# Official Journal L 257/2015

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 257 |
| | |
| English edition | Legislation | Volume 582 October 2015 |

ISSN 1977-0677

Official Journal

of the European Union

L 257

English edition

Legislation

Volume 582 October 2015

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Council Regulation (EU) 2015/1755 of 1 October 2015 concerning restrictive measures in view of the situation in Burundi | 1 |
| | * | Commission Implementing Regulation (EU) 2015/1756 of 21 September 2015 entering a name in the register of protected designations of origin and protected geographical indications (Citron de Menton (PGI)) | 11 |
| | * | Commission Implementing Regulation (EU) 2015/1757 of 28 September 2015 approving folpet as an active substance for use in biocidal products for product-type 6 (
  1
  ) | 12 |
| | * | Commission Implementing Regulation (EU) 2015/1758 of 28 September 2015 approving folpet as an existing active substance for use in biocidal products for product-types 7 and 9 (
  1
  ) | 15 |
| | * | Commission Implementing Regulation (EU) 2015/1759 of 28 September 2015 approving glutaraldehyde as an existing active substance for use in biocidal products for product-types 2, 3, 4, 6, 11 and 12 (
  1
  ) | 19 |
| | * | Commission Regulation (EU) 2015/1760 of 1 October 2015 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of the flavouring substance p-mentha-1,8-dien-7-al (
  1
  ) | 27 |
| | * | Commission Implementing Regulation (EU) 2015/1761 of 1 October 2015 amending Commission Regulation (EC) No 378/2005 as regards the Community Reference Laboratory reports, fees and the laboratories listed in Annex II thereto (
  1
  ) | 30 |
| | | Commission Implementing Regulation (EU) 2015/1762 of 1 October 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables | 35 |
| | | DECISIONS |
| | * | Council Decision (CFSP) 2015/1763 of 1 October 2015 concerning restrictive measures in view of the situation in Burundi | 37 |
| | * | Council Decision (CFSP) 2015/1764 of 1 October 2015 amending Decision 2014/512/CFSP concerning restrictive measures in view of Russia's actions destabilising the situation in Ukraine | 42 |
| | * | Commission Implementing Decision (EU) 2015/1765 of 30 September 2015 amending Annexes I and II to Decision 2004/558/EC as regards the infectious bovine rhinotracheitis-free status of the Federal State of Baden-Württemberg of Germany and of the region Valle d'Aosta of Italy
  (notified under document C(2015) 6572)

   (
  1
  ) | 44 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Council Regulation (EU) 2015/1755 of 1 October 2015 concerning restrictive measures in view of the situation in Burundi

1

*

Commission Implementing Regulation (EU) 2015/1756 of 21 September 2015 entering a name in the register of protected designations of origin and protected geographical indications (Citron de Menton (PGI))

11

*

Commission Implementing Regulation (EU) 2015/1757 of 28 September 2015 approving folpet as an active substance for use in biocidal products for product-type 6 (
  1
  )

1

12

*

Commission Implementing Regulation (EU) 2015/1758 of 28 September 2015 approving folpet as an existing active substance for use in biocidal products for product-types 7 and 9 (
  1
  )

1

15

*

Commission Implementing Regulation (EU) 2015/1759 of 28 September 2015 approving glutaraldehyde as an existing active substance for use in biocidal products for product-types 2, 3, 4, 6, 11 and 12 (
  1
  )

1

19

*

Commission Regulation (EU) 2015/1760 of 1 October 2015 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of the flavouring substance p-mentha-1,8-dien-7-al (
  1
  )

p

1

27

*

Commission Implementing Regulation (EU) 2015/1761 of 1 October 2015 amending Commission Regulation (EC) No 378/2005 as regards the Community Reference Laboratory reports, fees and the laboratories listed in Annex II thereto (
  1
  )

1

30

Commission Implementing Regulation (EU) 2015/1762 of 1 October 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables

35

DECISIONS

*

Council Decision (CFSP) 2015/1763 of 1 October 2015 concerning restrictive measures in view of the situation in Burundi

37

*

Council Decision (CFSP) 2015/1764 of 1 October 2015 amending Decision 2014/512/CFSP concerning restrictive measures in view of Russia's actions destabilising the situation in Ukraine

42

*

Commission Implementing Decision (EU) 2015/1765 of 30 September 2015 amending Annexes I and II to Decision 2004/558/EC as regards the infectious bovine rhinotracheitis-free status of the Federal State of Baden-Württemberg of Germany and of the region Valle d'Aosta of Italy
  (notified under document C(2015) 6572)

   (
  1
  )

(notified under document C(2015) 6572)

1

44

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

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.

---

II Non-legislative acts

REGULATIONS

| 2.10.2015 | EN | Official Journal of the European Union | L 257/1 |
| --- | --- | --- | --- |

2.10.2015

EN

Official Journal of the European Union

L 257/1

---

COUNCIL REGULATION (EU) 2015/1755

of 1 October 2015

concerning restrictive measures in view of the situation in Burundi

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 215 thereof,

Having regard to Council Decision (CFSP) 2015/1763 of 1 October 2015 concerning restrictive measures in respect of the situation in Burundi (1),

Having regard to the joint proposal from the High Representative of the Union for Foreign Affairs and Security Policy and the Commission,

Whereas:

| (1) | On 1 October 2015, the Council adopted Decision (CFSP) 2015/1763 concerning restrictive measures in view of the situation in Burundi providing for travel restrictions and the freezing of funds and economic resources of certain persons, entities or bodies responsible for undermining democracy or obstructing the search for a political solution in Burundi, including by acts of violence, repression or inciting violence, persons, entities or bodies involved in planning, directing, or committing acts that violate international human rights law or international humanitarian law, as applicable, or that constitute serious human rights abuses, in Burundi. Those persons, entities and bodies are listed in the Annex to Decision (CFSP) 2015/1763. |
| --- | --- |

(1)

On 1 October 2015, the Council adopted Decision (CFSP) 2015/1763 concerning restrictive measures in view of the situation in Burundi providing for travel restrictions and the freezing of funds and economic resources of certain persons, entities or bodies responsible for undermining democracy or obstructing the search for a political solution in Burundi, including by acts of violence, repression or inciting violence, persons, entities or bodies involved in planning, directing, or committing acts that violate international human rights law or international humanitarian law, as applicable, or that constitute serious human rights abuses, in Burundi. Those persons, entities and bodies are listed in the Annex to Decision (CFSP) 2015/1763.

| (2) | Further action by the Union is needed in order to implement Decision (CFSP) 2015/1763. |
| --- | --- |

(2)

Further action by the Union is needed in order to implement Decision (CFSP) 2015/1763.

| (3) | The High Representative of the Union for Foreign Affairs and Security Policy and the European Commission should make a proposal for a Regulation concerning restrictive measures in view of the situation in Burundi. |
| --- | --- |

(3)

The High Representative of the Union for Foreign Affairs and Security Policy and the European Commission should make a proposal for a Regulation concerning restrictive measures in view of the situation in Burundi.

| (4) | This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably the right to an effective remedy and to a fair trial and the right to the protection of personal data. This Regulation should be applied in accordance with those rights. |
| --- | --- |

(4)

This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably the right to an effective remedy and to a fair trial and the right to the protection of personal data. This Regulation should be applied in accordance with those rights.

| (5) | The power to amend the list in Annex I to this Regulation should be exercised by the Council, in view of the specific threat to international peace and security in the region posed by the situation in Burundi and in order to ensure consistency with the process for amending and reviewing the Annex to Decision (CFSP) 2015/1763. |
| --- | --- |

(5)

The power to amend the list in Annex I to this Regulation should be exercised by the Council, in view of the specific threat to international peace and security in the region posed by the situation in Burundi and in order to ensure consistency with the process for amending and reviewing the Annex to Decision (CFSP) 2015/1763.

| (6) | For the implementation of this Regulation, and in order to ensure maximum legal certainty within the Union, the names and other relevant data concerning natural and legal persons, entities and bodies whose funds and economic resources must be frozen in accordance with this Regulation, must be made public. Any processing of personal data should comply with Directive 95/46/EC (2) and Regulation (EC) No 45/2001 (3). |
| --- | --- |

(6)

For the implementation of this Regulation, and in order to ensure maximum legal certainty within the Union, the names and other relevant data concerning natural and legal persons, entities and bodies whose funds and economic resources must be frozen in accordance with this Regulation, must be made public. Any processing of personal data should comply with Directive 95/46/EC (2) and Regulation (EC) No 45/2001 (3).

| (7) | In order to ensure that the measures provided for in this Regulation are effective, it should enter into force immediately upon its publication, |
| --- | --- |

(7)

In order to ensure that the measures provided for in this Regulation are effective, it should enter into force immediately upon its publication,

HAS ADOPTED THIS REGULATION:

Article 1

For the purposes of this Regulation, the following definitions shall apply:

| (a) | ‘claim’ means any claim, whether asserted by legal proceedings or not, made before or after the date of entry into force of this Regulation, under or in connection with a contract or transaction, and includes in particular:






  (i) | a claim for performance of any obligation arising under or in connection with a contract or transaction; |
| --- | --- | --- |

(a)

‘claim’ means any claim, whether asserted by legal proceedings or not, made before or after the date of entry into force of this Regulation, under or in connection with a contract or transaction, and includes in particular:

(i)

a claim for performance of any obligation arising under or in connection with a contract or transaction;

| (ii) | a claim for extension or payment of a bond, financial guarantee or indemnity of whatever form; |
| --- | --- |

(ii)

a claim for extension or payment of a bond, financial guarantee or indemnity of whatever form;

| (iii) | a claim for compensation in respect of a contract or transaction; |
| --- | --- |

(iii)

a claim for compensation in respect of a contract or transaction;

| (iv) | a counterclaim; |
| --- | --- |

(iv)

a counterclaim;

| (v) | a claim for the recognition or enforcement, including by the procedure of exequatur, of a judgment, an arbitration award or an equivalent decision, wherever made or given; |
| --- | --- |

(v)

a claim for the recognition or enforcement, including by the procedure of exequatur, of a judgment, an arbitration award or an equivalent decision, wherever made or given;

| (b) | ‘contract or transaction’ means any transaction of whatever form and whatever the applicable law, whether comprising one or more contracts or similar obligations made between the same or different parties; for this purpose ‘contract’ includes a bond, guarantee or indemnity, particularly a financial guarantee or financial indemnity, and credit, whether legally independent or not, as well as any related provision arising under, or in connection with, the transaction; |
| --- | --- |

(b)

‘contract or transaction’ means any transaction of whatever form and whatever the applicable law, whether comprising one or more contracts or similar obligations made between the same or different parties; for this purpose ‘contract’ includes a bond, guarantee or indemnity, particularly a financial guarantee or financial indemnity, and credit, whether legally independent or not, as well as any related provision arising under, or in connection with, the transaction;

| (c) | ‘competent authorities’ refers to the competent authorities of the Member States as identified on the websites listed in Annex II; |
| --- | --- |

(c)

‘competent authorities’ refers to the competent authorities of the Member States as identified on the websites listed in Annex II;

| (d) | ‘economic resources’ means assets of every kind, whether tangible or intangible, movable or immovable, which are not funds, but may be used to obtain funds, goods or services; |
| --- | --- |

(d)

‘economic resources’ means assets of every kind, whether tangible or intangible, movable or immovable, which are not funds, but may be used to obtain funds, goods or services;

| (e) | ‘freezing of economic resources’ means preventing the use of economic resources to obtain funds, goods or services in any way, including, but not limited to, by selling, hiring or mortgaging them; |
| --- | --- |

(e)

‘freezing of economic resources’ means preventing the use of economic resources to obtain funds, goods or services in any way, including, but not limited to, by selling, hiring or mortgaging them;

| (f) | ‘freezing of funds’ means preventing any move, transfer, alteration, use of, access to, or dealing with funds in any way that would result in any change in their volume, amount, location, ownership, possession, character, destination or other change that would enable the funds to be used, including portfolio management; |
| --- | --- |

(f)

‘freezing of funds’ means preventing any move, transfer, alteration, use of, access to, or dealing with funds in any way that would result in any change in their volume, amount, location, ownership, possession, character, destination or other change that would enable the funds to be used, including portfolio management;

| (g) | ‘funds’ means financial assets and benefits of every kind, including, but not limited to:






  (i) | cash, cheques, claims on money, drafts, money orders and other payment instruments; |
| --- | --- | --- |

(g)

‘funds’ means financial assets and benefits of every kind, including, but not limited to:

(i)

cash, cheques, claims on money, drafts, money orders and other payment instruments;

| (ii) | deposits with financial institutions or other entities, balances on accounts, debts and debt obligations; |
| --- | --- |

(ii)

deposits with financial institutions or other entities, balances on accounts, debts and debt obligations;

| (iii) | publicly- and privately-traded securities and debt instruments, including stocks and shares, certificates representing securities, bonds, notes, warrants, debentures and derivatives contracts; |
| --- | --- |

(iii)

publicly- and privately-traded securities and debt instruments, including stocks and shares, certificates representing securities, bonds, notes, warrants, debentures and derivatives contracts;

| (iv) | interest, dividends or other income on or value accruing from or generated by assets; |
| --- | --- |

(iv)

interest, dividends or other income on or value accruing from or generated by assets;

| (v) | credit, right of set-off, guarantees, performance bonds or other financial commitments; |
| --- | --- |

(v)

credit, right of set-off, guarantees, performance bonds or other financial commitments;

| (vi) | letters of credit, bills of lading, bills of sale; and |
| --- | --- |

(vi)

letters of credit, bills of lading, bills of sale; and

| (vii) | documents showing evidence of an interest in funds or financial resources; |
| --- | --- |

(vii)

documents showing evidence of an interest in funds or financial resources;

| (h) | ‘territory of the Union’ means the territories of the Member States to which the Treaty is applicable, under the conditions laid down in the Treaty, including their airspace. |
| --- | --- |

(h)

‘territory of the Union’ means the territories of the Member States to which the Treaty is applicable, under the conditions laid down in the Treaty, including their airspace.

Article 2

1.   All funds and economic resources belonging to, owned, held or controlled by any natural or legal person, entity or body as listed in Annex I shall be frozen.

2.   No funds or economic resources shall be made available, directly or indirectly, to or for the benefit of natural or legal persons, entities or bodies listed in Annex I.

