title: Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices  Text with EEA relevance

text:
                  25.9.2013

                  EN

                  Official Journal of the European Union

                  L 253/8

         COMMISSION IMPLEMENTING REGULATION (EU) No 920/2013
         of 24 September 2013
         on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (1), and in particular Article 11(2) thereof,
         Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (2), and in particular Article 16(2) thereof,
         Whereas:

                     (1)

                     Technical progress has led to more complex devices and production methods implying new conformity assessment challenges for notified bodies. Those developments have resulted in variations in the level of competence of notified bodies and in different degrees of stringency applied by them. Accordingly, to ensure the smooth functioning of the internal market, it is necessary to determine a common interpretation of the main elements of the criteria for designation of notified bodies set out in Directive 90/385/EEC and Directive 93/42/EEC.

                     (2)

                     The common interpretation of the criteria for designation provided by this Regulation does not suffice to assure their consistent application. The assessment methods in the Member States differ. They have a tendency to differ ever more due to the mentioned increased complexity of the work of conformity assessment bodies. Furthermore, many ad hoc questions arise in the day-to-day designation practice, in relation with new technologies and products. For these reasons, it is necessary to provide for procedural obligations which ensure a constant dialogue between Member States on their general practices and on ad hoc questions. This will bring to the surface discrepancies in the methods used to assess the conformity assessment bodies and in the interpretation of the criteria for their designation set out in Directive 90/385/EEC and Directive 93/42/EEC. Bringing the discrepancies to the surface will permit to develop a common interpretation of the assessment methods, especially with regard to new technologies and devices.

                     (3)

                     To ensure a common approach from the designating authorities and neutral conditions for competition those authorities should base their decisions on a common set of documents which lay the ground for the verification of the criteria for designation set out in Directive 90/385/EEC and Directive 93/42/EEC.

                     (4)

                     To facilitate, in a view of the increasingly complex work of conformity assessment bodies, a common application of the criteria established for their designation, those bodies should be assessed by teams of assessors representing the knowledge and experience of different Member States and of the Commission. To facilitate such assessments, certain essential documents should be accessible to those involved in these activities. Designating authorities from Member States other than the Member State where the conformity assessment body is established should have the possibility to review the documentation related to the assessment and to comment on intended designations if they so wish. The access to those documents is necessary in order to allow the identification of weaknesses of the applicant conformity assessment bodies as well as discrepancies in the Member States’ assessment methods and in their interpretation of the criteria for designation set out in Directive 90/385/EEC and Directive 93/42/EEC.

                     (5)

                     In order to ensure that the common interpretation of the criteria established applies similarly to scope extensions, which often reflect new technologies or product types and renewal of designations of notified bodies, the procedure for the designation of conformity assessment bodies should also be followed in those situations.

                     (6)

                     The need for control and monitoring of notified bodies by the designating authorities has increased since technical progress has raised the risk that notified bodies do not possess the necessary competence with regard to new technologies or devices emerging within their scope of designation. As technical progress shortens product cycles and as the intervals of surveillance on-site assessments and of the monitoring vary between designating authorities, minimum requirements with regard to the intervals of the surveillance and monitoring of the notified bodies should be established and unannounced or short-notice on-site assessments should be organised.

                     (7)

                     When, in spite of the measures taken to ensure a coherent application and follow up of the requirements by the Member States, the competence of a notified body is in doubt, the Commission should have the possibility to investigate individual cases. The need for investigation by the Commission is exacerbated since technical progress has increased the risk that notified bodies do not possess the necessary competence with regard to new technologies or products falling under their scope of designation.

                     (8)

                     In order to increase transparency and mutual trust and to further align and develop their designation, extension and renewal procedures, above all in a view of new emerging interpretative questions regarding new technologies and devices, Member States should cooperate with each other and with the Commission. They should consult each other and the Commission on questions with general relevance for the implementation of this Regulation and inform each other and the Commission on their model assessment checklist, which constitutes the basis for their assessment practice.

                     (9)

                     The increased complexity of the tasks regarding the designation of the conformity assessment bodies, reflecting the increasing complexity of the work of those bodies, requires significant resources. Therefore, requirements should be imposed on the Member States with regard to the minimum level of available competent personnel, able and entrusted to operate in an independent way.

                     (10)

                     Designating authorities who are not in charge of market surveillance and vigilance for medical devices are not necessarily aware of deficiencies in the work of notified bodies which were spotted by the competent authorities when doing product checks. Furthermore, the designating authorities do not necessarily have all the product related knowledge which is sometimes needed to assess whether the notified bodies worked properly. Therefore, the designating authorities should consult the competent authorities.

                     (11)

                     Where designation is based on accreditation in the meaning of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (3), in order to ensure a transparent and coherent application of the criteria set out in Annex 8 to Directive 90/385/EEC and Annex XI to Directive 93/42/EEC, accreditation bodies on the one hand, and designating and competent authorities on the other hand should exchange information relevant for the assessment of notified bodies. The need for this exchange of information has proven to be particularly strong in respect to the conformity assessment bodies’ practices with regard to new technologies and devices and their ability to cover those technologies and devices and thus to fulfil the criteria for designation set out in Directive 90/385/EEC and Directive 93/42/EEC.

                     (12)

                     It is appropriate to provide for a phase-in period, so as to give designating authorities time to build up the necessary additional resources and adapt their procedures.

                     (13)

                     The complex technical and production developments have led some notified bodies to outsource parts of their assessments. It is therefore necessary to set the limits and to determine under which conditions this can be done. Notified bodies should be in control of their subcontractors and of their subsidiaries. They need to be endowed with the appropriate resources, including fully qualified staff to make their own assessments or to review the assessments made by external experts.

                     (14)

                     To ensure that decisions by notified bodies are not influenced by non-legitimate circumstances the organisation and operation of the bodies should ensure full impartiality. To be able to carry out their tasks in a coherent and systematic manner the bodies should possess a satisfactory management system including provisions on professional secrecy. In order to allow notified bodies to perform their work properly, the level of knowledge and competence of the personnel should be guaranteed at all times.

