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DIRECTIVE 90/384/EEC: EXPLANATION AND INTERPRETATION

The text of this document was prepared by the Directorate-General Industry of the European Commission, in collaboration with WELMEC Working Group 2. The Western European Legal Metrology Cooperation (WELMEC) is a collaboration between the national legal metrology authorities in all the countries of Western Europe, whose principal aim is to establish a harmonized and consistent approach to legal metrology in Europe and to develop and maintain mutual confidence between the legal metrology services.

WELMEC was created, in part, to deal with the obligations, responsibilities and opportunities resulting from the developments in the European Union, such as the establishment of the Internal Market and European Economic Area, and the corresponding new legislative instruments and policies.

This document provides explanation and interpretation in respect of the provisions contained in Council directive 90/384/EEC on non-automatic weighing instruments. It does not provide a systematic treatment of all provisions of the directive, rather deals only with those of the directive's elements of which experience has shown that further clarification was needed

The document will assist all interested parties in correctly interpreting and applying this piece of community legislation: Member States of the European Union and Signatories of the Agreement on the European Economic Area, who transposed the directive in their respective national legislations; manufacturers of non-automatic weighing instruments, whether established in the European Economic Area or in third countries; users of non-automatic weighing instruments; consume

Brussels, June 1994

DISCLAIMER

The text of this document corresponds to the opinion of the services of the European Commission at the time of preparation. The attention is drawn to the fact that a binding interpretation of Community legislation can only be given by the Court of Justice

Directive 90/384/EEC was adopted on 20 June 1990 and came into force on 1 January 1993. It was modified by directive 93/68/EEC of 22 July 1993, with effect from 1 January 1995.

The directive concerns all non-automatic weighing instruments and is total in application. This means that no national provisions dealing with the application field of the directive may exist any more, other than those transposing the directive

The application areas listed in Article 1.2(a) become controlled areas or continue as controlled areas as and from 1 January 1993. All other areas of use are deregulated and fall under Article 1.2(b) from that date.

Without prejudice to the provisions of the transition arrangements, all new instruments being placed on the Community market from 1 January 1993 must carry either the manufacturer's mark or name and the maximum weighing capacity, or the CE conformity marking and the green metrology sticker. In the latter case they shall satisfy the essential requirements that apply to them and their conformity with these essential requirements shall have been assessed in accordance with the provisions on conformity assessment.

An instrument in use on 1 January 1993 may continue in use according to the rules in force when the type/design was first placed on the market. It may or may not have been subject to metrological controls prior to 1 January 1993.

A weighing instrument is defined in Article 1.1 as a measuring instrument that uses the action of gravity on a body to determine the mass of the body. A characteristic that distinguishes a non-automatic weighing instrument from other weighing instruments is that an operator is required during the weighing operation to obtain the result, eg to place the load on the load receptor of the instrument. By this definition, the following types of weighing instrument among others are included: retail shops scales, laboratory balances, bathroom scales, baby scales and kitchen scale

Only measuring instruments that meet the definition in Article 1.1 of a non-automatic weighing instrument are within the scope of the directive. Furthermore, legal weighing instruments must indicate the value of the mass (Essential requirements 8.1 of Annex I).

The definition of a non-automatic weighing instrument does not cover instruments which are used for qualitative analysis that do not indicate mass but the related characteristic only (eg geological or metallurgical analysis, hectolitre mass of grain, ...), and counting instruments that do not display mass (eg coin counters, pill counters, parts counters

. FREEDOM OF MOVEMENT

Placing on the market

The minimal control foreseen by the directive is that an instrument must bear the manufacturer's mark or name, and its maximum weighing capacity. An instrument marked in this way is entitled to free movement on the Community market, that is to say, it can be marketed in any of the EC Member States without having to comply with any other requirements concerning metrology. However, the directive identifies certain applications that require the mandatory use of instruments that bear the CE conformity marking and the green metrology sticker.

The CE conformity marking and the green metrology sticker

The CE conformity marking, if accompanied by the green metrology sticker, signifies that the instrument carrying these two markings satisfies the essential requirements of directive 90/384/EEC and has been subjected to conformity assessment in accordance with it. Additionally, the CE marking signifies conformity with the provisions of all other directives applying to the instrument that require the affixing of the CE conformity marking.

The green metrology sticker is a supplementary metrology marking, mandatory under directive 90/384/EEC as the CE marking itself, that specifies that directive 90/384/EEC is (one of) the directive(s) with those essential requirements compliance is declared by the CE marking. The green metrology sticker is not to be regarded as what used to be known in the past as an initial verification mark. Such an initial verification mark does not exist any more for non-automatic weighing instruments. Consequently, like the CE marking, the green metrology sticker may not be removed from an instrument that is used for Article 1.2(a) purposes.

