# Official Journal L 140/2023

| | ISSN 1977-0677 |
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| Official Journal
  of the European Union | L 140 |
| | |
| English edition | Legislation | Volume 6630 May 2023 |

ISSN 1977-0677

Official Journal

of the European Union

L 140

English edition

Legislation

Volume 6630 May 2023

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | INTERNATIONAL AGREEMENTS |
| | * | Council Decision (EU) 2023/1040 of 15 May 2023 on the signing, on behalf of the Union, and provisional application of the Agreement between the European Union and Montenegro on operational activities carried out by the European Border and Coast Guard Agency in Montenegro | 1 |
| | * | Agreement between the European Union and Montenegro on operational activities carried out by the European Border and Coast Guard Agency in Montenegro | 4 |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2023/1041 of 24 May 2023 granting a Union authorisation for the biocidal product TWP 094 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  ) | 22 |
| | * | Commission Regulation (EU) 2023/1042 of 26 May 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for folpet in or on certain products (
  1
  ) | 37 |
| | | DECISIONS |
| | * | Council Decision (EU) 2023/1043 of 22 May 2023 establishing the position to be adopted on behalf of the European Union within the Committee on Trade in Civil Aircraft on the accession of Brazil to the Agreement on Trade in Civil Aircraft | 51 |
| | | ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS |
| | * | Decision No 2536/2023 of the Joint Sectoral Committee established under Article 14 of the United States – European Union amended Sectoral Annex for pharmaceutical good manufacturing practices (GMPs) (the Annex) on including veterinary products within the product coverage of the Annex of 11 May 2023 [2023/1044] | 53 |

Contents

II   Non-legislative acts

page

INTERNATIONAL AGREEMENTS

*

Council Decision (EU) 2023/1040 of 15 May 2023 on the signing, on behalf of the Union, and provisional application of the Agreement between the European Union and Montenegro on operational activities carried out by the European Border and Coast Guard Agency in Montenegro

1

*

Agreement between the European Union and Montenegro on operational activities carried out by the European Border and Coast Guard Agency in Montenegro

4

REGULATIONS

*

Commission Implementing Regulation (EU) 2023/1041 of 24 May 2023 granting a Union authorisation for the biocidal product TWP 094 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  )

1

22

*

Commission Regulation (EU) 2023/1042 of 26 May 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for folpet in or on certain products (
  1
  )

1

37

DECISIONS

*

Council Decision (EU) 2023/1043 of 22 May 2023 establishing the position to be adopted on behalf of the European Union within the Committee on Trade in Civil Aircraft on the accession of Brazil to the Agreement on Trade in Civil Aircraft

51

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

*

Decision No 2536/2023 of the Joint Sectoral Committee established under Article 14 of the United States – European Union amended Sectoral Annex for pharmaceutical good manufacturing practices (GMPs) (the Annex) on including veterinary products within the product coverage of the Annex of 11 May 2023 [2023/1044]

53

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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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II Non-legislative acts

INTERNATIONAL AGREEMENTS

| 30.5.2023 | EN | Official Journal of the European Union | L 140/1 |
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30.5.2023

EN

Official Journal of the European Union

L 140/1

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COUNCIL DECISION (EU) 2023/1040

of 15 May 2023

on the signing, on behalf of the Union, and provisional application of the Agreement between the European Union and Montenegro on operational activities carried out by the European Border and Coast Guard Agency in Montenegro

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 77(2), points (b) and (d), and Article 79(2), point (c), in conjunction with Article 218(5) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | Pursuant to Article 73(3) of Regulation (EU) 2019/1896 of the European Parliament and of the Council (1), in circumstances requiring the deployment of border management teams from the standing corps of the European Border and Coast Guard to a third country where the members of the teams will exercise executive powers, a status agreement is to be concluded by the Union with the third country concerned on the basis of Article 218 of the Treaty on the Functioning of the European Union. |
| --- | --- |

(1)

Pursuant to Article 73(3) of Regulation (EU) 2019/1896 of the European Parliament and of the Council (1), in circumstances requiring the deployment of border management teams from the standing corps of the European Border and Coast Guard to a third country where the members of the teams will exercise executive powers, a status agreement is to be concluded by the Union with the third country concerned on the basis of Article 218 of the Treaty on the Functioning of the European Union.

| (2) | On 18 November 2022, the Council authorised the Commission to open negotiations with Montenegro for an agreement on operational activities carried out by the European Border and Coast Guard Agency in Montenegro. |
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(2)

On 18 November 2022, the Council authorised the Commission to open negotiations with Montenegro for an agreement on operational activities carried out by the European Border and Coast Guard Agency in Montenegro.

| (3) | The negotiations were successfully concluded with the initialling of the Agreement between the European Union and Montenegro on operational activities carried out by the European Border and Coast Guard Agency in Montenegro (‘the Agreement’). |
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(3)

The negotiations were successfully concluded with the initialling of the Agreement between the European Union and Montenegro on operational activities carried out by the European Border and Coast Guard Agency in Montenegro (‘the Agreement’).

| (4) | This Decision constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (2); Ireland is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application. |
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(4)

This Decision constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (2); Ireland is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

| (5) | In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Decision and is not bound by it or subject to its application. Given that this Decision builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Decision whether it will implement it in its national law. |
| --- | --- |

(5)

In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Decision and is not bound by it or subject to its application. Given that this Decision builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Decision whether it will implement it in its national law.

| (6) | The Agreement should be signed and the attached declaration with regard to Iceland, Norway, Switzerland and Liechtenstein be approved, on behalf of the Union. |
| --- | --- |

(6)

The Agreement should be signed and the attached declaration with regard to Iceland, Norway, Switzerland and Liechtenstein be approved, on behalf of the Union.

| (7) | In order to allow for an urgent deployment of the European Border and Coast Guard standing corps on the territory of Montenegro, the Agreement should be applied on a provisional basis, pending the completion of the procedures necessary for its entry into force, |
| --- | --- |

(7)

In order to allow for an urgent deployment of the European Border and Coast Guard standing corps on the territory of Montenegro, the Agreement should be applied on a provisional basis, pending the completion of the procedures necessary for its entry into force,

HAS ADOPTED THIS DECISION:

Article 1

The signing, on behalf of the Union, of the Agreement between the European Union and Montenegro on operational activities carried out by the European Border and Coast Guard Agency in Montenegro (‘the Agreement’) is hereby authorised, subject to the conclusion of the said Agreement (3).

Article 2

The Declaration attached to this Decision shall be approved on behalf of the Union.

Article 3

The President of the Council is hereby authorised to designate the person(s) empowered to sign the Agreement on behalf of the Union.

Article 4

The Agreement shall be applied on a provisional basis, in accordance with Article 22(2), second subparagraph, thereof, as from the first day of the second month following the date of its signature, pending the completion of the procedures necessary for its entry into force (4).

Article 5

This Decision shall enter into force on on the date of its adoption.

Done at Brussels, 15 May 2023.

For the Council

The President

J. FORSSMED

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(1)  Regulation (EU) 2019/1896 of the European Parliament and of the Council of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 (OJ L 295, 14.11.2019, p. 1).

1

(2)  Council Decision 2002/192/EC of 28 February 2002 concerning Ireland’s request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20).

2

acquis

(3)  See page ... of this Official Journal.

3

(4)  The date of signature of the Agreement will be published in the Official Journal of the European Union by the General Secretariat of the Council.

4

Official Journal of the European Union

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DECLARATION WITH REGARD TO ICELAND, THE KINGDOM OF NORWAY, THE SWISS CONFEDERATION AND THE PRINCIPALITY OF LIECHTENSTEIN

The Parties to the Agreement between the European Union and Montenegro on operational activities carried out by the European Border and Coast Guard Agency in Montenegro take note of the close relationship between the European Union and Iceland, the Kingdom of Norway, the Swiss Confederation and the Principality of Liechtenstein, particularly by virtue of the Agreements of 18 May 1999 and 26 October 2004 concerning the association of those countries with the implementation, application and development of the Schengen acquis.

In such circumstances it is desirable that the authorities of Iceland, the Kingdom of Norway, the Swiss Confederation and the Principality of Liechtenstein, on the one hand, and Montenegro, on the other hand, conclude, without delay, bilateral agreements on operational activities carried out by the European Border and Coast Guard Agency in Montenegro in terms similar to those of the Agreement between the European Union and Montenegro on operational activities carried out by the European Border and Coast Guard Agency in Montenegro.

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| 30.5.2023 | EN | Official Journal of the European Union | L 140/4 |
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30.5.2023

EN

Official Journal of the European Union

L 140/4

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Agreement between the European Union and Montenegro on operational activities carried out by the European Border and Coast Guard Agency in Montenegro

THE EUROPEAN UNION,

and

MONTENEGRO,

hereinafter referred to individually as a "Party" and collectively as the "Parties",

WHEREAS situations may arise where the European Border and Coast Guard Agency ("the Agency") coordinates operational cooperation between the Member States of the European Union and Montenegro, including on the territory of Montenegro,

WHEREAS a legal framework in the form of a status agreement should be established for the situations where the team members deployed by the Agency will have executive powers on the territory of Montenegro,

WHEREAS the status agreement may provide for the establishment by the Agency of antenna offices on the territory of Montenegro to facilitate and improve coordination of operational activities and to ensure the effective management of the human and technical resources of the Agency,

CONSIDERING the high level of protection of personal data in Montenegro and the European Union,

CONSIDERING that Montenegro has ratified the Council of Europe Convention No. 108 of 28 January 1981 for the Protection of Individuals with regard to Automatic Processing of Personal Data and the additional Protocol thereto,

BEARING IN MIND that respect for human rights and democratic principles are fundamental principles governing the cooperation between the Parties,

CONSIDERING that Montenegro has ratified the Council of Europe Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950, the rights enumerated in which correspond to those in the Charter of Fundamental Rights of the European Union,

CONSIDERING that all operational activities of the Agency on the territory of Montenegro should fully respect fundamental rights and the international agreements to which the European Union, its Member States and/or Montenegro are party,

CONSIDERING that all persons participating in an operational activity are obliged to maintain the highest standards of integrity, ethical conduct and professionalism, as well as respect for fundamental rights, and to meet obligations imposed upon them by the provisions of the operational plan and the Agency’s code of conduct,

HAVE DECIDED TO CONCLUDE THIS AGREEMENT:

ARTICLE 1

Scope

1.   This Agreement governs all matters necessary for the deployment of border management teams from the European Border and Coast Guard standing corps to Montenegro where the team members may exercise executive powers.

2.   The deployment referred to in paragraph 1 may take place on the territory of Montenegro.

Subject to the obligations of the Parties under the law of the sea, in particular the 1982 United Nations Convention on the Law of the Sea, operational activities may also take place in the exclusive economic zone of Montenegro. Operational activities implemented under this Agreement shall not affect search and rescue obligations deriving from the law of the sea, in particular the 1982 United Nations Convention on the Law of the Sea, the 1974 International Convention for the Safety of Life at Sea and the 1979 International Convention on Maritime Search and Rescue.

3.   The status and delimitation under international law of the respective territories of the Member States and Montenegro is in no way affected either by this Agreement or by any act accomplished in its implementation by the Parties or on their behalf, including the establishment of operational plans or participation in cross-border operations.

ARTICLE 2

Definitions

For the purposes of this Agreement, the following definitions apply:

| (1) | "Agency" means the European Border and Coast Guard Agency established by Regulation (EU) 2019/1896 of the European Parliament and of the Council (1) or any amendment thereto; |
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(1)

"Agency" means the European Border and Coast Guard Agency established by Regulation (EU) 2019/1896 of the European Parliament and of the Council (1) or any amendment thereto;

| (2) | "operational activity" means a joint operation or a rapid border intervention; |
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(2)

"operational activity" means a joint operation or a rapid border intervention;

| (3) | "border control" means the activity carried out at a border, in accordance with and for the purposes of this Agreement, in response exclusively to an intention to cross or to the act of crossing that border, regardless of any other consideration, consisting of border checks, border surveillance and assessment of threats to the internal security of the state border; |
| --- | --- |

(3)

"border control" means the activity carried out at a border, in accordance with and for the purposes of this Agreement, in response exclusively to an intention to cross or to the act of crossing that border, regardless of any other consideration, consisting of border checks, border surveillance and assessment of threats to the internal security of the state border;

| (4) | "executive powers" means powers necessary to perform the tasks required for border control which are conducted on the territory of Montenegro during an operational activity as provided for in the operational plan; |
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(4)

"executive powers" means powers necessary to perform the tasks required for border control which are conducted on the territory of Montenegro during an operational activity as provided for in the operational plan;

| (5) | "operational plan" means a plan on the basis of which operational activities are carried out as provided for under Articles 38 and 74 of Regulation (EU) 2019/1896; |
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(5)

"operational plan" means a plan on the basis of which operational activities are carried out as provided for under Articles 38 and 74 of Regulation (EU) 2019/1896;

| (6) | "European Border and Coast Guard standing corps" means the European Border and Coast Guard standing corps provided for in Article 54 of Regulation (EU) 2019/1896; |
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(6)

"European Border and Coast Guard standing corps" means the European Border and Coast Guard standing corps provided for in Article 54 of Regulation (EU) 2019/1896;

| (7) | "border management teams" means teams formed from the European Border and Coast Guard standing corps to be deployed during joint operations and rapid border interventions at the external borders in Member States and in third countries; |
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(7)

"border management teams" means teams formed from the European Border and Coast Guard standing corps to be deployed during joint operations and rapid border interventions at the external borders in Member States and in third countries;

| (8) | "consultative forum" means the advisory body established by the Agency pursuant to Article 108 of Regulation (EU) 2019/1896; |
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(8)

"consultative forum" means the advisory body established by the Agency pursuant to Article 108 of Regulation (EU) 2019/1896;

| (9) | "EUROSUR" means the framework for information exchange and cooperation between the Member States and the Agency; |
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(9)

"EUROSUR" means the framework for information exchange and cooperation between the Member States and the Agency;

| (10) | "fundamental rights monitor" means the fundamental rights monitor as provided for in Article 110 of Regulation (EU) 2019/1896; |
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(10)

"fundamental rights monitor" means the fundamental rights monitor as provided for in Article 110 of Regulation (EU) 2019/1896;

| (11) | "home Member State" means the Member State from which a staff member is deployed or seconded to the European Border and Coast Guard standing corps; |
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(11)

"home Member State" means the Member State from which a staff member is deployed or seconded to the European Border and Coast Guard standing corps;

| (12) | "incident" means a situation relating to illegal immigration, cross-border crime or a risk to the lives of migrants at, along, or in proximity to, the external borders of the European Union or Montenegro; |
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(12)

"incident" means a situation relating to illegal immigration, cross-border crime or a risk to the lives of migrants at, along, or in proximity to, the external borders of the European Union or Montenegro;

| (13) | "joint operation" means an action coordinated or organised by the Agency to support the national authorities of Montenegro responsible for border control aimed at addressing challenges such as irregular migration, present or future threats at the borders of Montenegro or cross-border crime, or aimed at providing increased technical and operational assistance for the control of those borders; |
| --- | --- |

(13)

"joint operation" means an action coordinated or organised by the Agency to support the national authorities of Montenegro responsible for border control aimed at addressing challenges such as irregular migration, present or future threats at the borders of Montenegro or cross-border crime, or aimed at providing increased technical and operational assistance for the control of those borders;

| (14) | "team member" means a member of the European Border and Coast Guard standing corps deployed through a border management team to participate in an operational activity; |
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(14)

"team member" means a member of the European Border and Coast Guard standing corps deployed through a border management team to participate in an operational activity;

| (15) | "Member State" means a Member State of the European Union; |
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(15)

"Member State" means a Member State of the European Union;

| (16) | "operational area" means the geographical area wherein an operational activity is to take place; |
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(16)

"operational area" means the geographical area wherein an operational activity is to take place;

| (17) | "participating Member State" means a Member State which participates in an operational activity, by providing technical equipment or staff of the European Border and Coast Guard standing corps; |
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(17)

"participating Member State" means a Member State which participates in an operational activity, by providing technical equipment or staff of the European Border and Coast Guard standing corps;

| (18) | "personal data" means any information relating to an identified or identifiable natural person ("data subject"); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data or an online identifier, or by reference to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person; |
| --- | --- |

(18)

"personal data" means any information relating to an identified or identifiable natural person ("data subject"); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data or an online identifier, or by reference to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person;

| (19) | "rapid border intervention" means an action aimed at responding to a situation of specific and disproportionate challenge at the borders of Montenegro by deploying border management teams in the territory of Montenegro for a limited period of time to conduct border control together with the national authorities of Montenegro responsible for border control; |
| --- | --- |

(19)

"rapid border intervention" means an action aimed at responding to a situation of specific and disproportionate challenge at the borders of Montenegro by deploying border management teams in the territory of Montenegro for a limited period of time to conduct border control together with the national authorities of Montenegro responsible for border control;

| (20) | "statutory staff" means staff employed by the Agency in accordance with the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants of the Union laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (2). |
| --- | --- |

(20)

"statutory staff" means staff employed by the Agency in accordance with the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants of the Union laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (2).

ARTICLE 3

Launching operational activities

1.   An operational activity under this Agreement shall be launched by means of a written decision of the executive director of the Agency ("the executive director") upon a written request of the competent authorities of Montenegro. Such a request shall include a description of the situation, possible aims and envisaged needs, and the profiles of staff needed, including those staff having executive powers, as applicable.

2.   If the executive director considers that the requested operational activity would likely entail or lead to violations of fundamental rights or international protection obligations that are serious or persistent, then the executive director shall not launch the operational activity.

3.   If, following the receipt of a request under paragraph 1, the executive director considers that further information is necessary in order to decide whether to launch an operational activity, he or she may request further information or authorise Agency experts to travel to Montenegro in order to assess the situation there. Montenegro shall facilitate such travel.

4.   The executive director shall decide not to launch an operational activity if he or she considers there to be justified cause to suspend or terminate it pursuant to Article 18.

ARTICLE 4

Operational plan

1.   An operational plan shall be agreed upon for each operational activity between the Agency and Montenegro in accordance with Articles 38 and 74 of Regulation (EU) 2019/1896. The operational plan shall be binding on the Agency, Montenegro and the participating Member States.

