title: Commission Implementing Regulation (EU) 2015/897 of 11 June 2015 concerning the authorisation of thiamine hydrochloride and thiamine mononitrate as feed additives for all animal species (Text with EEA relevance)

text:
               12.6.2015

               EN

               Official Journal of the European Union

               L 147/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/897
   of 11 June 2015
   concerning the authorisation of thiamine hydrochloride and thiamine mononitrate as feed additives for all animal species
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
   Whereas:

               (1)

               Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

               (2)

               Thiamine hydrochloride and thiamine mononitrate were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

               (3)

               In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, three applications were submitted for the re-evaluation of thiamine hydrochloride and thiamine mononitrate as feed additives for all animal species and, in accordance with Article 7 of that Regulation, for a new use in water for drinking. The applicants requested these additives to be classified in the additive category ‘nutritional additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

               (4)

               The European Food Safety Authority (‘the Authority’) concluded in its opinions of 11 October 2011 (3) that, under the proposed conditions of use in feed, thiamine hydrochloride and thiamine mononitrate do not have adverse effects on animal health, human health or the environment. The Authority further concluded that thiamine hydrochloride and thiamine mononitrate are effective sources of vitamin B1 and that no safety concerns would arise for users. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

               (5)

               The assessment of thiamine hydrochloride and thiamine mononitrate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of these substances should be authorised as specified in the Annex to this Regulation.

               (6)

               Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

               (7)

               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
   The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.
   Article 2
   1.   The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 2 January 2016 in accordance with the rules applicable before 2 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted.
   2.   Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 2 July 2016 in accordance with the rules applicable before 2 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
   3.   Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 2 July 2017 in accordance with the rules applicable before 2 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
   Article 3
   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, 11 June 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

      (3)  EFSA Journal 2011;9(11):2411; EFSA Journal 2011;9(11):2412; EFSA Journal 2011;9(11):2413.

      ANNEX

                  Identification number of the additive

                  Name of the holder of the authorisation

                  Additive

                  Composition, chemical formula, description, analytical method

                  Species or category of animal

                  Maximum age

                  Minimum content

                  Maximum content

                  Other provisions

                  End of period of authorisation

                  mg of active substance/kg of complete feedingstuff with a moisture content of 12 % or mg of the active substance/l of water.

                     Nutritional additives: Vitamins, provitamins and chemically well-defined substances having similar effect

                  3a820

                  ‘Thiamine hydrochloride’ or ‘Vitamin B1’

                     Additive composition

                  Thiamine hydrochloride

                     Characterisation of the active substance

                  Thiamine hydrochloride
                  C12H17ClN4OSߦHCl
                  CAS No 67-03-8
                  Thiamine hydrochloride, solid form, produced by chemical synthesis.
                  Purity crieria: min. 98,5 % on anhydrous basis.

                     Analytical methods
                      (1)
                     :

                  For the characterisation of thiamine hydrochloride in the feed additive:

                              —

                              high performance liquid chromatography with UV detection (HPLC-UV) — US Pharmacopeia 32 (‘thiamine hydrochloride’ monograph).

                        For the quantification of thiamine hydrochloride in premixtures:

                              —

                              ion-exchange high performance liquid chromatography coupled to UV detector (HPLC-UV) — VDLUFA Bd. III, 13.9.1, or

                              —

                              reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FL) — decree 20.2.2006, Official Italian Journal No 50, 1.3.2006.

                        For the quantification of thiamine hydrochloride in feedingstuffs:

                              —

                              reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FL) — decree 20.2.2006, Official Italian Journal No 50, 1.3.2006.

                        For the quantification of thiamine hydrochloride in water:

                              —

                              reversed phase high performance liquid chromatography (HPLC) with post-column derivatisation and fluorescence detection.

                  All animal species

                  —

                  —

                  —

                              1.

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

                              2.

                              Thiamine hydrochloride may be used via water for drinking.