The green metrology sticker is applied to each of the devices to which the essential requirements apply (see paragraph 2 of chapter 5). The CE marking is carried by the main part of the instrument only.

Affixing the CE marking and the green metrology sticker to the instrument is the responsibility of the manufacturer. This does not imply that the affixation must necessarily be carried out by the manufacturer himself. It can be carried out under the manufacturer's responsibility by his authorized representative established within the Community.

Since the CE conformity marking and the green metrology sticker necessarily go together under the directive, for reasons of simplicity 'CE marking', 'CE marked instrument', etc., refers hereafter to CE marking plus green metrology sticker, unless specified otherwise.

Putting into service

The special areas of use requiring CE marked instruments are listed in Article 1.2(a) of the Directive. All other applications do not require CE marked instruments to be used, these are covered by Article 1.2(b).

The shape, design, construction or configuration of the instrument (e.g. bench scale, platform scale, weighbridge, ...) do not identify its use as an Article 1.2(a) or Article 1.2(b) use. Although the potential use of an instrument can sometimes be readily identified by its shape, design, etc., (e.g. price computing retail scale, kitchen scale, postal scale, ...), nevertheless the final decision can only be made when the instrument is put into service. Taking a postal scale as an example, post office use would be an Article 1.2.(a) application, private use in the mail room of a company would be an Article 1.2.(b) application.

Article 1.2.(a) uses

The applications that require the mandatory use of CE marked instruments cover the areas of commerce, health and public administration. They are specified in Article 1.2(a) and are:

1. determination of mass for commercial transactions, which deals with trading transactions where the goods are bought or sold by mass. The cost therefore is directly proportional to the mass of the product.

2. determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment. This type of use not only includes situations where the payment is directly proportional to the mass, e.g. remuneration, tax etc., but also situations where the mass value determines the cost of the service, e.g. post office use, laundry or airport baggage tariff, charge for transporting goods, disposal of waste.

3. determination of mass for the application of laws or regulations; expert opinion given in court proceedings, which covers the activities where an instrument is used by a person who is not an expert in metrology but is giving evidence based on weighing results. Instruments used for the same purposes by experts from metrological laboratories, government or public authority laboratories and forensic laboratories are therefore excluded on the condition that such laboratories keep their instruments properly maintained, calibrated and adjusted.

4. determination of mass in the practice of medicine for the weighing of patients for the purposes of monitoring, diagnosis and medical treatment, which covers those activities where medical staff are responsible for the weighing of patients. Examples are the use of weighing instruments in hospitals, health centres or taken into the community for medical purposes. Medical staff includes all persons that lawfully carry out the medical weighing tasks concerned in their Member State.

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, where medical laboratories are laboratories that carry out analyses at the request of medical practitioners and pharmaceutical laboratories are quality control laboratories of manufacturers of medicinal products for human use. Pharmaceutical laboratories do not include the research and development laboratories of manufacturers of these medicinal products.

6. the determination of price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages. The former case covers the use of instruments with price calculation, in particular price-calculating retail sales, and the latter refers to scales used to make up pre-weighed non-predetermined quantities. Direct sales to the public is explained in Chapter 14.

Article 1.2.(b) uses

All uses other than Article 1.2.(a) uses are Article 1.2.(b) uses and do not require CE marked instruments.

Uses for the following purposes are considered Article 1.2.(b) uses.

- Sports and sporting records;

- Domestic use (kitchen, bathroom, ...);

- Geological surveys;

- Veterinary medicine;

- Medical practice, except for the weighing of live patients;

- Goods inwards inspection, etc. (checking scales);

- Weighing of goods for customer information only and not for the final

determination of mass (not to be confused with self-service scales that are used for the final determination of mass);

- Weighing for any non-Article 1.2.(a) purpose against payment. The payment represents a situation of commercial transaction for the determination of mass, which does not convert the use into an Article 1.2.(a) use. (Ex: coin operated person weighers).

- The use in quality systems. The metrological requirements that a measuring instrument, used in the operation of a quality system, needs to fulfill are, inter alia, that it has appropriate accuracy and is properly calibrated and periodically recalibrated against traceable metrological standards by a metrological laboratory. These requirements apply regardless of the status of the system (private agreement between two parties, mandatory certification procedure, ...). Although they do not exclude the use of legal measuring instruments, they do not render them mandatory either.

