RoHS and REACH regulations protect the public and environment from hazardous substances. But what are they, how are they different, and what does it take to be compliant with both?
Everything these days is going digital. Cars now contain over 1,000 electronic parts and even homes are filled with electrical and electronic equipment (EEE) like virtual assistants, scales, camera doorbells, and more.
The electronics sector continues to grow as people fill their lives with intelligent devices that simplify–and sometimes complicate–their lives. But the proliferation of such tech also comes with a catch–as people buy, use, and replace their technology, they expose themselves and their environment to a growing number of potential environmental threats.
The inherent complexity of items like computers, laptops, smartphones, refrigerators, ovens, and power tools—each of which contains hundreds of different parts—presents a risk that one or more of those components are in some way hazardous to our health or our surrounding environment.
To manage this, governing bodies have enacted a variety of critically important regulations. These directives are intended to protect us from the potentially harmful substances found in EEE, chemical substances, and other products. In this article, we’ll discuss two of the most significant: RoHS and REACH.
The European Union established the RoHS and REACH directives in order to restrict the usage of dangerous substances across its membership.
RoHS, which stands for Restriction of Hazardous Substances, took effect on July 1, 2006, and remains the most important and widely adopted regulation dedicated to EEE in Europe. Its straightforward objective is to reduce the risks hazardous substances found in EEE pose to human health and the environment.
The original version of RoHS, called Directive 2002/95/EC, restricted six substances in electrical and electronic equipment. According to the European Commission, “all products with an electrical and electronic component, unless specifically excluded, have to comply with these restrictions.”
In 2011, the EU introduced Directive 2011/65/EU, also known as “RoHS 2.” This new directive expanded on the scope of the original directive and restricted the use of four additional substances.
The Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) was adopted by the European Union on June 1, 2007.
Unlike RoHS, which is limited to EEE, REACH is a sweeping regulation that applies to all chemical substances manufactured, imported, sold, or used within EU countries. Because many products incorporate chemicals at some point in the manufacturing process, REACH isn’t confined to the chemical industry.
The European Chemicals Agency, which oversees REACH, explains that “REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives.” These products include everything from clothing and furniture to home appliances and cleaning products. As there are few, if any, industries that do not use some type of chemical in their products, REACH is a directive that affects practically every manufacturer or importer doing business in Europe.
REACH’s first and most vital objective is effectively the same as that of RoHS. It aims to protect human beings and the environment from hazardous substances. In addition, the directive is focused on promoting competition among businesses involved in the chemicals industry and encouraging alternative methods of testing the hazardousness of substances that do not involve animals.
As alluded to earlier, the respective scopes of these two EU chemicals regulations are very different. RoHS, which is exclusively focused on EEE, covers a vast array of everyday items. These include household appliances of all sizes; laptops, smartphones, and other computer technology; power tools; video games; and various types of sports equipment. The RoHS reach encompasses all the billion-dollar industries you’d expect—computing, kitchen appliances, video games—and some that might not immediately jump to mind, including medical devices, e-cigarettes, and smart treadmills.
For all the products and industries that RoHS holds some level of regulatory power over, the directive’s scope is relatively small and highly specific. As of 2015, RoHS restricts use of the following 10 chemicals:
The EU regulation does not, however, prohibit outright the use of these 10 chemicals. Rather, it imposes maximum limits on the levels in which these chemicals can appear in products. For all the listed chemicals except for cadmium, this limit is .1% (this figure is often expressed as <1000 ppm, or parts per million). RoHS limits the use of cadmium to .01%, or <100 ppm.
Wrapping your head around RoHS is not especially challenging. The directive is a set list of chemicals that can’t exceed certain levels in the products you manufacture and/or import to the EU. REACH, conversely, is more complex and layered, with an intricate regulatory framework that is worth spelling out as clearly and carefully as possible. (It bears mentioning that REACH only applies to companies manufacturing or importing chemical substances weighing at least one metric ton per year.)
