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DIRECTIVE 2014/31/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 26 February 2014

on the harmonisation of the laws of the Member States relating to the making available on themarket of non-automatic weighing instruments

(recast)(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THEEUROPEAN UNION,

Having regard to the Treaty on the Functioning of the EuropeanUnion, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the nationalparliaments,

Having regard to the opinion of the European Economic andSocial Committee (1),

Acting in accordance with the ordinary legislative procedure ( 2),

Whereas:

(1) Directive 2009/23/EC of the European Parliament and ofthe Council of 23 April 2009 on non-automaticweighing instruments (3) has been substantiallyamended (4). Since further amendments are to be made,that Directive should be recast in the interests of clarity.

(2) Regulation (EC) No 765/2008 of the EuropeanParliament and of the Council of 9 July 2008 settingout the requirements for accreditation and marketsurveillance relating to the marketing of products (5)

lays down rules on the accreditation of conformityassessment bodies, provides a framework for themarket surveillance of products and for controls onproducts from third countries, and lays down thegeneral principles of the CE marking.

(3) Decision No 768/2008/EC of the European Parliamentand of the Council of 9 July 2008 on a common

framework for the marketing of products (6) lays downcommon principles and reference provisions intended toapply across sectoral legislation in order to provide acoherent basis for revision or recasts of that legislation.Directive 2009/23/EC should therefore be adapted tothat Decision.

(4) This Directive covers non-automatic weighing

instruments which are new to the Union market whenthey are placed on the market; that is to say they areeither new non-automatic weighing instruments made bya manufacturer established in the Union or non-automatic weighing instruments, whether new orsecond-hand, imported from a third country.

(5) Member States should have the responsibility ofprotecting the public against incorrect results ofweighing operations by means of non-automaticweighing instruments when used for certain categoriesof applications.

(6) This Directive should apply to all forms of supply,including distance selling.

(7) Economic operators should be responsible for thecompliance of non-automatic weighing instrumentswith this Directive in relation to their respective rolesin the supply chain, so as to ensure a high level ofprotection of public interests covered by this Directive,and to guarantee fair competition on the Union market.

(8) All economic operators intervening in the supply anddistribution chain should take appropriate measures toensure that they only make available on the marketnon-automatic weighing instruments which are inconformity with this Directive. It is necessary toprovide for a clear and proportionate distribution ofobligations which correspond to the role of eacheconomic operator in the supply and distribution chain.

(9) In order to facilitate communication between economicoperators, market surveillance authorities and end-users,

Member States should encourage economic operators toinclude a website address in addition to the postaladdress.

EN29.3.2014 Official Journal of the European Union L 96/107

(1) OJ C 181, 21.6.2012, p. 105.(2) Position of the European Parliament of 5 February 2014 (not yet

published in the Official Journal) and decision of the Council of20 February 2014.

(3) OJ L 122, 16.5.2009, p. 6. Directive 2009/23/EC is the codificationof Council Directive 90/384/EEC of 20 June 1990 on the harmon-ization of the laws of the Member States relating to non-automaticweighing instruments (OJ L 189, 20.7.1990, p. 1).

(4) See Annex V, Part A.(5) OJ L 218, 13.8.2008, p. 30. (6) OJ L 218, 13.8.2008, p. 82.

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(10) The manufacturer, having detailed knowledge of thedesign and production process, is best placed to carryout the conformity assessment procedure. Conformityassessment should therefore remain solely the obligationof the manufacturer.

(11) It is necessary to ensure that non-automatic weighinginstruments from third countries entering the Unionmarket comply with this Directive, and in particularthat appropriate conformity assessment procedures have

been carried out by manufacturers with regard to thosenon-automatic weighing instruments. Provision shouldtherefore be made for importers to make sure that thenon-automatic weighing instruments they place on themarket comply with the requirements of this Directiveand that they do not place on the market non-automaticweighing instruments which do not comply with suchrequirements or present a risk. Provision should also bemade for importers to make sure that conformity

assessment procedures have been carried out and thatmarking of non-automatic weighing instruments anddocumentation drawn up by manufacturers areavailable for inspection by the competent national auth-orities.

(12) When placing a non-automatic weighing instrument onthe market, every importer should indicate on the non-automatic weighing instrument his name, registered tradename or registered trade mark and the postal address atwhich he can be contacted. Exceptions should beprovided, including for cases where the importershould have to open the packaging only for the

purpose of putting his name and address on theinstrument.

(13) The distributor makes a non-automatic weighinginstrument available on the market after it has beenplaced on the market by the manufacturer or theimporter and should act with due care to ensure thatits handling of the non-automatic weighing instrumentdoes not adversely affect the compliance of thatinstrument.

(14) Any economic operator that either places a non-automatic weighing instrument on the market underhis own name or trade mark or modifies a non-automatic weighing instrument in such a way thatcompliance with this Directive may be affected should

be considered to be the manufacturer and shouldassume the obligations of the manufacturer.

(15) Distributors and importers, being close to the marketplace, should be involved in market surveillance taskscarried out by the competent national authorities, andshould be prepared to participate actively, providingthose authorities with all necessary information relating

to the non-automatic weighing instrument concerned.

(16) Ensuring traceability of a non-automatic weighinginstrument throughout the whole supply chain helps to

make market surveillance simpler and more efficient. Anefficient traceability system facilitates market surveillanceauthorities task of tracing economic operators who madenon-compliant non-automatic weighing instrumentsavailable on the market. When keeping the informationrequired under this Directive for the identification of

other economic operators, economic operators shouldnot be required to update such information in respectof other economic operators who have either suppliedthem with a non-automatic weighing instrument or towhom they have supplied a non-automatic weighinginstrument.

(17) This Directive should be limited to the expression of theessential requirements as regards metrology andperformance in relation to non-automatic weighinginstruments. In order to facilitate conformity assessmentwith those essential requirements as regards metrologyand performance, it is necessary to provide for apresumption of conformity for non-automatic weighinginstruments which are in conformity with harmonisedstandards that are adopted in accordance with Regulation(EU) No 1025/2012 of the European Parliament and ofthe Council of 25 October 2012 on European Standard-isation (1) for the purpose of expressing detailed technicalspecifications of those requirements, in particular as tothe metrological, design and construction characteristics.

(18) Regulation (EU) No 1025/2012 provides for a procedurefor objections to harmonised standards where thosestandards do not entirely satisfy the requirements of

this Directive.

(19) Assessment of conformity with the relevant metrologicaland technical provisions is necessary to provide effectiveprotection for users and third parties.

(20) In order to enable economic operators to demonstrateand the competent authorities to ensure that non-automatic weighing instruments made available on themarket conform to the essential requirements, it isnecessary to provide for conformity assessment

procedures. Decision No 768/2008/EC establishesmodules for conformity assessment procedures, whichinclude procedures from the least to the most stringent,in proportion to the level of risk involved and the levelof safety required. In order to ensure inter-sectoralcoherence and to avoid ad-hoc variants, conformityassessment procedures should be chosen from amongthose modules.

(21) Manufacturers should draw up an EU declaration ofconformity to provide information required under thisDirective on the conformity of a non-automaticweighing instrument with the requirements of thisDirective and of other relevant Union harmonisationlegislation.

ENL 96/108 Official Journal of the European Union 29.3.2014

(1) OJ L 316, 14.11.2012, p. 12.

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(22) To ensure effective access to information for marketsurveillance purposes, the information required toidentify all applicable Union acts should be available ina single EU declaration of conformity. In order to reducethe administrative burden on economic operators, thatsingle EU declaration of conformity may be a dossier

made up of relevant individual declarations ofconformity.

(23) The CE marking and the supplementary metrologymarking, indicating the conformity of a non-automaticweighing instrument, are the visible consequence of awhole process comprising conformity assessment in a

broad sense. General principles governing the CEmarking and its relationship to other markings are setout in Regulation (EC) No 765/2008. Rules governingthe affixing of the CE marking and the supplementarymetrology marking should be laid down in this Directive.

