Sustainable Product Policy: Impacts on the Manufacturing Industry

Today, there is an increasing focus on sustainability in product manufacturing. Governments around the globe have realized the urgent need to address issues like resource depletion, climate change, and environmental degradation. As a result, they are reevaluating their policies and regulations to ensure that manufacturing processes align with sustainable practices and prioritize consumer safety. These government policies play a crucial role in shaping the way products are manufactured, consumed, and disposed of. 

In this blog article, we will delve into how government policies influence sustainability in product manufacturing, exploring their impact on industries, businesses, and ultimately, the well-being of consumers and the planet.

What Is Sustainable Manufacturing?

Sustainable manufacturing is the practice of making products that cause minimal environmental damage. This approach accounts for all stages in the life-cycle of product manufacturing, from sourcing materials to final product delivery. Sustainable manufacturing practices prioritize efficient use of resources, including energy, water, and raw materials while also reducing waste, emissions, and pollutants. Additionally, sustainable manufacturing often seeks to promote social responsibility and ethical working conditions in product production. By implementing these practices, businesses can reduce their environmental footprint and consumers can have more eco-friendly purchasing options.

Sustainable manufacturing also leads to better consumer safety. By using non-toxic materials that are better for the environment, businesses can also help protect their customers from exposure to toxic chemicals in their products. Furthermore, sustainable manufacturing practices often emphasize the importance of quality assurance for products, which can reduce the number of defective items entering the market and minimize harm.

Government Policies to Promote Sustainable Products

Government regulation plays an important role in driving sustainable manufacturing practices. Sustainable product policies provide frameworks and incentives for manufacturers and consumers to support the production and purchasing of eco-friendly goods. Here are a few examples:

  1. Renewable energy incentives and requirements: Governments incentivize manufacturers to shift to renewable energy sources by offering tax credits, grants, and other financial incentives. They may also establish renewable energy requirements that mandate a certain percentage of a manufacturer’s energy consumption to come from renewable sources.
  2. Waste reduction and recycling programs: Governments implement policies to encourage waste reduction and recycling in manufacturing processes. They may introduce waste management regulations, establish recycling targets, and support initiatives that promote circular economy principles. Some local governments have also created recycling regulations for consumers, such as a fine for not recycling certain materials.
  3. Emissions standards and regulations: Governments set emissions standards and regulations to control and reduce pollution from manufacturing operations. These policies may include limits on greenhouse gas emissions, air pollutants, and wastewater discharges. Compliance with these standards often requires the adoption of cleaner technologies and processes.
  4. Labeling requirements for hazardous materials: Governments have implemented labeling requirements for products containing hazardous materials to inform consumers about potential risks associated with their use, including to human health and the environment. These labels provide vital information about the product’s composition, potential health hazards, and appropriate handling instructions. By mandating clear and accurate labeling, governments enable consumers to make informed choices and select products that are both safer and more sustainably align with both their environmental and health preferences. This policy also encourages manufacturers to find safer alternatives and helps promote the use of sustainable and non-toxic materials.
  5. Bans on toxic substances in products: Governments have enacted bans on the use of specific toxic substances in consumer products, aiming to protect public health and the environment. These bans restrict the manufacturing, importation, and sale of products containing harmful chemicals, such as lead, mercury, asbestos, and certain phthalates. These policies encourage sustainable product manufacturing by preventing environmental pollution and promoting the development and adoption of safer alternatives. They also work to promote consumer safety by reducing exposure to harmful substances.
  6. Consumer product safety regulations and standards: Aside from sustainability, many governments around the world have also implemented consumer product safety regulations and standards to protect consumers from unsafe products. These policies set forth requirements for manufacturers to ensure that their products meet certain safety standards, such as materials used, structural integrity, and performance. Through these regulations, governments contribute to sustainable product consumption by preventing the production and sale of goods that pose health risks, reducing the likelihood of accidents.

Examples of Successful Sustainable Product Policies

In recent years, governments around the world have implemented policies to drive sustainable product manufacturing and use. These policies have played a crucial role in fostering a transition towards more eco-friendly and socially responsible practices, benefiting both the environment and society at large. In this section, we will explore several examples of government policies that have effectively promoted sustainability, leading to positive changes in product manufacturing.

  1. EU’s EcoDesign Directive: The EcoDesign Directive establishes requirements for the energy efficiency and environmental performance of various product categories. By setting minimum standards, the directive has stimulated manufacturers to develop and produce energy-efficient and environmentally friendly products, leading to reduced energy consumption and resource use.
  2. California’s Green Chemistry Initiative: The Green Chemistry Initiative aims to promote safer and sustainable alternatives to hazardous chemicals used in manufacturing. The state has established regulations that require manufacturers to evaluate and identify safer alternatives for chemicals of concern, fostering the development and adoption of greener chemical formulations and manufacturing processes.
  3. The European Union’s RoHS Directive: The Restriction of Hazardous Substances (RoHS) directive restricts the use of certain hazardous substances in electrical and electronic equipment. By imposing strict limits on substances like lead, mercury, and cadmium, the EU ensures the reduction of hazardous e-waste and promotes the use of safer alternatives in electronics manufacturing.
  4. The Green Economy Program in South Korea: The Green Economy Program in South Korea has been implemented to boost sustainability within the manufacturing sector. This program provides companies with financial incentives, tax benefits, and support for technology upgrades, effectively encouraging the adoption of environmentally friendly practices. As a result of these initiatives, South Korean manufacturers have made substantial strides in reducing their carbon emissions and optimizing resource consumption.
  5. The Safe Drinking Water and Toxic Enforcement Act of California: Commonly known as Proposition 65, this regulation requires businesses to label their products with warnings regarding potential exposures to chemicals that have been identified as capable of causing cancer, birth defects, or other adverse reproductive health issues. Proposition 65 applies to many different products, including but not limited to foods, beverages, household items, and even work environments. Not only does this help protect consumers, but it encourages companies to use fewer potentially-harmful products in order to avoid this labeling requirement.
  6. Germany’s Renewable Energy Act (EEG): The EEG is a comprehensive policy that provides financial incentives and guaranteed feed-in tariffs for renewable energy producers. This policy has successfully encouraged the expansion of renewable energy generation like solar panels and wind turbine production. This regulation serves to make renewable energy more available to support energy-intensive processes like product manufacturing.

These sustainable product policies not only protect the environment and public health, but also foster industry innovation and the development of sustainable alternatives. As manufacturers begin to face fines or labeling requirements for products that aren’t eco-friendly, many are pushing to create new materials or processes that comply with new sustainable product policies. Companies that embrace sustainability may also boost their brand reputation. As more consumers begin to prioritize sustainability when making purchasing decisions, business owners who create more sustainable products can get a leg up on the competition. 

However, it is important to note that the journey toward sustainability is an ongoing process. Continued efforts are necessary to develop and enforce effective policies that address emerging environmental challenges and align with evolving consumer expectations. By strengthening the collaboration between governments, industries, and individuals, we can collectively work towards a more sustainable future for generations to come.

From Chemicals to Catastrophe: The Effects of Dangerous Toxic Chemicals in Electronics

In today’s digital era, electronic devices have become essential to our lives, offering convenience and connectivity. However, these gadgets hide a dark reality: the use of toxic chemicals during their manufacturing process. In this article, we’ll discuss the effects of these hazardous substances on our health and the environment, and explore the need for sustainable solutions.

Understanding Toxic Chemicals in Electronics

Toxic chemicals used in electronics manufacturing refer to substances that possess harmful properties and are utilized to manufacture electronic devices. These chemicals serve various purposes in electronics manufacturing, but can cause harm to human health and the environment alike. It is important to be aware of their presence – and potential risks. Some commonly used toxic substances in the electronics industry include lead, mercury, cadmium, brominated flame retardants (BFRs), and phthalates.

Purpose of Hazardous Substances in Electronics Production

Most electronics production requires the use of heavy metals and other potentially hazardous substances. Here’s how some of these materials are used.

