title: Commission Implementing Regulation (EU) 2016/1425 of 25 August 2016 approving the active substance isofetamid 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 231/30

            COMMISSION IMPLEMENTING REGULATION (EU) 2016/1425
      of 25 August 2016
      approving the active substance isofetamid 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 13(2) thereof,
      Whereas:

                  (1)

                  In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Belgium received on 22 January 2013 an application from ISK Biosciences Europe NV for the approval of the active substance isofetamid.

                  (2)

                  In accordance with Article 9(3) of that Regulation, Belgium, as 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 3 April 2013.

                  (3)

                  On 3 October 2014, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

                  (4)

                  The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, 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 of 31 August 2015.

                  (5)

                  On 28 October 2015, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance isofetamid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

                  (6)

                  On 8 March 2016, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for isofetamid and a draft Regulation providing that isofetamid is approved.

                  (7)

                  The applicant was given the possibility to submit comments on the review 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, and in particular the uses which were examined and detailed in the Commission review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

                  (9)

                  In accordance with Article 13(2) 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 require further confirmatory information.

                  (10)

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

                  (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
      Approval of the active substance
      The active substance isofetamid, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
      Article 2
      Amendment 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
      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 August 2016.

               For the Commission

               The President

            Jean-Claude JUNCKER

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

         (2)  EFSA Journal 2015;13(10):4265. Available online: www.efsa.europa.eu

         (3)  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).

         ANNEX I

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     Isofetamid
                     CAS No: 875915-78-9
                     CIPAC No: 972

                        N-[1,1-dimethyl-2-(4-isopropoxy-o-tolyl)-2-oxoethyl]-3-methylthiophene-2-carboxamide

                     ≥ 950 g/kg

                     15 September 2016

                     15 September 2026

                     For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isofetamid, and in particular Appendices I and II thereto, shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to the risk to operators, workers and aquatic organisms, in particular fish.
                     Conditions of use shall include risk mitigation measures, where appropriate.
                     The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                 (1)

                                 the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;

                                 (2)

                                 the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification;

                                 (3)

                                 the effect of water treatment process chlorination on the nature of residues, including the potential for the formation of chlorinated residues that may be formed from residues present in surface water, when surface water is abstracted for drinking water.

                           The applicant shall submit the information requested under points (1) and (2) by 15 March 2017 and the information requested under point (3) within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

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

         ANNEX II
         In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (*)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                        ‘100

                        Isofetamid
                        CAS No: 875915-78-9
                        CIPAC No: 972

                           N-[1,1-dimethyl-2-(4-isopropoxy-o-tolyl)-2-oxoethyl]-3-methylthiophene-2-carboxamide

                        ≥ 950 g/kg

                        15 September 2016

                        15 September 2026

                        For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isofetamid, and in particular Appendices I and II thereto, shall be taken into account.
                        In this overall assessment Member States shall pay particular attention to the risk to operators, workers and aquatic organisms, in particular fish.
                        Conditions of use shall include risk mitigation measures, where appropriate.
                        The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                    (1)

                                    the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;

                                    (2)

                                    the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification;

                                    (3)

                                    the effect of water treatment process chlorination on the nature of residues, including the potential for the formation of chlorinated residues that may be formed from residues present in surface water, when surface water is abstracted for drinking water.

                              The applicant shall submit the information requested under points (1) and (2) by 15 March 2017 and the information requested under point (3) within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.’

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


title: Commission Implementing Regulation (EU) No 4/2013 of 4 January 2013 fixing the allocation coefficient to be applied to applications for import licences for olive oil lodged from 31 December 2012 to 1 January 2013 under the Tunisian tariff quota and suspending the issue of import licences for the month of January 2013

text:
               5.1.2013

               EN

               Official Journal of the European Union

               L 2/3

         COMMISSION IMPLEMENTING REGULATION (EU) No 4/2013
   of 4 January 2013
   fixing the allocation coefficient to be applied to applications for import licences for olive oil lodged from 31 December 2012 to 1 January 2013 under the Tunisian tariff quota and suspending the issue of import licences for the month of January 2013
   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 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 (2), and in particular Article 7(2) thereof,
   Whereas:

               (1)

               Article 3(1) and (2) of Protocol No 1 (3) to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the Republic of Tunisia, of the other part (4), opens a tariff quota at a zero rate of duty for imports of untreated olive oil falling within CN codes 1509 10 10 and 1509 10 90, wholly obtained in Tunisia and transported direct from that country to the European Union, up to the limit laid down for each year.