(24) The conformity assessment procedures set out in thisDirective require the intervention of conformityassessment bodies, which are notified by the MemberStates to the Commission.

(25) Experience has shown that the criteria set out inDirective 2009/23/EC that conformity assessment

bodies have to fulfil to be notified to the Commissionare not sufficient to ensure a uniformly high level ofperformance of notified bodies throughout the Union.It is, however, essential that all notified bodies performtheir functions to the same level and under conditions of

fair competition. That requires the setting of obligatoryrequirements for conformity assessment bodies wishingto be notified in order to provide conformity assessmentservices.

(26) If a conformity assessment body demonstratesconformity with the criteria laid down in harmonisedstandards, it should be presumed to comply with thecorresponding requirements set out in this Directive.

(27) In order to ensure a consistent level of conformityassessment quality, it is also necessary to set

requirements for notifying authorities and other bodiesinvolved in the assessment, notification and monitoringof notified bodies.

(28) The system set out in this Directive should be comple-mented by the accreditation system provided for in Regu-lation (EC) No 765/2008. Since accreditation is anessential means of verifying the competence ofconformity assessment bodies, it should also be usedfor the purposes of notification.

(29) Transparent accreditation as provided for in Regulation

(EC) No 765/2008, ensuring the necessary level ofconfidence in certificates of conformity, should beconsidered by the national public authorities throughoutthe Union as the preferred means of demonstrating thetechnical competence of conformity assessment bodies.

However, national authorities may consider that theypossess the appropriate means of carrying out thatevaluation themselves. In such cases, in order to ensurethe appropriate level of credibility of evaluations carriedout by other national authorities, they should provide theCommission and the other Member States with the

necessary documentary evidence demonstrating thecompliance of the conformity assessment bodiesevaluated with the relevant regulatory requirements.

(30) Conformity assessment bodies frequently subcontractparts of their activities linked to the assessment ofconformity or have recourse to a subsidiary. In orderto safeguard the level of protection required for thenon-automatic weighing instruments to be placed onthe market, it is essential that conformity assessmentsubcontractors and subsidiaries fulfil the samerequirements as notified bodies in relation to the

performance of conformity assessment tasks. Therefore,it is important that the assessment of the competenceand the performance of bodies to be notified and themonitoring of bodies already notified cover also activitiescarried out by subcontractors and subsidiaries.

(31) It is necessary to increase the efficiency and transparencyof the notification procedure and, in particular, to adaptit to new technologies so as to enable online notification.

(32) Since notified bodies may offer their services throughout

the Union, it is appropriate to give the other MemberStates and the Commission the opportunity to raiseobjections concerning a notified body. It is thereforeimportant to provide for a period during which anydoubts or concerns as to the competence of conformityassessment bodies can be clarified before they startoperating as notified bodies.

(33) In the interests of competitiveness, it is crucial thatnotified bodies apply the conformity assessmentprocedures without creating unnecessary burdens foreconomic operators. For the same reason, and toensure equal treatment of economic operators,

consistency in the technical application of the conformityassessment procedures needs to be ensured. That can best

be achieved through appropriate coordination andcooperation between notified bodies.

(34) Member States should take all appropriate measures toensure that non-automatic weighing instruments may beplaced on the market only if, when properly stored andused for their intended purpose, or under conditions ofuse which can be reasonably foreseen, they do notendanger the health and safety of persons. Non-automatic weighing instruments should be considered

as non-compliant with the essential requirements laiddown in this Directive only under conditions of usewhich can be reasonably foreseen, that is when suchuse could result from lawful and readily predictablehuman behaviour.


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(35) In order to ensure legal certainty, it is necessary to clarifythat rules on Union market surveillance and control ofproducts entering the Union market provided for inRegulation (EC) No 765/2008 apply to non-automaticweighing instruments covered by this Directive. ThisDirective should not prevent Member States from

choosing the competent authorities to carry out thosetasks.

(36) Directive 2009/23/EC already provides for a safeguardprocedure allowing the Commission to examine the

justification for a measure taken by a Member Stateagainst non-automatic weighing instruments itconsiders being non-compliant. In order to increasetransparency and to reduce processing time, it isnecessary to improve the existing safeguard procedure,with a view to making it more efficient and drawingon expertise available in Member States.

(37) The existing system should be supplemented by aprocedure under which interested parties are informedof measures intended to be taken with regard to non-automatic weighing instruments presenting a risk toaspects of public interest protection covered by thisDirective. It should also allow market surveillance auth-orities, in cooperation with the relevant economic oper-ators, to act at an earlier stage in respect of such non-automatic weighing instruments.

(38) Where the Member States and the Commission agree asto the justification of a measure taken by a MemberState, no further involvement of the Commissionshould be required, except where non-compliance can

be attributed to shortcomings of a harmonised standard.

(39) In order to ensure uniform conditions for the implemen-tation of this Directive, implementing powers should beconferred on the Commission. Those powers should beexercised in accordance with Regulation (EU)No 182/2011 of the European Parliament and of the

Council of 16 February 2011 laying down the rulesand general principles concerning mechanisms forcontrol by Member States of the Commissions exerciseof implementing powers (1).

(40) The advisory procedure should be used for the adoptionof implementing acts requesting the notifying MemberState to take the necessary corrective measures inrespect of notified bodies that do not meet or nolonger meet the requirements for their notification.

(41) The examination procedure should be used for theadoption of implementing acts with respect to

compliant non-automatic weighing instruments whichpresent a risk to the health or safety of persons or toother aspects of public interest protection.

(42) In line with established practice, the committee set up bythis Directive can play a useful role in examining mattersconcerning the application of this Directive raised either

by its chair or by a representative of a Member State inaccordance with its rules of procedure.

(43) When matters relating to this Directive, other than itsimplementation or infringements, are being examined,i.e. in a Commission expert group, the EuropeanParliament should in line with existing practice receivefull information and documentation and, where appro-priate, an invitation to attend such meetings.

(44) The Commission should, by means of implementing actsand, given their special nature, acting without the appli-cation of Regulation (EU) No 182/2011, determinewhether measures taken by Member States in respect ofnon-compliant non-automatic weighing instruments are

justified or not.

(45) Member States should lay down rules on penaltiesapplicable to infringements of the provisions ofnational law adopted pursuant to this Directive andensure that those rules are enforced. The penalties

provided for should be effective, proportionate anddissuasive.

(46) It is necessary to provide for reasonable transitionalarrangements that allow the making available on themarket and/or putting into service, without the need tocomply with further product requirements, of non-automatic weighing instruments that have already beenplaced on the market in accordance with Directive2009/23/EC before the date of application of nationalmeasures transposing this Directive. Distributors shouldtherefore be able to supply non-automatic weighinginstruments that have been placed on the market,

namely stock that is already in the distribution chain,before the date of application of national measures trans-posing this Directive.

(47) Since the objective of this Directive, namely to ensurethat non-automatic weighing instruments on the marketfulfil the requirements providing for a high level ofprotection of public interests covered by this Directivewhile guaranteeing the functioning of the internalmarket, cannot be sufficiently achieved by the MemberStates but can rather, by reason of its scale and effects, be

better achieved at Union level, the Union may adopt

measures, in accordance with the principle of subsidiarityas set out in Article 5 of the Treaty on European Union.In accordance with the principle of proportionality, as setout in that Article, this Directive does not go beyondwhat is necessary in order to achieve that objective.


(1) OJ L 55, 28.2.2011, p. 13.

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(48) The obligation to transpose this Directive into nationallaw should be confined to those provisions whichrepresent a substantive amendment as compared to theearlier Directive. The obligation to transpose theprovisions which are unchanged arises under the earlierDirective.