2.   The operational plan shall set out in detail the organisational and procedural aspects of the operational activity, including:

| (a) | a description of the situation, with modus operandi and objectives of the deployment, including the operational aim; |
| --- | --- |

(a)

a description of the situation, with modus operandi and objectives of the deployment, including the operational aim;

| (b) | the estimated time that the operational activity is expected to last in order to achieve its objectives; |
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(b)

the estimated time that the operational activity is expected to last in order to achieve its objectives;

| (c) | the operational area; |
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(c)

the operational area;

| (d) | a detailed description of the tasks to be performed in the exercise of official function, including those requiring executive powers, responsibilities, including with regard to respect for fundamental rights and data protection requirements, and special instructions for the border management teams, including on permissible consultation of databases and permissible service weapons, ammunition and equipment in Montenegro; |
| --- | --- |

(d)

a detailed description of the tasks to be performed in the exercise of official function, including those requiring executive powers, responsibilities, including with regard to respect for fundamental rights and data protection requirements, and special instructions for the border management teams, including on permissible consultation of databases and permissible service weapons, ammunition and equipment in Montenegro;

| (e) | the composition of the border management team as well as the deployment of other relevant staff and the presence of other members of the statutory staff, including fundamental rights monitors; |
| --- | --- |

(e)

the composition of the border management team as well as the deployment of other relevant staff and the presence of other members of the statutory staff, including fundamental rights monitors;

| (f) | command and control provisions, including the names and ranks of the border police officers or other relevant staff of Montenegro responsible for cooperating with the team members and the Agency, in particular the names and ranks of those border police officers or other relevant staff who are in command during the period of deployment, and the place of the team members in the chain of command; |
| --- | --- |

(f)

command and control provisions, including the names and ranks of the border police officers or other relevant staff of Montenegro responsible for cooperating with the team members and the Agency, in particular the names and ranks of those border police officers or other relevant staff who are in command during the period of deployment, and the place of the team members in the chain of command;

| (g) | the technical equipment to be deployed during the operational activity, including specific requirements such as conditions for use, requested crew, transport and other logistics, and financial provisions; |
| --- | --- |

(g)

the technical equipment to be deployed during the operational activity, including specific requirements such as conditions for use, requested crew, transport and other logistics, and financial provisions;

| (h) | detailed provisions on immediate incident reporting by the Agency to the management board and to relevant authorities of the participating Member States and of Montenegro of any incident encountered in the course of an operational activity performed under this Agreement; |
| --- | --- |

(h)

detailed provisions on immediate incident reporting by the Agency to the management board and to relevant authorities of the participating Member States and of Montenegro of any incident encountered in the course of an operational activity performed under this Agreement;

| (i) | a reporting and evaluation scheme containing benchmarks for the evaluation report, including with regard to the protection of fundamental rights, and final date of submission of the final evaluation report; |
| --- | --- |

(i)

a reporting and evaluation scheme containing benchmarks for the evaluation report, including with regard to the protection of fundamental rights, and final date of submission of the final evaluation report;

| (j) | with regard to sea operations, specific information on the application of the relevant jurisdiction and applicable law in the operational area, including references to international, European Union and national law regarding interception, rescue at sea and disembarkation; |
| --- | --- |

(j)

with regard to sea operations, specific information on the application of the relevant jurisdiction and applicable law in the operational area, including references to international, European Union and national law regarding interception, rescue at sea and disembarkation;

| (k) | the terms of cooperation with the bodies, offices and agencies of the European Union other than the Agency, other third countries or international organisations; |
| --- | --- |

(k)

the terms of cooperation with the bodies, offices and agencies of the European Union other than the Agency, other third countries or international organisations;

| (l) | general instructions on how to ensure the safeguarding of fundamental rights during the operational activity including personal data protection and obligations deriving from applicable international human rights instruments; |
| --- | --- |

(l)

general instructions on how to ensure the safeguarding of fundamental rights during the operational activity including personal data protection and obligations deriving from applicable international human rights instruments;

| (m) | procedures whereby persons in need of international protection, victims of trafficking in human beings, unaccompanied minors and other persons in vulnerable situations are directed to the competent national authorities for appropriate assistance; |
| --- | --- |

(m)

procedures whereby persons in need of international protection, victims of trafficking in human beings, unaccompanied minors and other persons in vulnerable situations are directed to the competent national authorities for appropriate assistance;

| (n) | procedures setting out a mechanism to receive and transmit to the Agency and to Montenegro complaints (including those lodged under Article 8(5)) against any person participating in an operational activity, including border police officers or other relevant staff of Montenegro and team members, alleging breaches of fundamental rights in the context of their participation in an operational activity of the Agency; |
| --- | --- |

(n)

procedures setting out a mechanism to receive and transmit to the Agency and to Montenegro complaints (including those lodged under Article 8(5)) against any person participating in an operational activity, including border police officers or other relevant staff of Montenegro and team members, alleging breaches of fundamental rights in the context of their participation in an operational activity of the Agency;

| (o) | logistical arrangements, including information on working conditions and the environment of the areas in which the operational activity is to take place; and |
| --- | --- |

(o)

logistical arrangements, including information on working conditions and the environment of the areas in which the operational activity is to take place; and

| (p) | provisions concerning an antenna office, as established in accordance with Article 6. |
| --- | --- |

(p)

provisions concerning an antenna office, as established in accordance with Article 6.

3.   The operational plan and any amendments thereto or adaptations thereof shall be subject to the agreement of the Agency, Montenegro and any Member States neighbouring Montenegro or bordering the operational area, after consultation of the participating Member States. The Agency shall coordinate with the relevant Member States in order to confirm their agreement.

4.   Exchange of information and operational cooperation for the purposes of EUROSUR shall take place in accordance with the rules for establishing and sharing the specific situational pictures to be set out in the operational plan for the operational activity concerned.

5.   The evaluation of the operational activity in accordance with paragraph 2, point (i), shall be conducted jointly by Montenegro and the Agency.

6.   The terms of cooperation with the bodies, offices and agencies of the European Union in accordance with paragraph 2, point (k), shall be conducted in line with their respective mandates and within available resources.

ARTICLE 5

Incident reporting

1.   The Agency and the Ministry of the Interior – Police Directorate of Montenegro shall each have an incident reporting mechanism to allow timely reporting of any incident encountered in the course of an operational activity performed under this Agreement.

2.   The Agency and Montenegro shall assist each other in carrying out all necessary inquiries and investigations into any incident reported via the mechanism referred to in paragraph 1, such as identifying witnesses and collecting and producing evidence, including requests to obtain and, if appropriate, hand over items connected with a reported incident. The handing-over of any such items may be made subject to their return within the terms specified by the competent authority delivering them.

ARTICLE 6

Antenna offices

1.   The Agency may establish antenna offices on the territory of Montenegro to facilitate and improve coordination of operational activities and to ensure the effective management of the human and technical resources of the Agency. The location of the antenna office shall be established by the Agency, in consultation with the relevant authorities of Montenegro.

2.   The antenna offices shall be established in accordance with operational needs and remain operational for the period of time necessary for the Agency to carry out operational activities in Montenegro and the neighbouring region. Subject to the agreement of Montenegro, that period of time may be prolonged by the Agency.

3.   Each antenna office shall be managed by a representative of the Agency, appointed by the executive director as head of the antenna office, who shall oversee the overall work of the office.

4.   The antenna offices shall, where applicable:

| (a) | provide operational and logistical support and ensure the coordination of the Agency’s activities in the operational areas concerned; |
| --- | --- |

(a)

provide operational and logistical support and ensure the coordination of the Agency’s activities in the operational areas concerned;

| (b) | provide operational support to Montenegro in the operational areas concerned; |
| --- | --- |

(b)

provide operational support to Montenegro in the operational areas concerned;

| (c) | monitor the activities of the border management teams and regularly report to the Agency’s headquarters; |
| --- | --- |

(c)

monitor the activities of the border management teams and regularly report to the Agency’s headquarters;

| (d) | cooperate with Montenegro on all issues related to the practical implementation of the operational activities organised by the Agency in Montenegro, including any additional issues that might have occurred in the course of those activities; |
| --- | --- |

(d)

cooperate with Montenegro on all issues related to the practical implementation of the operational activities organised by the Agency in Montenegro, including any additional issues that might have occurred in the course of those activities;

| (e) | support the coordinating officer in his or her cooperation with Montenegro on all issues related to their contribution to operational activities organised by the Agency and, where necessary, liaise with the Agency’s headquarters; |
| --- | --- |

(e)

support the coordinating officer in his or her cooperation with Montenegro on all issues related to their contribution to operational activities organised by the Agency and, where necessary, liaise with the Agency’s headquarters;

| (f) | support the coordinating officer and fundamental rights monitor(s) assigned to monitor an operational activity in facilitating, where necessary, the coordination and communication between the border management teams and the relevant authorities of Montenegro, as well as any relevant tasks; |
| --- | --- |

(f)

support the coordinating officer and fundamental rights monitor(s) assigned to monitor an operational activity in facilitating, where necessary, the coordination and communication between the border management teams and the relevant authorities of Montenegro, as well as any relevant tasks;

| (g) | organise logistical support relating to the deployment of the team members and the deployment and use of technical equipment; |
| --- | --- |

(g)

organise logistical support relating to the deployment of the team members and the deployment and use of technical equipment;

| (h) | provide all other logistical support regarding the operational area for which a given antenna office is responsible, with a view to facilitating the smooth running of the operational activities organised by the Agency; |
| --- | --- |

(h)

provide all other logistical support regarding the operational area for which a given antenna office is responsible, with a view to facilitating the smooth running of the operational activities organised by the Agency;

| (i) | ensure the effective management of the Agency’s own equipment in the areas covered by its activities, including the possible registration and long-term maintenance of that equipment and any logistical support needed; and |
| --- | --- |

(i)

ensure the effective management of the Agency’s own equipment in the areas covered by its activities, including the possible registration and long-term maintenance of that equipment and any logistical support needed; and

| (j) | support other staff and/or activities of the Agency in Montenegro as agreed between the Agency and Montenegro. |
| --- | --- |

(j)

support other staff and/or activities of the Agency in Montenegro as agreed between the Agency and Montenegro.

5.   The Agency and Montenegro shall make the arrangements for the fulfilment of the tasks assigned to the antenna offices.

6.   Montenegro shall provide the Agency with assistance to ensure the operational capacity of the antenna offices. Further details shall be set out in a separate arrangement between Montenegro and the Agency.

ARTICLE 7

Coordinating officer

1.   Without prejudice to the role of antenna offices as described in Article 6, the executive director shall appoint one or more experts from the statutory staff to be deployed as coordinating officer(s) for each operational activity. The executive director shall notify Montenegro of such appointment.

2.   The role of the coordinating officer shall be to:

| (a) | act as an interface between the Agency, Montenegro and the team members, providing assistance, on behalf of the Agency, on all issues relating to the conditions of the deployment, to the border management teams; |
| --- | --- |

(a)

act as an interface between the Agency, Montenegro and the team members, providing assistance, on behalf of the Agency, on all issues relating to the conditions of the deployment, to the border management teams;

| (b) | monitor the correct implementation of the operational plan, including, in cooperation with the fundamental rights monitor(s), as regards the protection of fundamental rights, and report to the executive director thereon; |
| --- | --- |

(b)

monitor the correct implementation of the operational plan, including, in cooperation with the fundamental rights monitor(s), as regards the protection of fundamental rights, and report to the executive director thereon;

| (c) | act on behalf of the Agency in all aspects of the deployment of the border management teams and report to the Agency on all those aspects; and |
| --- | --- |

(c)

act on behalf of the Agency in all aspects of the deployment of the border management teams and report to the Agency on all those aspects; and

| (d) | foster cooperation and coordination among Montenegro and participating Member States. |
| --- | --- |

(d)

foster cooperation and coordination among Montenegro and participating Member States.

3.   In the context of operational activities, the executive director may authorise the coordinating officer to assist in resolving any disagreement on the execution of the operational plan and deployment of the border management teams.

4.   Montenegro shall issue only instructions that are in compliance with the operational plan to the team members. If the coordinating officer considers instructions issued to team members not to be in compliance with the operational plan or with applicable legal obligations, he or she shall immediately communicate this to the Montenegro officers carrying out a coordinating role and to the executive director. The executive director may take appropriate measures, including the suspension or the termination of the operational activity, in accordance with Article 18.

ARTICLE 8

Fundamental rights

1.   In performing their obligations under this Agreement, the Parties undertake to act in compliance with all applicable human rights instruments, including the 1950 Council of Europe Convention for the Protection of Human Rights and Fundamental Freedoms, the 1951 United Nations Convention Relating to the Status of Refugees and the 1967 Protocol thereto, the 1965 United Nations International Convention on the Elimination of All Forms of Racial Discrimination, the 1966 United Nations International Covenant on Civil and Political Rights, the 1979 United Nations Convention on the Elimination of All Forms of Discrimination against Women, the 1984 United Nations Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, the 1989 United Nations Convention on the Rights of the Child, the 2006 United Nations Convention on the Rights of Persons with Disabilities and the Charter of Fundamental Rights of the European Union.

2.   Team members shall, in the performance of their tasks and in the exercise of their powers, fully respect fundamental rights, including access to asylum procedures and human dignity, and shall pay particular attention to vulnerable persons. Any measures taken in the performance of their tasks and in the exercise of their powers shall be proportionate to the objectives pursued by such measures. While performing their tasks and exercising their powers, they shall not discriminate against persons on the basis of any grounds such as sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation, in line with Article 21 of the Charter of Fundamental Rights of the European Union.

Measures interfering with fundamental rights and freedoms may be taken by team members in the performance of their tasks or in the exercise of their powers only when necessary and proportionate to the objectives pursued by such measures and must respect the essence of those fundamental rights and freedoms in accordance with applicable international, European Union and national law.

This provision shall apply mutatis mutandis to all staff of national authorities of Montenegro participating in an operational activity.

3.   The Agency’s fundamental rights officer shall monitor each operational activity’s compliance with applicable fundamental rights standards. The fundamental rights officer, or his or her deputy, may carry out on-the-spot visits to Montenegro; he or she shall also provide opinions on the operational plans and inform the executive director about possible violations of fundamental rights relating to an operational activity. Montenegro shall support the fundamental rights officer’s monitoring efforts, as requested.

4.   The Agency and Montenegro agree to provide the consultative forum with timely and effective access to all information concerning respect for fundamental rights in relation to any operational activity performed under this Agreement, including through on-the-spot visits to the operational area.

5.   The Agency and Montenegro shall each have a complaints mechanism to process allegations of breaches of fundamental rights committed by their staff in the exercise of their official functions in the course of an operational activity performed under this Agreement. Those mechanisms shall be set out in the operational plan.

ARTICLE 9

Fundamental rights monitors

1.   The Agency’s fundamental rights officer shall assign at least one fundamental rights monitor to each operational activity to, inter alia, assist and advise the coordinating officer.

2.   The fundamental rights monitor shall monitor compliance with fundamental rights and provide advice and assistance on fundamental rights in the preparation, conduct and evaluation of the relevant operational activity. This shall include, in particular:

| (a) | following the preparation of operational plans and reporting to the fundamental rights officer to enable him or her to fulfil his or her tasks as provided for in Regulation (EU) 2019/1896; |
| --- | --- |

(a)

following the preparation of operational plans and reporting to the fundamental rights officer to enable him or her to fulfil his or her tasks as provided for in Regulation (EU) 2019/1896;

| (b) | conducting visits, including long-term visits, where operational activities take place; |
| --- | --- |

(b)

conducting visits, including long-term visits, where operational activities take place;

| (c) | cooperating and liaising with the coordinating officer and providing advice and assistance to him or her; |
| --- | --- |

(c)

cooperating and liaising with the coordinating officer and providing advice and assistance to him or her;

| (d) | informing the coordinating officer of and reporting to the fundamental rights officer on any concerns regarding possible violations of fundamental rights relating to the operational activity; and |
| --- | --- |

(d)

informing the coordinating officer of and reporting to the fundamental rights officer on any concerns regarding possible violations of fundamental rights relating to the operational activity; and

| (e) | contributing to the evaluation of the operational activity as referred to in Article 4(2), point (i). |
| --- | --- |

(e)

contributing to the evaluation of the operational activity as referred to in Article 4(2), point (i).

3.   Fundamental rights monitors, independent in the performance of their tasks, shall have access to all areas in which the operational activity takes place and to all documents relevant for the implementation of that activity.

4.   While present in the operational area, fundamental rights monitors shall wear insignia that clearly allow for their identification as fundamental rights monitors.

5.   The Agency’s fundamental rights officer may cooperate with the Institution of the Protector of Human Rights and Freedoms of Montenegro (Ombudsman).

ARTICLE 10

Team members

1.   Team members shall have the authority to perform the tasks, including those requiring executive powers, described in the operational plan.

2.   While performing their tasks and exercising their powers, team members shall comply with the laws and regulations of Montenegro as well as applicable international and European Union law.

3.   Team members may perform tasks and exercise powers in the territory of Montenegro only under instructions from, and in the presence of, border management authorities of Montenegro. Montenegro may authorise team members to perform specific tasks and to exercise specific powers on its territory in the absence of its border management authorities subject to the consent of the Agency or the home Member State, as appropriate.

4.   Team members who are statutory staff shall wear the uniform of the European Border and Coast Guard standing corps while performing their tasks and exercising their powers unless specified otherwise in the operational plan.

Team members who are not statutory staff shall wear their national uniform while performing their tasks and exercising their powers unless specified otherwise in the operational plan.

While on duty, all team members shall also wear visible personal identification and a blue brassard with the insignias of the European Union and of the Agency on their uniforms.

5.   Montenegro shall authorise relevant team members to perform tasks during an operational activity that require the use of force, including the carrying and use of service weapons, ammunition and other coercive means, in accordance with the relevant provisions of the operational plan, taking into account that:

| (a) | team members who are statutory staff may carry and use service weapons, ammunition and other coercive means subject to the consent of the Agency; |
| --- | --- |

(a)

team members who are statutory staff may carry and use service weapons, ammunition and other coercive means subject to the consent of the Agency;

| (b) | team members who are not statutory staff may carry and use service weapons, ammunition and other coercive means subject to the consent of the relevant home Member State. |
| --- | --- |

(b)

team members who are not statutory staff may carry and use service weapons, ammunition and other coercive means subject to the consent of the relevant home Member State.

