title: Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market  Text with EEA relevance

text:
               19.9.2012

               EN

               Official Journal of the European Union

               L 252/26

         COMMISSION IMPLEMENTING REGULATION (EU) No 844/2012
   of 18 September 2012
   setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
   (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 19 thereof,
   Whereas:

               (1)

               Regulation (EC) No 1107/2009 provides that the approval of an active substance may be renewed upon expiry.

               (2)

               It is appropriate to set out the provisions necessary for the implementation of the renewal procedure.

               (3)

               In particular, periods should be set for the different steps of the renewal procedure to ensure that it functions properly.

               (4)

               Rules should be set out as regards confidentiality and the publication of the application for renewal, the supplementary dossiers and their updates.

               (5)

               Rules should also be set out as regards the submission of the application for renewal and its contents and format. The applicant should be obliged to justify the submission of new information and to list separately studies concerning vertebrate animals that they intend to submit.

               (6)

               Rules should be set out as regards the checking of the application by the rapporteur Member State.

               (7)

               In order to ensure the proper functioning of the renewal procedure, the rapporteur Member State should, at the applicant’s request, organise prior to the submission of the supplementary dossier, a meeting to discuss the application.

               (8)

               The supplementary dossiers submitted for renewal should, in particular, include necessary new data and new risk assessments and demonstrate why such data and risk assessments are necessary.

               (9)

               Rules should be set out as regards the establishment of the admissibility of the application by the rapporteur Member State.

               (10)

               Where all applications submitted are inadmissible, the Commission should adopt a Regulation on the non-renewal of the active substance concerned.

               (11)

               Rules should be set out to ensure an independent, objective and transparent assessment of the active substance.

               (12)

               The applicant, the Member States, with the exception of the rapporteur Member State, and the public should be given the opportunity to submit comments on the draft renewal assessment report.

               (13)

               The European Food Safety Authority should provide conclusions and organise consultations of experts, except where the Commission informs it that a conclusion is not necessary.

               (14)

               Rules should be set out as regards the renewal report and the adoption of a regulation on the renewal of the approval of the active substance.

               (15)

               Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (2) should continue to apply with respect to the renewal of the approval of the active substances listed in Annex I thereto.

               (16)

               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:
   CHAPTER 1

      ADMISSIBILITY

      SECTION 1

         Application for renewal

   Article 1
   Submission of the application
   1.   An application for the renewal of an approval of an active substance shall be submitted by a producer of the active substance to the rapporteur Member State, as set out in the second column of the Annex to Commission Implementing Regulation (EU) No 686/2012 (3) and to the co-rapporteur Member State, as set out in the third column of that Annex, no later than three years before the expiry of the approval.
   When submitting an application, the applicant may, pursuant to Article 63 of Regulation (EC) No 1107/2009, request certain information to be kept confidential. In that event, the applicant shall present such parts of the application physically separated, setting out the reasons for requesting confidentiality.
   At the same time, the applicant shall submit any data protection claims pursuant to Article 59 of Regulation (EC) No 1107/2009.
   2.   The applicant shall send a copy of the application to the Commission, the other Member States and to the European Food Safety Authority (‘the Authority’), including the information on those parts of the application in respect of which confidentiality has been requested as referred to in paragraph 1.
   3.   A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation.
   Article 2
   Format and contents of the application
   1.   The application shall be submitted in the format set out in the Annex.
   2.   The application shall list the new information the applicant intends to submit. It shall demonstrate that such information is necessary in accordance with the first subparagraph of Article 15(2) of Regulation (EC) No 1107/2009.
   The application shall list separately any new studies involving vertebrate animals that the applicant intends to submit.
   Article 3
   Checking of the application
   1.   Where the application has been submitted by the date provided for in the first subparagraph of Article 1(1) and contains all the elements provided for in Article 2, the rapporteur Member State shall, within one month of the date of receipt of the application, inform the applicant, the co-rapporteur Member State, the Commission and the Authority of the date of receipt of the application and the fact that it has been submitted by the date provided for in the first subparagraph of Article 1(1) and contains all the elements provided for in Article 2.
   The rapporteur Member State shall assess any request for confidentiality. Upon a request for access to information, the rapporteur Member State shall decide what information is to be kept confidential.
   2.   Where the application has been submitted by the date provided for in the first subparagraph of Article 1(1) but one or more elements provided for in Article 2 are missing, the rapporteur Member State shall, within one month of the date of receipt of the application, inform the applicant which elements are missing and set a period of 14 days for the submission of those elements to the Rapporteur Member State and to the co-rapporteur Member State.
   Where the application contains all the elements provided for in Article 2 at the expiry of that period, the rapporteur Member State shall, without delay, proceed in accordance with paragraph 1.
   3.   Where the application has not been submitted by the date provided for in the first subparagraph of Article 1(1), or where the application still does not contain all the elements provided for in Article 2 at the expiry of the period set for the submission of the missing elements in accordance with paragraph 2, the rapporteur Member State shall, without delay, inform the applicant, the co-rapporteur Member State, the Commission, the other Member States and the Authority that the application is inadmissible and of the reasons why it is inadmissible.
   4.   Within 14 days from the date of receipt of the information that the application has been submitted by the date provided for in the first subparagraph of Article 1(1) and that it contains all the elements provided for in Article 2, the applicant shall submit to the Authority a copy of the application, including the information about those parts of the application in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
   At the same time, the applicant shall forward a copy of the application to the Authority, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
   5.   Where, by the date provided for in the first subparagraph of Article 1(1), two or more applications for the same active substance have been submitted separately and each of them contains all the elements provided for in Article 2, the rapporteur Member State shall communicate the contact details of each applicant to the other applicant(s).
   6.   The Commission shall publish, for each active substance, the names and the addresses of the applicants whose applications have been submitted by the date provided for in the first subparagraph of Article 1(1) and contain all the elements provided for in Article 2.
   Article 4
   Contacts prior to submission of supplementary dossiers
   The applicant may request a meeting with the rapporteur Member State and the co-rapporteur Member State to discuss the application.
   If requested, such pre-submission contacts shall take place prior to the submission of supplementary dossiers, as provided for in Article 6.
   Article 5
   Access to the application
   Upon receipt of the application, as provided for in Article 3(4), the Authority shall make it available to the public without delay, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009, unless there is an overriding public interest in its disclosure.