3.   Annex I shall include natural or legal persons, entities and bodies which, in accordance with Article 2(1) of Council Decision (CFSP) 2015/1763, have been identified by the Council as:

| (a) | undermining democracy or obstructing the search for a political solution in Burundi, including by acts of violence, repression or inciting violence; |
| --- | --- |

(a)

undermining democracy or obstructing the search for a political solution in Burundi, including by acts of violence, repression or inciting violence;

| (b) | being involved in planning, directing, or committing acts that violate international human rights law or international humanitarian law, as applicable, or that constitute serious human rights abuses, in Burundi; and |
| --- | --- |

(b)

being involved in planning, directing, or committing acts that violate international human rights law or international humanitarian law, as applicable, or that constitute serious human rights abuses, in Burundi; and

| (c) | associated with the persons, entities or bodies referred to in points (a) and (b). |
| --- | --- |

(c)

associated with the persons, entities or bodies referred to in points (a) and (b).

Article 3

1.   By way of derogation from Article 2, the competent authorities of the Member States may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the funds or economic resources concerned are:

| (a) | necessary to satisfy the basic needs of natural or legal persons listed in Annex I and dependent family members of such natural persons, including payments for foodstuffs, rent or mortgage, medicines and medical treatment, taxes, insurance premiums, and public utility charges; |
| --- | --- |

(a)

necessary to satisfy the basic needs of natural or legal persons listed in Annex I and dependent family members of such natural persons, including payments for foodstuffs, rent or mortgage, medicines and medical treatment, taxes, insurance premiums, and public utility charges;

| (b) | intended exclusively for payment of reasonable professional fees or reimbursement of incurred expenses associated with the provision of legal services; |
| --- | --- |

(b)

intended exclusively for payment of reasonable professional fees or reimbursement of incurred expenses associated with the provision of legal services;

| (c) | intended exclusively for payment of fees or service charges for routine holding or maintenance of frozen funds or economic resources; or |
| --- | --- |

(c)

intended exclusively for payment of fees or service charges for routine holding or maintenance of frozen funds or economic resources; or

| (d) | necessary for extraordinary expenses, provided that the relevant competent authority has notified the competent authorities of the other Member States and the Commission of the grounds on which it considers that a specific authorisation should be granted, at least two weeks prior to authorisation. |
| --- | --- |

(d)

necessary for extraordinary expenses, provided that the relevant competent authority has notified the competent authorities of the other Member States and the Commission of the grounds on which it considers that a specific authorisation should be granted, at least two weeks prior to authorisation.

2.   The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under paragraph 1.

Article 4

1.   By way of derogation from Article 2(1), the competent authorities of the Member States may authorise the release of certain frozen funds or economic resources, if the following conditions are met:

| (a) | the funds or economic resources are subject to an arbitral decision rendered prior to the date on which the natural or legal person, entity or body referred to in Article 2 was listed in Annex I, or of a judicial or administrative decision rendered in the Union, or a judicial decision enforceable in the Member State concerned, prior to or after that date; |
| --- | --- |

(a)

the funds or economic resources are subject to an arbitral decision rendered prior to the date on which the natural or legal person, entity or body referred to in Article 2 was listed in Annex I, or of a judicial or administrative decision rendered in the Union, or a judicial decision enforceable in the Member State concerned, prior to or after that date;

| (b) | the funds or economic resources will be used exclusively to satisfy claims secured by such a decision or recognised as valid in such a decision, within the limits set by applicable laws and regulations governing the rights of persons having such claims; |
| --- | --- |

(b)

the funds or economic resources will be used exclusively to satisfy claims secured by such a decision or recognised as valid in such a decision, within the limits set by applicable laws and regulations governing the rights of persons having such claims;

| (c) | the decision is not for the benefit of a natural or legal person, entity or body listed in Annex I; and |
| --- | --- |

(c)

the decision is not for the benefit of a natural or legal person, entity or body listed in Annex I; and

| (d) | recognising the decision is not contrary to public policy in the Member State concerned. |
| --- | --- |

(d)

recognising the decision is not contrary to public policy in the Member State concerned.

2.   The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under paragraph 1.

Article 5

1.   By way of derogation from Article 2(1) and provided that a payment by a natural or legal person, entity or body listed in Annex I is due under a contract or agreement that was concluded by, or an obligation that arose for, the natural or legal person, entity or body concerned before the date on which that natural or legal person, entity or body was included in Annex I, the competent authorities of the Member States may authorise, under such conditions as they deem appropriate, the release of certain frozen funds or economic resources, provided that the competent authority concerned has determined that:

| (a) | the funds or economic resources will be used for a payment by a natural or legal person, entity or body listed in Annex I; and |
| --- | --- |

(a)

the funds or economic resources will be used for a payment by a natural or legal person, entity or body listed in Annex I; and

| (b) | the payment is not in breach of Article 2(2). |
| --- | --- |

(b)

the payment is not in breach of Article 2(2).

2.   The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under paragraph 1.

Article 6

1.   Article 2(2) shall not prevent the crediting of the frozen accounts by financial or credit institutions that receive funds transferred by third parties onto the account of a listed natural or legal person, entity or body, provided that any additions to such accounts will also be frozen. The financial or credit institution shall inform the relevant competent authority about any such transaction without delay.

2.   Article 2(2) shall not apply to the addition to frozen accounts of:

| (a) | interest or other earnings on those accounts; |
| --- | --- |

(a)

interest or other earnings on those accounts;

| (b) | payments due under contracts, agreements or obligations that were concluded or arose before the date on which the natural or legal person, entity or body referred to in Article 2 was included in Annex I; or |
| --- | --- |

(b)

payments due under contracts, agreements or obligations that were concluded or arose before the date on which the natural or legal person, entity or body referred to in Article 2 was included in Annex I; or

| (c) | payments due under judicial, administrative or arbitral decisions rendered in a Member State or enforceable in the Member State concerned; |
| --- | --- |

(c)

payments due under judicial, administrative or arbitral decisions rendered in a Member State or enforceable in the Member State concerned;

provided that any such interest, other earnings and payments are frozen in accordance with Article 2(1).

Article 7

1.   Without prejudice to the applicable rules concerning reporting, confidentiality and professional secrecy, natural and legal persons, entities and bodies shall:

| (a) | supply immediately any information which would facilitate compliance with this Regulation, such as information on accounts and amounts frozen in accordance with Article 2, to the competent authority of the Member State where they are resident or located, and shall transmit such information, directly or through the Member State, to the Commission; and |
| --- | --- |

(a)

supply immediately any information which would facilitate compliance with this Regulation, such as information on accounts and amounts frozen in accordance with Article 2, to the competent authority of the Member State where they are resident or located, and shall transmit such information, directly or through the Member State, to the Commission; and

| (b) | cooperate with the competent authority in any verification of this information. |
| --- | --- |

(b)

cooperate with the competent authority in any verification of this information.

2.   Any additional information received directly by the Commission shall be made available to the Member States.

3.   Any information provided or received in accordance with this Article shall be used only for the purposes for which it was provided or received.

Article 8

It shall be prohibited to participate, knowingly and intentionally, in activities the object or effect of which is to circumvent the measures referred to in Article 2.

Article 9

1.   The freezing of funds and economic resources or the refusal to make funds or economic resources available, carried out in good faith on the basis that such action is in accordance with this Regulation, shall not give rise to liability of any kind on the part of the natural or legal person or entity or body implementing it, or its directors or employees, unless it is proved that the funds and economic resources were frozen or withheld as a result of negligence.

2.   Actions by natural or legal persons, entities or bodies shall not give rise to any liability of any kind on their part if they did not know, and had no reasonable cause to suspect, that their actions would infringe the measures set out in this Regulation.

Article 10

1.   No claims in connection with any contract or transaction the performance of which has been affected, directly or indirectly, in whole or in part, by the measures imposed under this Regulation, including claims for indemnity or any other claim of this type, such as a claim for compensation or a claim under a guarantee, notably a claim for extension or payment of a bond, guarantee or indemnity, particularly a financial guarantee or financial indemnity, of whatever form, shall be satisfied, if they are made by:

| (a) | designated natural or legal persons, entities or bodies listed in Annex I; |
| --- | --- |

(a)

designated natural or legal persons, entities or bodies listed in Annex I;

| (b) | any natural or legal person, entity or body acting through or on behalf of one of the persons, entities or bodies referred to in point (a). |
| --- | --- |

(b)

any natural or legal person, entity or body acting through or on behalf of one of the persons, entities or bodies referred to in point (a).

2.   In any proceedings for the enforcement of a claim, the onus of proving that satisfying the claim is not prohibited by paragraph 1 shall be on the natural or legal person, entity or body seeking the enforcement of that claim.

3.   This Article is without prejudice to the right of the natural or legal persons, entities and bodies referred to in paragraph 1 to judicial review of the legality of the non-performance of contractual obligations in accordance with this Regulation.

Article 11

1.   The Commission and Member States shall inform each other of the measures taken under this Regulation and share any other relevant information at their disposal in connection with this Regulation, in particular information:

| (a) | in respect of funds frozen under Article 2 and authorisations granted under Articles 3, 4 and 5; |
| --- | --- |

(a)

in respect of funds frozen under Article 2 and authorisations granted under Articles 3, 4 and 5;

| (b) | in respect of violation and enforcement problems and judgments handed down by national courts. |
| --- | --- |

(b)

in respect of violation and enforcement problems and judgments handed down by national courts.

2.   The Member States shall immediately inform each other and the Commission of any other relevant information at their disposal which might affect the effective implementation of this Regulation.

Article 12

The Commission shall be empowered to amend Annex II on the basis of information supplied by Member States.

Article 13

1.   Where the Council decides to subject a natural or legal person, entity or body to the measures referred to in Article 2(1), it shall amend Annex I accordingly.

2.   The Council shall communicate its decision, including the grounds for listing, to the natural or legal person, entity or body referred to in paragraph 1, either directly, if the address is known, or through the publication of a notice, providing such natural or legal person, entity or body with an opportunity to present observations.

3.   Where observations are submitted, or where substantial new evidence is presented, the Council shall review its decision and inform the natural or legal person, entity or body accordingly.

4.   The list in Annex I shall be reviewed at regular intervals and at least every 12 months.

Article 14

1.   Annex I shall include the grounds for the listing of natural or legal persons, entities or bodies concerned.

2.   Annex I shall include, where available, information necessary to identify the natural or legal persons, entities or bodies concerned. With regard to natural persons, such information may include names including aliases, date and place of birth, nationality, passport and ID card numbers, gender, address, if known, and function or profession. With regard to legal persons, entities and bodies, such information may include names, place and date of registration, registration number and place of business.

Article 15

1.   Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.

2.   Member States shall notify those rules to the Commission without delay after the entry into force of this Regulation and shall notify it of any subsequent amendment.

Article 16

1.   Member States shall designate the competent authorities referred to in this Regulation and identify them on the websites listed in Annex II. Member States shall notify the Commission of any changes in the addresses of their websites listed in Annex II.

2.   Member States shall notify the Commission of their competent authorities, including the contact details of those competent authorities, without delay after the entry into force of this Regulation, and shall notify it of any subsequent amendment.

3.   Where this Regulation sets out a requirement to notify, inform or otherwise communicate with the Commission, the address and other contact details to be used for such communication shall be those indicated in Annex II.

Article 17

This Regulation shall apply:

| (a) | within the territory of the Union, including its airspace; |
| --- | --- |

(a)

within the territory of the Union, including its airspace;

| (b) | on board of any aircraft or any vessel under the jurisdiction of a Member State; |
| --- | --- |

(b)

on board of any aircraft or any vessel under the jurisdiction of a Member State;

| (c) | to any natural person inside or outside the territory of the Union who is a national of a Member State; |
| --- | --- |

(c)

to any natural person inside or outside the territory of the Union who is a national of a Member State;

| (d) | to any legal person, entity or body, inside or outside the territory of the Union, which is incorporated or constituted under the law of a Member State; |
| --- | --- |

(d)

to any legal person, entity or body, inside or outside the territory of the Union, which is incorporated or constituted under the law of a Member State;

| (e) | to any legal person, entity or body in respect of any business done in whole or in part within the Union. |
| --- | --- |

(e)

to any legal person, entity or body in respect of any business done in whole or in part within the Union.

Article 18

This Regulation shall enter into force on the date 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 Luxembourg, 1 October 2015.

For the Council

The President

E. SCHNEIDER

---

(1)  See page 37 of this Official Journal.

1

(2)  Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).

2

(3)  Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).

3

---

ANNEX I

List of natural and legal persons, entities and bodies referred to in Article 2

| | Name | Identifying information | Grounds for designation |
| --- | --- | --- | --- |
| 1. | Godefroid BIZIMANA | DOB: 23.4.1968
  POB: NYAGASEKE, MABAYI, CIBITOKE
  Burundian nationality. Passport number: DP0001520 | Deputy Director-General of the National Police, responsible for undermining democracy by making operational decisions that have led to a disproportionate use of force and acts of violent repression towards peaceful demonstrations that started on 26 April 2015 following the announcement of the presidential candidacy of President Nkurunziza. |
| 2. | Gervais NDIRAKOBUCA alias NDAKUGARIKA | DOB: 1.8.1970
  Burundian nationality. Passport number: DP0000761 | Head of Cabinet of the Presidential Administration (Présidence) responsible for matters relating to the National Police. Responsible for obstructing the search for a political solution in Burundi by issuing instructions that led to disproportionate use of force, acts of violence, acts of repression and violations of international human rights law against protestors demonstrating from 26 April 2015 onwards, following the announcement of the presidential candidacy of President Nkurunziza, including on 26, 27 and 28 April in the Nyakabiga and Musaga districts in Bujumbura. |
| 3. | Mathias/Joseph NIYONZIMA alias KAZUNGU | Registration number (SNR): O/00064
  Burundian nationality. Passport number: OP0053090 | Officer of the National Intelligence Service. Responsible for obstructing the search for a political solution in Burundi by inciting violence and acts of repression during the demonstrations that started on 26 April 2015 following the announcement of the presidential candidacy of President Nkurunziza. Responsible for helping train, coordinate and arm the Imbonerakure paramilitary militias, including outside Burundi, who are responsible for acts of violence, repression and serious human rights abuses in Burundi. |
| 4. | Léonard NGENDAKUMANA | DOB: 24.11.1968
  Burundian nationality. Passport number: DP0000885 | Former ‘Chargé de Missions de la Présidence’ and former army general. Responsible for obstructing the search for a political solution in Burundi by participating in the attempted coup d'état of 13 May 2015 to overthrow the Burundi Government. Responsible for acts of violence — grenade attacks — committed in Burundi, as well as for incitement to violence. General Léonard Ngendakumana publicly supported violence as a means to achieve political goals. |

Name

Identifying information

Grounds for designation

1.

