title: Commission Implementing Regulation (EU) No 490/2012 of 8 June 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               9.6.2012

               EN

               Official Journal of the European Union

               L 150/76

         COMMISSION IMPLEMENTING REGULATION (EU) No 490/2012
   of 8 June 2012
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

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

               (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, 8 June 2012.

            For the Commission, On behalf of the President,
         José Manuel SILVA RODRÍGUEZ

            Director-General for Agriculture and Rural Development

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

      (2)  OJ L 157, 15.6.2011, p. 1.

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

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  AL

                  55,3

                  MK

                  52,8

                  TR

                  57,4

                  ZZ

                  55,2

                  0707 00 05

                  MK

                  18,0

                  TR

                  95,4

                  ZZ

                  56,7

                  0709 93 10

                  TR

                  99,6

                  ZZ

                  99,6

                  0805 50 10

                  BO

                  105,2

                  TR

                  110,6

                  ZA

                  91,9

                  ZZ

                  102,6

                  0808 10 80

                  AR

                  84,4

                  BR

                  80,0

                  CL

                  106,7

                  CN

                  136,2

                  NZ

                  136,2

                  US

                  121,4

                  ZA

                  114,0

                  ZZ

                  111,3

                  0809 10 00

                  TR

                  240,2

                  ZZ

                  240,2

                  0809 29 00

                  TR

                  421,6

                  ZZ

                  421,6

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


title: Commission Implementing Regulation (EU) No 403/2012 of 10 May 2012 amending for the 170th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al Qaida network

text:
               11.5.2012

               EN

               Official Journal of the European Union

               L 124/32

         COMMISSION IMPLEMENTING REGULATION (EU) No 403/2012
   of 10 May 2012
   amending for the 170th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al Qaida network
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network, (1) and in particular Article 7(1)(a) and 7a(5) thereof,
   Whereas:

               (1)

               Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

               (2)

               On 30 April 2012 and 3 May 2012 the Sanctions Committee of the United Nations Security Council decided to remove three natural persons from its list of persons, groups and entities to whom the freezing of funds and economic resources should apply after considering the de-listing requests submitted by these persons and the Comprehensive Reports of the Ombudsperson established pursuant to United Nations Security Council Resolution 1904(2009).

               (3)

               Annex I to Regulation (EC) No 881/2002 should therefore be updated accordingly.

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex I to Regulation (EC) No 881/2002 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 10 May 2012.

            For the Commission, On behalf of the President,

            Head of the Service for Foreign Policy Instruments

      (1)  OJ L 139, 29.5.2002, p. 9.

      ANNEX
      Annex I to Regulation (EC) No 881/2002 is amended as follows:

                  (1)

                  The following entries under the heading ‘Natural persons’ are deleted:
                  ‘Sa’d Abdullah Hussein Al-Sharif (alias Sa’d al-Sharif). Date of birth: 11.2.1964. Place of birth: Al-Medinah, Saudi Arabia. Nationality: Saudi Arabian. Passport No: (a) B 960789, (b) G 649385 (issued on 8.9.2006, expiring on 17.7.2011). Other information: Brother-in-law and close associate of Usama Bin Laden; said to be head of Usama Bin Laden's financial organization. Date of designation referred to in Article 2a (4) (b): 25.1.2001.’

                  (2)

                     ‘Mounir Ben Habib Ben Al-Taher Jarraya (alias (a) Mounir Jarraya, (b) Yarraya). Address: (a) Via Mirasole 11, Bologna, Italy, (b) 8 Via Ariosto, Casalecchio di Reno (Bologna), Italy. Date of birth: (a) 25.10.1963, (b) 15.10.1963. Place of birth: (a) Sfax, Tunisia, (b) Tunisia. Nationality: Tunisian. Passport No: L065947 (Tunisian passport issued on 28.10.1995, expired on 27.10.2000). Date of designation referred to in Article 2a (4) (b): 25.6.2003.’

                  (3)

                     ‘Fethi Ben Al-Rabei Ben Absha Mnasri (alias (a) Mnasri Fethi ben Rebai, (b) Mnasri Fethi ben al-Rabai, (c) Mnasri Fethi ben Rebaj, (d) Fethi Alic, (e) Amor, (f) Abu Omar, (g) Omar Tounsi, (h) Amar). Address: Birmingham, United Kingdom. Date of birth: (a) 6.3.1969, (b) 6.3.1963, (c) 3.6.1969. Place of birth: (a) Al-Sanadil Farm, Nefza, Governorate of Baja, Tunisia; (b) Tunisia; (c) Algeria. Nationality: Tunisian. Passport No: L497470 (Tunisian passport issued on 3.6.1997, expired on 2.6.2002). Other information: Mother’s name is Fatima Balayish. Date of designation referred to in Article 2a(4)(b): 25.6.2003.’


title: Commission Implementing Regulation (EU) No 409/2014 of 23 April 2014 entering a name in the register of traditional specialities guaranteed (Bacalhau de Cura Tradicional Portuguesa (TSG))

text:
               24.4.2014

               EN

               Official Journal of the European Union

               L 121/20

         COMMISSION IMPLEMENTING REGULATION (EU) No 409/2014
   of 23 April 2014
   entering a name in the register of traditional specialities guaranteed (Bacalhau de Cura Tradicional Portuguesa (TSG))
   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)(b) of Regulation (EU) No 1151/2012, Portugal's application to register the name ‘Bacalhau de Cura Tradicional Portuguesa’ 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 ‘Bacalhau de Cura Tradicional Portuguesa’ should therefore be entered in the register,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The name ‘Bacalhau de Cura Tradicional Portuguesa’ (TSG) is hereby entered in the register.
   The name referred to in the first paragraph identifies a product in Class 1.7. Fresh fish, molluscs and crustaceans and products derived therefrom of Annex II to Commission Regulation (EC) No 1216/2007 (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, 23 April 2014.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ C 292, 8.10.2013, p. 8.

      (3)  Commission Regulation (EC) No 1216/2007 of 18 October 2007 laying down detailed rules for the implementation of Council Regulation (EC) No 509/2006 on agricultural products and foodstuffs as traditional specialities guaranteed (OJ L 275, 19.10.2007, p. 3).


title: Commission Implementing Regulation (EU) No 838/2014 of 31 July 2014 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               1.8.2014

               EN

               Official Journal of the European Union

               L 230/13

         COMMISSION IMPLEMENTING REGULATION (EU) No 838/2014
   of 31 July 2014
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

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

               (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, 31 July 2014.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

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

      (2)  OJ L 157, 15.6.2011, p. 1.

