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31990L0396

Council Directive 90/396/EEC of 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels

Official Journal L 196 , 26/07/1990 P. 0015 - 0029 Finnish special edition: Chapter 13 Volume 19 P. 0228  Swedish special edition: Chapter 13 Volume 19 P. 0228

COUNCIL DIRECTIVE of 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels (90/396/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Member States are responsible for ensuring the health and safety on their territory of their people and, where appropriate, of domestic animals and goods in relation to the hazards arising out of the use of appliances burning gaseous fuels;  Whereas, in certain Member States, mandatory provisions define in particular the safety level required of appliances burning gaseous fuels by specifying design, operating characteristics and inspection procedures; whereas these mandatory provisions do  not necessarily lead to different safety levels from one Member State to another but do, by their disparity, hinder trade within the Community;  Whereas different conditions as regards types of gas and supply pressures are in force in the Member States; whereas these conditions are not harmonized because each Member State's energy supply and distribution situation is peculiar to it;  Whereas paragraphs 65 and 68 of the White Paper on the completion of the internal market, approved by the European Council in June 1985, provide for a new approach to legislative harmonization;  Whereas Community law provides - by way of derogation from one of the fundamental rules of the Community, namely the free movement of goods - that obstacles to movement within the Community resulting from disparities in national legislation relating to  the marketing of products must be accepted in so far as such obstacles can be recognized as being necessary to satisfy mandatory requirements; whereas, therefore, the harmonization of legislation in the  present case must be limited to the provisions necessary to satisfy both the mandatory and essential requirements regarding safety, health and energy conservation in relation to gas appliances; whereas these requirements must replace the national  provisions in this matter because they are essential requirements;  Whereas the maintenance or improvement of the level of safety attained in Member States constitutes one of the essential aims of this Directive and of safety as defined by the essential requirements;  Whereas the essential safety and health requirements must be observed in order to ensure that appliances burning gaseous fuels are safe; whereas energy conservation is considered essential; whereas these requirements must be applied with discernment to  take account of the state of the art at the time of construction;  Whereas this Directive therefore contains only essential requirements; whereas, to facilitate proof of conformity with the essential requirements, it is necessary to have harmonized standards at European level in particular as to the construction,  operation and installation of appliances burning gaseous fuels so that products complying with them may be assumed to conform to the essential requirements; whereas these standards, harmonized at European level, are drawn up by private bodies and must  remain non-mandatory texts; whereas for that purpose the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the competent bodies for the adoption of harmonized  standards in accordance with the general guidelines for cooperation between the Commission and those two bodies signed on 13 November 1984; whereas, for the purposes of this Directive, a harmonized standard is a technical specification (European  standard or harmonization document) adopted by one or both of those bodies upon a remit from the Commission in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of  technical standards and regulations (4), as last amended by Directive 88/182/EEC (5), and the abovementioned general guidelines;  Whereas, pending the adoption of harmonized standards within the meaning of this Directive, conformity with the essential requirements and the free movement of appliances burning gaseous fuels should be facilitated by the acceptance, at Community level,  of products conforming to the national  standards whose conformity with the essential requirements has been confirmed by a Community checking procedure;  Whereas a check on compliance with the relevant technical requirements is necessary in order to provide effective protection for users and third parties; whereas the existing certification procedures differ from one Member State to another; whereas, in  order to avoid multiple inspections, which are in effect barriers to the free movement of appliances burning gaseous fuels, arrangements should be made for the mutual recognition of certification procedures by the Member States; whereas, in order to  facilitate mutual recognition of certification procedures, harmonized Community procedures should be set up and the criteria for appointing the bodies responsible for carrying out these procedures should be harmonized;  Whereas the Member States' responsibility on their territory for safety, health and energy conservation covered by the essential requirements must be recognized in a safeguard clause providing for an adequate Community procedure;  Whereas the addressees of any decision taken under this Directive must be informed of the reasons for such a decision and the legal remedies available to them;  Whereas the Council adopted, on 17 September 1984, a framework Directive on gas appliances (84/530/EEC) (6), as last amended by Directive 86/312/EEC (7), and a separate Directive on gas water heaters (84/531/EEC) (8), as last amended by Directive  88/665/EEC (9); whereas those Directives cover the same area as this Directive and should therefore be repealed;  Whereas the measures aimed at the gradual establishment of the internal market must be adopted by 31 December 1992; whereas the internal market consists of an area without internal frontiers in which the free movement of goods, persons, services and  capital is ensured,  HAS ADOPTED THIS DIRECTIVE:    CHAPTER I Scope, placing on the market and free movement Article 1 1.  This Directive shall apply to:  - appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or  washing and having, where applicable, a normal water temperature not exceeding 105 gC, hereinafter referred to as 'appliances'. Forced draught burners and heating bodies to be equipped with such burners will also be considered as appliances,  - safety devices, controlling devices or regulating decives and sub-assemblies, other than forced draught burners and heating bodies to be equipped with such burners separately marketed for trade use and designed to be incorporated into an appliance  burning gaseous fuel or assembled to constitute such an appliance, hereinafter referred to as 'fittings'.  2.  Appliances specifically designed for use in industrial processes carried out on industrial premises are excluded from the scope defined in paragraph 1.  3.  For the purposes of this Directive, 'gaseous fuel' means any fuel which is in a gaseous state at a temperature of 15 gC under a pressure of 1 bar.  4.  For the purposes of this Directive, an appliance is said to be 'normally used' when it is:  - correctly installed and regularly serviced in accordance with the manufacturer's instructions,  - used with a normal variation in the gas quality and a normal fluctuation in the supply pressure, and - used in accordance with its intended purpose or in a way which can be reasonably foreseen.  Article 2 1.  Member States shall take all necessary steps to ensure that the appliances referred to in Article 1 may be placed on the market and put into service only if, when normally used, they do not compromise the safety of persons, domestic  animals and property.  2.  Member States shall communicate the types of gas and corresponding supply pressures used on their territory to the other Member States and the Commission before 1 January 1991. They shall also communicate all changes in good time. The Commission  shall ensure that this information is published in the Official Journal of the European Communities.  Article 3 Appliances and fittings as referred to in Article 1 shall satisfy the essential requirements applicable to them set out in Annex I.  Article 4 1.  Member States may not prohibit, restrict or impede the placing on the market and the putting into service of appliances which satisfy the essential requirements of this Directive.  2.  Member States may not prohibit, restrict or impede the placing on the market of fittings as referred to in Article 1 accompanied by a certificate as referred to in Article 8 (4).  Article 5 1.  Member States shall presume compliance with the essential requirements referred to in Article 3 of appliances and fittings when they conform to:  (a)  the national standards applicable to them implementing the harmonized standards whose reference numbers have been published in the Official Journal of the European Communities.  Member States shall publish the reference numbers of these national standards;  (b)  the national standards applicable to them referred to in paragraph 2 in so far as, in the areas covered by such standards, no harmonized standards exist.  2.  Member States shall communicate to the Commission the texts of their national standards as referred to in paragraph 1 (b) which they regard as complying with the essential requirements referred to in Article 3. The Commission shall forward these  national standards to the other Member States. In accordance with the procedure provided for in Article 6 (2), it shall notify the Member States of those national standards which are presumed to conform with the essential requirements referred to in  Article 3.  Article 6 1.  Where a Member State or the Commission considers that the standards referred to in Article 5 (1) do not entirely meet the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter  before the standing committee set up under Directive 83/189/EEC, hereinafter referred to as 'the committee', giving the reasons therefore. The committee shall deliver an opinion without delay.  In the light of the committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the publications referred to in Article 5 (1).  2.  After receipt of the communication referred to in Article 5 (2), the Commission shall consult the committee. Upon receipt of the latter's opinion, the Commission shall, within one month, inform the Member States whether or not the national  standard(s) in question are to enjoy the presumption of conformity; if they are, the Member States shall publish the reference numbers of those standards. The Commission shall also publish them in the Official Journal of the European Communities.  Article 7 1.  Where a Member State finds that normally used appliances bearing the EC mark might compromise the safety of persons, domestic animals or property, it shall take all appropriate measures to withdraw those appliances from the market and  prohibit or restrict their being placed on the market.  The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision and, in particular, whether non-compliance is due to:  (a)  failure to meet the essential requirements referred to in Article 3, where the appliance does not correspond to the standards referred to in Article 5 (1);  (b) incorrect application of the standards referred to in Article 5 (1);  (c) shortcomings in the standards referred to in Article 5 (1) themselves.  2.  The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that any measure as referred to in paragraph 1 is justified, it shall immediately so inform the Member  State that took the measure and the other Member States.  Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission, after consulting the parties concerned, shall bring the matter before the committee within two months if the Member State which has taken the  measures intends to maintain them, and shall initiate the procedures referred to in Article 6.  3.  Where an appliance which does not comply bears the EC mark, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof.  4.  The Commission shall ensure that the Member States are kept informed of the progress and outcome of the procedures.   CHAPTER II Means of certification of conformity Article 8 1.  The means of certification of conformity of series-manufactured appliances shall be:  (a)  the EC type-examination as referred to in section 1 of Annex II, and (b) prior to their being placed on the market, at the choice of the manufacturer:  - the EC declaration of conformity to type referred to in section 2 of Annex II, or - the EC declaration of conformity to type (guarantee of production quality) referred to in section 3 of Annex II, or - the EC declaration of conformity to type (guarantee of product quality) referred to in section 4 of Annex II, or - EC verification as referred to in section 5 of Annex II.  2.  In the case of production of an appliance as a single unit or in small quantities, EC verification by single unit, as referred to in section 6 of Annex II, may be chosen by the manufacturer.  3.  After completion of the procedures referred to in paragraphs 1 (b) and 2, the EC mark of conformity shall be affixed to conforming appliances in accordance with Article 10.  4.  The procedures referred to in paragraph 1 shall be applied in respect of fittings as referred to in Article 1 with the exception of the affixing of the EC mark of conformity and, where appropriate, the drawing-up of the declaration of conformity. A  certificate shall be issued declaring the conformity of the fittings with the provisions of this Directive which apply to them and stating their characteristics and how they must be incorporated into an appliance or assembled to assist compliance with  the essential requirements applicable to finished appliances.  The certificate shall be supplied with the fitting.  5.  Where the appliances are also subject to other Community Directives:  - their compliance with the essential requirements of this Directive shall be verified in accordance with the procedures laid down in paragraphs 1 and 2, and - it shall be ensured that they also comply with the essential requirements of the other Directives in accordance with the procedures laid down in those Directives.  The affixing of the EC mark as referred to in paragraph 3 shall certify that the provisions of all the applicable Directives have been complied with.  6.  Records and correspondence relating to the means of certification of conformity shall be drawn up in the official language(s) of the Member State where the body responsible for carrying out these procedures is established or in a language accepted  by it.  Article 9 1.  Each Member State shall notify the Commission and the other Member States of the bodies, hereinafter called the 'notified bodies', responsible for carrying out the procedures referred to in Article 8.  The Commission shall publish for information purposes in the Official Journal of the European Communities a list of the notified bodies with their identification symbols and shall ensure that the list is kept up to date.  2.  Member States shall apply the criteria set out in Annex V for assessing the bodies to be notified.  Bodies which satisfy the assessment criteria laid down in the applicable harmonized standards shall be presumed to satisfy the criteria set out in that Annex.  3.  A Member State which has notified a body must withdraw approval if it finds that the body no longer meets the criteria referred to in paragraph 2. It shall immediately inform the Commission and the other Member States accordingly.   CHAPTER III EC mark of conformity Article 10 1.  The EC mark of conformity and the inscriptions set out in Annex III shall be affixed in a visible, easily legible and indelible form to the appliance or to a data plate attached to it. The data plate shall be so designed that it cannot be  re-used.  2.  The affixing to appliances of marks which are likely to be confused with the EC mark shall be prohibited.  Article 11 Where it is established that the EC mark has been wrongly Where it is established that the EC mark has been wrongly affixed to appliances or that certification for fittings has been wrongly attributed because:  - the appliances or the fittings do not conform to the appliance or fitting as referred to in the EC type-examination certificate,  - the appliances or the fittings conform to the appliance or fitting as referred to in the EC type-examination certificate but do not meet the essential requirements applicable to them,  - the manufacturer has failed to fulfil his obligations as specified in Annex II,  the notified body shall withdraw the right to affix the EC mark or to issue the certificate and shall so inform the other notified bodies and report to the Member State concerned.  CHAPTER IV Final provisions Article 12 Any decision taken pursuant to this Directive which includes restriction on the placing on the market and/or putting into service of an appliance shall state the precise grounds on which it is based. It shall be notified without delay to the  party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.  Article 13 Directives 84/530/EEC and 84/531/EEC are hereby repealed.  Article 14 1.  Before 1 July 1991, Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall inform the Commission thereof.  They shall apply such provisions from 1 January 1992.  2.  However, in derogation from Article 2, Member States may, during the period up to 31 December 1995 and without prejudice to Articles 30 to 36 of the Treaty, permit the placing on the market and/or the putting into service of appliances and fittings  which comply with the regulations in force in the Member States before 1 January 1992.  3.  Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.  Article 15 This Directive is addressed to the Member States.   Done at Luxembourg, 29 June 1990.  For the Council The President M. SMITH  (1) OJ No C 42, 21. 2. 1989, p. 5 and OJ No C 260, 13. 10. 1989, p. 3. (2) OJ No C 158, 26. 6. 1989, p. 218 and Decision of 13 June 1980 (not yet published in the Official Journal). (3) OJ No C 194, 31. 7. 1989, p. 18.(4) OJ No L 109, 26. 4. 1983, p. 8. (5) OJ No L 81, 26. 3. 1988, p. 75.(6) OJ No L 300, 19. 11. 1984, p. 95. (7) OJ No L 196, 18. 7. 1986, p. 56. (8) OJ No L 300, 19. 11. 1984, p. 106. (9) OJ No L 382, 31. 12. 1988, p. 42.   ANNEX I   ESSENTIAL REQUIREMENTS  Preliminary remark The obligations resulting from the essential requirements for appliances in this Annex also apply to fittings where the corresponding risk exists.  1.  GENERAL CONDITIONS 1.1.  Appliances must be so designed and built as to operate safely and present no danger to persons, domestic animals or property when normally used as defined in Article 1 (4) of this Directive.  1.2.  When placed on the market, all appliances must:  - be accompanied by technical instructions intended for the installer,  - be accompanied by instructions for use and servicing, intended for the user,  - bear appropriate warning notices, which must also appear on the packaging.  The instructions and warning notices must be in the official language or languages of the Member States of destination.  1.2.1.  The technical instructions intended for the installer must contain all the instructions for installation, adjustment and servicing required to ensure that those operations are correctly performed and that the appliance may be used safely. In particular,  the instructions must specify:  - the type of gas used,  - the gas supply pressure used,  - the flow of fresh air required:  - for the combustion air supply,  - to avoid the formation of dangerous unburned gas mixtures for appliances not fitted with the device referred to in point 3.2.3,  - the conditions for the dispersal of combustion products,  - for forced draught burners and heating bodies intended to be equipped with such burners, their characteristics, the requirements for assembly, to assist compliance with the essential requirements applicable to finished appliances and, where  appropriate, the list of combinations recommended by the manufacturer.  1.2.2.  The instructions for use and servicing intended for the user must contain all the information required for safe use, and must in particular draw the user's attention to any restrictions on use.  1.2.3.  The warning notices on the appliance and its packaging must clearly state the type of gas used, the gas supply pressure and any restrictions on use, in particular the restriction whereby the appliance must be installed only in areas where there is  sufficient ventilation.  1.3.  Fittings intended to be part of an appliance must be so designed and built as to fulfil correctly their intended purpose when incorporated in accordance with the instructions for installation.  The instructions for installation, adjustment, operation and maintenance must be provided with the fittings concerned.  2.  MATERIALS 2.1.  Materials must be appropriate for their intended purpose and must withstand the technical, chemical and thermal conditions to which they will foreseeably be subjected.  2.2.  The properties of materials that are important for safety must be guaranteed by the manufacturer or the supplier of the appliance.  3.  DESIGN AND CONSTRUCTION 3.1.  General 3.1.1.  Appliances must be so constructed that, when used normally, no instability, distortion, breakage or wear likely to impair their safety can occur.  3.1.2.  Condensation produced at the start-up and/or during use must not affect the safety of appliances.  3.1.3.  Appliances must be so designed and constructed as to minimize the risk of explosion in the event of a fire of external origin.  3.1.4.  Appliances must be so constructed that water and inappropriate air penetration into the gas circuit does not occur.  3.1.5.  In the event of a normal fluctuation of auxiliary energy, appliances must continue to operate safely.  3.1.6.  Abnormal fluctuation or failure of auxiliary energy or its restoration must not lead to an unsafe situation.  3.1.7.  Appliances must be so designed and constructed as to obviate hazards of electrical origin. In the area in which it applies, compliance with the safety objectives in respect of electrical hazards laid down in Directive 73/23/EEC (;) shall be equivalent  to fulfilment of this requirement.  3.1.8.  All pressurized parts of an appliance must withstand the mechanical and thermal stresses to which they are subjected without any deformation affecting safety.  3.1.9.  Appliances must be so designed and constructed that failure of a safety, controlling or regulating device may not lead to an unsafe situation.  3.1.10.  If an appliance is equipped with safety and controlling devices, the functioning of the safety devices must not be overruled by that of the controlling devices.  3.1.11.  All parts of appliances which are set or adjusted at the stage of manufacture and which should not be manipulated by the user or the installer must be appropriately protected.  3.1.12.  Levers and other controlling and setting devices must be clearly marked and give appropriate instructions so as to prevent any error in handling. Their design must be such as to preclude accidental manipulation.  3.2.  Unburned gas release 3.2.1.  Appliances must be so constructed that the gas leakage rate is not dangerous.  3.2.2.  Appliances must be so constructed that gas release during ignition and re-ignition and after flame extinction is limited in order to avoid a dangerous accumulation of unburned gas in the appliance.  3.2.3.  Appliances intended to be used in indoor spaces and rooms must be fitted with a special device which avoids a dangerous accumulation of unburned gas in such spaces or rooms.  