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The scope of European Union's (EU) Restriction of Hazardous Substances (RoHS) directive has been widened to include more products, including medical and monitoring equipment under revisions of the law recently approved by the EU. RoHS restricts the use of six substances including lead, mercury, cadmium, hexavalent chromium, polychrominated biphenyls, and polybrominated diphenyl ether in electronics equipment. PBB and PBDE are flame retardants used in plastics in equipment.
When RoHS went into effect in 2006, medical equipment and monitoring and control equipment were not included in the law. However, changes to the directive now require OEMs building medical, monitoring and control equipment, and electrical equipment to comply with the law.
"The EU has now gone to 11 product categories," said Ken Stanvick, senior vice president of Design Chain Associates, a San Francisco consulting firm that advises companies about environmental laws and regulations and other supply chain issues.
"There were eight categories originally. Medical and monitoring were excluded from RoHS," Stanvick said. The EU now has added medical and monitoring equipment, as well as another category "which is kind of a catch-all category that basically includes any equipment that's not in the first 10 that meets the definition of electrical and electronic equipment," he said.
Stanvick added that the products not included in the directive include defense systems, automotive, and equipment used in space.
"Basically, if an electronics or electrical product is not specifically excluded, it is now included" under RoHS, Stanvick noted.
That means a wider range of products must now comply with the directive if they are to be sold in the EU, including some that have very little electronics.
For instance, greeting cards equipped with a chip that plays a birthday message or other audio will have to comply with RoHS. Other types of acquirement that have some electronics or electrical functionality will also have to comply.
The revised directive also has a CE marking requirement. The marking of CE (Conformité Européenne or European conformity) means that the OEM has verified that a product complies with all safety, health, and environmental protection requirements of laws of the EU.
The revised directive also calls for conformity documentation to be kept for 10 years. "The documentation must be available for local authorities in the member states in which the product is sold," said Stanvick. "Everybody in the supply chain really needs to be looking upstream to make sure that whatever they are buying has all the conformity requirement documents."
While product categories were added to the revised directive, no new substances were added to the original six. However, some other substances will be assessed in the future for possible RoHS inclusion.
The Association Connecting Electronics Industries (IPC) had lobbied that any changes to the directive "be underpinned by a solid scientific examination," said Fern Abrams, IPC director, government relations and environmental policy.
"As an industry, we convinced EU lawmakers of the complexities and implications of restricting substances without conducting thorough scientific analyses of those substances and their potential alternatives," noted Abrams. "Due to IPC's lobbying efforts, the revised RoHS directive does not restrict any additional substances."
However, the EU identified four substances for a "priority assessment." The substances are Hexabromocyclododecane (HBCDD), Bis (2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), and Dibutyl phthalate (DBP).
The revised directive will have an impact on buyers at medical and monitoring equipment OEMs, along with other electrical equipment manufacturers.
For instance, many OEMs outsource to electronics manufacturing services (EMS) providers. Buyers need to make sure that their EMS partners can maintain production while complying with RoHS, according to Stanvick.
Buyers must also make sure that the parts they buy are compliant and that non-compliant parts do not get designed into new products.
The good news for buyers is that most semiconductor companies and other component manufacturers have transitioned to RoHS-compliant parts.
Companies that do not comply with RoHS run the risk of having a product recalled under the revised law. "If a member country finds a piece of your equipment is not in compliance, the country can order you to recall all of your products. That's not a cheap proposition," said Stanvick.
In the past, companies could be fined for violations and the president of the company may have to explain to authorities in an EU member country about why the product was not compliant what is being done to make it compliant.
"They're not out for blood as long as you are cooperative and try to rectify the situation," Stanvick said.
Stanvick noted that the new revised RoHS will likely impact legislation in other countries. While the United States does not have a national RoHS-type law, some states—such as California—have laws that are similar to RoHS. Countries in Asia and South America also have laws with provisions similar to RoHS.
The revised RoHS will create an increased cost of doing business for the companies and industries that will now be covered by the directive.
"Companies have to dedicate resources either internally or externally" to gather information showing compliance, said Stanvick. "The information must be put into databases and maintained. It's part of the cost of doing business."
Stanvick also said some companies may have a hard time complying with the law and may complain about them. "But progressive companies have better things to do than to moan and groan about something they have no control over. So they put the right things in place, and make it as efficient as they can go forward," said Stanvick.
The revised RoHS directive is expected to go into effect not later than July 2, 2013.