title: 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)

eurovoc_concepts:
EU control
OECD
research body
safety standard
technological change

text: L 77/22 EN Official Journal of the European Communities 23. 3. 1999 COMMISSION DIRECTIVE 1999/12/EC of 8 March 1999 adapting to technical progress for the second time the Annex to Council Dir- ective 88/320/EEC on the inspection and verification of good laboratory practice (GLP) (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, HAS ADOPTED THIS DIRECTIVE: 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 to the Council Decision amending Decision-Recommendation on compliance with prin- ciples of good laboratory practice which affects the texts included in the Annex to Directive 88/320/EEC; the Annexes 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 the Directives adaptation to technical progress of concerning the elimination of technical barriers to trade in dangerous substances and preparations, 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 offi- cial 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 Commission Martin BANGEMANN Member of the Commission (1) OJ L 145, 11. 6. 1988, p. 35. (2) OJ L 11, 13. 1. 1990, p. 37. 23. 3. 1999 EN Official Journal of the European Communities L 77/23 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 proced- ures 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 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 — 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 opera- tional 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, (1) OJ L 15, 17. 1. 1987, p. 29. L 77/24 EN Official Journal of the European Communities 23. 3. 1999 — 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 (National) GLP Monitoring Authorities should: to the testing of chemicals. (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, 23. 3. 1999 EN Official Journal of the European Communities L 77/25 — 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. L 77/26 EN Official Journal of the European Communities 23. 3. 1999 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). 23. 3. 1999 EN Official Journal of the European Communities L 77/27 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. L 77/28 EN Official Journal of the European Communities 23. 3. 1999 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, 23. 3. 1999 EN Official Journal of the European Communities L 77/29 — 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, L 77/30 EN Official Journal of the European Communities 23. 3. 1999 — 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 concentra- tion 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. P h y s i c a l a n d c h e m i c a l s y s t e m s 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. B i o l o g i c a l t e s t s y s t e m s 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, 23. 3. 1999 EN Official Journal of the European Communities L 77/31 — written records are kept of examination, quarantine, morbidity, mortality, behaviour, diagnosis and treat- ment 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. L 77/32 EN Official Journal of the European Communities 23. 3. 1999 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. 23. 3. 1999 EN Official Journal of the European Communities L 77/33 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 formula- tions, analyses of feed, etc. , — attempt to determine, through the interview process if possible, the work assignments of selected individ- uals 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


title: INTERROGAZIONE SCRITTA n. 518/99 dell'on. Herbert BÖSCH Promozione di centrali idroelettriche tramite i programmi PHARE e TACIS

eurovoc_concepts:
Central and Eastern European Countries
EU programme
development policy
energy policy
financial aid
hydroelectric power
power plant
soft energy

formats: html pdf print

text: C 348/92 Gazzetta ufficiale delle Comunità europee IT 3. 12. 1999 (1999/C 348/114) INTERROGAZIONE SCRITTA E-0517/99 di Jens-Peter Bonde (I-EDN) alla Commissione (8 marzo 1999) Oggetto: Controlli veterinari È disposta la Commissione a autorizzare i paesi membri a introdurre controlli veterinari alle frontiere per prevenire la peste suina e altre epizoozie? Risposta data dal sig. Fischler in nome della Commissione (8 aprile 1999) La libera circolazione delle merci, compresi gli animali e i prodotti di origine animale, è uno degli obiettivi fondamentali della Comunità. Fin dal momento dell’istituzione del libero mercato interno, le frontiere tra gli stati membri non sono più il luogo in cui vengono effettuati i controlli veterinari sugli animali e i prodotti di origine animale. Conformemente alla direttiva 90/425/CEE del 26 giugno 1990, relativa ai controlli veterinari e zootecnici applicabili negli scambi intracomunitari di taluni animali vivi e prodotti di origine animale, nella prospettiva della realizzazione del mercato interno (1), i controlli necessari per verificare se gli animali e i prodotti di origine animale rispondono alle esigenze della legislazione comunitaria in campo veterinario debbono essere effettuati in primo luogo sul posto dal quale essi vengono spediti, sotto la responsabilità dello Stato membro che effettua l’invio. Comunque, gli Stati membri destinatari possono istituire controlli veterinari non discriminatori sul luogo di destinazione. In certe circostanze, i controlli veterinari possono essere anche effettuati durante il trasporto od in altri luoghi, come i mercati od i centri di raccolta. Per proteggere la Comunità dal rischio di introdurre malattie animali, come la peste suina classica, al momento in cui gli animali e i prodotti di origine animale arrivano da un paese terzo, si deve procedere a controlli veterinari ai posti di ispezione di frontiera di ciascuno Stato membro, sotto la responsabilità dello Stato membro stesso. La Commissione non intende proporre alcuna modifica alla legislazione comunitaria che possa essere in contrasto con principi che regolano l’attuale sistema di controlli veterinari nella Comunità. (1) GU L 224 del 18. 8. 1990. (1999/C 348/115) INTERROGAZIONE SCRITTA E-0518/99 di Herbert Bösch (PSE) alla Commissione (8 marzo 1999) Oggetto: Promozione di centrali idroelettriche tramite i programmi PHARE e TACIS Secondo talune voci non sono previsti incentivi per la modernizzazione e l’incremanto dell’efficienza delle centrali idroelettriche o per la promozione di fonti energetiche alternative decentrate nei PECO. Può la Commissione comunicare quanto segue: 1. Corrisponde al vero che non sono previsti aiuti finanziari per la modernizzazione e l’incremento dell’efficienza delle centrali idroelettriche o per la promozione di fonti energetiche alternative nei PECO nel quadro dei programmi PHARE e TACIS? 2. 3. Secondo quali criteri vengono sostenuti i progetti energetici nel quadro dei programmi PHARE e TACIS? Per quali tipi di produzione energetica (idrica, carbone, gas, atomica) sono previsti sostegni? 4. Quale criterio di suddivisione si applica per le singole modalità?


