title: Commission Implementing Regulation (EU) 2017/1455 of 10 August 2017 concerning the non-renewal of approval of the active substance picoxystrobin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance. )

text:
               11.8.2017

               EN

               Official Journal of the European Union

               L 208/28

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/1455
   of 10 August 2017
   concerning the non-renewal of approval of the active substance picoxystrobin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) and Article 78(2) thereof,
   Whereas:

               (1)

               Commission Directive 2003/84/EC (2) included picoxystrobin as active substance in Annex I to Council Directive 91/414/EEC (3).

               (2)

               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).

               (3)

               The approval of the active substance picoxystrobin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2017.

               (4)

               An application for the renewal of the approval of picoxystrobin was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

               (5)

               The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

               (6)

               The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 30 June 2015.

               (7)

               The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

               (8)

               On 1 June 2016 the Authority communicated to the Commission its conclusion (6) on whether picoxystrobin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The following concerns were identified: a clastogenic and aneugenic potential of metabolite IN-H8612 formed as a residue cannot be excluded and a high risk was identified for aquatic organisms and earthworms from exposure to picoxystrobin and for earthworm-eating mammals from exposure to metabolite IN-QDY63. Moreover, a number of areas of the assessment could not be finalised. Based on the data available in the dossier it was not considered possible to complete the assessment of genotoxicity for picoxystrobin and consequently health-based reference values for use in risk assessment could not be established and therefore consumer and non-dietary risk asessements could not be conducted. The compliance of the toxicity studies compared to the technical specification and the relevance of impurities could not be finalised given the incomplete assessment of the genotoxic potential of picoxystrobin. The absence of endocrine-mediated effects caused by picoxystrobin could also not be concluded. The dietary risk assessment from exposure to metabolites could not be finalised as further data are needed to define the toxicological profile of several metabolites; consequently, residue definitions for risk assessment purposes could not be derived. Furthermore, the genotoxic potential of several metabolites predicted to occur in groundwater could not be concluded based on the data available. Finally, the assessment of the risk from secondary poisoning via the aquatic food chain for birds and mammals could not be finalised.

               (9)

               The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the draft renewal report. The applicant submitted its comments, which have been carefully examined.

               (10)

               However, despite the arguments put forward by the applicant, the concerns related to the substance could not be eliminated.

               (11)

               Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 are satisfied. The approval of the active substance picoxystrobin should therefore not be renewed.

               (12)

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

               (13)

               Member States should be allowed sufficient time to withdraw authorisations for plant protection products containing picoxystrobin.

               (14)

               For plant protection products containing picoxystrobin, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 30 November 2018.

               (15)

               Commission Implementing Regulation (EU) 2016/950 (7) extended the expiry date of picoxystrobin to 31 October 2017 in order to allow the renewal process to be completed before the expiry of the approval of that substance. Given that a decision is taken ahead of this extended expiry date, this Regulation should apply as soon as possible.

               (16)

               This Regulation does not prejudice the submission of a further application for the approval of picoxystrobin in accordance with Article 7 of Regulation (EC) No 1107/2009.

               (17)

               The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Non-renewal of approval of active substance
   The approval of the active substance picoxystrobin is not renewed.
   Article 2
   Transitional measures
   Member States shall withdraw authorisations for plant protection products containing picoxystrobin as active substance by 30 November 2017 at the latest.
   Article 3
   Grace period
   Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 30 November 2018 at the latest.
   Article 4
   Amendments to Implementing Regulation (EU) No 540/2011
   In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 68, on picoxystrobin, is deleted.
   Article 5
   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, 10 August 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Commission Directive 2003/84/EC of 25 September 2003 amending Council Directive 91/414/EEC to include flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam as active substances (OJ L 247, 30.9.2003, p. 20).

      (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)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

      (6)  EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk assessment of the active substance picoxystrobin. EFSA Journal 2016;14(6):4515, 26 pp. doi:10.2903/j.efsa.2016.4515.

      (7)  Commission Implementing Regulation (EU) 2016/950 of 15 June 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,4-DB, beta-cyfluthrin, carfentrazone ethyl, Coniothyrium minitans Strain CON/M/91-08 (DSM 9660), cyazofamid, deltamethrin, dimethenamid-P, ethofumesate, fenamidone, flufenacet, flurtamone, foramsulfuron, fosthiazate, imazamox, iodosulfuron, iprodione, isoxaflutole, linuron, maleic hydrazide, mesotrione, oxasulfuron, pendimethalin, picoxystrobin, silthiofam and trifloxystrobin (OJ L 159, 16.6.2016, p. 3).


title: Commission Implementing Regulation (EU) 2017/688 of 11 April 2017 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               12.4.2017

               EN

               Official Journal of the European Union

               L 99/19

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/688
   of 11 April 2017
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

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

               (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, 11 April 2017.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General

            Directorate-General for Agriculture and Rural Development

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

      (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

                  EG

                  288,4

                  MA

                  126,5

                  TN

                  214,0

                  TR

                  126,8

                  ZZ

                  188,9

                  0707 00 05

                  MA

                  74,1

                  TR

                  158,2

                  ZZ

                  116,2

                  0709 93 10

                  MA

                  81,0

                  TR

                  144,0

                  ZZ

                  112,5

                  0805 10 22 , 0805 10 24 , 0805 10 28

                  EG

                  48,2

                  IL

                  77,7

                  MA

                  52,2

                  TN

                  59,3

                  TR

                  74,4

                  ZZ

                  62,4

                  0805 50 10

                  AR

                  61,0

                  TR

                  71,2

                  ZZ

                  66,1

                  0808 10 80

                  BR

                  100,7

                  CL

                  120,2

                  CN

                  109,3

                  NZ

                  158,2

                  TR

                  98,3

                  ZA

                  115,5

                  ZZ

                  117,0

                  0808 30 90

                  AR

                  114,9

                  CH

                  128,6

                  CL

                  136,0

                  CN

                  122,9

                  US

                  174,6

                  ZA

                  119,1

                  ZZ

                  132,7

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


title: Commission Implementing Regulation (EU) No 599/2012 of 5 July 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               6.7.2012

               EN

               Official Journal of the European Union

               L 176/62

         COMMISSION IMPLEMENTING REGULATION (EU) No 599/2012
   of 5 July 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, 5 July 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