Godefroid BIZIMANA

DOB: 23.4.1968

POB: NYAGASEKE, MABAYI, CIBITOKE

Burundian nationality. Passport number: DP0001520

Deputy Director-General of the National Police, responsible for undermining democracy by making operational decisions that have led to a disproportionate use of force and acts of violent repression towards peaceful demonstrations that started on 26 April 2015 following the announcement of the presidential candidacy of President Nkurunziza.

2.

Gervais NDIRAKOBUCA alias NDAKUGARIKA

DOB: 1.8.1970

Burundian nationality. Passport number: DP0000761

Head of Cabinet of the Presidential Administration (Présidence) responsible for matters relating to the National Police. Responsible for obstructing the search for a political solution in Burundi by issuing instructions that led to disproportionate use of force, acts of violence, acts of repression and violations of international human rights law against protestors demonstrating from 26 April 2015 onwards, following the announcement of the presidential candidacy of President Nkurunziza, including on 26, 27 and 28 April in the Nyakabiga and Musaga districts in Bujumbura.

3.

Mathias/Joseph NIYONZIMA alias KAZUNGU

Registration number (SNR): O/00064

Burundian nationality. Passport number: OP0053090

Officer of the National Intelligence Service. Responsible for obstructing the search for a political solution in Burundi by inciting violence and acts of repression during the demonstrations that started on 26 April 2015 following the announcement of the presidential candidacy of President Nkurunziza. Responsible for helping train, coordinate and arm the Imbonerakure paramilitary militias, including outside Burundi, who are responsible for acts of violence, repression and serious human rights abuses in Burundi.

4.

Léonard NGENDAKUMANA

DOB: 24.11.1968

Burundian nationality. Passport number: DP0000885

Former ‘Chargé de Missions de la Présidence’ and former army general. Responsible for obstructing the search for a political solution in Burundi by participating in the attempted coup d'état of 13 May 2015 to overthrow the Burundi Government. Responsible for acts of violence — grenade attacks — committed in Burundi, as well as for incitement to violence. General Léonard Ngendakumana publicly supported violence as a means to achieve political goals.

---

ANNEX II

Websites for information on the competent authorities and address for notification to the European Commission

BELGIUM

http://www.diplomatie.be/eusanctions

BULGARIA

http://www.mfa.bg/en/pages/135/index.html

CZECH REPUBLIC

http://www.mfcr.cz/mezinarodnisankce

DENMARK

http://um.dk/da/politik-og-diplomati/retsorden/sanktioner/

GERMANY

http://www.bmwi.de/DE/Themen/Aussenwirtschaft/aussenwirtschaftsrecht,did=404888.html

ESTONIA

http://www.vm.ee/est/kat_622/

IRELAND

http://www.dfa.ie/home/index.aspx?id=28519

GREECE

http://www.mfa.gr/en/foreign-policy/global-issues/international-sanctions.html

SPAIN

http://www.exteriores.gob.es/Portal/es/PoliticaExteriorCooperacion/GlobalizacionOportunidadesRiesgos/Documents/ORGANISMOS%20COMPETENTES%20SANCIONES%20INTERNACIONALES.pdf

FRANCE

http://www.diplomatie.gouv.fr/autorites-sanctions/

CROATIA

http://www.mvep.hr/sankcije

ITALY

http://www.esteri.it/MAE/IT/Politica_Europea/Deroghe.htm

CYPRUS

http://www.mfa.gov.cy/sanctions

LATVIA

http://www.mfa.gov.lv/en/security/4539

LITHUANIA

http://www.urm.lt/sanctions

LUXEMBOURG

http://www.mae.lu/sanctions

HUNGARY

http://2010-2014.kormany.hu/download/b/3b/70000/ENSZBT-ET-szankcios-tajekoztato.pdf

MALTA

https://www.gov.mt/en/Government/Government%20of%20Malta/Ministries%20and%20Entities/Officially%20Appointed%20Bodies/Pages/Boards/Sanctions-Monitoring-Board-.aspx

NETHERLANDS

http://www.rijksoverheid.nl/onderwerpen/internationale-sancties

AUSTRIA

http://www.bmeia.gv.at/view.php3?f_id=12750&LNG=en&version=

POLAND

http://www.msz.gov.pl

PORTUGAL

http://www.portugal.gov.pt/pt/os-ministerios/ministerio-dos-negocios-estrangeiros/quero-saber-mais/sobre-o-ministerio/medidas-restritivas/medidas-restritivas.aspx

ROMANIA

http://www.mae.ro/node/1548

SLOVENIA

http://www.mzz.gov.si/si/omejevalni_ukrepi

SLOVAKIA

http://www.mzv.sk/sk/europske_zalezitosti/europske_politiky-sankcie_eu

FINLAND

http://formin.finland.fi/kvyhteistyo/pakotteet

SWEDEN

http://www.ud.se/sanktioner

UNITED KINGDOM

https://www.gov.uk/sanctions-embargoes-and-restrictions

ADDRESS FOR NOTIFICATIONS TO THE EUROPEAN COMMISSION:

| European Commission |
| --- |
| Service for Foreign Policy Instruments (FPI) |
| EEAS 02/309 |
| 1049 Brussels |
| BELGIUM |

European Commission

Service for Foreign Policy Instruments (FPI)

EEAS 02/309

1049 Brussels

BELGIUM

E-mail: relex-sanctions@ec.europa.eu

---

| 2.10.2015 | EN | Official Journal of the European Union | L 257/11 |
| --- | --- | --- | --- |

2.10.2015

EN

Official Journal of the European Union

L 257/11

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1756

of 21 September 2015

entering a name in the register of protected designations of origin and protected geographical indications (Citron de Menton (PGI))

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:

| (1) | Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, France's application to register the name ‘Citron de Menton’ was published in the Official Journal of the European Union
   (2). |
| --- | --- |

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, France's application to register the name ‘Citron de Menton’ was published in the Official Journal of the European Union
   (2).

| (2) | As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Citron de Menton’ should therefore be entered in the register, |
| --- | --- |

(2)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Citron de Menton’ should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Citron de Menton’ (PGI) is hereby entered in the register.

The name specified in the first paragraph denotes a product in Class 1.6. Fruit, vegetables and cereals, fresh or processed, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

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, 21 September 2015.

For the Commission,

On behalf of the President,

Phil HOGAN

Member of the Commission

---

(1)  OJ L 343, 14.12.2012, p. 1.

1

(2)  OJ C 147, 5.5.2015, p. 11.

2

(3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).

3

---

| 2.10.2015 | EN | Official Journal of the European Union | L 257/12 |
| --- | --- | --- | --- |

2.10.2015

EN

Official Journal of the European Union

L 257/12

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1757

of 28 September 2015

approving folpet as an active substance for use in biocidal products for product-type 6

(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 90(2) thereof,

Whereas:

| (1) | Italy received on 13 July 2009 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council (2), for the inclusion of the active substance folpet in its Annex I for use in product-type 6, in-can preservatives, as defined in Annex V to that Directive, which correspond to product-type 6 as defined in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(1)

Italy received on 13 July 2009 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council (2), for the inclusion of the active substance folpet in its Annex I for use in product-type 6, in-can preservatives, as defined in Annex V to that Directive, which correspond to product-type 6 as defined in Annex V to Regulation (EU) No 528/2012.

| (2) | Italy submitted an assessment report, together with its recommendations, to the Commission on June 2011 in accordance with Article 11(2) of Directive 98/8/EC. |
| --- | --- |

(2)

Italy submitted an assessment report, together with its recommendations, to the Commission on June 2011 in accordance with Article 11(2) of Directive 98/8/EC.

| (3) | The opinion of the European Chemicals Agency was formulated on 17 June 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority. |
| --- | --- |

(3)

The opinion of the European Chemicals Agency was formulated on 17 June 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority.

| (4) | According to that opinion, biocidal products used for product-type 6 and containing folpet may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC provided that certain conditions concerning its use are satisfied. |
| --- | --- |

(4)

According to that opinion, biocidal products used for product-type 6 and containing folpet may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC provided that certain conditions concerning its use are satisfied.

| (5) | It is therefore appropriate to approve folpet for use in biocidal products for product-type 6 subject to compliance with the specific conditions in the Annex. |
| --- | --- |

(5)

It is therefore appropriate to approve folpet for use in biocidal products for product-type 6 subject to compliance with the specific conditions in the Annex.

| (6) | Since folpet meets the criteria for classification as skin sensitiser category 1 as defined in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3), treated articles treated with or incorporating folpet should be appropriately labelled when placed on the market. |
| --- | --- |

(6)

Since folpet meets the criteria for classification as skin sensitiser category 1 as defined in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3), treated articles treated with or incorporating folpet should be appropriately labelled when placed on the market.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(7)

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

Folpet is approved as an active substance for use in biocidal products for product-type 6, subject to the specifications and conditions set out in the Annex.

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, 28 September 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

2

(3)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

3

---

ANNEX

| Common Name | IUPAC Name
  Identification Numbers | Minimum degree of purity of the active substance (1) | Date of approval | Expiry date of approval | Product type | Specific conditions |
| --- | --- | --- | --- | --- | --- | --- |
| Folpet | IUPAC Name:
  N-(trichloromethylthio) phthalimide
  EC No: 205-088-6
  CAS No: 133-07-3 | 940 g/kg | 1 January 2016 | 31 December 2025 | 6 | The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
  The authorisations of biocidal products are subject to the following conditions.






  (1) | For industrial users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. |

Common Name

IUPAC Name

Identification Numbers

Minimum degree of purity of the active substance (1)

Date of approval

Expiry date of approval

Product type

Specific conditions

Folpet

IUPAC Name:

N-(trichloromethylthio) phthalimide

EC No: 205-088-6

CAS No: 133-07-3

940 g/kg

1 January 2016

31 December 2025

6

The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.

The authorisations of biocidal products are subject to the following conditions.

(1)

For industrial users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.

| (2) | In view of the risks to the soil compartment, labels and, where provided, safety data sheets of products shall indicate that measures shall be taken to protect the soil during the outdoor application of the preserved mixtures to prevent losses and minimise emissions to the environment, unless it can be demonstrated that risks can be reduced to an acceptable level by other means. |
| --- | --- |

(2)

In view of the risks to the soil compartment, labels and, where provided, safety data sheets of products shall indicate that measures shall be taken to protect the soil during the outdoor application of the preserved mixtures to prevent losses and minimise emissions to the environment, unless it can be demonstrated that risks can be reduced to an acceptable level by other means.

| (3) | In view of the risks to the soil compartment, products shall not be authorised for preservation of mixtures to be applied outdoor by spraying, unless it can be demonstrated that risks can be reduced to an acceptable level. |
| --- | --- |

(3)

In view of the risks to the soil compartment, products shall not be authorised for preservation of mixtures to be applied outdoor by spraying, unless it can be demonstrated that risks can be reduced to an acceptable level.

The placing on the market of treated articles is subject to the following condition.

The person responsible for the placing on the market of a treated article treated with or incorporating folpet shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

---

(1)  The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 11 of Directive 98/8/EC. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.

---

| 2.10.2015 | EN | Official Journal of the European Union | L 257/15 |
| --- | --- | --- | --- |

2.10.2015

EN

Official Journal of the European Union

L 257/15

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1758

of 28 September 2015

approving folpet as an existing active substance for use in biocidal products for product-types 7 and 9

(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 the third subparagraph of Article 89(1) thereof,

Whereas:

| (1) | Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. |
| --- | --- |

(1)

Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products.

| (2) | That list includes folpet. |
| --- | --- |

(2)

That list includes folpet.

| (3) | Folpet has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council (3) for use in product-type 7, film preservatives, and product-type 9, fibre, leather, rubber and polymerised materials preservatives, as defined in Annex V to that Directive, which correspond respectively to product-type 7 and 9, as defined in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(3)

Folpet has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council (3) for use in product-type 7, film preservatives, and product-type 9, fibre, leather, rubber and polymerised materials preservatives, as defined in Annex V to that Directive, which correspond respectively to product-type 7 and 9, as defined in Annex V to Regulation (EU) No 528/2012.

| (4) | Italy was designated as evaluating competent authority and submitted the assessment reports, together with its recommendations, to the Commission in June 2011 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007 (4). |
| --- | --- |

(4)

Italy was designated as evaluating competent authority and submitted the assessment reports, together with its recommendations, to the Commission in June 2011 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007 (4).

| (5) | In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 17 June 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating Competent Authority. |
| --- | --- |

(5)

In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 17 June 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating Competent Authority.

| (6) | According to those opinions, biocidal products used for product-types 7 and 9 and containing folpet may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC provided that certain conditions concerning its use are complied with. |
| --- | --- |

(6)

According to those opinions, biocidal products used for product-types 7 and 9 and containing folpet may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC provided that certain conditions concerning its use are complied with.

| (7) | It is therefore appropriate to approve folpet for use in biocidal products for product-types 7 and 9 subject to compliance with the specific conditions in the Annex. |
| --- | --- |

(7)

It is therefore appropriate to approve folpet for use in biocidal products for product-types 7 and 9 subject to compliance with the specific conditions in the Annex.

| (8) | Since folpet meets the criteria for classification as skin sensitiser category 1 as defined in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5), treated articles treated with or incorporating folpet should be appropriately labelled when placed on the market. |
| --- | --- |

(8)

Since folpet meets the criteria for classification as skin sensitiser category 1 as defined in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5), treated articles treated with or incorporating folpet should be appropriately labelled when placed on the market.

| (9) | A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. |
| --- | --- |

(9)

A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

| (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

Folpet is approved as an active substance for use in biocidal products for product-types 7 and 9, subject to the specifications and conditions set out in the Annex.

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, 28 September 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

2

(3)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

3

(4)  Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

4

(5)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

5

---

ANNEX

| Common Name | IUPAC Name
  Identification Numbers | Minimum degree of purity of the active substance (1) | Date of approval | Expiry date of approval | Product type | Specific conditions |
| --- | --- | --- | --- | --- | --- | --- |
| Folpet | IUPAC Name:
  N-(trichloromethylthio) phthalimide
  EC n°: 205-088-6
  CAS n°: 133-07-3 | 940 g/kg | 1 October 2016 | 30 September 2026 | 7 | The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.
  The authorisations of biocidal products are subject to the following conditions:






  (1) | For industrial users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. |

Common Name

IUPAC Name

Identification Numbers

Minimum degree of purity of the active substance (1)

Date of approval

Expiry date of approval

Product type

Specific conditions

Folpet

IUPAC Name:

N-(trichloromethylthio) phthalimide

EC n°: 205-088-6

CAS n°: 133-07-3

940 g/kg

1 October 2016

30 September 2026

7

The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.

