Avis juridique important

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31999L0012

Commission Directive 1999/12/EC of 8 March 1999 adapting to technical progress for the second time the Annex to Council Directive 88/320/EEC on the inspection and verification of good laboratory practice (GLP) (Text with EEA relevance)

Official Journal L 077 , 23/03/1999 P. 0022 - 0033

COMMISSION DIRECTIVE 1999/12/EC of 8 March 1999 adapting to technical progress for the second time the Annex to Council Directive 88/320/EEC on the inspection and verification of good laboratory practice (GLP) (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 88/320/EEC of 9 June 1988 on the inspection and verification of good laboratory practice (GLP) (1) as amended by Commission Directive 90/18/EEC (2), and in particular Article 7(2) thereof,Whereas, on 9 March 1995, the OECD Council adopted a Decision amending the Annexes to the Council Decision-Recommendation on compliance with principles of good laboratory practice which affects the texts included in the Annex to Directive 88/320/EEC;Whereas it is necessary to adapt for a second time the Annex to Directive 88/320/EEC so as to take account of the OECD Council Decision of 9 March 1995, and, by publishing the full text of the annexes on the inspection and verification of good laboratory practice, to facilitate the uniform interpretation thereof;Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the Directives concerning the elimination of technical barriers to trade in dangerous substances and preparations,HAS ADOPTED THIS DIRECTIVE:Article 1 The Annex to Directive 88/320/EEC is replaced by the Annex hereto.Article 2 1. Member States shall adopt the laws, regulations and administrative provisions necessary in order to comply with this Directive not later than 30 September 1999 and shall forthwith inform the Commission thereof.2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.Article 3 This Directive is addressed to the Member States.Done at Brussels, 8 March 1999.For the CommissionMartin BANGEMANNMember of the Commission(1) OJ L 145, 11. 6. 1988, p. 35.(2) OJ L 11, 13. 1. 1990, p. 37.ANNEX The provisions for the inspection and verification of GLP which are contained in parts A and B are those contained in Annexes I (Guides for compliance monitoring procedures for good laboratory practice) and II (Guidance for the conduct of test facility inspections and study audits) respectively of the OECD Council Decision-Recommendation on compliance with principles of good laboratory practice [C(89)87(Final)] of 2 October 1989 as revised by the OECD Council Decision amending the Annexes to the Council Decision-Recommendation on compliance with principles of good laboratory practice of 9 March 1995 [C(95)8(Final)].PART A REVISED GUIDES FOR COMPLIANCE MONITORING PROCEDURES FOR GOOD LABORATORY PRACTICE To facilitate the mutual acceptance of test data generated for submission to Regulatory Authorities of the OECD member countries, harmonisation of the procedures adopted to monitor good laboratory practice compliance, as well as comparability of their quality and rigour, are essential. The aim of this part of the Annex is to provide detailed practical guidance to the Member States on the structure, mechanisms and procedures they should adopt when establishing national good laboratory practice compliance monitoring programmes so that these programmes may be internationally acceptable.It is recognised that Member States will adopt GLP principles and establish compliance monitoring procedures according to national legal and administrative practices, and according to priorities they give to, for example the scope of initial and subsequent coverage concerning categories of chemicals and types of testing. Since Member States may establish more than one Good Laboratory Practice Monitoring Authority due to their legal framework for chemicals control, more than one good laboratory practice compliance programme may be established. The guidance set forth in the following paragraphs concerns each of these Authorities and compliance programmes, as appropriate.Definitions of terms The definitions of terms in the OECD principles of good laboratory practice adopted in Article 1 of Council Directive 87/18/EEC (1) are applicable to this part of the Annex. In addition, the following definitions apply:- GLP principles: principles of good laboratory practice that are consistent with the OECD principles of good laboratory practice as adopted in Article 1 of Directive 87/18/EEC,- GLP compliance monitoring: the periodic inspection of test facilities and/or auditing of studies for the purpose of verifying adherence to GLP principles,- (National) GLP compliance programme: the particular scheme established by a Member State to monitor good laboratory practice compliance by test facilities within its territories, by means of inspections and study audits,- (National) GLP Monitoring Authority: a body established within a Member State with responsibility for monitoring the good laboratory practice compliance of test facilities within its territories and for discharging other such functions related to good laboratory practice as may be nationally determined. It is understood that more than one such body may be established in a Member State,- Test facility inspection: an on-site examination of the test facility's procedures and practices to assess the degree of compliance with GLP principles. During inspections, the management structures and operational procedures of the test facility are examined, key technical personnel are interviewed, and the quality and integrity of data generated by the facility are assessed and reported,- Study audit: a comparison of raw data and associated records with the interim or final report in order to determine whether the raw data have been accurately reported, to determine whether testing was carried out in accordance with the study plan and standard operating procedures, to obtain additional information not provided in the report, and to establish whether practices were employed in the development of data that would impair their validity,- Inspector: a person who performs the test facility inspections and study audits on behalf of the (national) GLP Monitoring Authority,- GLP compliance status: the level of adherence of a test facility to the GLP principles as assessed by the (national) GLP Monitoring Authority,- Regulatory Authority: a national body with legal responsibility for aspects of the control of chemicals.Components of good laboratory practice compliance monitoring procedures Administration A (national) GLP compliance programme should be the responsibility of a properly constituted, legally identifiable body adequately staffed and working within a defined administrative framework.Member States should:- ensure that the (national) GLP Monitoring Authority is directly responsible for an adequate 'team` of inspectors having the necessary technical/scientific expertise or is ultimately responsible for such a team,- publish documents relating to the adoption of GLP principles within their territories,- publish documents providing details of the (national) GLP compliance programme, including information on the legal or administrative framework within which the programme operates and references to published acts, normative documents (e.g., regulations, codes of practice), inspection manuals, guidance notes, periodicity of inspections and/or criteria for inspection schedules, etc.,- maintain records of test facilities inspected (and their GLP compliance status) and of studies audited for both national and international purposes.Confidentiality (National) GLP Monitoring Authorities will have access to commercially valuable information and, on occasion, may even need to remove commercially sensitive documents from a test facility or refer to them in detail in their reports.Member States should:- make provision for the maintenance of confidentiality, not only by Inspectors but also by any other persons who gain access to confidential information as a result of GLP compliance monitoring activities,- ensure that, unless all commercially sensitive and confidential information has been excised, reports of test facility inspections and study audits are made available only to Regulatory Authorities and, where appropriate, to the test facilities inspected or concerned with study audits and/or to study sponsors.Personnel and training (National) GLP Monitoring Authorities should:- ensure that an adequate number of inspectors is available.The number of inspectors required will depend on:(a) the number of test facilities involved in the (national) GLP compliance programme;(b) the frequency with which the GLP compliance status of the test facilities is to be assessed;(c) the number and complexity of the studies undertaken by those test facilities;(d) the number of special inspections or audits requested by Regulatory Authorities,- ensure that inspectors are adequately qualified and trained.Inspectors should have qualifications and practical experience in the range of scientific disciplines relevant to the testing of chemicals. (National) GLP Monitoring Authorities should:(a) ensure that arrangements are made for the appropriate training of GLP inspectors, having regard to their individual qualifications and experience;(b) encourage consultations, including joint training activities where necessary, with the staff of (national) GLP Monitoring Authorities in other OECD member countries in order to promote international harmonisation in the interpretation and application of GLP principles, and in the monitoring of compliance with such principles,- ensure that inspectorate personnel, including experts under contract, have no financial or other interests in the test facilities inspected, the studies audited or the firms sponsoring such studies,- provide inspectors with a suitable means of identification (e.g., an identity card).Inspectors may be:- on the permanent staff of the (national) GLP Monitoring Authority,- on the permanent staff of a body separate from the (national) GLP Monitoring Authority, or- employed on contract, or in another way, by the (national) GLP Monitoring Authority to perform test facility inspections or study audits.In the latter two cases, the (national) GLP Monitoring Authority should have ultimate responsibility for determining the GLP compliance status of test facilities and the quality/acceptability of a study audit, and for taking any action based on the results of test facility inspections or study audits which may be necessary.