(49) This Directive should be without prejudice to theobligations of the Member States relating to the timelimits for transposition into national law and the datesof application of the Directives set out in Annex V,Part B,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER 1

GENERAL PROVISIONS

Article 1

Scope

1. This Directive shall apply to all non-automatic weighinginstruments.

2. For the purposes of this Directive, the following categoriesof use of non-automatic weighing instruments shall be distin-guished:

(a) determination of mass for commercial transactions;

(b) determination of mass for the calculation of a toll, tariff,tax, bonus, penalty, remuneration, indemnity or similar typeof payment;

(c) determination of mass for the application of laws or regu-lations or for an expert opinion given in court proceedings;

(d) determination of mass in the practice of medicine forweighing patients for the purposes of monitoring,diagnosis and medical treatment;

(e) determination of mass for making up medicines onprescription in a pharmacy and determination of mass inanalyses carried out in medical and pharmaceutical labora-tories;

(f) determination of price on the basis of mass for the purposesof direct sales to the public and the making-up ofprepackages;

(g) all applications other than those listed in points (a) to (f).

Article 2

Definitions

For the purposes of this Directive, the following definitions shallapply:

(1) weighing instrument means a measuring instrumentserving to determine the mass of a body by using theaction of gravity on that body. A weighing instrumentmay also serve to determine other mass-related magni-tudes, quantities, parameters or characteristics;

(2) non-automatic weighing instrument or instrument meansa weighing instrument requiring the intervention of anoperator during weighing;

(3) making available on the market means any supply of aninstrument for distribution or use on the Union market inthe course of a commercial activity, whether in return forpayment or free of charge;

(4) placing on the market means the first making available ofan instrument on the Union market;

(5) manufacturer means any natural or legal person whomanufactures an instrument or has an instrumentdesigned or manufactured, and markets that instrument

under his name or trade mark;

(6) authorised representative means any natural or legalperson established within the Union who has received awritten mandate from a manufacturer to act on his behalfin relation to specified tasks;

(7) importer means any natural or legal person establishedwithin the Union who places an instrument from a thirdcountry on the Union market;

(8) distributor means any natural or legal person in thesupply chain, other than the manufacturer or theimporter, who makes an instrument available on themarket;

(9) economic operators means the manufacturer, the auth-orised representative, the importer and the distributor;

(10) technical specification means a document that prescribestechnical requirements to be fulfilled by an instrument;

(11) harmonised standard means harmonised standard asdefined in point (c) of point 1 of Article 2 of Regulation(EU) No 1025/2012;


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(12) accreditation means accreditation as defined in point 10of Article 2 of Regulation (EC) No 765/2008;

(13) national accreditation body means national accreditation

body as defined in point 11 of Article 2 of Regulation (EC)No 765/2008;

(14) conformity assessment means the process demonstratingwhether the essential requirements of this Directiverelating to an instrument have been fulfilled;

(15) conformity assessment body means a body that performsconformity assessment activities including calibration,testing, certification and inspection;

(16) recall means any measure aimed at achieving the return ofan instrument that has already been made available to theend-user;

(17) withdrawal means any measure aimed at preventing aninstrument in the supply chain from being made availableon the market;

(18) Union harmonisation legislation means any Union legis-lation harmonising the conditions for the marketing ofproducts;

(19) CE marking means a marking by which the manufacturerindicates that the instrument is in conformity with theapplicable requirements set out in Union harmonisationlegislation providing for its affixing.

Article 3

Making available on the market and putting into service

1. Member States shall take all steps to ensure that onlyinstruments that meet the applicable requirements of thisDirective may be made available on the market.

2. Member States shall take all steps to ensure thatinstruments may not be put into service for the uses referredto in points (a) to (f) of Article 1(2) unless they meet therequirements of this Directive.

3. Member States shall take all steps to ensure thatinstruments put into service for the uses referred to in points(a) to (f) of Article 1(2) continue to conform to the applicablerequirements of this Directive.

Article 4

Essential requirements

Instruments used or intended to be used for the applicationslisted in points (a) to (f) of Article 1(2) shall satisfy the essentialrequirements set out in Annex I.

Where the instrument includes, or is connected to, deviceswhich are not used or intended to be used for the applicationslisted in points (a) to (f) of Article 1(2), such devices shall not besubject to those essential requirements.

Article 5

Free movement of instruments

1. Member States shall not impede the making available on

the market of instruments which meet the requirements of thisDirective.

2. Member States shall not impede the putting into service,for the uses referred to in points (a) to (f) of Article 1(2), ofinstruments which meet the requirements of this Directive.

CHAPTER 2

OBLIGATIONS OF ECONOMIC OPERATORS

Article 6

Obligations of manufacturers

1. When placing on the market their instruments intended tobe used for the applications listed in points (a) to (f) ofArticle 1(2), manufacturers shall ensure that they have beendesigned and manufactured in accordance with the essentialrequirements set out in Annex I.

2. For the instruments intended to be used for the appli-cations listed in points (a) to (f) of Article 1(2), manufacturersshall draw up the technical documentation referred to in AnnexII and carry out the relevant conformity assessment procedurereferred to in Article 13 or have it carried out.

Where compliance of an instrument intended to be used for theapplications listed in points (a) to (f) of Article 1(2) with theapplicable requirements has been demonstrated by thatconformity assessment procedure, manufacturers shall drawup an EU declaration of conformity and affix the CE markingand the supplementary metrology marking.

3. For the instruments intended to be used for the appli-

cations listed in points (a) to (f) of Article 1(2), manufacturersshall keep the technical documentation and the EU declarationof conformity for 10 years after the instrument has been placedon the market.


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4. Manufacturers shall ensure that procedures are in place forseries production to remain in conformity with this Directive.Changes in instrument design or characteristics and changes inthe harmonised standards or in other technical specifications byreference to which conformity of an instrument is declared shall

be adequately taken into account.

When deemed appropriate with regard to the risks presented byan instrument intended to be used for the applications listed inpoints (a) to (f) of Article 1(2), manufacturers shall carry outsample testing of instruments made available on the market,investigate, and, if necessary, keep a register of complaints, ofnon-conforming instruments and instrument recalls, and shallkeep distributors informed of any such monitoring.

5. Manufacturers shall ensure that instruments which theyhave placed on the market bear a type, batch or serialnumber or other element allowing their identification, as set

out in Annex III.

For the instruments intended to be used for the applicationslisted in points (a) to (f) of Article 1(2), manufacturers shall affixthe inscriptions provided for in point 1 of Annex III.

For the instruments not intended to be used for the applicationslisted in points (a) to (f) of Article 1(2), manufacturers shall affixthe inscriptions provided for in point 2 of Annex III.

Where an instrument which is intended to be used for any ofthe applications listed in points (a) to (f) of Article 1(2) includes,or is connected to, devices which are not used or intended to beused for the applications listed in points (a) to (f) of Article 1(2),manufacturers shall affix to each of those devices the restrictiveuse symbol as provided for in Article 18 and in point 3 ofAnnex III.

6. Manufacturers shall indicate on the instrument their name,registered trade name or registered trade mark and the postaladdress at which they can be contacted. The address shallindicate a single point at which the manufacturer can becontacted. The contact details shall be in a language easily

understood by end-users and market surveillance authorities.

7. Manufacturers shall ensure that the instrument intended tobe used for the applications listed in points (a) to (f) ofArticle 1(2) is accompanied by instructions and informationin a language which can be easily understood by end-users, asdetermined by the Member State concerned. Such instructionsand information, as well as any labelling, shall be clear, under-standable and intelligible.

8. Manufacturers who consider or have reason to believe thatan instrument which they have placed on the market is not in

conformity with this Directive shall immediately take thecorrective measures necessary to bring that instrument intoconformity, to withdraw it or recall it, if appropriate.Furthermore, where the instrument presents a risk, manufac-turers shall immediately inform the competent national

authorities of the Member States in which they made theinstrument available on the market to that effect, givingdetails, in particular, of the non-compliance and of anycorrective measures taken.

9. Manufacturers shall, further to a reasoned request from acompetent national authority, provide it with all theinformation and documentation in paper or electronic formnecessary to demonstrate the conformity of the instrumentwith this Directive, in a language which can be easilyunderstood by that authority. They shall cooperate with thatauthority, at its request, on any action taken to eliminate therisks posed by instruments which they have placed on themarket.

