The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019

(33A) (1) In this regulation— (a) any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive; (b) “CE marking” has the meaning given to it in Article 4(22); (c) “Module B” means the conformity assessment procedure set out under the heading “MODULE B: EU-TYPE EXAMINATION” in Annex II; (d) “Module H1” means the conformity assessment procedure set out under the heading “MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION” in Annex II; (e) “EU-design examination certificate” means an EU design certificate issued in accordance with Module H1; (f) “EU-type examination certificate” means an EU-type examination certificate issued in accordance with Module B; (g) “harmonised standard” has the meaning given to it in Article 4(14); (h) “instrument-specific Annexes” means Annexes III to XII. (2) Paragraph (3) applies where, before placing a regulated measuring instrument on the market, the manufacturer— (a) ensures that the regulated measuring instrument has been designed and manufactured in accordance with the essential requirements set out in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument; (b) ensures that the one of the relevant conformity assessment procedures listed in the relevant instrument-specific Annex that apply to that regulated measuring instrument in accordance with Article 17 have been carried out; (c) draws up the technical documentation referred to in Article 18; (d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English; (e) affixes a CE marking and the supplementary metrology marking, in accordance with Articles 21 and 22(1) to (6); (f) draws up an EU declaration of conformity, in accordance with Article 19; and (g) ensures that the EU declaration of conformity is prepared in or translated into English. (3) Where this paragraph applies— (a) the requirements of regulations 7(a) to (e), 48 and 52(2) are to be treated as being satisfied; (b) regulations 8, 9(2), 51, 68(1)(a) to (e), 72, 73 and 75 apply subject to the modifications in paragraph (8); and (c) regulations 36 to 39 do not apply. (4) Paragraph (5) applies where, before placing a regulated measuring instrument on the market, the importer ensures that— (a) the relevant conformity assessment procedures that apply to that measuring instrument in accordance with Article 17 have been carried out; (b) the manufacturer has drawn up the technical documentation referred to in Article 18; and (c) the measuring instrument bears the CE marking, and the supplementary metrology marking referred to in Article 21(2). (5) Where this paragraph applies— (a) the requirements of regulation 17(2)(a) to (c) are to be treated as being satisfied; and (b) regulations 18, 21, 23, 51, 68(1)(a) to (e), 72, 73 and 75 apply subject to the modifications in paragraph (8). (6) Paragraph (7) applies where, before making a regulated measuring instrument available on the market, a distributor ensures that the regulated measuring instrument bears the CE marking, and the supplementary metrology marking referred to in Article 21(2). (7) Where this paragraph applies— (a) regulation 28(1) is to be treated as being satisfied; and (b) regulations 29(1),30, 68(1)(a), 68(1)(b), 72 and 73 apply subject to the modifications in paragraph (8). (8) The modifications referred to in paragraphs (3)(b), (5)(b) and (7)(b) are that— (a) any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity; (b) any reference to “UK marking” is to be read as a reference to the CE marking; (c) any reference to “essential requirements” is to be read as a reference to the essential requirements referred to in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument; (d) any reference to “designated standard” is to be read as a reference to a harmonised standard; (e) any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures that apply to the regulated measuring instrument in accordance with Article 17; (f) any reference to “technical documentation” is a reference to the technical documentation referred to in Article 18; (g) any reference to “type examination certificate” is to be read as a reference to an EU-type examination certificate; and (h) any reference to “design examination certificate” is to be read as a reference to an EU-design examination certificate; (i) any reference to “M marking” is to be read as a reference to the supplementary metrology marking; and (j) any reference to “approved body” is to be read as a reference to the body that undertook any conformity assessment procedure in accordance with Article 13; (k) any reference to “authorised mark” includes the CE marking and the supplementary metrology marking. (33B) (1) In this regulation— (a) any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive; (b) “Module B” means the conformity assessment procedure set out under the heading “MODULE B: EU-TYPE EXAMINATION” in Annex II; (c) “EU-type examination certificate” means an EU-type examination certificate issued in accordance with Module B; (d) “harmonised standard” has the meaning given to it in Article 4(14); (e) “instrument-specific Annexes” means Annexes III to XII. (2) Paragraph (3) applies where— (a) in accordance with Article 17, one of the conformity assessment procedures listed in the instrument-specific Annex that applies to the regulated measuring instrument is Module B; and (b) before placing a regulated measuring instrument on the market, the manufacturer ensures that— (i) the regulated measuring instrument has been designed in accordance with the essential requirements set out in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument; and (ii) Module B has been complied with in respect of that regulated measuring instrument. (3) Where this paragraph applies— (a) any reference in regulation 7(c) to “relevant conformity assessment procedure” includes Module B; (b) any reference to “type examination certificate” in regulations 45(1)(j), 72(3)(b) and 73(3)(b) is to be read as a reference to “EU-type examination certificate”; and (c) any reference to “designated standard” in regulation 45(1)(f) is to be read as a reference to “harmonised standard. (33C) (1) Subject to paragraph (2), regulation 33A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 33A— (a) any regulated measuring instrument which was placed on the market pursuant to regulation 33A may continue to be made available on the market on or after the expiry of regulation 33A; (b) any obligation to which a person was subject under regulation 33A in respect of any regulated measuring instrument placed on the market pursuant to regulation 33A continues to have effect after the expiry of regulation 33A, in respect of that instrument. (3) Subject to paragraph (4), regulation 33B ceases to have effect at the end of the period of 12 months beginning with IP completion day. (4) Where a conformity assessment procedure has been completed pursuant to regulation 33B in relation to a regulated measuring instrument prior to the expiry of regulation 33B, regulation 33B continues to apply in respect of that instrument where— (a) the manufacturer arranges for the EU-Type examination certificate and any annexes to be transferred to an approved body; (b) the approved body referred to in sub-paragraph (a) accepts responsibility for the EU-Type examination certificate; and (c) the approved body issues a Type-examination certificate relying, or relying in part, on any examinations or tests undertaken prior to the issue of the EU-Type examination certificate. (5) In paragraph (4) “EU-Type examination certificate” has the meaning given to it in regulation 33B(1)(c). (33D) (1) Where paragraph (2) applies— (a) a regulated measuring instrument is to be treated as being in conformity with the essential requirements; and (b) each relevant economic operator is to be treated as having complied or as complying with the obligations imposed on them under Part 2. (2) This paragraph applies where— (a) a regulated measuring instrument is— (i) in conformity with the essential requirements, within the meaning of that term in regulation 2, as it applies in Northern Ireland; and (ii) qualifying Northern Ireland goods; and (b) each relevant economic operator has complied or is complying with the obligations imposed on them under Part 2, as that Part applies in Northern Ireland; and (c) an importer has complied with the obligations set out in paragraph (3). (3) The obligations referred to in paragraph (2)(c) are that, before placing the non-automatic weighing instrument on the market, the importer— (a) complies with regulation 19; (b) ensures that— (i) the relevant conformity assessment procedure has been carried out. (ii) the manufacturer has drawn up the technical documentation; and (iii) the regulated measuring instrument bears the CE marking. (4) In this regulation— - “CE marking” has the meaning given it in in regulation 2(1), as it applies in Northern Ireland; - “qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018; - “relevant conformity assessment procedure” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland; - “technical documentation” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland.