6.   The use of force, including the carrying and use of service weapons, ammunition and other coercive means, shall be exercised in accordance with the national law of Montenegro and in the presence of border management authorities of Montenegro. Montenegro may authorise team members to use force in the absence of relevant border management authorities of Montenegro, taking into account that:

| (a) | for team members who are statutory staff, such authorisation to use force in the absence of border management authorities of Montenegro shall be subject to the consent of the Agency; |
| --- | --- |

(a)

for team members who are statutory staff, such authorisation to use force in the absence of border management authorities of Montenegro shall be subject to the consent of the Agency;

| (b) | for team members who are not statutory staff, such authorisation to use force in the absence of border management authorities of Montenegro shall be subject to the consent of the relevant home Member State. |
| --- | --- |

(b)

for team members who are not statutory staff, such authorisation to use force in the absence of border management authorities of Montenegro shall be subject to the consent of the relevant home Member State.

Without prejudice to the requirements of the national law of Montenegro, any use of force by team members must be necessary and proportionate and comply fully with applicable international, European Union and national law, including, in particular, the requirements laid down in Annex V to Regulation (EU) 2019/1896.

7.   The Agency shall, in advance of the deployment of the team members, inform Montenegro of the service weapons, ammunition and other equipment team members may carry under paragraph 5. Montenegro may prohibit the carrying of certain service weapons, ammunition and other equipment, provided that its own law applies the same prohibition to its own border management authorities. Montenegro shall, in advance of the deployment of the team members, inform the Agency of the permissible service weapons, ammunition and equipment and of the conditions for their use. The Agency shall make this information available to Member States.

Montenegro shall make the necessary arrangements for the issuance of any necessary weapon permits and facilitate the import, export, transport and storage of weapons, ammunition and other equipment at the disposal of the team members as requested by the Agency. The procedure to issue the weapon permits shall be set out in the operational plan.

8.   Service weapons, ammunition and equipment may be used in legitimate self-defence and in legitimate defence of team members or of other persons in accordance with the national law of Montenegro in line with relevant principles of international and European Union law.

9.   Montenegro may authorise team members to consult its national databases if necessary for achieving operational aims specified in the operational plan. Montenegro shall ensure that it provides access to such databases in an efficient and effective manner.

Montenegro shall, in advance of the deployment of the team members, inform the Agency of the national databases which may be consulted.

Team members shall only consult data which are necessary for performing their tasks and exercising their powers. That consultation shall be carried out in accordance with the national data protection law of Montenegro and this Agreement.

10.   For the implementation of operational activities, Montenegro shall deploy officers of the Ministry of the Interior – Police Directorate of Montenegro who are able and willing to communicate in English to carry out a coordinating role on behalf of Montenegro in accordance with the operational plan.

ARTICLE 11

Privileges and immunities of the property, funds, assets and operations of the Agency

1.   Any premises and buildings of the Agency in Montenegro shall be inviolable. They shall be exempt from search, requisition, confiscation or expropriation.

2.   The Agency’s property and assets, including means of transport, communications, archives, any correspondence, documents, identity papers and financial assets shall be inviolable.

3.   The Agency’s assets include assets owned, co-owned, chartered or leased by a Member State and offered to the Agency. Upon the embarkation of representative(s) of competent national authorities, those shall be treated as assets being on government service and authorised to that effect.

4.   No measures of execution may be taken in respect of the Agency. The Agency’s property and assets shall not be the subject of any administrative or legal measure of constraint. Property of the Agency shall be free from seizure for the satisfaction of a judgment, decision or order.

5.   Upon a request by the relevant judicial authorities of Montenegro, the executive director may give consent for relevant national authorities of Montenegro to enter the premises and buildings and/or access to the property and assets of the Agency in cases of serious suspicion of criminal offences.

The consent of the executive director may be assumed in the event of a fire or other disaster requiring prompt protective action.

6.   Montenegro shall permit the entry and removal of articles and equipment deployed by the Agency to Montenegro for operational purposes.

7.   The Agency shall be exempt from all duties (including customs duties) and taxes as well as any prohibitions and restrictions on imports and exports in respect of articles and equipment intended for its official use, including articles and equipment imported or exported by a third party on behalf of the Agency.

ARTICLE 12

Privileges and immunities of team members

1.   The subsequent privileges and immunities granted to team members aim at ensuring the exercise of their official functions in the course of the actions carried out in accordance with the operational plan on the territory of Montenegro.

2.   Team members shall not be subject to any form of inquiry or legal proceedings in Montenegro or by authorities of Montenegro, except under the circumstances as referred to in paragraph 3.

3.   Team members shall enjoy immunity from the criminal, civil and administrative jurisdiction of Montenegro in respect of all acts performed by them in the exercise of their official functions.

Where the authorities of Montenegro intend to institute criminal, civil or administrative proceedings against a team member, the competent authorities of Montenegro shall immediately notify the executive director thereof. The notification procedure shall be in line with the applicable Agency decision thereon, which shall be set out in the operational plan.

Following receipt of such notification, the executive director shall, without undue delay, inform the relevant authorities of Montenegro whether the act in question was performed by the team member in the exercise of his or her official functions. If the act was stated as having been performed in the exercise of official functions, the proceedings shall not be initiated. If the act was stated as not having been performed in the exercise of official functions, the proceedings may be initiated. The qualification by the executive director shall be binding upon Montenegro, which shall not contest it.

Pending this qualification, the Agency shall refrain from taking any measure intended to jeopardise possible subsequent criminal prosecution of the team member by the competent authorities of Montenegro, including facilitating the departure of the concerned team member from Montenegro.

Privileges granted to team members and immunity from the criminal jurisdiction of Montenegro do not exempt them from the jurisdiction of the home Member State.

4.   The initiation of proceedings by team members shall preclude them from invoking immunity from jurisdiction in respect of any counter-claim directly connected with the principal claim.

5.   The premises, dwellings, means of transport and communications, and possessions, including any correspondence, documents, identity papers and assets of team members shall be inviolable, except in the case of measures of execution as permitted pursuant to paragraph 10.

6.   Montenegro shall be liable for any damage caused by team members to third parties in the exercise of their official functions.

7.   In the event of damage caused by gross negligence or wilful misconduct or not in the exercise of official functions by a team member who is a member of the statutory staff, Montenegro may request, via the executive director, that compensation be paid by the Agency.

In the event of damage caused by gross negligence or wilful misconduct or not in the exercise of official functions by a team member who is not a member of the statutory staff, Montenegro may request, via the executive director, that compensation be paid by the home Member State concerned.

8.   Neither Party nor any participating Member State nor the Agency shall be liable for damage caused in Montenegro due to a force majeure event beyond its control.

9.   Team members shall not be obliged to give evidence as witnesses in legal proceedings in Montenegro. Team members may give evidence through a statement submitted in accordance with the procedural law of Montenegro. Such submission shall not affect the immunity provided for under paragraph 3.

10.   No measures of execution may be taken in respect of team members, except in cases where criminal, civil or administrative proceedings not related to their official functions are instituted against them. Property of team members which is certified by the executive director to be necessary for the fulfilment of their official functions shall be free from seizure for the satisfaction of a judgment, decision or order. In criminal, civil or administrative proceedings, team members shall not be subject to any restrictions on their personal liberty or to any other measures of constraint.

11.   Team members shall, with respect to services rendered for the Agency, be exempt from social security provisions which may be in force in Montenegro.

12.   The salary and emoluments paid to team members by the Agency and/or the home Member States, as well as any income team members receive from outside Montenegro, shall not be taxed in any form in Montenegro.

13.   Montenegro shall permit the entry of articles for the personal use of team members and shall grant exemption from all customs duties, taxes, and related charges other than charges for storage, transport and similar services, in respect of such articles. Montenegro shall also allow the export of such articles.

14.   Team members’ personal baggage shall be exempt from inspection, unless there are serious grounds for suspecting that it contains articles that are not for the personal use of team members, or articles whose import or export is prohibited by the law or subject to quarantine regulations of Montenegro. Inspection of such personal baggage shall be conducted only in the presence of team members concerned or an authorised representative of the Agency.

15.   The Agency and Montenegro shall appoint contact points who shall be available at all times and shall be responsible for the exchange of information and immediate actions to be taken where an act performed by a team member may be in violation of criminal law as well as for the exchange of information and the operational activities in relation to any civil or administrative proceedings against a team member.

Until action is taken by the competent authorities of the home Member State, the Agency and Montenegro shall assist each other in carrying out all necessary inquiries and investigations into any alleged criminal offence in respect of which either the Agency or Montenegro, or both, have an interest in the identification of witnesses and in the collection and production of evidence, including the request to obtain and, if appropriate, the handing-over of items connected with a purported criminal offence. The handing-over of any such items may be made subject to their return within the terms specified by the competent authority delivering them.

ARTICLE 13

Injured or deceased team members

1.   Without prejudice to Article 12, the executive director shall have the right to take charge of, and make suitable arrangements for, the repatriation of any injured or deceased team members, as well as of their personal property.

2.   An autopsy shall be performed on a deceased team member only with the express consent of the home Member State concerned and in the presence of a representative of the Agency or of the home Member State concerned.

3.   Montenegro and the Agency shall cooperate to the fullest extent possible to enable the prompt repatriation of injured or deceased team members.

ARTICLE 14

Accreditation document

1.   The Agency shall issue a document in Montenegrin and in English to each team member for the purposes of identification vis-à-vis the national authorities of Montenegro and as proof of the holder’s rights to perform the tasks and exercise the powers referred to in Article 10 of this Agreement and in the operational plan ("the accreditation document").

2.   The accreditation document shall include the following information on the staff member: name and nationality, rank or job title, a recent digitised photograph, and tasks authorised to be performed during the deployment. The accreditation document shall include an expiry date.

3.   For the purposes of identification vis-à-vis the national authorities of Montenegro, team members shall be obliged to carry the accreditation document on their person at all times.

4.   Montenegro shall recognise the accreditation document, in combination with a valid travel document, as granting the relevant team member entry and stay in Montenegro without the need for a visa, residence permit, prior authorisation or any other document up to the day of its expiration.

5.   The accreditation document shall be returned to the Agency at the end of the deployment. The competent authorities of Montenegro shall be informed thereof.

ARTICLE 15

Application to staff not deployed as team members

Articles 12, 13 and 14 shall apply mutatis mutandis to all staff deployed to Montenegro under this Agreement or an operational plan thereunder who are not team members, including fundamental rights monitors and the statutory staff deployed to antenna offices.

ARTICLE 16

Protection of personal data

1.   The communication of personal data shall take place only if such communication is necessary for the implementation of this Agreement by the competent authorities of Montenegro or the Agency. The processing of personal data by an authority in a particular case, including the transfer of such personal data to the other Party, shall be subject to the data protection rules applicable to that authority. The Parties shall ensure the following minimum safeguards as a precondition for any data transfer:

| (a) | personal data must be processed lawfully, fairly, and in a transparent manner in relation to the data subject; |
| --- | --- |

(a)

personal data must be processed lawfully, fairly, and in a transparent manner in relation to the data subject;

| (b) | personal data must be collected for the specified, explicit and legitimate purpose of implementing this Agreement and not further processed by the communicating authority nor receiving authority in a way incompatible with that purpose; |
| --- | --- |

(b)

personal data must be collected for the specified, explicit and legitimate purpose of implementing this Agreement and not further processed by the communicating authority nor receiving authority in a way incompatible with that purpose;

| (c) | personal data must be adequate, relevant and limited to what is necessary in relation to the purpose for which they are collected or further processed; in particular, personal data communicated in accordance with the law applicable to the communicating authority may concern only one or more of the following:






  — | first name, |
| --- | --- | --- |

(c)

personal data must be adequate, relevant and limited to what is necessary in relation to the purpose for which they are collected or further processed; in particular, personal data communicated in accordance with the law applicable to the communicating authority may concern only one or more of the following:

—

first name,

| — | last name, |
| --- | --- |

—

last name,

| — | date of birth, |
| --- | --- |

—

date of birth,

| — | nationality, |
| --- | --- |

—

nationality,

| — | rank, |
| --- | --- |

—

rank,

| — | travel document bio page, |
| --- | --- |

—

travel document bio page,

| — | accreditation document, |
| --- | --- |

—

accreditation document,

| — | ID/passport/accreditation document picture, |
| --- | --- |

—

ID/passport/accreditation document picture,

| — | e-mail address, |
| --- | --- |

—

e-mail address,

| — | mobile phone number, |
| --- | --- |

—

mobile phone number,

| — | weapon details, |
| --- | --- |

—

weapon details,

| — | duration of the deployment, |
| --- | --- |

—

duration of the deployment,

| — | location of the deployment, |
| --- | --- |

—

location of the deployment,

| — | aircraft or vessel identification numbers, |
| --- | --- |

—

aircraft or vessel identification numbers,

| — | arrival date, |
| --- | --- |

—

arrival date,

| — | arrival airport/border crossing point, |
| --- | --- |

—

arrival airport/border crossing point,

| — | arrival flight number, |
| --- | --- |

—

arrival flight number,

| — | departure date, |
| --- | --- |

—

departure date,

| — | departure airport / border crossing point, |
| --- | --- |

—

departure airport / border crossing point,

| — | departure flight number, |
| --- | --- |

—

departure flight number,

| — | home Member State / third country, |
| --- | --- |

—

home Member State / third country,

| — | deploying authority, |
| --- | --- |

—

deploying authority,

| — | tasks/operational profile, |
| --- | --- |

—

tasks/operational profile,

| — | means of transportation, |
| --- | --- |

—

means of transportation,

| — | route |
| --- | --- |

—

route

of team members, Agency staff, relevant observers, or members of staff exchange programmes;

| (d) | personal data must be accurate and, where necessary, kept up to date; |
| --- | --- |

(d)

personal data must be accurate and, where necessary, kept up to date;

| (e) | personal data must be kept in a form which permits identification of data subjects for no longer than is necessary for the purpose for which the data were collected or for which they are further processed; |
| --- | --- |

(e)

personal data must be kept in a form which permits identification of data subjects for no longer than is necessary for the purpose for which the data were collected or for which they are further processed;

| (f) | personal data must be processed in a manner that ensures appropriate security of the personal data, taking into account the specific risks of processing, including protection against unauthorised or unlawful processing and against accidental loss, destruction or damage, using appropriate technical or organisational measures ("data breach"); the receiving Party shall take appropriate measures to address any data breach, and shall notify the communicating Party of such breach without undue delay and within 72 hours; |
| --- | --- |

(f)

personal data must be processed in a manner that ensures appropriate security of the personal data, taking into account the specific risks of processing, including protection against unauthorised or unlawful processing and against accidental loss, destruction or damage, using appropriate technical or organisational measures ("data breach"); the receiving Party shall take appropriate measures to address any data breach, and shall notify the communicating Party of such breach without undue delay and within 72 hours;

| (g) | both the communicating authority and the receiving authority shall take every reasonable step to ensure without delay the rectification or erasure, as appropriate, of personal data where the processing does not comply with this Article, in particular because those data are not adequate, relevant or accurate, or because they are excessive in relation to the purpose of processing; this includes the notification of any rectification or erasure to the other Party; |
| --- | --- |

(g)

both the communicating authority and the receiving authority shall take every reasonable step to ensure without delay the rectification or erasure, as appropriate, of personal data where the processing does not comply with this Article, in particular because those data are not adequate, relevant or accurate, or because they are excessive in relation to the purpose of processing; this includes the notification of any rectification or erasure to the other Party;

| (h) | upon request, the receiving authority shall inform the communicating authority of the use of the communicated data; |
| --- | --- |

(h)

upon request, the receiving authority shall inform the communicating authority of the use of the communicated data;

| (i) | personal data may be communicated only to the following competent authorities:






  — | the Agency; and |
| --- | --- | --- |

(i)

personal data may be communicated only to the following competent authorities:

—

the Agency; and

| — | the Ministry of the Interior – Police Directorate of Montenegro, |
| --- | --- |

—

the Ministry of the Interior – Police Directorate of Montenegro,

further communication to other bodies requires the prior authorisation of the communicating authority;

| (j) | the communicating and the receiving authorities are under an obligation to make a written record of the communication and receipt of personal data; |
| --- | --- |

(j)

the communicating and the receiving authorities are under an obligation to make a written record of the communication and receipt of personal data;

| (k) | independent oversight shall be in place to oversee data protection compliance, including to inspect such records; data subjects shall have the right to bring complaints to the oversight body, and to receive a response without undue delay; |
| --- | --- |

(k)

independent oversight shall be in place to oversee data protection compliance, including to inspect such records; data subjects shall have the right to bring complaints to the oversight body, and to receive a response without undue delay;

| (l) | data subjects shall have the right to receive information on the processing of their personal data, access such data and the rectification or erasure of inaccurate or unlawfully processed data, subject to necessary and proportionate limitations on important grounds of public interest; and |
| --- | --- |

(l)

data subjects shall have the right to receive information on the processing of their personal data, access such data and the rectification or erasure of inaccurate or unlawfully processed data, subject to necessary and proportionate limitations on important grounds of public interest; and

| (m) | data subjects shall have the right to effective administrative and judicial redress for violation of the aforementioned safeguards. |
| --- | --- |

(m)

data subjects shall have the right to effective administrative and judicial redress for violation of the aforementioned safeguards.

2.   Each Party shall conduct periodic reviews of its own policies and procedures that implement this Article. Upon request by the other Party, the Party that received the request shall review its personal data processing policies and procedures to ascertain and confirm that the safeguards in this Article are implemented effectively. The results of the review shall be communicated to the Party that requested the review within a reasonable time.

3.   The data protection safeguards under this Agreement shall be subject to oversight by the European Data Protection Supervisor and the Agency for Personal Data Protection and Free Access to Information of Montenegro.

4.   The Parties shall cooperate with the European Data Protection Supervisor, as the supervisory authority of the Agency.

5.   The Agency and Montenegro shall draw up a common report on the application of this Article at the end of each operational activity. That report shall be sent to the Agency’s fundamental rights officer and data protection officer as well as tothe Agency for Personal Data Protection and Free Access to Information of Montenegro.