(National) GLP compliance programmes GLP compliance monitoring is intended to ascertain whether test facilities have implemented GLP principles for the conduct of studies and are capable of assuring that the resulting data are of adequate quality. As indicated above, Member States should publish the details of their (national) GLP compliance programmes. Such information should, inter alia:- define the scope and extent of the programme.A (national) GLP compliance programme may cover only a limited range of chemicals, for example, industrial chemicals, pesticides, pharmaceuticals, etc., or may include all chemicals. The scope of the monitoring for compliance should be defined, both with respect to the categories of chemicals and to the types of tests subject to it, for example, physical, chemical, toxicological and/or ecotoxicological,- provide an indication as to the mechanism whereby test facilities enter the programme.The application of GLP principles to health and environmental safety data generated for regulatory purposes may be mandatory. A mechanism should be available whereby test facilities may have their compliance with GLP principles monitored by the appropriate (national) GLP Monitoring Authority,- provide information on categories of test facility inspections/study audits.A (national) GLP compliance programme should include:(a) provision for test facility inspections. These inspections include both a general test facility inspection and a study audit of one or more on-going or completed studies;(b) provisions for special test facility inspections/study audits at the request of a Regulatory Authority, for example, prompted by a query arising from the submission of data to a Regulatory Authority,- define the powers of inspectors for entry into test facilities and their access to data held by test facilities (including specimens, SOPs (standard operating procedures) other documentation, etc.).While inspectors will not normally wish to enter test facilities against the will of the facility's management, circumstances may arise where test facility entry and access to data are essential to protect public health or the environment. The powers available to the (national) GLP Monitoring Authority in such cases should be defined,- describe the test facility inspection and study audit procedures for verification of GLP compliance.The documentation should indicate the procedures which will be used to examine both the organisational processes and the conditions under which studies are planned, performed, monitored and recorded. Guidance for such procedures is available in part B of this Annex,- describe actions that may be taken as follow-up test facility inspections and study audits.Follow-up to test facility inspections and study audits When a test facility inspection or study audit has been completed, the inspector should prepare a written report of the findings.Member States should take action where deviations from GLP principles are found during or after a test facility inspection or study audit. The appropriate actions should be described in documents from the (national) GLP Monitoring Authority.If a test facility inspection or study audit reveals only minor deviations from GLP principles, the facility should be required to correct such minor deviations. The inspector may need, at an appropriate time, to return to the facility to verify that corrections have been introduced.Where no, or where only minor deviations have been found, the (national) GLP Monitoring Authority may:- issue a statement that the test facility has been inspected and found to be operating in compliance with GLP principles. The date of the inspections and, if appropriate, the categories of test inspected in the test facility at that time should be included. Such statements may be used to provide information to (national) GLP Monitoring Authorities in other OECD member countries,and/or- provide the Regulatory Authority which requested a study audit with a detailed report of the findings.Where serious deviations are found, the action taken by (national) GLP Monitoring Authorities will depend on the particular circumstances of each case and the legal or administrative provisions under which GLP compliance monitoring has been established within their countries. Actions which may be taken include, but are not limited to, the following:- issuance of a statement, giving details of the inadequacies or faults found which might affect the validity of studies conducted in the test facility,- issuance of a recommendation to a Regulatory Authority that a study be rejected,- suspension of test facility inspections or study audits of a test facility and, for example and where administratively possible, removal of the test facility from the (national) GLP compliance programme or from any existing list or register of test facilities subject to GLP test facility inspections,- requiring that a statement detailing the deviations be attached to specific study reports,- action through the courts, where warranted by circumstances and where legal/administrative procedures so permit.Appeals procedures Problems, or differences of opinion, between inspectors and test facility management will normally be resolved during the course of a test facility inspection or study audit. However, it may not always be possible for agreement to be reached. A procedure should exist whereby a test facility may make representations relating to the outcome of a test facility inspection or study audit for GLP compliance monitoring and/or relating to the action the GLP Monitoring Authority proposes to take thereon.PART B REVISED GUIDANCE FOR THE CONDUCT OF TEST FACILITY INSPECTIONS AND STUDY AUDITS Introduction The purpose of this part of the Annex is to provide guidance for the conduct of test facility inspections and study audits which would be mutually acceptable to OECD member countries. It is principally concerned with test facility inspections, an activity which occupies much of the time of GLP inspectors. A test facility inspection will usually include a study audit or review as a part of the inspection, but study audits will also have to be conducted from time to time at the request, for example, of a Regulatory Authority. General guidance for the conduct of study audits will be found at the end of this Annex.Test facility inspections are conducted to determine the degree of conformity of test facilities and studies with GLP principles and to determine the integrity of data to assure that resulting data are of adequate quality for assessment and decision-making by national Regulatory Authorities. They result in reports which describe the degree of adherence of a test facility to the GLP principles. Test facility inspections should be conducted on a regular, routine basis to establish and maintain records of the GLP compliance status of test facilities.Further clarification of many of the points in this part of the Annex may be obtained by referring to the OECD consensus documents on GLP (on, e.g., the role and responsibilities of the study director).Definitions of terms The definitions of terms in the OECD principles of good laboratory practice adopted in Article 1 of Directive 87/18/EEC and in part A of the Annex to this Directive are applicable to this part of the Annex.Test facility inspections Inspections for compliance with GLP principles may take place in any test facility generating health or environmental safety data for regulatory purposes. Inspectors may be required to audit data relating to the physical, chemical, toxicological or ecotoxicological properties of a substance or preparation. In some cases, inspectors may need assistance from experts in particular disciplines.The wide diversity of facilities (in terms both of physical layout and management structure), together with the variety of types of studies encountered by inspectors, means that the inspectors must use their own judgment to assess the degree and extent of compliance with GLP principles. Nevertheless, inspectors should strive for a consistent approach in evaluating whether, in the case of a particular test facility or study, an adequate level of compliance with each GLP principle has been achieved.In the following sections, guidance is provided on the various aspects of the testing facility, including its personnel and procedures, which are likely to be examined by inspectors. In each section, there is a statement of purpose, as well as an illustrative list of specific items which could be considered during the course of a test facility inspection. These lists are not meant to be comprehensive and should not be taken as such.Inspectors should not concern themselves with the scientific design of the study or the interpretation of the findings of studies with respect to risks for human health or the environment. These aspects are the responsibility of those Regulatory Authorities to which the data are submitted for regulatory purposes.Test facility inspections and study audits inevitably disturb the normal work in a facility. Inspectors should therefore carry out their work in a carefully planned way and, so far as practicable, respect the wishes of the management of the test facility as to the timing of visits to certain sections of the facility.Inspectors will, while conducting test facility inspections and study audits, have access to confidential, commercially valuable information. It is essential that they ensure that such information is seen by authorised personnel only. Their responsibilities in this respect will have been established within their (national) GLP compliance monitoring programme.Inspection procedures Pre-inspection Purpose: to familiarise the inspector with the facility which is about to be inspected in respect of management structure, physical layout of buildings and range of studies.Prior to conducting a test facility inspection or study audit, inspectors should familiarise themselves with the facility which is to be visited. Any existing information on the facility should be reviewed. This may include previous inspection reports, the layout of the facility, organisation charts, study reports, protocols and curricula vitae (CVs) of personnel. Such documents would provide information on:- the type, size and layout of the facility,- the range of studies likely to be encountered during the inspection,- the management structure of the facility.Inspectors should note, in particular, any deficiencies from previous test facility inspections. Where no previous test facility inspections have been conducted, a pre-inspection visit can be made to obtain relevant information.Test facilities may be informed of the date and time of inspector's arrival, the objective of their visit and the length of time they expect to be on the premises. This could allow the test facility to ensure that the appropriate