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The RoHS Recast: Are You Ready?
November 21, 2012 |Estimated reading time: 16 minutes
Editor's Note: This article originally appeared in the October 2012 issue of SMT Magazine.In 2002, the European Union (EU) enacted a law, the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive (2002/95/EC), which triggered massive changes in the way electrical and electronic equipment (EEE) is designed, manufactured, and sold in global markets. Although the RoHS Directive only covered certain EEE that was sold or distributed in the EU, the Directive’s restrictions on the use of lead, mercury, cadmium, hexavalent chromium, and certain brominated biphenyls in covered EEE sent ripple effects through global supply chains as producers sought to purge their product channels of noncompliant stock and suppliers sought to supply parts and components that would meet the RoHS substance restrictions.
Now, 10 years later, we face a new RoHS Directive. On June 8, 2011, the European Commission approved text that revises the original RoHS legislation. The new Directive, unofficially termed the RoHS Recast, was published in the EU Official Journal on July 1, 2011. The legislation will repeal the original RoHS Directive. EU member states will have until January 2, 2013 to transpose the RoHS Recast into law. If the member states do not transpose the Directive in time, the original RoHS Directive requirements will remain in effect. It is expected, however, that transposition will occur and currently covered EEE will need to meet RoHS Recast requirements effective January 2, 2013.
The RoHS Recast makes several changes to the original RoHS Directive. Although the RoHS Recast does not make any changes to the original RoHS Directive’s substance restrictions, it does significantly enlarge the law’s product scope and completely transforms the law’s compliance requirements. Unless producers and importers of covered EEE are aware of and take steps to address these changes, they may find themselves at risk for enforcement action. Key changes are explained in more detail below.
(1) Product Scope Expansion
a. New Definition of “Dependent” Expands Scope of EEE
The RoHS Recast adds a new definition of “dependent,” which modifies the original RoHS Directive’s definition of “electrical and electronic equipment” or “EEE.” The original RoHS Directive defined EEE as:
Equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields…and designed for use with a voltage rating not exceeding 1,000 volts for alternative current and 1,500 volts for direct current.
The original definition was interpreted to mean that EEE consists of products that depend on electric currents or electromagnetic fields to fulfill their basic functions. In other words, if a product is no longer powered by electric currents or electromagnetic fields and it cannot perform its basic (primary) function, it is not EEE.
The RoHS Recast added a new definition of “dependent” and defined that term to mean “needing electric currents or electromagnetic fields to fulfill at least one intended function (emphasis added).” This new definition expands the scope of the Directive to include products that use electricity or electromagnetic fields to perform secondary functions.
An example of a newly covered product under the RoHS Recast is a toy stuffed bear that has a battery-powered voice mechanism. Under the original RoHS Directive, the toy bear was not covered EEE because the battery-powered voice mechanism was not the bear’s primary intended function. Under the RoHS Recast, however, the stuffed bear would be covered EEE because the battery is required to achieve at least one of the toy bear’s intended functions--operation of its voice mechanism. This change significantly increases the scope of the RoHS Directive to encompass virtually all products with any electrical or electromagnetic function.
b. Addition of New Categories of Covered EEE
The product scope of the original RoHS Directive was derived from the Annexes contained in the Waste from Electrical and Electronic Equipment (WEEE) Directive. The RoHS Recast, on the other hand, derives its product scope from the “Categories of EEE covered by this Directive.” This change severs the previous connection between the WEEE Directive’s product scope and the RoHS Directive’s product scope. The RoHS Directive’s product scope is now listed in the RoHS Recast’s Annex 1. Covered categories include:
- Large household appliances;
- Small household appliances;
- IT and telecommunications equipment;
- Consumer equipment;
- Lighting equipment;
- Electrical and electronic tools;
- Toys, leisure and sports equipment;
- Medical devices;
- Monitoring and control instruments, including industrial monitoring and control instruments;
- Automatic dispensers; and
- Other EE not covered by any of the categories above.
The list of covered categories is identical to the original RoHS Directive’s product scope with two exceptions: 1) the inclusion of two categories of EEE, Category 8 – Medical Devices, and Category 9 – Monitoring and Control Instruments Devices, that were previously excluded from the RoHS Directive’s product scope; and (2) the inclusion of a new “catch-all” category, Category 11 – “other EE not covered by any of the categories above.”
