The New Low Voltage Directive 2014/35/EU: An Overview

Transcription

1 Directive 2014/35/EU: An Intertek Cleeve Road, Leatherhead, Surrey KT22 7SB UK

2 Introduction The scope of the LVD Directive... 3 Exclusions from the Directive... 3 Safety Objectives of the Directive... 4 Responsibilities of Economic Operators... 4 Using Testing to Harmonised Standards for compliance... 7 Assessment without Harmonised Standards for compliance... 7 Technical File Requirements... 7 Risk... 8 Declaration of Conformity... 8 CE Marking... 9 Managing Non-conformity... 9 Penalties... 9 Key Points Summary How Intertek can help Download your copy of the recast Directive from 1

3 Introduction Anyone involved in the development and manufacture of electrical products destined for the EU in 2016 will need to demonstrate the compliance of their products with the requirements of the recast Low Voltage Directive (LVD) 2014/35/EU as this comes into force 20 th April The EU Commission have updated (and aligned) a number of Directives relating to the compliance of products put on the market in the EU; and of these, the Low Voltage Directive arguably affects the most products types. Paragraph (4) of the introduction states: The Directive covers electrical equipment designed for use within certain voltage limits which is new to the Union market when it is placed on the market; that s is to say it is either new electrical equipment made by a manufacturer established in the Union or electrical equipment, whether new or second hand imported from a third country. The LVD is part of a group of legislation issued by the EU Commission to enable free movement of goods around the Europe and a high level of protection for people, domestic animals and property through conformity assessment, the use of visible CE Marking that communicates compliance with users and consumers and Declarations of product conformity that inform and educate the supply chain. Other Directives in this group include: The Eco-Design & Energy Labelling Directive Electromagnetic Compatibility Directive Gas Appliances Directive The ATEX Directive The Machinery Directive The Measurement Instruments Directive Radio Equipment Directive This paper is intended to provide an overview of the recast Low Voltage Directive 2014/35/EU and its requirements. 2

4 The Low Voltage Directive 2014/35/EU is a compulsory piece of legislation that covers the responsibilities of manufacturers, authorised representatives, importers and distributors (known collectively as economic operators ), National accreditation bodies, Notified Bodies and their sub-contractors and surveillance authorities in regard to the conformity assessment of electrical products being made available on the EU market. Article 3 explains: Electrical equipment may be made available on the Union market only if, having been constructed in accordance with good engineering practice in safety matters in force in the Union, it does not endanger the health or safety of persons and domestic animals, or property, when properly installed and maintained and used in applications for which it was made. The recast Directive has been redrafted to match the layout and language of other later Directives and the document has been updated and the contents bought in line with Decision No. 768/2008/EU on a Common Framework for the Marketing of Products in the EU. The scope of the LVD Directive The Directive applies to electrical equipment with a voltage rating of between 50 and 1000V for alternating current and between 75 and 1500V for direct current. Exclusions from the Directive Specific items are explicitly excluded from the scope of the Directive. These are: Electrical equipment for potentially explosive atmospheres Equipment for radiology and medical purposes Electrical parts for goods and passenger lifts Electricity meters Plugs and socket outlets for domestic use Electric fence controllers. Equipment for ships, aircraft or railways covered by safety provisions of international bodies Custom electrical kits built for R & D purposes Notes: This list differs from the previous version of the Directive. Power tools, lawn mowers and electrical garden equipment items are no longer specifically excluded. 3

