The Non-automatic Weighing Instruments (EEC Requirements) Regulations 1995

Explanatory Note

(This note is not part of the Regulations)

These Regulations (“the Regulations”) replace, with amendments, the Non-automatic Weighing Instruments (EEC Requirements) Regulations 1992 as amended (“the 1992 Regulations”). They implement Council Directive 90/384/EEC (as amended by Council Directive 93/68/EEC) on the harmonisation of the laws of the member States relating to non-automatic weighing instruments (“instruments”), defined in regulation 2(1)).

On and after 1st January 2003, they replace the Weights and Measures Act 1985 (except for the purposes of Part III of the Act (use for trade)) and the Measuring Instruments (EEC Requirements) Regulations 1988, in so far as they relate to such instruments, but instruments in use immediately before that date may continue to be used under existing provisions in accordance with regulation 3.

In accordance with the Directive, the Regulations distinguish between two categories of use—

(1) instruments used for an application set out in Article 1.2(a) of the Directive repeated in Schedule 3 (“Schedule 3 applications”) must satisfy the essential requirements set out in Annex I of the Directive (set out in Schedule 2) (regulation5) and

(2) instruments which are used for any other application must bear only certain inscriptions (regulation 6).

Provisions of the Regulations

The Regulations—

(1) prohibit the use of instruments for Schedule 3 applications and the supply of instruments for other applications unless the relevant requirements have been met (regulation 4)

(2) provide for conformity to relevant national standards corresponding to harmonised standards adopted by one or both of the European Committee for Standardisation and the European Committee for Electrotechnical Standardisation to be taken as a means of satisfying the essential requirements (regulation 7)

(3) specify the weights to be used for testing instruments for the purposes of EC verification, EC unit verification, EC declaration of type conformity and testing in service (regulation 8)

(4) provide for designation by the Secretary of State of bodies to carry out the examination, evaluation and surveillance of quality systems operated by manufactures of instruments and EC verification (“approved bodies”) for the variation, amendment or withdrawal of approval; the inspection by the Secretary of State for the performance of its functions as an approved body; and for the designation of all weights and measures authorities to carry out inspection and testing of instruments (regulation 9)

(5) provide for the Secretary of State to consider application for type-examination, to issue EC type-approval certificates and additions to such certificates approving modifications or additions to approved types (regulation 10 and Schedule 1)

(6) provide for only one application for EC type-examination to be made in respect of any one instrument (regulation 10(10))

(7) provide for EC verification, the procedure whereby—

(i)the manufacturer ensures and declares that the instruments have been manufactured in conformity with the approved type (where appropriate) and satisfy the relevant provisions of the Directive by affixing the CE conformity marking and the sticker, and

(ii)an approved body examines and tests such instruments to verify the same by affixing its identification number (regulation 11, 18 and Schedule 4)

(8) provide for EC unit verification, the procedure whereby—

(i)the manufacturer ensures and declares that a single instrument satisfies the relevant provisions of the Directive, including the essential requirements, by affixing the CE conformity marking and the sticker, and

(ii)the Secretary of State examines and tests the instrument to verify the same by affixing his identification number (regulations 12, 18 and Schedule 4)

(9) provide for approved bodies to approve manufacturers' quality systems, thus authorising them to make EC declarations of type conformity in respect of instruments manufactured by them and to affix the CE marking and the sticker (regulations 13 and 18 and Schedule 4)

(10) specify the examinations and tests and regulate the places where the tests may be carried out, for the purposes of EC verification, EC unit verification and EC declaration of type conformity (regulation 14)

(11) provide for the periodic surveillance by an approved body of the manufacturer’s maintenance and application of the approved quality system and for withdrawal of the approval of the quality system if its requirements are not met (regulations 15 and 17)

(12) provide for the suspension of EC declarations of type conformity in certain circumstances and for a review procedure (regulations 16 and 21)

(13) forbid the affixing of the CE marking to an instrument if this would indicate compliance with other binding Community provisions with which the instrument does not comply (regulation 19)

