# Official Journal L 120/2017

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 120 |
| | |
| English edition | Legislation | Volume 6011 May 2017 |

ISSN 1977-0677

Official Journal

of the European Union

L 120

English edition

Legislation

Volume 6011 May 2017

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2017/791 of 26 April 2017 entering a name in the register of protected designations of origin and protected geographical indications (Stupavské Zelé (PDO)) | 1 |
| | * | Commission Regulation (EU) 2017/792 of 5 May 2017 establishing a temporary prohibition of fishing for redfish in NAFO 3M area by vessels flying the flag of a Member State of the European Union | 3 |
| | * | Commission Implementing Regulation (EU) 2017/793 of 10 May 2017 amending Regulation (EC) No 180/2008 as regards extending the period of designation of the EU Reference Laboratory for equine diseases other than African horse sickness (
  1
  ) | 5 |
| | * | Commission Implementing Regulation (EU) 2017/794 of 10 May 2017 approving silicon dioxide Kieselguhr as an existing active substance for use in biocidal products of product-type 18 (
  1
  ) | 7 |
| | * | Commission Implementing Regulation (EU) 2017/795 of 10 May 2017 approving pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide as an existing active substance for use in biocidal products of product-type 18 (
  1
  ) | 10 |
| | * | Commission Implementing Regulation (EU) 2017/796 of 10 May 2017 approving dichlofluanid as an existing active substance for use in biocidal products of product-type 21 (
  1
  ) | 13 |
| | | Commission Implementing Regulation (EU) 2017/797 of 10 May 2017 establishing the standard import values for determining the entry price of certain fruit and vegetables | 17 |
| | | DECISIONS |
| | * | Council Decision (EU) 2017/798 of 25 April 2017 authorising the opening of negotiations with the Government of Japan for an agreement on cooperation in the area of competition policy between the European Union and the Government of Japan | 19 |
| | * | Council Decision (EU) 2017/799 of 5 May 2017 appointing three members and two alternate members, proposed by the Republic of Cyprus, of the Committee of the Regions | 20 |
| | * | Commission Implementing Decision (EU) 2017/800 of 8 May 2017 amending Decision 2009/821/EC as regards the lists of border inspection posts and veterinary units in Traces
  (notified under document C(2017) 2899)

   (
  1
  ) | 22 |
| | * | Commission Implementing Decision (EU) 2017/801 of 8 May 2017 amending Implementing Decision (EU) 2016/715 setting out measures in respect of certain fruits originating in certain third countries to prevent the introduction into and the spread within the Union of the harmful organism Phyllosticta citricarpa (McAlpine) Van der Aa
  (notified under document C(2017) 2894) | 26 |
| | * | Commission Implementing Decision (EU) 2017/802 of 10 May 2017 not approving PHMB (1600; 1.8) as an existing active substance for use in biocidal products for product-type 5 (
  1
  ) | 29 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2017/791 of 26 April 2017 entering a name in the register of protected designations of origin and protected geographical indications (Stupavské Zelé (PDO))

1

*

Commission Regulation (EU) 2017/792 of 5 May 2017 establishing a temporary prohibition of fishing for redfish in NAFO 3M area by vessels flying the flag of a Member State of the European Union

3

*

Commission Implementing Regulation (EU) 2017/793 of 10 May 2017 amending Regulation (EC) No 180/2008 as regards extending the period of designation of the EU Reference Laboratory for equine diseases other than African horse sickness (
  1
  )

1

5

*

Commission Implementing Regulation (EU) 2017/794 of 10 May 2017 approving silicon dioxide Kieselguhr as an existing active substance for use in biocidal products of product-type 18 (
  1
  )

1

7

*

Commission Implementing Regulation (EU) 2017/795 of 10 May 2017 approving pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide as an existing active substance for use in biocidal products of product-type 18 (
  1
  )

1

10

*

Commission Implementing Regulation (EU) 2017/796 of 10 May 2017 approving dichlofluanid as an existing active substance for use in biocidal products of product-type 21 (
  1
  )

1

13

Commission Implementing Regulation (EU) 2017/797 of 10 May 2017 establishing the standard import values for determining the entry price of certain fruit and vegetables

17

DECISIONS

*

Council Decision (EU) 2017/798 of 25 April 2017 authorising the opening of negotiations with the Government of Japan for an agreement on cooperation in the area of competition policy between the European Union and the Government of Japan

19

*

Council Decision (EU) 2017/799 of 5 May 2017 appointing three members and two alternate members, proposed by the Republic of Cyprus, of the Committee of the Regions

20

*

Commission Implementing Decision (EU) 2017/800 of 8 May 2017 amending Decision 2009/821/EC as regards the lists of border inspection posts and veterinary units in Traces
  (notified under document C(2017) 2899)

   (
  1
  )

(notified under document C(2017) 2899)

1

22

*

Commission Implementing Decision (EU) 2017/801 of 8 May 2017 amending Implementing Decision (EU) 2016/715 setting out measures in respect of certain fruits originating in certain third countries to prevent the introduction into and the spread within the Union of the harmful organism Phyllosticta citricarpa (McAlpine) Van der Aa
  (notified under document C(2017) 2894)

Phyllosticta citricarpa

(notified under document C(2017) 2894)

26

*

Commission Implementing Decision (EU) 2017/802 of 10 May 2017 not approving PHMB (1600; 1.8) as an existing active substance for use in biocidal products for product-type 5 (
  1
  )

1

29

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to Commission Delegated Regulation (EU) 2017/653 of 8 March 2017 supplementing Regulation (EU) No 1286/2014 of the European Parliament and of the Council on key information documents for packaged retail and insurance-based investment products (PRIIPs) by laying down regulatory technical standards with regard to the presentation, content, review and revision of key information documents and the conditions for fulfilling the requirement to provide such documents ( OJ L 100, 12.4.2017 ) | 31 |

Corrigenda

*

Corrigendum to Commission Delegated Regulation (EU) 2017/653 of 8 March 2017 supplementing Regulation (EU) No 1286/2014 of the European Parliament and of the Council on key information documents for packaged retail and insurance-based investment products (PRIIPs) by laying down regulatory technical standards with regard to the presentation, content, review and revision of key information documents and the conditions for fulfilling the requirement to provide such documents ( OJ L 100, 12.4.2017 )

( OJ L 100, 12.4.2017 )

31

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

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(1)   Text with EEA relevance.

1

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

EN

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

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

---

II Non-legislative acts

REGULATIONS

| 11.5.2017 | EN | Official Journal of the European Union | L 120/1 |
| --- | --- | --- | --- |

11.5.2017

EN

Official Journal of the European Union

L 120/1

---

COMMISSION IMPLEMENTING REGULATION (EU) 2017/791

of 26 April 2017

entering a name in the register of protected designations of origin and protected geographical indications (Stupavské Zelé (PDO))

THE EUROPEAN COMMISSION,

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

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

Whereas:

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

(1)

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

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

(2)

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

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Stupavské Zelé’ (PDO) is hereby entered in the register.

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

Article 2

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

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

Done at Brussels, 26 April 2017.

For the Commission,

On behalf of the President,

Phil HOGAN

Member of the Commission

---

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

1

(2)  
  OJ C 5, 7.1.2017, p. 6.