                              3.

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

                  2 July 2025

                  Identification number of the additive

                  Name of the holder of the authorisation

                  Additive

                  Composition, chemical formula, description, analytical method

                  Species or category of animal

                  Maximum age

                  Minimum content

                  Maximum content

                  Other provisions

                  End of period of authorisation

                  mg of active substance/kg of complete feedingstuff with a moisture content of 12 % or mg of the active substance/l of water

                     Nutritional additives: Vitamins, provitamins and chemically well-defined substances having similar effect

                  3a821

                  ‘Thiamine mononitrate’ or ‘Vitamin B1’

                     Additive composition

                  Thiamine mononitrate

                     Characterisation of the active substance

                  Thiamine mononitrate
                  C12 H17N4OSߦNO3

                  CAS number: 532-43-4
                  Thiamine mononitrate, solid form, produced by chemical synthesis.
                  Purity criteria: min. 98 %, on anhydrous basis.

                     Analytical methods
                      (2)
                     :

                  For the characterisation of thiamine mononitrate in the feed additive:

                              —

                              high performance liquid chromatography with UV detection (HPLC-UV) — US Pharmacopeia 32 (‘thiamine mononitrate’ monograph).

                        For the quantification of thiamine mononitrate in premixtures:

                              —

                              ion-exchange high performance liquid chromatography coupled to UV detector (HPLC-UV) — VDLUFA Bd. III, 13.9.1, or

                              —

                              reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FL) — decree 20.2.2006, Official Italian Journal No 50, 1.3.2006.

                        For the quantification of thiamine mononitrate in feedingstuffs:

                              —

                              reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FL) — decree 20.2.2006, Official Italian Journal No 50, 1.3.2006.

                        For the quantification of thiamine mononitrate in water:

                              —

                              reversed phase high performance liquid chromatography (HPLC) with post-column derivatisation and fluorescence detection.

                  All animal species

                  —

                  —

                  —

                              1.

                              Thiamine mononitrate may be placed on the market and used as an additive consisting of a preparation.

                              2.

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

                              3.

                              Thiamine mononitrate may be used via water for drinking.

                              4.

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

                  2 July 2025

         (1)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

         (2)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports


title: Commission Implementing Regulation (EU) 2016/2129 of 5 December 2016 amending Implementing Regulation (EU) 2015/220 laying down rules for the application of Council Regulation (EC) No 1217/2009 setting up a network for the collection of accountancy data on the incomes and business operation of agricultural holdings in the European Union

text:
               6.12.2016

               EN

               Official Journal of the European Union

               L 331/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/2129
   of 5 December 2016
   amending Implementing Regulation (EU) 2015/220 laying down rules for the application of Council Regulation (EC) No 1217/2009 setting up a network for the collection of accountancy data on the incomes and business operation of agricultural holdings in the European Union
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1217/2009 of 30 November 2009 setting up a network for the collection of accountancy data on the incomes and business operation of agricultural holdings in the European Union (1), and in particular the third subparagraph of Article 5(1), Article 5a(2) and (4), Article 5b(7) and the third subparagraph of Article 8(3) thereof,
   Whereas:

               (1)

               Annex I to Commission Implementing Regulation (EU) 2015/220 (2) sets out the threshold of economic size per Member State. Given that the importance of larger agricultural holdings in the agricultural structure in Bulgaria and Austria is increasing, it is appropriate to increase the threshold of economic size for these Member States laid down in that Annex.

               (2)

               Annex II to Implementing Regulation (EU) 2015/220 sets out the number of returning holdings per Member State and per Farm Accountancy Data Network (FADN) division. Due to structural changes of agriculture in Bulgaria, it is appropriate to adjust accordingly the number of returning holdings per division for this Member State laid down in that Annex. Due to structural changes in agriculture in Denmark and Austria which have led to a decrease in the overall number of holdings, it is appropriate to decrease accordingly the number of returning holdings for those Member States laid down in that Annex.

