# Official Journal L 283/2013

| | ISSN 1977-0677
  doi:10.3000/19770677.L_2013.283.eng |
| --- | --- |
| Official Journal
  of the European Union | L 283 |
| | |
| English edition | Legislation | Volume 5625 October 2013 |

ISSN 1977-0677

doi:10.3000/19770677.L_2013.283.eng

Official Journal

of the European Union

L 283

English edition

Legislation

Volume 5625 October 2013

---

| Contents | | I   Legislative acts | page |
| --- | --- | --- | --- |
| | | DECISIONS |
| | * | Decision No 1025/2013/EU of the European Parliament and of the Council of 22 October 2013 providing macro-financial assistance to the Kyrgyz Republic | 1 |

Contents

I   Legislative acts

page

DECISIONS

*

Decision No 1025/2013/EU of the European Parliament and of the Council of 22 October 2013 providing macro-financial assistance to the Kyrgyz Republic

1

| | | II   Non-legislative acts |
| --- | --- | --- |
| | | REGULATIONS |
| | * | Council Implementing Regulation (EU) No 1026/2013 of 22 October 2013 terminating the partial interim review concerning the anti-dumping measures applicable to imports of certain iron or steel fasteners originating in the People’s Republic of China, as extended to imports consigned from Malaysia, whether declared as originating in Malaysia or not | 7 |
| | * | Commission Regulation (EU) No 1027/2013 of 23 October 2013 establishing a prohibition of fishing for cod in Skagerrak area by vessels flying the flag of Sweden | 9 |
| | * | Commission Regulation (EU) No 1028/2013 of 23 October 2013 establishing a prohibition of fishing for redfish in EU and International waters of V, international waters of XII and XIV by vessels flying the flag of Germany | 11 |
| | * | Commission Regulation (EU) No 1029/2013 of 23 October 2013 establishing a prohibition of fishing for hake in VI and VII; EU and international waters of Vb; international waters of XII and XIV by vessels flying the flag of the Netherlands | 13 |
| | * | Commission Implementing Regulation (EU) No 1030/2013 of 24 October 2013 amending Regulation (EC) No 889/2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control | 15 |
| | * | Commission Implementing Regulation (EU) No 1031/2013 of 24 October 2013 approving the active substance penflufen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (
  1
  ) | 17 |
| | * | Commission Implementing Regulation (EU) No 1032/2013 of 24 October 2013 approving bromoacetic acid as an existing active substance for use in biocidal products for product-type 4 (
  1
  ) | 22 |
| | * | Commission Implementing Regulation (EU) No 1033/2013 of 24 October 2013 approving copper sulphate pentahydrate as an existing active substance for use in biocidal products for product-type 2 (
  1
  ) | 25 |
| | * | Commission Implementing Regulation (EU) No 1034/2013 of 24 October 2013 approving aluminium phosphide releasing phosphine as an active substance for use in biocidal products for product type 20 (
  1
  ) | 28 |
| | * | Commission Implementing Regulation (EU) No 1035/2013 of 24 October 2013 approving benzoic acid as an existing active substance for use in biocidal products for product-types 3 and 4 (
  1
  ) | 31 |
| | * | Commission Implementing Regulation (EU) No 1036/2013 of 24 October 2013 approving etofenprox as an existing active substance for use in biocidal products for product-type 18 (
  1
  ) | 35 |
| | * | Commission Implementing Regulation (EU) No 1037/2013 of 24 October 2013 approving IPBC as an existing active substance for use in biocidal products for product-type 6 (
  1
  ) | 38 |
| | * | Commission Implementing Regulation (EU) No 1038/2013 of 24 October 2013 approving tebuconazole as an existing active substance for use in biocidal products for product-types 7 and 10 (
  1
  ) | 40 |
| | * | Commission Implementing Regulation (EU) No 1039/2013 of 24 October 2013 modifying the approval of nonanoic acid as an existing active substance for use in biocidal products for product-type 2 (
  1
  ) | 43 |
| | * | Commission Implementing Regulation (EU) No 1040/2013 of 24 October 2013 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive for pigs for fattening and minor porcine species for fattening other than Sus scrofa domesticus and turkeys for fattening (holder of authorisation Aveve NV) (
  1
  ) | 46 |
| | | Commission Implementing Regulation (EU) No 1041/2013 of 24 October 2013 establishing the standard import values for determining the entry price of certain fruit and vegetables | 50 |

II   Non-legislative acts

REGULATIONS

*

Council Implementing Regulation (EU) No 1026/2013 of 22 October 2013 terminating the partial interim review concerning the anti-dumping measures applicable to imports of certain iron or steel fasteners originating in the People’s Republic of China, as extended to imports consigned from Malaysia, whether declared as originating in Malaysia or not

7

*

Commission Regulation (EU) No 1027/2013 of 23 October 2013 establishing a prohibition of fishing for cod in Skagerrak area by vessels flying the flag of Sweden

9

*

Commission Regulation (EU) No 1028/2013 of 23 October 2013 establishing a prohibition of fishing for redfish in EU and International waters of V, international waters of XII and XIV by vessels flying the flag of Germany

11

*

Commission Regulation (EU) No 1029/2013 of 23 October 2013 establishing a prohibition of fishing for hake in VI and VII; EU and international waters of Vb; international waters of XII and XIV by vessels flying the flag of the Netherlands

13

*

Commission Implementing Regulation (EU) No 1030/2013 of 24 October 2013 amending Regulation (EC) No 889/2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control

15

*

Commission Implementing Regulation (EU) No 1031/2013 of 24 October 2013 approving the active substance penflufen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (
  1
  )

1

17

*

Commission Implementing Regulation (EU) No 1032/2013 of 24 October 2013 approving bromoacetic acid as an existing active substance for use in biocidal products for product-type 4 (
  1
  )

1

22

*

Commission Implementing Regulation (EU) No 1033/2013 of 24 October 2013 approving copper sulphate pentahydrate as an existing active substance for use in biocidal products for product-type 2 (
  1
  )

1

25

*

Commission Implementing Regulation (EU) No 1034/2013 of 24 October 2013 approving aluminium phosphide releasing phosphine as an active substance for use in biocidal products for product type 20 (
  1
  )

1

28

*

Commission Implementing Regulation (EU) No 1035/2013 of 24 October 2013 approving benzoic acid as an existing active substance for use in biocidal products for product-types 3 and 4 (
  1
  )

1

31

*

Commission Implementing Regulation (EU) No 1036/2013 of 24 October 2013 approving etofenprox as an existing active substance for use in biocidal products for product-type 18 (
  1
  )

1

35

*

Commission Implementing Regulation (EU) No 1037/2013 of 24 October 2013 approving IPBC as an existing active substance for use in biocidal products for product-type 6 (
  1
  )

1

38

*

Commission Implementing Regulation (EU) No 1038/2013 of 24 October 2013 approving tebuconazole as an existing active substance for use in biocidal products for product-types 7 and 10 (
  1
  )

1

40

*

Commission Implementing Regulation (EU) No 1039/2013 of 24 October 2013 modifying the approval of nonanoic acid as an existing active substance for use in biocidal products for product-type 2 (
  1
  )

1

43

*

Commission Implementing Regulation (EU) No 1040/2013 of 24 October 2013 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive for pigs for fattening and minor porcine species for fattening other than Sus scrofa domesticus and turkeys for fattening (holder of authorisation Aveve NV) (
  1
  )

Trichoderma reesei

Trichoderma reesei

Sus scrofa domesticus

1

46

Commission Implementing Regulation (EU) No 1041/2013 of 24 October 2013 establishing the standard import values for determining the entry price of certain fruit and vegetables

50

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

---

(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.

---

I Legislative acts

DECISIONS

| 25.10.2013 | EN | Official Journal of the European Union | L 283/1 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/1

---

DECISION No 1025/2013/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 22 October 2013

providing macro-financial assistance to the Kyrgyz Republic

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 209 thereof,

Having regard to the proposal from the European Commission,

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

Acting in accordance with the ordinary legislative procedure (1),

Whereas:

| (1) | Cooperation between the Union and the Kyrgyz Republic is based on the Partnership and Cooperation Agreement establishing a partnership between the European Communities and their Member States, of the one part, and the Kyrgyz Republic, of the other part (2) (PCA) that entered into force in 1999. The Union grants Generalised System of Preferences treatment to the Kyrgyz Republic. |
| --- | --- |

(1)

Cooperation between the Union and the Kyrgyz Republic is based on the Partnership and Cooperation Agreement establishing a partnership between the European Communities and their Member States, of the one part, and the Kyrgyz Republic, of the other part (2) (PCA) that entered into force in 1999. The Union grants Generalised System of Preferences treatment to the Kyrgyz Republic.

| (2) | The Kyrgyz economy was affected in 2009 by the international financial crisis and in June 2010 by ethnic violence. These events disrupted economic activities, creating substantial public expenditure needs for reconstruction and social assistance, and resulted in important external and budgetary financial gaps. |
| --- | --- |

(2)

The Kyrgyz economy was affected in 2009 by the international financial crisis and in June 2010 by ethnic violence. These events disrupted economic activities, creating substantial public expenditure needs for reconstruction and social assistance, and resulted in important external and budgetary financial gaps.

| (3) | At a High Level Donors Meeting held in Bishkek on 27 July 2010, the international community pledged USD 1,1 billion in emergency support to assist in the recovery of the Kyrgyz Republic. At that meeting, the Union announced that it would provide up to EUR 117,9 million in financial assistance. |
| --- | --- |

(3)

At a High Level Donors Meeting held in Bishkek on 27 July 2010, the international community pledged USD 1,1 billion in emergency support to assist in the recovery of the Kyrgyz Republic. At that meeting, the Union announced that it would provide up to EUR 117,9 million in financial assistance.

| (4) | The Council, meeting in its foreign affairs configuration, in its conclusions on the Kyrgyz Republic of 26 July 2010, welcomed the efforts of the new Kyrgyz government to establish a democratic institutional framework and invited the Commission to continue providing assistance, including in the form of new assistance programmes, to the authorities of the Kyrgyz Republic in the implementation of their reform programme and to contribute to the sustainable economic and social development of the country. |
| --- | --- |

(4)

The Council, meeting in its foreign affairs configuration, in its conclusions on the Kyrgyz Republic of 26 July 2010, welcomed the efforts of the new Kyrgyz government to establish a democratic institutional framework and invited the Commission to continue providing assistance, including in the form of new assistance programmes, to the authorities of the Kyrgyz Republic in the implementation of their reform programme and to contribute to the sustainable economic and social development of the country.

| (5) | Union political and economic support to the Kyrgyz Republic’s incipient parliamentary democracy would provide a political signal of the Union’s strong support to democratic reforms in Central Asia, consistent with the Union’s policy towards the region, as set out in the Union Strategy for Central Asia (2007-13) and in the Council conclusions on Central Asia of 25 June 2012. |
| --- | --- |

(5)

Union political and economic support to the Kyrgyz Republic’s incipient parliamentary democracy would provide a political signal of the Union’s strong support to democratic reforms in Central Asia, consistent with the Union’s policy towards the region, as set out in the Union Strategy for Central Asia (2007-13) and in the Council conclusions on Central Asia of 25 June 2012.

| (6) | In line with the Joint Declaration by the European Parliament and the Council adopted together with Decision No 778/2013/EU of the European Parliament and of the Council (3), Union macro-financial assistance should be an exceptional financial instrument of untied and undesignated balance-of-payments support which aims at restoring a beneficiary’s sustainable external finance situation and should underpin the implementation of a policy programme containing strong adjustment and structural reform measures designed to improve the balance of payment position, in particular over the programme period, and reinforce the implementation of relevant agreements and programmes with the Union. |
| --- | --- |

(6)

In line with the Joint Declaration by the European Parliament and the Council adopted together with Decision No 778/2013/EU of the European Parliament and of the Council (3), Union macro-financial assistance should be an exceptional financial instrument of untied and undesignated balance-of-payments support which aims at restoring a beneficiary’s sustainable external finance situation and should underpin the implementation of a policy programme containing strong adjustment and structural reform measures designed to improve the balance of payment position, in particular over the programme period, and reinforce the implementation of relevant agreements and programmes with the Union.