The authorisations of biocidal products are subject to the following conditions:

(1)

For industrial users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.

| (2) | In view of the risks to the soil compartment, labels and, where provided, safety data sheets of products shall indicate that measures shall be taken to protect the soil during the outdoor application by brushing of the preserved mixtures to prevent losses and minimise emissions to the environment, unless it can be demonstrated that risks can be reduced to an acceptable level by other means. |
| --- | --- |

(2)

In view of the risks to the soil compartment, labels and, where provided, safety data sheets of products shall indicate that measures shall be taken to protect the soil during the outdoor application by brushing of the preserved mixtures to prevent losses and minimise emissions to the environment, unless it can be demonstrated that risks can be reduced to an acceptable level by other means.

| (3) | In view of the risks to the soil compartment, products shall not be authorised for preservation of mixtures to be applied outdoor by spraying, unless it can be demonstrated that risks can be reduced to an acceptable level. |
| --- | --- |

(3)

In view of the risks to the soil compartment, products shall not be authorised for preservation of mixtures to be applied outdoor by spraying, unless it can be demonstrated that risks can be reduced to an acceptable level.

The placing on the market of treated articles is subject to the following condition:

The person responsible for the placing on the market of a treated article treated with or incorporating folpet shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of the Regulation (EU) No 528/2012.

9

The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.

The authorisations of biocidal products are subject to the following condition:

For industrial users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.

The placing on the market of treated articles is subject to the following condition:

The person responsible for the placing on the market of a treated article treated with or incorporating folpet shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of the Regulation (EU) No 528/2012.

---

(1)  The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 16(2) of Directive 98/8/EC. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.

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| 2.10.2015 | EN | Official Journal of the European Union | L 257/19 |
| --- | --- | --- | --- |

2.10.2015

EN

Official Journal of the European Union

L 257/19

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1759

of 28 September 2015

approving glutaraldehyde as an existing active substance for use in biocidal products for product-types 2, 3, 4, 6, 11 and 12

(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 the third subparagraph of Article 89(1) thereof,

Whereas:

| (1) | Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. |
| --- | --- |

(1)

Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products.

| (2) | That list includes glutaraldehyde. |
| --- | --- |

(2)

That list includes glutaraldehyde.

| (3) | Glutaraldehyde has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council (3) for use in product-type 2, private area and public health area disinfectants and other biocidal products, product-type 3, veterinary hygiene biocidal products, product-type 4, food and feed area disinfectants, product-type 6, in-can preservatives, product-type 11, preservatives for liquid-cooling and processing systems, and product-type 12, slimicides, as defined in Annex V to that Directive, which correspond respectively to product-types 2, 3, 4, 6, 11 and 12 as defined in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(3)

Glutaraldehyde has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council (3) for use in product-type 2, private area and public health area disinfectants and other biocidal products, product-type 3, veterinary hygiene biocidal products, product-type 4, food and feed area disinfectants, product-type 6, in-can preservatives, product-type 11, preservatives for liquid-cooling and processing systems, and product-type 12, slimicides, as defined in Annex V to that Directive, which correspond respectively to product-types 2, 3, 4, 6, 11 and 12 as defined in Annex V to Regulation (EU) No 528/2012.

| (4) | Finland was designated as evaluating competent authority and submitted the assessment reports, together with its recommendations, to the Commission on 30 March 2011 and 31 January 2013 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007 (4). |
| --- | --- |

(4)

Finland was designated as evaluating competent authority and submitted the assessment reports, together with its recommendations, to the Commission on 30 March 2011 and 31 January 2013 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007 (4).

| (5) | In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 1 October 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority. |
| --- | --- |

(5)

In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 1 October 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority.

| (6) | According to those opinions, biocidal products used for product-types 2, 3, 4, 6, 11 and 12 and containing glutaraldehyde may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain conditions concerning its use are complied with. |
| --- | --- |

(6)

According to those opinions, biocidal products used for product-types 2, 3, 4, 6, 11 and 12 and containing glutaraldehyde may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain conditions concerning its use are complied with.

| (7) | It is therefore appropriate to approve glutaraldehyde for use in biocidal products for product-types 2, 3, 4, 6, 11 and 12 subject to compliance with the specific conditions in the Annex. |
| --- | --- |

(7)

It is therefore appropriate to approve glutaraldehyde for use in biocidal products for product-types 2, 3, 4, 6, 11 and 12 subject to compliance with the specific conditions in the Annex.

| (8) | The opinions conclude that glutaraldehyde meets the criteria for classification as a respiratory sensitiser as defined in point 3.4.1.1 of Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5). |
| --- | --- |

(8)

The opinions conclude that glutaraldehyde meets the criteria for classification as a respiratory sensitiser as defined in point 3.4.1.1 of Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5).

| (9) | Since, pursuant to Article 90(2) of Regulation (EU) No 528/2012, substances for which the Member States' evaluation has been completed by 1 September 2013 should be approved in accordance with Directive 98/8/EC, the period of approval should be 10 years, in accordance with the practice established under that Directive. |
| --- | --- |

(9)

Since, pursuant to Article 90(2) of Regulation (EU) No 528/2012, substances for which the Member States' evaluation has been completed by 1 September 2013 should be approved in accordance with Directive 98/8/EC, the period of approval should be 10 years, in accordance with the practice established under that Directive.

| (10) | For the purposes of Article 23 of Regulation (EU) No 528/2012 however, glutaraldehyde meets the conditions of Article 10(1)(b) of that Regulation and should therefore be considered a candidate for substitution. |
| --- | --- |

(10)

For the purposes of Article 23 of Regulation (EU) No 528/2012 however, glutaraldehyde meets the conditions of Article 10(1)(b) of that Regulation and should therefore be considered a candidate for substitution.

| (11) | For the use in product-type 4, the evaluation did not address the incorporation of biocidal products containing glutaraldehyde in materials and articles intended to come into contact directly or indirectly with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council (6). Such materials may require the establishment of specific limits on the migration into food, as referred to in Article 5(1)(e) of Regulation (EC) No 1935/2004. The approval should therefore not cover such use unless the Commission has established such limits or it has been established pursuant to that Regulation that such limits are not necessary. |
| --- | --- |

(11)

For the use in product-type 4, the evaluation did not address the incorporation of biocidal products containing glutaraldehyde in materials and articles intended to come into contact directly or indirectly with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council (6). Such materials may require the establishment of specific limits on the migration into food, as referred to in Article 5(1)(e) of Regulation (EC) No 1935/2004. The approval should therefore not cover such use unless the Commission has established such limits or it has been established pursuant to that Regulation that such limits are not necessary.

| (12) | Since glutaraldehyde meets the criteria for classification as respiratory sensitiser, and as skin sensitiser sub-category 1A as defined in Annex I to Regulation (EC) No 1272/2008, treated articles treated with or incorporating glutaraldehyde should be appropriately labelled when placed on the market. |
| --- | --- |

(12)

Since glutaraldehyde meets the criteria for classification as respiratory sensitiser, and as skin sensitiser sub-category 1A as defined in Annex I to Regulation (EC) No 1272/2008, treated articles treated with or incorporating glutaraldehyde should be appropriately labelled when placed on the market.

| (13) | A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. |
| --- | --- |

(13)

A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

| (14) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(14)

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

Glutaraldehyde is approved as an active substance for use in biocidal products for product-types 2, 3, 4, 6, 11 and 12, subject to the specifications and conditions set out in the Annex.

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, 28 September 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

2

(3)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

3

(4)  Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

4

(5)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

5

(6)  Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).

6

---

ANNEX

| Common Name | IUPAC Name
  Identification Numbers | Minimum degree of purity of the active substance (1) | Date of approval | Expiry date of approval | Product type | Specific conditions |
| --- | --- | --- | --- | --- | --- | --- |
| Glutaraldehyde | IUPAC Name:
  1,5-pentanedial
  EC No: 203-856-5
  CAS No: 111-30-8 | 950 g/kg dry weight (95 %) | 1 October 2016 | 30 September 2026 | 2 | Glutaraldehyde is considered a candidate for substitution in accordance with Article 10(1)(b) of Regulation (EU) No 528/2012.
  The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
  The authorisations of biocidal products are subject to the following conditions.






  (1) | For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. |

Common Name

IUPAC Name

Identification Numbers

Minimum degree of purity of the active substance (1)

Date of approval

Expiry date of approval

Product type

Specific conditions

Glutaraldehyde

IUPAC Name:

1,5-pentanedial

EC No: 203-856-5

CAS No: 111-30-8

950 g/kg dry weight (95 %)

1 October 2016

30 September 2026

2

Glutaraldehyde is considered a candidate for substitution in accordance with Article 10(1)(b) of Regulation (EU) No 528/2012.

The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.

The authorisations of biocidal products are subject to the following conditions.

(1)

For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.

| (2) | In view of the risks to professional users, products cannot be applied by wiping unless it can be demonstrated that risks can be reduced to an acceptable level. |
| --- | --- |

(2)

In view of the risks to professional users, products cannot be applied by wiping unless it can be demonstrated that risks can be reduced to an acceptable level.

The placing on the market of treated articles is subject to the following condition.

The person responsible for the placing on the market of a treated article treated with or incorporating glutaraldehyde shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

3

Glutaraldehyde is considered a candidate for substitution in accordance with Article 10(1)(b) of Regulation (EU) No 528/2012.

The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.

The authorisations of biocidal products are subject to the following conditions.

| (1) | For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. |
| --- | --- |

(1)

For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.

| (2) | Application by fogging shall be restricted to trained professionals. |
| --- | --- |

(2)

Application by fogging shall be restricted to trained professionals.

| (3) | For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (2) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (3) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. |
| --- | --- |

(3)

For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (2) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (3) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

The placing on the market of treated articles is subject to the following condition.

The person responsible for the placing on the market of a treated article treated with or incorporating glutaraldehyde shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

4

Glutaraldehyde is considered a candidate for substitution in accordance with Article 10(1)(b) of Regulation (EU) No 528/2012.

The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.

The authorisations of biocidal products are subject to the following conditions.

| (1) | For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. |
| --- | --- |

(1)

For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.

| (2) | For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. |
| --- | --- |

(2)

For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

| (3) | Products shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of glutaraldehyde into food or it has been established pursuant to that Regulation that such limits are not necessary. |
| --- | --- |

(3)

Products shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of glutaraldehyde into food or it has been established pursuant to that Regulation that such limits are not necessary.

The placing on the market of treated articles is subject to the following condition.

The person responsible for the placing on the market of a treated article treated with or incorporating glutaraldehyde shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

6

Glutaraldehyde is considered a candidate for substitution in accordance with Article 10(1)(b) of Regulation (EU) No 528/2012.

The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.

The authorisations of biocidal products are subject to the following conditions.

| (1) | For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. |
| --- | --- |

(1)

For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.

| (2) | In view of the risks to human health, products intended for non-professional users shall not contain glutaraldehyde at a concentration triggering classification as skin sensitiser, unless exposure can be reduced to an acceptable level by other means than the wearing of personal protective equipment. |
| --- | --- |

(2)

In view of the risks to human health, products intended for non-professional users shall not contain glutaraldehyde at a concentration triggering classification as skin sensitiser, unless exposure can be reduced to an acceptable level by other means than the wearing of personal protective equipment.

| (3) | In view of the risks to the environment, products shall not be authorised for preservation of drilling and cementing fluids unless it can be demonstrated that risks can be reduced to an acceptable level. |
| --- | --- |

(3)

In view of the risks to the environment, products shall not be authorised for preservation of drilling and cementing fluids unless it can be demonstrated that risks can be reduced to an acceptable level.

The placing on the market of treated articles is subject to the following conditions.

| (1) | Mixtures treated with or incorporating glutaraldehyde shall not contain glutaraldehyde at a concentration triggering classification as skin sensitiser, unless exposure can be reduced to an acceptable level by other means than the wearing of personal protective equipment. |
| --- | --- |

(1)

Mixtures treated with or incorporating glutaraldehyde shall not contain glutaraldehyde at a concentration triggering classification as skin sensitiser, unless exposure can be reduced to an acceptable level by other means than the wearing of personal protective equipment.

| (2) | The person responsible for the placing on the market of a treated article treated with or incorporating glutaraldehyde shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. |
| --- | --- |

(2)

The person responsible for the placing on the market of a treated article treated with or incorporating glutaraldehyde shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

11

Glutaraldehyde is considered a candidate for substitution in accordance with Article 10(1)(b) of Regulation (EU) No 528/2012.

The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.

The authorisations of biocidal products are subject to the following conditions.

| (1) | For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. |
| --- | --- |

(1)

For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.

| (2) | In view of the risks to the soil and surface water, products shall not be authorised for use in small open recirculating cooling systems, unless it can be demonstrated that risks can be reduced to an acceptable level. |
| --- | --- |

(2)

In view of the risks to the soil and surface water, products shall not be authorised for use in small open recirculating cooling systems, unless it can be demonstrated that risks can be reduced to an acceptable level.

| (3) | In view of the risks to the environment, products shall not be authorised for preservation of hydrotesting water unless it can be demonstrated that risks can be reduced to an acceptable level. |
| --- | --- |

(3)

In view of the risks to the environment, products shall not be authorised for preservation of hydrotesting water unless it can be demonstrated that risks can be reduced to an acceptable level.

The placing on the market of treated articles is subject to the following condition.

The person responsible for the placing on the market of a treated article treated with or incorporating glutaraldehyde shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

12

Glutaraldehyde is considered a candidate for substitution in accordance with Article 10(1)(b) of Regulation (EU) No 528/2012.

The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.

The authorisations of biocidal products are subject to the following conditions.

| (1) | For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. |
| --- | --- |

(1)

For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.

| (2) | In view of the risks to the environment, products shall not be authorised for use in pulp or paper mills which are not connected to a wastewater treatment plant unless it can be demonstrated that risks can be reduced to an acceptable level. |
| --- | --- |

(2)

In view of the risks to the environment, products shall not be authorised for use in pulp or paper mills which are not connected to a wastewater treatment plant unless it can be demonstrated that risks can be reduced to an acceptable level.