                  TR

                  50,2

                  ZZ

                  50,2

                  0707 00 05

                  TR

                  103,2

                  ZZ

                  103,2

                  0709 93 10

                  TR

                  115,5

                  ZZ

                  115,5

                  0805 50 10

                  AR

                  89,2

                  TR

                  54,0

                  UY

                  85,8

                  ZA

                  94,1

                  ZZ

                  80,8

                  0808 10 80

                  AR

                  200,7

                  BR

                  79,0

                  CL

                  111,2

                  CN

                  100,6

                  NZ

                  133,5

                  US

                  144,1

                  UY

                  58,9

                  ZA

                  107,5

                  ZZ

                  116,9

                  0808 30 90

                  AR

                  206,9

                  CL

                  113,3

                  CN

                  83,4

                  NZ

                  207,2

                  ZA

                  127,2

                  ZZ

                  147,6

                  0809 10 00

                  TR

                  182,6

                  ZZ

                  182,6

                  0809 29 00

                  TR

                  327,1

                  ZZ

                  327,1

                  0809 30

                  TR

                  207,2

                  ZZ

                  207,2

         (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) No 1209/2013 of 25 November 2013 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications [Camembert de Normandie (PDO)]

text:
               28.11.2013

               EN

               Official Journal of the European Union

               L 317/17

         COMMISSION IMPLEMENTING REGULATION (EU) No 1209/2013
   of 25 November 2013
   approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications [Camembert de Normandie (PDO)]
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
   Whereas:

               (1)

               By virtue of the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined France’s application for the approval of amendments to the specification for the protected designation of origin ‘Camembert de Normandie’, registered under Commission Regulation (EC) No 1107/96 (2).

               (2)

               Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union
                   (3) as required by Article 50(2)(a) of that Regulation.

               (3)

               As no statement of objection under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments should be approved,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The amendments to the specification published in the Official Journal of the European Union regarding the name contained in the Annex to this Regulation are hereby approved.
   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, 25 November 2013.

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

            Member of the Commission

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

      (2)  OJ L 148, 21.6.1996, p. 1.

      (3)  OJ C 140, 18.5.2013, p. 20.

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

         Class 1.3.   Cheeses

      FRANCE
      Camembert de Normandie (PDO)


title: Commission Implementing Regulation (EU) 2016/1426 of 25 August 2016 renewing the approval of the active substance ethofumesate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

text:
                  26.8.2016

                  EN

                  Official Journal of the European Union

                  L 231/34

            COMMISSION IMPLEMENTING REGULATION (EU) 2016/1426
      of 25 August 2016
      renewing the approval of the active substance ethofumesate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) thereof,
      Whereas:

                  (1)

                  The approval of the active substance ethofumesate, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2), expires on 31 July 2017.

                  (2)

                  An application for the renewal of the approval of ethofumesate was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (3) within the time period provided for in that Article.

                  (3)

                  The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

                  (4)

                  The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 28 January 2015.

                  (5)

                  The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

                  (6)

                  On 18 December 2015 the Authority communicated to the Commission its conclusion (4) on whether ethofumesate can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for ethofumesate to the Standing Committee on Plants, Animals, Food and Feed on 8 March 2016.

                  (7)

                  The applicant was given the possibility to submit comments on the renewal report.

                  (8)

                  It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

                  (9)

                  It is therefore appropriate to renew the approval of ethofumesate.

                  (10)

                  The risk assessment for the renewal of the approval of ethofumesate is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing ethofumesate may be authorised. It is therefore appropriate not to maintain the restriction to uses as a herbicide.

                  (11)

                  In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to set maximum limits for two toxicologically relevant impurities in the active substance as manufactured.

                  (12)

                  In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

                  (13)

                  Commission Implementing Regulation (EU) 2016/950 (5) extended the expiry date of ethofumesate in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on renewal has been taken ahead of the extended expiry date, this Regulation should apply from 1 November 2016.

                  (14)

                  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
      Renewal of the approval of active substance
      The approval of the active substance ethofumesate, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.
      Article 2
      Amendments to Implementing Regulation (EU) No 540/2011
      The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
      Article 3
      Entry into force and date of application
      This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
      It shall apply from 1 November 2016.

         This Regulation shall be binding in its entirety and directly applicable in all Member States.
         Done at Brussels, 25 August 2016.

               For the Commission

               The President

            Jean-Claude JUNCKER

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

         (2)  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).

         (3)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

         (4)  EFSA Journal 2016;14(1):4374, 141 pp. doi:10.2903/j.efsa.2016.4374.

         (5)  Commission Implementing Regulation (EU) 2016/950 of 15 June 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,4-DB, beta-cyfluthrin, carfentrazone ethyl, Coniothyrium minitans Strain CON/M/91-08 (DSM 9660), cyazofamid, deltamethrin, dimethenamid-P, ethofumesate, fenamidone, flufenacet, flurtamone, foramsulfuron, fosthiazate, imazamox, iodosulfuron, iprodione, isoxaflutole, linuron, maleic hydrazide, mesotrione, oxasulfuron, pendimethalin, picoxystrobin, silthiofam and trifloxystrobin (OJ L 159, 16.6.2016, p. 3).

         ANNEX I

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     Ethofumesate
                     CAS No 26225-79-6
                     CIPAC No 233

                     (RS)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-yl methanesulfonate

                     ≥ 970 g/kg
                     The following impurities are of toxicological concern and must not exceed the following levels in the technical material:

                                 —

                                 EMS; ethyl methane sulfonate: maximum of 0,1 mg/kg

                                 —

                                 iBMS; iso-butyl methane sulfonate: maximum of 0,1 mg/kg

                     1 November 2016

                     31 October 2031

                     For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on ethofumesate, and in particular Appendices I and II thereof, shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 the risk to aquatic organisms.

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

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

         ANNEX II
         The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                     (1)

                     in Part A, entry 29 on ethofumesate is deleted;

                     (2)

                     in Part B, the following entry is added:

                                 Number

                                 Common Name, Identification Numbers

                                 IUPAC Name

                                 Purity (*)

                                 Date of approval

                                 Expiration of approval

                                 Specific provisions

                                 ‘102

                                 Ethofumesate
                                 CAS No 26225-79-6
                                 CIPAC No 233

                                 (RS)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-yl methanesulfonate

                                 ≥ 970 g/kg
                                 The following impurities are of toxicological concern and must not exceed the following levels in the technical material:

                                             —

                                             EMS; ethyl methane sulfonate: maximum of 0,1 mg/kg

                                             —

                                             iBMS; iso-butyl methane sulfonate: maximum of 0,1 mg/kg

                                 1 November 2016

                                 31 October 2031

                                 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on ethofumesate, and in particular Appendices I and II thereof, shall be taken into account.
                                 In this overall assessment Member States shall pay particular attention to:

                                             —

                                             the risk to aquatic organisms.