| (7) | The economic adjustment and reform process of the Kyrgyz Republic is supported by financial assistance from the International Monetary Fund (IMF). In June 2011, the Kyrgyz authorities and the IMF agreed on a non-precautionary three-year IMF Extended Credit Facility (‘IMF programme’) of SDR 66,6 million (Special Drawing Rights) in support of the country. The IMF approved the fourth review of that programme in June 2013. The objectives of the IMF programme are consistent with the purpose of the Union macro-financial assistance, namely to alleviate short-term balance of payment difficulties, and the implementation of strong adjustment measures consistent with the aim of Union macro-financial assistance. |
| --- | --- |

(7)

The economic adjustment and reform process of the Kyrgyz Republic is supported by financial assistance from the International Monetary Fund (IMF). In June 2011, the Kyrgyz authorities and the IMF agreed on a non-precautionary three-year IMF Extended Credit Facility (‘IMF programme’) of SDR 66,6 million (Special Drawing Rights) in support of the country. The IMF approved the fourth review of that programme in June 2013. The objectives of the IMF programme are consistent with the purpose of the Union macro-financial assistance, namely to alleviate short-term balance of payment difficulties, and the implementation of strong adjustment measures consistent with the aim of Union macro-financial assistance.

| (8) | The Union provides sectoral budget support to the Kyrgyz Republic under the Development Cooperation Instrument of a total of EUR 33 million over the period 2011-13 to support reforms in social protection, education and public financial management. |
| --- | --- |

(8)

The Union provides sectoral budget support to the Kyrgyz Republic under the Development Cooperation Instrument of a total of EUR 33 million over the period 2011-13 to support reforms in social protection, education and public financial management.

| (9) | In 2010, in view of the worsening economic situation and outlook, the Kyrgyz Republic requested Union macro-financial assistance. |
| --- | --- |

(9)

In 2010, in view of the worsening economic situation and outlook, the Kyrgyz Republic requested Union macro-financial assistance.

| (10) | Given the Kyrgyz Republic’s strategic importance for the Union, as well as the determining role it plays in regional stability, the Kyrgyz Republic should, exceptionally, be considered to be eligible to receive Union macro-financial assistance. |
| --- | --- |

(10)

Given the Kyrgyz Republic’s strategic importance for the Union, as well as the determining role it plays in regional stability, the Kyrgyz Republic should, exceptionally, be considered to be eligible to receive Union macro-financial assistance.

| (11) | Given that there is still a significant residual external financing gap in the balance of payments of the Kyrgyz Republic over and above the resources provided by IMF and other multilateral institutions, and despite the implementation of strong economic stabilisation and reform programmes by the Kyrgyz Republic, the Union macro-financial assistance to be provided to the Kyrgyz Republic (‘the Union’s macro-financial assistance’) is, under the current exceptional circumstances, considered to be an appropriate response to the Kyrgyz Republic’s request to support economic stabilisation in conjunction with the IMF programme. |
| --- | --- |

(11)

Given that there is still a significant residual external financing gap in the balance of payments of the Kyrgyz Republic over and above the resources provided by IMF and other multilateral institutions, and despite the implementation of strong economic stabilisation and reform programmes by the Kyrgyz Republic, the Union macro-financial assistance to be provided to the Kyrgyz Republic (‘the Union’s macro-financial assistance’) is, under the current exceptional circumstances, considered to be an appropriate response to the Kyrgyz Republic’s request to support economic stabilisation in conjunction with the IMF programme.

| (12) | The Union’s macro-financial assistance should aim to support the restoration of a sustainable external financing situation for the Kyrgyz Republic, thereby supporting its economic and social development. |
| --- | --- |

(12)

The Union’s macro-financial assistance should aim to support the restoration of a sustainable external financing situation for the Kyrgyz Republic, thereby supporting its economic and social development.

| (13) | The determination of the amount of the Union’s macro-financial assistance is based on a complete quantitative assessment of the Kyrgyz Republic’s residual external financing needs, and takes into account its capacity to finance itself with its own resources, in particular the international reserves at its disposal. The Union’s macro-financial assistance should complement the programmes and resources provided by the IMF and the World Bank. The determination of the amount of the assistance also takes into account expected financial contributions from multilateral donors and the need to ensure fair burden sharing between the Union and other donors, as well as the pre-existing deployment of the Union’s other external financing instruments in the Kyrgyz Republic and the added value of the overall Union involvement. |
| --- | --- |

(13)

The determination of the amount of the Union’s macro-financial assistance is based on a complete quantitative assessment of the Kyrgyz Republic’s residual external financing needs, and takes into account its capacity to finance itself with its own resources, in particular the international reserves at its disposal. The Union’s macro-financial assistance should complement the programmes and resources provided by the IMF and the World Bank. The determination of the amount of the assistance also takes into account expected financial contributions from multilateral donors and the need to ensure fair burden sharing between the Union and other donors, as well as the pre-existing deployment of the Union’s other external financing instruments in the Kyrgyz Republic and the added value of the overall Union involvement.

| (14) | Taking into consideration the Kyrgyz Republic’s residual external financing needs, the level of its economic development, as measured by per capita income and poverty ratios, its capacity to finance itself with its own resources, in particular the international reserves at its disposal, and the assessment of its ability to repay drawing on debt sustainability analysis, a part of the assistance should be provided in the form of grants. |
| --- | --- |

(14)

Taking into consideration the Kyrgyz Republic’s residual external financing needs, the level of its economic development, as measured by per capita income and poverty ratios, its capacity to finance itself with its own resources, in particular the international reserves at its disposal, and the assessment of its ability to repay drawing on debt sustainability analysis, a part of the assistance should be provided in the form of grants.

| (15) | The Commission should ensure that the Union’s macro-financial assistance is legally and substantially in line with the key principles, objectives and measures taken within the different areas of external action and other relevant Union policies. |
| --- | --- |

(15)

The Commission should ensure that the Union’s macro-financial assistance is legally and substantially in line with the key principles, objectives and measures taken within the different areas of external action and other relevant Union policies.

| (16) | The Union’s macro-financial assistance should support the Union’s external policy towards the Kyrgyz Republic. Commission services and the European External Action Service should work closely together throughout the macro-financial assistance operation in order to coordinate, and to ensure the consistency of, Union external policy. |
| --- | --- |

(16)

The Union’s macro-financial assistance should support the Union’s external policy towards the Kyrgyz Republic. Commission services and the European External Action Service should work closely together throughout the macro-financial assistance operation in order to coordinate, and to ensure the consistency of, Union external policy.

| (17) | The Union’s macro-financial assistance should support the Kyrgyz Republic’s commitment to values shared with the Union, including democracy, the rule of law, good governance, respect for human rights, sustainable development and poverty reduction, as well as its commitment to the principles of open, rule-based and fair trade. |
| --- | --- |

(17)

The Union’s macro-financial assistance should support the Kyrgyz Republic’s commitment to values shared with the Union, including democracy, the rule of law, good governance, respect for human rights, sustainable development and poverty reduction, as well as its commitment to the principles of open, rule-based and fair trade.

| (18) | A precondition for granting the Union’s macro-financial assistance should be that the Kyrgyz Republic respects effective democratic mechanisms, including a multi-party parliamentary system and the rule of law, and guarantees respect for human rights. In addition, the specific objectives of the Union’s macro-financial assistance should strengthen the efficiency, transparency and accountability of public finance management systems in the Kyrgyz Republic. Both fulfilment of the precondition and the achievement of those objectives should be regularly monitored by the Commission. |
| --- | --- |

(18)

A precondition for granting the Union’s macro-financial assistance should be that the Kyrgyz Republic respects effective democratic mechanisms, including a multi-party parliamentary system and the rule of law, and guarantees respect for human rights. In addition, the specific objectives of the Union’s macro-financial assistance should strengthen the efficiency, transparency and accountability of public finance management systems in the Kyrgyz Republic. Both fulfilment of the precondition and the achievement of those objectives should be regularly monitored by the Commission.

| (19) | In order to ensure that the Union’s financial interests linked to the Union’s macro-financial assistance are protected efficiently, the Kyrgyz Republic should take appropriate measures relating to the prevention of, and fight against, fraud, corruption and any other irregularities linked to the assistance. In addition, provision should be made for the Commission to carry out checks and for the Court of Auditors to carry out audits. |
| --- | --- |

(19)

In order to ensure that the Union’s financial interests linked to the Union’s macro-financial assistance are protected efficiently, the Kyrgyz Republic should take appropriate measures relating to the prevention of, and fight against, fraud, corruption and any other irregularities linked to the assistance. In addition, provision should be made for the Commission to carry out checks and for the Court of Auditors to carry out audits.

| (20) | Release of the Union’s macro-financial assistance is without prejudice to the powers of the European Parliament and the Council. |
| --- | --- |

(20)

Release of the Union’s macro-financial assistance is without prejudice to the powers of the European Parliament and the Council.

| (21) | The amounts of macro-financial assistance provided in the form of grants and the amounts of the provision required for macro-financial assistance in the form of loans should be consistent with the budgetary appropriations provided for in the multiannual financial framework. |
| --- | --- |

(21)

The amounts of macro-financial assistance provided in the form of grants and the amounts of the provision required for macro-financial assistance in the form of loans should be consistent with the budgetary appropriations provided for in the multiannual financial framework.

| (22) | The Union’s macro-financial assistance should be managed by the Commission. In order to ensure that the European Parliament and the Council are able to follow the implementation of this Decision, the Commission should regularly inform them of developments relating to the assistance and provide them with relevant documents. |
| --- | --- |

(22)

The Union’s macro-financial assistance should be managed by the Commission. In order to ensure that the European Parliament and the Council are able to follow the implementation of this Decision, the Commission should regularly inform them of developments relating to the assistance and provide them with relevant documents.

| (23) | In order to ensure uniform conditions for the implementation of this Decision, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (4). |
| --- | --- |

(23)

In order to ensure uniform conditions for the implementation of this Decision, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (4).

| (24) | The Union’s macro-financial assistance should be subject to economic policy conditions, to be laid down in a Memorandum of Understanding. In order to ensure uniform conditions of implementation and for reasons of efficiency, the Commission should be empowered to negotiate such conditions with the Kyrgyz authorities under the supervision of the committee of representatives of the Member States in accordance with Regulation (EU) No 182/2011. Under that Regulation, the advisory procedure should, as a general rule, apply in all cases other than as provided for in that Regulation. Considering the potentially important impact of assistance of more than EUR 90 million, it is appropriate that the examination procedure be used for operations above that threshold. Considering the amount of the Union’s macro-financial assistance to the Kyrgyz Republic, the advisory procedure should apply to the adoption of the Memorandum of Understanding, and to any reduction, suspension or cancellation of the assistance. |
| --- | --- |

(24)

The Union’s macro-financial assistance should be subject to economic policy conditions, to be laid down in a Memorandum of Understanding. In order to ensure uniform conditions of implementation and for reasons of efficiency, the Commission should be empowered to negotiate such conditions with the Kyrgyz authorities under the supervision of the committee of representatives of the Member States in accordance with Regulation (EU) No 182/2011. Under that Regulation, the advisory procedure should, as a general rule, apply in all cases other than as provided for in that Regulation. Considering the potentially important impact of assistance of more than EUR 90 million, it is appropriate that the examination procedure be used for operations above that threshold. Considering the amount of the Union’s macro-financial assistance to the Kyrgyz Republic, the advisory procedure should apply to the adoption of the Memorandum of Understanding, and to any reduction, suspension or cancellation of the assistance.

| (25) | According to the IMF, the Kyrgyz Republic falls under the category of emerging and developing economies; according to the World Bank, the Kyrgyz Republic is part of the group of low-income economies and International Development Association (IDA) countries; according to the UN-OHRLLS (5), the Kyrgyz Republic falls under the category of ‘landlocked-developing country’; according to the OECD’s Development Assistance Committee, it is in the list of other low income countries. Therefore, the Kyrgyz Republic should be considered to be a developing country in the sense of Article 208 of the Treaty, which justifies the choice of Article 209 of the Treaty as a legal basis for this Decision, |
| --- | --- |

(25)

According to the IMF, the Kyrgyz Republic falls under the category of emerging and developing economies; according to the World Bank, the Kyrgyz Republic is part of the group of low-income economies and International Development Association (IDA) countries; according to the UN-OHRLLS (5), the Kyrgyz Republic falls under the category of ‘landlocked-developing country’; according to the OECD’s Development Assistance Committee, it is in the list of other low income countries. Therefore, the Kyrgyz Republic should be considered to be a developing country in the sense of Article 208 of the Treaty, which justifies the choice of Article 209 of the Treaty as a legal basis for this Decision,

HAVE ADOPTED THIS DECISION:

Article 1

1.   The Union shall make macro-financial assistance available to the Kyrgyz Republic (‘the Union’s macro-financial assistance’) of a maximum amount of EUR 30 million, with a view to supporting the Kyrgyz Republic’s economic stabilisation and covering its balance of payments needs as identified in the current IMF programme. Of that maximum amount, up to EUR 15 million shall be provided in the form of loans and up to EUR 15 million in the form of grants. The release of the Union’s macro-financial assistance is subject to the approval of the Union budget for the relevant year by the European Parliament and the Council.