                     (15)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee set up by Article 6(2) of Directive 90/385/EEC,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Definitions
            For the purposes of this Regulation, the following definitions shall apply:

                        (a)

                        ‘device’ means active implantable medical devices as defined in Article 1(2)(c) of Directive 90/385/EEC or medical devices and their accessories as defined in Article 1(2) of Directive 93/42/EEC;

                        (b)

                        ‘conformity assessment body’ means a body which performs calibration, testing, certification and inspection activities under Article R1(13) in Annex I to Decision No 768/2008/EC of the European Parliament and of the Council (4);

                        (c)

                        ‘notified body’ means a conformity assessment body which has been notified by a Member State in accordance with Article 11 of Directive 90/385/EEC or Article 16 of Directive 93/42/EEC;

                        (d)

                        ‘accreditation body’ means the sole body in a Member State that performs accreditation with authority derived from the State as laid down by Article 2(10) of Regulation (EC) No 765/2008;

                        (e)

                        ‘designating authority’ means the authority(ies) entrusted by a Member State to assess, designate, notify and monitor notified bodies under Directive 90/385/EEC or Directive 93/42/EEC;

                        (f)

                        ‘competent authority’ means the authority(ies) in charge of market surveillance and/or of vigilance for devices;

                        (g)

                        ‘on-site assessment’ means a verification in the premises of the body or of one of its subcontractors or subsidiaries by the designating authority;

                        (h)

                        ‘surveillance on-site assessment’ means a periodic routine on-site assessment which is neither the on-site assessment undertaken for the initial designation, nor the on-site assessment undertaken for the renewal of the designation;

                        (i)

                        ‘observed audit’ means a designating authority's assessment of the performance of a notified body’s audit team in the premises of the body's client;

                        (j)

                        ‘functions’ means the tasks to be fulfilled by the body’s staff and its external experts, namely: auditing of the quality systems, product related technical documentation review, review of clinical evaluations and investigations, device testing and, for each of the previously mentioned items, the final review and decision making thereon;

                        (k)

                        ‘subcontracting’ means the transfer of tasks to one of the following:

                                    (i)

                                    a legal person;

                                    (ii)

                                    a natural person who further delegates these tasks or parts thereof;

                                    (iii)

                                    several natural or legal persons who jointly perform these tasks.

            Article 2
            Interpretation of designation criteria
            The criteria set out in Annex 8 to Directive 90/385/EEC or in Annex XI to Directive 93/42/EEC shall be applied as laid down in Annex I.

            Article 3
            Procedure for the designation of notified bodies

               1.   When applying for designation as a notified body, a conformity assessment body shall use the application form set out in Annex II. If the conformity assessment body submits the application and documents annexed to the application on paper, it shall also submit an electronic copy of the application and its annexes.
               The application shall specify the conformity assessment activities, the conformity assessment procedures and the fields of competence for which the conformity assessment body wishes to be notified, the latter by indicating the codes used in the ‘New Approach Notified and Designated Organisations’ Information System (5) and subdivisions of those fields.

               2.   The designating authority of the Member State where the conformity assessment body is established shall assess that body in accordance with an assessment check-list that covers at least the items listed in Annex II. The assessment shall include an on-site assessment.
               Representatives of designating authorities of two other Member States shall, in coordination with the designating authority of the Member State in which the conformity assessment body is established and together with a representative of the Commission, participate to the assessment of the conformity assessment body, including the on-site assessment. The designating authority of the Member State where the conformity assessment body is established shall give those representatives timely access to the documents necessary to assess the conformity assessment body. They shall produce within 45 days after the on-site assessment a report, which shall contain at least a summary of identified non-compliances with the criteria set out in Annex I and recommendation with regard to the designation of the notified body.

               3.   The Member States shall make available a pool of assessors for the Commission to call upon for each assessment.

               4.   The designating authority of the Member State where the conformity assessment body is established shall upload into a data storage system managed by the Commission, the assessment report drafted by the representatives referred to in paragraph 2, its own assessment report and, if not contained therein, an on-site assessment report.

               5.   The designating authorities of all the other Member States shall be informed of the application and may request to get access to certain or all the documents referred to in paragraph 4. Those authorities and the Commission may review all the documents referred to in paragraph 4, may raise questions or concerns and may request further documentation within one month after the last upload of one of those documents. Within the same period of time, they may request an exchange of views on the application, organised by the Commission.

               6.   The designating authority of the Member State where the conformity assessment body is established shall respond to the questions, concerns and requests for further documentation within four weeks following their receipt.
               The designating authorities of the other Member States or the Commission may individually or jointly address recommendations to the designating authority of the Member State where the conformity assessment body is established within four weeks following the receipt of the response. That designating authority shall take account of the recommendations when it takes the decision on the designation of the conformity assessment body. If it does not follow the recommendations, it shall give the reasons therefor within two weeks after its decision.

               7.   The Member State shall notify to the Commission its decision on the designation of a conformity assessment body by means of the ‘New Approach Notified and Designated Organisations’ Information System.
               The validity of the designation shall be limited up to a maximum of five years.

            Article 4
            Extension and renewal of designation

               1.   An extension of the scope of the notified body's designation may be granted in accordance with Article 3.

               2.   A designation as notified body may be renewed in accordance with Article 3 before the end of the validity period of the previous designation.

               3.   For the purposes of paragraph 2, the procedure set out in Article 3(2) shall include, where appropriate, an observed audit.

               4.   Extension and renewal procedures may be combined.

               5.   Notified bodies already designated before the entry into force of this Regulation and for which the designation does not have a stated validity period or has a validity period exceeding five years, shall be subject to renewal at least within three years of entry into force of this Regulation.

            Article 5
            Surveillance and monitoring

               1.   For the purpose of surveillance, the designating authority of the Member State where the notified body is established shall assess an appropriate number of notified body’s reviews of the manufacturer’s clinical evaluations and shall carry out an appropriate number of file reviews, surveillance on-site assessments and observed audits at the following intervals:

                           (a)

                           at least every 12 months for notified bodies with more than 100 clients;

                           (b)

                           at least every 18 months for all other notified bodies.

                     That designating authority shall, in particular, examine changes which have occurred since the last assessment and the work the notified body has performed since that assessment.

               2.   Surveillance and monitoring conducted by the designating authorities shall appropriately address subsidiaries.

               3.   The designating authority of the Member State where the notified body is established shall continuously monitor that body to ensure ongoing compliance with the applicable requirements. That authority shall provide for a systematic follow-up of complaints, vigilance reports and other information, including from other Member States, which might indicate the non-fulfilment of the obligations by a notified body or its deviation from common or best practice.
               In addition to surveillance or renewal on-site assessments, the designating authority of the Member State where the notified body is established shall initiate unannounced or short-notice on-site assessments if those on-site assessments are needed to verify compliance.