The placing on the market of treated articles is subject to the following condition.

The person responsible for the placing on the market of a treated article treated with or incorporating glutaraldehyde shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

---

(1)  The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 16(2) of Directive 98/8/EC. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.

(2)  Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

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

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| 2.10.2015 | EN | Official Journal of the European Union | L 257/27 |
| --- | --- | --- | --- |

2.10.2015

EN

Official Journal of the European Union

L 257/27

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COMMISSION REGULATION (EU) 2015/1760

of 1 October 2015

amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of the flavouring substance p-mentha-1,8-dien-7-al

(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 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (1), and in particular Article 11(3) thereof,

Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2), and in particular Article 7(6) thereof,

Whereas:

| (1) | Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use. |
| --- | --- |

(1)

Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use.

| (2) | Commission Implementing Regulation (EU) No 872/2012 (3) adopted a list of flavouring substances and introduced that list in Part A of Annex I to Regulation (EC) No 1334/2008. |
| --- | --- |

(2)

Commission Implementing Regulation (EU) No 872/2012 (3) adopted a list of flavouring substances and introduced that list in Part A of Annex I to Regulation (EC) No 1334/2008.

| (3) | That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application submitted by a Member State or by an interested party. |
| --- | --- |

(3)

That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application submitted by a Member State or by an interested party.

| (4) | The flavouring substance p-mentha-1,8-dien-7-al (FL-no 05.117) is included in the list as a flavouring substance under evaluation for which additional scientific data must be submitted. Such data has been submitted by the applicant. |
| --- | --- |

(4)

The flavouring substance p-mentha-1,8-dien-7-al (FL-no 05.117) is included in the list as a flavouring substance under evaluation for which additional scientific data must be submitted. Such data has been submitted by the applicant.

| (5) | The European Food Safety Authority evaluated the submitted data and concluded in its scientific opinion of 24 June 2015 (4) that p-mentha-1,8-dien-7-al (FL-no 05.117) is genotoxic in vivo and therefore its use as a flavouring substance raises a safety concern. |
| --- | --- |

(5)

The European Food Safety Authority evaluated the submitted data and concluded in its scientific opinion of 24 June 2015 (4) that p-mentha-1,8-dien-7-al (FL-no 05.117) is genotoxic in vivo and therefore its use as a flavouring substance raises a safety concern.

| (6) | The substance p-mentha-1,8-dien-7-al (FL-no 05.117) occurs naturally in the peel of fruits from some plants from the genera Perilla, Citrus and others. |
| --- | --- |

(6)

The substance p-mentha-1,8-dien-7-al (FL-no 05.117) occurs naturally in the peel of fruits from some plants from the genera Perilla, Citrus and others.

| (7) | Accordingly the use of p-mentha-1,8-dien-7-al (FL-no 05.117) does not comply with the general conditions of use for flavourings set out in Article 4(a) of Regulation (EC) No 1334/2008. Consequently, that substance should be removed from the list without delay in order to protect human health. |
| --- | --- |

(7)

Accordingly the use of p-mentha-1,8-dien-7-al (FL-no 05.117) does not comply with the general conditions of use for flavourings set out in Article 4(a) of Regulation (EC) No 1334/2008. Consequently, that substance should be removed from the list without delay in order to protect human health.

| (8) | The Commission should use the urgency procedure for the removal of a substance which raises a safety concern from the Union list. |
| --- | --- |

(8)

The Commission should use the urgency procedure for the removal of a substance which raises a safety concern from the Union list.

| (9) | Due to low use levels and the low total amount that p-mentha-1,8-dien-7-al (FL-no 05.117) has been added to foods in the Union, the presence of that substance in food does not raise immediate safety concerns. Therefore, taking into account also technical reasons, transitional periods should be laid down to cover food containing the flavouring substance p-mentha-1,8-dien-7-al (FL-no 05.117), which has been placed on the market or dispatched from third countries for the Union, before the date of entry into force of this Regulation. |
| --- | --- |

(9)

Due to low use levels and the low total amount that p-mentha-1,8-dien-7-al (FL-no 05.117) has been added to foods in the Union, the presence of that substance in food does not raise immediate safety concerns. Therefore, taking into account also technical reasons, transitional periods should be laid down to cover food containing the flavouring substance p-mentha-1,8-dien-7-al (FL-no 05.117), which has been placed on the market or dispatched from third countries for the Union, before the date of entry into force of this Regulation.

| (10) | Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended accordingly. |
| --- | --- |

(10)

Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended accordingly.

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(11)

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

Part A of Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation.

Article 2

1.   Foods to which the flavouring substance p-mentha-1,8-dien-7-al (FL-no 05.117) has been added which were lawfully placed on the market before the date of entry into force of this Regulation may be marketed until their date of minimum durability or use by date.

2.   Foods imported into the Union to which the flavouring substance p-mentha-1,8-dien-7-al (FL-no 05.117) has been added may be marketed until their date of minimum durability or use by date where the importer of such food can demonstrate that they were dispatched from the third country concerned and were en route to the Union before the date of entry into force of this Regulation.

Article 3

This Regulation shall enter into force on the 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, 1 October 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 354, 31.12.2008, p. 34.

1

(2)  OJ L 354, 31.12.2008, p. 1.

2

(3)  Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC (OJ L 267, 2.10.2012, p. 1).

3

(4)  Scientific Opinion on Flavouring Group Evaluation 208 Revision 1 (FGE.208Rev1): Consideration of genotoxicity data on representatives for 10 alicyclic aldehydes with the α,β-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19. EFSA Journal 2015;13(7):4173, 28 pp. doi:10.2903/j.efsa.2015.4173 Available online: www.efsa.europa.eu/efsajournal

4

---

ANNEX

In Part A of Annex I to Regulation (EC) No 1334/2008, the following entry is deleted:

| ‘05.117 | p-Mentha-1,8-dien-7-al | 2111-75-3 | 973 | 11788 | | | 2 | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |

‘05.117

p-Mentha-1,8-dien-7-al

2111-75-3

973

11788

2

EFSA’

---

| 2.10.2015 | EN | Official Journal of the European Union | L 257/30 |
| --- | --- | --- | --- |

2.10.2015

EN

Official Journal of the European Union

L 257/30

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1761

of 1 October 2015

amending Commission Regulation (EC) No 378/2005 as regards the Community Reference Laboratory reports, fees and the laboratories listed in Annex II thereto

(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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular the first subparagraph of Article 7(4) and the third paragraph of Article 21 thereof,

After consulting the European Food Safety Authority,

Whereas:

| (1) | Regulation (EC) No 1831/2003 establishes the procedure for authorising the placing on the market and use of feed additives in animal nutrition. It provides that any person seeking authorisation for a feed additive or a new use of a feed additive is to submit an application for authorisation in accordance with that Regulation. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 establishes the procedure for authorising the placing on the market and use of feed additives in animal nutrition. It provides that any person seeking authorisation for a feed additive or a new use of a feed additive is to submit an application for authorisation in accordance with that Regulation.

| (2) | Commission Regulation (EC) No 378/2005 (2) lays down detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards applications for authorisation of a feed additive or for a new use of a feed additive and the duties and tasks of the Community Reference Laboratory (‘CRL’). |
| --- | --- |

(2)

Commission Regulation (EC) No 378/2005 (2) lays down detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards applications for authorisation of a feed additive or for a new use of a feed additive and the duties and tasks of the Community Reference Laboratory (‘CRL’).

| (3) | Article 5 of Regulation (EC) No 378/2005 provides that the CRL is to submit a full evaluation report to the European Food Safety Authority (‘the Authority’) for each application for authorisation of a feed additive. Exceptions to the requirement to submit an evaluation report are made for applications for a new use of a feed additive or applications for changing the terms of an existing authorisation, provided that the proposed conditions for the new use or for the change in the terms of the authorisation fall within the scope of the method of analysis previously submitted in accordance with the requirements laid down in Annex II to Commission Regulation (EC) No 429/2008 (3) and already evaluated. Furthermore, Article 4 of that Regulation provides that the CRL is to charge applicants fees for submitting applications for authorisation. Exception is made where no samples are required and the CRL does not need to issue a report, as the method of analysis has already been evaluated. However, applications for renewal of authorisations of feed additives do not benefit from those exceptions. |
| --- | --- |

(3)

Article 5 of Regulation (EC) No 378/2005 provides that the CRL is to submit a full evaluation report to the European Food Safety Authority (‘the Authority’) for each application for authorisation of a feed additive. Exceptions to the requirement to submit an evaluation report are made for applications for a new use of a feed additive or applications for changing the terms of an existing authorisation, provided that the proposed conditions for the new use or for the change in the terms of the authorisation fall within the scope of the method of analysis previously submitted in accordance with the requirements laid down in Annex II to Commission Regulation (EC) No 429/2008 (3) and already evaluated. Furthermore, Article 4 of that Regulation provides that the CRL is to charge applicants fees for submitting applications for authorisation. Exception is made where no samples are required and the CRL does not need to issue a report, as the method of analysis has already been evaluated. However, applications for renewal of authorisations of feed additives do not benefit from those exceptions.

| (4) | Experience has shown that the exceptions to the requirements concerning evaluation reports and submission fees should also be extended to the applications for renewal of authorisations of feed additives. Article 5 of and Annex IV to Regulation (EC) No 378/2005 should therefore be amended accordingly. |
| --- | --- |

(4)

Experience has shown that the exceptions to the requirements concerning evaluation reports and submission fees should also be extended to the applications for renewal of authorisations of feed additives. Article 5 of and Annex IV to Regulation (EC) No 378/2005 should therefore be amended accordingly.

| (5) | Annex II to Regulation (EC) No 378/2005 sets out a list of national reference laboratories assisting the CRL in its duties and tasks. Several Member States have informed the Commission that their national reference laboratories taking part in the consortium have changed because other laboratories have been designated for that purpose or the name or address of the laboratories have changed. Annex II to Regulation (EC) No 378/2005 should therefore be adapted accordingly. |
| --- | --- |

(5)

Annex II to Regulation (EC) No 378/2005 sets out a list of national reference laboratories assisting the CRL in its duties and tasks. Several Member States have informed the Commission that their national reference laboratories taking part in the consortium have changed because other laboratories have been designated for that purpose or the name or address of the laboratories have changed. Annex II to Regulation (EC) No 378/2005 should therefore be adapted accordingly.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(6)

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

Regulation (EC) No 378/2005 is amended as follows:

| (1) | Article 5(4) is replaced by the following:
  ‘4.   An evaluation report shall not be required for:






  (a) | applications for a new use of a feed additive submitted in accordance with Article 4(1) of Regulation (EC) No 1831/2003, when the proposed conditions for placing the feed additive on the market for the new use fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the CRL; |
| --- | --- | --- |

(1)

Article 5(4) is replaced by the following:

‘4.   An evaluation report shall not be required for:

(a)

applications for a new use of a feed additive submitted in accordance with Article 4(1) of Regulation (EC) No 1831/2003, when the proposed conditions for placing the feed additive on the market for the new use fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the CRL;

| (b) | applications for changing the terms of an existing authorisation submitted in accordance with Article 13(3) of Regulation (EC) No 1831/2003, when the proposed change or the new conditions for placing the feed additive on the market fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the CRL; |
| --- | --- |

(b)

applications for changing the terms of an existing authorisation submitted in accordance with Article 13(3) of Regulation (EC) No 1831/2003, when the proposed change or the new conditions for placing the feed additive on the market fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the CRL;

| (c) | applications for renewal of an existing authorisation submitted in accordance with Article 14 of Regulation (EC) No 1831/2003, when the conditions for placing the feed additive on the market fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the CRL. |
| --- | --- |

(c)

applications for renewal of an existing authorisation submitted in accordance with Article 14 of Regulation (EC) No 1831/2003, when the conditions for placing the feed additive on the market fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the CRL.

Notwithstanding paragraph 4, the Commission, the CRL or the Authority may, on the basis of legitimate factors relevant to the application, consider that a new evaluation of the methods of analysis is necessary. In such cases the applicant shall be informed by the CRL.’;

| (2) | Annex II is replaced by the text as set out in the Annex to this Regulation; |
| --- | --- |

(2)

Annex II is replaced by the text as set out in the Annex to this Regulation;

| (3) | in Annex IV, under the title ‘Rates according to the type of application for authorisations of feed additives in accordance with Regulation (EC) No 1831/2003’, point 5 is replaced by the following:






  ‘5. | Renewal of an authorisation of a feed additive (Article 14 of Regulation (EC) No 1831/2003):






  — | Fee = component 2 = EUR 4 000 |
| --- | --- | --- | --- |

(3)

in Annex IV, under the title ‘Rates according to the type of application for authorisations of feed additives in accordance with Regulation (EC) No 1831/2003’, point 5 is replaced by the following:

‘5.

Renewal of an authorisation of a feed additive (Article 14 of Regulation (EC) No 1831/2003):

—

Fee = component 2 = EUR 4 000

| — | when Article 5(4)(c) applies: Fee = EUR 0.’ |
| --- | --- |

—

when Article 5(4)(c) applies: Fee = EUR 0.’

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, 1 October 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 268, 18.10.2003, p. 29.

1

(2)  Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8).

2

(3)  Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1).

3

---

ANNEX

‘ANNEX II

Community reference laboratory and consortium of national reference laboratories, as referred to in Article 6(2)

COMMUNITY REFERENCE LABORATORY

Joint Research Centre of the European Commission. Institute for Reference Materials and Measurements. Geel, Belgium.

NATIONAL REFERENCE LABORATORIES OF THE MEMBER STATES

Belgique/België

| — | Federaal Laboratorium voor de Voedselveiligheid Tervuren (FLVVT –FAVV); |
| --- | --- |

—

Federaal Laboratorium voor de Voedselveiligheid Tervuren (FLVVT –FAVV);

| — | Vlaamse Instelling voor Technologisch Onderzoek (VITO), Mol; |
| --- | --- |

—

Vlaamse Instelling voor Technologisch Onderzoek (VITO), Mol;

| — | Centre wallon de Recherches agronomiques (CRA-W), Gembloux. |
| --- | --- |

—

Centre wallon de Recherches agronomiques (CRA-W), Gembloux.

Česká republika

| — | Ústřední kontrolní a zkušební ústav zemědělský (ÚKZÚZ), Praha. |
| --- | --- |

—

Ústřední kontrolní a zkušební ústav zemědělský (ÚKZÚZ), Praha.