2.   In order to finance the loan component of the Union’s macro-financial assistance, the Commission shall be empowered on behalf of the Union to borrow the necessary funds on the capital markets or from financial institutions and to on-lend them to the Kyrgyz Republic. The loans shall have a maximum maturity of 15 years.

3.   The release of the Union’s macro-financial assistance shall be managed by the Commission in a manner consistent with the agreements or understandings reached between the IMF and the Kyrgyz Republic, and with the key principles and objectives of economic reforms set out in the PCA and in the Union Strategy for Central Asia (2007-13). The Commission shall regularly inform the European Parliament and the Council of developments regarding the Union’s macro-financial assistance, including disbursements thereof, and shall provide those institutions with the relevant documents in due time.

4.   The Union’s macro-financial assistance shall be made available for a period of two years from the first day after the entry into force of the Memorandum of Understanding referred to in Article 3(1).

5.   Where the financing needs of the Kyrgyz Republic decrease fundamentally during the period of the disbursement of the Union’s macro-financial assistance compared to the initial projections, the Commission, acting in accordance with the advisory procedure referred to in Article 7(2), shall reduce the amount of the assistance or suspend or cancel it.

Article 2

A pre-condition for granting the Union’s macro-financial assistance shall be that the Kyrgyz Republic respects effective democratic mechanisms, including a multi-party parliamentary system and the rule of law, and guarantees respect for human rights. The Commission shall monitor the fulfilment of this pre-condition throughout the life-cycle of the Union’s macro-financial assistance. This Article shall be applied in accordance with Council Decision 2010/427/EU (6).

Article 3

1.   The Commission, in accordance with the advisory procedure referred to in Article 7(2), shall agree with the Kyrgyz authorities on clearly defined economic policy and financial conditions, focusing on structural reforms and sound public finances, to which the Union’s macro-financial assistance is to be subject, to be laid down in a Memorandum of Understanding (‘the Memorandum of Understanding’) which shall include a timeframe for the fulfilment of those conditions. The economic policy and financial conditions set out in the Memorandum of Understanding shall be consistent with the agreements or understandings referred to in Article 1(3), including the macroeconomic adjustment and structural reform programmes implemented by the Kyrgyz Republic, with the support of the IMF.

2.   Those conditions shall aim, in particular, to enhance the efficiency, transparency and accountability of the Union’s macro-financial assistance, including public finance management systems in the Kyrgyz Republic. Progress in mutual market opening, the development of rules-based and fair trade and other priorities in the context of the Union’s external policy shall also be duly taken into account when designing the policy measures. Progress in attaining those objectives shall be regularly monitored by the Commission.

3.   The detailed financial terms of the Union’s macro-financial assistance shall be laid down in a Grant Agreement and a Loan Agreement to be agreed between the Commission and the Kyrgyz authorities.

4.   During the implementation of the Union’s macro-financial assistance, the Commission shall monitor the soundness of the Kyrgyz Republic’s financial arrangements, the administrative procedures and the internal and external control mechanisms which are relevant to the assistance, as well as the Kyrgyz Republic’s adherence to the agreed timeframe.

5.   The Commission shall verify at regular intervals that the conditions in Article 4(3) continue to be met, including that the economic policies of the Kyrgyz Republic are in accordance with the objectives of the Union’s macro-financial assistance. In so doing, the Commission shall coordinate closely with the IMF and the World Bank, and, where necessary, with the European Parliament and the Council.

Article 4

1.   Subject to the conditions in paragraph 3, the Union’s macro-financial assistance shall be made available by the Commission in two instalments, each of which shall consist of a loan and a grant element. The size of each instalment shall be laid down in the Memorandum of Understanding.

2.   The amounts of the Union’s macro-financial assistance provided in the form of loans shall be provisioned, where required, in accordance with Council Regulation (EC, Euratom) No 480/2009 (7).

3.   The Commission shall decide on the release of the instalments subject to the fulfilment of all of the following conditions:

| (a) | the precondition set out in Article 2; |
| --- | --- |

(a)

the precondition set out in Article 2;

| (b) | a continuous satisfactory track record of implementing a policy programme that contains strong adjustment and structural reform measures supported by a non-precautionary IMF credit arrangement; and |
| --- | --- |

(b)

a continuous satisfactory track record of implementing a policy programme that contains strong adjustment and structural reform measures supported by a non-precautionary IMF credit arrangement; and

| (c) | the implementation, within a specific time-frame, of the economic policy conditions agreed in the Memorandum of Understanding. |
| --- | --- |

(c)

the implementation, within a specific time-frame, of the economic policy conditions agreed in the Memorandum of Understanding.

The disbursement of the second instalment shall not take place earlier than three months after the release of the first instalment.

4.   Where the conditions in paragraph 3 are not met, the Commission shall temporarily suspend or cancel the disbursement of the Union’s macro-financial assistance. In such cases, it shall inform the European Parliament and the Council of the reasons for that suspension or cancellation.

5.   The Union’s macro-financial assistance shall be disbursed to the National Bank of the Kyrgyz Republic. Subject to provisions to be agreed in the Memorandum of Understanding, including a confirmation of residual budgetary financing needs, the Union funds may be transferred to the Treasury of the Kyrgyz Republic as the final beneficiary.

Article 5

1.   The borrowing and lending operations related to the loan component of the Union’s macro-financial assistance shall be carried out in euro using the same value date and shall not involve the Union in the transformation of maturities, or expose it to any exchange or interest rate risks, or to any other commercial risk.

2.   Where the circumstances permit, and if the Kyrgyz Republic so requests, the Commission may take the steps necessary to ensure that an early repayment clause is included in the loan terms and conditions and that it is matched by a corresponding clause in the terms and conditions of the borrowing operations.

3.   Where circumstances permit an improvement of the interest rate of the loan and if the Kyrgyz Republic so requests, the Commission may decide to refinance all or part of its initial borrowings or may restructure the corresponding financial conditions. Refinancing or restructuring operations shall be carried out in accordance with paragraphs 1 and 4 and shall not have the effect of extending the maturity of the borrowings concerned or of increasing the amount of capital outstanding at the date of the refinancing or restructuring.

4.   All costs incurred by the Union which relate to the borrowing and lending operations under this Decision shall be borne by the Kyrgyz Republic.

5.   The Commission shall inform the European Parliament and the Council of developments in the operations referred to in paragraphs 2 and 3.

Article 6

1.   The Union’s macro-financial assistance shall be implemented in accordance with Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (8) and Commission Delegated Regulation (EU) No 1268/2012 (9).

2.   The implementation of the Union’s macro-financial assistance shall be under direct management.

3.   The Memorandum of Understanding, the Loan Agreement and the Grant Agreement to be agreed with the Kyrgyz authorities shall contain provisions:

| (a) | ensuring that the Kyrgyz Republic regularly checks that financing provided from the budget of the Union has been properly used, takes appropriate measures to prevent irregularities and fraud and, if necessary, takes legal action to recover any funds provided under this Decision that have been misappropriated; |
| --- | --- |

(a)

ensuring that the Kyrgyz Republic regularly checks that financing provided from the budget of the Union has been properly used, takes appropriate measures to prevent irregularities and fraud and, if necessary, takes legal action to recover any funds provided under this Decision that have been misappropriated;

| (b) | ensuring the protection of the Union’s financial interests, in particular providing for specific measures in relation to the prevention of, and fight against, fraud, corruption and any other irregularities affecting the Union’s macro-financial assistance, in accordance with Council Regulation (EC, Euratom) No 2988/95 (10), Council Regulation (Euratom, EC) No 2185/96 (11) and Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (12); |
| --- | --- |

(b)

ensuring the protection of the Union’s financial interests, in particular providing for specific measures in relation to the prevention of, and fight against, fraud, corruption and any other irregularities affecting the Union’s macro-financial assistance, in accordance with Council Regulation (EC, Euratom) No 2988/95 (10), Council Regulation (Euratom, EC) No 2185/96 (11) and Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (12);

| (c) | expressly authorising the Commission, including the European Anti-Fraud Office, or its representatives to carry out checks, including on-the-spot checks and inspections; |
| --- | --- |

(c)

expressly authorising the Commission, including the European Anti-Fraud Office, or its representatives to carry out checks, including on-the-spot checks and inspections;

| (d) | expressly authorising the Commission and the Court of Auditors to perform audits during and after the availability period of the Union’s macro-financial assistance, including document audits and on-the-spot audits, such as operational assessments; |
| --- | --- |

(d)

expressly authorising the Commission and the Court of Auditors to perform audits during and after the availability period of the Union’s macro-financial assistance, including document audits and on-the-spot audits, such as operational assessments;

| (e) | ensuring that the Union is entitled to full repayment of the grant and/or early repayment of the loan where it has been established that, in relation to the management of the Union’s macro-financial assistance, the Kyrgyz Republic has engaged in any act of fraud or corruption or any other illegal activity detrimental to the financial interests of the Union. |
| --- | --- |

(e)

ensuring that the Union is entitled to full repayment of the grant and/or early repayment of the loan where it has been established that, in relation to the management of the Union’s macro-financial assistance, the Kyrgyz Republic has engaged in any act of fraud or corruption or any other illegal activity detrimental to the financial interests of the Union.

4.   During the implementation of the Union’s macro-financial assistance, the Commission shall monitor, by means of operational assessments, the soundness of the Kyrgyz Republic’s financial arrangements, the administrative procedures, and the internal and external control mechanisms which are relevant to such assistance.

Article 7

1.   The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.   Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

Article 8

1.   By 30 June of each year, the Commission shall submit to the European Parliament and to the Council a report on the implementation of this Decision in the preceding year, including an evaluation of that implementation. The report shall:

| (a) | examine the progress made in implementing the Union’s macro-financial assistance; |
| --- | --- |

(a)

examine the progress made in implementing the Union’s macro-financial assistance;

| (b) | assess the economic situation and prospects of the Kyrgyz Republic, as well as progress made in implementing the policy measures referred to in Article 3(1); |
| --- | --- |

(b)

assess the economic situation and prospects of the Kyrgyz Republic, as well as progress made in implementing the policy measures referred to in Article 3(1);

| (c) | indicate the connection between the economic policy conditions as laid down in the Memorandum of Understanding, the Kyrgyz Republic’s ongoing economic and fiscal performance and the Commission’s decisions to release the instalments of the Union’s macro-financial assistance. |
| --- | --- |

(c)

indicate the connection between the economic policy conditions as laid down in the Memorandum of Understanding, the Kyrgyz Republic’s ongoing economic and fiscal performance and the Commission’s decisions to release the instalments of the Union’s macro-financial assistance.

2.   Not later than two years after the expiry of the availability period referred to in Article 1(4), the Commission shall submit to the European Parliament and to the Council an ex-post evaluation report, assessing the results and efficiency of the completed Union’s macro-financial assistance and the extent to which it has contributed to the aims of the assistance.

Article 9

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

Done at Strasbourg, 22 October 2013.

For the European Parliament

The President

M. SCHULZ

For the Council

The President

V. LEŠKEVIČIUS

---

(1)  Position of the European Parliament of 11 December 2012 and position of the Council at first reading of 23 September 2013 (not yet published in the Official Journal). Position of the European Parliament of 22 October 2013 (not yet published in the Official Journal).

1

(2)  OJ L 196, 28.7.1999, p. 48.

2

(3)  Decision No 778/2013/EU of the European Parliament and of the Council of 12 August 2013 providing further macro-financial assistance to Georgia(OJ L 218, 14.8.2013, p. 15).

3

(4)  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

4

(5)  UN Office of the High Representative for the Least Developed Countries, Landlocked Developing Countries and SmallIslandDeveloping States.

5

(6)  Council Decision 2010/427/EU of 26 July 2010 establishing the organisation and functioning of the European External Action Service (OJ L 201, 3.8.2010, p. 30).