            Article 6
            Investigation of the competence of a notified body

               1.   The Commission may investigate cases regarding the competence of a notified body or the fulfilment of the requirements and responsibilities to which a notified body is subject under Directive 90/385/EEC and Directive 93/42/EEC.

               2.   Investigations will start with a consultation of the designating authority of the Member State where the notified body is established. Upon request, that designating authority shall, within four weeks, provide the Commission with all relevant information concerning the relevant notified body.

               3.   The Commission will ensure that all sensitive information obtained in the course of its investigations is treated confidentially.

               4.   When the notified body no longer meets the requirements for its notification, the Commission will inform the Member State where that body is established and may request the Member State to take the necessary corrective measures.

            Article 7
            Exchange of experience on designation and supervision of conformity assessment bodies

               1.   Designating authorities shall consult each other and the Commission on questions with general relevance with regard to the implementation of this Regulation and the interpretation of the provisions of Directive 90/385/EEC and of Directive 93/42/EEC in relation with conformity assessment bodies.

               2.   Designating authorities shall communicate to each other and the Commission by 31 December 2013 the model assessment check-list used in accordance with Article 3(2) and thereafter the adaptations made to this check-list.

               3.   When the assessment reports referred to in Article 3(4) indicate discrepancies in the general practice of designating authorities, Member States or the Commission may request an exchange of views, which will be organised by the latter.

            Article 8
            Operating of designating authorities

               1.   Designating authorities shall have a sufficient number of competent personnel at their disposal for the proper performance of their tasks. Those authorities shall be established, organised and operated so as to safeguard the objectivity and impartiality of their activities and to avoid any conflicts of interests with conformity assessment bodies. The designating authorities shall be organised so that each decision relating to a notification of a conformity assessment body is not taken by the same member of personnel who carried out the assessment of that body.

               2.   Where designating authorities are not in charge of market surveillance and vigilance for medical devices, they shall involve the competent authorities of that Member State for all tasks incumbent to them in accordance with this Regulation. They shall in particular consult the competent authorities of that Member State prior to taking decisions and invite them to attend all types of assessments.

            Article 9
            Cooperation with accreditation bodies
            Where designation is based on accreditation in the meaning of Regulation (EC) No 765/2008, Member States shall ensure that the accreditation body that has accredited a particular notified body is kept informed by the competent authorities on incident reports and other information that relate to matters under the control of the notified body when the information may be relevant for the assessment of the performance of the notified body. Member States shall ensure that the accreditation body in charge of the accreditation of a particular conformity assessment body is kept informed by the designating authority of the Member State where the conformity assessment body is established on findings relevant for the accreditation. The accreditation body shall inform the designating authority of the Member State where the conformity assessment body is established on its findings.

            Article 10
            Entry into force and date of application
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply to extension of designations as from 25 December 2013.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 24 September 2013.

                  For the Commission

                  The President

               José Manuel BARROSO

            (1)  OJ L 189, 20.7.1990, p. 17.

            (2)  OJ L 169, 12.7.1993, p. 1.

            (3)  OJ L 218, 13.8.2008, p. 30.

            (4)  OJ L 218, 13.8.2008, p. 82.

            (5)  ‘NANDO’; see http://ec.europa.eu/enterprise/newapproach/nando

            ANNEX I

               Interpretation of the criteria set out in Annex 8 to Directive 90/385/EEC and in Annex XI to Directive 93/42/EEC

                        1.

                        Sections 1 and 5 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:

                                    1.1.

                                    The conformity assessment body shall be a third-party body that is independent of the manufacturer of the product in relation to which it performs conformity assessment activities. The conformity assessment body shall also be independent of any other economic operator having an interest in the product as well as of any competitor of the manufacturer.

                                    1.2.

                                    That conformity assessment body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities. The conformity assessment body shall have procedures in place that effectively ensure identification, investigation and resolution of any case in which a conflict of interests may arise, including involvement of its staff in consultancy services in the field of medical devices prior to taking up employment with the body.

                                    1.3.

                                    That conformity assessment body, its top management and the personnel responsible for carrying out the conformity assessment tasks shall not:

                                                (a)

                                                engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified;

                                                (b)

                                                offer or provide any service which may jeopardise the confidence in their independence, impartiality or objectivity. In particular, they shall not offer or provide or have offered or provided, during the last three years, consultancy services to the manufacturer, his authorised representative, a supplier or a commercial competitor as regards Union requirements for the design, construction, marketing or maintenance of the products or processes under assessment. This does not preclude conformity assessment activities for manufacturers and economic operators mentioned above or general training activities relating to medical device regulations or related standards that are not client specific.

                                    1.4.

                                    The conformity assessment body’s top level management and its assessment personnel shall be impartial. The remuneration of the top level management and assessment personnel of a conformity assessment body shall not depend on the number or the results of assessments carried out.

                                    1.5.

                                    When a conformity assessment body is owned by a public entity or institution, the Member State shall ensure and document the independence of the conformity assessment body and the absence of any conflict of interests between, on the one hand, the designating authority and/or competent authority and, on the other hand, the conformity assessment body.

                                    1.6.

                                    The conformity assessment body shall ensure and document that the activities of its subsidiaries or subcontractors, or of any associated body, do not affect its independence, impartiality or objectivity in its conformity assessment activities.

                                    1.7.

                                    The requirements of points 1.1 to 1.6 do not preclude exchanges of technical information and regulatory guidance between a body and a manufacturer seeking their conformity assessment.

                        2.

                        The second paragraph of Section 2 of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:

                                    2.1.

                                    Subcontracting shall be limited to specific tasks. The subcontracting of the auditing of quality management systems or of products related reviews in its entirety is not allowed. The conformity assessment body shall in particular keep internal the review of the qualification and the monitoring of the performance of the external experts, the experts’ assignment to specific conformity assessment activities, and the final review and decision-making functions.

                                    2.2.

                                    Where a conformity assessment body subcontracts specific tasks or consults external experts related to the conformity assessment, it shall have a policy describing the conditions under which subcontracting or the consultation of external experts may take place. Any subcontracting or consultation of external experts shall be properly documented and be subject to a written agreement covering, among others, confidentiality and conflict of interests.

                                    2.3.

                                    The conformity assessment body shall establish procedures for assessing and monitoring the competence of all subcontractors and external experts used.

                        3.

                        Sections 3 and 4 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:

                                    3.1.

