Understanding REACH, RoHS, and Prop 65
Compliance measures can be difficult to track. Here's a quick and easy guide for REACH, RoHS, and Prop 65.
REACH, EU/China RoHS, and Prop 65 are three important compliance measures for many industries, and especially electronics. The three policies will be outlined and discussed below. If you ever need a quick refresher on REACH, RoHS, or Prop 65, then you're in the right place.
Let's get right to it:
What Is REACH?
Created by the European Union (EU), REACH regulates the Registration, Evaluation, Authorisation, and restriction of Chemicals. The goal of REACH is to limit the potential risks chemical substances impose on both human health and the environment. REACH is enforced by the European Chemicals Agency (ECHA). The ECHA manages the technical, administrative, and scientific aspects of REACH.
How REACH Affects Electronics
Thousands of chemicals used in electronic components are affected by REACH guidelines. End products and substance mixtures or solutions are also reviewed under REACH policies. REACH identifies Substances of Very High Concern (SVHC), which are the most hazardous and highly regulated substances involved in manufacturing. SVHCs are difficult to authorize, especially if a safer alternative exists.
When you get a moment, scan the candidate list for SVHCs at the official ECHA website. You may find a chemical used in one of your products violates REACH. This could lead to a disruption in your company’s supply chain.
However, you may not know what chemicals are used in your products. In that case, you will need to gather information about the chemicals in your products first. Contact your suppliers for full-disclosure substance data to ensure you are not receiving any components containing substances that violate REACH.
If you cannot access full-disclosure substance data, at least request a non-use SVHC statement. Suppliers should notify you when SVHC concentration exceeds 0.1% in concentration. However, the reality of the situation is your company remains at risk if it relies on its suppliers for notification.
Necessary documentation is essential, as companies are required to submit registered dossiers to the ECHA. These registered dossiers inform the ECHA that the sum of all electronic components produced or sold does not exceed the limits imposed by REACH.
REACH Updates for 2022
The EU Commission is prepping for a partial revision of REACH in 2022. The partial revision will be a continued focus on SVHC, polymers, mixtures, and simplifying restriction and authorization processes.
The six, primary regulatory matters that are expected to be implemented in the 2022 revision of REACH are as follows:
- Waste, SVHC, and recovered substances
- Combined exposure
- Polymers/Polymers of concern
- Endocrine Disrupting Substances (EDS)
- Chemical substances and environmental effects
- Dossier quality update and upkeep
What to Know About EU RoHS
Also known as Directive 2002/95/EC, RoHS (Restriction of Hazardous Substances) originated in the European Union and restricts the use of specific hazardous substances in certain electrical and electronic components. EU RoHS was first entered into force on July 21, 2011.
Substance thresholds restricted by EU RoHS:
- Lead (Pb) $$ (≤ 0.1 percent or 1,000 ppm)
- Mercury (Hg) (≤ 0.1 percent or 1,000 ppm)
- Cadmium (Cd) (≤ 0.1 percent or 1,000 ppm)
- Hexavalent chromium (CrVI) (≤ 0.1 percent or 1,000 ppm)
- Polybrominated biphenyls (PBB) (≤ 0.1 percent or 1,000 ppm)
- Polybrominated diphenyl ethers (PBDE) (≤ 0.1 percent or 1,000 ppm)
- Bis(2-ethylhexyl) phthalate (DEHP) (≤ 0.1 percent or 1,000 ppm)
- Benzyl butyl phthalate (BBP) (≤ 0.1 percent or 1,000 ppm)
- Dibutyl phthalate (DBP) (≤ 0.1 percent or 1,000 ppm)
- Diisobutyl phthalate (DIBP) (≤ 0.1 percent or 1,000 ppm)
All products with electrical and electronic components must comply with the restrictions placed by RoHS on the above substances. Only products with specific exemptions may be excluded from the above restrictions.
The ten substances restricted by EU RoHS are considered hazardous to our environment and pollute landfills, while also posing hazardous risks to someone's health if exposed during manufacturing or disposal.