               (2)

               Article 2(2) of Commission Regulation (EC) No 1918/2006 of 20 December 2006 opening and providing for the administration of tariff quota for olive oil originating in Tunisia (5) lays down monthly quantitative limits for the issue of import licences.

               (3)

               Import licence applications have been submitted to the competent authorities under Article 3(1) of Regulation (EC) No 1918/2006 in respect of a total quantity exceeding the limit laid down for the month of January in Article 2(2) of that Regulation.

               (4)

               In these circumstances, the Commission must set an allocation coefficient allowing import licences to be issued in proportion to the quantity available.

               (5)

               Since the limit for the month of January has been reached, no more import licences can be issued for that month,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The quantities for which import licence applications were lodged for 31 December 2012 and 1 January 2013 under Article 3(1) of Regulation (EC) No 1918/2006 shall be multiplied by an allocation coefficient of 17,687732 %.
   The issue of import licences in respect of amounts applied for as from 7 January 2013 shall be suspended for January 2013.
   Article 2
   This Regulation shall enter into force on 5 January 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 4 January 2013.

            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 238, 1.9.2006, p. 13.

      (3)  OJ L 97, 30.3.1998, p. 57.

      (4)  OJ L 97, 30.3.1998, p. 2.

      (5)  OJ L 365, 21.12.2006, p. 84.


title: Commission Implementing Regulation (EU) No 669/2014 of 18 June 2014 concerning the authorisation of calcium D-pantothenate and D-panthenol as feed additives for all animal species  Text with EEA relevance

text:
               19.6.2014

               EN

               Official Journal of the European Union

               L 179/62

         COMMISSION IMPLEMENTING REGULATION (EU) No 669/2014
   of 18 June 2014
   concerning the authorisation of calcium D-pantothenate and D-panthenol 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)

               Calcium D-pantothenate and D-panthenol were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for use on all animal species as part of the group ‘Vitamins, pro-vitamins and chemically well-defined substances having similar effect’. Those feed additives were subsequently entered in the Community 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, two applications were submitted for the re-evaluation of calcium D-pantothenate and D-panthenol as feed additives for all animal species and, in accordance with Article 7 of that Regulation, for a change in the terms of the authorisation as regards their use via drinking water. The applicants requested those 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, calcium D-pantothenate and D-panthenol do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that calcium D-pantothenate and D-panthenol are regarded as effective sources of pantothenic acid and that no safety concerns would arise for users provided that appropriate protective measures are taken. 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 calcium D-pantothenate and D-panthenol 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 the disposal of existing stocks of the additives, pre-mixtures and compound feed containing them, as authorised by Directive 70/524/EEC.

               (7)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         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 additives in animal nutrition subject to the conditions laid down in that Annex.
   Article 2
   The substances specified in the Annex and feed containing those substances, which are produced and labelled before 9 January 2015 in accordance with the rules applicable before 9 July 2014 may continue to be placed on the market and used until the existing stocks are exhausted.
   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, 18 June 2014.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 270, 14.12.1970, p. 1.

      (3)  EFSA Journal 2011; 9(11):2409 and EFSA Journal 2011; 9(11):2410.

      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

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

                  Category: Nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect

                  3a841

                  —

                  Calcium D-pantothenate

                     Additive composition

                  Calcium D-pantothenate.

                     Characterisation of the active substance

                  Calcium D-pantothenate
                  Ca[C9H16NO5]2

                  CAS No: 137-08-6
                  Calcium D-pantothenate, solid form, produced by chemical synthesis.
                  Purity criteria:

                              1.

                              Min. 98 % (on dry basis)

                              2.

                              Max. 0,5 % 3-aminopropionic acid.

                     Method of Analysis
                      (1)

                              —

                              For the determination of Calcium D-pantothenate in the feed additive: potentiometric titration with perchloric acid and identification by specific optical rotation (European Pharmacopoeia monograph 0470).

                              —

                              For the determination of Calcium D-pantothenate in premixtures and feedingstuffs: Reverse Phase High-Performance Liquid Chromatography coupled to a single-quadrupole mass selective detector (RP-HPLC-MS).

                  All animal species.

                  —

                  —

                  —

                              1.

                              May be used also via water for drinking.

                              2.

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

                              3.

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

                  19 June 2024

                  3a842

                  —

                  D-Panthenol

                     Additive composition

                  D-Panthenol

                     Characterisation of the active substance.