6

(7)  Council Regulation (EC, Euratom) No 480/2009 of 25 May 2009 establishing a Guarantee Fund for external actions (OJ L 145, 10.6.2009, p. 10).

7

(8)  Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1).

8

(9)  Commission Delegated Regulation (EU) No 1268/2012 of 29 October 2012 on the rules of application of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council on the financial rules applicable to the general budget of the Union (OJ L 362, 31.12.2012, p. 1).

9

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

10

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

11

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

12

---

II Non-legislative acts

REGULATIONS

| 25.10.2013 | EN | Official Journal of the European Union | L 283/7 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/7

---

COUNCIL IMPLEMENTING REGULATION (EU) No 1026/2013

of 22 October 2013

terminating the partial interim review concerning the anti-dumping measures applicable to imports of certain iron or steel fasteners originating in the People’s Republic of China, as extended to imports consigned from Malaysia, whether declared as originating in Malaysia or not

THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to Council Regulation (EC) No 1225/2009 of 30 November 2009 on protection against dumped imports from countries not members of the European Community (1) (‘the basic Regulation’), and in particular Articles 11(3) and 13(4) thereof,

Having regard to the proposal submitted by the European Commission after consulting the Advisory Committee,

Whereas:

1.   PROCEDURE

1.1.   Measures in force

| (1) | By Regulation (EC) No 91/2009 (2), as amended by Council Implementing Regulation (EU) No 924/2012 (3), the Council imposed a definitive anti-dumping duty on imports of certain iron or steel fasteners currently falling within CN codes ex 7318 12 90, ex 7318 14 91, ex 7318 14 99, ex 7318 15 59, ex 7318 15 69, ex 7318 15 81, ex 7318 15 89, ex 7318 15 90, ex 7318 21 00 and ex 7318 22 00 originating in the People’s Republic of China (the ‘measures in force’). |
| --- | --- |

(1)

By Regulation (EC) No 91/2009 (2), as amended by Council Implementing Regulation (EU) No 924/2012 (3), the Council imposed a definitive anti-dumping duty on imports of certain iron or steel fasteners currently falling within CN codes ex 7318 12 90, ex 7318 14 91, ex 7318 14 99, ex 7318 15 59, ex 7318 15 69, ex 7318 15 81, ex 7318 15 89, ex 7318 15 90, ex 7318 21 00 and ex 7318 22 00 originating in the People’s Republic of China (the ‘measures in force’).

| (2) | By Implementing Regulation (EU) No 723/2011 (4), the Council extended the measures in force to imports of certain iron or steel fasteners consigned from Malaysia, whether declared as originating in Malaysia or not (the ‘measures in force as extended’). |
| --- | --- |

(2)

By Implementing Regulation (EU) No 723/2011 (4), the Council extended the measures in force to imports of certain iron or steel fasteners consigned from Malaysia, whether declared as originating in Malaysia or not (the ‘measures in force as extended’).

1.2.   Request for a partial interim review

| (3) | A request for a partial interim review pursuant to Articles 11(3) and 13(4) of the basic Regulation was lodged by Malaysian Precision Manufacturing SDN BHD (‘the applicant’), an exporting producer from Malaysia. |
| --- | --- |

(3)

A request for a partial interim review pursuant to Articles 11(3) and 13(4) of the basic Regulation was lodged by Malaysian Precision Manufacturing SDN BHD (‘the applicant’), an exporting producer from Malaysia.

| (4) | The request was limited in scope to granting an exemption from the measures in force as extended to the applicant. |
| --- | --- |

(4)

The request was limited in scope to granting an exemption from the measures in force as extended to the applicant.

| (5) | In the request, the applicant claimed that it is a genuine producer of certain iron or steel fasteners and that it is able to produce the entire quantity of certain iron or steel fasteners that it has shipped to the Union since the start of the investigation period of the anti-circumvention investigation leading to the imposition of the measures in force as extended. |
| --- | --- |

(5)

In the request, the applicant claimed that it is a genuine producer of certain iron or steel fasteners and that it is able to produce the entire quantity of certain iron or steel fasteners that it has shipped to the Union since the start of the investigation period of the anti-circumvention investigation leading to the imposition of the measures in force as extended.

| (6) | The applicant provided prima facie evidence that it has been established as a producer of certain iron or steel fasteners in Malaysia long before the imposition of the measures in force. In addition, the applicant claimed that although it is related to certain producers of certain iron or steel fasteners located in the People’s Republic of China, its relationships with its related companies in the People’s Republic of China had been established before the imposition of the measures in force, and that these relationships have not been used to circumvent the measures in force as extended. |
| --- | --- |

(6)

The applicant provided prima facie evidence that it has been established as a producer of certain iron or steel fasteners in Malaysia long before the imposition of the measures in force. In addition, the applicant claimed that although it is related to certain producers of certain iron or steel fasteners located in the People’s Republic of China, its relationships with its related companies in the People’s Republic of China had been established before the imposition of the measures in force, and that these relationships have not been used to circumvent the measures in force as extended.

1.3.   Initiation of a partial interim review

| (7) | On 14 May 2013, having determined, after consulting the Advisory Committee, that the request contained sufficient prima facie evidence to justify the initiation of a partial interim review, the Commission initiated a partial interim review pursuant to Articles 11(3) and 13(4) of the basic Regulation by a notice published in the Official Journal of the European Union
   (5) (‘the Notice of initiation’). That partial interim review was limited to the examination of the possibility of granting an exemption from the measures in force as extended to the applicant. |
| --- | --- |

(7)

On 14 May 2013, having determined, after consulting the Advisory Committee, that the request contained sufficient prima facie evidence to justify the initiation of a partial interim review, the Commission initiated a partial interim review pursuant to Articles 11(3) and 13(4) of the basic Regulation by a notice published in the Official Journal of the European Union
   (5) (‘the Notice of initiation’). That partial interim review was limited to the examination of the possibility of granting an exemption from the measures in force as extended to the applicant.

1.4.   Interested parties

| (8) | The Commission officially informed the applicant, the representatives of Malaysia and the People’s Republic of China and the association of Union producers about the initiation of the partial interim review. Interested parties were given the opportunity to make their views known in writing and to a request a hearing within the time limit set in the Notice of initiation. Only the applicant came forward. No hearing has been requested. |
| --- | --- |

(8)

The Commission officially informed the applicant, the representatives of Malaysia and the People’s Republic of China and the association of Union producers about the initiation of the partial interim review. Interested parties were given the opportunity to make their views known in writing and to a request a hearing within the time limit set in the Notice of initiation. Only the applicant came forward. No hearing has been requested.

| (9) | In order to obtain the information deemed necessary for its investigation, the Commission sent a questionnaire to the applicant, who did not provide any reply within the deadline set for that purpose. |
| --- | --- |

(9)

In order to obtain the information deemed necessary for its investigation, the Commission sent a questionnaire to the applicant, who did not provide any reply within the deadline set for that purpose.

2.   WITHDRAWAL OF THE REQUEST AND TERMINATION OF THE PROCEEDING

| (10) | On 18 June 2013, the applicant withdrew its request for the partial interim review of the measures in force as extended. The applicant claimed that it was not able to provide the Commission with the data requested in the questionnaire as regards its related companies. Furthermore, the applicant complained that the deadline for submitting the questionnaire reply was too short. However, no substantiated request for an extension of the time limit for submitting the reply to the questionnaire has been made. |
| --- | --- |

(10)

On 18 June 2013, the applicant withdrew its request for the partial interim review of the measures in force as extended. The applicant claimed that it was not able to provide the Commission with the data requested in the questionnaire as regards its related companies. Furthermore, the applicant complained that the deadline for submitting the questionnaire reply was too short. However, no substantiated request for an extension of the time limit for submitting the reply to the questionnaire has been made.

| (11) | In view of the withdrawal, it was considered whether it would be warranted to continue the review investigation ex officio. The Commission found that no compelling reasons existed which would lead to the conclusion that termination would not be in the Union interest. On this basis, the review investigation should be terminated. |
| --- | --- |

(11)

In view of the withdrawal, it was considered whether it would be warranted to continue the review investigation ex officio. The Commission found that no compelling reasons existed which would lead to the conclusion that termination would not be in the Union interest. On this basis, the review investigation should be terminated.

| (12) | Interested parties were informed of the intention to terminate the review investigation and were given the opportunity to comment. No comments were received. |
| --- | --- |

(12)

Interested parties were informed of the intention to terminate the review investigation and were given the opportunity to comment. No comments were received.

| (13) | It is therefore concluded that the partial interim review concerning the anti-dumping measures applicable to imports of certain iron or steel fasteners originating in the People’s Republic of China, as extended to imports of certain iron or steel fasteners consigned from Malaysia, whether declared as originating in Malaysia or not, should be terminated without amending the anti-dumping measures in force as extended, |
| --- | --- |

(13)

It is therefore concluded that the partial interim review concerning the anti-dumping measures applicable to imports of certain iron or steel fasteners originating in the People’s Republic of China, as extended to imports of certain iron or steel fasteners consigned from Malaysia, whether declared as originating in Malaysia or not, should be terminated without amending the anti-dumping measures in force as extended,

HAS ADOPTED THIS REGULATION:

Article 1

The partial interim review of the anti-dumping measures applicable to imports of certain iron or steel fasteners originating in the People's Republic of China, as extended to imports of certain iron or steel fasteners consigned from Malaysia, whether declared as originating in Malaysia or not, initiated pursuant to Articles 11(3) and 13(4) of Regulation (EC) No 1225/2009 is hereby terminated without amending the anti-dumping measures in force as extended.

Article 2

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 Luxembourg, 22 October 2013.

For the Council

The President

L. LINKEVIČIUS

---

(1)  OJ L 343, 22.12.2009, p. 51.

1

(2)  OJ L 29, 31.1.2009, p. 1.

2

(3)  OJ L 275, 10.10.2012, p. 1.

3

(4)  OJ L 194, 26.7.2011, p. 6.

4

(5)  OJ C 134, 14.5.2013, p. 34.

5

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/9 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/9

---

COMMISSION REGULATION (EU) No 1027/2013

of 23 October 2013

establishing a prohibition of fishing for cod in Skagerrak area by vessels flying the flag of Sweden

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

| (1) | Council Regulation (EU) No 40/2013 of 21 January 2013 fixing for 2013 the fishing opportunities available in EU waters and, to EU vessels, in certain non-EU waters for certain fish stocks and groups of fish stocks which are subject to international negotiations or agreements (2), lays down quotas for 2013. |
| --- | --- |

(1)

Council Regulation (EU) No 40/2013 of 21 January 2013 fixing for 2013 the fishing opportunities available in EU waters and, to EU vessels, in certain non-EU waters for certain fish stocks and groups of fish stocks which are subject to international negotiations or agreements (2), lays down quotas for 2013.

| (2) | According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2013. |
| --- | --- |

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2013.

| (3) | It is therefore necessary to prohibit fishing activities for that stock, |
| --- | --- |

(3)

It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2013 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

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, 23 October 2013.

For the Commission, On behalf of the President,

Lowri EVANS

Director-General for Maritime Affairs and Fisheries

---

(1)  OJ L 343, 22.12.2009, p. 1.

1

(2)  OJ L 23, 25.1.2013, p. 54.

2

---

ANNEX

| No | 60/TQ40 |
| --- | --- |
| Member State | Sweden |
| Stock | COD/03AN |
| Species | Cod (Gadus Morhua) |
| Zone | Skagerrak |
| Date | 11.10.2013 |

No

60/TQ40

Member State

Sweden

Stock

COD/03AN

Species

Cod (Gadus Morhua)

Zone

Skagerrak

Date

11.10.2013

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/11 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/11

---

COMMISSION REGULATION (EU) No 1028/2013

of 23 October 2013

establishing a prohibition of fishing for redfish in EU and International waters of V, international waters of XII and XIV by vessels flying the flag of Germany

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

| (1) | Council Regulation (EU) No 40/2013 of 21 January 2013 fixing for 2013 the fishing opportunities available in EU waters and, to EU vessels, in certain non-EU waters for certain fish stocks and groups of fish stocks which are subject to international negotiations or agreements (2), lays down quotas for 2013. |
| --- | --- |

(1)

Council Regulation (EU) No 40/2013 of 21 January 2013 fixing for 2013 the fishing opportunities available in EU waters and, to EU vessels, in certain non-EU waters for certain fish stocks and groups of fish stocks which are subject to international negotiations or agreements (2), lays down quotas for 2013.

| (2) | According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2013. |
| --- | --- |

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2013.

| (3) | It is therefore necessary to prohibit fishing activities for that stock, |
| --- | --- |

(3)

It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2013 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

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, 23 October 2013.

