 2014/34/EU are published in Commission Implementing Decision (EU) 2019/1202 (4). In order to ensure that the references of harmonised standards drafted in support of Directive 2014/34/EU are listed in the same act, the references of standards EN 15188:2020 and EN 15188:2007 should be included in that Implementing Decision. |
| --- | --- |

(9)

References of harmonised standards drafted in support of Directive 2014/34/EU are published in Commission Implementing Decision (EU) 2019/1202 (4). In order to ensure that the references of harmonised standards drafted in support of Directive 2014/34/EU are listed in the same act, the references of standards EN 15188:2020 and EN 15188:2007 should be included in that Implementing Decision.

| (10) | Implementing Decision (EU) 2019/1202 should therefore be amended accordingly. |
| --- | --- |

(10)

Implementing Decision (EU) 2019/1202 should therefore be amended accordingly.

| (11) | Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the day of its publication, |
| --- | --- |

(11)

Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the day of its publication,

HAS ADOPTED THIS DECISION:

Article 1

Annex I to Implementing Decision (EU) 2019/1202 is amended in accordance with Annex I to this Decision.

Article 2

Annex II to Implementing Decision (EU) 2019/1202 is amended in accordance with Annex II to this Decision.

Article 3

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

Done at Brussels, 26 May 2021.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  OJ L 316, 14.11.2012, p. 12.

1

(2)  Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309).

2

(3)  Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 100, 19.4.1994, p. 1).

3

(4)  Commission Implementing Decision (EU) 2019/1202 of 12 July 2019 on the harmonised standards for equipment and protective systems intended for use in potentially explosive atmospheres drafted in support of Directive 2014/34/EU of the European Parliament and of the Council (OJ L 189, 15.7.2019, p. 71).

4

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ANNEX I

In Annex I to Implementing Decision (EU) 2019/1202 the following entry is added:

| No | Reference of the standard |
| --- | --- |
| ‘3. | EN 15188:2020
  Determination of the spontaneous ignition behaviour of dust accumulations’. |

No

Reference of the standard

‘3.

EN 15188:2020

Determination of the spontaneous ignition behaviour of dust accumulations’.

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ANNEX II

In Annex II to Implementing Decision (EU) 2019/1202, the following entry is added:

| No | Reference of the standard | Date of withdrawal |
| --- | --- | --- |
| ‘3. | EN 15188:2007
  Determination of the spontaneous ignition behaviour of dust accumulations | 27 November 2022’. |

No

Reference of the standard

Date of withdrawal

‘3.

EN 15188:2007

Determination of the spontaneous ignition behaviour of dust accumulations

27 November 2022’.

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Corrigenda

| 27.5.2021 | EN | Official Journal of the European Union | L 186/32 |
| --- | --- | --- | --- |

27.5.2021

EN

Official Journal of the European Union

L 186/32

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Corrigendum to to Commission Implementing Regulation (EU) 2019/238 of 8 February 2019 amending Regulation (EU) No 37/2010 to classify the substance ovotransferrin as regards its maximum residue limit

(
  Official Journal of the European Union L 39 of 11 February 2019
  )

On page 6, in the annex, in the amendment to Table 1 of the Annex to Regulation (EU) No 37/2010:

for:

‘Not for use in animals from which eggs are produced’,

read:

‘Not for use in animals from which eggs are produced for human consumption’.

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| 27.5.2021 | EN | Official Journal of the European Union | L 186/33 |
| --- | --- | --- | --- |

27.5.2021

EN

Official Journal of the European Union

L 186/33

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Corrigendum to Commission Implementing Regulation (EU) 2021/810 of 20 May 2021 amending Implementing Regulation (EU) 2021/2021/808 as regards transitional provisions for certain substances listed in Annex II to Decision 2002/657/EC

(
  Official Journal of the European Union L 180 of 21 May 2021
  )

The title is replaced with the following:

‘Commission Implementing Regulation (EU) 2021/810 of 20 May 2021 amending Implementing Regulation (EU) 2021/808 as regards transitional provisions for certain substances listed in Annex II to Decision 2002/657/EC’.

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