Article 7

Authorised representatives

1. A manufacturer may, by a written mandate, appoint anauthorised representative.

The obligations laid down in Article 6(1) and the obligation todraw up technical documentation referred to in Article 6(2)shall not form part of the authorised representatives mandate.

2. An authorised representative shall perform the tasksspecified in the mandate received from the manufacturer. Themandate shall allow the authorised representative to do at least

the following:

(a) keep the EU declaration of conformity and the technicaldocumentation at the disposal of national marketsurveillance authorities for 10 years after the instrumenthas been placed on the market;

(b) further to a reasoned request from a competent nationalauthority, provide that authority with all the informationand documentation necessary to demonstrate theconformity of an instrument;

(c) cooperate with the competent national authorities, at theirrequest, on any action taken to eliminate the risks posed byinstruments covered by the authorised representativesmandate.

Article 8

Obligations of importers

1. Importers shall place only compliant instruments on themarket.

2. Before placing on the market an instrument intended tobe used for the applications listed in points (a) to (f) ofArticle 1(2), importers shall ensure that the appropriate


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conformity assessment procedure referred to in Article 13 hasbeen carried out by the manufacturer. They shall ensure that themanufacturer has drawn up the technical documentation, thatthe instrument bears the CE marking and the supplementarymetrology marking and is accompanied by the required docu-ments, and that the manufacturer has complied with the

requirements set out in Article 6(5) and (6).

Where an importer considers or has reason to believe that aninstrument intended to be used for the applications listed inpoints (a) to (f) of Article 1(2) is not in conformity with theessential requirements set out in Annex I, he shall not place theinstrument on the market until it has been brought intoconformity. Furthermore, where the instrument presents arisk, the importer shall inform the manufacturer and themarket surveillance authorities to that effect.

Before placing on the market an instrument not intended to beused for the applications listed in points (a) to (f) of Article 1(2)importers shall ensure that the manufacturer has complied withthe requirements set out in Article 6(5) and (6).

3. Importers shall indicate on the instrument their name,registered trade name or registered trade mark and the postaladdress at which they can be contacted. Where this wouldrequire the packaging to be opened, those indications may begiven on the packaging and in a document accompanying theinstrument. The contact details shall be in a language easilyunderstood by end-users and market surveillance authorities.

4. Importers shall ensure that the instrument intended to beused for the applications listed in points (a) to (f) of Article 1(2)is accompanied by instructions and information in a languagewhich can be easily understood by end-users, as determined bythe Member State concerned.

5. Importers shall ensure that, while an instrument intendedto be used for the applications listed in points (a) to (f) ofArticle 1(2) is under their responsibility, its storage ortransport conditions do not jeopardise its compliance withthe essential requirements set out in Annex I.

6. When deemed appropriate with regard to the riskspresented by an instrument intended to be used for the appli-cations listed in points (a) to (f) of Article 1(2), importers shallcarry out sample testing of instruments made available on themarket, investigate, and, if necessary, keep a register ofcomplaints, of non-conforming instruments and instrumentrecalls, and shall keep distributors informed of any such moni-toring.

7. Importers who consider or have reason to believe that an

instrument which they have placed on the market is not inconformity with this Directive shall immediately take thecorrective measures necessary to bring that instrument intoconformity, to withdraw it or recall it, if appropriate.Furthermore, where the instrument presents a risk, importers

shall immediately inform the competent national authorities ofthe Member States in which they made the instrument availableon the market to that effect, giving details, in particular, of thenon-compliance and of any corrective measures taken.

8. For the instruments intended to be used for the appli-cations listed in points (a) to (f) of Article 1(2), importersshall, for 10 years after the instrument has been placed onthe market keep a copy of the EU declaration of conformityat the disposal of the market surveillance authorities and ensurethat the technical documentation can be made available to thoseauthorities, upon request.

9. Importers shall, further to a reasoned request from acompetent national authority, provide it with all theinformation and documentation in paper or electronic formnecessary to demonstrate the conformity of an instrument ina language which can be easily understood by that authority.They shall cooperate with that authority, at its request, on anyaction taken to eliminate the risks posed by instruments whichthey have placed on the market.

Article 9

Obligations of distributors

1. When making an instrument available on the marketdistributors shall act with due care in relation to therequirements of this Directive.

2. Before making an instrument intended to be used for theapplications listed in points (a) to (f) of Article 1(2) available onthe market, distributors shall verify that the instrument bearsthe CE marking, and the supplementary metrology marking,that it is accompanied by the required documents and byinstructions and information in a language which can beeasily understood by end-users in the Member State in whichthe instrument is to be made available on the market, and thatthe manufacturer and the importer have complied with therequirements set out in Article 6(5) and (6) and Article 8(3)respectively.

Where a distributor considers or has reason to believe that aninstrument intended to be used for the applications listed inpoints (a) to (f) of Article 1(2) is not in conformity with theessential requirements set out in Annex I, he shall not make theinstrument available on the market until it has been broughtinto conformity. Furthermore, where the instrument presents arisk, the distributor shall inform the manufacturer or theimporter to that effect as well as the market surveillance auth-orities.

Before making an instrument not intended to be used for theapplications listed in points (a) to (f) of Article 1(2) available onthe market, distributors shall verify that the manufacturer andthe importer have complied with the requirements set out inArticle 6(5) and (6) and Article 8(3) respectively.


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3. Distributors shall ensure that, while an instrumentintended to be used for the applications listed in points (a) to(f) of Article 1(2) is under their responsibility, its storage ortransport conditions do not jeopardise its compliance withthe essential requirements set out in Annex I.

4. Distributors who consider or have reason to believe thatan instrument which they have made available on the market isnot in conformity with this Directive shall make sure that thecorrective measures necessary to bring that instrument intoconformity, to withdraw it or recall it, if appropriate, aretaken. Furthermore, where the instrument presents a risk,distributors shall immediately inform the competent nationalauthorities of the Member States in which they made theinstrument available on the market to that effect, givingdetails, in particular, of the non-compliance and of anycorrective measures taken.

5. Distributors shall, further to a reasoned request from acompetent national authority, provide it with all theinformation and documentation in paper or electronic formnecessary to demonstrate the conformity of an instrument.They shall cooperate with that authority, at its request, onany action taken to eliminate the risks posed by instrumentswhich they have made available on the market.

Article 10

Cases in which obligations of manufacturers apply toimporters and distributors

An importer or distributor shall be considered a manufacturerfor the purposes of this Directive and he shall be subject to theobligations of the manufacturer under Article 6, where heplaces an instrument on the market under his name or trademark or modifies an instrument already placed on the market insuch a way that compliance with this Directive may be affected.

Article 11

Identification of economic operators

For instruments intended to be used for the applications listed

in points (a) to (f) of Article 1(2), economic operators shall, onrequest, identify the following to the market surveillance auth-orities:

(a) any economic operator who has supplied them with aninstrument;

(b) any economic operator to whom they have supplied aninstrument.

Economic operators shall be able to present the informationreferred to in the first paragraph for 10 years after they have

been supplied with the instrument and for 10 years after theyhave supplied the instrument.

CHAPTER 3

CONFORMITY OF INSTRUMENTS

Article 12

Presumption of conformity of instruments

Instruments which are in conformity with harmonised standardsor parts thereof the references of which have been published intheOfficial Journal of the European Union shall be presumed to bein conformity with the essential requirements set out in Annex Icovered by those standards or parts thereof.

Article 13

Conformity assessment procedures

1. The conformity of instruments to the essentialrequirements set out in Annex I may be established by either

of the following conformity assessment procedures as selectedby the manufacturer:

(a) Module B as set out in point 1 of Annex II, followed eitherby Module D as set out in point 2 of Annex II, or byModule F as set out in point 4 of Annex II.

However, Module B shall not be compulsory forinstruments which do not use electronic devices and theload-measuring device of which does not use a spring to

balance the load. For those instruments not submitted toModule B, Module D1 as set out in point 3 of Annex II orModule F1 as set out in point 5 of Annex II shall apply;

(b) Module G as set out in point 6 of Annex II.