               (3)

               In view of the changes provided for in this Regulation, Bulgaria, Denmark and Austria should be requested to revise their respective selection plans for the accounting year 2017.

               (4)

               Part B of Annex IV to Implementing Regulation (EU) 2015/220 sets out the correspondence between the headings of the Farm Structure Surveys (FSS) referred to in Regulation (EC) No 1166/2008 of the European Parliament and of the Council (3) and the farm return of the FADN. Since no calculation of the standard output for ‘Other rabbits’ is required, it is necessary to adjust the correspondence between the headings of the FSS and the FADN by removing the mentioned characteristic.

               (5)

               Annexes VI, VII and VIII to Implementing Regulation (EU) 2015/220 set out the method for the calculation to determine the standard outputs, the method by which the importance of the gainful activities is estimated and the form and layout of the farm return respectively. For the sake of clarity, those Annexes should provide for additional information and clarification relating to certain instructions and definitions.

               (6)

               Implementing Regulation (EU) 2015/220 should therefore be amended accordingly.

               (7)

               The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Farm Accountancy Data Network,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Implementing Regulation (EU) 2015/220 is amended as follows:

               (1)

               in Article 3(2), the following subparagraph is added:
               ‘Bulgaria, Denmark and Austria shall revise the respective selection plans they notified for the accounting year 2017. They shall notify their respective revised selection plans for that accounting year to the Commission by 31 March 2017.’;

               (2)

               Annexes I, II, IV, VI, VII and VIII are amended in accordance with the Annex to this Regulation.

         Article 2
   This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
   It shall apply from the accounting year 2017.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 5 December 2016.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 328, 15.12.2009, p. 27.

      (2)  Commission Implementing Regulation (EU) 2015/220 of 3 February 2015 laying down rules for the application of Council Regulation (EC) No 1217/2009 setting up a network for the collection of accountancy data on the incomes and business operation of agricultural holdings in the European Union (OJ L 46, 19.2.2015, p. 1).

      (3)  Regulation (EC) No 1166/2008 of the European Parliament and of the Council of 19 November 2008 on farm structure surveys and the survey on agricultural production methods and repealing Council Regulation (EEC) No 571/88 (OJ L 321, 1.12.2008, p. 14).

      ANNEX
      Annexes I, II, IV, VI, VII and VIII to Implementing Regulation (EU) 2015/220 are amended as follows:

                  (1)

                  Annex I is amended as follows:

                              (a)

                              the entry concerning Bulgaria is replaced by the following:

                                          ‘Bulgaria

                                          4 000 ’

                              (b)

                              the entry concerning Austria is replaced by the following:

                                          ‘Austria

                                          15 000 ’

                  (2)

                  Annex II is amended as follows:

                              (a)

                              the entry concerning Bulgaria is replaced by the following:

                                          ‘BULGARIA

                                          831

                                          Северозападен (Severozapaden)

                                          393

                                          832

                                          Северен централен (Severen tsentralen)

                                          377

                                          833

                                          Североизточен (Severoiztochen)

                                          347

                                          834

                                          Югозападен (Yugozapaden)

                                          222

                                          835

                                          Южен централен (Yuzhen tsentralen)

                                          482

                                          836

                                          Югоизточен (Yugoiztochen)

                                          381

                                          Total Bulgaria

                                          2 202 ’

                              (b)

                              the entry concerning Denmark is replaced by the following:

                                          ‘370

                                          DENMARK

                                          1 850 ’

                              (c)

                              the entry concerning Austria is replaced by the following:

                                          ‘660

                                          AUSTRIA

                                          1 800 ’

                  (3)

                  In Annex IV, part B, in the table, the entry concerning code 3.06. is replaced by the following:

                              ‘3.06.

                              C_6

                              Rabbits, breeding females

                                          610.