      SECTION 2

         Supplementary dossiers

   Article 6
   Submission of supplementary dossiers
   1.   Where the rapporteur Member State has informed the applicant in accordance with Article 3(1) that its application has been submitted by the date provided for in the first subparagraph of Article 1(1) and that it contains all the elements provided for in Article 2, the applicant shall submit the supplementary dossiers to the rapporteur Member State, the co-rapporteur Member State, the Commission and the Authority.
   2.   The contents of the supplementary summary dossier and the supplementary complete dossier shall comply with Article 7.
   3.   The supplementary dossiers shall be submitted no later than 30 months before the expiry of the approval.
   4.   Where there is more than one applicant requesting renewal of the approval of the same active substance, those applicants shall take all reasonable steps to submit their dossiers jointly.
   Where such dossiers are not submitted jointly by all the applicants concerned, the reasons shall be set out in the dossiers.
   5.   When submitting the supplementary dossiers, the applicant may pursuant to Article 63 of Regulation (EC) No 1107/2009 request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information.
   Article 7
   Contents of supplementary dossiers
   1.   The supplementary summary dossier shall include the following:

               (a)

               a copy of the application;

               (b)

               where the applicant is joined or replaced by one or more other applicants, the name and address of that applicant or those other applicants and, if applicable, the name of the association of producers provided for in Article 1(3);

               (c)

               information with respect to one or more representative uses on a widely grown crop in each zone of at least one plant protection product containing the active substance, demonstrating that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are fulfilled; where the information submitted does not cover all zones or does not concern a widely grown crop, a justification shall be submitted;

               (d)

               data and risk assessments which were not part of the approval dossier or subsequent renewal dossiers and which are necessary:

                           (i)

                           to reflect changes in legal requirements which have occurred since the approval or last renewal of the approval of the active substance concerned;

                           (ii)

                           to reflect changes in scientific and technical knowledge since the approval or last renewal of the approval of the active substance concerned;

                           (iii)

                           to reflect changes to representative uses; or

                           (iv)

                           because the application is for an amended renewal;

               (e)

               for each point of the data requirements for the active substance, as set out in a Regulation setting out data requirements for active substances under Regulation (EC) No 1107/2009, for which new data are necessary in accordance with point (d), the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried them out and the reason why each test or study is necessary;

               (f)

               for each point of the data requirements for the plant protection product, as set out in a Regulation setting out data requirements for plant protection products under Regulation (EC) No 1107/2009, for which new data are necessary in accordance with point (d), the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried out the tests and studies, for one or more plant protection products which are representative of the supported uses, and the reason why each test or study is necessary;

               (g)

               where relevant, documented evidence as referred to in Article 4(7) of Regulation (EC) No 1107/2009;

               (h)

               for each test or study involving vertebrate animals, a description of the steps taken to avoid animal testing on vertebrate animals;

               (i)

               where relevant, a copy of an application for maximum residue levels as referred to in Article 7 of Regulation (EC) No 396/2005 of the European Parliament and of the Council (4);

               (j)

               where relevant, a copy of the proposal for classification where it is considered that the substance has to be classified or reclassified in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5);

               (k)

               an assessment of all information submitted;

               (l)

               a checklist demonstrating that the supplementary dossier provided for in paragraph 3 is complete in view of the uses applied for and indicating which data are new;

               (m)

               the summaries and results of scientific peer-reviewed open literature, as referred in Article 8(5) of Regulation (EC) No 1107/2009.

         2.   The uses referred to in paragraph 1(c) shall, where appropriate, include the uses evaluated for the approval or subsequent renewals. At least one plant protection product referred to in paragraph 1(c) shall contain no other active substance, where such a product exists for a representative use.
   3.   The supplementary complete dossier shall contain the full text of each test and study report referred to in paragraph 1(e), (f) and (m).
   It shall not contain any reports of tests or studies involving the deliberate administration of the active substance or the plant protection product containing it to humans.
   Article 8
   Admissibility of the application
   1.   Where the supplementary dossiers have been submitted by the date provided for in Article 6(3) and contain all the elements provided for in Article 7, the rapporteur Member State shall, within a period of one month, inform the applicant, the co-rapporteur Member State, the Commission and the Authority of the date of receipt of the supplementary dossiers and of the admissibility of the application.
   The rapporteur Member State shall assess any requests for confidentiality. In the event of a request for access to information, the rapporteur Member State shall decide what information is to be kept confidential.
   2.   Where the supplementary dossiers have been submitted by the date provided for in Article 6(3), but one or more elements provided for in Article 7 are missing, the rapporteur Member State shall, within a period of one month from the date of receipt of the supplementary dossiers, inform the applicant which elements are missing and set a period of 14 days for the submission of those elements to the rapporteur Member State and co-rapporteur Member State.
   Where at the expiry of that period the supplementary dossiers contain all the elements provided for in Article 7, the rapporteur Member State shall, without delay, proceed in accordance with paragraph 1.
   3.   After receiving the information that the application is admissible, the applicant shall immediately forward the supplementary dossiers to the other Member States, the Commission and the Authority, including the information about those parts of the dossier in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
   At the same time, the applicant shall forward the supplementary summary dossiers to the Authority, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
   4.   The Authority shall make the supplementary summary dossier available to the public, without delay, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009, unless there is an overriding public interest in its disclosure.
   5.   At the request of the Authority or a Member State, the applicant shall make available the dossiers submitted for the approval and subsequent renewals of the approval, where it has access to them.
   6.   Where the supplementary dossiers have not been submitted by the date referred to in Article 6(3), or where at the end of the period set for the submission of the missing elements in accordance with paragraph 2 of this Article the supplementary dossiers still do not contain all the elements provided for in Article 7, the rapporteur Member State shall, without delay, inform the applicant, the co-rapporteur Member State, the Commission, the other Member States and the Authority that the application is inadmissible and of the reasons why it is inadmissible.
   Article 9
   Replacement of the applicant
   An applicant may be replaced by another producer in respect of all of its rights and obligations under this Regulation by informing the rapporteur Member State, through a joint declaration by the applicant and the other producer. In that case, the applicant and the other producer shall, at the same time, inform the co-rapporteur Member State, the Commission, the other Member States, the Authority and any other applicants that have submitted an application for the same active substance of the replacement.
   Article 10
   Adoption of non-renewal Regulation
   The Commission shall adopt a Regulation on the non-renewal of the approval of an active substance in accordance with Article 20(1)(b) of Regulation (EC) No 1107/2009 where all of the applications submitted for that active substance are inadmissible in accordance with Article 3(3) of this Regulation or Article 8(6) thereof.
   CHAPTER 2

      ASSESSMENT

   Article 11
   Assessment by the rapporteur Member State and the co-rapporteur Member State
   1.   Where the application is admissible in accordance with Article 8(1), the rapporteur Member State shall, after consulting the co-rapporteur Member State, at the latest 12 months after the date referred to in Article 6(3), prepare and submit to the Commission, with a copy to the Authority, a report assessing whether the active substance can be expected to meet the approval criteria, as provided for in Article 4 of Regulation (EC) No 1107/2009 (‘the draft renewal assessment report’).
   2.   The draft renewal assessment report shall also include the following:

               (a)

               a recommendation with regard to the renewal of the approval;

               (b)

               a recommendation on whether the substance should be considered a ‘low-risk’ substance;

               (c)

               a recommendation on whether the substance should be considered a candidate for substitution;

               (d)

               where relevant, a proposal to set maximum residue levels;

               (e)

               where relevant, a suggestion for the classification or reclassification of the active substance in accordance with Regulation (EC) No 1272/2008;

               (f)

               a conclusion on which of the new studies included in the supplementary dossiers are relevant for the assessment;

               (g)

               a recommendation as to the parts of the report on which a consultation of experts is to be organised in accordance with Article 13(1);

               (h)

               the points on which the co-rapporteur Member State did not agree with the assessment by the rapporteur Member State, where relevant.

