title: Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells   (Text with EEA relevance)

text:
               25.10.2006

               EN

               Official Journal of the European Union

               L 294/32

      COMMISSION DIRECTIVE 2006/86/EC
   of 24 October 2006
   implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (1), and in particular Article 8, Articles 11(4) and 28(a), (c), (g) and (h) thereof,
   Whereas:

               (1)

               Directive 2004/23/EC lays down standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications, and of manufactured products derived from human tissues and cells intended for human applications, so as to ensure a high level of human health protection.

               (2)

               In order to prevent the transmission of diseases by human tissues and cells for human applications and to ensure an equivalent level of quality and safety, Directive 2004/23/EC calls for the establishment of specific technical requirements for each one of the steps in the human tissues and cells application process, including standards and specifications with regard to a quality system for tissue establishments.

               (3)

               An accreditation, designation, authorisation or licensing system for tissue establishments and for the preparation processes at the tissue establishments should be established in Member States in accordance with Directive 2004/23/EC, in order to ensure a high level of protection of human health. It is necessary to lay down the technical requirements for this system.

               (4)

               The requirements for accreditation, designation, authorisation or licensing of tissue establishments should cover the organisation and management, personnel, equipment and materials, facilities/premises, documentation and records and quality review. Accredited, designated, authorised or licensed tissue establishments should comply with additional requirements for the specific activities they carry out.

               (5)

               The air quality standard during the processing of tissues and cells is a key factor that may influence the risk of tissue or cell contamination. An air quality with particle counts and microbial colony counts equivalent to those of Grade A, as defined in the European Guide to Good Manufacturing Practice, Annex 1 and Commission Directive 2003/94/EC (2), is generally required. However, in certain situations, an air quality with particle counts and microbial colony counts equivalent to those of Grade A standard is not indicated. In these circumstances it should be demonstrated and documented that the chosen environment achieves the quality and safety required for the type of tissue and cells, process and human application concerned.

               (6)

               The scope of this Directive should embrace the quality and safety of human tissues and cells during coding, processing, preservation, storage and distribution to the healthcare establishment where they will be applied to the human body. However, it should not extend to the human application of these tissues and cells (such as implantation surgery, perfusion, insemination or transfer of embryos). The provisions of this Directive concerning traceability and the reporting of serious adverse reactions and events apply also to the donation, procurement and testing of human tissues and cells regulated by Commission Directive 2006/17/EC (3).

               (7)

               The use of tissues and cells for human application carries a risk of disease transmission and other potential adverse effects in recipients. In order to monitor and reduce these effects, specific requirements for traceability and a Community procedure for notifying serious adverse reactions and events should be set out.

               (8)

               Suspected serious adverse reactions, in the donor or in the recipient, and serious adverse events from donation to distribution of tissues and cells, which may influence the quality and safety of tissues and cells and which may be attributed to procurement (including donor evaluation and selection), testing, processing, preservation, storage and distribution of human tissues and cells should be notified without delay to the competent authority.

               (9)

               Serious adverse reactions may be detected during or following procurement in living donors or during or following human application. They should be reported to the associated tissue establishment for subsequent investigation and notification to the competent authority. This should not preclude a procurement organisation or an organisation responsible for human application from also directly notifying the competent authority if it so wishes. This Directive should define the minimum data needed for notification to the competent authority, without prejudice to the ability of Member States to maintain or introduce in their territory more stringent and protective measures which comply with the requirements of the Treaty.

               (10)

               In order to minimise transmission costs, avoid overlaps and increase administrative efficiency, modern technologies and e-government solutions should be used to perform the tasks related to the transmission and treatment of information. These technologies should be based on a standard exchange format using a system suitable for the management of reference data.

               (11)

               To facilitate traceability and information on the main characteristics and properties of tissues and cells, it is necessary to lay down the basic data to be included in a single European code.

               (12)

               This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union.

               (13)

               The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 29 of Directive 2004/23/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Scope
   1.   This Directive shall apply to the coding, processing, preservation, storage and distribution of:

               (a)

               human tissues and cells intended for human applications; and

               (b)

               manufactured products derived from human tissues and cells intended for human applications, where those products are not covered by other directives.

         2.   The provisions of Articles 5 to 9 of this Directive, concerning traceability and the reporting of serious adverse reactions and events shall also apply to the donation, procurement and testing of human tissues and cells.
   Article 2
   Definitions
   For the purposes of this Directive, the following definitions apply:

               (a)

               ‘reproductive cells’ means all tissues and cells intended to be used for the purpose of assisted reproduction;

               (b)

               ‘partner donation’ means the donation of reproductive cells between a man and a woman who declare that they have an intimate physical relationship;

               (c)

               ‘quality system’ means the organisational structure, defined responsibilities, procedures, processes, and resources for implementing quality management and includes all activities which contribute to quality, directly or indirectly;

               (d)

               ‘quality management’ means the coordinated activities to direct and control an organisation with regard to quality;

               (e)

               ‘Standard Operating Procedures’(SOPs) means written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product;

               (f)

               ‘validation’ (or ‘qualification’ in the case of equipment or environments) means establishing documented evidence that provides a high degree of assurance that a specific process, piece of equipment or environment will consistently produce a product meeting its predetermined specifications and quality attributes; a process is validated to evaluate the performance of a system with regard to its effectiveness based on intended use;

               (g)

               ‘traceability’ means the ability to locate and identify the tissue/cell during any step from procurement, through processing, testing and storage, to distribution to the recipient or disposal, which also implies the ability to identify the donor and the tissue establishment or the manufacturing facility receiving, processing or storing the tissue/cells, and the ability to identify the recipient(s) at the medical facility/facilities applying the tissue/cells to the recipient(s); traceability also covers the ability to locate and identify all relevant data relating to products and materials coming into contact with those tissues/cells;

               (h)

               ‘critical’ means potentially having an effect on the quality and/or safety of or having contact with the cells and tissues;

               (i)

               ‘procurement organisation’ means a health care establishment or a unit of a hospital or another body that undertakes the procurement of human tissues and cells and that may not be accredited, designated, authorised or licensed as a tissue establishment;

               (j)

               ‘organisations responsible for human application’ means a health care establishment or a unit of a hospital or another body which carries out human application of human tissues and cells.

         Article 3
   Requirements for the accreditation, designation, authorisation or licensing of tissue establishments
   A tissue establishment must comply with the requirements set out in Annex I.
   Article 4
   Requirements for the accreditation, designation, authorisation, licensing of tissue and cell preparation processes
   Preparation processes at the tissue establishments must comply with the requirements set out in Annex II.
   Article 5
   Notification of serious adverse reactions
   1.   Member States shall ensure that:

               (a)

               procurement organisations have procedures in place to retain the records of tissues and cells procured and to notify tissue establishments without delay of any serious adverse reactions in the living donor which may influence the quality and safety of tissues and cells;

               (b)

               organisations responsible for human application of tissues and cells have procedures in place to retain the records of tissues and cells applied and to notify tissue establishments without delay of any serious adverse reactions observed during and after clinical application which may be linked to the quality and safety of tissues and cells;

               (c)

               tissue establishments that distribute tissue and cells for human application provide information to the organisation responsible for human application of tissues and cells about how that organisation should report serious adverse reactions as referred to in (b).

         2.   Member States shall ensure that tissue establishments:

               (a)

               have procedures in place to communicate to the competent authority without delay all relevant available information about suspected serious adverse reactions as referred to in paragraph 1(a) and (b);

               (b)

               have procedures in place to communicate to the competent authority without delay the conclusion of the investigation to analyse the cause and the ensuing outcome.

         3.   Member States shall ensure that:

               (a)

               the responsible person referred to in Article 17 of Directive 2004/23/EC notifies the competent authority of the information included in the notification set out in Part A of Annex III;

               (b)

               tissue establishments notify the competent authority of the actions taken with respect to other implicated tissues and cells that have been distributed for human applications;

               (c)

               tissue establishments notify the competent authority of the conclusion of the investigation, supplying at least the information set out in Part B of Annex III.

         Article 6
   Notification of serious adverse events
   1.   Member States shall ensure that:

               (a)

               procurement organisations and tissue establishments have procedures in place to retain the records and to notify tissue establishments without delay of any serious adverse events that occur during procurement which may influence the quality and/or safety of human tissues and cells;

               (b)

               organisations responsible for human application of tissues and cells have procedures in place to notify tissue establishments without delay of any serious adverse events that may influence the quality and safety of the tissues and cells;

               (c)

               tissue establishments provide to the organisation responsible for human application information about how that organisation should report serious adverse events to them that may influence the quality and safety of the tissues and cells.

