Industry support for effective compliance BTHA Guidance - The Low Voltage Directive (LVD) Directive 2014/35/EU On the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (recast) Comparison of Toy Safety Directive Obligations and those under LVD Record of Amendments Version Date Amendment Section/page affected 1 24/9/16 First publication n/a 2 10/4/17 Addition of disclaimer statement Cover page LEGAL NOTICE This document contains guidance only. It is intended to explain obligations and how to fulfil them. However readers are reminded that the text of the original regulation, directive or standard is the only authentic legal reference and that the information in this document does not constitute legal advice. The British Toy and Hobby Association does not accept any liability with regard to the contents of this document.
Primary Authority Assurance Milton Keynes Council has assured this BTHA advice and guidance as primary authority advice. The level of assurance that this document can give individual members is detailed below: 1 Milton Keynes Primary Authority Partners British Toy and Hobby Association members who have a coordinated primary authority partnership with Milton Keynes Council. Milton Keynes Council accepts responsibility for being the principle source of local authority regulatory advice and guidance for these members. Such members can legally rely on the guidance contained within this document. Any proposed enforcement action against primary authority partners, that is inconstant with this BTHA primary authority assured advice, will be directed against. This means that Milton Keynes Primary Authority may direct an enforcing authority not to take proposed enforcement action (thereby blocking the enforcement action) where such action is inconsistent with primary authority advice. 2 Other Primary Authority Partners British Toy and Hobby Association members who have a primary authority partnership with a Council other than Milton Keynes. Such members can have this guidance assured as primary authority advice within their own Primary Authority Partnership. MKC can, if required, work with these other primary authorities to encourage this advice to be assured within their own partnerships. Once this primary authority advice is issued, such members can legally rely on the guidance contained within these documents. This means that the member s primary authority may direct an enforcing authority not to take proposed enforcement action (thereby blocking the enforcement action) where such action is inconsistent with primary authority advice. 3 No Primary Authority Partnership British Toy and Hobby Association members and stakeholders who do not have a primary authority partnership with Milton Keynes or any other Council. Such members can use the guidance with the knowledge that it is BTHA approved guidance however as the members are not in a primary authority partnership they cannot legally rely on this guidance The guidance is intended to explain legal obligations and how to fulfil them, however readers are reminded that the text of the original regulation, directive or standard is the only authentic legal reference and that the information in this document does not constitute legal advice. The British Toy and Hobby Association does not accept any liability with regard to the contents of this document. Further details regarding the BHTA Primary Authority agreements can be obtained from the BTHA.
Contents 1. Introduction 2. Overview 3. Scope 4. Requirements 5. Obligations of Economic Operators a) Technical Documentation b) Conformity Assessment c) Conformity of Series Production d) Bring non-conforming EEE into compliance. Inform authorities if there is a safety risk. Recall or withdraw Provide information to authorities on request. e) EC Declaration of Conformity. f) Affix conformity marking (CE mark), type, batch or serial number to toy or packaging g) Keep register of complaints, non-conforming toys and recalls h) Ensure the required documents (instructions and safety information) accompany the toy in the correct languages 6. Structure of LVD and Associated guidance
1. Introduction The previous Low Voltage Directive 2006/95/EC will be replaced by the new LVD Directive 2014/35/EU on 20 April 2016. The new Directive entered into force on 15/4/2014 and is applicable for products from 20/4/2016. The LVD covers all health and safety risks of electrical equipment operating with a voltage between 50 and 1000 V for alternating current and between 75 and 1500 V for direct current. It is important to note that if a product is covered by the Radio Equipment Directive (RED) after 13/6/16, even if voltages are within the scope of the LVD Directive, the product is not covered by the LVD Directive. 2. Overview This updated Directive brings it in line with the new legislative framework which means that it is similar to the Toys Safety Directive; it requires CE marking and a Declaration of Conformity. This document provides guidance for Toy companies who are already in compliance with the requirements of the Toy Safety Directive and highlights important differences between the Directives. Lastly this guide gives an overview of the Directive s structure outlining the chapters, articles, annexes, and appendices. 3. Scope The LVD covers all health and safety risks of electrical equipment operating with a voltage between 50 and 1000 V for alternating current. Also between 75 and 1 500 V for direct current, other than the equipment and phenomena listed in Annex II of the Directive. It is important to note that these voltage ratings refer to the voltage of the electrical input or output, not to voltages that may appear inside the equipment. Consumer goods with a voltage below 50 V for alternating current or 75 V for direct current are dealt with by the General Product Safety Directive (GPSD) 2001/95/EC, which aims to ensure that only safe consumer products are sold in the EU. In general battery operated toys are not covered by the scope of the LVD as they are covered by the Toy Safety Directive. Products with mains power supplies, chargers, and other mains operated items, e.g. blowers are covered by the LVD. This means that, for example, a train set with a transformer would be covered as follows: Transformer LVD Remaining train set Toy Safety Directive