6.   The Agency and Montenegro shall set out detailed rules on the communication and processing of personal data for the purposes of operational activities under this Agreement in specific provisions of the relevant operational plans. Those provisions shall comply with the relevant requirements of European Union law and the law of Montenegro. They shall describe, inter alia, the intended purpose of the communication, the controller(s) and all roles and responsibilities, the categories of data communicated, the specific data retention periods, and all minimum safeguards. In the interest of transparency and foreseeability, those provisions shall be made publicly available in accordance with the relevant guidance of the European Data Protection Board.

ARTICLE 17

Exchange of classified and sensitive non-classified information

1.   Any exchange, sharing or dissemination of classified information in the framework of this Agreement shall be covered by a separate administrative arrangement concluded between the Agency and the relevant authorities of Montenegro that shall be subject to the prior approval of the European Commission.

2.   Any exchange of sensitive non-classified information in the framework of this Agreement:

| (a) | shall be handled by the Agency in accordance with Article 9(5) of Commission Decision (EU, Euratom) 2015/443 (3) and by Montenegro in accordance with its national law; |
| --- | --- |

(a)

shall be handled by the Agency in accordance with Article 9(5) of Commission Decision (EU, Euratom) 2015/443 (3) and by Montenegro in accordance with its national law;

| (b) | shall receive a level of protection by the receiving Party that is equivalent to the level of protection offered by the measures applied to that information by the communicating Party in terms of confidentiality, integrity and availability; and |
| --- | --- |

(b)

shall receive a level of protection by the receiving Party that is equivalent to the level of protection offered by the measures applied to that information by the communicating Party in terms of confidentiality, integrity and availability; and

| (c) | shall be conducted via an information exchange system that fulfils the criteria of availability, confidentiality and integrity for sensitive non-classified information, such as the communication network referred to in Article 14 of Regulation (EU) 2019/1896. |
| --- | --- |

(c)

shall be conducted via an information exchange system that fulfils the criteria of availability, confidentiality and integrity for sensitive non-classified information, such as the communication network referred to in Article 14 of Regulation (EU) 2019/1896.

3.   The Parties shall comply with intellectual property rights related to any data processed in the framework of this Agreement.

ARTICLE 18

Decision to suspend, terminate and/or withdraw financing for an operational activity

1.   If the conditions to conduct an operational activity are no longer fulfilled, including as notified by Montenegro, the executive director shall terminate that operational activity after informing Montenegro. Such information shall be made in writing and shall include the reasons therefor.

2.   If this Agreement or an operational plan has not been respected by Montenegro, the executive director may withdraw financing of the relevant operational activity, and/or suspend or terminate it, after informing Montenegro in writing.

3.   If the security of any participant of an operational activity deployed in Montenegro cannot be guaranteed, the executive director may suspend or terminate the relevant operational activity or aspects thereof.

4.   If the executive director considers that violations of fundamental rights or international protection obligations that are of a serious nature or are likely to persist have taken place or are likely to take place in relation to an operational activity performed under this Agreement, he or she shall withdraw the financing of the relevant operational activity, and/or suspend or terminate it, after informing Montenegro.

5.   Montenegro may request the executive director to suspend or terminate an operational activity. Such request shall be made in writing and shall include the reasons therefor.

6.   A suspension, termination or withdrawal of financing under this Article shall take effect from the date of notification to Montenegro. It shall not affect any rights or obligations arising out of the application of this Agreement or the operational plan before such suspension, termination or withdrawal of financing.

7.   Montenegro may request the termination of deployment of any team member, or other relevant staff member, who does not respect this Agreement or an operational plan thereunder or who commits serious violations of Montenegrin legislation. The decision to terminate the deployment shall be made by the executive director or the respective home Member State, as appropriate, and notified to the relevant authorities of Montenegro.

ARTICLE 19

Combating fraud

1.   Montenegro shall notify the Agency, the European Public Prosecutor’s Office and/or the European Anti-Fraud Office forthwith if it becomes aware of the existence of credible allegations of fraud, corruption or any other illegal activities connected to the implementation of this Agreement that may affect the interests of the European Union.

2.   Where such allegations relate to European Union funds disbursed in relation to this Agreement, Montenegro shall provide all necessary assistance to the European Public Prosecutor’s Office and/or the European Anti-Fraud Office in relation to investigative activities on its territory, including facilitating interviews, on-the-spot checks and inspections (including access to information systems and databases in Montenegro) and facilitating access to any relevant information concerning the technical and financial management of matters financed partly or wholly by the European Union.

ARTICLE 20

Implementation of this Agreement

1.   For Montenegro, this Agreement shall be implemented by the Ministry of the Interior – Police Directorate of Montenegro.

2.   For the European Union, this Agreement shall be implemented by the Agency.

ARTICLE 21

Dispute settlement

1.   Any disputes arising in connection with the application of this Agreement shall be examined jointly by representatives of the Agency and the competent authorities Montenegro.

2.   Failing any prior settlement, disputes concerning the interpretation or application of this Agreement shall be settled exclusively by negotiation between the Parties.

ARTICLE 22

Entry into force, provisional application, amendment, duration, suspension and termination of the Agreement and termination of predecessor Agreement

1.   This Agreement shall be subject to ratification, acceptance or approval by the Parties in accordance with their own internal legal procedures. The Parties shall notify one another of the completion of the procedures necessary for that purpose.

2.   This Agreement shall enter into force on the first day of the second month following the date on which the Parties have notified each other of the completion of the internal legal procedures in accordance with paragraph 1.

Pending the completion of the procedures necessary for its entry into force, this Agreement shall be applied on a provisional basis as from the first day of the second month following the date of its signature by the Parties.

3.   This Agreement may be amended only in writing by mutual consent of the Parties.

4.   This Agreement is concluded for an indefinite period. It may be suspended or terminated by written agreement between the Parties or unilaterally by either Party.

In the event of a unilateral suspension or termination, the Party wishing to suspend or terminate shall notify the other Party thereof in writing. A unilateral termination or suspension of this Agreement shall take effect on the first day of the second month following the month during which the notification was given.

5.   The Status Agreement between the European Union and Montenegro on actions carried out by the European Border and Coast Guard Agency in Montenegro, signed in Luxembourg on 7 October 2019, is hereby repealed and replaced by this Agreement.

During the period when this Agreement is applied on a provisional basis, the application of the Status Agreement between the European Union and Montenegro on actions carried out by the European Border and Coast Guard Agency in Montenegro, signed in Luxembourg on 7 October 2019, shall be suspended.

Any operational activity launched on the basis of the Status Agreement between the European Union and Montenegro on actions carried out by the European Border and Coast Guard Agency in Montenegro, signed in Luxembourg on 7 October 2019, that are ongoing at the time of the provisional application or entry into force of this Agreement may continue, subject to the amendment or adaptation of the respective operational plan in line with this Agreement.

6.   Notifications made in accordance with this Article shall be sent, in the case of the European Union, to the Secretary-General of the Council of the European Union and, in the case of Montenegro, to the Ministry of Foreign Affairs of Montenegro.

Done in duplicate in the Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish and Montenegrin languages, each of those texts being equally authentic.

IN WITNESS WHEREOF, the undersigned Plenipotentiaries, duly authorised to this effect, have signed this Agreement.

Image 1L1402023EN110120230515EN0001.00013131DECLARATION WITH REGARD TO ICELAND, THE KINGDOM OF NORWAY, THE SWISS CONFEDERATION AND THE PRINCIPALITY OF LIECHTENSTEINThe Parties to the Agreement between the European Union and Montenegro on operational activities carried out by the European Border and Coast Guard Agency in Montenegro take note of the close relationship between the European Union and Iceland, the Kingdom of Norway, the Swiss Confederation and the Principality of Liechtenstein, particularly by virtue of the Agreements of 18 May 1999 and 26 October 2004 concerning the association of those countries with the implementation, application and development of the Schengen acquis.In such circumstances it is desirable that the authorities of Iceland, the Kingdom of Norway, the Swiss Confederation and the Principality of Liechtenstein, on the one hand, and Montenegro, on the other hand, conclude, without delay, bilateral agreements on operational activities carried out by the European Border and Coast Guard Agency in Montenegro in terms similar to those of the Agreement between the European Union and Montenegro on operational activities carried out by the European Border and Coast Guard Agency in Montenegro.

---

(1)  Regulation (EU) 2019/1896 of the European Parliament and of the Council of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 (OJ EU L 295, 14.11.2019, p. 1).

1

(2)  OJ EC L 56, 4.3.1968, p. 1.

2

(3)  Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ EU L 72, 17.3.2015, p. 41).

3

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REGULATIONS

| 30.5.2023 | EN | Official Journal of the European Union | L 140/22 |
| --- | --- | --- | --- |

30.5.2023

EN

Official Journal of the European Union

L 140/22

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/1041

of 24 May 2023

granting a Union authorisation for the biocidal product ‘TWP 094’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:

| (1) | On 12 November 2018, TROY CHEMICAL COMPANY BV submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product named TWP 094 of product-type 8, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Denmark had agreed to evaluate the application. The application was recorded under case number BC-QN044827-14 in the Register for Biocidal Products. |
| --- | --- |

(1)

On 12 November 2018, TROY CHEMICAL COMPANY BV submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product named TWP 094 of product-type 8, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Denmark had agreed to evaluate the application. The application was recorded under case number BC-QN044827-14 in the Register for Biocidal Products.

| (2) | TWP 094 contains 3-Iodo-2-propynyl butylcarbamate (IPBC) as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 8. |
| --- | --- |

(2)

TWP 094 contains 3-Iodo-2-propynyl butylcarbamate (IPBC) as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 8.

| (3) | On 7 January 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency. |
| --- | --- |

(3)

On 7 January 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

| (4) | On 5 July 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of TWP 094 and the final assessment report on the biocidal product, in accordance with Article 44(3) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

On 5 July 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of TWP 094 and the final assessment report on the biocidal product, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

| (5) | The opinion concludes that TWP 094 is a biocidal product within the meaning of Article 3(1), point (a), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation. |
| --- | --- |

(5)

The opinion concludes that TWP 094 is a biocidal product within the meaning of Article 3(1), point (a), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.

| (6) | On 18 August 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(6)

On 18 August 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

| (7) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for TWP 094. |
| --- | --- |

(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for TWP 094.

| (8) | In its opinion, the Agency states that the authorisation holder is to complete a long-term storage test at ambient temperature for TWP 094 and provide a test on persistent foaming and a test on the degree of dissolution and dilution stability for the soluble concentrate formulation type of the product as a condition in the authorisation. The results of the long-term storage test should confirm the shelf life of the biocidal product of one year granted based on an accelerated storage stability test and the submitted interim results of a long-term storage stability test at ambient temperature. The information to be provided on persistent foaming and degree of dissolution and dilution stability should confirm the technical properties of the product for the formulation type soluble concentrate of the product. |
| --- | --- |

(8)

In its opinion, the Agency states that the authorisation holder is to complete a long-term storage test at ambient temperature for TWP 094 and provide a test on persistent foaming and a test on the degree of dissolution and dilution stability for the soluble concentrate formulation type of the product as a condition in the authorisation. The results of the long-term storage test should confirm the shelf life of the biocidal product of one year granted based on an accelerated storage stability test and the submitted interim results of a long-term storage stability test at ambient temperature. The information to be provided on persistent foaming and degree of dissolution and dilution stability should confirm the technical properties of the product for the formulation type soluble concentrate of the product.

| (9) | The Commission agrees with the opinion of the Agency and considers that the submission of the results of the test and the information for the soluble concentrate formulation type should be a condition relating to the making available on the market and use of the biocidal product TWP 094 pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation based on existing data. |
| --- | --- |

(9)

The Commission agrees with the opinion of the Agency and considers that the submission of the results of the test and the information for the soluble concentrate formulation type should be a condition relating to the making available on the market and use of the biocidal product TWP 094 pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation based on existing data.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0028968-0000 is hereby granted to TROY CHEMICAL COMPANY BV for the making available on the market and use of the biocidal product TWP 094 subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.

The Union authorisation is valid from 19 June 2023 to 31 May 2033.

Article 2

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

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

Done at Brussels, 24 May 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  OJ L 167, 27.6.2012, p. 1.

1

(2)  ECHA opinion of 16 June 2022 on the Union authorisation of TWP 094 (ECHA/BPC/348/2022), https://echa.europa.eu/opinions-on-union-authorisation

2

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ANNEX I

TERMS AND CONDITIONS (EU-0028968-0000)

The authorisation holder shall conduct a long-term storage test at ambient temperature for the product TWP 094 to confirm the shelf life of the biocidal product of 12 months. The study must include a test of degree of dissolution and dilution stability after storage for 12 months at ambient temperature. If the degradation exceeds 10%, efficacy data and information on the degradation products and their impact on risk assessment is required and shall be included.

The authorisation holder shall provide a test of persistent foaming and a test on degree of dissolution and dilution stability to confirm the soluble concentrate formulation type of the product TWP 094.

By 19 June 2024 the authorisation holder shall submit the results of the test and the information to the Agency.

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ANNEX II

Summary of product characteristics for a biocidal product

TWP 094

Product type 8 - Wood preservatives (Preservatives)

Authorisation number: EU-0028968-0000

R4BP asset number: EU-0028968-0000

1.   ADMINISTRATIVE INFORMATION

1.1.   Trade name(s) of the product

| Trade name(s) | TWP 094
  StoPrim Protect W 22
  Aqua Holz-Imprägnier-Grund
  Gjøco Impregnering Aqua
  Omnia Preservative
  Voima Aqua Base
  Aqua IG-16
  Aqua Holz-Imprägnierung
  Induline SW-906
  Sadolin QD Wood Preserver WB
  Holz-Öl Imprägniergrund WX
  Imprägniergrund W21000
  Imprägniergrund W219
  Protox Woodprotect
  B3 Grundingsolie WP
  GVK-Pohjuste Plus
  Pinja Base
  Grundolja
  Villa Protect
  Primex Olja plus
  Primex Olja
  Valtti Plus Primer
  Gori Professional Træimprægnering Vandig
  Sigmalife WB Primer
  GORI Transparent grunder træværk 11
  IM151A
  profilan-prevent pro
  impralan-Grund I100 pro
  impralan-Grund G300 pro
  impralan-Grund G400 pro
  Rhenocryl pro-TL 30 EU
  Rhenocryl pro-TL 45 EU
  Holzschutzgrund / sous-couche de protection du bois
  Impregnační základ
  Impregnačný základ
  Houtimpregneer
  Grund pentru protecția lemnului
  Holzschutzgrundierung
  Osmo Træimprægnering WR Aqua 4019
  Osmo Träimpregnering WR Aqua 4019
  Osmo Treimpregnering WR Aqua 4019
  Osmo Puunsuojapohjuste WR Aqua 4019
  Osmo Color Träimpregnering WR Aqua 4019
  Osmo Imprégnation pour le bois WR aqua 4019
  Osmo Holz-Imprägnierung WR Aqua 4019
  Osmo Impregnace dřeva WR Aqua 4019
  Osmo Impregnácia dreva WR Aqua 4019
  Osmo Impregnazione per legno WR Aqua 4019
  Osmo Impregnálás WR Aqua 4019
  Osmo Impregnat do drewna WR Aqua 4019
  Osmo Houtimpregneer WR Aqua 4019
  Osmo Imprégnation pour le bois WR aqua 4019
  Osmo Holz-Imprägnierung WR Aqua 4019
  Osmo Houtimpregneer WR Aqua 4019
  Osmo Impregnarea lemnului WR Aqua 4019
  Osmo WR Base Coat Aqua 4019
  Osmo Color Puiduimmutus WR Aqua 4019
  Osmo Impregnēšana kokam WR Aqua 4019
  Osmo Impregnavimas WR Aqua 4019
  Osmo WR Base Coat Aqua 4019
  Osmo Impregnación para madera WR Aqua 4019
  Osmo Impregnação para madeira WR Aqua 4019
  Osmo Impregnacija lesa WR Aqua 4019
  Osmo Impregnacija drva WR Aqua 4019
  Flügger 01 Wood Tex Grund-olie
  Flügger 01 Wood Tex Grund-olja
  Flügger 01 Wood Tex Grunn-olje
  Flügger 01 Wood Tex Grundieröl
  Flügger 01 Wood Tex Primaire Bois Hydrofuge
  Flügger 01 Wood Tex Olej-gruntujacy
  Flügger 01 Wood Tex
  Flügger 01 Wood Tex Grundolie
  Holzschutzgrund
  WOODEX AQUA BASE +
  AM0572/00 Hydroplus protettivo per legno
  458-0004/2 Idro Ceopren protettivo per legno
  HI2550 Linea Blu protettivo per Legno
  AM0572/00 Hydroplus Wood protection
  458-0004/2 IDRO CEOPREN Wood protection
  HI2550 Linea Blu Wood Protection
  AA1960 Laqvin Seal
  37647 Ronseal Multi-Purpose Wood Treatment
  37648 Ronseal Multi-Purpose Wood Treatment
  MasqueWoodPro 10
  CETOL WP 5000-02
  BAUFIX Holz-Imprägnierung
  YM---M103/-----
  674840 HF PROTECTIVE PRIMER W
  Grundolja V
  Ronseal Wood Preserver
  Ronseal Trade Wood Preserver
  Screwfix Wood Preserver
  B&Q Wood Preserver
  Good Home Wood Preserver
  Sherwin Williams Wood Preserver
  Ronseal Fence Life Wood Preserver
  Ronseal Shed & Fence Preserver
  Castorama Traitement Bois Extérieur
  Brico Depot Traitement Bois Extérieur
  Good Home Traitement Bois Extérieur
  Altax Traitement Bois Extérieur
  Ronseal Traitement Bois Extérieur
  Valspar Traitement Bois Extérieur
  Valspar Pro Traitement Bois Extérieur
  Sherwin Williams Traitement Bois Extérieur
  Luxens Traitement Bois Extérieur
  Castorama Impregnat do drewna
  Good Home Impregnat do drewna
  Altax Impregnat do drewna
  Valspar Impregnat do drewna
  Valspar Pro Impregnat do drewna
  Sherwin Williams Impregnat do drewna
  Luxens Impregnat do drewna
  Castorama Conservant pentru lemn
  Good Home Conservant pentru lemn
  Altax pentru lemn
  Valspar pentru lemn
  Valspar Pro pentru lemn
  Sherwin Williams pentru lemn |
| --- | --- |