5 Safety Objectives of the Directive ANNEX I outlines the safety objectives for electrical product. This can be summarised as follows: To provide information on the product or it s accompanying documentation to enable it to be used safely for its intended purpose. The equipment and it s parts shall be made in a way that it can be properly assembled and connected The equipment shall be designed in such a way as to protect against, physical harm to people and domestic animals, that temperatures, {electrical} arcs or radiation are not produced, that people, domestic animals and property are protected against non-electrical dangers that come about through use of the electrical product and that the insulation used in the product is suitable for foreseeable conditions. That equipment should meet mechanical requirements so as not to cause a danger to people, domestic animals and property That it is resistant to non-mechanical influences in expected conditions That it does not endanger people, domestic animals and property in foreseeable overload conditions. Note: Paragraph 25 makes a specific point that Electrical equipment should be considered as non-compliant with the safety objectives laid down in this Directive only under conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour which offers a degree of protection to manufacturers regarding unforeseen misuse of their product. What can be considered misuse is arguable, but this provision does reinforce the importance of compliance being assessed in context of use intended by the manufacture. Responsibilities of Economic Operators All economic operators in the supply chain have a responsibility to: take appropriate measures to ensure that they only make available on the market electrical equipment which is in conformity with this Directive. (Paragraph 7) The summary table below outlines the specific conformity responsibilities of each operator. Task Manufacturer Authorised Rep Importer Distributor Design and build in accordance with ANNEX I Only place compliant product on the market 4

6 Draw-up technical documentation outlined in ANNEX III Ensure all compliance documentation is in place Keep documentation for 10 years after the product is placed on the market Ensure series production should remain in conformity - even as Standards change Can carry out sample testing to protect safety of users Keep a register of complaints Ensure products carry identifying data such as batch details or serial no. on product (or packaging or documentation if product is too small to carry it) Check identifying data is in place Include their name and address and a clear point of company contact Check contact data is in place Ensure instructions and safety data is included Take corrective actions immediately a product is believed not to comply and notify national authorities Notify Manufacturer and market surveillance authorities if equipment presents a risk To store and transport goods in a way that does not compromise the compliance of the product Co-operate with national authorities. providing information (+importer notification) on request NOTE: If importers or distributors place a manufacturers product on the market under their own trade name or brand, they will be considered the manufacturer and have to meet the manufacturer s obligations Manufacturers Conformity assessment is the sole responsibility of the manufacturer, but his authorised representative can also fulfil certain duties on his behalf. Manufacturers are also encouraged by the legislation to include a web address alongside their postal address on the product (paragraph 8) to enable greater traceability of the product. 5

7 Authorised representatives at very least they should hold the CE Conformity Documentation for 10 years after the end of production, provide the authorities with this documentation on request and cooperate with the authorities on eliminating risks that the products pose. Importers Importers must check that the compliance work for the product has been completed, and provide their contact details on the products alongside the Manufacturers (to ensure tracability). They must ensure that instructions and information is issued with the product in a language acceptable to the member state and they must not jeopardise the product s compliance in their storage or transportation of the product. They also have an obligation to take corrective action where a product isn t in compliance or if it poses a risk to report it to the national authorities in all the countries that they made it available to. They must hold documentation for 10 years after the last sale and cooperate national authorities on risk elimination. Distributors Distributors must apply due care concerning the Directive basically they should verify that the product bears CE Marking, and is accompanied by the appropriate documentation in a language easily understood but the end users. If they believe a product not Importers /Distributors reduce your risks! Many organisations forget that the judders and jolts of transportation can fracture product casings, break internal solders and cause secured components to dislodge. Similarly the thermal shock of hot days and cold nights in storage can impact the integrity of a product. Environmental testing can identify if an importer is jeopardising product compliance with the way they are handling and storing products. to be in compliance, they shall not put it on the market. If a product poses a risk, they must notify the importer, manufacturer and their national authority and provide the authorities with all associated documentation on request. Like importers they too must not jeopardise product compliance during transportation or storage. 6

8 Using Testing to Harmonised Standards for compliance Harmonised standards are generally international standards that have been adopted by the European Union having been formally published as acceptable in the Official Journal. The Official Journal has a list of harmonised standards and the date to which a revision can be used to presume conformity to the Directive. If your product fully complies with the current appropriate product Standard, you can assume conformity with the requirements of the Directive and compile all of the appropriate documentation around the results of this testing. TIP: When Declaring Conformity, you must use the current version of the applicable product Standard. Manufacturers should therefore check in the Official Journal that the version of the Standard that they are using to assess their device is the latest one; so keep an eye on the date of withdrawal. Assessment without Harmonised Standards for compliance If it is not possible to demonstrate conformity via testing to harmonised Standards because they don t exist or haven t been harmonised yet, the Directive makes some provision for the acceptance of IEC and other International Standards as a basis of conformity instead (see Article 13). If a harmonised Standard does exist, then it should be used. Similarly, if no harmonised or IEC standard exists, National Standards can be applied instead if they can cover the product. Technical File Requirements It is now stated that the Technical Documentation shall make it possible to assess the apparatus conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall cover, as far as relevant, the design, manufacture and operation of the apparatus and include at least the following; a general description; conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc., and the descriptions and explanations necessary for their understanding; a list of the harmonised standards applied in full or in part, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements. Where applied, parts of partly applied harmonised standards should be specified; results of design calculations made, examinations carried out, etc.; test results 7