                                          Rabbits, breeding females’

                  (4)

                  In Annex VI, Section 2, point (b), first indent, the last sentence is replaced by the following:
                  ‘Less-favoured areas and areas facing natural and other specific constraints are not considered as geographical units.’

                  (5)

                  In Annex VII, part A, the second sentence of the third paragraph is replaced by the following:
                  ‘Wine and olive oil production are regarded as agricultural activities if the bought-in proportion of wine or olive oil is not significant.’

                  (6)

                  In Annex VIII, table D, the description of the category concerning code 7020 is replaced by the following:
                  ‘All other intangible assets that cannot easily be bought or sold (e.g. software, licences, etc.). The heading must be completed and the amounts entered are subject to depreciation in column DY.’


title: Commission Implementing Regulation (EU) 2016/2074 of 25 November 2016 amending Regulation (EU) No 37/2010 as regards the substance aluminium salicylate, basic (Text with EEA relevance )

text:
               26.11.2016

               EN

               Official Journal of the European Union

               L 320/29

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/2074
   of 25 November 2016
   amending Regulation (EU) No 37/2010 as regards the substance aluminium salicylate, basic
   (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 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and the Council (1), and in particular Article 14 in conjunction with Article 17 thereof,
   Having regard to the opinion of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,
   Whereas:

               (1)

               Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (hereinafter ‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is established in a Regulation.

               (2)

               Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.

               (3)

               Aluminium salicylate, basic is currently included in that table as an allowed substance for topical use in all food producing species, except bovine, caprine, equidae, rabbit and fin fish. Aluminium salicylate, basic is also allowed substance for bovine, caprine, equidae and rabbit species according to provisional MRL set for that substance which expire on 31 December 2016.

               (4)

               An application for the modification of the existing entry for aluminium salicylate, basic to remove the provisional status of the MRL in bovine, caprine, equidae and rabbit species has been submitted to the European Medicines Agency (hereinafter ‘EMA’).

               (5)

               The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended the removal of the provisional status of the MRL for aluminium salicylate, basic in bovine, caprine, equidae and rabbit species.

               (6)

               Regulation (EU) No 37/2010 should therefore be amended accordingly.

               (7)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.
   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.
   It shall apply from 25 January 2017.

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

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 152, 16.6.2009, p. 11.

      (2)  Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).

      ANNEX
      In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance 'aluminium salicylate, basic is replaced by the following:

                     Pharmacologically active Substance

                     Marker residue

                     Animal Species

                     MRL

                     Target Tissues

                     Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009)

                     Therapeutic classification

                     ‘aluminium salicylate, basic

                     Salicylic acid

                     Bovine,
                     caprine,
                     Equidae,
                     rabbit

                     200 μg/kg
                     500 μg/kg
                     1 500  μg/kg
                     1 500  μg/kg

                     Muscle
                     Fat
                     Liver
                     Kidney

                     NO ENTRY

                     Antidiarrheal and intestinal anti-inflammatory agents’

                     Bovine,
                     caprine,
                     Equidae

                     9 μg/kg

                     Milk

                     NOT APPLICABLE

                     All food producing species except bovine, caprine, Equidae, rabbit and fin fish

                     No MRL required

                     NOT APPLICABLE

                     For topical use only


title: Commission Implementing Regulation (EU) 2016/1673 of 16 September 2016 establishing the allocation coefficient to be applied to the quantities covered by the applications for import rights lodged from 1 to 7 September 2016 under the tariff quotas opened by Implementing Regulation (EU) 2015/2078 for poultrymeat originating in Ukraine

text:
               17.9.2016

               EN

               Official Journal of the European Union

               L 253/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/1673
   of 16 September 2016
   establishing the allocation coefficient to be applied to the quantities covered by the applications for import rights lodged from 1 to 7 September 2016 under the tariff quotas opened by Implementing Regulation (EU) 2015/2078 for poultrymeat originating in Ukraine
   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), and in particular Article 188(1) and (3) thereof,
   Whereas:

               (1)

               Commission Implementing Regulation (EU) 2015/2078 (2) opened annual tariff quotas for imports of poultrymeat products originating in Ukraine.

