These guidelines have been prepared with a view to assist all parties directly or indirectly involved in the application of Directive 73/23/EEC, the "Low Voltage" Directive. They supersede guidance on the application of that Directive which was given in the Commission's communication of 15 December 1981.
They have been drawn up by European Commission services and discussed with a Working Party of Government Experts, representatives of European industry and European standardization bodies. These guidelines reflect the consensus views reached between Commission services and representatives of the Member States in the Working Party.
Readers' attention is drawn to the fact that this Guide is intended only for facilitating the application of the "Low Voltage" Directive and it is the text of the Directive which is legally binding.
This document is not a legally binding interpretation of the Directive. However, it represents a reference for ensuring consistent application of the Directive by all those involved.
These guidelines are not exhaustive: they focus on certain issues only, which, in the light of the experience, are of direct and specific interest for the application of the "Low Voltage" Directive. They are intended to complement the "Guide to the implementation of Community harmonization directives": published for the first time by the Commission in 1994, as far as issues related in particular to the application of this Directive are concerned. In particular, for the definitions of concepts like "placing on the market", "manufacturer", authorised representative", "importer or person responsible for placing the product on the market", the Guide mentioned above should be consulted.
The issues covered by these guidelines are:
the scope of the "Low Voltage" Directive
the safety requirements applicable
the conformity assessment procedure applicable, including CE marking
the relationships with certain other Directives.
Reader’s attention is drawn to the fact that certain products subject to the "Low Voltage" Directive are also subject to other directives. In order to be allowed on the EC market these products must comply also with the provisions of those directives. These guidelines refer to the application of the "Low Voltage" Directive and clarify the relationship between that Directive and certain other directives.
II. THE "LOW VOLTAGE" DIRECTIVE
Directive 73/23/EEC was adopted by the Council on 19 February 1973 with the aim of harmonising the laws of the Member States relating to electrical equipment designed for use within certain voltage limits.
In 1993 that Directive was amended by Directive 93/68/EEC, the so-called "CE marking Directive", solely in respect of the procedures for conformity assessment and conformity marking. The objective of this amendment was to align the provisions concerning conformity assessment and the CE marking of electrical equipment on those introduced for the "new approach" directives.
The provisions introduced by the amendment mentioned become mandatory with effect from 1 January 1997.
The "Low Voltage" Directive is a "total" harmonisation directive in the sense that it has superseded existing national regulations in the field covered: electrical equipment may only be put on the market if it is in conformity with the requirements of the Directive and, on the other hand, Member States may not impede free circulation or the marketing of conforming equipment.
III. SCOPE OF THE "LOW VOLTAGE" DIRECTIVE
Which products are covered?
The Directive applies to all electrical equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current and between 75 and 1500 V for direct current. Voltage ratings refer to the voltage of the electrical input or output, not to voltages which may appear inside the equipment.
Battery operated equipment outside the voltage rating is obviously outside the scope of the LVD. Nevertheless, the accompanying battery-charger as well as equipment with integrated power supply units within the voltage ranges of the Directive, are in the scope of the LVD. This applies also, in the case of battery-operated equipment with supply voltage rating under 50 V AC and 75 V DC, for their accompanying power supply unit (e.g. Notebooks).
However, the following are excluded from the scope of the "Low Voltage" Directive:
Electrical equipment for use in a potentially explosive atmosphere
Electrical equipment for radiology and medical purposes
Electrical parts for lifts
which are covered by other Community directives, and
Plugs and socket outlets for domestic use
Electric fence controllers
Specialised electrical equipment, for use on ships, aircraft or railways which complies with the safety provisions drawn up by international bodies in which the Member States participate,
which so far are not covered by any Community directive and therefore must not be CE marked.
Broadly, the Directive covers consumer and capital goods designed to operate within those voltage limits, including in particular electrical appliances, hand-held electrically driven tools, lighting equipment including ballasts, switch gear and control gear, electric wiring, appliance couplers and cord sets, electrical installation equipment, etc. The Commission confirms, as already expressed in the Communication of 15 December 1982, that cable management systems are covered by the "Low Voltage" Directive.
Are "components" included in the scope?
In general, the scope of the Directive includes both electrical equipment intended for incorporation into other equipment and equipment intended to be used directly without being incorporated.
However, some types of electrical devices, designed and manufactured for being used as basic components to be incorporated into other electrical equipment, are such that their safety to a very large extent depends on how they are integrated into the final product and the overall characteristics of the final product. These basic components include electronic and certain other components.
Taking into account the objectives of the "Low Voltage" Directive, such basic components, the safety of which can only, to a very large extent, be assessed taking into account how they are incorporated, are not covered as such by the Directive. In particular, they must not be CE marked.
However, other electrical components which are intended for being incorporated into other electrical equipment, but for which a safety assessment is feasible, like - for example - some types of transformers and electrical motors, are covered as such by the Directive and must be CE marked.
Moreover, the scope of the exclusion of basic components must not be misunderstood and extended to items like lamps, starters, fuses, switches for household use, elements of electrical installations, etc., which, even if they are often used in conjunction with other electrical equipment and have to be properly installed in order to deliver their useful function, are themselves to be considered electrical equipment in the sense of the Directive.
Which safety aspects are covered by the Directive?
The Directive covers all risks arising from the use of electrical equipment, including not just electrical ones but also mechanical, chemical (such as, in particular, emission of aggressive substances) and all other risks. The Directive also covers health aspects of noise and vibrations, and ergonomic aspects as far as ergonomic requirements are necessary to protect against hazards in the sense of the Directive.
Article 2 and Annex I lay down eleven "Safety objectives", which represent the essential requirements of this Directive.
It should be noted that electromagnetic compatibility (emission and immunity) aspects are excluded from the scope of this Directive and are separately regulated under Directive 89/336/EEC.
Radiation aspects referred to in Annex I to the Directive are limited to those directly relevant for health and safety of persons and domestic animals and do not cover electromagnetic disturbances in the sense of the EMC Directive.
Finally, it should also be noted again that for certain electrical equipment, the provisions of other directives also apply.
IV. SAFETY REQUIREMENTS FOR PLACING ON THE EU MARKET ELECTRICAL EQUIPMENT COVERED BY THE "LOW VOLTAGE" DIRECTIVE
Which are the mandatory safety requirements applicable in the EU?
Article 2 of the Directive states:
"1. The Member States shall take all appropriate measures to ensure that electrical equipment may be placed on the market only if, having been constructed in accordance with good engineering practice in safety matters in force in the Community, it does not endanger the safety of persons, domestic animals or property when properly installed and maintained and used in applications for which it was made.
2. The principal elements of the safety objective referred to in paragraph 1 are listed in Annex 1."
Member States must ensure the freedom to place on the market and the free movement of electrical equipment which is in conformity with the requirements of the Directive.
As far as substantive safety requirements are concerned, eleven "objectives" are mentioned in Annex 1 to the directive.
These are the mandatory safety provisions which products must comply with in order to be allowed onto the EU market and benefit from freedom of movement in the Community (Articles 2 and 3). Consequently, any national standards or national specifications related to the safety of electrical equipment do not have a mandatory status and may not be a condition for its placing on the market.
Article 7 of the Directive provides for mutual recognition of national standards in case of absence of standards within the meaning of Articles 5 and 6. However, such national standards might, in certain cases, not cover all the "safety objectives" of the Directive. Therefore, manufacturers using those standards should carefully check compliance with all the safety requirements of the Directive.
The phrase at the end of Article 7 ("if it ensures a safety level equivalent to that required in their own territory") does not, per se, authorise Member States to require compliance with safety levels other than those resulting from the "safety objectives".
Nevertheless, compliance with the safety objectives of the Directive - which are henceforth identical for the whole Community - may imply in some cases compliance with different requirements from one Member State to another to take account of different objective situations, e.g. requirements resulting from supply systems which vary from one region of the Community to another.
In the light of the above, national laws or regulations requiring compliance with particular technical specifications (where they exist) may not be considered to be mandatory. They may only eventually have the status of specifications giving presumption of conformity, when appropriate.
It follows that manufacturers can no longer be obliged to comply with national specifications in the case of equipment otherwise satisfying the "safety objectives" of the Directive. Where the standards referred to in Articles 5 or 6 do not yet exist, manufacturers are, of course, entitled to comply with any appropriate specifications in order to facilitate demonstrating conformity with the "safety objectives".
The non mandatory nature of specifications in national rules is from the point of view of EC law confirmed by the rulings of the Court of Justice, according to which national authorities and courts must not apply national provisions which conflict with Community provisions
The existence of national laws or regulations cannot prevent the drawing up of harmonised standards in accordance with Article 5.
Nor can such provisions be imposed in addition to, or instead of, the technical specifications contained in the harmonised standards, as they have ceased to be binding.
Within the field covered by the Directive there is therefore no longer any point in referring to such provisions under "A-deviations" in "harmonisation documents" (HD) or "European standards" (EN)
Keeping these provisions in the legal system of the Member States in the form of obligatory provisions would constitute an infringement to the Directive and expose the Member States in question to the procedure set out in Article 169 of the Treaty.
How to ensure conformity to those requirements?
Products are presumed to conform to the safety objectives of the "Low Voltage" Directive where the equipment has been manufactured in accordance with technical standards which, in the order laid down by the Directive, are as follows:
- European standards (EN or HD), which are referred to as harmonised standards in the Directive, drawn up in accordance with Article 5 by the bodies notified by the Member States (in fact, these are standards made by CENELEC);
- where standards as defined in Article 5 have not yet been drawn up and published, international rules issued by the two international bodies, the International Commission on the rules for the approval of electrical equipment (CEE), (no longer exists, its duties have been taken over by CENELEC) or the International Electrotechnical Commission (IEC) (Article 6(1)), and published in accordance with the procedure laid down in Article 6(2) and (3);
- where standards as defined in Article 5 or international standards as defined in Article 6 do not yet exist, the national standards of the Member State of manufacturer (Article 7).
The standards referred to in Articles 5, 6 and 7, the application of which remains voluntary, provide a presumption of conformity for equipment manufactured in accordance with those standards.
The presumption of conformity provided by harmonised standards arises at the moment of national publication of standards, according to article 5; the listing in the Official Journal of the EC is only for information.
Alternatively, the manufacturer may construct the product in conformity with the essential requirements (safety objectives) of the directive, without applying harmonised, international or national standards. In such a case the product will not benefit from presumption of conformity conferred by the use of such standards and the manufacturer must include in the technical documentation (see chapter V) a description of the solutions adopted to satisfy the safety aspects of the Directive.
V. CONFORMITY ASSESSMENT PROCEDURES UNDER THE "LOW VOLTAGE" DIRECTIVE
What are the conformity assessment procedures to be applied?
Article 8 and Annex N of the Directive describe the procedure by which themanufacturer or his authorised representative established in the Community ensures and declares conformity of the electrical equipment with the provisions of the Directive. This includes three main elements.
Before a product is placed on the market the manufacturer puts together the technical documentation which makes it possible to assess whether the electrical equipment complies with the requirements of the Directive (see below)
Declaration of conformity.
The manufacturer or his authorised representative
established in the Community are also required, and are the only ones authorised to do so, to draw up in writing a declaration of conformity (see below) before placing the product on the market.
Before it is placed on the market the electrical equipment must have the "CE" marking affixed. Only the manufacturer or his authorised representative established in the Community are authorised to affix the "CE" marking (see below) .
Where no standards within the meaning of the Directive have been applied, the manufacturer has to provide within the technical documentation a description of the solutions adopted to satisfy the safety requirements of the Directive.
In case of challenge by the authorities in charge of market surveillance, a report in the sense of Article 8(2) (which however is not obligatory) is considered an element of proof. In fact, in addition to the three basic conformity assessment measures mentioned above, Article 8(2) provides, in the event that conformity is challenged, for the possible submission to the market surveillance authority of a report drawn up by a notified body as evidence that the electrical equipment complies with the safety objectives (Article 2 and Annex I).
The manufacturer or his authorised representative established in the Community may wish in certain cases to ask in advance for a report to be drawn up by a notified body in accordance with the procedure provided for in Article 11 and to keep it together with the technical documentation. The availability of such a report would make matters easier and speedier in the event of a challenge by the authorities.
The main function of article 8.2 is to provide the conditions most favourable to progress and dynamism in the Electrotechnical industry. It thus facilitates the marketing of high-tech electrical equipment which, being such, cannot benefit from the support of any technical standards since often such standards are drawn up after the development of a technical innovation.
What must be included in the technical documentation?
It must include details of the design, manufacture and operation of the electrical equipment in so far as these details are needed to assess the conformity of the electrical equipment with the requirements of the Directive.
Accordingly, it contains:
a general description of the electrical equipment,
design and manufacture drawings plus diagrams of components, sub-assemblies, circuits, etc.,
descriptions and explanations needed to understand the above mentioned drawings and diagrams plus the operation of the electrical equipment,
a list of the standards used, in full or in part, and a description of the solutions employed to meet the safety aspects of this directive when standards have not been applied,
the results of design calculations and of checks carried out, etc.,
test reports (in fact, the test reports which may be available, either established by the manufacturer or a third party).
Who must keep the technical documentation and where?
The manufacturer or his authorised representative established in the Community must keep this documentation at the disposal of the national authorities for inspection purposes for at least ten years from the last date of manufacture of the product. The technical documentation may be kept on electronic support, provided that it is easily accessible for inspection. Where the manufacturer is not established in the Community and he has no authorised representative in the Community, this obligation is incumbent upon the importer or the person responsible for placing the product on the Community market.
This technical documentation must be kept within the Community.
Where must the CE marking be affixed?
The "CE" conformity marking is placed by the manufacturer. or his authorised representative established in the Community. on the electrical equipment or, failing that, on the packaging, the instructions for use or the guarantee.
In spite of the differences in this point between the various linguistic versions of the Directive, in order to ensure consistency and prevent unjustified burdens, Article 10(2) of the Directive should be read as establishing the following order of priority: the "CE" marking must be placed on the product or, if this is not feasible (under technical/economic conditions which are reasonable in the light of the proportionality principle) on the packaging, the instructions for use or the guarantee.
What are the meaning of, and requirements for the CE marking?
The CE marking declares conformity of an electrical equipment with the essential requirements and conformity assessment procedures set out under the "Low Voltage" Directive and all the other directives applicable to it.
The "CE" conformity marking must be affixed visibly, legibly and indelibly.
The affixing of markings which are likely to deceive third parties as to the meaning and form of the "CE" marking is prohibited.
Who must keep the declaration of conformity and where?
The manufacturer, or his authorised representative established in the Community, or, when the manufacturer is not established in the Community and has no authorised representative in the Community, the importer or person responsible for placing the product on the market, must keep a copy of the declaration of conformity at the disposal of the national authorities for inspection purposes, in the same way as the technical documentation. Thus the national market surveillance authorities may, if appropriate, require a copy of the declaration of conformity.
What must be included in the declaration of conformity?
Annex III.B of the Directive describes the content of the declaration of conformity as follows:
- name and address of the manufacturer or his authorised representative established within the Community,
- a description of the electrical equipment,
- reference to the harmonised standards,
- where appropriate, reference to the specifications on which conformity is declared,
- identification of the signatory who has been empowered to enter into commitments on behalf of the manufacturer or his authorised representative established within the Community,
- the last two digits of the year in which the CE marking was affixed (for the first time).
The declaration of conformity must be drawn up at least in one of the official languages of the Community.
VI. RELATIONSHIPS BETWEEN THE "LOW VOLTAGE" DIRECTIVE AND CERTAIN OTHER COMMUNITY DIRECTIVES
What are the requirements applicable to electrical equipment which is also a "machine" (within the meaning of the "Machinery Directive")?
Certain electrical equipment are also "machinery" within the meaning of Directive 89/392/EEC as amended.
Both the "Low Voltage"Directive and the "Machinery"Directive cover a wide range of risks. Therefore, the scopes of the two Directives overlap in the case of certain electrical equipment, and a clarification on how to implement the Directives in those cases is necessary.
Certain electrical equipment which are also machinery, are excluded altogether from the scope of the "Machinery" Directive, by virtue of Article 1(5) of that Directive.
Article 1(5) of the "Machinery" Directive states that:
"Where, for machinery, the risks are mainly of electrical origin, such machinery shall be covered exclusively by Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits".
In general, in order to determine whether the exclusion from the scope of the "Machinery" Directive under Article 1(5) applies to a specific product which may be considered to be "Machinery" in the sense of Directive 89/392 and an electrical equipment in the sense of Directive 73/23, the manufacturer has to perform a risk assessment of that product.
The European Standard EN 1050 (Safety of Machinery - Principles for risk assessment) provides for principles which may be applied for performing such risk assessment.
When the results of the risk assessment by the manufacturer show that the risks are mainly of electrical origin, the machinery equipment will be covered exclusively by the "Low Voltage" Directive, which anyhow deals with all the safety aspects, including mechanical safety.
In determining whether the risks related to particular products are mainly of electrical origin, manufacturers may be assisted by risk assessment performed by the relevant standardisation bodies in relation to harmonised standards for the products considered, when it has led to publication of such standards under only the "Low Voltage"Directive or only the "Machinery"Directive based on consideration of the dominant risks.
Apart from machinery covered by Article 1(5), all machinery having an electrical supply and designed to operate between 50 and 1000 V in AC or 75 and 1500 V in DC is covered by both the "Machinery" Directive and the "Low Voltage" Directive, applying in a complementary way.
In fact, paragraph 1.5.1 of Annex I of the "Machinery" Directive says:
"1.5.1 Electricity supply
Where machinery has an electricity supply it must be designed, constructed and equipped so that all hazards of an electrical nature are or can be prevented.
The specific rules in force relating to electrical equipment designed for use within certain voltage limits must apply to machinery which is subject to those limits."
Therefore, in the case of machinery with an electrical supply within the voltage limits of the "Low Voltage" Directive:
a) the essential requirements of the "Low Voltage" Directive related to electrical risks shall be complied with and compliance with the relevant harmonised standards published under the "Low Voltage" Directive shall give a presumption of conformity with such essential requirements.
b) for all such machinery, including those falling under Annex IV of the "Machinery"Directive, the conformity assessment procedures set out in Article 8 of the "Machinery" Directive shall apply. In the case where a type- examination of the machinery is required, the notified body will take into account the results of the conformity assessment procedures of the "Low Voltage" Directive which apply to the intrinsic electrical safety of the electrical components of the machinery, whereas direct examination by the notified body will apply, i.a., to all risks arising from the way in which the electrical components are incorporated into a machinery and ensure their proper functioning.
Obviously, the considerations made in paragraph 9 above for electrical components apply as appropriate to the electrical components of a machinery.
To ensure consistency of application, CEN & CENELEC, under a mandate of the Commission have been requested to ensure that all harmonised electrical equipment standards comply with all the relevant Essential Safety Requirements of both the "Low Voltage" Directive and the "Machinery" Directive.
What are the requirements applicable to electrical equipment which is intended for hire permanently incorporated in construction works?
Some types of electrical equipment covered by the "Low Voltage" Directive are manufactured with a view to being permanently incorporated in construc-tion works. Consequently, such equipment must also be fit for use and meet the essential requirements as provided for by Directive 89/106/EEC and set out in the interpreting documents used as a reference to establish the harmonised standards under that Directive, and comply with the conformity assessment procedures set out in its Article 13.
As a result, application to such electrical equipment of the provisions of the "Construction Products" Directive presupposes the existence of both harmonised standards within the meaning of the "Construction Products" Directive and decisions concerning the conformity assessment procedures, again within the meaning; of that Directive.
Should these essential conditions not be met, the provisions of Directive 89/106/EEC cannot in practice be applied to the relevant electrical equipment.
However, the "Low Voltage" Directive sets a wide range of safety objectives, overlapping with essential requirements in Annex I to Directive 89/106/EEC. In order to best ensure the objectives of both directives, existing harmonised standards (as published under the "Low Voltage" Directive) are being examined in order to ensure that they are also consistent with the relevant essential requirements of the "Construction Products" Directive.
What is the relation with the "Telecommunication Terminal Equipment" and "Satellites" directives
Some electrical equipment is also considered as "terminal equipment": within the meaning of Article 2 of the "Telecommunication Terminal Equipment" Directive, or as "Satellite earth station equipment" within the meaning of Article 1 of the "Satellites" Directive.
That said, Article 4 of both directives implies that the equipment also covered by the "Low Voltage" Directive must continue to comply with all the provi- sions of that Directive, including the conformity assessment procedures and the affixing of the "CE" marking.
What is the relation with the "Gas Appliances" Directive
Appliances covered by the "Gas Appliances" Directive often include electrical components which fall also under the "Low Voltage" Directive. In particular, Article 1 of the "Gas Appliances" Directive specifies that the Directive also applies to safety devices, controlling devices or regulating devices and subassemblies (separately marketed for trade use and designed to be incorporated into an appliance burning gaseous fuel or assembled to constitute such an appliance". Some of these components, are or include electrical equipment. The "Gas Appliance" Directive and the "Low Voltage" Directive apply in a complementary way to electrical components (designed to be used in the voltage ranges of that Directive) incorporated (or to be incorporated) into gas appliances.
Conformity assessment within the framework of the "Gas Appliance" Directive shall be conducted in accordance with the procedure laid down in that Directive, taking into account the results of the conformity assessment procedures of the "Low Voltage" Directive, applied, in relation to the "Safety objectives" of this last Directive to electrical components of gas appliances. The safety aspects of the way in which the electrical components are incorporated into the gas appliances and ensure their proper functioning will be subject to direct examination by notified bodies.