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

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


title: Commission Implementing Regulation (EU) No 464/2013 of 17 May 2013 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               18.5.2013

               EN

               Official Journal of the European Union

               L 134/15

         COMMISSION IMPLEMENTING REGULATION (EU) No 464/2013
   of 17 May 2013
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

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

               (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, 17 May 2013.

            For the Commission, On behalf of the President,
         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

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

      (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

                  MA

                  48,2

                  TN

                  47,4

                  TR

                  77,3

                  ZZ

                  57,6

                  0707 00 05

                  AL

                  27,7

                  MK

                  41,5

                  TR

                  132,0

                  ZZ

                  67,1

                  0709 93 10

                  TR

                  137,0

                  ZZ

                  137,0

                  0805 10 20

                  EG

                  52,9

                  IL

                  61,5

                  MA

                  73,9

                  TR

                  59,9

                  ZZ

                  62,1

                  0805 50 10

                  AR

                  113,7

                  EG

                  68,1

                  TR

                  70,0

                  ZA

                  109,7

                  ZZ

                  90,4

                  0808 10 80

                  AR

                  120,8

                  BR

                  100,5

                  CL

                  117,4

                  CN

                  72,6

                  MK

                  39,0

                  NZ

                  155,5

                  US

                  208,2

                  ZA

                  114,0

                  ZZ

                  116,0

         (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 405/2014 of 23 April 2014 approving lauric acid as an existing active substance for use in biocidal products for product-type 19  Text with EEA relevance

text:
               24.4.2014

               EN

               Official Journal of the European Union

               L 121/8

         COMMISSION IMPLEMENTING REGULATION (EU) No 405/2014
   of 23 April 2014
   approving lauric acid as an existing active substance for use in biocidal products for product-type 19
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,
   Whereas:

               (1)

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

               (2)

               Lauric acid has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 19, repellents and attractants, as defined in Annex V to that Directive, which corresponds to product-type 19 as defined in Annex V to Regulation (EU) No 528/2012.

               (3)

               Germany was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 17 May 2010 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

               (4)

               The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated in an assessment report reviewed within the Standing Committee on Biocidal Products on 13 March 2014.

               (5)

               According to that assessment report, biocidal products used for product-type 19 and containing lauric acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, provided that certain specifications and conditions relating to its use are satisfied.

               (6)

               It is therefore appropriate to approve lauric acid for use in biocidal products for product-type 19 subject to compliance with such specifications and conditions.

               (7)

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

               (8)

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

               (9)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Lauric acid shall be approved as an active substance for use in biocidal products for product-type 19, subject to the specifications and conditions set out in the Annex.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 23 April 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 167, 27.6.2012, p. 1.

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

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

      ANNEX

                  Common Name

                  IUPAC Name
                  Identification Numbers

                  Minimum degree of purity of the active substance (1)

                  Date of approval

                  Expiry date of approval

                  Product type

                  Specific conditions (2)

                  Lauric acid

                  IUPAC Name:
                  Dodecanoic acid
                  EC No: 205-582-1
                  CAS No: 143-07-7

                  980 g/kg

                  1 November 2015

                  31 October 2025

                  19

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

         (1)  The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.

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


title: Commission Implementing Regulation (EU) No 884/2014 of 13 August 2014 imposing special conditions governing the import of certain feed and food from certain third countries due to contamination risk by aflatoxins and repealing Regulation (EC) No 1152/2009  Text with EEA relevance

text:
               14.8.2014

               EN

               Official Journal of the European Union

               L 242/4

         COMMISSION IMPLEMENTING REGULATION (EU) No 884/2014
   of 13 August 2014
   imposing special conditions governing the import of certain feed and food from certain third countries due to contamination risk by aflatoxins and repealing Regulation (EC) No 1152/2009
   (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 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (1), and in particular Article 53(1)(b)(ii) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1152/2009 (2) has to be amended substantially and the scope has to be extended to feed.

               (2)

               Commission Regulation (EC) No 1881/2006 (3) lays down permitted maximum levels of aflatoxins in food for the protection of public health. It can be observed that these maximum levels of aflatoxins are frequently exceeded in certain foods from certain countries. Such contamination constitutes a serious threat to public health within the Union and it is therefore appropriate to adopt special conditions at the Union level.

               (3)

               Directive 2002/32/EC of the European Parliament and of the Council (4) lays down maximum permitted levels of aflatoxin B1 in feed for the protection of animal and public health. It can be observed that the maximum levels of aflatoxin B1 are frequently exceeded in certain feed from certain countries. Such contamination constitutes a serious threat to animal and public health within the Union and it is therefore appropriate to adopt special conditions at the Union level.

               (4)

               For the protection of animal and public health it is important that compound feed and food containing to a significant amount the feed and food covered by this Regulation are also within the scope of this Regulation. To ensure harmonised enforcement of controls across the EU of processed and compound feed and food, it is appropriate to establish a threshold level. It is furthermore appropriate to exclude non-commercial consignments from the application of the provisions of this Regulation. The sampling and the analysis of consignments should be performed in accordance with the relevant Union legislation.

               (5)

               The provisions on sampling and analysis for the control of aflatoxins in feed are established by Commission Regulation (EC) No 152/2009 (5) and in food by Commission Regulation (EC) No 401/2006 (6).

               (6)

               Given that for the application of special conditions governing the import of feed from certain third countries due to contamination risk by aflatoxins the similar provisions are of application as those for the application of the special conditions governing the import of food from certain third countries due to contamination risk by aflatoxins, it is appropriate to include feed and food, for which special conditions are imposed because of the risk of aflatoxin contamination into one Regulation. It is therefore appropriate to include into this Regulation the provisions as regards groundnuts from India and Ghana and the watermelon seeds from Nigeria provided for in Commission Implementing Regulation (EU) No 91/2013 (7). Implementing Regulation (EU) No 91/2013 should be replaced simultaneously by a new Regulation laying down the provisions as regards okra and curry leaves from India.

