EUR-Lex - 32004L0010 - EN Avis juridique important | 32004L0010 Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) (Text with EEA relevance) Official Journal L 050 , 20/02/2004 P. 0044 - 0059 Directive 2004/10/EC of the European Parliament and of the Councilof 11 February 2004on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version)(Text with EEA relevance)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission,Having regard to the opinion of the European Economic and Social Committee(1),Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),Whereas:(1) Council Directive 87/18/EEC of 18 December 1986 on the harmonisation of laws, regulations and administrative provisions relating to the application of principles of good laboratory practice and the verification of their applications for tests on chemical substances(3) has been significantly amended. In the interests of clarity and rationality the said Directive should be codified.(2) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(4) requires tests to be carried out on chemical substances in order to enable their potential risk to man and the environment to be determined.(3) When the active substances in pesticides undergo tests they should do so in accordance with Directive 67/548/EEC.(4) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(5) and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(6) lay down that non-clinical tests on pharmaceutical products are to be carried out in accordance with the principles of good laboratory practice (GLP) in force in the Community for chemical substances, compliance with which is also required by other Community legislation.(5) The methods to be used for these tests are laid down in Annex V to Directive 67/548/EEC.(6) It is necessary to comply with the principles of GLP in carrying out the tests laid down by Directive 67/548/EEC so as to ensure that the results are comparable and of high quality.(7) The resources devoted to the tests should not be wasted by having to repeat tests owing to differences in laboratory practice from one Member State to another.(8) The Council of the Organisation for Economic Cooperation and Development (OECD) took a Decision on 12 May 1981 on the mutual acceptance of data for the evaluation of chemical products. It issued a recommendation on 26 July 1983 concerning the mutual recognition of compliance with GLP. The principles of GLP have been modified by OECD Council Decision (C(97) 186 (final)).(9) Animal protection requires that the number of experiments conducted on animals be restricted. Mutual recognition of the results of tests obtained using standard and recognised methods is an essential condition for reducing the number of experiments in this area.(10) It is necessary to set up a procedure allowing rapid adaptation of the principles of GLP.(11) This Directive should be without prejudice to the obligations of the Member States concerning the time limits for transposition of the directives set out in Annex II, part B,HAVE ADOPTED THIS DIRECTIVE:Article 11. Member States shall take all measures necessary to ensure that laboratories carrying out tests on chemical products, in accordance with Directive 67/548/EEC, comply with the principles of good laboratory practice (GLP) as laid down in Annex I to this Directive.2. Paragraph 1 shall apply also where other Community provisions provide for the application of the principles of GLP in respect of tests on chemical products to evaluate their safety for man and/or the environment.Article 2When submitting results, the laboratories referred to in Article 1 shall certify that the tests have been carried out in conformity with the principles of GLP referred to in that Article.Article 31. Member States shall adopt the measures necessary for verification of compliance with the principles of GLP. These measures shall include, in particular, inspections and study checks in accordance with the recommendations of the OECD in this area.2. Member States shall notify to the Commission the name or names of the authority or authorities responsible for verifying compliance with the principles of GLP, as referred to in paragraph 1. The Commission shall inform the other Member States thereof.Article 4Any adaptation to the principles of GLP mentioned in Article 1 shall be adopted in accordance with the procedure referred to in Article 29 of Directive 67/548/EEC.Article 51. Where Community provisions require application of the principles of GLP following the entry into force of this Directive for tests on chemical products, Member States may not, on grounds relating to the principles of GLP, prohibit, restrict or impede the placing on the market of chemical products if the principles applied by the laboratories concerned are in conformity with those mentioned in Article 1.2. Should a Member State establish on the basis of detailed evidence that the application of the principles of GLP and the verification of their application for tests on chemical substances show that, although a chemical substance has been examined in accordance with the requirements of this Directive, it presents a danger to man and the environment, the Member State may provisionally prohibit or make subject to special conditions the marketing of that substance on its territory. It shall immediately inform the Commission and the other Member States thereof and give the grounds for its decision.The Commission shall, within six weeks, consult the Member States concerned and then give its opinion and take suitable measures without delay.Should the Commission consider that technical adaptations to this Directive are necessary, those adaptations shall be adopted either by the Commission or by the Council in accordance with the procedure referred to in Article 4. In that case, the Member State which adopted the safeguard measures may maintain them until the entry into force of those adaptations.Article 6Directive 87/18/EEC is hereby repealed, without prejudice to the obligations of the Member States concerning the time limits for transposition of the Directives set out in Annex II, part B.References made to the repealed Directive shall be construed as being made to this Directive and shall be read in accordance with the correlation table in Annex III.Article 7This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.Article 8This Directive is addressed to the Member States.Done at Strasbourg, 11 February 2004.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentM. McDowell(1) OJ C 85, 8.4.2003, p. 138.(2) Opinion of the European Parliament of 1 July 2003 (not yet published in the Official Journal) and Decision of the Council of 20 January 2004.(3) OJ L 15, 17.1.1987, p. 29. Directive as amended by Commission Directive 1999/11/EC (OJ L 77, 23.3.1999, p. 8).(4) OJ 196, 16.8.1967, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).(5) OJ L 311, 28.11.2001, p. 1.(6) OJ L 311, 28. 11. 2001, p. 67. Directive as amended by Commission Directive 2003/63/EC (OJ L 159, 27.6.2003, p. 46).ANNEX ITHE OECD PRINCIPLES OF GOOD LABORATORY PRACTICE (GLP)CONTENTS>TABLE>SECTION I INTRODUCTIONPrefaceGovernment and industry are concerned about the quality of non-clinical health and environmental safety studies upon which hazard assessments are based. As a consequence, OECD Member States have established criteria for the performance of these studies.To avoid different schemes of implementation that could impede international trade in chemicals, OECD Member States have pursued international harmonisation of test methods and good laboratory practice. In 1979 and 1980 an international group of experts, established under the special programme on the control of chemicals, developed the "OECD principles of good laboratory practice" (GLP), utilising common managerial and scientific practices and experience from various national and international sources. These principles of GLP were adopted by the OECD Council in 1981, as an Annex to the Council Decision on the mutual acceptance of data in the assessment of chemicals (C(81) 30 (final)).In 1995 and 1996, a new group of experts was formed to revise and update the principles. The current document is the result of the consensus reached by that group. It cancels and replaces the original principles adopted in 1981.The purpose of these principles of good laboratory practice is to promote the development of quality test data. Comparable quality of test data forms the basis for the mutual acceptance of data among countries. If individual countries can confidently rely on test data developed in other countries, duplicative testing can be avoided, thereby saving time and resources. The application of these principles should help to avoid the creation of technical barriers to trade, and further improve the protection of human health and the environment.1. ScopeThese principles of good laboratory practice should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals. These test items are frequently synthetic chemicals, but may be of natural or biological origin and, in some circumstances, may be living organisms. The purpose of testing these test items is to obtain data on their properties and/or their safety with respect to human health and/or the environment.Non-clinical health and environmental safety studies covered by the principles of good laboratory practice include work conducted in the laboratory, in greenhouses, and in the field.Unless specifically exempted by national legislation, these principles of good laboratory practice apply to all non-clinical health and environmental safety studies required by regulation for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial chemicals.2. Definition of terms2.1. Good laboratory practiceGood laboratory practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.2.2. Terms concerning the organisation of a test