         3.   The rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge. It shall take into account the supplementary dossiers, and, where appropriate, the dossiers submitted for the approval and subsequent renewals of approval.
   4.   The rapporteur Member State shall first establish whether the approval criteria set out in points 3.6.2, 3.6.3, 3.6.4 and 3.7 of Annex II to Regulation (EC) No 1107/2009 are satisfied.
   Where those criteria are not satisfied, the draft renewal assessment report shall be limited to those parts of the assessment, unless Article 4(7) of Regulation (EC) No 1107/2009 applies.
   5.   Where the rapporteur Member State requires additional information, it shall set a period for the applicant to supply that information. That period shall not lead to an extension of the period of 12 months provided for in paragraph 1. The applicant may, pursuant to Article 63 of Regulation (EC) No 1107/2009, request such information to be kept confidential.
   6.   The rapporteur Member State may consult the Authority and request additional technical or scientific information from other Member States. Such consultations and requests shall not lead to an extension of the period of 12 months provided for in paragraph 1.
   7.   Information submitted by the applicant without having been requested, or provided after the expiry of the period set for its submission in accordance with the first sentence of paragraph 5, shall not be taken into account, unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009.
   8.   When submitting the draft renewal assessment report to the Commission, the rapporteur Member State shall request the applicant to submit the supplementary summary dossiers, updated to include the additional information requested by the rapporteur Member State in accordance with paragraph 5 or submitted in accordance with Article 56 of Regulation (EC) No 1107/2009, to the co-rapporteur Member State, the Commission, the other Member States and to the Authority.
   The applicant may pursuant to Article 63 of Regulation (EC) No 1107/2009 request such information to be kept confidential. Any such requests shall be addressed to the Authority.
   Article 12
   Comments on the draft renewal assessment report
   1.   The Authority shall circulate the draft renewal assessment report received from the rapporteur Member State to the applicant and to the other Member States at the latest 30 days after its receipt.
   2.   The Authority shall make the draft renewal assessment report available to the public, after giving the applicant two weeks to request, pursuant to Article 63 of Regulation (EC) No 1107/2009, that certain parts of the draft renewal assessment report are kept confidential.
   3.   The Authority shall allow a period of 60 days from the date the report is made available to the public for the submission of written comments. Such comments shall be communicated to the Authority, which shall collate and forward those comments, including its own comments, to the Commission.
   4.   The Authority shall make the updated supplementary summary dossiers available to the public, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009, unless there is an overriding public interest in its disclosure.
   Article 13
   Conclusion by the Authority
   1.   Within five months from the expiry of the period referred to in Article 12(3), the Authority shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents applicable at the date of the submission of the supplementary dossiers on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority shall, where appropriate, organise a consultation of experts, including experts from the rapporteur Member State and co-rapporteur Member State. The Authority shall communicate its conclusion to the applicant, the Member States and the Commission.
   By way of derogation from the first subparagraph, the Commission may inform the Authority without delay after the period referred to in Article 12(3) has expired that a conclusion is not necessary.
   2.   After giving the applicant two weeks to request, pursuant to Article 63 of Regulation (EC) No 1107/2009, that certain parts of the conclusion be kept confidential, the Authority shall make its conclusion available to the public, excluding any information in respect of which confidentiality has been granted by the Authority, unless there is an overriding public interest in its disclosure.
   3.   Where the Authority considers that additional information from the applicant is necessary, it shall, in consultation with the rapporteur Member State, set a period not exceeding one month for the applicant to supply such information to the Member States, the Commission and the Authority. The rapporteur Member State shall, within 60 days from the date of receipt of the additional information evaluate the information received and send its evaluation to the Authority.
   Where the first subparagraph applies, the period referred to in paragraph 1 shall be extended by the periods referred to in the first subparagraph of this paragraph.
   4.   The Authority may ask the Commission to consult a European Union reference laboratory designated, pursuant to Regulation (EC) No 882/2004 of the European Parliament and of the Council (6), for the purposes of verifying whether the analytical method for the determination of the residues proposed by the applicant is satisfactory and complies with the requirements in Article 29(1)(g) of Regulation (EC) No 1107/2009. The applicant shall, if requested by the European Union reference laboratory, provide samples and analytical standards.
   5.   Information submitted by the applicant without having been requested, or provided after the expiry of the period set for its submission in accordance with the first subparagraph of paragraph 3, shall not be taken into account, unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009.
   Article 14
   Renewal report and renewal Regulation
   1.   The Commission shall present to the Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 a renewal report and a draft Regulation within six months from the date of receipt of the conclusion of the Authority or in cases where there is no such conclusion of the Authority, the expiry of the period referred to in Article 12(3) of this Regulation.
   The renewal report and the draft Regulation shall take into account the draft renewal assessment report of the rapporteur Member State, the comments referred to in Article 12(3) of this Regulation and the conclusion of the Authority, where such a conclusion has been submitted.
   The applicant shall be given the possibility to submit comments on the renewal report within a period of 14 days.
   2.   On the basis of the renewal report and taking into account comments submitted by the applicant within the period referred to in the third subparagraph of paragraph 1, the Commission shall adopt a Regulation in accordance with Article 20(1) of Regulation (EC) No 1107/2009.
   CHAPTER 3

      TRANSITIONAL AND FINAL PROVISIONS

   Article 15
   Transitional provisions
   Regulation (EU) No 1141/2010 shall continue to apply with respect to the renewal of the approval of active substances listed in Annex I thereto.
   Article 16
   Entry into force and application
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 January 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 18 September 2012.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 322, 8.12.2010, p. 10.

      (3)  OJ L 200, 27.7.2012, p. 5.

      (4)  OJ L 70, 16.3.2005, p. 1.

      (5)  OJ L 353, 31.12.2008, p. 1.

      (6)  OJ L 165, 30.4.2004, p. 1.

      ANNEX

         Format for applications, as provided for in Article 2(1)

      The application shall be in writing, signed by the applicant, and sent to the rapporteur Member State and to the co-rapporteur Member State.
      A copy of the application shall be sent to the European Commission, DG Health and Consumers, 1049 Brussels, Belgium, to the European Food Safety Authority, Via Carlo Magno 1/A, 43126 Parma, Italy and to the other Member States.
      MODEL
      1.   Information concerning the applicant

                  1.1.

                  Name and address of the applicant including the name of the natural person responsible for the application and other obligations resulting from this Regulation:

                              1.1.1.

                                          (a)

                                          Telephone No:

                                          (b)

                                          E-mail address:

                              1.1.2.

                                          (a)

                                          Contact:

                                          (b)

                                          Alternative contact:

            2.   Information to facilitate identification

                  2.1.

                  Common name (proposed or ISO-accepted) specifying, where relevant, any variants thereof such as salts, esters or amines manufactured by the producer.

                  2.2.

                  Chemical name (IUPAC and CAS nomenclature).

                  2.3.

                  CAS, CIPAC and EC numbers (if available).

                  2.4.

                  Empirical and structural formula, molecular mass.

                  2.5.

                  Specification of purity of the active substance in g/kg which must be, whenever possible, identical or already accepted as equivalent to the one listed in the Annex to Commission Implementing Regulation (EU) No 540/2011 (1).

                  2.6.

                  Classification and labelling of the active substance in accordance with the provisions of Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2) (health and environment effects).

            3.   New information

                  3.1.

                  List of new information intended to be submitted together with a justification showing that they are considered necessary, in accordance with Article 15(2) of Regulation (EC) No 1107/2009.

                  3.2.

                  List of new studies intended to be submitted on vertebrate animals.

                  3.3.

                  Timetable of any new and ongoing studies.

            The applicant confirms that the above information submitted included in the application is correct.
      Date and signature (of the person competent to act for the applicant referred to under point 1.1).

         (1)  OJ L 153, 11.6.2011, p. 1.

