Latest news on the RoHS directive – RoHS 2 or RoHS 3?

Does RoHS mean anything to you? The abbreviation stands for "Restriction of Hazardous Substances," with the official German name "Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment" [3]. By now, I think every electronics developer is familiar with the term "RoHS." But perhaps not everyone is aware that another major change in implementation is coming this year. The transition period for exemptions for many medical products ends on July 21, 2021, after which stricter requirements, often referred to as RoHS 3, will apply.

In this article, we'll cover the various guidelines and their supplements. We'll then discuss how we, as a development service provider, address the issue.

A brief overview of the origins of the RoHS Directive:

Contents

The aim of the RoHS Directive and its national implementation is: "...to increase the recycling and/or reuse of such products. The legislation also requires that certain hazardous substances (heavy metals such as lead, mercury, cadmium, and hexavalent chromium, as well as flame retardants such as polybrominated biphenyls (PBBs) or polybrominated diphenyl ethers (PBDEs)) must be replaced with safer alternatives. Waste electrical and electronic equipment (WEEE) poses environmental and health risks if inadequately treated. The RoHS and WEEE Directives on electrical and electronic equipment (WEEE) were revised in 2011 and 2012 to address the rapidly growing waste stream of such products. The aim is to increase the amount of WEEE that is appropriately treated and to reduce the amount that is disposed of." [1]

Electronic devices placed on the market in the European Union must comply with the directive, with certain exceptions.

Devices are categorized in Annex 1 of the Directive [3]. Medical devices belong to Category 8.
The exceptions are defined in Annexes 3 and 4, e.g. in the consolidated version [6].

Directive 2015/863 imposes restrictions on additional substances and further reduces previously applicable exemptions. Details can be found in the European Union publications linked in the article.

MEDtech Ingenieur acts as a development service provider in the medical technology sector. We test the RoHS compliance of our circuits and printed circuit boards during development using, among other measures:

• Specification of RoHS conformity in the manufacturing documents, i.e. specification for the manufacturers
• Checking component parts lists with databases such as:
  • Digikey BOM Tool
  • Silicon Expert Comparison
• Confirmation of conformity by suppliers and manufacturers

Responsibilities

The person placing the product on the market is responsible for CE conformity, of which RoHS conformity is a part.

RoHS symbols and signs are used by many manufacturers, but are expressly discouraged by the EU. The EU states: "From 2 January 2013, CE marking shall be the only marking which attests the conformity of the product with the requirements of RoHS 2. Pursuant to EC/765/2008, markings, signs, or inscriptions that are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited." (see Q8.12 in [2]).

Conclusion

What is often referred to as RoHS 3 is officially an extension of RoHS 2. Whether the next major revision will be called RoHS 3 or given a different name, we will probably see in 2024.

The original RoHS directive applies only in Europe, but many other countries have similar directives and laws. Perhaps the most well-known is China RoHS.
An overview of this can be found, for example, at: https://www.chemsafetypro.com/Topics/Restriction/EU_RoHS_2_EU_RoHS_Directive.html

If you have any questions or comments, or would like to share your experiences on the topic, please feel free to leave a comment or contact us.

Links and references