         2.   In the case of assisted reproduction, any type of gamete or embryo misidentification or mix-up shall be considered to be a serious adverse event. All persons or procurement organisations or organisations responsible for human application performing assisted reproduction shall report such events to the supplying tissue establishments for investigation and notification to the competent authority.
   3.   Member States shall ensure that tissue establishments:

               (a)

               have procedures in place to communicate to the competent authority without delay all relevant available information about suspected serious adverse events as referred to in paragraph 1(a) and (b);

               (b)

               have procedures in place to communicate to the competent authority without delay the conclusion of the investigation to analyse the cause and the ensuing outcome.

         4.   Member States shall ensure that:

               (a)

               the responsible person referred to in Article 17 of Directive 2004/23/EC notifies the competent authority of the information included in the notification set out in Part A of Annex IV;

               (b)

               tissue establishments evaluate serious adverse events to identify preventable causes within the process;

               (c)

               tissue establishments notify the competent authority of the conclusion of the investigation, supplying at least the information set out in Part B of Annex IV.

         Article 7
   Annual reports
   1.   Member States shall submit to the Commission an annual report, by 30 June of the following year, on the notification of serious adverse reactions and events received by the competent authority. The Commission shall submit to the competent authorities of Member States a summary of the reports received. The competent authority shall make this report available to tissue establishments.
   2.   Data transmission shall comply with the data exchange format specifications as set out in Annex V, part A and B, and shall provide all the information necessary to identify the sender and maintain its reference data.
   Article 8
   Communication of information between competent authorities and to the Commission
   Member States shall ensure that their competent authorities communicate to each other and to the Commission such information as is appropriate with regard to serious adverse reactions and events, in order to guarantee that adequate actions are taken.
   Article 9
   Traceability
   1.   Tissue establishments shall have effective and accurate systems to uniquely identify and label cells/tissues received and distributed.
   2.   Tissue establishments and organisations responsible for human application shall retain the data set out in Annex VI for at least 30 years, in an appropriate and readable storage medium.
   Article 10
   European coding system
   1.   A single European identifying code shall be allocated to all donated material at the tissue establishment, to ensure proper identification of the donor and the traceability of all donated material and to provide information on the main characteristics and properties of tissues and cells. The code shall incorporate at least the information set out in Annex VII.
   2.   Paragraph 1 shall not apply to partner donation of reproductive cells.
   Article 11
   Transposition
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 September 2007, at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 10 of this Directive, by 1 September 2008.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 12
   Entry into force
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 13
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 24 October 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 102, 7.4.2004, p. 48.

      (2)  http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm and OJ L 262, 14.10.2003, p. 22.

      (3)  OJ L 38, 9.2.2006, p. 40.

      ANNEX I
      Requirements for accreditation, designation, authorisation or licensing of tissue establishments as referred to in Article 3
      A.   ORGANISATION AND MANAGEMENT

                  1.

                  A responsible person must be appointed having qualifications and responsibilities as provided in Article 17 of Directive 2004/23/EC.

                  2.

                  A tissue establishment must have an organisational structure and operational procedures appropriate to the activities for which accreditation/designation/authorisation/licensing is sought; there must be an organisational chart which clearly defines accountability and reporting relationships.

                  3.

                  Every tissue establishment must have access to a nominated medical registered practitioner to advise on and oversee the establishment’s medical activities such as donor selection, review of clinical outcomes of applied tissues and cells or interaction as appropriate with clinical users.

                  4.

                  There must be a documented quality management system applied to the activities for which accreditation/designation/authorisation or licensing is sought, in accordance with the standards laid down in this Directive.

                  5.

                  It must be ensured that the risks inherent in the use and handling of biological material are identified and minimised, consistent with maintaining adequate quality and safety for the intended purpose of the tissues and cells. The risks include those relating in particular to the procedures, environment, staff health status specific to the tissue establishment.

                  6.

                  Agreements between tissue establishments and third parties must comply with Article 24 of Directive 2004/23/EC. Third party agreements must specify the terms of the relationship and responsibilities as well as the protocols to be followed to meet the required performance specification.

                  7.

                  There must be a documented system in place, supervised by the responsible person, for ratifying that tissues and/or cells meet appropriate specifications for safety and quality for release and for their distribution.

                  8.

                  In the event of termination of activities the agreements concluded and the procedures adopted in accordance with Article 21(5) of Directive 2004/23/EC shall include traceability data and material concerning the quality and safety of cells and tissues.

                  9.

                  There must be a documented system in place that ensures the identification of every unit of tissue or cells at all stages of the activities for which accreditation/designation/authorisation/licensing is sought.

            B.   PERSONNEL

                  1.

                  The personnel in tissue establishments must be available in sufficient number and be qualified for the tasks they perform. The competency of the personnel must be evaluated at appropriate intervals specified in the quality system.

                  2.

                  All personnel should have clear, documented and up-to-date job descriptions. Their tasks, responsibilities and accountability must be clearly documented and understood.

                  3.

                  Personnel must be provided with initial/basic training, updated training as required when procedures change or scientific knowledge develops and adequate opportunities for relevant professional development. The training programme must ensure and document that each individual:

                              (a)

                              has demonstrated competence in the performance of their designated tasks;

                              (b)

                              has an adequate knowledge and understanding of the scientific/technical processes and principles relevant to their designated tasks;

                              (c)

                              understands the organisational framework, quality system and health and safety rules of the establishment in which they work, and

                              (d)

                              is adequately informed of the broader ethical, legal and regulatory context of their work.

            C.   EQUIPMENT AND MATERIALS

                  1.

                  All equipment and material must be designed and maintained to suit its intended purpose and must minimise any hazard to recipients and/or staff.

                  2.

                  All critical equipment and technical devices must be identified and validated, regularly inspected and preventively maintained in accordance with the manufacturers' instructions. Where equipment or materials affect critical processing or storage parameters (e.g. temperature, pressure, particle counts, microbial contamination levels), they must be identified and must be the subject of appropriate monitoring, alerts, alarms and corrective action, as required, to detect malfunctions and defects and to ensure that the critical parameters are maintained within acceptable limits at all times. All equipment with a critical measuring function must be calibrated against a traceable standard if available.

                  3.

                  New and repaired equipment must be tested when installed and must be validated before use. Test results must be documented.

                  4.

                  Maintenance, servicing, cleaning, disinfection and sanitation of all critical equipment must be performed regularly and recorded accordingly.

                  5.

                  Procedures for the operation of each piece of critical equipment, detailing the action to be taken in the event of malfunctions or failure, must be available.

                  6.

                  The procedures for the activities for which accreditation/designation/authorisation/licensing is sought, must detail the specifications for all critical materials and reagents. In particular, specifications for additives (e.g. solutions) and packaging materials must be defined. Critical reagents and materials must meet documented requirements and specifications and when applicable the requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (1) and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (2).

            D.   FACILITIES/PREMISES

                  1.

                  A tissue establishment must have suitable facilities to carry out the activities for which accreditation/designation/authorisation or licensing is sought, in accordance with the standards laid down in this Directive.

                  2.

                  When these activities include processing of tissues and cells while exposed to the environment, this must take place in an environment with specified air quality and cleanliness in order to minimise the risk of contamination, including cross-contamination between donations. The effectiveness of these measures must be validated and monitored.

                  3.

                  Unless otherwise specified in point 4, where tissues or cells are exposed to the environment during processing, without a subsequent microbial inactivation process, an air quality with particle counts and microbial colony counts equivalent to those of Grade A as defined in the current European Guide to Good Manufacturing Practice (GMP), Annex 1 and Directive 2003/94/EC is required with a background environment appropriate for the processing of the tissue/cell concerned but at least equivalent to GMP Grade D in terms of particles and microbial counts.

                  4.

                  A less stringent environment than specified in point 3 may be acceptable where:

                              (a)

                              a validated microbial inactivation or validated terminal sterilisation process is applied;

                              (b)

                              or, where it is demonstrated that exposure in a Grade A environment has a detrimental effect on the required properties of the tissue or cell concerned;

                              (c)

                              or, where it is demonstrated that the mode and route of application of the tissue or cell to the recipient implies a significantly lower risk of transmitting bacterial or fungal infection to the recipient than with cell and tissue transplantation;

                              (d)

                              or, where it is not technically possible to carry out the required process in a Grade A environment (for example, due to requirements for specific equipment in the processing area that is not fully compatible with Grade A).

                  5.

