: Key Topics Under Review Written By: James Calder, Manager Global Services July 6, 2010 Intertek 100-505 March Road, Kanata, ON K2K 3A4 rohs@intertek.com +1 613.599.4321 www.intertek.com/rohs
Table of Contents Introduction... 2 Key Topics Under Review... 2 1. Expanding the Scope... 3 a. Medical and Monitor and Control Equipment... 3 b. Open Scope... 3 2. New Substances for Restriction... 5 a. Suggested Restricted Substances... 5 b. Nanomaterials... 6 3. Clarify Existing and Adding New Definitions... 6 a. Clarity... 6 b. Definition Discussion... 6 4. Exemptions... 8 a. New Exemptions... 8 b. Exemption Timelines... 8 5. Production Control and Standards... 9 a. Market Surveillance... 9 b. Internal Production Control... 9 Conclusion... 11 www.intertek.com/rohs 1
Introduction The European Union s current RoHS Directive (2002/95/EC) ( RoHS ), restricting hazardous substances in electrical and electronic equipment, enters its fourth year of implementation. To meet its deadline of July 2006, industry had to implement the RoHS Directive s requirements long before the deadline to ensure continued supply of electronics. The law s key requirement is to ensure that lead, cadmium, hexavalent chromium, mercury and two polybrominated flame retardants (PBDE and PBBE) are restricted for use in electrical and electronic equipment ( EEE ). An important point of the RoHS Directive (Article 6) is to have a review concerning its implementation and potential expansion. December 2008 has seen the first draft of the proposed changes to the RoHS Directive and has been receiving significant scrutiny by legislative bodies, industry, and environmental groups. After many readings, consultations, amendments, votes, and debate, it would appear that the majority of the issues are being resolved and it is expected at this time to move forward towards the first European Parliament plenary vote on October 18 th. This white paper will go through the proposal in detail and discuss its potential impact to the electronics industry Key Topics Under Review Article 6 of the RoHS Directive sets a mandate that the European Commission ( EC ) shall perform a review while taking into account new scientific evidence. The most preeminent topics surrounding the review of the RoHS Directive are as follows: Expanding the scope (i.e. Medical and Monitor and Control Equipment) Addition of new substances for restriction Clarification of existing and adding new definitions Exemptions Production Control and Standards www.intertek.com/rohs 2
To properly understand these topics, this document will discuss each topic in detail. 1. Expanding the Scope a. Medical and Monitor and Control Equipment Currently, the RoHS Directive does not capture its own defined scope of covered products. Instead, it references Categories 1-7 and 10 of Annex 1A in the WEEE Directive (2002/96/EC). This excludes Medical (Category 8) and Monitor and Control Equipment (Category 9). A study was performed in 2006 to review the inclusion of these two categories. This study supported the addition of these categories to the scope of the RoHS Directive. The study recommends application exemptions for these two categories that reduce some of the impact on restricting the use of the six substances in these two categories. During the whole process of recasting the RoHS Directive, there has never been any strong opposition to including medical and monitor and control equipment. The dates for including EEE covered under these two categories occur on January 1 st of the following years: 2014 Medical Devices and Monitor and Control Equipment 2016 In Vitro Medical Devices 2017 Industrial Monitor and Control Equipment These dates are based on the assumption that entry into force for the new RoHS Directive shall occur by the end of 2011. Active Implanted Medical Devices have no target date for inclusion into the RoHS Directive, but mandates the European Commission to perform a review of a possible inclusion by 2020. The medical device and monitor and control industry has been actively preparing their RoHS inclusion based on the above dates and it is highly doubtful at this time that these dates will change. b. Open Scope Members of European Parliament ( MEP ) have voted in favour of an open scope, which means that all electrical and electronic material would be covered by the legislation, unless specifically excluded. This is designed to achieve www.intertek.com/rohs 3
greater legal clarity than is afforded by the current rules, which take the opposite approach. MEPs recommended that certain areas be excluded from the Directive's scope, including inter alia, renewable energy generation, certain large-scale installations and industrial tools, and material for military purposes and vehicles. They suggested that the European Commission could propose further exclusions within a transitional period of 18 months after the recast Directive enters into force. Exclusions would be subject to review in 2014. Some of these specific exclusions include: equipment which is necessary for the protection of the essential interests of the security of Member States, including arms, munitions and war material intended for specifically military purposes; equipment which is specifically designed as part of another type of equipment that does not fall within the scope of this Directive and can fulfill its function only if it is part of that equipment; means of transport for persons or goods; large scale fixed installations, except monitoring and control equipment; large scale stationary industrial tools, except monitoring and control equipment; equipment which is manufactured in the Community or imported, and designed for the purposes of research and development and not made available on the market for sale to the general public; non-road mobile machinery intended exclusively for professional use; equipment designed to be sent into space; No later than [TBD], the Commission shall submit a report examining the need for further exclusions of equipment in category 11 from the scope of this Directive where the long-term contribution to the objectives of this Directive by the inclusion of such equipment would be disproportionately low as compared to the long-term costs thereof, to be accompanied by a legislative proposal, if appropriate. www.intertek.com/rohs 4