Also the use of instruments by

- Metrological enforcement agents;

- Metrological experts (eg national metrology laboratories, ...);

- Government or public authority laboratories, forensic laboratories,

Relationship with directive 76/211/EEC

Council directive 76/211/EEC on the making up by mass or by volume of certain prepackaged products provides in its Annex I, point 4 that legally controlled instruments must be used for the making up or the checking of prepackages. The use of a non-automatic weighing instrument for any of these two alternatives is therefore an Article 1.2.(a) use. The right to choose between the two alternatives offered by directive 76/211/EEC is not affected, however, by directive 90/384/EEC.

TRANSITION ARRANGEMENTS

Article 1.2.(a) applications in certain Member States do not require CE marked instruments until 1 January 2003, if on 31 December 1992, the particular Member State has not had requirements to use a controlled instrument for that application. Therefore, these Member States must allow the introduction onto their markets of instruments not carrying the CE marking plus green metrology sticker, for use in these areas for the full transition period (i.e. 10 years). However, the Member States are requested to encourage all manufacturers interested in these application areas to manufacture instruments capable of meeting the essential requirements, sufficiently in advance of the cutoff date of 1 January 2003.

In relation to type approvals, a distinction is made between EEC type approvals (granted under Council directive 73/360/EEC) and national type approvals (those granted under national legislation other than that which transposes directive 73/360/EEC).

An EEC type approval shall not be granted after 31 December 1992. Those approvals that have an expiry date later than 31 December 1992 shall not be renewed.

A national type approval shall not be granted after 31 December 1992. Those valid on 1 January 1993 may be renewed or modified provided their validity after renewal or modification does not extend beyond 31 December 2002.

ESSENTIAL REQUIREMENTS

Annex I of the Directive contains the essential requirements that must be met by a non-automatic weighing instrument that is used in Article 1.2.(a) applications. These are the technical and metrological performance requirements for the instrument and include the maximum permitted error.

The essential requirements apply also to devices, included in or connected to a non-automatic weighing instrument that is used for an Article 1.2.(a) application, if these devices are themselves also used for that application.

The only exception to this rule is the case of supplementary indicating or printing devices that are included in or connected to a non-automatic weighing instrument that is not used for direct sales to the public, if

- they repeat the result of the weighing operation and cannot influence the correct functioning of the instrument, and

- the result of the weighing operation is printed or recorded correctly and indelibly by a part of the instrument that meets the essential requirements, and

- this result is accessible to both parties concerned by the measurement.

Even through they may be used for Article 1.2.(a) applications, those supplementary indicating or printing devices do not have to satisfy the essential requirements, in which case they must carry the red symbol of restricted use (see chapter 10).

EUROPEAN STANDARD EN 45501

A harmonized European standard for non-automatic weighing instruments, EN 45501:1992/AC:1993, has been adopted by CEN/CENELEC. This standard not only sets down technical solutions to the essential requirements but also the tests that can be used to establish conformity with the performance requirements.

The references of this harmonized standard were published, in accordance with Article 5.2, in the Official Journal of the European Communities, nr. C 153 of 04.06.1994, page 17. Application of this standard, in whole or in part, provides presumption of conformity with the corresponding essential requirements.

CONFORMITY ASSESSMENT

General

The procedures used to establish conformity with the essential requirements are laid down in Annex II of the Directive.

A non-automatic weighing instrument must undergo type examination unless it does not contain electronic devices and its load measuring device does not use a spring to balance the load. (The latter instruments are so simple that one can abstain from type examination). The type examination is followed by either EC declaration of type conformity (guarantee of production quality) or EC verification.

Instruments that are custom-designed and custom-made for a specific application need only undergo EC unit verification. This procedure is also open to very small production series of instruments.

The conformity assessment procedures

EC type examination

A certification body, chosen by the manufacturer or his authorized representative established within the Community from among the bodies notified to the Commission for carrying out such work, tests and certifies that an instrument, representative of the production envisaged, meets the essential requirements of the Directive. The notified body issues a type approval certificate that, inter alia, contains enough information for the identification of the instrument. The certificate has a validity of 10 years but may be subsequently renewed. In special circumstances, such as the application of new technologies, the validity of the certificate may be reduced to 2 years with the allowance for an extension of 3 years.

EC declaration of type conformity (guarantee of production quality)

To use the procedure of EC declaration of type conformity (guarantee of production quality) a manufacturer must make application for approval of his production quality system to one of the bodies notified to the Commission for carrying out such work. Furthermore, the correct application of the quality system must be surveyed by that notified body. The EC declaration of type conformity (guarantee of production quality) allows that the CE marking and the green metrology sticker are affixed to the products without verification of the products by a notified body.