2. The documents and correspondence relating to theconformity assessment procedures referred to in paragraph 1shall be drawn up in one of the official languages of theMember State where those procedures are carried out, or in alanguage accepted by the body notified in accordance with

Article 19.

Article 14

EU declaration of conformity

1. The EU declaration of conformity shall state that thefulfilment of the essential requirements set out in Annex I has

been demonstrated.

2. The EU declaration of conformity shall have the model

structure set out in Annex IV, shall contain the elementsspecified in the relevant modules set out in Annex II andshall be continuously updated. It shall be translated into thelanguage or languages required by the Member State in whichthe instrument is placed or made available on the market.


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3. Where an instrument is subject to more than one Unionact requiring an EU declaration of conformity, a single EUdeclaration of conformity shall be drawn up in respect of allsuch Union acts. That declaration shall contain the identificationof the Union acts concerned including their publication refer-ences.

4. By drawing up the EU declaration of conformity, themanufacturer shall assume responsibility for the complianceof the instrument with the requirements laid down in thisDirective.

Article 15

Conformity marking

The conformity of an instrument intended to be used for theapplications listed in points (a) to (f) of Article 1(2) with thisDirective shall be indicated by the presence, on the instrument,of the CE marking and the supplementary metrology markingas specified in Article 16.

Article 16

General principles of the CE marking and of thesupplementary metrology marking

1. The CE marking shall be subject to the general principlesset out in Article 30 of Regulation (EC) No 765/2008.

2. The supplementary metrology marking shall consist of the

capital letter M and the last two digits of the year of itsaffixing, surrounded by a rectangle. The height of therectangle shall be equal to the height of the CE marking.

3. The general principles set out in Article 30 of Regulation(EC) No 765/2008 shall apply, mutatis mutandis, to the supple-mentary metrology marking.

Article 17

Rules and conditions for affixing the CE marking, thesupplementary metrology marking and other markings

1. The CE marking and the supplementary metrologymarking shall be affixed visibly, legibly and indelibly to theinstrument or to its data plate.

2. The CE marking and the supplementary metrologymarking shall be affixed before the instrument is placed onthe market.

3. The supplementary metrology marking shall immediatelyfollow the CE marking.

4. The CE marking and the supplementary metrologymarking shall be followed by the identification number(s) ofthe notified body or bodies involved in the productioncontrol phase as set out in Annex II.

The identification number of the notified body shall be affixedby the body itself or, under its instructions, by the manufactureror his authorised representative.

5. The CE marking, the supplementary metrology marking

and the identification number(s) of the notified body or bodiesmay be followed by any other mark indicating a special risk oruse.

6. Member States shall build upon existing mechanisms toensure correct application of the regime governing the CEmarking and shall take appropriate action in the event ofimproper use of that marking.

Article 18

Restrictive use symbol

The symbol referred to in the fourth subparagraph ofArticle 6(5) and specified in point 3 of Annex III shall beaffixed to the devices in a clearly visible and indelible form.

CHAPTER 4

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Article 19

Notification

Member States shall notify the Commission and the otherMember States of bodies authorised to carry out third-partyconformity assessment tasks under this Directive.

Article 20

Notifying authorities

1. Member States shall designate a notifying authority thatshall be responsible for setting up and carrying out thenecessary procedures for the assessment and notification ofconformity assessment bodies and the monitoring of notified

bodies, including compliance with Article 25.

2. Member States may decide that the assessment and moni-toring referred to in paragraph 1 shall be carried out by anational accreditation body within the meaning of and inaccordance with Regulation (EC) No 765/2008.

3. Where the notifying authority delegates or otherwiseentrusts the assessment, notification or monitoring referred toin paragraph 1 to a body which is not a governmental entity,that body shall be a legal entity and shall comply mutatismutandis with the requirements laid down in Article 21. Inaddition it shall have arrangements to cover liabilities arisingout of its activities.

4. The notifying authority shall take full responsibility for thetasks performed by the body referred to in paragraph 3.


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Article 21

Requirements relating to notifying authorities

1. A notifying authority shall be established in such a waythat no conflict of interest with conformity assessment bodiesoccurs.

2. A notifying authority shall be organised and operated soas to safeguard the objectivity and impartiality of its activities.

3. A notifying authority shall be organised in such a waythat each decision relating to notification of a conformityassessment body is taken by competent persons differentfrom those who carried out the assessment.

4. A notifying authority shall not offer or provide anyactivities that conformity assessment bodies perform orconsultancy services on a commercial or competitive basis.

5. A notifying authority shall safeguard the confidentiality ofthe information it obtains.

6. A notifying authority shall have a sufficient number ofcompetent personnel at its disposal for the proper performanceof its tasks.

Article 22

Information obligation on notifying authorities

Member States shall inform the Commission of their proceduresfor the assessment and notification of conformity assessment

bodies and the monitoring of notified bodies, and of anychanges thereto.

The Commission shall make that information publicly available.

Article 23

Requirements relating to notified bodies

1. For the purposes of notification, a conformity assessmentbody shall meet the requirements laid down in paragraphs 2to 11.

2. A conformity assessment body shall be established underthe national law of a Member State and have legal personality.

3. A conformity assessment body shall be a third-party bodyindependent of the organisation or the instrument it assesses.

A body belonging to a business association or professionalfederation representing undertakings involved in the design,

manufacturing, provision, assembly, use or maintenance ofinstruments which it assesses, may, on condition that its inde-pendence and the absence of any conflict of interest are demon -strated, be considered such a body.

4. A conformity assessment body, its top level managementand the personnel responsible for carrying out the conformityassessment tasks shall not be the designer, manufacturer,supplier, installer, purchaser, owner, user or maintainer of theinstruments which they assess, nor the representative of any ofthose parties. This shall not preclude the use of assessedinstruments that are necessary for the operations of theconformity assessment body or the use of such instrumentsfor personal purposes.

A conformity assessment body, its top level management andthe personnel responsible for carrying out the conformityassessment tasks shall not be directly involved in the design,manufacture or construction, the marketing, installation, use ormaintenance of those instruments, or represent the partiesengaged in those activities. They shall not engage in anyactivity that may conflict with their independence of

judgement or integrity in relation to conformity assessmentactivities for which they are notified. This shall in particularapply to consultancy services.

Conformity assessment bodies shall ensure that the activities oftheir subsidiaries or subcontractors do not affect the confiden-tiality, objectivity or impartiality of their conformity assessment

activities.

5. Conformity assessment bodies and their personnel shallcarry out the conformity assessment activities with the highestdegree of professional integrity and the requisite technicalcompetence in the specific field and shall be free from allpressures and inducements, particularly financial, which mightinfluence their judgement or the results of their conformityassessment activities, especially as regards persons or groupsof persons with an interest in the results of those activities.

6. A conformity assessment body shall be capable ofcarrying out all the conformity assessment tasks assigned to it

by Annex II and in relation to which it has been notified,whether those tasks are carried out by the conformityassessment body itself or on its behalf and under its responsi-

bility.

At all times and for each conformity assessment procedure andeach kind or category of instruments in relation to which it has

been notified, a conformity assessment body shall have at itsdisposal the necessary:

(a) personnel with technical knowledge and sufficient andappropriate experience to perform the conformityassessment tasks;


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(b) descriptions of procedures in accordance with whichconformity assessment is carried out, ensuring the trans-parency and the ability of reproduction of those procedures.It shall have appropriate policies and procedures in placethat distinguish between tasks it carries out as a notified

body and other activities;

(c) procedures for the performance of activities which take dueaccount of the size of an undertaking, the sector in which itoperates, its structure, the degree of complexity of theinstrument technology in question and the mass or serialnature of the production process.

A conformity assessment body shall have the means necessaryto perform the technical and administrative tasks connectedwith the conformity assessment activities in an appropriatemanner and shall have access to all necessary equipment or

facilities.