title: QUESTION ECRITE no 513/99 de Sérgio RIBEIRO Accord commercial avec la République d'Afrique du Sud dans le secteur du textile et de l'habillement

eurovoc_concepts:
EU industrial policy
South Africa
clothing industry
common commercial policy
tariff reduction
textile industry
trade agreement (EU)
trade cooperation

formats: pdf print

text: 29. 1. 2000 FR Journal officiel des CommunautØs europØennes C 27 E/19 (2000/C 27 E/020) QUESTION (cid:201)CRITE E-0513/99 posØe par SØrgio Ribeiro (GUE/NGL) (cid:224) la Commission (8 mars 1999) Objet: Accord commercial avec la RØpublique d(cid:146)Afrique du Sud dans le secteur du textile et de l(cid:146)habillement Selon des reprØsentants du secteur concernØ, la rØduction (voire l(cid:146)Ølimination) des droits de douane pour diffØrentes catØgories de produits du secteur du textile et de l(cid:146)habillement est en train d(cid:146)Œtre nØgociØe dans le cadre de l(cid:146)accord commercial avec l(cid:146)Afrique du Sud. Une telle libØralisation serait asymØtrique et entra(cid:238)nerait une plus grande ouverture du marchØ communautaire. Ce secteur occupe toujours, (cid:224) l(cid:146)heure actuelle, une place importante dans l(cid:146)Øconomie de l(cid:146)Union europØenne. Il reprØsente au total plus de 4 % de la VAB en 1996 et prŁs de 8 % des emplois de l(cid:146)industrie de la transformation, et a un grand poids Øconomique et social dans certains pays et rØgions de l(cid:146)UE. Le secteur du textile et de l(cid:146)habillement a connu de grandes difficultØs, avec la perte de 600 000 emplois entre 1990 et 1996. Cet effondrement de l(cid:146)emploi devrait Œtre suivi par la suppression de 800 000 nou- veaux postes au cours des prochaines annØes. Cette situation et ces perspectives sont imputables (cid:224) l(cid:146)ampleur toujours croissante de la libØralisation commerciale, qui se traduit notamment par des accords bilatØraux (c(cid:146)est le cas par exemple de l(cid:146)accord avec la Turquie), par l(cid:146)entrØe dans la derniŁre phase de l(cid:146)accord sur le textile et l(cid:146)habillement et par l(cid:146)ouverture, depuis le 1er janvier 1998, aux pays candidats (cid:224) l(cid:146)adhØsion. Ce processus a mis ce secteur en question face (cid:224) d(cid:146)importantes contraintes concurrentielle, et il n(cid:146)est pas rare qu(cid:146)il ait ØtØ utilisØ comme «monnaie d(cid:146)Øchange» lors de certaines nØgociations mondiales. En outre, il serait un des secteurs les plus touchØs (sinon le plus touchØ) par la crise dite «asiatique». DŁs lors, la Commission pourrait-elle indiquer si ces informations relatives (cid:224) l(cid:146)accord avec l(cid:146)Afrique du Sud sont exactes, (cid:224) quelles catØgories de produits appartenant (cid:224) ce secteur s(cid:146)applique la nØgociation, quels sont les engagements pris au niveau de la rØduction ou de l(cid:146)Ølimination des droits de douane, quel est le calendrier du dØsarmement douanier et quelles en seront les consØquences? (2000/C 27 E/021) QUESTION (cid:201)CRITE E-0514/99 posØe par SØrgio Ribeiro (GUE/NGL) (cid:224) la Commission (8 mars 1999) Objet: Accord commercial avec la RØpublique d(cid:146)Afrique du Sud dans le secteur du textile et de l(cid:146)habillement Des nØgociations concernant la conclusion d(cid:146)un accord commercial avec l(cid:146)Afrique du Sud sont en cours. Comme cet accord pourrait contenir des clauses relatives au secteur du textile et de l(cid:146)habillement, la Commission pourrait-elle indiquer, aprŁs avoir rØpondu (cid:224) une autre question portant sur ces nØgociations et sur leurs modalitØs, quelles prØcautions elle prend actuellement pour la dØfense des marques euro- pØennes et la lutte contre la contrefa(cid:231)on, et quels mØcanismes de compensation interne elle compte mettre en avant en prØvision des consØquences de cet accord pour les industriels de ce secteur, et plus particuliŁrement les PME? RØponse commune aux questions Øcrites E-0513/99 et E-0514/99 donnØe par M. Pinheiro au nom de la Commission (7 mai 1999) La Commission a nØgociØ un accord de commerce, de dØveloppement et de coopØration avec l(cid:146)Afrique du Sud conformØment aux directives de nØgociation qu(cid:146)elle a re(cid:231)ues du Conseil en juin 1995 et mars 1996. Selon ces derniŁres directives, les nØgociations, dans le domaine commercial, avaient pour objet l(cid:146)Øta- blissement d(cid:146)une zone de libre Øchange (ZLE), au cours d(cid:146)une pØriode transitoire d(cid:146)une durØe maximale de 10 ans en principe, conformØment aux rŁgles de l(cid:146)Organisation mondiale du commerce (OMC)


title: INTERROGAZIONE SCRITTA n. 506/99 dell'on. Klaus LUKAS Sesta direttiva IVA - Austria

eurovoc_concepts:
Austria
VAT rate
building plot
derogation from EU law
property leasing