               (2)

               For the quota with order number 09.4273, the quantities covered by the applications for import licences lodged from 1 to 7 September 2016 for the subperiod from 1 October to 31 December 2016 exceed those available. The extent to which import rights may be allocated should therefore be determined and an allocation coefficient laid down to be applied to the quantities applied for, calculated in accordance with Article 6(3) in conjunction with Article 7(2) of Commission Regulation (EC) No 1301/2006 (3).

               (3)

               In order to ensure efficient management of the measure, 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 quantities covered by the applications for import rights lodged under Implementing Regulation (EU) 2015/2078 for the subperiod from 1 October to 31 December 2016 shall be multiplied by the allocation coefficient set out 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, 16 September 2016.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

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

      (2)  Commission Implementing Regulation (EU) 2015/2078 of 18 November 2015 opening and providing for the administration of Union import tariff quotas for poultrymeat originating in Ukraine (OJ L 302, 19.11.2015, p. 63).

      (3)  Commission Regulation (EC) No 1301/2006 of 31 August 2006 laying down common rules for the administration of import tariff quotas for agricultural products managed by a system of import licences (OJ L 238, 1.9.2006, p. 13).

      ANNEX

                  Order No

                  Allocation coefficient — applications lodged for the subperiod from 1 October to 31 December 2016
                  (%)

                  09.4273

                  2,424195

                  09.4274

                  —


title: Commission Implementing Regulation (EU) 2017/1863 of 16 October 2017 approving amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication (Almansa (PDO))

text:
               17.10.2017

               EN

               Official Journal of the European Union

               L 266/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/1863
   of 16 October 2017
   approving amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication (Almansa (PDO))
   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), and in particular Article 99 thereof,
   Whereas:

               (1)

               The Commission examined Spain's application pursuant to Article 105 of Regulation (EU) No 1308/2013 for the approval of amendments to the specification for the Protected Designation of Origin ‘Almansa’, protected under Regulation (EEC) No 2247/73 of the Commission (2).

               (2)

               The Commission published the application for the approval of amendments to the specification, as required by Article 97(3) of Regulation (EU) No 1308/2013, in the Official Journal of the European Union
                   (3).

               (3)

               No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

               (4)

               The amendments to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013.

               (5)

               The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Almansa’ (PDO) 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, 16 October 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Regulation (EEC) No 2247/73 of the Commission of 16 August 1973 on the control of quality wines produced in specified regions (OJ L 230, 18.8.1973, p. 12) and the list of quality wines produced in specified regions published by the Commission pursuant to Article 3(2) thereof, as amended in the Official Journal of the European Communities (OJ C 146, 13.6.1986, p. 11).

      (3)  OJ C 194, 17.6.2017, p. 33.


title: Commission Implementing Regulation (EU) No 762/2014 of 14 July 2014 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               15.7.2014

               EN

               Official Journal of the European Union

               L 207/15

         COMMISSION IMPLEMENTING REGULATION (EU) No 762/2014
   of 14 July 2014
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

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

               (2)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 14 July 2014.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

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

      (2)  OJ L 157, 15.6.2011, p. 1.