9 Risk Although not explicit in the Directive, except within Annex III Module A, a risk assessment may be required before placing product on the market. Details of the risk assessment should be contained within the Technical File. The risk assessment may just be a declaration that the safety standard to which the product was tested covers all the relevant risks but, in many cases, this may not be the case. There may be ergonomic risks not covered by the standard as these may be specific to the particular product. Furthermore, they may be increased risk due to the market is which the product is to be sold, for example a product may be aimed at younger persons or the elderly where not all risks may be covered by the standard. For further information refer to the Blue Guide Declaration of Conformity The Declaration of Conformity shall have the structure set out in Annex IV (which effectively acts as a template for the DoC). This document shall be continuously updated as required. It must also be translated into the language or languages required by the member states in which the product is placed on the market. You must include: 1. Product Model/product (product, type, batch or serial number 2. Name and address of the manufacture and, where applicable, his authorise representative 3. This declaration of conformity is issued under the sole responsibility of the manufacturer. 4. Object of the declaration (identification of product allowing traceability; it may, where necessary for the identification of the product, include an image) 5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation: 6. References to the relevant harmonised Standards used or references to other technical specifications in relation to which conformity is declared: 7. Additional information: Signed for and on behalf of: (place and date of issue): (name, function) (signature) And, of course, the new Directive number should be employed: 2014/35/EU. It is interesting to note, that your Declaration of Conformity can be a dossier of DoCs that cover all of Declarations to other CE marking Directives. (Paragraph 22). NOTE: It is important to remember that the person who signs the Declaration of Conformity is taking legal responsibility for the compliance of the product and could potentially be liable to fines or imprisonment in the event of serious product non-conformity involving a prosecution process. 8

10 CE Marking Managing Non-conformity If your product is compliant with the requirements of the Directive, you can apply CE Marking to your product. It should be affixed visibly, legibly and indelibly to the product to its data plate or where this is not possible, it s packaging and accompanying documentation. It must be affixed before the product is placed on the market. If a product is not believed to be compliant, corrective action is immediately required from the manufacturer (or his agent), or the importer (whichever is taking responsibility of the product in the EU) to either bring it into conformity, or withdraw it from the market. National authorities must also be notified. If a national authority believes a product not to be compliant, it will carry out an evaluation, and if it is not compliant the economic operators involved will be required to carry out corrective actions or conduct a product recall. If the non-compliance affects other countries, the national authority will notify the EU commission and other member states of the issue. In their communication they must provide information to enable recognition of the product (batch no, brand name etc.) and identify whether the electrical equipment has failed or if the harmonised Standards used to evaluate the product have short-comings. Other member states have up to 3 months to contest the corrective action but if they fail to contest it in this time, it will be deemed justified. Then other member states must also ensure that they take similar action (including withdrawal or restriction). The success of this approach is heavily dependent on the traceability of the product; both in terms of product model and batch numbers and the cooperation of economic operators with the authorities. Being able to identify and track down products that present risk (and the parties responsible for them) is a fundamental benefit of this legislation and enables the policing of the legislation. Penalties Failing to include CE Marking, appropriate documentation and markings leads to what is described in the Directive as Formal Non-compliance (Article 22). The National authority is obliged to restrict or prohibit the product being made available on the market in these circumstances. This means that a product could be technically safe, but is not compliant due to the lack of documentation or markings accompanying it. 9