2

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

3

---

| 11.5.2017 | EN | Official Journal of the European Union | L 120/3 |
| --- | --- | --- | --- |

11.5.2017

EN

Official Journal of the European Union

L 120/3

---

COMMISSION REGULATION (EU) 2017/792

of 5 May 2017

establishing a temporary prohibition of fishing for redfish in NAFO 3M area by vessels flying the flag of a Member State of the European Union

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) 2017/127 (2) lays down quotas for 2017. |
| --- | --- |

(1)

Council Regulation (EU) 2017/127 (2) lays down quotas for 2017.

| (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 European Union have exhausted the mid-term quota allocated for the period before 1 July 2017. |
| --- | --- |

(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 European Union have exhausted the mid-term quota allocated for the period before 1 July 2017.

| (3) | It is therefore necessary to prohibit directed fishing activities for that stock until 30 June 2017, |
| --- | --- |

(3)

It is therefore necessary to prohibit directed fishing activities for that stock until 30 June 2017,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member States referred to in the Annex to this Regulation for the stock referred to therein for the period from 1 January 2017 until 30 June 2017 included shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Directed fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member States referred to therein shall be prohibited from the date set out in that Annex until 30 June 2017 included.

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.

Official Journal of the European Union

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

Done at Brussels, 5 May 2017.

For the Commission,

On behalf of the President,

João AGUIAR MACHADO

Director-General

Directorate-General for Maritime Affairs and Fisheries

---

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

1

(2)  Council Regulation (EU) 2017/127 of 20 January 2017 fixing for 2017 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters (OJ L 24, 28.1.2017, p. 1).

2

---

ANNEX

| No | 07/TQ127 |
| --- | --- |
| Member State | European Union (All Member States) |
| Stock | RED/N3M. |
| Species | Redfish (Sebastes spp.) |
| Zone | NAFO 3M |
| Closing period | 27.2.2017-30.6.2017 |

No

07/TQ127

Member State

European Union (All Member States)

Stock

RED/N3M.

Species

Redfish (Sebastes spp.)

Zone

NAFO 3M

Closing period

27.2.2017-30.6.2017

---

| 11.5.2017 | EN | Official Journal of the European Union | L 120/5 |
| --- | --- | --- | --- |

11.5.2017

EN

Official Journal of the European Union

L 120/5

---

COMMISSION IMPLEMENTING REGULATION (EU) 2017/793

of 10 May 2017

amending Regulation (EC) No 180/2008 as regards extending the period of designation of the EU Reference Laboratory for equine diseases other than African horse sickness

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and importation from third countries of equidae (1), and in particular Article 19(d) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 180/2008 (2) designated the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES) with its laboratories for animal health and equine diseases, France, as the EU reference laboratory for equine diseases other than African horse sickness, and the Annex thereto sets outs its functions, tasks and procedures regarding collaboration with the laboratories responsible for diagnosing infectious diseases of equidae in the Member States. |
| --- | --- |

(1)

Commission Regulation (EC) No 180/2008 (2) designated the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES) with its laboratories for animal health and equine diseases, France, as the EU reference laboratory for equine diseases other than African horse sickness, and the Annex thereto sets outs its functions, tasks and procedures regarding collaboration with the laboratories responsible for diagnosing infectious diseases of equidae in the Member States.

| (2) | Regulation (EC) No 180/2008, as adopted by the Commission in 2008, designated Agence française de sécurité sanitaire des aliments (AFSSA) as the EU reference laboratory for equine diseases other than African horse sickness for an initial period of five years expiring on 30 June 2013. Commission Regulation (EU) No 208/2011 (3) updated Regulation (EC) No 180/2008 as regards the name of the institution, i.e. Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES). Regulation (EC) No 180/2008, as amended by Commission Implementing Regulation (EU) No 72/2013 (4), extended the period of designation of ANSES for a further period of five years expiring on 30 June 2018. |
| --- | --- |

(2)

Regulation (EC) No 180/2008, as adopted by the Commission in 2008, designated Agence française de sécurité sanitaire des aliments (AFSSA) as the EU reference laboratory for equine diseases other than African horse sickness for an initial period of five years expiring on 30 June 2013. Commission Regulation (EU) No 208/2011 (3) updated Regulation (EC) No 180/2008 as regards the name of the institution, i.e. Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES). Regulation (EC) No 180/2008, as amended by Commission Implementing Regulation (EU) No 72/2013 (4), extended the period of designation of ANSES for a further period of five years expiring on 30 June 2018.

| (3) | For more than eight years, ANSES has fulfilled its functions, tasks and procedures, and thus significantly improved the capabilities of the national reference laboratories for the diagnosis and differential diagnosis of particular equine diseases. |
| --- | --- |

(3)

For more than eight years, ANSES has fulfilled its functions, tasks and procedures, and thus significantly improved the capabilities of the national reference laboratories for the diagnosis and differential diagnosis of particular equine diseases.

| (4) | In order to ensure a high quality and uniformity of analytical and diagnostic results in the Union, it is important that ANSES continues to carry out its activities as the EU reference laboratory for equine diseases other than African horse for a further five-year period. |
| --- | --- |

(4)

In order to ensure a high quality and uniformity of analytical and diagnostic results in the Union, it is important that ANSES continues to carry out its activities as the EU reference laboratory for equine diseases other than African horse for a further five-year period.

| (5) | Regulation (EC) No 180/2008 should therefore be amended accordingly. |
| --- | --- |

(5)

Regulation (EC) No 180/2008 should therefore be amended accordingly.

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

(6)

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

HAS ADOPTED THIS REGULATION:

Article 1

In Article 1(1) of Regulation (EC) No 180/2008, the date ‘30 June 2018’ is replaced by the date ‘30 June 2023’.

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, 10 May 2017.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 192, 23.7.2010, p. 1.

1

(2)  Commission Regulation (EC) No 180/2008 of 28 February 2008 concerning the Community reference laboratory for equine diseases other than African horse sickness and amending Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council (OJ L 56, 29.2.2008, p. 4).

2

(3)  Commission Regulation (EU) No 208/2011 of 2 March 2011 amending Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council and Commission Regulations (EC) No 180/2008 and (EC) No 737/2008 as regards lists and names of EU reference laboratories (OJ L 58, 3.3.2011, p. 29).

3

(4)  Commission Implementing Regulation (EU) No 72/2013 of 25 January 2013 amending Regulations (EC) No 180/2008 and (EC) No 737/2008 as regards the period of designation of certain laboratories as EU reference laboratories (OJ L 26, 26.1.2013, p. 9).

4

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| 11.5.2017 | EN | Official Journal of the European Union | L 120/7 |
| --- | --- | --- | --- |

11.5.2017

EN

Official Journal of the European Union

L 120/7

---

COMMISSION IMPLEMENTING REGULATION (EU) 2017/794

of 10 May 2017

approving silicon dioxide Kieselguhr as an existing active substance for use in biocidal products of 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 articular the third subparagraph of Article 89(1) thereof,

Whereas:

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

(1)

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

| (2) | Silicon dioxide Kieselguhr has been evaluated for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(2)

Silicon dioxide Kieselguhr has been evaluated for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to Regulation (EU) No 528/2012.

| (3) | France was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 18 December 2015. |
| --- | --- |

(3)

France was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 18 December 2015.

| (4) | In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 11 October 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. |
| --- | --- |

(4)

In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 11 October 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

| (5) | According to that opinion, biocidal products of product-type 18 containing silicon dioxide Kieselguhr may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with. |
| --- | --- |

(5)

According to that opinion, biocidal products of product-type 18 containing silicon dioxide Kieselguhr may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

| (6) | It is therefore appropriate to approve silicon dioxide Kieselguhr for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions. |
| --- | --- |

(6)

It is therefore appropriate to approve silicon dioxide Kieselguhr for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.

| (7) | A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. |
| --- | --- |

(7)

