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EC) - Overview of Regulatory Requirements

Date: April 27, 2011
Source: Admin

The RoHS regulation, often called the lead-free directive (the reasons for calling it so become apparent once the subsequent paragraphs are gone through) restricts the use six substances. The following Table reveals the substances restricted, the maximum permissible concentration allowed in respect of each such substance, the product components that contain the said restricted substances and the testing approaches.

Restricted substances	Maximum permitted concentrations	Product components containing the restricted Substances	Typical Testing Approaches
Lead	1000 PPM, by weight of homogenous material	Paints and pigments, PVC (vinyl) cables as a stabilizer (e.g. power cords, USB cables), solders, printed circuit board finishes, leads, internal and external interconnects, glass in television and photographic products (e.g. CRT television screens and camera lenses), metal parts, lamps and bulbs, batteries	Wet chemical digestion followed by ICP (Inductively coupled plasma) or AAS (atomic absorption) spectroscopy XRF (X-ray fluorescence) spectroscopy
Mercury	1000 PPM, by weight of homogenous material	Lighting applications and automotive switches, fluorescent lamps (used in laptops for backlighting) and mercury tilt switches	Wet chemical digestion followed by AAS XRF
Cadmium	100 PPM, by weight of homogenous material	Plastic pigmentation, nickel-cadmium (NiCd) batteries and CdS photocells (used in night lights).	Wet chemical digestion followed by ICP or AAS XRF
Hexavalent Chromium	1000 PPM, by weight of homogenous material	Used for metal finishes to prevent corrosion.	Wet chemical digestion followed by UV-VIS spectroscopy XRF (for elemental Cr only)
Polybrominated biphenyls (PBB) and Polybrominated diphenyl ethers (PBDE)	1000 PPM, by weight of homogenous material	Used primarily as flame retardants	Solvent extraction followed by gas chromatography/mass spectroscopy XRF (for elemental Br only

The directive applies to equipment as defined by the WEEE (Waste Electrical and Electronic Equipment) directive. The applicable numeric categories are as follows:

1. Large and small household appliances.

2. IT equipment.

3. Telecommunications equipment (infrastructure equipment exempted in some countries)

4. Consumer equipment.

5. Lighting equipment—including light bulbs.

6. Electronic and electrical tools.

7. Toys, leisure, and sports equipment.

8. Medical devices (currently exempt)

9. Monitoring and control instruments (currently exempt)

10. Automatic dispensers.

11. Semiconductor devices

RoHS applies to these products in the EU whether made within the EU or imported. Certain exemptions apply, and these are updated on occasion by the EU.

Product exemptions

Medical devices and monitoring and control instruments (covered by Category 8 and Category 9) are temporarily exempt from the RoHS regulation as these are manufactured in small numbers and generally have a long product life. Further, these products have critical applications and their failure can be extremely disruptive and even catastrophic. Hence the EU commissioned a study to assess when and if the RoHS directive should be applied to these products. The study recommended that Category 8 and Category 9 products remain exempt from the RoHS directive until 2012 or 2018 depending upon specific product sub-categories and applications. Since the EU has not yet implemented this recommendation, it is not known when RoHS will be made applicable to Category 8 and Category 9 products.

Hazardous materials and the high-tech trash problem

RoHS and other efforts to reduce hazardous materials in electronics are meant in part to address the global issue of consumer electronics waste. As newer technology arrives every now and then, consumers discard their obsolete products sooner than later. This waste ends up in landfills and in countries like China, for recycling. RoHS helps reduce damage to people and the environment in third-world countries where much of today's "high-tech trash" ends up. The use of lead-free solders and components has provided immediate health benefits to electronics industry workers in prototype and manufacturing operations.

Life-cycle impact assessment of lead-free solder

RoHS reflects contemporary research over the past 50 years in biological toxicology that acknowledges the long-term effects of low-level chemical exposure on populations. New testing is capable of detecting much smaller concentrations of environmental toxins. Researchers are associating these exposures with neurological, developmental, and reproductive changes. RoHS and other environmental laws contrast with historical and contemporary laws that seek to address only acute toxicology, that is, direct exposure to large amounts of toxins causing severe injury or death.

The United States Environmental Protection Agency (EPA) has published a life-cycle assessment (LCA) of the environmental impacts of lead-free and tin-lead solder, as used in electronic products. For bar solders, when only lead-free solders were considered, the tin/copper alternative had the lowest (best) scores. For paste solders, bismuth/tin/silver had the lowest impact scores among the lead-free alternatives in every category except non-renewable resource consumption. For both paste and bar solders, all of the lead-free solder alternatives had a lower (better) LCA score in toxicity categories than tin/lead solder. This is primarily due to the toxicity of lead, and the amount of lead that leaches from printed wiring board assemblies, as determined by the leachability study conducted by the partnership. The study results have provided the industry with an objective analysis of the life-cycle environmental impacts of alternative lead-free solders. This assessment also allowed the industry to redirect efforts toward products and processes that reduced the solders’ environmental footprint, including energy consumption, releases of toxic chemicals, and potential risks to human health and the environment.

The ten steps needed to comply with the RoHS Directive

Manufacturers had to comply with significant, and potentially costly, compliance requirements in order to meet the RoHS deadline of July 1, 2006. However, clear requirements for implementation, in particular, the actions that constituted compliance were lacking. Hence the actions necessary to prove to regulatory bodies and customers that RoHS had been complied with, had to be defined. So, the European Commission formed a Technical Adaptation Committee (TAC) comprised of representatives from EU member states. TAC was required to establish a process for ensuring that the RoHS substance ban provisions were complied with. Amongst other things, TAC was required to devise a method to ensure RoHS compliance and enforcement. The following are the ten steps towards developing and implementing a strategy for compliance:

1. Determine the company’s legal exposure.

2. Constitute a corporate-wide compliance team.

3. Draft a corporate RoHS compliance statement.

4. Develop an internal RoHS compliance “roadmap.”

5. Assess the company’s supply-chain exposure.

6. Qualify suppliers.

7. Establish a supply chain material declaration process.

8. Perform limited testing and validate results.

9. Exchange RoHS compliance data with customers.

10. Incorporate RoHS compliance strategy into company-wide operations.

Labeling

RoHS does not require any specific product labeling. However many manufacturers have adopted their own compliance marks to minimize confusion. Visual indicators in use today include explicit "RoHS compliant" labels, green leaves, check marks, and "PB-Free" markings. In addition, the closely related WEEE trash-can logo with an "X" across indicates that the product may be compliant. Chinese RoHS labels depict the alphabet ‘E’ in lower case inscribed in a circle with arrows, to convey compliance.

The proposed RoHS II has attempted to address this issue by requiring the CE mark and introducing an additional provision, called the Trading Standards. CE marking or CE mark is a mandatory conformance mark on many products marketed in the European Economic Area (EEA). The CE marking assures the consumer that the product complies with the important requirements of the applicable EC directives. CE is the acronym for "Conformité Européenne" ("European Conformity").

RoHS II

The European Parliament completed its first reading of the draft of RoHS II in November 2010. Items that were previously questioned have now been clarified and RoHS II is on its way to becoming a CE Mark directive. As a result, CE marking will be affixed to all finished products, in line with Module A of Annex II of 768/2008/CE. With CE marking, the responsibility now rests on manufacturers, importers and distributors. CE declaration remains the manufacturer’s obligation, while the release of compliant products to the EU market becomes the responsibility of importers and distributors. The CE mark will now not only mean that an electrical or electronic product complies with all applicable regulations - for example, the low voltage directive or the electromagnetic compatibility requirement; it will also indicate compliance with RoHS. Thus product compliance and conformity assessment will now include the obligation to comply with RoHS.

RoHS II introduces no new restricted substances. But it introduces a simplified mechanism for the review and amendment of the list of restricted substances in future. Substances highlighted for future review include hexabromocyclododecane (HBCDD), phthalates (DEHP, BBP, DBP) and nanomaterials.

In its current draft form, RoHS II exempts the following ten types of electrical and electronic equipment:

1. Equipment pertaining to the security and protection of Member States, including arms, munitions and war materials intended specifically for military use; equipment designed to be sent into space

2. Equipment designed for installation as part of equipment that is exempt from the directive, specifically if the equipment is only for use in exempt equipment and can only be replaced by equipment of the exact same design

3. Large scale stationary industrial tools

4. Large scale fixed installations

5. Transport means for persons or goods, excluding electric two-wheel vehicles that are not type-approved

6. Mobile machinery unintended for road use that is available exclusively for professional use

7. Active implantable medical devices

8. Solar panels intended for use in a system that is designed, assembled and installed by professionals for permanent use at a specific location for the production of energy from solar light for public, commercial, industrial or residential use

9. Equipment designed solely for the purposes of research and development and for utilization on a strictly business-to-business basis.

10. Besides these general exempt Electrical and Electronic Equipment (EEE), there are some specific exemptions of restricted substances in specific applications. Annex III and Annex IV define where otherwise restricted substances may be applied. It is to be noted that in future, exemptions will have an expiration date. Interested parties have to seek renewal of exemption within the prescribed time failing which the exemption will lapse.

No new restricted substances have been introduced and the publication of the directive is expected in 2011.

RoHS II seeks to redefine homogeneous materials

RoHS II, however, seeks to define ‘homogeneous material’ afresh. Accordingly, a homogeneous material is ‘a material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be mechanically disjointed into different materials, meaning that the materials cannot be separated by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes.’

Formal adoption of RoHS II by the European Council was expected in the first quarter of 2011, with the directive becoming mandatory legislation 20 days after publication in the Official Journal of the European Union