facility1. Test facility means the persons, premises and operational unit(s) that are necessary for conducting the non-clinical health and environmental safety study. For multisite studies, those which are conducted at more than one site, the test facility comprises the site at which the study director is located and all individual test sites, which individually or collectively can be considered to be test facilities.2. Test site means the location(s) at which a phase(s) of a study is conducted.3. Test facility management means the person(s) who has the authority and formal responsibility for the organisation and functioning of the test facility according to these principles of good laboratory practice.4. Test site management (if appointed) means the person(s) responsible for ensuring that the phase(s) of the study, for which he is responsible, are conducted according to these principles of good laboratory practice.5. Sponsor means an entity which commissions, supports and/or submits a non-clinical health and environmental safety study.6. Study director means the individual responsible for the overall conduct of the non-clinical health and environmental safety study.7. Principal investigator means an individual who, for a multisite study, acts on behalf of the study director and has defined responsibility for delegated phases of the study. The study director's responsibility for the overall conduct of the study cannot be delegated to the principal investigator(s); this includes approval of the study plan and its amendments, approval of the final report, and ensuring that all applicable principles of good laboratory practice are followed.8. Quality assurance programme: means a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these principles of good laboratory practice.9. Standard operating procedures (SOPs) means documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines.10. Master schedule means a compilation of information to assist in the assessment of workload and for the tracking of studies at a test facility.2.3. Terms concerning the non-clinical health and environmental safety study1. Non-clinical health and environmental safety study, henceforth referred to simply as "study", means an experiment or set of experiments in which a test item is examined under laboratory conditions or in the environment to obtain data on its properties and/or its safety, intended for submission to appropriate regulatory authorities.2. Short-term study means a study of short duration with widely used, routine techniques.3. Study plan means a document which defines the objectives and experimental design for the conduct of the study, and includes any amendments.4. Study plan amendment means an intended change to the study plan after the study initiation date.5. Study plan deviation means an unintended departure from the study plan after the study initiation date.6. Test system means any biological, chemical or physical system, or a combination, thereof used in a study.7. Raw data means all original test facility records and documentation, or verified copies thereof, which are the result of the original observations and activities in a study. Raw data also may include, for example, photographs, microfilm or microfiche copies, computer readable media, dictated observations, recorded data from automated instruments, or any other data storage medium that has been recognised as capable of providing secure storage of information for a time period as stated in section 10 below.8. Specimen means any material derived from a test system for examination, analysis, or retention.9. Experimental starting date means the date on which the first study-specific data are collected.10. Experimental completion date means the last date on which data are collected from the study.11. Study initiation date means the date the study director signs the study plan.12. Study completion date means the date the study director signs the final report.2.4. Terms concerning the test item1. Test item means an article that is the subject of a study.2. Reference item (control item) means any article used to provide a basis for comparison with the test item.3. Batch means a specific quantity or lot of a test item or reference item produced during a defined cycle of manufacture in such a way that it could be expected to be of a uniform character and should be designated as such.4. Vehicle means any agent which serves as a carrier used to mix, disperse, or solubilise the test item or reference item to facilitate the administration/application to the test system.SECTION II GOOD LABORATORY PRACTICE PRINCIPLES1. Test facility organisation and personnel1.1. Test facility management's responsibilities1. Each test facility management should ensure that these principles of good laboratory practice are complied with, in its test facility.2. At a minimum it should:(a) ensure that a statement exists which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by these principles of good laboratory practice;(b) ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study;(c) ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual;(d) ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions;(e) ensure that appropriate and technically valid standard operating procedures are established and followed, and approve all original and revised standard operating procedures;(f) ensure that there is a quality assurance programme with designated personnel and assure that the quality assurance responsibility is being performed in accordance with these principles of good laboratory practice;(g) ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the study director before the study is initiated. Replacement of a study director should be done according to established procedures, and should be documented;(h) ensure, in the event of a multisite study, that, if needed, a principal investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a principal investigator should be done according to established procedures, and should be documented;(i) ensure documented approval of the study plan by the study director;(j) ensure that the study director has made the approval study plan available to the quality assurance personnel;(k) ensure the maintenance of a historical file of all standard operating procedures;(l) ensure that an individual is identified as responsible for the management of the archive(s);(m) ensure the maintenance of a master schedule;(n) ensure that test facility supplies meet requirements appropriate to their use in a study;(o) ensure for a multisite study that clear lines of communication exist between the study director, principal investigator(s), the quality assurance programme(s) and study personnel;(p) ensure that test and reference items are appropriately characterised;(q) establish procedures to ensure that computerised systems are suitable for their intended purpose, and are validated, operated and maintained in accordance with these principles of good laboratory practice.3. When a phase(s) of a study is conducted at a test site, test site management (if appointed) will have the responsibilities as defined above with the following exceptions: 1.1.2(g), (i), (j) and (o).1.2. Study director's responsibilities1. The study director is the single point of study control and has the responsibility for the overall conduct of the study and for its final report.2. These responsibilities should include, but not be limited to, the following functions. The study director should:(a) approve the study plan and any amendments to the study plan by dated signature;(b) ensure that the quality assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the quality assurance personnel as required during the conduct of the study;(c) ensure that study plans and amendments and standard operating procedures are available to study personnel;(d) ensure that the study plan and the final report for a multisite study identify and define the role of any principal investigator(s) and any test facilities and test sites involved in the conduct of the study;(e) ensure that the procedures specified in the study plan are followed, and assess and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary; acknowledge deviations from standard operating procedures during the conduct of the study;(f) ensure that all raw data generated are fully documented and recorded;(g) ensure that computerised systems used in the study have been validated;(h) sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these principles of good laboratory practice;(i) ensure that after completion (including termination) of the study, the study plan, the final report, raw data and supporting material are archived.1.3. Principal investigator's responsibilitiesThe principal investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable principles of good laboratory practice.1.4. Study personnel's responsibilities1. All personnel involved in the conduct of the study must be knowledgeable in those parts of the principles of good laboratory practice which are applicable to their involvement in the study.2. Study personnel will have access to the study plan and appropriate standard operating procedures applicable to their involvement in the study. It is their responsibility to comply with the instructions given in these documents. Any deviation from these instructions should be documented and communicated directly to the study director, and/or if appropriate, the principal investigator(s).3. All study personnel are responsible for recording raw data promptly and accurately and in compliance with these principles of good laboratory practice, and are responsible for the quality of their data.4. Study personnel should exercise health precautions to minimise risk to themselves and to ensure the integrity of the study. They should communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study.2. Quality assurance programme2.1. General1. The test facility should have a documented quality assurance programme to assure that studies performed are in compliance with these principles of good laboratory practice.2. The quality assurance programme should be carried out by an individual or by individuals designated by and directly responsible to management and who are familiar with the test procedures.3. This individual(s) should not be involved in the conduct of the study being assured.2.2. Responsibilities of the quality assurance personnelThe responsibilities of the quality assurance personnel include, but are not limited to, the following functions. They should:(a) maintain copies of all approved study plans and standard operating procedures in use in the test facility and have access to an up-to-date copy of the master schedule;(b) verify that the study plan contains the information required for compliance with these principles of good laboratory practice. This verification should be documented;(c) conduct inspections to determine if all studies are conducted in accordance with these principles of good laboratory practice. Inspections should also determine that study plans and standard operating procedures have been made available to study personnel and are being followed.Inspections can be of three types as specified by quality assurance programme standard operating procedures:- study-based inspections,- facility-based inspections,- process-based inspections.Records of such inspections should be retained;(d) inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies;(e) promptly report any inspection results in writing to management and to the study director, and to the principal investigator(s) and the respective management, when applicable;(f) prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phase(s) of the study inspected, and the dates inspection results were reported to management and the study director and principal investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.3. Facilities3.1. General1. The test facility should be of suitable size, construction and location to meet the requirements of the study and to minimise disturbance that would interfere with the validity of the study.2. The design of the test facility should provide an adequate degree of separation of the different activities to assure the proper conduct of each study.3.2. Test system facilities1. The test facility should have a sufficient number of rooms or areas to assure the isolation of test systems and the isolation of individual projects, involving substances or organisms known to be or suspected of being biohazardous.2. Suitable rooms or areas should be available for the diagnosis, treatment and control of diseases, in order to ensure that there is no unacceptable degree of deterioration of test systems.3. There should be storage rooms or areas as needed for supplies and equipment. Storage rooms or areas should be separated from rooms or areas housing the test systems and should provide adequate protection against infestation, contamination, and/or deterioration.3.3. Facilities for handling test and reference items1. To prevent contamination or mix-ups, there should be separate rooms or areas for receipt and storage of the test and reference items, and mixing of the test items with a vehicle.2. Storage rooms or areas for the test items should be separate from rooms or areas containing the test systems. They should be adequate to preserve identity, concentration, purity, and stability, and ensure safe storage for hazardous substances.3.4. Archive facilitiesArchive facilities should be provided for the secure storage and retrieval of study plans, raw data, final reports, samples of test items and specimens. Archive design and archive conditions should protect contents from untimely deterioration.3.5. Waste disposalHandling and disposal of wastes should be carried out in such a way as not to jeopardise the integrity of studies. This includes provision for appropriate collection, storage and disposal facilities, and decontamination and transportation procedures.4. Apparatus, material, and reagents1. Apparatus, including validated computerised systems, used for the generation, storage and retrieval of data, and for controlling environmental factors relevant to the study should be suitably located and of appropriate design and adequate capacity.2. Apparatus used in a study should be periodically inspected, cleaned, maintained, and calibrated according to standard operating procedures. Records of these activities should be maintained. Calibration should, where appropriate, be traceable to national or international standards of measurement.3. Apparatus and materials used in a study should not interfere adversely with the test systems.4. Chemicals, reagents, and solutions should be labelled to indicate identity (with concentration if appropriate), expiry date and specific storage instructions. Information concerning source, preparation date and stability should be available. The expiry date may be extended on the basis of documented evaluation or analysis.5. Test systems5.1. Physical/chemical1. Apparatus used for the generation of physical/chemical data should be suitably located and of appropriate design and adequate capacity.2. The integrity of the physical/chemical test systems should be ensured.5.2. Biological1. Proper conditions should be established and maintained for the storage, housing, handling and care of biological test systems, in order to ensure the quality of the data.2. Newly received animal and plant test systems should be isolated until their health status has been evaluated. If any unusual mortality or morbidity occurs, this lot should not be used in studies and, when appropriate, should be humanely destroyed. At the experimental starting date of a study, test systems should be free of any disease or condition that might interfere with the purpose or conduct of the study. Test systems that become diseased or injured during the course of a study should be isolated and treated, if necessary to maintain the integrity of the study. Any diagnosis and treatment of any disease before or during a study should be recorded.3. Records of source, date of arrival, and arrival condition of test systems should be maintained.4. Biological test systems should be acclimatised to the test environment for an adequate period before the first administration/application of the test or reference item.5. All information needed to properly identify the test systems should appear on their housing or containers. Individual test systems that are to be removed from their housing or containers during the conduct of the study should bear appropriate identification, wherever possible.6. During use, housing or containers for test systems should be cleaned and sanitised at appropriate intervals. Any material that comes into contact with the test system should be free of contaminants at levels that would interfere with the study. Bedding for animals should be changed as required by sound husbandry practice. Use of pest control agents should be documented.7. Test systems used in field studies should be located so as to avoid interference in the study from spray drift and from past usage of pesticides.6. Test and reference items6.1. Receipt, handling, sampling and storage1. Records including test item and reference item characterisation, date of receipt, expiry date, quantities received and used in studies should be maintained.2. Handling, sampling, and storage procedures should be identified in order that the homogeneity and stability are assured to the degree possible and contamination or mix-up are precluded.3. Storage container(s) should carry identification information, expiry date, and specific storage instructions.6.2. Characterisation1. Each test and reference item should be appropriately identified (e.g. code, chemical abstracts service registry number (CAS number), name, biological parameters).2. For each study, the identity, including batch number, purity, composition, concentrations, or other characteristics to appropriately define each batch of the test or reference items should be known.3. In cases where the test item is supplied by the sponsor, there should be a mechanism, developed in cooperation between the sponsor and the test facility, to verify the identity of the test item subject to the study.4. The stability of test and reference items under storage and test conditions should be known for all studies.5. If the test item is administered or applied in a vehicle, the homogeneity, concentration and stability of the test item in that vehicle should be determined. For test items used in field studies (e.g. tank mixes), these may be determined through separate laboratory experiments.6. A sample for analytical purposes from each batch of test item should be retained for all studies except short-term studies.7. Standard operating procedures1. A test facility should have written standard operating procedures approved by test facility management that are intended to ensure the quality and integrity of the data generated by that test facility. Revisions to standard operating procedures should be approved by test facility management.2. Each separate test facility unit or area should have immediately available current standard operating procedures relevant to the activities being performed therein. Published text books, analytical methods, articles and manuals may be used as supplements to these standard operating procedures.3. Deviations from standard operating procedures related to the study should be documented and should be acknowledged by the study director and the principal investigator(s), as applicable.4. Standard operating procedures should be available for, but not be limited to, the following categories of test facility activities. The details given under each heading are to be considered as illustrative examples.1. Test and reference itemsReceipt, identification, labelling, handling, sampling and storage.2. Apparatus, materials and reagents(a) Apparatus:use, maintenance, cleaning and calibration(b) Computerised systems:validation, operation, maintenance, security, change control and back-up(c) Materials, reagents and solutions:preparation and labelling.3. Record keeping, reporting, storage, and retrievalCoding of studies, data collection, preparation of reports, indexing systems, handling of data, including the use of computerised systems.4. Test system (where appropriate)(a) Room preparation and environmental room conditions for the test system.