Amendment to Part 3

19

Omit Part 3 (non-prescribed measuring instruments).

Amendment to regulation 36

20

For regulation 36 (introductory), substitute—

(36) This chapter applies for the purposes of establishing whether a regulated measuring instrument complies with the essential requirements.

Amendment to regulation 37

21

In regulation 37 (methods of establishing conformity with the essential requirements)—

• (a) in the opening words insert “ regulated ” before “measuring”;

• (b) in paragraph (a)—

• (i) for “harmonised”, the first time it appears, substitute “ designated ”; and

• (ii) omit from “where” to “Union”;

• (c) in paragraph (b), for “in the Official Journal of the European Union”, substitute “ by the Secretary of State ”.

Amendment to regulation 38

22

In regulation 38 (presumptions of conformity of measuring instruments)—

• (a) in paragraphs (1) and (2) and in the heading, before “measuring” insert “ regulated ”;

• (b) in paragraphs (1) and (3), for “harmonised”, substitute “ designated ”.

Amendment to regulation 39

23

In regulation 39 (conformity assessment procedures)—

• (a) in paragraph (1)—

• (i) before “measuring” insert “ regulated ” in both places it occurs;

• (ii) for “1” substitute “ 1C to 1J ”; and

• (b) in paragraph (2), for “A notified” substitute “ An approved ”.