  1. Lead – Manufacturers frequently use lead in soldering materials to create electrical connections in electronic components. Lead is chosen for its excellent conductivity and malleability.
  2. Mercury – Certain types of lighting, such as LCD screen backlights and fluorescent lamps, contain mercury. Mercury enables the production of bright and efficient lighting but carries significant toxicity risks.
  3. Cadmium – Electronic devices commonly include cadmium in batteries, semiconductors, and other components. Cadmium plays a crucial role in enhancing device functionality.
  4. Brominated Flame Retardants (BFRs) – Manufacturers add brominated flame retardants to electronic products to reduce flammability and enhance fire resistance. BFRs are commonly found in circuit boards, cables, plastic casings, and other key components
  5. Phthalates – Electronic devices often contain phthalates, a group of chemicals used as plasticizers. Phthalates enhance flexibility, durability, and resilience in cables, wiring, connectors, and other plastic elements commonly found in electronic products.

Read more: Understanding Restriction of Hazardous Substances in Electronics

Toxic Chemicals in Electronics and E-Waste: Health Risks

Exposure to toxic chemicals in electronics manufacturing can have significant health implications for both workers involved in the production processes and the end-users of electronic devices.

Workers

Workers within the electronics industry encounter direct exposure to these hazardous substances throughout different manufacturing stages. Health impacts, including acute symptoms and disease, can occur as a result of this exposure. For example, contact with lead can result in poisoning, leading to severe health problems such as neurological damage and impaired cognitive function, and in severe cases can lead to coma and death. Mercury exposure has the potential to harm the nervous system, kidneys, and lungs. Cadmium exposure has been linked to lung and prostate cancer, in addition to kidney and liver damage. Moreover, the utilization of brominated flame retardants and phthalates has been associated with disturbing endocrine disruption, reproductive complications, and developmental challenges.

End-Users

The presence of toxic chemicals in electronics typically are not of concern to customers, as the chemicals are used inside the device. When used as directed, it’s unlikely that the user will be exposed to the substance. However, over time, electronic devices may release small amounts of these toxic chemicals into the environment, particularly when the electronic device is improperly disposed of (for example, if the device ends up in a landfill, where it leaches the chemicals over time). These substances can contaminate soil, water, and air, posing a threat to human health and ecosystems, and potentially entering the food chain.

It is crucial to acknowledge the health risks associated with toxic chemicals in electronics and take proactive measures to mitigate their effects. Implementing strict safety protocols and regulations in manufacturing facilities, promoting proper disposal and recycling practices, and pursuing the development of alternative materials are essential steps toward reducing exposure and creating a safer environment for workers and consumers alike.

Toxic Chemicals in Electronics and E-Waste: Environmental Impacts

The manufacturing and disposal of electronic devices significantly contribute to environmental pollution by releasing toxic chemicals into the air, water, and soil at different stages of their lifespan, including raw material extraction, component manufacturing, product assembly, surface treatment, product usage, and disposal.

Air Pollution

Air pollution happens when volatile organic compounds (VOCs) and other toxic fumes from electronics manufacturing are released into the atmosphere. When these VOCs combine with nitrogen oxide and are exposed to sunlight, they create ground-level ozone also known as “smog.” High levels of smog contribute to air pollution that causes visibility issues, respiratory issues, damage to plants and trees, and crop contamination. Additionally, certain VOCs like sulfur dioxide and nitrogen oxide can react chemically in the atmosphere, leading to the formation of acid rain, which can harm soil and water ecosystems. 

E-waste, electronics at the end of their lifecycle, is also a contributor to air pollution. When electronics are improperly disposed of, such as through incineration or landfilling rather than recycling, they can release toxic substances and hazardous pollutants. For instance, the burning of plastics and other materials containing brominated flame retardants (BFRs) results in the emission of dioxins and furans, highly toxic compounds known for their persistence in the environment and detrimental health effects. Additionally, the incineration of electronic waste releases heavy metals like lead, mercury, and cadmium into the atmosphere. As discussed above, these metals commonly found in electronic devices pose significant risks to both human health and the environment. Inhaling these airborne pollutants can lead to respiratory problems, and nervous system damage, and can even contribute to the development of specific types of cancer.

Water Pollution

Water pollution is another consequence of toxic chemicals released during electronics manufacturing. Wastewater containing heavy metals, solvents, and other contaminants flows into water bodies, endangering aquatic life and compromising the quality of drinking water sources. Improper treatment or disposal of this wastewater exacerbates the problem, allowing pollutants to enter rivers, lakes, and oceans. This can destroy marine habitats and lead to ecological imbalance and marine species extinction.

Improper e-waste management in landfills can also lead to the release of toxic chemicals into groundwater and nearby water bodies, posing risks to water quality and marine life. Substances like lead, mercury, cadmium, and brominated flame retardants (BFRs) can seep into the water, persisting for a long period of time, and accumulating in the food chain. As these pollutants accumulate, they can negatively affect aquatic species and humans who consume contaminated seafood, posing health risks. 

Soil Contamination

Soil contamination arises from mishandling and improper disposal of manufacturing byproducts. Toxic chemicals from these byproducts infiltrate the soil, contaminating agricultural land and potentially entering the food chain, thereby posing health risks to humans and wildlife.

Improper disposal or the deposition of electronic devices in landfills can also lead to soil contamination, as the toxic chemicals present in their components can gradually spread into the soil, seeping into groundwater and impacting the nearby vegetation. This, in turn, poses a threat to agricultural land and forests, potentially resulting in lower crop yields, poor crop quality, or even deforestation in dramatic cases of contamination. Additionally, if appropriate measures are not taken to manage these contaminated soils, the toxic chemicals can enter the food chain, presenting risks to both humans and wildlife through the consumption of contaminated produce or grazing on polluted land.

Promoting Safer, More Sustainable Electronics

To reduce the detrimental effects of toxic chemicals in electronics, the electronics industry must prioritize sustainability and environmental stewardship by integrating green design principles and embracing sustainable practices. At the same time, consumers play a vital role in reducing the negative impacts of electronics by raising awareness and educating themselves about the proper disposal methods for electronic waste.

Green Design and Innovation

One of the most significant aspects of promoting safe, sustainable electronics is the development of alternative materials and manufacturing techniques. Companies may start researching and investing in eco-friendly materials that minimize or eliminate the use of toxic chemicals. For instance, bio-based plastics, recycled materials, and non-toxic alternatives to traditional flame retardants may be used to replace some of the more environmentally-detrimental components of electronics. Sustainable manufacturing practices, such as energy-efficient processes and waste reduction strategies, are also good ways to minimize the environmental footprint of electronics production.

Transitioning towards greener electronics manufacturing offers numerous advantages. Not only does it help protect human health and the environment, but it also presents economic benefits. Sustainable products often have longer lifespans, require fewer resources for production, and can be easier to recycle. Additionally, as consumer demand for eco-friendly electronics grows, manufacturers who prioritize sustainability can gain a competitive edge and strengthen their brand reputation.

Consumer Awareness and Responsible Disposal

To address the escalating issue of electronics hazardous waste, it is vital to increase consumer awareness regarding the importance of responsible disposal and the consequences of their purchasing decisions. 

  1. Encouraging Informed Choices

Consumers should be encouraged to consider the environmental impact of the products they buy. This includes looking for devices that are designed with eco-friendly materials and with recyclability in mind. By opting for energy-efficient electronics with longer lifespans, consumers can reduce their overall e-waste footprint.

  1. Promoting Recycling Programs and Safe Disposal Methods

Electronics recycling programs play a critical role in diverting e-waste from landfills and recovering valuable materials. It is important to promote these programs and inform consumers about the available options for recycling their old devices. Additionally, educating consumers about the toxic chemicals in e-waste and safe disposal methods, such as proper battery removal and data wiping, helps prevent potential harm to the environment and human health and even personal data breaches.

  1. Providing Resources and Tips

To facilitate responsible e-waste management, it is essential to provide consumers with resources and tips on how to dispose of their electronic devices properly. This can include information about local recycling centers, collection events, and mail-in recycling programs. Additionally, guidance on how to extend the lifespan of electronics through maintenance and repairs can help reduce the need for frequent replacements.

Final Thoughts

As we continue to produce more and more electronic devices, the impact of toxic chemicals in electronics is becoming a more pressing concern for human health and the environment transitioning to safer, more sustainable electronics requires collaboration between the electronics industry and consumers. Manufacturers must prioritize sustainability through research on alternative materials, eco-friendly manufacturing practices, and waste reduction. Meanwhile, consumers play a vital role by making informed choices and participating in electronic recycling programs. Together, we can reduce hazardous waste, protect human health, and preserve the environment, paving the way for a healthier world.