               (7)

               Based on the control results and the outcome of Food and Veterinary Office (FVO) audits, following changes to products to be subject to specific conditions and/or control frequencies are appropriate:

                           —

                           deletion of special conditions for import of almonds from the US because of favourable control results and favourable outcome of FVO inspection audit,

                           —

                           reduction of sampling frequency on hazelnuts from Turkey given the favourable control results and favourable outcome of FVO inspection audit,

                           —

                           reduction of sampling frequency for Brazil nuts in shell from Brazil given the absence of non-compliance also related to the very low quantities imported into the EU.

               (8)

               The control system provided for the feed and food covered by this Regulation has been applied since many years and has continuously been improved based on the gained experiences. A full harmonisation of the controls on the import of food of non-animal origin is not possible because it is impossible to perform all required physical controls on aflatoxins at the designated point of entry. The control on the presence of aflatoxins in accordance with Regulation (EC) No 401/2006 is time consuming and requires an unloading of the consignment. Furthermore, many commodities covered by this Regulation are transported in vacuum packing and destruction of the vacuum packing through the sampling might result in quality loss in case the consignment needs to be transported over a long distance after the physical control. However in order to reduce administrative burden, it is appropriate to harmonise as much as possible the administrative documents related to the controls on feed and food of non-animal origin. Therefore, while the conditions for import for the feed and food covered by this Regulation are not identical for the feed and food covered by Commission Regulation (EC) No 669/2009 (8), it is appropriate to use the same Common Entry Document (CED) in view of administrative simplification for the feed and food business operators. However, it is necessary for the application of that CED for this Regulation, to provide additional explanatory notes in the notes for guidance to address the differences in the control systems.

               (9)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Scope
   1.   Without prejudice to the provisions of Council Regulation (EEC) No 2913/92 (9), this Regulation shall apply to the import of the following feed and food falling within the CN codes and TARIC classifications set out in Annex I:

               (a)

               Brazil nuts in shell and mixtures of nuts or dried fruits containing Brazil nuts in shell (food) originating in or consigned from Brazil;

               (b)

               groundnuts in shell and shelled, peanut butter, groundnuts otherwise prepared or preserved (feed and food) originating in or consigned from China;

               (c)

               groundnuts in shell and shelled, peanut butter, groundnuts otherwise prepared or preserved (feed and food) originating in or consigned from Egypt;

               (d)

               pistachios in shell and shelled, pistachios otherwise prepared or preserved (food) originating in or consigned from Iran;

               (e)

               the following food originating in or consigned from Turkey:

                           (i)

                           dried figs;

                           (ii)

                           hazelnuts (Corylus sp.) in shell and shelled;

                           (iii)

                           pistachios in shell and shelled;

                           (iv)

                           mixtures of nuts or dried fruits containing figs, hazelnuts or pistachios;

                           (v)

                           fig paste, pistachio paste and hazelnut paste;

                           (vi)

                           hazelnuts, figs and pistachios, prepared or preserved, including mixtures;

                           (vii)

                           flour, meal and powder of hazelnuts and pistachios;

                           (viii)

                           cut, sliced and broken hazelnuts;

                           (ix)

                           hazelnut oil;

               (f)

               groundnuts in shell and shelled, peanut butter, groundnuts otherwise prepared or preserved (feed and food) originating in or consigned from Ghana;

               (g)

               groundnuts in shell and shelled, peanut butter, groundnuts otherwise prepared or preserved (feed and food) originating in or consigned from India;

               (h)

               watermelon seeds and derived products (food) originating in or consigned from Nigeria.

         2.   This Regulation shall also apply to feed and food processed from the feed and food referred to in paragraph 1 and to compound feed and food, containing any of the feed or food referred to in paragraph 1 in a quantity above 20 %.
   3.   This Regulation shall not apply to consignments of feed and food referred to in paragraphs 1 and 2 which are destined to a private person for personal consumption and use only. In case of doubt, the burden of proof lies with the recipient of the consignment.
   Article 2
   Definitions
   For the purposes of this Regulation, the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 and in Article 2 of Regulation (EC) No 882/2004 of the European Parliament and of the Council (10) shall apply.
   In addition, the following definitions shall apply:

               (a)

               ‘designated points of import (DPI)’ means any point designated by the competent authority, through which the feed or food referred to in Article 1 may be imported into the Union;

               (b)

               ‘designated point of entry (DPE)’ means the point of entry as defined in Article 3 (b) of Regulation (EC) No 669/2009.

         For the purpose of this Regulation, a consignment corresponds to a lot as referred to in Regulations (EC) No 401/2006 and (EC) No 152/2009.
   Article 3
   Import into the Union
   Consignments of feed and food referred to in Article 1(1) and (2) (hereafter referred to as feed and food) may only be imported into the Union in accordance with the procedures laid down in this Regulation.
   Article 4
   Results of sampling and analysis
   1.   Each consignment of feed and food shall be accompanied by the results of sampling and analysis performed by the competent authorities of the country of origin, or of the country where the consignment is consigned from if that country is different from the country of origin, to ascertain compliance with Union legislation on maximum levels of aflatoxins.
   2.   The sampling and the analysis referred to in paragraph 1 must be performed in accordance with Regulation (EC) No 152/2009 for aflatoxins in feed and with Regulation (EC) No 401/2006 for aflatoxins in food.
   Article 5
   Health certificate
   1.   Each consignment shall also be accompanied by a health certificate in accordance with the model set out in Annex II.
   2.   The health certificate shall be completed, signed and verified by an authorised representative of the competent authority of the country of origin or the competent authority of the country where the consignment is consigned from if that country is different from the country of origin.
   The competent authority of the country of origin is

               (a)

               the Ministério da Agricultura, Pecuária e Abastecimento (MAPA) for food from Brazil;

               (b)

               the State Administration for Entry-Exit inspection and Quarantine of the People's Republic of China for feed and food from China;

               (c)

               the Egyptian Ministry of Agriculture for feed and food from Egypt;

               (d)

               the Iranian Ministry of Health for food from Iran;

               (e)

               the General Directorate of Protection and Control of the Ministry of Agriculture and Rural Affairs of the Republic of Turkey for food from Turkey;

               (f)

               the Ghana Standards Authority for feed and food from Ghana;

               (g)

               the Export Inspection Council of India of the Ministry of Commerce and Industry for feed and food from India;

               (h)

               the National Agency for Food and Drug Administration and Control (Nafdac) for food from Nigeria.