         (2)  OJ L 353, 31.12.2008, p. 1.


title: Commission Implementing Regulation (EU) 2015/2232 of 2 December 2015 authorising an increase of the limits for the enrichment of wine produced using the grapes harvested in 2015 in all wine-growing regions of Denmark, the Netherlands, Sweden and the United Kingdom

text:
               3.12.2015

               EN

               Official Journal of the European Union

               L 317/24

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/2232
   of 2 December 2015
   authorising an increase of the limits for the enrichment of wine produced using the grapes harvested in 2015 in all wine-growing regions of Denmark, the Netherlands, Sweden and the United Kingdom
   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 91 thereof,
   Whereas:

               (1)

               Point A.3 of Part I of Annex VIII to Regulation (EU) No 1308/2013 provides that Member States may request that the limits for increasing the alcoholic strength (enrichment) of wine by volume be raised by up to 0,5 % in years in which climatic conditions have been exceptionally unfavourable.

               (2)

               Denmark, the Netherlands, Sweden and the United Kingdom have requested such increases of the limits for enrichment of the wine produced using the grapes harvested in the year 2015, as climatic conditions during the growing season have been exceptionally unfavourable.

               (3)

               Due to the exceptionally adverse weather conditions during 2015, the limits on increases in the natural alcoholic strength provided for in point A.2 of Part I of Annex VIII to Regulation (EU) No 1308/2013 do not enable the production of wine with an appropriate total alcoholic strength in certain wine-growing regions for which there would normally be market demand.

               (4)

               It is therefore appropriate to authorise an increase of the limits for the enrichment of wine produced using wine grapes harvested in 2015, in Denmark, the Netherlands, Sweden and the United Kingdom.

               (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
   By way of derogation from point A.3 of Part I of Annex VIII to Regulation (EU) No 1308/2013, in all wine-growing regions of Denmark, the Netherlands, Sweden and the United Kingdom, the increase in natural alcoholic strength by volume of fresh grapes harvested in the year 2015, grape must, grape must in fermentation, new wine still in fermentation and wine produced using the grapes harvested in the year 2015, shall not exceed 3,5 % vol.
   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.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 2 December 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

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


title: Commission Implementing Regulation (EU) 2016/68 of 21 January 2016 on common procedures and specifications necessary for the interconnection of electronic registers of driver cards

text:
               22.1.2016

               EN

               Official Journal of the European Union

               L 15/51

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/68
   of 21 January 2016
   on common procedures and specifications necessary for the interconnection of electronic registers of driver cards
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 165/2014 of the European Parliament and of the Council of 4 February 2014 on tachographs in road transport (1), and in particular Article 31(5) thereof,
   Whereas:

               (1)

               Regulation (EU) No 165/2014 provides for the obligation of Member States to exchange data electronically in order to ensure the uniqueness of the driver cards issued.

               (2)

               In order to facilitate the exchange of electronic data on driver cards by Member States, the Commission set up the messaging system TACHOnet, which allows Member States to request information to the other Member States on the issuance of driver cards, as well as on their status.

               (3)

               Regulation (EU) No 165/2014 makes mandatory the interconnection of electronic national registers on driver cards throughout the Union, either using the TACHOnet messaging system or a compatible system. However, in case of a compatible system, the exchange of electronic data with all other Member States must be possible through the TACHOnet messaging system.

               (4)

               It is necessary therefore to lay down the compulsory common procedures and specifications for TACHOnet, including the format of the data exchanged, the technical procedures for electronic consultation of the national electronic registers, access procedures and security mechanisms.

               (5)

               The measures provided for in this Regulation are in accordance with the opinion of the Committee referred to in Article 42(3) of Regulation (EU) No 165/2014,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Subject-matter
   This Regulation lays down the requirements regarding the obligatory connection of the national electronic registers on driver cards to the TACHOnet messaging system referred to in Article 31 of Regulation (EU) No 165/2014.
   Article 2
   Definitions
   In addition to the definitions laid down in Article 2 of Regulation (EU) No 165/2014, the following definitions shall apply:

               (a)

               ‘asynchronous interface’ means a process whereby a message in response to a request is returned on a new HTTP connection;

               (b)

               ‘broadcast search’ means a request message from a Member State addressed to all other Member States;

               (c)

               ‘card issuing authority’ (‘CIA’) means the entity empowered by a Member State for the issuing and management of tachograph cards;

               (d)

               ‘central hub’ means the information system enabling the routing of TACHOnet messages between Member States;

               (e)

               ‘national system’ means the information system set up in each Member State for the purpose of emitting, processing and responding to TACHOnet messages;

               (f)

               ‘synchronous interface’ means a process whereby a message in response to a request is returned on the same HTTP connection used for the request;

               (g)

               ‘requesting Member State’ means the Member State emitting a request or a notification, which is then routed to the appropriate responding Member State(s);

               (h)

               ‘responding Member State’ means the Member State to whom the TACHOnet request or notification is directed;

               (i)

               ‘singlecast search’ means a request message from a Member State addressed to a single Member State;

               (j)

               ‘tachograph card’, means either a driver card or a workshop card, as defined in Article 2(f) and (k) of Regulation (EU) No 165/2014.

         Article 3
   Obligation to connect to TACHOnet
   Member States shall connect the national electronic registers referred to in Article 31(1) of Regulation (EU) No 165/2014, to TACHOnet messaging system.
   Article 4
   Technical specifications
   TACHOnet messaging system shall fulfil the technical specifications laid down in Annexes I to VII.
   Article 5
   Use of TACHOnet
   Member States shall follow the procedures set out in Annex VIII.
   Member States shall provide access to TACHOnet messaging system to their national card issuing authorities and control officers carrying out the duties referred to in Article 38 of Regulation (EU) No 165/2014, in order to facilitate effective checks of the validity, status and uniqueness of driver cards.
   Article 6
   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.
   It shall apply from 2 March 2018.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 21 January 2016.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 60, 28.2.2014, p. 1.

      ANNEX I

         General aspects of TACHOnet messaging system

      1.   Architecture

      TACHOnet messaging system shall be composed of the following parts:

                  1.1.

                  A central hub, which shall be able to receive a request from the requesting Member State, validate it and process it by forwarding it to the responding Member States. The central hub shall wait for each responding Member State to answer, consolidate all the answers and forward the consolidated response to the requesting Member State.
                  All TACHOnet messages shall be routed by the central hub.

                  1.2.

                  National systems of the Member States, which shall be fitted with an interface capable of both sending requests to the central hub and receiving the corresponding replies. National systems may use propriety or commercial software to transmit and receive messages from the central hub.

            2.   Management

      2.1.   The central hub shall be managed by the Commission, which shall be responsible for the technical operation and maintenance of the central hub.
      2.2.   The central hub shall not store data for a period exceeding six months, other than the logging and statistical data set out in Annex VII.
      2.3.   The central hub shall not provide access to personal data, except for authorized Commission personnel, when necessary for the purpose of monitoring, maintenance and troubleshooting.
      2.4.   Member States shall be responsible for:

                  2.4.1.

                  The setup and management of their national systems, including the interface with the central hub.

                  2.4.2.

                  The installation and maintenance of their national system, both hardware and software, whether proprietary or commercial.

                  2.4.3.

                  The correct interoperability of their national system with the central hub, including the management of error messages received from the central hub.

                  2.4.4.

                  Taking all the measures to ensure the confidentiality, integrity and availability of the information.

                  2.4.5.

                  The operation of the national systems in accordance with the service levels set out in Annex VI.