For the Commission, On behalf of the President,

Lowri EVANS

Director-General for Maritime Affairs and Fisheries

---

(1)  OJ L 343, 22.12.2009, p. 1.

1

(2)  OJ L 23, 25.1.2013, p. 54.

2

---

ANNEX

| No | 61/TQ40 |
| --- | --- |
| Member State | Germany |
| Stock | RED/51214D |
| Species | Redfish (Sebastes spp.) |
| Zone | EU and International waters of V, international waters of XII and XIV |
| Date | 9.10.2013 |

No

61/TQ40

Member State

Germany

Stock

RED/51214D

Species

Redfish (Sebastes spp.)

Zone

EU and International waters of V, international waters of XII and XIV

Date

9.10.2013

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/13 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/13

---

COMMISSION REGULATION (EU) No 1029/2013

of 23 October 2013

establishing a prohibition of fishing for hake in VI and VII; EU and international waters of Vb; international waters of XII and XIV by vessels flying the flag of the Netherlands

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

| (1) | Council Regulation (EU) No 39/2013 of 21 January 2013 fixing for 2013 the fishing opportunities available to EU vessels for certain fish stocks and groups of fish stocks which are not subject to international negotiations or agreements (2), lays down quotas for 2013. |
| --- | --- |

(1)

Council Regulation (EU) No 39/2013 of 21 January 2013 fixing for 2013 the fishing opportunities available to EU vessels for certain fish stocks and groups of fish stocks which are not subject to international negotiations or agreements (2), lays down quotas for 2013.

| (2) | According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2013. |
| --- | --- |

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2013.

| (3) | It is therefore necessary to prohibit fishing activities for that stock, |
| --- | --- |

(3)

It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2013 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

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, 23 October 2013.

For the Commission, On behalf of the President,

Lowri EVANS

Director-General for Maritime Affairs and Fisheries

---

(1)  OJ L 343, 22.12.2009, p. 1.

1

(2)  OJ L 23, 25.1.2013, p. 1.

2

---

ANNEX

| No | 59/TQ39 |
| --- | --- |
| Member State | The Netherlands |
| Stock | HKE/571214 |
| Species | Hake (Merluccius merluccius) |
| Zone | VI and VII; EU and international waters of Vb; international waters of XII and XIV |
| Date | 7.10.2013 |

No

59/TQ39

Member State

The Netherlands

Stock

HKE/571214

Species

Hake (Merluccius merluccius)

Zone

VI and VII; EU and international waters of Vb; international waters of XII and XIV

Date

7.10.2013

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/15 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/15

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1030/2013

of 24 October 2013

amending Regulation (EC) No 889/2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (1), and in particular Articles 13(3) and 15(2) and Article 40 thereof,

Whereas:

| (1) | Regulation (EC) No 834/2007 establishes basic requirements for the organic production of seaweed and aquaculture animals. Detailed rules for the implementation of those requirements are laid down in Commission Regulation (EC) No 889/2008 (2), as amended in particular by Commission Regulation (EC) No 710/2009 (3). |
| --- | --- |

(1)

Regulation (EC) No 834/2007 establishes basic requirements for the organic production of seaweed and aquaculture animals. Detailed rules for the implementation of those requirements are laid down in Commission Regulation (EC) No 889/2008 (2), as amended in particular by Commission Regulation (EC) No 710/2009 (3).

| (2) | Pursuant to Article 95(11) of Regulation (EC) No 889/2008 national authorities may, for a period expiring on 1 July 2013, authorise those aquaculture and seaweed production units which were established and produced under nationally accepted organic rules before 1 January 2009 to keep their organic status under specified conditions. |
| --- | --- |

(2)

Pursuant to Article 95(11) of Regulation (EC) No 889/2008 national authorities may, for a period expiring on 1 July 2013, authorise those aquaculture and seaweed production units which were established and produced under nationally accepted organic rules before 1 January 2009 to keep their organic status under specified conditions.

| (3) | Seven Member States recently submitted requests for a revision of the rules on products, substances and techniques which can be used in organic aquaculture production. Those requests should be evaluated by the Expert group for technical advice on organic production established by Commission Decision 2009/427/EC (4). |
| --- | --- |

(3)

Seven Member States recently submitted requests for a revision of the rules on products, substances and techniques which can be used in organic aquaculture production. Those requests should be evaluated by the Expert group for technical advice on organic production established by Commission Decision 2009/427/EC (4).

| (4) | Organic production of seaweed and of aquaculture animals are still relatively new fields, characterised by a wide diversity and a high level of technical complexity and it has become apparent that a longer period of transition is needed. |
| --- | --- |

(4)

Organic production of seaweed and of aquaculture animals are still relatively new fields, characterised by a wide diversity and a high level of technical complexity and it has become apparent that a longer period of transition is needed.

| (5) | In order to allow for continuity and time for the necessary evaluation of the requests submitted by Member States and avoid disruption for production units which were established and producing under nationally accepted rules before 1 January 2009, it is appropriate to extend the transitional period set up by Article 95(11) of Regulation (EC) No 889/2008. |
| --- | --- |

(5)

In order to allow for continuity and time for the necessary evaluation of the requests submitted by Member States and avoid disruption for production units which were established and producing under nationally accepted rules before 1 January 2009, it is appropriate to extend the transitional period set up by Article 95(11) of Regulation (EC) No 889/2008.

| (6) | In order to ensure that there is no disruption in the organic status of those production units, this Regulation should apply from 1 July 2013. |
| --- | --- |

(6)

In order to ensure that there is no disruption in the organic status of those production units, this Regulation should apply from 1 July 2013.

| (7) | Regulation (EC) No 889/2008 should therefore be amended accordingly. |
| --- | --- |

(7)

Regulation (EC) No 889/2008 should therefore be amended accordingly.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the regulatory Committee on organic production, |
| --- | --- |

(8)

The measures provided for in this Regulation are in accordance with the opinion of the regulatory Committee on organic production,

HAS ADOPTED THIS REGULATION:

Article 1

In paragraph 11 of Article 95 of Regulation (EC) No 889/2008, ‘1 July 2013’ is replaced by ‘1 January 2015’.

Article 2

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

It shall apply from 1 July 2013.

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

Done at Brussels, 24 October 2013.

For the Commission

The President

José Manuel BARROSO

---

(1)  OJ L 189, 20.7.2007, p. 1.

1

(2)  OJ L 250, 18.9.2008, p. 1.

2

(3)  OJ L 204, 6.8.2009. p. 15.

3

(4)  OJ L 139, 5.6.2009, p. 29.

4

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/17 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/17

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1031/2013

of 24 October 2013

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

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,

Whereas:

| (1) | In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For penflufen the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2010/672/EU (3). |
| --- | --- |

(1)

In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For penflufen the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2010/672/EU (3).

| (2) | In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 9 December 2009 an application from Bayer CropScience AG for the inclusion of the active substance penflufen in Annex I to Directive 91/414/EEC. Decision 2010/672/EU confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. |
| --- | --- |

(2)

In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 9 December 2009 an application from Bayer CropScience AG for the inclusion of the active substance penflufen in Annex I to Directive 91/414/EEC. Decision 2010/672/EU confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

| (3) | For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 4 August 2011. |
| --- | --- |

(3)

For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 4 August 2011.

| (4) | The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the review of the pesticide risk assessment of the active substance penflufen (4) on 30 July 2012. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and the draft assessment report was finalised on 15 March 2013 in the format of the Commission review report for penflufen. |
| --- | --- |

(4)

The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the review of the pesticide risk assessment of the active substance penflufen (4) on 30 July 2012. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and the draft assessment report was finalised on 15 March 2013 in the format of the Commission review report for penflufen.

| (5) | It has appeared from the various examinations made that plant protection products containing penflufen may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve penflufen. |
| --- | --- |

(5)

It has appeared from the various examinations made that plant protection products containing penflufen may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve penflufen.

| (6) | In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information. |
| --- | --- |

(6)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

| (7) | A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval. |
| --- | --- |

(7)

A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

| (8) | Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing penflufen. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles. |
| --- | --- |

(8)

Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing penflufen. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

| (9) | The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances. |
| --- | --- |

(9)

The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

| (10) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (6) should be amended accordingly. |
| --- | --- |

(10)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (6) should be amended accordingly.

| (11) | The Standing Committee on the Food chain and Animal Health did not deliver an opinion. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion, |
| --- | --- |

(11)

The Standing Committee on the Food chain and Animal Health did not deliver an opinion. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

HAS ADOPTED THIS REGULATION:

Article 1

Approval of active substance

The active substance penflufen, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2

Re-evaluation of plant protection products

1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing penflufen as an active substance by 31 July 2014.

By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in part B of the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.

2.   By way of derogation from paragraph 1, for each authorised plant protection product containing penflufen as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 January 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account part B of the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.

Following that determination Member States shall:

| (a) | in the case of a product containing penflufen as the only active substance, where necessary, amend or withdraw the authorisation by 31 July 2015 at the latest; or |
| --- | --- |

(a)

in the case of a product containing penflufen as the only active substance, where necessary, amend or withdraw the authorisation by 31 July 2015 at the latest; or

| (b) | in the case of a product containing penflufen as one of several active substances, where necessary, amend or withdraw the authorisation by 31 July 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest. |
| --- | --- |

(b)

in the case of a product containing penflufen as one of several active substances, where necessary, amend or withdraw the authorisation by 31 July 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

Article 3

Amendments to Implementing Regulation (EU) No 540/2011

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

Article 4

Entry into force and date of application

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

It shall apply from 1 February 2014.

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

Done at Brussels, 24 October 2013.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  OJ L 230, 19.8.1991, p. 1.

2

(3)  OJ L 290, 6.11.2010, p. 51.

3

(4)  EFSA Journal 2012; 10(8):2860. Available online: www.efsa.europa.eu

4

(5)  OJ L 366, 15.12.1992, p. 10.

5

(6)  OJ L 153, 11.6.2011, p. 1.

6

---

ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Penflufen
  CAS No 494793-67-8
  CIPAC No 826 | 2’-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide | ≥ 950 g/kg
  1:1 (R:S) ratio of enantiomers | 1 February 2014 | 31 January 2024 | PART A
  Only uses to treat seed potato tubers before or during planting, may be authorised, limited to one application every third year on the same field.
  PART B
  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on penflufen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  (a) | the protection of operators; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Penflufen

CAS No 494793-67-8

CIPAC No 826

2’-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide

≥ 950 g/kg

1:1 (R:S) ratio of enantiomers

1 February 2014

31 January 2024

PART A

Only uses to treat seed potato tubers before or during planting, may be authorised, limited to one application every third year on the same field.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on penflufen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.

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

(a)

the protection of operators;

| (b) | the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. |
| --- | --- |

(b)

the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

| (1) | the long term risk to birds; |
| --- | --- |

(1)

the long term risk to birds;

| (2) | the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for groundwater if penflufen is classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2) as ‘carcinogen category 2’. |
| --- | --- |

(2)

the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for groundwater if penflufen is classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2) as ‘carcinogen category 2’.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 September 2015 and the information set out in point (2) within six months from the notification of the classification decision concerning that substance.

The purity given in this entry is based on a pilot plant production. The examining Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

---

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

(2)  OJ L 353, 31.12.2008, p. 1.

---

ANNEX II

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

| Number | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- |
| ‘55 | Penflufen
  CAS No 494793-67-8
  CIPAC No 826 | 2’-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide | ≥ 950 g/kg
  1:1 (R:S) ratio of enantiomers | 1 February 2014 | 31 January 2024 | PART A
  Only uses to treat seed potato tubers before or during planting, may be authorised, limited to one application every third year on the same field.
  PART B
  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on penflufen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  (a) | the protection of operators; |

Number

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘55

Penflufen

CAS No 494793-67-8

CIPAC No 826

2’-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide

≥ 950 g/kg

1:1 (R:S) ratio of enantiomers

1 February 2014

31 January 2024

PART A

Only uses to treat seed potato tubers before or during planting, may be authorised, limited to one application every third year on the same field.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on penflufen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.