         3.   The health certificate shall be drawn up in the official language, or in one of the official languages, of the Member State where the designated point of entry is located. However, a Member State may consent to health certificates being drawn up in another official language of the Union.
   4.   The health certificate shall only be valid during four months from the date of issue.
   Article 6
   Identification
   Each consignment of food and feed shall be identified with an identification code (consignment code) which corresponds to the identification code on the results of the sampling and analysis referred to in Article 4 and the health certificate referred to in Article 5. Each individual bag, or other packaging form, of the consignment shall be identified with that identification code.
   Article 7
   Prior notification of consignments
   1.   Feed and food business operators or their representatives shall give prior notification of the estimated date and time of physical arrival of the feed and food to the competent authorities at the DPE and of the nature of the consignment.
   2.   For the purpose of prior notification, they shall complete Part I of the common entry document (CED) referred to in Article 3 (a) of Regulation (EC) No 669/2009 and transmit that document to the competent authority at the DPE, at least one working day prior to the physical arrival of the consignment.
   3.   For the completion of the CED in application of this Regulation, feed and food business operators shall take into account the notes for guidance laid down in Annex III.
   4.   In case the DPI is different from the DPE, the feed and food business operator shall notify the competent authority at the DPI at least one working day prior to the physical arrival of the consignment. The notification shall be done by sending by the feed and food business operator a copy of the CED completed as regards the documentary control by the competent authority at the DPE.
   5.   CEDs shall be drawn up in the official language, or in one of the official languages, of the Member State where the DPE is located. However, a Member State may consent to CEDs being drawn up in another official language of the Union.
   Article 8
   Designated points of import (DPI)
   The competent authorities in Member States shall ensure that the DPI complies with following requirements:

               (a)

               the presence of trained staff to perform official controls on consignments of feed and food;

               (b)

               the availability of detailed instructions regarding sampling and the sending of the samples to the laboratory, in accordance with provisions in Annex I to Regulation (EC) No 152/2009 for feed and in Annex I to Regulation (EC) No 401/2006 for food;

               (c)

               the possibility to perform the unloading and the sampling in a sheltered place at the designated point of import; it must be possible to place the consignment of the feed and food under the official control of the competent authority from the DPI onwards in cases where, after agreement by the competent authority, the consignment has to be transported to a place in the immediate neighbourhood of the DPI in order to perform the sampling;

               (d)

               the availability of storage rooms, warehouses to store detained consignments of feed and food in good conditions while awaiting the results of analysis;

               (e)

               the availability of unloading equipment and appropriate sampling equipment;

               (f)

               the availability of an official laboratory for aflatoxin analysis, situated at a place to which the samples can be transported within a short period of time and which is able to perform the analysis within a due time-limit.

         The Member States shall maintain and make publicly available an up-to-date list of the DPIs. The Member States shall communicate them to the Commission.
   The Commission shall display the national links to those lists on the Commission's website, for information purposes.
   Feed and food business operators shall ensure the unloading of the consignment of feed and food necessary for representative sampling to take place.
   In the case of special transport or specific packaging forms, the operator shall make available to the official inspector the appropriate sampling equipment insofar as the sampling cannot be representatively performed with the usual sampling equipment.
   Article 9
   Official controls
   1.   All official controls before the completion of the CED shall be performed within 15 working days from the moment the consignment is offered for import and physically available for sampling at the DPI.
   2.   Consignments of the feed and food can only enter the Union through the DPE. The competent authority at the DPE shall carry out documentary checks on each consignment of the feed and food intended for import into the Union to ascertain compliance with the requirements laid down in Articles 4 and 5.
   For the purpose of this Regulation, Points of Entry can be designated which are only authorised to perform the documentary checks. In that case these DPE have not to comply with the minimum requirements as provided for in Article 4 of Regulation (EC) No 669/2009.
   3.   Where a consignment of feed and food is not accompanied by the results of sampling and analysis and the health certificate or where the results of sampling and analysis or the health certificate do not comply with the provisions of the Regulation, the consignment may not enter the Union for import into the Union and must be re-dispatched to the country of origin or destroyed.
   4.   The competent authority at the DPE shall authorise transfer of the consignment to a DPI after favourable completion of the checks referred to in paragraph 2. The original certificate, results of sampling and analysis referred to in article 4 and the CED shall accompany the consignment during transfer. The competent authority of the DPE shall immediately inform the competent authority at the DPI of the sending of the consignment and the business operator has to inform the competent authority at the DPI of the arrival of the consignment at least one working day prior to the physical arrival of the consignment. In case the business operator decides to change the DPI after the consignment has left the DPE, the documents have to be presented again to the competent authority of the DPE to agree and to perform the necessary changes on the CED and the competent authority of the DPE informs consequently the relevant DPIs of these changes.
   5.   The competent authority at the DPI shall carry out an identity check and a physical check by taking a sample for analysis of aflatoxin B1 for feed or aflatoxin B1 and total aflatoxin contamination for food on certain consignments at a frequency set out in Annex I to this Regulation before acceptance for release for free circulation into the Union. The sampling is carried out for feed in accordance with Annex I to Regulation (EC) No 152/2009 and for food in accordance with Annex I to Regulation (EC) No 401/2006.
   6.   After completion of the checks, the competent authorities shall, for checks carried out by them,

               (a)

               complete the relevant entries of Part II of the CED;

               (b)

               join the results of sampling and analysis carried out;

               (c)

               provide and fill the CED reference number on the CED;

               (d)

               stamp and sign the original of the CED;

               (e)

               make and retain a copy of the signed and stamped CED.

         For the completion of the CED in application of this Regulation, the competent authority shall take into account the notes for guidance laid down in Annex III.
   7.   The original of the health certificate referred to in Article 5, the results of sampling and analysis referred to in Article 4 and the CED shall accompany the consignment during its transfer until it is released for free circulation.
   Article 10
   Splitting of a consignment
   1.   Consignments shall not be split until all official controls have been completed, and the CED has been fully completed by the competent authorities as provided for in Article 9.
   2.   In the case of subsequent splitting of the consignment, an authenticated copy of the CED shall accompany each part of the consignment during its transport until it is released for free circulation.
   Article 11
   Release for free circulation
   The release for free circulation of consignments shall be subject to the presentation (physically or electronically) by the feed and food business operator or their representative to the custom authorities of a CED duly completed by the competent authority once all official controls have been carried out. The custom authorities shall only release the consignment for free circulation if a favourable decision by the competent authority is indicated in box II.14 and signed in box II.21 of the CED.
   Article 12
   Non-compliance
   If the official controls establish non-compliance with the relevant Union legislation, the competent authority shall complete Part III of the CED and action shall be taken pursuant to Articles 19, 20 and 21 of Regulation (EC) No 882/2004.
   Article 13
   Reports
   Member States shall submit to the Commission every three months a report of all analytical results of official controls on consignments of feed and food pursuant to this Regulation. That report shall be submitted during the month following each quarter.
   The report shall include the following information:

               —

               the number of consignments imported,

               —

               the number of consignments subjected to sampling for analysis,

               —

               the results of the checks as provided for in Article 9(5).