                                    At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been or wishes to be notified, a conformity assessment body shall have within its organisation the following elements:

                                                (a)

                                                the necessary administrative, technical, clinical and scientific personnel with technical and scientific knowledge and sufficient and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks, including the assessment of clinical data;

                                                (b)

                                                a documented process for the conduct of the conformity assessment procedures for which it is designated (1) taking into account their respective specificities, including legally required consultations, in respect of the different categories of devices covered by the scope of notification, ensuring transparency and the ability of reproduction of those procedures.

                                    3.2.

                                    The conformity assessment body shall have the necessary personnel and shall possess or have access to all equipment and facilities needed to perform properly the technical and administrative tasks entailed in the conformity assessment activities in relation to which it has been notified.

                                    3.3.

                                    The conformity assessment body shall have at its disposal the financial resources required to conduct its conformity assessment activities and related business operations. It shall document and provide evidence of its financial capacity and its sustainable economic viability, taking into account specific circumstances during an initial start-up phase.

                                    3.4.

                                    The conformity assessment body shall have a quality management system in place and operating.

                                    3.5.

                                    The experience and knowledge of the personnel responsible for carrying out conformity assessment activities shall be interpreted as including the following:

                                                (a)

                                                sound scientific, technical and vocational training, in particular in the relevant fields of medicine, pharmacy, engineering or other relevant sciences, covering all the conformity assessment activities in relation to which the body has been notified or wishes to be notified;

                                                (b)

                                                substantial relevant experience covering all the conformity assessment activities in relation to which the body has been notified or wishes to be notified;

                                                (c)

                                                satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

                                                (d)

                                                appropriate knowledge and understanding of the relevant provisions of the medical devices legislation and of the applicable harmonised standards;

                                                (e)

                                                the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

                                    3.6.

                                    The conformity assessment body shall establish and document qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities (knowledge, experience and other competence required) and the required training (initial and ongoing training). The qualification criteria shall address the various functions within the conformity assessment process (e.g. auditing, product evaluation/testing, design dossier/file review, decision-making) as well as the devices, technologies and areas (e.g. biocompatibility, sterilisation, tissues and cells of animal origin, clinical evaluation) covered by the scope of designation.

                                    3.7.

                                    The conformity assessment body shall have procedures in place to ensure that its subsidiaries operate on the basis of the same operating procedures and with the same stringency as its headquarters.

                                    3.8.

                                    Where subcontractors or external experts are used in the context of the conformity assessment, in particular regarding novel, invasive and implantable medical devices or technologies, the conformity assessment body shall have adequate internal competence in each product area for which it is designated to direct the conformity assessment, to verify the appropriateness and validity of expert opinions and make the decision on the certification. The internal competence requested shall cover technological, clinical and auditing aspects.

                        4.

                        Sections 6 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:

                                    4.1.

                                    The conformity assessment body shall take out appropriate liability insurance corresponding to the conformity assessment activities for which it is notified, including the possible suspension, restriction or withdrawal of certificates, and the geographic scope of its activities, unless liability is assumed by the State under domestic legislation or the Member State itself carries out the inspections directly.

                        5.

                        Sections 7 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:

                                    5.1.

                                    The conformity assessment body shall ensure that confidentiality of the information which comes into its possession during the performance of the conformity assessment activities is observed by its personnel, committees, subsidiaries, subcontractors or any associated body, except when disclosure is required by law. To this end, it shall have documented procedures in place.

                                    5.2.

                                    The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks, except in relation to the designating authorities and the competent authorities or the Commission. Proprietary rights shall be protected. To this end, the conformity assessment body shall have documented procedures in place.

               (1)  See Annex II Item 41.

            ANNEX II

               Application form to be submitted when applying for designation as notified body

            Designating authority: …
            Name of the applying conformity assessment body: …
            Previous name (if applicable): …
            EU Notified Body number (if applicable): …
            Address: …
            …
            …
            …
            Contact person: …
            E-mail: …
            Telephone: …
            Legal form of the conformity assessment body: …
            Company registration number: …
            At company register: …
            …
            …
            The following documents shall be added. In case of extension or renewal, only new or modified documents shall be submitted.

                        Item/issue

                        Corresponding Annex I section

                        Attachment number + Reference
                        (Section/page)

                        ORGANISATIONAL AND GENERAL REQUIREMENTS

                           Legal status and organisational structure

                        1

                        Company statutes

                        2

                        Extract of company registration or enrolment act (Company register)

                        3

                        Documentation on the activities of the organisation to which the conformity assessment body belongs (if any) and its relationship with the conformity assessment body

                        4

                        Documentation on entities the conformity assessment body owns (if any), either within the Member State or outside, and the relationship with those entities

                        5

                        Description of legal ownership and the legal or natural persons exercising control of the conformity assessment body

                        6

                        Description of organisational structure and the operational management of the conformity assessment body

                        7

                        Descriptions of functions, responsibilities and authorities of top-level management

                        8

                        List of all staff who have an influence in the conformity assessment activities

                        9

                        Documentation on other services provided by the conformity assessment body (if any) (e.g. consultancy relevant to devices, training etc.)

                        10

                        Documentation on accreditation(s) relevant to this application

                           Independence and impartiality

                        11

                        Documentation on structures, policies and procedures to safeguard and promote the principles of impartiality throughout the organisation, personnel and assessment activities, including ethical rules or codes of conduct

                        12

                        Description of how the conformity assessment body ensures that the activities of subsidiaries, subcontractors and external experts do not affect its independence, impartiality or objectivity

                        13

                        Documentation on the impartiality of the top-level management and personnel involved in conformity assessment activities, including their remuneration and bonuses

                        14

                        Documentation on conflict of interest and resolution of potential conflict procedure/form

                        15

                        Description of independence of the conformity assessment body from the designating authority and from the competent authority, in particular when this body is a public entity/institution

                           Confidentiality

                        16

                        Documentation on professional secrecy procedure including protection of proprietary data

                           Liability

                        17

                        Documentation of the liability insurance, proof that the liability insurance covers cases where the notified body may be obliged to withdraw or suspend certificates

                           Financial resources

                        18

                        Documentation of the financial resources required to conduct the conformity assessment activities, related operations, including the ongoing commitments for certificates issued to demonstrate the continuing viability of the notified body and consistency with the range of products certified

                           Quality system

                        19

                        Quality Manual and a list of related documentation on the implementation, maintenance and operation of a quality management system, including policies for assignment of personnel to activities and their responsibilities

