EUR-Lex - 31991L0412 - EN Avis juridique important | 31991L0412 Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products Official Journal L 228 , 17/08/1991 P. 0070 - 0073 Finnish special edition: Chapter 3 Volume 38 P. 0156 Swedish special edition: Chapter 3 Volume 38 P. 0156 COMMISSION DIRECTIVE of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (91/412/EEC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 81/851/EEC of 28 September 1981 concerning the approximation of the laws of the Member States relating to veterinary medicinal products (1), as last amended by Directive 90/676/EEC (2), and in particular Article 27a, Having regard to Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products (3), Whereas all veterinary medicinal products manufactured or imported into the Community, including medicinal products intended for export should be manufactured in accordance with the principles and guidelines of good manufacturing practice; Whereas, in accordance with national legislation, Member States may require compliance with these principles of good manufacturing practice during the manufacture of products intended for use in clinical trials; Whereas the detailed guidelines mentioned in Article 27a of Directive 81/851/EEC have been published by the Commission after consultation with the pharmaceutical inspection services of the Member States in the form of a "Guide to good manufacturing practice for medicinal products"; Whereas it is necessary that all manufacturers should operate an effective quality management of their manufacturing operations, and that this requires the implementation of a pharmaceutical quality assurance system; Whereas officials representing the competent authorities should report on whether the manufacturer complies with good manufacturing practice and that these reports should be communicated upon reasoned request to the competent authorities of another Member State; Whereas the principles and guidelines of good manufacturing practice should primarily concern personnel, premises and equipment, documentation, production, quality control, contracting out, complaints and product recall, and self inspection; Whereas the principles and guidelines envisaged by this Directive are in conformity with the opinion of the Committee for Adaptation of Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector created by Article 2b of Directive 81/852/EEC of 28 September 1981 concerning the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (4), as last amended by Directive 87/20/EEC (5), HAS ADOPTED THIS DIRECTIVE: CHAPTER I GENERAL PROVISIONS Article 1 This Directive lays down the principles and guidelines of good manufacturing practice for veterinary medicinal products whose manufacture requires the authorization referred to in Article 24 of Directive 81/851/EEC. Article 2 For the purposes of this Directive, the definition of medicinal products set out in Article 1 (2) of Council Directive 65/65/EEC (6), and the definition of veterinary medicinal products set out in Article 1 (2) of Directive 81/851/EEC, shall apply. In addition, - "manufacturer" shall mean any holder of the authorization referred to in Article 24 of Directive 81/851/EEC, - "qualified person" shall mean the person referred to in Article 29 of Directive 81/851/EEC, (1) OJ No L 317, 6.11.1981, p. 1. (2) OJ No L 373, 31.12.1990, p. 15. (3) OJ No L 373, 31.12.1990, p. 26. (4) OJ No L 317, 6.11.1981, p. 16. (5) OJ No L 15, 17.1.1987, p. 34. (6) OJ No 22, 9.2.1965, p. 369/65. - "pharmaceutical quality assurance" shall mean the sum total of the organized arrangements made with the object of ensuring that veterinary medicinal products are of the quality required for their intended use, - "good manufacturing practice" shall mean the part of quality assurance with ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. Article 3 By means of the repeated inspections referred to in Article 34 of Directive 81/851/EEC, the Member States shall ensure that manufacturers respect the principles and guidelines of good manufacturing practice laid down by this Directive. For the interpretation of these principles and guidelines of good manufacturing practice, the manufacturers and the agents of the competent authorities refer to the detailed guidelines referred to in Article 27a of Directive 81/851/EEC. These detailed guidelines are published by the Commission in the "Guide to good manufacturing practice for medicinal products" and in its annexes (Office for Official Publications of the European Communities, The Rules Governing Medicinal Products in the European Community, Volume IV). Article 4 The manufacturers shall ensure that the manufacturing operations are carried out in accordance with good manufacturing practice and with the manufacturing authorization. For veterinary medicinal products imported from third countries, the importer shall ensure that the veterinary medicinal products have been manufactured by manufacturers duly authorized and conforming to good manufacturing practice standards, at least equivalent to those laid down by the Community. Article 5 The manufacturer shall ensure that all manufacturing operations subject to an authorization for marketing are carried out in accordance with the information given in the application for marketing authorization as accepted by the competent authorities. The manufacturers shall regularly review their manufacturing methods in the light of scientific and technical progress. When a modification to the marketing authorization dossier is necessary, the application for modification must be submitted to the competent authorities. CHAPTER II PRINCIPLES AND GUIDELINES OF GOOD MANUFACTURING PRACTICE Article 6 Quality management The manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different services involved. Article 7 Personnel 1. At each manufacturing site, the manufacturer shall have competent and appropriately qualified personnel at his disposal in sufficient number to achieve the pharmaceutical quality assurance objectives. 