      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

                  TR

                  41,5

                  ZZ

                  41,5

                  0707 00 05

                  MK

                  65,0

                  TR

                  96,7

                  ZZ

                  80,9

                  0709 93 10

                  TR

                  97,2

                  ZZ

                  97,2

                  0805 50 10

                  AR

                  133,0

                  CL

                  172,6

                  MGB

                  99,6

                  UY

                  146,9

                  ZA

                  153,1

                  ZZ

                  141,0

                  0806 10 10

                  BR

                  155,1

                  CL

                  90,0

                  EG

                  176,8

                  MA

                  146,7

                  TR

                  164,3

                  ZZ

                  146,6

                  0808 10 80

                  AR

                  155,6

                  BR

                  104,4

                  CL

                  105,9

                  NZ

                  134,3

                  US

                  155,8

                  ZA

                  125,7

                  ZZ

                  130,3

                  0808 30 90

                  AR

                  59,5

                  CL

                  90,3

                  NZ

                  177,1

                  TR

                  191,6

                  ZA

                  92,9

                  ZZ

                  122,3

                  0809 29 00

                  CA

                  324,1

                  TR

                  394,7

                  US

                  408,0

                  ZZ

                  375,6

                  0809 30

                  MK

                  60,3

                  TR

                  140,2

                  ZZ

                  100,3

                  0809 40 05

                  BA

                  42,8

                  MK

                  126,8

                  TR

                  141,2

                  ZZ

                  103,6

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


title: Commission Implementing Regulation (EU) No 449/2011 of 6 May 2011 entering certain names in the register of protected designations of origin and protected geographical indications (陕西苹果 (Shaanxi ping guo) (PDO), 龙井茶 (Longjing Cha) (PDO), 琯溪蜜柚 (Guanxi Mi You) (PDO), 蠡县麻山药 (Lixian Ma Shan Yao) (PGI))

text:
               11.5.2011

               EN

               Official Journal of the European Union

               L 122/67

         COMMISSION IMPLEMENTING REGULATION (EU) No 449/2011
   of 6 May 2011
   entering certain names in the register of protected designations of origin and protected geographical indications ( (Shaanxi ping guo) (PDO),  (Longjing Cha) (PDO),  (Guanxi Mi You) (PDO),  (Lixian Ma Shan Yao) (PGI))
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (1), and in particular the first subparagraph of Article 7(4) thereof,
   Whereas:

               (1)

            Pursuant to the first subparagraph of Article 6(2) of Regulation (EC) No 510/2006, the applications of the People’s Republic of China to register the names ‘
                   (Shaanxi ping guo)’, ‘
                   (Longjing Cha)’, ‘
                   (Guanxi Mi You)’ and ‘
                   (Lixian Ma Shan Yao)’ were published in the Official Journal of the European Union
                (2).

               (2)

               As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, these names should therefore be entered in the register,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The names contained in the Annex to this Regulation are hereby entered in the register.
   Article 2
   This Regulation shall enter into force on the 20th day following 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, 6 May 2011.

            For the Commission, On behalf of the President,
         Dacian CIOLOŞ

            Member of the Commission

      (1)  OJ L 93, 31.3.2006, p. 12.

      (2)  OJ C 252, 18.9.2010, p. 16; OJ C 254, 22.9.2010, p. 6; OJ C 257, 24.9.2010, p. 3; OJ C 257, 24.9.2010, p. 7.

      ANNEX
      Agricultural products intended for human consumption listed in Annex I to the Treaty:

         Class 1.6.   Fruit, vegetables and cereals, fresh or processed

      PEOPLE’S REPUBLIC OF CHINA

                      (Guanxi Mi You) (PDO)

                      (Lixian Ma Shan Yao) (PGI)

                      (Shaanxi ping guo) (PDO)

         Class 1.8.   Other products of Annex I to the Treaty (spices, etc.)

      PEOPLE’S REPUBLIC OF CHINA

          (Longjing Cha) (PDO)


title: Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015 laying down detailed rules for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, monitoring user compliance and best practices

text:
               20.10.2015

               EN

               Official Journal of the European Union

               L 275/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/1866
   of 13 October 2015
   laying down detailed rules for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, monitoring user compliance and best practices
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union (1), and in particular Article 5(5), Article 7(6) and Article 8(7) thereof,
   Whereas:

               (1)

               Regulation (EU) No 511/2014 establishes rules governing compliance with access and benefit-sharing for genetic resources and traditional knowledge associated with genetic resources in accordance with the provisions of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (the ‘Nagoya Protocol’). The effective implementation of that Regulation will also contribute to the conservation of biological diversity and the sustainable use of its components, in accordance with the provisions of the Convention on Biological Diversity.

               (2)

               Articles 5 and 8 of Regulation (EU) No 511/2014 provide for voluntary tools, namely registered collections and best practices, to assist users in complying with their due diligence obligation. Identifying and registering collections which effectively apply measures that result in supplying genetic resources and related information only with documentation providing evidence of legal access and ensuring the establishment of mutually agreed terms, where required, is expected to assist users in complying with that obligation. Users which obtain genetic resources from a collection included in the register should be considered to have exercised due diligence as regards the seeking of information. Identifying and recognising as best practices measures that are particularly suitable for achieving compliance with the system of implementation of the Nagoya Protocol, at an affordable cost and with legal certainty, is also expected to assist users in fulfilling the due diligence obligation. The effective implementation of a recognized best practice by users should be considered by the competent authorities in their checks on user compliance. In order to ensure uniform conditions for the implementation of those provisions, detailed rules are required regarding the procedures to be followed in the case of a request for registration of a collection or part thereof and regarding recognition of best practices.

               (3)

               Where an applicant wishing to be included in the register is a member of a network of collections, it is useful that such applicant provides information on any other collections or parts thereof from the same network that were or are the subject of an application in other Member States. In order to facilitate the fair and consistent treatment of applicants in different Member States, when verifying the collections or parts thereof, the competent authorities of the Member States that have been made aware of such applications in relation to different collections or parts thereof within a network should consider exchanging information with the authorities of those Member States in which applications have been made by other members of the network.

               (4)

               Regulation (EU) No 511/2014 applies to genetic resources and to traditional knowledge associated with genetic resources. The material for the utilisation of which a due diligence declaration is required includes: genetic resources, traditional knowledge associated with genetic resources and a combination of both.

               (5)

               In order to ensure uniform conditions for the implementation of provisions on monitoring user compliance, detailed rules are required regarding the declarations to be made by recipients of funding for research involving the utilisation of genetic resources and traditional knowledge associated with genetic resources, as well as regarding the declarations to be made by users at the stage of final development of a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources.

               (6)

               When monitoring user compliance at the stage of research funding, it is important to ensure that recipients of funding understand their obligations under Regulation (EU) No 511/2014 and that they exercise due diligence. It is equally important to provide information to the Access and Benefit-Sharing Clearing House (‘ABS Clearing House’), and to ensure that such information is useful for the functioning and implementation of the Nagoya Protocol. Where an internationally recognised certificate of compliance is not available, other relevant information should be submitted. In order to balance the objectives of submitting useful information to the ABS Clearing House and of not overburdening the recipients of funding for research, only information which is essential for the identification of genetic resources should be exchanged at this check-point.

               (7)

               The monitoring of user compliance is effective when carried out in the Member State where the utilisation takes place. It is therefore appropriate that the declaration of due diligence is submitted to the competent authority of the Member State where the recipient of funding is established, as this is where the research involving utilisation of genetic resources and traditional knowledge associated with genetic resources typically takes place.

               (8)

               The unnecessary multiplication of due diligence declarations should be avoided. Therefore, a declaration made by recipients of research funding may cover more than one genetic resource or any traditional knowledge associated with genetic resources. A single declaration may also be made by several users jointly conducting research involving the utilisation of genetic resources and traditional knowledge associated with genetic resources funded by one grant. In this context, a special role should be given to the project co-ordinator, who should be responsible for submitting the declarations on behalf of the users concerned. In the light of Article 12 of Regulation (EU) No 511/2014, the competent authority receiving the declarations submitted by the project co-ordinator should exchange the information with its counterparts in the other Member States concerned.