(b) Procedures for receipt, transfer, proper placement, characterisation, identification and care of the test system.(c) Test system preparation, observations and examinations, before, during and at the conclusion of the study.(d) Handling of test system individuals found moribund or dead during the study.(e) Collection, identification and handling of specimens including necropsy and histopathology.(f) Siting and placement of test systems in test plots.5. Quality assurance proceduresOperation of Quality Assurance personnel in planning, scheduling, performing, documenting and reporting inspections.8. Performance of the study8.1. Study plan1. For each study, a written plan should exist prior to the initiation of the study. The study plan should be approved by dated signature of the study director and verified for GLP compliance by quality assurance personnel as specified in section II2(20)(b). The study plan should also be approved by the test facility management and the sponsor, if required by national regulation or legislation in the country where the study is being performed.2. (a) Amendments to the study plan should be justified and approved by dated signature of the study director and maintained with the study plan.(b) Deviations from the study plan should be described, explained, acknowledged and dated in a timely fashion by the study director and/or principal investigator(s) and maintained with the study raw data.3. For short-term studies, a general study plan accompanied by a study specific supplement may be used.8.2. Content of the study planThe study plan should contain, but not be limited to the following information:1. Identification of the study, the test item and reference item(a) A descriptive title(b) A statement which reveals the nature and purpose of the study(c) Identification of the test item by code or name (IUPAC; CAS number, biological parameters, etc.)(d) The reference item to be used.2. Information concerning the sponsor and the test facility(a) Name and address of the sponsor(b) Name and address of any test facilities and test sites involved(c) Name and address of the study director(d) Name and address of the principal investigator(s), and the phase(s) of the study delegated by the study director and under the responsibility of the principal investigator(s).3. Dates(a) The date of approval of the study plan by signature of the study director. The date of approval of the study plan by signature of the test facility management and sponsor if required by national regulation or legislation in the country where the study is being performed.(b) The proposed experimental starting and completion dates.4. Test methodsReference to the OECD test guideline or other test guideline or method to be used.5. Issues (where applicable)(a) The justification for selection of the test system(b) Characterisation of the test system, such as the species, strain, substrain, source of supply, number, body weight range, sex, age and other pertinent information(c) The method of administration and the reason for its choice(d) The dose levels and/or concentration(s), frequency, and duration of administration/application;(e) Detailed information on the experimental design, including a description of the chronological procedure of the study, all methods, materials and conditions, type and frequency of analysis, measurements, observations and examinations to be performed, and statistical methods to be used (if any).6. RecordsA list of records to be retained.8.3. Conduct of the study1. A unique identification should be given to each study. All items concerning this study should carry this identification. Specimens from the study should be identified to confirm their origin. Such identification should enable traceability, as appropriate for the specimen and study.2. The study should be conducted in accordance with the study plan.3. All data generated during the conduct of the study should be recorded directly, promptly, accurately, and legibly by the individual entering the data. These entries should be signed or initialled and dated.4. Any change in the raw data should be made so as not to obscure the previous entry, should indicate the reason for change and should be dated and signed or initialled by the individual making the change.5. Data generated as a direct computer input should be identified at the time of data input by the individual(s) responsible for direct data entries. Computerised system design should always provide for the retention of full audit trails to show all changes to the data without obscuring the original data. It should be possible to associate all changes to data with the persons having made those changes, for example, by use of timed and dated (electronic) signatures. Reason for changes should be given.9. Reporting of study results9.1. General1. A final report should be prepared for each study. In the case of short-term studies, a standardised final report accompanied by a study specific extension may be prepared.2. Reports of principal investigators or scientists involved in the study should be signed and dated by them.3. The final report should be signed and dated by the study director to indicate acceptance of responsibility for the validity of the data. The extent of compliance with these principles of good laboratory practice should be indicated.4. Corrections and additions to a final report should be in the form of amendments. Amendments should clearly specify the reason for the corrections or additions and should be signed and dated by the study director.5. Reformatting of the final report to comply with the submission requirements of a national registration or regulatory authority does not constitute a correction, addition or amendment to the final report.9.2. Content of the final reportThe final report should include, but not be limited to, the following information:1. Identification of the study, the test item and reference item(a) A descriptive title(b) Identification of the test item by code or name (IUPAC, CAS number, biological parameters, etc.)(c) Identification of the reference item by name(d) Characterisation of the test item including purity, stability and homogeneity.2. Information concerning the sponsor and the test facility(a) Name and address of the sponsor(b) Name and address of any test facilities and test sites involved(c) Name and address of the study director(d) Name and address of the principal investigator(s) and the phase(s) of the study delegated, if applicable(e) Name and address of scientists having contributed reports to the final report.3. DatesExperimental starting and completion dates.4. StatementA quality assurance programme statement listing the types of inspections made and their dates, including the phase(s) inspected, and the dates any inspection results were reported to management and to the study director and principal investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.5. Description of materials and test methods(a) Description of methods and materials used(b) Reference to OECD test guideline or other test guideline or method.6. Results(a) A summary of results(b) All information and data required by the study plan(c) A presentation of the results, including calculations and determinations of statistical significance(d) An evaluation and discussion of the results and, where appropriate, conclusions.7. StorageThe location(s) where the study plan, samples of test and reference items, specimens, raw data and the final report are to be stored.10. Storage and retention of records and materials10.1. The following should be retained in the archives for the period specified by the appropriate authorities:(a) the study plan, raw data, samples of test and reference items, specimens, and the final report of each study;(b) records of all inspections performed by the quality assurance programme, as well as master schedules;(c) records of qualifications, training, experience and job descriptions of personnel;(d) records and reports of the maintenance and calibration of apparatus;(e) validation documentation for computerised systems;(f) the historical file of all standard operating procedures;(g) environmental monitoring records.In the absence of a required retention period, the final disposition of any study materials should be documented. When samples of test and reference items and specimens are disposed of before the expiry of the required retention period for any reason, this should be justified and documented. Samples of test and reference items and specimens should be retained only as long as the quality of the preparation permits evaluation.10.2. Material retained in the archives should be indexed so as to facilitate orderly storage and retrieval.10.3. Only personnel authorised by management should have access to the archives. Movement of material in and out of the archives should be properly recorded.10.4. If a test facility or an archive contracting facility goes out of business and has no legal successor, the archive should be transferred to the archives of the sponsor(s) of the study(s).ANNEX IIPART ARepealed Directive and its amendment(Article 6)>TABLE>PART BDeadlines for transposition into national law(Article 6)>TABLE>ANNEX IIICorrelation table>TABLE>