2. The duties of managerial and supervisory staff, including the qualified person(s), responsible for implementing and operating good manufacturing practice shall be defined in job descriptions. Their hierarchical relationships shall be defined in an organizational chart. Organizational charts and job descriptions shall be approved in accordance with the manufacturer's internal procedures. 3. Staff referred to in paragraph 2 shall be given sufficient authority to carry out their responsibilities correctly. 4. Personnel shall receive initial and continuing training including the theory and application of the concept of quality assurance and good manufacturing practice. 5. Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes include procedures relating to health, hygiene and clothing of personnel. Article 8 Premises and equipment 1. Premises and manufacturing equipment shall be located, designed, constructed, adapted and maintained to suit the intended operations. 2. Lay out, design and operation must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid contamination, cross contamination and, in general, any adverse effect on the quality of the product. 3. Premises and equipment intended to be used for manufacturing operations which are critical for the quality of the products shall be subjected to appropriate qualification. Article 9 Documentation 1. The manufacturer shall have a system of documentation based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the different manufacturing operations that they perform. Documents shall be clear, free from errors and kept up to-date. Pre-established procedures for general manufacturing operations and conditions shall be available, together with specific documents for the manufacture of each batch. This set of documents shall make it possible to trace the history of the manufacture of each batch. The batch documentation shall be retained for at least one year after the expiry date of the batches to which it relates, or at least five years after the certification referred to in Article 30 (2) of Directive 81/851/EEC, whichever is the longer. 2. When electronic, photographic or other data processing systems are used instead of written documents, the manufacturer shall have validated the system by proving that the data will be appropriately stored during the anticipated period of storage. Data stored by these systems shall be made readily available in legible form. The electronically stored data shall be protected against loss or damage of data (e.g. by duplication or back-up and transfer onto another storage system). Article 10 Production The different production operations shall be carried out according to pre-established instructions and procedures and in accordance with good manufacturing practice. Adequate and sufficient resources shall be made available for the in-process controls. Appropriate technical and/or organizational measures shall be taken to avoid cross contamination and mix-ups. Any new manufacture or important modification of a manufacturing process shall be validated. Critical phases of manufacturing process shall be regularly revalidated. Article 11 Quality control 1. The manufacturer shall establish and maintain a quality control department. This department shall be placed under the authority of a person having the required qualifications and shall be independent of the other departments. 2. The quality control department shall have at its disposal one or more quality control laboratories appropriately staffed and equipped to carry out the necessary examination and testing of starting materials, packaging materials and intermediate and finished products testing. Resorting to outside laboratories is authorized in accordance with Article 12 of this Directive and after the authorization referred to in Article 10 (2) of Directive 81/851/EEC has been granted. 3. During the final control of finished products before their release for the sale or distribution, in addition to analytical results, the quality control department shall take into account essential information such as the production conditions, the results of in-process controls, the examination of the manufacturing documents and the conformity of the products to their specifications (including the final finished pack). 4. Samples of each batch of finished products shall be retained for at least one year after the expiry date. Unless in the Member State of manufacture a longer period is required, samples of starting materials (other than solvents, gases and water) used shall be retained for at least two years after the release of the product. This period may be shortened if their stability, as mentioned in the relevant specification, is shorter. All these samples shall be maintained at the disposal of the competent authorities. For certain veterinary medicinal products manufactured individually or in small quantities, or when their storage could raise special problems, other sampling and retaining conditions may be defined in agreement with the competent authority. Article 12 Work contracted out 1. Any manufacturing operation or operation linked with the manufacture which is carried out under contract, shall be the subject of a written contract between the contract giver and the contract acceptor. 2. The contract shall clearly define the responsibilities of each party and in particular the observance of good manufacturing practice by the contract acceptor and the manner in which the qualified person responsible for releasing each batch shall undertake his full responsibilities 3. The contract acceptor shall not further sub-contract any of the work entrusted to him by the contract giver without the written authorization of the contract giver. 