text: C 27 E/18 Gazzetta ufficiale delle Comunit(cid:224) europee IT 29. 1. 2000 Per quanto riguarda lo Spazio economico europeo, il governo francese, tramite una dichiarazione allegata all(cid:146)atto finale del Protocollo, ha fatto presente che l(cid:146)Accordo sullo Spazio economico europeo non si applica ai paesi e territori d(cid:146)oltremare associati alla Comunit(cid:224) economica europea, in conformit(cid:224) alle disposizioni del trattato che istituisce la Comunit(cid:224) economica europea (5). (1) GU C 325 del 12. 11. 1999, pag. 114. (2) GU L 329 del 29. 11. 1997. (3) Anche se l(cid:146)art. 183 (5) del trattato CE menziona solamente il diritto di stabilimento, l(cid:146)art. 232 della suddetta Decisione del Consiglio fa riferimento alle disposizioni applicabili allo stabilimento e alla fornitura di servizi. Si veda anche l(cid:146)art. 233b della stessa Decisione del Consiglio riguardante il riconoscimento delle qualifiche professio- nali. (4) Ai sensi dell(cid:146)art. 5(1) dell(cid:146)Atto di adesione della Danimarca all(cid:146)accordo di Schengen, tale accordo non si applica alla Groenlandia. Tuttavia, ai sensi dell(cid:146)art. 5(2) dello stesso atto, le persone che viaggiano tra la Groenlandia e i paesi Schengen (o l(cid:146)Islanda e la Norvegia) non sono controllate alle frontiere. (5) Cfr. protocollo che adegua l(cid:146)accordo sullo Spazio economico europeo (cid:129) Atto finale (cid:129) Dichiarazione comune (cid:129) Verbale concordato (cid:129) Dichiarazione del governo francese, GU L 1 del 3. 1. 1994. (2000/C 27 E/019) INTERROGAZIONE SCRITTA E-0506/99 di Klaus Lukas (NI) alla Commissione (8 marzo 1999) Oggetto: Sesta direttiva IVA (cid:129) Austria Nell(cid:146)ambito dei negoziati di adesione, all(cid:146)Austria Ł stata concessa una deroga relativamente all(cid:146)applicazione della sesta direttiva IVA. Ai sensi di detta deroga, fino al 31 dicembre 1998 l(cid:146)Austria era autorizzata ad applicare un(cid:146)aliquota ridotta sulla locazione di beni immobili ad uso residenziale. Alla luce di quanto sopra, pu(cid:242) la Commissione rispondere ai seguenti quesiti: 1. 2. 3. 4. Il governo federale austriaco ha chiesto una proroga della deroga in parola? In caso affermativo, quando Ł stata presentata la relativa domanda e quali provvedimenti ha adottato la Commissione? In caso negativo, quali sono le conseguenze dello scadere della deroga per quanto concerne l(cid:146)aliquota applicabile? Pu(cid:242) la Commissione fornire dati precisi circa l(cid:146)aliquota applicata a partire dal 1o gennaio 1999 per la locazione di immobili ad uso residenziale? Risposta data dal sig. Monti in nome della Commissione (26 aprile 1999) 1. e 2. fin al 31 dicembre 1998 un(cid:146)aliquota ridotta sulla locazione di beni immobili ad uso residenziale. Il governo austriaco non ha chiesto una proroga della deroga che autorizza l(cid:146)Austria ad applicare 3. e 4. Di conseguenza, allo scadere della deroga succitata, a decorrere dal 1 gennaio 1999 l(cid:146)Austria deve applicare il regime comune dell(cid:146)IVA alla locazione di beni immobili ad uso residenziale. In linea di principio, il governo austriaco deve esonerare queste locazioni in applicazione dell(cid:146)articolo 13, punto B, paragrafo b) della sesta direttiva 77/388/CEE del Consiglio, del 17 maggio 1977, in materia di armonizza- zione delle legislazioni degli Stati membri relative alle imposte sulla cifra di affari (cid:129) sistema comune di imposta sul valore aggiunto: base imponibile uniforme (1). L(cid:146)Austria pu(cid:242) tuttavia accordare ai contribuenti il diritto di optare per l(cid:146)imposizione di queste operazioni (articolo 13, punto C, paragrafo a) della sesta direttiva sull(cid:146)IVA). Nel caso in cui un contribuente decida di adottare detta opzione per quanto riguarda l(cid:146)imposizione della locazione di un bene immobile, sar(cid:224) necessario applicare l(cid:146)aliquota normale dell(cid:146)IVA. (1) GU L 145 del 13. 6. 1977


eurovoc_concepts:
Association Council (EU)
Czechia
EU programme
European social policy
health policy