Danmark

| — | Fødevarestyrelsens Laboratorie Aarhus (kemisk); |
| --- | --- |

—

Fødevarestyrelsens Laboratorie Aarhus (kemisk);

| — | Fødevarestyrelsens Laboratorie Ringsted (kemisk og mikrobiologisk). |
| --- | --- |

—

Fødevarestyrelsens Laboratorie Ringsted (kemisk og mikrobiologisk).

Deutschland

| — | Sachgebiet Futtermittel des Bayrischen Landesamtes für Gesundheit und Lebensmittelsicherheit (LGL), Oberschleißheim; |
| --- | --- |

—

Sachgebiet Futtermittel des Bayrischen Landesamtes für Gesundheit und Lebensmittelsicherheit (LGL), Oberschleißheim;

| — | Landwirtschaftliche Untersuchungs- und Forschungsanstalt (LUFA), Speyer; |
| --- | --- |

—

Landwirtschaftliche Untersuchungs- und Forschungsanstalt (LUFA), Speyer;

| — | Staatliche Betriebsgesellschaft für Umwelt und Landwirtschaft. Geschäftsbereich 6 — Labore Landwirtschaft, Nossen; |
| --- | --- |

—

Staatliche Betriebsgesellschaft für Umwelt und Landwirtschaft. Geschäftsbereich 6 — Labore Landwirtschaft, Nossen;

| — | Thüringer Landesanstalt für Landwirtschaft (TLL). Abteilung Untersuchungswesen. Jena. |
| --- | --- |

—

Thüringer Landesanstalt für Landwirtschaft (TLL). Abteilung Untersuchungswesen. Jena.

Eesti

| — | Põllumajandusuuringute Keskus (PMK). Jääkide ja saasteainete labor, Saku, Harjumaa; |
| --- | --- |

—

Põllumajandusuuringute Keskus (PMK). Jääkide ja saasteainete labor, Saku, Harjumaa;

| — | Põllumajandusuuringute Keskus (PMK), Taimse materjali labor, Saku, Harjumaa. |
| --- | --- |

—

Põllumajandusuuringute Keskus (PMK), Taimse materjali labor, Saku, Harjumaa.

España

| — | Laboratorio Arbitral Agroalimentario. Ministerio de Agricultura, Alimentación y Medio Ambiente, Madrid; |
| --- | --- |

—

Laboratorio Arbitral Agroalimentario. Ministerio de Agricultura, Alimentación y Medio Ambiente, Madrid;

| — | Laboratori Agroalimentari, Departament d'Agricultura, Ramaderia, PESCA, Alimentació i Medi Natural. Generalitat de Catalunya, Cabrils. |
| --- | --- |

—

Laboratori Agroalimentari, Departament d'Agricultura, Ramaderia, PESCA, Alimentació i Medi Natural. Generalitat de Catalunya, Cabrils.

France

| — | Laboratoire de Rennes (SCL L35), Service Commun des Laboratoires DGCCRF et DGDDI, Rennes. |
| --- | --- |

—

Laboratoire de Rennes (SCL L35), Service Commun des Laboratoires DGCCRF et DGDDI, Rennes.

Éire/Ireland

| — | The State Laboratory, Kildare. |
| --- | --- |

—

The State Laboratory, Kildare.

Ελλάδα

| — | Εργαστήριο Ελέγχου Κυκλοφορίας Ζωοτροφών Θεσσαλονίκης. |
| --- | --- |

—

Εργαστήριο Ελέγχου Κυκλοφορίας Ζωοτροφών Θεσσαλονίκης.

Italia

| — | Istituto Superiore di Sanità. Dipartimento di Sanità Pubblica Veterinaria e Sicurezza Alimentare, Roma; |
| --- | --- |

—

Istituto Superiore di Sanità. Dipartimento di Sanità Pubblica Veterinaria e Sicurezza Alimentare, Roma;

| — | Centro di referenza nazionale per la sorveglienza ed il controllo degli alimenti per gli animali (CReAA), Torino. |
| --- | --- |

—

Centro di referenza nazionale per la sorveglienza ed il controllo degli alimenti per gli animali (CReAA), Torino.

Kypros

| — | Feedingstuffs Analytical Laboratory, Department of Agriculture, Nicosia. |
| --- | --- |

—

Feedingstuffs Analytical Laboratory, Department of Agriculture, Nicosia.

Latvija

| — | Pārtikas drošības, dzīvnieku veselības un vides zinātniskais institūts BIOR, Rīga. |
| --- | --- |

—

Pārtikas drošības, dzīvnieku veselības un vides zinātniskais institūts BIOR, Rīga.

Lietuva

| — | Nacionalinis maisto ir veterinarijos rizikos vertinimo institutas, Vilnius. |
| --- | --- |

—

Nacionalinis maisto ir veterinarijos rizikos vertinimo institutas, Vilnius.

Luxembourg

| — | Laboratoire de Contrôle et d'essais — ASTA, Ettelbruck. |
| --- | --- |

—

Laboratoire de Contrôle et d'essais — ASTA, Ettelbruck.

Magyarország

| — | Nemzeti Élelmiszerlánc-biztonsági Hivatal, Élelmiszer- és Takarmánybiztonsági Igazgatóság, Takarmányvizsgáló Nemzeti Referencia Laboratórium, Budapest. |
| --- | --- |

—

Nemzeti Élelmiszerlánc-biztonsági Hivatal, Élelmiszer- és Takarmánybiztonsági Igazgatóság, Takarmányvizsgáló Nemzeti Referencia Laboratórium, Budapest.

Nederland

| — | RIKILT Wageningen UR, Wageningen. |
| --- | --- |

—

RIKILT Wageningen UR, Wageningen.

Österreich

| — | Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES), Wien. |
| --- | --- |

—

Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES), Wien.

Polska

| — | Instytut Zootechniki — Państwowy Instytut Badawczy, Krajowe Laboratorium Pasz, Lublin; |
| --- | --- |

—

Instytut Zootechniki — Państwowy Instytut Badawczy, Krajowe Laboratorium Pasz, Lublin;

| — | Państwowy Instytut Weterynaryjny, Pulawy. |
| --- | --- |

—

Państwowy Instytut Weterynaryjny, Pulawy.

Portugal

| — | Instituto Nacional de Investigação Agrária e Veterinária, I.P. (INIAV,IP), Lisboa. |
| --- | --- |

—

Instituto Nacional de Investigação Agrária e Veterinária, I.P. (INIAV,IP), Lisboa.

Slovenija

| — | Univerza v Ljubljani. Veterinarska fakulteta. Nacionalni veterinarski inštitut. Enota za patologijo prehrane in higieno okolja, Ljubljana; |
| --- | --- |

—

Univerza v Ljubljani. Veterinarska fakulteta. Nacionalni veterinarski inštitut. Enota za patologijo prehrane in higieno okolja, Ljubljana;

| — | Kmetijski inštitut Slovenije, Ljubljana. |
| --- | --- |

—

Kmetijski inštitut Slovenije, Ljubljana.

Slovensko

| — | Skúšobné laboratórium analýzy krmív, Ústredný kontrolný a skúšobný ústav poľnohospodársky, Bratislava. |
| --- | --- |

—

Skúšobné laboratórium analýzy krmív, Ústredný kontrolný a skúšobný ústav poľnohospodársky, Bratislava.

Suomi/Finland

| — | Elintarviketurvallisuusvirasto/Livsmedelssäkerhetsverket (Evira), Helsinki/Helsingfors. |
| --- | --- |

—

Elintarviketurvallisuusvirasto/Livsmedelssäkerhetsverket (Evira), Helsinki/Helsingfors.

Sverige

| — | Avdelningen för kemi, miljö och fodersäkerhet, Statens Veterinärmedicinska Anstalt (SVA), Uppsala. |
| --- | --- |

—

Avdelningen för kemi, miljö och fodersäkerhet, Statens Veterinärmedicinska Anstalt (SVA), Uppsala.

United Kingdom

| — | LGC Ltd, Teddington. |
| --- | --- |

—

LGC Ltd, Teddington.

NATIONAL REFERENCE LABORATORIES OF EFTA COUNTRIES

Norway

| — | The National Institute of Nutrition and Seafood Research (NIFES), Bergen.’ |
| --- | --- |

—

The National Institute of Nutrition and Seafood Research (NIFES), Bergen.’

---

| 2.10.2015 | EN | Official Journal of the European Union | L 257/35 |
| --- | --- | --- | --- |

2.10.2015

EN

Official Journal of the European Union

L 257/35

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1762

of 1 October 2015

establishing the standard import values for determining the entry price of certain fruit and vegetables

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),

Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,

Whereas:

| (1) | Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto. |
| --- | --- |

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

| (2) | The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union, |
| --- | --- |

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day 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, 1 October 2015.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General for Agriculture and Rural Development

---

(1)  OJ L 347, 20.12.2013, p. 671.

1

(2)  OJ L 157, 15.6.2011, p. 1.

2

---

ANNEX

Standard import values for determining the entry price of certain fruit and vegetables

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | AL | 46,6 |
| MA | 171,9 |
| MK | 47,2 |
| TR | 81,2 |
| XS | 39,0 |
| ZZ | 77,2 |
| 0707 00 05 | AL | 46,1 |
| MK | 41,5 |
| TR | 122,2 |
| ZZ | 69,9 |
| 0709 93 10 | TR | 132,0 |
| ZZ | 132,0 |
| 0805 50 10 | AR | 137,3 |
| BO | 141,4 |
| CL | 176,4 |
| EG | 55,4 |
| UY | 92,0 |
| ZA | 142,1 |
| ZZ | 124,1 |
| 0806 10 10 | BR | 257,8 |
| EG | 176,0 |
| MK | 32,3 |
| TR | 146,1 |
| ZA | 128,8 |
| ZZ | 148,2 |
| 0808 10 80 | AR | 264,2 |
| BR | 35,7 |
| CL | 127,4 |
| NZ | 160,2 |
| US | 107,9 |
| UY | 48,0 |
| ZA | 132,3 |
| ZZ | 125,1 |
| 0808 30 90 | AR | 131,9 |
| CL | 148,3 |
| TR | 129,3 |
| XS | 96,2 |
| ZA | 220,9 |
| ZZ | 145,3 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

AL

46,6

MA

171,9

MK

47,2

TR

81,2

XS

39,0

ZZ

77,2

0707 00 05

AL

46,1

MK

41,5

TR

122,2

ZZ

69,9

0709 93 10

TR

132,0

ZZ

132,0

0805 50 10

AR

137,3

BO

141,4

CL

176,4

EG

55,4

UY

92,0

ZA

142,1

ZZ

124,1

0806 10 10

BR

257,8

EG

176,0

MK

32,3

TR

146,1

ZA

128,8

ZZ

148,2

0808 10 80

AR

264,2

BR

35,7

CL

127,4

NZ

160,2

US

107,9

UY

48,0

ZA

132,3

ZZ

125,1

0808 30 90

AR

131,9

CL

148,3

TR

129,3

XS

96,2

ZA

220,9

ZZ

145,3

---

(1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.

---

DECISIONS

| 2.10.2015 | EN | Official Journal of the European Union | L 257/37 |
| --- | --- | --- | --- |

2.10.2015

EN

Official Journal of the European Union

L 257/37

---

COUNCIL DECISION (CFSP) 2015/1763

of 1 October 2015

concerning restrictive measures in view of the situation in Burundi

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 29 thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

| (1) | On 16 March 2015, the European Union reiterated the position it has taken since the beginning of the crisis in Burundi, that only through dialogue leading to consensus, in compliance with the Arusha Agreement for Peace and Reconciliation of 2000 and the Burundian Constitution, could a lasting political solution be found in the interests of security and democracy for all Burundi's people. |
| --- | --- |

(1)

On 16 March 2015, the European Union reiterated the position it has taken since the beginning of the crisis in Burundi, that only through dialogue leading to consensus, in compliance with the Arusha Agreement for Peace and Reconciliation of 2000 and the Burundian Constitution, could a lasting political solution be found in the interests of security and democracy for all Burundi's people.

| (2) | On 18 May 2015, the Council condemned the attempted coup in Burundi and also any act of violence or abuse of the constitutional order, whoever the perpetrators may be, and expressed its deep concern at the situation in Burundi. The Council also expressed its determination to take all measures necessary against Burundian parties whose actions perpetuate violence and hamper the search for a political solution. |
| --- | --- |

(2)

On 18 May 2015, the Council condemned the attempted coup in Burundi and also any act of violence or abuse of the constitutional order, whoever the perpetrators may be, and expressed its deep concern at the situation in Burundi. The Council also expressed its determination to take all measures necessary against Burundian parties whose actions perpetuate violence and hamper the search for a political solution.

| (3) | On 22 June 2015, the Council expressed its deep concern at both the number of victims and the number of cases of serious human rights violations reported since the beginning of the crisis, particularly those abuses attributed to the security forces and to members of the Imbonerakure. The Council also reiterated that it was determined to adopt, if necessary, targeted restrictive measures against those whose actions might have led or might lead to acts of violence and repression and serious human rights violations, and/or might hamper the search for a political solution within the framework proposed by the African Union and the East African Community. |
| --- | --- |

(3)

On 22 June 2015, the Council expressed its deep concern at both the number of victims and the number of cases of serious human rights violations reported since the beginning of the crisis, particularly those abuses attributed to the security forces and to members of the Imbonerakure. The Council also reiterated that it was determined to adopt, if necessary, targeted restrictive measures against those whose actions might have led or might lead to acts of violence and repression and serious human rights violations, and/or might hamper the search for a political solution within the framework proposed by the African Union and the East African Community.

| (4) | On 23 July 2015, the European Union regretted that the Burundi government had not fully implemented the relevant decisions of the African Union and the East African Community that would have paved the way for credible and inclusive elections. |
| --- | --- |

(4)

On 23 July 2015, the European Union regretted that the Burundi government had not fully implemented the relevant decisions of the African Union and the East African Community that would have paved the way for credible and inclusive elections.

| (5) | The Council has remained seriously concerned about the situation in Burundi. In the current circumstances and, in line with the Council Conclusions of June 2015, travel restrictions and an asset freeze should be imposed against persons, entities or bodies undermining democracy or obstructing the search for a political solution in Burundi, including by acts of violence, repression or inciting violence, persons, entities or bodies involved in planning, directing, or committing acts that violate international human rights law or international humanitarian law, as applicable, or that constitute serious human rights abuses, in Burundi, as well as persons, entities or bodies associated with them. |
| --- | --- |

(5)

The Council has remained seriously concerned about the situation in Burundi. In the current circumstances and, in line with the Council Conclusions of June 2015, travel restrictions and an asset freeze should be imposed against persons, entities or bodies undermining democracy or obstructing the search for a political solution in Burundi, including by acts of violence, repression or inciting violence, persons, entities or bodies involved in planning, directing, or committing acts that violate international human rights law or international humanitarian law, as applicable, or that constitute serious human rights abuses, in Burundi, as well as persons, entities or bodies associated with them.

| (6) | Further action by the Union is needed in order to implement certain measures, |
| --- | --- |

(6)

Further action by the Union is needed in order to implement certain measures,

HAS ADOPTED THIS DECISION:

Article 1

1.   Member States shall take the measures necessary to prevent the entry into, or transit through, their territories of:

| (a) | natural persons undermining democracy or obstructing the search for a political solution in Burundi, including by acts of violence, repression or inciting violence; |
| --- | --- |

(a)

natural persons undermining democracy or obstructing the search for a political solution in Burundi, including by acts of violence, repression or inciting violence;

| (b) | natural persons involved in planning, directing, or committing acts that violate international human rights law or international humanitarian law, as applicable, or that constitute serious human rights abuses, in Burundi; and |
| --- | --- |

(b)

natural persons involved in planning, directing, or committing acts that violate international human rights law or international humanitarian law, as applicable, or that constitute serious human rights abuses, in Burundi; and

| (c) | natural persons associated with those referred to in points (a) and (b); |
| --- | --- |

(c)

natural persons associated with those referred to in points (a) and (b);

as listed in the Annex.