4. Requirements When placing electrical equipment on the market, Manufacturers shall ensure that it has been designed and manufactured in accordance with the safety objectives referred to in Article 3 in and set out in Annex I. The LVD requires that electrical equipment does not endanger the health and safety of persons and, unlike the Toy Safety Directive, also requires that that domestic animals or property are considered. The Toy Safety Directive lists essential and particular safety requirements for toys, whereas, the LVD Directive outlines Principle Elements of the Safety Objectives. These cover: general conditions, hazards arising from equipment, protection from hazards which may be caused by external influences. 5. Obligations of Economic Operators Economic Operators involved with the manufacture and supply of electrical equipment have various obligations imposed on them by the Directive. It is important to note that a company s Economic Operator role may be different for the LVD than it is under the Toy Safety Directive. The following definitions apply: Manufacturer Importer Distributor Authorised Representative Operator who manufactures electrical equipment or has electrical equipment designed or manufactured, and markets that equipment under his name or trade mark Operator established within the Union who places electrical equipment from a third country on the Union market Operator other than the Manufacturer or the Importer, who makes an electrical equipment available on the market Operator established within the EU who has received a written mandate from a Manufacturer to act on his behalf in relation to specified tasks The obligations of Economic Operators are essentially the same as those for the Toy Safety Directive (bearing in mind that the Economic Operator role may be different). In addition to complying with the Principle Elements of the Safety Objectives the following differences in the obligations of Economic Operators should be noted.
(a) Technical Documentation The LVD documentation can be combined with the technical documentation held for the Toy Safety Directive. Technical Documentation requirements differ in that the LVD Directive states that the documentation shall make it possible to assess the electrical equipment s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). In addition, the technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall, wherever applicable, contain at least the following elements: a general description of the electrical equipment, conceptual design and manufacturing drawings and schemes of components, subassemblies, circuits, etc., descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product, a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union or international or national standards referred to in Articles 13 and 14 and, where those harmonised standards or international or national standards have not been applied, descriptions of the solutions adopted to meet the safety objectives of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards or international or national standards referred to in Articles 13 and 14, the technical documentation shall specify the parts which have been applied, results of design calculations made, examinations carried out, etc., and test reports. (b) Conformity Assessment Unlike the Toy Safety Directive, the LVD specifically mentions and allows, international or national standards and other technical specifications, as well as EU harmonised standards to be used to demonstrate conformity of electrical equipment. A list of Harmonised Standards for Directive 2006/95/EC can be found here. http://ec.europa.eu/growth/single-market/european-standards/harmonisedstandards/low-voltage/index_en.htm (c) Conformity of Series Production The LVD allows international or national standards and other technical specifications, as well as EU harmonised standards to be used to demonstrate conformity of electrical equipment. Because of this, Manufacturers must ensure that procedures are in place to ensure conformity of series production should there be any changes to all the standards and technical specifications used for this demonstration of conformity.
(d) Bring non-conforming EEE into compliance. Inform authorities if there is a safety risk. Recall or withdraw Provide information to authorities on request With regards to products not in conformity or presenting a risk the obligations of Manufacturers and Importers are the same as for the Toy Safety Directive. However, Distributors must inform Manufacturers and Importers and also the competent authorities if there is a safety risk. Moreover, they must not make available on the market, products that are not in conformance with the Directive. (e) EC Declaration of Conformity The Declaration of Conformity can be combined with the Toy Safety Directive Declaration of Conformity. This is stated in the so called Blue Guide : A single Declaration of Conformity is required whenever a product is covered by several pieces of Union harmonisation legislation requiring an EU Declaration of Conformity. The single Declaration of Conformity can be made up of a dossier containing all relevant individual declarations of conformity (f) Affix conformity marking (CE mark), type, batch or serial number to toy or packaging CE marking principles are the same for the Toy Safety Directive so in principle the guidance given for CE marking contained within the BTHA s Markings and Warnings guide to the Toy Safety Directive can be used. Unlike the Toy Safety Directive an Authorised Representative is able to affix the CE marking provided that it is mandated. (g) Keep register of complaints, non-conforming toys and recalls Unlike in the Toy Safety Directive, in addition to keeping their own register, Importers under the LVD Directive, are obliged to inform Distributors of any issues. (h) Ensure the required documents (instructions and safety information) accompany the toy in the correct languages Unlike in the Toy Safety Directive, it is the Manufacturer s as well as the Importer s responsibility to ensure that the required documents are in the correct languages.