Appliances which are not fitted with such devices must be used only in areas where there is sufficient ventilation to avoid a dangerous accumulation of unburned gas.  Member States may define on their territory adequate space ventilation conditions for the installation of such appliances, bearing in mind the features peculiar to them.  Large-scale kitchen appliances and appliances powered by gas containing toxic components must be equipped with the aforesaid device.  3.3.  Ignition Appliances must be so constructed that, when used normally:  - ignition and re-ignition is smooth,  - cross-lighting is assured.  3.4.  Combustion 3.4.1.  Appliances must be so constructed that, when used normally, flame stability is assured and combustion products do not contain unacceptable concentrations of substances harmful to health.  (;) OJ No L 77, 26. 3. 1973, p. 29.  3.4.2.  Appliances must be so constructed that, when used normally, there will be no accidental release of combustion products.  3.4.3.  Appliances connected to a flue for the dispersal of combustion products must be so constructed that in abnormal draught conditions there is no release of combustion products in a dangerous quantity into the room concerned.  3.4.4.  Independent flueless domestic heating appliances and flueless instantaneous water heaters must not cause, in the room or space concerned, a carbon monoxide concentration likely to present a danger to the health of persons exposed, bearing in mind the  foreseeable duration of their exposure.  3.5.  Rational use of energy Appliances must be so constructed as to ensure rational use of energy, reflecting the state of the art and taking into account safety aspects.  3.6.  Temperatures3.6.1.  Parts of appliances which are intended to be placed in close proximity to the floor or other surfaces must not reach temperatures which present a danger in the surrounding area.  3.6.2.  The surface temperature of knobs and levers of appliances intended to be manipulated must not present a danger to the user.  3.6.3.  The surface temperatures of external parts of appliances intended for domestic use, with the exception of surfaces or parts which are associated with the transmission of heat, must not under operating conditions present a danger to the user and in  particular to children, for whom an appropriate reaction time must be taken into account.  3.7.  Foodstuffs and water used for sanitary purposes Without prejudice to the Community rules in this area, materials and components used in the construction of an appliance, which may come into contact with food or water used for sanitary purposes, must not impair their quality.    ANNEX II   PROCEDURE FOR CERTIFICATION OF CONFORMITY  1.  EC TYPE-EXAMINATION 1.1.  The EC type-examination is that part of the procedure by which a notified body checks and certifies that an appliance, representative of the production envisaged, meets the provisions of this Directive which apply to it.  1.2.  The application for type-examination must be lodged by the manufacturer or his authorized representative established within the Community with a single notified body.  1.2.1.  The application must include:  - the name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address,  - a written declaration that the application has not been lodged with any other notified body,  - the design documentation, as described in Annex IV.  1.2.2.  The manufacturer must place at the disposal of the notified body an appliance, representative of the production envisaged, hereinafter called 'type'. The notified body may request further samples of the type if needed for the test programme.  The type may additionally cover variants of the product provided that those variants do not have different characteristics with respect to types of risk.  1.3.  The notified body must:  1.3.1.  examine the design documentation and verify that the type has been manufactured in conformity with the design documentation and identify the elements which have been designed in accordance with the applicable provisions of the standards referred to in  Article 5 and the essential requirements of this Directive;  1.3.2.  perform, or have performed, the appropriate examinations and/or tests to check whether the solutions adopted by the manufacturer meet the essential requirements where the standards referred to in Article 5 have not been applied;  1.3.3.  perform, or have performed, the appropriate examinations and/or tests to check whether the applicable standards have effectively been applied where the manufacturer has chosen to do so, thereby assuring conformity with the essential requirements.  1.4.  Where the type satisfies the provisions of this Directive, the notified body must issue an EC type- examination certificate to the applicant. The certificate must contain the conclusions of the examination, the conditions, if any, for its validity and the necessary data for identification of the approved type and, if relevant, descriptions of its  functioning. Relevant technical elements such as drawings and diagrams must be annexed to the certificate.  1.5.  The notified body must inform the other notified bodies forthwith of the issuing of the EC type- examination certificate and any additions to the said type as referred to in point 1.7. They may obtain a copy of the EC type-examination certificate and/or its additions and on a reasoned request may obtain a copy of the Annexes to the certificate and  the reports on the examinations and tests carried out.  1.6.  A notified body which refuses to issue or withdraws an EC type-examination certificate must inform the Member State which notified it and the other notified bodies accordingly, giving the reasons for its decision.  1.7.  The applicant must keep the notified body that has issued the EC type-examination certificate informed of all modifications to the approved type which might affect conformity with the essential requirements.  Modifications to the approved type must receive additional approval from the notified body that issued the EC type-examination certificate where such changes affect conformity with the essential requirements or the prescribed conditions for use of the  appliance. This additional approval is to be given in the form of an addition to the original EC type-examination certificate.  2.  EC DECLARATION OF CONFORMITY TO TYPE 2.1.  The EC declaration of conformity to type is that part of the procedure whereby the manufacturer declares that the appliances concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the essential  requirements of this Directive which apply to them. The manufacturer must affix the EC mark on each appliance and draw up a written declaration of conformity. The declaration of conformity may cover one or more appliances and must be kept by the  manufacturer. The EC mark must be accompanied by the identification symbol of the notified body responsible for the random checks set out in point 2.3.  2.2.  The manufacturer must take all necessary measures to ensure that the manufacturing process, including final product inspection and testing, results in homogeneity of production and conformity of the appliances with the type as described in the EC  type-examination certificate and with the requirements of this Directive which apply to them. A notified body, chosen by the manufacturer, must carry out random checks on the appliances as set out in point  2.3.  2.3.  On-site checks of appliances must be undertaken at random by the notified body at intervals of one year or less. An adequate number of appliances must be examined and appropriate tests as set out in the applicable standards referred to in Article 5 or  equivalent tests must be carried out in order to ensure conformity with the corresponding essential requirements of this Directive. The notified body shall in each case determine whether these tests need to be carried out in full or in part. Where one  or more appliances are rejected, the notified body shall take the appropriate measures to prevent the marketing thereof.  3.  EC DECLARATION OF CONFORMITY TO TYPE (guarantee of production quality) 3.1.  The EC declaration of conformity to type (guarantee of production quality) is the procedure whereby a manufacturer who fulfils the obligations in point 3.2 declares that the appliances concerned are in conformity with the type as described in the EC  type-examination certificate and satisfy the essential requirements of this Directive which applies to them. The manufacturer must affix the EC mark to each appliance and draw up a written declaration of conformity. This declaration may cover one or  more appliances and must be kept by the manufacturer. The EC mark must be accompanied by the identification symbol of the notified body responsible for EC surveillance.  3.2.  The manufacturer shall apply a quality system that ensures conformity of the appliances with the type as described in the EC type-examination certificate and with the essential requirements of this Directive which apply to them. The manufacturer is  subject to EC surveillance as specified in point 3.4.  3.3.  Quality system 3.3.1.  The manufacturer must lodge an application for approval of his quality system with a notified body of his choice for the appliances in question.  The application must include:  - the quality system documentation,  - an undertaking to carry out the obligations arising from the quality system as approved,  - an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness,  - documentation relating to the approved type and a copy of the EC type-examination certificate.  3.3.2.  All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and logical manner in the form of measures, procedures and written instructions. This quality system documentation must permit a uniform  interpretation of the quality programmes, plans, manuals and records. It shall contain, in particular, an adequate description of:  - the quality objectives, the organizational structure and responsibilities of management and of their powers with regard to appliance quality,  - the manufacturing processes, quality control and quality assurance techniques and systematic actions that will be used,  - the examinations and tests that will be carried out before, during and after manufacture and the frequency with which they will be carried out,  - the method of monitoring attainment of the required appliance quality and the effective operation of the quality system.  3.3.3.  The notified body shall examine and evaluate the quality system to determine whether it satisfies the requirements referred to in point 3.3.2. It will presume conformity with these requirements in respect of quality systems that implement the  corresponding harmonized standard.  It must notify its decision to the manufacturer and inform the other notified bodies thereof. The notification to the manufacturer must contain the conclusions of the examination, the name and address of the notified body and the reasoned assessment  decision in respect of the appliances concerned.  3.3.4.  The manufacturer must keep the notified body that has approved the quality system informed of any updating of the quality system in relation to changes brought about by, for example, new technologies and quality concepts.  The notified body must examine the proposed modifications and decide whether the modified quality system complies with the relevant provisions or whether reappraisal is necessary. It must notify the manufacturer of its decision. The notification must  include the conclusions of the inspection and the reasoned assessment decision.  3.3.5.  A notified body that withdraws approval of a quality system must so inform the other notified bodies, giving the reasons for the decision.  3.4.  EC surveillance 3.4.1.  The purpose of EC surveillance is to ensure that the manufacturer duly fulfils the obligations arising out of the approved quality system.  3.4.2.  