personnel and documentation are available. In cases where particular documents or records are to be examined, it may be useful to identify these to the test facility in advance of the visit so that they will be immediately available during the test facility inspection.Starting conference Purpose: to inform the management and staff of the facility of the reason for the test facility inspection or study audit that is about to take place, and to identify the facility areas, study(ies) selected for audit, documents and personnel likely to be involved.The administrative and practical details of a test facility inspection or study audit should be discussed with the management of the facility at the start of the visit. At the starting conference, inspectors should:- outline the purpose and scope of the visit,- describe the documentation which will be required for the test facility inspection, such as lists of on-going and completed studies, study plans, standard operating procedures, study reports, etc. Access to and, if necessary, arrangements for the copying of relevant documents should be agreed on at this time,- clarify or request information as to the management structure (organisation) and personnel of the facility,- request information as to the conduct of studies not subject to GLP principles in the areas of the test facility where GLP studies are being conducted,- make an initial determination as to the parts of the facility to be covered during the test facility inspection,- describe the documents and specimens that will be needed for on-going or completed study(ies) selected for study audit,- indicate that a closing conference will be held at the completion of the inspection.Before proceeding further with a test facility inspection, it is advisable for the inspector(s) to establish contact with the facility's quality assurance (QA) unit.As a general rule, when inspecting a facility, inspectors will find it helpful to be accompanied by a member of the QA unit.Inspectors may wish to request that a room be set aside for examination of documents and other activities.Organisation and personnel Purpose: to determine whether the test facility has sufficient qualified personnel, staff resources and support services for the variety and number of studies undertaken; the organisational structure is appropriate, and management has established a policy regarding training and staff health surveillance appropriate to the studies undertaken in the facility.The management should be asked to produce certain documents, such as:- floor plans,- facility management and scientific organisation charts,- CVs of personnel involved in the type(s) of studies selected for the study audit,- list(s) of on-going and completed studies with information on the type of study, initiation/completion dates, test system, method of application of test substance and name of study director,- staff health surveillance policies,- staff job descriptions and staff training programmes and records,- an index to the facility's standard operating procedures (SOPs),- specific SOPs as related to the studies or procedures being inspected or audited,- list(s) of the study directors and sponsors associated with the study(ies) being audited.The inspector should check, in particular:- lists of on-going and completed studies to ascertain the level of work being undertaken by the test facility,- the identity and qualifications of the study director(s), the head of the quality assurance unit and other personnel,- existence of SOPs for all relevant areas of testing.Quality assurance programme Purpose: to determine whether the mechanisms used to assure management that studies are conducted in accordance with GLP principles are adequate.The head of the quality assurance (QA) unit should be asked to demonstrate the systems and methods for QA inspection and monitoring of studies, and the system for recording observations made during QA monitoring. Inspectors should check:- the qualifications of the head of QA, and of all QA staff,- that the QA unit functions independently from the staff involved in the studies,- how the QA unit schedules and conducts inspections, how it monitors identified critical phases in a study, and what resources are available for QA inspections and monitoring activities,- that where studies are of such short duration that monitoring of each study is impracticable, arrangements exist for monitoring on a sample basis,- the extent and depth of QA monitoring during the practical phases of the study,- the extent and depth of QA monitoring of routine test facility operation,- the QA procedure for checking the final report to ensure its agreement with the raw data,- that management receives reports from QA concerning problems likely to affect the quality or integrity of a study,- the actions taken by QA when deviations are found,- the QA role, if any, if studies or parts of studies are done in contract laboratories,- the part played, if any, by QA in the review, revision and updating of SOPs.Facilities Purpose: to determine if the test facility, whether indoor or outdoor, is of suitable size, design and location to meet the demands of the studies being undertaken.The inspector should check that:- the design enables an adequate degree of separation so that, for example, test substances, animals, diets, pathological specimens, etc. of one study cannot be confused with those of another,- environmental control and monitoring procedures exist and function adequately in critical areas, for example, animal and other biological test systems rooms, test substance storage areas, laboratory areas,- the general housekeeping is adequate for the various facilities and that there are, if necessary, pest control procedures.Care, housing and containment of biological test systems Purpose: to determine whether the test facility, if engaged in studies using animals or other biological test systems, has support facilities and conditions for their care, housing and containment, adequate to prevent stress and other problems which could affect the test system and hence the quality of data.A test facility may be carrying out studies which require a diversity of animal or plant species as well as microbial or other cellular or sub-cellular systems. The type of test systems being used will determine the aspects relating to care, housing or containment that the inspector will monitor. Using his judgment, the inspector will check, according to the test systems, that:- there are facilities adequate for the test systems used and for testing needs,- there are arrangements to quarantine animals and plants being introduced into the facility and that these arrangements are working satisfactorily,- there are arrangements to isolate animals (or other elements of a test system, if necessary) known to be, or suspected of being, diseased or carriers of disease,- there is adequate monitoring and record-keeping of health, behaviour or other aspects, as appropriate to the test system,- the equipment for maintaining the environmental conditions required for each test system is adequate, well maintained, and effective,- animal cages, racks, tanks and other containers, as well as accessory equipment, are kept sufficiently clean,- analyses to check environmental conditions and support systems are carried out as required,- facilities exist for removal and disposal of animal waste and refuse from the test systems and that these are operated so as to minimise vermin infestation, odours, disease hazards and environmental contamination,- storage areas are provided for animal feed or equivalent materials for all test systems; that these areas are not used for the storage of other materials such as test substances, pest control chemicals or disinfectants, and that they are separate from areas in which animals are housed or other biological test systems are kept,- stored feed and bedding are protected from deterioration by adverse environmental conditions, infestation or contamination.Apparatus, materials, reagents and specimens Purpose: to determine whether the test facility has suitably located, operational apparatus in sufficient quantity and of adequate capacity to meet the requirements of the tests being conducted in the facility and that the materials, reagents and specimens are properly labelled, used and stored.The inspector should check that:- apparatus is clean and in good working order,- records have been kept of operation, maintenance, verification, calibration and validation of measuring equipment and apparatus (including computerised systems),- materials and chemical reagents are properly labelled and stored at appropriate temperatures and that expiry dates are not being ignored. Labels for reagents should indicate their source, identity and concentration and/or other pertinent information,- specimens are well identified by test system, study, nature and date of collection,- apparatus and materials used do not alter to any appreciable extent the test systems.Test systems Purpose: to determine whether adequate procedures exist for the handling and control of the variety of test systems required by the studies undertaken in the facility, for example, chemical and physical systems, cellular and microbic systems, plants or animals.Physical and chemical systems The inspector should check that:- where required by study plans, the stability of test and reference substances was determined and that the reference substances specified in test plans were used,- in automated systems, data generated as graphs, recorder traces or computer print-outs are documented as raw data and archived.Biological test systems Taking account of the relevant aspects referred to above relating to care, housing or containment of biological test systems, the inspector should check that:- test systems are as specified in study plans,- test systems are adequately and, if necessary and appropriate, uniquely identified throughout the study, and that records exist regarding receipt of the test systems and document fully the number of test systems received, used, replaced or discarded,- housing or containers of test systems are properly identified with all the necessary information,- there is an adequate separation of studies being conducted on the same animal species (or the same biological test systems) but with different substances,- there is an adequate separation of animal species (and other biological test systems) either in space or in time,- the biological test system environment is as specified in the study plan or in SOPs for aspects such as temperature, or light/dark cycles,- the recording of the receipt, handling, housing or containment, care and health evaluation is appropriate to the test systems,- written