RoHS is a mandatory standard originating from the European Union, which officially came into effect on July 1, 2006. Subsequently, the European Union launched ROHS 2.0 (2011/65/EU) to replace the original ROHS (2002/95/EC) directive, which came into effect on July 21, 2011.

RoHS 2.0 not only expands the regulatory scope, but also sets an eight year transition period. During this period, newly regulated electrical and electronic equipment can still enter the EU market without fully complying with RoHS 2.0 regulations. However, after the transition period ended on July 22, 2019, the European Commission found that there were several issues with the regulatory scope of RoHS 2.0, and therefore it was necessary to make legal amendments. Therefore, on January 26, 2017, the European Commission proposed a revision to the RoHS 2.0 directive, which gave rise to RoHS certification 3.0.

RoHS 3.0 (EU Directive 2015/863) further expands the regulatory scope to cover 11 categories of fully functional products and adds four new restricted substances - all phthalates, which are mainly used as insulation plasticizers and have been included in the RoHS list of SVHC (Substances of Very High Concern). The following are four newly added restricted substances in RoHS 3.0:

Cadmium (limit 0.01%)

Lead (limit 0.1%)

Mercury (limit 0.1%)

Hexavalent chromium (limit 0.1%)

Polybrominated biphenyls (PBB) (limit 0.1%)

Polybrominated diphenyl ethers (PBDE) (limit 0.1%)

Di (2-ethylhexyl) phthalate (DEHP) (limit 0.1%)

Butyl benzyl phthalate (BBP) (limit 0.1%)

Dibutyl phthalate (DBP) (limit 0.1%)

Diisobutyl phthalate (DIBP) (limit 0.1%)

It should be noted that the transition period for medical devices has been extended by two years. The regulations that comply with RoHS 3.0 standards are: Starting from July 22, 2021, restrictions on DEHP, BBP, DBP, and DIBP will apply to medical devices, including in vitro medical devices, as well as monitoring and control instruments, including industrial monitoring and control instruments