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

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  AL

                  53,5

                  MK

                  97,3

                  TR

                  59,3

                  ZZ

                  70,0

                  0707 00 05

                  AL

                  74,4

                  MK

                  27,7

                  TR

                  76,3

                  ZZ

                  59,5

                  0709 93 10

                  TR

                  99,0

                  ZZ

                  99,0

                  0805 50 10

                  AR

                  106,0

                  TR

                  148,4

                  UY

                  119,0

                  ZA

                  128,3

                  ZZ

                  125,4

                  0808 10 80

                  AR

                  122,5

                  BR

                  84,6

                  CL

                  116,1

                  NZ

                  129,0

                  US

                  142,6

                  ZA

                  139,7

                  ZZ

                  122,4

                  0808 30 90

                  AR

                  80,4

                  CL

                  146,7

                  NZ

                  191,9

                  ZA

                  121,6

                  ZZ

                  135,2

                  0809 10 00

                  BA

                  82,8

                  MK

                  85,8

                  TR

                  238,6

                  XS

                  85,6

                  ZZ

                  123,2

                  0809 29 00

                  TR

                  326,6

                  ZZ

                  326,6

                  0809 30

                  MK

                  57,0

                  TR

                  139,2

                  XS

                  50,2

                  ZZ

                  82,1

                  0809 40 05

                  BA

                  61,9

                  ZZ

                  61,9

         (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) 2015/1594 of 21 September 2015 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (Rocamadour (PDO))

text:
               24.9.2015

               EN

               Official Journal of the European Union

               L 248/38

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/1594
   of 21 September 2015
   approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (Rocamadour (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 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 ‘Rocamadour’, registered under Commission Regulation (EC) No 38/1999 (2) as amended by Regulation (EC) No 939/2008 (3).

               (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
                   (4) as required by Article 50(2)(a) of that Regulation.

               (3)

               As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification 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 ‘Rocamadour’ (PDO) 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, 21 September 2015.

            For the Commission,

            On behalf of the President,

         Phil HOGAN

            Member of the Commission

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

      (2)  Commission Regulation (EC) No 38/1999 of 8 January 1999 supplementing the Annex to Regulation (EC) No 2400/96 on the entry of certain names in the ‘Register of protected designations of origin and protected geographical indications’ provided for in Council Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (OJ L 5, 9.1.1999, p. 62).

      (3)  Commission Regulation (EC) No 939/2008 of 24 September 2008 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (Rocamadour (PDO)) (OJ L 257, 25.9.2008, p. 12).

      (4)  OJ C 145, 1.5.2015, p. 15.


title: Commission Implementing Regulation (EU) 2015/1054 of 1 July 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               2.7.2015

               EN

               Official Journal of the European Union

               L 171/12

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/1054
   of 1 July 2015
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

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

               (2)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 1 July 2015.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

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

      (2)  OJ L 157, 15.6.2011, p. 1.

      ANNEX

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

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  AL

                  32,3

                  MA

                  139,7

                  MK

                  31,3

                  ZZ

                  67,8

                  0707 00 05

                  TR

                  106,1

                  ZZ

                  106,1

                  0709 93 10

                  TR

                  116,8

                  ZZ

                  116,8

                  0805 50 10

                  AR

                  99,2

                  BO

                  144,3

                  UY

                  130,0

                  ZA

                  146,2

                  ZZ

                  129,9

                  0808 10 80

                  AR

                  114,9

                  BR

                  98,2

                  CL

                  128,2

                  NZ

                  144,5

                  US

                  164,6

                  ZA

                  124,2

                  ZZ

                  129,1

                  0809 10 00

                  IL

                  315,1

                  TR

                  243,7

                  ZZ

                  279,4

                  0809 29 00

                  TR

                  301,3

                  ZZ

                  301,3

                  0809 40 05

                  IL

                  241,9

                  ZZ

                  241,9

         (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) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution  Text with EEA relevance

text:
               12.3.2015

               EN

               Official Journal of the European Union

               L 67/18

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/408
   of 11 March 2015
   on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution
   (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 78(2) thereof,
   Whereas:

               (1)

               Active substances are to be identified as candidates for substitution if they meet one or more criteria set out in point 4 of Annex II to Regulation (EC) No 1107/2009.

               (2)

               Pursuant to Article 80(7) of Regulation (EC) No 1107/2009, the Commission has to establish a list of substances included in Annex I to Council Directive 91/414/EEC (2) which satisfy the criteria set out in point 4 of Annex II to Regulation (EC) No 1107/2009, hereinafter: ‘list of candidates for substitution’.