7. The personnel responsible for carrying out conformityassessment tasks shall have the following:

(a) sound technical and vocational training covering all theconformity assessment activities in relation to which theconformity assessment body has been notified;

(b) satisfactory knowledge of the requirements of the

assessments they carry out and adequate authority tocarry out those assessments;

(c) appropriate knowledge and understanding of the essentialrequirements set out in Annex I, of the applicableharmonised standards and of the relevant provisions ofUnion harmonisation legislation and of national legislation;

(d) the ability to draw up certificates, records and reportsdemonstrating that assessments have been carried out.

8. The impartiality of the conformity assessment bodies, theirtop level management and of the personnel responsible forcarrying out the conformity assessment tasks shall be guar-anteed.

The remuneration of the top level management and personnelresponsible for carrying out the conformity assessment tasks ofa conformity assessment body shall not depend on the numberof assessments carried out or on the results of those assess-ments.

9. Conformity assessment bodies shall take out liabilityinsurance unless liability is assumed by the State in accordancewith national law, or the Member State itself is directlyresponsible for the conformity assessment.

10. The personnel of a conformity assessment body shallobserve professional secrecy with regard to all informationobtained in carrying out their tasks under Annex II or anyprovision of national law giving effect to it, except in relationto the competent authorities of the Member State in which itsactivities are carried out. Proprietary rights shall be protected.

11. Conformity assessment bodies shall participate in, orensure that their personnel responsible for carrying theconformity assessment tasks are informed of, the relevant stan-dardisation activities and the activities of the notified body coor-dination group established under the relevant Union harmon-isation legislation and shall apply as general guidance theadministrative decisions and documents produced as a resultof the work of that group.

Article 24

Presumption of conformity of notified bodies

Where a conformity assessment body demonstrates itsconformity with the criteria laid down in the relevantharmonised standards or parts thereof the references of whichhave been published in the Official Journal of the European Unionit shall be presumed to comply with the requirements set out inArticle 23 in so far as the applicable harmonised standardscover those requirements.

Article 25

Subsidiaries of and subcontracting by notified bodies

1. Where a notified body subcontracts specific tasksconnected with conformity assessment or has recourse to asubsidiary, it shall ensure that the subcontractor or thesubsidiary meets the requirements set out in Article 23 andshall inform the notifying authority accordingly.

2. Notified bodies shall take full responsibility for the tasksperformed by subcontractors or subsidiaries wherever these areestablished.

3. Activities may be subcontracted or carried out by asubsidiary only with the agreement of the client.

4. Notified bodies shall keep at the disposal of the notifyingauthority the relevant documents concerning the assessment ofthe qualifications of the subcontractor or the subsidiary and thework carried out by them under Annex II.

Article 26

Application for notification

1. A conformity assessment body shall submit an applicationfor notification to the notifying authority of the Member Statein which it is established.


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2. The application for notification shall be accompanied by adescription of the conformity assessment activities, theconformity assessment module or modules and the instrumentor instruments for which that body claims to be competent, aswell as by an accreditation certificate, where one exists, issued

by a national accreditation body attesting that the conformity

assessment body fulfils the requirements laid down inArticle 23.

3. Where the conformity assessment body concerned cannotprovide an accreditation certificate, it shall provide the notifyingauthority with all the documentary evidence necessary for theverification, recognition and regular monitoring of itscompliance with the requirements laid down in Article 23.

Article 27

Notification procedure

1. Notifying authorities may notify only conformityassessment bodies which have satisfied the requirements laiddown in Article 23.

2. They shall notify the Commission and the other MemberStates using the electronic notification tool developed andmanaged by the Commission.

3. The notification shall include full details of the conformityassessment activities, the conformity assessment module ormodules and instrument or instruments concerned and therelevant attestation of competence.

4. Where a notification is not based on an accreditationcertificate as referred to in Article 26(2), the notifyingauthority shall provide the Commission and the otherMember States with documentary evidence which attests tothe conformity assessment bodys competence and thearrangements in place to ensure that that body will bemonitored regularly and will continue to satisfy therequirements laid down in Article 23.

5. The body concerned may perform the activities of anotified body only where no objections are raised by theCommission or the other Member States within two weeks ofa notification where an accreditation certificate is used or withintwo months of a notification where accreditation is not used.

Only such a body shall be considered a notified body for thepurposes of this Directive.

6. The notifying authority shall notify the Commission andthe other Member States of any subsequent relevant changes tothe notification.

Article 28

Identification numbers and lists of notified bodies

1. The Commission shall assign an identification number toa notified body.

It shall assign a single such number even where the body isnotified under several Union acts.

2. The Commission shall make publicly available the list ofthe bodies notified under this Directive, including the identifi-cation numbers that have been assigned to them and theactivities for which they have been notified.

The Commission shall ensure that the list is kept up to date.

Article 29

Changes to notifications

1. Where a notifying authority has ascertained or has beeninformed that a notified body no longer meets the requirementslaid down in Article 23, or that it is failing to fulfil itsobligations, the notifying authority shall restrict, suspend orwithdraw notification as appropriate, depending on the seri-ousness of the failure to meet those requirements or fulfilthose obligations. It shall immediately inform the Commission

and the other Member States accordingly.

2. In the event of restriction, suspension or withdrawal ofnotification, or where the notified body has ceased its activity,the notifying Member State shall take appropriate steps toensure that the files of that body are either processed byanother notified body or kept available for the responsiblenotifying and market surveillance authorities at their request.

Article 30

Challenge of the competence of notified bodies1. The Commission shall investigate all cases where itdoubts, or doubt is brought to its attention regarding, thecompetence of a notified body or the continued fulfilment bya notified body of the requirements and responsibilities towhich it is subject.

2. The notifying Member State shall provide theCommission, on request, with all information relating to the

basis for the notification or the maintenance of the competenceof the notified body concerned.

3. The Commission shall ensure that all sensitive informationobtained in the course of its investigations is treated confiden-tially.


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4. Where the Commission ascertains that a notified bodydoes not meet or no longer meets the requirements for itsnotification, it shall adopt an implementing act requesting thenotifying Member State to take the necessary correctivemeasures, including withdrawal of notification if necessary.

That implementing act shall be adopted in accordance with theadvisory procedure referred to in Article 41(2).

Article 31

Operational obligations of notified bodies

1. Notified bodies shall carry out conformity assessments inaccordance with the conformity assessment procedures providedfor in Annex II.

2. Conformity assessments shall be carried out in a propor-tionate manner, avoiding unnecessary burdens for economicoperators. Conformity assessment bodies shall perform theiractivities taking due account of the size of an undertaking,the sector in which it operates, its structure, the degree ofcomplexity of the instrument technology in question and themass or serial nature of the production process.

In so doing they shall nevertheless respect the degree of rigourand the level of protection required for the compliance of theinstrument with this Directive.

3. Where a notified body finds that the essentialrequirements set out in Annex I or corresponding harmonisedstandards or other technical specifications have not been met bya manufacturer, it shall require that manufacturer to take appro-priate corrective measures and shall not issue a certificate ofconformity.

4. Where, in the course of the monitoring of conformityfollowing the issue of a certificate, a notified body finds thatan instrument no longer complies, it shall require the manu -facturer to take appropriate corrective measures and shallsuspend or withdraw the certificate if necessary.

5. Where corrective measures are not taken or do not havethe required effect, the notified body shall restrict, suspend orwithdraw any certificates, as appropriate.

Article 32

Appeal against decisions of notified bodies

Member States shall ensure that an appeal procedure againstdecisions of the notified bodies is available.

Article 33

Information obligation on notified bodies

1. Notified bodies shall inform the notifying authority of thefollowing:

(a) any refusal, restriction, suspension or withdrawal of acertificate;

(b) any circumstances affecting the scope of or conditions fornotification;

(c) any request for information which they have received frommarket surveillance authorities regarding conformityassessment activities;

(d) on request, conformity assessment activities performedwithin the scope of their notification and any otheractivity performed, including cross-border activities andsubcontracting.

2. Notified bodies shall provide the other bodies notifiedunder this Directive carrying out similar conformity assessmentactivities covering the same instruments with relevantinformation on issues relating to negative and, on request,positive conformity assessment results.