text: 21. 4. 1999 EN Official Journal of the European Communities C 110/9 Proposal for a Council Decision concerning the Community position within the Association Council on the participation of the Czech Republic in the Community programmes in the fields of health and social policy (1999/C 110/08) COM(1999) 97 final (cid:151) 1999/0064(CNS) (Submitted by the Commission on 8 March 1999) THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 129 and Article 235, in conjunction with Article 228, paragraph 3, first alinea thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament, Whereas the additional Protocol to the Europe Agreement establishing an association between the European Communities and their Member States, of the one part, and the Czech Republic, of the other part, has been concluded by Decision of the Council and the Commission of 4 December 1995, Whereas, according to Article 1 of the Additional Protocol, the Czech Republic may participate in Community framework programmes, specific programmes, projects or other actions notably in the fields of health and social policy and, pursuant to Article 2, the terms and conditions of the Czech Republic’s participation in the activities referred to in Article 1 shall be decided by the Association Council, Whereas Decision No 645/96/EC of the European Parliament and of the Council of 29 March 1996 adopting a programme of Community action on health promotion, information, education and training within the framework for action in the field of public health (1996 to 2000) (1) and in particular Article 6(2) thereof, Decision No 646/96/EC of the European Parliament and of the Council of 29 March 1996 adopting an action plan to combat cancer within the framework for action in the field of public health (1996 to 2000) (2) and in particular Article 6(2) thereof, Decision No 647/96/EC of the European Parliament and of the Council of 29 March 1996 adopting a programme of Community action on the prevention of AIDS and certain other communicable diseases within the framework for action in the field of public health (1996 to 2000) (3) and in particular Article 6(2) thereof, Decision No 102/97/EC of the European Parliament and of the Council of 16 December 1996 adopting a programme of Community action on the prevention of drug dependence within the framework for action in the field of public health (1996 to 2000) (4) and in particular Article 6(2) thereof, and Council Decision 95/593/EC of 22 December 1995 on a medium-term Community action for men and women programme on equal opportunities (1996 to 2000) (5) and in particular Article 6(1) thereof, provide that these programmes shall be open to the partici- pation of associated central European countries in accordance with the conditions set out in the additional Protocols to the Association Agreements on participation in Community programmes, HAS DECIDED AS FOLLOWS: The position to be taken by the Community within the Association Council established by the Europe Agreement between the European Communities and their Member States, of the one part, and the Czech Republic, of the other part, concerning the participation of in Community programmes in the fields of health and social policy is that set out in the attached draft decision of the Association Council. the Czech Republic (1) OJ L 95, 16. 4. 1996, p. 1. (2) OJ L 95, 16. 4. 1996, p. 9. (3) OJ L 95, 16. 4. 1996, p. 16. (4) OJ L 19, 22. 1. 1997, p. 25. (5) OJ L 335, 30. 12. 1995, p. 37. C 110/10 EN Official Journal of the European Communities 21. 4. 1999 Draft Decision of the EC-Czech Republic Association Council adopting the terms and conditions for the participation of the Czech Republic in Community programmes in the fields of health and social policy THE ASSOCIATION COUNCIL Having regard to the Europe Agreement establishing an association between the European Communities and their Member States, of the one part, and the Czech Republic of the other part (1), Having regard to the Additional Protocol to the Europe Agreement establishing an association between the European Communities and their Member States, of the one part, and the Czech Republic, of the other part, concerning the Czech Republic’s participation in Community programmes (2), and in particular Articles 1 and 2 thereof, Whereas, according to Article 1 of the said Additional Protocol, the Czech Republic may participate in Community framework programmes, specific programmes, projects or other Community actions notably in the fields of health and social policy, Whereas, according to Article 2 of the said Additional Protocol the terms and conditions for the partici- pation of the Czech Republic in the activities referred to in Aticle 1 are to be decided by the Association Council, HAS DECIDED AS FOLLOWS: Article 1 The Czech Republic shall participate in the European Community programmes for health promotion combating cancer, prevention of AIDS and other communicable diseases, drug dependence and equal opportunities for men and women according to the terms and conditions set out in Annexes I and II which shall form an integral part of this Decision. This Decision shall apply until 31 December 2000. Article 2 This Decision shall enter into force on the day of its adoption. Article 3 (1) OJ L 360, 31. 12. 1994, p. 2. (2) OJ L 317, 30. 12. 1995, p. 45. 21. 4. 1999 EN Official Journal of the European Communities C 110/11 TERMS AND CONDITIONS FOR THE PARTICIPATION OF THE CZECH REPUBLIC IN THE PROGRAMMES FOR HEALTH PROMOTION, COMBATING CANCER, PREVENTION OF AIDS AND OTHER COMMUNICABLE DISEASES, DRUG DEPENDENCE AND EQUAL OPPORTUNITIES FOR MEN AND WOMEN ANNEX I 1. The Czech Republic shall participate in all activities of the health promotion, combating cancer, prevention of AIDS and other communicable diseases, drug dependence and equal opportunities for men and women programmes (hereinafter called (cid:145)the programmes(cid:146)) in conformity, unless otherwise provided in this Decision, with the objectives, criteria, procedures and deadlines as defined in Decision No 645/96/EC of the European Parliament and of the information, Council of 29 March 1996 adopting a programme of Community action on health promotion, education and training within the framework for action in the field of public health (1996 to 2000) and in particular Article 6(2) thereof, Decision No 646/96/EC of the European Parliament and of the Council of 29 March 1996 adopting an action plan to combat cancer within the framework for action in the field of public health (1996 to 2000) and in particular Article 6(2) thereof, Decision No 647/96/EC of the European Parliament and of the Council of 29 March 1996 adopting a programme of Community action on the prevention of AIDS and certain other communicable diseases within the framework for action in the field of public health (1996 to 2000) and in particular Article 6(2) thereof, Decision No 102/97/EC of the European Parliament and of the Council of 16 December 1996 adopting a programme of Community action on the prevention of drug dependence within the framework for action in the field of public health (1996 to 2000) and in particular Article 6(2) thereof, and Council Decision 95/593/EC of 22 December 1995 on a medium-term Community action programme on equal opportunities for men and women (1996 to 2000) and in particular Article 6(1) thereof. 