records are kept of examination, quarantine, morbidity, mortality, behaviour, diagnosis and treatment of animal and plant test systems or other similar aspects as appropriate to each biological test system,- there are provisions for the appropriate disposal of test systems at the end of tests.Test and reference substances Purpose: to determine whether the test facility has procedures designed (i) to ensure that the identity, potency, quantity and composition of test and reference substances are in accordance with their specifications, and (ii) to properly receive and store test and reference substances.The inspector should check that:- there are written records on the receipt (including identification of the person responsible), and for the handling, sampling, usage and storage of tests and reference substances,- test and reference substances containers are properly labelled,- storage conditions are appropriate to preserve the concentration, purity and stability of the test and reference substances,- there are written records on the determination of identity, purity, composition, stability, and for the prevention of contamination of test and reference substances, where applicable,- there are procedures for the determination of the homogeneity and stability of mixtures containing test and reference substances, where applicable,- containers holding mixtures (or dilutions) of the test and reference substances are labelled and that records are kept of the homogeneity and stability of their contents, where applicable,- when the test is of longer than four weeks duration, samples from each batch of test and reference substances have been taken for analytical purposes and that they have been retained for an appropriate time,- procedures for mixing substances are designed to prevent errors in identification or cross-contamination.Standard operating procedures Purpose: to determine whether the test facility has written SOPs relating to all the important aspects of its operations, considering that one of the most important management techniques for controlling facility operations is the use of written SOPs. These relate directly to the routine elements of tests conducted by the test facility.The inspector should check that:- each test facility area has immediately available relevant, authorised copies of SOPs,- procedures exist for revision and updating of SOPs,- any amendments or changes to SOPs have been authorised and dated,- historical files of SOPs are maintained,- SOPs are available for, but not necessarily limited to, the following activities:(i) receipt; determination of identity, purity, composition and stability; labelling; handling; sampling; usage; and storage of test and reference substances;(ii) use, maintenance, cleaning, calibration and validation of measuring apparatus, computerised systems and environmental control equipment;(iii) preparation of reagents and dosing formulations;(iv) record-keeping, reporting, storage and retrieval of records and reports;(v) preparation and environmental control of areas containing the test systems;(vi) receipt, transfer, location, characterisation, identification and care of test systems;(vii) handling of the test systems before, during and at the termination of the study;(viii) disposal of test systems;(ix) use of pest control and cleaning agents;(x) quality assurance programme operations.Performance of the study Purpose: to verify that written study plans exist and that the plans and the conduct of the study are in accordance with GLP principles.The inspector should check that:- the study plan was signed by the study director,- any amendments to the study plan were signed and dated by the study director,- the date of the agreement to the study plan by the sponsor was recorded (where applicable),- measurements, observations and examinations were in accordance with the study plan and relevant SOPs,- the results of these measurements, observations and examinations were recorded directly, promptly, accurately and legibly and were signed (or initialled) and dated,- any changes in the raw data, including data stored in computers, did not obscure previous entries, included the reason for the change and identified the person responsible for the change and the date it was made,- computer-generated or stored data have been identified and that the procedures to protect them against unauthorised amendments or loss are adequate,- the computerised systems used within the study are reliable, accurate and have been validated,- any unforeseen events recorded in the raw data have been investigated and evaluated,- the results presented in the reports of the study (interim or final) are consistent and complete and that they correctly reflect the raw data.Reporting of study results Purpose: to determine whether final reports are prepared in accordance with GLP principles.When examining a final report, the inspector should check that:- it is signed and dated by the study director to indicate acceptance of responsibility for the validity of the study and confirming that the study was conducted in accordance with GLP principles,- it is signed and dated by other principal scientists, if reports from cooperating disciplines are included,- a quality assurance statement is included in the report and that it is signed and dated,- any amendments were made by the responsible personnel,- it lists the archive location of all samples, specimens and raw data.Storage and retention of records Purpose: to determine whether the facility has generated adequate records and reports and whether adequate provision has been made for the safe storage and retention of records and materials;The inspector should check:- that a person has been identified as responsible for the archive,- the archive facilities for the storage of study plans, raw data (including that from discontinued GLP studies), final reports, samples and specimens and records of education and training of personnel,- the procedures for retrieval of archived materials,- the procedures whereby access to the archives is limited to authorised personnel and records are kept of personnel given access to raw data, slides, etc.,- that an inventory is maintained of materials removed from, and returned to, the archives,- that records and materials are retained for the required or appropriate period of time and are protected from loss or damage by fire, adverse environmental conditions, etc.Study audits Test facility inspections will generally include, inter alia, study audits, which review on-going or completed studies. Specific study audits are also often requested by Regulatory Authorities, and can be conducted independently of test facility inspections. Because of the wide variation in the types of studies which might be audited, only general guidance is appropriate, and inspectors and others taking part in study audits will always need to exercise judgment as to the nature and extent of their examinations. The objective should be to reconstruct the study by comparing the final report with the study plan, relevant SOPs, raw data and other archived material.In some cases, inspectors may need assistance from other experts in order to conduct an effective study audit, for example, where there is a need to examine tissue sections under the microscope.When conducting a study audit, the inspector should:- obtain names, job descriptions and summaries of training and experience for selected personnel engaged in the study(ies) such as the study director and principal scientists,- check that there is sufficient staff trained in relevant areas for the study(ies) undertaken,- identify individual items of apparatus or special equipment used in the study and examine the calibration, maintenance and service records for the equipment,- review the records relating to the stability of the test substances, analyses of test substance and formulations, analyses of feed, etc.,- attempt to determine, through the interview process if possible, the work assignments of selected individuals participating in the study to ascertain if these individuals had the time to accomplish the tasks specified in the study plan or report,- obtain copies of all documentation concerning control procedures or forming integral parts of the study, including:(i) the study plan;(ii) SOPs in use at the time the study was done;(iii) logbooks, laboratory notebooks, files, worksheets, print-outs of computer-stored data, etc.; checking of calculations, where appropriate;(iv) the final report.In studies in which animals (i.e., rodents and other mammals) are used, the inspectors should follow a certain percentage of individual animals from their arrival at the test facility to autopsy. They should pay particular attention to the records relating to:- animal body weight, food/water intake, dose formulation and administration, etc.,- clinical observations and autopsy findings,- clinical chemistry,- pathology.Completion of inspection or study audit When a test facility inspection or study audit has been completed, the inspector should be prepared to discuss his findings with representatives of the test facility at a closing conference and should prepare a written report, i.e., the inspection report.A test facility inspection of any large facility is likely to reveal a number of minor deviations from GLP principles but, normally, these will not be sufficiently serious to affect the validity of studies emanating from that test facility. In such cases, it is reasonable for an inspector to report that the facility is operating in compliance with GLP principles according to the criteria established by the (national) GLP Monitoring Authority. Nevertheless, details of the inadequacies or faults detected should be provided to the test facility and assurances sought from its senior management that action will be taken to remedy them.The inspector may need to revisit the facility after a period of time to verify that necessary action has been taken.If a serious deviation from the GLP principles is identified during a test facility inspection or study audit which, in the opinion of the inspector, may have affected the validity of that study, or of other studies performed at the facility, the inspector should report back to the (national) GLP Monitoring Authority. The action taken by that Authority and/or the Regulatory Authority, as appropriate, will depend on the nature and extent of the non-compliance and the legal and/or administrative provisions within the GLP compliance programme.Where a study audit has been conducted at the request of a Regulatory Authority, a full report of the findings should be prepared and sent via the relevant (national) GLP Monitoring Authority.(1) OJ L 15, 17. 1. 1987, p. 29.