Summary: Good laboratory practice: tests on chemical substances Good laboratory practice: tests on chemical substances SUMMARY OF: Directive 2004/10/EC — rules on the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances WHAT IS THE AIM OF THE DIRECTIVE? It codifies the EU legislation on the application of the principles of good laboratory practice (GLP) and the verification of their applications for tests on chemical substances and repeals Directive 87/18/EEC. KEY POINTS The directive requires EU countries to take all measures necessary to ensure that laboratories carrying out tests on chemical products, in accordance with Regulation (EC) No 1272/2008 on the classification, packaging and labelling of chemicals and their mixtures, comply with the principles of good laboratory practice as laid down in Annex I to the directive. It also applies where other EU rules provide for the application of the principles of GLP to tests on chemical products to evaluate their safety for human health and/or the environment. The tests are carried out on chemical products to obtain data on their properties and their safety with regard to human health and the environment. When submitting results, laboratories must certify that the tests were carried out in accordance with the principles of good laboratory practice. EU countries must adopt the measures necessary to verify compliance with the principles of good laboratory practice including, in particular, inspections and checks conducted in accordance with the relevant principles of the Organisation for Economic Cooperation and Development. EU countries may not, on grounds relating to the principles of GLP, prohibit, restrict or impede the placing on the market of chemical products if the principles applied by the laboratories concerned comply with this directive. An EU country may provisionally ban or make subject to special conditions the marketing of a chemical product on its territory, where the application of the principles of GLP and the verification of their application for tests on chemical substances show that, although it has been examined in accordance with the requirements of this directive, it presents a danger to human health or the environment. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 11 March 2004. The Directive 2004/10/EC codifies and replaces Directive 87/18/EEC and its subsequent amendments. The original Directive 87/18/EEC had to become law in the EU countries by 30 June 1988. BACKGROUND For more information, see: Good Laboratory Practice (European Commission). MAIN DOCUMENT Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) (OJ L 50, 20.2.2004, pp. 44-59) Successive amendments to Directive 2004/10/EC have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, pp. 1-1355) See consolidated version. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, pp. 1-849). Text republished in corrigendum (OJ L 136, 29.5.2007, pp. 3-280) See consolidated version. Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (OJ L 50, 20.2.2004, pp. 28-43) See consolidated version. last update 06.09.2018


EUR-Lex - 32003L0088 - EN Avis juridique important | 32003L0088 Directive 2003/88/EC of the European Parliament and of the Council of 4 November 2003 concerning certain aspects of the organisation of working time Official Journal L 299 , 18/11/2003 P. 0009 - 0019 Directive 2003/88/EC of the European Parliament and of the Councilof 4 November 2003concerning certain aspects of the organisation of working timeTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 137(2) thereof,Having regard to the proposal from the Commission,Having regard to the opinion of the European Economic and Social Committee(1),Having consulted the Committee of the Regions,Acting in accordance with the procedure referred to in Article 251 of the Treaty(2),Whereas:(1) Council Directive 93/104/EC of 23 November 1993, concerning certain aspects of the organisation of working time(3), which lays down minimum safety and health requirements for the organisation of working time, in respect of periods of daily rest, breaks, weekly rest, maximum weekly working time, annual leave and aspects of night work, shift work and patterns of work, has been significantly amended. In order to clarify matters, a codification of the provisions in question should be drawn up.(2) Article 137 of the Treaty provides that the Community is to support and complement the activities of the Member States with a view to improving the working environment to protect workers' health and safety. Directives adopted on the basis of that Article are to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings.(3) The provisions of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(4) remain fully applicable to the areas covered by this Directive without prejudice to more stringent and/or specific provisions contained herein.(4) The improvement of workers' safety, hygiene and health at work is an objective which should not be subordinated to purely economic considerations.(5) All workers should have adequate rest periods. The concept of "rest" must be expressed in units of time, i.e. in days, hours and/or fractions thereof. Community workers must be granted minimum daily, weekly and annual periods of rest and adequate breaks. It is also necessary in this context to place a maximum limit on weekly working hours.(6) Account should be taken of the principles of the International Labour Organisation with regard to the organisation of working time, including those relating to night work.(7) Research has shown that the human body is more sensitive at night to environmental disturbances and also to certain burdensome forms of work organisation and that long periods of night work can be detrimental to the health of workers and can endanger safety at the workplace.(8) There is a need to limit the duration of periods of night work, including overtime, and to provide for employers who regularly use night workers to bring this information to the attention of the competent authorities if they so request.(9) It is important that night workers should be entitled to a free health assessment prior to their assignment and thereafter at regular intervals and that whenever possible they should be transferred to day work for which they are suited if they suffer from health problems.(10) The situation of night and shift workers requires that the level of safety and health protection should be adapted to the nature of their work and that the organisation and functioning of protection and prevention services and resources should be efficient.(11) Specific working conditions may have detrimental effects on the safety and health of workers. The organisation of work according to a certain pattern must take account of the general principle of adapting work to the worker.(12) A European Agreement in respect of the working time of seafarers has been put into effect by means of Council Directive 1999/63/EC of 21 June 1999 concerning the Agreement on the organisation of working time of seafarers concluded by the European Community Shipowners' Association (ECSA) and the Federation of Transport Workers' Unions in the European Union (FST)(5) based on Article 139(2) of the Treaty. Accordingly, the provisions of this Directive should not apply to seafarers.(13) In the case of those "share-fishermen" who are employees, it is for the Member States to determine, pursuant to this Directive, the conditions for entitlement to, and granting of, annual leave, including the arrangements for payments.(14) Specific standards laid down in other Community instruments relating, for example, to rest periods, working time, annual leave and night work for certain categories of workers should take precedence over the provisions of this Directive.(15) In view of the question likely to be raised by the organisation of working time within an undertaking, it appears desirable to provide for flexibility in the application of certain provisions of this Directive, whilst ensuring compliance with the principles of protecting the safety and health of workers.(16) It is necessary to provide that certain provisions may be subject to derogations implemented, according to the case, by the Member States or the two sides of industry. As a general rule, in the event of a derogation, the workers concerned must be given equivalent compensatory rest periods.