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Decision of measuring instruments and market participants

Original Language Title: Besluit meetinstrumenten en marktdeelnemers

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Decision of 14 April 2016 laying down rules on the requirements to be met by measuring instruments before they are placed on the market, put into service or used, as well as on conformity assessments of measuring instruments and Obligations of economic operators and amending the Measure 2006 Decision (Decision measuring instruments and economic operators)

We Willem-Alexander, at the grace of God, King of the Netherlands, Prince of Orange-Nassau, etc. etc. etc.

On the nomination of Our Minister for Economic Affairs of 29 January 2016, no. WJZ/16006109;

Having regard to 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 the market of non-automatic weighing instruments (PbEU L 96), Directive 2014/32 /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 the market of measuring instruments (PbEU L 96), Directive 2009 /34/EC of the European Parliament and of the European Union of 23 April 2009 on general provisions applicable to measuring instruments and methods of metrological control, Directive 75 /107/EEC -of the Council of the European Communities of 19 December 1974 on the approximation of the laws of the Member States relating to bottles used as tape sizes (PbEG L 96) and on the approximation of the laws of the Member States relating to the making Articles 5 , 9 , 26 and 36 of the Metrology Act , Article 3, 1st paragraph, of the Law on Medical Devices , and Article 66, first paragraph, of the Pharmaceutical Act ;

The Department for the Advisory Board of the State Hearing (Opinion of 9 March 2016, No W15.16.0021/IV);

Having regard to the further report of Our Minister of Economic Affairs of 11 April 2016, No WJZ/16042206;

Have found good and understand:

Chapter 1. Conceptual provisions

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Article 1

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For the purposes of this Decision and the provisions based thereon, the following definitions shall apply:

  • conformity assessment procedure: Module A, A2, B, C, C2, D, D1, E, E1, F, F1, G, H or H1 of Annex II to the Directive, either measuring instruments or module B, D, D1, F, F1 or G of the Directive, non-automatic weighing instruments;

  • CE marking: Marking, in accordance with the model set out in Annex II to Regulation (EC) No 248 The European Parliament and the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 765/2008 339/93 (PbEU L 218);

  • instrument-specific Annex: Annex III, IV, V, VI, VII, VIII, IX, X, XI or XII to the Directive measuring instruments;

  • Non-automatic weighing instrument: Instrument for determining the mass of a body using the action of gravity on that body, which requires the weighing of an operator to be used as well as instruments which are used in addition to the weight of the body for the determination of mass-related quantities, quantities, parameters or characteristics;

  • Directive on tap-measuring bottles: Directive 75 /107/EEC of the Council of the European Communities of 19 December 1974 on the approximation of the laws of the Member States relating to bottles used as tapmates (PbEG L 42),

  • Directive measuring instruments: Directive 2014/32 /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 the market of measuring instruments (PbEU L 96);

  • Directive measuring instruments and metrological control methods: Directive 2009 /34/EC of the European Parliament and of the Council of 23 April 2009 on general provisions applicable to measuring instruments and metrological control methods (PbEU L 106);

  • Non-automatic weighing instruments: 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 the market of non-automatic weighing instruments (PbEU L 96);

  • Tape size bottle: 'tape bottle' means a tape size bottle as referred to in Article 1 of the Directive on tap-measuring bottles;

  • Law: Metrology Act .

Chapter 2. Measuring tasks for a specific application

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Article 2

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A measurement task for a specific application as referred to in Article 5, first paragraph, of the Act the trade, the supply under occupation or the holding and the fixing of taxes or other charges shall be the following:

  • a. Measuring a flow of gaseous fuel, whether or not under redirection of the amount measured under measurement conditions to a quantity under basic conditions, for domestic use, commercial use or light industrial Use;

  • b. Measuring an active electrical energy consumed within a circuit for domestic use, commercial use, or light industrial use;

  • c. Measuring thermal energy emitted by a liquid in a thermal energy meter, for domestic use, commercial use, or light industrial use;

  • d. Measure continuously and dynamically in volume or mass of flowing liquids other than water, whether or not under redirection of the amount measured under measurement conditions to a quantity under basic conditions, within a closed lead, for the benefit of

    • 1 °. the fixing of a quantity of fuel, whether or not in the form of a liquid gas, when refuting motor vehicles, small vessels and small aeroplanes;