Trade name(s)

TWP 094

StoPrim Protect W 22

Aqua Holz-Imprägnier-Grund

Gjøco Impregnering Aqua

Omnia Preservative

Voima Aqua Base

Aqua IG-16

Aqua Holz-Imprägnierung

Induline SW-906

Sadolin QD Wood Preserver WB

Holz-Öl Imprägniergrund WX

Imprägniergrund W21000

Imprägniergrund W219

Protox Woodprotect

B3 Grundingsolie WP

GVK-Pohjuste Plus

Pinja Base

Grundolja

Villa Protect

Primex Olja plus

Primex Olja

Valtti Plus Primer

Gori Professional Træimprægnering Vandig

Sigmalife WB Primer

GORI Transparent grunder træværk 11

IM151A

profilan-prevent pro

impralan-Grund I100 pro

impralan-Grund G300 pro

impralan-Grund G400 pro

Rhenocryl pro-TL 30 EU

Rhenocryl pro-TL 45 EU

Holzschutzgrund / sous-couche de protection du bois

Impregnační základ

Impregnačný základ

Houtimpregneer

Grund pentru protecția lemnului

Holzschutzgrundierung

Osmo Træimprægnering WR Aqua 4019

Osmo Träimpregnering WR Aqua 4019

Osmo Treimpregnering WR Aqua 4019

Osmo Puunsuojapohjuste WR Aqua 4019

Osmo Color Träimpregnering WR Aqua 4019

Osmo Imprégnation pour le bois WR aqua 4019

Osmo Holz-Imprägnierung WR Aqua 4019

Osmo Impregnace dřeva WR Aqua 4019

Osmo Impregnácia dreva WR Aqua 4019

Osmo Impregnazione per legno WR Aqua 4019

Osmo Impregnálás WR Aqua 4019

Osmo Impregnat do drewna WR Aqua 4019

Osmo Houtimpregneer WR Aqua 4019

Osmo Imprégnation pour le bois WR aqua 4019

Osmo Holz-Imprägnierung WR Aqua 4019

Osmo Houtimpregneer WR Aqua 4019

Osmo Impregnarea lemnului WR Aqua 4019

Osmo WR Base Coat Aqua 4019

Osmo Color Puiduimmutus WR Aqua 4019

Osmo Impregnēšana kokam WR Aqua 4019

Osmo Impregnavimas WR Aqua 4019

Osmo WR Base Coat Aqua 4019

Osmo Impregnación para madera WR Aqua 4019

Osmo Impregnação para madeira WR Aqua 4019

Osmo Impregnacija lesa WR Aqua 4019

Osmo Impregnacija drva WR Aqua 4019

Flügger 01 Wood Tex Grund-olie

Flügger 01 Wood Tex Grund-olja

Flügger 01 Wood Tex Grunn-olje

Flügger 01 Wood Tex Grundieröl

Flügger 01 Wood Tex Primaire Bois Hydrofuge

Flügger 01 Wood Tex Olej-gruntujacy

Flügger 01 Wood Tex

Flügger 01 Wood Tex Grundolie

Holzschutzgrund

WOODEX AQUA BASE +

AM0572/00 Hydroplus protettivo per legno

458-0004/2 Idro Ceopren protettivo per legno

HI2550 Linea Blu protettivo per Legno

AM0572/00 Hydroplus Wood protection

458-0004/2 IDRO CEOPREN Wood protection

HI2550 Linea Blu Wood Protection

AA1960 Laqvin Seal

37647 Ronseal Multi-Purpose Wood Treatment

37648 Ronseal Multi-Purpose Wood Treatment

MasqueWoodPro 10

CETOL WP 5000-02

BAUFIX Holz-Imprägnierung

YM---M103/-----

674840 HF PROTECTIVE PRIMER W

Grundolja V

Ronseal Wood Preserver

Ronseal Trade Wood Preserver

Screwfix Wood Preserver

B&Q Wood Preserver

Good Home Wood Preserver

Sherwin Williams Wood Preserver

Ronseal Fence Life Wood Preserver

Ronseal Shed & Fence Preserver

Castorama Traitement Bois Extérieur

Brico Depot Traitement Bois Extérieur

Good Home Traitement Bois Extérieur

Altax Traitement Bois Extérieur

Ronseal Traitement Bois Extérieur

Valspar Traitement Bois Extérieur

Valspar Pro Traitement Bois Extérieur

Sherwin Williams Traitement Bois Extérieur

Luxens Traitement Bois Extérieur

Castorama Impregnat do drewna

Good Home Impregnat do drewna

Altax Impregnat do drewna

Valspar Impregnat do drewna

Valspar Pro Impregnat do drewna

Sherwin Williams Impregnat do drewna

Luxens Impregnat do drewna

Castorama Conservant pentru lemn

Good Home Conservant pentru lemn

Altax pentru lemn

Valspar pentru lemn

Valspar Pro pentru lemn

Sherwin Williams pentru lemn

1.2.   Authorisation holder

| Name and address of the authorisation holder | Name | TROY CHEMICAL COMPANY BV |
| --- | --- | --- |
| Address | Poortweg 4C, 2612PA Delft Netherlands |
| Authorisation number | EU-0028968-0000 |
| R4BP asset number | EU-0028968-0000 |
| Date of the authorisation | 19 June 2023 |
| Expiry date of the authorisation | 31 May 2033 |

Name and address of the authorisation holder

Name

TROY CHEMICAL COMPANY BV

Address

Poortweg 4C, 2612PA Delft Netherlands

Authorisation number

EU-0028968-0000

R4BP asset number

EU-0028968-0000

Date of the authorisation

19 June 2023

Expiry date of the authorisation

31 May 2033

1.3.   Manufacturer(s) of the product

| Name of manufacturer | Troy Chemical Company BV |
| --- | --- |
| Address of manufacturer | Poortweg 4C, 2612 PA Delft Netherlands |
| Location of manufacturing sites | Westelijke Randweg 9, 4791 RT Klundert Netherlands
  Industriepark 23, 56593 Horhausen Germany
  Geschwister-Scholl-Straße 127, 39218 Schönebeck/Elbe Germany
  Mecklenburger Str. 229, 23568 Lübeck Germany
  Halchtersche Str. 33, 38304 Wolfenbüttel Germany
  Am Nordturm 5, 46562 Voerde Germany
  Am Alten Galgen 14, 56410 Montabaur Germany |

Name of manufacturer

Troy Chemical Company BV

Address of manufacturer

Poortweg 4C, 2612 PA Delft Netherlands

Location of manufacturing sites

Westelijke Randweg 9, 4791 RT Klundert Netherlands

Industriepark 23, 56593 Horhausen Germany

Geschwister-Scholl-Straße 127, 39218 Schönebeck/Elbe Germany

Mecklenburger Str. 229, 23568 Lübeck Germany

Halchtersche Str. 33, 38304 Wolfenbüttel Germany

Am Nordturm 5, 46562 Voerde Germany

Am Alten Galgen 14, 56410 Montabaur Germany

| Name of manufacturer | Tikkurila Oyj |
| --- | --- |
| Address of manufacturer | Kuninkaalantie 1, FI-01301 Vantaa Finland |
| Location of manufacturing sites | Kuninkaalantie 1, FI-01301 Vantaa Finland
  uL.Mościckiego 23, 39-200 DĘBICA Poland |

Name of manufacturer

Tikkurila Oyj

Address of manufacturer

Kuninkaalantie 1, FI-01301 Vantaa Finland

Location of manufacturing sites

Kuninkaalantie 1, FI-01301 Vantaa Finland

uL.Mościckiego 23, 39-200 DĘBICA Poland

| Name of manufacturer | Akzo Nobel Industrial Coatings AB |
| --- | --- |
| Address of manufacturer | Staffanstorpsvägen 50, 20517 Malmö Sweden |
| Location of manufacturing sites | Staffanstorpsvägen 50, 20517 Malmö Sweden |

Name of manufacturer

Akzo Nobel Industrial Coatings AB

Address of manufacturer

Staffanstorpsvägen 50, 20517 Malmö Sweden

Location of manufacturing sites

Staffanstorpsvägen 50, 20517 Malmö Sweden

| Name of manufacturer | Schulz Farben- und Lackfabrik GmbH |
| --- | --- |
| Address of manufacturer | An der Altnah 10, 55450 Langenlonsheim Germany |
| Location of manufacturing sites | An der Altnah 10, 55450 Langenlonsheim Germany |

Name of manufacturer

Schulz Farben- und Lackfabrik GmbH

Address of manufacturer

An der Altnah 10, 55450 Langenlonsheim Germany

Location of manufacturing sites

An der Altnah 10, 55450 Langenlonsheim Germany

| Name of manufacturer | Remmers GmbH |
| --- | --- |
| Address of manufacturer | Bernhard-Remmers-Straße 13, 49624 Löningen Germany |
| Location of manufacturing sites | Bernhard-Remmers-Straße 13, 49624 Löningen Germany
  Füllenbruchstr. 13, 32120 Hiddenhausen Germany |

Name of manufacturer

Remmers GmbH

Address of manufacturer

Bernhard-Remmers-Straße 13, 49624 Löningen Germany

Location of manufacturing sites

Bernhard-Remmers-Straße 13, 49624 Löningen Germany

Füllenbruchstr. 13, 32120 Hiddenhausen Germany

| Name of manufacturer | Remmers Industrielacke GmbH |
| --- | --- |
| Address of manufacturer | Füllenbruchstr. 13, 32120 Hiddenhausen Germany |
| Location of manufacturing sites | Füllenbruchstr. 13, 32120 Hiddenhausen Germany |

Name of manufacturer

Remmers Industrielacke GmbH

Address of manufacturer

Füllenbruchstr. 13, 32120 Hiddenhausen Germany

Location of manufacturing sites

Füllenbruchstr. 13, 32120 Hiddenhausen Germany

| Name of manufacturer | Teknos A/S |
| --- | --- |
| Address of manufacturer | Industrivej 16, DK-6580 Vamdrup Denmark |
| Location of manufacturing sites | Industrivej 16, DK-6580 Vamdrup Denmark |

Name of manufacturer

Teknos A/S

Address of manufacturer

Industrivej 16, DK-6580 Vamdrup Denmark

Location of manufacturing sites

Industrivej 16, DK-6580 Vamdrup Denmark

| Name of manufacturer | Sherwin Williams |
| --- | --- |
| Address of manufacturer | Thorncliffe Park Estate, Thorncliffe Rd, Chapeltown, S35 2YP Sheffield United Kingdom |
| Location of manufacturing sites | Thorncliffe Park Estate, Thorncliffe Rd, Chapeltown,, S35 2YP Sheffield United Kingdom
  Kopanińska 7, 60-119 Brodziszewo Poland |

Name of manufacturer

Sherwin Williams

Address of manufacturer

Thorncliffe Park Estate, Thorncliffe Rd, Chapeltown, S35 2YP Sheffield United Kingdom

Location of manufacturing sites

Thorncliffe Park Estate, Thorncliffe Rd, Chapeltown,, S35 2YP Sheffield United Kingdom

Kopanińska 7, 60-119 Brodziszewo Poland

| Name of manufacturer | Sherwin-Williams Italy S.r.l. |
| --- | --- |
| Address of manufacturer | Via Del Fiffo 12, 40065 Pianoro (BO) Italy |
| Location of manufacturing sites | Via Del Fiffo 12, 40065 Pianoro (BO) Italy |

Name of manufacturer

Sherwin-Williams Italy S.r.l.

Address of manufacturer

Via Del Fiffo 12, 40065 Pianoro (BO) Italy

Location of manufacturing sites

Via Del Fiffo 12, 40065 Pianoro (BO) Italy

| Name of manufacturer | Sherwin-Williams Sweden AB |
| --- | --- |
| Address of manufacturer | Bellö, 570 32 Hjältevad Sweden |
| Location of manufacturing sites | Bellö, 570 32 Hjältevad Sweden |

Name of manufacturer

Sherwin-Williams Sweden AB

Address of manufacturer

Bellö, 570 32 Hjältevad Sweden

Location of manufacturing sites

Bellö, 570 32 Hjältevad Sweden

| Name of manufacturer | PPG Industries (Dyrup A/S) |
| --- | --- |
| Address of manufacturer | Gladsaxevej 300, 2860 Gladsaxe Denmark |
| Location of manufacturing sites | Gladsaxevej 300, 2860 Gladsaxe Denmark |

Name of manufacturer

PPG Industries (Dyrup A/S)

Address of manufacturer

Gladsaxevej 300, 2860 Gladsaxe Denmark

Location of manufacturing sites

Gladsaxevej 300, 2860 Gladsaxe Denmark

1.4.   Manufacturer(s) of the active substance(s)

| Active substance | 3-iodo-2-propynylbutylcarbamate (IPBC) |
| --- | --- |
| Name of manufacturer | Troy Corporation |
| Address of manufacturer | 8 Vreeland Road, Florham Park, NJ 07105 New Jersey United States |
| Location of manufacturing sites | One Avenue L, NJ 07105 Newark United States |

Active substance

3-iodo-2-propynylbutylcarbamate (IPBC)

Name of manufacturer

Troy Corporation

Address of manufacturer

8 Vreeland Road, Florham Park, NJ 07105 New Jersey United States

Location of manufacturing sites

One Avenue L, NJ 07105 Newark United States

| Active substance | 3-iodo-2-propynylbutylcarbamate (IPBC) |
| --- | --- |
| Name of manufacturer | Troy Chemical Company BV |
| Address of manufacturer | Poortweg 4C, 2612 PA Delft Netherlands |
| Location of manufacturing sites | Industriepark 23, 56593 Horhausen Germany |

Active substance

3-iodo-2-propynylbutylcarbamate (IPBC)

Name of manufacturer

Troy Chemical Company BV

Address of manufacturer

Poortweg 4C, 2612 PA Delft Netherlands

Location of manufacturing sites

Industriepark 23, 56593 Horhausen Germany

2.   PRODUCT COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the product

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| 3-iodo-2-propynylbutylcarbamate (IPBC) | | Active Substance | 55406-53-6 | 259-627-5 | 0,75 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

3-iodo-2-propynylbutylcarbamate (IPBC)

Active Substance

55406-53-6

259-627-5

0,75

2.2.   Type of formulation

Any other liquid (AL) and Soluble concentrate (SL)

3.   HAZARD AND PRECAUTIONARY STATEMENTS

| Hazard statements | Harmful to aquatic life with long lasting effects.
  Contains 3-iodo-2-propynyl butylcarbamate (IPBC). May produce an allergic reaction. |
| --- | --- |
| Precautionary statements | Avoid release to the environment.
  Dispose of contents in accordance with local / national regulations.
  Dispose of container in accordance with local / national regulations. |

Hazard statements

Harmful to aquatic life with long lasting effects.

Contains 3-iodo-2-propynyl butylcarbamate (IPBC). May produce an allergic reaction.

Precautionary statements

Avoid release to the environment.

Dispose of contents in accordance with local / national regulations.

Dispose of container in accordance with local / national regulations.

4.   AUTHORISED USE(S)

4.1.   Use description

Table 1. Use # 1 – Brushing and rolling (general public, professional)

| Product type | PT08 - Wood preservatives (Preservatives) |
| --- | --- |
| Where relevant, an exact description of the authorised use | Fungicide. |
| Target organism(s) (including development stage) | Common name: Blue stain fungi
  Development stage:
  Scientific name: Basidiomycetes:
  Common name: Brown rot fungi
  Development stage: |
| Field(s) of use | Indoor
  Outdoor
  Softwood
  Preventative treatment
  Use class 2 as described in EN standard 335:2013 (situation in which the wood or wood-based product is under cover and not exposed to the weather (particularly rain and wind-driven rain) but where occasional, but not persistent, wetting can occur.
  Use class 3 as described in EN standard 335:2013 (situation in which the wood or wood-based product is above ground and exposed to the weather (particularly rain)
  See section 6 for the full titles of the EN standards. |
| Application method(s) | Method: brushing and rolling
  Detailed description:
  Superficial treatment |
| Application rate(s) and frequency | Application Rate: 100 ml/m2 (against blue stain fungi); 150 - 160 ml/m2 (against wood-rotting fungi)
  Dilution (%): - Ready-to-use product
  Number and timing of application:
  1 application |
| Category(ies) of users | Professional
  General public (non-professional) |
| Pack sizes and packaging material | Can (high-density polyethylene) HDPE: 0,375 l, 0,75 l, 1,0 l, 2,5 l, 5,0 l
  For professional use only:
  Can HDPE: 10 l, 20 l, 25 l |

Product type

PT08 - Wood preservatives (Preservatives)

Where relevant, an exact description of the authorised use

Fungicide.

Target organism(s) (including development stage)

Common name: Blue stain fungi

Development stage:

Scientific name: Basidiomycetes:

Common name: Brown rot fungi

Development stage:

Field(s) of use

Indoor

Outdoor

Softwood

Preventative treatment

Use class 2 as described in EN standard 335:2013 (situation in which the wood or wood-based product is under cover and not exposed to the weather (particularly rain and wind-driven rain) but where occasional, but not persistent, wetting can occur.

Use class 3 as described in EN standard 335:2013 (situation in which the wood or wood-based product is above ground and exposed to the weather (particularly rain)

See section 6 for the full titles of the EN standards.

Application method(s)

Method: brushing and rolling

Detailed description:

Superficial treatment

Application rate(s) and frequency

Application Rate: 100 ml/m2 (against blue stain fungi); 150 - 160 ml/m2 (against wood-rotting fungi)

Dilution (%): - Ready-to-use product

Number and timing of application:

1 application

Category(ies) of users

Professional

General public (non-professional)

Pack sizes and packaging material

Can (high-density polyethylene) HDPE: 0,375 l, 0,75 l, 1,0 l, 2,5 l, 5,0 l

For professional use only:

Can HDPE: 10 l, 20 l, 25 l

4.1.1.   Use-specific instructions for use

Do not dilute (ready-to-use).