                  D-Panthenol
                  C9H19NO4

                  CAS No: 81-13-0
                  D-Panthenol, liquid form, produced by chemical synthesis
                  Purity criteria:

                              1.

                              Min. 98 % on anhydrous basis (water < 1 %)

                              2.

                              Max. 0,5 % 3-aminopropanol.

                     Method of Analysis
                      (1)

                              —

                              For the determination of D-panthenol in the feed additive: titration with perchloric acid and potassium hydrogen phthalate and identification by specific optical rotation and infrared spectroscopy (European Pharmacopoeia monograph 0761).

                              —

                              For the determination of D-panthenol in water: Reverse Phase High-Performance Liquid Chromatography, coupled to UV detector (RP-HPLC).

                  All animal species

                  —

                  —

                              1.

                              To be used only via water for drinking.

                              2.

                              In the directions for use of the additive indicate the storage conditions.

                              3.

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

                  19 June 2024

         (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) No 717/2012 of 6 August 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               7.8.2012

               EN

               Official Journal of the European Union

               L 210/8

         COMMISSION IMPLEMENTING REGULATION (EU) No 717/2012
   of 6 August 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, 6 August 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

                  54,5

                  XS

                  32,3

                  ZZ

                  43,4

                  0707 00 05

                  TR

                  100,7

                  ZZ

                  100,7

                  0709 93 10

                  TR

                  104,3

                  ZZ

                  104,3

                  0805 50 10

                  AR

                  96,8

                  UY

                  90,7

                  ZA

                  95,8

                  ZZ

                  94,4

                  0806 10 10

                  CL

                  226,1

                  EG

                  218,7

                  IL

                  138,6

                  MA

                  158,7

                  MX

                  185,5

                  TN

                  203,8

                  TR

                  145,9

                  ZZ

                  182,5

                  0808 10 80

                  AR

                  164,4

                  BR

                  92,8

                  CL

                  126,4

                  NZ

                  125,0

                  US

                  165,5

                  ZA

                  103,6

                  ZZ

                  129,6

                  0808 30 90

                  AR

                  200,3

                  CL

                  132,4

                  ZA

                  114,5

                  ZZ

                  149,1

                  0809 29 00

                  CA

                  627,1

                  TR

                  424,2

                  ZZ

                  525,7

                  0809 30

                  TR

                  165,5

                  ZZ

                  165,5

                  0809 40 05

                  BA

                  62,7

                  IL

                  69,8

                  MK

                  70,3

                  ZZ

                  67,6

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


title: Commission Implementing Regulation (EU) 2015/2083 of 18 November 2015 concerning the non-approval of Tanacetum vulgare L. as a basic substance 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:
               19.11.2015

               EN

               Official Journal of the European Union

               L 302/87

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/2083
   of 18 November 2015
   concerning the non-approval of Tanacetum vulgare L. as a basic substance 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 23(5) in conjunction with Article 13(2) thereof,
   Whereas:

               (1)

               In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 26 April 2013 an application from the Institut Technique de l'Agriculture Biologique (ITAB) for the approval of Tanacetum vulgare L. as basic substance. That application was accompanied by the information required under the second subparagraph of Article 23(3).

               (2)

               The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 30 September 2014 (2). The Commission presented the review report (3) and the draft of this Regulation on the non-approval of Tanacetum vulgare L. to the Standing Committee on Plants, Animals, Food and Feed on 20 March 2015.

               (3)

               The documentation provided by the applicant shows that Tanacetum vulgare L. does not fulfil the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4).

               (4)

               Specific concerns were identified in the Technical Report of the Authority regarding exposure to camphor, thujones and 1,8-cineole and, as a result, the assessment of the risk to operators, workers, bystanders, consumers and non-target organisms could not be finalised.

               (5)

               The Commission invited the applicant to submit its comments on the Technical Report of the Authority and on the draft review report. The applicant submitted its comments, which have been carefully examined.

               (6)

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

               (7)

               Consequently, as laid down in the Commission review report, it has not been established that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve Tanacetum vulgare L. as basic substance.

               (8)

               This Regulation does not prejudice the submission of a further application for the approval of Tanacetum vulgare L. as basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.

               (9)

               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
   Non-approval as basic substance
   The substance Tanacetum vulgare L. is not approved as basic substance.
   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, 18 November 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Outcome of the consultation with Member States and EFSA on the basic substance application for Tanacetum vulgare for use in plant protection as repellent on orchards, vineyards, vegetables and ornamentals. EFSA supporting publication 2014:EN-666. 35pp.

      (3)  http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN

      (4)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1.)