               (3)

               To ensure the consistency of the policy of the Union as regards active substances that have properties identifying them as candidates for substitution and to apply equal treatment to such substances, the Commission should also include in that list active substances approved under Regulation (EC) No 1107/2009 pursuant to the transitional provisions of Article 80(1).

               (4)

               From the information contained in either the review report, or the conclusions of the European Food Safety Authority (3) or the Draft Assessment Report and related addenda and peer review reports, or from the classification in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (4), it was possible to identify the substances which satisfy the criteria set out in point 4 of Annex II to Regulation (EC) No 1107/2009. These documents provide information, where relevant, concerning the applicable Acceptable Daily Intake (ADI), Acute Reference Dose (ARfD) or Acceptable Operator Exposure Level (AOEL), the information concerning persistent, bio-accumulative and toxic (PBT) properties of the substances, information concerning critical effects referred to in the third indent of point 4 of Annex II to Regulation (EC) No 1107/2009, the proportion of non-active isomers, the classification in accordance with Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B and toxic for reproduction category 1A or 1B, the endocrine disrupting properties. Based on that information, the substances set out in the Annex to this Regulation were identified as satisfying one or more criteria set out in point 4 of Annex II to Regulation (EC) No 1107/2009. The information has been consolidated and can be found in a support tool for the establishment of the list of candidates for substitution, which is available on the Commission website (5).

               (5)

               The Acceptable Daily Intake (ADI) of the active substances 1-methylcyclopropene, amitrole, diclofop, dimethoate, ethoprophos, fenamiphos, fipronil, fluometuron, haloxyfop-P, metam, oxamyl, sulcotrione and triazoxide is significantly lower than that of the majority of the approved active substances within their respective groups of substances/use categories. The Acute Reference Dose (ARfD) of the active substances dimoxystrobin, fenamiphos, methomyl and oxamyl is significantly lower than that of the majority of the approved active substances within their respective groups of substances/use categories. The Acceptable Operator Exposure Level (AOEL) of the active substances amitrole, bromadiolone, difenacoum, dimethoate, diquat, ethoprophos, fenamiphos, fluquinconazole, metam, sulcotrione, triazoxide and warfarin is significantly lower than that of the majority of the approved active substances within their respective groups of substances/use categories. It is therefore appropriate to include those active substances in the list of candidates for substitution.

               (6)

               The active substances lufenuron, oxyfluorfen and quinoxyfen meet the criteria to be considered a persistent and bioaccumulative substance. The active substances amitrole, bifenthrin, bromuconazole, chlorotoluron (unstated stereochemistry), copper compounds (variants copper hydroxide, copper oxychloride, copper oxide, Bordeaux mixture and tribasic copper sulphate), cyproconazole, cyprodinil, difenoconazole, diflufenican, dimoxystrobin, diquat, epoxiconazole, fenbutatin oxide, fludioxonil, flufenacet, fluopicolide, fluquinconazole, haloxyfop-P, imazamox, imazosulfuron, isoproturon, isopyrazam, lenacil, lufenuron, metconazole, metribuzin, metsulfuron-methyl, myclobutanil, nicosulfuron, oxadiazon, oxyfluorfen, paclobutrazol, pirimicarb, prochloraz, propiconazole, propoxycarbazone, prosulfuron, quinoxyfen, tebuconazole, tebufenpyrad, tepraloxydim, tri-allate, triasulfuron and ziram meet the criteria to be considered a persistent and toxic substance. The active substances aclonifen, difenacoum, esfenvalerate, etofenprox, etoxazole, famoxadone, lambda-cyhalothrin, lufenuron, oxyfluorfen, pendimethalin and quinoxyfen meet the criteria to be considered a bioaccumulative and toxic substance. It is therefore appropriate to include those active substances in the list of candidates for substitution.

