Industry support for effective compliance BTHA Guidance on The Restriction Of The Use Of Certain Hazardous Substances In Electrical and Electronic Equipment (recast) (RoHS) Directive 2011/65/EU Comparison of Toy Safety Directive obligations and those under RoHS Version 2 Record of Amendments Version Date Amendment Section/page affected 1 11/01/2016 First publication n/a 2 03/01/2017 Formatting changes 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.
Contents 1. Introduction 2. Overview 3. Scope 4. Restrictions 5. Obligations of Economic Operators a) Technical Documentation b) Conformity Assessment c) Bring non-conforming EEE into compliance. Inform authorities if there is a safety risk. Recall or withdraw Provide information to authorities on request. d) EC Declaration of Conformity e) Affix conformity marking (CE mark), type, batch or serial number to toy or packaging f) Keep register of complaints, non-conforming toys and recalls g) Ensure the required documents (instructions and safety information) accompany the toy in the correct languages 6. Structure of RoHS and associated guidance
1. Introduction The following guide has been developed with the help and input of the National Measurement & Regulation Office (NMRO) who is responsible for the enforcement of the RoHS Directive in the UK. Restrictions on certain hazardous substances in electrical equipment have been in place in Europe since 2006 when the original RoHS Directive (2002/95/EC) came into force. The new RoHS Directive 2001/65/EU was published in the Official Journal of the European Union on July 1, 2011 and entered into force on 02 Jan 2013. The new Directive introduced CE marking and Declaration of Conformity requirements as well as including more products within its scope. The RoHS Directive concerns the restriction of the use of certain hazardous substances in electrical and electronic equipment including certain toys. Toys, leisure and sports equipment are covered in category 7. This RoHS Directive bans the placing on the EU market of new EEE containing more than the agreed levels of certain substances This guide should be read in conjunction with the National Measurement Regulation Office guide, which can be found here: https://www.gov.uk/guidance/rohs-compliance-and-guidance Also see BIS - GOVERNMENT GUIDANCE NOTES FOR ROHS 2 2. Overview This update to the 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 is intended to provide guidance for toy companies who are already in compliance with the requirements of the Toy Safety Directive and highlights the important differences between the Toy Safety Directive and RoHS Directive. The guide includes an overview of the RoHS Directive s structure outlining the chapters, articles, annexes, and appendices. Also included is guidance regarding the scope of the RoHS Directive as this has been subject to changes that mean that toys previously not in scope will now be in scope. Specific deadlines apply to this change.
3. Scope For toys with a primary electrical function that were subject to the requirements of the original RoHS Directive there is no change to the scope and the requirements of the recast Directive apply immediately. Toys that were considered to be outside of the scope of the original Directive based on primary function will now be included in the scope (as it now includes equipment that needs electric currents or electromagnetic fields to fulfil at least one intended function) but Manufacturers will have a transition period and all electrical toys placed on the market after 22nd July 2019 must be in compliance. Note: The primary function argument was never adopted by Belgium, Denmark, Estonia, Finland, France, Ireland, Netherlands and Sweden; therefore in these countries all toys with any electrical function should be considered to be included in the scope of the recast RoHS Directive immediately. Toy with primary electrical function? Yes In scope, RoHS Directive applies No Placed on the market in BE, DK, EE, FI, FR, IE, NL, SE? Yes In scope, RoHS Directive applies No In scope from 23 rd July 2019
4. Restrictions The substance restrictions in the RoHS Directive are: Maximum concentration of 0.1% in homogeneous material of: Lead Mercury Hexavalent chromium Polybrominated biphenyls (PBB) Polybrominated diphenyl ether (PBDE) Maximum concentration of 0.01% in homogeneous material of: Cadmium These restrictions include the following substances under Commission Delegated Directive (EU) 2015/863 and will apply from 22 nd July 2019. Maximum concentration of 0.1% in homogeneous material of the following phthalates: DEHP BBP DBP DIBP 5. Obligations of Economic Operators Economic Operators involved with the manufacture and supply of EEE 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 RoHS than it is under the Toy Safety Directive. The following definitions apply: Manufacturer Importer Distributor Authorised Representative Operator that manufactures a EEE or who has EEE designed or manufactures and markets it under his name or trademark Operator that is established within the European Union, who places an EEE from a third country on the European Union market Operator other than the Manufacturer or the Importer, who makes EEE 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 ensuring that toys do not contain the substances listed in Annex II of the Directive the following differences in the obligations of Economic Operators should be noted.
(a) Technical Documentation The RoHS documentation can be combined with the technical documentation held for the Toy Safety Directive. Technical Documentation requirements differ in that the RoHS Directive requires more detail with regards to the descriptions of the product and its components, subassemblies circuits etc. The documentation shall make it possible to assess the product's conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). 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 product, conceptual design and manufacturing drawings and schemes of components, sub-assemblies, 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 and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied, results of design calculations made, examinations carried out, etc., and test reports. The standard BS EN 50581:2012 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances is harmonised and gives a presumption of conformity under the RoHS Directive. (b) Conformity Assessment If testing is used to demonstrate a product or a component s compliance with the requirements of the RoHS Directive the standard BS EN 62321:2009 Electrotechnical products. Determination of levels of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers) may be used. Article 16 - Presumption of conformity states that materials, components and EEE which are demonstrably in compliance using tests and measurements or by assessment against harmonised standards are presumed to comply with the Directive. (c) Bring non-conforming EEE into compliance. Inform authorities if there is a safety risk. Recall or withdraw Provide information to authorities on request. Under the Toy Safety Directive where the toy presents a risk, Manufactures, Importers, Distributors and Authorised Representatives shall immediately inform the competent national authorities of the Member States. Under RoHS, Manufacturers, Importers and Authorised Representatives are obligated to do this when there is reason to believe that EEE which they have placed on the market is not in conformity with the Directive. Furthermore, Importers, Distributors and Authorised Representatives are obliged to also inform the Manufacturer (this is not a specific obligation for the Toy Safety Directive but is assumed that this would be done by most Economic Operators). A set of requirements within RoHS has been published by the National Measurement and Regualtion Office, which place a set of obligations on Economic Operators to act in a proactive manner when a non compliance is found: Non-Complying Product Notifications and Actions Guidance September 2013.
(d) EC Declaration of Conformity. Both the Toy Safety Directive and the RoHS Directive specify the text of the respective Declarations of Conformity. The RoHS Directive states that Declaration of Conformity can be combined with the Toy Safety Directive Declaration of Conformity. Although the Toy Safety Directive does not specifically state that this is allowed the principle of producing one Declaration of Conformity is stated in the 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 (e) 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. This is with the exception that under RoHS, if a toy has a data plate, the CE mark should appear on this. (f) 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 RoHS Directive, are obliged to inform Distributors of any issues. (g) Ensure the required documents (instructions and safety information) accompany the toy in the correct languages Unlike in the Toy Safety Directive, under RoHS, 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 RoHS and Associated guidance This section does not give specific guidance to the RoHS 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 2 Scope 3 Definitions 4 Prevention This Directive lays down rules on the restriction of the use of hazardous substances in electrical and electronic equipment (EEE) with a view to contributing to the protection of human health and the environment, including the environmentally sound recovery and disposal of waste EEE. This states that the Directive applies to EEE falling within the categories set out in Annex I. It also gives a list of exclusions; these exclusions are not relevant to toys. 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. This concerns the obligation of a member state to ensure that non-compliant EEE, is not placed on the market. It also contains scope extensions and related dates. 5 6 Adaptation of the Annexes to scientific and technical progress Review and amendment of list of restricted substances in Annex II This concerns the scientific process with regards to keeping the exemptions up to date. This concerns the reviewing of the restricted substances list.
Article Title Details 7 Obligations of Manufacturers 8 Obligations of Authorised Representatives 9 Obligations of Importers 10 Obligations of Distributors See Section 5 of this guide. 11 Cases in which obligations of Manufacturers apply to Importers and Distributors 12 Identification of Economic Operators 13 EU Declaration of Conformity See Section 5 (d) of this guide. 14 General principles of the CE marking 15 Rules and conditions for affixing the CE marking Presumption of conformity See Section 5(e) of this guide. The UK has adopted self-declaration by Manufacturers as the basis of the compliance regime for RoHS confirmed by a DoC and the affixing of a CE mark in the same way as the Toy Safety Directive. 16 Presumption of conformity This article means that Member States shall presume toys bearing the CE mark, when applied to demote compliance with the RoHS Directive are in conformity unless there is evidence to the contrary. Also See section 5(b). 17 18 Formal objection to a harmonised standard Market surveillance and controls of EEE entering the Union market This concerns member states and standards development committees. It is not essential that Economic Operators be concerned with the detail of this article. Details of enforcement powers are shown in BIS - GOVERNMENT GUIDANCE NOTES FOR ROHS 2 This details requirements when a non-compliant product is found. The related Statutory Instrument should also be referred to: UK 2012 No.3032. 19 Committee procedure 20 Exercise of the delegation 21 Revocation of the delegation It is not essential that Economic Operators be concerned with the detail of these articles. 22 Objections to delegated acts
Article Title Details 23 Penalties Details of penalties are shown in: BIS Government guidance notes for RoHS 2 A set of requirements within RoHS2 has been published by the National Measurement & Regulation Office, which place a set of obligations on Economic Operators to act in a proactive manner when a non compliance is found: Non-Complying Product Notifications and Actions Guidance September 2013 Failure to comply with these requirements generates a criminal offence in the UK. The related Statutory Instrument should also be referred to: UK 2012 No.3032. 24 Review 25 Transposition 26 Repeal 27 Entry into force It is not essential that Economic Operators be concerned with the detail of these articles. 28 Addressees Annex I II III IV V VI Categories of EEE covered by the Directive Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials Applications exempted from the restriction in Article 4(1) Applications exempted from the restriction in Article 4(1) specific to medical devices and monitoring and control instruments Applications for granting, renewing and revoking exemptions as referred to in Article 5 EU DECLARATION OF CONFORMITY Toys, leisure and sports equipment are covered in category 7. This article shows the Maximum concentrations allowed of the restricted substances. See section 4. This is a list of exemptions. This is a list of exemptions. This is a list of exemptions. This annex contains the text for the Declaration of Conformity. VII Repealed Directive with its successive amendments It is not essential that Economic Operators be concerned with the detail VIII Correlation table of these articles.