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

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(8)

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

Silicon dioxide Kieselguhr is approved as an active substance for use in biocidal products of 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, 10 May 2017.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

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

2

---

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 |
| --- | --- | --- | --- | --- | --- | --- |
| Silicon dioxide Kieselguhr | IUPAC Name:
  Silicon dioxide Kieselguhr
  EC No: Not available
  CAS No: 61790-53-2 | 1 000 g/kg by wt (100 %) | 1 November 2018 | 31 October 2028 | 18 | The authorisations of biocidal products are subject to the following conditions:






  (1) | the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance; |

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

Silicon dioxide Kieselguhr

IUPAC Name:

Silicon dioxide Kieselguhr

EC No: Not available

CAS No: 61790-53-2

1 000 g/kg by wt (100 %)

1 November 2018

31 October 2028

18

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

(1)

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

| (2) | in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:






  (a) | professional users; |
| --- | --- | --- |

(2)

in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:

(a)

professional users;

| (b) | non-professional users; |
| --- | --- |

(b)

non-professional users;

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

(3)

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

---

(1)  The purity indicated in this column was the minimum degree of purity of the active substance evaluated in accordance with Article 89(1) 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 to be technically equivalent to the evaluated active substance.

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

(3)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).

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| 11.5.2017 | EN | Official Journal of the European Union | L 120/10 |
| --- | --- | --- | --- |

11.5.2017

EN

Official Journal of the European Union

L 120/10

---

COMMISSION IMPLEMENTING REGULATION (EU) 2017/795

of 10 May 2017

approving pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide as an existing active substance for use in biocidal products of 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 Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes silicon dioxide (as a nanomaterial formed by aggregates and agglomerates), to be renamed pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide, as the result of its evaluation. |
| --- | --- |

(1)

Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes silicon dioxide (as a nanomaterial formed by aggregates and agglomerates), to be renamed pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide, as the result of its evaluation.

| (2) | Pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide has been evaluated for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(2)

Pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide has been evaluated for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to Regulation (EU) No 528/2012.

| (3) | France was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 18 December 2015. |
| --- | --- |

(3)

France was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 18 December 2015.

| (4) | In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 11 October 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. |
| --- | --- |

(4)

In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 11 October 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

| (5) | According to that opinion, biocidal products of product-type 18 containing pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with. |
| --- | --- |

(5)

According to that opinion, biocidal products of product-type 18 containing pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

| (6) | It is therefore appropriate to approve pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions. |
| --- | --- |

(6)

It is therefore appropriate to approve pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.

| (7) | Since pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide as evaluated is a nanomaterial, the approval should cover such nanomaterials pursuant to Article 4(4) of Regulation (EU) No 528/2012 provided that certain specifications and conditions relating to their use are satisfied. |
| --- | --- |

(7)

Since pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide as evaluated is a nanomaterial, the approval should cover such nanomaterials pursuant to Article 4(4) of Regulation (EU) No 528/2012 provided that certain specifications and conditions relating to their use are satisfied.

| (8) | A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. |
| --- | --- |

(8)

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

| (9) | 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

Pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide is approved as an active substance for use in biocidal products of 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, 10 May 2017.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

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

2

---

ANNEX

| Common Name | IUPAC Name
  Identification Numbers | Minimum degree of purity of the active substance (1) | Reference structural characteristics (2) | Date of approval | Expiry date of approval | Product type | Specific conditions |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide | IUPAC Name:
  Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica
  EC No: 272-697-1
  CAS No: 68909-20-6 | 998 g/kg (purity of core measured after ignition). | — | Carbon content: 3,0-4,0 %; |

Common Name

IUPAC Name

Identification Numbers

Minimum degree of purity of the active substance (1)

Reference structural characteristics (2)

Date of approval

Expiry date of approval

Product type

Specific conditions

Pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide

IUPAC Name:

Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica

EC No: 272-697-1

CAS No: 68909-20-6

998 g/kg (purity of core measured after ignition).

—

Carbon content: 3,0-4,0 %;

| — | Primary particle size: 6,9-8,6 nm; |
| --- | --- |

—

Primary particle size: 6,9-8,6 nm;

| — | Specific surface area: 217-225 m2/g; |
| --- | --- |

—

Specific surface area: 217-225 m2/g;

| — | Size of stable aggregated particles: > 70 nm; |
| --- | --- |

—

Size of stable aggregated particles: > 70 nm;

| — | Surface treatment: with > 90 % of the surface surface-treated with hexamethylsilazane (CAS 999-97-3) |
| --- | --- |

—

Surface treatment: with > 90 % of the surface surface-treated with hexamethylsilazane (CAS 999-97-3)

1 November 2018

31 October 2028

18

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

| (1) | the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance; |
| --- | --- |

(1)

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

| (2) | in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users; |
| --- | --- |

(2)

in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users;

| (3) | for products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (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)

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 evaluated in accordance with Article 89(1) 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 to be technically equivalent to the evaluated active substance.

(2)  The structural characteristics indicated in this column were the ones of the active substance used for the evaluation made in accordance with Article 89(1) of Regulation (EU) No 528/2012.

(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).

---

| 11.5.2017 | EN | Official Journal of the European Union | L 120/13 |
| --- | --- | --- | --- |

11.5.2017

EN

Official Journal of the European Union

L 120/13

---

COMMISSION IMPLEMENTING REGULATION (EU) 2017/796

of 10 May 2017

approving dichlofluanid as an existing active substance for use in biocidal products of product-type 21

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,

Whereas:

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

(1)

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

| (2) | Dichlofluanid has been evaluated for use in products of product-type 21, antifouling products, as described in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(2)

Dichlofluanid has been evaluated for use in products of product-type 21, antifouling products, as described in Annex V to Regulation (EU) No 528/2012.

| (3) | The United Kingdom was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 22 October 2015. |
| --- | --- |

(3)

The United Kingdom was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 22 October 2015.

| (4) | In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 11 October 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. |
| --- | --- |

(4)

In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 11 October 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

| (5) | According to that opinion, biocidal products of product-type 21 containing dichlofluanid may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with. |
| --- | --- |

(5)

According to that opinion, biocidal products of product-type 21 containing dichlofluanid may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

| (6) | The acceptability of the risks related to the use of antifouling products, as well as the suitability of the proposed risk mitigation measures, should however be further confirmed. In order to facilitate, at the time of the renewal of the approvals of existing antifouling active substances, the review and comparison of the risks and benefits of those substances as well as of the risk mitigation measures applied, the expiry date of approval of all those substances should be the same. |
| --- | --- |

(6)

The acceptability of the risks related to the use of antifouling products, as well as the suitability of the proposed risk mitigation measures, should however be further confirmed. In order to facilitate, at the time of the renewal of the approvals of existing antifouling active substances, the review and comparison of the risks and benefits of those substances as well as of the risk mitigation measures applied, the expiry date of approval of all those substances should be the same.

| (7) | It is therefore appropriate to approve dichlofluanid for use in biocidal products of product-type 21, subject to compliance with certain specifications and conditions. |
| --- | --- |

(7)

It is therefore appropriate to approve dichlofluanid for use in biocidal products of product-type 21, subject to compliance with certain specifications and conditions.

| (8) | Since dichlofluanid meets the criteria for classification as skin sensitiser category 1 as defined in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3), treated articles treated with or incorporating dichlofluanid should be appropriately labelled when placed on the market. |
| --- | --- |

(8)

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

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

(9)

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

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

(10)

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

HAS ADOPTED THIS REGULATION:

Article 1

Dichlofluanid is approved as an active substance for use in biocidal products of product-type 21, 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, 10 May 2017.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

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

2

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

3

---

ANNEX

| Common Name | IUPAC Name
  Identification Numbers | Minimum degree of purity of the active substance (1) | Date of approval | Expiry date of approval | Product type | Specific conditions |
| --- | --- | --- | --- | --- | --- | --- |
| Dichlofluanid | IUPAC Name:
  N-(Dichlorofluoromethylthio)-N′,N′-dimethyl-N-phenylsulfamide
  EC No: 214-118-7
  CAS No: 1085-98-9 | 96 % w/w | 1 November 2018 | 31 December 2025 | 21 | 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.
  In the event that products containing dichlofluanid are subsequently authorised for use by non-professional users, persons making products available on the market for non-professional users shall ensure that the products are supplied with appropriate gloves.
  The authorisations of biocidal products are subject to the following conditions:






  (1) | Products containing dichlofluanid shall not be authorised or used to control the growth and settlement of fouling organisms on freshwater going vessels. |

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

Dichlofluanid

IUPAC Name:

N-(Dichlorofluoromethylthio)-N′,N′-dimethyl-N-phenylsulfamide

EC No: 214-118-7

CAS No: 1085-98-9

96 % w/w

1 November 2018

31 December 2025

21

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.

In the event that products containing dichlofluanid are subsequently authorised for use by non-professional users, persons making products available on the market for non-professional users shall ensure that the products are supplied with appropriate gloves.

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

(1)

Products containing dichlofluanid shall not be authorised or used to control the growth and settlement of fouling organisms on freshwater going vessels.

| (2) | 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 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.

| (3) | Labels and, where provided, instructions for use shall indicate that children shall be kept away until treated surfaces are dry. |
| --- | --- |

(3)

Labels and, where provided, instructions for use shall indicate that children shall be kept away until treated surfaces are dry.

| (4) | Labels and, where provided, safety data sheets of products authorised shall indicate that application, maintenance and repair activities shall be conducted within a contained area, on an impermeable hard standing with bunding or on soil covered with an impermeable material to prevent losses and minimise emissions to the environment, and that any losses or waste containing dichlofluanid shall be collected for reuse or disposal. |
| --- | --- |

(4)

Labels and, where provided, safety data sheets of products authorised shall indicate that application, maintenance and repair activities shall be conducted within a contained area, on an impermeable hard standing with bunding or on soil covered with an impermeable material to prevent losses and minimise emissions to the environment, and that any losses or waste containing dichlofluanid shall be collected for reuse or disposal.

| (5) | For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (2) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (3) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. |
| --- | --- |

(5)

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

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

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

---

(1)  The purity indicated in this column was the minimum degree of purity of the active substance evaluated in accordance with Article 89(1) 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 to be technically equivalent to the evaluated active substance.

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

(3)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).

---

| 11.5.2017 | EN | Official Journal of the European Union | L 120/17 |
| --- | --- | --- | --- |

11.5.2017

EN

Official Journal of the European Union

L 120/17

---

COMMISSION IMPLEMENTING REGULATION (EU) 2017/797

of 10 May 2017

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

THE EUROPEAN COMMISSION,

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

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

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

Whereas:

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

(1)

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

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

(2)

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

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

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

Done at Brussels, 10 May 2017.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General

Directorate-General for Agriculture and Rural Development

---

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

1

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

2

---

ANNEX

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

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | EG | 176,8 |
| MA | 100,6 |
| TR | 89,0 |
| ZZ | 122,1 |
| 0707 00 05 | MA | 79,4 |
| TR | 116,3 |
| ZZ | 97,9 |
| 0709 93 10 | TR | 134,4 |
| ZZ | 134,4 |
| 0805 10 22 , 0805 10 24 , 0805 10 28 | EG | 47,7 |
| MA | 55,9 |
| ZZ | 51,8 |
| 0805 50 10 | TR | 60,0 |
| ZA | 157,0 |
| ZZ | 108,5 |
| 0808 10 80 | AR | 111,7 |
| BR | 106,5 |
| CL | 115,0 |
| CN | 145,5 |
| NZ | 124,5 |
| US | 111,3 |
| ZA | 98,7 |
| ZZ | 116,2 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

EG

176,8

MA

100,6

TR

89,0

ZZ

122,1

0707 00 05

MA

79,4

TR

116,3

ZZ

97,9

0709 93 10

TR

134,4

ZZ

134,4

0805 10 22 , 0805 10 24 , 0805 10 28

EG

47,7

MA

55,9

ZZ

51,8

0805 50 10

TR

60,0

ZA

157,0

ZZ

108,5

0808 10 80

AR

111,7

BR

106,5

CL

115,0

CN

145,5

NZ

124,5

US

111,3

ZA

98,7

ZZ

116,2

---

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

---

DECISIONS

| 11.5.2017 | EN | Official Journal of the European Union | L 120/19 |
| --- | --- | --- | --- |

11.5.2017

EN

Official Journal of the European Union

L 120/19

---

COUNCIL DECISION (EU) 2017/798

of 25 April 2017

authorising the opening of negotiations with the Government of Japan for an agreement on cooperation in the area of competition policy between the European Union and the Government of Japan

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 103 and 352, in conjunction with Article 218(3) and (4) thereof,

Having regard to the recommendation from the European Commission,

Whereas negotiations should be opened with a view to concluding an agreement between the European Union and the Government of Japan on cooperation in the area of competition policy,

HAS ADOPTED THIS DECISION:

Article 1

1.   The Commission is hereby authorised to open negotiations with the Government of Japan for an agreement adding provisions to the Agreement between the European Community and the Government of Japan concerning cooperation on anti-competitive activities (1) on the exchange of evidence in competition investigations on a reciprocal basis.

2.   The negotiations shall be conducted on the basis of the negotiating directives of the Council set out in the addendum to this Decision.

Article 2

The Commission is hereby nominated as the Union negotiator.

Article 3

The negotiations shall be conducted in consultation with the Council Working Party on Competition.

Article 4

This Decision is addressed to the Commission.

Done at Luxembourg, 25 April 2017.

For the Council

The President

I. BORG

---

(1)  
  OJ L 183, 22.7.2003, p. 12.

1

---

| 11.5.2017 | EN | Official Journal of the European Union | L 120/20 |
| --- | --- | --- | --- |

11.5.2017

EN

Official Journal of the European Union

L 120/20

---

COUNCIL DECISION (EU) 2017/799

of 5 May 2017

appointing three members and two alternate members, proposed by the Republic of Cyprus, of the Committee of the Regions

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 305 thereof,

Having regard to the proposal of the Government of Cyprus,

Whereas:

| (1) | On 26 January 2015, 5 February 2015 and 23 June 2015, the Council adopted Decisions (EU) 2015/116 (1), (EU) 2015/190 (2) and (EU) 2015/994 (3) appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020. On 26 July 2016, by Council Decision (EU) 2016/1233 (4), Mr Georgios GEORGIOU was replaced by Mr Kyriakos CHATZITTOFIS as a member and Mr Kyriakos CHATZITTOFIS was replaced by Mr Stavros YEROLATSITES as an alternate member. |
| --- | --- |

(1)

On 26 January 2015, 5 February 2015 and 23 June 2015, the Council adopted Decisions (EU) 2015/116 (1), (EU) 2015/190 (2) and (EU) 2015/994 (3) appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020. On 26 July 2016, by Council Decision (EU) 2016/1233 (4), Mr Georgios GEORGIOU was replaced by Mr Kyriakos CHATZITTOFIS as a member and Mr Kyriakos CHATZITTOFIS was replaced by Mr Stavros YEROLATSITES as an alternate member.