title: Council Directive 2006/69/EC of 24 July 2006 amending Directive 77/388/EEC as regards certain measures to simplify the procedure for charging value added tax and to assist in countering tax evasion or avoidance, and repealing certain Decisions granting derogations

text:
               12.8.2006

               EN

               Official Journal of the European Union

               L 221/9

      COUNCIL DIRECTIVE 2006/69/EC
   of 24 July 2006
   amending Directive 77/388/EEC as regards certain measures to simplify the procedure for charging value added tax and to assist in countering tax evasion or avoidance, and repealing certain Decisions granting derogations
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 93 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Parliament (1),
   Having regard to the opinion of the European Economic and Social Committee (2),
   Whereas:

               (1)

               In order to combat tax evasion or avoidance and to simplify the procedure for charging value added tax, certain derogations covering similar problems were granted under varying terms to individual Member States by the Council pursuant to Article 27(1) of Sixth Council Directive 77/388/EEC of 17 May 1977 on the harmonisation of the laws of the Member States relating to turnover taxes — Common system of value added tax: uniform basis of assessment (3). A solution to the said problems should be made available to all Member States through incorporation into that Directive. Those measures should be proportionate and limited to countering the problem concerned. Given that the Member States have different needs, that incorporation should be limited to extending the option of adopting the rules concerned to all Member States, as and when the need arises.

               (2)

               Member States should be able to take action to ensure that measures provided for in Directive 77/388/EEC relating to the taxable person and the transfer of a business as a going concern are not being exploited to evade and avoid tax.

               (3)

               It should be possible for Member States to intervene as regards the value of supplies and acquisitions in specific limited circumstances, to ensure that there is no loss of tax through the use of connected parties to derive tax benefits.

               (4)

               It should be possible for Member States to include, within the taxable amount of a transaction which involves the working of investment gold provided by a customer, the value of that investment gold where, by virtue of being worked, the gold loses its status of investment gold.

               (5)

               It should be emphasised that certain services with the nature of capital items may be included in the scheme which allows the adjustment of deductions for capital items over the lifetime of the asset, according to its actual use.

               (6)

               Member States should be able, in specific cases, to designate the recipient of supplies as the person responsible for paying and accounting for value added tax. This should assist Member States in simplifying the rules and countering tax evasion and avoidance in identified sectors and on certain types of transactions.

               (7)

               Directive 77/388/EEC should therefore be amended accordingly.

               (8)

               Consequently, Member States should not be able to continue to avail themselves of individual derogations granted to them by certain Council Decisions adopted pursuant to Article 27(1) of Directive 77/388/EEC and which are covered by the provisions in this Directive. The Decisions concerned should therefore be explicitly repealed. This Directive should not affect measures applied by Member States pursuant to Article 27(5) of Directive 77/388/EEC; nor should it affect derogations which have been granted pursuant to Article 27(1) of that Directive and which have not been repealed by this Directive.

               (9)

               The application of certain provisions in this Directive should be optional and they should allow Member States a certain degree of discretion. Where appropriate for reasons of transparency, it should be provided that Member States should inform the other Member States through the Advisory Committee on value added tax established under Article 29 of Directive 77/388/EEC of any national law adopted pursuant to those provisions. Such information should not be necessary with respect to national measures taken under a Decision which is repealed by this Directive, or which expires at the date of this Directive's entry into force, but which a Member State continues to apply under the provisions of this Directive,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 77/388/EEC is amended as follows:

               1.

               In Article 4(4), the following subparagraph shall be added:
               ‘A Member State exercising the option provided for in the second subparagraph, may adopt any measures needed to prevent tax evasion or avoidance through the use of this provision.’.

               2.

               In Article 5(8) the second sentence shall be replaced by the following:
               ‘Where appropriate, Member States may, in cases where the recipient is not wholly liable to tax, take the measures necessary to prevent distortion of competition. They may also adopt any measures needed to prevent tax evasion or avoidance through the use of this provision.’.

               3.

               Article 11(A) shall be amended as follows:

                           (a)

                           in paragraph (1)(d) the second subparagraph shall be deleted;

                           (b)

                           the following paragraphs shall be added:
                           ‘5.   Member States shall have the option of including in the taxable amount in respect of the supply of goods and services, the value of exempt investment gold within the meaning of Article 26b, which has been provided by the customer to be used as a basis for working and which as a result, loses its VAT exempt investment gold status when such goods and services are supplied. The value to be used is the open market value of the investment gold at the time that those goods and services are supplied.
                           6.   In order to prevent tax evasion or avoidance, Member States may take measures to ensure that the taxable amount in respect of a supply of goods or services shall be the open market value. The option shall be applied only in respect of supplies of goods and services involving family or other close personal ties, management, ownership, membership, financial or legal ties as defined by the Member State. For these purposes legal ties may include the relationship between an employer and employee or the employee's family, or any other closely connected persons.
                           The option in the first subparagraph may apply only in any of the following circumstances:

                                       (a)

                                       where the consideration is lower than the open market value and the recipient of the supply does not have a full right of deduction under Article 17;

                                       (b)

                                       where the consideration is lower than the open market value and the supplier does not have a full right of deduction under Article 17 and the supply is subject to an exemption under Article 13 or Article 28(3)(b);

                                       (c)

                                       where the consideration is higher than the open market value and the supplier does not have a full right of deduction under Article 17.

                                 Member States may restrict the categories of suppliers or recipients to whom the measures in the first and the second subparagraph shall apply.
                           Member States shall inform the Committee established in accordance with Article 29 of any new national measure adopted pursuant to the provisions of this paragraph.
                           7.   For the purposes of this Directive, “open market value” shall mean the full amount that, in order to obtain the goods or services in question at that time, a customer at the same marketing stage at which the supply of goods or services takes place, would have to pay, under conditions of fair competition, to a supplier at arm's length within the territory of the Member State in which the supply is subject to tax.
                           Where no comparable supply of goods or services can be ascertained, “open market value” shall mean, in respect of goods, an amount that is not less than the purchase price of the goods or of similar goods or, in the absence of a purchase price, the cost price, determined at the time of supply; in respect of services it shall mean not less than the full cost to the taxable person of providing the service.’.

               4.

               Article 17(4), in the version set out in Article 28f(1), shall be amended as follows:

                           (a)

                           in point (a) of the second subparagraph ‘Article 21(1)(a) and (c)’ shall be replaced by ‘Article 21(1)(a), (1)(c) or (1)(f) or Article 21(2)(c)’;

                           (b)

                           in point (b) of the second subparagraph ‘Article 21(1)(a)’ shall be replaced by ‘Article 21(1)(a), or (1)(f) or Article 21(2)(c)’.

               5.

               In Article 18(1)(d), in the version set out in Article 28f(2), ‘Article 21(1)’ shall be replaced by ‘Article 21(1) or Article 21(2)(c)’.

               6.