                  In point 4(a), (b), (c) and (d), an environment must be specified. It must be demonstrated and documented that the chosen environment achieves the quality and safety required, at least taking into account the intended purpose, mode of application and immune status of the recipient. Appropriate garments and equipment for personal protection and hygiene must be provided in each relevant department of the tissue establishment along with written hygiene and gowning instructions.

                  6.

                  When the activities for which accreditation/designation/authorisation or licensing is sought involve storage of tissues and cells, the storage conditions necessary to maintain the required tissue and cell properties, including relevant parameters such as temperature, humidity or air quality must be defined.

                  7.

                  Critical parameters (e.g. temperature, humidity, air quality) must be controlled, monitored, and recorded to demonstrate compliance with the specified storage conditions.

                  8.

                  Storage facilities must be provided that clearly separate and distinguish tissues and cells prior to release/in quarantine from those that are released and from those that are rejected, in order to prevent mix-up and cross-contamination between them. Physically separate areas or storage devices or secured segregation within the device must be allocated in both quarantine and released storage locations for holding certain tissue and cells collected in compliance with special criteria.

                  9.

                  The tissue establishment must have written policies and procedures for controlled access, cleaning and maintenance, waste disposal and for the re-provision of services in an emergency situation.

            E.   DOCUMENTATION AND RECORDS

                  1.

                  There must be a system in place that results in clearly defined and effective documentation, correct records and registers and authorised Standard Operating Procedures (SOPs), for the activities for which accreditation/designation/authorisation/licensing is sought. Documents must be regularly reviewed and must conform to the standards laid down in this Directive. The system must ensure that work performed is standardised, and that all steps are traceable; i.e. coding, donor eligibility, procurement, processing, preservation, storage, transport, distribution or disposal, including aspects relating to quality control and quality assurance.

                  2.

                  For every critical activity, the materials, equipment and personnel involved must be identified and documented.

                  3.

                  In the tissue establishments all changes to documents must be reviewed, dated, approved, documented and implemented promptly by authorised personnel.

                  4.

                  A document control procedure must be established to provide for the history of document reviews and changes and to ensure that only current versions of documents are in use.

                  5.

                  Records must be shown to be reliable and a true representation of the results.

                  6.

                  Records must be legible and indelible and may be handwritten or transferred to another validated system, such as a computer or microfilm.

                  7.

                  Without prejudice to Article 9(2), all records, including raw data, which are critical to the safety and quality of the tissues and cells shall be kept so as to ensure access to these data for at least 10 years after expiry date, clinical use or disposal.

                  8.

                  Records must meet the confidentiality requirements laid down in Article 14 of Directive 2004/23/EC. Access to registers and data must be restricted to persons authorised by the responsible person, and to the competent authority for the purpose of inspection and control measures.

            F.   QUALITY REVIEW

                  1.

                  An audit system must be in place for the activities for which accreditation/designation/authorisation/licensing is sought. Trained and competent persons must conduct the audit in an independent way, at least every two years, in order to verify compliance with the approved protocols and the regulatory requirements. Findings and corrective actions must be documented.

                  2.

                  Deviations from the required standards of quality and safety must lead to documented investigations, which include a decision on possible corrective and preventive actions. The fate of non-conforming tissues and cells must be decided in accordance with written procedures supervised by the responsible person and recorded. All affected tissues and cells must be identified and accounted for.

                  3.

                  Corrective actions must be documented, initiated and completed in a timely and effective manner. Preventive and corrective actions should be assessed for effectiveness after implementation.

                  4.

                  The tissue establishment should have processes in place for review of the performance of the quality management system to ensure continuous and systematic improvement.

         (1)  OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

         (2)  OJ L 331, 7.12.1998, p. 1. Directive as amended by Regulation (EC) No 1882/2003.

      ANNEX II
      Requirements for the authorisation of tissue and cell preparation processes at the tissue establishments as referred to in Article 4
      The competent authority shall authorise each tissue and cell preparation process after evaluation of the donor selection criteria and procurement procedures, the protocols for each step of the process, the quality management criteria, and the final quantitative and qualitative criteria for cells and tissues. This evaluation must comply at least with the requirements set out in this Annex.
      A.   RECEPTION AT THE TISSUE ESTABLISHMENT
      Upon reception of procured tissues and cells at the tissue establishment, the tissues and cells must comply with the requirements defined in Directive 2006/17/EC.
      B.   PROCESSING
      When the activities for which the accreditation/designation/authorisation/licensing is sought include processing of tissues and cells, the tissue establishment procedures must comply with the following criteria:

                  1.

                  The critical processing procedures must be validated and must not render the tissues or cells clinically ineffective or harmful to the recipient. This validation may be based on studies performed by the establishment itself, or on data from published studies or, for well established processing procedures, by retrospective evaluation of the clinical results for tissues supplied by the establishment.

                  2.

                  It has to be demonstrated that the validated process can be carried out consistently and effectively in the tissue establishment environment by the staff.

                  3.

                  The procedures must be documented in SOPs which must conform to the validated method and to the standards laid down in this Directive, accordingly with Annex I(E), points 1 to 4.

                  4.

                  It must be ensured that all processes are conducted in accordance with the approved SOPs.

                  5.

                  Where a microbial inactivation procedure is applied to the tissue or cells, it must be specified, documented, and validated.

                  6.

                  Before implementing any significant change in processing, the modified process must be validated and documented.

                  7.

                  The processing procedures must undergo regular critical evaluation to ensure that they continue to achieve the intended results.

                  8.

                  Procedures for discarding tissue and cells must prevent the contamination of other donations and products, the processing environment or personnel. These procedures must comply with national regulations.

            C.   STORAGE AND RELEASE OF PRODUCTS
      When the activities for which the accreditation/designation/authorisation/licensing is sought include storage and release of tissues and cells, the authorised tissue establishment procedures must comply with the following criteria:

                  1.

                  Maximum storage time must be specified for each type of storage condition. The selected period must reflect among others possible deterioration of the required tissue and cell properties.

                  2.

                  There must be a system of inventory hold for tissues and/or cells to ensure that they cannot be released until all requirements laid down in this Directive have been satisfied. There must be a standard operating procedure that details the circumstances, responsibilities and procedures for the release of tissues and cells for distribution.

                  3.

                  A system for identification of tissues and cells throughout any phase of processing in the tissue establishment must clearly distinguish released from non-released (quarantined) and discarded products.

                  4.

                  Records must demonstrate that before tissues and cells are released all appropriate specifications are met, in particular all current declaration forms, relevant medical records, processing records and test results have been verified according to a written procedure by a person authorised for this task by the responsible person as specified in Article 17 of Directive 2004/23/EC. If a computer is used to release results from the laboratory, an audit trail should indicate who was responsible for their release.

                  5.

                  A documented risk assessment approved by the responsible person as defined in Article 17 of Directive 2004/23/EC must be undertaken to determine the fate of all stored tissues and cells following the introduction of any new donor selection or testing criterion or any significantly modified processing step that enhances safety or quality.

            D.   DISTRIBUTION AND RECALL
      When the activities for which the accreditation/designation/authorisation/licensing is sought include distribution of tissues and cells, the authorised tissue establishment procedures must comply with the following criteria:

                  1.

                  Critical transport conditions, such as temperature and time limit must be defined to maintain the required tissue and cell properties.

                  2.

                  The container/package must be secure and ensure that the tissue and cells are maintained in the specified conditions. All containers and packages need to be validated as fit for purpose.

                  3.

                  Where distribution is carried out by a contracted third party, a documented agreement must be in place to ensure that the required conditions are maintained.

                  4.

                  There must be personnel authorised within the tissue establishment to assess the need for recall and to initiate and coordinate the necessary actions.

                  5.

                  An effective recall procedure must be in place, including a description of the responsibilities and actions to be taken. This must include notification to the competent authority.

                  6.

                  Actions must be taken within pre-defined periods of time and must include tracing all relevant tissues and cells and, where applicable, must include trace-back. The purpose of the investigation is to identify any donor who might have contributed to causing the reaction in the recipient and to retrieve available tissues and cells from that donor, as well as to notify consignees and recipients of tissues and cells procured from the same donor in the event that they might have been put at risk.

                  7.

                  Procedures must be in place for the handling of requests for tissues and cells. The rules for allocation of tissues and cells to certain patients or health care institutions must be documented and made available to these parties upon request.

                  8.

                  A documented system must be in place for the handling of returned products including criteria for their acceptance into the inventory, if applicable.

            E.   FINAL LABELLING FOR DISTRIBUTION

                  1.