         Article 14
   Costs
   All costs resulting from the official controls including sampling, analysis, storage and any measures taken following non-compliance, shall be borne by the feed and food business operators.
   Article 15
   Repeal
   Regulation (EC) No 1152/2009 is hereby repealed.
   References to the repealed Regulation shall be construed as references to this Regulation and should be read with the correlation table in Annex IV.
   Article 16
   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 August 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 31, 1.2.2002, p. 1.

      (2)  Commission Regulation (EC) No 1152/2009 of 27 November 2009 imposing special conditions governing the import of certain foodstuffs from certain third countries due to contamination risk by aflatoxins and repealing Decision 2006/504/EC (OJ L 313, 28.11.2009, p. 40).

      (3)  Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (OJ L 364, 20.12.2006, p. 5).

      (4)  Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10).

      (5)  Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).

      (6)  Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs (OJ L 70, 9.3.2006, p. 12).

      (7)  Commission Implementing Regulation (EU) No 91/2013 of 31 January 2013 laying down specific conditions applicable to the import of groundnuts from Ghana and India, okra and curry leaves from India and watermelon seeds from Nigeria and amending Regulations (EC) No 669/2009 and (EC) No 1152/2009 (OJ L 33, 2.2.2013, p. 2).

      (8)  Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC (OJ L 194, 25.7.2009, p. 11).

      (9)  Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (OJ L 302, 19.10.1992, p. 1).

      (10)  Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).

      ANNEX I
      Feed and food subject to the measures provided for in this Regulation:

                  Feed and food
                  (intended use)

                  CN code (1)

                  TARIC sub-division

                  Country of origin or country of consignment

                  Frequency of physical and identity checks (%) at import

                              —

                              Brazil nuts in shell

                              —

                           0801 21 00

                  Brazil (BR)

                  Random

                              —

                              Mixtures of nuts or dried fruits and containing Brazil nuts in shell.

                              —

                           ex 0813 50

                        (Food)

                              —

                              Groundnuts (peanuts), in shell

                              —

                           1202 41 00

                  China (CN)

                  20

                              —

                              Groundnuts (peanuts), shelled

                              —

                           1202 42 00

                              —

                              Peanut butter

                              —

                           2008 11 10

                              —

                              Groundnuts (peanuts), otherwise prepared or preserved

                              —

                              2008 11 91; 2008 11 96; 2008 11 98

                        (Feed and Food)

                              —

                              Groundnuts (peanuts), in shell

                              —

                           1202 41 00

                  Egypt (EG)

                  20

                              —

                              Groundnuts (peanuts), shelled

                              —

                           1202 42 00

                              —

                              Peanut butter

                              —

                           2008 11 10

                              —

                              Groundnuts (peanuts), otherwise prepared or preserved

                              —

                              2008 11 91; 2008 11 96; 2008 11 98

                        (Feed and Food)

                              —

                              Pistachios, in shell

                              —

                           0802 51 00

                  Iran (IR)

                  50

                              —

                              Pistachios, shelled

                              —

                           0802 52 00

                              —

                              Mixtures of nuts or dried fruits containing pistachios

                              —

                           ex 0813 50

                              —

                              Pistachio paste

                              —

                              ex 2007 10 or 2007 99

                              —

                              Pistachios, prepared or preserved, including mixtures

                              —

                              2008 19 13;

                              —

                           2008 19 93

                              —

                           ex 2008 97

                              —

                              Flour, meal and powder of pistachios

                              —

                           ex 1106 30 90

                        (Food)

                              —

                              Dried figs

                              —

                           0804 20 90

                  Turkey (TR)

                  20

                              —

                              Mixtures of nuts or dried fruits containing figs

                              —

                           ex 0813 50

                              —

                              Fig paste

                              —

                              ex 2007 10 or 2007 99

                              —

                              Figs, prepared or preserved, including mixtures

                              —

                           ex 2008 99

                              —

                           ex 2008 97

                        (Food)

                              —

                              Hazelnuts (Corylus sp.) in shell

                              —

                           0802 21 00

                  Turkey (TR)

                  Random

                              —

                              Hazelnuts (Corylus sp.) shelled

                              —

                           0802 22 00

                              —

                              Mixtures of nuts or dried fruits containing hazelnuts

                              —

                           ex 0813 50

                              —

                              Hazelnut paste

                              —

                              ex 2007 10 or 2007 99

                              —

                              Hazelnuts, prepared or preserved, including mixtures

                              —

                           ex 2008 19

                              —

                           ex 2008 97

                              —

                              Flour, meal and powder of hazelnuts

                              —

                           ex 1106 30 90

                              —

                              Cut, sliced and broken hazelnuts

                              —

                              ex 0802 22 00; 2008 19

                              —

                              Hazelnut oil

                              —

                           ex 1515 90 99

                        (Food)

                              —

                              Pistachios, in shell

                              —

                           0802 51 00

                  Turkey (TR)

                  50

                              —

                              Pistachios, shelled

                              —

                           0802 52 00

                              —

                              Mixtures of nuts or dried fruits containing pistachios

                              —

                           ex 0813 50

                              —

                              Pistachio paste

                              —

                              ex 2007 10 or 2007 99

                              —

                              Pistachios, prepared or preserved, including mixtures

                              —

                              2008 19 13;

                              —

                           2008 19 93

                              —

                           ex 2008 97

                              —

                              Flour, meal and powder of pistachios

                              —

                              ex 1106 30 90

                        (Food)

                              —

                              Groundnuts (peanuts), in shell

                              —

                           1202 41 00

                  Ghana (GH)

                  50

                              —

                              Groundnuts (peanuts), shelled

                              —

                           1202 42 00

                              —

                              Peanut butter

                              —

                           2008 11 10

                              —

                              Groundnuts (peanuts), otherwise prepared or preserved

                              —

                              2008 11 91; 2008 11 96; 2008 11 98

                        (Feed and Food)