Insert of regulation 39A

24

After regulation 39, insert—

(39A) (1) Where the one or more of the conditions in paragraph (2) are met, the Secretary of State may by regulations make provision to amend Schedules 1C to 1J in relation to any of the following matters— (a) maximum permissible errors (MPEs) and accuracy classes; (b) rated operating conditions; (c) critical change values; and (d) disturbances. (2) The conditions referred to in paragraph (1) are that the Secretary of State considers that the purpose of the provision is to— (a) take into account scientific or technical progress; or (b) provide adequate protection of consumers or other end users. (3) The power to make regulations under this regulation includes the power— (a) to make different provision for different cases; and (b) to make such supplemental, consequential and transitional provision as the Secretary of State considers appropriate (4) Regulations made under paragraph (1) are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.

Amendment to regulation 40

25

In regulation 40 (capacity serving measures – accredited in house bodies)—

• (a) in paragraph (2) for “of Annex II to the Directive” substitute “ in Schedule 1B ”;

• (b) in paragraphs (3) and (4)(c), before “measuring” insert “ regulated ”; and

• (c) for paragraph (5) substitute—

(5) An accredited in-house body need not be approved by the Secretary of State, but information concerning its accreditation must be given by the undertaking of which it forms part to the Secretary of State at the request of the Secretary of State.

Amendment to regulation 41

26

For regulation 41 (subsidiaries and contractors) substitute—

(41) (1) An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided— (a) the body is satisfied that the subcontractor or subsidiary meets the approved body requirements; (b) the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and (c) the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person. (2) The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established). (3) Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation concerning— (a) the assessment of the qualifications of the subcontractor or the subsidiary; and (b) the conformity assessment activity carried out by the subcontractor or subsidiary. (4) In this regulation “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006 .

Amendment to regulation 42

27

In regulation 42 (fees)—

• (a) for “a United Kingdom notified” substitute “ an approved ” in both places in which it occurs;

• (b) in paragraph (2)(a) for “United Kingdom notified” substitute “ approved ”.

Amendment to regulation 44

28

In regulation 44 (general requirements to be met by technical documentation)—

• (a) in paragraphs (1)(a), (2)(b) and (2)(c) before “measuring” insert “ regulated ”;

• (b) in paragraph (1)(b) for “the Directive” substitute “ these Regulations ”.

Amendment to regulation 45

29

In regulation 45 (specific information to be included in technical documentation), in paragraph (1)—

• (a) before “measuring” insert “ regulated ” in each place it occurs;

• (b) in sub-paragraph (f)—

• (i) for “harmonised”, substitute “ designated ”; and

• (ii) omit “, the references of which have been published in the Official Journal of the European Union”;

• (c) in sub-paragraph (g) for “harmonised” substitute “ designated ”;

• (d) in sub-paragraph (i)(i) for “the Directive” substitute “ these Regulations ”;

• (e) in sub-paragraph (i)(ii ) for “, water and thermal-energy” substitute “ and water ”;

• (f) in sub-paragraph (j)—

• (i) for “EU-type” substitute “ type ”;

• (ii) omit “EU” in the second place it occurs.

Amendment to the heading of Chapter 3

30

In the heading to Chapter 3 omit “EU”.

Amendment to regulation 46

31

In regulation 46 (application of Chapter)—

• (a) omit “EU”; and

• (b) before “measuring” insert “ regulated ”.

Amendment to regulation 47

32

In regulation 47 (form and contents of EU declaration of conformity etc)—

• (a) in paragraphs (1) and (2) and in the heading, omit “EU”;

• (b) in paragraph (1)(b) for “Annex II to the Directive” substitute “ Schedule 1B ”; and

• (c) in paragraph (1)(c) for “Annex XIII to the Directive” substitute “ Schedule 1K ”.

Amendment to regulation 48

33

For regulation 48 (measuring instruments that require more than one declaration of conformity) substitute—

(48) Where a regulated measuring instrument is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.

Amendment to regulation 49

34

In regulation 49 (responsibility of manufacturer that draws up declaration of conformity)—

• (a) for “an EU” substitute “ a ”; and

• (b) before “measuring” insert “ regulated ” in both places it occurs.