Article 34

Exchange of experience

The Commission shall provide for the organisation of exchangeof experience between the Member States national authorities

responsible for notification policy.

Article 35

Coordination of notified bodies

The Commission shall ensure that appropriate coordination andcooperation between bodies notified under this Directive are putin place and properly operated in the form of a sectoral or crosssectoral group or groups of notified bodies.

Member States shall ensure that the bodies notified by themparticipate in the work of that group or those groups, directlyor by means of designated representatives.


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CHAPTER 5

UNION MARKET SURVEILLANCE, CONTROL OFINSTRUMENTS ENTERING THE UNION MARKET AND UNION

SAFEGUARD PROCEDURE

Article 36Union market surveillance and control of instruments

entering the Union market

Article 15(3) and Articles 16 to 29 of Regulation (EC)No 765/2008 shall apply to instruments covered by Article 1of this Directive.

Article 37

Procedure for dealing with instruments presenting a risk atnational level

1. Where the market surveillance authorities of one MemberState have sufficient reason to believe that an instrumentcovered by this Directive presents a risk to aspects of publicinterest protection covered by this Directive, they shall carry outan evaluation in relation to the instrument concerned coveringall relevant requirements laid down in this Directive. Therelevant economic operators shall cooperate as necessary withthe market surveillance authorities for that purpose.

Where, in the course of the evaluation referred to in the firstsubparagraph, the market surveillance authorities find that theinstrument does not comply with the requirements laid down inthis Directive, they shall without delay require the relevant

economic operator to take all appropriate corrective actionsto bring the instrument into compliance with those require-ments, to withdraw the instrument from the market, or torecall it within a reasonable period, commensurate with thenature of the risk, as they may prescribe.

The market surveillance authorities shall inform the relevantnotified body accordingly.

Article 21 of Regulation (EC) No 765/2008 shall apply to themeasures referred to in the second subparagraph of this para -

graph.

2. Where the market surveillance authorities consider thatnon-compliance is not restricted to their national territory,they shall inform the Commission and the other MemberStates of the results of the evaluation and of the actionswhich they have required the economic operator to take.

3. The economic operator shall ensure that all appropriatecorrective action is taken in respect of all the instrumentsconcerned that it has made available on the market throughoutthe Union.

4. Where the relevant economic operator does not takeadequate corrective action within the period referred to in the

second subparagraph of paragraph 1, the market surveillanceauthorities shall take all appropriate provisional measures toprohibit or restrict the instruments being made available ontheir national market, to withdraw the instrument from thatmarket or to recall it.

The market surveillance authorities shall inform theCommission and the other Member States, without delay, ofthose measures.

5. The information referred to in the second subparagraph ofparagraph 4 shall include all available details, in particular thedata necessary for the identification of the non-compliantinstrument, the origin of the instrument, the nature of thenon-compliance alleged and the risk involved, the nature andduration of the national measures taken and the arguments putforward by the relevant economic operator. In particular, themarket surveillance authorities shall indicate whether the non-compliance is due to either of the following:

(a) failure of the instrument to meet requirements relating tothe aspects of public interest protection laid down in thisDirective; or

(b) shortcomings in the harmonised standards referred to inArticle 12 conferring a presumption of conformity.

6. Member States other than the Member State initiating theprocedure under this Article shall without delay inform theCommission and the other Member States of any measuresadopted and of any additional information at their disposalrelating to the non-compliance of the instrument concerned,and, in the event of disagreement with the adopted nationalmeasure, of their objections.

7. Where, within three months of receipt of the informationreferred to in the second subparagraph of paragraph 4, noobjection has been raised by either a Member State or the

Commission in respect of a provisional measure taken by aMember State, that measure shall be deemed justified.

8. Member States shall ensure that appropriate restrictivemeasures, such as withdrawal of the instrument from themarket, are taken in respect of the instrument concernedwithout delay.

Article 38

Union safeguard procedure

1. Where, on completion of the procedure set out inArticle 37(3) and (4), objections are raised against a measuretaken by a Member State, or where the Commission considers anational measure to be contrary to Union legislation, the


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Commission shall without delay enter into consultation withthe Member States and the relevant economic operator oroperators and shall evaluate the national measure. On the

basis of the results of that evaluation, the Commission shalladopt an implementing act determining whether the nationalmeasure is justified or not.

The Commission shall address its decision to all Member Statesand shall immediately communicate it to them and the relevanteconomic operator or operators.

2. If the national measure is considered justified, all MemberStates shall take the necessary measures to ensure that the non-compliant instrument is withdrawn from their market, and shallinform the Commission accordingly. If the national measure isconsidered unjustified, the Member State concerned shall

withdraw that measure.

3. Where the national measure is considered justified and thenon-compliance of the instrument is attributed to shortcomingsin the harmonised standards referred to in point (b) ofArticle 37(5) of this Directive, the Commission shall applythe procedure provided for in Article 11 of Regulation (EU)No 1025/2012.

Article 39

Compliant instruments which present a risk

1. Where, having carried out an evaluation underArticle 37(1), a Member State finds that although an instrumentis in compliance with this Directive, it presents a risk to aspectsof public interest protection, it shall require the relevanteconomic operator to take all appropriate measures to ensurethat the instrument concerned, when placed on the market, nolonger presents that risk, to withdraw the instrument from themarket or to recall it within a reasonable period, commensuratewith the nature of the risk, as it may prescribe.

2. The economic operator shall ensure that corrective actionis taken in respect of all the instruments concerned that he hasmade available on the market throughout the Union.

3. The Member State shall immediately inform theCommission and the other Member States. That informationshall include all available details, in particular the datanecessary for the identification of the instrument concerned,the origin and the supply chain of the instrument, the natureof the risk involved and the nature and duration of the nationalmeasures taken.

4. The Commission shall without delay enter into consul-tation with the Member States and the relevant economic

operator or operators and shall evaluate the national measurestaken. On the basis of the results of that evaluation, theCommission shall decide by means of implementing actswhether the national measure is justified or not, and wherenecessary, propose appropriate measures.

The implementing acts referred to in the first subparagraph ofthis paragraph shall be adopted in accordance with the exam-ination procedure referred to in Article 41(3).

5. The Commission shall address its decision to all MemberStates and shall immediately communicate it to them and therelevant economic operator or operators.

Article 40

Formal non-compliance

1. Without prejudice to Article 37, where a Member Statemakes one of the following findings, it shall require the relevanteconomic operator to put an end to the non-complianceconcerned:

(a) the CE marking or the supplementary metrology markinghas been affixed in violation of Article 30 of Regulation(EC) No 765/2008 or of Article 17 of this Directive;

(b) the CE marking or the supplementary metrology markinghas not been affixed;

(c) the inscriptions provided for in Article 6(5) have not beenaffixed or have been affixed in violation of Article 6(5);

(d) the identification number of the notified body, where thatbody is involved in the production control phase, has beenaffixed in violation of Article 17 or has not been affixed;

(e) the EU declaration of conformity has not been drawn up;

(f) the EU declaration of conformity has not been drawn upcorrectly;

(g) technical documentation is either not available or notcomplete;

(h) the information referred to in Article 6(6) or 8(3) is absent,false or incomplete;

(i) any other administrative requirement provided for inArticle 6 or 8 is not fulfilled.


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2. Where the non-compliance referred to in paragraph 1persists, the Member State concerned shall take all appropriatemeasures to restrict or prohibit the instrument being madeavailable on the market or ensure that it is recalled orwithdrawn from the market.

CHAPTER 6

COMMITTEE, TRANSITIONAL AND FINAL PROVISIONS

Article 41

Committee procedure

1. The Commission shall be assisted by the Committee onnon-automatic weighing instruments. That committee shall

be a committee within the meaning of Regulation (EU)No 182/2011.

2. Where reference is made to this paragraph, Article 4 ofRegulation (EU) No 182/2011 shall apply.

3. Where reference is made to this paragraph, Article 5 ofRegulation (EU) No 182/2011 shall apply.

4. The committee shall be consulted by the Commission onany matter for which consultation of sectoral experts is required

by Regulation (EU) No 1025/2012 or by any other Union legis-lation.