Promoting Green Consumerism: The Importance of Education and Awareness in Encouraging the Adoption of Safe, Eco-Friendly Products

Green consumerism refers to the practice of purchasing goods and services that are environmentally sustainable, socially responsible, and ethically produced. This includes buying products that have a low carbon footprint, are made with sustainable materials, and are free from harmful chemicals, among other things. The goal of green consumerism is to reduce the negative impact of consumption on the environment and promote sustainable development. 

In this article, we will delve into the importance of green consumerism, highlighting the critical role of education and awareness in promoting eco-friendly products.

Why Green Consumerism Is Important

The world’s growing population and increasing demand for products and resources have caused severe environmental degradation and pollution. Over 70% of the earth’s natural resources are consumed to make products for human needs, which worsens issues such as climate change, deforestation, and pollution that threaten our planet’s health. Many products that are harmful to the environment also pose risks to human health. This is why it’s important to promote the adoption of safer, eco-friendly products.

Green consumerism plays a critical role in reducing our ecological footprint and minimizing negative environmental impacts. It also encourages businesses to prioritize sustainability and ethical production practices, which often leads to better working conditions, fair wages, and increased social responsibility. Adopting green consumerism can contribute to a healthier planet for future generations.

What Are the Challenges in Adopting Green Consumerism?

Adopting green consumerism comes with its own set of challenges. Here are some of the major ones.

Limited Consumer Awareness of Sustainability

One of the biggest challenges in adopting green consumerism is a simple lack of consumer awareness of sustainability. Many consumers are not aware of the impact of their purchasing decisions on the environment and their health. Instead, they prioritize convenience, affordability, and immediate gratification over environmental concerns.

Limited Availability and Accessibility of Eco-Friendly Products

Another challenge is the lack of availability and accessibility of eco-friendly products. In some cases, more environmentally-friendly products are more expensive or difficult to find, making it challenging for consumers to make sustainable choices. Additionally, the lack of regulations and labeling standards in some industries can make it difficult for consumers to discern which products are truly sustainable and which are simply marketed that way.

Lack of Supply Chain Transparency and Regulations

Finally, the complexity of global supply chains can make it difficult for even the manufacturer to ensure that their products are safe and sustainable. Manufacturers, brands, and retailers may have difficulty tracing the sources of raw materials in order to determine if they are ethically sourced, tested for hazardous materials, and produced in a sustainable manner.

How Education and Increased Awareness Support Green Consumerism

Education is an important tool in increasing awareness and promoting green consumerism. In order to make informed choices that prioritize sustainability and safety, consumers must understand the impact of their purchasing decisions on the environment. Education can empower consumers to recognize and prioritize eco-friendly and non-toxic products and understand the impact of their choices. 

For example, there are a variety of certifications that the sustainability and safety of products. By teaching consumers to recognize the relevant certifications – and which ones are the true mark of a non-toxic, sustainable product – they can make more informed purchasing decisions. Examples of such certifications include Fair Trade, which indicates ethical production, and ISO 14000 which indicates environmentally-friendly production.

As more consumers transition towards safer and more sustainable alternatives, demand for sustainable products will grow. This will likely encourage manufacturers, brands, and retailers to produce more sustainable products, and thus generate a positive feedback loop that fosters a greener economy.

Furthermore, educating consumers on how to maximize their use of products is an important way to reduce waste. For example, consumers can learn how to properly dispose of recyclable materials to prevent contamination of recycling streams and divert hazardous materials from landfills. Additionally, consumers can be taught to use eco-friendly products in a way that reduces their environmental impact, such as using energy-efficient appliances or reducing water usage. 

Final Thoughts

Green consumerism provides a critical solution to address the growing environmental issues caused by the production and consumption of products vital to our day-to-day lives. Despite the challenges associated with pushing more customers to “buy green,” including lack of awareness, limited availability and accessibility of eco-friendly products, and weak regulation covering green products and labeling, green consumerism is possible. We can overcome these obstacles through education and awareness initiatives. By educating consumers about the impact of their choices and raising awareness of the negative impact of traditional products on the environment and health, we can promote the adoption of eco-friendly and safer products. This, in turn, can drive demand for sustainable products, incentivizing companies to prioritize sustainability and ethical production practices. Ultimately, our collective effort to promote green consumerism will help create a healthier planet and better living conditions.

EU Environmental Regulation: What Is the Difference Between RoHS, REACH and WEEE?

Since the early 2000s, the European Union has passed several directives that aim to create products that are not only safer for human health, but also more environmentally friendly. These directives include RoHS, REACH, and WEEE. All three of these regulations must be taken into account when placing products on the EU market.

Table of Contents

What Is RoHS?

RoHS stands for Restriction of Hazardous Substances. The RoHS directive, issued in the European Union, restricts the use of several hazardous materials in electronic and electrical equipment (EEE). All EEE products sold in the EU must comply with RoHS.

RoHS defines EEE as: “Equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields” (Directive 2011/65/EU). All EU directives that focus on EEE (such as WEEE) use the same definition.

The RoHS directive currently limits the use of ten hazardous substances within EEE in the European Union. The current restrictions are the result of one original directive and two additions known as RoHS II and RoHS III.

Substances Restricted by RoHS

The ten hazardous materials currently included in RoHS can only be used in electronic equipment under the maximum levels laid out by the directive. The allowable amount for each substance except cadmium is 1000 ppm. The allowable amount for cadmium is 100 ppm.

The materials include:

Read more: What is RoHS?

Who Is Subject to RoHS Regulation?

Any manufacturer, importer, or distributor of electronic and electrical equipment (EEE) sold in the EU market must be compliant with RoHS. Even small components of EEE, such as cables or other sub-assemblies, must comply with RoHS standards. 

It is the manufacturer’s responsibility to ensure their product complies with RoHS. The manufacturing and testing requirements necessary for RoHS compliance may also increase costs for manufacturers. 

Read more: What is ‘RoHS Compliant’?

What is REACH?

REACH stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals, and is an EU regulation that manages and restricts the use of hazardous chemicals in products manufactured and sold in the EU. Like RoHS, REACH restricts hazardous chemicals, but is not specific to electronics, as RoHS is.

The regulation entered into force on June 1, 2007. 

REACH is designed to protect human health and the environment from the effects of harmful chemicals. The regulation also helps the European Chemicals Agency (ECHA) gather information about chemical substances used in products on the EU market. Ultimately, the goal of REACH is to encourage companies to research and use safer alternatives.

All EU manufacturers and importers must register any substances used (above a specific yearly amount) with ECHA. This helps to:

  • Identify risks that these substances pose to human health
  • Prove to ECHA that the company is managing that risk
  • Create guidelines for safe use of their product to protect public health of consumers

Products Restricted by REACH

REACH has an extremely widespread impact, as it applies to all chemical substances used in products manufactured, imported and sold on the EU market. This does not include only industrial processes, but also products we use every day, such as clothes or cleaning products.

REACH also applies to chemicals used in electronic products. When a substance that is restricted by RoHS is added to the list of REACH restricted chemicals, RoHS and REACH may overlap. Usually RoHS is given priority when it comes to regulating EEE, but authorities often try to ensure that REACH and RoHS are compatible.

There are several products that have total exemption from REACH regulation, such as radioactive materials. There are also partial exemptions, products that are exempt from certain restrictions. For example, substances used in food or medicinal products are exempt from the registration and authorisation requirements. For a full list of total and partial exemptions, visit the European Chemicals Agency website.

Substances Restricted by REACH

Chemicals that are regulated by REACH are known as SVHCs, Substances of Very High Concern. SVHCs include chemicals that are carcinogenic or mutagenic, cause reproductive problems, or bioaccumulate. 

SVHCs include several substances also restricted by RoHS, such as phthalates, cadmium, lead, and mercury.

REACH requires companies to disclose and report SVHCs used in their products or packaging.

If a chemical’s risk is viewed to be unmanageable, its use can be banned entirely, restricted, or require prior authorization from the ECHA before use in production. Companies must ensure that their products do not contain substances in amounts exceeding REACH thresholds.

A full list of restricted SVHCs can be found on the ECHA website. 

Who is Subject to REACH Regulation?

REACH affects companies in almost every sector of industry. Companies are responsible for complying with REACH regulation. This includes:

  • Manufacturers in the EU, both of chemicals and finished products
  • Importers in the EU, both of chemicals, chemical mixtures, and finished products
  • Downstream companies: If you handle chemicals in a professional or industrial setting, you may be subject to REACH regulation.