4. The contract acceptor shall respect the principles and guidelines of good manufacturing practice and shall submit to inspections carried out by the competent authorities as provided for by Article 34 of Directive 81/851/EEC. Article 13 Complaints and product recall The manufacturer shall implement a system for recording and reviewing complaints together with an effective system for recalling promptly and at any time the veterinary medicinal products in the distribution network. Any complaint concerning a quality defect shall be recorded and investigation by the manufacturer. The competent authority shall be informed by the manufacturer of any quality defect that could result in a recall or abnormal restriction on the supply. In so far as possible, the countries of destination shall also be indicated. Any recall shall be made in accordance with the requirements referred to in Article 42 of Directive 81/851/EEC. Article 14 Self-inspection The manufacturer shall conduct repeated self-inspections as part of the quality assurance system in order to monitor the implementation and respect of good manufacturing practice and to propose any necessary corrective measures. Records of such self-inspections and any further corrective action shall be maintained. CHAPTER III FINAL PROVISIONS Article 15 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 23 July 1993. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 16 This Directive is addressed to the Member States. Done at Brussels, 23 July 1991. For the Commission Martin BANGEMANN Vice-President

Summary: Veterinary medicines — good manufacturing practice Veterinary medicines — good manufacturing practice SUMMARY OF: Commission Directive 91/412/EEC — good manufacturing practice for veterinary medicines SUMMARY WHAT DOES THIS DIRECTIVE DO? It sets out the principles and guidelines of good manufacturing practice for medicines for animal use. KEY POINTS National authorities must organise regular inspections to ensure manufacturers comply with the principles and guidelines set out in the legislation. Manufacturers must: ensure that their activities are properly authorised and respect good manufacturing practice; regularly review their manufacturing methods in the light of scientific and technical progress; establish and implement an effective pharmaceutical quality assurance system, involving management and staff; have enough competent and qualified staff to ensure quality standards are met; define the duties of the managerial and supervisory staff and provide them with appropriate training; establish and maintain documentation records, a quality control system under a suitably qualified person and hygiene programmes; conduct frequent inspections of their operations and take any necessary corrective measures; implement a system to respond to, and investigate, complaints and have measures in place to promptly recall any medicines if necessary, while informing the competent authorities of their action. The premises and equipment used must be located, designed, constructed, adapted and maintained to suit their intended purpose, minimise the risk of error and allow effective cleaning and maintenance. The quality control system includes access to quality control laboratories and must retain samples of each batch of medicines for at least a year after their expiry date. Any work contracted out must be authorised by a written contract setting out the responsibilities of both parties in complying with good manufacturing practice. Importers must ensure that the imported products have been manufactured according to standards that are at least equivalent to those in the EU. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 23 July 1991. EU countries had to incorporate it into national law by 23 July 1993. BACKGROUND For more information, see: ‘Quality of medicines and Good Manufacturing Practices (GMP)’ on the European Commission’s website ‘Good-manufacturing-practice and good-distribution-practice compliance’ on the European Medicines Agency’s website ACT Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, pp. 70–73) RELATED ACTS Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, pp. 1–33). Subsequent amendments to Regulation (EC) No 726/2004 have been incorporated into the basic text. This consolidated version is of documentary value only. Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (OJ L 136, 30.4.2004, pp. 58–84) 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 (OJ L 311, 28.11.2001, pp. 1–66). See consolidated version. last update 19.04.2016


21.6.1990 EN Official Journal of the European Communities L 156/14 COUNCIL DIRECTIVE of 29 May 1990 on the minimum safety and health requirements for work with display screen equipment (fifth individual Directive within the meaning of Article 16 (1) of Directive 87/391/EEC) (90/270/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 118a thereof, Having regard to the Commission proposal (1) drawn up after consultation with the Advisory Committee on Safety, Hygiene and Health Protection at Work, In cooperation with the European Parliament (2) Having regard to the opinion of the Economic and Social Committee (3), Whereas Article 118a of the Treaty provides that the Council shall adopt, by means of Directives, minimum requirements designed to encourage improvements, especially in the working environment, to ensure a better level of protection of workers' safety and health; Whereas, under the terms of that Article, those Directives shall avoid imposing administrative, financial and legal constraints, in a way which would hold back the creation and development of small and medium-sized undertakings; Whereas the communication from the Commission on its programme concerning safety, hygiene and health at work (4) provides for the adoption of measures in respect of new technologies; whereas the Council has taken note thereof in its resolution of 21 December 1987 on safety, hygiene and health at work (5); Whereas compliance with the minimum requirements for ensuring a better level of safety at workstations with display screens is essential for ensuring the safety and health of workers; Whereas this Directive is an individual Directive within the meaning of Article 16 (1) 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 (6); whereas the provisions of the latter are therefore fully applicable to the use by workers of display screen equipment, without prejudice to