               (9)

               In order to monitor user compliance under Article 7(2) of Regulation (EU) No 511/2014, the final stage of utilisation, meaning the stage of final development of a product should be determined. The stage of final development of a product can be identified with legal certainty as having been completed at the time when either market approval or authorisation is sought or a notification required prior to placing for the first time on the Union market is made or, where neither market approval or authorisation nor a notification is required, at the time of placing for the first time on the Union market a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources. In some cases, it may not be the user that is requesting market approval or authorisation, making a notification or placing a product for the first time on the Union market. In order to effectively address all activities that utilise genetic resources and traditional knowledge associated with genetic resources within the Union, the due diligence declaration should, in those cases, be made by the user selling or transferring in any other way the result of the utilisation. Effective monitoring of user compliance within the Union should also address cases where the utilisation has ended in the Union and its outcome is sold or transferred in any other way outside the Union without placing a product on the Union market.

               (10)

               Those different events that give rise to the due diligence declaration by the user at the stage of final development of a product are exclusive of each other, and therefore the declaration should only be made once. As the stage of final development of a product is reached before any of those events occur, the due diligence declaration should be made prior to the first event occurring.

               (11)

               The information provided in the due diligence declarations is to be submitted by the competent authorities to the ABS Clearing House pursuant to Article 7(3) of Regulation (EU) No 511/2014. Where an internationally recognised certificate of compliance is not available, other relevant information provided in accordance with Article 17(4) of the Nagoya Protocol, as specified in Article 4(3)(b) of Regulation (EU) No 511/2014, should be submitted. In order to ensure efficient operation of the Nagoya Protocol and the ABS Clearing House in particular, only information which will facilitate the monitoring by the competent national authorities referred to in Article 13(2) of the Nagoya Protocol should be exchanged.

               (12)

               A due diligence declaration is required only for genetic resources or traditional knowledge associated with genetic resources obtained from a Party to the Nagoya Protocol that has established relevant access and benefit-sharing legislation or regulatory requirements pursuant to Article 6(1) and Article 7 of the Nagoya Protocol.

               (13)

               In the light of the novelty of measures introduced, it is appropriate to review this Regulation. In this context, the reports referred to in Article 16(1) of Regulation (EU) No 511/2014 may prove useful and therefore should be taken into account, where available.

               (14)

               The measures provided for in this Regulation are in accordance with the opinion of the ABS Committee,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Subject matter
   This Regulation lays down detailed rules concerning the implementation of Articles 5, 7 and 8 of Regulation (EU) No 511/2014 which refer to the register of collections, the monitoring of user compliance, and to best practices.
   Article 2
   Register of collections
   The register established by the Commission in accordance with Article 5 of Regulation (EU) No 511/2014 shall include the following information for each collection or part thereof:

               (a)

               a registration code assigned by the Commission;

               (b)

               name given to the collection or part thereof and its contact details;

               (c)

               name and contact details of the holder;

               (d)

               category of the collection or part thereof;

               (e)

               short description of the collection or part thereof;

               (f)

               link to database, where available;

               (g)

               institution within competent authority of the Member State that verified the capacity of the collection to comply with Article 5(3) of Regulation (EU) No 511/2014;

               (h)

               date of inclusion in the register;

               (i)

               other existing identifier, where available;

               (j)

               where applicable, date of removal from the register.

         Article 3
   Request for inclusion in the register and notification to the Commission
   1.   A request for inclusion of a collection or a part thereof in the register, referred to in Article 5(2) of Regulation (EU) No 511/2014, shall contain the information specified in Annex I to this Regulation.
   Following the inclusion in the register of a collection or a part thereof, the collection holder shall notify the competent authority of any significant changes that influence the collection's capacity to comply with the criteria set out in Article 5(3) of Regulation (EU) No 511/2014 and of any changes to the information previously submitted on the basis of Part A of Annex I to this Regulation.
   2.   Where an applicant is a member of a network of collections, when applying for inclusion of a collection or a part thereof in the register, the applicant may inform the competent authorities about any other collections or parts thereof from the same network that were or are the subject of an application in other Member States for inclusion in the register.
   When verifying the collections or parts thereof, the competent authorities of Member States that have been made aware of such applications, shall consider exchanging information with the competent authorities of those Member States where the other applications from the network have been made.
   3.   The verification referred to in Article 5(2) of Regulation (EU) No 511/2014 may include the following:

               (a)

               on-the-spot checks;

               (b)

               examination of selected documentation and records of a collection or part thereof, which are relevant for demonstrating compliance with Article 5(3) of Regulation (EU) No 511/2014;

               (c)

               examination of whether selected samples of genetic resources and related information of the collection concerned have been documented in accordance with Article 5(3) of Regulation (EU) 511/2014;

               (d)

               examination of whether the collection holder has the capacity to consistently supply genetic resources to third persons for their utilisation in accordance with Article 5(3) of Regulation (EU) No 511/2014;

               (e)

               interviews with relevant persons, such as the collection holder, staff, external verifiers, and users obtaining samples from that collection.

         4.   For the purposes of the notification referred to in Article 5(2) of Regulation (EU) No 511/2014, the competent authority shall provide the Commission with the information submitted by the collection holder on the basis of Part A of Annex I to this Regulation. The competent authority shall notify the Commission of any subsequent changes to that information.
   Article 4
   Checks on registered collections and remedial actions
   1.   The verification referred to Article 5(4) of Regulation (EU) No 511/2014 by the competent authorities shall be effective, proportionate and capable of detecting cases of non-compliance with Article 5(3) of that Regulation. It shall be conducted on the basis of a periodically reviewed plan developed using a risk-based approach. The plan should provide for a minimum level of checks and allow for differentiation in the frequency of checks.
   2.   Where there are substantiated concerns that a collection or part thereof included in the register no longer meets the criteria set out in Article 5(3) of Regulation (EU) No 511/2014, the competent authority shall carry out additional verification.
   3.   The verification referred to in paragraph 1 and 2 may include the following:

               (a)

               on-the-spot checks;

               (b)

               examination of selected documentation and records of a collection or part thereof, which are relevant for demonstrating compliance with Article 5(3) of Regulation (EU) No 511/2014;

               (c)

               examination of whether selected samples of genetic resources and related information have been documented and supplied to third persons for their utilisation in accordance with Article 5(3) of Regulation (EU) No 511/2014;

               (d)

               interviews with relevant persons, such as the collection holder, staff, external verifiers, and users obtaining samples from that collection.