2. The terms and conditions for the submission, assessment and selection of applications related to eligible institutions, organisations and individuals of the Czech Republic will be as far as possible in conformity with those prevailing in the Member States of the Community. 3. To ensure the Community dimension of the programmes, transnational projects and activities proposed by the Czech Republic will be required to include a minimum number of partners from the Member States of the Community. This minimum number will be decided in the framework of the implementation of the programmes, taking into account the nature of the various activities, the number of partners in a given project, and the number of countries participating in the programmes. 4. The Czech Republic will pay each year a contribution to the general budget of the European Communities to cover the costs resulting from its participation in the programmes (see Annex II). The Association Committeee is entitled to adapt this contribution whenever necessary. 5. The Member States of the Community and the Czech Republic will make every effort, within the framework of the existing provisions, to facilitate the free movement and residence of all eligible persons to the programmes moving between the Czech Republic and the Member States of the Community for the purpose of participating in activities covered by the Decision. 6. Without prejudice to the responsibilities of the Commission and the Court of Auditors of the European Community in relation to the monitoring and evaluation of the programmes pursuant to the Decisions concerning health promotion, combating cancer, prevention of AIDS and other communicable diseases, drug dependence and equal opportunities for men and women (articles 7, 7, 7, 7 and 11 respectively), the participation of the Czech Republic in the programmes will be continuously monitored on a partnership basis involving the Czech Republic and the Commission of the European Communities. The Czech Republic will submit the necessary reports to the Commission and take part in other specific activities set out by the Community in that context. 7. Without prejudice to the procedures referred to in Article 5 of the Decision on health promotion, Article 5 of the Decision on combating cancer, Article 5 of the Decision on prevention of AIDS and other communicable diseases, Article 5 of the Decision on drug dependence and Article 9 of the Decision on equal opportunities for men and women, the Czech Republic will be invited to any coordination meeting on any question concerning the implemen- tation of this Decision prior to the regular meetings of the Programme Committees. The Commission will inform the Czech Republic about the results of such regular meetings. 8. The language to be used as regards the application process, contracts, reports to be submitted and other adminis- trative arrangements for the programmes will be one of the official languages of the Community. C 110/12 EN Official Journal of the European Communities 21. 4. 1999 ANNEX II FINANCIAL CONTRIBUTION OF THE CZECH REPUBLIC TO HEALTH PROMOTION, COMBATING CANCER, PREVENTION OF AIDS AND OTHER COMMUNICABLE DISEASES, DRUG DEPENDENCE AND EQUAL OPPORTUNITIES FOR MEN AND WOMEN 1. The financial contribution of the Czech Republic will cover: (cid:151) financial support from the programmes to Czech participants, (cid:151) supplementary costs of an administrative nature related to the management of the programmes by the Commission stemming from the Czech Republic’s participation. 2. For every financial year, the aggregated amount of subsidies or any other financial support received from the programmes by the Czech beneficiaries will not exceed the contribution paid by the Czech Republic, after deduction of the supplementary administrative costs. Should the contribution paid by the Czech Republic to the general budget of the European Communities, after deduction of the supplementary administrative costs, be higher than the aggregated amount of subsidies or other financial support received by the Czech beneficiaries from the programmes, the Commission will transfer the balance to the next budgetary exercise, and it will be deducted from the following year’s contribution. Should such a balance be left when the programmes come to an end, the corresponding amount will be reimbursed to the Czech Republic. 3. Health promotion The Czech Republic’s annual contribution will be of EUR 164 031 from 1999. From this sum, an amount of EUR 10 731 will cover supplementary administrative costs related to the management of the programme by the Commission stemming from the Czech Republic’s participation. 4. Combating cancer The Czech Republic’s annual contribution will be of EUR 284 320 from 1999. From this sum, an amount of EUR the programme by the 18 600 will cover supplementary administrative costs related to the management of Commission stemming from the Czech Republic’s participation. 5. Prevention of AIDS and other communicable diseases The Czech Republic’s annual contribution will be of EUR 218 708 from 1999. From this sum, an amount of EUR 14 308 will cover supplementary administrative costs related to the management of the programme by the Commission stemming from the Czech Republic’s participation. 6. Drug dependence The Czech Republic’s annual contribution will be of EUR 109 354 from 1999. From this sum, an amount of EUR 7 154 will cover supplementary administrative costs related to the management of the programme by the Commission stemming from the Czech Republic’s participation. 7. Equal opportunities for men and women The Czech Republic’s annual contribution will be of EUR 163 870 from 1999. From this sum, an amount of EUR 10 720 will cover supplementary administrative costs related to the management of the programme by the Commission stemming from the Czech Republic’s participation. 8. The financial regulations applicable to the general budget of the Community will apply, notably to the management of the contribution of the Czech Republic. Upon entry into force of this Decision and at the beginning of each following year, the Commission will send to the Czech Republic a call for funds corresponding to its contribution to the costs under this Decision. This contribution will be expressed in euro and paid into an euro bank account of the Commission. The Czech Republic will pay its contribution to the annual costs under this Decision according to the call for funds and at the latest three months after the call for funds is sent. Any delay in the payment of the contribution shall give rise to the payment of interest by the Czech Republic on the outstanding amount from the due date. The interest rate corresponds to the rate applied by the European Monetary Cooperation Fund, for the month of the due date, for its operations in euro, increased by 1,5 percentage points. 9. The Czech Republic will pay the supplementary costs of an administrative nature referred to in paragraphs 3, 4, 5, 6 and 7 from its national budget. 10. The Czech Republic will pay 50 % of the remaining cost of its participation from its national budget. Subject to regular PHARE programming procedures, the remaining 50 % will be paid from the Czech Republic’s annual PHARE allocation


