title: Commission Implementing Regulation (EU) 2016/2216 of 8 December 2016 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               9.12.2016

               EN

               Official Journal of the European Union

               L 334/33

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/2216
   of 8 December 2016
   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, 8 December 2016.

            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

                  MA

                  90,5

                  TN

                  123,9

                  TR

                  111,7

                  ZZ

                  108,7

                  0707 00 05

                  EG

                  191,7

                  MA

                  77,0

                  TR

                  157,1

                  ZZ

                  141,9

                  0709 93 10

                  MA

                  141,2

                  TR

                  156,7

                  ZZ

                  149,0

                  0805 10 20

                  TR

                  70,4

                  UY

                  62,9

                  ZA

                  27,9

                  ZZ

                  53,7

                  0805 20 10

                  MA

                  70,6

                  ZZ

                  70,6

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

                  IL

                  114,7

                  TR

                  68,2

                  ZZ

                  91,5

                  0805 50 10

                  TR

                  81,7

                  ZZ

                  81,7

                  0808 10 80

                  ZA

                  36,6

                  ZZ

                  36,6

                  0808 30 90

                  CN

                  86,1

                  ZZ

                  86,1

         (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) 2017/455 of 15 March 2017 concerning the authorisation of a preparation of Lactobacillus fermentum (NCIMB 41636), Lactobacillus plantarum (NCIMB 41638) and Lactobacillus rhamnosus (NCIMB 41640) as a feed additive for dogs (Text with EEA relevance. )

text:
                  16.3.2017

                  EN

                  Official Journal of the European Union

                  L 71/15

            COMMISSION IMPLEMENTING REGULATION (EU) 2017/455
      of 15 March 2017
      concerning the authorisation of a preparation of Lactobacillus fermentum (NCIMB 41636), Lactobacillus plantarum (NCIMB 41638) and Lactobacillus rhamnosus (NCIMB 41640) as a feed additive for dogs
      (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.

                  (2)

                  In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of the preparation of Lactobacillus fermentum (NCIMB 41636), Lactobacillus plantarum (NCIMB 41638) and Lactobacillus rhamnosus (NCIMB 41640). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                  (3)

                  The application concerns the authorisation of the preparation of Lactobacillus fermentum (NCIMB 41636), Lactobacillus plantarum (NCIMB 41638) and Lactobacillus rhamnosus (NCIMB 41640) as a feed additive for dogs to be classified in the additive category ‘technological additives’.

                  (4)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 1 December 2015 (2) that the preparation of Lactobacillus fermentum (NCIMB 41636), Lactobacillus plantarum (NCIMB 41638) and Lactobacillus rhamnosus (NCIMB 41640) does not have an adverse effect on animal health, human health or the environment. The Authority has also concluded that the addition of the additive to pasteurised milk or to an oat-based product results in an acidification contributing to the preservation of the resulting food intended for dogs. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                  (5)

                  The assessment of the preparation of Lactobacillus fermentum (NCIMB 41636), Lactobacillus plantarum (NCIMB 41638) and Lactobacillus rhamnosus (NCIMB 41640) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation.

                  (6)

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

            HAS ADOPTED THIS REGULATION:
      Article 1
      The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘preservatives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
      Article 2
      This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

         This Regulation shall be binding in its entirety and directly applicable in all Member States.
         Done at Brussels, 15 March 2017.

               For the Commission

               The President

            Jean-Claude JUNCKER

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

         (2)  EFSA Journal 2016;14(1):4340.