    • 2 °. the determination of a quantity of cryogenic fluids;

    • 3 °. the determination of a quantity of liquids when loading ships; or

    • 4 °. In other cases, the determination of a quantity of liquids;

  • e. To determine the mass of a body on the basis of the action of gravity on that body, without the intervention of an operator and according to a pre-determined program of automatic processes, and in particular

    • 1 °. the determination of the mass of separate separate loads or separate loads in advance, with or without the subdivision of articles of different mass or for the control of prepackages;

    • 2 °. To determine the mass in filling containers with a pre-determined and virtually constant quantity of bulk goods;

    • 3 °. determining the mass of bulk goods by dividing it into separate loads, then determining the mass of the individual load and finally adding together the mass of the individual loads;

    • 4 °. the uninterrupted determination of the mass of bulk goods on a continuous moving conveyor belt;

    • 5 °. the determination of the mass of trains and railway wagons;

  • f. Calculate on the basis of a signal issued by a remote signal generator to measure distance and the measurement of time in relation to the determination of taxi charges;

  • g. Determine the length of the edges of the smallest casing-parallel rectangular parallel-pipedum of a product.


Article 3

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A measurement task for a specific application as referred to in Article 5, first paragraph, of the Act it is:

  • a. in the conduct of trade;

  • b. in calculating a duty, levy, tax, premium, fine, fee or similar amounts due,

  • c. in the application of statutory regulations or other decisions of administrative organs or for judicial expertise,

  • d. in determining the price on the basis of the mass for direct sales to the public and for pre-packaged articles,

  • e. in determining the mass in medical practice for the weighing of patients for observation, diagnosis and medical treatments,

  • f. in determining the mass for the manufacture of prescription drugs in pharmacy and determining the mass during analyses carried out in medical and pharmaceutical laboratories;

Determination of the mass of a body using the action of gravity on that body, requiring the weighing of an operator, whether or not accompanied by the determination of mass-related material quantities, parameters, or characteristics.


Article 4 [ Enter into force at a time to be determined]

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Chapter 3. Measuring instruments

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§ 3.1. Requirements for measuring instruments

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Article 5

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Measuring instruments and components, as referred to in parts a to g, before being placed on the market, put into service or presented on the market for placing into service, shall comply with the requirements of Annex I to the Directive. measuring instruments included essential requirements and the applicable essential requirements in the instrument-specific Annex mentioned below by the measuring instrument:

  • a. Gas meters and volume retraining instruments with an in Article 2 (a) , the task referred to: Annex IV,

  • b. kilowatt-meter meters with an in Article 2 (b) , the task referred to: Annex V;

  • c. Thermal energy meters with an in Article 2 (c) , the task referred to: Annex VI;

  • d. Liquid measurement equipment with an in Article 2, part d , task referred to: Annex VII;

  • e. automatic weighing instruments with an in Article 2 (e) , the task referred to: Annex VIII,

  • f. Valuing parameters with a Article 2 (f) , the task referred to: Annex IX;

  • g. Multidimensional measuring instruments with an in Article 2, part g , the task referred to: Annex XI, Chapters I and IV.


Article 6

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  • 1 A non-automatic weighing instrument with a measurement task for a specific application as intended Article 3 where it is placed on the market, put into service, offered for placing in service on the market, or used in accordance with the essential requirements of Annex I to the Directive, non-automatic weighing instruments.

  • 2 If the non-automatic weighing instrument contains or is connected to devices not covered by the measurement task in a specific scope as specified in the Annex Article 3 are intended, the requirements referred to in paragraph 1 shall not apply to those establishments.


Article 7

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  • 1 Measuring instruments referred to in points (a) to (f) and, where appropriate, further indicated in the instrument-specific annex mentioned below with the measuring instrument, shall comply with the requirements of obtaining a CE marking and the additional metrological marking on the essential requirements set out in Annex I to the Directive and the relevant essential requirements set out in the relevant instrument-specific Annex:

    • a. Water meters intended for domestic, commercial and light industrial use: Annex III;

    • (b) length-of-length: Annex X, Chapter I;

    • c. Content-retention ates: Annex X, Chapter II;

    • d. length-measuring instruments: Annex XI, Chapters I and II;

    • e. surface measuring instruments: Annex XI, Chapters I and III;

    • f. exhaust gas analysers intended for inspection and professional maintenance of motor vehicles in use: Annex XII.