| (2) | Three members' seats on the Committee of the Regions have become vacant following the end of the terms of office of Mr Kyriakos CHATZITTOFIS, Ms Louisa MAVROMMATI and Mr Charalambos PITTAS. |
| --- | --- |

(2)

Three members' seats on the Committee of the Regions have become vacant following the end of the terms of office of Mr Kyriakos CHATZITTOFIS, Ms Louisa MAVROMMATI and Mr Charalambos PITTAS.

| (3) | One alternate member's seat on the Committee of the Regions has become vacant following the end of the term of office of Mr Stavros YEROLATSITES. |
| --- | --- |

(3)

One alternate member's seat on the Committee of the Regions has become vacant following the end of the term of office of Mr Stavros YEROLATSITES.

| (4) | An alternate member's seat has become vacant following the appointment of Mr Stavros STAVRINIDES as a member of the Committee of the Regions, |
| --- | --- |

(4)

An alternate member's seat has become vacant following the appointment of Mr Stavros STAVRINIDES as a member of the Committee of the Regions,

HAS ADOPTED THIS DECISION:

Article 1

The following are hereby appointed to the Committee of the Regions for the remainder of the current term of office:

| (a) | as members:






  — | Mr Nikos ANASTASIOU, Mayor of Kato Polemidia Municipality, |
| --- | --- | --- |

(a)

as members:

—

Mr Nikos ANASTASIOU, Mayor of Kato Polemidia Municipality,

| — | Mr Andros KARAYIANNIS, Mayor of Deryneia Municipality, |
| --- | --- |

—

Mr Andros KARAYIANNIS, Mayor of Deryneia Municipality,

| — | Mr Stavros STAVRINIDES, Municipal Councillor of Strovolos Municipality; |
| --- | --- |

—

Mr Stavros STAVRINIDES, Municipal Councillor of Strovolos Municipality;

and

| (b) | as alternate members:






  — | Mr Kyprianos ANDRONIKOU, Mayor of Dromolaxia — Meneou Municipality, |
| --- | --- | --- |

(b)

as alternate members:

—

Mr Kyprianos ANDRONIKOU, Mayor of Dromolaxia — Meneou Municipality,

| — | Mr Theodoros ANTONIOU AVVAS, Mayor of Mesa Yitonia Municipality. |
| --- | --- |

—

Mr Theodoros ANTONIOU AVVAS, Mayor of Mesa Yitonia Municipality.

Article 2

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

Done at Brussels, 5 May 2017.

For the Council

The President

L. GRECH

---

(1)  Council Decision (EU) 2015/116 of 26 January 2015 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020 (OJ L 20, 27.1.2015, p. 42).

1

(2)  Council Decision (EU) 2015/190 of 5 February 2015 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020 (OJ L 31, 7.2.2015, p. 25).

2

(3)  Council Decision (EU) 2015/994 of 23 June 2015 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020 (OJ L 159, 25.6.2015, p. 70).

3

(4)  Council Decision (EU) 2016/1233 of 26 July 2016 appointing a member and an alternate member, proposed by the Republic of Cyprus, of the Committee of the Regions (OJ L 202, 28.7.2016, p. 41).

4

---

| 11.5.2017 | EN | Official Journal of the European Union | L 120/22 |
| --- | --- | --- | --- |

11.5.2017

EN

Official Journal of the European Union

L 120/22

---

COMMISSION IMPLEMENTING DECISION (EU) 2017/800

of 8 May 2017

amending Decision 2009/821/EC as regards the lists of border inspection posts and veterinary units in Traces

(notified under document C(2017) 2899)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (1), and in particular Article 20(1) and (3) thereof,

Having regard to Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (2), and in particular the second sentence of the second subparagraph of Article 6(4) and Article 6(5) thereof,

Having regard to Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (3), and in particular Article 6(2) thereof,

Whereas:

| (1) | Commission Decision 2009/821/EC (4) lays down a list of border inspection posts approved in accordance with Directives 91/496/EEC and 97/78/EC. That list is set out in Annex I to that Decision. |
| --- | --- |

(1)

Commission Decision 2009/821/EC (4) lays down a list of border inspection posts approved in accordance with Directives 91/496/EEC and 97/78/EC. That list is set out in Annex I to that Decision.

| (2) | Following communication from Spain, the category other animals for the border inspection post at the airport of Alicante should be restricted to the animals of small size. Therefore, footnote (10) should be added to the category O for that border inspection post in Annex I to Decision 2009/821/EC. |
| --- | --- |

(2)

Following communication from Spain, the category other animals for the border inspection post at the airport of Alicante should be restricted to the animals of small size. Therefore, footnote (10) should be added to the category O for that border inspection post in Annex I to Decision 2009/821/EC.

| (3) | Following communication from France, the approval for the border inspection post at the airport of Lyon-Saint Exupéry should be extended to registered equidae. Therefore, the entry for that border inspection post should be amended in Annex I to Decision 2009/821/EC. |
| --- | --- |

(3)

Following communication from France, the approval for the border inspection post at the airport of Lyon-Saint Exupéry should be extended to registered equidae. Therefore, the entry for that border inspection post should be amended in Annex I to Decision 2009/821/EC.

| (4) | The Netherlands communicated that an inspection centre at the border inspection post at the port of Amsterdam should be deleted and that an inspection centre at the border inspection post at the port of Rotterdam moved to a new location. Therefore, the entries for those border inspection posts as set out in Annex I to Decision 2009/821/EC should be amended accordingly. |
| --- | --- |

(4)

The Netherlands communicated that an inspection centre at the border inspection post at the port of Amsterdam should be deleted and that an inspection centre at the border inspection post at the port of Rotterdam moved to a new location. Therefore, the entries for those border inspection posts as set out in Annex I to Decision 2009/821/EC should be amended accordingly.

| (5) | Annex II to Decision 2009/821/EC lays down the list of central, regional and local units in the integrated computerised veterinary system (Traces). |
| --- | --- |

(5)

Annex II to Decision 2009/821/EC lays down the list of central, regional and local units in the integrated computerised veterinary system (Traces).

| (6) | Following communication from Ireland, Italy and Austria, changes should be brought to the list of local units in Traces for those countries set out in Annex II to Decision 2009/821/EC. |
| --- | --- |

(6)

Following communication from Ireland, Italy and Austria, changes should be brought to the list of local units in Traces for those countries set out in Annex II to Decision 2009/821/EC.

| (7) | Decision 2009/821/EC should therefore be amended accordingly. |
| --- | --- |

(7)

Decision 2009/821/EC should therefore be amended accordingly.

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

(8)

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

HAS ADOPTED THIS DECISION:

Article 1

Annexes I and II to Decision 2009/821/EC are amended in accordance with the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 8 May 2017.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

---

(1)  
  OJ L 224, 18.8.1990, p. 29.

1

(2)  
  OJ L 268, 24.9.1991, p. 56.

2

(3)  
  OJ L 24, 30.1.1998, p. 9.

3

(4)  Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border inspection posts, laying down certain rules on the inspections carried out by Commission veterinary experts and laying down the veterinary units in TRACES (OJ L 296, 12.11.2009, p. 1).