                  The primary tissue/cell container must provide:

                              (a)

                              type of tissues and cells, identification number or code of the tissue/cells, and lot or batch number where applicable;

                              (b)

                              identification of the tissue establishment;

                              (c)

                              expiry date;

                              (d)

                              in the case of autologous donation, this has to be specified (for autologous use only) and the donor/recipient has to be identified;

                              (e)

                              in the case of directed donations - the label must identify the intended recipient;

                              (f)

                              when tissues and cells are known to be positive for a relevant infectious disease marker, it must be marked as: BIOLOGICAL HAZARD.

                        If any of the information under points (d) and (e) above cannot be included on the primary container label, it must be provided on a separate sheet accompanying the primary container. This sheet must be packaged with the primary container in a manner that ensures that they remain together.

                  2.

                  The following information must be provided either on the label or in accompanying documentation:

                              (a)

                              description (definition) and, if relevant, dimensions of the tissue or cell product;

                              (b)

                              morphology and functional data where relevant;

                              (c)

                              date of distribution of the tissue/cells;

                              (d)

                              biological determinations carried out on the donor and results;

                              (e)

                              storage recommendations;

                              (f)

                              instructions for opening the container, package, and any required manipulation/reconstitution;

                              (g)

                              expiry dates after opening/manipulation;

                              (h)

                              instructions for reporting serious adverse reactions and/or events as set out in Articles 5 to 6;

                              (i)

                              presence of potential harmful residues (e.g. antibiotics, ethylene oxide etc).

            F.   EXTERNAL LABELLING OF THE SHIPPING CONTAINER
      For transport, the primary container must be placed in a shipping container that must be labelled with at least the following information:

                  (a)

                  identification of the originating tissue establishment, including an address and phone number;

                  (b)

                  identification of the organisation responsible for human application of destination, including address and phone number;

                  (c)

                  a statement that the package contains human tissue/cells and HANDLE WITH CARE;

                  (d)

                  where living cells are required for the function of the graft, such as stem cells gametes and embryos, the following must be added: ‘DO NOT IRRADIATE’;

                  (e)

                  recommended transport conditions (e.g. keep cool, in upright position, etc.);

                  (f)

                  safety instructions/method of cooling (when applicable).

      ANNEX III
      NOTIFICATION OF SERIOUS ADVERSE REACTIONS

      ANNEX IV
      NOTIFICATION OF SERIOUS ADVERSE EVENTS

      ANNEX V
      ANNUAL NOTIFICATION FORMAT

      ANNEX VI
      Information on the minimum donor/recipient data set to be kept as required in Article 9
      A.   BY TISSUE ESTABLISHMENTS
      Donor identification
      Donation identification that will include at least:

                  —

                  Identification of the procurement organisation or Tissue establishment

                  —

                  Unique Donation ID number

                  —

                  Date of procurement

                  —

                  Place of procurement

                  —

                  Type of donation (e.g. single v multi-tissue; autologous v allogenic; living v deceased)

            Product identification that will include at least:

                  —

                  Identification of the tissue establishment

                  —

                  Type of tissue and cell/product (basic nomenclature)

                  —

                  Pool number (if applicable)

                  —

                  Split number (if applicable)

                  —

                  Expiry date

                  —

                  Tissue/cell status (i.e. quarantined, suitable for use etc.)

                  —

                  Description and origin of the products, processing steps applied, materials and additives coming into contact with tissues and cells and having an effect on their quality and/or safety.

                  —

                  Identification of the facility issuing the final label

            Human application identification that will include at least:

                  —

                  Date of distribution/disposal

                  —

                  Identification of the clinician or end user/facility

            B.   BY ORGANISATIONS RESPONSIBLE FOR HUMAN APPLICATION

                  (a)

                  Identification of the supplier tissue establishment

                  (b)

                  Identification of the clinician or end user/facility

                  (c)

                  Type of tissues and cells

                  (d)

                  Product identification

                  (e)

                  Identification of the recipient

                  (f)

                  Date of application

      ANNEX VII
      Information contained in the European Coding System

                  (a)

                  Donation identification:

                              —

                              Unique ID number

                              —

                              Identification of the tissue establishment

                  (b)

                  Product identification:

                              —

                              Product code (basic nomenclature)

                              —

                              Split number (if applicable)

                              —

                              Expiry date


Avis juridique important

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31979L0700

Commission Directive 79/700/EEC of 24 July 1979 establishing Community methods of sampling for the official control of pesticide residues in and on fruit and vegetables

Official Journal L 207 , 15/08/1979 P. 0026 - 0028 Finnish special edition: Chapter 3 Volume 11 P. 0075  Greek special edition: Chapter 03 Volume 26 P. 0062  Swedish special edition: Chapter 3 Volume 11 P. 0075  Spanish special edition: Chapter 03 Volume 16 P. 0209  Portuguese special edition Chapter 03 Volume 16 P. 0209

COMMISSION DIRECTIVE  of 24 July 1979  establishing Community methods of sampling for the official control of pesticide residues in and on fruit and vegetables  (79/700/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (1), and in particular Article 6 thereof,  Whereas that Directive requires that the official checks provided for therein to ensure compliance with maximum levels for pesticide residues in and on fruit and vegetables shall be carried out according to Community methods of sampling and of qualitative and quantitative analysis;  Whereas, as a first stage, methods of sampling should be laid down;  Whereas, in formulating these methods, it has been recognized that on account of the variation in size, state and packaging (if any) of fruit and vegetables which are in circulation, the methods will only be practicable if certain operations are sufficiently empirical;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,  HAS ADOPTED THIS DIRECTIVE:    Article 1 The Member States shall require that sampling for the checks provided for in Article 6 of Directive 76/895/EEC be carried out in accordance with the methods described in the Annex hereto.   Article 2 The Member States shall, not later than 31 December 1980, bring into force the laws, regulations or administrative provisions necessary to comply with the provisions of this Directive. They shall forthwith notify the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 24 July 1979.  For the Commission  Finn GUNDELACH  Vice-President  (1)OJ No L 340, 9.12.1976, p. 26.     ANNEX METHODS OF SAMPLING     1. PURPOSE AND SCOPE  Samples intended for the official control of the levels of pesticide residues in and on fruit and vegetables shall be taken according to the methods described below. Final and laboratory samples thus obtained shall be considered as representative of the lots. Compliance with any maximum levels laid down in accordance with Directive 76/895/EEC shall be established on the basis of the levels determined in the final and laboratory samples.       2. SAMPLING OFFICERS  The samples shall be taken by officers authorized for that purpose by the Member States.       3. DEFINITIONS      3.1. Lot  An identifiable quantity of goods having characteristics presumed to be uniform.           3.2. Incremental sample  A quantity taken from a single place in the lot.           3.3. Aggregate sample  The aggregate of incremental samples taken from the same lot.           3.4. Final sample  The aggregate sample or a representative part of the aggregate sample obtained from the latter by a process of reduction.           3.5. Laboratory sample  Sample intended for the laboratory. A representative portion of the final sample.                  4. SAMPLING PROCEDURE      4.1. Material to be sampled  Each lot which is to be examined must be sampled separately.           4.2. Precautions to be taken  In the course of sampling and preparation of the laboratory samples precautions must be taken to avoid any changes which would affect the residue content, adversely affect the analytical determinations or make the laboratory samples unrepresentative.           4.3. Incremental samples  As far as possible these should be taken at various places distributed throughout the lot. Departure from this procedure must be recorded in the record provided for under 5. Goods which are wholly or extensively spoiled are not to be used for sampling. The combined total of the incremental samples must never be less than that required for the laboratory samples as provided for in 4.6.         4.3.1. The minimum number of incremental samples to be taken is given in Table A below. As far as possible the samples should be of similar size.  TABLE A >PIC FILE= "T0015069">                4.3.2. In the case of frozen goods or if the weight of the lot is unknown to the sampling officer or cannot be sufficiently accurately estimated, the minimum number of incremented samples may, by way of derogation from 4.3.1, be determined in accordance with Table B.  TABLE B >PIC FILE= "T0015070">                           4.4. Preparation of the aggregate sample  The aggregate sample is made up by uniting and mixing the incremental samples.           4.5. Preparation of the final sample  The aggregate sample may be used as it stands as the final sample.  If the aggregate sample is too large, the final sample may be prepared from it by a suitable method of reduction, for example by quartering, rejecting two diagonally opposite quarters, mixing and requartering the remainder and so on until the size required is reached. In this process, however, individual fruits and vegetables must not be cut or divided.           4.6. Preparation of laboratory samples        4.6.1. As many laboratory samples as required by national rules shall be prepared from the final sample.               4.6.2. For mushrooms and truffles, culinary herbs and capers, each laboratory sample shall weigh at least 0 75 kg.               4.6.3. For other fruit and vegetables, each laboratory sample shall weigh at least 1 kg and shall consist of at least 10 individual fruits or vegetables. However, if the weight of 10 individual fruits or vegetables exceeds 5 kg, the laboratory sample may consist of only five.                                 5. PACKAGING AND TRANSMISSION OF LABORATORY SAMPLES  Each laboratory sample shall be placed in a clean, inert container offering adequate protection from contamination and against damage in transit. The container shall then be labelled and sealed in such a manner that it cannot be opened or the label removed without damaging the seal. As in 4.2, all necessary precautions shall be taken to avoid any change of composition of the laboratory sample which might arise during transportation or storage.  A record must be kept of each sampling, permitting each lot to be identified unambiguously and giving the date and place of sampling together with any additional information likely to be of assistance to the analyst.