         4.   The collection holder and its staff shall provide all assistance necessary to facilitate the verification referred to in paragraphs 1, 2 and 3.
   5.   Remedial actions or measures referred to in Article 5(4) of Regulation (EU) No 511/2014 shall be effective and proportionate and address shortcomings which, if left unaddressed, would permanently compromise the capacity of a registered collection to comply with Article 5(3) of that Regulation. They may require the collection holder concerned to put in place additional tools or to improve its capacity to apply existing tools. The collection holder shall report to the competent authority on the implementation of the identified remedial actions or measures.
   Article 5
   Due diligence declaration at the stage of research funding
   1.   A recipient of funding for research involving the utilisation of genetic resources and traditional knowledge associated with genetic resources shall make the due diligence declaration requested pursuant to Article 7(1) of Regulation (EU) No 511/2014 to the competent authority of the Member State in which the recipient is established. If the recipient is not established in the Union and the research is carried out in the Union, the due diligence declaration shall be made to the competent authority of the Member State in which the research is carried out.
   2.   The due diligence declaration shall be made by submitting the completed template set out in Annex II. It shall be made after the first instalment of funding has been received and all the genetic resources and traditional knowledge associated with genetic resources that are utilised in the funded research have been obtained, but no later than at the time of the final report, or in absence of such report, at the project end. The time of submission of such declaration may be further specified by the national authorities.
   3.   Where the same research project is funded from more than one source or involves more than one recipient, the recipient(s) may decide to make only one declaration. That declaration shall be submitted by the project co-ordinator to the competent authority of the Member State in which the project co-ordinator is established. If the project co-coordinator is not established in the Union and the research is carried out in the Union, the due diligence declaration shall be made to the competent authority of one of the Member States in which the research is carried out.
   4.   Where the competent authority that receives the declaration referred to in paragraphs 2 and 3 is not responsible for its transmission pursuant to Article 7(3) of Regulation (EU) No 511/2014, it shall forward that declaration to the competent authority responsible for such transmission without undue delay.
   5.   For the purposes of this Article and Annex II, ‘funding for research’ means any financial contribution by means of a grant to carry out research, whether from commercial or non-commercial sources. It does not cover internal budgetary resources of private or public entities
   Article 6
   Due diligence declaration at the stage of final development of a product
   1.   For the utilisation of genetic resources and traditional knowledge associated with genetic resources users shall make the due diligence declaration pursuant to Article 7(2) of Regulation (EU) No 511/2014 to the competent authority of the Member State in which the user is established. That declaration shall be made by submitting the completed template set out in Annex III to this Regulation.
   2.   The due diligence declaration referred to in paragraph 1 shall only be made once, prior to the first of the following events occurring:

               (a)

               market approval or authorisation is sought for a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources;

               (b)

               a notification required prior to placing for the first time on the Union market is made for a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources;

               (c)

               placing on the Union market for the first time a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources for which no market approval, authorisation or notification is required;

               (d)

               the result of the utilisation is sold or transferred in any other way to a natural or legal person within the Union in order for that person to carry out one of the activities referred to in points (a), (b) and (c);

               (e)

               the utilisation in the Union has ended and its outcome is sold or transferred in any other way to a natural or legal person outside the Union.

         3.   For the purposes of this Article and Annex III, ‘result of the utilisation’ means products, precursors or predecessors to a product, as well as parts of products to be incorporated into a final product, blueprints or designs, based on which manufacturing and production could be carried out without further utilisation of the genetic resource and traditional knowledge associated with genetic resources.
   4.   For the purposes of this Article and Annex III, ‘placing on the Union market’ means the first making available of a product developed via utilisation of genetic resources and traditional knowledge associated with genetic resources on the Union market, where making available means the supply by any means, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge. Placing on the market does not include pre-commercial trials, including clinical, field or pest resistance trials, nor the making available of unauthorised medicinal products in order to provide treatment options for individual patients or groups of patients.
   Article 7
   Transmission of information
   1.   In accordance with Article 7(3) of Regulation (EU) No 511/2014, and unless the information is confidential within the meaning of Article 7(5) of Regulation (EU) No 511/2014, the competent authorities shall transmit to the ABS Clearing House the information received on the basis of Part A of Annexes II and III to this Regulation without undue delay and at the latest one month after the information has been received.
   2.   Where essential information, such as on the user and utilisation, on the place of access, or on the genetic resource, without which the record could not be published on the ABS Clearing House, is considered confidential, the competent authorities shall consider instead transmitting that essential information directly to the competent national authorities referred to in Article 13(2) of the Nagoya Protocol.
   3.   In accordance with Article 7(3) of Regulation (EU) No 511/2014, the competent authorities shall transmit to the Commission the information received on the basis of Annexes II and III to this Regulation, unless such information is confidential within the meaning of Article 7(5) of Regulation (EU) No 511/2014.
   4.   Where the Commission is not provided access to this information on a permanent basis through electronic means, such transmission shall be made once every six months, starting from 9 November 2016.
   Article 8
   Application for recognition of a best practice
   1.   An application submitted in accordance with Article 8(1) of Regulation (EU) No 511/2014 shall be made to the Commission by providing the information and supporting documentation specified in Annex IV to this Regulation.
   2.   An interested party that does not represent users but is involved in the access, collection, transfer or commercialisation of genetic resources or in developing measures and policy related to genetic resources shall provide with its application information, as specified in Annex IV to this Regulation, on its legitimate interest in developing and overseeing a combination of procedures, tools or mechanisms, which, when effectively implemented by a user, enables that user to comply with the obligations provided for in Articles 4 and 7 of Regulation (EU) No 511/2014.
   3.   The Commission shall send a copy of the application and supporting documentation to the competent authorities of all the Member States.
   4.   The competent authorities may submit comments to the Commission regarding the application within two months of receiving the documents referred to in paragraph 3.
   5.   The Commission shall acknowledge receipt of an application and provide the applicant with a reference number within 20 working days from the date of receipt of the application.
   The Commission shall provide the applicant with an indicative time limit within which a decision on the application will be taken.
   The Commission shall inform the applicant if additional information or documentation is required in order for it to carry out the assessment of the application.
   6.   The applicant shall submit to the Commission any additional information and documentation requested without undue delay.
   7.   The Commission shall send a copy of the documents referred to in paragraph 6 to the competent authorities of all the Member States.
   8.   The competent authorities may submit comments to the Commission regarding the information or documentation referred to in paragraph 6 within two months of receiving the copy of those documents.
   9.   The Commission shall inform the applicant each time it revises the indicative time limit within which a decision on the application will be taken due to the necessity to obtain additional information or documents for the assessment of the application.
   The Commission shall inform the applicant in writing of the status of the assessment of the application at least every six months.
   Article 9
   Recognition and withdrawal of recognition as best practice
   1.   Where the Commission decides to grant recognition as best practice under Article 8(2) of Regulation (EU) No 511/2014 or to withdraw the recognition of best practice under Article 8(5) of that Regulation, the Commission shall inform of that decision without undue delay the association of users or the other interested parties, as well as the competent authorities of the Member States.
   2.   The Commission shall state reasons for its decision to grant recognition as best practice or to withdraw the recognition of best practice and it shall publish that decision in the register established under Article 8(6) of Regulation (EU) No 511/2014.
   Article 10
   Information on subsequent changes to a recognised best practice
   1.   Where the Commission is informed, pursuant to Article 8(3) of Regulation (EU) No 511/2014, of any changes or updates made to a recognized best practice, the Commission shall send a copy of that information to the competent authorities of all the Member States.
   2.   The competent authorities may submit comments to the Commission regarding such changes or updates within two months of receiving the information.
   3.   The Commission shall assess, taking into consideration the comments referred to in paragraph 2 of this Article, whether the changed or updated combination of procedures, tools or mechanisms still enables users to comply with their obligations provided for in Articles 4 and 7 of Regulation (EU) No 511/2014.
   4.   The competent authorities shall inform the Commission without undue delay of any information resulting from checks carried out pursuant to Article 9 of Regulation (EU) No 511/2014 indicating non-compliance with Articles 4 and 7 of that Regulation, which may indicate possible deficiencies in the best practice.
   Article 11
   Deficiency in best practice
   1.   Where the Commission receives substantiated information regarding repeated or significant cases of non-compliance with Articles 4 and 7 of Regulation (EU) No 511/2014 by a user implementing a best practice, the Commission shall request the association of users or the other interested parties to submit observations regarding the alleged non-compliance and whether those cases indicate possible deficiencies in the best practice.
   2.   Where the association of users or the other interested parties submit observations, they shall do so within three months.
   3.   The Commission shall examine those observations and any supporting documentation and send copies thereof to the competent authorities of all the Member States.
   4.   The competent authorities may submit comments to the Commission regarding those observations and supporting documentation within two months of receiving the copy of those documents.
   5.   Where the Commission examines possible deficiencies in a best practice and cases of non-compliance with the obligations provided for in Articles 4 and 7 of Regulation (EU) No 511/2014, as referred to in Article 8(4) of that Regulation, the association of users or the other interested parties subject to examination shall co-operate with the Commission and assist it in its actions. Where the association of users or the other interested parties subject to examination fails to do so, the Commission may, without further consideration, withdraw recognition of the best practice.
   6.   The results of the examination carried out by the Commission shall be conclusive and shall include any remedial actions to be taken by the association of users or the other interested parties. The examination may also result in a decision to withdraw recognition of the best practice.
   Article 12
   Review
   The Commission shall review the functioning and effectiveness of this Regulation, taking into account the experience gathered in its implementation and with a view to its potential revision. Such review should consider the impact of this Regulation on micro, small and medium-sized enterprises, public research institutions and specific sectors, as well as relevant developments at the international level, in particular those related to the ABS Clearing House.
   Article 13
   Entry into force
   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, 13 October 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 150, 20.5.2014, p. 59.