title: QUESTION ECRITE no 524/99 de Daniel VARELA SUANZES-CARPEGNA L'industrie de la conserve de produits de la pêche et de l'aquaculture dans l'Union européenne

eurovoc_concepts:
aid to industry
aquaculture
cannery
export refund
fishery product
food aid
health control
import policy
monetary compensatory amount
tariff reduction

text: C 370/50 Journal officiel des Communautés européennes FR 21. 12. 1999 (1999/C 370/063) QUESTION ÉCRITE E-0523/99 posée par Jan Mulder (ELDR) à la Commission (8 mars 1999) Objet: Interview du directeur général Landaburu dans la publication «Nederlandse Gemeente» des 18-25 décembre 1998 sur les États membres contributeurs? La publication «Nederlandse Gemeente» des 18-25 décembre 1998 publie une interview de M. Landaburu, Directeur général de la Direction générale de la politique régionale et de la cohésion de la Commission européenne. Dans le titre de cet article, ce haut fonctionnaire de l’Union européenne fustige les Pays-Bas en déclarant que «les contributeurs nés? sont très arrogants». La Commission européenne souscrit-elle aux déclarations du Directeur général Landaburu, à supposer 1. que celles-ci aient été reprises avec exactitude? La Commission estime-t-elle qu’il appartient à un fonctionnaire de la Commission de faire des 2. déclarations sur le comportement d’un État membre précis en ce qui concerne sa contribution au budget de l’Union européenne? Réponse donnée par Mme Wulf-Mathies au nom de la Commission (27 avril 1999) Les propos prêtés au directeur général de la Direction générale de la politique régionale et de la 1. cohésion ressortent d’une rencontre informelle avec un groupe de journalistes de la presse régionale consacrée, notamment, aux négociations relatives à l’Agenda 2000 et aux multiples situations de blocage qui étaient alors perceptibles. À aucun moment, il n’y a eu d’intention de disqualification des États membres dans le sens invoqué, mais il a certainement été fait état de la «fermeté» des contributeurs nets et de leur opposition aux «pays de la cohésion» sur l’interprétation du concept de la stablisation. lors de cette discussion, 2. Dans un souci de transparence et d’information de la presse et à travers elle, du citoyen européen, il n’apparaît pas inopportun que celui-ci soit informé de la teneur et parfois de la dureté des discussions entre les États membres, tant sur le thème des recettes que des dépenses du budget de la Communauté. (1999/C 370/064) QUESTION ÉCRITE E-0524/99 posée par Daniel Varela Suanzes-Carpegna (PPE) à la Commission (8 mars 1999) Objet: L’industrie de la conserve de produits de la pêche et de l’aquaculture dans l’Union européenne Au cours de la période de session de juin 1998, le Parlement européen a examiné et adopté le rapport d’initiative sur l’industrie de la conserve de produits de la pêche et de l’aquaculture dans l’Union européenne (A4-0137/98) (1), dans les conclusions duquel il invitait la Commission à élaborer une étude sur l’industrie de la conserve des produits de la pêche et de l’aquaculture dans l’Union européenne: entreprises, évolution de ce secteur d’activité au cours des dernières années dans les différents États membres, informations relatives à la production, à l’origine des matières premières, au volume des exportations et des importations, à l’emploi, aux normes techniques et sanitaires, au régime douanier et, d’une manière générale, à la législation applicable à ce secteur et à la codification de celle-ci. La Commission peut-elle indiquer quelles dispositions elle a prises en vue de faire droit à la demande de l’Assemblée européenne et de procéder à l’étude demandée et à la codification de la législation applicable au secteur de la conserve? (1) JO C 210 du 6. 7. 1998, p. 295