The manufacturer must allow the notified body access for inspection purposes to the place of manufacture, inspection, testing and storage and must provide it with all necessary information, in particular:  - the quality system documentation,  - the quality records, such as inspection reports and test data, calibration data, reports on qualifications of the staff concerned, etc.  3.4.3.  The notified body must carry out a check at least once every two years to ensure that the manufacturer is maintaining and applying the approved quality system and must supply a report of the check to the manufacturer.  3.4.4.  Furthermore, the notified body may make unannounced visits to the manufacturer. During these visits, the notified body may carry out tests on appliances or have them carried out. It must supply the manufacturer with an inspection report and, if  appropriate, a test report.  3.4.5.  The manufacturer may supply the notified body's report on request.  4.  EC DECLARATION OF TYPE CONFORMITY (guarantee of product quality) 4.1.  The EC declaration of type conformity (guarantee of product quality) is that part of the procedure whereby a manufacturer who fulfils the obligations in point 4.2 declares that the appliances concerned are in conformity with the type as described in the  EC type-examination certificate and satisfy the essential requirements of this Directive which apply to them. The manufacturer must affix the EC mark to each appliance and draw up a written declaration of conformity. This declaration may cover one or  more appliances and must be kept by the manufacturer. The EC mark must be accompanied by the identification symbol of the notified body responsible for EC surveillance.  4.2.  The manufacturer shall apply an approved quality system for the final inspection of the appliances and the tests, as specified in point 4.3, and is subject to EC surveillance as specified in point 4.4.  4.3.  Quality system 4.3.1 Under this procedure, the manufacturer must lodge an application for approval of his quality system with a notified body of his choice for the appliances in question.  The application must include:  - the quality system documentation,  - an undertaking to carry out the obligations arising from the quality system as approved,  - an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness,  - the documentation relating to the approved type and a copy of the EC type-examination certificate.  4.3.2.  As part of the quality system, each appliance must be examined and appropriate tests as laid down in the applicable standard(s) referred to in Article 5 or equivalent tests carried out to check its conformity with the essential requirements relating to  it in this Directive.  All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and logical manner in the form of measures, procedures and written instructions. This quality system documentation must permit a uniform  interpretation of the quality programmes, plans, manuals and records.  The quality system documentation shall contain, in particular, an adequate description of:  - the quality objectives, the organizational structure and responsibilities of management and of their powers with regard to appliance quality,  - the checks and tests to be carried out after manufacture,  - the method of verifying the effective operation of the quality system.  4.3.3.  The notified body shall examine and evaluate the quality system to determine whether it satisfies the requirements referred to in point 4.3.2. It will presume conformity with these requirements in respect of quality systems that implement the  corresponding harmonized standard. It must notify the manufacturer of its decision and inform the other notified bodies thereof. The notification to the manufacturer must contain the conclusions of the examination, the name and address of the notified  body and the reasoned assessment decision for the appliances concerned.  4.3.4.  The manufacturer must keep the notified body which approved the quality system informed of any adaptation of the quality system made necessary, e.g. by new technology and quality concepts.  The notified body must examine the proposed changes and decide whether the amended quality system satisfies the relevant provisions or whether a reassessment is necessary. It must notify the manufacturer of its decision. The notification must contain  the conclusions of the inspection and the reasoned assessment decision.  4.3.5.  A notified body which withdraws approval of a quality system must inform the other notified bodies that it has done so and give reasons for its decision.  4.4.  EC surveillance 4.4.1.  The purpose of EC surveillance is to ensure that the manufacturer duly fulfils the obligations arising out of the approved quality system.  4.4.2.  The manufacturer must allow the notified body access for inspection to the place of inspection, testing and storage and must provide it with all necessary information, in particular:  - the quality system documentation,  - the quality files such as inspection reports and test data, calibration data, report on qualifications of the staff concerned, etc.  4.4.3.  The notified body must carry out a check at least once every two years to ensure that the manufacturer is maintaining and applying the approved quality system and must supply a report on the check to the manufacturer.  4.4.4.  Furthermore, the notified body may make unannounced visits to the manufacturer. During these visits, the body may carry out tests on appliances or have them carried out. It must supply the manufacturer with an inspection report and, if appropriate, a  test report.  4.4.5.  The manufacturer may supply the notified body's report on request.  5.  EC VERIFICATION 5.1.  EC verification is that part of the procedure whereby a notified body checks and certifies that the appliances are in conformity with the type as described in the EC type-approval certificate and satisfy the essential requirements of this Directive  which apply to them.  5.2.  EC verification may, at the choice of the manufacturer, be carried out by checking and testing each appliance as specified in point 5.3 or by checking and testing the appliance on a statistical basis as specified in point 5.4.  5.3.  Verification by checking and testing each appliance 5.3.1.  Each appliance must be examined and appropriate tests as defined in the relevant standards referred to in Article 5 or equivalent tests must be carried out in order to check its conformity with the relevant essential requirements of this Directive.  5.3.2.  The notified body must affix the EC mark on each approved appliance and draw up a written certificate of conformity. The certificate may cover one or more appliances and is kept by the manufacturer. The EC mark must be accompanied by the identification  symbol of the notified body.  5.4.  Statistical verification 5.4.1.  The manufacturer must submit his appliances in the form of homogeneous batches and take all necessary measures to ensure that the manufacturing process results in the homogeneity of each product batch.  5.4.2.  Where appropriate, the manufacturer may affix the EC mark on each appliance during the manufacturing process. The EC mark must be accompanied by the identification symbol of the notified body responsible for the statistical verification.  5.4.3.  Appliances must be subject to statistical control by attributes. They should be grouped into identifiable batches consisting of units of a single model which are manufactured under the same conditions. At random intervals a batch is examined. The  appliances constituting a sample are examined individually and appropriate tests as laid down in the applicable standard(s) referred to in Article 5 or equivalent tests are carried out to determine whether the batch is to be accepted or rejected.  A sampling plan with the following operating characteristics is applied:  - a standard quality level corresponding to a 95 % probability of acceptance with a percentage of non-conformity between 0,5 and 1,5 %,  - a limit quality corresponding to a 5 % probability of acceptance with a percentage of non-conformity between 5 and 10 %.  5.4.4.  If a batch is accepted, the notified body must draw up a written certificate of conformity which is kept by the manufacturer. All the appliances in the batch may be placed on the market, except those in the sample which have been identified as not  conforming.  If a batch is rejected, the competent notified body must take the appropriate measures to prevent its being placed on the market. Should batches be rejected frequently, the notified body may suspend statistical verification.  6.  EC VERIFICATION BY UNIT 6.1.  EC verification by unit is the procedure whereby a notified body checks and certifies that an appliance is in conformity with the requirements of this Directive which apply to it. The notified body must affix the EC mark on the appliance and draw up a  written certificate of conformity.  The certificate is kept by the manufacturer.  6.2.  The design documentation referred to in Annex IV must be made available to the notified body.  6.3.  The appliance must be examined and appropriate tests taking account of the design documentation carried out in order to ensure conformity of the appliance with the essential requirements of this Directive.  If deemed necessary by the notified body, the examinations and the appropriate tests may be carried out after installation of the appliance.    ANNEX III   EC MARK AND INSCRIPTIONS  1.  The EC mark consists of the symbol CE as shown below, followed by the last two digits of the year in which the mark was affixed and the identification symbol of the notified body that has carried out the random checks, EC  surveillance or EC verification.  2.  The appliance or its data plate must bear the EC mark together with the following inscriptions:  - the manufacturer's name or identification symbol,  - the trade name of the appliance,  - the type of electrical supply used, if applicable,  - the appliance category.  Information needed for installation purposes may be added according to the nature of the appliance.    ANNEX IV   DESIGN DOCUMENTATION  The design documentation must contain the following information, in so far as is required by the notified body for assessment:  - a general description of the appliance,  - conceptual designs and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,  - descriptions and explanations necessary for the understanding of the above, including the operation of the appliances,  - a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where the standards referred to in Article 5 have not been applied,  - test reports,  - manuals for installation and use.  Where appropriate, the design documentation must contain the following elements:  - attestations relating to the equipment incorporated in the appliance,  - attestations and certificates relating to the methods of manufacture and/or inspection and/or monitoring of the appliance,  - any other document making it possible for the notified body to improve its assessment.    ANNEX V   MINIMUM CRITERIA FOR ASSESSMENT OF NOTIFIED BODIES  The notified bodies designated by the Member States must fulfil the following minimum conditions:  - availability of personnel and of the necessary means and equipment,  - technical competence and professional integrity of personnel,  - independence in carrying out tests, preparing reports, issuing certificates and performing the surveillance provided for in this Directive, of management and technical staff in relation to all circles, groups or persons directly or indirectly involved  in the field of the appliances,  - maintenance of professional secrecy by staff,  - possession of civil liability insurance unless that liability is covered by the State under national law.  Fulfilment of the conditions in the first two indents must be periodically verified by the competent authorities of the Member States or by bodies designated by the Member States.


Avis juridique important

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31990L0384

Council Directive 90/384/EEC of 20 June 1990 on the harmonization of the laws of the Member States relating to non-automatic weighing instruments

Official Journal L 189 , 20/07/1990 P. 0001 - 0016

COUNCIL DIRECTIVE of 20 June 1990 on the harmonization of the laws of the Member States relating to non-automatic weighing instruments (90/384/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Member States have the responsibility of protecting the public against incorrect results of weighing operations by means of non-automatic weighing instruments when used for certain categories of applications;  Whereas, in each Member State, mandatory provisions fix in particular the necessary performance requirements of non-automatic weighing instruments by specifying metrological and technical requirements, together with inspection procedures before and after going into service; whereas these mandatory provisions do not necessarily lead to different levels of  protection from one Member State to another but do, by their disparity, impede trade within the Community;  Whereas the national provisions ensuring such protection must be harmonized in order to guarantee the free movement of non-automatic weighing instruments while ensuring a justified level of protection in the Community;   OJ No C 297, 25. 11. 1989, p. 13.   OJ No C 149, 18. 6. 1990.   Whereas Community legislation as it stands at present provides that, notwithstanding one of the fundamental rules of the Community, namely the free movement of goods, barriers to intra-Community movement resulting from disparities in national laws on  the use of products have to be accepted in so far as the provisions of those national laws are recognized as necessary to ensure that the products concerned meet essential requirements; whereas the harmonization of laws in the present case must therefore be confined to those provisions needed to ensure that non-automatic weighing instruments  satisfy the essential metrological and performance requirements; whereas, because they are essential, these requirements must replace the corresponding national provisions;  Whereas this Directive therefore contains only mandatory and essential requirements; whereas, to facilitate proof of conformity with the essential requirements, it is necessary to have harmonized standards at European level, in particular as to the  metrological, design and construction characteristics, so that instruments complying with those harmonized standards may be assumed to conform to the essential requirements; whereas these standards, harmonized at European level, are drawn up by private  bodies and must remain non-mandatory texts; whereas for that purpose the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the competent bodies for the adoption of  harmonized standards in accordance with the general guidelines for cooperation between the Commission and those two bodies signed on 13 November 1984; whereas, within the meaning of this Directive, a harmonized standard is a technical specification  (European standard or harmonized document) adopted by one or both of those bodies upon a remit from the Commission in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (4), as amended by Directive 88/182/EEC (5), and the abovementioned general guidelines;  Whereas assessment of conformity with the relevant metrological and technical provisions is necessary to provide effective protection for users and third parties; whereas, the existing conformity assessment procedures differ from one Member State to  another; whereas, to avoid multiple assessments of conformity, which are in effect barriers to the free movement of the instruments, arrangements should be made for the mutual recognition of conformity assessment procedures by the Member States;  whereas, to facilitate the mutual recognition of conformity assessment procedures, harmonized Community procedures should be set up, together with harmonized criteria for the designation of the bodies responsible for carrying out tasks pertaining to the  conformity assessment procedures;  Whereas it is therefore essential to ensure that such designated bodies ensure a high level of quality throughout the Community;  Whereas the presence on a non-automatic weighing instrument of the EC mark of conformity or of the sticker bearing the letter 'M' indicates that there is a presumption that it satisfies the provisions of this Directive and therefore makes it unnecessary  to repeat the assessments of conformity already carried out;  Whereas the measures aimed at the gradual establishment of the internal market must be adopted by 31 December 1992; whereas the internal market consists of an area without internal frontiers within which the free movement of goods, persons, services and  capital is guaranteed,  HAS ADOPTED THIS DIRECTIVE:    CHAPTER I Scope, placing on the market, free movement Article 1 1.  A weighing instrument is defined as a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities,  parameters or characteristics.  A non-automatic weighing instrument is defined as a weighing instrument requiring the intervention of an operator during weighing.  This Directive applies to all non-automatic weighing instruments, hereinafter referred to as 'instruments'.   2.  A distinction is made in this Directive between two categories of instrument use:  (a)  1.  determination of mass for commercial transactions;  2.  determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;  3.  determination of mass for the application of laws or regulations; expert opinion given in court proceedings;  4.  determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;  5.  determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories;  6.  determination of price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages;  (b) all applications other than those listed in point 2 (a) of this Article.  Article 2 1.  Member States shall take all steps to ensure that instruments may not be placed on the market unless they meet the requirements of this Directive which apply to them.  2.  Member States shall take all steps to ensure that instruments may not be put into service for the uses referred to in Article 1 (2) (a) unless they meet the requirements of this Directive which apply to them.  Article 3 Instruments used for the applications listed in Article 1 (2) (a) must satisfy the essential requirements set out in Annex I.  In cases where the instrument includes or is connected to devices which are not used for the applications listed in Article 1 (2) (a), such devices shall not be subject to the essential requirements.  Article 4 1.  Member States shall not impede the placing on the market of instruments which meet the requirements of this Directive which apply to them.  2.  Member States shall not impede the putting into service for the uses referred to in Article 1 (2) (a) of instruments which meet the requirements of this Directive which apply to them.  Article 5 1.  Member States shall presume conformity with the essential requirements referred to in Article 3 in respect of instruments which comply with the relevant national standards implementing the harmonized standards that meet the essential  requirements referred to in Article 3.  2.  The Commission shall publish the references of the harmonized standards referred to in paragraph 1 in the Official Journal of the European Communities.  Member States shall publish the references of the national standards referred to in paragraph 1.  Article 6 Where a Member State or the Commission considers that the harmonized standards referred to in Article 5 (1) do not fully meet the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the  matter before the Standing Committee set up under Directive 83/189/EEC, hereinafter referred to as 'the Committee', giving its reasons for doing so. The Committee shall deliver an opinion without delay.  In the light of the Committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the publications referred to in Article 5 (2).  Article 7 1.  Where a Member State considers that instruments bearing the EC mark of conformity referred to in Annex 2, sections 2, 3 and 4, do not meet the requirements of this Directive when properly installed and used for the purposes for which they  are intended, it shall take all appropriate measures to withdraw those instruments from the market or to prohibit or restrict their being put into service and/or placed on the market.  The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision, and in particular whether non-compliance is due to:  (a)  failure to meet the essential requirements referred to in Article 3, where instruments do not meet the standards referred to in Article 5 (1);  (b) incorrect application of the standards referred to in Article 5 (1);  (c) shortcomings in the standards referred to in Article 5 (1) themselves.  2.  The Commission shall enter into consultation with the parties concerned as soon as possible.  After such consultation the Commission shall immediately inform the Member State, which took the action, of the result. Should it find that the measure is justified it shall immediately inform the other Member States.  If the decision is attributed to shortcomings in the standards, the Commission, after consulting the parties concerned, shall bring the matter before the Committee within two months if the Member State which has taken the measures intends to maintain them, and shall subsequently initiate the procedures referred to in Article 6.  3.  Where an instrument which does not comply bears the EC mark of conformity, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof.  4.  The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.   CHAPTER II Conformity assessment Article 8 1.  The conformity of instruments to the essential requirements set out in Annex I may be certified by either of the following procedures as selected by the applicant:  (a)  EC type examination as referred to in Annex II.1, followed either by the EC declaration of type conformity (guarantee of production quality) as referred to in Annex II.2, or by the EC verification as referred to in Annex II.3.  However, EC type examination shall not be compulsory for instruments which do not use electronic devices and whose load-measuring device does not use a spring to balance the load;  (b) EC unit verification as referred to in Annex II.4.  2.  The documents and correspondence relating to the procedures referred to in paragraph 1 shall be drafted in an official language of the Member State where the said procedures are to be carried out, or in a language accepted by the competent body.  3.  Where the instruments are subject to other Community Directives concerning other aspects, the EC mark referred to in Article 10 shall indicate in these cases that the instruments also fulfil the requirements of the other Directives.  Article 9 1.  Member States shall notify to the other Member States and the Commission the bodies which they have designated for carrying out tasks pertaining to the procedure referred to in Article 8, the specific tasks for which each body has been  designated, and the identification codes of the designated bodies.  The Commission shall publish the list of these notified bodies, together with the tasks for which they have been designated, in the Official Journal of the European Communities and shall ensure that the list is kept up to date.  2.  Member States shall apply the minimum criteria set out in Annex V for the designation of bodies. Bodies which satisfy the criteria fixed by the relevant harmonized standards shall be presumed to satisfy the criteria set out in Annex V.  3.  A Member State which has designated a body shall cancel the designation if the body no longer meets the criteria for designation referred to in paragraph 2. It shall immediately inform the other Member States and the Commission thereof and withdraw  the notification.   CHAPTER III EC mark of conformity and inscriptions Article 10 1.  The EC mark of conformity and the required supplementary data as described in Annex IV.1 shall be affixed in a clearly visible, easily legible and indelible form to instruments for which EC conformity has been established.  2.  The inscriptions referred to in Annex IV.2 shall be affixed in a clearly visible, easily legible and indelible form to all other instruments.  3.  The affixing to instruments of marks which are likely to be confused with the EC mark of conformity shall be prohibited.  Article 11 Where it is established that the EC mark of conformity has been wrongly affixed to instruments:  - not conforming to the standards referred to in Article 5 (1), where the manufacturer has chosen to manufacture instruments that conform to those standards,  - not conforming to an approved type,  - conforming to an approved type which does not meet the essential requirements applicable to it,  - in respect of which the manufacturer has failed to fulfil his obligations under the EC declaration of type conformity (guarantee of production quality),  the competent notified body shall, where necessary, withdraw the EC type-approval and/or the approval of the quality system. Withdrawal of EC type-approval shall have the effect of prohibiting submission for EC verification and the EC declaration of  type conformity (guarantee of production quality).  Article 12 Where an instrument which is used for any of the applications referred to in Article 1 (2) (a) includes or is connected to devices that have not been subject to conformity assessment as referred to in Article 8, each of these devices shall  bear the symbol restricting its use as defined by Annex IV.3. This symbol shall be affixed to the devices in a clearly visible and indelible form.   CHAPTER IV Final provisions Article 13 Member States shall take all steps to ensure that instruments bearing the EC mark attesting conformity with the requirements of this Directive continue to conform to those requirements.  Article 14 Any decision taken pursuant to this Directive and resulting in restrictions on the putting into service of an instrument shall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party  concerned, who shall at the same time be informed of the judicial remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.  Article 15 1.  Member States shall, before 1 July 1992, adopt and publish the laws, regulations and administrative provisions necessary in order to comply with this Directive. They shall forthwith inform the Commission thereof.  2.  Member States shall apply such provisions from 1 January 1993.  3.  However, by way of derogation from paragraph 2, Member States shall permit during a period of 10 years from the date on which they apply the provisions referred to in paragraph 1 the placing on the market and/or putting into service of instruments which conform to the rules in force before that date.  4.  Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.  5.  Directive 73/360/EEC shall be repealed as from 1 January 1993, except as regards the application of paragraph 3.  Article 16 This Directive is addressed to the Member States.   Done at Luxembourg, 20 June 1990.  For the Council The President D. J. O'MALLEY  (1) OJ No C 55, 4. 3. 1989, p. 6, and(2) OJ No C 158, 26. 6. 1989, p. 221, and(3) OJ No C 194, 31. 7. 1989, p. 1.(4) OJ No L 109, 26. 4. 1983, p. 8. (5) OJ No L 81, 26. 3. 1988, p. 75.   ANNEX I  The essential requirements that must be met by the instruments referred to in Article 1 (2) (a) are set out below. The terminology used is that of the Organisation internationale de Métrologie Légale.  Preliminary observation Where an instrument includes or is connected to more than one indicating or printing device used for the applications listed in Article 1 (2) (a), those devices which repeat the results of the weighing operation and which cannot influence the correct  functioning of the instrument shall not be subject to the essential requirements if the weighing results are printed or recorded correctly and indelibly by a part of the instrument which meets the essential requirements and the results are accessible to  both parties concerned by the measurement. However, in the case of instruments used for direct sales to the public, display and printing devices for the vendor and the customer must fulfil the essential requirements.   METROLOGICAL REQUIREMENTS 1.  Units of mass The units of mass used shall be the legal units within the meaning of Directive 80/181/EEC (1), as last amended by Directive 85/1/EEC (2).  Subject to compliance with this condition, the following units are permitted:  - SI untis: kilogram, microgram, milligram, gram, tonne,  - Imperial units: pound, ounce (avoirdupois), Troy ounce,  - other non-SI units: metric carat, if weighing precious stones.  For instruments that make use of the Imperial units of mass referred to above, the relevant essential requirements specified below shall be converted to the said Imperial units, using simple interpolation.  2.  Accuracy classes 2.1.  The following accuracy classes have been defined:  IIII  special IIII  high IIII  medium IIII  ordinary The specifications of these classes are given in Table 1.  TABLE 1  Accuracy classes   Class Verification scale interval (e) Minimum capacity (Min) Number of verification scale intervals n = Max n =  e minimum value minimum value maximum value IIII 0,001 g 9 e 9 0,005 g 100 e 50 000 - IIII 0,001 g 9 e 9 0,005 g  20 e    100 100 000 0,1   g 9 e 9 0,005 g  50 e  5 000 100 000 IIII 0,1   g 9 e 9 2 g,   20 e    100  10 000 5,    g 9 e 9 0,005 g  20 e    500  10 000 IIII 5,    g 9 e 9 0,005 g  10 e    100   1 000  The minimum capacity is reduced to 5e for instruments in classes II and III for determining a conveying tariff.   2.2.  Scale intervals 2.2.1.  The actual scale interval (d) and the verification scale interval (e) shall be in the form:  1×10k, 2×10k, or 5×10k mass units,  k being any integer or zero.  2.2.2.  For all instruments other than those with auxiliary indicating devices:  d = e 2.2.3.  For instruments with auxiliary indicating devices the following conditions apply:  e = 1×10k g d <  e 9 10 d except for instruments of class 1 with d <  10-4 g, for which e = 10-3 g.  3.  Classification 3.1.  Instruments with one weighing range Instruments equipped with an auxiliary indicating device shall belong to class I or class II. For these instruments the minimum capacity lower limits for these two classes are obtained from Table 1 by replacement in column 3 of the verification scale  interval (e) by the actual scale interval (d).  If d < 10-4 g, the maximum capacity of class 1 may be less than 50 000 e.  3.2.  Instruments with multiple weighing ranges Multiple weighing ranges are permitted, provided they are clearly indicated on the instrument. Each individual weighing range is classified according to 3.1. If the weighing ranges fall into different accuracy classes the instrument shall comply with  the severest of the requirements that apply for the accuracy classes in which the weighing ranges fall.  3.3.  Multi-interval instruments 3.3.1.  Instruments with one weighing range may have several partial weighing ranges (multi-interval instruments).  Multi-interval instruments shall not be equipped with an auxiliary indicating device.  3.3.2.  Each partial weighing range 1 of multi-interval instruments is defined by:  - its verification scale interval ei   with   - its verification scale interval ei with e(i + 1) > ei - its maximum capacity Maxi with Maxr = Max - its minimum capacity Mini with Mini  = Max (i - 1) and Min1  = Min where:  i = 1, 2, . . . r,  i = partial weighing range number,  r = the total number of partial weighing ranges.  All capacities are capacities of net load, irrespective of the value of any tare used.  3.3.3.  The partial weighing ranges are classified according to Table 2. All partial weighing ranges shall fall into the same accuracy class, this class being the instrument's accuracy class.  TABLE 2  Multi-interval instruments  i = 1, 2, . . . r i = partial weighing range number r = total number of partial weighing ranges   Class Verification scale interval (e) Minimum capacity (Min) Number of verification scale intervals Minimum value Minimum value (¹) n =  Maxi  n = e(i + 1) Maximum value n = Maxi n = ei IIII 0,001 g § ei § 0,05 g 100 e1 50 000 - IIII 0,001 g § ei § 0,05 g  20 e1  5 000 100 000 0,1   g § ei § 0,05 g  50 e1  5 000 100 000 IIII 0,1   g § ei § 0,05 g  20 e1    500  10 000 IIII 5,    g § ei § 0,05 g  10 e1     50   1 000 (¹) For i = r the corresponding column of Table 1 applies, with e replaced by er.   4.  Accuracy 4.1.  On implementation of the procedures laid down in Article 8, the error of indication shall not exceed the maximum permissible error of indication as shown in Table 3. In case of digital indication the error of indication shall be corrected for the  rounding error.  The maximum permissible errors apply to the net and tare value for all possible loads, excluded preset tare values.  TABLE 3  Maximum permissible errors      Load Class I Class II Class III Class IIII Maximum permissible error       0 e 9 m 9  50 000 e      0 e 9 m 9   5 000 e     0 e 9 m 9    500 e   0 e 9 m 9    50 e ± 0,5 e  50 000 e <  m 9 200 000 e  5 000 e <  m 9  20 000 e   500 e <  m 9  2 000 e  50 e <  m 9   200 e ± 1,0 e 200 000 e <  m 9 200 000 e 20 000 e <  m 9 100 000 e 2 000 e <  m 9 10 000 e 200 e <  m 9 1 000 e ± 1,5 e  4.2.  The maximum permissible errors in service are twice the maximum permissible errors fixed in section 4.1.  5.  Weighing results of an instrument shall be repeatable, and shall be reproducible by the other indicating devices used and with other methods of balancing used.  The weighing results shall be sufficiently insensitive to changes in the position of the load on the load receptor.  6.  The instrument shall react to small variations in the load.  7.  Influence quantities and time 7.1.  Instruments of classes II, III and IIII, liable to be used in a tilted position, shall be sufficiently insensitive to the degree of tilting that can exist in a normal installed condition.  7.2.  The instruments shall meet the metrological requirements within the temperature range specified by the manufacturer. The value of this range shall be at least equal to:   5 °C for an instrument in class I,  15 °C for an instrument in class II,  30 °C for an instrument in class III or IIII.  In the absence of a manufacturer's specification, the temperature range of -10 °C to +40 °C applies.  7.3.  Instruments operated from a mains power supply shall meet the metrological requirements under conditions of power supply within the limits of normal fluctuation.  