      ANNEX I

         Information to be provided with a request for inclusion in the register of collections pursuant to Article 3(1)

      PART A

         Information to be included in the register

      Pursuant to Article 3(1) the information to be provided with a request for inclusion in the register of collections is as follows:

                  1.

                  Information on the holder of the collection (name, type of entity, address, e-mail, telephone number).

                  2.

                  Information on whether the application concerns a collection or part of a collection.

                  3.

                  Information on the collection or the relevant part thereof (name; identifier (code/ number), where available; address(es), website, where available; link to the collection's online database of genetic resources, where available).

                  4.

                  A brief description of the collection or the relevant part thereof.
                  Where only part of a collection is to be included in the register, details on the relevant part(s) and its(their) distinctive features should be provided.

                  5.

                  Collection category
                  The application should provide information on the category to which the collection or part thereof belongs.

                     Table of categories

                              Specificities

                              Entire specimens (1)

                              Parts

                              Seeds, sexual spores, or embryos

                              Gametes
                              ♀ ♂

                              Somatic cells

                              Nucleic acids

                              Other parts (2)

                              Animal

                              Vertebrate

                              Invertebrate

                              Plants

                              Algae

                              Protista

                              Fungi

                              Bacteria

                              Archaea

                              Viruses

                              Other groupings (3)

            PART B

         Evidence of the capacity of the collection or of the relevant part thereof to comply with Article 5(3) of Regulation (EU) No 511/2014

      Any of the following documentation may be attached (or linked) to the application as evidence of the capacity of the collection or the relevant part thereof to comply with Article 5(3) of Regulation (EU) No 511/2014:

                  (a)

                  codes of conduct, guidelines or standards, whether national or international, developed by associations or organisations, and adhered to by the collection, and information relating to the collection's instruments for the application of those codes of conduct, guidelines or standards;

                  (b)

                  relevant principles, guidelines, codes of conduct or manuals of procedures, developed and applied within the collection, and any additional instruments for their application;

                  (c)

                  certification of the collection under relevant schemes, whether national or international;

                  (d)

                  information about participation of the collection in any international collection networks, and about associated applications for inclusion in the register of collections filed by partner collections in other Member States (optional);

                  (e)

                  any other relevant documentation.

         (1)  When no particular parts of a specimen are concerned, refer to the appropriate cell of ‘entire specimens’.

         (2)  ‘Other parts’ include asexual reproductive parts, vegetative reproduction structures, such as stem, cutting, tuber, rhizomes.

         (3)  ‘Other groupings’ include slime molds, etc.

      ANNEX II

         Template for a due diligence declaration to be submitted at the stage of research funding pursuant to Article 5(2)

      PART A

         Information to be transmitted to the ABS Clearing House pursuant to Article 7(3) of Regulation (EU) No 511/2014

         If the information provided is confidential within the meaning of Article 7(5) of Regulation (EU) No 511/2014, please provide it nonetheless, tick the respective box and provide the justification for confidentiality at the end of this Annex.

         If you marked as confidential essential information (such as about the genetic resources or traditional knowledge associated with genetic resources, access place, form of utilisation), without which the record would not be published on the website of the ABS Clearing House, this information will not be shared with the ABS Clearing House, but it may be passed on directly to the competent authorities of the provider country.

         At least one declaration is required per grant received, i.e. different recipients under one grant may choose to submit either individual declarations or a joint declaration, through the project coordinator.

      I am making this declaration for the utilisation of:

         Please tick the appropriate box or boxes:

                  ☐ Genetic resources

                  ☐ Traditional knowledge associated with genetic resources

                  1.

                  Subject matter of the research or identification code of the grant:
                  ☐ Confidential

                  2.

                  Recipient or recipients of funding, including contact details:

                              Name:

                              Address:

                              E-mail:

                              Telephone:

                              Website, where available:

                  3.

                  Information on exercise of due diligence:

                              (a)

                              ☐ An internationally recognised certificate of compliance (i) was issued for my (entity's) access or (ii) covers the terms of this access to the genetic resource(s) and traditional knowledge associated with genetic resources.
                              Where this box is ticked, please indicate the unique identifier of the internationally recognised certificate of compliance:
                              Please go to point 1 of Part B.

                              (b)

                              Where the box in point (a) has not been ticked, please fill in the following information:

                                          (i)

                                          Place of access:
                                          ☐ Confidential

                                          (ii)

                                          Description of the genetic resources or traditional knowledge associated with genetic resources utilised; or unique identifier(s), where available:
                                          ☐ Confidential

                                          (iii)

                                          Identifier of access permit or its equivalent (1), where available:
                                          ☐ Confidential

                                    Please go to point 2 of Part B.

            PART B

         Information not to be transmitted to the ABS Clearing House

                  1.

                  I declare that I will keep and transfer to subsequent user(s) a copy of the internationally recognised certificate of compliance as well as information on the content of the mutually agreed terms relevant for subsequent users.

                     Please go to point 3.

                  2.

                  I declare that I am in possession of the following information, which I will keep and transfer to subsequent user(s):

                              (a)

                              date of access;

                              (b)

                              person or entity having granted prior informed consent, where applicable;

                              (c)

                              person or entity to whom prior informed consent was granted (where applicable), if not granted directly to me or my entity;

                              (d)

                              mutually agreed terms, where applicable;

                              (e)

                              the source from which I or my entity obtained the genetic resource and traditional knowledge associated with genetic resources;

                              (f)

                              presence or absence of rights and obligations relating to access and benefit-sharing, including rights and obligations regarding subsequent applications and commercialisation.