Apply the product to the wood with a brush or roller and let dry for approximately 24 hours. Cleaning of the tools can be performed using mild soap and water.

Use of a topcoat is required. The topcoat cannot contain a film- or wood preservative. The topcoat should be maintained.

The product protects the wood surface against blue stain fungi on wood that is minimum ‘moderately to slightly durable to fungi’ according to EN 350:2016: Durability Class (DC) 3-4. See section 6 for the full title of the EN standards.

4.1.2.   Use-specific risk mitigation measures

Do not use/apply directly on or near food, feed or drinks, or on surfaces or utensils likely to be in direct contact with food, feed, drinks and livestock/pets.

Do not apply near bodies of surface water.

During product application (to timbers) and whilst surfaces are drying, do not contaminate the environment. All losses of the product have to be contained by covering the ground (e.g. by tarpaulin) and disposed of in a safe way.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general direction for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general direction for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general direction for use.

4.2.   Use description

Table 2. Use # 2 – Manual dipping (professional)

| Product type | PT08 - Wood preservatives (Preservatives) |
| --- | --- |
| Where relevant, an exact description of the authorised use | Fungicide. |
| Target organism(s) (including development stage) | Common name: Blue stain fungi
  Development stage:
  Scientific name: Basidiomycetes:
  Common name: Brown rot fungi
  Development stage: |
| Field(s) of use | Indoor
  Softwood
  Preventative treatment
  Use class 2
  Use class 3 |
| Application method(s) | Method: manual dipping
  Detailed description:
  Superficial treatment |
| Application rate(s) and frequency | Application Rate: 100 ml/m2 (against blue stain fungi); 150 - 160 ml/m2 (against wood-rotting fungi)
  Dilution (%): - Ready-to-use product
  Number and timing of application:
  1 application |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Can HDPE: 0,375 l, 0,75 l, 1,0 l, 2,5 l, 5,0 l, 10 l, 20 l, 25 l |

Product type

PT08 - Wood preservatives (Preservatives)

Where relevant, an exact description of the authorised use

Fungicide.

Target organism(s) (including development stage)

Common name: Blue stain fungi

Development stage:

Scientific name: Basidiomycetes:

Common name: Brown rot fungi

Development stage:

Field(s) of use

Indoor

Softwood

Preventative treatment

Use class 2

Use class 3

Application method(s)

Method: manual dipping

Detailed description:

Superficial treatment

Application rate(s) and frequency

Application Rate: 100 ml/m2 (against blue stain fungi); 150 - 160 ml/m2 (against wood-rotting fungi)

Dilution (%): - Ready-to-use product

Number and timing of application:

1 application

Category(ies) of users

Professional

Pack sizes and packaging material

Can HDPE: 0,375 l, 0,75 l, 1,0 l, 2,5 l, 5,0 l, 10 l, 20 l, 25 l

4.2.1.   Use-specific instructions for use

Do not dilute (ready-to-use).

Drying time: Dry to handle and ready for topcoat: approximately 24 hours.

Cleaning of tools: Use water and mild soap.

Use of a topcoat is required. The topcoat cannot contain a film- or wood preservative. The topcoat should be maintained.

The product protects the wood surface against blue stain fungi on wood that is minimum ‘moderately to slightly durable to fungi’ according to EN 350:2016: Durability Class (DC) 3-4. See section 6 for the full title of the EN standards.

4.2.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves during product handling phase classified under the European Standard EN 374 or equivalent. Glove material to be specified by the authorisation holder within product information.

Wear a protective coverall (type 6, EN 13034 or equivalent).

This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.

See section 6 for the full titles of the EN standards and legislation.

Application by manual dipping shall be performed for a maximum of 30 minutes per day.

Do not use/apply directly on or near food, feed or drinks, or on surfaces or utensils likely to be in direct contact with food, feed, drinks and livestock/pets.

During product application (to timbers) and whilst surfaces are drying, do not contaminate the environment. All losses of the product have to be contained by covering the ground (e.g. by tarpaulin) and disposed of in a safe way.

Freshly treated timber must be stored after treatment under shelter or on a hard, impermeable surface to prevent direct losses to soil and water.

Any losses should be collected for reuse or disposal.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general direction for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general direction for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general direction for use.

4.3.   Use description

Table 3. Use # 3 – Automated dipping, automated spraying, flow coating/deluging (industrial)

| Product type | PT08 - Wood preservatives (Preservatives) |
| --- | --- |
| Where relevant, an exact description of the authorised use | Fungicide. |
| Target organism(s) (including development stage) | Common name: Blue stain fungi
  Development stage:
  Scientific name: Basidiomycetes:
  Common name: Brown rot fungi
  Development stage: |
| Field(s) of use | Indoor
  Softwood
  Preventative treatment
  Use class 2
  Use class 3 |
| Application method(s) | Method: automated dipping, automated spraying, flow coating/deluging
  Detailed description:
  Superficial treatment.
  Similar to flow coating/deluging, automated spraying is assumed to be an
  essentially fully enclosed
  process, whereby operator exposure occurs mainly by handling wet treated wood. |
| Application rate(s) and frequency | Application Rate: 100 ml/m2 (against blue stain fungi); 150 - 160 ml/m2 (against wood-rotting fungi)
  Dilution (%): - Ready-to-use product
  Number and timing of application:
  1 application |
| Category(ies) of users | Industrial |
| Pack sizes and packaging material | Can/ intermediate bulk container (IBC) HDPE: 120 l, 220 l, 1 000 l |

Product type

PT08 - Wood preservatives (Preservatives)

Where relevant, an exact description of the authorised use

Fungicide.

Target organism(s) (including development stage)

Common name: Blue stain fungi

Development stage:

Scientific name: Basidiomycetes:

Common name: Brown rot fungi

Development stage:

Field(s) of use

Indoor

Softwood

Preventative treatment

Use class 2

Use class 3

Application method(s)

Method: automated dipping, automated spraying, flow coating/deluging

Detailed description:

Superficial treatment.

Similar to flow coating/deluging, automated spraying is assumed to be an
  essentially fully enclosed
  process, whereby operator exposure occurs mainly by handling wet treated wood.

Application rate(s) and frequency

Application Rate: 100 ml/m2 (against blue stain fungi); 150 - 160 ml/m2 (against wood-rotting fungi)

Dilution (%): - Ready-to-use product

Number and timing of application:

1 application

Category(ies) of users

Industrial

Pack sizes and packaging material

Can/ intermediate bulk container (IBC) HDPE: 120 l, 220 l, 1 000 l

4.3.1.   Use-specific instructions for use

Do not dilute (ready-to-use).

Drying time:until dry to touch.

Use of a topcoat is required. The topcoat cannot contain a film- or wood preservative. The topcoat shall be maintained.

The product protects the wood surface against blue stain fungi on wood that is minimum ‘moderately to slightly durable to fungi’ according to EN 350:2016: Durability Class (DC) 3-4. See section 6 for the full title of the EN standards.

4.3.2.   Use-specific risk mitigation measures

The product must only be loaded into industrial application equipment via a fully-automated pumping/transfer system.

Wear protective chemical resistant gloves during product handling phase classified under the European Standard EN 374 or equivalent. Glove material to be specified by the authorisation holder within product information.

Wear a protective coverall (type 6, EN 13034 or equivalent).

This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.

See section 6 for the full titles of EN standards and legislation.

The product must only be used in fully automated dipping processes where all steps in the treatment and drying process are mechanised and no manual handling takes place, including when the treated articles are transported through the dip tank to draining/drying and storage (if not already surface dry before moving to storage). Where appropriate, the wooden articles to be treated must be fully secured (e.g. via tension belts or clamping devices) prior to treatment and during the dipping process, and must not be manually handled until after the treated articles are surface dry.

Freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil, sewer and water.

Any losses of the product shall be collected for reuse or disposal.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general direction for use.

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general direction for use.

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general direction for use.

4.4.   Use description

Table 4. Use # 4 – Double vacuum/low pressure process (industrial)

| Product type | PT08 - Wood preservatives (Preservatives) |
| --- | --- |
| Where relevant, an exact description of the authorised use | Fungicide. |
| Target organism(s) (including development stage) | Scientific name: Basidiomycetes:
  Common name: Brown rot fungi
  Development stage: |
| Field(s) of use | Indoor
  Softwood
  Preventative treatment
  Use class 2
  Use class 3 |
| Application method(s) | Method: Double vacuum/low pressure process
  Detailed description:
  Penetrative treatment. |
| Application rate(s) and frequency | Application Rate: 74.6 - 79.5 kg/m3

  Dilution (%): 10% in-use solution (1 part product: 9 parts water)
  Number and timing of application:
  1 application |
| Category(ies) of users | Industrial |
| Pack sizes and packaging material | Can/IBC HDPE: 120 l, 220 l, 1 000 l |

Product type

PT08 - Wood preservatives (Preservatives)

Where relevant, an exact description of the authorised use

Fungicide.

Target organism(s) (including development stage)

Scientific name: Basidiomycetes:

Common name: Brown rot fungi

Development stage:

Field(s) of use

Indoor

Softwood

Preventative treatment

Use class 2

Use class 3

Application method(s)

Method: Double vacuum/low pressure process

Detailed description:

Penetrative treatment.

Application rate(s) and frequency

Application Rate: 74.6 - 79.5 kg/m3

Dilution (%): 10% in-use solution (1 part product: 9 parts water)

Number and timing of application:

1 application

Category(ies) of users

Industrial

Pack sizes and packaging material

Can/IBC HDPE: 120 l, 220 l, 1 000 l

4.4.1.   Use-specific instructions for use

Drying time: until dry to touch.

4.4.2.   Use-specific risk mitigation measures

The product must only be loaded into industrial application equipment via a fully-automated pumping/transfer system.

Wear protective chemical resistant gloves during product handling phase classified under the European Standard EN 374 or equivalent. Glove material to be specified by the authorisation holder within product information.

Wear a protective coverall (type 6, EN 13034 or equivalent).

This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.

See section 6 for full titles of the EN standards and legislation.

Freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil, sewer or water.

Any losses of the product shall be collected for reuse or disposal.

4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general direction for use.

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general direction for use.

4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general direction for use.

5.   GENERAL DIRECTIONS FOR USE (1)

5.1.   Instructions for use

Comply with the instructions for use.

Do not use product on wood or wooden structures intended for use indoors, except for internal surfaces of external window frames and of external doors/door frames.

The temperature must be above 5°C and relative humidity below 80% during application and drying.

Stir product before use.

Avoid contact with skin and eyes.

Wash hands and face after application and use of the product, and before eating, drinking or smoking.

5.2.   Risk mitigation measures

Do not use on wood which may come in direct contact with food, feed and livestock.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.

IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.

IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

When seeking medical advice, have the product container or label at hand.

5.4.   Instructions for safe disposal of the product and its packaging

This product and its container must be disposed of safely as hazardous waste.

Any product collected during application that is not reused must be disposed of safely as hazardous waste.

Dispose of packaging and of unused product in accordance with local regulations. If required, consult a professional waste operator or local authority.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children and non-target animals/pets.

Do not store near food, drink and animal feeding stuff.

Shelf life: 12 months.

Store below 35°C.

Store in a cool, dry, well-ventilated place.

Protect from frost.

Protect from light.

Opened containers must be carefully resealed and kept upright to prevent leakage.

6.   OTHER INFORMATION

Regarding Use 1 and Use 2: Professionals and/or trained professionals if required by national legislation.

Full titles of EN standards and legislation mentioned in section 4.1.1, 4.2.1, 4.3.1, 4.2.2, 4.3.2 and 4.4.2:

EN 335:2013 - Durability of wood and wood-based products - Use classes: definitions, application to solid wood and wood-based products

EN 350:2016, Durability of wood and wood-based products - Testing and classification of the durability to biological agents of wood and wood-based materials

EN 374 – Protective gloves against dangerous chemicals and micro-organisms. Part 1: terminology and performance requirements for chemical risks.

EN 13034 - Protective clothing against liquid chemicals. Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment).

Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).

---

(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.

---

| 30.5.2023 | EN | Official Journal of the European Union | L 140/37 |
| --- | --- | --- | --- |

30.5.2023

EN

Official Journal of the European Union

L 140/37

---

COMMISSION REGULATION (EU) 2023/1042

of 26 May 2023

amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for folpet in or on certain products

(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 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1), point (a), thereof,

Whereas:

| (1) | Maximum residue levels (‘MRLs’) for folpet were set in Annex II to Regulation (EC) No 396/2005. |
| --- | --- |

(1)

Maximum residue levels (‘MRLs’) for folpet were set in Annex II to Regulation (EC) No 396/2005.

| (2) | An application pursuant to Article 6(1) of Regulation (EC) No 396/2005 was submitted requesting a modification of the existing MRL for folpet in lettuces. |
| --- | --- |

(2)

An application pursuant to Article 6(1) of Regulation (EC) No 396/2005 was submitted requesting a modification of the existing MRL for folpet in lettuces.

| (3) | In accordance with Article 8 of Regulation (EC) No 396/2005, this application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. |
| --- | --- |

(3)

In accordance with Article 8 of Regulation (EC) No 396/2005, this application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission.

| (4) | The European Food Safety Authority (‘the Authority’) assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals, and gave a reasoned opinion on the proposed MRL (2). It forwarded the opinion to the applicant, the Commission and the Member States and made it available to the public. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals, and gave a reasoned opinion on the proposed MRL (2). It forwarded the opinion to the applicant, the Commission and the Member States and made it available to the public.

| (5) | As regards the modification to the MRL requested by the applicant, the Authority concluded that all requirements with respect to completeness of data submission were met and that the modification to the MRL requested by the applicant was acceptable with regard to consumer safety, on the basis of a consumer exposure assessment for 27 specific European consumer groups. In so concluding, the Authority took into account the most recent data on the toxicological properties of the substance. Neither the long-term exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed a risk that the acceptable daily intake or the acute reference dose is exceeded. |
| --- | --- |

(5)

As regards the modification to the MRL requested by the applicant, the Authority concluded that all requirements with respect to completeness of data submission were met and that the modification to the MRL requested by the applicant was acceptable with regard to consumer safety, on the basis of a consumer exposure assessment for 27 specific European consumer groups. In so concluding, the Authority took into account the most recent data on the toxicological properties of the substance. Neither the long-term exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed a risk that the acceptable daily intake or the acute reference dose is exceeded.

| (6) | Based on the reasoned opinion of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, the proposed modification to the MRL fulfils the requirements of Article 14(2) of that Regulation. |
| --- | --- |

(6)

Based on the reasoned opinion of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, the proposed modification to the MRL fulfils the requirements of Article 14(2) of that Regulation.

| (7) | Regulation (EC) No 396/2005 should therefore be amended accordingly. |
| --- | --- |

(7)

Regulation (EC) No 396/2005 should therefore be amended accordingly.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(8)

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

Annex II to Regulation (EC) No 396/2005 is amended in accordance with the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 26 May 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 70, 16.3.2005, p. 1.

1

(2)  Reasoned opinion on the modification of the existing maximum residue level for folpet in lettuces. EFSA Journal 2022;20(4):7309.

2

---

ANNEX

In Annex II to Regulation (EC) No 396/2005, the column for folpet is replaced by the following:

‘Pesticide residues and maximum residue levels (mg/kg)

| Code number | Groups and examples of individual products to which the MRLs apply (1) | Folpet (sum of folpet and phtalimide, expressed as folpet) (R) |
| --- | --- | --- |
| (1) | (2) | (3) |
| 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | |
| 0110000 | Citrus fruits | 0,03  ((*)) |
| 0110010 | Grapefruits | |
| 0110020 | Oranges | |
| 0110030 | Lemons | |
| 0110040 | Limes | |
| 0110050 | Mandarins | |
| 0110990 | Others (2) | |
| 0120000 | Tree nuts | 0,07  ((*)) |
| 0120010 | Almonds | |
| 0120020 | Brazil nuts | |
| 0120030 | Cashew nuts | |
| 0120040 | Chestnuts | |
| 0120050 | Coconuts | |
| 0120060 | Hazelnuts/cobnuts | |
| 0120070 | Macadamias | |
| 0120080 | Pecans | |
| 0120090 | Pine nut kernels | |
| 0120100 | Pistachios | |
| 0120110 | Walnuts | |
| 0120990 | Others (2) | |
| 0130000 | Pome fruits | |
| 0130010 | Apples | 0,3 |
| 0130020 | Pears | 0,3 |
| 0130030 | Quinces | 0,03  ((*)) |
| 0130040 | Medlars | 0,03  ((*)) |
| 0130050 | Loquats/Japanese medlars | 0,03  ((*)) |
| 0130990 | Others (2) | 0,03  ((*)) |
| 0140000 | Stone fruits | 0,03  ((*)) |
| 0140010 | Apricots | |
| 0140020 | Cherries (sweet) | |
| 0140030 | Peaches | |
| 0140040 | Plums | |
| 0140990 | Others (2) | |
| 0150000 | Berries and small fruits | |
| 0151000 | (a) | grapes |

Code number

Groups and examples of individual products to which the MRLs apply (1)

Folpet (sum of folpet and phtalimide, expressed as folpet) (R)

(1)

(2)

(3)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0110000

Citrus fruits

0,03  ((*))

0110010

Grapefruits

0110020

Oranges

0110030

Lemons

0110040

Limes

0110050

Mandarins

0110990

Others (2)

0120000

Tree nuts

0,07  ((*))

0120010

Almonds

0120020

Brazil nuts

0120030

Cashew nuts

0120040

Chestnuts

0120050

Coconuts

0120060

Hazelnuts/cobnuts

0120070

Macadamias

0120080

Pecans

0120090

Pine nut kernels

0120100

Pistachios

0120110

Walnuts

0120990

Others (2)

0130000

Pome fruits

0130010

Apples

0,3

0130020

Pears

0,3

0130030

Quinces

0,03  ((*))

0130040

Medlars

0,03  ((*))

0130050

Loquats/Japanese medlars

0,03  ((*))

0130990

Others (2)

0,03  ((*))

0140000

Stone fruits

0,03  ((*))

0140010

Apricots

0140020

Cherries (sweet)