2. New Substances for Restriction a. Suggested Restricted Substances The hot topic for the new RoHS Directive has always been will there be more substances restricted under the RoHS Directive? This has been receiving intense pressure from government authorities, industry groups and especially environmental interest groups. Even with the latter s strong efforts, the current answer to the question is no. As part of its duties, the European Commission contracted a study that would review hazardous substances present in EEE, to select candidate substances for a potential inclusion into the RoHS Directive, to evaluate possible substitutes, and to propose policy options for each candidate substance. The conclusion of this report allowed the European Commission to recommend four (4) substances for possible inclusion into the RoHS Directive as follows: 1. Hexabromocyclododecane (HBCDD) 2. Bis (2-ethylhexyl) phthalate (DEHP) 3. Butyl benzyl phthalate (BBP) 4. Dibutylphthalate (DBP) During the negotiating period for the new RoHS Directive, the following suggested substances were put on the table for potential restriction: 1. Brominated flame retardants 2. Chlorinated flame retardants 3. Polyvinylchloride (PVC) 4. Medium-chain chlorinated paraffins (MCCP) 5. Phthalates meeting the criteria for classification as carcinogenic, mutagenic or toxic to reproduction category 1A or 1B in accordance with Regulation (EC) No 1272/2008. In the end, Members of European Parliament (MEPs) called for further evaluation for the above five (5) substance groups and not their immediate restriction. To strengthen the ability of adding new restricted substances, the proposal has included definitions for availability of a substitute and reliability. Industry can breathe a sigh of relief that no new substances have been added to the RoHS Directive but should be assured that these substances will receive www.intertek.com/rohs 5
significant pressure for restriction. Therefore, industry should prepare itself in understanding the impact of no longer using these substances in their electronics. b. Nanomaterials In June 2010, MEPs took a tough line on nanomaterials, an area not specifically addressed in the Commission proposal. They called for a ban on nanosilver and long multi-walled carbon nanotubes. They also said that other electrical and electronic material containing nanomaterials should be labelled, and that the manufacturers should be obliged to provide safety data to the European Commission. Nanosilver has the majority of its use as an antibacterial technology, especially in washing machines, refrigerators, air conditioners, air purifiers, vacuum cleaners, and medical devices. Multi-walled carbon nanotubes tend to be used in the electronic industry for transistors, ultracapacitors, electricity storage, and many other applications being currently in development. 3. Clarify Existing and Adding New Definitions a. Clarity Many definitions within the existing RoHS Directive have been either lacking or unclear as to their application. The majority of the industry has had to rely on the European Commission s FAQ. The problem with the FAQ is that it is not a legal document and has caused consternation during the application of the law s definitions to products and practices. The new law looks to improve by adding definitions and clarity on some contentious issues during the previous law s years of implementation. Some key definitions are discussed below. b. Definition Discussion dependent means that the electrical and electronic equipment needs electricity to fulfill at least one of its basic functions; This changes some of the previously interpreted definitions surrounding EEE where products were determined to fall under scope if their primary function required electricity to function and not just one of their functions. www.intertek.com/rohs 6
cables means all cables inside electrical and electronic equipment and all cables that serve as connection or extension to connect the equipment to the relevant grid; Since the law will encompass an open scope, cables will be included and therefore need their appropriate definition. large scale fixed installations mean a particular combination of several types of apparatus and, where applicable, other devices, assembled and installed permanently at a predefined location. It shall not include electrical and electronic components which may, during the lifespan of the installation concerned, be replaced from time to time and which can fulfill their function also by not being part of that installation; This definition has always been a contentious issue. Many electronics are installed into buildings, homes, and other fixed locations but it was unclear as to how the definition should be applied. This shows that most EEE without a typical lifespan and use in relevance to the premises defined as a fixed installation would need to abide by restrictions under the RoHS Directive. "homogeneous material" means either a material of uniform composition throughout or a material that can not be mechanically disjointed into different materials, meaning that the materials can not[ ] be separated by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes. Applying conformity to the RoHS Directive had many complications when homogenous material was never properly defined. The above definition has been previously used from the FAQ but now can be applied as a legal definition. "conformity assessment" means the process demonstrating whether the requirements of the present Directive relating to EEE, are met. The procedure for complying with European Directives has typically applied to conformity assessment but has not properly been applied when it comes to the RoHS Directive since it does not fall under the umbrella of CE. This will now change and will be discussed further in section Production Control and Standards. This is a non-exhaustive list of definitions, and depending on each company s product(s), the ones discussed or not discussed could have far reaching impact to current and/or future substance use. www.intertek.com/rohs 7
