New Guide Offers Advice to Economic Operators on Meeting LVD Obligations


11 December 2018

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The EU Low Voltage Directive (LVD) specifies obligations for economic operators, meaning manufacturers of in-scope electrical equipment, authorized representatives of manufacturers, importers and distributors.

If you are involved in the supply of electrical equipment for placing on the EU market, you will be, or work for, an economic operator. As such, the European Commission’s new guidelines regarding the application of the LVD – “the LVD Guide” – is likely to be of interest to you. In particular, Chapter 2 of the LVD Guide identifies the legal obligations falling upon economic operators and gives advice on how these obligations can be interpreted and fulfilled. The advice can broadly be divided between that which has general application – this relates to legal obligations that can fall upon two or more economic operators – and that which is for individual economic operators (e.g. a manufacturer, an importer, etc.). This article will consider the advice with general application first before moving to tabulate advice specific to individual economic operators.

It should be noted that although the LVD Guide is published by the European Commission (accessible at http://ec.europa.eu/DocsRoom/documents/31221) it is not legally binding.

Advice related to obligations that can fall upon two or more economic operators
As written in the LVD, legal obligations falling upon two or more economic operators can sometimes be insufficiently detailed to account for which operator has direct responsibility for their fulfilment. The LVD Guide recognizes where challenges arise and provides some useful advice for industry, as follows.

Provision of information/documentation in response to an authority
Any economic operator involved in the supply of electrical equipment falling in scope of the LVD faces the obligation to provide a competent national authority with “all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the electrical equipment [with the LVD]” (Articles 6(9), 7(2)(b), 8(9) and 9(5) of the LVD). Providing this information and documentation should follow what the LVD terms a “reasoned request”, however this is not elaborated upon any further in the Directive. All the economic operators also share the obligation to “cooperate with [the] authority, at its request, on any action taken to eliminate the risks posed by electrical equipment which they have placed on the market” (Articles 6(9), 7(2)(c), 8(9) and 9(5) of the LVD). As the LVD Guide acknowledges, there is no specific time limit when it comes to providing requested information and documentation. It is then suggested that this is likely to be judged on a case-by-case basis with a possible default period 10 working days. More interestingly, perhaps, is the comment in the LVD Guide that Member States are “free to fix a default period in their national laws” – something that does not appear to have been legislated for to date. Whether a default period is written into any national legislation in the future only time will tell.

Translation of instructions and safety information
Manufacturers, importers and distributors share the obligation to ensure that in-scope electrical equipment is accompanied by instructions and safety information in “a language which can be easily understood by consumers and other end-users, as determined by the Member States concerned.” However, as the LVD Guide points out, the Directive does not state which of the three economic operators is responsible for translating the information. The LVD Guide’s advice is to begin with a point of principle: it is for each economic operator that makes in-scope electrical equipment available in an EU Member State to ensure that instructions are available in all the languages required. Furthermore, economic operators may wish to share meeting the obligation via contractual arrangements. The LVD Guide contextualizes this by discussing a situation where a manufacturer provides the instructions and safety information in a set of languages applicable to EU Member States where he intends to ship the equipment. However, if the equipment then sees movement into a market not originally intended for supply by the manufacturer, the importer and the distributor must ensure translation into the required language(s).

Translation of the Declaration of Conformity (DoC)
Upon request by a national authority, the DoC is to be made available in the language required by the Member State in whose territory the electrical equipment is placed on the market. Just as with instructions and safety information discussed above, the LVD does not state which economic operator must fulfil this obligation (the manufacturer is to draw up the DoC, but is not necessarily obliged to translate it). Also just as with instructions and safety information, the LVD Guide suggests the fulfilment of the obligation is addressed in contractual arrangements between relevant economic operators.

Addressing formal non-compliance
Article 22 of the LVD identifies various non-compliance issues (e.g. absence of a CE marking, no DoC, etc.) that “the relevant economic operator” may be obliged to address, although says nothing about the time in which one or more of these issues must be resolved in. Unfortunately the LVD Guide offers little additional direction here, merely suggesting it is for authorities to judge on a case-by-case basis and, for economic operators, good cooperation with the authorities is key.

Presumption of conformity
The presumption of conformity is only conferred when the reference of the harmonized standard is published in the EU Official Journal. Also, it is just the harmonized standard that is relevant – guidance documents on harmonized standards cannot confer the presumption of conformity.

Equipment modification and/or “own labeling” of the equipment by an importer or distributor
The LVD Guide is clear that the importer or distributor is considered the manufacturer in these situations and should therefore assume the corresponding obligations. This means replacing/updating the DoC (it should be in the importer’s or distributor’s name and signed by a suitable representative of the business) but not necessarily replacing test reports, certificates and other accompanying documentation provided this remains relevant.