title: ΓΡΑΠΤΗ ΕΡΩΤΗΣΗ αρ θ. 531/99 του Daniel VARELA SUANZES- CARPEGNA Βιομηχανία κονσερβοποίησης αλιευτικών προiόντων και υδατοκαλλιέργεια στην Ευρωπαiκή Ένωση

text: C 370/52 Επι΄σηµη Εφηµερι΄δα των Ευρωπαι¨κω΄ν Κοινοτη΄των EL 21. 12. 1999 (1999/C 370/068) ΓΡΑΠΤΗ ΕΡΩΤΗΣΗ E-0529/99 υποβολη΄: Daniel Varela Suanzes-Carpegna (PPE) προς την Επιτροπη΄ (8 Μαρτι΄ου 1999) Θε΄µα: Βιοµηχανι΄α κονσερβοποι΄ησης αλιευτικω΄ν προïο΄ντων και υδατοκαλλιε΄ργεια στην Ευρωπαïκη΄ Ένωση Στη συνεδρι΄αση της ολοµε΄λειας του Ιουνι΄ου 1998 το Ευρωπαι¨κο΄ Κοινοβου΄λιο συζη΄τησε και ενε΄κρινε την ε΄κθεση πρωτοβουλι΄ας σχετικα΄ µε τη βιοµηχανι΄α κονσερβοποι΄ησης αλιευτικω΄ν προι¨ο΄ντων και την υδατοκαλλιε΄ργεια στην Ευρωπαι¨κη΄ Ένωση (A4-0137/98) (1), µε την οποι΄α, µεταξυ΄ α΄λλων, απαιτου΄σε την ε΄νταση των ελε΄γχων στα προι¨ο΄ντα τρι΄των χωρω΄ν, σε σχε΄ση µε την Οδηγι΄α 91/493/ΕΟΚ (2), σχετικα΄ µε τους υγειονοµικου΄ς κανο΄νες που διε΄πουν την παραγωγη΄ αλιευτικω΄ν προι¨ο΄ντων, ω΄στε τα προι¨ο΄ντα των χωρω΄ν αυτω΄ν να µην υπο΄κεινται σε λιγο΄τερο αυστηρου΄ς υγειονοµικου΄ς κανο΄νες απο΄ ο΄,τι η κοινοτικη΄ παραγωγη΄. Μπορει΄ η Επιτροπη΄ να µας πληροφορη΄σει σε ποιε΄ς ενε΄ργειες ε΄χει προβει΄ για να ικανοποιηθει΄ η απαι΄τηση της ολοµε΄λειας του Ευρωπαι¨κου΄ Κοινοβουλι΄ου; (1) (2) ΕΕ C 210 της 6. 7. 1998, σελ. 295. ΕΕ L 268 της 24. 9. 1991, σελ. 15. (1999/C 370/069) ΓΡΑΠΤΗ ΕΡΩΤΗΣΗ E-0530/99 υποβολη΄: Daniel Varela Suanzes-Carpegna (PPE) προς την Επιτροπη΄ (8 Μαρτι΄ου 1999) Θε΄µα: Βιοµηχανι΄α κονσερβοποι΄ησης αλιευτικω΄ν προïο΄ντων και υδατοκαλλιε΄ργεια στην Ευρωπαïκη΄ Ένωση Στη συνεδρι΄αση της ολοµε΄λειας του Ιουνι΄ου 1998 το Ευρωπαι¨κο΄ Κοινοβου΄λιο συζη΄τησε και ενε΄κρινε την ε΄κθεση πρωτοβουλι΄ας σχετικα΄ µε τη βιοµηχανι΄α κονσερβοποι΄ησης αλιευτικω΄ν προι¨ο΄ντων και την υδατοκαλλιε΄ργεια στην Ευρωπαι¨κη΄ Ένωση (A4-0137/98) (1), µε την οποι΄α, µεταξυ΄ α΄λλων εξε΄φραζε τη γνω΄µη ο΄τι η Ένωση θα πρε΄πει να αναπτυ΄ξει µια πολιτικη΄ εφοδιασµου΄ που να ανταποκρι΄νεται στις πραγµατικε΄ς ανα΄γκες της κοινοτικη΄ς µεταποι- ητικη΄ς βιοµηχανι΄ας στο συ΄νολο΄ της, υποστηρι΄ζοντας τον κοινοτικο΄ στο΄λο και διασφαλι΄ζοντας την ανα΄ πα΄σα στιγµη΄ προ΄σβαση στην αναγκαι΄α πρω΄τη υ΄λη, υπο΄ τις βε΄λτιστες συνθη΄κες που προσφε΄ρει η παγκο΄σµια αγορα΄. Μπορει΄ η Επιτροπη΄ να µας πληροφορη΄σει σε ποιε΄ς ενε΄ργειες ε΄χει προβει΄ για την εφαρµογη΄ των ο΄σων ζη΄τησε το Κοινοβου΄λιο; (1) ΕΕ C 210 της 6. 7. 1998, σελ. 295. (1999/C 370/070) ΓΡΑΠΤΗ ΕΡΩΤΗΣΗ E-0531/99 υποβολη΄: Daniel Varela Suanzes-Carpegna (PPE) προς την Επιτροπη΄ (8 Μαρτι΄ου 1999) Θε΄µα: Βιοµηχανι΄α κονσερβοποι΄ησης αλιευτικω΄ν προïο΄ντων και υδατοκαλλιε΄ργεια στην Ευρωπαïκη΄ Ένωση Στη συνεδρι΄αση της ολοµε΄λειας του Ιουνι΄ου 1998 το Ευρωπαι¨κο΄ Κοινοβου΄λιο συζη΄τησε και ενε΄κρινε την ε΄κθεση πρωτοβουλι΄ας σχετικα΄ µε τη βιοµηχανι΄α κονσερβοποι΄ησης αλιευτικω΄ν προι¨ο΄ντων και την υδατοκαλλιε΄ργεια στην Ερωπαι¨κη΄ Ένωση (A4-0137/98) (1), µε την οποι΄α, µεταξυ΄ α΄λλων, καλου΄σε την Επιτροπη΄ να προωθη΄σει διαφηµι- στικε΄ς εκστρατει΄ες υπε΄ρ της κοινοτικη΄ς παραγωγη΄ς κονσερβοποιηµε΄νων αλιευτικω΄ν προι¨ο΄ντων, διαδι΄δοντας την προε΄λευση, την ποιο΄τητα, τις εγγυη΄σεις παραγωγη΄ς και την υψηλη΄ θρεπτικη΄ τους αξι΄α, που επιτρε΄πουν στους καταναλωτε΄ς να διαπιστω΄σουν την υψηλη΄ ποιο΄τητα των κοινοτικω΄ν προι¨ο΄ντων. Μπορει΄ η Επιτροπη΄ να µας πληροφορη΄σει σε ποιε΄ς ενε΄ργειες ε΄χει προβει΄ για την εφαρµογη΄ των ο΄σων ζη΄τησε το Ευρωπαι¨κο΄ Κοινοβου΄λιο; (1) ΕΕ C 210 της 6. 7. 1993, σελ. 295


