RoHS 2011/65/EU Amendment – ECIA Update, March 2019

The EU Restriction of Hazardous Substances (RoHS) landscape is being significantly modified in 2019.  After more than a dozen years of only six substances, four new substances are being added to one of the most widely known environmental compliance legislations in the world.

The Delegated Directive (EU) 2015/863 amends Annex II of the RoHS 2 Directive 2011/65/EU by adding four new substances (phthalates) for restriction:  Bis (2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP), and Diisobutyl phthalate (DIBP).  The four phthalates will bring the total number of RoHS substances for most Electrical and Electronic Equipment (EEE) to ten, effective July 22, 2019.

Note:  while the addition of the four phthalates is sometimes colloquially referred to as “RoHS 3,” (EU) 2015/863 is only an amendment to RoHS 2 (2011/65/EU) and doesn’t repeal 2011/65/EU or advance the numeration of EU RoHS directives.  Also, a “RoHS 3” recast is being considered now for implementation in a number of years with seven more substances potentially being added.  Therefore, ECIA will refrain from using “RoHS 3” to refer to the (EU) 2015/863 amendment. 

See related resource #1 below for more details.

DEHP, BBP, DBP and DIBP are primarily used as plasticizers to soften plastics, and are likely to be lurking in cables, wiring, handle grips, gaskets, vinyl, labels, inks, synthetic rubber, adhesives and glues, paints, coatings, polymers, polymer resistors, and other materials.

These phthalates are not new on the compliance scene.  They are listed by the European Chemical Agency (ECHA) as being reproductive toxins and endocrine disruptors, and hence have been listed in the REACH Candidate List of Substances of Very High Concern (SVHC List) as well as being restricted in plastic toys and childcare products via Entry 51 of the REACH Annex XVII restrictions.  In July 2020, amendments to Entry 51 will take affect that expand the scope from only toys and childcare products to open scope with exclusions (e.g. EEE covered by RoHS will be excluded).  In addition, three of the phthalates - DEHP, BBP, and DBP - are listed as California Proposition 65 chemicals.

Given the potential harm these four phthalates may have on human and environmental health and the availability of less potentially harmful substitutes, the EU has decided to restrict these substances in EEE. The maximum allowable concentration for each of the four substances will be 0.1% of the homogeneous material by weight.  No RoHS exemptions exist at this time for the phthalates.  Marking and Declaration of Conformance (DoC) requirements will not change.

The 2015 amendment allows a grace period for compliance which is quickly drawing to a close.  Restrictions on the new substances shall apply for most EEE product placed on the EU market from July 22, 2019 and onward.  However, for medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, the restrictions become effective July 22, 2021.

ECIA members are already seeing many customer requests for RoHS status including all 10 RoHS substances and should expect the volume of requests to increase.  While certain manufacturers are currently making RoHS (EU) 2015/863 statements available via websites and email, there is much more to do in our industry in a short period of time to adequately prepare for this very impactful change.

Additional information available to ECIA members below: