COUNCIL DIRECTIVE of 20 June 1990 on the harmonization of the laws of the Member States relating to non-automatic weighing instruments (90/384/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas Member States have the responsibility of protecting the public against incorrect results of weighing operations by means of non-automatic weighing instruments when used for certain categories of applications;
Whereas, in each Member State, mandatory provisions fix
in particular the necessary performance requirements
of non-automatic weighing instruments by specifying metrological and technical requirements, together with inspection procedures before and after going into service; whereas these mandatory provisions do not necessarily lead to different levels of protection from one Member State to another but do, by their disparity, impede trade within the Community;
Whereas the national provisions ensuring such protection must be harmonized in order to guarantee the free movement of non-automatic weighing instruments while ensuring a justified level of protection in the Community;
OJ No C 297, 25. 11. 1989, p. 13.
OJ No C 149, 18. 6. 1990.
Whereas Community legislation as it stands at present provides that, notwithstanding one of the fundamental rules of the Community, namely the free movement of goods, barriers to intra-Community movement resulting from disparities in national laws on the use of products have to be accepted in so far as the provisions of those national laws
are recognized as necessary to ensure that the products concerned meet essential requirements; whereas the harmonization of laws in the present case must therefore be confined to those provisions needed to ensure that non-automatic weighing instruments satisfy the essential metrological and performance requirements; whereas, because they are essential, these requirements must replace the corresponding national provisions;
Whereas this Directive therefore contains only mandatory and essential requirements; whereas, to facilitate proof of conformity with the essential requirements, it is necessary to have harmonized standards at European level, in particular as to the metrological, design and construction characteristics, so that instruments complying with those harmonized standards may be assumed to conform to the essential requirements; whereas these standards, harmonized at European level, are drawn up by private bodies and must remain non-mandatory texts; whereas for that purpose the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the competent bodies for the adoption of harmonized standards in accordance with the general guidelines for cooperation between the Commission and those two bodies signed on 13 November 1984; whereas, within the meaning of this Directive, a harmonized standard is a technical specification (European standard or harmonized document) adopted by one or both of those bodies upon a remit from the Commission in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in
the field of technical standards and regulations (4), as amended by Directive 88/182/EEC (5), and the abovementioned general guidelines;
Whereas assessment of conformity with the relevant metrological and technical provisions is necessary to provide effective protection for users and third parties; whereas, the existing conformity assessment procedures differ from one Member State to another; whereas, to avoid multiple assessments of conformity, which are in effect barriers to the free movement of the instruments, arrangements should be made for the mutual recognition of conformity assessment procedures by the Member States; whereas, to facilitate the mutual recognition of conformity assessment procedures, harmonized Community procedures should be set up, together with harmonized criteria for the designation of the bodies responsible for carrying out tasks pertaining to the conformity assessment procedures;
Whereas it is therefore essential to ensure that such designated bodies ensure a high level of quality throughout the Community;
Whereas the presence on a non-automatic weighing instrument of the EC mark of conformity or of the sticker bearing the letter 'M' indicates that there is a presumption that it satisfies the provisions of this Directive and therefore makes it unnecessary to repeat the assessments of conformity already carried out;
Whereas the measures aimed at the gradual establishment of the internal market must be adopted by 31 December 1992; whereas the internal market consists of an area without internal frontiers within which the free movement of goods, persons, services and capital is guaranteed,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
Scope, placing on the market, free movement
Article 1
1. A weighing instrument is defined as a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics.
A non-automatic weighing instrument is defined as a weighing instrument requiring the intervention of an operator during weighing.
This Directive applies to all non-automatic weighing instruments, hereinafter referred to as 'instruments'.
2. A distinction is made in this Directive between two categories of instrument use:
(a) 1. determination of mass for commercial transactions;
2. determination of mass for the calculation of a
toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;
3. determination of mass for the application of laws
or regulations; expert opinion given in court proceedings;
4. determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;
5. determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories;
6. determination of price on the basis of mass for
the purposes of direct sales to the public and the making-up of prepackages;
(b)
all applications other than those listed in point 2 (a) of this Article.
Article 2
1. Member States shall take all steps to ensure that instruments may not be placed on the market unless they meet the requirements of this Directive which apply to them.
2. Member States shall take all steps to ensure that instruments may not be put into service for the uses referred to in Article 1 (2) (a) unless they meet the requirements of this Directive which apply to them.
Article 3
Instruments used for the applications listed in Article 1 (2) (a) must satisfy the essential requirements set out in Annex I.
In cases where the instrument includes or is connected to devices which are not used for the applications listed in Article 1 (2) (a), such devices shall not be subject to the essential requirements.
Article 4
1. Member States shall not impede the placing on the market of instruments which meet the requirements of this Directive which apply to them.
2. Member States shall not impede the putting into service for the uses referred to in Article 1 (2) (a) of instruments which meet the requirements of this Directive which apply to them.
Article 5
1. Member States shall presume conformity with the essential requirements referred to in Article 3 in respect of instruments which comply with the relevant national standards implementing the harmonized standards that meet the essential requirements referred to in Article 3.
2. The Commission shall publish the references of the harmonized standards referred to in paragraph 1 in the Official Journal of the European Communities.
Member States shall publish the references of the national standards referred to in paragraph 1.
Article 6
Where a Member State or the Commission considers that the harmonized standards referred to in Article 5 (1) do not fully meet the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the Standing Committee set up under Directive 83/189/EEC, hereinafter referred to as 'the Committee', giving its reasons for doing so. The Committee shall deliver an opinion without delay.