EC verification

EC verification is the procedure under which a notified body, chosen by the manufacturer or his authorized representative, carries out tests to assure itself that the individual instruments conform to the approved type and to those of the essential requirements that are to be checked upon completion of the manufacture. In case no type examination is required, the tests will assure conformity with the essential requirements

EC unit verification

When a single instrument or very limited number of instruments is/are manufactured, usually custom-designed, the manufacturer or his authorized representative in the Community may choose to have conformity established by unit verification. This is the procedure where a notified body establishes conformity of the instrument with the essential requirements of the Directive, without the instrument first having received a type approval

Execution in two stage

The conformity assessment procedures of EC declaration of type conformity, EC verification and EC unit verification may be carried out in a single stage or in two separate stages, at the manufacturer's choice. In the case of EC declaration of type conformity we are referring to those tests of the final product which form part of the manufacturer's quality system. The provisions relating to the choice of one or two stages, the place of their performance and the responsibilities of the bodies involved are contained in point 5 of Annex II of the Directive.

Criteria for the choice of one or two stage procedure, and place of assessment

After type examination (unless the instrument is exempted from it), one of the procedures referred to above must be carried out. The procedure chosen is, in principle, carried out in one stage at the manufacturer's works, provided transport of the instrument to its place of use, after establishment of its conformity, does not require dismantling; the putting into service at the place of use does not require assembly or installation work that is likely to affect the instrument's performance; and the gravity value at the place of use is accounted for when adjusting the instrument, if the weighing results are sensitive to gravity. The manufacturer may, however, choose to have the procedure carried out in two stages.

In case the conditions referred to above are not satisfied, the procedure is carried out either in one stage at the place of use, or in two stages, where stage one is carried out at the manufacturer's works and stage two at the place of use. If the weighing results are gravity dependent, stage two must as a minimum comprise all examinations and tests whose outcome is gravity dependent. In all cases (i.e. whether the weighing results are gravity dependent or not), stage two must comprise all examinations and tests not carried out in stage one.

Responsibilities of the bodies involved

When any of the relevant procedures above are carried out in one stage, each instrument must carry the identification number of the notified body that has performed the EC verification or EC unit verification, or the body responsible for the approval and supervision of the manufacturer's quality system.

When the procedure is carried out in two stages each instrument that passes from the first stage to the second must be accompanied by a certificate that details the examinations and tests carried out in the first stage and the necessary data for the identification of the instrument. The certificate is drawn up by the notified body in the case of EC verification or EC unit verification, or the manufacturer when he operates a quality system.

The tests and examinations that have not been carried out in the first stage must be carried out in the second stage. In the case of an instrument sensitive to gravity the second stager must comprise all examinations and tests where the results are gravity dependent.

The identification number of the body or bodies involved in the two stages must be affixed to the instrument. Where two different bodies have been involved both their numbers are affixed.

A manufacturer who operates a quality system may carry out the second stage himself if his quality system certification extends to the place of use of the instrument, otherwise he may opt for EC verification to finish the second stage

AFFIXATION OF CONFORMITY MARKS AND IDENTIFICATION NUMBERS

On completion of the conformity assessment the CE conformity marking and the green metrology sticker must be affixed by the manufacturer or his authorized representative. This does not mean that the physical affixation must wait until this point in time. Since the affixation of CE marking and metrology sticker is the responsibility of the manufacturer, the manufacturer may make provision for these markings in advance, the important point being that the markings have no legal significance until all the procedures are successfully completed and the instrument is placed on the market.

Likewise, the affixation of their identification numbers is the responsibility of the notified bodies. Therefore, a notified body may affix its identification number itself, or have it affixed under its responsibility, e.g. by the manufacturer, if satisfactory (to the notified body) arrangements are made. Again, the physical affixation may be carried out in advance.

OTHER MARKINGS AND INSCRIPTIONS

A CE marked instrument shall also carry the additional markings and inscriptions, detailing the instrument's specifications, according to the requirements of Annexe IV of the directive.

A CE marked instrument is presumed to be placed on the market for Art. 1.2. (a) uses and must therefore satisfy all provisions of the directive pertaining to this category of use, including the requirements on markings and inscriptions (identification number of the notified body involved, last two digits of the year of affixing of the CE marking, ....). An instrument placed on the market for Art. 1.2.(b) uses may not carry any of the markings and inscriptions required for Art. 1.2.(a) uses. It must at least carry the manufacturer's mark or name and the maximum weighing capacity.