                        20

                        Documentation on the procedure(s) for control of documents

                        21

                        Documentation on the procedure(s) for control of records

                        22

                        Documentation on the procedure(s) for management review

                        23

                        Documentation on the procedure(s) for internal audits

                        24

                        Documentation on the procedure(s) for corrective and preventive actions

                        25

                        Documentation on the procedure(s) for complaints and appeals

                           Resource requirements

                           General

                        26

                        Description of own laboratories and testing facilities

                        27

                        Employment contracts and other agreements with internal personnel, in particular in relation to impartiality, independence, conflict of interest (attach a standard contract template)

                        28

                        Contracts and other agreements with subcontractors and external experts, in particular for impartiality, independence, conflict of interest (attach a standard contract template)

                           Qualification and authorisation of personnel

                        29

                        List of all permanent and temporary personnel (technical, administrative etc.) including information on professional qualification, past experience and the types of contracts held

                        30

                        List of all external personnel (e.g. external experts, external auditors) including information on professional qualification, past experience and on the types of contracts held

                        31

                        Qualification matrix linking the body's staff and its external experts to the functions to be accomplished by them and to the fields of competence for which the body has been notified or wishes to be notified

                        32

                        Qualification criteria for the different functions (see point 31)

                        33

                        Documentation on the procedure(s) for selection and assignment of internal or external personnel involved in the conformity assessment activities, including conditions for the attribution of tasks to external personnel and the supervision of their expertise

                        34

                        Documentation demonstrating that the management of the conformity assessment body has appropriate knowledge to set up and operate a system for:

                                    —

                                    the selection of the personnel deployed during the conformity assessment,

                                    —

                                    the verification of the knowledge and experience of this personnel,

                                    —

                                    the assignment of the personnel to their tasks,

                                    —

                                    the verification of the performance of the personnel,

                                    —

                                    the definition and the verification of their initial and ongoing training

                        35

                        Documentation on the procedure assuring ongoing monitoring of competences and performance monitoring

                        36

                        Documentation on standard training programmes conducted by the conformity assessment body relevant to the conformity assessment activities

                           Subcontractors

                        37

                        List of all subcontractors (not individual external experts) used for conformity assessment activities

                        38

                        Subcontractor policy and procedure

                        39

                        Documentation demonstrating adequate core competence within the conformity assessment body to assess, select, contract, and to verify the appropriateness and validity of subcontractor activities

                        40

                        Examples of standard template contract, prohibiting further subcontracting by legal persons and specifically including provisions to ensure confidentiality and conflict of interest management with subcontractors (attach examples)

                           Process

                        41

                        Documentation on procedures relating to conformity assessment activities and other related documents reflecting the scope of conformity assessment activities including, in particular procedures relating to:

                                    —

                                    Qualification and classification

                                    —

                                    Quality system assessments

                                    —

                                    Risk management

                                    —

                                    Pre-clinical data evaluation

                                    —

                                    Clinical evaluation

                                    —

                                    Representative sampling of technical documentation

                                    —

                                    Post-market clinical follow up

                                    —

                                    Communications from regulatory authorities including competent authorities and designating authorities

                                    —

                                    Communication and analysis of the impact of vigilance reports on device certification

                                    —

                                    Consultation procedures for drug-device combination products, devices utilising animal tissue, devices utilising human blood derivatives

                                    —

                                    Review and decision making on certificate issuance including approval responsibilities

                                    —

                                    Review and decision making on certificate suspension, restriction, withdrawal and refusal including approval responsibilities

                        42

                        Checklists, templates, reports and certificates used for the conformity assessment activities

                        Name and signature of an authorised representative of the applicant conformity assessment body (unless electronic signature is accepted)

                        Place and date


title: Commission Implementing Regulation (EU) 2016/1924 of 3 November 2016 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               4.11.2016

               EN

               Official Journal of the European Union

               L 297/14

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/1924
   of 3 November 2016
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

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

               (2)

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

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

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 3 November 2016.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

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

      (2)  OJ L 157, 15.6.2011, p. 1.

      ANNEX

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

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  MA

                  104,9

                  ZZ

                  104,9

                  0707 00 05

                  TR

                  142,5

                  ZZ

                  142,5

                  0709 93 10

                  MA

                  91,2

                  TR

                  148,9

                  ZZ

                  120,1

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

                  PE

                  132,9

                  TR

                  74,7

                  ZZ

                  103,8

                  0805 50 10

                  AR

                  67,2

                  BR

                  79,0

                  CL

                  77,0

                  TR

                  87,7

                  ZA

                  65,7

                  ZZ

                  75,3

                  0806 10 10

                  BR

                  307,6

                  PE

                  304,9

                  TR

                  151,1

                  ZZ

                  254,5

                  0808 10 80

                  AR

                  260,6

                  AU

                  236,5

                  CL

                  139,2

                  NZ

                  145,3

                  ZA

                  126,7

                  ZZ

                  181,7

                  0808 30 90

                  TR

                  176,8

                  ZZ

                  176,8

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


title: Commission Implementing Regulation (EU) 2015/807 of 22 May 2015 amending for the 232nd time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaeda network

text:
               23.5.2015

               EN

               Official Journal of the European Union

               L 128/16

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/807
   of 22 May 2015
   amending for the 232nd time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaeda network
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network (1), and in particular point (a) of Article 7(1) and Article 7a(5) thereof,
   Whereas:

               (1)

               Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

               (2)

               On 18 May 2015, the Sanctions Committee of the United Nations Security Council (UNSC) decided to remove one person from its list of persons, groups and entities to whom the freezing of funds and economic resources should apply.

               (3)

               Annex I to Regulation (EC) No 881/2002 should therefore be updated accordingly,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex I to Regulation (EC) No 881/2002 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the 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, 22 May 2015.

            For the Commission,

            On behalf of the President,

            Head of the Service for Foreign Policy Instruments

      (1)  OJ L 139, 29.5.2002, p. 9.