In the light of the Committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the publications referred to in Article 5 (2).
Article 7
1. Where a Member State considers that instruments bearing the EC mark of conformity referred to in Annex 2, sections 2, 3 and 4, do not meet the requirements of this Directive when properly installed and used for the purposes for which they are intended, it shall take all appropriate measures to withdraw those instruments from the market or to prohibit or restrict their being put into service and/or placed on the market.
The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision, and in particular whether non-compliance is due to:
(a) failure to meet the essential requirements referred to in Article 3, where instruments do not meet the standards referred to in Article 5 (1);
(b)
incorrect application of the standards referred to in Article 5 (1);
(c)
shortcomings in the standards referred to in Article 5 (1) themselves.
2. The Commission shall enter into consultation with the parties concerned as soon as possible.
After such consultation the Commission shall immediately inform the Member State, which took the action, of the result. Should it find that the measure is justified it shall immediately inform the other Member States.
If the decision is attributed to shortcomings in the standards, the Commission, after consulting the parties concerned, shall bring the matter before the Committee within two months if the Member State which has taken the measures intends
to maintain them, and shall subsequently initiate the procedures referred to in Article 6.
3. Where an instrument which does not comply bears the EC mark of conformity, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.
CHAPTER II
Conformity assessment
Article 8
1. The conformity of instruments to the essential requirements set out in Annex I may be certified by either of the following procedures as selected by the applicant:
(a) EC type examination as referred to in Annex II.1, followed either by the EC declaration of type conformity (guarantee of production quality) as referred to in Annex II.2, or by the EC verification as referred to in Annex II.3.
However, EC type examination shall not be compulsory for instruments which do not use electronic devices and whose load-measuring device does not use a spring to balance the load;
(b)
EC unit verification as referred to in Annex II.4.
2. The documents and correspondence relating to the procedures referred to in paragraph 1 shall be drafted in an official language of the Member State where the said procedures are to be carried out, or in a language accepted by the competent body.
3. Where the instruments are subject to other Community Directives concerning other aspects, the EC mark referred to in Article 10 shall indicate in these cases that the instruments also fulfil the requirements of the other Directives.
Article 9
1. Member States shall notify to the other Member States and the Commission the bodies which they have designated for carrying out tasks pertaining to the procedure referred to in Article 8, the specific tasks for which each body has been designated, and the identification codes of the designated bodies.
The Commission shall publish the list of these notified bodies, together with the tasks for which they have been designated, in the Official Journal of the European Communities and shall ensure that the list is kept up to date.
2. Member States shall apply the minimum criteria set out in Annex V for the designation of bodies. Bodies which satisfy the criteria fixed by the relevant harmonized standards shall be presumed to satisfy the criteria set out in Annex V.
3. A Member State which has designated a body shall cancel the designation if the body no longer meets the criteria for designation referred to in paragraph 2. It shall immediately inform the other Member States and the Commission thereof and withdraw the notification.
CHAPTER III
EC mark of conformity and inscriptions
Article 10
1. The EC mark of conformity and the required supplementary data as described in Annex IV.1 shall be affixed in a clearly visible, easily legible and indelible form
to instruments for which EC conformity has been established.
2. The inscriptions referred to in Annex IV.2 shall be affixed in a clearly visible, easily legible and indelible form to all other instruments.
3. The affixing to instruments of marks which are likely to be confused with the EC mark of conformity shall be prohibited.
Article 11
Where it is established that the EC mark of conformity has been wrongly affixed to instruments:
- not conforming to the standards referred to in Article 5 (1), where the manufacturer has chosen to manufacture instruments that conform to those standards,
- not conforming to an approved type,
- conforming to an approved type which does not meet the essential requirements applicable to it,
- in respect of which the manufacturer has failed to fulfil his obligations under the EC declaration of type conformity (guarantee of production quality),
the competent notified body shall, where necessary, withdraw the EC type-approval and/or the approval of the quality system. Withdrawal of EC type-approval shall have the effect of prohibiting submission for EC verification and the EC declaration of type conformity (guarantee of production quality).
Article 12
Where an instrument which is used for any of the applications referred to in Article 1 (2) (a) includes or is connected to devices that have not been subject to conformity assessment as referred to in Article 8, each of these devices shall bear the symbol restricting its use as defined by Annex IV.3. This symbol shall be affixed to the devices in a clearly visible and indelible form.
CHAPTER IV
Final provisions
Article 13
Member States shall take all steps to ensure that instruments bearing the EC mark attesting conformity with the requirements of this Directive continue to conform to those requirements.
Article 14
Any decision taken pursuant to this Directive and resulting in restrictions on the putting into service of an instrument shall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the judicial remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.
Article 15
1. Member States shall, before 1 July 1992, adopt and publish the laws, regulations and administrative provisions necessary in order to comply with this Directive. They shall forthwith inform the Commission thereof.
2. Member States shall apply such provisions from 1 January 1993.
3. However, by way of derogation from paragraph 2, Member States shall permit during a period of 10 years from the date on which they apply the provisions referred to in
paragraph 1 the placing on the market and/or putting into service of instruments which conform to the rules in force before that date.
4. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.
5. Directive 73/360/EEC shall be repealed as from 1 January 1993, except as regards the application of paragraph 3.
Article 16
This Directive is addressed to the Member States.
Done at Luxembourg, 20 June 1990.