(14) provide for the issue of notices to a manufacturer in cases where the CE marking has been wrongly affixed, for a review procedure and for withdrawal of the EC type-approval certificate (regulations 20 and 21)

(15) give information about the validity of judicial review of decisions of the Secretary of State and of approved bodies (regulation 22)

(16) provide for penalties and forfeiture in connection with the unauthorised affixing of the CE marking, inscriptions and sticker (regulation 23)

(17) provide for the affixing of disqualification stickers on instruments and for powers of inspection, testing and entry (regulations 24, 25, 27 and 38)

(18) provide for the withdrawal from the market, and from use, of instruments which are not satisfactory (regulation 26)

(19) make provision in relation to instruments which are used for trade (regulations 28 to 37) regulation 28 prohibits use of instruments for weighing outside their weighing range solely in relation to gold and other precious metals, precious stones and pearls and drugs and other pharmaceutical products; and

(20) provide penalties for obstruction of, or failure to assist, authorised persons for prosecution of offences (regulations 39 and 40 to 42).

The Regulations (except regulations 28 to 37) apply with modifications to Northern Ireland (regulation 43 and Schedule 5).

Modifications of the 1992 Regulations

The changes of substance from the Non-automatic Weighing Instruments (EEC Requirements) Regulations 1992 are as follows. The Regulations—

(a)allow for the affixing of the EC mark of conformity in accordance with the 1992 Regulations until 1st January 1997 (regulation 1)

(b)amend the definitions of EC verification and EC unit verification (regulation 2(1))

(c)amend the procedures for EC verification and EC unit verification to permit both the manufacturer or his authorised representative to apply the CE marking (regulations 11 and 12)

(d)require the manufacturer or his authorised representative in the case of EC verification and EC unit verification to draw up a written declaration of conformity to the approved type and the Directive (regulations 11, 12 and 13)

(e)require the approved body in the case of EC verification to supply to the manufacturer or his authorised representative a written certificate of conformity relating to the tests carried out (regulation 11);

(f)require the Secretary of State in the case of EC unit verification to supply to the manufacturer or his authorised representative a written certificate of conformity relating to the tests carried out (regulation 12)

(g)amend the procedure for EC declaration of type conformity to permit the manufacturer’s authorised representative (in addition to the manufacturer) to apply the CE marking (regulation 13)

(h)provide that the CE marking is as illustrated in Schedule 4 without the addition of the last two digits of the year in which it was affixed (regulation 18(5))

(i)amend the provisions relating to conformity with other directives, where those directives include transitional arrangements, so that the manufacturer is now required to make a positive declaration specifying other directives which he has applied (regulation 19) and

(j)simplify the provisions relating to the wrongful affixing of the CE marking so that they apply only to an instrument which does not meet the requirements of the Regulations (regulation 20).

Relevant national standards

In the United Kingdom, the relevant national standards referred to—

• in regulations 7, 8(2), 10(2)(c) and 14(8) are currently British Standard Specification for Metrological aspects of non-automatic weighing instruments BS EN 45501: 1994+AC:1994; and

• in regulation 13(3) are currently Quality system Model for quality assurance in production and installations BS EN ISO 9002:1994.

Copies of these British Standards can be obtained from any of the sales outlets operated by the British Standards Institution (BSI), by post from the BSI at Linford Wood, Milton Keynes, MK14 6LE and at any HMSO bookshop.

International Organisation for Legal Metrology

Copies of Nonautomatic weighing instruments, Part I: Metrological and technical requirements-Tests (see regulation 2(4) may be obtained from the International Organisation for Legal Metrology, 11 rue Turgot, Paris, 75009, France.

Compliance Cost Assessment

A Compliance Cost Assessment of the impact that these Regulations will have on business will be available in the libraries of the Houses of Parliament once the Regulations, having been made, are laid before Parliament and from the National Weights and Measures Laboratory, Stanton Avenue, Teddington, Middlesex, TW11 0JZ.