2.   Paragraph 1 shall not oblige a Member State to refuse its own nationals entry into its territory.

3.   Paragraph 1 shall be without prejudice to the cases where a Member State is bound by an obligation of international law, namely:

| (a) | as a host country of an international intergovernmental organisation; |
| --- | --- |

(a)

as a host country of an international intergovernmental organisation;

| (b) | as a host country to an international conference convened by, or under the auspices of, the United Nations; |
| --- | --- |

(b)

as a host country to an international conference convened by, or under the auspices of, the United Nations;

| (c) | under a multilateral agreement conferring privileges and immunities; or |
| --- | --- |

(c)

under a multilateral agreement conferring privileges and immunities; or

| (d) | pursuant to the 1929 Treaty of Conciliation (Lateran Pact) concluded by the Holy See (Vatican City State) and Italy. |
| --- | --- |

(d)

pursuant to the 1929 Treaty of Conciliation (Lateran Pact) concluded by the Holy See (Vatican City State) and Italy.

4.   Paragraph 3 shall be considered as applying also in cases where a Member State is host country of the Organisation for Security and Cooperation in Europe (OSCE).

5.   The Council shall be duly informed in all cases where a Member State grants an exemption pursuant to paragraph 3 or 4.

6.   Member States may grant exemptions from the measures imposed under paragraph 1 where travel is justified on the grounds of urgent humanitarian need, or on grounds of attending intergovernmental meetings and those promoted or hosted by the European Union, or hosted by a Member State holding the Chairmanship in office of the OSCE, where a political dialogue is conducted that directly promotes the policy objectives of restrictive measures, including democracy, human rights and the rule of law in Burundi.

7.   A Member State wishing to grant exemptions referred to in paragraph 6 shall notify the Council in writing. The exemption shall be deemed to be granted unless one or more of the Council members raises an objection in writing within two working days of receiving notification of the proposed exemption. Should one or more of the Council members raise an objection, the Council, acting by a qualified majority, may decide to grant the proposed exemption.

8.   Where, pursuant to paragraphs 3, 4, 6 or 7 a Member State authorises the entry into, or transit through its territory of persons listed in the Annex, the authorisation shall be strictly limited to the purpose for which it is given and to the persons directly concerned thereby.

Article 2

1.   All funds and economic resources belonging to, owned, held or controlled by:

| (a) | natural or legal persons, entities or bodies undermining democracy or obstructing the search for a political solution in Burundi, including by acts of violence, repression or inciting violence; |
| --- | --- |

(a)

natural or legal persons, entities or bodies undermining democracy or obstructing the search for a political solution in Burundi, including by acts of violence, repression or inciting violence;

| (b) | natural or legal persons, entities or bodies involved in planning, directing, or committing acts that violate international human rights law or international humanitarian law, as applicable, or that constitute serious human rights abuses, in Burundi; and |
| --- | --- |

(b)

natural or legal persons, entities or bodies involved in planning, directing, or committing acts that violate international human rights law or international humanitarian law, as applicable, or that constitute serious human rights abuses, in Burundi; and

| (c) | natural or legal persons, entities or bodies associated with the persons, entities or bodies referred to in points (a) and (b); |
| --- | --- |

(c)

natural or legal persons, entities or bodies associated with the persons, entities or bodies referred to in points (a) and (b);

as listed in the Annex, shall be frozen.

2.   No funds or economic resources shall be made available directly or indirectly to or for the benefit of the natural or legal persons, entities or bodies listed in the Annex.

3.   The competent authority of a Member State may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as it deems appropriate, after having determined that the funds or economic resources concerned are:

| (a) | necessary to satisfy the basic needs of the natural or legal persons, entities or bodies listed in the Annex and dependent family members of such natural persons, including payments for foodstuffs, rent or mortgage, medicines and medical treatment, taxes, insurance premiums, and public utility charges; |
| --- | --- |

(a)

necessary to satisfy the basic needs of the natural or legal persons, entities or bodies listed in the Annex and dependent family members of such natural persons, including payments for foodstuffs, rent or mortgage, medicines and medical treatment, taxes, insurance premiums, and public utility charges;

| (b) | intended exclusively for the payment of reasonable professional fees and the reimbursement of incurred expenses associated with the provision of legal services; |
| --- | --- |

(b)

intended exclusively for the payment of reasonable professional fees and the reimbursement of incurred expenses associated with the provision of legal services;

| (c) | intended exclusively for the payment of fees or service charges for the routine holding or maintenance of frozen funds or economic resources; or |
| --- | --- |

(c)

intended exclusively for the payment of fees or service charges for the routine holding or maintenance of frozen funds or economic resources; or

| (d) | necessary for extraordinary expenses, provided that the competent authority has notified the competent authorities of the other Member States and the Commission of the grounds on which it considers that a specific authorisation should be granted, at least two weeks prior to the authorisation. |
| --- | --- |

(d)

necessary for extraordinary expenses, provided that the competent authority has notified the competent authorities of the other Member States and the Commission of the grounds on which it considers that a specific authorisation should be granted, at least two weeks prior to the authorisation.

The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under this paragraph.

4.   By way of derogation from paragraph 1, the competent authorities of a Member State may authorise the release of certain frozen funds or economic resources, provided that the following conditions are met:

| (a) | the funds or economic resources are the subject of an arbitral decision rendered prior to the date on which the natural or legal person, entity or body referred to in paragraph 1 was listed in the Annex, or of a judicial or administrative decision rendered in the Union, or a judicial decision enforceable in the Member State concerned, prior to or after that date; |
| --- | --- |

(a)

the funds or economic resources are the subject of an arbitral decision rendered prior to the date on which the natural or legal person, entity or body referred to in paragraph 1 was listed in the Annex, or of a judicial or administrative decision rendered in the Union, or a judicial decision enforceable in the Member State concerned, prior to or after that date;

| (b) | the funds or economic resources will be used exclusively to satisfy claims secured by such a decision or recognised as valid in such a decision, within the limits set by applicable laws and regulations governing the rights of persons having such claims; |
| --- | --- |

(b)

the funds or economic resources will be used exclusively to satisfy claims secured by such a decision or recognised as valid in such a decision, within the limits set by applicable laws and regulations governing the rights of persons having such claims;

| (c) | the decision is not for the benefit of a natural or legal person, entity or body listed in the Annex; and |
| --- | --- |

(c)

the decision is not for the benefit of a natural or legal person, entity or body listed in the Annex; and

| (d) | recognition of the decision is not contrary to public policy in the Member State concerned. |
| --- | --- |

(d)

recognition of the decision is not contrary to public policy in the Member State concerned.

The Member State concerned shall inform the other Member States and the Commission of any authorisations granted under this paragraph.

5.   Paragraph 1 shall not prevent a natural or legal person, an entity or body listed in the Annex from making a payment due under a contract entered into prior to the date on which such natural or legal person, entity or body was listed therein, provided that the Member State concerned has determined that the payment is not, directly or indirectly, received by a natural or legal person, entity or body referred to in paragraph 1.

6.   Paragraph 2 shall not apply to the addition to frozen accounts of:

| (a) | interest or other earnings on those accounts; |
| --- | --- |

(a)

interest or other earnings on those accounts;

| (b) | payments due under contracts, agreements or obligations that were concluded or arose prior to the date on which those accounts became subject to the measures provided for in paragraphs 1 and 2; or |
| --- | --- |

(b)

payments due under contracts, agreements or obligations that were concluded or arose prior to the date on which those accounts became subject to the measures provided for in paragraphs 1 and 2; or

| (c) | payments due under judicial, administrative or arbitral decisions rendered in the Union or enforceable in the Member State concerned; |
| --- | --- |

(c)

payments due under judicial, administrative or arbitral decisions rendered in the Union or enforceable in the Member State concerned;

provided that any such interest, other earnings and payments remain subject to the measures provided for in paragraph 1.

Article 3

1.   The Council, acting upon a proposal from a Member State or from the High Representative of the Union for Foreign Affairs and Security Policy, shall establish and amend the list in the Annex.

2.   The Council shall communicate the decision referred to in paragraph 1, including the grounds for the listing, to the natural or legal person, entity or body concerned, either directly, if the address is known, or through the publication of a notice, providing such person, entity or body with an opportunity to present observations.

3.   Where observations are submitted, or where substantial new evidence is presented, the Council shall review the decision referred to in paragraph 1 and inform the natural or legal person, entity or body concerned accordingly.

Article 4

1.   The Annex shall include the grounds for listing the natural and legal persons, entities and bodies referred to in Article 1(1) and Article 2(1).

2.   The Annex shall also contain, where available, the information necessary to identify the natural or legal persons, entities or bodies concerned. With regard to natural persons, such information may include names, including aliases, date and place of birth, nationality, passport and identity card numbers, gender, address if known, and function or profession. With regard to legal persons, entities or bodies, such information may include names, place and date of registration, registration number and place of business.

Article 5

In order to maximise the impact of the measures set out in this Decision, the Union shall encourage third States to adopt restrictive measures similar to those provided for in this Decision.

Article 6

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

This Decision shall apply until 3 October 2016.

This Decision shall be kept under constant review. It shall be renewed, or amended as appropriate, if the Council deems that its objectives have not been met.

Done at Luxembourg, 1 October 2015.

For the Council

The President

E. SCHNEIDER

---

ANNEX

List of natural and legal persons, entities and bodies referred to in Articles 1 and 2

| | Name | Identifying information | Grounds for designation |
| --- | --- | --- | --- |
| 1. | Godefroid BIZIMANA | DOB: 23.4.1968
  POB: NYAGASEKE, MABAYI, CIBITOKE
  Burundian nationality. Passport number: DP0001520 | Deputy Director General of the National Police, responsible for undermining democracy by making operational decisions that have led to a disproportionate use of force and acts of violent repression towards peaceful demonstrations that started on 26 April 2015 following the announcement of the presidential candidacy of President Nkurunziza. |
| 2. | Gervais NDIRAKOBUCA alias NDAKUGARIKA | DOB: 1.8.1970
  Burundian nationality. Passport number: DP0000761 | Head of Cabinet of the Presidential Administration (Présidence) responsible for matters relating to the National Police. Responsible for obstructing the search for a political solution in Burundi by issuing instructions that led to disproportionate use of force, acts of violence, acts of repression and violations of international human rights law against protestors demonstrating from 26 April 2015 onwards, following the announcement of the presidential candidacy of President Nkurunziza, including on 26, 27 and 28 April in the Nyakabiga and Musaga districts in Bujumbura. |
| 3. | Mathias/Joseph NIYONZIMA alias KAZUNGU | Registration number (SNR): O/00064
  Burundian nationality. Passport number: OP0053090 | Officer of the National Intelligence Service. Responsible for obstructing the search for a political solution in Burundi by inciting violence and acts of repression during the demonstrations that started on 26 April 2015 following the announcement of the presidential candidacy of President Nkurunziza. Responsible for helping train, coordinate and arm the Imbonerakure paramilitary militias, including outside Burundi, who are responsible for acts of violence, repression and serious human rights abuses in Burundi. |
| 4. | Léonard NGENDAKUMANA | DOB: 24.11.1968
  Burundian nationality. Passport number: DP0000885 | Former ‘Chargé de Missions de la Présidence’ and former army general. Responsible for obstructing the search for a political solution in Burundi by participating in the attempted coup d'état of 13 May 2015 to overthrow the Burundi Government. Responsible for acts of violence — grenade attacks — committed in Burundi, as well as for incitement to violence. General Léonard Ngendakumana publicly supported violence as a means to achieve political goals. |

Name

Identifying information

Grounds for designation

1.

Godefroid BIZIMANA

DOB: 23.4.1968

POB: NYAGASEKE, MABAYI, CIBITOKE

Burundian nationality. Passport number: DP0001520

Deputy Director General of the National Police, responsible for undermining democracy by making operational decisions that have led to a disproportionate use of force and acts of violent repression towards peaceful demonstrations that started on 26 April 2015 following the announcement of the presidential candidacy of President Nkurunziza.

2.

Gervais NDIRAKOBUCA alias NDAKUGARIKA

DOB: 1.8.1970

Burundian nationality. Passport number: DP0000761

Head of Cabinet of the Presidential Administration (Présidence) responsible for matters relating to the National Police. Responsible for obstructing the search for a political solution in Burundi by issuing instructions that led to disproportionate use of force, acts of violence, acts of repression and violations of international human rights law against protestors demonstrating from 26 April 2015 onwards, following the announcement of the presidential candidacy of President Nkurunziza, including on 26, 27 and 28 April in the Nyakabiga and Musaga districts in Bujumbura.

3.

Mathias/Joseph NIYONZIMA alias KAZUNGU

Registration number (SNR): O/00064

Burundian nationality. Passport number: OP0053090

Officer of the National Intelligence Service. Responsible for obstructing the search for a political solution in Burundi by inciting violence and acts of repression during the demonstrations that started on 26 April 2015 following the announcement of the presidential candidacy of President Nkurunziza. Responsible for helping train, coordinate and arm the Imbonerakure paramilitary militias, including outside Burundi, who are responsible for acts of violence, repression and serious human rights abuses in Burundi.