                              —

                              Groundnuts (peanuts), in shell

                              —

                           1202 41 00

                  India (IN)

                  20

                              —

                              Groundnuts (peanuts), shelled

                              —

                           1202 42 00

                              —

                              Peanut butter

                              —

                           2008 11 10

                              —

                              Groundnuts (peanuts), otherwise prepared or preserved

                              —

                              2008 11 91; 2008 11 96; 2008 11 98

                        (Feed and food)

                  Watermelon (egusi, Citrullus lanatus) seeds and derived products

                  ex 1207 70 00;
                  ex 1106 30 90;
                  ex 2008 99 99

                  10
                  30
                  50

                  Nigeria (NG)

                  50

                        (Food)

      ANNEX II

      ANNEX III
      Notes for guidance for the CED in application of this Regulation in case of feed and food imported from certain third countries due to contamination of these products by aflatoxins

                  General

                  For the use of the CED in application of this Regulation, whenever ‘DPE’ is mentioned, this should be read as ‘designated point of entry’ or ‘designated point of import’ as stipulated in the specific notes for each box. Whenever ‘control point’ is mentioned, this should be read as ‘designated point of import’.
                  Complete the document in capital letters. Notes are shown against the relevant box number.

                     Part I

                     This section is to be completed by the feed and food business operator or their representative, unless otherwise indicated.

                  Box I.1.

                  Consignor: name and full address of the natural or legal person (feed and food business operator) dispatching the consignment. Information on telephone and fax numbers or e-mail address is recommended.

                  Box I.2.

                  All three fields in this box are to be filled in by the authorities of the DPI as defined in Article 2. Attribute a CED reference number in the first box. The CED reference number might be filled in by the authorities of the DPE. Indicate the name of the DPI and its number respectively in the second and third boxes.

                  Box I.3.

                  Consignee: indicate name and full address of the natural or legal person (feed and food business operator) to whom the consignment is destined. Information on telephone and fax numbers or e-mail address is recommended.

                  Box I.4.

                  Person responsible for the consignment: (also agent, declarant or feed and food business operator) indicate name and full address of the person who is in charge of the consignment when presented to the DPE and makes the necessary declarations to the competent authorities on behalf of the importer. Information on telephone and fax numbers or e-mail address is recommended.

                  Box I.5.

                  Country of origin: indicate the country where the commodity is originating from, grown, harvested or produced.

                  Box I.6.

                  Country from where consigned: indicate the country where the consignment was placed aboard the means of final transport for the journey to the Union.

                  Box I.7.

                  Importer: indicate name and full address. Information on telephone and fax numbers or e-mail address is recommended.

                  Box I.8.

                  Place of destination: indicate delivery address in the Union. Information on telephone and fax numbers or e-mail address is recommended.

                  Box I.9.

                  Arrival at the DPE (estimated date): give the estimated date on which the consignment is expected to arrive at the DPE.

                  Box I.10.

                  Documents: indicate the date of issue and the number of official documents accompanying the consignment, as appropriate.

                  Box I.11.

                  Means of transport: tick the box to indicate the means of arrival transport.
                  Identification: give full details of the means of transport. For aircraft, indicate the flight number. For vessels, indicate the ship's name. For road vehicles: indicate the registration number plate with trailer number if appropriate. For railway transport: indicate the train identity and wagon number.
                  Documentary references: number of airway bill, bill of lading or commercial number for railway or truck.

                  Box I.12.

                  Description of the commodity: provide a detailed description of the commodity using the terminology in Article 1.

                  Box I.13.

                  Commodity code: use the code identifying the commodity as listed in Annex I (including the TARIC subdivision, if applicable).

                  Box I.14.

                  Gross weight: specify overall weight in kg or tonnes. This is defined as the aggregate mass of the products and of the immediate containers and all their packaging, but excluding transport containers and other transport equipment.
                  Net weight: specify weight of actual product in kg or tonnes, excluding packaging. This is defined as the mass of the products themselves without immediate containers or any packaging.

                  Box I.15.

                  Number of packages: specify the number of packages in the consignment.

                  Box I.16.

                  Temperature: tick the appropriate mode of transport/storage temperature.

                  Box I.17.

                  Type of packaging: identify the type of packaging of products.

                  Box I.18.

                  Commodity intended for: tick the appropriate box depending on whether the commodity is destined for human consumption without prior sorting or other physical treatment (in this case tick ‘human consumption’) or is intended for human consumption after such treatment (tick ‘further process’ in this case), or is intended for use as ‘feedingstuff’ (in this case tick ‘feedingstuffs’).

                  Box I.19.

                  Seal number and container number: give all seal and container identification numbers where relevant.

                  Box I.20.

                  For transfer to Control Point: in case the consignment is intended for import (cf. Box I.22) and the operator uses the option to have the identity and physical control performed at a specific DPI, tick the box and identify in detail the DPI.

                  Box I.21.

                  Not applicable.

                  Box I.22.

                  For import: tick the box in case the consignment is intended for import.

                  Box I.23.

                  Not applicable.

                  Box I.24.

                  Means of transport to Control Point: tick the appropriate means of transport used for transfer to the DPI.

                     Part II

                     This section is to be completed by the competent authority.

                  General

                  Box II.1 is to be completed by the competent authority of the DPI. Boxes II.2 to II.9 with the exception of II.4 are to be completed by the customs services or the authorities competent for the documentary control. Boxes II.10 to II.21 are to be completed by the competent authorities of the DPI.

                  Box II.1.

                  CED Reference number: use the same CED reference number as in Box I.2.

                  Box II.2.

                  Customs Document Reference: for use by customs services if necessary.

                  Box II.3.

                  Documentary Check: to be completed for all consignments.

                  Box II.4.

                  Consignments selected for physical checks: not applicable in the framework of this Regulation.

                  Box II.5.

                  ACCEPTABLE for transfer: in case the consignment is acceptable for transfer to a DPI following a satisfactory documentary check, the competent authority at the DPE shall tick the box and indicate to which DPI the consignment shall be transferred for a possible physical check (following information given in Box I.20).
                  Onward transportation is not applicable for this Regulation.

                  Box II.6.

                  NOT ACCEPTABLE: in case the consignment is not acceptable for transfer to a DPI due to the unsatisfactory outcome of the documentary checks, the competent authority at the DPE shall tick the box and indicate clearly the action to be carried out in case of rejection of the consignment. The address of the destination establishment in case of ‘Re-dispatching’, ‘Destruction’, ‘Transformation’ and ‘Use for other purpose’ should be entered in Box II.7.

