As part of the service AvISO Consultancy offer, we provide our clients with quarterly updates of any changes to legal compliance. By doing this, we keep our clients up to date with any changes in their legal compliance obligations.
Within the legal texts published between the 1st April and 30th June 2019 there was an update to the Restriction of Hazardous Substances - RoHS 3 (EU Directive 2015/863), here’s an update of these recent amendments.
RoHS stands for Restriction of Hazardous Substances and impacts the entire electronics industry and many electrical products as well. The original RoHS, also known as Directive 2002/95/EC, originated in the European Union in 2002 and restricts the use of six hazardous materials found in electrical and electronic products. All applicable products in the EU market since July 1, 2006, must pass RoHS compliance.
Directive 2011/65/EU was published in 2011 by the EU, which is known as RoHS-Recast or RoHS 2. RoHS 2 includes a CE-marking directive, with RoHS compliance now being required for CE marking of products. RoHS 2 also added Categories 8 and 9 and has additional compliance record keeping requirements.
Directive 2015/863 is known as RoHS 3. RoHS 3 adds four additional restricted substances (phthalates) to the list of six. RoHS 3 Deadline is 22 July 2019.
Any business that sells applicable electrical or electronic products, equipment, sub-assemblies, cables, components, or spare parts directly to RoHS-directed countries, or sells to resellers, distributors or integrators that in turn sell products to these countries, is impacted if they utilise any of the restricted 10 substances.
With the rapid spread of digitisation, the world's production of electrical and electronic devices is exploding. Besides mobile devices think about the coming wave of IoT, smart home assistants, robots, drones, 3D printers, and home medical devices to all corners of the planet....they are all regulated under RoHS.
RoHS 3 (EU Directive 2015/863)
RoHS 3 (EU Directive 2015/863) adds Category 11 (catch-all) products and adds four new restricted substances - all phthalates. The four phthalates are mainly used as insulation plasticizers and are on the REACH list of SVHC (Substances of Very High Concern).
The expanded list for RoHS 3 is thus as follows:
* Cadmium (0.01 %)
* Lead (0.1 %)
* Mercury (0.1 %)
* Hexavalent chromium (0.1 %)
* Polybrominated biphenyls (PBB) (0.1 %)
* Polybrominated diphenyl ethers (PBDE) (0.1 %)
* Bis(2-ethylhexyl) phthalate (DEHP) (0.1 %)
* Butyl benzyl phthalate (BBP) (0.1 %)
* Dibutyl phthalate (DBP) (0.1 %)
* Diisobutyl phthalate (DIBP) (0.1 %)
Extension exemption: Of note is that medical devices have a two-year extension to meet RoHS 3 compliance:
"The restriction of DEHP, BBP, DBP, and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021."
Category 11 products include all other electronic and electrical equipment not covered under the other categories. Included are 2-wheeled vehicles, electronic nicotine delivery systems (ENDS) such as e-cigarettes, cannabis vaporizers, and vape pens. Also included are electrical cables that are less than 250V working voltage.
If you feel any of the above amendments affect your business and would like a no-obligation chat, please contact us.
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