  • 2 A tape size bottle shall comply with the applicable requirements of Annex I (5) of the Directive on tape size bottles for the purpose of applying the EEC sign.

  • 3 The operator shall be prohibited from placing on the market a measuring instrument as referred to in paragraph 1 with a CE marking and the supplementary metrology marking, or a tape bottle bearing the EEC sign as referred to in the second paragraph. bring them or to offer them on the market, if they do not meet the requirements of the second subparagraph of Article 2 (2).


Article 8 [ Enter into force at a time to be determined]

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Article 9

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  • 1 A measuring instrument as intended Article 5 or Article 7, first paragraph , which complies with:

    • (a) the harmonised standards or parts thereof the reference numbers of which have been published in the Official Journal of the European Union; or

    • (b) parts of normative documents, the list of which has been published in the Official Journal of the European Union,

    shall be deemed to conform to the essential requirements set out in Annex I to the Directive, and in the applicable instrument-specific annex, which shall, by the standards or parts thereof, as referred to in point (a), be subject to the corresponding essential requirements as defined in point (b) of this Directive. parts of normative documents, shall be covered.

  • 2 A non-automatic weighing instrument as intended Article 6 which complies with the harmonised standards or parts thereof the reference numbers of which have been published in the Official Journal of the European Union, shall be deemed to conform to the automatic weighing instruments set out in Annex I to the Directive. contain essential requirements which are covered by those standards or parts thereof.


Article 10

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  • 1 The manufacturer of a measuring instrument as intended Article 5 or Article 7, first paragraph , any technical solution which complies with the essential requirements set out in Annex I to the Directive and in the instrument-specific Annex may be chosen.

  • 2 The manufacturer does not need to demonstrate the conformity of the instrument with the requirements referred to in paragraph 1 when it correctly applies the solutions used in the vehicle. Article 9, first paragraph These harmonised standards or normative documents have been set out.


Article 11

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  • 1 By ministerial arrangement rules are laid down regarding requirements where measuring instruments as intended. Articles 5 , 6 and 8 comply with the requirements.

  • 2 By ministerial arrangement rules may be laid down regarding the manner of installation and otherwise of the circumstances under which a measuring instrument as referred to in Article 5 , Article 6 or Article 8 is used.


§ 3.2. Conformity assessment

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Article 12

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  • 1 A measuring instrument as intended Article 5 or Article 7, first paragraph , at the choice of the manufacturer, shall undergo one of the conformity assessment procedures of the measuring instruments directive set out in the instrument-specific Annex for that instrument.

  • 2 If the conformity assessment procedure of a measuring instrument referred to in the first paragraph provides for a test, that test shall be presumed to be satisfied when the test programme corresponding to that test has been carried out in accordance with the requirements of the Article 9, first paragraph , such harmonised standards or normative documents and the test results shall ensure that the essential requirements set out in Annex I to the Directive measuring instruments and in the applicable instrument-specific Annex are fulfilled.

  • 3 A non-automatic weighing instrument as intended Article 6 The manufacturer shall, at the choice of the manufacturer, undergo a conformity assessment in accordance with one of the procedures referred to in Article 13 (1) (a) and (b) of the Directive.

  • 4 The documents and correspondence relating to the procedures referred to in paragraph 1 and third paragraph shall be drawn up in one of the official languages of the Member State in which the designated authority concerned is established or in another Member State. language accepted by that authority.


Article 13 [ Enter into force at a time to be determined]

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Article 14

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  • 1 For a regular measuring instrument as referred to in Article 5 , Article 6 or Article 8 The conformity assessment shall be carried out by means of an inspection.

  • 2 The inspection shall be carried out by a body designated for the measuring instrument concerned or by a person with a qualification as referred to in the Annex for the instrument concerned. Article 11 of the Act .

  • 3 In the case of a ministerial arrangement, detailed rules may be laid down for the verification.


Article 15

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Tape-measuring bottles shall be checked for compliance with the requirements of the Directive on tap-measuring bottles by sampling in accordance with the applicable requirements of the Directive on tap-measuring bottles.