In terms of Category 8 – Medical Devices, and Category 9 – Monitoring and Control Instruments Devices, the RoHS Recast specifically covers these previously excluded product categories. Effective July 22, 2014, most medical equipment and monitoring and control devices will be covered by the RoHS Directive. In vitro medical devices (not active implantable medical devices) will have until July 22, 2016, to come into compliance and industrial monitoring and control devices will have until July 22, 2017, to become RoHS Directive compliant.
The RoHS Recast also expands the RoHS Directive’s product scope coverage to include Category 11 – “other EEE not covered” by a specific EEE category, thereby extending the RoHS provisions to cover all electrical and electronic equipment (EEE). Under the new RoHS Recast, all EEE will be covered (unless specifically excluded) by July 23, 2019. As mentioned above, EEE now includes all products that use electricity or electromagnetic fields for any purpose.
c. Expansion and Clarification of Exclusions
The RoHS Recast expanded and clarified original the RoHS Directive exclusion list. The original RoHS Directive derived many of its exclusions from the WEEE Directive. The RoHS Recast specifically lists the original RoHS Directive exclusions (that were derived from the original WEEE Directive) and adds a few new ones. Exclusions now 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 (derived from the original WEEE Directive);
- Equipment designed to be sent into space (new);
- Equipment which is specifically designed, and is to be installed, as part of another type of equipment that is excluded or does not fall within the scope of this Directive, which can fulfill its function only if it is a part of that equipment, and can be replaced only by the same specifically designed equipment (derived from original WEEE Directive but modified);
- Large-scale stationary industry tools (derived from original WEEE Directive);
- Large-scale fixed installations (new but expansion of original “large-scale stationary industrial tool” exclusion that was derived original WEEE Directive);
- Means of transport for persons or goods, excluding electric two-wheeled vehicles which are not type-approved (new);
- Non-road mobile machinery made available exclusively for professional use (new);
- Active implantable medical devices (new);
- Photovoltaic panels intended to be used in a system that is designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential applications (new); and
- Equipment specifically designed solely for the purpose of research and development only made available on a business-to-business basis (new).
Although it appears that there are now many new exclusions to the RoHS Directive’s substance restrictions, the European Commission has stated that the exclusions are to be interpreted narrowly. EEE that has multiple or dual uses that could result in the EEE being “in scope” as well as “out of scope,” such as EEE that is used for both military and civilian purposes, must meet the Directive’s requirements even though it would be out of scope if used solely for an excluded purpose.
d. Inclusion of Cables as Covered EEE
One of the more controversial aspects of the RoHS Recast is its treatment of cables. The European Commission has stated in a draft Frequently Asked Questions (FAQ) document that cables are within the scope of the RoHS Recast if they meet the definitions of EEE in Article 3(1) or cables in Article 3(5). Article 3(5) defines cables as “all cables with a rated voltage of less than 250 volts that serve as a connection or an extension to connect EEE to the electrical outlet or to connect two or more EEE to each other.” The Commission states in the FAQ document that “[m]ost types of cables will meet these definitions as cables are both dependent on electrical currents and electromagnetic fields to work properly and are primarily used for the transfer of electrical currents and electromagnetic fields.”
Several industry trade groups have expressed concern with the Commission’s interpretation and have argued that cables are not independent EEE and instead are components. Unfortunately, it appears that the Commission is not willing to accept these argument, having stated in the original RoHS Draft FAQ Document that cables were covered EEE. Although the Draft FAQ Document is not legally binding, it represents the position of EU Member States and, therefore, it will likely form the foundation for enforcement actions. This may force economic actors to classify standalone, external cables as EEE that must meet all RoHS Recast provisions, including CE marking, on the date when the equipment with which they are used are covered by the RoHS Recast (e.g., July 2, 2013, for cables used with information technology or consumer equipment). The CE marking of cables, which are ubiquitous in number and small in size, represents a significant new cost and recordkeeping burden for impacted producers.