4

---

ANNEX

Annexes I and II to Decision 2009/821/EC are amended as follows:

| (1) | Annex I is amended as follows:






  (a) | in the part concerning Spain, the entry for the airport at Alicante is replaced by the following:










  ‘Alicante | ES ALC 4 | A | | HC(2), NHC(2) | O(10)’ |
| --- | --- | --- | --- | --- | --- | --- | --- |

(1)

Annex I is amended as follows:

(a)

in the part concerning Spain, the entry for the airport at Alicante is replaced by the following:

‘Alicante

ES ALC 4

A

HC(2), NHC(2)

O(10)’

| (b) | in the part concerning France, the entry for the airport at Lyon-Saint Exupéry is replaced by the following:










  ‘Lyon- Saint Exupéry | FR LIO 4 | A | | HC-T(1), HC-NT, NHC | E’ |
| --- | --- | --- | --- | --- | --- | --- |

(b)

in the part concerning France, the entry for the airport at Lyon-Saint Exupéry is replaced by the following:

‘Lyon- Saint Exupéry

FR LIO 4

A

HC-T(1), HC-NT, NHC

E’

| (c) | the part concerning the Netherlands is amended as follows:






  (i) | the entry for the port at Amsterdam is replaced by the following:










  ‘Amsterdam | NL AMS 1 | P | Cornelis Vrolijk | HC-T(FR)(2)(3) | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Daalimpex, Velsen | HC-T | |
| PCA | HC(2), NHC(2) | |
| Kloosterboer Ijmuiden | HC-T(FR) | |
| Blankendaal Coldstores, Velsen | HC-T(FR)(2)’ | |

(c)

the part concerning the Netherlands is amended as follows:

(i)

the entry for the port at Amsterdam is replaced by the following:

‘Amsterdam

NL AMS 1

P

Cornelis Vrolijk

HC-T(FR)(2)(3)

Daalimpex, Velsen

HC-T

PCA

HC(2), NHC(2)

Kloosterboer Ijmuiden

HC-T(FR)

Blankendaal Coldstores, Velsen

HC-T(FR)(2)’

| (ii) | the entry for the port at Rotterdam is replaced by the following:










  ‘Rotterdam | NL RTM 1 | P | Eurofrigo Karimatastraat | HC, NHC-T(FR), NHC-NT | |
| --- | --- | --- | --- | --- | --- | --- |
| Eurofrigo, Abel Tasmanstraat | HC | |
| Frigocare Rotterdam B.V. | HC(2) | |
| Agro Merchants Maasvlakte B.V. | HC(2), NHC(2) | |
| Kloosterboer Delta Terminal | HC(2) | |
| Maastank B.V. | NHC-NT(6)’ | |

(ii)

the entry for the port at Rotterdam is replaced by the following:

‘Rotterdam

NL RTM 1

P

Eurofrigo Karimatastraat

HC, NHC-T(FR), NHC-NT

Eurofrigo, Abel Tasmanstraat

HC

Frigocare Rotterdam B.V.

HC(2)

Agro Merchants Maasvlakte B.V.

HC(2), NHC(2)

Kloosterboer Delta Terminal

HC(2)

Maastank B.V.

NHC-NT(6)’

| (2) | Annex II is amended as follows:






  (a) | in the part concerning Ireland, the entries for the local units ‘IE00400 CORK CITY’ and ‘IE10400 CLONAKILTY’ are replaced by the following:






  ‘IE00400 | CORK’ |
| --- | --- | --- | --- |

(2)

Annex II is amended as follows:

(a)

in the part concerning Ireland, the entries for the local units ‘IE00400 CORK CITY’ and ‘IE10400 CLONAKILTY’ are replaced by the following:

‘IE00400

CORK’

| (b) | the part concerning Italy is amended as follows:






  (i) | the entries for the regional unit ‘IT00020 SARDEGNA’ are replaced by the following:

  ‘IT00020 SARDEGNA






  IT00120 | AZIENDA PER LA TUTELA DELLA SALUTE’ |
| --- | --- | --- | --- |

(b)

the part concerning Italy is amended as follows:

(i)

the entries for the regional unit ‘IT00020 SARDEGNA’ are replaced by the following:

‘IT00020 SARDEGNA

IT00120

AZIENDA PER LA TUTELA DELLA SALUTE’

| (ii) | the entries for the regional unit ‘IT00005 VENETO’ are replaced by the following:

  ‘IT00005 VENETO






  IT00105 | AZIENDA ULSS N. 1 DOLOMITI |
| --- | --- | --- |
| IT00305 | AZIENDA ULSS N. 7 PEDEMONTANA |
| IT00605 | AZIENDA ULSS N. 8 BERICA |
| IT00905 | AZIENDA ULSS N. 2 MARCA TREVIGIANA |
| IT01005 | AZIENDA ULSS N. 4 VENETO ORIENTALE |
| IT01205 | AZIENDA ULSS N. 3 SERENISSIMA |
| IT01605 | AZIENDA ULSS N. 6 EUGANEA |
| IT01805 | AZIENDA ULSS N. 5 POLESANA |
| IT02005 | AZIENDA ULSS N. 9 SCALIGERA’ |

(ii)

the entries for the regional unit ‘IT00005 VENETO’ are replaced by the following:

‘IT00005 VENETO

IT00105

AZIENDA ULSS N. 1 DOLOMITI

IT00305

AZIENDA ULSS N. 7 PEDEMONTANA

IT00605

AZIENDA ULSS N. 8 BERICA

IT00905

AZIENDA ULSS N. 2 MARCA TREVIGIANA

IT01005

AZIENDA ULSS N. 4 VENETO ORIENTALE

IT01205

AZIENDA ULSS N. 3 SERENISSIMA

IT01605

AZIENDA ULSS N. 6 EUGANEA

IT01805

AZIENDA ULSS N. 5 POLESANA

IT02005

AZIENDA ULSS N. 9 SCALIGERA’

| (c) | in the part concerning Austria, the entry for the local unit ‘AT00324 Wien Umgebung’ is deleted. |
| --- | --- |

(c)

in the part concerning Austria, the entry for the local unit ‘AT00324 Wien Umgebung’ is deleted.

---

| 11.5.2017 | EN | Official Journal of the European Union | L 120/26 |
| --- | --- | --- | --- |

11.5.2017

EN

Official Journal of the European Union

L 120/26

---

COMMISSION IMPLEMENTING DECISION (EU) 2017/801

of 8 May 2017

amending Implementing Decision (EU) 2016/715 setting out measures in respect of certain fruits originating in certain third countries to prevent the introduction into and the spread within the Union of the harmful organism Phyllosticta citricarpa (McAlpine) Van der Aa

(notified under document C(2017) 2894)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular the fourth sentence of Article 16(3) thereof,

Whereas:

| (1) | Guignardia citricarpa Kiely (all strains pathogenic to Citrus), which following the approval of a new code for fungal nomenclature by the International Botanical Congress, has been referred to as Phyllosticta citricarpa (McAlpine) Van der Aa, hereinafter ‘Phyllosticta citricarpa’, is a harmful organism listed in point (c)(11) of Section I of Part A of Annex II to Directive 2000/29/EC. It is not known to occur in the Union. It is the causative agent of Citrus black spot disease and poses a significant threat to citrus cultivation in the Union. |
| --- | --- |

(1)

Guignardia citricarpa Kiely (all strains pathogenic to Citrus), which following the approval of a new code for fungal nomenclature by the International Botanical Congress, has been referred to as Phyllosticta citricarpa (McAlpine) Van der Aa, hereinafter ‘Phyllosticta citricarpa’, is a harmful organism listed in point (c)(11) of Section I of Part A of Annex II to Directive 2000/29/EC. It is not known to occur in the Union. It is the causative agent of Citrus black spot disease and poses a significant threat to citrus cultivation in the Union.

