Electrical products and medical devices which are manufactured in the United States, and sold in the EU may be significantly impacted by updates to two sets of regulations:

  • RoHS, the Restrictions of Hazardous Substance Directive, and
  • REACH, the Registration, Evaluation, and Authorization of Chemicals.

RoHS 2 (the new version of RoHS) is a broadening of the original directive and makes a number of clarifications. REACH, implemented in 2007, has a 20 year implementation schedule and has ongoing updates.

Both are EU and UK based systems of risk management which can affect various manufacturing processes using chemicals, especially companies which produce cables and medical devices. RoHS restrictions are based on six hazardous substances (lead, cadmium, mercury, hexavalent chromium, PBDE and PBB) in the production of certain electronics. REACH restrictions apply to products placed on the European market and come into effect if human health or environmental risk can be proven, the chemicals cannot be controlled, and substitutes exist.

RoHS restricts the use of substances which present a high level of concern, such as the use of lead in the manufacture of certain electronic equipment. REACH has affected companies which use substances of high concern, as well as created laws relating to these substances, such as requiring companies to label items which contain certain substances. REACH went into effect in 2007 and has been the strictest law to date in the EU regulating chemical substances from international supplies.

The RoHS 2 directive is an evolution of the original RoHS, addressing the same substances but improving the legal clarity. It requires periodic reevaluations to broaden the scope of electrical equipment, cables, and spare parts (including medical devices). The RoHS 2 re-cast includes a broader scope of electrical cable products; you can learn which specific categories apply to certain products here. There are some products which are excluded from RoHS, including large scale industrial tools, as well as products which are specifically designed to function within another product.

The REACH updates are less notable than the RoHS updates but nonetheless important. For example, REACH may soon ban the use of BPA and will affect the use of reagents. Also important to note, REACH is now accelerating the phase out of hazardous substances. The list of SVHC’s (Substances of Very High Concern) has recently been updated, and you can find it here.

Manufacturers of electronic equipment and medical devices should understand the nuances of these re-cast programs if they intend to sell to the EU market.


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