                  3.

                  Where the genetic resource(s) was(were) obtained from a registered collection, please provide the registration code of the collection:

                  4.

                  The research grant is funded by the following sources:

                              Private ☐

                              Public ☐

                  5.

                  Member State(s) in which the research involving utilisation of genetic resources and traditional knowledge associated with genetic resources takes place or has taken place:

                        Confidentiality

                  If you have declared that some information is confidential within the meaning of Article 7(5) of Regulation (EU) No 511/2014, please state the reasons for each piece of information for which you have declared that confidentiality applies:

                              Date:

                              Place:

                              Signature (2):

         (1)  Evidence of the decision to grant prior informed consent or approval for access to genetic resources and traditional knowledge associated with genetic resources.

         (2)  Signature of the recipient of funding or individual responsible within the research institution.

      ANNEX III

         Template for a due diligence declaration to be submitted at the stage of final development of a product pursuant to Article 6(1)

      PART A

         Information to be transmitted to the ABS Clearing House pursuant to Article 7(3) of Regulation (EU) No 511/2014

         If the information provided is confidential within the meaning of Article 7(5) of Regulation (EU) No 511/2014, please provide it nonetheless, tick the respective box and provide the justification for confidentiality at the end of this Annex.

         If you marked as confidential essential information (such as about the genetic resources or traditional knowledge associated with genetic resources, access place, form of utilisation) without which the record would not be published on the website of the ABS Clearing House, this information will not be shared with the Clearing House but it may be passed on directly to the competent authorities of the provider country.

         If the utilisation has involved more than one genetic resource or any traditional knowledge associated with genetic resources, please provide relevant information for each genetic resource or any traditional knowledge utilised.

      I declare that I have fulfilled the obligations under Article 4 of Regulation (EU) No 511/2014. I am making this declaration for the utilisation of:

         Please tick the appropriate box or boxes:

                  ☐ Genetic resources

                  ☐ Traditional knowledge associated with genetic resources

                  1.

                  Name of the product or description of the result of the utilisation (1) or description of the outcome of the utilisation (2):
                  ☐ Confidential

                  2.

                  Contact details of the user:

                              Name:

                              Address:

                              E-mail:

                              Telephone:

                              Website, where available:

                  3.

                  The declaration is made on the occasion of the following event:
                  Please tick the appropriate box:

                              ☐ (a)

                              market approval or authorisation is sought for a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources;

                              ☐ (b)

                              a notification required prior to placing for the first time on the Union market is made for a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources;

                              ☐ (c)

                              placing for the first time on the Union market a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources, for which no market approval, authorisation or notification is required;

                              ☐ (d)

                              the result of the utilisation is sold or transferred in any other way to a natural or legal person within the Union in order for that person to carry out one of the activities referred to in points (a), (b) and (c);

                              ☐ (e)

                              the utilisation has ended in the Union and its outcome is sold or transferred in any other way to a natural or legal person outside the Union.

                  4.

                  Information on exercise of due diligence:

                              (a)

                              ☐ An internationally recognised certificate of compliance (i) was issued for my (entity's) access or (ii) covers the terms of this access to the genetic resource(s) and traditional knowledge associated with genetic resources.
                              Where this box is ticked, please indicate the unique identifier of the internationally recognised certificate of compliance:
                              Please go to point 2 of Part B.

                              (b)

                              Where the box in point (a) has not been ticked, please fill in the following information:

                                          (i)

                                          Place of access:
                                          ☐ Confidential

                                          (ii)

                                          Description of the genetic resource or traditional knowledge associated with genetic resources utilised, or unique identifier(s), where available:
                                          ☐ Confidential

                                          (iii)

                                          Date of access:
                                          ☐ Confidential

                                          (iv)

                                          Identifier of access permit or its equivalent (3), where available:
                                          ☐ Confidential

                                          (v)

                                          Person or entity who granted prior informed consent:
                                          ☐ Confidential

                                          (vi)

                                          Person or entity to whom the prior informed consent was granted:
                                          ☐ Confidential

                                          (vii)

                                          Is the utilisation of genetic resources and traditional knowledge associated with genetic resources subject to mutually agreed terms?

                                                      Yes ☐

                                                      No ☐

                                                ☐ Confidential
                                          Please go to point 1 of Part B.

            PART B

         Information not to be transmitted to the ABS Clearing House

                  1.

                  Information on exercise of due diligence:

                              (a)

                              Direct source of the genetic resource and the traditional knowledge associated with genetic resources:

                              (b)

                              Are there any restrictions in the mutually agreed terms limiting the possible utilisation of the genetic resource(s) or the traditional knowledge associated with genetic resources, e.g. allowing for non-commercial utilisation only?

                                          Yes ☐

                                          No ☐

                                          Not applicable ☐

                              (c)

                              Have there been rights and obligations agreed regarding subsequent applications and commercialisation in the mutually agreed terms?

                                          Yes ☐

                                          No ☐

                                          Not applicable ☐

                  2.

                  If the genetic resource(s) was(were) obtained from a registered collection, please provide the registration code of the collection:

                  3.

                  If you are implementing a best practice recognised under Article 8 of Regulation (EU) No 511/2014, please provide the registration number:

                  4.

                  Which category best describes your product (optional)?

                              ☐ (a)

                              cosmetics

                              ☐ (b)

                              medicinal products

                              ☐ (c)

                              food and beverage

                              ☐ (d)

                              biological control

                              ☐ (e)

                              plant breeding

                              ☐ (f)

                              animal breeding

                              ☐ (g)

                              other, please specify:

                  5.

                  Member State(s) in which the utilisation of genetic resources and traditional knowledge associated with genetic resources has taken place:

                  6.

                  Member State(s) in which the product is to be placed on the market, following the procedure for approval, authorisation or notification referred to in Article 6(2)(a) and (b) of Commission Regulation (EU) 2015/1866 or placed on the market in accordance with Article 6(2)(c) of that Regulation:

                        Confidentiality

                  If you have declared that some information is confidential within the meaning of Article 7(5) of Regulation (EU) No 511/2014, please state the reasons for each piece of information for which you have declared that confidentiality applies:

                              Date:

                              Place:

                              Signature (4):

         (1)  ‘Result of the utilisation of genetic resources and traditional knowledge associated with genetic resources’ means products, precursors or predecessors to a product, as well as parts of products to be incorporated into a final product, blueprints or designs, based on which manufacturing and production could be carried out without further utilisation of the genetic resource and traditional knowledge associated with genetic resources.

         (2)  Where the utilisation in the Union has ended and its outcome is sold or transferred in any other way to a natural or legal person outside the Union.

         (3)  Evidence of the decision to grant prior informed consent or approval for access to genetic resources and traditional knowledge associated with genetic resources.

         (4)  Signature of the person legally responsible for the stage of final development of a product.

      ANNEX IV

         Information to be provided with an application for recognition of best practice pursuant to Article 8(1)

      Pursuant to Article 8(1) the information to be provided with the application for recognition of best practice is as follows:

                  1.

                  Information whether the application is made on behalf of an association of users or other interested parties.