Unlike RoHS and WEEE, companies established outside the EU are not obligated to comply with REACH, even if their products are imported into the EU market. Instead, it is the importers that lie within the EU who are responsible for ensuring REACH compliance.

Regulation and compliance differs by the type of product placed on the market. However, all companies must identify the risks of the substances they manufacture or use in manufacturing, and then demonstrate to ECHA how they are safely and effectively managing that substance’s use. Additionally, information on how to manage risk when using that product must be communicated to consumers.

What is WEEE?

WEEE, Waste Electrical and Electronic Equipment Regulation, is an EU directive that aims to improve the collection, treatment, and recycling processes of electronic and electrical equipment (EEE) that is no longer in use.

The directive works to:

  • Reduce the amount of e-waste that ends up in landfills
  • Encourage redesign of EEE so that it can be dismantled and properly disposed of
  • Increase re-use of WEEE and its components and materials

To achieve these goals, WEEE requires Member States to set specific targets for the amount (by weight) of EEE collected, recycled, and recovered. These targets differ by country.

Products Restricted by WEEE

As of 2018, all EEE is included under WEEE, as every EEE device becomes WEEE at the end of its use.

EEE subject to WEEE regulation is classified under six categories:

  1. Temperature exchange equipment
  2. Screens, monitors, and equipment containing screens with a surface larger than 100 cm2.
  3. Lamps
  4. Large equipment (any dimension larger than 50cm)
  5. Small equipment (no dimension larger than 50cm)
  6. Small IT and telecommunication equipment

Read more: What is WEEE?

Who is Subject to WEEE Regulation?

All producers of EEE must comply with WEEE requirements. The directive defines producers as anyone who:

  • Manufactures and sells EEE under his/her own brand
  • Resells EEE produced by other suppliers under his/her own brand
  • Imports or exports EEE into an EU Member State
  • Sells EEE by “distance” (for example, over the internet) to Member States, even if this seller is in a different country.

The directive sets out specific requirements producers must follow to be WEEE compliant, such as reporting the amount of EEE placed on the market and providing e-waste recycling services to customers. 

Read more: WEEE Compliance

Similar Objectives: Goals of RoHS, REACH, and WEEE

RoHS, REACH, and WEEE all share a similar objective: to protect the environment and human health. 

RoHS- The RoHS directive restricts the use of toxic materials in EEE. RoHS aims not only to protect the health of users of EEE devices, but also to reduce occupational health hazards for manufacturers of EEE. RoHS also keeps hazardous materials from accumulating in the environment after EEE is thrown out.  

REACH- REACH aims to protect human health from the effects of dangerous chemical substances used in products we use in our everyday lives, ranging from clothing to furniture. REACH also seeks to protect the environment by keeping large amounts of dangerous chemicals out of manufacturing, and out of landfills when products are disposed of.

WEEE- WEEE aims to safeguard human health from the effects of EEE at the end of its lifecycle. By improving recycling of e-waste, WEEE keeps hazardous materials used in EEE out of landfills, and thus, out of soil, water, and air. This protects the environment, animals, and human health against toxic materials contained in EEE.

Read more about each regulation’s protection of human health and the environment below.

All three regulations seek to protect the environment and human health by placing requirements on manufacturers and producers of potentially harmful products, rather than on consumers. 

Different Methods: Requirements of RoHS, REACH, and WEEE

While RoHS, REACH, and WEEE all aim to protect the environment and human health, each regulation works to achieve this goal through a different method or set of requirements. 

RoHS, REACH, and WEEE create requirements that fall into three categories, based on where in a product’s life cycle the requirements are focused: during a product’s manufacturing, during a product’s use, or upon a product’s disposal. Even requirements that target the same stage in a product’s life cycle vary greatly by directive.

Product Manufacturing Requirements

Each regulation creates requirements that manufacturers or importers must follow either before placing the product on the market or upon placing the product on the market.

RoHS- RoHS requires that manufacturers of EEE do not exceed the allowable limits of restricted substances. 

Manufacturers must follow a series of steps to confirm compliance and demonstrate compliance to authorities and the public, including testing the product and compiling documentation about the product’s manufacturing. These steps must be taken prior to the product’s placement on the market.

Read more: What is ‘RoHS Compliant’?

REACH- Like RoHS, REACH works to keep dangerous chemicals out of products sold on the EU market. 

Manufacturers and importers are required to research and report on the chemicals used in their products in order to prove the company is able to safely manage the chemical’s risk. Companies must register with the European Chemical Agency before manufacturing a product using potentially toxic chemicals.

REACH requirements emphasize information gathering, as all data is reported to the European Chemical Agency, who compiles data and makes decisions about requirements for chemical use on a case by case basis.

WEEE- Under WEEE, producers must take several steps upon placing EEE products on the market. Producers must:

  • Register and report the volume of EEE placed on the EU market to the correct governing body (which varies by country). 
  • Provide recyclers with the necessary information on how to recycle the EEE product or prepare the product to be re-used.

Read more: WEEE Compliance

Product Use Requirements

Each regulation requires manufacturers to create a marking or messaging that is intended to educate the buyer.

RoHS- RoHS requires manufacturers to put a CE marking on RoHS compliant EEE products. This shows authorities and the public that the product has been carefully evaluated and documented, and does not exceed allowable amounts of hazardous substances restricted by RoHS.

REACH- REACH requires manufacturers and importers of products that use dangerous chemicals to provide guidelines to consumers for how to use the products safely and properly.

WEEE- WEEE requires that all compliant EEE be marked with the “WEEE symbol,” a recycling bin that is crossed out. This helps customers to properly dispose of their EEE products.

Product Disposal Requirements

Only WEEE creates requirements related to disposal of products at the end of their lifecycle.

WEEE- Producers of EEE must create or finance a system for customers to recycle old EEE. This may entail a collection service or a drop-off location. This recycling program must be free of charge to the customer. 

Customers are not penalized for improper disposal, but still benefit from recycling of e-waste. Read more: What is WEEE?

Impacts of ROHS, REACH, and WEEE

EU environmental regulation’s importance can be summarized into three main areas of impact: the market, the environment, and consumer health. RoHS, REACH, and WEEE all impact the cost of relevant products for sellers and buyers and work to protect the natural environment and human health.

1) The Market

All three regulations raise costs for sellers, as they must use new materials or create new compliance programs. This in turn raises costs for buyers, who pay increased prices for their devices. 

RoHS- RoHS raises costs for sellers and buyers of EEE alike. 

EEE manufacturers must use less hazardous and often more expensive methods to produce RoHS-compliant products. Additionally, testing EEE products and ensuring RoHS compliance may be costly.

Buyers also experience increased prices of electronics in order to offset costs faced by manufacturers.

REACH- Like RoHS, REACH may increase costs for sellers and buyers. Manufacturers face increased expenses related to registering with the ECHA. Additionally, using substitute chemicals may be costly.

Buyers may experience increased costs as a result of REACH requirements on manufacturers.

WEEE-  Prices may increase for producers as a result of WEEE requirements, such as the creation of new recycling programs.  However, WEEE allows companies to save costs on materials, as companies can begin to use reused, and thus cheaper, materials. 

Buyers may also face higher prices for their electronic devices due to WEEE. As producers pay increased costs to produce WEEE-compliant products and recycling programs, consumers often offset these costs by paying more for their devices

WEEE has wider-spread market impact as well; a central goal of WEEE is to create a circular economy, an economy in which industry reuses and recycles raw materials. The circular economy minimizes waste and addresses resource scarcity in a world of finite raw materials.

2) The Environment

All three regulations work to keep hazardous materials out of landfills, and thus out of water, soil, and air. This protects the environment and other species from the toxic effects of hazardous materials.

RoHS- The restricted materials listed in RoHS act as environmental pollutants that often end up in landfills. By limiting the amount of these hazardous substances that may be used, RoHS protects the environment and increases the amount of EEE that can be recycled safely.

REACH- REACH reduces the amount of toxic chemicals used in everyday products. Not only does this make the manufacturing process safer, but it also keeps those hazardous chemicals out of the environment when products are disposed of. 

SVHCs restricted by REACH can have far reaching environmental effects, such as river acidification and injury to wildlife. By requiring prior authorization for use of these chemicals, or by outright banning them, REACH works to ensure companies are effectively managing environmental risks.