         ANNEX

                     Identification number of the additive

                     Name of the holder of authorisation

                     Additive

                     Composition, chemical formula, description, analytical method

                     Species or category of animal

                     Maximum age

                     Minimum content

                     Maximum content

                     Other provisions

                     End of period of authorisation

                     CFU of additive/kg of feed material

                        Category of technological additives. Functional group: preservatives

                     1a001

                     —

                        Lactobacillus fermentum (NCIMB 41636), Lactobacillus plantarum (NCIMB 41638) and Lactobacillus rhamnosus (NCIMB 41640)

                        Additive composition

                     Preparation of Lactobacillus fermentum (NCIMB 41636), Lactobacillus plantarum (NCIMB 41638) and Lactobacillus rhamnosus (NCIMB 41640) containing a minimum of total Lactobacilli of 1,0 × 108 CFU/g additive (having a minimum of each Lactobacillus of 1,0 × 107 CFU/g additive)

                        Characterisation of the active substance

                     Viable cells of Lactobacillus fermentum (NCIMB 41636), Lactobacillus plantarum (NCIMB 41638) and Lactobacillus rhamnosus (NCIMB 41640)

                        Analytical method
                         (1)

                     Enumeration in the feed additive: spread plate method on MRS agar (EN 15787)
                     Identification: Pulsed Field Gel Electrophoresis (PFGE).

                     Dogs

                     —

                     —

                     —

                                 1.

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

                                 2.

                                 This additive shall be used only in oat derived products and pasteurised milk.

                                 3.

                                 Recommended use levels of additive:

                                             —

                                             6 × 108 CFU/kg of oat derived products (90 % moisture content);

                                             —

                                             2,7 × 1010 CFU/kg of pasteurised milk.

                                 4.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including skin protection.

                     5 April 2027

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


title: Commission Implementing Regulation (EU) 2016/1826 of 14 October 2016 concerning the non-approval of the active substance tricyclazole, 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 (Text with EEA relevance)

text:
               15.10.2016

               EN

               Official Journal of the European Union

               L 279/88

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/1826
   of 14 October 2016
   concerning the non-approval of the active substance tricyclazole, 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
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) thereof,
   Whereas:

               (1)

               In accordance with Article 7(1) of Regulation (EC) No 1107/2009, on 21 December 2012, Italy received an application from Dow AgroSciences for the approval of the active substance tricyclazole.

               (2)

               In accordance with Article 9(3) of that Regulation, the rapporteur Member State notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter ‘the Authority’) of the admissibility of the application on 4 February 2013.

               (3)

               For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 11(2) and (3) of that Regulation, for the use proposed by the applicant. The rapporteur Member State submitted a draft assessment report to the Commission and the Authority on 7 January 2014.

               (4)

               The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of that Regulation, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report.

               (5)

               The draft assessment report was reviewed by the Member States and the Authority. The Authority presented to the Commission its conclusion on the risk assessment of the active substance tricyclazole (2) on 18 February 2015. The Authority concluded that the assessment of the genotoxic and carcinogenic potential of the substance was inconclusive and therefore reference values (ADI, ARfD and AOEL) for use in human health risk assessments could not be established. Consequently, the risk assessments for operators, workers, bystanders, residents and consumers could not be conducted. It further concluded that the test material used in the toxicity studies was not representative of the proposed technical specification for the active substance and associated impurities. In addition, certain areas of the assessment could not be finalised, including the potential of tricyclazole to act as an endocrine disruptor and the potential for groundwater contamination by metabolites whose toxicological relevance is unknown.

               (6)

               The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 13(1) of Regulation (EC) No 1107/2009, on the draft review report. The applicant submitted its comments, which have been carefully examined.

               (7)

               However, despite the arguments put forward by the applicant, the concerns referred to in recital 5 could not be eliminated.

               (8)

               Consequently, it has not been demonstrated that it may be expected that, with respect to one or more representative uses of at least one plant protection product containing tricyclazole, the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. The active substance tricyclazole should therefore not be approved pursuant to Article 13(2) of Regulation (EC) No 1107/2009.

               (9)

               This Regulation does not prejudice the submission of a further application for tricyclazole pursuant to Article 7 of Regulation (EC) No 1107/2009.

               (10)

               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-approval of active substance
   The active substance tricyclazole is not approved.
   Article 2
   Entry into force
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 14 October 2016.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  EFSA Journal 2015;13(2):4032 Available online: www.efsa.europa.eu/efsajournal