6. Structure of LVD and Associated guidance This does not give specific guidance to the LVD Directive but does contain information where there are significant differences between this Directive and the Toy Safety Directive. The guide also provides information where other guides, including BTHA guides are available which adequately cover the subject. For every chapter, article, annex, and appendix of the Directive this chapter: Shows where this guide and other guides, including BTHA guides, covers the subject Indicates the parts of the Directive that are not of concern for toy companies Article Title Details 1 Subject Matter and Scope 2 Definitions This Directive shall apply to electrical equipment designed for use with a voltage rating of between 50 and 1 000 V for alternating current and between 75 and 1 500 V for direct current, other than the equipment and phenomena listed in Annex II. Further information regarding the scope of the Directive is given in Section 3 of this document. This article includes a list of definitions of phrases and words referenced throughout the Directive. 3 Making available on the market and safety objectives 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 and safety of persons and domestic animals, or property, when properly installed and maintained and used in applications for which it was made. The principal elements of the safety objectives are listed in Annex I of the Directive. 4 Free Movement 5 Supply of Electricity The Member States shall not impede, for the aspects covered by this Directive, the making available on the market of electrical equipment which complies with this Directive. In relation to electrical equipment, the Member States shall ensure that stricter safety requirements than the safety objectives referred to in Article 3 and set out in Annex I are not imposed by electricity supply bodies for connection to the grid, or for the supply of electricity to users of electrical equipment.
Article Title Details 6 Obligations of Manufacturers 7 Obligations of Authorised Representatives 8 Obligations of Importers 9 Obligations of Distributors See Section 5 of this guide. 10 Cases in which obligations of Manufacturers apply to Importers and Distributors 11 Identification of Economic Operators 12 13 14 Presumption of conformity on the basis of harmonised standards Presumption of conformity on the basis of international standards Presumption of conformity on the basis of national standards See Section 5 (b) of this guide. 15 EU Declaration of Conformity See Section 5 (e) of this guide. 16 General principles of the CE marking 17 18 19 Rules and conditions for affixing the CE marking Union market surveillance and control of electrical equipment entering the Union market Procedure for dealing with electrical equipment presenting a risk at national level See Section 5(f) of this guide. Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to electrical equipment. The Electrical Equipment (Safety) Regulations 1994 are primarily enforced by the local authority trading standards departments with regard to consumer products. 20 Union safeguard procedure It is not essential that Economic Operators be concerned with the detail of this article.
Article Title Details 21 Compliant electrical equipment which presents a risk See section 5 (d). Member states must also inform the Commission if a conforming product presents a risk so that appropriate action can be taken. 22 Formal non compliance 23 Committee procedure 24 Penalties 25 Transitional Provisions 26 Transposition It is not essential that Economic Operators be concerned with the detail of these articles. 27 Repeal 28 Entry into force 29 Addresses
Annex I II III IV V VI PRINCIPAL ELEMENTS OF THE SAFETY OBJECTIVES FOR ELECTRICAL EQUIPMENT DESIGNED FOR USE WITHIN CERTAIN VOLTAGE LIMITS EQUIPMENT AND PHENOMENA OUTSIDE THE SCOPE OF THIS DIRECTIVE MODULE A Internal production control EU DECLARATION OF CONFORMITY Time-limits for transposition into national law and dates of application of the Directives set out in Part B of Annex V to Directive 2006/95/EC CORRELATION TABLE This article outlines the principle elements of the safety objectives. See Section 4. This outlines equipment that is outside the scope of the Directive; it has no relevance to toys. This annex outlines details with regards to Module A (internal production control) as a way of demonstrating conformity. This Annex also shows details of: Technical Documentation required (section 5a of this guide), Manufacturing requirements, CE Marking (see section 5 (f) of this guide). Declaration of Conformity (see section 5 (e) of this guide). Lastly it provides details of the Authorised Representative s obligations with regards to the CE marking (see section 5 (f) and the Declaration of Conformity. This annex contains the text for the Declaration of Conformity. Transposition dates of the previous Directives. This section shows how the 2006/95/EC Directive correlates with the new LVD Directive.