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

(a)

the protection of operators;

| (b) | the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. |
| --- | --- |

(b)

the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

| (1) | the long term risk to birds; |
| --- | --- |

(1)

the long term risk to birds;

| (2) | the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for groundwater if penflufen is classified under Regulation (EC) No 1272/2008 as ‘carcinogen category 2’. |
| --- | --- |

(2)

the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for groundwater if penflufen is classified under Regulation (EC) No 1272/2008 as ‘carcinogen category 2’.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 September 2015 and the information set out in point (2) within six months from the notification of the classification decision concerning that substance.

The purity given in this entry is based on a pilot plant production. The examining Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.’

---

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

1

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/22 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/22

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1032/2013

of 24 October 2013

approving bromoacetic acid as an existing active substance for use in biocidal products for product-type 4

(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 Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes bromoacetic acid. |
| --- | --- |

(1)

Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes bromoacetic acid.

| (2) | Bromoacetic acid has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 4, food and feed area disinfectants, as defined in Annex V to that Directive, which corresponds to product-type 4 as defined in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(2)

Bromoacetic acid has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 4, food and feed area disinfectants, as defined in Annex V to that Directive, which corresponds to product-type 4 as defined in Annex V to Regulation (EU) No 528/2012.

| (3) | Spain was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 22 January 2011 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
| --- | --- |

(3)

Spain was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 22 January 2011 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

| (4) | The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report. |
| --- | --- |

(4)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report.

| (5) | It appears from that report that biocidal products used for product-type 4 and containing bromoacetic acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. |
| --- | --- |

(5)

It appears from that report that biocidal products used for product-type 4 and containing bromoacetic acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.

| (6) | It is therefore appropriate to approve bromoacetic acid for use in biocidal products for product-type 4. |
| --- | --- |

(6)

It is therefore appropriate to approve bromoacetic acid for use in biocidal products for product-type 4.

| (7) | Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(7)

Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.

| (8) | The evaluation did not address the incorporation of biocidal products containing bromoacetic acid 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 (4). 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. |
| --- | --- |

(8)

The evaluation did not address the incorporation of biocidal products containing bromoacetic acid 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 (4). 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.

| (9) | A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed. |
| --- | --- |

(9)

A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed.

| (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

Bromoacetic acid shall be approved as an active substance for use in biocidal products for product-type 4, 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, 24 October 2013.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  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).

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)  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).

4

---

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 (2) |
| --- | --- | --- | --- | --- | --- | --- |
| Bromoacetic acid | IUPAC Name:
  2-bromo-ethanoic acid
  EC No: 201-175-8
  CAS No: 79-08-3 | 946 g/kg | 1 July 2015 | 30 June 2025 | 4 | 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.
  Authorisations are subject to the following condition:






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

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 (2)

Bromoacetic acid

IUPAC Name:

2-bromo-ethanoic acid

EC No: 201-175-8

CAS No: 79-08-3

946 g/kg

1 July 2015

30 June 2025

4

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.

Authorisations are subject to the following condition:

(1)

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

| (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 (3) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (4) 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 (3) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (4) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

| (3) | Products containing bromoacetic acid 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 bromoacetic acid into food or it has been established pursuant to that Regulation that such limits are not necessary. |
| --- | --- |

(3)

Products containing bromoacetic acid 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 bromoacetic acid into food or it has been established pursuant to that Regulation that such limits are not necessary.

Where a treated article has been treated with or intentionally incorporates bromoacetic acid, and where necessary due to the possibility of skin contact as well as the release of bromoacetic acid under normal conditions of use, the person responsible for placing the treated article on the market shall ensure that the label provides information on the risk of skin sensitisation, as well as the information referred to 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 8 of Regulation (EU) No 528/2012. 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)  For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm

(3)  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).

(4)  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).

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/25 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/25

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1033/2013

of 24 October 2013

approving copper sulphate pentahydrate as an existing active substance for use in biocidal products for product-type 2

(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 Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes copper sulphate. |
| --- | --- |

(1)

Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes copper sulphate.

| (2) | Copper sulphate has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 2, private area and public health area disinfectants and other biocidal products, as defined in Annex V to that Directive, which corresponds to product-type 2 as defined in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(2)

Copper sulphate has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 2, private area and public health area disinfectants and other biocidal products, as defined in Annex V to that Directive, which corresponds to product-type 2 as defined in Annex V to Regulation (EU) No 528/2012.

| (3) | The data submitted for the purpose of the evaluation allowed conclusions to be drawn only regarding a certain form of copper sulphate, i.e. copper sulphate pentahydrate CAS No 7758-99-8. The evaluation did not allow conclusions to be drawn regarding any other substance complying with the definition of copper sulphate CAS 7758-99-7 in the abovementioned list of active substances in Regulation (EC) No 1451/2007. Therefore, only copper sulphate pentahydrate should be covered by the approval. |
| --- | --- |

(3)

The data submitted for the purpose of the evaluation allowed conclusions to be drawn only regarding a certain form of copper sulphate, i.e. copper sulphate pentahydrate CAS No 7758-99-8. The evaluation did not allow conclusions to be drawn regarding any other substance complying with the definition of copper sulphate CAS 7758-99-7 in the abovementioned list of active substances in Regulation (EC) No 1451/2007. Therefore, only copper sulphate pentahydrate should be covered by the approval.

| (4) | France was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 5 April 2011 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
| --- | --- |

(4)

France was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 5 April 2011 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

| (5) | The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report. |
| --- | --- |

(5)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report.

| (6) | It appears from that report that biocidal products used for product-type 2 and containing copper sulphate pentahydrate may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. |
| --- | --- |

(6)

It appears from that report that biocidal products used for product-type 2 and containing copper sulphate pentahydrate may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.

| (7) | It is therefore appropriate to approve copper sulphate for use in biocidal products for product-type 2. |
| --- | --- |

(7)

It is therefore appropriate to approve copper sulphate for use in biocidal products for product-type 2.

| (8) | Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(8)

Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.

| (9) | A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed. |
| --- | --- |

(9)

A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed.

| (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

Copper sulphate pentahydrate shall be approved as an active substance for use in biocidal products for product-type 2, 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, 24 October 2013.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  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).

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

---

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 (2) |
| --- | --- | --- | --- | --- | --- | --- |
| Copper sulphate pentahydrate | IUPAC Name: copper sulphate pentahydrate
  EC No: 231-847-6 (3)

  CAS No: 7758-99-8 | 999 g/kg | 1 July 2015 | 30 June 2025 | 2 | 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.
  Authorisations are subject to the following condition:
  For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment. |

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 (2)

Copper sulphate pentahydrate

IUPAC Name: copper sulphate pentahydrate

EC No: 231-847-6 (3)

CAS No: 7758-99-8

999 g/kg

1 July 2015

30 June 2025

2

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.

Authorisations are subject to the following condition:

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

---

(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 8 of Regulation (EU) No 528/2012. 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)  For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm

(3)  Only copper sulphate pentahydrate should be considered under this EC number

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/28 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/28

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1034/2013

of 24 October 2013

approving aluminium phosphide releasing phosphine as an active substance for use in biocidal products for product type 20

(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 Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes aluminium phosphide. |
| --- | --- |

(1)

Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes aluminium phosphide.

| (2) | Aluminium phosphide has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 23, products for the control of other vertebrates, as defined in Annex V to that Directive, which corresponds to product-type 20 as defined in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(2)

Aluminium phosphide has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 23, products for the control of other vertebrates, as defined in Annex V to that Directive, which corresponds to product-type 20 as defined in Annex V to Regulation (EU) No 528/2012.

| (3) | Germany was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 23 July 2010 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
| --- | --- |

(3)

Germany was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 23 July 2010 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

| (4) | The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report. |
| --- | --- |

(4)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report.

| (5) | It appears from that report that biocidal products used for product-type 23 and containing aluminium phosphide may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. |
| --- | --- |

(5)

It appears from that report that biocidal products used for product-type 23 and containing aluminium phosphide may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.

| (6) | It is therefore appropriate to approve aluminium phosphide releasing phosphine for use in biocidal products for product-type 20. |
| --- | --- |

(6)

It is therefore appropriate to approve aluminium phosphide releasing phosphine for use in biocidal products for product-type 20.

| (7) | Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(7)

Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.

| (8) | A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed. |
| --- | --- |

(8)

A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(9)

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

Aluminium phosphide releasing phosphine shall be approved as an active substance for use in biocidal products for product-type 20, 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, 24 October 2013.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  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).

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

---

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 (2) |
| --- | --- | --- | --- | --- | --- | --- |
| Aluminium phosphide releasing phosphine | IUPAC Name: Aluminium phosphide
  EC No: 244-088-0
  CAS No: 20859-73-8 | 830 g/kg | 1 July 2015 | 30 June 2025 | 20 | 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.
  Authorisations are subject to the following conditions:






  (1) | Products shall only be sold to and used by specifically trained professionals. |

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 (2)

Aluminium phosphide releasing phosphine

IUPAC Name: Aluminium phosphide

EC No: 244-088-0

CAS No: 20859-73-8

830 g/kg

1 July 2015

30 June 2025

20

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.

Authorisations are subject to the following conditions:

(1)

Products shall only be sold to and used by specifically trained professionals.

| (2) | In view of the risks identified for operators, appropriate risk mitigation measures must be applied. These include, amongst others, the use of appropriate personal protective equipment, the use of applicators and the presentation of the product in a form designed to reduce operator exposure to an acceptable level. |
| --- | --- |

(2)

In view of the risks identified for operators, appropriate risk mitigation measures must be applied. These include, amongst others, the use of appropriate personal protective equipment, the use of applicators and the presentation of the product in a form designed to reduce operator exposure to an acceptable level.

| (3) | In view of the risks identified for terrestrial non-target species, appropriate risk reduction measures must be applied. These include, amongst others, the non-treatment of areas where other burrowing mammals than the target species are present. |
| --- | --- |

(3)

In view of the risks identified for terrestrial non-target species, appropriate risk reduction measures must be applied. These include, amongst others, the non-treatment of areas where other burrowing mammals than the target species are present.

---

(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 8 of Regulation (EU) No 528/2012. 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)  For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/31 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/31

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1035/2013

of 24 October 2013

approving benzoic acid as an existing active substance for use in biocidal products for product-types 3 and 4

(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 Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes benzoic acid. |
| --- | --- |

(1)

Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes benzoic acid.

| (2) | Benzoic acid has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 3, veterinary hygiene biocidal products, and product-type 4, food and feed area disinfectants, as defined in Annex V to that Directive, which correspond respectively to product-types 3 and 4 as defined in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(2)

Benzoic acid has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 3, veterinary hygiene biocidal products, and product-type 4, food and feed area disinfectants, as defined in Annex V to that Directive, which correspond respectively to product-types 3 and 4 as defined in Annex V to Regulation (EU) No 528/2012.

| (3) | Germany was designated as Rapporteur Member State and submitted the competent authority reports, together with recommendations, to the Commission on 3 February 2011 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
| --- | --- |

(3)

Germany was designated as Rapporteur Member State and submitted the competent authority reports, together with recommendations, to the Commission on 3 February 2011 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

| (4) | The competent authority reports were reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in two assessment reports. |
| --- | --- |

(4)

The competent authority reports were reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in two assessment reports.

| (5) | It appears from those reports that biocidal products used for product-types 3 and 4 and containing benzoic acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. |
| --- | --- |

(5)

It appears from those reports that biocidal products used for product-types 3 and 4 and containing benzoic acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.

| (6) | It is therefore appropriate to approve benzoic acid for use in biocidal products for product-types 3 and 4. |
| --- | --- |

(6)

It is therefore appropriate to approve benzoic acid for use in biocidal products for product-types 3 and 4.

| (7) | Since the evaluations did not address nanomaterials, the approvals should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(7)

Since the evaluations did not address nanomaterials, the approvals should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.

| (8) | For the use in product-type 4, the evaluation did not adress the incorporation of biocidal products containing benzoic acid 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 (4). 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. |
| --- | --- |

(8)

For the use in product-type 4, the evaluation did not adress the incorporation of biocidal products containing benzoic acid 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 (4). 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.

| (9) | A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed. |
| --- | --- |

(9)

A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed.

| (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

Benzoic acid shall be approved as an active substance for use in biocidal products for product-types 3 and 4, 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, 24 October 2013.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  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).

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)  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).