| (2) | Commission Implementing Decision (EU) 2016/715 (2) lays down measures in respect of fruits of Citrus L., Fortunella Swingle, Poncirus Raf., and their hybrids, other than fruits of Citrus aurantium L. and Citrus latifolia Tanaka (hereinafter: ‘the specified fruits’), originating in Brazil, South Africa or Uruguay, to prevent the introduction into and the spread within the Union of Phyllosticta citricarpa. |
| --- | --- |

(2)

Commission Implementing Decision (EU) 2016/715 (2) lays down measures in respect of fruits of Citrus L., Fortunella Swingle, Poncirus Raf., and their hybrids, other than fruits of Citrus aurantium L. and Citrus latifolia Tanaka (hereinafter: ‘the specified fruits’), originating in Brazil, South Africa or Uruguay, to prevent the introduction into and the spread within the Union of Phyllosticta citricarpa.

| (3) | Since the adoption of that Decision, interceptions of Phyllosticta citricarpa have recurrently been notified by Member States between May and October 2016, as a result of their import inspections of the specified fruits originating in Argentina. |
| --- | --- |

(3)

Since the adoption of that Decision, interceptions of Phyllosticta citricarpa have recurrently been notified by Member States between May and October 2016, as a result of their import inspections of the specified fruits originating in Argentina.

| (4) | The Commission has assessed those recurring interceptions and has concluded that the phytosanitary certification in Argentina did not sufficiently guarantee the absence of Phyllosticta citricarpa. Therefore, the phytosanitary safeguards currently in place in Argentina are insufficient to prevent the introduction of Phyllosticta citricarpa into the Union. |
| --- | --- |

(4)

The Commission has assessed those recurring interceptions and has concluded that the phytosanitary certification in Argentina did not sufficiently guarantee the absence of Phyllosticta citricarpa. Therefore, the phytosanitary safeguards currently in place in Argentina are insufficient to prevent the introduction of Phyllosticta citricarpa into the Union.

| (5) | Consequently, the introduction into the Union of those fruits should be subject to certain requirements. Those requirements should be the same as the requirements for specified fruits originating in South Africa and Uruguay and should apply to specified fruits destined for other purposes than the industrial processing into juice, as well as to the specified fruits destined exclusively for industrial processing into juice. |
| --- | --- |

(5)

Consequently, the introduction into the Union of those fruits should be subject to certain requirements. Those requirements should be the same as the requirements for specified fruits originating in South Africa and Uruguay and should apply to specified fruits destined for other purposes than the industrial processing into juice, as well as to the specified fruits destined exclusively for industrial processing into juice.

| (6) | Given that the interceptions of the specified fruits originating in Argentina have been on different species and varieties, no additional testing for latent infection is required, as it is set out in the case of specified fruits of Citrus sinensis (L.) Osbeck ‘Valencia’ originating in South Africa and Uruguay. |
| --- | --- |

(6)

Given that the interceptions of the specified fruits originating in Argentina have been on different species and varieties, no additional testing for latent infection is required, as it is set out in the case of specified fruits of Citrus sinensis (L.) Osbeck ‘Valencia’ originating in South Africa and Uruguay.

| (7) | Implementing Decision (EU) 2016/715 should therefore be amended accordingly. |
| --- | --- |

(7)

Implementing Decision (EU) 2016/715 should therefore be amended accordingly.

| (8) | The measures set out in this Decision should apply from 5 June 2017 to allow the National Plant Protection Organisations, responsible official bodies and operators concerned sufficient time to adapt to the new requirements. |
| --- | --- |

(8)

The measures set out in this Decision should apply from 5 June 2017 to allow the National Plant Protection Organisations, responsible official bodies and operators concerned sufficient time to adapt to the new requirements.

| (9) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(9)

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

HAS ADOPTED THIS DECISION:

Article 1

Implementing Decision (EU) 2016/715 is amended as follows:

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

  ‘Article 1
  Subject matter
  This Decision lays down measures in respect of certain fruits originating in Argentina, Brazil, South Africa and Uruguay to prevent the introduction into and the spread within the Union of Phyllosticta citricarpa.’; |
| --- | --- |

(1)

Article 1 is replaced by the following:

‘Article 1

Subject matter

This Decision lays down measures in respect of certain fruits originating in Argentina, Brazil, South Africa and Uruguay to prevent the introduction into and the spread within the Union of Phyllosticta citricarpa.’;

| (2) | in Article 2, point (b) is replaced by the following:






  ‘(b) | “specified fruits” means fruits of Citrus L., Fortunella Swingle, Poncirus Raf., and their hybrids, other than fruits of Citrus aurantium L. and Citrus latifolia Tanaka.’; |
| --- | --- | --- |

(2)

in Article 2, point (b) is replaced by the following:

‘(b)

“specified fruits” means fruits of Citrus

Fortunella

Poncirus

Citrus aurantium

Citrus latifolia

| (3) | in Article 3, paragraph 1 is replaced by the following:

  ‘1.   By way of derogation from point 16.4(c) and (d) of Section I of Part A of Annex IV to Directive 2000/29/EC, specified fruits originating in Argentina, Brazil, South Africa or Uruguay, other than fruits destined exclusively for industrial processing into juice, shall be introduced into the Union in accordance with Articles 4 to 7 of this Decision.’; |
| --- | --- |

(3)

in Article 3, paragraph 1 is replaced by the following:

‘1.   By way of derogation from point 16.4(c) and (d) of Section I of Part A of Annex IV to Directive 2000/29/EC, specified fruits originating in Argentina, Brazil, South Africa or Uruguay, other than fruits destined exclusively for industrial processing into juice, shall be introduced into the Union in accordance with Articles 4 to 7 of this Decision.’;

| (4) | the following Article 5a is inserted:

  ‘Article 5a
  Introduction into the Union of specified fruits originating in Argentina
  Specified fruits originating in Argentina shall be accompanied by a phytosanitary certificate, as referred to in the first subparagraph of point (ii) of Article 13(1) of Directive 2000/29/EC, including under the heading “Additional declaration” the following elements:






  (a) | a statement that the specified fruits originate in a field of production which has been subjected to treatments against Phyllosticta citricarpa carried out at the appropriate time since the beginning of the last cycle of vegetation; |
| --- | --- | --- |

(4)

the following Article 5a is inserted:

‘Article 5a

Introduction into the Union of specified fruits originating in Argentina

Specified fruits originating in Argentina shall be accompanied by a phytosanitary certificate, as referred to in the first subparagraph of point (ii) of Article 13(1) of Directive 2000/29/EC, including under the heading “Additional declaration” the following elements:

(a)

a statement that the specified fruits originate in a field of production which has been subjected to treatments against Phyllosticta citricarpa carried out at the appropriate time since the beginning of the last cycle of vegetation;

| (b) | a statement that an appropriate official inspection has been carried out in the field of production during the growing season, and no symptoms of Phyllosticta citricarpa have been detected in the specified fruit since the beginning of the last cycle of vegetation; |
| --- | --- |

(b)

a statement that an appropriate official inspection has been carried out in the field of production during the growing season, and no symptoms of Phyllosticta citricarpa have been detected in the specified fruit since the beginning of the last cycle of vegetation;

| (c) | a statement that a sample has been taken along the line between arrival and packaging in the packing facilities of at least 600 fruits of each species per 30 tonnes, or part thereof, selected as much as possible on the basis of any possible symptom of Phyllosticta citricarpa, and all sampled fruits showing symptoms have been tested and found free of that harmful organism.’; |
| --- | --- |

(c)

a statement that a sample has been taken along the line between arrival and packaging in the packing facilities of at least 600 fruits of each species per 30 tonnes, or part thereof, selected as much as possible on the basis of any possible symptom of Phyllosticta citricarpa, and all sampled fruits showing symptoms have been tested and found free of that harmful organism.’;

| (5) | in Article 6, the title and paragraph 1 are replaced by the following:

  ‘Article 6
  Requirements concerning inspection of the specified fruits originating in Argentina, South Africa and Uruguay within the Union

  1.   Specified fruits originating in Argentina, South Africa and Uruguay shall be visually inspected at the point of entry or at the place of destination established in accordance with Commission Directive 2004/103/EC (*1). Those inspections shall be carried out on samples of at least 200 fruits of each species of the specified fruits by batch of 30 tonnes, or part thereof, selected on the basis of any possible symptom of Phyllosticta citricarpa.