Advice for individual economic operators
This is as tabulated below.

Economic Operator LVD Article Obligation Advice Given in the LVD Guide
Manufacturer 6(1) Electrical equipment shall be designed and manufactured in accordance with LVD safety objectives. This applies to every single product manufactured and placed on the EU market.
6(4) Procedures shall exist for series production to remain in conformity with the Directive. From page 27: …it is therefore crucial that the manufacturer monitors any changes in hardware/software, developments in applicable standards and legislation and that the state of the art is taken into account adequately. In addition, the considerations given by the manufacturer to these changes shall be reported in the technical documentation.
6(5) Electrical equipment shall bear a type, batch or serial number for identification purposes.

From page 28: The important point is that the numbering must allow making a clear link to the relevant documentation that demonstrates the conformity of the specific type of product, in particular the Declaration of Conformity.

A barcode can also be used if this is considered by a manufacturer as an appropriate way of enabling the manufacturer to identify and trace its products. Depending on the product, it is up to the manufacturer to determine whether the barcode or other identifier should allow the identification of each individual single product or just the relevant batch or type. But manufacturers should be aware that when public authorities recall products and if it is not possible to distinguish between type, batch or serial number or other element allowing identification of the product, all products of the type might be required to be removed from the market.

6(5) Where the size or nature of the electrical equipment does not allow it, the numbering or other identifier (e.g. barcode) shall be provided on the equipment packaging or in an accompanying document. If the information is not visible at first sight, it must be easily and safely accessible.
6(6) The manufacturer's name, registered trade name or registered trade mark and the postal address at which they can be contacted shall go on the electrical equipment or, failing that, the equipment packaging or in a document accompanying the equipment.

It is up to the manufacturer to assess where the information is affixed.

Relevant factors are size and physical characteristics of the equipment. Aesthetics are not deemed to be reason enough to present the information on the equipment's packaging or in an accompanying document.

From pages 28-29:

The address or the country does not necessarily have to be translated into the language of the Member State where the equipment is made available on the market. However, the characters of the language used must allow identifying the origin and the name of the company. This is not possible with certain alphabets.

If the information is put inside the electrical equipment, it must be easily accessible to market surveillance authorities without damaging the equipment or the need for disassembling it with specific tools.

6(7) Electrical equipment shall be accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-user. From page 29: The LVD does not make a distinction about who the user of the product is. Both the instructions and safety information accompanying the electrical equipment can be included in a single document. Manufacturers should implement the legal requirements of the Member States regarding languages.
6(8) Where the electrical equipment presents a risk, manufacturers shall immediately inform the competent national authorities. The LVD Guide says little about assessing risk, other than it is the manufacturer's responsibility and that the assessment should be focused upon the LVD's safety objectives.
Authorized representative 7(1) A manufacturer may appoint an authorized representative by a written mandate. The LVD Guide says that this is at the choice of the manufacturer and he is not obliged to do so.
Importer 8(2) The electrical equipment shall be accompanied by required documents. For an importer, the required documents are only the instructions and safety information.
8(8) For 10 years after the electrical equipment is placed on the EU market, the importer shall keep a copy of the DoC and ensure that technical documentation can be made available.

From page 33:

…the importer is advised to get formal assurance from the manufacturer that the documents will be made available when requested by the market surveillance authority. The technical documentation can be given directly by the manufacturer to the market surveillance authorities. What is important is that the authorities receive the documentation and that at the importer's request, the manufacturer provides the information to Member States.

Distributor 9(2) The electrical equipment shall be accompanied by required documents and by instructions and safety information. For a distributor, the requirements are the instructions and safety information (seemingly there is no other set of required documents beyond these).
9(2) The distributor shall ensure that the manufacturer and the importer have complied with the requirements set out in Article 6(5) and (6) and Article 8(3).

From page 34:

The distributor does not have to keep a copy of the Declaration of Conformity or the technical documentation. However he must be able to identify the manufacturer, his authorized representative, the importer or the person who has provided him with the product in order to assist the market surveillance authority in its efforts to obtain the EU Declaration of Conformity and the necessary parts of the technical documentation.

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Written by Dr Alex Martin

Dr Alex Martin, Senior Regulatory Consultant, RINA Alex is a technical professional with over 10 years’ experience working on product regulation, standards and policy issues in the UK and internationally. The focus of this work has been largely environmental, covering the likes of batteries, biocidal products, ecodesign, energy labeling, packaging, REACH, RoHS, timber sustainability and WEEE. Alex is also knowledgeable on a range of EU and UK product safety and consumer protection legislation (e.g. GPSD, LVD, PPE, toy safety, textile and footwear materials, product liability and guarantees) and quality, environmental and social compliance management standards.