4

---

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 (2) |
| --- | --- | --- | --- | --- | --- | --- |
| Benzoic acid | IUPAC Name: Benzoic acid
  EC No: 200-618-2
  CAS No: 65-85-0 | 990 g/kg | 1 July 2015 | 30 June 2025 | 3 | 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.
  Authorisations are subject to the following conditions:






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

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 (2)

Benzoic acid

IUPAC Name: Benzoic acid

EC No: 200-618-2

CAS No: 65-85-0

990 g/kg

1 July 2015

30 June 2025

3

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.

Authorisations are subject to the following conditions:

(1)

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

| (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 (3) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (4) 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 (3) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (4) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

4

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.

Authorisations are subject to the following conditions:

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

(1)

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

| (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 or Regulation (EC) No 396/2005 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 or Regulation (EC) No 396/2005 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

| (3) | Products containing benzoic acid 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 benzoic acid into food or it has been established pursuant to that Regulation that such limits are not necessary. |
| --- | --- |

(3)

Products containing benzoic acid 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 benzoic acid into food or it has been established pursuant to that Regulation that such limits are not necessary.

---

(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 8 of Regulation (EU) No 528/2012. 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)  For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm

(3)  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).

(4)  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).

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/35 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/35

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1036/2013

of 24 October 2013

approving etofenprox as an existing active substance for use in biocidal products for product-type 18

(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 Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes etofenprox. |
| --- | --- |

(1)

Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes etofenprox.

| (2) | Etofenprox has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive, which corresponds to product-type 18 as defined in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(2)

Etofenprox has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive, which corresponds to product-type 18 as defined in Annex V to Regulation (EU) No 528/2012.

| (3) | Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 9 August 2011 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
| --- | --- |

(3)

Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 9 August 2011 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

| (4) | The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report. |
| --- | --- |

(4)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report.

| (5) | It appears from that report that biocidal products used for product-type 18 and containing etofenprox may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. |
| --- | --- |

(5)

It appears from that report that biocidal products used for product-type 18 and containing etofenprox may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.

| (6) | It also appears from the reports that the characteristics of etofenprox render it liable to bioaccumulate (B) and toxic (T), in accordance with the criteria laid down in Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4). The period of approval should be 10 years in consistency with the current practice under Directive 98/8/EC, since the conditions of Article 90(2) of Regulation (EU) No 528/2012 are not met. However, for the purpose of authorising products in accordance with Article 23 of Regulation (EU) No 528/2012, etofenprox shall be considered as a candidate for substitution pursuant to Article 10(1)(d) of that Regulation. |
| --- | --- |

(6)

It also appears from the reports that the characteristics of etofenprox render it liable to bioaccumulate (B) and toxic (T), in accordance with the criteria laid down in Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4). The period of approval should be 10 years in consistency with the current practice under Directive 98/8/EC, since the conditions of Article 90(2) of Regulation (EU) No 528/2012 are not met. However, for the purpose of authorising products in accordance with Article 23 of Regulation (EU) No 528/2012, etofenprox shall be considered as a candidate for substitution pursuant to Article 10(1)(d) of that Regulation.

| (7) | It is therefore appropriate to approve etofenprox for use in biocidal products for product-type 18. |
| --- | --- |

(7)

It is therefore appropriate to approve etofenprox for use in biocidal products for product-type 18.

| (8) | Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(8)

Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.

| (9) | A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed. |
| --- | --- |

(9)

A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed.

| (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

Etofenprox shall be approved as an active substance for use in biocidal products for product-type 18, 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, 24 October 2013.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  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).

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)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

4

---

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 (2) |
| --- | --- | --- | --- | --- | --- | --- |
| Etofenprox | IUPAC Name:
  3-phenoxybenzyl-2-(4-ethoxyphenyl)-2-methylpropylether
  EC No: 407-980-2
  CAS No: 80844-07-1 | 970 g/kg | 1 July 2015 | 30 June 2025 | 18 | Etofenprox is considered a candidate for substitution in accordance with article 10(1)(d) 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.
  Authorisations are subject to the following conditions:






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

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 (2)

Etofenprox

IUPAC Name:

3-phenoxybenzyl-2-(4-ethoxyphenyl)-2-methylpropylether

EC No: 407-980-2

CAS No: 80844-07-1

970 g/kg

1 July 2015

30 June 2025

18

Etofenprox is considered a candidate for substitution in accordance with article 10(1)(d) 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.

Authorisations are subject to the following conditions:

(1)

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

| (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 (3) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (4) 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 (3) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (4) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

---

(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 8 of Regulation (EU) No 528/2012. 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)  For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm

(3)  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).

(4)  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).

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/38 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/38

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1037/2013

of 24 October 2013

approving IPBC as an existing 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 the third subparagraph of Article 89(1) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes IPBC. |
| --- | --- |

(1)

Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes IPBC.

| (2) | IPBC has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 6, in-can preservatives, as defined in Annex V to that Directive, which corresponds to product-type 6 as defined in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(2)

IPBC has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 6, in-can preservatives, as defined in Annex V to that Directive, which corresponds to product-type 6 as defined in Annex V to Regulation (EU) No 528/2012.

| (3) | Denmark was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 27 June 2011 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
| --- | --- |

(3)

Denmark was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 27 June 2011 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

| (4) | The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report. |
| --- | --- |

(4)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report.

| (5) | It appears from that report that biocidal products used for product-type 6 and containing IPBC may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. |
| --- | --- |

(5)

It appears from that report that biocidal products used for product-type 6 and containing IPBC may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.

| (6) | It is therefore appropriate to approve IPBC for use in biocidal products for product-type 6. |
| --- | --- |

(6)

It is therefore appropriate to approve IPBC for use in biocidal products for product-type 6.

| (7) | Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(7)

Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.

| (8) | A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed. |
| --- | --- |

(8)

A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(9)

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

IPBC shall be 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, 24 October 2013.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  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).

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

---

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 (2) |
| --- | --- | --- | --- | --- | --- | --- |
| IPBC | IUPAC Name:
  3-iodo-2-propynyl butylcarbamate
  EC No: 259-627-5
  CAS No: 55406-53-6 | 980 g/kg | 1 July 2015 | 30 June 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.
  Authorisations are subject to the following condition:
  For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment.
  Where a treated article has been treated with or intentionally incorporates IPBC, and where necessary due to the possibility of skin contact as well as the release of IPBC under normal conditions of use, the person responsible for placing the treated article on the market shall ensure that the label provides information on the risk of skin sensitisation, as well as the information referred to in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. |

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 (2)

IPBC

IUPAC Name:

3-iodo-2-propynyl butylcarbamate

EC No: 259-627-5

CAS No: 55406-53-6

980 g/kg

1 July 2015

30 June 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.

Authorisations are subject to the following condition:

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

Where a treated article has been treated with or intentionally incorporates IPBC, and where necessary due to the possibility of skin contact as well as the release of IPBC under normal conditions of use, the person responsible for placing the treated article on the market shall ensure that the label provides information on the risk of skin sensitisation, as well as the information referred to 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 8 of Regulation (EU) No 528/2012. 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)  For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/40 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/40

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1038/2013

of 24 October 2013

approving tebuconazole as an existing active substance for use in biocidal products for product-types 7 and 10

(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 Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes tebuconazole. |
| --- | --- |

(1)

Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes tebuconazole.

| (2) | Tebuconazole has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 7, film preservatives, and product-type 10, masonry preservatives, as defined in Annex V to that Directive, which correspond respectively to product-types 7 and 10 as defined in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(2)

Tebuconazole has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 7, film preservatives, and product-type 10, masonry preservatives, as defined in Annex V to that Directive, which correspond respectively to product-types 7 and 10 as defined in Annex V to Regulation (EU) No 528/2012.

| (3) | Denmark was designated as rapporteur Member State and submitted the competent authority reports, together with recommendations, to the Commission on 16 April 2012 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
| --- | --- |

(3)

Denmark was designated as rapporteur Member State and submitted the competent authority reports, together with recommendations, to the Commission on 16 April 2012 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

| (4) | The competent authority reports were reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in two assessment reports. |
| --- | --- |

(4)

The competent authority reports were reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in two assessment reports.

| (5) | It appears from those reports that biocidal products used for product-types 7 and 10 and containing tebuconazole may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. |
| --- | --- |

(5)

It appears from those reports that biocidal products used for product-types 7 and 10 and containing tebuconazole may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.

| (6) | It also appears from the reports that the characteristics of tebuconazole render it very persistent (vP) and toxic (T) in accordance with the criteria laid down in Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4). The period of approval should be 10 years in consistency with the current practice under Directive 98/8/EC, since the conditions of Article 90(2) of Regulation (EU) No 528/2012 are not met. However, for the purpose of authorising products in accordance with Article 23 of Regulation (EU) No 528/2012, tebuconazole shall be considered as a candidate for substitution pursuant to Article 10(1)(d) of that Regulation. |
| --- | --- |

(6)

It also appears from the reports that the characteristics of tebuconazole render it very persistent (vP) and toxic (T) in accordance with the criteria laid down in Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4). The period of approval should be 10 years in consistency with the current practice under Directive 98/8/EC, since the conditions of Article 90(2) of Regulation (EU) No 528/2012 are not met. However, for the purpose of authorising products in accordance with Article 23 of Regulation (EU) No 528/2012, tebuconazole shall be considered as a candidate for substitution pursuant to Article 10(1)(d) of that Regulation.

| (7) | It is therefore appropriate to approve tebuconazole for use in biocidal products for product-types 7 and 10. |
| --- | --- |

(7)

It is therefore appropriate to approve tebuconazole for use in biocidal products for product-types 7 and 10.

| (8) | Since the evaluations did not address nanomaterials, the approvals should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(8)

Since the evaluations did not address nanomaterials, the approvals should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.

| (9) | A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed. |
| --- | --- |

(9)

A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed.

| (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

Tebuconazole shall be approved as an active substance for use in biocidal products for product-types 7 and 10, 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, 24 October 2013.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  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).

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)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

4

---

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 (2) |
| --- | --- | --- | --- | --- | --- | --- |
| Tebuconazole | IUPAC Name:
  1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol
  EC No: 403-640-2
  CAS No: 107534-96-3 | 950 g/kg | 1 July 2015 | 30 June 2025 | 7 | Tebuconazole is considered a candidate for substitution in accordance with Article 10(1)(d) 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.
  Authorisations are subject to the following condition:
  For industrial users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment. |
| 10 | Tebuconazole is considered a candidate for substitution in accordance with Article 10(1)(d) 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.
  Authorisations are subject to the following conditions:






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

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 (2)

Tebuconazole

IUPAC Name:

1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol

EC No: 403-640-2

CAS No: 107534-96-3

950 g/kg

1 July 2015

30 June 2025

7

Tebuconazole is considered a candidate for substitution in accordance with Article 10(1)(d) 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.

Authorisations are subject to the following condition:

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

10

Tebuconazole is considered a candidate for substitution in accordance with Article 10(1)(d) 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.

Authorisations are subject to the following conditions:

(1)

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

| (2) | In the view of the risk for the soil compartment, tebuconazole shall not be used in a sealant that will be used to seal vertical joints outside residential facades (e.g. between two houses), unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level by other means. |
| --- | --- |

(2)

In the view of the risk for the soil compartment, tebuconazole shall not be used in a sealant that will be used to seal vertical joints outside residential facades (e.g. between two houses), unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level by other means.