To understand REACH, it helps to start with something called the “Candidate List.” The European Chemicals Agency (ECHA) maintains a Candidate List of substances deemed toxic to human health or the environment. These chemicals are officially recognized as substances of very high concern, or SVHC. They include carcinogens, mutagens, reproductive toxins, and chemicals that are bioaccumulative (they accumulate in the bodies and blood of living organisms, including humans). Once ECHA identifies a substance as an SVHC, that substance becomes a part of the Candidate List, and the designation immediately triggers several legal obligations on the part of all companies with products that include the designated chemical. These include:
Once a substance is included on the Candidate List, the ECHA may recommend that it be added to the Authorisation List (sometimes referred to as Annex XIV). The somewhat misleadingly named Authorisation List is essentially a list of chemicals restricted by the EU. When a substance is officially added to this list, it receives a “sunset date” after which its sale and use is strictly prohibited unless an explicit authorization is granted.
Companies looking to manufacture, sell, or import EEE within the EU’s 27 member countries must execute several steps to demonstrate compliance with RoHS. While there is no official “RoHS certificate” or other RoHS certification document issued by a regulatory agency, the EU requires businesses to carry out a “conformity assessment” to determine whether their product is RoHS-compliant. The conformity assessment primarily consists of three measures:
According to the RoHS Directive, all EEE must bear a CE marking, which indicates that a product is in compliance with all requisite regulations. This CE marking should be affixed to the product in a permanent and legible fashion.
RoHS also requires manufacturers to put together detailed documentation outlining features and characteristics of the electrical and electronic equipment. This technical documentation includes, but is not limited to: product descriptions; manufacturing designs and drawings; technical specifications; and harmonized standards. In addition, manufacturers should include test reports demonstrating compliance with RoHS.
Finally, companies manufacturing or importing EEE in the EU must create a Declaration of Conformity (DoC). This document, which asserts a product’s adherence to the RoHS Directive, should include the following:
Because of the incredibly broad scope of REACH, significantly more companies are affected by its compliance requirements than those imposed by RoHS.
Companies manufacturing or importing chemical substances in the EU weighing one ton per year or more are required to register these substances with the ECHA. (While “substances” can refer to chemicals on their own, it more often means chemicals in a mixture or incorporated into articles like clothes, equipment, or toys.)
In order to register these chemical substances, businesses must submit a registration dossier to the ECHA. This dossier includes information on the properties and characteristics of the substance; means by which people and the environment can become exposed to it; safe use protocols and risk management measures; and, when applicable, the substance’s hazard classification.
There’s no question that manufacturers and importers have the most critical responsibilities in properly adhering to REACH and ECHA requirements. Nevertheless, other stakeholders along the supply chain should also be invested in best practices and protocols surrounding chemical substances. Distributors, for example, have an obligation to communicate key information about chemicals and their safe use along the supply chain, including to downstream users. And downstream users, for their part, should be practicing safe use at their own sites and conveying relevant information to their customers.
All parties participating in the manufacturing, distributing, and sales of chemical substances in the EU should have a strong sense of commitment and buy-in to REACH compliance, supply chain transparency, and overall safety.
RoHS and REACH Exemptions
Both EU chemical regulation directives allow for certain exemptions based on a host of specific criteria. For the RoHS Directive, exemptions are sometimes allowed if compliance with the chemical substances limits is exceedingly difficult, impractical, or otherwise highly burdensome for a particular manufacturer or industry. According to the European Commission, RoHS exemptions are considered based on the availability and practicality of substitutes; the health, safety, and socioeconomic implications of those substitutes; and potential effects on industry innovation. Current exemptions include mercury in certain types of fluorescent light bulbs and lead as an alloying element in steel. Companies may apply for specific exemptions from the directive, but decisions typically take between 18 and 24 months.
A complete list of RoHS exemptions can be found in Annexes III and IV of Directive 2011/65/EU (also known as RoHS 2).
The REACH Directive provides exemptions that fall into three categories: total exemptions, partial exemptions, and substances for which registration does not apply. Generally, these chemical substances are exempted because they’re regulated through other legislation. What follows is a partial list for each of these categories. Complete lists for each category can be found on the ECHA website.