Instruments operated from battery power shall indicate whenever the voltage drops below the minimum required value and shall under those circumstances either continue to function correctly or be automatically put out of service.  7.4.  Electronic instruments, except those in class I and in class II if e is less than 1 g, shall meet the metrological requirements under conditions of high relative humidity at the upper limit of their temperature range.  7.5.  Loading an instrument in class II, III or IIII for a prolonged period of time shall have a negligible influence on the indication at load or on the zero indication immediately after removal of the load.  7.6.  Under other conditions the instruments shall either continue to function correctly or be automatically put out of service (3).   DESIGN AND CONSTRUCTION 8.  General requirements 8.1.  Design and construction of the instruments shall be such that the instruments will preserve their metrological qualities when properly used and installed, and when used in an environment for which they are intended. The value of the mass must be  indicated.  8.2.  When exposed to disturbances, electronic instruments shall not display the effects of significant faults, or shall automatically detect and indicate them.  Upon automatic detection of a significant fault, electronic instruments shall provide a visual or audible alarm that shall continue until the user takes corrective action or the fault disappears.  8.3.  The requirements of 8.1 and 8.2 shall be met on a lasting basis during a period of time that is normal in view of the intended use of such instruments.  Digital electronic devices shall always exercise adequate control of the correct operation of the measuring process, of the indicating facility, and of all data storage and data transfer.  Upon automatic detection of a significant durability error, electronic instruments shall provide a visual or audible alarm that shall continue until the user takes corrective action or the error disappears.  8.4.  When external equipment is connected to an electronic instrument through an appropriate interface the metrological qualities of the instrument shall not be adversely influenced.  8.5.  The instruments shall have no characteristics likely to facilitate fraudulent use, whereas possibilities for unintentional misuse shall be minimal. Components that may not be dismantled or adjusted by the user shall be secured against such actions.  8.6.  Instruments shall be designed to permit ready execution of the statutory controls laid down by this Directive.  9.  Indication of weighing results and other weight values The indication of the weighing results and other weight values shall be accurate, unambiguous and non-misleading and the indicating device shall permit easy reading of the indication under normal conditions of use.  The names and symbols of the units referred to in paragraph 1 of this Annex shall comply with the provisions of Directive 80/181/EEC (4) with the addition of the symbol for the metric carat which shall be the symbol 'ct'.   Indication shall be impossible above the maximum capacity (Max), increased by 9e.  An auxiliary indicating device is permitted only to the right of the decimal mark. An extended indicating device may be used only temporarily, and printing shall be inhibited during its functioning.  Secondary indications may be shown, provided that they cannot be mistaken for primary indications.  10.  Printing of weighing results and other weight values Printed results shall be correct, suitably identified and unambiguous. The printing shall be clear, legible, non-erasable and durable.  11.  Levelling When appropriate, instruments shall be fitted with a levelling device and a level indicator, sufficiently sensitive to allow proper installation.  12.  Zeroing Instruments may be equipped with zeroing devices. The operation of these devices shall result in accurate zeroing and shall not cause incorrect measuring results.  13.  Tare devices and preset tare devices The instruments may have one or more tare devices and a preset tare device. The operation of the tare devices shall result in accurate zeroing and shall ensure correct net weighing. The operation of the preset tare device shall ensure correct  determination of the calculated net value.  14.  Instruments for direct sales to the public with a maximum capacity not greater than 100 kg: additional requirements Instruments for direct sale to the public shall show all essential information about the weighing operation and, in the case of price-indicating instruments, shall clearly show the customer the price calculation of the product to be purchased.  The price to pay, if indicated, shall be accurate.  Price-computing instruments shall display the essential indications long enough for the customer to read them properly.  Price-computing instruments may perform functions other than per-article weighing and price computation only if all indications related to all transactions are printed clearly, unambiguously and conveniently arranged on a ticket or label for the  customer.  Instruments shall bear no characteristics that can cause, directly or indirectly, indications whose interpretation is not easy or straightforward.  Instruments shall safeguard customers against incorrect sales transactions due to their malfunctioning.  Auxiliary indicating devices and extended indicating devices are not permitted.  Supplementary devices are permitted only if they cannot lead to fraudulent use.  Instruments similar to those normally used for direct sales to the public which do not satisfy the requirements of this section must carry near to the display the indelible marking 'Not to be used for direct sale to the public'.  15.  Price labelling instruments Price labelling instruments shall meet the requirements of price indicating instruments for direct sale to the public, as far as applicable to the instrument in question. The printing of a price label shall be impossible below a minimum capacity.   (1) OJ No L 39, 15. 12. 1980, p. 39. (2) OJ No L 2, 3. 1. 1985, p. 11.(3) OJ No L 33, 15. 2. 1980, p. 39.   ANNEX II  1.  EC type-examination 1.1.  EC type-examination is the procedure whereby a notified body verifies and certifies that an instrument, representative of the production envisaged, meets the requirements of this Directive that apply to it.  1.2.  The application for type-examination shall be lodged by the manufacturer or his authorized representative established within the Community with a single notified body.  The application shall include:  - the name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address in addition,  - a written declaration that the application has not been lodged with any other notified body,  - the design documentation, as described in Annex III.  The applicant shall place at the disposal of the notified body an instrument, representative of the production envisaged, hereinafter called the 'type'.  1.3.  The notified body shall:  1.3.1.  examine the design documentation and verify that the type has been manufactured in accordance with that documentation;  1.3.2.  agree with the applicant on the location where the examinations and/or tests shall be carried out;  1.3.3.  perform or have performed the appropriate examinations and/or tests to check whether the solutions adopted by the manufacturer meet the essential requirements where the standards referred to in Article 5 have not been applied;  1.3.4.  perform or have performed the appropriate examinations and/or tests to check whether, where the manufacturer has chosen to apply the relevant standards, these have been applied effectively, thereby assuring conformity with the essential requirements.  1.4.  Where the type meets the provisions of this Directive, the notified body shall issue an EC type-approval certificate to the applicant. The certificate shall contain the conclusions of the examination, conditions (if any) for its validity, the necessary  data for identification of the approved instrument and, if relevant, a description of its functioning. All the relevant technical elements such as drawings and layouts shall be annexed to the EC type-approval certificate.  The certificate shall have a validity period of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each.  In the event of fundamental changes to the design of the instrument, e.g. as a result of the application of new techniques, the validity of the certificate may be limited to two years and extended by three years.  1.5.  Each notified body shall periodically make available to all Member States the list of:  - applications received for EC type-examination,  - EC type-approval certificates issued,  - applications for type-certificates refused,  - additions and amendments relating to documents already issued.  Each notified body shall moreover inform all the Member States forthwith of withdrawals of EC type-approval certificates.  Each Member State shall make this information available to the bodies which it has notified 1.6.  The other notified bodies may receive a copy of the certificates together with the Annexes to them.  1.7.  The applicant shall keep the notified body that has issued the EC type-approval certificate informed of any modification to the approved type.  Modifications to the approved type must receive additional approval from the notified body that issued the EC type-approval certificate where such changes influence conformity with the essential requirements of this Directive or the prescribed  conditions for use of the instrument. This additional approval is given in the form of an addition to the original EC type-approval certificate.  2.  EC declaration of type conformity (guarantee of production quality) 2.1.  The EC declaration of type conformity (guarantee of production quality) is the procedure whereby the manufacturer who satisfies the obligations of paragraph 2.2 declares that the instruments concerned are, where applicable, in conformity with the type  as described in the EC type-approval certificate and satisfy the requirements of this Directive that apply to them.  The manufacturer shall affix the EC mark to each instrument as well as the inscriptions provided for in Annex IV.  The EC mark shall be accompanied by the identification symbol of the notified body responsible for the EC surveillance referred to in paragraph 2.4.  2.2.  The manufacturer shall have adequately implemented a quality system as specified in paragraph 2.3 and shall be subject to EC surveillance as specified in paragraph 2.4.  2.3.  Quality system 2.3.1.  The manufacturer shall lodge an application for approval of this quality system with a notified body.  The application shall include:  - an undertaking to carry out the obligations arising from the approved quality system,  - an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness.  The manufacturer shall make available to the notified body all relevant information, in particular the quality system's documentation and the design documentation of the instrument.  2.3.2.  The quality system shall ensure conformity of the instruments with the type as described in the EC type-approval certificate and with the requirements of this Directive that apply to them.  