                  2.

                  Contact details of the association of users or other interested parties (name, address, e-mail, telephone, and website, where available).

                  3.

                  If the application is made by an association of users, the following should be provided:

                              (a)

                              evidence of being established in accordance with the requirements of the Member State in which the applicant is located;

                              (b)

                              description of the organisation and structure of the association.

                  4.

                  If the application is made by other interested parties, the reasons for having legitimate interest in the subject matter of Regulation (EU) No 511/2014 should be explained.

                  5.

                  The information provided should describe how the applicant is involved in developing measures and policies related to genetic resources, or how the applicant accesses, collects, transfers or commercialises genetic resources and traditional knowledge associated with genetic resources.

                  6.

                  Description of the combination of procedures, tools or mechanisms, developed by the applicant, which, when effectively implemented, enable users to comply with the obligations provided for in Articles 4 and 7 of Regulation (EU) No 511/2014.

                  7.

                  Description of how the overseeing of the procedures, tools or mechanisms referred to in point 6 will be carried out.

                  8.

                  Information on Member State(s) in which the applicant is located and in which it operates.

                  9.

                  Information on Member State(s) where the users implementing the best practice overseen by the association or the other interested party operate.

         List of supporting documents related to points 5 and 6:

                  (a)

                  list of relevant personnel working for organization applying or any sub-contractors, with description of their duties related to the development and overseeing of best practices;

                  (b)

                  declaration of absence of conflict of interest, on the part of applicant and any sub-contractors, in developing and overseeing the combination of procedures, tools or mechanisms (1);

                  (c)

                  where tasks related to development of best practices or overseeing such practices or both are sub-contracted, description of those tasks.

         (1)  Payment of fees or voluntary contributions by users to an association should not be considered as creating a conflict of interest.


title: Commission Implementing Regulation (EU) No 1272/2014 of 28 November 2014 amending Regulation (EEC) No 2454/93 as regards the marking of containers for the purpose of their temporary importation  Text with EEA relevance

text:
               29.11.2014

               EN

               Official Journal of the European Union

               L 344/14

         COMMISSION IMPLEMENTING REGULATION (EU) No 1272/2014
   of 28 November 2014
   amending Regulation (EEC) No 2454/93 as regards the marking of containers for the purpose of their temporary importation
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (1), and in particular Article 247 thereof,
   Whereas:

               (1)

               The Union is a Contracting Party to the Convention on Temporary Admission concluded in Istanbul on 26 June 1990 (hereafter ‘the Istanbul Convention’). Annex B.3 to the Istanbul Convention contains provisions concerning containers, pallets, packings, samples and other goods imported in connection with a commercial operation. The Administrative Committee for the Convention on Temporary Admission recommended at its 12th meeting on 25 March 2013 an amendment to Appendix II to Annex B.3 to the Istanbul Convention containing provisions concerning the marking of containers. The amendment came into force on 4 November 2014.

               (2)

               The Istanbul Convention is not directly applicable in the Union. Its amendment should therefore be incorporated into Union law in order to ensure that the Union complies with its international obligations.

               (3)

               Commission Regulation (EEC) No 2454/93 (2) should therefore be amended accordingly.

               (4)

               The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Article 557 of Regulation (EEC) No 2454/93 is amended as follows:

               (1)

               in paragraph 1, the first subparagraph is replaced by the following:
               ‘1.   Total relief from import duties shall be granted for containers where they have been durably marked in an appropriate and clearly visible place with all of the following information:

                           (a)

                           the identification of the owner or operator, which may be shown either by its full name or by an established identification system, symbols such as emblems or flags being excluded;

                           (b)

                           the identification marks and numbers of the container, given by the owner or operator;

                           (c)

                           the tare weight of the container, including all its permanently fixed equipment.’

                     ;

               (2)

               in paragraph 1 after the first subparagraph, the following subparagraph is inserted:
               ‘For freight containers considered for maritime use, or for any other container utilising an ISO standard prefix (i.e. four capital letters ending in U), the identification of the owner or principal operator and the container serial number and check digit of the container shall adhere to International Standard ISO 6346 and its annexes.’.
         Article 2
   This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 28 November 2014.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 302, 19.10.1992, p. 1.

      (2)  Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code (OJ L 253, 11.10.1993, p. 1).


title: Commission Implementing Regulation (EU) No 1107/2012 of 27 November 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               28.11.2012

               EN

               Official Journal of the European Union

               L 328/16

         COMMISSION IMPLEMENTING REGULATION (EU) No 1107/2012
   of 27 November 2012
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

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

               (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, 27 November 2012.

            For the Commission, On behalf of the President,
         José Manuel SILVA RODRÍGUEZ

            Director-General for Agriculture and Rural Development

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

      (2)  OJ L 157, 15.6.2011, p. 1.

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

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  AL

                  44,1

                  MA

                  50,0

                  MK

                  37,4

                  TN

                  73,5

                  TR

                  64,0

                  ZZ

                  53,8

                  0707 00 05

                  AL

                  64,5

                  MA

                  141,4

                  MK

                  58,4

                  TR

                  89,6

                  ZZ

                  88,5

                  0709 93 10

                  MA

                  88,6

                  TR

                  100,6

                  ZZ

                  94,6

                  0805 20 10

                  MA

                  76,3

                  ZZ

                  76,3

                  0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90

                  CN

                  65,5

                  HR

                  35,6

                  TR

                  81,7

                  ZZ

                  60,9

                  0805 50 10

                  AR

                  68,7

                  TR

                  85,8

                  ZA

                  49,1

                  ZZ

                  67,9

                  0808 10 80

                  MK

                  38,5

                  NZ

                  138,3

                  US

                  125,4

                  ZA

                  113,0

                  ZZ

                  103,8

                  0808 30 90

                  CN

                  59,5

                  TR

                  116,3

                  US

                  136,8

                  ZZ

                  104,2

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


title: Commission Implementing Regulation (EU) 2017/438 of 13 March 2017 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance abamectin (Text with EEA relevance. )

text:
               14.3.2017

               EN

               Official Journal of the European Union

               L 67/67

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/438
   of 13 March 2017
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance abamectin
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) thereof,
   Whereas:

               (1)

               Commission Directive 2008/107/EC (2) included the active substance abamectin as an active substance in Annex I to Council Directive 91/414/EEC (3) for uses as an acaricide and as an insecticide. Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

               (2)

               In accordance with Article 7(1) of Regulation (EC) No 1107/2009, on 29 August 2013 the producer of the active substance Syngenta Crop Protection AG submitted an application to the designated rapporteur Member State, the Netherlands, seeking an amendment to the conditions of approval of abamectin in order to provide for its use as a nematicide. In accordance with Article 9(3) of that Regulation, the Netherlands notified the applicant, the other Member States, the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 18 March 2014 that the application was admissible.

               (3)

               The designated rapporteur Member State assessed the new use of the active substance abamectin in relation to potential effects on human and animal health and the environment in accordance with the provisions of Article 4 of Regulation (EC) No 1107/2009, and submitted a draft assessment report to the Commission and to the Authority on 14 April 2015. In accordance with Article 12(3) of that Regulation additional information was requested from the applicant. The Netherlands evaluated the additional information and submitted an updated draft assessment report to the Commission and to the Authority in 15 February 2016.