title: Commission Directive 2012/45/EU of 3 December 2012 adapting for the second time the Annexes to Directive 2008/68/EC of the European Parliament and of the Council on the inland transport of dangerous goods to scientific and technical progress  Text with EEA relevance

text:
               4.12.2012

               EN

               Official Journal of the European Union

               L 332/18

         COMMISSION DIRECTIVE 2012/45/EU
   of 3 December 2012
   adapting for the second time the Annexes to Directive 2008/68/EC of the European Parliament and of the Council on the inland transport of dangerous goods to scientific and technical progress
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (1), and in particular Article 8(1) thereof,
   Whereas:

               (1)

               Annex I, Section I.1, Annex II, Section II.1 and Annex III, Section III.1 to Directive 2008/68/EC refer to provisions set out in international agreements on the inland transport of dangerous goods by road, rail and inland waterways as defined in Article 2 of that Directive.

               (2)

               The provisions of these international agreements are updated every two years. Consequently, the last amended versions of these agreements shall apply as from 1 January 2013, with a transitional period up to 30 June 2013.

               (3)

               Annex I, Section I.1, Annex II, Section II.1 and Annex III, Section III.1 to Directive 2008/68/EC should therefore be amended accordingly.

               (4)

               The measures provided for in this Directive are in accordance with the opinion of the Committee on the Transport of Dangerous Goods,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments to Directive 2008/68/EC
   Directive 2008/68/EC is amended as follows:

               (1)

               in Annex I, Section I.1 is replaced by the following:
               ‘I.1.   ADR

               Annexes A and B to the ADR, as applicable with effect from 1 January 2013, it being understood that “contracting party” is replaced by “Member State” as appropriate.’;

               (2)

               in Annex II, Section II.1 is replaced by the following:
               ‘II.1.   RID

               Annex to the RID, appearing in Appendix C to the COTIF, as applicable with effect from 1 January 2013, it being understood that “RID Contracting State” is replaced by “Member State” as appropriate.’;

               (3)

               in Annex III, Section III.1 is replaced by the following:
               ‘III.1.   ADN

               Annexed Regulations to the ADN, as applicable with effect from 1 January 2013, as well as Articles 3(f), 3(h), 8(1), 8(3) of the ADN, it being understood that “contracting party” is replaced by “Member State” as appropriate.’.

         Article 2
   Transposition
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2013 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   Entry into force
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 3 December 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 260, 30.9.2008, p. 13.


Avis juridique important

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31979L0795

Commission Directive 79/795/EEC of 20 July 1979 adapting to technical progress Council Directive 71/127/EEC on the approximation of the laws of the Member States relating to the rear-view mirrors of motor vehicles

Official Journal L 239 , 22/09/1979 P. 0001 - 0023 Finnish special edition: Chapter 13 Volume 10 P. 0057  Greek special edition: Chapter 13 Volume 8 P. 0198  Swedish special edition: Chapter 13 Volume 10 P. 0057  Spanish special edition: Chapter 13 Volume 10 P. 0167  Portuguese special edition Chapter 13 Volume 10 P. 0167