(2) Substance Restrictions
a. No Changes to Restricted Substance List
The original RoHS Directive restricted lead (0.1%), mercury (0.1%), cadmium (0.01%), hexavalent chromium (0.1%), and polybrominated biphenyls and certain polybrominated diphenyl ethers (0.1%) at the homogeneous level in covered EEE effective July 1, 2006. The RoHS Recast does not add any new chemical substances to the original RoHS Directive’s restricted substance list. It also does not change the maximum concentration values of the restricted substances in covered EEE that trigger regulatory requirements. Four substances, however, are specifically identified for priority assessment in a non-binding recital: Hexabromocyclododecane (HBCDD), Bis (2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), and Dibutylphthalate (DBP). Another non-binding recital identifies nanomaterials as a potential future restricted substance category.
b. New Process for Review and Amendment of Restricted Substance List
The RoHS Recast establishes a new process for the review and amendment of the restricted substance list and sets a July 22, 2014 deadline for initial review and amendment of the restricted substance list. The RoHS Recast attempts to establish a framework for ensuring that any new substance restrictions are coherent with the REACH Regulation, which is the regulation that governs chemicals and their safe use in the EU; however, it is unclear how this coordination will occur. Recital 28 of the RoHS Recast requires that during the review of the Directive, a thorough analysis of its coherence with REACH shall be carried out by the Commission. There is recognition, therefore, that future substance restrictions under the RoHS Directive will need to be considered in the context of REACH review and assessment. This may result in a more science-based approach to future substance restrictions under RoHS.
c. New Effective Dates for Previously Excluded Covered Products
Article 4(3) establishes the dates when the RoHS substance restriction provisions go into effect for previously excluded and newly covered EEE categories. The RoHS restrictions will be effective for medical devices and monitoring and control instruments that are placed on the European market after July 22, 2014, in vitro diagnostic medical devices which are placed on the market after July 22, 2016, and industrial monitoring and control instruments which are placed on the market after July 22, 2017.
d. New Effective Date for Newly Covered EEE
Article 2(2) of the RoHS Recast states that non-compliant EEE outside the scope of the original RoHS Directive, but now covered by the RoHS Recast (Category 11 “open scope” and newly covered EEE), will not be subject to the RoHS substance restrictions until July 23, 2019. Unlike other covered EEE, which can be placed on the European market prior to its RoHS effective date and can be sold or distributed in the EU after that date even if they do not meet RoHS requirements, Article 2(2) has been read to establish a “hard stop” to the distribution of “open scope” and newly covered EEE after July 22, 2019. This means that the distribution chain within the EU must be clear of any non-compliant products by July 22, 2019.
e. Application of Restriction Substance Provision to Cables and Spare Parts intended for Repair, Reuse or Upgrading
Article 4(4) establishes the effective date of the RoHS substance provisions for cables and spare parts that are used to repair, refurbish, and reuse previously excluded EEE. It reads that the substance restrictions do not apply to cables or spare parts for the repair, reuse, updating of functionalities or upgrading of capacity of EEE placed on the market prior to July 1, 2006, medical devices placed on the market prior to July 2, 2014, in vitro diagnostic medical devices placed on the market prior to July 22, 2016, monitoring and control instruments placed on the market prior to July 22, 2017, and EEE which benefitted from an exemption and which was placed on the market prior to the expiration of the exemption. This means that cables and spare parts that are intended to be used with excluded EEE for repair or refurbishment purposes will not be covered by the RoHS substance provisions. Interestingly, this Article supports the interpretation that cables are components and not independent EEE; however, as stated above, the European Commission disagrees with this interpretation.
(3) Exemptions
a. Exemption Process
The RoHS Recast establishes clearer and more transparent rules for granting, renewing, or deleting application-specific exemptions. The RoHS Recast requires the Commission to take action on an exemption request within six months prior to the expiration of an existing exemption. Deadlines are also set that require manufacturers to apply for the renewal of existing exemptions. Applications must be filed eighteen months prior to the expiration of an exemption. These deadlines should provide more certainty to the exemption process going forward.
b. Exemption Criteria
The original RoHS Directive allowed for exemptions to be granted in cases where the substance restriction was not practical or when the environmental, health, and consumer safety impacts of substitution resulted in a negative outcome. The RoHS Recast adds three new criteria to the exemption evaluation process: reliability of chemical substitutes, availability of substitutes, and the socio-economic impact of substitution
c. Expiration of Exemptions
The RoHS Recast adds expiration dates for certain existing application-specific exemptions and establishes a new process that provides for maximum time limits for the new application-specific exemptions--five years for categories 1-7, 10, and 11 and seven years for categories 8 and 9. The RoHS Recast also places the burden on producers and affected entities to apply for exemptions and carry out necessary assessments to justify exemptions. Exemptions will no longer be applicable when their validity period has expired or if they are revoked because the conditions that allowed for their exemption are no longer met.