All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written rules, procedures and instructions. This quality system documentation shall ensure a proper  understanding of the quality programmes, plans, manuals and records.  It shall contain in particular an adequate description of:  - the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality,  - the manufacturing process, the quality control and assurance techniques and the systematic measures that will be used,  - the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out,  - the means to monitor the achievement of the required product quality and the effective operation of the quality system.  2.3.3.  The notified body shall examine and evaluate the quality system to determine whether it satisfies the requirements referred to in paragraph 2.3.2. It shall presume conformity with these requirements in respect of quality systems that implement the  corresponding harmonized standard.  It shall notify its decision to the manufacturer and inform the other notified bodies thereof. The notification to the manufacturer shall contain the conclusions of the examination and, in the event of refusal, the justification for the decision.  2.3.4.  The manufacturer or his authorized representative shall keep the notified body that has approved the quality system informed of any updating of the quality assurance system in relation to changes brought about by, e.g. new technologies and new quality  concepts.  2.3.5.  Any notified body that withdraws approval of a quality system shall so inform the other notified bodies.  2.4.  EC surveillance 2.4.1.  The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.  2.4.2.  The manufacturer shall grant the notified body access for inspection purposes to the manufacture, inspection, testing and storage premises and shall provide it with all necessary information, in particular:  - the quality system documentation,  - the design documentation,  - the quality records, e.g. the inspection reports and tests and calibration data, reports on the qualifications of the personnel concerned, etc.  The notified body shall periodically carry out audits in order to ensure that the manufacturer is maintaining and applying the quality system; it shall provide the manufacturer with an audit report.  In addition, the notified body may carry out unscheduled visits to the manufacturer. During such visits, the notified body may carry out full or partial audits. It shall provide the manufacturer with a report on the visit, and, where appropriate, an  audit report.  2.4.3.  The notified body shall ensure that the manufacturer maintains and applies the approved quality system.  3.  EC verification 3.1.  The EC verification is the procedure whereby a notified body checks and attest that instruments concerned are, where appropriate, in conformity with the type as described in the EC type-approval certificate and satisfy the requirements of this Directive  that apply to them. The notified body shall affix the EC mark to each instrument.  3.2.  Each instrument shall be examined and appropriate tests as set out in the relevant standards referred to in Article 5, or equivalent tests, shall be carried out to ensure its conformity with the essential requirements of this Directive.  3.3.  The EC mark referred to in 3.1 above shall be accompanied by the identification symbol of the notified body.  3.4.  For instruments not subject to EC-type approval, the design documentation referred to in Annex III must be accessible to the notified body to the extent that the latter so requests.  4.  EC unit verification 4.1.  EC unit verification is the procedure whereby a notified body checks and attests that an instrument, generally designed for a specific application, satisfies the requirements of this Directive which apply to it. The notified body shall affix the EC mark  to the instrument.  4.2.  The instrument shall be examined and appropriate tests as set out in the relevant standards referred to in Article 5, or equivalent tests, shall be carried out to ensure its conformity with the relevant requirements of this Directive.  4.3.  The EC mark referred to in 4.1. shall be accompanied by the identification symbol of the notified body.  4.4.  The design documentation of the instrument as specified in Annex III shall be made available to the notified body.  5.  Common provisions 5.1.  The EC declaration of type conformity (guarantee of production quality), the EC verification, and the EC unit verification may be carried out at the manufacturer's works or any other location if transport to the place of use does not require dismantling  of the instrument, if the taking into service at the place of use does not require assembly of the instrument or other technical installation work likely to affect the instrument's performance, and if the gravity value at the place of putting into  service is taken into consideration or if the instrument's performance is insensitive to gravity variations. In all other cases, they shall be carried out at the place of use of the instrument.  5.2.  If the instrument's performance is sensitive to gravity variations the procedures referred to in 5.1 may be carried out in two stages, where the second stage shall comprise all examinations and tests of which the outcome is gravity-dependent, and the  first stage all other examinations and tests. The second stage shall be carried out at the place of use of the instrument. If a Member State has established gravity zones on its territory the expression 'at the place of use of the instrument' may be  read as 'in the gravity zone of use of the instrument'.  5.3.1.  Where a manufacturer has opted for execution in two stages of one of the procedures mentioned in 5.1, and where these two stages will be carried out by different parties, an instrument which has undergone the first stage of the procedure concerned shall  carry the identification symbol of the notified body involved in that stage.  5.3.2.  The party which has carried out the first stage of the procedure shall issue for each of the instruments a certificate, containing the necessary data for identification of the instrument and specifying the examinations and tests that have been carried  out.  The party which carries out the second stage of the procedure shall carry out those examinations and tests that have not yet been carried out.  5.3.3.  The manufacturer who has opted for the EC declaration of type conformity (guarantee of production quality) in stage one may either use this same procedure in stage two or decide to continue in stage two with EC verification.  5.3.4.  The EC mark shall be affixed to the instrument after completion of the second stage together with the identification symbol of the notified body involved in stage two.    ANNEX III   DESIGN DOCUMENTATION  The technical documentation must render the design, manufacture and operation of the product intelligible and enable an assessment to be made of its conformity with the requirements of the Directive.  The documentation shall include in so far as relevant for assessment:  - a general description of the type,  - conceptual designs and manufacturing drawings and plans of components, sub-assemblies, circuits, etc.,  - descriptions and explanations necessary for the understanding of the above, including the operation of the instrument,  - a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where the standards referred to in Article 5 have not been applied,  - results of design calculations made and of examinations, etc.,  - test reports,  - the EC type-approval certificates and the results of relevant tests on instruments containing parts identical to those in the design.    ANNEX IV  1.  Instruments subject to the EC conformity assessment procedure 1.1.  These instruments must bear:  (a)  - the EC mark of conformity comprising the EC symbol as described in Annex VI, followed by the last two digits of the year in which it was affixed,  - the identification symbol(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.  The abovementioned mark and inscriptions shall be affixed to the instrument, distinctly grouped together;  (b) a green sticker at least 12,5 mm × 12,5 mm square bearing a capital letter 'M' printed in black;  (c) the following inscriptions:  - the number of the EC type-approval certificate, where appropriate,  - the manufacturer's mark or name,  - the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles,  - maximum capacity in the form Max . . .,  - minimum capacity in the form Min . . .,  - verification scale interval in the form e =,  plus, when applicable:  - serial number,  - for instruments consisting of separate but associated units: identification mark on each unit,  - scale interval if it is different from e, in the form d = . . .,  - maximum additive tare effect, in the form T = + . . .,  - maximum subtractive tare effect if it is different from Max, in the form T = - . . .,  - tare interval if it is different from d, in the form dT = . . .,  - maximum safe load if it is different from Max, in the form Lim . . .,  - the special temperature limits, in the form . . . gC/. . . gC,  - ratio between load recepter and load.  1.2.  The instruments shall have adequate facilities for the affixing of the EC mark of conformity and/or inscriptions. These shall be such that it shall be impossible to remove the mark and inscriptions without damaging them, and that the mark and  inscriptions shall be visible when the instrument is in its regular operating position.  1.3.  Where a data plate is used it shall be possible to seal the plate unless it cannot be removed without being destroyed. If the data plate is sealable it shall be possible to apply a control mark to it.  1.4.  The inscriptions Max, Min, e, d, shall also be shown near the display of the result if they are not already located there.  1.5.  Each load measuring device which is connected or can be connected to one or more load receptors shall bear the relevant inscriptions relating to the said load receptors.  2.  Other instruments The other instruments must bear:  - the manufacturer's mark or name,  - maximum capacity in the form Max . . .  These instruments may not bear the stickers provided for in 1.1 (b).  3.  Restrictive use symbol specified in Article 12 This symbol shall be constituted by a capital letter 'M' printed in black on a red background at least 25 mm×25 mm square with two intersecting diagonals forming a cross.    ANNEX V  Set out below are the minimum criteria to be applied by Member States when designating bodies for the carrying-out of tasks pertaining to the procedures referred to in Article 8.  1.  The bodies shall dispose of the necessary personnel, means and equipment.  2.  The personnel shall have technical competence and professional integrity.  integrity.  3.  The bodies shall work independently of all circles, groups or persons having direct or indirect interest in non-automatic weighing instruments regarding the carrying-out of the tests, the preparation of the reports, the issuing of the certificates  and the surveillance requested by this Directive.  4.  The personnel shall respect the professional secret.  5.  The bodies shall have taken out a civil liability insurance if their civil liability is not covered by the State under national law.  The fulfilment of the conditions under points 1 and 2 shall be periodically verified by the Member States.    ANNEX VI