COMMISSION DIRECTIVE  of 20 July 1979  adapting to technical progress Council Directive 71/127/EEC on the approximation of the laws of the Member States relating to the rear-view mirrors of motor vehicles  (79/795/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), as last amended by Directive 78/547/EEC (2), and in particular Articles 11, 12 and 13 thereof,  Having regard to Council Directive 71/127/EEC of 1 March 1971 on the approximation of the laws of the Member States relating to the rear-view mirrors of motor vehicles (3),  Whereas, in the light of the experience gained and in view of the present state of technology, it is now possible to make the relevant provisions fuller, more stringent and better adapted to actual test conditions;  Whereas Council Directive 71/127/EEC provides that specifications on external rear-view mirrors adjustable from the driving position are to be drawn up as soon as technological development permits;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of Directives for the Removal of Technical Barriers to Trade in the Motor Vehicles Sector,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 71/127/EEC is hereby amended as follows:    1. The last subparagraph of Article 3 (2) is amended to read as follows:  "There shall be failure to conform to the approved type, within the meaning of the first subparagraph, where the requirements of item 2 of Annex I are not observed."       2. Article 7 is replaced by the following:  "1. With effect from 1 February 1980, no Member State may, on grounds relating to rear-view mirrors:      (a)        - refuse, in respect of a type of motor vehicle, to grant EEC type-approval, to issue the document referred to in the last indent of Article 10 (1) of Directive 70/156/EEC, or to grant national type-approval, or               - prohibit the entry into service of the vehicles,                if the rear-view mirrors of this type of vehicle or of these vehicles comply with the provisions of this Directive;           (b)  - refuse, in respect of a type of rear-view mirror, to grant EEC component  (1)OJ No L 42, 23.2.1970, p. 1. (2)OJ No L 168, 26.6.1978, p. 39. (3)OJ No L 68, 22.3.1971, p. 1.   type-approval or national type-approval, if these rear-view mirrors comply with the provisions of this Directive, or  - prohibit the placing on the market of rear-view mirrors which bear the EEC component type-approval mark laid down in this Directive.  2. With effect from 1 October 1981 a Member State:        (a)          - shall not issue the document referred to in the last indent of Article 10 (1) of Directive 70/156/EEC in respect of a type of vehicle of which the rear-view mirrors do not comply with the provisions of this Directive,                   - may refuse to grant national type-approval in respect of a type of vehicle of which the rear-view mirrors do not comply with the provisions of this Directive;                                 (b)          - shall not grant EEC component type-approval in respect of a type of rear-view mirror if the latter does not comply with the provisions of this Directive,                   - may refuse to grant national component type-approval in respect of a type of rear-view mirror if the latter does not comply with the provisions of this Directive.                                    3. With effect from 1 October 1984 Member States:      - may prohibit the entry into service of vehicles of which the rear-view mirrors do not comply with the provisions of this Directive,           - may prohibit the placing on the market of rear-view mirrors which do not bear the EEC component type-approval mark laid down in this Directive."             3. Annexes I, II and III are replaced by Annexes I, II, III and IV to this Directive.          Article 2 Member States shall bring into force the provisions necessary to comply with this Directive not later than 1 February 1980. They shall forthwith inform the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 20 July 1979.  For the Commission  Étienne DAVIGNON  Member of the Commission     ANNEX I    1. DEFINITIONS      1.1. "Rear-view mirror" means any device intended to give, within the field of vision defined in item 3.4, a clear view to the rear, excluding complex optical systems such as periscopes.           1.2. "Interior rear-view mirror" means a device as defined in item 1.1 which can be fitted in the passenger compartment of a vehicle.           1.3. "Exterior rear-view mirror" means a device as defined in item 1.1 which can be mounted on the external surface of a vehicle.           1.4. "Additional rear-view mirror" means a rear-view mirror other than a device of the type defined in item 1.1 which can be fitted to the inside or outside of the vehicle provided that it complies with the provisions of item 2 other than 2.1.1, 2.2 and 2.3.4.           1.5. "Rear-view mirror type" means devices which do not differ in respect of the following essential characteristics:        1.5.1. the dimensions and radius of curvature of the rear-view mirror's reflecting surface:               1.5.2. the design, shape or materials of the rear-view mirrors, including the connection with the bodywork.                          1.6. "Class of rear-view mirrors" means all devices having one or more common characteristics or functions. Interior rear-view mirrors are grouped in Class I. Additional interior rear-view mirrors are grouped in Class Is.  Exterior rear-view mirrors are grouped in Classes II and III.  Additional exterior rear-view mirrors are grouped in Classes IIs and IIIs.           1.7. "r" means the average of the radii of curvature measured over the reflecting surface, in accordance with the method described in item 2 of Appendix 1 to this Annex.           1.8. "The principal radii of curvature at one point on the reflecting surface (ri)" means the values obtained with the apparatus defined in Appendix 1, measured on the arc of the reflecting surface passing through the centre of the mirror parallel to the segment b, as defined in item 2.2.2.1, and on the arc perpendicular to this segment.           1.9. "The radius of curvature at one point on the reflecting surface (rp)" means the arithmetical average of the principal radii of curvature ri and r'i, i.e.: >PIC FILE= "T0015073">            1.10. "Centre of the mirror" means the centroid of the visible area of the reflecting surface.           1.11. "The radius of curvature of the constituent parts of the rear-view mirror" means the radius "c" of the arc of the circle which most closely approximates to the curved form of the part in question.           1.12. "The driver's ocular points" means two points 65 mm apart and 635 mm vertically above point R of the driver's seat as defined in Annex IV. The straight line joining these points runs perpendicular to the vertical longitudinal median plane of the vehicle. The centre of the segment joining the two ocular points is in a vertical longitudinal plane which must pass through the centre of the driver's designated seating position, as specified by the vehicle manufacturer.           1.13. "Ambinocular vision" means the total field of vision obtained by the superimposition of the monocular fields of the right eye and the left eye (see diagram below).   >PIC FILE= "T0015074">            1.14. "Type of vehicle as regards rear-view mirrors" means motor vehicles which are identical in respect of the following basic features:        1.14.1. the bodywork features which reduce the field of vision;               1.14.2. the coordinates of point R;               1.14.3. the prescribed positions and types of rear-view mirror.                          1.15. "Vehicles of categories M1, M2, M3, N1, N2 and N3" means those defined in Annex I to Directive 70/156/EEC.                  2. PROVISIONS RELATING TO EEC COMPONENT TYPE-APPROVAL OF REAR-VIEW MIRRORS      2.1. General specifications        2.1.1. All rear-view mirrors must be adjustable.         >PIC FILE= "T0015314">        2.1.3. When the rear-view mirror is mounted on a plane surface, all parts, irrespective of the adjustment position of the device, including those parts remaining attached to the support after the test provided for in 2.4.2, which are in potential, static contact with a sphere either 165 mm in diameter in the case of an interior rear-view mirror or 100 mm in diameter in the case of an exterior rear-view mirror, must have a radius of curvature "c" of not less than 2 75 mm.          2.1.3.1. Edges of fixing holes or recesses of which the diameter or longest diagonal is less than 12 mm are exempt from the radius requirements of item 2.1.3 provided that they are blunted.                                  2.1.4. The attachment device on the vehicle must be so designed that a cylinder with a 50 mm radius, having as its axis the axis, or one of the axes, of pivot or rotation which ensure deflection of the rear-view mirror in the direction of impact concerned, passes through at least part of the surface to which the device is attached.               2.1.5. The parts of exterior rear-view mirrors referred to in items 2.1.2 and 2.1.3 which are made of a material with a Shore A hardness not exceeding 60 are exempt from the relevant provisions.                2.1.6. In the case of those parts of interior rear-view mirrors which are made of a material with a Shore A hardness of less than 50 and which are mounted on a rigid support, the requirements of items 2.1.2 and 2.1.3 shall only apply to the support.                          2.2. Dimensions        2.2.1. Interior rear-view mirrors (Class I)  The dimensions of the reflecting surface must be such that it is possible to inscribe thereon a rectangle one side of which is 4 cm and the other "a" cm in length, where >PIC FILE= "T0015075">                2.2.2. Exterior rear-view mirrors (classes II and III)          2.2.2.1. The dimensions of the reflecting surface must be such that it is possible to inscribe therein:            - a rectangle 4 cm high the base length of which, measured in centimetres, has the value "a",                       - a segment which is parallel to the height of the rectangle and the length of which, expressed in centimetres, has the value "b".                                          2.2.2.2. The minimum values of "a" and "b" are given in the table below: >PIC FILE= "T0015076">                                              2.3. Reflecting surface and coefficients of reflection        2.3.1. The reflecting surface of a rear-view mirror must be either flat or spherically convex.               2.3.2. Differences between the radii of curvature          2.3.2.1. The difference between ri or r'i and rp at each reference point must not exceed 0 715 r.                   2.3.2.2. The difference between any of the radii of curvature (rp1, rp2, and rp3) and r must not exceed 0 715 r.                   2.3.2.3. When r is not less than 3 000 mm, the value of 0 715 r quoted in items 2.3.2.1 and 2.3.2.2 is replaced by 0 725 r.                                  2.3.3. The value of "r" must be not less than:          - 1 800 mm for Class II rear-view mirrors,                   - 1 200 mm for Class I and III rear-view mirrors.                                  2.3.4. The value of the normal coefficient of reflection, as determined according to the method described in Appendix 2 to this Annex, must be not less than 40 %.  If the mirror has two positions ("day" and "night"), the "day" position must allow the colours of the signals used for road traffic to be recognized. The value of the normal coefficient of reflection in the "night" position must be not less than 4 %.               2.3.5. The reflecting surface must retain the characteristics laid down in item 2.3.4 in spite of prolonged exposure to adverse weather conditions in normal use.                          2.4. Tests        2.4.1. The reaction of rear-view mirrors to impact and bending on the holder fixed to the stem or support shall be tested in the manner described in items 2.4.2 and 2.4.3.           2.4.1.1. The test provided for in item 2.4.2 shall not be required in the case of any Class II or IIs exterior rear-view mirror of which no part is less than 2 m from the ground, regardless of the adjustment position, when the vehicle is under a load corresponding to its maximum technically permissible weight.  