            2.5.   MOVEHUB web portal
      The Commission shall provide a web based application with secured access, referred to as ‘MOVEHUB web portal’, providing at least the following services:

                  (a)

                  Member State availability statistics;

                  (b)

                  notification of maintenance on the central hub and Member State national systems;

                  (c)

                  aggregated reports;

                  (d)

                  contact management;

                  (e)

                  XSD schemas.

            2.6.   Contact management
      2.6.1.   The contact management functionality shall provide each Member State with the ability to manage the contact details regarding policy, business, operational and technical users of that Member State, being each Member State's competent authority the responsible for the maintenance of its own contacts. It shall be possible to view, but not edit, the contact details of the other Member States.
      2.6.2.   TACHOnet shall use the contact details referred to in point 2.6.1 to populate the contact details in response messages.

      ANNEX II

         Functionalities of TACHOnet messaging system

      1.   The following functionalities shall be provided through TACHOnet messaging system:

                  1.1.

                  Check Issued Cards (CIC): allows the requesting Member State to send a Check Issued Cards Request to one or all responding Member States, to determine if a card applicant already possesses a driver card issued by the responding Member States. The responding Member States shall reply to the request by sending a Check Issued Cards Response.

                  1.2.

                  Check Card Status (CCS): allows the requesting Member State to ask the responding Member State about the details of a card issued by the latter by sending a Check Card Status Request. The responding Member State shall reply to the request by sending a Check Card Status Response.

                  1.3.

                  Modify Card Status (MCS): allows the requesting Member State to notify the responding Member State, through a Modify Card Status Request, that the status of a card issued by the latter has changed. The responding Member State shall reply with a Modify Card Status Acknowledgement.

                  1.4.

                  Issued Card Driving License (ICDL): allows the requesting Member State to notify the responding Member State, through an Issued Card Driving Licence Request, that a card has been issued by the former against a driving licence issued by the latter. The responding Member State shall reply with an Issued Card Driving Licence Response.

            2.   Other message types deemed suitable for the efficient functioning of TACHOnet shall be included, for instance error notifications.
      3.   National systems shall recognize the card statuses listed in the Appendix to this Annex, when using any of the functionalities described in point 1. However, Member States are not required to implement an administrative procedure that makes use of all of the listed statuses.
      4.   When a Member State receives a response or notification giving a status that is not used in its administrative procedures, the national system shall translate the status on the received message to the appropriate value in that procedure. The message shall not be rejected by the responding Member State, as long as the status in the message is listed in the Appendix of this Annex.
      5.   The card status listed in the Appendix to this Annex shall not be used to determine if a driver card is valid for driving. When a Member State queries the register of the card issuing Member State via the CCS functionality, the response shall contain the dedicated field ‘valid for driving’. The national administrative procedures shall be such that CCS responses always contain the appropriate ‘valid for driving’ value.

         Appendix

            Card statuses

                     Card Status

                     Definition

                     Application

                     The CIA has received an application to issue a driver card. This information has been registered and stored in the database with the generated search keys.

                     Approved

                     The CIA has approved the application for the tachograph card.

                     Rejected

                     The CIA did not approve the application.

                     Personalised

                     The tachograph card has been personalised.

                     Dispatched

                     The National Authority has dispatched the driver card to the relevant driver or delivering agency.

                     Handed Over

                     The National Authority has handed over the driver card to the relevant driver.

                     Confiscated

                     The driver card has been taken from the driver by the competent authority.

                     Suspended

                     The driver card has been taken temporarily from the driver.

                     Withdrawn

                     The CIA has decided to withdraw the driver card. The card has been permanently invalidated.

                     Surrendered

                     The tachograph card has been returned to the CIA, and declared no longer needed.

                     Lost

                     The tachograph card has been declared lost to the CIA.

                     Stolen

                     The tachograph card has been reported stolen to the CIA. A stolen card is considered lost.

                     Malfunctioning

                     The tachograph card has been reported as malfunctioning to the CIA.

                     Expired

                     The period of validity of the tachograph card has expired.

                     Replaced

                     The tachograph card, which has been reported lost, stolen or malfunctioning, has been replaced by a new card. The data on the new card is the same, with the exception of the card number replacement index, which has been increased by one.

                     Renewed

                     The tachograph card has been renewed because of a change of administrative data or the validity period coming to an end. The card number of the new card is the same, with the exception of the card number renewal index, which has been increased by one.

                     In Exchange

                     The CIA that issued a driver card has received a notification that the procedure to exchange that card for a driver card issued by the CIA of another Member State has started.

                     Exchanged

                     The CIA that issued a driver card has received a notification that the procedure to exchange that card for a driver card issued by the CIA of another Member State has completed.

      ANNEX III

         Message provisions of TACHOnet messaging system

      1.   General technical requirements

      1.1.   The central hub shall provide both synchronous and asynchronous interfaces for the exchange of messages. Member States may choose the most suitable technology to interface with their own applications.
      1.2.   All messages exchanged between the central hub and the national systems must be UTF-8 encoded.
      1.3.   National systems shall be capable of receiving and processing messages containing Greek or Cyrillic characters.
      2.   XML messages structure and Schema definition (XSD)

      2.1.   The general structure of XML messages shall follow the format defined by the XSD schemas installed in the central hub.
      2.2.   The central hub and the national systems shall transmit and receive messages that conform to the message XSD schema.
      2.3.   National systems shall be capable of sending, receiving and processing all messages corresponding to any of the functionalities set out in Annex I.
      2.4.   The XML messages shall include at least the minimum requirements laid down in the Appendix to this Annex.

         Appendix

            Minimum requirements for the content of the XML messages

                     Common Header

                     Mandatory

                     Version

                     The official version of the XML specifications will be specified through the namespace defined in the message XSD and in the version attribute of the Header element of any XML message. The version number (‘n.m’) will be defined as fixed value in every release of the XML Schema Definition file (xsd).

                     Yes

                     Test Identifier

                     Optional id for testing. The originator of the test will populate the id and all participants in the workflow will forward/return the same id. In production it should be ignored and will not be used if it is supplied.

                     No

                     Technical Identifier

                     A UUID uniquely identifying each individual message. The sender generates a UUID and populates this attribute. This data is not used in any business capacity.

                     Yes

                     Workflow Identifier

                     The workflowId is a UUID and should be generated by the requesting Member State. This id is then used in all messages to correlate the workflow.

                     Yes

                     Sent At

                     The date and time (UTC) that the message was sent.

                     Yes

                     Timeout

                     This is an optional date and time (in UTC format) attribute. This value will be set only by the Hub for forwarded requests. This will inform the responding Member State of the time when the request will be timed out. This value is not required in MS2TCN_<x>_Req and all response messages. It is optional so that the same header definition can be used for all message types regardless of whether or not the timeoutValue attribute is required.

                     No

                     From

                     The ISO 3166-1 Alpha 2 code of the Member State sending the message or ‘EU’.

                     Yes

                     To

                     The ISO 3166-1 Alpha 2 code of the Member State to which the message is being sent or ‘EU’.

                     Yes

                     Check Issued Cards Request

                     Mandatory

                     Family Name

                     Driver's family as displayed on the card.

                     Yes

                     First Name

                     Driver's first/given name as detailed on the card (a missing first name does not indicate a wildcard search).

                     No

                     Date of Birth

                     Driver's date of birth as displayed on the card.