more stringent and/or specific provisions contained in the present Directive; Whereas employers are obliged to keep themselves informed of the latest advances in technology and scientific findings concerning workstation design so that they can make any changes necessary so as to be able to guarantee a better level of protection of workers' safety and health; Whereas the ergonomic aspects are of particular importance for a workstation with display screen equipment; Whereas this Directive is a practical contribution towards creating the social dimension of the internal market; Whereas, pursuant to Decision 74/325/EEC (7), the Advisory Committee on Safety, Hygiene and Health Protection at Work shall be consulted by the Commission on the drawing-up of proposals in this field, HAS ADOPTED THIS DIRECTIVE: SECTION I GENERAL PROVISIONS Article 1 Subject 1. This Directive, which is the fifth individual Directive within the meaning of Article 16 (1) of Directive 89/391 /EEC, lays down minimum safety and health requirements for work with display screen equipment as defined in Article 2. 2. The provisions of Directive 89/391/EEC are fully applicable to the whole field referred to in paragraph 1, without prejudice to more stringent and/or specific provisions contained in the present Directive. 3. This Directive shall not apply to: (a) drivers' cabs or control cabs for vehicles or machinery; (b) computer systems on board a means of transport; (c) computer systems mainly intended for public use; (d) ‘portable’ systems not in prolonged use at a workstation; (e) calculators, cash registers and any equipment having a small data or measurement display required for direct use of the equipment; (f) typewriters of traditional design, of the type known as ‘typewriter with window’. Article 2 Definitions For the purpose of this Directive, the following terms shall have the following meanings: (a) display screen equipment: an alphanumeric or graphic display screen, regardless of the display process employed; (b) workstation: an assembly comprising display screen equipment, which may be provided with a keyboard or input device and /or software determining the operator/machine interface, optional accessories, peripherals including the diskette drive, telephone, modem, printer, document holder, work chair and work desk or work surface, and the immediate work environment; (c) worker: any worker as defined in Article 3 (a) of Directive 89/391/EEC who habitually uses display screen equipment as a significant part of his normal work. SECTION II EMPLOYERS' OBLIGATIONS Article 3 Analysis of workstations 1. Employers shall be obliged to perform an analysis of workstations in order to evaluate the safety and health conditions to which they give rise for their workers, particularly as regards possible risks to eyesight, physical problems and problems of mental stress. 2. Emyployers shall take appropriate measures to remedy the risks found, on the basis of the evaluation referred to in paragraph 1, taking account of the additional and/or combined effects of the risks so found. Article 4 Workstations put into service for the first time Employers must take the appropriate steps to ensure that workstations first put into service after 31 December 1992 meet the minimum requirements laid down in the Annex. Article 5 Workstations already put into service Employers must take the appropriate steps to ensure that workstations already put into service on or before 31 December 1992 are adapted to comply with the minimum requirements laid down in the Annex not later than four years after that date. Article 6 Information for, and training of, workers 1. Without prejudice to Article 10 of Directive 89/391/EEC, workers shall receive information on all aspects of safety and health relating to their workstation, in particular information on such measures applicable to workstations as are implemented under Articles 3, 7 and 9. In all cases, workers or their representatives shall be informed of any health and safety measure taken in compliance with this Directive. 2. Without prejudice to Article 12 of Directive 89/391/EEC, every worker shall also receive training in use of the workstation before commencing this type of work and whenever the organization of the workstation is substantially modified. Article 7 Daily work routine The employer must plan the worker's activities in such a way that daily work on a display screen is periodically interrupted by breaks or changes of activity reducing the workload at the display screen. Article 8 Worker consultation and participation Consultation and participation of workers and/or their representatives shall take place in accordance with Article 11 of Directive 89/391/EEC on the matters covered by this Directive, including its Annex. Article 9 Protection of workers' eyes and eyesight 1. Workers shall be entitled to an appropriate eye and eyesight test carried out by a person with the necessary capabilities: — before commencing display screen work, — at regular intervals thereafter, and — if they experience visual difficulties which may be due to display screen work. 2. Workers shall be entitled to an ophthalmological examination if the results of the test referred to in paragraph 1 show that this is necessary. 3. If the results of the test referred to in paragraph 1 or of the examination referred to in paragraph 2 show that it is necessary and if normal corrective appliances cannot be used, workers must be provided with special corrective appliances appropriate for the work concerned. 4. Measures taken pursuant to this Article may in no circumstances involve workes in additional financial cost. 5. Protection of workers' eyes and eyesight may be provided as part of a national health system. SECTION III MISCELLANEOUS PROVISIONS Article 10 Adaptations to the Annex The strictly technical adaptations to the Annex to take account of technical progress, developments in international regulations and specifications and knowledge in the field of display screen equipment shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC. Article 11 Final provisions 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1992. They shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt, or have already adopted, in the field covered by this Directive. 