               In Article 20(4), the following subparagraph shall be added:
               ‘Member States may also apply paragraphs 2 and 3 to services which have characteristics similar to those normally attributed to capital goods.’.

               7.

               In Article 21(2), in the version set out in Article 28g, the following point shall be added:

                           ‘(c)

                           where the following supplies are carried out, Member States may lay down that the person liable to pay tax is the taxable person to whom those supplies are made:

                                       (i)

                                       the supply of construction work, including repair, cleaning, maintenance, alteration and demolition services in relation to immovable property, as well as the handing over of construction works considered to be a supply of goods by virtue of Article 5(5);

                                       (ii)

                                       the supply of staff engaged in activities covered by (i);

                                       (iii)

                                       the supply of immovable property, as referred to in Article 13(B)(g) and (h), where the supplier has opted for taxation of the supply pursuant to point (C)(b) of that Article;

                                       (iv)

                                       the supply of used material, used material which cannot be re-used in the same state, scrap, industrial and non industrial waste, recyclable waste, part processed waste and certain goods and services, as identified in Annex M;

                                       (v)

                                       the supply of goods provided as security by one taxable person to another in execution of that security;

                                       (vi)

                                       the supply of goods following the cession of the reservation of ownership to an assignee and the exercising of this right by the assignee;

                                       (vii)

                                       the supply of immovable property sold by the judgment debtor in a compulsory sale procedure.

                                 For the purposes of this point, Member States may provide that a taxable person who also carries out activities or transactions that are not considered to be taxable supplies of goods or services in accordance with Article 2 shall be deemed to be a taxable person in respect of supplies received as referred to in the first subparagraph. A non-taxable body governed by public law, may be deemed to be a taxable person in respect of supplies received as referred to in (v), (vi) and (vii).
                           For the purposes of this point, Member States may specify the supplies of goods and services covered, and the categories of suppliers or recipients to whom these measures may apply. They may also limit the application of this measure to some of the supplies of goods and services listed in Annex M.
                           Member States shall inform the Committee established in accordance with Article 29 of any new national measure adopted pursuant to the provisions of this point.’.

               8.

               Annex M set out in Annex I to this Directive shall be added.

         Article 2
   Decisions listed in Annex II of this Directive shall be repealed with effect from 1 January 2008.
   Article 3
   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply the provisions necessary to comply with Article 1(3), as concerns a new Article 11A(7) of Directive 77/388/EEC, and with Article 1(4), as concerns the reference in Article 17(4) points (a) and (b) of Directive 77/388/EEC in the version set out in Article 28f(1) to Article 21(1)(f) of that Directive, from 1 January 2008 at the latest.
   When Member States adopt provisions under this Directive, they shall forthwith communicate to the Commission the text of those provisions, which shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   Article 4
   This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 24 July 2006.

            For the Council

            The President

         K. RAJAMÄKI

      (1)  Opinion of 6 July 2006 (not yet published in the Official Journal).

      (2)  OJ C 65, 17.3.2006, p. 103.

      (3)  OJ L 145, 13.6.1977, p. 1. Directive as last amended by Directive 2006/18/EC (OJ L 51, 22.2.2006, p. 12).

      ANNEX I

            ‘ANNEX M
            List of supplies of goods and services as referred to in Article 21(2)(c)(iv)

                        (a)

                        the supply of ferrous and non ferrous waste, scrap, and used materials including that of semi-finished products resulting from the processing, manufacturing or melting down of ferrous and non-ferrous metals and their alloys;

                        (b)

                        the supply of ferrous and non-ferrous semi-processed products and certain associated processing services;

                        (c)

                        the supply of residues and other recyclable materials consisting of ferrous and non-ferrous metals, their alloys, slag, ash, scale and industrial residues containing metals or their alloys and the supply of selection, cutting, fragmenting and pressing services for these products;

                        (d)

                        the supply of, and certain processing services relating to, ferrous and non-ferrous waste as well as parings, scrap, waste and used and recyclable material consisting of cullet, glass, paper, paperboard and board, rags, bone, leather, imitation leather, parchment, raw hides and skins, tendons and sinews, twine, cordage, rope, cables, rubber and plastic;

                        (e)

                        the supply of the materials referred to in this annex after processing in the form of cleaning, polishing, selection, cutting, fragmenting, pressing or casting into ingots;

                        (f)

                        the supply of scrap and waste from the working of base materials.’

      ANNEX II
      List of Decisions under Article 27 of Directive 77/388/EEC repealed by this Directive

                  The Council Decision deemed to have been adopted on 15 April 1984 authorising the United Kingdom to apply a measure derogating from the Sixth Directive with a view to avoiding certain types of fraud or tax evasion on supplies of gold, gold coins and gold scrap between taxable persons by a special tax accounting scheme (1).

                  The Council Decision deemed to have been adopted on 11 April 1987 authorising the United Kingdom to apply a measure derogating from Article 11 of Directive 77/388/EEC (2).

                  Council Decision 88/498/EEC (3) authorising the Kingdom of the Netherlands to apply a measure derogating from Article 21(1)(a) of Directive 77/388/EEC.

                  A Council Decision deemed to have been adopted on 18 February 1997 under the procedure contained in Article 27(4) of Directive 77/388/EEC in its version of 17 May 1977 authorising the Republic of France to apply a measure derogating from Articles 2 and 10 of Directive 77/388/EEC. This decision follows notification of the request to Member States on 18 December 1996.

                  Council Decision 98/23/EC (4) authorising the United Kingdom to extend application of a measure derogating from Article 28e(1) of Directive 77/388/EEC.

                  Council Decision 2002/439/EC (5) authorising Germany to apply a measure derogating from Article 21 of Directive 77/388/EEC.

                  Council Decision 2002/880/EC (6) authorising Austria to apply a measure derogating from Article 21 of Directive 77/388/EEC.

                  Council Decision 2004/290/EC (7) authorising Germany to apply a measure derogating from Article 21 of Directive 77/388/EEC.

                  Council Decision 2004/736/EC (8) authorising the United Kingdom to introduce a special measure derogating from Article 11 of Directive 77/388/EEC.

                  Council Decision 2004/758/EC (9) authorising Austria to apply a measure derogating from Article 21 of Directive 77/388/EEC.

         (1)  OJ L 264, 5.10.1984, p. 27.

         (2)  OJ L 132, 21.5.1987, p. 22.

         (3)  OJ L 269, 29.9.1988, p. 54.

         (4)  OJ L 8, 14.1.1998, p. 24. Decision as last amended by Decision 2003/909/EC (OJ L 342, 30.12.2003, p. 49).

         (5)  OJ L 151, 11.6.2002, p. 12.

         (6)  OJ L 306, 8.11.2002, p. 24.

         (7)  OJ L 94, 31.3.2004, p. 59.

         (8)  OJ L 325, 28.10.2004, p. 58.

         (9)  OJ L 336, 12.11.2004, p. 38.