(17) This Directive should not affect the obligations of the Member States concerning the deadlines for transposition of the Directives set out in Annex I, part B,HAVE ADOPTED THIS DIRECTIVE:CHAPTER 1SCOPE AND DEFINITIONSArticle 1Purpose and scope1. This Directive lays down minimum safety and health requirements for the organisation of working time.2. This Directive applies to:(a) minimum periods of daily rest, weekly rest and annual leave, to breaks and maximum weekly working time; and(b) certain aspects of night work, shift work and patterns of work.3. This Directive shall apply to all sectors of activity, both public and private, within the meaning of Article 2 of Directive 89/391/EEC, without prejudice to Articles 14, 17, 18 and 19 of this Directive.This Directive shall not apply to seafarers, as defined in Directive 1999/63/EC without prejudice to Article 2(8) of this Directive.4. The provisions of Directive 89/391/EEC are fully applicable to the matters referred to in paragraph 2, without prejudice to more stringent and/or specific provisions contained in this Directive.Article 2DefinitionsFor the purposes of this Directive, the following definitions shall apply:1. "working time" means any period during which the worker is working, at the employer's disposal and carrying out his activity or duties, in accordance with national laws and/or practice;2. "rest period" means any period which is not working time;3. "night time" means any period of not less than seven hours, as defined by national law, and which must include, in any case, the period between midnight and 5.00;4. "night worker" means:(a) on the one hand, any worker, who, during night time, works at least three hours of his daily working time as a normal course; and(b) on the other hand, any worker who is likely during night time to work a certain proportion of his annual working time, as defined at the choice of the Member State concerned:(i) by national legislation, following consultation with the two sides of industry; or(ii) by collective agreements or agreements concluded between the two sides of industry at national or regional level;5. "shift work" means any method of organising work in shifts whereby workers succeed each other at the same work stations according to a certain pattern, including a rotating pattern, and which may be continuous or discontinuous, entailing the need for workers to work at different times over a given period of days or weeks;6. "shift worker" means any worker whose work schedule is part of shift work;7. "mobile worker" means any worker employed as a member of travelling or flying personnel by an undertaking which operates transport services for passengers or goods by road, air or inland waterway;8. "offshore work" means work performed mainly on or from offshore installations (including drilling rigs), directly or indirectly in connection with the exploration, extraction or exploitation of mineral resources, including hydrocarbons, and diving in connection with such activities, whether performed from an offshore installation or a vessel;9. "adequate rest" means that workers have regular rest periods, the duration of which is expressed in units of time and which are sufficiently long and continuous to ensure that, as a result of fatigue or other irregular working patterns, they do not cause injury to themselves, to fellow workers or to others and that they do not damage their health, either in the short term or in the longer term.CHAPTER 2MINIMUM REST PERIODS - OTHER ASPECTS OF THE ORGANISATION OF WORKING TIMEArticle 3Daily restMember States shall take the measures necessary to ensure that every worker is entitled to a minimum daily rest period of 11 consecutive hours per 24-hour period.Article 4BreaksMember States shall take the measures necessary to ensure that, where the working day is longer than six hours, every worker is entitled to a rest break, the details of which, including duration and the terms on which it is granted, shall be laid down in collective agreements or agreements between the two sides of industry or, failing that, by national legislation.Article 5Weekly rest periodMember States shall take the measures necessary to ensure that, per each seven-day period, every worker is entitled to a minimum uninterrupted rest period of 24 hours plus the 11 hours' daily rest referred to in Article 3.If objective, technical or work organisation conditions so justify, a minimum rest period of 24 hours may be applied.Article 6Maximum weekly working timeMember States shall take the measures necessary to ensure that, in keeping with the need to protect the safety and health of workers:(a) the period of weekly working time is limited by means of laws, regulations or administrative provisions or by collective agreements or agreements between the two sides of industry;(b) the average working time for each seven-day period, including overtime, does not exceed 48 hours.Article 7Annual leave1. Member States shall take the measures necessary to ensure that every worker is entitled to paid annual leave of at least four weeks in accordance with the conditions for entitlement to, and granting of, such leave laid down by national legislation and/or practice.2. The minimum period of paid annual leave may not be replaced by an allowance in lieu, except where the employment relationship is terminated.CHAPTER 3NIGHT WORK - SHIFT WORK - PATTERNS OF WORKArticle 8Length of night workMember States shall take the measures necessary to ensure that:(a) normal hours of work for night workers do not exceed an average of eight hours in any 24-hour period;(b) night workers whose work involves special hazards or heavy physical or mental strain do not work more than eight hours in any period of 24 hours during which they perform night work.For the purposes of point (b), work involving special hazards or heavy physical or mental strain shall be defined by national legislation and/or practice or by collective agreements or agreements concluded between the two sides of industry, taking account of the specific effects and hazards of night work.Article 9Health assessment and transfer of night workers to day work1. Member States shall take the measures necessary to ensure that:(a) night workers are entitled to a free health assessment before their assignment and thereafter at regular intervals;(b) night workers suffering from health problems recognised as being connected with the fact that they perform night work are transferred whenever possible to day work to which they are suited.2. The free health assessment referred to in paragraph 1(a) must comply with medical confidentiality.3. The free health assessment referred to in paragraph 1(a) may be conducted within the national health system.Article 10Guarantees for night-time workingMember States may make the work of certain categories of night workers subject to certain guarantees, under conditions laid down by national legislation and/or practice, in the case of workers who incur risks to their safety or health linked to night-time working.Article 11Notification of regular use of night workersMember States shall take the measures necessary to ensure that an employer who regularly uses night workers brings this information to the attention of the competent authorities if they so request.Article 12Safety and health protectionMember States shall take the measures necessary to ensure that:(a) night workers and shift workers have safety and health protection appropriate to the nature of their work;(b) appropriate protection and prevention services or facilities with regard to the safety and health of night workers and shift workers are equivalent to those applicable to other workers and are available at all times.Article 13Pattern of workMember States shall take the measures necessary to ensure that an employer who intends to organise work according to a certain pattern takes account of the general principle of adapting work to the worker, with a view, in particular, to alleviating monotonous work and work at a predetermined work-rate, depending on the type of activity, and of safety and health requirements, especially as regards breaks during working time.CHAPTER 4MISCELLANEOUS PROVISIONSArticle 14More specific Community provisionsThis Directive shall not apply where other Community instruments contain more specific requirements relating to the organisation of working time for certain occupations or occupational activities.Article 15More favourable provisionsThis Directive shall not affect Member States' right to apply or introduce laws, regulations or administrative provisions more favourable to the protection of the safety and health of workers or to facilitate or permit the application of collective agreements or agreements concluded between the two sides of industry which are more favourable to the protection of the safety and health of workers.Article 16Reference periodsMember States may lay down:(a) for the application of Article 5 (weekly rest period), a reference period not exceeding 14 days;(b) for the application of Article 6 (maximum weekly working time), a reference period not exceeding four months.The periods of paid annual leave, granted in accordance with Article 7, and the periods of sick leave shall not be included or shall be neutral in the calculation of the average;(c) for the application of Article 8 (length of night work), a reference period defined after consultation of the two sides of industry or by collective agreements or agreements concluded between the two sides of industry at national or regional level.If the minimum weekly rest period of 24 hours required by Article 5 falls within that reference period, it shall not be included in the calculation of the average.CHAPTER 5DEROGATIONS AND EXCEPTIONSArticle 17Derogations1. With due regard for the general principles of the protection of the safety and health of workers, Member States may derogate from Articles 3 to 6, 8 and 16 when, on account of the specific characteristics of the activity concerned, the duration of the working time is not measured and/or predetermined or can be determined by the workers themselves, and particularly in the case of:(a) managing executives or other persons with autonomous decision-taking powers;(b) family workers; or(c) workers officiating at religious ceremonies in churches and religious communities.2. Derogations provided for in paragraphs 3, 4 and 5 may be adopted by means of laws, regulations or administrative provisions or by means of collective agreements or agreements between the two sides of industry provided that the workers concerned are afforded equivalent periods of compensatory rest or that, in exceptional cases in which it is not possible, for objective reasons, to grant such equivalent periods of compensatory rest, the workers concerned are afforded appropriate protection.3. In accordance with paragraph 2 of this Article derogations may be made from Articles 3, 4, 5, 8 and 16:(a) in the case of activities where the worker's place of work and his place of residence are distant from one another, including offshore work, or where the worker's different