               (7)

               The active substances mecoprop and metalaxyl contain a significant proportion of non-active isomers. It is therefore appropriate to include those active substances in the list of candidates for substitution.

               (8)

               The active substances carbendazim, epoxiconazole, flumioxazine, glufosinate, linuron, oxadiargyl, quizalofop-P (variant quizalofop-P-tefuryl) and warfarin are or are to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 1A or 1B. It is therefore appropriate to include those active substances in the list of candidates for substitution.

               (9)

               Since measures concerning specific scientific criteria for the determination of endocrine disrupting properties, as referred to in the first paragraph of point 3.6.5 of Annex II to Regulation (EC) No 1107/2009, have not yet been adopted, it was to be established in accordance with the third paragraph thereof whether a substance is to be considered as having such properties. In accordance with that provision the active substances chlorotoluron (unstated stereochemistry), dimoxystrobin, epoxiconazole, molinate, profoxydim, tepraloxydim and thiacloprid are to be considered as having endocrine disrupting properties that may cause adverse effects in humans. It is therefore appropriate to include those active substances in the list of candidates for substitution.

               (10)

               Member States and interested parties should be provided with a reasonable period to adapt to the provisions of this Regulation.

               (11)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Candidates for substitution
   Active substances included in Annex I to Directive 91/414/EEC which fulfil the criteria set out in point 4 of Annex II to Regulation (EC) No 1107/2009 shall be as set out in the list in the Annex to this Regulation.
   The first paragraph shall also apply to active substances approved under Regulation (EC) No 1107/2009 pursuant to the transitional measures of Article 80(1).
   Article 2
   Transitional measures
   Article 1 and the Annex shall not apply to applications for the authorisation of plant protection products submitted before 1 August 2015.
   Article 3
   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, 11 March 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  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).

      (3)  http://www.efsa.europa.eu/en/publications/efsajournal.htm

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

      (5)  http://ec.europa.eu/food/plant/pesticides/index_en.htm

      ANNEX

                  1-methylcyclopropene

                  aclonifen

                  amitrole

                  bifenthrin

                  bromadiolone

                  bromuconazole

                  carbendazim

                  chlorotoluron (unstated stereochemistry)

                  copper compounds (variants copper hydroxide, copper oxychloride, copper oxide, Bordeaux mixture and tribasic copper sulphate)

                  cyproconazole

                  cyprodinil

                  diclofop

                  difenacoum

                  difenoconazole

                  diflufenican

                  dimethoate

                  dimoxystrobin

                  diquat

                  epoxiconazole

                  esfenvalerate

                  ethoprophos

                  etofenprox

                  etoxazole

                  famoxadone

                  fenamiphos

                  fenbutatin oxide

                  fipronil

                  fludioxonil

                  flufenacet

                  flumioxazine

                  fluometuron

                  fluopicolide

                  fluquinconazole

                  glufosinate

                  haloxyfop-P

                  imazamox

                  imazosulfuron

                  isoproturon

                  isopyrazam

                  lambda-cyhalothrin

                  lenacil

                  linuron

                  lufenuron

                  mecoprop

                  metalaxyl

                  metam

                  metconazole

                  methomyl

                  metribuzin

                  metsulfuron-methyl

                  molinate

                  myclobutanil

                  nicosulfuron

                  oxadiargyl

                  oxadiazon

                  oxamyl

                  oxyfluorfen

                  paclobutrazol

                  pendimethalin

                  pirimicarb

                  prochloraz

                  profoxydim

                  propiconazole

                  propoxycarbazone

                  prosulfuron

                  quinoxyfen

                  quizalofop-P (variant quizalofop-P-tefuryl)

                  sulcotrione

                  tebuconazole

                  tebufenpyrad

                  tepraloxydim

                  thiacloprid

                  tri-allate

                  triasulfuron

                  triazoxide

                  warfarin

                  ziram