                     Yes

                     Driving Licence Number

                     The driver's driving licence number.

                     No

                     Driving Licence Issuing Country

                     The country that issued the driver's driving licence.

                     No

                     Check Issued Cards Response

                     Mandatory

                     Status Code

                     The status code of the search (e.g. found, not found, error, etc.).

                     Yes

                     Status Message

                     An explanatory status description (if necessary).

                     No

                        Found Driver Details

                     Yes

                     Family Name

                     The family name of any found drivers.

                     Yes

                     First Name

                     The first name(s) of any found drivers.

                     No

                     Date of Birth

                     The date of birth of any found drivers.

                     Yes

                     Place of Birth

                     The place of birth of any found drivers.

                     No

                     Driver Card Number

                     The found driver's card number.

                     Yes

                     Driver Card Status

                     The found driver's card status.

                     Yes

                     Driver Card Issuing Authority

                     The name of the authority that issued the found driver's card.

                     Yes

                     Driver Card Start of Validity Date

                     The date of the start of validity of the found driver's card.

                     Yes

                     Driver Card Expiry Date

                     The date of expiry the found driver's card.

                     Yes

                     Driver Card Status Modified Date

                     The date that the found driver's card was last modified.

                     Yes

                     Search Mechanism

                     Was the card found by the NYSIIS search or a custom search.

                     Yes

                     Temporary Card

                     The found card is a temporary card

                     No

                     Driving Licence Number

                     The found driver's driving licence number.

                     Yes

                     Driving Licence Issuing Country

                     The issuing country of the found driver's driving licence.

                     Yes

                     Driving Licence Status

                     The status of the found driver's driving licence.

                     No

                     Driving Licence Issuing Date

                     The issuing date of the found driver's driving licence.

                     No

                     Driving Licence Expiry Date

                     The expiry date of the found driver's driving licence.

                     No

                     Check Card Status Request

                     Mandatory

                     Driver Card Number

                     The number of the card for which details are required.

                     Yes

                     Check Card Status Response

                     Mandatory

                     Status Code

                     The status code of the details request (e.g. found, not found, error, etc.).

                     Yes

                     Status Message

                     An explanatory status description (if necessary).

                     No

                     Card Status

                     The status of the requested card.

                     Yes

                     Card Issuing Authority

                     The name of the authority that issued the requested card.

                     Yes

                     Card Start of Validity Date

                     The date of the start of validity of the requested card.

                     Yes

                     Card Expiry Date

                     The date of expiry the requested card.

                     Yes

                     Card Status Modified Date

                     The date that the requested card was last modified.

                     Yes

                     Valid for Driving

                     The found card is/is not valid for driving.

                     Yes

                     Temporary Card

                     The found card is a temporary card

                     No

                        Workshop Card

                     Workshop Name

                     The name of the workshop to which the card was issued.

                     Yes

                     Workshop Address

                     The address of the workshop to which the card was issued.

                     Yes

                     Family Name

                     The family name of the person to whom the card is issued.

                     No

                     First Name

                     The first name of the person to who the card is issued.

                     No

                     Date of Birth

                     The date of birth of the person to whom the card is issued.

                     No

                        Card Holder Details

                     Family Name

                     The family name of the driver to whom the card was issued.

                     Yes

                     First Name

                     The first name of the driver to whom the card was issued.

                     No

                     Date of Birth

                     The date of birth of the driver to whom the card was issued.

                     Yes

                     Place of Birth

                     The place of birth of the driver to whom the card was issued.

                     No

                     Driving Licence Number

                     The driving licence number of the driver to whom the card was issued.

                     Yes

                     Driving Licence Issuing Country

                     The country that issued driving licence number to the driver to whom the card was issued.

                     Yes

                     Driving Licence Status

                     The status of the driving licence of the driver to whom the card was issued.

                     No

                     Driving Licence Issuing Date

                     The issuing date of the driving licence of the driver to whom the card was issued.

                     No

                     Driving Licence Expiry Date

                     The expiry date of the driving licence of the driver to whom the card was issued.

                     No

                     Modify Card Status Request

                     Mandatory

                     Driver Card Number

                     The number of the card who's status has changed.

                     Yes

                     New Driver Card Status

                     The status to which the card has been changed.

                     Yes

                     Modification Reason

                     The (free text) reason for the card status change.

                     No

                     Driver Card Status Modified Date

                     The date and time that the card status was modified.

                     Yes

                        Declared By

                     Authority

                     The name of the authority that made the card status change.

                     Yes

                     Family Name

                     The family name of the person who made the card status change.

                     No

                     First Name

                     The first name of the person who made the card status change.

                     No

                     Phone

                     The phone number of the person who made the card status change.

                     No

                     E-mail

                     The e-mail address of the person who made the card status change.

                     No

                     Modify Card Status Acknowledgement

                     Mandatory

                     Status Code

                     The status code of the acknowledgement (ok, not found, error, etc.).

                     Yes

                     Acknowledgement type

                     The type of the acknowledgment: for request or response

                     Yes

                     Status Message

                     An explanatory status description (if necessary).

                     No

                     Modify Card Status Response

                     Mandatory

                     Status Code

                     The status code of the register update (ok, not ok, error, etc.).

                     Yes

                     Status Message

                     An explanatory status description (if necessary).

                     No

                     Issued Card Driving Licence Request

                     Mandatory

                     Driver Card Number

                     The number of the driver card that has been issued.

                     Yes

                     Driving Licence Number

                     The number of the foreign driving licence that was used to apply for the driver card.

                     Yes

                     Issued Card Driving Licence Response

                     Mandatory

                     Status Code

                     A status code acknowledging the notification (ok, not ok, error, etc.).

                     Yes

                     Status Message

                     An explanatory status description (if necessary).

                     No

                     Family Name

                     The family name of the driver to whom the card was issued.

                     Yes

                     First Name

                     The first name of the driver to whom the card was issued.

                     No

                     Date of Birth

                     The date of birth of the driver to whom the card was issued.

                     Yes

      ANNEX IV

         Transliteration and NYSIIS (New York State Identification and Intelligence System) Services

      1.   The NYSIIS algorithm implemented in the central hub shall be used to encode the names of all the drivers in the national register.
      2.   When searching for a card via the CIC functionality the NYSIIS keys shall be used as the primary search mechanism.
      3.   Additionally, Member States may employ a custom algorithm to return additional results.
      4.   The search results shall indicate the search mechanism which was used to find a record, either NYSIIS or custom.
      5.   If a Member State chooses to record ICDL notifications then the NYSIIS keys contained in the notification shall be recorded as part of the ICDL data.
      5.1.   When searching the ICDL data the Member State shall use the NYSIIS keys of the applicant's name.

      ANNEX V

         Security requirements

      1.   HTTPS shall be used for the exchange of messages between the central hub and the national systems.
      2.   National systems shall use the PKI certificates provided by the Commission for the purposes of securing the transmission of messages between the national system and the central hub.
      3.   National systems shall implement, as a minimum, certificates using the SHA-2 (SHA-256) signature hash algorithm and a 2 048 bit public key length.

