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Electrical and electronic equipment products sold in the European Union (EU) must prove their compliance with the European directive on the Restriction of Hazardous Substances (RoHS). This directive reduces the risk of exposure to dangerous chemicals for both humans and the environment. It restricts the content of ten hazardous substances in the manufacture of electronics ranging from appliances to medical devices to communications equipment.

These substances include: 

• Lead (Pb)
• Mercury (Hg)
• Cadmium (Cd)
• Hexavalent Chromium (Cr(VI))
• Polybrominated Biphenyls (PBB)
• Polybrominated Diphenyl Ethers (PBDE)
• Bis(2-Ethylhexyl) phthalate (DEHP)
• Benzyl butyl phthalate (BBP)
• Dibutyl phthalate (DBP)
• Diisobutyl phthalate (DIBP)

The maximum concentration values for each of these restricted substances is 0.1%, except for cadmium with a limit of 0.01%. After the latest RoHS directive changes were implemented in 2019, expanding the list of controlled substances from six to ten, exemptions were added for certain industries. One key exemption for medical devices and other equipment is expiring in July of this year.  

What does the expiration of the RoHS exemptions mean for my business? 

On July 21, 2021, exemptions to the RoHS “Directive (EU) 2015/863” for the usage of lead in medical devices will expire. After this date, the use of lead will be restricted to a concentration of 0.1% for the following uses when manufacturing medical devices: 

• As an alloying element in steel, aluminum or copper
• In high melting temperature type solders
• In electrical and electronic components with glass or ceramic

Medical devices will also be required to comply with RoHS3 restrictions on the use of phthalate plasticizers DEHP, BBP, DBP, and DIBP. 

These restrictions will impact medical devices and equipment, with a few exceptions: in vitro diagnostic medical devices and monitoring and control instruments will remain exempted until 2023 and 2024. 

The expiration of these exemptions will affect other categories as well, including consumer electronics devices, lighting, and computing equipment. 

With these exemptions expiring, manufacturers introducing new medical devices or other electronic equipment will need to ensure compliance to the latest RoHS standards to maintain European market access. This could mean additional testing to determine if your product components and materials contain hazardous substances like lead and phthalates, and potentially to validate alternative materials. 

Element offers expertise in RoHS compliance testing

Element helps customers ensure RoHS compliance by performing quick, reliable testing of component materials to verify levels of the restricted substances. Our scientists thoroughly document all RoHS testing results for our customers' records. We can provide a smooth path to market for your medical devices and consumer electronics. 

For more information on RoHS testing or to speak with one of our experts, contact us today.