Registration is not required for several other categories, including substances that pose minimal risks to humans and the environment, occur in nature, and were already registered and have been recovered through a waste recovery process.
With enough research and due diligence, the EU directives can become relatively clear. However, that doesn’t mean they’re easy to adhere to. Businesses importing or manufacturing products in the EU may find significant challenges during the compliance process.
It’s one thing to have to pull together all the technical documentation required to comply with the RoHS Directive. But what if a company’s lab results reveal that its product contains one of the ten chemicals at levels exceeding the maximum allowed by the directive? At that point, businesses need to start making consequential decisions. If they want to convert their product so that it becomes RoHS-compliant, they have to first review the Bill of Materials (BOM) and determine what parts and/or raw materials are noncompliant. Then, they need to carry out a search for replacement components. Finally, they need to overhaul their assembly process. Taken as a whole, the product conversion process can be expensive and time-consuming, especially with electrical and electronic equipment that could have over 100 separately designed components.
The alternative is obsolescence: discontinuing a product because a company decides that the costs of compliance are just too great.
The REACH Directive comes with its own substantial hurdles. According to Cefic, the European Chemical Industry Council, completing the REACH registration dossier is a costly, time-intensive undertaking. Companies must fill out over 2,000 data fields in an ECHA database; complete dozens of chemical and toxicological studies; and, depending on the volume of the chemical substance being manufactured, carry out testing on over 1,000 lab animals. The organization estimates the cost to register a substance at somewhere between 50,000 and 2,000,000 euros.
The consequences for noncompliance with the EU directives vary between member states, but they follow certain broad guidelines. If a country’s enforcement authority finds a product to be in violation of a regulatory directive, it will notify the violating company and submit a request for technical documentation. The next step is removal from market. During this step, the enforcement agency will either request that the company complete a voluntary recall or, failing that, carry out a forced removal.
Companies with products found to be in violation of an EU directive also face financial penalties. Although these penalties vary, they’re often in the range of tens of thousands of euros. But a 30,000 euro fine doesn’t really paint a full or accurate picture of the true cost of noncompliance. Businesses forced to carry out a recall of one of their cornerstone products could shed millions in lost sales and revenue. A 2017 Allianz study found that the average EEE product recall cost companies over $11 million.
Cases of noncompliance with the EU directives rarely fall into the public eye. In July of 2020, however, Nikon Corporation was forced to issue a recall for its Nikon F6 film camera, an older-generation product whose sales had become relatively limited since its release in 2004.
As it turned out, the Nikon F6 was in violation of a July 2019 update to the RoHS Directive, often referred to as RoHS 3, which restricted the use of dibutyl phthalate (DBP). Though it was a small recall—only 152 units that were sold after the restriction went into effect were impacted—it was nevertheless an unwanted blemish for the company.
The bottom line is that violating these directives is at best a costly inconvenience and at worst a financial and PR disaster for businesses. Simply put, accessing the EU market means adhering to RoHS and REACH.
Companies looking to operate in one or more of the EU’s member states should have a comprehensive understanding of what it means to be both RoHS compliant and REACH compliant. Ensuring compliance for your products entails having strong supply chain transparency, regularly monitoring your adherence to the specifics of both directives, and working with a testing laboratory.
Maintaining supply chain transparency may be the single most important of these mandates. In order to possess absolute certainty that your products are adhering to RoHS and REACH regulations, businesses need to have maximum visibility into their suppliers and the components they design and manufacture. In many cases, this means having a premium supply chain risk management (SCRM) platform that can offer data and insights into suppliers’ practices, including dependencies, vulnerabilities, and levels of risk. Being able to see into your supply chain at a moment’s notice can be the difference between moving with agility when regulatory changes touch down and being stuck in a frantic state of uncertainty.
Finally, businesses should have an internal commitment to building strong, consistent sustainability practices. RoHS and REACH exist for a reason, and companies should feel a sense of moral imperative to be developing products that prioritize safety and sustainability. When these values and principles exist at the core of a business, all the compliance obligations—registration, studies, testing, fees, even product conversions—become that much easier.
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