Amendment to regulation 50

35

In regulation 50 (conformity with Directive requirements to be indicated by the CE marking)—

• (a) in the heading omit “Directive”; and

• (b) in the regulation and in the heading, for “CE”, substitute “ UK ”.

Amendment to regulation 51

36

For regulation 51 (general principles relating to the M marking), substitute—

(51) (1) An economic operator must not affix the UK marking or the M marking to a regulated measuring instrument unless— (a) that economic operator is the manufacturer of the regulated measuring instrument; and (b) the conformity of the regulated measuring instrument with the essential requirements has been demonstrated by a relevant conformity assessment procedure. (2) An economic operator must not affix a marking to a regulated measuring instrument which is not the UK marking or the M marking but which purports to attest that the regulated measuring instrument satisfies the essential requirements. (3) An economic operator must not affix to a regulated measuring instrument a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the marking. (4) An economic operator must not affix to a regulated measuring instrument any other marking if the visibility, legibility and meaning of the UK marking or the M marking would be impaired as a result.

Amendment to regulation 52

37

In regulation 52 (rules and conditions for affixing the CE marking and the M marking)—

• (a) in paragraphs (1) to (6) before “measuring” insert “ regulated ” in each place it occurs;

• (b) in paragraphs (1) and (7) and in the heading, for “CE”, substitute “ UK ”;

• (bb) in paragraph (2) for “or its data plate” substitute “ , its data plate, or where regulation 7(2) applies, to a label affixed to the measuring instrument or to a document accompanying the measuring instrument; ”

• (c) in paragraph (4) omit “, not being sub-assemblies”;

• (d) in paragraph (8) for “Annex II to the Directive” substitute “ Schedule 1B ”; and

• (e) in paragraphs (8), (9) and (10) for “notified” substitute “ approved ”.

Amendment to Part 5

38

For Part 5 substitute—

(53) (1) An approved body is a conformity assessment body which— (a) has been approved by the Secretary of State pursuant to the procedure set out in regulation 54 (approval of conformity assessment bodies); or (b) immediately before IP completion day was a notified body in respect of which the Secretary of State had taken no action under regulation 60(1) or (2) as they had effect immediately before IP completion day to suspend or withdraw the body's status as a notified body. (2) Paragraph (1) has effect subject to regulation 57 (restriction, suspension or withdrawal of approval). (3) In this Part— - “notified body” means a body— 1. which the Secretary of State had before IP completion day notified to the European Commission and the member States of the European Union, in accordance with Article 23 of the Directive; and 2. in respect of which no objections had been raised, as referred to in regulation 53(2)(b), as it had effect immediately before IP completion day; - “approved body requirements” means the requirements set out in Schedule 5. (54) (1) The Secretary of State may approve only those conformity assessment bodies that qualify for approval. (2) A conformity assessment body qualifies for approval if the first and second conditions below are met. (3) The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by— (a) a description of— (i) the conformity assessment activities that the conformity assessment body intends to carry out; (ii) the conformity assessment procedure in respect of which the conformity assessment body claims to be competent; and (iii) the regulated measuring instrument for which the conformity assessment body claims to be competent; and (b) either— (i) an accreditation certificate; or (ii) the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements. (4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements. (5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b)(i), as sufficient evidence that the conformity assessment body meets the approved body requirements. (6) When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may– (a) have regard to any other matter which appears to the Secretary of State to be relevant; and (b) set conditions that the conformity assessment body must meet. (7) For the purposes of this regulation “accreditation certificate” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements. (55) (1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such standard), the Secretary of State is to presume that the conformity assessment body meets the approved body requirements covered by that standard (or that part of that standard). (2) The presumption in paragraph (1) is rebuttable. (56) The Secretary of State must monitor each approved body with a view to verifying that the body— (a) continues to meet the approved body requirements; (b) meets any conditions set— (i) in accordance with regulation 54(6)(b); or (ii) in the case of an approved body which was a notified body immediately before IP completion day, in accordance with regulation 54(6)(b) as it applied immediately before IP completion day; and (c) carries out its functions in accordance with these Regulations. (57) (1) Where the Secretary of State determines that an approved body— (a) no longer meets an approved body requirement, or (b) is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 54(6)(b), the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 54 (approval of conformity assessment bodies). (2) With the consent of an approved body, or where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 56(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 54 (approval of conformity assessment bodies). (3) In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the non-compliance. (4) Before taking action under paragraph (1) or (2), the Secretary of State must— (a) give notice in writing to the approved body of the proposed action and the reasons for it; (b) give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and (c) consider any such representations made by the approved body. (5) Where the Secretary of State has taken action in respect of an approved body under paragraph (1) or (2), or where an approved body has ceased its activity, the approved body must— (a) on the request of the Secretary of State, transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or (b) in the absence of a request under sub-paragraph (a), ensure that its files relating to the activities it has undertaken as an approved body are kept available for the Secretary of State and competent authorities for a period of 10 years from the date they were created. (6) The activities undertaken as an approved body referred to in paragraph (5) include any activities that the body has undertaken as a notified body. (7) The Secretary of State may impose a monetary penalty on an approved body that fails to comply with any requirement imposed by or under paragraph (5). (8) Schedule 7 has effect in relation to a monetary penalty imposed under paragraph (7). (58) (1) The Secretary of State must— (a) assign an approved body identification number to each approved body; and (b) compile and maintain a register of— (i) approved bodies; (ii) their approved body identification numbers; (iii) the activities for which they have been approved; and (iv) any restrictions on those activities. (2) The register referred to in paragraph (1) must be made publicly available. (59) (1) The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State— (a) assessing whether a conformity assessment body meets the approved body requirements; and (b) monitoring approved bodies in accordance with regulation 56; (2) Where the Secretary of State authorises the UK national accreditation body pursuant to paragraph (1), the Secretary of State remains fully responsible for anything done pursuant to that authorisation.