WEEE- Many electronic devices contain materials such as heavy metals and chemicals that have large environmental consequences upon becoming e-waste. WEEE protects against improper disposal of EEE, which creates environmental pollution, destroys habitats, and impacts the health of other species.

When e-waste is improperly disposed of, toxins and particles are released into the air, causing pollution. These toxic materials can also leech into the soil or groundwater, which can impact crops and drinking water. 

Lastly, WEEE takes up land area when it sits in landfills. By increasing proper recycling measures and encouraging reuse of materials, the WEEE directive helps reduce the amount of space landfills use globally. 

3) Consumer Health

All three regulations protect human health, either by keeping toxic materials out of the manufacturing process or by reducing human exposure to toxic materials in product waste.

RoHS- Several materials restricted by RoHS create toxic waste and occupational hazards that negatively impact human health. EEE that uses higher than allowed amounts of restricted substances cause health problems not only for workers manufacturing the products, but also for recyclers of the products. 

Manufacturing products that use restricted substances also negatively impacts the health of communities located near manufacturing plants.

Lastly, RoHS works to protect human health during the use of products. For example, toys whose paint contains lead, a toxic heavy metal, are not RoHS compliant.

REACH- REACH protects human health by managing the use of dangerous chemicals in products we use every day. SVHCs restricted by REACH can cause extreme damage to human health, such as reproductive harm and cancer. 

REACH helps gather information on dangerous chemicals and ensures that the risks to human health are being managed.  If the ECHA determines that a chemical’s risk cannot be managed and will harm manufacturers or consumers, then the chemical will no longer be used in products sold on the EU market.

WEEE- The WEEE directive works to reduce risks to human health caused by exposure to e-waste. 

E-waste can contain toxic substances such as lead, mercury, sulfur and cadmium. If these materials are not disposed of properly, the buildup of contamination in water and soil can cause health problems.

A 2013 WHO study found that exposure to e-waste can cause severe health impacts, including adverse birth outcomes, changes in thyroid function and cell function and decreased lung function (Grant et al. 2013). By creating proper and accessible recycling pathways, WEEE reduces human exposure to e-waste.

RoHS, REACH, and WEEE at a Glance: Comparison Table

RoHSREACHWEEE
Scope: Restricted ProductsRoHS applies to all EEE sold on the UK market, with some exemptions, listed in Article 2 of RoHS 2 (Directive 2011/65/EU).

Read more: What is ‘RoHS Compliant’?
REACH applies to all parts and products sold on the EU market, with some exemptions, listed on the European Chemicals Agency website.WEEE applies to all EEE products sold on the EU market at the end of their life-cycle, with some exemptions.

Read more: WEEE Exemptions.
Restricted SubstancesRoHS includes 10 restricted hazardous substances that are restricted by ppm.
These substances are evaluated at the homogenous materials level.
REACH restricts a list of over 200 SVHCs (Substances of Very High Concern) that are subject to registration, restriction, or prior authorization. The full list can be found on the ECHA website.WEEE does not include restricted substances.
Party Responsible for ComplianceAll manufacturers of EEE sold on the EU market.Manufacturers, importers, and downstream users of chemicals and products restricted by REACH.All producers of EEE sold or distributed on the EU market.

Read more: WEEE Compliance
Relevance to Companies Outside the EUAll companies who sell or import their products in the EU must comply, even if they are established outside of the EU.Companies that are not based in the EU are not subject to REACH regulation. Instead, importers based in the EU must ensure compliance.All producers who sell or import their products in the EU must comply, even if they are established outside of the EU.
EnforcementRoHS is a directive, so each Member State must put it into law separately, and is responsible for enforcement.REACH is a regulation, so it is legally binding across all Member StatesWEEE is a directive, so each Member State must put it into law separately, and is responsible for enforcement.
NoncompliancePenalties may include financial and legal consequences, such as fines and orders to stop shipping or selling a product. Penalties differ across Member States.Penalties may include financial and legal consequences, such as fines and orders to stop shipping or selling a product. Legal consequences may include imprisonment. Penalties differ across Member States.Penalties may include financial and legal consequences, such as fines or prosecution. Companies are often provided with a warning letter following inspection before further steps are taken. Penalties differ across Member States.

What Is the Function of Heavy Metals in Electronics?

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Devices that consumers use every day, such as televisions and computers, contain heavy metals. This article explores why heavy metals are used in electronics and, as well as the toxic effects of those heavy metals.

What Are Heavy Metals?

There is no agreed upon definition of heavy metals. Instead, heavy metals have two definitions.

  1. Heavy metals are metals that have a high density (particles are packed closely together). 

Most heavy metals under this definition have a high atomic number (the number of protons in the nucleus of an atom) and a high atomic weight (the total weight of the atoms making up an element).

  1. Heavy metals are metals with relatively high density that are toxic at low concentrations, meaning even a small amount of the metal is toxic.

To be considered a heavy metal, the material must meet either of these definitions, but does not need to meet both. Some metals, such as mercury or lead, are both high density and toxic at low concentrations. Other metals may simply fit one of the definitions.

Many of the metals you’ve heard of, such as iron, copper, platinum, and gold, are heavy metals due to their high density. Some of these high density heavy metals, such as iron, cobalt, and zinc act as nutrients. Others, such as silver, are not toxic in small amounts, but can be toxic in higher amounts or different states.

Other heavy metals, such as hexavalent chromium and cadmium, are highly toxic in low concentrations and can cause severe health problems when a human is exposed.

Which Heavy Metals are Found in Electronics?

Heavy metals are necessary to create many of the electronic devices an average consumer uses every day. The following heavy metals, while not the only heavy metals used, perform important functions in a wide variety of electronics. 

Cadmium

Cadmium is a heavy metal used in electronics, and is popular due to its malleability. Cadmium selenide, a cadmium compound, is an easily shaped metal that is most often used as semiconductors. 

Semiconductors can conduct electricity in high heat, but not in low heat. Cadmium is a good semiconductor because it is highly resistant to high temperatures. Semiconductors like cadmium selenide have a conductivity (ability to conduct electricity) that lies in between a conductor (like metal) and a non-conductive insulator (like ceramic). As temperature rises, the conductivity of the semiconductor increases, and the cadmium material can act as a conductor. At low temperatures, the same material blocks the flow of electricity. 

Semiconductors are found in most electronic devices today. Semiconductors have an extremely wide variety of functions, but generally they work to amplify signals in a circuit, convert energy, and pass current in a specific direction.

Cadmium also is resistant to corrosion. This makes it a popular metal to use as a protective shield against corrosion in electronics.

Read more about cadmium in electronics: Cadmium

Mercury

Mercury is a heavy metal commonly used in LCD (liquid crystal display) screens. LCD screens use cold-cathode fluorescent lamps (CCFLs) that contain mercury. CCFLs include fluorescent tubes that work to backlight an LCD TV or monitor screen. The light is produced when electricity is used to excite (add energy to) mercury vapor. The vapor is discharged, which creates a fluorescent coating on the inside of the tube that emits light.

Mercury is also used in some laptop screen shutoffs. In a mercury tilt switch used in some laptops, mercury moves to the other side when the laptop is opened or closed. This shift turns the screen on or off.

Mercury was also used to create switches in televisions that were produced before 1991.

Read more about mercury in electronics: Mercury


Lead

Lead is considered one of the most important metals in electronic production. Lead is malleable, does not break easily, and, when combined with tin, has a low melting point, which means it can be worked with at a lower temperature and is less sensitive to variations in temperature.

The main use of lead in electronics is lead soldering. Lead-tin soldering is used to attach electronic components. The lead solder connects two metals securely, allowing an electric signal to pass through. For example, lead solder could attach a wire to a circuit board

Lead is also used in alloys (a mixture) with other metals, such as copper and steel, which expands the use of these metals. Lead alloy in steel is often used in electronic products.

Read more about lead in electronics: Lead

Nickel

Nickel is a heavy metal used in a variety of electrical equipment and devices. Pure nickel conducts electricity well, is magnetic, and is resistant to corrosion. Nickel is often used in electronic wiring. 

Nickel is often used in electronics in alloy form, particularly in heating coils of electric appliances like irons, toaster ovens, and grills. Nickel is also used in powder form in cell phone capacitors, a device that stores electrical energy. Nickel powder may also be mixed in with a non-conductive substance, such as silicone and rubber, to allow for conductivity through the substance. This technique is most frequently used in cell phone microphones.