  (*1)  Commission Directive 2004/103/EC of 7 October 2004 on identity and plant health checks of plants, plant products or other objects, listed in Part B of Annex V to Council Directive 2000/29/EC, which may be carried out at a place other than the point of entry into the Community or at a place close by and specifying the conditions related to these checks (OJ L 313, 12.10.2004, p. 16).’;" |
| --- | --- |

(5)

in Article 6, the title and paragraph 1 are replaced by the following:

‘Article 6

Requirements concerning inspection of the specified fruits originating in Argentina, South Africa and Uruguay within the Union

1.   Specified fruits originating in Argentina, South Africa and Uruguay shall be visually inspected at the point of entry or at the place of destination established in accordance with Commission Directive 2004/103/EC (*1). Those inspections shall be carried out on samples of at least 200 fruits of each species of the specified fruits by batch of 30 tonnes, or part thereof, selected on the basis of any possible symptom of Phyllosticta citricarpa.

(*1)  Commission Directive 2004/103/EC of 7 October 2004 on identity and plant health checks of plants, plant products or other objects, listed in Part B of Annex V to Council Directive 2000/29/EC, which may be carried out at a place other than the point of entry into the Community or at a place close by and specifying the conditions related to these checks (OJ L 313, 12.10.2004, p. 16).’;"

*1

| (6) | in Article 7, point (c) is replaced by the following:






  ‘(c) | in the case of the specified fruits originating in Argentina, South Africa and Uruguay, in addition to points (a) and (b), detailed information on the pre- and post-harvest treatments has been kept.’; |
| --- | --- | --- |

(6)

in Article 7, point (c) is replaced by the following:

‘(c)

in the case of the specified fruits originating in Argentina, South Africa and Uruguay, in addition to points (a) and (b), detailed information on the pre- and post-harvest treatments has been kept.’;

| (7) | in Article 8, paragraph 1 is replaced by the following:

  ‘1.   By way of derogation from point 16.4(d) of Section I of Part A of Annex IV to Directive 2000/29/EC, specified fruits originating in Argentina, Brazil, South Africa or Uruguay, destined exclusively for industrial processing into juice, shall only be introduced into, and moved within, the Union in accordance with Articles 9 to 17 of this Decision.’ |
| --- | --- |

(7)

in Article 8, paragraph 1 is replaced by the following:

‘1.   By way of derogation from point 16.4(d) of Section I of Part A of Annex IV to Directive 2000/29/EC, specified fruits originating in Argentina, Brazil, South Africa or Uruguay, destined exclusively for industrial processing into juice, shall only be introduced into, and moved within, the Union in accordance with Articles 9 to 17 of this Decision.’

Article 2

This Decision shall apply from 5 June 2017.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 8 May 2017.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

---

(1)  
  OJ L 169, 10.7.2000, p. 1.

1

(2)  Commission Implementing Decision (EU) 2016/715 of 11 May 2016 setting out measures in respect of certain fruits originating in certain third countries to prevent the introduction into and the spread within the Union of the harmful organism Phyllosticta citricarpa (McAlpine) Van der Aa (OJ L 125, 13.5.2016, p. 16).

2

Phyllosticta citricarpa

---

| 11.5.2017 | EN | Official Journal of the European Union | L 120/29 |
| --- | --- | --- | --- |

11.5.2017

EN

Official Journal of the European Union

L 120/29

---

COMMISSION IMPLEMENTING DECISION (EU) 2017/802

of 10 May 2017

not approving PHMB (1600; 1.8) as an existing active substance for use in biocidal products for product-type 5

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,

Whereas:

| (1) | Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes PHMB (1600; 1.8). |
| --- | --- |

(1)

Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes PHMB (1600; 1.8).

| (2) | PHMB (1600; 1.8) has been evaluated for use in products of product-type 5, drinking water, as defined in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(2)

PHMB (1600; 1.8) has been evaluated for use in products of product-type 5, drinking water, as defined in Annex V to Regulation (EU) No 528/2012.

| (3) | France was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 23 November 2015. |
| --- | --- |

(3)

France was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 23 November 2015.

| (4) | In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 12 October 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. |
| --- | --- |

(4)

In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 12 October 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

| (5) | According to that opinion, biocidal products used for product-type 5 and containing PHMB (1600; 1.8) may not be expected to satisfy the requirements laid down in Article 19(1)(b) of Regulation (EU) No 528/2012. For that product-type, the scenarios evaluated in the environmental risk assessments identified unacceptable risks. |
| --- | --- |

(5)

According to that opinion, biocidal products used for product-type 5 and containing PHMB (1600; 1.8) may not be expected to satisfy the requirements laid down in Article 19(1)(b) of Regulation (EU) No 528/2012. For that product-type, the scenarios evaluated in the environmental risk assessments identified unacceptable risks.

| (6) | It is therefore not appropriate to approve PHMB (1600; 1.8) for use in biocidal products for product-type 5. |
| --- | --- |

(6)

It is therefore not appropriate to approve PHMB (1600; 1.8) for use in biocidal products for product-type 5.

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

(7)

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

HAS ADOPTED THIS DECISION:

Article 1

PHMB (1600; 1.8) (EC No: n.a., CAS No 27083-27-8 and 32289-58-0) is not approved as an active substance for use in biocidal products for product-type 5.

Article 2

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

Done at Brussels, 10 May 2017.

For the Commission

The President

Jean-Claude JUNCKER

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

1

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

2

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Corrigenda

| 11.5.2017 | EN | Official Journal of the European Union | L 120/31 |
| --- | --- | --- | --- |

11.5.2017

EN

Official Journal of the European Union

L 120/31

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Corrigendum to Commission Delegated Regulation (EU) 2017/653 of 8 March 2017 supplementing Regulation (EU) No 1286/2014 of the European Parliament and of the Council on key information documents for packaged retail and insurance-based investment products (PRIIPs) by laying down regulatory technical standards with regard to the presentation, content, review and revision of key information documents and the conditions for fulfilling the requirement to provide such documents

(
  Official Journal of the European Union L 100 of 12 April 2017
  )

On page 17, Annex II, point 13, the formula is replaced by the following:

‘

  Formula

  ’

on page 17, Annex II, point 17, the formula is replaced by the following:

‘

  Formula

  ’

on page 28, Annex IV, point 13(d) is replaced by the following:

| ‘(d) | Calculate the return for each contract by summing returns from selected periods and correcting these returns to ensure that the expected return measured from the simulated return's distribution is as below





  where E*[r
  bootstrapped
  ] is the new simulated mean.’. |
| --- | --- |

‘(d)

Formula

where E*[r
  bootstrapped
  ] is the new simulated mean.’.

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