Amendment to regulation 63

39

In regulation 63 (regulated measuring instruments presenting a risk)—

• (a) in paragraph (5) for “notified”, substitute “ approved ”;

• (b) omit paragraph (6);

• (c) in paragraph (7) for “on the market throughout the European Economic Area”, substitute “ in the United Kingdom ”;

• (d) omit paragraph (9);

• (e) omit paragraph (10).

Amendment to regulation 64

40

Omit regulation 64 (EU safeguard procedure).

Amendment to regulation 65

41

In regulation 65 (compliant regulated measuring instruments which present a risk) omit paragraph (3).

Amendment to regulation 68

42

In regulation 68 (compliance notice procedure), in paragraph (1)—

• (a) in sub-paragraphs (a) and (b) for “CE” substitute “ UK ” in each place in which it occurs;

• (b) in sub-paragraph (a) for “Article 30 of the RAMS regulation or the requirements of these Regulations” substitute “ regulation 51 or regulation 52 ”;

• (c) in sub-paragraph (c) for “notified” substitute “ approved ” in each place in which it occurs; and

• (d) in sub-paragraph (d) omit “EU”.

Amendment to regulation 69

43

In regulation 69 (enforcement notices)—

• (a) in paragraph (5)—

• (i) for “a United Kingdom notified” substitute “ an approved ”;

• (ii) for “that notified” substitute “ that approved ”; and

• (b) omit paragraph (6).

Amendment to regulation 72

44

In regulation 72 (disqualification)—

• (a) in paragraph (2)—

• (i) in sub-paragraph (a) for “CE”, substitute “ UK ”;

• (ii) in sub-paragraph (c) for “notified”, substitute “ approved ”; and

• (b) in paragraph 3(b) omit “EU-” in each place it occurs.

Amendment to regulation 73

45

In regulation 73 (requalification) in paragraph 3(b), omit “EU-” in each place it occurs.

Amendment to regulation 75

46

In regulation 75 (unauthorised application of authorised marks), paragraph (5)—

• (a) in sub-paragraph (a) for “CE” substitute “ UK ”; and

• (b) in sub-paragraph (c) for “notified” substitute “ approved ”.

Amendment to regulation 81

47

In regulation 81 (review) omit paragraph (2).

Amendment to Schedule 1

48

Omit Schedule 1 (essential requirements and applicable conformity assessment procedures).