Hexavalent Chromium

Hexavalent chromium is a form of the heavy metal chromium that is not found in nature, and is thus manmade. Hexavalent chromium is commonly used in anticorrosive coatings on metal parts in electronics or as a pigment or paint.

The process of protecting metal from corrosion using hexavalent chromium is called chromating or passivation. In passivation, a thin layer of chromium salts are added to a metal in an electronic device. Chromium-coated metal is used in many components, including nuts and bolts, electric switches, and antennae.

Read more about chromium in electronics: Hexavalent Chromium

Exposure to Heavy Metals

Some heavy metals used in electronics are toxic. Exposure to heavy metals used in electronics can cause serious environmental and health problems. 

Most people are not exposed to heavy metals when using electronics. For example, it is unlikely that you are frequently exposed to your phone’s circuit board or the inner workings of your LCD television screen. However, exposure may occur either during manufacturing of electronics or during recycling, when the parts are broken down and heavy metals are exposed.

According to a paper published at Stanford University in 2011, heavy metals can harm not only workers in the production and recycling phases, but also communities located near manufacturing plants (Nimpuno et al. 2011).

Additionally, if electronics are not recycled and are instead allowed to break down in a landfill, it is likely that heavy metals will eventually leak out. This not only creates a risk of toxic exposure for humans, but also has severe environmental impacts. Toxic substances can leach into water, soil, and air, harming not only human health, but other species.

Negative Impacts of Heavy Metals

Cadmium

Exposure to cadmium is most famous for causing a degenerative bone disease, Itai-itai disease. This disease was caused by cadmium poisoning contracted as a result of mining. Cadmium is highly water soluble, and so as mining byproducts, including cadmium, were released into a nearby river, cadmium pollution occurred. Eventually, cadmium was absorbed into crops irrigated by the river, causing widespread disease.

Cadmium can also soften the bones and cause kidney damage.

Mercury

Mercury exposure at high levels can cause a host of health impacts, including damage to the brain, heart, lungs, kidneys, central nervous system, and immune system. 

Mercury can be released into the air a number of ways, one of which is through burning of electronic products containing mercury. Mercury can be transported in the air for great distances before it is deposited in soil and water.

While mercury exposure is most common by eating seafood containing mercury, exposure to mercury vapor is also possible if an electronic device containing mercury breaks. For example, if an LCD screen containing cold-cathode fluorescent lamps (which contain mercury) breaks, toxic mercury dust or powder can be released.

Mercury can also cause significant environmental damage. When animals are exposed to mercury at high levels, death and reproductive damage can occur.

Lead

There is no safe exposure level to lead. When lead is swallowed or breathed in, or enters the body another way, it gets stored in blood, which can cause long-term harm.

 Lead exposure, particularly in children, can cause damage to the brain and nervous system, slowed growth, and problems with hearing and speech. Long term exposure in adults can also cause fertility problems, heart disease, and kidney disease.

Nickel

Industrial use of nickel has led to environmental pollution and has increased human exposure to the toxic heavy metal.

Nickel has a wide variety of health impacts caused by exposure, including allergy, headaches, cardiovascular and kidney diseases, lung fibrosis, lung and nasal cancer. While research is ongoing as to the mechanism for these diseases (how nickel acts in the body to cause the disease), inhalation is the clear route of exposure that causes respiratory tract cancer.

Hexavalent Chromium

Hexavalent chromium is carcinogenic and causes a wide range of health problems, particularly in people exposed to the metal in manufacturing.

If hexavalent chromium is breathed at high levels, it can cause lung cancer, damage to the respiratory tract, and damage to the eyes and skin (dermatitis). Prolonged exposure, such as working in a factory that uses hexavalent chromium to produce anti-corrosive coatings, is especially dangerous.

Solutions: Reducing the Risk of Heavy Metals in Electronics

Several countries have enacted legislation that aims to reduce the risks, both to the environment and human health, associated with heavy metals. The most impactful legislation in this area comes from the EU, in the form of RoHS and WEEE directives.

RoHS: Restriction of Hazardous Substances

RoHS stands for Restriction of Hazardous Substances. The RoHS directive, issued in the European Union, restricts the use of several hazardous materials in electronic and electrical equipment (EEE). 

Manufacturers may not use restricted substances in amounts above 1000ppm (cadmium’s limit is 100ppm). Restricted substances include heavy metals Cadmium (Cd), Mercury (Hg), Lead (Pb), and Hexavalent Chromium (Cr VI).

RoHS restrictions help reduce the risk of exposure to toxic heavy metals in electronics. For example, if those electronic devices were to break or be put in landfill, it is less likely that high amounts of toxic metals will leak out.

Read more: What is RoHS?

WEEE: Waste Electrical and Electronic Equipment

Waste Electrical and Electronic Equipment (WEEE) is an EU directive that aims to improve the collection, treatment, and recycling processes of electronic and electrical equipment (EEE) that is no longer in use. WEEE helps reduce the amount of electronic waste that ends up in landfills, and helps ensure proper, safe disposal of electronic waste.

Read more: What is WEEE?

What is RoHS? Understanding Restriction of Hazardous Substances in Electronics

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What Is RoHS?

RoHS stands for Restriction of Hazardous Substances. The RoHS directive, issued in the European Union, restricts the use of several hazardous materials in electronic and electrical equipment (EEE). All EEE products sold in the EU must comply with RoHS.

The RoHS directive currently limits the use of ten hazardous substances within EEE in the European Union. The current restrictions are the result of one original directive and two additions known as RoHS 2 and 3.

RoHS 1 – The original directive, Directive 2002/95/EC, was issued in 2002, and included six materials deemed to be hazardous to human health and the environment. 

RoHS 2 – In 2011, the original directive was superseded by Directive 2011/65/EU, known as RoHS 2. RoHS 2 included additional requirements for assessment of electronic products in the EU, as well as additional categories of appliances subject to RoHS.

RoHS 3 – The directive was amended in 2015 when Directive EU 2015/863, or RoHS 3, added 4 new restricted phthalates. RoHS 3 is simply an amendment to its predecessor, and businesses must still comply with all requirements of RoHS 2.

Read more: The Difference Between RoHS 1, 2 and 3

Which Hazardous Substances Are Restricted by RoHS?

The ten hazardous materials included in RoHS can only be used under the maximum levels laid out by the directive. The allowable amount for each substance except cadmium is 1000 ppm. The allowable amount for cadmium is 100 ppm.

The materials include:

Which Products Are Restricted?

EEE regulated under RoHS includes a wide variety of products separated into eleven categories, ranging from large household appliances to medical devices. The eleventh category is all-encompassing, as it includes any EEE not covered in the previous ten categories. 

It is important that manufacturers determine whether their product fits the definition of EEE, because all EEE is subject to RoHS compliance requirements. RoHS defines EEE as: “equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields” (Directive 2011/65/EU). 

Even small components of EEE, such as cables or other sub-assemblies, must comply with RoHS standards. 

Who Does RoHS Impact?

RoHS has widespread impact, but directly affects sellers of EEE and buyers of EEE.

1) Sellers of EEE: Manufacturers, Importers, and Distributors

Any manufacturer, importer, or distributor of electronic and electrical equipment (EEE) sold in the EU market must be compliant with RoHS.

It is the manufacturer’s responsibility to ensure their product complies with RoHS. The manufacturing and testing requirements necessary for RoHS compliance may also increase costs for manufacturers. 

Read more: What is ‘RoHS Compliant’?

EEE regulated under RoHS includes a wide variety of products separated into eleven categories ranging from large household appliances like dishwashers to medical devices. 

Rules similar to RoHS have spread to other regions, including India, China, South Korea, the UAE, Vietnam, Japan, and the United States, including California and New Jersey. It is important for electronic companies to remain aware of shifting hazardous substance legislation in markets around the world.

2) Buyers of EEE: Consumers

Buyers may be impacted by higher prices of EEE due to RoHS. These increased prices, however, come in exchange for better protection of human health and the environment. 

RoHS often increases the cost of manufacturing EEE, as more testing and regulation is required. These increased manufacturing costs are then reflected in increased prices for consumers.

RoHS requires many EEE manufacturers to use new or different processes in order to remain below the allowable limits for hazardous materials. While these alternative methods and materials do have environmental benefits, they often cost more to implement, especially at first. Increased consumer prices act to offset these costs.