3. Member States shall report to the Commission every four years on the practical implementation of the provisions of this Directive, indicating the points of view of employers and workers. The Commission shall inform the European Parliament, the Council, the Economic and Social Committee and the Advisory Committee on Safety, Hygiene and Health Protection at Work. 4. The Commission shall submit a report on the implementation of this Directive at regular intervals to the European Parliament, the Council and the Economic and Social Committee, taking into account paragraphs 1, 2 and 3. Article 12 This Directive is addressed to the Member States. Done at Brussels, 29 May 1990. For the Council The President B. AHERN (1) OJ No C 113, 29. 4.1988, p. 7 and OJ No C 130, 26. 5.1989, p. 5. (2) OJ No C 12, 16. 1. 1989, p. 92 and OJ No C 113, 7. 5. 1990. (3) OJ No C 318, 12. 12. 1988, p. 32. (4) OJ No C 28, 3. 2. 1988, p. 3. (5) OJ No C 28, 3. 2. 1988, p. 1. (6) OJ No L 183, 29. 6. 1989, p. 1. (7) OJ No L 185, 9. 7. 1974, p. 15. Annex MINIMUM REQUIREMENTS (Articles 4 and 5) Preliminary remark The obligations laid down in this Annex shall apply in order to achieve the objectives of this Directive and to the extent that, firstly, the components concerned are present at the workstation, and secondly, the inherent requirements or characteristics of the task do not preclude it. 1. EQUIPMENT (a) General comment The use as such of the equipment must not be a source of risk for workers. (b) Display screen The characters on the screen shall be well-defined and clearly formed, of adequate size and with adequate spacing between the characters and lines. The image on the screen should be stable, with no flickering or other forms of instability. The brightness and/or the contrast between the characters and the background shall be easily adjustable by the operator, and also be easily adjustable to ambient conditions. The screen must swivel and tilt easily and freely to suit the needs of the operator. It shall be possible to use a separate base for the screen or an adjustable table. The screen shall be free of reflective glare and reflections liable to cause discomfort to the user. (c) Keyboard The keyboard shall be tiltable and separate from the screen so as to allow the worker to find a comfortable working position avoiding fatigue in the arms or hands. The space in front of the keyboard shall be sufficient to provide support for the hands and arms of the operator. The keyboard shall have a matt surface to avoid reflective glare. The arrangement of the keyboard and the characteristics of the keys shall be such as to facilitate the use of the keyboard. The symbols on the keys shall be adequately contrasted and legible from the design working position. (d) Work desk or work surface The work desk or work surface shall have a sufficiently large, low-reflectance surface and allow a flexible arrangement of the screen, keyboard, documents and related equipment. The document holder shall be stable and adjustable and shall be positioned so as to minimize the need for uncomfortable head and eye movements. There shall be adequate space for workers to find a comfortable position. (e) Work chair The work chair shall be stable and allow the operator easy freedom of movement and a comfortable position. The seat shall be adjustable in height. The seat back shall be adjustable in both height and tilt. A footrest shall be made available to any one who wishes for one. 2. ENVIRONMENT (a) Space requirements The workstation shall be dimensioned and designed so as to provide sufficient space for the user to change position and vary movements. (b) Lighting Room lighting and/or spot lighting (work lamps) shall ensure satisfactory lighting conditions and an appropriate contrast between the screen and the background environment, taking into account the type of work and the user's vision requirements. Possible disturbing glare and reflections on the screen or other equipment shall be prevented by coordinating workplace and workstation layout with the positioning and technical characteristics of the artificial light sources. (c) Reflections and glare Workstations shall be so designed that sources of light, such as windows and other openings, transparent or translucid walls, and brightly coloured fixtures or walls cause no direct glare and, as far as possible, no reflections on the screen. Windows shall be fitted with a suitable system of adjustable covering to attenuate the daylight that falls on the workstation. (d) Noise Noise emitted by equipment belonging to workstation(s) shall be taken into account when a workstation is being equipped, in particular so as not to distract attention or disturb speech. (e) Heat Equipment belonging to workstation(s) shall not produce excess heat which could cause discomfort to workers. (f) Radiation All radiation with the exception of the visible part of the electromagnetic spectrum shall be reduced to negligible levels from the point of view of the protection of workers' safety and health. (g) Humidity An adequate level of humidity shall be established and maintained. 3. OPERATOR/COMPUTER INTERFACE In designing, selecting, commissioning and modifying software, and in designing tasks using display screen equipment, the employer shall take into account the following principles: (a) software must be suitable for the task; (b) software must be easy to use and, where appropriate, adaptable to the operator's level of knowledge or experience; no quantitative or qualitative checking facility may be used without the knowledge of the workers; (c) systems must provide feedback to workers on their performance; (d) systems must display information in a format and at a pace which are adapted to operators; (e) the principles of software ergonomics must be applied, in particular to human data processing.