The committee may furthermore examine any other matterconcerning the application of this Directive raised either by itschair or by a representative of a Member State in accordancewith its rules of procedure.

Article 42

Penalties

Member States shall lay down rules on penalties applicable toinfringements by economic operators of the provisions ofnational law adopted pursuant to this Directive and shall takeall measures necessary to ensure that they are enforced. Suchrules may include criminal penalties for serious infringements

The penalties provided for shall be effective, proportionate anddissuasive.

Article 43

Transitional provisions

Member States shall not impede the making available on themarket and/or the putting into service of instruments covered

by Directive 2009/23/EC which are in conformity with thatDirective and which were placed on the market before20 April 2016.

Certificates issued under Directive 2009/23/EC shall be validunder this Directive.

Article 44

Transposition

1. Member States shall adopt and publish, by 19 April 2016the laws, regulations and administrative provisions necessary tocomply with points (3) to (19) of Article 2, Articles 6 to 17,Articles 19 to 43 and Annex II, III and IV. They shall forthwithcommunicate the text of those measures to the Commission.

They shall apply those measures from 20 April 2016.

When Member States adopt those measures, they shall contain areference to this Directive or be accompanied by such areference on the occasion of their official publication. Theyshall also include a statement that references in existing laws,regulations and administrative provisions to the Directiverepealed by this Directive shall be construed as references tothis Directive. Member States shall determine how suchreference is to be made and how that statement is to be formu -lated.

2. Member States shall communicate to the Commission thetext of the main provisions of national law which they adopt inthe field covered by this Directive.

Article 45

Repeal

Directive 2009/23/EC, as amended by the Regulation listed inAnnex V, Part A, is repealed with effect from 20 April 2016,

without prejudice to the obligations of the Member Statesrelating to the time limits for transposition into national lawand the dates of application of the Directives set out in AnnexV, Part B.

References to the repealed Directive shall be construed asreferences to this Directive and shall be read in accordancewith the correlation table in Annex VI.

Article 46

Entry into force and application

This Directive shall enter into force on the twentieth dayfollowing that of its publication in the Official Journal of theEuropean Union.


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Article 1, points (1) and (2) of Article 2, Articles 3, 4, 5 and 18 and Annexes I, V and VI shall apply from20 April 2016.

Article 47

Addressees

This Directive is addressed to the Member States.

Done at Strasbourg, 26 February 2014.

For the European Parliament

The President

M. SCHULZ

For the Council

The President

D. KOURKOULAS


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ANNEX I

ESSENTIAL REQUIREMENTS

The terminology used is that of the International Organisation of Legal Metrology.

Preliminary observation

Where an instrument includes, or is connected to, more than one indicating or printing device used for the applicationslisted in points (a) to (f) of Article 1(2), those devices which repeat the results of the weighing operation and whichcannot influence the correct functioning of the instrument shall not be subject to the essential requirements if theweighing results are printed or recorded correctly and indelibly by a part of the instrument which meets the essentialrequirements and the results are accessible to both parties concerned by the measurement. However, in the case ofinstruments used for direct sales to the public, display and printing devices for the vendor and the customer must fulfilthe essential requirements.

Metrological requirements

1. Units of mass

The units of mass used shall be the legal units within the meaning of Council Directive 80/181/EEC of

20 December 1979 on the approximation of the laws of the Member States relating to units of measurement ( 1).

Subject to compliance with this condition, the following units are permitted:

(a) SI units: kilogram, microgram, milligram, gram, tonne;

(b) imperial unit: troy ounce, if weighing precious metals;

(c) other non-SI unit: metric carat, if weighing precious stones.

For instruments that make use of the imperial unit of mass referred to above, the relevant essential requirementsspecified below shall be converted to that unit, using simple interpolation.

2. Accuracy classes

2.1. The following accuracy classes have been defined:

(a) I special

(b) II high

(c) III medium

(d) 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)/(e))

minimum value minimum value maximum value

I 0,001 g e 100 e 50 000

II 0,001 g e 0,05 g 20 e 100 100 000

0,1 g e 50 e 5 000 100 000

III 0,1 g e 2 g 20 e 100 10 000

5 g e 20 e 500 10 000

IIII 5 g e 10 e 100 1 000


(1) OJ L 39, 15.2.1980, p. 40.

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The minimum capacity is reduced to 5 e for instruments in classes II and III for determining a conveying tariff.

2.2. S c a l e i n t e r v a l s

2.2.1. The actual scale interval (d) and the verification scale interval (e) shall be in the form:

1 10k, 2 10

k, or 5 10

kmass 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 10 d.

Those conditions do not apply for instruments of class I with d < 104 g, for which e = 103 g.

3. Classification

3.1. I n s t r u m e n t s w i t h o n e w e i g h i n g r a n g e

Instruments equipped with an auxiliary indicating device shall belong to class I or class II. For these instrumentsthe minimum capacity lower limits for these two classes are obtained from Table 1 by replacement in column 3 ofthe verification scale interval (e) by the actual scale interval (d).

If d < 104 g, the maximum capacity of class I may be less than 50 000 e.

3.2. I n s t r u m e n t s w i t h m u l t i p l e w e i g h i n g r a n g e s

Multiple weighing ranges are permitted, provided they are clearly indicated on the instrument. Each individualweighing range is classified according to point 3.1. If the weighing ranges fall into different accuracy classes theinstrument shall comply with the severest of the requirements that apply for the accuracy classes in which theweighing ranges fall.

3.3. M u l t i - i n t e r v a l i n s t r u m e n t s

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 i of multi-interval instruments is defined by:

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 sameaccuracy class, that class being the instruments accuracy class.


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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 valueMinimum value (1)

n Maxi=ei1

Maximum value

n Maxi=ei

I 0,001 g ei 100 e1 50 000

II 0,001 g ei 0,05 g 20 e1 5 000 100 000

0,1 g ei 50 e1 5 000 100 000

III 0,1 g ei 20 e1 500 10 000

IIII 5g

ei 10 e

1 50 1 000

(1) For i = r, the corresponding column of Table 1 applies, with e replaced by e r.

4. Accuracy

4.1. On implementation of the procedures laid down in Article 13, the error of indication shall not exceed themaximum permissible error of indication as shown in Table 3. In the case of digital indication the error ofindication shall be corrected for the rounding error.

The maximum permissible errors apply to the net value and tare value for all possible loads, excluding preset tarevalues.

Table 3

Maximum permissible errors

LoadMaximum permissible

errorClass I Class II Class III Class IIII

0 m 50 000 e 0 m 5 000 e 0 m 500 e 0 m 50 e 0,5 e

50 000 e < m 200 000 e

5 000 e < m 20 000 e

500 e < m 2 000 e 50 e < m 200 e 1,0 e

200 000 e < m 20 000 e < m 100 000 e

2 000 e < m 10 000 e

200 e < m 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 devicesused and in accordance 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 thedegree of tilting that can occur in normal use.

7.2. The instruments shall meet the metrological requirements within the temperature range specified by the manu-facturer. The value of this range shall be at least equal to:

(a) 5 C for an instrument in class I;


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(b) 15 C for an instrument in class II;

(c) 30 C for an instrument in class III or IIII.

In the absence of a manufacturers 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 ofpower supply within the limits of normal fluctuation.

Instruments operated from battery power shall indicate whenever the voltage drops below the minimum requiredvalue and shall under those circumstances either continue to function correctly or be automatically put out ofservice.

7.4. Electronic instruments, except those in class I and in class II if e is less than 1 g, shall meet the metrologicalrequirements 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 theindication 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 ofservice.

Design and construction

8. General requirements

8.1. Design and construction of the instruments shall be such that the instruments will preserve their metrologicalqualities when properly used and installed and when used in an environment for which they are intended. Thevalue 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 thatshall continue until the user takes corrective action or the fault disappears.

8.3. The requirements of points 8.1 and 8.2 shall be m

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