3) Other: The General Public

Ultimately, RoHS affects everyone, as RoHS works to protect the health of our environment and communities. Read more about the environmental impact of RoHS below.

Even the rare person who does not buy or use any electronic equipment may be affected by the negative environmental and health effects of improper disposal of electronic waste, commonly referred to as e-waste. 

Additionally, the restriction of certain levels of hazardous substances protects human health during the use of products. For example, toys whose paint contains lead, a toxic heavy metal, are not RoHS compliant.

Why is RoHS Important?

RoHS’s importance can be summarized into three main areas of impact: the market, the environment, and consumer health. While RoHS creates increased costs for sellers and buyers of EEE, the directive also protects the natural environment and human health.

1) The Market

As discussed previously under “Buyers of EEE,” RoHS raises costs for sellers and buyers of EEE alike. 

EEE manufacturers must use less hazardous and often more expensive methods to produce RoHS-compliant products. Additionally, testing EEE products and ensuring RoHS compliance may be costly.

Buyers also experience increased prices of electronics in their day to day lives as a result of RoHS.

Of course, these increased prices come hand in hand with safer, more environmentally friendly devices.

2) The Environment

The restricted materials listed in RoHS act as environmental pollutants that often end up in landfills. By limiting the amount of these hazardous substances that may be used, RoHS protects the environment and increases the amount of EEE that can be recycled safely.

RoHS works in tandem with WEEE, an e-waste directive, to minimize the negative environmental impacts of e-waste. 

Learn more: Waste Electrical and Electronic Equipment (WEEE).

3) Consumer Health

RoHS works to protect consumers of EEE and broader communities from the harmful health effects of hazardous materials. RoHS aims to minimize health impacts caused by EEE in every stage of a product’s lifecycle, from production to use to disposal.

Several materials restricted by RoHS create toxic waste and occupational hazards that negatively impact human health. According to a paper published at Stanford University in 2011, the materials restricted by RoHS can harm not only workers in the production and recycling phases, but also communities located near manufacturing plants (Nimpuno et al. 2011).

RoHS 1 vs. RoHS 2 vs. RoHS 3: A Comparison

Restriction of Hazardous Substances: The Difference Between RoHS 1 vs. RoHS 2 vs. RoHS 3

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What Is RoHS?

RoHS stands for Restriction of Hazardous Substances. The RoHS directive, issued in the European Union, restricts the use of several hazardous materials in electronic and electrical equipment (EEE). 

The RoHS directive currently limits the use of ten hazardous substances within EEE in the European Union. The current restrictions are the result of one original directive, RoHS 1, and two additions known as RoHS 2 and 3. This article will describe RoHS 1 vs RoHS 2 vs RoHS 3, helping you to understand the similarities, differences, and regulatory requirements for each.

RoHS regulation has evolved over the years to fit ever-increasing concerns about the effects of toxic materials. Each RoHS directive works to restrict the use of hazardous substances in order to protect both the environment and human health.

What is EEE?

It is important that manufacturers, importers and distributors determine whether their product fits the definition of EEE, because all EEE sold in the EU is subject to RoHS compliance requirements. 

All three directives define EEE in the same way: “Equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields” (Directive 2002/95/EC).

Who Is Responsible for Compliance?

All three iterations of the RoHS directive are directed at any manufacturer, importer, or distributor of electronic and electrical equipment (EEE) sold in the EU. Even small components of EEE, such as cables or other sub-assemblies, must comply with RoHS standards. 

Under RoHS, it is the manufacturer’s responsibility to ensure their product complies with RoHS. 

Read more: What is ‘RoHS Compliant’?

RoHS 1: Directive 2002/95/EC

The original directive RoHS 1 was issued in 2002, and limits the use of six materials within EEE deemed to be hazardous to human health and the environment. 

Why Was RoHS 1 Created?

In 2002, the European Council commissioned research on hazardous substances found in electronics. These substances not only proved to be harmful to human health, but also caused environmental problems when EEE was disposed of.

As efforts to increase recycling of electronic products started in the EU, regulators found that materials such as cadmium and mercury could not be recycled safely, even if proper recycling methods were used. The RoHS directive’s method to keep these substances out of landfill is to simply restrict their use in products in the first place.

RoHS 1 aims to reduce risks to human health and the environment by taking hazardous substances out of electronic products, and instead, requiring the use of alternative, safer materials. 

Restricted Substances and Products Under RoHS 1

Manufacturers of EEE products must not exceed the maximum levels laid out by the directive. The allowable amount for each substance except cadmium is 1000 ppm. The allowable amount for cadmium is 100 ppm.

The materials include:

  • Cadmium (Cd)
  • Mercury (Hg)
  • Lead (Pb)
  • Hexavalent Chromium (Cr VI)
  • Polybrominated Biphenyls (PBB)
  • Polybrominated Diphenyl Ethers (PBDE)

RoHS 1 focused on eight categories of EEE. The categories were taken from the original WEEE directive, a related directive focused on EEE recycling. EEE categories regulated under RoHS 1 include:

  • Category 1: Large household appliances (eg. refrigerators)
  • Category 2: Small household appliances (eg. hair dryers)
  • Category 3: Computing & communications equipment (eg. computers)
  • Category 4: Consumer electronics  (eg. televisions)
  • Category 5: Lighting (eg. lamps)
  • Category 6: Power tools (eg. electric drills)
  • Category 7: Toys, leisure and sports equipment (eg. electronic dolls)
  • Category 10: Automatic dispensers (eg. vending machines)

RoHS 2: Directive 2011/65/EU

In 2011, the original directive was superseded by Directive 2011/65/EU, known as RoHS 2 or RoHS Recast. RoHS 2 created additional categories of EEE subject to regulation and created new compliance requirements for manufacturers and importers.

Why Was RoHS 2 Created?

As scientific research progresses, more manufacturing substances are found to be hazardous. However, new substitutes for restricted substances are also discovered. RoHS 1 takes scientific progress into account by mandating the directive be updated, if necessary, in order to better address and implement new manufacturing methods and materials. 

RoHS 2 was created to ensure that the RoHS directive was up to date with scientific progress made since the passage of RoHS 1. This included expanding the scope of the restricted products and creating new compliance requirements.

RoHS 2 was also created to bring the RoHS directive better in line with other environmental regulations in the EU, such as WEEE and REACH. 

Restricted Products Under RoHS 2

All categories in RoHS 1 are also regulated under RoHS 2, in addition to two new categories of EEE added by RoHS 2. This includes:

  • Category 8: Medical devices and equipment, such as in-vitro diagnostic devices, known as IVDs. Read more: RoHS Category 8
  • Category 9: Monitoring and control instruments, such as thermostats and smoke detectors. Read more: RoHS Category 9

RoHS 2 also included a list of product types that are exempt from compliance. For example, military equipment and active implantable medical devices are not restricted by RoHS. Exempt products are listed in Article 2 of RoHS 2 (Directive 2011/65/EU)

Read more about RoHS exemptions: What is ‘RoHS Compliant’?

Compliance Requirements under RoHS 2

RoHS 2 created new compliance requirements for manufacturers and importers of EEE. This includes a declaration of conformity and a CE marking.

The declaration of conformity (sometimes known as a certificate of compliance) is the final step in RoHS compliance. This is a legal document that contains information about the product and the measures taken to ensure compliance. The manufacturer signs the declaration of conformity before the product is put on the market to certify that the product is RoHS compliant. 

The CE marking is a visible mark on the product that demonstrates that the manufacturer has taken the proper steps to ensure the product meets RoHS requirements. 

RoHS 3: Directive EU 2015/863

RoHS 3 was passed in 2015 as an amendment to RoHS 2. As RoHS 3 is merely an amendment, companies that are RoHS compliant must comply with all of RoHS 2 as well as updates included in RoHS 3. RoHS 3 added new types of restricted products, as well as four new hazardous substances.

Why Was RoHS 3 Created?

The main purpose of RoHS 3’s creation was to add a new class of restricted chemicals, phthalates. The amendment was passed partly in response to research showing that these chemicals, mainly used as insulation plasticizers, can have serious adverse health and environmental impacts.