places of work are distant from one another;(b) in the case of security and surveillance activities requiring a permanent presence in order to protect property and persons, particularly security guards and caretakers or security firms;(c) in the case of activities involving the need for continuity of service or production, particularly:(i) services relating to the reception, treatment and/or care provided by hospitals or similar establishments, including the activities of doctors in training, residential institutions and prisons;(ii) dock or airport workers;(iii) press, radio, television, cinematographic production, postal and telecommunications services, ambulance, fire and civil protection services;(iv) gas, water and electricity production, transmission and distribution, household refuse collection and incineration plants;(v) industries in which work cannot be interrupted on technical grounds;(vi) research and development activities;(vii) agriculture;(viii) workers concerned with the carriage of passengers on regular urban transport services;(d) where there is a foreseeable surge of activity, particularly in:(i) agriculture;(ii) tourism;(iii) postal services;(e) in the case of persons working in railway transport:(i) whose activities are intermittent;(ii) who spend their working time on board trains; or(iii) whose activities are linked to transport timetables and to ensuring the continuity and regularity of traffic;(f) in the circumstances described in Article 5(4) of Directive 89/391/EEC;(g) in cases of accident or imminent risk of accident.4. In accordance with paragraph 2 of this Article derogations may be made from Articles 3 and 5:(a) in the case of shift work activities, each time the worker changes shift and cannot take daily and/or weekly rest periods between the end of one shift and the start of the next one;(b) in the case of activities involving periods of work split up over the day, particularly those of cleaning staff.5. In accordance with paragraph 2 of this Article, derogations may be made from Article 6 and Article 16(b), in the case of doctors in training, in accordance with the provisions set out in the second to the seventh subparagraphs of this paragraph.With respect to Article 6 derogations referred to in the first subparagraph shall be permitted for a transitional period of five years from 1 August 2004.Member States may have up to two more years, if necessary, to take account of difficulties in meeting the working time provisions with respect to their responsibilities for the organisation and delivery of health services and medical care. At least six months before the end of the transitional period, the Member State concerned shall inform the Commission giving its reasons, so that the Commission can give an opinion, after appropriate consultations, within the three months following receipt of such information. If the Member State does not follow the opinion of the Commission, it will justify its decision. The notification and justification of the Member State and the opinion of the Commission shall be published in the Official Journal of the European Union and forwarded to the European Parliament.Member States may have an additional period of up to one year, if necessary, to take account of special difficulties in meeting the responsibilities referred to in the third subparagraph. They shall follow the procedure set out in that subparagraph.Member States shall ensure that in no case will the number of weekly working hours exceed an average of 58 during the first three years of the transitional period, an average of 56 for the following two years and an average of 52 for any remaining period.The employer shall consult the representatives of the employees in good time with a view to reaching an agreement, wherever possible, on the arrangements applying to the transitional period. Within the limits set out in the fifth subparagraph, such an agreement may cover:(a) the average number of weekly hours of work during the transitional period; and(b) the measures to be adopted to reduce weekly working hours to an average of 48 by the end of the transitional period.With respect to Article 16(b) derogations referred to in the first subparagraph shall be permitted provided that the reference period does not exceed 12 months, during the first part of the transitional period specified in the fifth subparagraph, and six months thereafter.Article 18Derogations by collective agreementsDerogations may be made from Articles 3, 4, 5, 8 and 16 by means of collective agreements or agreements concluded between the two sides of industry at national or regional level or, in conformity with the rules laid down by them, by means of collective agreements or agreements concluded between the two sides of industry at a lower level.Member States in which there is no statutory system ensuring the conclusion of collective agreements or agreements concluded between the two sides of industry at national or regional level, on the matters covered by this Directive, or those Member States in which there is a specific legislative framework for this purpose and within the limits thereof, may, in accordance with national legislation and/or practice, allow derogations from Articles 3, 4, 5, 8 and 16 by way of collective agreements or agreements concluded between the two sides of industry at the appropriate collective level.The derogations provided for in the first and second subparagraphs shall be allowed on condition that equivalent compensating rest periods are granted to the workers concerned or, in exceptional cases where it is not possible for objective reasons to grant such periods, the workers concerned are afforded appropriate protection.Member States may lay down rules:(a) for the application of this Article by the two sides of industry; and(b) for the extension of the provisions of collective agreements or agreements concluded in conformity with this Article to other workers in accordance with national legislation and/or practice.Article 19Limitations to derogations from reference periodsThe option to derogate from Article 16(b), provided for in Article 17(3) and in Article 18, may not result in the establishment of a reference period exceeding six months.However, Member States shall have the option, subject to compliance with the general principles relating to the protection of the safety and health of workers, of allowing, for objective or technical reasons or reasons concerning the organisation of work, collective agreements or agreements concluded between the two sides of industry to set reference periods in no event exceeding 12 months.Before 23 November 2003, the Council shall, on the basis of a Commission proposal accompanied by an appraisal report, re-examine the provisions of this Article and decide what action to take.Article 20Mobile workers and offshore work1. Articles 3, 4, 5 and 8 shall not apply to mobile workers.Member States shall, however, take the necessary measures to ensure that such mobile workers are entitled to adequate rest, except in the circumstances laid down in Article 17(3)(f) and (g).2. Subject to compliance with the general principles relating to the protection of the safety and health of workers, and provided that there is consultation of representatives of the employer and employees concerned and efforts to encourage all relevant forms of social dialogue, including negotiation if the parties so wish, Member States may, for objective or technical reasons or reasons concerning the organisation of work, extend the reference period referred to in Article 16(b) to 12 months in respect of workers who mainly perform offshore work.3. Not later than 1 August 2005 the Commission shall, after consulting the Member States and management and labour at European level, review the operation of the provisions with regard to offshore workers from a health and safety perspective with a view to presenting, if need be, the appropriate modifications.Article 21Workers on board seagoing fishing vessels1. Articles 3 to 6 and 8 shall not apply to any worker on board a seagoing fishing vessel flying the flag of a Member State.Member States shall, however, take the necessary measures to ensure that any worker on board a seagoing fishing vessel flying the flag of a Member State is entitled to adequate rest and to limit the number of hours of work to 48 hours a week on average calculated over a reference period not exceeding 12 months.2. Within the limits set out in paragraph 1, second subparagraph, and paragraphs 3 and 4 Member States shall take the necessary measures to ensure that, in keeping with the need to protect the safety and health of such workers:(a) the working hours are limited to a maximum number of hours which shall not be exceeded in a given period of time; or(b) a minimum number of hours of rest are provided within a given period of time.The maximum number of hours of work or minimum number of hours of rest shall be specified by law, regulations, administrative provisions or by collective agreements or agreements between the two sides of the industry.3. The limits on hours of work or rest shall be either:(a) maximum hours of work which shall not exceed:(i) 14 hours in any 24-hour period; and(ii) 72 hours in any seven-day period;or(b) minimum hours of rest which shall not be less than:(i) 10 hours in any 24-hour period; and(ii) 77 hours in any seven-day period.4. Hours of rest may be divided into no more than two periods, one of which shall be at least six hours in length, and the interval between consecutive periods of rest shall not exceed 14 hours.5. In accordance with the general principles of the protection of the health and safety of workers, and for objective or technical reasons or reasons concerning the organisation of work, Member States may allow exceptions, including the establishment of