In such cases the manufacturer is required to provide a description stipulating that the rear-view mirror must be mounted in such a way that none of its parts, in any of the possible adjustment positions, is less than 2 m above the ground when the vehicle is under a load corresponding to its maximum technically permissible weight. >PIC FILE= "T0015077">                                   2.4.2. Impact test          2.4.2.1. Description of the test rig.            2.4.2.1.1. The test rig consists of a pendulum capable of swinging about two horizontal axes at right angles to each other, one of which is perpendicular to the plane containing the "release" trajectory of the pendulum.  The end of the pendulum comprises a hammer formed by a rigid sphere with a diameter of 165 ± 1 mm and having a 5 mm-thick rubber covering of Shore hardness A 50.  A device is provided which permits determination of the maximum angle assumed by the arm in the plane of release.  A support firmly fixed to the structure of the pendulum serves to hold the specimens in compliance with the impact requirements specified in item 2.4.2.2.6.  Figure 1 below gives the dimensions of the test rig and the special design specifications.   >PIC FILE= "T0015078">    >PIC FILE= "T0015079">                                           2.4.2.2. Description of the test.            2.4.2.2.1. The procedure used to clamp the rear-view mirror to the support shall be that recommended by the manufacturer of the device or, where appropriate, by the vehicle manufacturer.                       2.4.2.2.2. Positioning of the rear-view mirror for the test.              2.4.2.2.2.1. Rear-view mirrors shall be so positioned on the pendulum impact rig such that the axes which are horizontal and vertical when the rear-view mirror is installed on a vehicle in accordance with the demander's mounting instructions are in a similar position.                           2.4.2.2.2.2. When a rear-view mirror is adjustable with respect to the base, the test position shall be that in which any pivoting device is least likely to operate, within the limits of adjustment provided by the demander.                           2.4.2.2.2.3. When the rear-view mirror has a device for adjusting its distance from the base, the device must be set in the position in which the distance between the holder and the base is shortest.                           2.4.2.2.2.4. When the reflecting surface is mobile in the holder, it shall be so adjusted that the upper corner which is furthest from the vehicle is in the position of greatest projection relative to the holder.                                                  2.4.2.2.3. Except in the case of test 2 for interior rear-view mirrors (see item 2.4.2.2.6.1), when the pendulum is in a vertical position the horizontal and longitudinal vertical planes passing through the centre of the hammer shall pass through the centre of the mirror as defined in item 1.10. The longitudinal direction of oscillation of the pendulum shall be parallel to the longitudinal median plane of the vehicle.                       2.4.2.2.4. When, under the conditions governing adjustment laid down in items 2.4.2.2.1 and 2.4.2.2.2, parts of the rear-view mirror limit the return of the hammer, the point of impact must be displaced in a direction perpendicular to the axis of rotation or pivoting in question.  This displacement must be no greater than is strictly necessary for the execution of the test ; it must be limited in such a way that:              - either the sphere delimiting the hammer remains at least tangential to the cylinder as defined in paragraph 2.1.4,                           - or the point of contact with the hammer is located at least 10 mm from the periphery of the reflecting surface.                                                  2.4.2.2.5. The test consists in allowing the hammer to fall from a height corresponding to a pendulum angle of 60º from the vertical so that the hammer strikes the rear-view mirror at the moment when the pendulum reaches the vertical position.                       2.4.2.2.6. The rear-view mirrors are subjected to impact under the following different conditions:              2.4.2.2.6.1. Interior rear-view mirrors                - Test 1 - The point of impact shall be as defined in item 2.4.2.2.3. The impact must be such that the hammer strikes the rear-view mirror on the reflecting surface side.                               - Test 2 - Point of impact on the edge of the housing, so that the impact produced makes an angle of 45º with the plane of the mirror and is situated in the horizontal plane passing through the centre of the mirror. The impact must occur on the reflecting surface side.                                                          2.4.2.2.6.2. Exterior rear-view mirrors                - Test 1 - The point of impact shall be as defined in item 2.4.2.2.3 or 2.4.2.2.4. The impact must be such that the hammer strikes the rear-view mirror on the reflecting surface side.                               - Test 2 - The point of impact shall be as defined in item 2.4.2.2.3 or 2.4.2.2.4. The impact must be such that the hammer strikes the rear-view mirror on the side opposite to the reflecting surface.                                                                                2.4.3. Bending test on the holder fixed to the stem          2.4.3.1. Description of the test  The holder is placed horizontally in a device in such a way that the adjustment parts of the mounting can be clamped securely. In the direction of the greatest dimension of the holder, the end nearest to the point of fixing on the adjustment part is immobilized by means of a fixed stop 15 mm wide covering the entire width of the holder.  At the other end, a stop identical to the one described above is placed on the holder so that the specified test load can be applied to it (Figure 2).  The end of the holder opposite that at which the force is applied may be clamped instead of simply blocked, as shown in Figure 2. >PIC FILE= "T0015080">                    2.4.3.2. The test load is 25 kg. It is applied for one minute.                                             2.5. Results of the tests        2.5.1. In the tests described in item 2.4.2, the pendulum must continue to swing after impact in such a way that the projection of the position assumed by the arm on the plane of release makes an angle of at least 20º with the vertical.  The accuracy of measurement of the angle shall be within ± 1º.  This requirement is not applicable to rear-view mirrors stuck to the windscreen, in respect of which the requirement stipulated in item 2.5.2 shall apply after the test.               2.5.2. Should the mounting of the rear-view mirror break during the tests described in item 2.4.2 for rear-view mirrors stuck to the windscreen, the part remaining must not project beyond the base by more than 1 cm and the configuration remaining after the test must satisfy the conditions laid down in item 2.1.3.               2.5.3. The mirror must not break during the tests described in items 2.4.2 and 2.4.3. However, breakage of the mirror will be allowed if one of the following conditions is fulfilled:           2.5.3.1. the fragments of glass still adhere to the back of the holder or to a surface firmly attached to the holder ; partial separation of the glass from its backing is admissible provided this does not exceed 2 75 mm on either side of the cracks. It is permissible for small splinters to become detached from the surface of the glass at the point of impact;                   2.5.3.2. the mirror is made of safety glass.                                             2.6. EEC component type-approval conditions and marking        2.6.1. Application for EEC component type-approval          2.6.1.1. Application for EEC component type-approval for a type of rear-view mirror shall be made by the holder of the trade mark or name, or by his authorized representative.                   2.6.1.2. For each type of rear-view mirror the application shall be accompanied by:            2.6.1.2.1. a technical description, specifying in particular the type(s) of vehicle for which the rear-view mirror is intended;                       2.6.1.2.2. sufficiently detailed drawings for identification of the rear-view mirror, together with instructions for mounting : the drawings must show the proposed position of the EEC component type-approval mark;                       2.6.1.2.3. four rear-view mirrors : three for use in the tests and one to be retained by the laboratory for any further examination that might subsequently prove necessary. Additional specimens may be called for at the request of the laboratory.                                                         2.6.2. EEC component type-approval mark          2.6.2.1. The EEC component type-approval mark shall consist of a rectangle surrounding the lower case letter "e" followed by the distinguishing letter(s) or number of the Member State which has granted the component type-approval:  1 for Germany,  2 for France,  3 for Italy,  4 for the Netherlands,  6 for Belgium,  11 for the United Kingdom,  13 for Luxembourg,  18 for Denmark,  IRL for Ireland.  It must also include in the vicinity of the rectangle the EEC component type-approval number.  This number shall consist of the component type-approval number shown on the certificate completed for the type (see Annex II), preceded by two figures indicating the sequence number of the latest amendment to Council Directive 71/127/EEC on the date EEC component type-approval was granted. The amendment sequence number and the component type-approval number shown on the certificate shall be separated by an asterisk. In this Directive the sequence number is 01.                   2.6.2.2. The abovementioned type-approval mark (symbol and number) shall be indelibly inscribed on an essential part of the rear-view mirror in such a way as to be clearly visible even after the rear-view mirror has been mounted on a vehicle.   >PIC FILE= "T0015081">    >PIC FILE= "T0015082">                                                     3. REQUIREMENTS CONCERNING FITTING TO VEHICLES      3.1. General        3.1.1. Rear-view mirrors must be fixed in such a way that the mirror does not move so as significantly to change the field of vision as measured or vibrate to an extent which would cause the driver to misinterpret the nature of the image perceived.          3.1.1.1. The conditions laid down in item 3.1.1 must be maintained when the vehicle is moving at speeds of up to 80 % of its maximum design speed, but not exceeding 150 km/h.                                  3.1.2. Exterior rear-view mirrors fitted on vehicles of categories M2, M3, N2 and N3 must be Class II mirrors and those fitted on vehicles of categories M1 and N1 must be Class II or Class III mirrors.                          3.2. Number and position        3.2.1. Rear-view mirrors must be so placed that the driver, when sitting on the driving seat in a normal driving position, has a clear view of the road to the rear of the vehicle.               3.2.2. All vehicles of categories M1 and N1 must be fitted with both an interior and an exterior rear-view mirror. The latter must be fitted on the left side of the vehicle in Member States with right-hand rule of the road and on the right side of the vehicle in Member States with left-hand rule of the road.  (1)The numbers in the diagram are for guidance only.           3.2.2.1. If the interior rear-view mirror does not meet the requirements laid down in item 3.4.2, an additional exterior rear-view mirror must be fitted to the vehicle. The latter shall be fitted to the right side of the vehicle in Member States with right-hand rule of the road and to the left side of the vehicle in Member States with left-hand rule of the road.                   3.2.2.2. If the interior rear-view mirror does not provide any rearward vision, its presence shall not be required.                                  3.2.3. All vehicles in categories M2, M3, N2 and N3 must be fitted with two exterior rear-view mirrors, one on each side of the vehicle.               