4. Exemptions The exemptions themselves led to many uncertainties in understanding their relevance to specific applications and being able to communicate them up and down the supply chain. Recent RoHS enforcement has shown that many companies still do not understand how to interpret and apply exemptions. The new RoHS Directive looks to minimize this issue. New considerations will be taken into account for granting exemptions such as: the reliability of substitutes to not be assured the negative environmental, health, and consumer safety impacts caused by the substitutions to likely outweigh the environmental, health and consumer safety benefits thereof based on a life-cycle assessment where relevant. a. New Exemptions With the addition of Medical Devices (Category 8) and Monitor and Control Devices (Category 9), exemptions need to be applied to these EEE since the previous RoHS Directive does not consider them in scope. A new Annex has been added to the future RoHS Directive to apply these exemptions specifically for these two EEE categories in excess of the preexisting exemptions for all EEE historically under scope of the RoHS Directive. b. Exemption Timelines The current exemption process does not have a clear and defined process for when exemptions will be removed from the RoHS Directive. The intention of allowing an exemption is to provide industry an appropriate time to find alternatives and substitute non-hazardous substances that allow for the same quality as previously exempt substances. The new RoHS Directive provides clear wording on the exemption timeline. Exemptions will have a validity period of up to eight (8) years for Medical Devices and Monitor and Control Equipment. For all other EEE under scope of the new RoHS Directive, exemptions will have a validity period of up to four (4) years. The specific exemptions shall indicate the date of granting the exemption, of its renewal, of its expiry, and of the grace period where applicable. www.intertek.com/rohs 8
The duration of the grace period shall be decided on a case-by-case basis and shall not exceed 18 months from the application of the prohibition or the expiry of the exemption. Applications for exemptions must be requested no later than eighteen (18) months before the prohibition applies, or before the exemption expires (depending on the situation). The European Commission shall take a decision no later than six (6) months before the prohibition applies, or before the exemption expires, as the case may be. In case the European Commission has not taken a decision by that time, the exemption shall be valid or remain valid until six (6) months after the Commission has taken a decision. 5. Production Control and Standards a. Market Surveillance Market surveillance and controls of EEE entering the Community market Member States shall carry out market surveillance, in accordance with Articles 15 29 of Regulation (EC) No 765/2008. This means that the new RoHS Directive will apply the harmonized community legislation responsible for the CE Mark. After the entry into force of the new RoHS Directive, placing the CE mark on EEE states that the manufacturer, or importer/distributor, has assured that no substances restricted under the new RoHS Directive are above the allowable levels in their EEE. This also means that harmonized standards need to acknowledged and applied, as with other CE Directives. The production control of EEE has manufacturers, or importers/distributors ensuring that manufacturers, apply module A of Annex II to Decision No 768/2008/EC. b. Internal Production Control Summarized below is wordage from the relevant parts of module A of Annex II to Decision No. 768/2008/EC and proposal for the New RoHS Directive: www.intertek.com/rohs 9
Technical documentation The manufacturer shall establish the technical documentation. 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 harmonized 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. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of the legislative instruments that apply to them. Conformity marking and declaration of conformity The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that satisfies the applicable requirements of the legislative instrument. The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product for which it has been drawn up. A copy of the declaration of conformity shall be made available to the relevant authorities upon request. www.intertek.com/rohs 10
Testing When deemed appropriate with regard to the risks covered by this Directive and presented by a product, manufacturers, to protect the health and safety of consumers, carry out sample testing of marketed EEE, investigate, and, if necessary, keep a register of complaints, of nonconforming EEE and product recalls, and keep distributors informed of any such monitoring. Conclusion Recent enforcement still demonstrates that almost a quarter of EEE entering the European Union market is non-compliant. The original intention of the RoHS Directive is to ensure that EEE does not contain hazardous substances, since they can cause potential harm to human health and the environment, especially at the waste treatment stage. To ensure the reduction of these potential health and environmental issues, the expectation is for RoHS enforcement to increase. This increase of enforcement is much more feasible with the anticipated new RoHS Directive s clarification on scope, understanding of covered substances, definitions, exemptions, and expected production control procedures. Since the CE mark will be applied to this Directive, European Union importers and distributors are going to find that they are more responsible for ensuring compliance throughout the supply chain. Due to the volume of EEE being manufactured outside of the European Union, especially in the Far East, communication on compliance and procedures has always been a difficult task. Now, importers and distributors will obligate their suppliers outside of the European Union to meet internal production control procedures before import. All parties within the supply chain must ensure proper communication, since the implementation of some of the new RoHS Directive s procedures could take significant effort and time. For more information, please contact Intertek at +1 613-599-4321, email rohs@intertek.com, or visit our website at www.intertek.com/rohs. This whitepaper is based on current publicly available documents and surrounds a topic that has yet to finalize its legislative process. The overall authorities are the European Commission and European Parliament. It is recommended that producers, importers, distributors, and retailers obtain legal advice in matters of interpretation or application, where there is potential for substantial business impact. 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 www.intertek.com/rohs 11