                  Box II.7.

                  Details of Controlled Destinations (II.6): indicate as appropriate approval number and address (or ship's name and port) for all destinations where further control of the consignment is required, for example for Box II.6, ‘Re-dispatching’, ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’.

                  Box II.8.

                  Full identification of DPE and official stamp: indicate here the full identification of the DPE and the official stamp of the competent authority at this point.

                  Box II.9.

                  Official inspector: signature of the official responsible of the competent authority at the DPE.

                  Box II.10.

                  Not applicable.

                  Box II.11.

                  Identity Check: tick the boxes to indicate whether the identity checks have been performed and with which results.

                  Box II.12.

                  Physical Check: indicate here the results of the physical checks in case the physical check has taken place.

                  Box II.13.

                  Laboratory tests: tick the box to indicate whether the consignment has been selected for sampling and analysis.
                  Tested for: indicate for which (aflatoxin B1 and/or total) and by which analytical method a laboratory test is carried out.
                  Results: indicate the results of the laboratory test and tick the appropriate box.

                  Box II.14.

                  ACCEPTABLE for release for free circulation: tick the box in case the consignment is to be released for free circulation within the Union.
                  Tick one of the boxes (‘Human consumption’, ‘Further process’, ‘Feedingstuff’ or ‘Other’) to indicate the further use.

                  Box II.15.

                  Not applicable.

                  Box II.16.

                  NOT ACCEPTABLE: tick the box in case of rejection of the consignment due to the unsatisfactory outcome of the identity or physical checks.
                  Indicate clearly the action to be carried out in such case by ticking one of the boxes (‘Re-dispatching’, ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’). The address of the establishment of destination shall be entered in Box II.18.

                  Box II.17.

                  Reasons for refusal: tick the appropriate box. Use as appropriate to add relevant information.

                  Box II.18.

                  Details of controlled destinations (II.16): give as appropriate approval number and address (or ship's name and port) for all destinations where further control of the consignment is required following information indicated in Box II.16.

                  Box II.19.

                  Consignment resealed: use this box when the original seal recorded on a consignment is destroyed on opening the container. A consolidated list of all seals that have been used for this purpose must be kept.

                  Box II.20.

                  Full identification of DPE/Control Point and official stamp: put here the full identification of the DPI and the official stamp of the competent authority at the DPI.

                  Box II.21.

                  Official Inspector: put name (in capital letters), date of issuing and signature of the official responsible of the competent authority at the DPI.

                     Part III

                     This section is to be completed by the competent authority.

                  Box III.1.

                  Details on re-dispatching: the competent authority at the DPE or at the DPI indicates the means of transport used, its identification, the country of destination and the date of re-dispatching, as soon as they are known.

                  Box III.2.

                  Follow-up: indicate the local competent authority unit responsible, as appropriate, for the supervision in case of ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’ of the consignment. This competent authority shall report here the result of the arrival of the consignment and the correspondence.

                  Box III.3.

                  Official Inspector: signature of the official responsible for the competent authority at the DPI in case of ‘Re-dispatching’. Signature of the official responsible for the local competent authority in case of ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’.

      ANNEX IV
      Correlation table referred to in Article 15

                  Regulation (EC) No 1152/2009

                  This Regulation

                  Article 1

                  Article 1 and Annex I

                  Article 2

                  Article 2

                  Article 3

                  Article 3

                  Article 4(1)

                  Articles 4(1) and 5(1) and (2)

                  Article 4(2)

                  Article 5(3)

                  Article 4(3)

                  Article 5(4)

                  Article 4(4)

                  Article 4(2)

                  Article 4(5)

                  Article 6

                  Article 5

                  Article 7

                  Article 6

                  Article 8

                  Article 7(1)

                  Article 9(1)

                  Article 7(2)

                  Article 9(2) and (3)

                  Article 7(3)

                  Article 9(4)

                  Article 7(4)

                  Article 9(5)

                  Article 7(5)

                  Annex I

                  Article 7(6)

                  Article 9(6)

                  Article 7(7)

                  Article 9(7)

                  Article 7(8)

                  Article 11

                  Article 7(9)

                  Article 13

                  Article 8

                  Article 10

                  Article 9

                  —

                  Article 10

                  Article 14

                  Article 11

                  Article 15

                  Article 12

                  —

                  Article 13

                  Article 16

                  Annex I

                  Annex II

                  Annex II

                  Annex III


title: Commission Implementing Regulation (EU) 2016/1408 of 12 August 2016 entering a name in the register of protected designations of origin and protected geographical indications (Steirische Käferbohne (PDO))

text:
               24.8.2016

               EN

               Official Journal of the European Union

               L 229/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/1408
   of 12 August 2016
   entering a name in the register of protected designations of origin and protected geographical indications (Steirische Käferbohne (PDO))
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
   Whereas:

               (1)

               Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Austria's application to register the name ‘Steirische Käferbohne’ 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 ‘Steirische Käferbohne’ should therefore be entered in the register,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The name ‘Steirische Käferbohne’ (PDO) is hereby entered in the register.
   The name specified in the first paragraph denotes a product in Class 1.6. Fruit, vegetables and cereals, fresh or processed, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 12 August 2016.

            For the Commission,

            On behalf of the President,

         Violeta BULC

            Member of the Commission

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

      (2)  OJ C 127, 9.4.2016, p. 9.

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


title: Commission Implementing Regulation (EU) 2015/2061 of 4 November 2015 entering a name in the register of protected designations of origin and protected geographical indications (Oberlausitzer Biokarpfen (PGI))

text:
               18.11.2015

               EN

               Official Journal of the European Union

               L 301/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/2061
   of 4 November 2015
   entering a name in the register of protected designations of origin and protected geographical indications (Oberlausitzer Biokarpfen (PGI))
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
   Whereas:

               (1)

               Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Germany's application to register the name ‘Oberlausitzer Biokarpfen’ 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 ‘Oberlausitzer Biokarpfen’ should therefore be entered in the register,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The name ‘Oberlausitzer Biokarpfen’ (PGI) is hereby entered in the register.
   The name specified in the first paragraph denotes a product in Class 1.7. — Fresh fish, molluscs and crustaceans and products derived therefrom, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 4 November 2015.

            For the Commission,

            On behalf of the President,

         Phil HOGAN

            Member of the Commission

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

      (2)  OJ C 212, 27.6.2015, p. 9.

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