      ANNEX VI

         Service levels

      1.   National systems shall fulfil the following minimum level of service:
      1.1.   They shall be available 24 hours a day, 7 days a week.
      1.2.   Their availability shall be monitored by a heartbeat message issued from the central hub.
      1.3.   Their availability rate shall be 98 %, according to the following table (the figures have been rounded to the nearest convenient unit):

                  An availability of

                  means an unavailability of

                  Daily

                  Monthly

                  Yearly

                  98 %

                  0,5 hours

                  15 hours

                  7,5 days

            Member States are encouraged to respect the daily availability rate, however it is recognised that certain necessary activities, such as system maintenance, require a down time of more than 30 minutes. However, the monthly and yearly availability rates remain mandatory.
      1.4.   They shall respond to a minimum of 98 % of the requests forwarded to them in one calendar month.
      1.5.   They shall respond to requests within 10 seconds.
      1.6.   The global request timeout (time within which the requestor may wait for a response) shall not exceed 20 seconds.
      1.7.   They shall be able to service a request rate of 6 messages per second.
      1.8.   National systems may not send requests to the TACHOnet hub at a rate exceeding 2 requests per second.
      1.9.   Every national system shall be able to cope with potential technical problems of the central hub or national systems in other Member States. These include, but are not limited to:

                  (a)

                  loss of connection to the central hub;

                  (b)

                  no response to a request;

                  (c)

                  receipt of responses after message timeout;

                  (d)

                  receipt of unsolicited messages;

                  (e)

                  receipt of invalid messages.

            2.   The central hub shall:
      2.1.   feature an availability rate of 98 %;
      2.2.   provide to national systems notification of any errors, either via the response message or via a dedicated error message. The national systems, in turn, shall receive these dedicated error messages and have an escalation workflow in place to take any appropriate action to rectify the notified error.
      3.   Maintenance
      Member States shall notify other Member States and the Commission of any routine maintenance activities via the web application, at least one week before the beginning of those activities if technically possible.

      ANNEX VII

         Logging and Statistics of the data collected at the central hub

      1.   In order to ensure privacy, the data for statistical purposes shall be anonymous. Data identifying a specific card, driver or driver licence shall not be available for statistical purposes.
      2.   Logging information shall keep track of all transactions for monitoring and debugging purposes, and allow the generation of statistics about these transactions.
      3.   Personal data shall not be retained in the logs for more than 6 months. Statistical information shall be retained indefinitely.
      4.   The statistical data used for reporting shall include:

                  (a)

                  the requesting Member State;

                  (b)

                  the responding Member State;

                  (c)

                  the type of message;

                  (d)

                  the status code of the response;

                  (e)

                  the date and time of the messages;

                  (f)

                  the response time.

      ANNEX VIII

         Use of TACHOnet messaging system

      1.   Issuing of driver cards

      1.1.   When the applicant for a driver card holds a driving licence issued in a Member State different than the Member State of application, a broadcast Check Issued Card search shall be performed by the Member State of application.
      1.2.   Member States issuing a driver card to a driver holding a driving license issued in another Member State, shall immediately notify the latter, through the Issued Card Driving Licence function, that a driver card has been issued.
      1.3.   When the applicant for a driver card holds a driving licence issued in the Member State of application, and for which an ICDL notification had been previously recorded in its national register, the Member State shall perform either a singlecast CIC or a Check Card Status search to the Member State that sent the ICDL notification.
      1.4.   Every ICDL notification shall be recorded in the national register of the Member State receiving it.
      1.5.   Member States shall perform a broadcast CIC search for, at least, 30 % of applications presented by drivers holding a licence issued in that Member State.
      1.6.   Member States may choose not to use the ICDL functionality as provided for in points 1.3 to 1.5. In this case, they shall carry out a broadcast CIC search for every application received.
      1.7.   Member States shall notify the Commission by no later than the date of application of this Regulation on whether they will record the ICDL notifications in their national registers or they will follow the procedure in point 1.6.
      1.8.   Member States that, five years or less before the date of application of this Regulation, did not record ICDL notifications in their national registers as set out in point 1.4, shall perform a broadcast CIC search for the 100 % of applications, except for driving licences for which an ICDL notification has been recorded, in which case point 1.3 shall apply.
      1.9.   The obligation provided for in point 1.8 shall apply for a period of five years as from the date in which the recording of ICDL notifications has been effectively implemented in the national register of each Member State.
      2.   Withdrawn, suspended or stolen driver cards

      2.1.   If, in accordance with Article 26(7) and Article 29(2) of Regulation (EU) No 165/2014, a driver card has been withdrawn, suspended or declared as stolen in a Member State other than the issuing Member State, the competent authority of the former shall:

                  (a)

                  check the actual status of the card by sending a CCS request to the issuing Member State. If the number of the card is not known, a singlecast CIC request shall be sent before the aforementioned CCS request;

                  (b)

                  send a MCS notification through the TACHOnet messaging system to the issuing Member State.

            3.   Exchange of driver cards

      3.1.   Where the holder of a driver card applies for the exchange of the driver card in a Member State other than the issuing Member State, the competent authority of the former shall check the actual status of the card by sending a CCS request to the latter.
      3.2.   Once the status of the driver card has been checked and it is valid for exchange, the competent authority of the Member State where the application has been made, shall send a MCS request through the TACHOnet messaging system to the issuing Member State.
      3.3.   Member States renewing or exchanging a driver card to a driver holding a driving license issued in another Member State, shall immediately notify the issuing Member State, through the ICDL function, that the driver card has been renewed or exchanged.


title: Commission Implementing Regulation (EU) 2017/368 of 2 March 2017 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               3.3.2017

               EN

               Official Journal of the European Union

               L 56/208

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/368
   of 2 March 2017
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

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

               (2)

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

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

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 2 March 2017.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General

            Directorate-General for Agriculture and Rural Development

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

      (2)  OJ L 157, 15.6.2011, p. 1.

      ANNEX

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

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  EG

                  235,2

                  IL

                  149,3

                  MA

                  90,0

                  TR

                  92,9

                  ZZ

                  141,9

                  0707 00 05

                  MA

                  79,2

                  TR

                  177,0

                  ZZ

                  128,1

                  0709 91 00

                  EG

                  97,7

                  ZZ

                  97,7

                  0709 93 10

                  MA

                  51,8

                  TR

                  151,2

                  ZZ

                  101,5

                  0805 10 22 , 0805 10 24 , 0805 10 28

                  EG

                  45,0

                  IL

                  72,5

                  MA

                  48,3

                  TN

                  49,2

                  TR

                  73,7

                  ZZ

                  57,7

                  0805 50 10

                  EG

                  74,7

                  TR

                  77,0

                  ZZ

                  75,9

                  0808 10 80

                  CN

                  116,5

                  US

                  128,5

                  ZZ

                  122,5

                  0808 30 90

                  CL

                  225,3

                  CN

                  88,7

                  ZA

                  115,2

                  ZZ

                  143,1

         (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) No 1220/2011 of 25 November 2011 amending Regulation (EC) No 867/2008 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 as regards operators’ organisations in the olive sector, their work programmes and the financing thereof

text:
               26.11.2011

               EN

               Official Journal of the European Union

               L 313/6

         COMMISSION IMPLEMENTING REGULATION (EU) No 1220/2011
   of 25 November 2011
   amending Regulation (EC) No 867/2008 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 as regards operators’ organisations in the olive sector, their work programmes and the financing thereof
   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), and in particular the third subparagraph of Article 103(2) in conjunction with Article 4 thereof,
   Whereas:

               (1)

               In the light of experience gained from implementing the work programmes of operators’ organisations in the olive sector, certain amendments should be made to Commission Regulation (EC) No 867/2008 (2).