Insertion of Schedules

49

Before Schedule 2 insert—

SCHEDULE 1A A regulated measuring instrument shall provide a high level of metrological protection in order that any party affected can have confidence in the result of measurement, and shall be designed and manufactured to a high level of quality in respect of the measurement technology and security of the measurement data. The essential requirements that shall be met by regulated measuring instruments are set out below and are supplemented, where appropriate, by instrument-specific requirements in Schedules 1C to 1J that provide more detail on certain aspects of the general requirements. The solutions adopted in the pursuit of the essential requirements shall take account of the intended use of the instrument and any foreseeable misuse thereof. DEFINITIONS

Measurand	The measurand is the particular quantity subject to measurement
Influence quantity	An influence quantity is a quantity that is not the measurand but that affects the result of measurement.
Rated Operating Conditions	The rated operating conditions are the values for the measurand and influence quantities making up the normal working conditions of an instrument.
Disturbance	An influence quantity having a value within the limits specified in the appropriate requirement but outside the specified rated operating conditions of the regulated measuring instrument. An influence quantity is a disturbance if for that influence quantity the rated operating conditions are not specified.
Critical change value	The critical change value is the value at which the change in the measurement result is considered undesirable.
Material Measure	A material measure is a device intended to reproduce or supply in a permanent manner during its use one or more known values of a given quantity.
Direct sales	A trading transaction is direct sales if:— the measurement result serves as the basis for the price to pay; and— at least one of the parties involved in the transaction related to measurement is a consumer or any other party requiring a similar level of protection; and— all the parties in the transaction accept the measurement result at that time and place.
Climatic environments	Climatic environments are the conditions in which regulated measuring instruments may be used. To cope with climatic differences, a range of temperature limits has been defined.
Utility	A utility is regarded as a supplier of electricity, gas or water.

ESSENTIAL REQUIREMENTS (1) (1) Under rated operating conditions and in the absence of a disturbance, the error of measurement shall not exceed the maximum permissible error (MPE) value as laid down in the appropriate instrument-specific requirements. Unless stated otherwise in the instrument-specific Schedules, MPE is expressed as a bilateral value of the deviation from the true measurement value. (1) Under rated operating conditions and in the presence of a disturbance, the performance requirement shall be as laid down in the appropriate instrument-specific requirements. Where the instrument is intended to be used in a specified permanent continuous electromagnetic field the permitted performance during the radiated electromagnetic field-amplitude modulated test shall be within MPE. (1) The manufacturer shall specify the climatic, mechanical and electromagnetic environments in which the instrument is intended to be used, power supply and other influence quantities likely to affect its accuracy, taking account of the requirements laid down in the appropriate instrument-specific Schedules. (1) Climatic environments The manufacturer shall specify the upper temperature limit and the lower temperature limit from any of the values in Table 1 unless otherwise specified in Schedules 1C to 1J and indicate whether the instrument is designed for condensing or non-condensing humidity as well as the intended location for the instrument, i.e. open or closed.

	Temperature Limits	Temperature Limits	Temperature Limits	Temperature Limits
Upper temperature limit	30 oC	40 oC	55 oC	70 oC
Lower temperature limit	5 oC	-10 oC	-25 oC	-40 oC

(1) (a) Mechanical environments are classified into classes M1 to M3 as described below.

M1	This class applies to instruments used in locations with vibration and shocks of low significance, e.g. for instruments fastened to light supporting structures subject to negligible vibrations and shocks transmitted from local blasting or pile-driving activities, slamming doors, etc.
M2	This class applies to instruments used in locations with significant or high levels of vibration and shock, e.g. transmitted from machines and passing vehicles in the vicinity or adjacent to heavy machines, conveyor belts, etc.
M3	This class applies to instruments used in locations where the level of vibration and shock is high and very high, e.g. for instruments mounted directly on machines, conveyor belts, etc.

(b) The following influence quantities shall be considered in relation with mechanical environments:
- — vibration
- — mechanical shock

(1) (a) Electromagnetic environments are classified into classes E1, E2 or E3 as described below, unless otherwise laid down in the appropriate instrument-specific Schedules.

E1	This class applies to instruments used in locations with electromagnetic disturbances corresponding to those likely to be found in residential, commercial and light industrial buildings.
E2	This class applies to instruments used in locations with electromagnetic disturbances corresponding to those likely to be found in other industrial buildings.
E3	This class applies to instruments supplied by the battery of a vehicle. Such instruments shall comply with the requirements of E2 and the following additional requirements:— voltage reductions caused by energising the starter-motor circuits of internal combustion engines,— load dump transients occurring in the event of a discharged battery being disconnected while the engine is running.