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- What are the conformity assessment procedures to be applied?
- What must be included in the technical documentation?
- Who must keep the technical documentation and where?
- Where must the CE marking be affixed?
- What is the meaning of, and are the requirements of the CE marking?
- Who must keep the declaration of conformity and where?
- What must be included in the declaration of conformity?
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Which are the mandatory safety requirements applicable in the EU?
- Article 2 of the Directive states:
- 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.
- 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 [17].
- 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) [18]
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 Articles 226, 227 and 228 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:
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.
A harmonised standard can be used to provide a presumption of conformity at the moment of the first national publication [21] of the standard according to Article 5, second paragraph, and in this regard the listing in the Official Journal of the EU is only for information, in accordance with Article 5, third paragraph. The Official Journal also contains the date of cessation of presumption of conformity of the superseded standard, which is considered to be the date beyond which a harmonised standard is no longer considered to be up to date in the light of technological progress and the developments in good engineering practice in safety matters (Article 5, second paragraph). In this regard the listing therefore provides the definitive text.
- 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.
[17] Judgements in Case 106/77 Simmenthal (ECR 1978, p. 645) and in Case 148/78 Ratti (ECR 1979, p. 1646).
[18] However, deviation may be justified in special cases by objective situations referred to at the end of paragraph 15.
[19] The differences between "harmonised standards" according to the new approach and harmonised standards under the "Low Voltage" Directive are explained in the "Guide to the implementation of Community harmonisation Directives based on the new approach", see in particular footnotes 73 and 74 at p. 28.
[20] "CEE" does not exist any longer but its activities are now continued by CENELEC.
[21] It is up to each Member State to determine in the national laws transposing the LVD which national publication confers this presumption under the pre-conditions that the publication is widely available and references all published standards. After this first publication it may be used not only in the territory concerned but anywhere in the world to gain a presumption of conformity.
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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 [25]:
The declaration of conformity must be drawn up at least in one of the official languages of the Community.
A number of questions have been raised on the issue of the Declaration and the need to show compliance to the latest Directive.
It was further accepted, that from the date on which Directive 2006/95/EC came into force (i.e. 16th January 2007), all newly issued documents, especially Declarations of Conformity and Technical Files, where references are made, should refer to this Directive.
However, there is no need to update existing documents, as long as no other corrections are necessary.
[22] These obligations do not extend to an importer who will, in general, not have a detailed knowledge of which directives have been considered or technical specifications applied.
[23] Annex IV of the "Low Voltage" Directive states that the manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the products with the technical documentation and the requirements of the Directive.
[24] With regard to electrical consumer products, cf. also the obligations of "distributors" under Article 5(2) and (3) of the General Product Safety Directive (GPSD) 2001/95/EC. The relationship between the LVD and the GPSD is discussed in Section VI below.
[25] See also EN 45014 containing an example of a declaration of conformity.
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