0140030

Peaches

0140040

Plums

0140990

Others (2)

0150000

Berries and small fruits

0151000

(a)

grapes

0151010

Table grapes

6

0151020

Wine grapes

20

0152000

| (b) | strawberries |
| --- | --- |

(b)

strawberries

5 (+)

0153000

| (c) | cane fruits |
| --- | --- |

(c)

cane fruits

0,03  ((*))

0153010

Blackberries

0153020

Dewberries

0153030

Raspberries (red and yellow)

0153990

Others (2)

0154000

| (d) | other small fruits and berries |
| --- | --- |

(d)

other small fruits and berries

0,03  ((*))

0154010

Blueberries

0154020

Cranberries

0154030

Currants (black, red and white)

0154040

Gooseberries (green, red and yellow)

0154050

Rose hips

0154060

Mulberries (black and white)

0154070

Azaroles/Mediterranean medlars

0154080

Elderberries

0154990

Others (2)

0160000

Miscellaneous fruitswith

0161000

| (a) | edible peel |
| --- | --- |

(a)

edible peel

0161010

Dates

0,03  ((*))

0161020

Figs

0,03  ((*))

0161030

Table olives

0,15  ((*))(+)

0161040

Kumquats

0,03  ((*))

0161050

Carambolas

0,03  ((*))

0161060

Kaki/Japanese persimmons

0,03  ((*))

0161070

Jambuls/jambolans

0,03  ((*))

0161990

Others (2)

0,03  ((*))

0162000

| (b) | inedible peel, small |
| --- | --- |

(b)

inedible peel, small

0,03  ((*))

0162010

Kiwi fruits (green, red, yellow)

0162020

Litchis/lychees

0162030

Passionfruits/maracujas

0162040

Prickly pears/cactus fruits

0162050

Star apples/cainitos

0162060

American persimmons/Virginia kaki

0162990

Others (2)

0163000

| (c) | inedible peel, large |
| --- | --- |

(c)

inedible peel, large

0,03  ((*))

0163010

Avocados

0163020

Bananas

0163030

Mangoes

0163040

Papayas

0163050

Granate apples/pomegranates

0163060

Cherimoyas

0163070

Guavas

0163080

Pineapples

0163090

Breadfruits

0163100

Durians

0163110

Soursops/guanabanas

0163990

Others (2)

0200000

VEGETABLES, FRESH or FROZEN

0210000

Root and tuber vegetables

0211000

| (a) | potatoes |
| --- | --- |

(a)

potatoes

0,06  ((*))(+)

0212000

| (b) | tropical root and tuber vegetables |
| --- | --- |

(b)

tropical root and tuber vegetables

0,03  ((*))

0212010

Cassava roots/manioc

0212020

Sweet potatoes

0212030

Yams

0212040

Arrowroots

0212990

Others (2)

0213000

| (c) | other root and tuber vegetables except sugar beets |
| --- | --- |

(c)

other root and tuber vegetables except sugar beets

0213010

Beetroots

0,03  ((*))

0213020

Carrots

0,03  ((*))

0213030

Celeriacs/turnip rooted celeries

0,03  ((*))

0213040

Horseradishes

0,03  ((*))

0213050

Jerusalem artichokes

0,03  ((*))

0213060

Parsnips

0,03  ((*))

0213070

Parsley roots/Hamburg roots parsley

0,03  ((*))

0213080

Radishes

0,04  ((*))(+)

0213090

Salsifies

0,04  ((*))(+)

0213100

Swedes/rutabagas

0,03  ((*))

0213110

Turnips

0,03  ((*))

0213990

Others (2)

0,03  ((*))

0220000

Bulb vegetables

0,03  ((*))

0220010

Garlic

0220020

Onions

0220030

Shallots

0220040

Spring onions/green onions and Welsh onions

0220990

Others (2)

0230000

Fruiting vegetables

0231000

| (a) | Solanaceae and Malvaceae |
| --- | --- |

(a)

Solanaceae and Malvaceae

0231010

Tomatoes

5 (+)

0231020

Sweet peppers/bell peppers

0,03  ((*))

0231030

Aubergines/eggplants

0,03  ((*))

0231040

Okra/lady's fingers

0,03  ((*))

0231990

Others (2)

0,03  ((*))

0232000

| (b) | cucurbits with edible peel |
| --- | --- |

(b)

cucurbits with edible peel

0,03  ((*))

0232010

Cucumbers

0232020

Gherkins

0232030

Courgettes

0232990

Others (2)

0233000

| (c) | cucurbits with inedible peel |
| --- | --- |

(c)

cucurbits with inedible peel

0233010

Melons

0,4 (+)

0233020

Pumpkins

0,03  ((*))

0233030

Watermelons

0,03  ((*))

0233990

Others (2)

0,03  ((*))

0234000

| (d) | sweet corn |
| --- | --- |

(d)

sweet corn

0,03  ((*))

0239000

| (e) | other fruiting vegetables |
| --- | --- |

(e)

other fruiting vegetables

0,03  ((*))

0240000

Brassica vegetables(excluding brassica roots and brassica baby leaf crops)

0,03  ((*))

0241000

| (a) | flowering brassica |
| --- | --- |

(a)

flowering brassica

0241010

Broccoli

0241020

Cauliflowers

0241990

Others (2)

0242000

| (b) | head brassica |
| --- | --- |

(b)

head brassica

0242010

Brussels sprouts

0242020

Head cabbages

0242990

Others (2)

0243000

| (c) | leafy brassica |
| --- | --- |

(c)

leafy brassica

0243010

Chinese cabbages/pe-tsai

0243020

Kales

0243990

Others (2)

0244000

| (d) | kohlrabies |
| --- | --- |

(d)

kohlrabies

0250000

Leaf vegetables, herbs and edible flowers

0251000

| (a) | lettuces and salad plants |
| --- | --- |

(a)

lettuces and salad plants

0251010

Lamb's lettuces/corn salads

0,03  ((*))

0251020

Lettuces

1,5

0251030

Escaroles/broad-leaved endives

0,03  ((*))

0251040

Cresses and other sprouts and shoots

0,03  ((*))

0251050

Land cresses

0,03  ((*))

0251060

Roman rocket/rucola

0,03  ((*))

0251070

Red mustards

0,03  ((*))

0251080

Baby leaf crops (including brassica species)

0,03  ((*))

0251990

Others (2)

0,03  ((*))

0252000

| (b) | spinaches and similar leaves |
| --- | --- |

(b)

spinaches and similar leaves

0,03  ((*))

0252010

Spinaches

0252020

Purslanes

0252030

Chards/beet leaves

0252990

Others (2)

0253000

| (c) | grape leaves and similar species |
| --- | --- |

(c)

grape leaves and similar species

0,03  ((*))

0254000

| (d) | watercresses |
| --- | --- |

(d)

watercresses

0,03  ((*))

0255000

| (e) | witloofs/Belgian endives |
| --- | --- |

(e)

witloofs/Belgian endives

0,03  ((*))

0256000

| (f) | herbs and edible flowers |
| --- | --- |

(f)

herbs and edible flowers

0,06  ((*))

0256010

Chervil

0256020

Chives

0256030

Celery leaves

0256040

Parsley

0256050

Sage

0256060

Rosemary

0256070

Thyme

0256080

Basil and edible flowers

0256090

Laurel/bay leaves

0256100

Tarragon

0256990

Others (2)

0260000

Legume vegetables

0,03  ((*))

0260010

Beans (with pods)

0260020

Beans (without pods)

0260030

Peas (with pods)

0260040

Peas (without pods)

0260050

Lentils

0260990

Others (2)

0270000

Stem vegetables

0,03  ((*))

0270010

Asparagus

0270020

Cardoons

0270030

Celeries

0270040

Florence fennels

0270050

Globe artichokes

0270060

Leeks

0270070

Rhubarbs

0270080

Bamboo shoots

0270090

Palm hearts

0270990

Others (2)

0280000

Fungi, mosses and lichens

0,03  ((*))

0280010

Cultivated fungi

0280020

Wild fungi

0280990

Mosses and lichens

0290000

Algae and prokaryotes organisms

0,03  ((*))

0300000

PULSES

0,07  ((*))

0300010

Beans

0300020

Lentils

0300030

Peas

0300040

Lupins/lupini beans

0300990

Others (2)

0400000

OILSEEDS AND OIL FRUITS

0401000

Oilseeds

0,07  ((*))

0401010

Linseeds

0401020

Peanuts/groundnuts

0401030

Poppy seeds

0401040

Sesame seeds

0401050

Sunflower seeds

0401060

Rapeseeds/canola seeds

0401070

Soyabeans

0401080

Mustard seeds

0401090

Cotton seeds

0401100

Pumpkin seeds

0401110

Safflower seeds

0401120

Borage seeds

0401130

Gold of pleasure seeds

0401140

Hemp seeds

0401150

Castor beans

0401990

Others (2)

0402000

Oil fruits

0402010

Olives for oil production

0,15  ((*))(+)

0402020

Oil palms kernels

0,07  ((*))

0402030

Oil palms fruits

0,07  ((*))

0402040

Kapok

0,07  ((*))

0402990

Others (2)

0,07  ((*))

0500000

CEREALS

0500010

Barley

2

0500020

Buckwheat and other pseudocereals

0,07  ((*))

0500030

Maize/corn

0,07  ((*))

0500040

Common millet/proso millet

0,07  ((*))

0500050

Oat

2

0500060

Rice

0,07  ((*))

0500070

Rye

0,3

0500080

Sorghum

0,07  ((*))

0500090

Wheat

0,4 (+)

0500990

Others (2)

0,07  ((*))

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

0,1  ((*))

0610000

Teas

0620000

Coffee beans

0630000

Herbal infusions from

0631000

| (a) | flowers |
| --- | --- |

(a)

flowers

0631010

Chamomile

0631020

Hibiscus/roselle

0631030

Rose

0631040

Jasmine

0631050

Lime/linden

0631990

Others (2)

0632000

| (b) | leaves and herbs |
| --- | --- |

(b)

leaves and herbs

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others (2)

0633000

| (c) | roots |
| --- | --- |

(c)

roots

0633010

Valerian

0633020

Ginseng

0633990

Others (2)

0639000

| (d) | any other parts of the plant |
| --- | --- |

(d)

any other parts of the plant

0640000

Cocoa beans

0650000

Carobs/Saint John's breads

0700000

HOPS

400 (+)

0800000

SPICES

0810000

Seed spices

0,1  ((*))

0810010

Anise/aniseed

0810020

Black caraway/black cumin

0810030

Celery

0810040

Coriander

0810050

Cumin

0810060

Dill

0810070

Fennel

0810080

Fenugreek

0810090

Nutmeg

0810990

Others (2)

0820000

Fruit spices

0,1  ((*))

0820010

Allspice/pimento

0820020

Sichuan pepper

0820030

Caraway

0820040

Cardamom

0820050

Juniper berry

0820060

Peppercorn (black, green and white)

0820070

Vanilla

0820080

Tamarind

0820990

Others (2)

0830000

Bark spices

0,1  ((*))

0830010

Cinnamon

0830990

Others (2)

0840000

Root and rhizome spices

0840010

Liquorice

0,1  ((*))

0840020

Ginger (10)

0840030

Turmeric/curcuma

0,1  ((*))

0840040

Horseradish (11)

0840990

Others (2)

0,1  ((*))

0850000

Bud spices

0,1  ((*))

0850010

Cloves

0850020

Capers

0850990

Others (2)

0860000

Flower pistil spices

0,1  ((*))

0860010

Saffron

0860990

Others (2)

0870000

Aril spices

0,1  ((*))

0870010

Mace

0870990

Others (2)

0900000

SUGAR PLANTS

0,03  ((*))

0900010

Sugar beet roots

0900020

Sugar canes

0900030

Chicory roots

0900990

Others (2)

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

0,05  ((*))

1010000

Commodities from

1011000

| (a) | swine |
| --- | --- |

(a)

swine

1011010

Muscle

1011020

Fat

1011030

Liver

1011040

Kidney

1011050

Edible offals (other than liver and kidney)

1011990

Others (2)

1012000

| (b) | bovine |
| --- | --- |

(b)

bovine

1012010

Muscle

1012020

Fat

1012030

Liver

1012040

Kidney

1012050

Edible offals (other than liver and kidney)

1012990

Others (2)

1013000

| (c) | sheep |
| --- | --- |

(c)

sheep

1013010

Muscle

1013020

Fat

1013030

Liver

1013040

Kidney

1013050

Edible offals (other than liver and kidney)

1013990

Others (2)

1014000

| d) | goat |
| --- | --- |

d)

goat

1014010

Muscle

1014020

Fat

1014030

Liver

1014040

Kidney

1014050

Edible offals (other than liver and kidney)

1014990

Others (2)

1015000

| (e) | equine |
| --- | --- |

(e)

equine

1015010

Muscle

1015020

Fat

1015030

Liver

1015040

Kidney

1015050

Edible offals (other than liver and kidney)

1015990

Others (2)

1016000

| (f) | poultry |
| --- | --- |

(f)

poultry

1016010

Muscle

(+)

1016020

Fat

(+)

1016030

Liver

(+)

1016040

Kidney

1016050

Edible offals (other than liver and kidney)

1016990

Others (2)

1017000

| (g) | other farmed terrestrial animals |
| --- | --- |

(g)

other farmed terrestrial animals

1017010

Muscle

1017020

Fat

1017030

Liver

1017040

Kidney

1017050

Edible offals (other than liver and kidney)

1017990

Others (2)

1020000

Milk

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others (2)

1030000

Birds eggs

(+)

1030010

Chicken

(+)

1030020

Duck

(+)

1030030

Geese

(+)

1030040

Quail

(+)

1030990

Others (2)

(+)

1040000

Honey and other apiculture products (7)

1050000

Amphibians and Reptiles

1060000

Terrestrial invertebrate animals

1070000

Wild terrestrial vertebrate animals

1100000

PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)

1200000

PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)

1300000

PROCESSED FOOD PRODUCTS (9)

Folpet (sum of folpet and phtalimide, expressed as folpet) (R)

The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 6 February 2018, or, if that information is not submitted by that date, the lack of it.

0152000 (b) strawberries

The European Food Safety Authority identified some information on analytical methods and storage stability as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 6 February 2018, or, if that information is not submitted by that date, the lack of it.

0161030 Table olives

0402010 Olives for oil production

The European Food Safety Authority identified some information on residue trials and analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 6 February 2018, or, if that information is not submitted by that date, the lack of it.

0211000 (a) potatoes

0231010 Tomatoes

0233010 Melons

0500090 Wheat

The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 6 February 2018, or, if that information is not submitted by that date, the lack of it.

0213080 Radishes

0213090 Salsifies

0700000 HOPS

The European Food Safety Authority identified some information on the nature and magnitude of residues as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 6 February 2018, or, if that information is not submitted by that date, the lack of it.

1016010 Muscle

1016020 Fat

1016030 Liver

1030000 Birds eggs

1030010 Chicken

1030020 Duck

1030030 Geese

1030040 Quail

1030990 Others (2)’

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((*))  Indicates lower limit of analytical determination

(*)

(1)  For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I

1

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DECISIONS

| 30.5.2023 | EN | Official Journal of the European Union | L 140/51 |
| --- | --- | --- | --- |

30.5.2023

EN

Official Journal of the European Union

L 140/51

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COUNCIL DECISION (EU) 2023/1043

of 22 May 2023

establishing the position to be adopted on behalf of the European Union within the Committee on Trade in Civil Aircraft on the accession of Brazil to the Agreement on Trade in Civil Aircraft

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(4), first subparagraph, in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | The Agreement on Trade in Civil Aircraft (1) (the ‘Agreement’) was concluded by the Union by Council Decision 80/271/EEC (2) and entered into force on 1 January 1980. |
| --- | --- |

(1)

The Agreement on Trade in Civil Aircraft (1) (the ‘Agreement’) was concluded by the Union by Council Decision 80/271/EEC (2) and entered into force on 1 January 1980.

| (2) | Brazil submitted its application to the Committee on Trade in Civil Aircraft (the ‘Committee’) for accession to the Agreement, together with its proposed tariff commitments, on 14 June 2022. |
| --- | --- |

(2)

Brazil submitted its application to the Committee on Trade in Civil Aircraft (the ‘Committee’) for accession to the Agreement, together with its proposed tariff commitments, on 14 June 2022.

| (3) | In view of those commitments, Brazil’s application for accession to the Agreement meets the requirements set out therein. |
| --- | --- |

(3)

In view of those commitments, Brazil’s application for accession to the Agreement meets the requirements set out therein.

| (4) | Brazil’s accession to the Agreement is expected to make a positive contribution to free and undistorted trade in the civil aircraft sector. |
| --- | --- |

(4)

Brazil’s accession to the Agreement is expected to make a positive contribution to free and undistorted trade in the civil aircraft sector.

| (5) | Pursuant to Article 9.1.3 of the Agreement and point 5 of the Guidance Note on the Implementation of Article 9.1.3 of the Agreement, the Committee has the power to take a decision agreeing to the terms of accession and to give its consent to the applicant government to deposit with the Director-General of the WTO an instrument of accession, which states the terms so agreed. |
| --- | --- |

(5)

Pursuant to Article 9.1.3 of the Agreement and point 5 of the Guidance Note on the Implementation of Article 9.1.3 of the Agreement, the Committee has the power to take a decision agreeing to the terms of accession and to give its consent to the applicant government to deposit with the Director-General of the WTO an instrument of accession, which states the terms so agreed.

| (6) | It is therefore appropriate to establish the position to be adopted on the Union’s behalf within the Committee in relation to the accession of Brazil to the Agreement, |
| --- | --- |

(6)

It is therefore appropriate to establish the position to be adopted on the Union’s behalf within the Committee in relation to the accession of Brazil to the Agreement,

HAS ADOPTED THIS DECISION:

Article 1

The position to be adopted on the Union’s behalf within the Committee on Trade in Civil Aircraft shall be to approve the accession of Brazil to the Agreement on Trade in Civil Aircraft.

Article 2

This Decision shall enter into force on the date of its adoption.

Done at Brussels, 22 May 2023.

For the Council

The President

E. BUSCH

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(1)  OJ L 71, 17.3.1980, p. 58.

