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Ensuring On-going Compliance with the RoHS Directive

Posted by J. Gieseke on Apr 29, 2015 9:32:55 AM

Fundamentally, RoHS restricts six substances: 4 heavy metals (lead, cadmium, mercury, hexavalent chromium) and two flame-retardants (PBBs and PBDEs). The concentration limits for all these substances is .1% of any homogenous material – except for cadmium (.01%). Despite the fact that RoHS only applies to electrical and electronic equipment (EEE ) placed on the EU market, it has been highly influential in pushing similar (but NOT identical) requirements in many other geographies.

RoHS has also instigated a global change in the design and composition of off-the-shelf components that affects many industries, including the equipment industry. As a result, changes in RoHS are noteworthy even for manufacturers whose products are out of scope or are sold outside the EU. In that regard, all equipment manufacturers should be aware that the key business risks to be mitigated are enforced obsolescence and design changes, as well as the loss of market access due to non-compliance.

Like most legislation, RoHS is not a static animal. It was “recast” at the beginning of 2013 and is now commonly known as RoHS2 (directive 2011/65/EU). Below are key changes between RoHS1 and RoHS2.


Substance Scope

Although the substances and their allowable concentration limits did not change between RoHS1 and RoHS2, the addition of further substances is imminent. The EU Commission is proposing to restrict four plasticizers (DEHP, BBP, DBP, DiBP) and one flame retardant (HBCDD), which has been identified as a Persistent Organic Pollutant and will be banned globally, irrespective of RoHS. All of these proposed substances are already REACH SVHCs. No timetable has been published, but the earliest any ban could take effect is probably between mid-2017 and 2019.

Furthermore, RoHS’ expansion of substance scope does not end there. An additional round of restrictions is envisioned. The most likely candidates are TBBPA (another flame retardant), MCCP (a flame retardant and plasticizer) and even PVC. Several other substances are also possibilities.

In regard to future substances, ERA Technology is currently an invited member of a working group of representatives from industry, EU Member States and NGOs. The group was formed by the European Commission to consider improvements in the methodology for identifying future substance restrictions. ERA’s main focus is establishing an approach that considers potential alternatives to substances that are proposed for restriction. This approach is meant to be even-handed and evidence-based, while taking into account the entire product life cycle.


Product Scope

The original RoHS directive focused mainly on consumer and other high volume products in 8 categories. The recast brings several other categories within scope at different times:

  • July 22, 2014 - Medical devices, Monitoring and control instruments
  • July 22, 2016 - In Vitro Diagnostics (IVD)
  • July 22, 2017 - Industrial monitoring and control instruments
  • July 22, 2019 - Other equipment (subject to review)

The first of these dates has already passed. Changing product designs and processes to meet this deadline, as well as future ones, has been the focus of intense activity.


‘Like most legislation, RoHS2 is not a static animal’

In addition, the recast has brought in a broader understanding of what constitutes EEE. Previously, many (but not all) EU Member States considered EEE to be in scope only if the product’s main function depended on electricity (Under this definition, for example, a petrol lawn mower was out of scope, even though it has a spark plug.) But now, under RoHS2, EEE includes products with any electrical function. Any product within this broadened interpretation must comply by July 22, 2019.

Note that there are other important issues regarding the impact of the above deadlines and recast product categorizations (e.g. what is “industrial”), but they are beyond the scope of this summary article.

Please review the Table


Key EU RoHS2 Compliance Dates

12/31/2014 Last date for EU Member States to implement changes to RoHS’ Exemptions List (Directives 2014/69/EU – 2014/76/EU )
4/13/2015 Exemption 4d for mercury in high pressure mercury (vapour) lamps expires
4/13/2016 Exemption 2 (b) 2 for mercury in non-linear halophosphate lamps expires
6/30/2016 Exemption 33 (Annex IV) for lead in solder on populated printed circuit boards for class Iia mobile medical devices expires
7/21/2016 Default expiration date for exemptions in Electrical and Electronic Equipment (except RoHS Categories 8 and 9), where not otherwise specified Substance restrictions extended to in vitro medical devices
7/22/2017 Substance restrictions extended to industrial monitoring and control instruments
12/31/2017 Expiration of exemption 1g for mercury in single capped CFLs <30W: 3.5 mg and exemption 28 (Annex IV) for lead in solders for mounting cadmium telluride and cadmium zinc telluride digital array detectors to printed circuit boards
12/31/2018 Expiration of exemption 4g for mercury in hand-crafted luminous discharge tubes used in certain signs and lighting; exemption 41 for lead in solders and termination finishes of components and circuit boards in ignition modules and other engine control systems; and exemption 37 (Annex IV) for Category 8 and 9 exemptions for lead in platinized platinum electrodes for conductivity measurements
7/22/2019 Substance restrictions expanded to category 11 (other EEE not otherwise exempt) – open scope
12/31/2019 Certain exemptions (24, 30, 32 and 38) for Categories 8 and 9 will expire
6/30/2020 Exemption 27 (Annex IV) for lead in solders, coating and connections in certain medical devices expires
12/31/2020 Expiration of exemptions 33 (Annex IV) for lead in solder on populated printed circuit boards for class IIb mobile medical devices; for lead in other than C-press compliant pin connector systems for industrial monitoring and control instruments; and for lead in dielectric ceramic in capacitors for industrial monitoring and control instruments.
6/30/2021 Certain exemptions (12, 22, 23, 25, 26 and 29) for Categories 8 and 9 will expire
7/21/2021 Expiration of exemption 31 for lead, cadmium and hexavalent chromium in reused spare parts recovered from medical devices in closed loop lead in micro-channel plates in medical devices and monitoring and control instruments; systems; exemption 39 (Annex IV) for and exemption 34 (Annex IV) lead as an activator in fluorescent powder of some discharge lamps
7/21/2023 Exemption 39 (Annex IV) for lead in micro-channel plates in in-vitro medical devices expires
7/21/2024 Expiration of exemption 39 (Annex IV) for lead in micro-channel plates in industrial monitoring and control instruments, as well as exemption 35 (Annex IV) for mercury in cold cathode fluorescent lamps in certain liquid crystal displays in industrial monitoring and control instruments



Topics: Industry Updates, Regulatory, RoHS


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