(4) New Conformity Assessment Requirements
The biggest change posed by the RoHS Recast is the transition to a compliance system that is based on the New Approach, which requires that compliance to certain EU Directives be demonstrated by a Declaration of Conformity (DoC) and application of the CE mark to the covered product. The RoHS Recast will require producers to produce and maintain technical files and documentation to support their DoC. This is a significant difference from the original RoHS Directive which did not prescribe specific documentation, recordkeeping, conformance, or marking requirements.
a. Declaration of Conformity
Regulation 765/2008 sets out the requirements for accreditation and market surveillance related to the marketing of products covered by the New Approach. When a product that is covered by a New Approach Directive is placed on the EU market, the manufacturer or its authorized EU representative is required to prepare a DoC as part of the conformity assessment procedure. A DoC is a declaration made by the manufacturer or its authorized representative that the equipment is in conformity with the requirements of the applicable Directive or Directives. For the RoHS Recast, this means that the substance restriction provisions have been meet for all covered EEE placed on the EU market after its relevant effective date. If the product is subject to more than one Directive, the DoC should cover all relevant Directive requirements.
b. Technical Documentation Requirements
To prepare a DOC, producers must prepare technical documentation that supports their determination that covered products meet the requirements set forth in the relevant Directives. Technical documentation requirements, which will be required to be maintained for 10 years, are found at Decision 768/2008. Module A of Annex II of Decision 768/2008/EC contains a list of technical documentation which supports the product’s conformity. Required documents include the following:
- 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 harmonized standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union [ITALICS];
- Results of design calculations made, examinations carried out; and
- Test reports.
c. EN 50581
In October 2011 the European Commission directed CENELEC, which is a European standards body, to develop a standard, EN 50581, entitled “Technical documentation for the evaluation of electrical and electronic products with respect to restriction of hazardous substances” that producers may use to meet RoHS Recast technical documentation requirements. That standard was approved in June 2012 and is expected to be published in the Official Journal [ITALICS] shortly. Article 16 (2) of the RoHS Recast states that a manufacturer who demonstrates conformance with harmonized standards that are published in the Official Journal [ITALICS] shall be presumed to comply with the requirements of the RoHS Recast. Once it is published, therefore, EN 50581 will establish a presumptive method for establishing conformity with the RoHS Recast.
d. CE Mark
The RoHS Recast will require covered EEE to bear the CE mark to demonstrate compliance with the RoHS substance restriction provisions. Components, subassemblies, and spare parts that are not independent EEE do not need to be CE marked. The CE mark shall be affixed visibly, legibly and indelibly to the finished EEE or to its data plate. Where that is not possible or warranted on account of the nature of the EEE, it shall be affixed to the packaging and to the accompanying documents. From July 2, 2013, EEE in scope that bears the CE mark will be presumed to be in conformity with the RoHS Recast. CE marking is the only marking that will attest to the conformity of the product to the RoHS Recast.
Conclusion
Although the RoHS Recast does not modify the basic framework of the RoHS Directive and leaves its substance restrictions largely unchanged, the RoHS Recast casts a wider net over EEE products--encompassing previously excluded product categories, adding new product categories, and eliminating old exemptions and loopholes. Furthermore, the RoHS Recast establishes a new compliance methodology that will necessitate new data gathering, recordkeeping, and marking procedures for covered producers and importers. Newly covered entities, as well as previously covered entities, will need to immediately start tracking, managing, recording, and planning to meet these new compliance obligations. Holly Evans is the President and Founder of Strategic Counsel, LLC, a full service environmental law and policy firm located in Washington, DC. She has more than 15 years’ experience representing members of the global electronics industry on environmental, health, and safety issues. Prior to forming Strategic Counsel, she served as Deputy General Counsel and Director of Environmental Programs for the Electronic Industries Alliance (EIA) and also served as Director of Government Relations for IPC, and a congressional fellow for Senator Joseph Lieberman (I-CT). Evans can be reached at hevans@strategiccounsel.org. Visit www.strategiccounsel.org for more information.