      ANNEX
      In Annex I to Regulation (EC) No 881/2002 the following entry under the heading ‘Natural persons’ is deleted:

         ‘Abdul Rahim Al-Talhi (alias (a) 'Abdul-Rahim Hammad al-Talhi, (b) Abd' Al-Rahim Hamad al-Tahi, (c) Abdulrheem Hammad A Altalhi, (d) Abe Al-Rahim al-Talahi, (e) Abd Al-Rahim Al Tahli, (f) 'Abd al-Rahim al- Talhi, (g) Abdulrahim Al Tahi, (h) Abdulrahim al-Talji, (i) 'Abd-Al-Rahim al Talji, (j) Abdul Rahim Hammad Ahmad Al-Talhi, (k) Abdul Rahim, (l) Abu Al Bara'a Al Naji, (m) Shuwayb Junayd. Address: Buraydah, Saudi Arabia. Date of birth: 8.12.1961. Place of birth: Al-Shefa, Al-Taif, Saudi Arabia. Passport No: F275043 (Saudi Arabian, issued on 29.5.2004, expired on 5.4.2009). Nationality: Saudi Arabian. Other information: Involved in the financing of, arms supply to and otherwise provided assistance to the Abu Sayyaf Group. Date of designation referred to in point (b) of Article 2a(4): 9.10.2007.’


title: Commission Implementing Regulation (EU) No 1030/2014 of 29 September 2014 laying down implementing technical standards with regard to the uniform formats and date for the disclosure of the values used to identify global systemically important institutions according to Regulation (EU) No 575/2013 of the European Parliament and of the Council  Text with EEA relevance

text:
               30.9.2014

               EN

               Official Journal of the European Union

               L 284/14

         COMMISSION IMPLEMENTING REGULATION (EU) No 1030/2014
   of 29 September 2014
   laying down implementing technical standards with regard to the uniform formats and date for the disclosure of the values used to identify global systemically important institutions according to Regulation (EU) No 575/2013 of the European Parliament and of the Council
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (1), and in particular the third subparagraph of Article 441(2) thereof,
   Whereas:

               (1)

               In order to help ensure global consistency in disclosure and transparency in the process of identification of global systemically important institutions (G-SIIs), those institutions are required to publicly disclose indicator values used in that process.

               (2)

               The disclosure templates used by institutions identified as G-SIIs in accordance with Article 131 of Directive 2013/36/EU of the European Parliament and of the Council (2) should take into account international standards, particularly those issued by the Basel Committee on Banking Supervision.

               (3)

               In order to ensure consistency and comparability of the collected information, the reporting reference date should be set to coincide with an institution's financial year-end figures of the previous year or any other date agreed with its relevant authority.

               (4)

               With a view to facilitating public access to the disclosed information, and seeing that data from all Member States are needed to perform the identification process, the European Banking Authority (EBA) should collect each institution's information and publish it on its website.

               (5)

               This Regulation is based on the draft implementing technical standards submitted by the EBA to the Commission.

               (6)

               The EBA has conducted open public consultations on the draft implementing technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the opinion of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (3),

         HAS ADOPTED THIS REGULATION:
   Article 1
   Uniform format
   G-SIIs shall fill out the template set out in the Annex to this Regulation in electronic format as published on the website of the European Banking Authority (EBA). By using that template, G-SIIs shall publicly disclose the values of the indicators used for determining the score of the institutions in accordance with the identification methodology referred to in Article 131 of Directive 2013/36/EU.
   G-SIIs shall not be bound to disclose publicly the ancillary data and ancillary indicators.
   Article 2
   Date of disclosure
   G-SIIs shall publicly disclose the financial year-end information referred to in Article 1 no later than four months after each financial year-end.
   Relevant authorities may allow institutions whose financial year-end is 30 June to report indicator values based on their position at 31 December. In any case, the information shall be disclosed no later than 31 July.
   Article 3
   Disclosure location
   Institutions may publicly disclose the values of the indicators specified in the template set out in the Annex to this Regulation in the medium they determine to disclose the information required by Part Eight of Regulation (EU) No 575/2013 in accordance with Article 434 of that Regulation.
   Where the disclosures of the values of the indicators are not included in the medium referred to in the first paragraph, the G-SII shall provide a direct reference to the completed disclosures on the institution's website or to the medium in which they are made available.
   Without undue delay, following the disclosure of that information by the G-SIIs, relevant authorities shall send those completed templates to EBA for centralisation purposes on its website.
   Article 4
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 29 September 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 176, 27.6.2013, p. 1.

      (2)  Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).

      (3)  Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12).

      ANNEX
      Data required to identify G-SIIs

         General Bank Data

                     Section 1: General Information

                     Response

                              a.

                              General information provided by the national supervisor:

                              (1)

                              Country code

                              (2)

                              Bank name

                              (3)

                              Submission date (yyyy-mm-dd)

                              b.

                              General Information provided by the reporting institution:

                              (1)

                              Reporting date (yyyy-mm-dd)

                              (2)

                              Reporting currency

                              (3)

                              Euro conversion rate

                              (4)

                              Reporting unit

                              (5)

                              Accounting standard

                              (6)

                              Location of public disclosure

         Size Indicator

                     Section 2: Total Exposures

                     Amount

                              a.

                              Counterparty exposure of derivatives contracts (method 1)

                              b.

                              Gross value of securities financing transactions (SFTs)

                              c.

                              Counterparty exposure of SFTs

                              d.

                              Other assets

                              (1)

                              Securities received in SFTs that are recognised as assets

                              e.

                              Total on-balance sheet items (sum of items 2.a, 2.b, 2.c, and 2.d, minus 2.d.(1))

                              f.

                              Potential future exposure of derivative contracts (method 1)

                              g.

                              Notional amount of off-balance sheet items with a 0 % CCF

                              (1)

                              Unconditionally cancellable credit card commitments

                              (2)

                              Other unconditionally cancellable commitments

                              h.

                              Notional amount of off-balance sheet items with a 20 % CCF

                              i.

                              Notional amount of off-balance sheet items with a 50 % CCF

                              j.

                              Notional amount of off-balance sheet items with a 100 % CCF

                              k.

                              Total off-balance sheet items (sum of items 2.f, 2.g, and 2.h through 2.j, minus 0,9 times the sum of items 2.g.(1) and 2.g.(2))

                              l.

                              Entities consolidated for accounting purposes but not for risk-based regulatory purposes:

                              (1)

                              On-balance sheet assets

                              (2)

                              Potential future exposure of derivatives contracts

                              (3)

                              Unconditionally cancellable commitments

                              (4)

                              Other off-balance sheet commitments

                              (5)

                              Investment value in the consolidated entities

                              m.

                              Regulatory adjustments

                              n.

                              Ancillary data:

                              (1)

                              Receivables for cash collateral posted in derivatives transactions

                              (2)

                              Net notional amount of credit derivatives

                              (3)

                              Net notional amount of credit derivatives for entities in item 2.l.

                              (4)

                              On and off-balance sheet exposures between entities included in item 2.l.

                              (5)

                              On and off-balance sheet exposures of entities included in item 2.l. to entities consolidated for risk-based regulatory purposes

                              (6)

                              On and off-balance sheet exposures of entities consolidated for risk-based regulatory purposes to entities included in item 2.l.