Summary: Work with display screen equipment Work with display screen equipment SUMMARY OF: Directive 90/270/EEC on the minimum safety and health requirements for work with display screen equipment WHAT IS THE AIM OF THE DIRECTIVE? It lays down minimum safety and health requirements for work with display screen equipment* in the European Union (EU). KEY POINTS Scope The directive contains rules that supplement the general rules contained in Directive 89/391/EEC concerning health and safety of workers at work (see summary). It should be noted, however, that this directive does not apply to: drivers’ cabins or control cabs for vehicles or machinery; computer systems on board a means of transport; computer systems mainly intended for public use; portable systems, except in prolonged use at a workstation*; calculators, cash registers and any equipment having a small data or measurement display required for direct use of the equipment; typewriters of traditional design, of the type known as ‘typewriters with window’. Employers’ obligations To ensure the safety and health of workers, employers are obliged to: perform an analysis of workstations in order to evaluate the safety and health conditions, and to take appropriate measures to remedy the risks found and bring them in line with the requirements of the directive;inform workers about and provide training on all measures connected to their health and safety, and relating to their workstation. In addition, they must plan the activities of workers in such a way that daily work on display screen equipment is periodically interrupted by breaks or changes of activity. They must provide workers with training regarding the use of the workstation before commencing this type of work, and whenever there is a substantial change made to the organisation of the workstation. Protection of workers’ eyes and eyesight Workers are entitled to an eye and eyesight test before commencing their display screen work, and again at regular intervals during their activities and if they experience visual difficulties. If necessary and if normal corrective appliances cannot be used, workers must be provided with special corrective appliances appropriate for the work concerned, without charge. Delegated acts The European Commission is empowered to adopt delegated acts, in accordance with Article 10a of Regulation (EU) 2019/1243, to make strictly technical amendments to the annex, in order to take account of technical progress, developments in international regulations or specifications and knowledge in the field of display screen equipment. Review of the legislation As part of its strategic framework on health and safety at work 2021–2027, published in June 2021, the Commission is planning to review Directive 90/270/EEC in view of digitalisation since the directive was first adopted. FROM WHEN DOES THE DIRECTIVE APPLY? Directive 90/270/EEC has applied since 11 June 1990 and had to become law (transposition) in the EU Member States by 31 December 1992. BACKGROUND For further information, see: Directive 90/270/EEC – display screen equipment (European Agency for Safety and Health at Work). KEY TERMS Display screen equipment. An alphanumeric or graphic display screen, regardless of the display process employed. Workstation. An assembly comprising display screen equipment, which may be provided with a keyboard or input device and/or software determining the operator/machine interface, optional accessories, peripherals including the diskette drive, telephone, modem, printer, document holder, work chair and work desk or work surface, and the immediate work environment. MAIN DOCUMENT Council Directive 90/270/EEC of 29 May 1990 on the minimum safety and health requirements for work with display screen equipment (fifth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 156, 21.6.1990, pp. 14–18). Successive amendments to Directive 90/270/EEC have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions – EU strategic framework on health and safety at work 2021–2027 – occupational safety and health in a changing world of work (COM(2021) 323 final, 28.6.2021). 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 (OJ L 183, 29.6.1989, pp. 1–8). See consolidated version. last update 10.11.2021