If you’re a business that sells any kinds of goods in the EU, you’ve probably heard of RoHS and REACH compliance and/or been told your products need it. These two chemical safety regulations are mentioned so often together it’s easy to forget they’re separate regulations at all, much less how they differ from each other.
But RoHS and REACH are two different regulations, and you should understand the differences between them. That’s because everything from electrical enclosure boxes to kids’ toys to cell phones can fall under one or both of these chemical safety laws. By understanding both, your business will gain a clearer picture of its compliance responsibilities when doing business in the EU.
This guide is intended to serve as an entry point for learning more about your business’s responsibilities under RoHS and REACH. It shouldn’t be taken to constitute legal or compliance advice.
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What Is RoHS?
The Restriction of Hazardous Substances directive, or RoHS, is an EU directive that bans or restricts a list of 10 substances from all electrical and electronic equipment (EEE). These substances, which include lead, cadmium and mercury, are widely known to be extremely hazardous to human health. The list of regulated equipment is huge and includes many different types of consumer and professional devices.
RoHS places strict limits on the amount of these regulated substances that can be present in finished EEE products. None of the substances may be present in concentrations of over 1,000 parts per million (ppm), except the highly toxic cadmium which has an even lower limit of 100 ppm.
Since RoHS is a directive, every country in the EU has the authority to implement it through their own laws (so long as the laws have the same effects). Thus, a business should always check how the countries it plans to sell its products in implement RoHS.
What Is REACH?
Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) is the EU’s most wide-ranging hazardous chemical regulation. It requires businesses that use certain hazardous chemicals in the manufacture of their products to register with the European Chemicals Agency (ECHA) and develop standards for safely using their products.
One of the most important components of REACH is its list of Substances of Very High Concern (SVHCs). The SVHC list breaks down into three subcategories:
- Candidate List: Substances that could soon be placed on the Authorization or Restricted List and require additional compliance documentation if present over a certain quantity.
- Authorization List (Annex XIV): Substances that manufacturers must apply to ECHA for authorization to use after a certain “sunset date.”
- Restricted List (Annex XVII): Substances the EU has completely banned from use.
REACH is an EU regulation, so it’s implemented using the same structures throughout the EU. Note also the ECHA updates the SVHC list regularly, so it’s always important to check to make sure you’re working with the most current version.
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Comparing RoHS and REACH
Let’s look at the many ways in which RoHS and REACH are different. RoHS is a highly specific and targeted law affecting 10 substances and how they’re used within the EEE sector. REACH, by contrast, is quite broad in scope: It applies to nearly every sector in the EU economy and regulates hundreds of substances between its three lists.
REACH is concerned with the safety of a chemical throughout its life cycle, including during the manufacturing process. RoHS instead focuses on the finished product, whether it’s safe for end users and what hazards it may present during and after disposal.
The two laws also evaluate substances differently. RoHS evaluates substances as homogenous materials, which basically means analyzing the content of each discrete part in your product. REACH evaluates substances at the “article level,” which is a trickier definition but can be defined to include multiple homogeneous materials.
Thus, we can see that you shouldn’t assume that just because your product is RoHS-compliant, it’s REACH-compliant, too (or vice versa). The two standards have different thresholds for hazardous materials and require substance concentrations to be measured using different methods.
However, there’s a reason why you hear these two laws mentioned together so often: For many businesses, both RoHS and REACH compliance is mandatory. The two laws are designed to work together to form a complete regulatory structure for potentially hazardous chemicals in the EU market.
Do My Products Need to Be Tested for Compliance?
Compliance with REACH and RoHS is mandatory, but testing isn’t always. If your business can affirm its products don’t contain any regulated substances and there’s no reason to believe they would, you may not be required to supply testing documentation.
However, this requires a sufficient level of transparency in your supply chain to ensure your products actually are compliant. For this reason, many businesses require their suppliers to provide them with RoHS and REACH compliance certificates for components and materials the business purchases.
In addition, independent testing is still the best way to ensure your components are RoHS and REACH compliant. For example, an electronics manufacturer may want to certify the IP66 outdoor enclosures they’re purchasing for its outdoor Wi-Fi routers are compliant. They could do so by having sample items independently tested by a laboratory.
Consequences of Non-Compliance with RoHS or REACH
Refusal of EU market access is the main consequence for non-compliance with RoHS and REACH standards. A business is not allowed to sell its products in the EU market unless it has provided EU regulators with all the required compliance documentation, based on the business’s own knowledge of its products.
What happens when these violations occur? EU regulatory organizations can impose penalties for violations, such as:
- Falsifying compliance documentation or making it intentionally misleading
- Obstructing compliance investigators
- Selling unregistered products containing restricted substances
Compliance violations can lead to administrative penalties or criminal penalties. Criminal penalties are reserved for violations that could endanger public health, and these penalties can be much more serious, including prison time and fines in the millions of euros.