                              (7)

                              Total exposures for the calculation of the leverage ratio (January 2014 definition)

                              o.

                              Total exposures indicator (sum of items 2.e, 2.k, 2.l.(1), 2.l.(2), 0,1 times 2.l.(3), 2.l.(4), minus the sum of items 2.l.(5) and 2.m)

         Interconnectedness Indicators

                     Section 3: Intra-Financial System Assets

                     Amount

                              a.

                              Funds deposited with or lent to other financial institutions

                              (1)

                              Certificates of deposit

                              b.

                              Undrawn committed lines extended to other financial institutions

                              c.

                              Holdings of securities issued by other financial institutions:

                              (1)

                              Secured debt securities

                              (2)

                              Senior unsecured debt securities

                              (3)

                              Subordinated debt securities

                              (4)

                              Commercial paper

                              (5)

                              Stock (including par and surplus of common and preferred shares)

                              (6)

                              Offsetting short positions in relation to the specific stock holdings included in item 3.c.(5)

                              d.

                              Net positive current exposure of securities financing transactions with other financial institutions

                              e.

                              Over-the-counter (OTC) derivatives with other financial institutions that have a net positive fair value:

                              (1)

                              Net positive fair value (include collateral held if it is within the master netting agreement)

                              (2)

                              Potential future exposure

                              f.

                              Intra-financial system assets indicator (sum of items 3.a, 3.b through 3.c.(5), 3.d, 3.e.(1), and 3.e.(2), minus 3.c.(6))

                     Section 4: Intra-Financial System Liabilities

                     Amount

                              a.

                              Deposits due to depository institutions

                              b.

                              Deposits due to non-depository financial institutions

                              c.

                              Undrawn committed lines obtained from other financial institutions

                              d.

                              Net negative current exposure of securities financing transactions with other financial institutions

                              e.

                              OTC derivatives with other financial institutions that have a net negative fair value:

                              (1)

                              Net negative fair value (include collateral provided if it is within the master netting agreement)

                              (2)

                              Potential future exposure

                              f.

                              Ancillary data:

                              (1)

                              Funds borrowed from other financial institutions

                              (2)

                              Certificates of deposit included in items 4.a and 4.b

                              g.

                              Intra-financial system liabilities indicator (sum of items 4.a through 4.e.(2))

                     Section 5: Securities Outstanding

                     Amount

                              a.

                              Secured debt securities

                              b.

                              Senior unsecured debt securities

                              c.

                              Subordinated debt securities

                              d.

                              Commercial paper

                              e.

                              Certificates of deposit

                              f.

                              Common equity

                              g.

                              Preferred shares and any other forms of subordinated funding not captured in item 5.c.

                              h.

                              Ancillary data:

                              (1)

                              Book value of equities for which a market price is unavailable

                              i.

                              Securities outstanding indicator (sum of items 5.a through 5.g)

         Substitutability/Financial Institution Infrastructure Indicators

                     Section 6: Payments made in the reporting year (excluding intragroup payments)

                     Reported in

                     Amount in specified currency

                     Amount

                              a.

                              Australian dollars

                  AUD

                              b.

                              Brazilian real

                  BRL

                              c.

                              Canadian dollars

                  CAD

                              d.

                              Swiss francs

                  CHF

                              e.

                              Chinese yuan

                  CNY

                              f.

                              Euros

                  EUR

                              g.

                              British pounds

                  GBP

                              h.

                              Hong Kong dollars

                  HKD

                              i.

                              Indian rupee

                  INR

                              j.

                              Japanese yen

                  JPY

                              k.

                              Swedish krona

                  SEK

                              l.

                              United States dollars

                  USD

                              m.

                              Ancillary data:

                              (1)

                              Mexican pesos

                  MXN

                              (2)

                              New Zealand dollars

                  NZD

                              (3)

                              Russian rubles

                  RUB

                              n.

                              Payments activity indicator (sum of items 6.a through 6.l)

                     Section 7: Assets Under Custody

                     Amount

                              a.

                              Assets under custody indicator

                     Section 8: Underwritten Transactions in Debt and Equity Markets

                     Amount

                              a.

                              Equity underwriting activity

                              b.

                              Debt underwriting activity

                              c.

                              Underwriting activity indicator (sum of items 8.a and 8.b)

         Complexity Indicators

                     Section 9: Notional Amount of Over-the-Counter (OTC) Derivatives

                     Amount

                              a.

                              OTC derivatives cleared through a central counterparty

                              b.

                              OTC derivatives settled bilaterally

                              c.

                              OTC derivatives indicator (sum of items 9.a and 9.b)

                     Section 10: Trading and Available-for-Sale Securities

                     Amount

                              a.

                              Held-for-trading securities (HFT)

                              b.

                              Available-for-sale securities (AFS)

                              c.

                              Trading and AFS securities that meet the definition of Level 1 assets

                              d.

                              Trading and AFS securities that meet the definition of Level 2 assets, with haircuts

                              e.

                              Ancillary data:

                              (1)

                              Held-to-maturity securities

                              f.

                              Trading and AFS securities indicator (sum of items 10.a and 10.b, minus the sum of 10.c and 10.d)

                     Section 11: Level 3 Assets

                     Amount

                              a.

                              Level 3 assets indicator

         Cross-Jurisdictional Activity Indicators

                     Section 12: Cross-Jurisdictional Claims

                     Amount

                              a.

                              Foreign claims on an ultimate risk basis (excluding derivatives activity)

                              b.

                              Ancillary data:

                              (1)

                              Foreign derivative claims on an ultimate risk basis

                              c.

                              Cross-jurisdictional claims indicator (item 12.a)

                     Section 13: Cross-Jurisdictional Liabilities

                     Amount

                              a.

                              Foreign liabilities (excluding derivatives and local liabilities in local currency)

                              (1)

                              Any foreign liabilities to related offices included in item 13.a.

                              b.

                              Local liabilities in local currency (excluding derivatives activity)

                              c.

                              Ancillary data:

                              (1)

                              Foreign derivative liabilities on an ultimate risk basis

                              d.

                              Cross-jurisdictional liabilities indicator (sum of items 13.a and 13.b, minus 13.a.(1))

         Additional Indicators

                     Section 14: Ancillary Indicators

                     Amount

                              a.

                              Total liabilities

                              b.

                              Retail funding

                              c.

                              Wholesale funding dependence ratio (the difference between items 14.a and 14.b, divided by 14.a)

                              d.