---

(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 8 of Regulation (EU) No 528/2012. 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)  For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/43 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/43

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1039/2013

of 24 October 2013

modifying the approval of nonanoic acid as an existing active substance for use in biocidal products for product-type 2

(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 Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes nonanoic acid. |
| --- | --- |

(1)

Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes nonanoic acid.

| (2) | Nonanoic acid has been included into Annex I to Directive 98/8/EC for use in product-type 2 through Commission Directive 2012/41/EU (4), and is therefore considered as approved for that product-type by virtue of Article 86 of Regulation (EU) No 528/2012. |
| --- | --- |

(2)

Nonanoic acid has been included into Annex I to Directive 98/8/EC for use in product-type 2 through Commission Directive 2012/41/EU (4), and is therefore considered as approved for that product-type by virtue of Article 86 of Regulation (EU) No 528/2012.

| (3) | Furthermore, nonanoic acid has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 10, masonry preservatives, as defined in Annex V to that Directive. The evaluation covered use as an algaecide for the curative treatment of construction materials. That specific use is now covered by product-type 2 as defined in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(3)

Furthermore, nonanoic acid has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 10, masonry preservatives, as defined in Annex V to that Directive. The evaluation covered use as an algaecide for the curative treatment of construction materials. That specific use is now covered by product-type 2 as defined in Annex V to Regulation (EU) No 528/2012.

| (4) | Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 3 April 2012 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
| --- | --- |

(4)

Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 3 April 2012 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

| (5) | The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report. |
| --- | --- |

(5)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report.

| (6) | It appears from that report that biocidal products used as an algaecide for the curative treatment of construction materials and containing nonanoic acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. |
| --- | --- |

(6)

It appears from that report that biocidal products used as an algaecide for the curative treatment of construction materials and containing nonanoic acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.

| (7) | The existing approval of nonanoic acid for product-type 2 does not cover the conditions resulting from the evaluation of products used as an algaecide for the curative treatment of construction materials. It is therefore appropriate to complement that existing approval with those conditions. For the purpose of allowing all interested parties to prepare themselves to meet the new requirements following from the recent redefinition of biocidal product-types, it is furthermore appropriate to modify the date of approval originally provided for by Directive 2012/41/EU. |
| --- | --- |

(7)

The existing approval of nonanoic acid for product-type 2 does not cover the conditions resulting from the evaluation of products used as an algaecide for the curative treatment of construction materials. It is therefore appropriate to complement that existing approval with those conditions. For the purpose of allowing all interested parties to prepare themselves to meet the new requirements following from the recent redefinition of biocidal product-types, it is furthermore appropriate to modify the date of approval originally provided for by Directive 2012/41/EU.

| (8) | Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(8)

Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(9)

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

Nonanoic acid shall be approved as an active substance for use in biocidal products for product-type 2, subject to the specifications, the new conditions and the new date of approval 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, 24 October 2013.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  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).

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 Directive No 2012/41/EU of 26 November 2012 amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion in Annex I thereto of the active substance nonanoic acid to product type 2 (OJ L 327, 27.11.2012, p. 28).

4

---

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 (2) |
| --- | --- | --- | --- | --- | --- | --- |
| Nonanoic acid, Pelargonic acid | IUPAC Name: Nonanoic acid
  EC No: 203-931-2
  CAS No: 112-05-0 | 896 g/kg | 1 October 2015 | 30 September 2025 | 2 | 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.
  Authorisations are subject to the following conditions:






  1. | Unless it can be demonstrated in the application for product authorisation that risks for human health can be reduced to acceptable levels by other means, authorisation shall be subject to the following conditions:






  (a) | Instructions for use informing on how to minimize aerosol exposure. |

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 (2)

Nonanoic acid, Pelargonic acid

IUPAC Name: Nonanoic acid

EC No: 203-931-2

CAS No: 112-05-0

896 g/kg

1 October 2015

30 September 2025

2

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.

Authorisations are subject to the following conditions:

1.

Unless it can be demonstrated in the application for product authorisation that risks for human health can be reduced to acceptable levels by other means, authorisation shall be subject to the following conditions:

(a)

Instructions for use informing on how to minimize aerosol exposure.

| (b) | Authorisation of products for non-professional users are subject to the packaging being designed to minimise user exposure. |
| --- | --- |

(b)

Authorisation of products for non-professional users are subject to the packaging being designed to minimise user exposure.

| 2. | Authorisation of products used as algaecide for outdoor remedial treatment of construction materials shall be subject to safe operating procedures and risk mitigation measures in order to protect the environment. |
| --- | --- |

2.

Authorisation of products used as algaecide for outdoor remedial treatment of construction materials shall be subject to safe operating procedures and risk mitigation measures in order to protect the environment.

---

(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 8 of Regulation (EU) No 528/2012. 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)  For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/46 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/46

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1040/2013

of 24 October 2013

concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive for pigs for fattening and minor porcine species for fattening other than Sus scrofa domesticus and turkeys for fattening (holder of authorisation Aveve NV)

(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 Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | That application concerns the authorisation of a new use of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive for pigs for fattening and minor porcine species for fattening other than Sus scrofa domesticus, and turkeys for fattening, to be classified in the additive category ‘zootechnical additives’. |
| --- | --- |

(3)

That application concerns the authorisation of a new use of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive for pigs for fattening and minor porcine species for fattening other than Sus scrofa domesticus, and turkeys for fattening, to be classified in the additive category ‘zootechnical additives’.

| (4) | The use of that preparation was authorised for 10 years for chickens for fattening by Commission Regulation (EC) No 1091/2009 (2), for weaned piglets by Commission Implementing Regulation (EU) No 1088/2011 (3) and for laying hens and minor poultry species for fattening and laying by Commission Implementing Regulation (EU) No 989/2012 (4). |
| --- | --- |

(4)

The use of that preparation was authorised for 10 years for chickens for fattening by Commission Regulation (EC) No 1091/2009 (2), for weaned piglets by Commission Implementing Regulation (EU) No 1088/2011 (3) and for laying hens and minor poultry species for fattening and laying by Commission Implementing Regulation (EU) No 989/2012 (4).

| (5) | The European Food Safety Authority (‘the Authority’) in its opinions of 12 March 2013 (5) confirmed its previous conclusions that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) does not have an adverse effect on animal health, human health or the environment. The Authority concluded that the additive has the potential to improve the zootechnical performance in pigs for fattening and that this conclusion can be extrapolated to minor porcine species for fattening other than Sus scrofa domesticus. The Authority also concluded that the additive has the potential to improve the final body weight and feed to gain ratio in turkeys for fattening. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(5)

The European Food Safety Authority (‘the Authority’) in its opinions of 12 March 2013 (5) confirmed its previous conclusions that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) does not have an adverse effect on animal health, human health or the environment. The Authority concluded that the additive has the potential to improve the zootechnical performance in pigs for fattening and that this conclusion can be extrapolated to minor porcine species for fattening other than Sus scrofa domesticus. The Authority also concluded that the additive has the potential to improve the final body weight and feed to gain ratio in turkeys for fattening. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (6) | The assessment of the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(6)

The assessment of the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition subject to the conditions laid down in that 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, 24 October 2013.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  Commission Regulation (EC) No 1091/2009 of 13 November 2009 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive for chickens for fattening (holder of authorisation Aveve NV) (OJ L 299, 14.11.2009, p. 6).

2

Trichoderma reesei

Trichoderma reesei

(3)  Commission Implementing Regulation (EU) No 1088/2011 of 27 October 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MULC 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MULC 49754) as a feed additive for weaned piglets (holder of authorisation Aveve NV) (OJ L 281, 28.10.2011, p. 14).

3

Trichoderma reesei

Trichoderma reesei

(4)  Commission Implementing Regulation (EU) No 989/2012 of 25 October 2012 concerning the authorisation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MULC 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MULC 49754) as a feed additive for laying hens and minor poultry species for fattening and laying (holder of authorisation Aveve NV)

4

Trichoderma reesei

Trichoderma reesei

(OJ L 297, 26.10.2012, p. 11).

(5)  EFSA Journal 2013; 11(4):3171 and EFSA Journal 2013; 11(4):3172.

5

EFSA Journal 2013

EFSA Journal 2013

---

ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method. | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Units of activity/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: digestibility enhancers |
| 4a9 | Aveve NV | Endo-1,4-beta-xylanase
  EC 3.2.1.8
  Endo-1,3(4)-beta-glucanase
  EC 3.2.1.6 | | Additive composition

  Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) having a minimum activity of: 40 000 XU (1) and 9 000 BGU (2)/g Solid and liquid forms |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method.

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a9

Aveve NV

Endo-1,4-beta-xylanase

EC 3.2.1.8

Endo-1,3(4)-beta-glucanase

EC 3.2.1.6

Additive composition

Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) having a minimum activity of: 40 000 XU (1) and 9 000 BGU (2)/g Solid and liquid forms

| | Characterisation of the active substance

  endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) |
| --- | --- |

Characterisation of the active substance

endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754)

| | Analytical method
   (3)

  Characterisation of the active substance in the additive:






  — | colorimetric method based on reaction of dinitrosalicylic acid on reducing sugar produced by action of endo-1,4-beta-xylanase on a xylan containing substrate; |
| --- | --- | --- |

Analytical method
   (3)

Characterisation of the active substance in the additive:

—

colorimetric method based on reaction of dinitrosalicylic acid on reducing sugar produced by action of endo-1,4-beta-xylanase on a xylan containing substrate;

| — | colorimetric method based on reaction of dinitrosalicylic acid on reducing sugar produced by action of endo-1,3(4)-beta-glucanase on a beta-glucan containing substrate. |
| --- | --- |

—

colorimetric method based on reaction of dinitrosalicylic acid on reducing sugar produced by action of endo-1,3(4)-beta-glucanase on a beta-glucan containing substrate.

Characterisation of the active substances in the feedingstuffs:

| — | colorimetric method measuring water soluble dye released by action of endo-1,4-beta-xylanase from dye cross-linked wheat arabinoxylan substrate; |
| --- | --- |

—

colorimetric method measuring water soluble dye released by action of endo-1,4-beta-xylanase from dye cross-linked wheat arabinoxylan substrate;

| — | colorimetric method measuring water soluble dye released by action of endo-1,3(4)-beta-glucanase from dye cross-linked barley betaglucan substrate. |
| --- | --- |

—

colorimetric method measuring water soluble dye released by action of endo-1,3(4)-beta-glucanase from dye cross-linked barley betaglucan substrate.

Pigs for fattening

Minor porcine species for fattening other than Sus scrofa domesticus

Turkeys for fattening

—

4 000 XU

900 BGU

—

| 1. | In the directions for use of the additive and premixture, indicate the storage conditions, and stability to pelleting. |
| --- | --- |

1.

In the directions for use of the additive and premixture, indicate the storage conditions, and stability to pelleting.

| 2. | For use in feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans) |
| --- | --- |

2.

For use in feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans)

| 3. | For safety: breathing protection, glasses and gloves shall be used during handling. |
| --- | --- |

3.

For safety: breathing protection, glasses and gloves shall be used during handling.

14 November 2023

---

(1)  XU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) per minute from xylan of oat spelt at pH 4,8 and 50 °C.

(2)  BGU is the amount of enzyme which liberates 1 micromole of reducing sugars (cellobiose equivalents) per minute from ß-glucan of barley at pH 5,0 and 50 °C.

(3)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

---

| 25.10.2013 | EN | Official Journal of the European Union | L 283/50 |
| --- | --- | --- | --- |

25.10.2013

EN

Official Journal of the European Union

L 283/50

---

COMMISSION IMPLEMENTING REGULATION (EU) No 1041/2013

of 24 October 2013

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 Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (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, 24 October 2013.

For the Commission, On behalf of the President,

Jerzy PLEWA

Director-General for Agriculture and Rural Development

---

(1)  OJ L 299, 16.11.2007, p. 1.

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 | MA | 41,8 |
| MK | 56,9 |
| ZZ | 49,4 |
| 0707 00 05 | MK | 59,9 |
| TR | 147,7 |
| ZZ | 103,8 |
| 0709 93 10 | TR | 147,7 |
| ZZ | 147,7 |
| 0805 50 10 | AR | 12,9 |
| CL | 77,5 |
| IL | 100,2 |
| TR | 78,4 |
| ZA | 82,0 |
| ZZ | 70,2 |
| 0806 10 10 | BR | 315,2 |
| TR | 173,3 |
| ZZ | 244,3 |
| 0808 10 80 | CL | 142,9 |
| IL | 85,8 |
| NZ | 189,4 |
| US | 167,9 |
| ZA | 109,9 |
| ZZ | 139,2 |
| 0808 30 90 | CN | 64,1 |
| TR | 122,6 |
| US | 165,9 |
| ZZ | 117,5 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

MA

41,8

MK

56,9

ZZ

49,4

0707 00 05

MK

59,9

TR

147,7

ZZ

103,8

0709 93 10

TR

147,7

ZZ

147,7

0805 50 10

AR

12,9

CL

77,5

IL

100,2

TR

78,4

ZA

82,0

ZZ

70,2

0806 10 10

BR

315,2

TR

173,3

ZZ

244,3

0808 10 80

CL

142,9

IL

85,8

NZ

189,4

US

167,9

ZA

109,9

ZZ

139,2

0808 30 90

CN

64,1

TR

122,6

US

165,9

ZZ

117,5

---

(1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.

---