While RoHS is enforced by the EU, companies around the world are still affected by the regulation. Any company selling electronic parts or products directly to companies in the EU or indirectly to countries in the EU (via distributors, resellers, etc.) is impacted by RoHS compliance.
But don't forget about China RoHS!
Difference Between EU and China RoHS
One of the first differences between EU and China RoHS is the substances banned by each directive. China RoHS restricts all of the same substances as EU RoHS except for the four new phthalates added to the EU directive in 2015: Bis
- Bis(2-ethylhexyl) phthalate (DEHP)
- Benzyl butyl phthalate (BBP)
- Dibutyl phthalate (DBP)
- Diisobutyl phthalate (DIBP
Unlike EU RoHS, China RoHS does not exempt products for large commercial applications such as Large Scale Industrial Tools and Large Scale Fixed Installations.
Additionally, China RoHS restricts substance concentrations for each homogenous material in the product, while EU RoHS imposes substance concentration restrictions for a product as a whole.
Because of these differences, many products that qualify for EU RoHS compliance may not qualify for China RoHS compliance.
EU RoHS Updates Timeline
EU RoHS 2 was published in 2011 and came into effect in July of 2013. The primary addition in EU RoHS 2 came in the form of a CE-marking directive.
This directive required companies to use a certification mark on their products to indicate they comply with all environmental and public health safety guidelines directed by RoHS.
Since 2014, RoHS has received 5 updates:
- 2014: Non-industrial control and monitoring instruments and most medical devices were added to RoHS compliance product categories.
- 2016: In-vitro diagnostic medical devices (IVDs) were added to RoHS compliance product categories.
- 2017: Industrial monitoring and control instruments were added to the product categories list.
- 2019: DEHP, BBP, DBP, and DIBP were added to the restricted substances list, and new product category 11 was added
- 2021: Category 8 and 9 medical devices now must comply with restricted substances added in 2019
The listed updates above culminate into RoHS 3, which is the most recent and up-to-date version of the EU's directive.
While RoHS updates do not occur frequently, it can still be difficult for companies to certify their compliance with the regulation.
Tracking RoHS Compliance
Using a simple spreadsheet listing to track RoHS compliance is fine.
Until it isn't.
Once your company is challenged by the directive, it has 30 days to gather compliance documentation on every single component in your bill of materials. And that documentation includes the traceability of all the information. This means presenting full material declarations on every component, including the packaging and labeling.
Using comprehensive compliance data, with full material declarations and organizational features, helps you avoid these challenges from the RoHS directive and avoid nightmare scenarios.
What Is California Prop 65?
California's Proposition 65 is an update to the Safe Drinking Water and Toxic Enforcement Act of 1986. Prop 65 is all about chemicals, and that is just how it can affect electronics suppliers and manufacturers. Any company with products sold in California must warn consumers about any chemicals in a product that the state of California has linked to cancer, birth defects, or reproductive harm.
What Substances Are in Prop 65?
The proposition has over 900 substances in its list, which is updated annually. Of the 900 substances, about 100 are commonly found in electronic parts and products.
The extensive list of Prop 65 substances can be found on the California Office of Environmental Health Hazard Assessment (OEHHA) website.
Updates to Prop 65 in 2021
The latest update to Prop 65 took place in March of 2021 and saw the addition of two new substances to the list:
Effective March 19, 2021, the OEHHA is adding molybdenum trioxide and indium tin oxide to the list of chemicals known to the State of California to cause cancer for purposes of Proposition 65.
The basis for the listings was described in a public notice published in the October 9, 2020, issue of the California Regulatory Notice Register (Register 2020, No. 41-Z). The title of the notice was “Notice of Intent to List Chemicals by the Labor Code Mechanism: Molybdenum Trioxide and Indium Tin Oxide.” The publication of the notice initiated a 45-day public comment period. We received one comment on molybdenum trioxide. The comment and OEHHA’s response are posted with the Notice of Intent to List.
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