4.

Léonard NGENDAKUMANA

DOB: 24.11.1968

Burundian nationality. Passport number: DP0000885

Former ‘Chargé de Missions de la Présidence’ and former army general. Responsible for obstructing the search for a political solution in Burundi by participating in the attempted coup d'état of 13 May 2015 to overthrow the Burundi Government. Responsible for acts of violence — grenade attacks — committed in Burundi, as well as for incitement to violence. General Léonard Ngendakumana publicly supported violence as a means to achieve political goals.

---

| 2.10.2015 | EN | Official Journal of the European Union | L 257/42 |
| --- | --- | --- | --- |

2.10.2015

EN

Official Journal of the European Union

L 257/42

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COUNCIL DECISION (CFSP) 2015/1764

of 1 October 2015

amending Decision 2014/512/CFSP concerning restrictive measures in view of Russia's actions destabilising the situation in Ukraine

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 29 thereof,

Whereas:

| (1) | On 31 July 2014, the Council adopted Decision 2014/512/CFSP (1) concerning restrictive measures in view of Russia's actions destabilising the situation in Ukraine. |
| --- | --- |

(1)

On 31 July 2014, the Council adopted Decision 2014/512/CFSP (1) concerning restrictive measures in view of Russia's actions destabilising the situation in Ukraine.

| (2) | The Council considers that those restrictive measures should not affect the European space industry. |
| --- | --- |

(2)

The Council considers that those restrictive measures should not affect the European space industry.

| (3) | Therefore, certain operations concerning specific pyrotechnics referred to in the Common Military List of the European Union (2), necessary for the use of launchers operated by launch service providers of Member States or established in a Member State, or for the use of launches of space programmes of the Union, its Member States or of the European Space Agency, or for the fuelling of satellites by satellites manufacturers established in a Member State, should be permitted, |
| --- | --- |

(3)

Therefore, certain operations concerning specific pyrotechnics referred to in the Common Military List of the European Union (2), necessary for the use of launchers operated by launch service providers of Member States or established in a Member State, or for the use of launches of space programmes of the Union, its Member States or of the European Space Agency, or for the fuelling of satellites by satellites manufacturers established in a Member State, should be permitted,

HAS ADOPTED THIS DECISION:

Article 1

Decision 2014/512/CFSP is hereby amended as follows:

| (1) | in Article 2, the following paragraphs are added:
  ‘5.   The prohibitions in paragraphs 1 and 3 shall not apply to:






  (a) | the sale, supply, transfer or export and to the import, purchase or transport of hydrazine (CAS 302-01-2) in concentrations of 70 per cent or more; |
| --- | --- | --- |

(1)

in Article 2, the following paragraphs are added:

‘5.   The prohibitions in paragraphs 1 and 3 shall not apply to:

(a)

the sale, supply, transfer or export and to the import, purchase or transport of hydrazine (CAS 302-01-2) in concentrations of 70 per cent or more;

| (b) | the import, purchase or transport of unsymmetrical dimethyl hydrazine (CAS 57-14-7); |
| --- | --- |

(b)

the import, purchase or transport of unsymmetrical dimethyl hydrazine (CAS 57-14-7);

| (c) | the sale, supply, transfer or export and to the import, purchase or transport of monomethyl hydrazine (CAS 60-34-4); |
| --- | --- |

(c)

the sale, supply, transfer or export and to the import, purchase or transport of monomethyl hydrazine (CAS 60-34-4);

for use of launchers operated by European launch service providers, or for the use of launches of European space programmes, or for the fuelling of satellites by European satellites manufacturers.

The amount of any export of hydrazine shall be calculated in accordance with the launch or launches or the satellites for which it is made and shall not exceed a total quantity of 800 kg for each individual launch or satellite. The amount of any export of monomethyl hydrazine shall be calculated in accordance with the launch or launches or the satellites for which it is made.

6.   The prohibitions in paragraph 2 shall not apply to the provision of technical assistance, brokering services or other services, and to the provision of financing or financial assistance, related to the operations referred to in points (a), (b) and (c) of paragraph 5.

7.   The operations referred to in points (a), (b) and (c) of paragraph 5 and in paragraph 6 shall be subject to prior authorisation by the competent authorities of the Member States. Member States shall duly inform the Council in all cases where they grant an authorisation. The information shall include the details of the amounts transferred and of the end-use.’;

| (2) | in Article 9(1) the following subparagraph is added:
  ‘Article 2(6) shall apply from 9 October 2015.’ |
| --- | --- |

(2)

in Article 9(1) the following subparagraph is added:

‘Article 2(6) shall apply from 9 October 2015.’

Article 2

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

Done at Luxembourg, 1 October 2015.

For the Council

The President

E. SCHNEIDER

---

(1)  Decision 2014/512/CFSP of 31 July 2014 concerning restrictive measures in view of Russia's actions destabilising the situation in Ukraine (OJ L 229, 31.7.2014, p. 13).

1

(2)  OJ C 129, 21.4.2015, p. 1.

2

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| 2.10.2015 | EN | Official Journal of the European Union | L 257/44 |
| --- | --- | --- | --- |

2.10.2015

EN

Official Journal of the European Union

L 257/44

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COMMISSION IMPLEMENTING DECISION (EU) 2015/1765

of 30 September 2015

amending Annexes I and II to Decision 2004/558/EC as regards the infectious bovine rhinotracheitis-free status of the Federal State of Baden-Württemberg of Germany and of the region Valle d'Aosta of Italy

(notified under document C(2015) 6572)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (1), and in particular Article 9(2) and 10(2) thereof,

Whereas:

| (1) | Directive 64/432/EEC lays down rules for trade within the Union in bovine animals. Article 9 thereof provides that a Member State which has a compulsory national control programme for one of the contagious diseases listed in Annex E(II) thereto, may submit its programme to the Commission for approval. That list includes infectious bovine rhinotracheitis. Infectious bovine rhinotracheitis is the description of the most prominent clinical signs of the infection with the bovine herpesvirus type 1 (BHV1). Article 9 of Directive 64/432/EEC also provides for the definition of the additional guarantees which may be required in intra-Union trade. |
| --- | --- |

(1)

Directive 64/432/EEC lays down rules for trade within the Union in bovine animals. Article 9 thereof provides that a Member State which has a compulsory national control programme for one of the contagious diseases listed in Annex E(II) thereto, may submit its programme to the Commission for approval. That list includes infectious bovine rhinotracheitis. Infectious bovine rhinotracheitis is the description of the most prominent clinical signs of the infection with the bovine herpesvirus type 1 (BHV1). Article 9 of Directive 64/432/EEC also provides for the definition of the additional guarantees which may be required in intra-Union trade.

| (2) | In addition, Article 10 of Directive 64/432/EEC provides that where a Member State considers that its territory or part thereof is free from one of the diseases listed in Annex E(II) to that Directive, it is to present appropriate supporting documentation to the Commission. That Article also provides for the definition of the additional guarantees which may be required in intra-Union trade. |
| --- | --- |

(2)

In addition, Article 10 of Directive 64/432/EEC provides that where a Member State considers that its territory or part thereof is free from one of the diseases listed in Annex E(II) to that Directive, it is to present appropriate supporting documentation to the Commission. That Article also provides for the definition of the additional guarantees which may be required in intra-Union trade.

| (3) | Commission Decision 2004/558/EC (2) approves the programmes for the control and eradication of BHV1 presented by the Member States listed in Annex I thereto for the regions listed in that Annex and for which additional guarantees apply in accordance with Article 9 of Directive 64/432/EEC. |
| --- | --- |

(3)

Commission Decision 2004/558/EC (2) approves the programmes for the control and eradication of BHV1 presented by the Member States listed in Annex I thereto for the regions listed in that Annex and for which additional guarantees apply in accordance with Article 9 of Directive 64/432/EEC.

| (4) | In addition, Annex II to Decision 2004/558/EC lists the regions of the Member States that are considered free of BHV1 and to which additional guarantees apply in accordance with Article 10 of Directive 64/432/EEC. |
| --- | --- |

(4)

In addition, Annex II to Decision 2004/558/EC lists the regions of the Member States that are considered free of BHV1 and to which additional guarantees apply in accordance with Article 10 of Directive 64/432/EEC.

| (5) | All regions of Germany, with the exception of the Federal States of Bavaria, Thuringia, Saxony, Saxony-Anhalt, Brandenburg, Berlin and Mecklenburg-Western Pomerania are currently listed in Annex I to Decision 2004/558/EC. Those Federal States are free of BHV1 and are therefore listed in Annex II to that Decision. |
| --- | --- |

(5)

All regions of Germany, with the exception of the Federal States of Bavaria, Thuringia, Saxony, Saxony-Anhalt, Brandenburg, Berlin and Mecklenburg-Western Pomerania are currently listed in Annex I to Decision 2004/558/EC. Those Federal States are free of BHV1 and are therefore listed in Annex II to that Decision.

| (6) | Germany has submitted to the Commission supporting documentation for the Federal State of Baden-Württemberg to be considered free of BHV1 and for the additional guarantees in accordance with Article 10 of Directive 64/432/EEC. |
| --- | --- |

(6)

Germany has submitted to the Commission supporting documentation for the Federal State of Baden-Württemberg to be considered free of BHV1 and for the additional guarantees in accordance with Article 10 of Directive 64/432/EEC.

| (7) | Following the evaluation of the supporting documentation submitted by Germany, the Federal State of Baden-Württemberg should no longer be listed in Annex I to Decision 2004/558/EC, but instead be listed in Annex II thereto and the application of the additional guarantees in accordance with Article 10 of Directive 64/432/EEC should be extended to it. Annexes I and II to Decision 2004/558/EC should therefore be amended accordingly. |
| --- | --- |

(7)

Following the evaluation of the supporting documentation submitted by Germany, the Federal State of Baden-Württemberg should no longer be listed in Annex I to Decision 2004/558/EC, but instead be listed in Annex II thereto and the application of the additional guarantees in accordance with Article 10 of Directive 64/432/EEC should be extended to it. Annexes I and II to Decision 2004/558/EC should therefore be amended accordingly.

| (8) | The region Valle d'Aosta in Italy is currently listed in Annex I to Decision 2004/558/EC. |
| --- | --- |

(8)

The region Valle d'Aosta in Italy is currently listed in Annex I to Decision 2004/558/EC.

| (9) | Italy has submitted to the Commission supporting documentation for the region Valle d'Aosta to be considered free of BHV1 and for the additional guarantees in accordance with Article 10 of Directive 64/432/EEC. |
| --- | --- |

(9)

Italy has submitted to the Commission supporting documentation for the region Valle d'Aosta to be considered free of BHV1 and for the additional guarantees in accordance with Article 10 of Directive 64/432/EEC.

| (10) | Following the evaluation of the supporting documentation submitted by Italy, the region Valle d'Aosta should no longer be listed in Annex I to Decision 2004/558/EC, but instead be listed in Annex II thereto and the application of the additional guarantees in accordance with Article 10 of Directive 64/432/EEC should be extended to it. Annexes I and II to Decision 2004/558/EC should therefore be amended accordingly. |
| --- | --- |

(10)

Following the evaluation of the supporting documentation submitted by Italy, the region Valle d'Aosta should no longer be listed in Annex I to Decision 2004/558/EC, but instead be listed in Annex II thereto and the application of the additional guarantees in accordance with Article 10 of Directive 64/432/EEC should be extended to it. Annexes I and II to Decision 2004/558/EC should therefore be amended accordingly.

| (11) | Decision 2004/558/EC should therefore be amended accordingly. |
| --- | --- |

(11)

Decision 2004/558/EC should therefore be amended accordingly.

| (12) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(12)

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

HAS ADOPTED THIS DECISION:

Article 1

Annexes I and II to Decision 2004/558/EC are replaced by the text in the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 30 September 2015.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

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(1)  OJ 121, 29.7.1964, p. 1977/64.

1

(2)  Commission Decision 2004/558/EC of 15 July 2004 implementing Council Directive 64/432/EEC as regards additional guarantees for intra-Community trade in bovine animals relating to infectious bovine rhinotracheitis and the approval of the eradication programmes presented by certain Member States (OJ L 249, 23.7.2004, p. 20).

2

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ANNEX

ANNEX I

| Member States | Regions of Member States to which the additional guarantees for infectious bovine rhinotracheitis apply in accordance with Article 9 of Directive 64/432/EEC |
| --- | --- |
| Belgium | All regions |
| Czech Republic | All regions |
| Germany | The Federal States of:
  Bremen
  Hamburg
  Hesse
  Lower Saxony
  North Rhine-Westphalia
  Rhineland-Palatinate
  Saarland
  Schleswig-Holstein |
| Italy | Region Friuli-Venezia Giulia
  Autonomous Province of Trento |

Member States

Regions of Member States to which the additional guarantees for infectious bovine rhinotracheitis apply in accordance with Article 9 of Directive 64/432/EEC

Belgium

All regions

Czech Republic

All regions

Germany

The Federal States of:

Bremen

Hamburg

Hesse

Lower Saxony

North Rhine-Westphalia

Rhineland-Palatinate

Saarland

Schleswig-Holstein

Italy

Region Friuli-Venezia Giulia

Autonomous Province of Trento

ANNEX II

| Member States | Regions of Member States to which the additional guarantees for infectious bovine rhinotracheitis apply in accordance with Article 10 of Directive 64/432/EEC |
| --- | --- |
| Denmark | All regions |
| Germany | The Federal States of:
  Baden-Württemberg
  Bavaria
  Berlin
  Brandenburg
  Mecklenburg-Western Pomerania
  Saxony
  Saxony-Anhalt
  Thuringia |
| Italy | Region Valle d'Aosta
  Autonomous Province of Bolzano |
| Austria | All regions |
| Finland | All regions |
| Sweden | All regions |

Member States

Regions of Member States to which the additional guarantees for infectious bovine rhinotracheitis apply in accordance with Article 10 of Directive 64/432/EEC

Denmark

All regions

Germany

The Federal States of:

Baden-Württemberg

Bavaria

Berlin

Brandenburg

Mecklenburg-Western Pomerania

Saxony

Saxony-Anhalt

Thuringia

Italy

Region Valle d'Aosta

Autonomous Province of Bolzano

Austria

All regions

Finland

All regions

Sweden

All regions

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