title: Richtlijn 1999/10/EG van de Commissie van 8 maart 1999 houdende afwijkingen van artikel 7 van Richtlijn 79/112/EEG van de Raad inzake de etikettering van levensmiddelen (Voor de EER relevante tekst)

eurovoc_concepts:
derogation from EU law
foodstuff
labelling

text: L 69/22 NL Publicatieblad van de Europese Gemeenschappen 16. 3. 1999 RICHTLIJN 1999/10/EG VAN DE COMMISSIE van 8 maart 1999 houdende afwijkingen van artikel 7 van Richtlijn 79/112/EEG van de Raad inzake de etikettering van levensmiddelen (Voor de EER relevante tekst) DE COMMISSIE VAN DE EUROPESE GEMEENSCHAPPEN, Gelet op het Verdrag tot oprichting van de Europese Gemeenschap, Gelet op Richtlijn 79/112/EEG van de Raad van 18 december 1978 betreffende de onderlinge aanpassing van de wetgevingen der lidstaten inzake etikettering en presentatie van levensmiddelen alsmede inzake de daar- voor gemaakte reclame (1), laatstelijk gew¶zigd bij Richt- lijn 97/4/EG van het Europees Parlement en de Raad (2), inzonderheid op artikel 7, lid 3, onder d), en lid 4, Overwegende dat in artikel 7, lid 2, onder a) en b), van Richtlijn 79/112/EEG wordt bepaald dat de hoeveelheid van een ingredi(cid:137)nt op de etikettering van een levens- middel moet worden vermeld wanneer dit ingredi(cid:137)nt in de verkoopbenaming voorkomt of opvallend op de etiket- tering wordt aangegeven; Overwegende dat krachtens Richtlijn 94/54/EG van de Commissie (3), gewijzigd bij Richtlijn 96/21/EG van de Raad (4), de vermelding „met „met suiker(s) en zoetstof(fen)” verplicht is op de etikettering van producten die deze ingredi(cid:137)nten bevatten; dat deze vermelding samen met de verkoopbenaming moet worden aangebracht; zoetstof(fen)” of Overwegende dat de in de Richtlijn 94/54/EG opge- nomen verplichting deze vermelding aan te brengen meebrengt dat de vermelding van de hoeveelheid van dit ingredi(cid:137)nt of deze ingredi(cid:137)nten krachtens artikel 7, lid 2, onder a) en/of b), van Richtlijn 79/112/EEG verplicht is; Overwegende dat de vermelding van de hoeveelheid zoet- stoffen echter geen factor is die bij de aankoop van een levensmiddel bepalend is voor de keuze van de consu- ment; Overwegende dat voorts vermeldingen inzake de toevoe- ging van vitaminen en mineralen tot gevolg hebben dat voedingswaarde-etikettering overeenkomstig Richtlijn 90/ 496/EEG van de Raad (5) verplicht is; Overwegende dat deze vermeldingen worden beschouwd als een integrerend deel van de handelsbenaming of als een opvallend aangegeven ingredi(cid:137)nt in de zin van artikel 7, lid 2, onder a) en/of b), van Richtlijn 79/112/EEG en derhalve tot gevolg hebben dat de vermelding van de hoeveelheid vitaminen en mineralen verplicht is; (1) PB L 33 van 8. 2. 1979, blz. 1. (2) PB L 43 van 14. 2. 1997, blz. 21. (3) PB L 300 van 23. 11. 1994, blz. 14. (4) PB L 88 van 5. 4. 1996, blz. 5. (5) PB L 276 van 6. 10. 1990, blz. 40. Overwegende dat deze dubbele informatie niet nuttig is voor de consument en deze zelfs in verwarring kan brengen, aangezien de hoeveelheid krachtens artikel 7, lid 4, van Richtlijn 79/112/EEG als percentage moet worden vermeld, terw¶l de hoeveelheid voor de voedingswaarde- etikettering in milligram moet worden vermeld; Overwegende dat gelet op het voorgaande nieuwe uitzon- deringen op de voorschriften inzake de kwantitatieve vermelding van ingredi(cid:137)nten dienen te worden vastge- steld; Overwegende dat overigens in artikel 7, lid 4, van Richt- lijn 79/112/EEG wordt bepaald dat de vermelde hoeveel- heid, uitgedrukt als percentage, overeenstemt met de hoeveelheid van het ingredi(cid:137)nt of de ingredi(cid:137)nten op het ogenblik waarop zij werden gebruikt; dat in dit lid echter wordt bepaald dat uitzonderingen op dit principe moge- lijk zijn; Overwegende dat voorts de samenstelling van bepaalde levensmiddelen zich aanzienlijk wijzigt door de bereiding of door andere behandelingen, waarbij vochtverlies van ingredi(cid:137)nten optreedt; Overwegende dat voor deze producten een uitzondering op de in artikel 7, lid 4, van Richtlijn 79/112/EEG vermelde wijze van berekening van de hoeveelheden van de ingredi(cid:137)nten nodig blijkt om te zorgen voor een betere benadering van de werkelijke samenstelling van het levensmiddel en zodoende misleiding van de consument te voorkomen; Overwegende dat in artikel 6, lid 5, onder a), van Richtlijn 79/112/EEG hetzelfde beginsel wordt gehanteerd voor de volgorde van de ingredi(cid:137)nten in de lijst van ingredi(cid:137)nten; Overwegende dat echter in dit artikel 6 uitzonderingen voor bepaalde levensmiddelen of ingredi(cid:137)nten zijn opge- nomen en dat derhalve met het oog op de samenhang identieke uitzonderingen voor de wijze van berekening van de hoeveelheden dienen te worden vastgesteld; Overwegende dat de doelstellingen van de voorgenomen maatregel, namelijk de waarborging van een effectieve tenuitvoerlegging van het beginsel dat de hoeveelheden van de ingredi(cid:137)nten dienen te worden vermeld, overeen- komstig het subsidiariteitsbeginsel en het evenredigheids- beginsel, zoals neergelegd in artikel 3 B van het Verdrag, niet voldoende door de lidstaten kunnen worden verwe- zenlijkt, daar de basisvoorschriften in de communautaire wetgeving zijn opgenomen; dat deze richtlijn zich beperkt tot het vereiste minimum om deze doelstellingen te verwezenlijken en niet verder gaat dan hiertoe nodig is; 16. 3. 1999 NL Publicatieblad van de Europese Gemeenschappen L 69/23 Overwegende dat de in deze richtlijn vervatte maatregelen in overeenstemming zijn met het advies van het Perma- nent Comit(cid:130) voor levensmiddelen, HEEFT DE VOLGENDE RICHTLIJN VASTGESTELD: Artikel 1 Artikel 7, lid 2, onder a) en b), van Richtlijn 79/ 1. 112/EEG is niet van toepassing in de gevallen waarin overeenkomstig het bepaalde in Richtlijn 94/54/EG de vermelding „zoetstof(fen)” of „suiker(s) en zoetstof(fen)” samen met de verkoopbenaming van een levensmiddel wordt aangebracht. 2. Artikel 7, lid 2, onder a) en b), van Richtlijn 79/ 112/EEG is niet van toepassing op de vermeldingen inzake de toevoeging van vitaminen en mineralen, in de gevallen waarin voor deze stoffen een voedingswaarde- etikettering van toepassing is. Artikel 2 In afwijking van het in artikel 7, lid 4, van Richtlijn 1. 79/112/EEG neergelegde beginsel geldt voor de vermel- ding van de hoeveelheid van de ingredi(cid:137)nten het bepaalde in de leden 2 en 3 van dit artikel. Voor levensmiddelen waarbij door een thermische of 2. andere behandeling vochtverlies is opgetreden, komt de vermelde hoeveelheid overeen met de gebruikte hoeveel- heid van het ingredi(cid:137)nt of de ingredi(cid:137)nten, uitgedrukt als gehalte van het eindproduct. Deze hoeveelheid wordt uitgedrukt als percentage. Wanneer de hoeveelheid van een ingredi(cid:137)nt of de totale hoeveelheid van alle ingredi(cid:137)nten, die op de verpakking is vermeld, echter groter is dan 100 %, wordt de hoeveel- heid in plaats daarvan vermeld als het gewicht van de hoeveelheid ingredi(cid:137)nt of ingredi(cid:137)nten die voor de berei- ding van 100 gram eindproduct is of zijn gebruikt. 3. De hoeveelheid van vluchtige ingredi(cid:137)nten wordt vermeld als hun gewichtspercentage in het eindproduct. De hoeveelheid van ingredi(cid:137)nten die in geconcentreerde of gedroogde vorm worden gebruikt en tijdens de fabri- cage worden gereconstitueerd kan worden vermeld als hun gewichtspercentage voordat zij werden geconcen- treerd of gedroogd. Wanneer het om geconcentreerde of gedroogde levens- middelen gaat waaraan water moet worden toegevoegd, kan de hoeveelheid van de ingredi(cid:137)nten worden uitge- drukt als gewichtspercentage in het gereconstitueerde product. Artikel 3 De lidstaten nemen uiterlijk op 31 augustus 1999 de nodige wettelijke en bestuursrechtelijke bepalingen aan om ervoor te zorgen dat: — de handel in producten die aan deze richtlijn voldoen uiterlijk op 1 september 1999 wordt toegestaan; — producten die niet aan deze richtlijn voldoen uiterlijk op 14 februari 2000 worden verboden. De handel in producten die niet aan deze richtlijn voldoen maar v(cid:155)(cid:155)r deze datum in de handel zijn gebracht of zijn ge(cid:137)tiketteerd, is echter toegestaan zolang de voorraad strekt. Zij stellen de Commissie daarvan onverwijld in kennis. Wanneer de lidstaten deze bepalingen aannemen, wordt in die bepalingen naar de onderhavige richtlijn verwezen of wordt hiernaar verwezen bij de offici(cid:137)le bekendmaking van die bepalingen. De regels voor deze verwijzing worden vastgesteld door de lidstaten. Artikel 4 Deze richtlijn treedt in werking op de twintigste dag volgende op die van haar bekendmaking in het publica- tieblad van de Europese Gemeenschappen. Artikel 5 Deze richtlijn is gericht tot de lidstaten. Gedaan te Brussel, 8 maart 1999. Voor de Commissie Martin BANGEMANN Lid van de Commissie