The only exception to the above rules is provided by those cases where it is without any doubt that the CE marking was affixed under another directive. An example of such a situation is the case of an electronic kitchen or bathroom scale, which must, after expiration of the transition period of directive 89/336/EEC on electromagnetic compatibility, carry the CE marking (without the green metrology sticker) under that directive.

The red symbol of restricted use

Devices that are connected to or included as part of a CE marked instrument and have not been subject to conformity assessment must bear the red symbol of restricted use with the capital letter M in black crossed by an X. These devices may not be used for any of the Article 1.2.(a) purposes.

The only exception of this rule are the supplementary indicating or printing devices referred to in the third paragraph of chapter 5. If these supplementary devices have not been subject to conformity assessment they must bear the red symbol of restricted use, but may nevertheless be used for Article 1.2.(a) purposes.

SUPERVISION OF INSTRUMENTS IN USE

All instruments used for Article 1.2.(a) purposes must be supervised to see that they continue to comply with the requirements of the directive. The Member States are free to establish their own systems of inspection and control but they should ensure that these do not lead to barriers to trade.

This means inter alia that the provisions for marking of the instruments under the national systems of inspection and control, to show their status to user and inspector, shall not lead to the obligation of having to satisfy additional requirements before they can be placed on the market or put into service.

NATIONAL RULES APPLYING TO THE USE

Member States are free to establish national rules on the use of legal measuring instruments, providing these do not lead to barriers to trade. This means e.g. requirements for the installation of an instrument such that customers can see the platform and the mass indication where a freight or postage is determined, or for additional labeling of the instrument in relation to its use to be put on by the user.

REPEALS

Directive 73/360/EEC is repealed from the 1 January 1993 except as for the transition arrangements.

MISCELLANEOUS

Direct sales

A situation of direct sales exists when all of the following conditions are satisfied:

1. The weighing operation is carried out for, and simultaneously with, a trading transaction where goods are bought or sold by mass;

2. The customer is present when the weighing operation is carried out;

3. All aspects of the trading transaction are concluded at that time and place.

Condition nr. 1 excludes weighing operations for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity, or similar type of payment. Direct sales is strictly limited to the buying and selling of goods.

The customer in a trading transaction where goods are bought or sold by mass is the party that is not responsible for the instrument being used for the weighing. The customer is usually the buying party but can, in some cases, be the selling party.

Where the weighing instrument used is a self service instrument, operated by the customer in the absence of the other party, this is direct sales.

Direct sales to the public

Direct sales to the public exists when direct sales as defined above is taking place in respect of goods being bought or sold by a private person being the ultimate consumer.

Field trials

Where a need to carry out trials in working conditions is established, this shall be dealt with by issuing a type approval certificate, limited in time according to point 1.4 of Annex II of the directive (two years, with possibility of extension by another three years), and, if necessary, limited in validity according to paragraph 1 of the same point. In the latter case, conditions for validity that one might think of could be, e.g. the number of instruments covered by the certificate, the location in which the instruments must be installed, and the like.

Hybrid instruments

Hybrid instruments are instruments that perform more than one measurement function.

Where a measuring instrument has a non-automatic weighing mode of operation together with one or more other measurement modes, then the instrument must be the subject of conformity assessment under directive 90/384/EEC in so far as it relates to the non-automatic weighing mode of operation. The other measurement modes could relate to automatic weighing, volume or length measurement, pressure measurement, etc.

The EC type approval certificate issued must clearly state that the EC conformity marking and green metrology sticker cover only the non-automatic weighing mode of operation and that the other measurement modes are the subject of national controls. These other measurement modes may not be the subject of national prescriptions in all Member States.

A hybrid instrument having a non-automatic weighing mode of operation may therefore carry the CE conformity marking, as well as a national marking where appropriate.

Where an automatic weighing instruments has a non-automatic mode of operation for the purpose of calibration or setting up only, then the weighing instrument is only subject to national controls related to automatic weighing instruments, not to directive 90/304/EEC.

Of particular relevance is directive 89/336/EEC on electromagnetic compatibility, amended by directive 92/31EEC. Instruments that are used for Article 1.2.(a) applications are covered, for their immunity against electromagnetic disturbances, by directive 90/384/EEC. For their emission of electromagnetic disturbances, however, they are covered by directive 89/336/EEC. Instruments used for Article 1.2(b) purposes are covered by directive 89/336/EEC for emission and immunity.