               (2)

               In order to ensure better implementation of Article 103 of Regulation (EC) No 1234/2007 and to ensure that the financial interests of the Union are protected where producer organisations are beneficiaries of rural development measures under Council Regulation (EC) No 1698/2005 of 20 September 2005 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) (3), provision should be made for the approval of operators’ organisations in the olive sector to be immediately refused, suspended or withdrawn if the latter have been penalised under those Regulations.

               (3)

               With regard to market monitoring and administrative management, it is useful to focus on subjects linked to measures planned under the work programmes of the operators’ organisations, whereas in the field of improving the production quality of olive oil and table olives, for reasons of effectiveness, provision should be made for new types of technical assistance.

               (4)

               To improve consistency in the activities which are eligible for Union funding, it is desirable, with regard to controlling olive fly, to restrict financing to those measures provided for in point (b)(iii) of Article 5(1) of Regulation (EC) No 867/2008.

               (5)

               In consideration of the experience gained, it is necessary to increase the minimum percentage of Union funding allocated to reducing the environmental impact of olive cultivation in order to reflect the important developments in this area. Similarly, in order to make the best possible use of the resources allocated to work programmes, there should be a reduction in the general expenses element of expenditure on implementation.

               (6)

               Administrative procedures should be simplified where amendments to a programme involve substituting one measure with another and where the planned budget for each measure is less than EUR 10 000 but where the initial objective of the programme remains unchanged.

               (7)

               To facilitate the implementation of programmes, the conditions for the release of securities linked to advances should be made more flexible provided that the eligible expenditure has been implemented and verified.

               (8)

               A new deadline should be set for the Member States concerned to notify the Commission of national measures taken to implement this Regulation.

               (9)

               Regulation (EC) No 867/2008 should be amended accordingly.

               (10)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Regulation (EC) No 867/2008 is amended as follows:

               (1)

               in Article 3(5) the following subparagraph (c) is added:

                           ‘(c)

                           has been penalised for infringing the scheme to fund the activities of operators’ organisations provided for in Article 103 of Regulation (EC) No 1234/2007 or for an infringement of the application of a rural development measure provided for in Council Regulation (EC) No 1698/2005 (4).

               (2)

               Article 5(1) is amended as follows:

                           (a)

                           point (a)(ii) is replaced by the following:

                                       ‘(ii)

                                       drawing up studies on subjects linked to the other measures provided for in the work programme of the operators’ organisation concerned;’;

                           (b)

                           point (c) shall be amended as follows:

                                       (i)

                                       point (i) is replaced by the following:

                                                   ‘(i)

                                                   improving conditions for growing, harvesting, delivering and storing olives prior to processing, in accordance with the technical specifications laid down by the competent national authority;’;

                                       (ii)

                                       point (iii) shall be replaced by the following:

                                                   ‘(iii)

                                                   improving conditions for storage and use of the residues of olive oil and table olive production and improving olive oil bottling conditions;’;

                                       (iii)

                                       point (iv) shall be replaced by the following:

                                                   ‘(iv)

                                                   technical assistance for production, for the olive processing industry, for producers of table olives, for mills and for packaging, relating to aspects linked to product quality;’;

                                       (iv)

                                       point (vi) shall be replaced by the following:

                                                   ‘(vi)

                                                   training tasters to carry out organoleptic checks on virgin olive oils and on table olives.’;

               (3)

               in Article 6, the first paragraph is replaced by the following:
               ‘In each Member State a minimum of 30 % of the Union funding available under Article 103 of Regulation (EC) No 1234/2007 shall be allocated to the area of activity referred to in point (b) of the first subparagraph of Article 5(1) of this Regulation, and a minimum of 12 % of that Union funding shall be allocated to the area referred to in point (d) of the first subparagraph of Article 5(1).’;

               (4)

               in Article 7(1), the following point (g) is added:

                           ‘(g)

                           measures and activities relating to controlling olive fly with the exception of measures provided for in point (b)(iii) of Article 5(1).’;

               (5)

               point (d) of the second subparagraph of Article 8(2) is replaced by the following:

                           ‘(d)

                           the planned expenditure, broken down by measure and by area of measure as referred to in Article 5(1), with details for each 12-month period from the date of approval of the work programme, distinguishing the overheads, which must not exceed 5 % of the total, and the other main types of costs;’;

               (6)

               in Article 10, the following paragraph 6 is added:
               ‘6.   By way of derogation from paragraphs 2 and 4, where amendments to a work programme involve substituting one measure with another measure in the same area, and where the planned budget for each measure is less than EUR 10 000, the operators’ organisation must notify the competent authority two months before the new measure is implemented. If the competent authority does not object within one month of notification, the amendment shall be deemed to have been accepted. The notification shall be accompanied by supporting documentation specifying the aim, nature and implications of the proposed amendment and shall demonstrate that the amendment concerned does not alter the initial objective of the programme in question.’;

               (7)

               Article 11(5) is replaced by the following text:
               ‘5.   By a date to be determined by the Member State but no later than the end of each year of implementation of the work programme, the operators’ organisations concerned may lodge an application for release of the security referred to in paragraph 4 up to an amount equal to all the expenditure under the initial instalment actually carried out and verified by the Member State. The Member State shall lay down which supporting documents shall accompany this application and check them and shall release the securities corresponding to the expenditure concerned no later than in the course of the second month following that in which the application is lodged.’;

               (8)

               in Article 18(1), the introductory sentence shall be replaced by the following:
               ‘1.   No later than 31 January following each period of three years beginning on 1 April in accordance with Article 8, the Member States producing olive oil shall notify the Commission of the national measures implementing this Regulation, and in particular those relating to:’.

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

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 25 November 2011.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 237, 4.9.2008, p. 5.

      (3)  OJ L 277, 21.10.2005, p. 1.

      (4)  OJ L 277, 21.10.2005, p. 1.’;


title: Commission Implementing Regulation (EU) No 123/2012 of 13 February 2012 amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance monepantel  Text with EEA relevance

text:
               14.2.2012

               EN

               Official Journal of the European Union

               L 40/4

         COMMISSION IMPLEMENTING REGULATION (EU) No 123/2012
   of 13 February 2012
   amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance monepantel
   (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)

               The maximum residue limit (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 should be established in accordance with Regulation (EC) No 470/2009.

               (2)

               Pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin are set out in the Annex to 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 (2).

               (3)

               Monepantel is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for ovine and caprine species, applicable to muscle, fat, liver, and kidney, excluding animals producing milk for human consumption. The provisional maximum residue limits for that substance set out for caprine species expired on 1 January 2012.

               (4)

               Additional data were provided and assessed leading the Committee for Medicinal Products for Veterinary Use to recommend that the provisional MRLs for monepantel for caprine species should be set as definitive.

               (5)

               The entry for monepantel in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended accordingly.

               (6)

               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 third day following its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 13 February 2012.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 15, 20.1.2010, p. 1.

      ANNEX
      The entry monepantel in Table 1 of the Annex to Regulation (EU) No 37/2010 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

                     ‘Monepantel

                     Monepantel-sulfone

                     Ovine, caprine

                     700 μg/kg

                     Muscle

                     Not for use in animals producing milk for human consumption.

                     Antiparasitic agents/Agents acting against endoparasites’

                     7 000 μg/kg

                     Fat

                     5 000 μg/kg

                     Liver

                     2 000 μg/kg

                     Kidney