reference periods, to the limits laid down in paragraph 1, second subparagraph, and paragraphs 3 and 4. Such exceptions shall, as far as possible, comply with the standards laid down but may take account of more frequent or longer leave periods or the granting of compensatory leave for the workers. These exceptions may be laid down by means of:(a) laws, regulations or administrative provisions provided there is consultation, where possible, of the representatives of the employers and workers concerned and efforts are made to encourage all relevant forms of social dialogue; or(b) collective agreements or agreements between the two sides of industry.6. The master of a seagoing fishing vessel shall have the right to require workers on board to perform any hours of work necessary for the immediate safety of the vessel, persons on board or cargo, or for the purpose of giving assistance to other vessels or persons in distress at sea.7. Members States may provide that workers on board seagoing fishing vessels for which national legislation or practice determines that these vessels are not allowed to operate in a specific period of the calendar year exceeding one month, shall take annual leave in accordance with Article 7 within that period.Article 22Miscellaneous provisions1. A Member State shall have the option not to apply Article 6, while respecting the general principles of the protection of the safety and health of workers, and provided it takes the necessary measures to ensure that:(a) no employer requires a worker to work more than 48 hours over a seven-day period, calculated as an average for the reference period referred to in Article 16(b), unless he has first obtained the worker's agreement to perform such work;(b) no worker is subjected to any detriment by his employer because he is not willing to give his agreement to perform such work;(c) the employer keeps up-to-date records of all workers who carry out such work;(d) the records are placed at the disposal of the competent authorities, which may, for reasons connected with the safety and/or health of workers, prohibit or restrict the possibility of exceeding the maximum weekly working hours;(e) the employer provides the competent authorities at their request with information on cases in which agreement has been given by workers to perform work exceeding 48 hours over a period of seven days, calculated as an average for the reference period referred to in Article 16(b).Before 23 November 2003, the Council shall, on the basis of a Commission proposal accompanied by an appraisal report, re-examine the provisions of this paragraph and decide on what action to take.2. Member States shall have the option, as regards the application of Article 7, of making use of a transitional period of not more than three years from 23 November 1996, provided that during that transitional period:(a) every worker receives three weeks' paid annual leave in accordance with the conditions for the entitlement to, and granting of, such leave laid down by national legislation and/or practice; and(b) the three-week period of paid annual leave may not be replaced by an allowance in lieu, except where the employment relationship is terminated.3. If Member States avail themselves of the options provided for in this Article, they shall forthwith inform the Commission thereof.CHAPTER 6FINAL PROVISIONSArticle 23Level of ProtectionWithout prejudice to the right of Member States to develop, in the light of changing circumstances, different legislative, regulatory or contractual provisions in the field of working time, as long as the minimum requirements provided for in this Directive are complied with, implementation of this Directive shall not constitute valid grounds for reducing the general level of protection afforded to workers.Article 24Reports1. Member States shall communicate to the Commission the texts of the provisions of national law already adopted or being adopted in the field governed by this Directive.2. Member States shall report to the Commission every five years on the practical implementation of the provisions of this Directive, indicating the viewpoints of the two sides of industry.The Commission shall inform the European Parliament, the Council, the European Economic and Social Committee and the Advisory Committee on Safety, Hygiene and Health Protection at Work thereof.3. Every five years from 23 November 1996 the Commission shall submit to the European Parliament, the Council and the European Economic and Social Committee a report on the application of this Directive taking into account Articles 22 and 23 and paragraphs 1 and 2 of this Article.Article 25Review of the operation of the provisions with regard to workers on board seagoing fishing vesselsNot later than 1 August 2009 the Commission shall, after consulting the Member States and management and labour at European level, review the operation of the provisions with regard to workers on board seagoing fishing vessels, and, in particular examine whether these provisions remain appropriate, in particular, as far as health and safety are concerned with a view to proposing suitable amendments, if necessary.Article 26Review of the operation of the provisions with regard to workers concerned with the carriage of passengersNot later than 1 August 2005 the Commission shall, after consulting the Member States and management and labour at European level, review the operation of the provisions with regard to workers concerned with the carriage of passengers on regular urban transport services, with a view to presenting, if need be, the appropriate modifications to ensure a coherent and suitable approach in the sector.Article 27Repeal1. Directive 93/104/EC, as amended by the Directive referred to in Annex I, part A, shall be repealed, without prejudice to the obligations of the Member States in respect of the deadlines for transposition laid down in Annex I, part B.2. The references made to the said repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex II.Article 28Entry into forceThis Directive shall enter into force on 2 August 2004.Article 29AddresseesThis Directive is addressed to the Member States.Done at Brussels, 4 November 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentG. Tremonti(1) OJ C 61, 14.3.2003, p. 123.(2) Opinion of the European Parliament of 17 December 2002 (not yet published in the Official Journal) and Council Decision of 22 September 2003.(3) OJ L 307, 13.12.1993, p. 18. Directive as amended by Directive 2000/34/EC of the European Parliament and of the Council (OJ L 195, 1.8.2000, p. 41).(4) OJ L 183, 29.6.1989, p. 1.(5) OJ L 167, 2.7.1999, p. 33.ANNEX IPART AREPEALED DIRECTIVE AND ITS AMENDMENT(Article 27)>TABLE>PART BDEADLINES FOR TRANSPOSITION INTO NATIONAL LAW(Article 27)>TABLE>ANNEX IICORRELATION TABLE>TABLE>

Summary: Organisation of working time Organisation of working time SUMMARY OF: Directive 2003/88/EC – certain aspects of the organisation of working time WHAT IS THE AIM OF THIS DIRECTIVE? It sets out minimum safety and health requirements for the organisation of the working time of workers. These cover: minimum periods of daily and weekly rest, annual leave, breaks and maximum weekly working time; aspects of night and shift work. KEY POINTS EU countries EU countries must ensure that all workers are entitled to: a minimum daily rest period of 11 consecutive hours in every 24; a rest break in any working day longer than 6 hours; an uninterrupted 24-hour rest period every 7 days, in addition to the daily 11 hours; at least 4 weeks paid annual leave; a maximum average working week of 48 hours, including overtime, over 7 days. Normal night work should be no more than 8 hours on average in any 24-hour period. Night workers are entitled to free health checks at regular intervals. National authorities National authorities may: use reference periods, ranging from 14 days to 4 months, to calculate weekly rest periods and maximum weekly working time; exempt managing executives, other senior decision makers, family workers and religious officials from the legislation. Derogations to certain provisions may also apply for any of the following: security and surveillance activities requiring a permanent presence to protect people or property; continuity of service or production in areas such as hospitals, docks, airports, the media and agriculture; a foreseeable surge of activity (notably agriculture, tourism, postal services, railways, accidents); derogations agreed in collective agreements between employers and employees. The legislation does not apply to seafarers; nor does it apply to workers covered by more specific rules (such as mobile workers in the road transport, civil aviation, cross-border railway or inland waterway transport sectors). EU countries may apply more favourable health and safety provisions if they wish. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 2 August 2004. BACKGROUND Working Conditions - Working Time Directive MAIN DOCUMENT Directive 2003/88/EC of the European Parliament and of the Council of 4 November 2003 concerning certain aspects of the organisation of working time (OJ L 299, 18.11.2003, pp. 9–19) RELATED DOCUMENTS Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions: Reviewing the Working Time Directive (first-phase consultation of the social partners at European Union level under Article 154 of the TFEU) (COM(2010) 106 final, 24.3.2010) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Reviewing the Working Time Directive (Second-phase consultation of the social partners at European Union level under Article 154 TFEU) (COM(2010) 801 final, 21.12.2010) Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on implementation by Member States of Directive 2003/88/EC (‘The Working Time Directive’) (COM(2010) 802 final, 21.12.2010) last update 01.12.2016