               (4)

               On 29 April 2016 the Authority communicated to the Commission its conclusion (5) on whether the new uses of the active substance abamectin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft addendum to the review report for abamectin and a draft Regulation to the Standing Committee on Plants, Animals, Food and Feed on 7 December 2016.

               (5)

               The applicant was invited to submit comments on the review report.

               (6)

               It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that, when the plant protection product is used as a nematicide, the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to allow the use of the active substance abamectin as a nematicide.

               (7)

               In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in light of current scientific and technical knowledge, it is necessary and appropriate to grant approval subject to certain conditions and to require the applicant to provide further confirmatory information.

               (8)

               The approval of abamectin provided that some confirmatory data shall be submitted within two years after the entry into force of Directive 2008/107/EC. The applicant at whose request abamectin was approved submitted the requested information, which was assessed by the Netherlands. A safe use was confirmed for the original approval. Therefore this issue is finalised and there is no need to keep this provision.

               (9)

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

               (10)

               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
   Amendment to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   Entry into force
   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, 13 March 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Commission Directive 2008/107/EC of 25 November 2008 amending Council Directive 91/414/EEC to include abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim as active substances (OJ L 316, 26.11.2008, p. 4).

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

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

      (5)  EFSA Journal 2014;12(5):3692. Available online: www.efsa.europa.eu

      ANNEX
      The column ‘Specific provisions’ of row 210, abamectin, of Part A of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:

         ‘PART A
         Only uses as insecticide, acaricide and nematicide may be authorised.
         PART B
         In assessing applications to authorise plant protection products containing abamectin for uses other than citrus, lettuce and tomatoes, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information are provided before such an authorisation is granted.
         For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on abamectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 and of the addendum to the review report on abamectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed dated 24 January 2017 shall be taken into account.
         In this overall assessment Member States must pay particular attention to:

                     —

                     the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

                     —

                     the residues in food of plant origin and evaluate the dietary exposure of consumers,

                     —

                     the protection of bees, non-target arthropods, soil organisms, birds, mammals and aquatic organisms. In relation to these identified risks, risk mitigation measures, such as buffer zones and waiting periods, should be applied where appropriate.

               The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water by two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.’


title: Commission Implementing Regulation (EU) No 484/2013 of 24 May 2013 amending Regulation (EC) No 718/2007 implementing Council Regulation (EC) No 1085/2006 establishing an instrument for pre-accession assistance (IPA)

text:
               25.5.2013

               EN

               Official Journal of the European Union

               L 139/11

         COMMISSION IMPLEMENTING REGULATION (EU) No 484/2013
   of 24 May 2013
   amending Regulation (EC) No 718/2007 implementing Council Regulation (EC) No 1085/2006 establishing an instrument for pre-accession assistance (IPA)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1085/2006 of 17 July 2006 establishing an Instrument for Pre-Accession Assistance (IPA) (1) (‘the IPA Regulation’), and in particular Article 3(3) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 718/2007 of 12 June 2007 implementing Council Regulation (EC) No 1085/2006 establishing an instrument for pre-accession assistance (IPA) (2) provides for detailed rules for the implementation of the IPA Regulation.

               (2)

               In order to achieve the objectives under areas of assistance of transition assistance and institution building component, for some operations, like those contributing to the resolution of the refugees’ and displaced persons’ housing problem in the Western Balkans the eligibility of expenditure for purchase of land and existing buildings is indispensable and constitutes a core of the action. The eligibility of the expenditure for purchase of land and existing buildings should be provided for in a new derogation.

               (3)

               Regulation (EC) No 718/2007 should therefore be amended accordingly.

               (4)

               The provisions laid down in this Regulation are in accordance with the opinion of the IPA Committee,

         HAS ADOPTED THIS REGULATION:
   Article 1
   In Article 66(3) of Regulation (EC) No 718/2007, the following point (d) is added:

               ‘(d)

               purchase of land and existing buildings when justified by the nature of the operation’.

         Article 2
   This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 24 May 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 210, 31.7.2006, p. 82.

      (2)  OJ L 170, 29.6.2007, p. 1.


title: Commission Implementing Regulation (EU) No 968/2012 of 19 October 2012 adding to the 2012-2013 fishing quota for anchovy in the Bay of Biscay the quantities withheld by France in the fishing season 2011-2012 pursuant to Article 4(2) of Council Regulation (EC) No 847/96

text:
               20.10.2012

               EN

               Official Journal of the European Union

               L 290/8

         COMMISSION IMPLEMENTING REGULATION (EU) No 968/2012
   of 19 October 2012
   adding to the 2012-2013 fishing quota for anchovy in the Bay of Biscay the quantities withheld by France in the fishing season 2011-2012 pursuant to Article 4(2) of Council Regulation (EC) No 847/96
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 847/96 of 6 May 1996 introducing additional conditions for year-to-year management of TACs and quotas (1), and in particular Article 4(2) thereof,
   Whereas:

               (1)

               According to Article 4(2) of Regulation (EC) No 847/96, Member States may ask the Commission, before 31 October of the year of application of a fishing quota allocated to them, to withhold a maximum of 10 % of that quota to be transferred to the following year. The Commission is to add to the relevant quota the quantity withheld.

               (2)

               For the 2011/2012 fishing season, Council Regulation (EU) No 716/2011 (2) allocated to France a quota of 2 970 tonnes of anchovy in the Bay of Biscay.

               (3)

               However, taking into account exchanges of fishing opportunities in accordance with Article 20(5) of Council Regulation (EC) No 2371/2002 (3), quota transfers in accordance with Article 4(2) of Regulation (EC) No 847/96 and/or reallocation and deduction of fishing opportunities in accordance with Articles 37 and 105 of Council Regulation (EC) No 1224/2009 (4), the quota available to France for that stock during the 2011-2012 fishing season amounted to 6 362 tonnes.

               (4)

               At the end of that fishing season France reported catches of anchovy in the Bay of Biscay for a total amount of 4 198 tonnes.

               (5)

               France has requested pursuant to Article 4(2) of Regulation (EC) No 847/96 that part of its anchovy’s quota for the 2011-2012 fishing season be withheld and transferred to the following fishing season. Within the limits indicated by that Regulation, the quantities withheld should be added to the quota established by Council Regulation (EU) No 694/2012 (5) for the 2012-2013 fishing season.

               (6)

               The measures provided for in this Regulation are in accordance with the opinion of the Committee for Fisheries and Aquaculture,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The fishing quota for anchovy in the Bay of Biscay allocated to France by Regulation (EU) No 694/2012 shall be increased by 636 tonnes.

               Country ID

               Stock Id

               Species

               Zone name

               Final quota 2011/2012

               Catches 2011/2012

               % final quota

               Transferred quantity

               Initial quota 2012/2013
               R. 694/2012

               Revised quota 2012/2013

               FRA

               ANE/08.

               Anchovy

               VIII (Bay of Biscay)

               6 362 t

               4 198 t

               65,9 %

               636 t

               2 070 t

               2 706 t

         Article 2
   This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 19 October 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 115, 9.5.1996, p. 3.

      (2)  OJ L 193, 23.7.2011, p. 11.

      (3)  OJ L 358, 31.12.2002, p. 59.

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

      (5)  OJ L 203, 31.7.2012, p. 26.