                              Foreign net revenue

                              e.

                              Total net revenue

                              f.

                              Total gross revenue

                              g.

                              Gross value of cash lent and gross fair value of securities lent in SFTs

                              h.

                              Gross value of cash borrowed and gross fair value of securities borrowed in SFTs

                              i.

                              Gross positive fair value of over-the-counter (OTC) derivatives transactions

                              j.

                              Gross negative fair value of OTC derivatives transactions

                     Amount in single units

                              k.

                              Number of jurisdictions


title: Commission Implementing Regulation (EU) 2015/1786 of 6 October 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               7.10.2015

               EN

               Official Journal of the European Union

               L 260/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/1786
   of 6 October 2015
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

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

               (2)

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

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

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 6 October 2015.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

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

      (2)  OJ L 157, 15.6.2011, p. 1.

      ANNEX

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

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  AL

                  33,9

                  MA

                  201,3

                  MK

                  44,1

                  TR

                  73,3

                  ZZ

                  88,2

                  0707 00 05

                  AL

                  46,1

                  TR

                  122,2

                  ZZ

                  84,2

                  0709 93 10

                  TR

                  140,9

                  ZZ

                  140,9

                  0805 50 10

                  AR

                  127,3

                  BO

                  160,8

                  CL

                  149,1

                  TR

                  98,8

                  UY

                  104,8

                  ZA

                  143,1

                  ZZ

                  130,7

                  0806 10 10

                  BR

                  257,8

                  EG

                  187,3

                  MK

                  96,2

                  TR

                  168,7

                  ZA

                  128,8

                  ZZ

                  167,8

                  0808 10 80

                  CL

                  149,5

                  MK

                  23,1

                  NZ

                  140,9

                  US

                  137,2

                  ZA

                  148,0

                  ZZ

                  119,7

                  0808 30 90

                  AR

                  131,8

                  TR

                  130,4

                  XS

                  95,7

                  ZA

                  149,1

                  ZZ

                  126,8

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


title: Commission Implementing Regulation (EU) 2015/2033 of 13 November 2015 renewing the approval of the active substance 2,4-D in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

text:
               14.11.2015

               EN

               Official Journal of the European Union

               L 298/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/2033
   of 13 November 2015
   renewing the approval of the active substance 2,4-D in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) thereof,
   Whereas:

               (1)

               The approval of the active substance 2,4-D, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2), expires on 31 December 2015.

               (2)

               An application for the renewal of the inclusion of 2,4-D in Annex I to Council Directive 91/414/EEC (3) was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (4) within the time period provided for in that Article.

               (3)

               The applicant submitted the supplementary dossiers required in accordance with Article 9 of Regulation (EU) No 1141/2010. The application was found to be complete by the rapporteur Member State.

               (4)

               The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 4 March 2013.

               (5)

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

               (6)

               On 7 August 2014 and 11 March 2015 (5) the Authority communicated to the Commission its conclusion on whether 2,4-D can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft review report for 2,4-D to the Standing Committee on Plants, Animals, Food and Feed on 28 May 2015.

               (7)

               It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that the approval criteria provided for in Article 4 are satisfied. Those approval criteria are therefore deemed to be satisfied.

               (8)

               It is therefore appropriate to renew the approval of 2,4-D.

               (9)

               In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

               (10)

               The risk assessment for the renewal of the approval of 2,4-D is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing 2,4-D may be authorised. It is therefore appropriate not to maintain the restriction to uses as a herbicide.

               (11)

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

               (12)

               This Regulation should apply from the day after the date of expiry of the approval of the active substance 2,4-D, as referred to in recital 1.

               (13)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Renewal of the approval of active substance
   The approval of the active substance 2,4-D, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.
   Article 2
   Amendments to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 3
   Entry into force and date of application
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 January 2016.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 13 November 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

      (3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

      (4)  Commission 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 (OJ L 322, 8.12.2010, p. 10).

      (5)  EFSA Journal 2014; 12(9): 3812. Available online: www.efsa.europa.eu

      ANNEX I

                  Common Name,
                  Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  2,4-D
                  CAS No: 94-75-7
                  CIPAC No: 1

                  (2,4-dichlorophenoxy)acetic acid

                  ≥ 960 g/kg
                  Impurities:

                              Free phenols (expressed as 2,4-DCP): not more than 3 g/kg.

                              Sum of dioxins and furans (WHO-TCDD TEQ) (2): not more than 0,01 mg/kg.

                  1 January 2016

                  31 December 2030

                  For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 2,4-D, and in particular Appendices I and II thereof, shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, terrestrial organisms and consumers in cases of uses above 750 g/ha.
                  Conditions of use shall include risk mitigation measures, where appropriate.
                  The applicant shall submit to the Commission, the Member States and the Authority:

                              (1)

                              confirmatory information in the form of the submission of the complete results from the existing extended one-generation study;

                              (2)

                              confirmatory information in the form of the submission of the Amphibian Metamorphosis Assay (AMA) (OECD (2009) Test No 231) as to verify the potential endocrine properties of the substance.

                        The information set out in point (1) shall be submitted by 4 June 2016 and the information set out in point (2) by 4 December 2017.

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

         (2)  Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)).

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

                  (1)

                  in Part A, entry 27 on 2,4-D is deleted;

                  (2)

                  in Part B, the following entry is added:

                              ‘94

                              2,4-D
                              CAS No: 94-75-7
                              CIPAC No: 1

                              (2,4-dichlorophenoxy) acetic acid

                              ≥ 960 g/kg
                              Impurities:

                                          Free phenols (expressed as 2,4-DCP): not more than 3 g/kg.

                                          Sum of dioxins and furans (WHO-TCDD TEQ) (1): not more than 0,01 mg/kg.

                              1 January 2016

                              31 December 2030

                              For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 2,4-D, and in particular Appendices I and II thereof, shall be taken into account.
                              In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, terrestrial organisms and consumers in cases of uses above 750 g/ha.
                              Conditions of use shall include risk mitigation measures, where appropriate.
                              The notifier shall submit to the Commission, the Member States and the Authority:

                                          (1)

                                          confirmatory information in the form of the submission of the complete study results from the existing extended one-generation study;

                                          (2)

                                          confirmatory information in the form of the submission of the Amphibian Metamorphosis Assay (AMA) (OECD (2009) Test No 231) as to verify the potential endocrine properties of the substance.

                                    The information set out in point (1) shall be submitted by 4 June 2016 and the information set out in point (2) by 4 December 2017.

         (1)  Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)).’