Article 16

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  • 1 The designated body performing review operations in the framework of a conformity assessment as referred to in Article 3 (2) of the EC Treaty. Article 12, first or third member , in doing so, ensure the implementation of its obligations related to those key activities, which are provided for in the conformity assessment procedure.

  • 2 The designated body which carries out the review operations in the context of a conformity assessment as referred to in Article 3 (2) of the EC Treaty Article 13, first paragraph , in doing so, ensure implementation of the obligations contained in a conformity assessment procedure as referred to in Article 13, first paragraph, and in the Annex The rules laid down in this Decision have been entrusted to it.

  • 3 In so far as a conformity assessment procedure provides for the obligation to provide data to the Member State by which the designated authority is designated, or to other Member States, data shall be provided in the Netherlands provide to our Minister.

  • 4 In so far as a conformity assessment procedure provides for the provision of information to the Member States of the European Union or the European Commission, such communication shall be made by the intervention of our Minister.


Article 17

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  • 1 For the purpose of carrying out a check as specified in Article 15 Our minister is designated as a competent service.

  • 2 Our Minister, having regard to the relevant provisions of the Directive, carries out the means of measuring instruments and metrological control and the directive on tape-measuring containers for the work which results from his task at the time of the audit.


§ 3.3. Markings and markings

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Article 18

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  • 1 The conformity of a measuring instrument to be placed on the market, or to be put into service, as referred to in Article 5 or Article 7, first paragraph , or of a non-automatic weighing instrument, as intended Article 6 with the at or under the law the CE marking and the supplementary metrology marking, as set out in Article 21 (2) of the Directive, provides for the non-automatic weighing instruments of the measuring instruments Directive.

  • 2 The markings referred to in paragraph 1 and other markings shall be affixed in accordance with the applicable conformity assessment procedure and Articles 21 and 22 of the measuring instruments Directive, respectively, and in Articles 16 and 16 of the Directive. 17 of the Directive non-automatic weighing instruments.

  • 3 If Article 6, second paragraph , applies to each of those establishments which do not carry out a conformity assessment as referred to in Article 2 (2). Article 12, third paragraph The restricted use symbol, as defined in point 3 of Annex III to the Directive, is subject to a clearly visible and indelible display of non-automatic weighing instruments.


Article 19

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  • 1 Non-automatic weighing machine not intended for a specific use as intended for the purpose of Article 3 it shall bear the inscriptions provided for in point 2 of Annex III to the Directive.

  • 2 The inscriptions referred to in paragraph 1 shall be clearly visible, easily legible and indelible.

  • 3 Operators shall prohibit the placing on the market of non-automatic weighing instruments referred to in the first paragraph if they do not comply with the requirements set out in paragraph 1.


Article 20

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The conformity of a tap-size bottle to be placed on the market or in use with the by-or-in the law the following requirements are demonstrated by the Article 7, second paragraph That was the E.E.E.G sign. The sign shall be affixed by the manufacturer in accordance with the requirements of the Directive, by means of measurement and metrological measurement and by the Directive on 'tapmeasuring bottles'.


Article 21 [ Enter into force at a time to be determined]

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Article 22

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  • 1 The conformity of a controlled measuring instrument used in accordance with the requirements of the Regulation Article 7 of the Act has been subjected to an inspection by means of a marking which shall be established by means of a ministerial arrangement. In the case of ministerial arrangements, rules may also be laid down as to the place and method of affixing of the mark.

  • 2 The mark referred to in paragraph 1 shall be affixed by a body designated for the instrument concerned or a person having an approval granted for that specific measuring instrument, as referred to in the first paragraph of this Article. Article 11 of the Act .

Chapter 4. Obligations of operators

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Article 23

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The competent national authority in Articles 8, eighth and ninth paragraph, point 9, second paragraph, points (b) and (c), 10, seventh and ninth paragraphs, 11, fourth and fifth paragraphs, of the instruments of measurement, and Articles 6, eighth and ninth paragraph, 7, second paragraph, of the Directive. Under (b) and (c), (8), seventh and ninth paragraphs, 9, fourth and fifth paragraphs, of the Directive, non-automatic weighing instruments shall be our Minister.


Article 24

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  • 1 The manufacturer of a measuring instrument as intended Article 5 or Article 7, first paragraph , complies with the obligations laid down in Articles 8, 18 and 19 of the measuring instruments directive.