3.2.4. Exterior rear-view mirrors shall be visible through the side windows or through the portion of the windscreen that is swept by the windscreen wiper. This provision shall not apply to exterior rear-view mirrors fitted on the right side of vehicles of categories M2 and M3 in Member States with right-hand rule of the road and on the left side of vehicles of the same categories in Member States with left-hand rule of the road.               3.2.5. In the case of any vehicle which is in chassis/cab form when the field of vision is measured, the minimum and maximum body widths shall be stated by the manufacturer and, if necessary, simulated by dummy head boards. All vehicle and mirror configurations taken into consideration during the tests shall be shown on the type-approval certificate.               3.2.6. A two-plane or "double" mirror is not permitted if both planes are necessary to meet the field-of-vision requirements. However, if the main glass meets all the requirements for a Class II or III mirror, it is acceptable. The auxiliary glass will be taken into account in the determination of the height from the ground and of the projection in accordance with item 3.2.10. The enclosure of the auxiliary glass must also comply with the conditions specified in item 2.1.2.               3.2.7. The prescribed exterior rear-view mirror on the driver's side of the vehicle must be so located that an angle of not more than 55º is formed between the vertical longitudinal median plane of the vehicle and the vertical plane passing through the centre of the rear-view mirror and through the centre of the straight line 65 mm long which joins the driver's two ocular points.               3.2.8. Rear-view mirrors must not project beyond the external bodywork of the vehicle substantially more than is necessary to comply with the requirements concerning fields of vision laid down in item 3.4.               3.2.9. Where the lower edge of an exterior rear-view mirror is less than 2 m above the ground when the vehicle is laden, this rear-view mirror must not project more than 0 720 m beyond the overall width of the vehicle measured without rear-view mirrors.               3.2.10. Subject to the requirements of items 3.2.8 and 3.2.9, rear-view mirrors may project beyond the permissible maximum widths of vehicles.                          3.3. Adjustment        3.3.1. The interior rear-view mirror must be capable of being adjustable by the driver from his driving position.               3.3.2. The exterior rear-view mirror situated on the driver's side must be capable of being adjusted from inside the vehicle while the door is closed, although the window may be open. The mirror may, however, be locked in position from the outside.               3.3.3. The requirements of item 3.3.2 do not apply to exterior rear-view mirrors which, after having been knocked out of alignment, can be returned to their former position without the need for adjustment.                          3.4. Fields of vision        3.4.1. General  The fields of vision defined below must apply in respect of ambinocular vision, the eyes being at the "driver's ocular points" as defined in item 1.12 above. The fields of vision shall be determined when the vehicle is in running order as defined in item 2.6 of Annex I to Directive 70/156/EEC and is carrying in addition one front-seat passenger, the mass of the passenger being 75 kg ± 1 %. They must be established through windows which have a total light transmission factor of at least 70 % measured perpendicularly to the surface.               3.4.2. Interior rear-view mirror  The field of vision must be such that the driver can see at least a 20 m-wide, flat, horizontal portion of the road centred on the vertical longitudinal median plane of the vehicle and extending from 60 m behind the driver's ocular points (Figure 3) to the horizon.          3.4.2.1. It is permissible for the field of vision to be reduced by the presence of head restraints and such devices as sun visors, rear windscreen wipers and heating elements, provided  that they do not obscure more than 15 % of the prescribed field of vision when projected onto a vertical plane perpendicular to the longitudinal median plane of the vehicle.                                  3.4.3. Left-hand exterior rear-view mirror for vehicles driven on the right of the road and right-hand exterior rear-view mirror for vehicles driven on the left of the road.          3.4.3.1. The field of vision must be such that the driver can see at least a 2 750 m-wide, flat, horizontal portion of the road, which is bounded on the right (in the case of vehicles driven on the right), or on the left (in the case of vehicles driven on the left) by the plane which is parallel to the median longitudinal vertical plane passing through the outermost point of the vehicle on the left (in the case of vehicles driven on the right), or on the right (in the case of vehicles driven on the left) and extends from 10 m behind the driver's ocular points to the horizon (Figure 4).                                  3.4.4. Right-hand exterior rear-view mirror for vehicles driven on the right and left-hand exterior rear-view mirror for vehicles driven on the left.          3.4.4.1. The field of vision must be such that the driver can see at least a 3 750 m-wide, flat, horizontal portion of the road, which is bounded on the left (in the case of vehicles driven on the right), or on the right (in the case of vehicles driven on the left) by a plane parallel to the median longitudinal vertical plane of the vehicle and passing through the outermost point of the vehicle on the right (in the case of vehicles driven on the right) or on the left (in the case of vehicles driven on the left) and which extends from 30 m behind the driver's ocular points to the horizon.                   3.4.4.2. In addition, the road must be visible to the driver over a width of 0 775 m, from a point 4 m behind the vertical plane passing through the driver's ocular points (Figure 4).                                  3.4.5. Obstructions  In the determination of the fields of vision specified above, no account is taken of obstructions caused by door handles, outline marker lights, direction indicators, the extremities of rear bumpers and obstructions due to the bodywork similar to those caused by the abovementioned elements.               3.4.6. Test procedure  The field of vision shall be determined by placing powerful light sources at the ocular points and examining the light reflected on a vertical monitoring screen. Other, equivalent methods may be used.   >PIC FILE= "T0015083">    Appendix 1  PROCEDURE FOR DETERMINING THE RADIUS OF CURVATURE "r" OF A MIRROR'S REFLECTION SURFACE          1. MEASUREMENTS            1.1. Equipment  The "spherometer" described in Figure 1 is used.                       1.2. Measuring points              1.2.1. The principal radii of curvature shall be measured at three points situated as close as possible to positions at one third, half and two thirds of the distance along the arc of the reflecting surface passing through the centre of the mirror and parallel to segment b, or of the arc passing through the centre of the mirror which is perpendicular to it if this arc is the longer.                           1.2.2. Where, owing to the size of the mirror, it is impossible to obtain measurements in the directions defined in item 1.8 of Annex I, the technical services responsible for the tests may take measurements at the said point in two perpendicular directions as close as possible to those prescribed above.                                                                     2. CALCULATION OF THE RADIUS OF CURVATURE (r)  "r" expressed in mm is calculated from the formula: >PIC FILE= "T0015084">   where:  rp1 = the radius of curvature at the first measuring point,  rp2 = the radius of curvature at the second measuring point,  rp3 = the radius of curvature at the third measuring point.   >PIC FILE= "T0015085">     Appendix 2  TEST METHOD FOR DETERMINING REFLECTIVITY   1. DEFINITIONS  >PIC FILE= "T0015086">   2. APPARATUS            2.1. General  The apparatus shall consist of a light source, a holder ror the test sample, a receiver unit with a photodetector and an indicating meter (see figure 1), and means of eliminating the effects of extraneous light.  The receiver may incorporate a light-integrating sphere to facilitate measuring the reflectance of non-flat (convex) mirrors (see figure 2).                       2.2. Spectral characteristics of light source and receiver  The light source shall consist of a CIE standard source A and associated optics to provide a near-collimated light beam. A voltage stabilizer is recommended in order to maintain a fixed lamp voltage during instrument operation.  The receiver shall have a photodetector with a spectral response proportional to the photopic luminosity function of the CIE (1931) standard colorimetric observer (see table). Any other combination of illuminant-filter-receptor giving the overall equivalent of CIE standard illuminant A and photopic vision may be used. When an integrating sphere is used in the receiver, the interior surface of the sphere shall be coated with a matt (diffusive) spectrally non-selective white coating.                       2.3. Geometrical conditions >PIC FILE= "T0015312">   When an integrating sphere is used in the receiver section, the sphere shall have a minimum diameter of 127 mm (5 in). The sample and incident beam apertures in the sphere wall shall be of such a size as to admit the entire incident and reflected light beams. The photodetector shall be so located as not to receive direct light from either the incident or the reflected beam.  >PIC FILE= "T0015315">                         2.4. Electrical characteristics of the photodetector-indicator unit  The photodetector output as read on the indicating meter shall be a linear function of the light intensity on the photosensitive area. Means (electrical and/or optical) shall be provided to facilitate zeroing and calibration adjustments. Such means shall not affect the linearity or the spectral characteristics of the instrument. The accuracy of the receptor-indicator unit shall be within ± 2 % of full scale, or ± 10 % of the magnitude of the reading, whichever is the smaller.                       2.5. Sample holder  The mechanism shall be capable of locating the test sample so that the axes of the source arm and receptor intersect at the reflecting surface. The reflecting surface may lie within or at either face of the mirror sample, depending on whether it is a first-surface, second-surface or prismatic "flip"-type mirror.                                         3. PROCEDURE            3.1. Direct calibration method  In the direct calibration method, air is used as the reference standard. This method is applicable for those instruments which are so constructed as to permit calibration at the 100 % point by swinging the receiver to a position directly on the axis of the light source (see figure 1).  It may be desired in some cases (such as when measuring low-reflectivity surfaces) to use an intermediate calibration point (between 0 and 100 % on the scale) with this method. In these cases, a neutral density filter of known transmittance shall be inserted in the optical path, and the calibration control shall then be adjusted until the meter reads the percentage transmission of the neutral density filter. This filter shall be removed before reflectivity measurements are performed.                       3.2. Indirect calibration method  The indirect calibration method is applicable in the case of instruments with fixed source and receiver geometry. A properly calibrated and maintained reflectance standard is required. This reference standard should preferably be a flat mirror with a reflectance value as near as possible to that of the test samples.                       3.3. Flat mirror measurement  The reflectance of flat mirror samples can be measured on instruments employing either the direct or the indirect calibration method. The reflectance value is read directly from the indicating meter. >PIC FILE= "T0015087">    >PIC FILE= "T0015088">    >PIC FILE= "T0015089">     ANNEX II MODEL EEC COMPONENT TYPE-APPROVAL CERTIFICATE  >PIC FILE= "T0015090">     ANNEX III  ANNEX TO THE EEC TYPE-APPROVAL CERTIFICATE FOR A VEHICLE WITH REGARD TO  THE INSTALLATION OF REAR-VIEW MIRRORS (Articles 4 (2) and 10 of Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers)  >PIC FILE= "T0015091">   >PIC FILE= "T9001085">   ANNEX IV PROCEDURE FOR DETERMINING THE H POINT AND VERIFYING THE RELATIVE POSITIONS OF THE R AND H POINTS  The relevant parts of Annex III to Directive 77/649/EEC are applicable.