Maker and seller beware! The European Union’s “RoHS” hazardous-substances restriction scheme is undergoing a significant recast and it’s critical that manufacturers and distributors of electrical and electronic equipment in EU markets familiarize themselves with the new rules and prepare accordingly. We’ve been watching these developments and offer the following observations and advice.
Here are the highlights of “RoHS 2”:
· Manufacturers are required to draw up and retain extensive technical documentation on products (down to the homogeneous-material level) establishing that the restricted substances are not present in their products. This means a lot of investigation into goods and materials purchased from suppliers.
· Manufacturers need to establish internal production control procedures to ensure compliance. Procedures need to include batch, serial and type logs, corrective measures protocols (including ways to remove product that is found to be non-conforming) and ways to keep EU distributors current about compliance issues.
· The changes go into effect 2 January 2013. This is the enforcement date – all product sold on or after this date must comply (DO NOT sell old inventory that doesn’t comply).
· RoHS 2 is now a CE-marking directive. You can no longer affix the CE mark without complying with RoHS 2.·
· New categories of specific products are being added: medical devices and monitoring and control instruments (both effective 22 July 2014); IV diagnostic medical devices (effective 22 July 2016; and industrial monitoring and control instruments (effective 22 July 2017). All other electrical and electronic equipment will be covered effective 22 July 2019.
These changes are backed by enforcement language: each EU member state is expected to step up market surveillance in order to ensure that products sold in the EU comply with the new rules (but we would think that actual enforcement will not match the words on paper, given the significant budget constraints in EU governments.). So, it’s time to make sure all EU-bound electrical and electronics products comply.
There are other RoHS-type schemes around the world (e.g., China RoHS) and we’re expecting that these regulations will be updated soon to mirror what’s being done in the EU. We’ll be watching for those developments and keep you up to date.
Contact us if you want to know more about RoHS 2.