  • 2 The manufacturer of a non-automatic weighing instrument shall meet the obligations laid down in Articles 6 and 14 and Annex II of the Directive non-automatic weighing instruments.


Article 25 [ Enter into force at a time to be determined]

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Article 26

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The manufacturer of a tape-measuring bottle shall carry out the work and comply with the obligations laid down in the Directive on 'tapmeasuring bottles'.


Article 27

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  • 1 The manufacturer of a measuring instrument as intended in the Articles 5 or 7, first paragraph , or a non-automatic weighing instrument, may appoint an authorised representative to act on his behalf in respect of certain obligations and activities. The designation does not include obligations under Article 8 (1) of the Directive, first paragraph, and Article 6 (1) of the Directive, neither automatic weighing instruments nor the provisions of Article 8 (2) of the Directive. measuring instruments and Article 6 (2) of the Directive on non-automatic weighing instruments as a requirement to draw up technical documentation.

  • 2 An agent referred to in paragraph 1 shall carry out the tasks assigned to it in the designation. The designation shall include at least the following tasks:

    • (a) hold the EU declaration of conformity and the technical documentation at the disposal of our Minister and other relevant supervisory bodies for 10 years after the measuring instrument has been placed on the market;

    • b. provide the reasoned request of Our Minister with all the necessary information and documentation to demonstrate the conformity of the measuring instrument;

    • (c) assisting the Minister, at the request of our Minister, of any action taken to eliminate the risks of the measuring instruments for which he has been designated as authorised representative.


Article 28

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  • 1 The importer of a measuring instrument as referred to in Article 5 or Article 7, first paragraph , complies with the obligations laid down in Article 10 of the measuring instruments directive.

  • 2 The importer of a non-automatic weighing machine complies with the obligations set out in Article 8 of the Directive on non-automatic weighing instruments.


Article 29

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  • 1 The distributor of a measuring instrument as referred to in Article 5 or Article 7, first paragraph , complies with the obligations laid down in Article 11 of the measuring instruments directive.

  • 2 The distributor of a non-automatic weighing instrument complies with the obligations laid down in Article 9 of the Directive on non-automatic weighing instruments.


Article 30

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The importer or distributor of a measuring instrument as referred to in the Articles 5 or 7, first paragraph , or a non-automatic weighing machine, as defined in the Directive, is considered to be non-automatic weighing instruments and complies with the requirements of the Directive. Article 24 Said obligations of the manufacturer where it places a measuring instrument or non-automatic weighing instrument on the market under his own name or trade mark or modifies a measuring instrument already placed on the market in such a way that the conformity with the product may be affected by relevant directives.


Article 31

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An in case of a measuring instrument as defined in the Articles 5 , 6 or 7, first paragraph , operator concerned shall be given 10 years after the measuring instrument has been delivered to him and 10 years after it has supplied the instrument with the information referred to in Article 13 of the measuring instruments directive and Article 11 of the Directive. non-automatic weighing instruments.

Chapter 5. Other and final provisions

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Article 32

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An amendment to the Directive measuring instruments, non-automatic weighing instruments, the Directive on measuring instruments and control methods or the directive on tape-measuring bottles is to apply to the application of this Decision from the point of view of the the date on which the amendment in question must be implemented, unless a ministerial order, published in the Official Journal, provides for a change in time.


Article 33

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Article 34

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The declaration of authorisation issued for the entry into force of this Decision for a conformity assessment as referred to in Article 13 shall be valid for 10 years from the date of entry into force of this Decision.


Article 35

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Article 36

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Article 37

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Article 38

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The Measuring instrument decision I shall be withdrawn.


Article 39 [ Enter into force at a time to be determined]

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Article 40

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This Decision shall enter into force with effect from 20 April 2016, with the exception of:


Article 41

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This decision is referred to as: Decision measuring instruments and economic operators.

Charges and orders that this Decision will be placed in the Official Journal by means of the note of explanatory note accompanying it.

Wassenaar, 14 April 2016

William-Alexander

The Minister for Economic Affairs,

H.G.J. Kamp

Published the nineteenth April 2016

The Minister for Security and Justice,

G.A. van der Steur


Annex referred to in Annex Article 13 of the Decision measuring instruments and economic operators [ Treeenters into force at a point to be defined]

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