Avis juridique important

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31989L0369

Council Directive 89/369/EEC of 8 June 1989 on the prevention of air pollution from new municipal waste incineration plants

Official Journal L 163 , 14/06/1989 P. 0032 - 0036 Finnish special edition: Chapter 15 Volume 9 P. 0061  Swedish special edition: Chapter 15 Volume 9 P. 0061

*****COUNCIL  DIRECTIVE  of 8 June 1989  on the prevention of air pollution from new municipal waste incineration plants  (89/369/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 130s thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the 1973 (4), 1977 (5), 1983 (6) and 1987 (7) European Community action programmes on the environment stress the importance of the prevention and reduction of air pollution;  Whereas the Council resolution of 19 October 1987 (8) on the action programme on the environnement for 1987 to 1992 states that it is important for Community action to concentrate, inter alia, on implementation of appropriate standards in order to ensure a high level of public health and environmental protection;  Whereas Council Directive 75/442/EEC of 15 July 1975 on waste (9) provides that waste must be disposed of without endangering human health and without harming the environment; whereas, to this end, the same Directive stipulates that any installation or undertaking treating waste must obtain a permit from the competent authority relating, inter alia, to the precautions to be taken;  Whereas Council Directive 84/360/EEC of 28 June 1984 on the combating of air pollution from industrial plants (10) provides that prior authorization shall be required to operate new industrial installations and in particular waste incineration plants; whereas this authorization may be issued only when all appropriate preventive measures against air pollution have been taken, including the application of the best available technology not entailing excessive costs;  Whereas the abovementioned Directive 84/360/EEC stipulates that the Council, acting unanimously on a proposal from the Commission, shall, if necessary, fix emission limit values based on the best available technology not entailing excessive costs and suitable measurement techniques and methods;  Whereas incineration of municipal waste gives rise to emissons of substances which can cause air pollution and thereby harm public health and the environment; whereas in some cases this pollution may have transboundary features;  Whereas the techniques for reducing emissions of certain pollutants from municipal waste incineration plants are well established; whereas they can be applied reasonably economically in new incineration plants; whereas they provide a means of attaining concentrations of pollutants in the combustion gases not exceeding certain limit values;  Whereas Community limit values for dioxins and furans should be fixed as soon as possible;  Whereas all the Member States have laws, regulations and administrative provisions concerning the combating of air pollution from stationary plants; whereas several Member States have specific provisions on municipal waste-incineration plants;  Whereas the Community, by fixing emission limit values and other pollution-prevention requirements, helps increase the effectiveness of the action taken by the Member States to combat air pollution from municipal waste-incineration plants;  Whereas, in order to ensure an effective protection of the environment, requirements and conditions should be laid down for authorization for any new municipal waste-incineration plant; whereas these requirements must include an obligation to observe emission limit values for certain pollutants and appropriate combustion conditions, taking account of the technical character of the plant and of the operating conditions;  Whereas provision must be made for appropriate measurements and verifications at the incineration plants; whereas the public must be informed of the conditions imposed and of the results obtained;  Whereas, as well as the establishment of emission limit values, it is important to encourage the development and dissemination of knowledge and use of clean technology as part of the preventive efforts to combat environmental pollution in the Community, especially regarding waste disposal;  Whereas, in accordance with Article 130t of the Treaty, the adoption of such Community provisions does not prevent any Member State from maintaining or introducing more stringent measures for the protection of the environment compatible with the Treaty,  HAS ADOPTED THIS DIRECTIVE:  Article 1  For the purposes of this Directive:  1. 'Air pollution' means the introduction by man, directly or indirectly, of substances or energy into the air resulting in deleterious effects of such a nature as to endanger human health, harm living resources and ecosystems and material property and impair or interefere with amenities and other legitimate uses of the environment.  2. 'Emission limit value' means the concentration and/or mass of polluting substances which is not to be exceeded in emissions from plants during a specified period.  3. 'Municipal waste' means domestic refuse, as well as commercial or trade refuse and other waste which, because of its nature or composition, is similar to domestic refuse.  4. 'Municipal waste-incineration plant' means any technical equipment used for the treatment of municipal waste by incineration, with or without recovery of the combustion heat generated, but excluding plants used specifically for the incineration of sewage sludge, chemical, toxic and dangerous waste, medical waste from hospitals or other types of special waste, on land or at sea, even if these plants may burn municipal waste as well.  This definition covers the site and the entire installation comprising the incinerator, its waste, fuel and air supply systems and the devices and systems for checking incineration operations and continuously recording and monitoring incineration conditions.  5. 'New municipal waste-incineration plant' means a municipal waste incineration plant for which authorization to operate is granted as from the date specified in Article 12 (1).  6. 'Nominal capacity' of the incineration plant means the sum of the incineration capacities of the furnaces of which the plant is composed, as specified by the constructor and confirmed by the operator, with due account being taken, in particular, of the calorific value of the waste, expressed as the quantity of waste incinerated per hour.  Article 2  Without prejudice to Article 4 of Directive 84/360/EEC, Member States shall take the necessary measures to ensure that the conditions laid down in Articles 3 to 10 of this Directive are attached to the prior authorization required to operate all new municipal waste-incineration plants under Article 3 of Directive 84/360/EEC and under Article 8 of Directive 75/442/EEC.  Article 3  1. The following emission limit values, standardized at the following conditions: temperature 273 K, pressure 101,3 kPa, 11 % oxygen or 9 % CO2, dry gas, shall apply to new municipal waste incineration plants:  Emission limit values in mg/nm 3 as a function of the nominal capacity of the incineration plant  1.2.3.4 //  //  //  //  // Pollutant  // less than 1 tonne/h  // 1 tonne/h or more but less than 3 tonnes/h   // 3 tonnes/h or more   //    //   //   //   // Total dust   // 200   // 100  // 30   //    //   //   //   // Heavy metals   //   //   //  // - Pb+Cr+Cu+Mn   // -   // 5   // 5   // - Ni+As   // -  // 1   // 1   // - Cd and Hg   // -   // 0,2   // 0,2   //  //   //   //   // Hydrochloric acid (HC1)   // 250   // 100  // 50   //    //   //   //   // Hydrofluoric acid (HF)   // -  // 4   // 2   //    //   //   //   // Sulphur dioxide (SO2)  // -   // 300   // 300   //    //   //   //  2. In regard to plants with a capacity of less than one tonne/h, the emission limit values may refer to an oxygen level of 17 %. In this case, the concentration values may not exceed those laid down in paragraph 1, divided by 2,5.  3. By way of derogation from paragraph 1, the competent authorities of a Member State may grant an authorization for plants with a nominal capacity of less than one tonne/h where special local conditions so require, provided that a limit value of 500 mg/nm 3 of total dust and all the provisions of Directive 84/360/EEC are complied with. The Member State concerned shall inform the Commission of these cases, which shall be the subject of consultations with it. The Commission shall in turn inform the other Member States thereof.  4. The competent authorities shall lay down emission limit values for pollutants other than those mentioned in paragraph 1 when they consider this to be appropriate because of the composition of the waste to be incinerated and of the characteristics of the incineration plant. For the purposes of laying down these emission limit values, the authorities shall take account of the potential harmful effects of the pollutants in question on human health and the environment and of the best available technology not entailing excessive costs. In particular, the competent authorities may fix emission limit values for dioxins and furans until such time as a Community directive concerning this specific question is adopted.  Article 4  1. All new municipal waste-incineration plants must be designed, equipped and operated in such a way that the gas resulting from the combustion of the waste is raised, after the last injection of combustion air, in a controlled and homogeneous fashion and even in the most unfavourable conditions, to a temperature of at least 850 oC at least two seconds in the presence of at least 6 % oxygen.  2. All new municipal waste incineration plants shall observe the following conditions when in operation:  (a) the concentration of carbon monoxide (CO) in the combustion gases must not exceed 100 mg/nm3;  (b) the concentration of organic compounds (expressed as total carbon) in the combustion gases must not exceed 20 mg/nm3.  The limits stipulated under (a) and (b) above shall be standardized at the following conditions: temperature 273 K, pressure 101,3 kPa, 11 % oxygen or 9 % CO2, dry gas.  3. Conditions different from those laid down in paragraph 1 may be authorized if appropriate techniques are used in the incineration furnaces or combustion-gas treatment equipment, provided that the competent authorities have satisfied themselves that, with the use of these techniques, the levels of polychlorinated dibenzodioxins (PCDDs) and of polychlorinated dibenzofurans (DCDFs) emitted will be equivalent to, or lower than, those obtained with the technical conditions laid down in paragraph 1.  Decisions taken under the provisions of this paragraph and the results of verifications made shall be communicated to the Commission by the competent authorities designated for this purpose by the Member States.  4. All new municipal waste-incineration plants must be designed, equipped and operated in such a way as to prevent emissions into the air giving rise to significant ground-level air pollution; in particular, waste gases shall be discharged in a controlled fashion by means of a stack.  The competent authority shall ensure that the stack height is calculated in such a way as to safeguard human health and the environment.  Article 5  1. The temperatures and the oxygen content laid down in Article 4 are minimum values to be observed at all times when the plant is in operation.  2. The carbon monoxide (CO) concentration laid down in Article 4 (2) (a) is the limit value for the hourly average for all plants. In addition, in the case of plants of nominal capacity of 1 tonne/h or more, at least 90 % of all measurements taken in any 24 hour period must be below 150 mg/nm3. Those averages shall be calculated by taking into account only the hours in which the plant is actually in operation, including the start-up and shut-off periods.  3. In the case of the other substances to be continuously monitored under Article 6:  (a) none of the moving seven-day averages of the concentration values measures for these substances may exceed the corresponding limit values;  (b) none of the daily averages of the concentration values measured for these substances may exceed the corresponding limit value by more than 30 %.  For the purposes of calculating the abovementioned average values, only the periods in which the plant is actually in operation shall be taken into account, including the start-up and shut-off periods.  4. Where only discontinuous measurements are required, the emission limit values shall be regarded as having been complied with if the results of each of the series of measurements defined and determined according to the rules laid down by the competent authorities under Articles 6 (3), (4) and (5) do not exceed the emission limit values. Article 6  1. The following measurements shall be taken at new municipal waste-incineration plants:  (a) concentrations of certain substances in the combustion gases:  (i) concentrations of total dust, CO, oxygen and HCl shall be continuously measured, and recorded in the case of plants of a nominal capacity equal to, or greater than, 1 tonne/h;  (ii) the following shall be measured periodically:  - concentrations of the heavy metals referred to in Article 3 (1), of HF, and of SO2, in the case of plants of a nominal capacity equal to, or greater than, 1 tonne/h,  - concentrations of total dust, of HCl, of CO and of oxygen in the case of plants of a nominal capacity of lesse than 1 tonne/h,  - concentrations of organic compounds (expressed as total carbon) in general;  (b) operating parameters:  (i) the temperatures of the gases in the area where the conditions imposed by Article 4 (1) are satisfied and the water vapour content of the combusion gases shall be continuously measured and recorded. Continuous measurement of the water vapour content shall not be necessary provided that the combustion gas is dried before the emissions are analysed;  (ii) the residence time of the combusion gases at the minimum temperature of 850 oC specified in Article 4 (1) must be the subject of appropriate verifications at least once when the incinceration plant is first brought into service and under the most unfavourable operating conditions envisaged.  2. The results of the measurements referred to in paragraph 1 shall be standardized at the following conditions:  temperature 273 K, pressure 101,3 kPa, 11 % oxygen or 9 % CO2, dry gas.  Where Article 3 (2) is applied, however, they may be standardized at the following conditions:  temperature 273 K, pressure 101,3 kPa, 17 % oxygen, dry gas.  3. All the measurement results shall be recorded, processed and presented in an appropriate fashion so that the competent authorities can verify compliance with the conditions laid down, in accordance with procedures to be decided upon by those authorities.  4. The sampling and measurement procedures used to satisfy the obligations imposed by paragraph 1 and the location of the sampling or measurement points shall require the prior approval of the competent authorities.  5. For the periodic measurements, the competent authorites shall lay down appropriate measurement programmes to ensure that the results are representative of the normal level of emissions of the substances concerned.  The results obtained must be suitable for verifying that the limit values applicable have been observed.  Article 7  All new municipal waste-incineration plants shall be equipped with auxiliary burners. These burners must be switched on automatically when the temperature of the combustion gases falls below 850 oC. They shall also be used during plant start-up and shut-down operations in order to ensure that the abovementioned minimum temperature is maintained at all times during these operations and as long as the waste is in the combustion chamber.  Article 8  1. Should the measurements taken show that the limit values laid down in this Directive have been exceeded, the competent authority shall be informed is soon as possible. It shall ensure that the plant concerned does not continue to operate while failing to comply with emission standards and shall take the necessary measures to ensure it is modified or no longer operated.  2. The competent authorities shall lay down the maximum permissible period of any technically unavoidable stoppages of the purification devices during which the concentrations in the discharges into the air of the substances which these devices are intended to reduce exceed the limit values laid down. In case of a breakdown, the operator shall reduce or close down operations as soon as practicable and until normal operations can be restored. Under no circumstances may the plant continue to operate more than eight hours uninterrupted; moreover, the cumulative duration over a year of operation in such conditions shall be less than 96 hours.  The dust content of the discharges shall under no circumstances exceed 600 mg/nm3 during the periods referred to in the preceding subparagraph and all the other conditions, in particular the combustion conditions, shall be complied with.  Article 9  The information required by Article 9 of Directive 84/360/EEC and, in accordance with appropriate procedures and in the form decided upon by the competent authorities, the results of the controls provided for in Articles 5 and 6 shall be made available to the public, subject to respect of provisions applicable in respect of commercial secrecy.  Article 10  Exceptionally, Member States may derogate from some of the provisions of this Directive in the case of plants which are specifically designed to burn waste-derived fuels (i.e. fuel manufactured from the combustible fraction of municipal waste by advanced mechanical processes designed to maximize the recycling potential of such waste and which contain no more than 15 % ash prior to any addition of substances to enhance fuel properties) where compliance with such provisions would entail excessive costs or if, given the technical characteristics of the plant in question, such provisions are inappropriate from a technical viewpoint, provided that:  - those plants burn no waste other than that defined above (apart from back-up fuels used for start-up operations),  - the provisions of Directive 84/360/EEC are complied with.  Article 11  1. In the framework of the verification required by Article 11 of Directive 84/360/EEC and also in relation to Article 4 of that Directive, Member States shall take the necessary measures to ensure that compliance with the conditions relating to new incineration plants pursuant to this Directive is verified by the competent authorities.  2. This Directive shall be without prejudice to the requirement of Article 12 of Directive 84/360/EEC for Member States to revise, where necessary, the conditions imposed in the authorization granted to an incineration plant.  Article 12  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 December 1990. They shall forthwith inform the Commission thereof.  2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.  Article 13  This Directive is addressed to the Member States.  Done at Luxembourg, 8 June 1989.  For the Council  The President  J. L. SAENZ COSCULLUELA  (1) OJ No C 75, 23. 3. 1988, p. 4.  (2) OJ No C 69, 20. 3. 1989, p. 219.  (3) OJ No C 318, 12. 12. 1988, p. 3.  (4) OJ No C 112, 20. 12. 1973, p. 1.  (5) OJ No C 139, 13. 6. 1977, p. 1.  (6) OJ No C 46, 17. 2. 1983, p. 1.  (7) OJ No C 328, 7. 12. 1987, p. 1.  (8) OJ No C 328, 7. 12. 1987, p. 1.  (9) OJ No L 194, 25. 7. 1975, p. 39.  (10) OJ No L 188, 16. 7. 1984, p. 20.