11 Each member state will determine their own penalties for non-compliance but these can include criminal charges in the case of serious infringement. Penalties must be effective, proportionate and dissuasive. Note: It s worth noting that non-compliance doesn t necessarily mean dangerous. Something as simple as incorrect documentation presented with a device can lead to a non-conformity, and in most cases these can be easily resolved when identified. Some non-conformities are serious though and may require for the product to be recalled, which will have a significant financial implication for the company involved. Key Points There is no requirement for a Notified Body to be involved in conformity assessment (Paragraph 9). The Directive applies to any products being placed on the market in the European Union, regardless of the county of origin. The Directive applies to all products, new or second hand, entering the EU for the first time and sold either between individuals, in retail outlets through distance selling (such as advertising) or online. Conformity assessment is solely the obligation of the manufacture. If you rebadge a product with your name or logo, you effectively become the manufacturer with all of the related responsibilities. Product traceability is key as it helps the surveillance authorities to police conformity declarations and secure corrective actions from those responsible, should something go wrong. Non-conformity with the Directive requires immediate corrective action to bring the product into conformity Not all non-conformities mean a product is dangerous, but regardless, corrective action will need to be taken. Summary CE Marking a product when it complies with all relevant Directives is not a new process, so meeting the recast requirements should be familiar ground for most companies. The recast Directive uses clearer language to explain the obligations of the economic operators involved. It leaves less room for misinterpretation and it is more explicit about how an organisation communicates with their customers, supply chain and the authorities. Compliance with the Directive is mandatory in Europe for the devices covered by it. When you re working to achieve compliance, remember that it is part of a suite of Directives that form the infrastructure of the CE Marking regulations so compliance work for the LVD shouldn t be undertaken in isolation. You will still need to consider device characteristics such as electromagnetic emissions and immunity under EMC Directive, the material safety under the Restriction of 10

12 Hazardous Substances (RoHS) Directive and even perhaps the energy efficiency of the product under the EcoDesign Directive so check which Directives apply. Successful testing to EU harmonised Standards is widely used by manufacturers to provide specific evidence of conformity with the LVD. Manufacturers should also use an appropriately constructed technical file as a basis of their CE Marking and Declaration of Conformity activity. Getting the associated paperwork right is key, as incorrect or incomplete documentation can lead to a non-conformity that requires corrective action. 11

13 How Intertek can help Working with manufacturers to ensure that electrical products meet the requirements of European Directives that relate to them is a core activity for Intertek. Our engineering experts provide support and guidance at every point during the design process to ensure products comply with market requirements through design review and pre-compliance testing, full testing to Standards and stringent professional assessment. Whether you need advice on factory production control, building a technical file or even how CE Marking should be applied, we can help. We are an EU Notified Body under the LVD Directive, a member of the IECEx scheme and a Nationally Recognised Test Laboratory (NRTL) for North America, so get in touch with us today no matter what your market access needs. Contact us Intertek House Cleeve Road Leatherhead Surrey KT22 7SB Tel: info.uk@intertek.com Full services in support of CE Marking As CE Marking isn t just about compliance with one Directive, Intertek provides a variety of services to help you meet the requirements of all applicable Directives. From the Low Voltage Directive, the Restriction of Hazardous Substances and Energy Related Products requirements to EMC and RED we can assist as much or as little as you need to help you get CE Marking for the EU right. For Importers & Distributors Intertek can check technical materials on your behalf to confirm that compliance has been completed. Intertek can conduct vibration and temperature testing on products to determine their susceptibility to jolts, shocks and vibrations and to extremes of temperature. Factory Production Control Many EU Directives require factory production control to be in place for CE Marking. This is essentially documented processes and procedures in place for product production to ensure on-going consistency and professionalism. Certified ISO 9001assessment from Intertek meets Factory Production Control requirements. For more information on specific testing and certification information, please contact Intertek at WORLDLAB, icenter@intertek.com, or visit our website at This publication is copyright Intertek and may not be reproduced or transmitted in any form in whole or in part without the prior written permission of Intertek. While due care has been taken during the preparation of this document, Intertek cannot be held responsible for the accuracy of the information herein or for any consequence arising from it. Clients are encouraged to seek Intertek s current advice on their specific needs before acting upon any of the content. 12