1

(2)  Council Decision 80/271/EEC of 10 December 1979 concerning the conclusion of the Multilateral Agreements resulting from the 1973 to 1979 trade negotiations (OJ L 71, 17.3.1980, p. 1).

2

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ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

| 30.5.2023 | EN | Official Journal of the European Union | L 140/53 |
| --- | --- | --- | --- |

30.5.2023

EN

Official Journal of the European Union

L 140/53

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Decision No 2536/2023 of the Joint Sectoral Committee established under Article 14 of the United States – European Union amended Sectoral Annex for pharmaceutical good manufacturing practices (GMPs) (the ‘Annex’) on including veterinary products within the product coverage of the Annex

of 11 May 2023 [2023/1044]

THE JOINT SECTORAL COMMITTEE,

Whereas Article 20 of the Annex requires the Joint Sectoral Committee to consider whether to include veterinary products within the product coverage of the Annex,

Whereas the Joint Sectoral Committee has duly considered to include veterinary products, as defined in Appendix 3, paragraph 6, within the product coverage of the Annex,

Taking into account that Article 4(2) of the Annex expressly excludes veterinary immunologicals from the product coverage of the Annex,

Recognizing that any decision to include veterinary products within the product coverage of the Annex can be implemented only after successful mutual assessments of each Party’s authorities in accordance with Article 5 and Appendix 4 of the Annex,

Recognizing that to this end the Parties have agreed that each Party will complete the assessment of the other party regulatory authorities as set out in Attachment A to this Decision,

Recognizing that the Food and Drug Administration (‘FDA’) has completed the assessment of 14 authorities of the Member States of the European Union (‘EU’) competent for veterinary products (of which five are competent for veterinary products only, and considering that at least one capability assessment of those five authorities of the EU Member States, is favorable) in accordance with paragraph II.A of Appendix 4,

Recognizing that the EU has completed the assessment of the FDA in accordance with paragraph II.B of Appendix 4,

Recognizing that the FDA addressed the outstanding observations resulting from the audit in accordance with paragraph II.B (i) of Appendix 4,

Recognizing that FDA has already satisfied paragraph II.B (ii) of Appendix 4 as part of the EU’s assessment of the FDA for human pharmaceuticals.

Confirming that Article 9 of the Annex does not apply to veterinary products, mutatis mutandis, until the date on which all authorities of the Member States of the EU competent for veterinary products listed in Appendix 2 have been recognized by the FDA,

Considering that the List of Authorities in Appendix 2 of the Annex need to be updated,

HAS DECIDED AS FOLLOWS:

| 1. | Veterinary products, as defined in Appendix 3, paragraph 6, are included within the product coverage of the Annex.
  FDA shall complete the capability assessment of the authorities of all the Member States of the EU according to Attachment A to this Decision,
  FDA has addressed the outstanding observations resulting from the audit in accordance with paragraph II.B (i) of Appendix 4.
  Article 9 of the Annex will apply to veterinary products on the date on which all EU Member State authorities competent for veterinary products listed in Appendix 2, have been recognized by the FDA. |
| --- | --- |

1.

FDA shall complete the capability assessment of the authorities of all the Member States of the EU according to Attachment A to this Decision,

FDA has addressed the outstanding observations resulting from the audit in accordance with paragraph II.B (i) of Appendix 4.

Article 9 of the Annex will apply to veterinary products on the date on which all EU Member State authorities competent for veterinary products listed in Appendix 2, have been recognized by the FDA.

| 2. | The text of Appendix 2 of the Annex is replaced with the text of the Appendix 2 in Attachment B to this Decision.
  Attachment A: Schedule for Assessment of Member State Authorities for Veterinary Products
  Attachment B: Appendix 2 List of Authorities
  This Decision, done in duplicate, shall be signed by the co-chairs of the Joint Sectoral Committee as referred to in Article 14(2) of the Annex. This Decision shall be effective from the date of the later of these signatures. |
| --- | --- |

2.

Attachment A: Schedule for Assessment of Member State Authorities for Veterinary Products

Attachment B: Appendix 2 List of Authorities

This Decision, done in duplicate, shall be signed by the co-chairs of the Joint Sectoral Committee as referred to in Article 14(2) of the Annex. This Decision shall be effective from the date of the later of these signatures.

On behalf of the United States of America

Mark ABDOO

Signed in Silver Spring, MD, on 5 May 2023

On behalf of the European Union

Sylvain GIRAUD

Signed in Brussels, on 11 May 2023

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ATTACHMENT A

Schedule for Assessment of Member State Authorities for Veterinary Products

1.

| — | No later than 1 December 2022: capability assessment packages from nineteen Member States authorities; |
| --- | --- |

—

No later than 1 December 2022: capability assessment packages from nineteen Member States authorities;

| — | No later than 1 June 2023: capability assessment packages from four additional Member States authorities; |
| --- | --- |

—

No later than 1 June 2023: capability assessment packages from four additional Member States authorities;

| — | No later than 1 December 2023: capability assessment packages from four additional Member State authorities; |
| --- | --- |

—

No later than 1 December 2023: capability assessment packages from four additional Member State authorities;

| — | No later than 1 February 2024: any remaining capability assessment packages (due to FDA’s determination that a full capability assessment is needed for a dual human and veterinary competence authority of a Member State) |
| --- | --- |

—

No later than 1 February 2024: any remaining capability assessment packages (due to FDA’s determination that a full capability assessment is needed for a dual human and veterinary competence authority of a Member State)

2.

| — | 31 December 2022: seventeen capability assessments |
| --- | --- |

—

31 December 2022: seventeen capability assessments

| — | 31 December 2023: five additional capability assessments |
| --- | --- |

—

31 December 2023: five additional capability assessments

| — | 31 July 2024: five additional capability assessments |
| --- | --- |

—

31 July 2024: five additional capability assessments

3.

| (a) | The EU shall submit a final audit report to the FDA no later than 60 days before the due date of the capability assessment package for the Member State authority. |
| --- | --- |

(a)

The EU shall submit a final audit report to the FDA no later than 60 days before the due date of the capability assessment package for the Member State authority.

| (b) | The FDA shall provide a finalized capability assessment package checklist to the Member State authority no later than 20 days after the FDA receives the audit report. |
| --- | --- |

(b)

The FDA shall provide a finalized capability assessment package checklist to the Member State authority no later than 20 days after the FDA receives the audit report.

| (c) | The Member State authority shall submit the capability assessment package to FDA no later than 40 days after that Member State authority receives the capability assessment package checklist. |
| --- | --- |

(c)

The Member State authority shall submit the capability assessment package to FDA no later than 40 days after that Member State authority receives the capability assessment package checklist.

4.

The deadline for delivering capability assessment packages will be automatically extended by 3 months, if these cannot be completed in time due to repercussions of measures related to the COVID-19 pandemic or similar disruptive event, such as travel restrictions, quarantine measures, sick leaves and resource shortages arising thereof. The EU shall inform the FDA in a timely manner of relevant delays and shall propose an updated timeline for agreement in the Joint Sectoral Committee.

5.

The communication of the recognition of Member States authorities assessed shall be done promptly following the conclusion of the capability assessment (on a rolling basis) and in line with Article 7 of the Annex.

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ATTACHMENT B

Appendix 2 List of Authorities

United States:

The Food and Drug Administration

European Union:

| Country | For medicinal products for human use | For veterinary medicinal products |
| --- | --- | --- |
| Austria | Austrian Agency for Health and Food Safety / Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH | See responsible authority for medicinal products for human use |
| Belgium | Federal Agency for Medicines and Health Products – FAMHP / Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten – FAGG / Agence fédérale des médicaments et des produits de santé – AFMPS | See responsible authority for medicinal products for human use |
| Bulgaria | Bulgarian Drug Agency / Изпълнителна агенция по лекарствата | Bulgarian Food Safety Agency / Българска агенция по безопасност на храните |
| Croatia | Agency for Medicinal Products and Medical Devices / Agencija za lijekove i medicinske proizvode (HALMED) | Agency for Medicinal Products and Medical Devices / Agencija za lijekove i medicinske proizvode (HALMED)

  Ministry of Agriculture, Veterinary and Food Safety Directorate / Ministarstvo poljoprivrede, Uprava za veterinarstvo i sigurnost hrane |
| Cyprus | Ministry of Health – Pharmaceutical Services / Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας | Ministry of Agriculture, Rural Development and Environment – Veterinary Services / Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος – Κτηνιατρικές Υπηρεσίες |
| Czechia | State Institute for Drug Control / Státní ústav pro kontrolu léčiv (SÚKL) | Institute for State Control of Veterinary Biologicals and Medicines / Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (ÚSKVBL) |
| Denmark | Danish Medicines Agency / Lægemiddelstyrelsen | See responsible authority for medicinal products for human use |
| Estonia | State Agency of Medicines / Ravimiamet | See responsible authority for medicinal products for human use |
| Finland | Finnish Medicines Agency / Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA) | See responsible authority for medicinal products for human use |
| France | French National Agency for Medicines and Health Products Safety / Agence nationale de sécurité du médicament et des produits de santé (ANSM) | French agency for food, environmental and occupational health safety – French Agency for Veterinary Medicinal Products / Agence Nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail – Agence Nationale du Médicament Vétérinaire (Anses-ANMV) |
| Germany | Federal Institute for Drugs and Medical Devices / Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

  Paul-Ehrlich-Institute (PEI), Federal Institute for Vaccines and Biomedicines / Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel

  Federal Ministry of Health / Bundesministerium für Gesundheit (BMG)

  Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices / Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG
   (1) | Federal Office for Consumer Protection and Food Safety / Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)

  Federal Ministry of Food and Agriculture / Bundesministerium für Ernährung und Landwirtschaft |
| Greece | National Organisation for Medicines / Ethnikos Organismos Farmakon (EOF) – (Εθνικός Οργανισμός Φαρμάκων)) | See responsible authority for medicinal products for human use |
| Hungary | National Institute of Pharmacy and Nutrition / Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet | National Food Chain Safety Office, Directorate of Veterinary Medicinal Products / Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI) |
| Ireland | Health Products Regulatory Authority (HPRA) | See responsible authority for medicinal products for human use |
| Italy | Italian Medicines Agency / Agenzia Italiana del Farmaco | Ministry of Health, Direction General for Animal Health and Veterinary Medicinal Products / Ministero della Salute, Direzione Generale della Sanità Animale e dei Farmaci Veterinari |
| Latvia | State Agency of Medicines / Zāļu valsts aģentūra | Food and Veterinary Service / Pārtikas un veterinārais dienests |
| Lithuania | State Medicines Control Agency / Valstybinė vaistų kontrolės tarnyba | State Food and Veterinary Service / Valstybinė maisto ir veterinarijos tarnyba |
| Luxembourg | Ministry of Health, Division of Pharmacy and Medicines / Ministère de la Santé, Division de la Pharmacie et des Médicaments | See responsible authority for medicinal products for human use |
| Malta | Malta Medicines Authority (MMA) | The Animal Health and Welfare Department (AHWD) |
| Netherlands | Healthcare and Youth Care Inspectorate, Ministry of Health, Welfare and Sport / Inspectie Gezondheidszorg en Jeugd (IGJ), Ministerie van Volksgezondheid, Welzijn en Sport | Medicines Evaluation Board (MEB) / College ter Beoordeling van Geneesmiddelen (CBG)

  Veterinary Medicinal Products Unit / Bureau Diergeneesmiddelen |
| Poland | Chief Pharmaceutical Inspectorate / Główny Inspektorat Farmaceutyczny (GIF) | See responsible authority for medicinal products for human use |
| Portugal | National Authority of Medicines and Health Products / INFARMED, I.P Autoridade Nacional do Medicamento e Produtos de Saúde, I.P | General Directorate of Food and Veterinary / Direção-Geral de Alimentação e Veterinária (DGAV) |
| Romania | National Agency for Medicines and Medical Devices of Romania / Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale din România | National Sanitary Veterinary and Food Safety Authority / Autoritatea Naţională Sanitară Veterinară şi pentru Siguranţa Alimentelor |
| Slovakia | State Institute for Drug Control / Štátny ústav pre kontrolu liečiv (ŠÚKL) | Institute for State Control of Veterinary Biologicals and Medicaments / Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (USKVBL) |
| Slovenia | Agency for Medicinal Products and Medical Devices of the Republic of Slovenia / Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) | See responsible authority for medicinal products for human use |
| Spain | Spanish Agency of Medicines and Medical Devices / Agencia Española de Medicamentos y Productos Sanitarios
   (2) | See responsible authority for medicinal products for human use |
| Sweden | Swedish Medical Product Agency / Läkemedelsverket | See responsible authority for medicinal products for human use |

Country

For medicinal products for human use

For veterinary medicinal products

Austria

Austrian Agency for Health and Food Safety / Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH

See responsible authority for medicinal products for human use

Belgium

Federal Agency for Medicines and Health Products – FAMHP / Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten – FAGG / Agence fédérale des médicaments et des produits de santé – AFMPS

See responsible authority for medicinal products for human use

Bulgaria

Bulgarian Drug Agency / Изпълнителна агенция по лекарствата

Bulgarian Food Safety Agency / Българска агенция по безопасност на храните

Croatia

Agency for Medicinal Products and Medical Devices / Agencija za lijekove i medicinske proizvode (HALMED)

Agency for Medicinal Products and Medical Devices / Agencija za lijekove i medicinske proizvode (HALMED)

Ministry of Agriculture, Veterinary and Food Safety Directorate / Ministarstvo poljoprivrede, Uprava za veterinarstvo i sigurnost hrane

Cyprus

Ministry of Health – Pharmaceutical Services / Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας

Ministry of Agriculture, Rural Development and Environment – Veterinary Services / Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος – Κτηνιατρικές Υπηρεσίες

Czechia

State Institute for Drug Control / Státní ústav pro kontrolu léčiv (SÚKL)

Institute for State Control of Veterinary Biologicals and Medicines / Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (ÚSKVBL)

Denmark

Danish Medicines Agency / Lægemiddelstyrelsen

See responsible authority for medicinal products for human use

Estonia

State Agency of Medicines / Ravimiamet

See responsible authority for medicinal products for human use

Finland

Finnish Medicines Agency / Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA)

See responsible authority for medicinal products for human use

France

French National Agency for Medicines and Health Products Safety / Agence nationale de sécurité du médicament et des produits de santé (ANSM)

French agency for food, environmental and occupational health safety – French Agency for Veterinary Medicinal Products / Agence Nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail – Agence Nationale du Médicament Vétérinaire (Anses-ANMV)

Germany

Federal Institute for Drugs and Medical Devices / Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Paul-Ehrlich-Institute (PEI), Federal Institute for Vaccines and Biomedicines / Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel

Federal Ministry of Health / Bundesministerium für Gesundheit (BMG)

Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices / Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG
   (1)

Federal Office for Consumer Protection and Food Safety / Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)

Federal Ministry of Food and Agriculture / Bundesministerium für Ernährung und Landwirtschaft

Greece

National Organisation for Medicines / Ethnikos Organismos Farmakon (EOF) – (Εθνικός Οργανισμός Φαρμάκων))

See responsible authority for medicinal products for human use

Hungary

National Institute of Pharmacy and Nutrition / Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet

National Food Chain Safety Office, Directorate of Veterinary Medicinal Products / Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI)

Ireland

Health Products Regulatory Authority (HPRA)

See responsible authority for medicinal products for human use

Italy

Italian Medicines Agency / Agenzia Italiana del Farmaco

Ministry of Health, Direction General for Animal Health and Veterinary Medicinal Products / Ministero della Salute, Direzione Generale della Sanità Animale e dei Farmaci Veterinari

Latvia

State Agency of Medicines / Zāļu valsts aģentūra

Food and Veterinary Service / Pārtikas un veterinārais dienests

Lithuania

State Medicines Control Agency / Valstybinė vaistų kontrolės tarnyba

State Food and Veterinary Service / Valstybinė maisto ir veterinarijos tarnyba

Luxembourg

Ministry of Health, Division of Pharmacy and Medicines / Ministère de la Santé, Division de la Pharmacie et des Médicaments

See responsible authority for medicinal products for human use

Malta

Malta Medicines Authority (MMA)

The Animal Health and Welfare Department (AHWD)

Netherlands

Healthcare and Youth Care Inspectorate, Ministry of Health, Welfare and Sport / Inspectie Gezondheidszorg en Jeugd (IGJ), Ministerie van Volksgezondheid, Welzijn en Sport

Medicines Evaluation Board (MEB) / College ter Beoordeling van Geneesmiddelen (CBG)

Veterinary Medicinal Products Unit / Bureau Diergeneesmiddelen

Poland

Chief Pharmaceutical Inspectorate / Główny Inspektorat Farmaceutyczny (GIF)

See responsible authority for medicinal products for human use

Portugal

National Authority of Medicines and Health Products / INFARMED, I.P Autoridade Nacional do Medicamento e Produtos de Saúde, I.P

General Directorate of Food and Veterinary / Direção-Geral de Alimentação e Veterinária (DGAV)

Romania

National Agency for Medicines and Medical Devices of Romania / Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale din România

National Sanitary Veterinary and Food Safety Authority / Autoritatea Naţională Sanitară Veterinară şi pentru Siguranţa Alimentelor

Slovakia

State Institute for Drug Control / Štátny ústav pre kontrolu liečiv (ŠÚKL)

Institute for State Control of Veterinary Biologicals and Medicaments / Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (USKVBL)

Slovenia

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia / Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)

See responsible authority for medicinal products for human use

Spain

Spanish Agency of Medicines and Medical Devices / Agencia Española de Medicamentos y Productos Sanitarios
   (2)

See responsible authority for medicinal products for human use

Sweden

Swedish Medical Product Agency / Läkemedelsverket

See responsible authority for medicinal products for human use

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(1)  For the purpose of this Annex, and without prejudice to the internal division of competence in Germany on matters falling within the scope of this Annex, ZLG shall be understood as coordinating authority for all competent Laender authorities issuing GMP documents and conducting pharmaceutical inspections.

(2)  For the purpose of this Annex, and without prejudice to the internal division of competence in Spain on matters falling within the scope of this Annex, Agencia Española de Medicamentos y Productos Sanitarios shall be understood as covering all the competent regional authorities issuing GMP documents and conducting pharmaceutical inspections.

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