Restricted Substances under RoHS 3

In addition to the previously restricted substances, RoHS 3 adds four phthalates. These substances may not be used in EEE at amounts above 1000 ppm:

  • Bis(2-ethylhexyl) phthalate (DEHP)
  • Butyl benzyl phthalate (BBP)
  • Dibutyl phthalate (DBP)
  • Diisobutyl phthalate (DIBP) 

Restricted Products under RoHS 3

RoHS 3 greatly expanded the scope of the RoHS directive by introducing a new category of restricted EEE products that serves as a “catch all” category. 

Category 11 includes any EEE not covered in the previous ten categories. For example, this includes EEE products such as two-wheeled electric vehicles, e-cigarettes and vapes, and electrical cables of less than 250 volts.

Read more: RoHS Category 11

Global RoHS Legislation

While RoHS 1, 2, and 3 apply only in the EU and its Member States, rules similar to RoHS have spread to other regions, including India, the UAE, China, South Korea, Vietnam, Japan, and U.S. states California and New Jersey. It is important for electronic companies to remain aware of shifting hazardous substance legislation in markets around the world.

Why Is RoHS Important?

RoHS has important impacts on the market, and also helps reduce environmental and health risks resulting from hazardous substances.

The Market: Increased Costs

RoHS increases costs for both sellers and buyers of EEE. All three RoHS directives increase costs for sellers due to new manufacturing and testing requirements necessary for compliance. Buyers often face higher prices for their devices as a result of these increased costs of manufacturing.

The Environment: Reduced Pollution

The restricted materials listed in RoHS act as environmental pollutants that often end up in landfills. By limiting the amount of these hazardous substances that may be used, RoHS protects the environment and increases the amount of EEE that can be recycled safely.

Human Health: Reduced Disease

RoHS aims to minimize health impacts caused by EEE in every stage of a product’s lifecycle, from production to use to disposal.

Several materials restricted by RoHS create occupational hazards during manufacturing and toxic waste upon product disposal, both of which negatively impact human health. 

Additionally, restriction of certain levels of hazardous substances protects human health during the use of products. For example, toys whose paint contains lead, a toxic heavy metal, are not RoHS compliant.

Now that you know the difference between RoHS 1 vs. RoHS 2 vs. RoHS 3, learn more about the impact of RoHS: What is RoHS?

RoHS Category 11: The Catchall Category

Understanding Restriction of Hazardous Substances in Electronics

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What Is RoHS?

RoHS stands for Restriction of Hazardous Substances. The RoHS directive, issued in the European Union, restricts the use of several hazardous materials in electronic and electrical equipment (EEE). All EEE products sold in the EU must comply with RoHS.

The RoHS directive currently limits the use of ten hazardous substances within EEE in the European Union. 

The ten hazardous materials included in RoHS must be used in electronics only below specific thresholds. The allowable amount for each substance except cadmium is 1000 ppm. The allowable amount for cadmium is 100 ppm.

The materials include:

Which Products Does RoHS Restrict?

It is important that manufacturers determine whether their product fits the definition of EEE, because all EEE, including smaller components, is subject to RoHS compliance requirements. RoHS defines EEE as: “equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields” (Directive 2011/65/EU). 

RoHS breaks down restricted EEE into 11 categories. The current categories are the result of one original directive and two additions known as RoHS 2 and 3. Read more: The Difference Between RoHS 1, 2 and 3

The current categories are:

  • Category 1: Large household appliances (eg. refrigerators)
  • Category 2: Small household appliances (eg. hair dryers)
  • Category 3: Computing & communications equipment (eg. computers)
  • Category 4: Consumer electronics  (eg. televisions)
  • Category 5: Lighting (eg. lamps)
  • Category 6: Power tools (eg. electric drills)
  • Category 7: Toys, leisure and sports equipment (eg. electronic dolls)
  • Category 8: Medical devices and equipment, such as in-vitro diagnostic devices, known as IVDs
  • Category 9: Monitoring and control instruments, such as thermostats and smoke detectors
  • Category 10: Automatic dispensers (eg. vending machines)
  • Category 11: Any EEE not covered in the previous ten categories. 

Categories 8 and 9 were added by RoHS 2 (Directive 2011/65/EU), and Category 11 was added by RoHS 3 (Directive EU 2015/863). The other categories were included in the original RoHS directive. As of July 22, 2021 all EEE under every category must comply with RoHS.

What Is Included in RoHS Category 11?

RoHS Category 11 acts as a ‘catchall’ category, as it includes all EEE that is not covered in the previous ten categories. The inclusion of category 11 in RoHS greatly expanded the scope of RoHS, as any product that falls under the definition of EEE must comply with RoHS.

Products that are not included in the previous categories but are added by category 11 include, but are not limited to:

e-bike - rohs category 11
Electric bike covered under RoHS category 11
  • Two-wheeled electric vehicles
  • Electronic nicotine delivery systems (ENDS) such as e-cigarettes and vapes
  • Electrical cables of less than 250 volts
  • Non-finished cables such as cable reels without plugs

This list is not exhaustive, and manufacturers must assess their EEE on a case by case basis to determine if it is within the scope of products regulated by RoHS.

Exemptions

While RoHS Category 11 technically expands RoHS to all EEE, the directive still includes several exemptions.

RoHS Exemption Categories

RoHS includes categories of EEE that are exempt from regulation:

  • Equipment necessary for security, including arms, munitions and material intended for military purposes
  • Equipment designed to be sent into space
  • Large -scale stationary industrial tools
  • Large-scale fixed installations
  • Means of transport for people or goods
  • Non-road mobile machinery exclusively for professional use
  • Active implantable medical devices
  • Permanently installed photovoltaic panels to produce solar energy
  • Equipment designed for business-business research
  • Equipment that is designed to be installed in another type of equipment that is excluded under RoHS.

Any EEE that falls under one of these definitions is not subject to RoHS regulation.

It is important that manufacturers are certain that their non-compliant product is included under one of the exempt categories, as placing a non-exempt, non-RoHS compliant product on the market can result in penalties. 

Restricted Substances with No Safe Substitutions

RoHS also includes exemptions to allow use of hazardous substances only in specific applications, such as in specific types of devices. Manufacturers can apply for these exemptions when no safe alternative to the restricted substance can be found and the product cannot be made otherwise.

For example, the use of hexavalent chromium above 1000ppm is permitted in specific devices, such as spare parts for x-ray systems placed on the EU market.

A full list of substances exempt from restrictions when used in specific applications can be found on the European Chemicals Agency website.

The RoHS directive pushes companies to search for alternative substances and processes that are RoHS compliant, even while using the original, exempted material. If a viable alternative is not found, extension of the exemption is possible.

To encourage innovation, these specific exemptions are temporary and expire on a set date. Manufacturers must remain aware of exemption expiration dates so as not to continue use of a material or application that is no longer exempt.

Impact of RoHS Category 11

Because of its wide scope, category 11 has widely spread impacts. Category 11 greatly expanded the reach of RoHS regulations to include products and manufacturers that may not have been previously affected. 

Increased Price of Production

The inclusion of category 11 may increase prices for EEE, as manufacturers must take steps to ensure RoHS compliance. Manufacturers of this equipment must use less hazardous and often more expensive methods to produce RoHS-compliant products. Additionally, testing products and ensuring RoHS compliance may be costly.

Buyers of EEE may also face increased prices as a result of increased production costs.

Increased Scientific & Technological Innovation

However, increased costs come hand in hand with increased innovation. RoHS pushes scientific and technological progress in the electronics industry, as EEE products and production processes are redesigned to exclude restricted substances.

Decreased Risk to the Environment and Human Health

By expanding RoHS to all EEE, Category 11 reduces the amount of hazardous substances used in manufacturing of electronics. The restricted materials listed in RoHS act as environmental pollutants that often end up in landfills. By limiting the amount of these hazardous substances that may be used, RoHS protects the environment and increases the amount of EEE that can be recycled safely.

Exposure to RoHS-restricted substances can also harm human health. By expanding the scope of products included under RoHS, category 11 works to reduce the chance of exposure to harmful substances, both when using EEE products and when EEE products are manufactured or recycled.

Read more about the impact of RoHS: What is RoHS?

RoHS Category 9: Monitoring and Control Equipment

Understanding Restriction of Hazardous Substances in Electronics

Table of Contents

What Is RoHS?

RoHS stands for Restriction of Hazardous Substances. The RoHS directive, issued in the European Union, restricts the use of several hazardous materials in electronic and electrical equipment (EEE). All EEE products sold in the EU must comply with RoHS.

The RoHS directive currently limits the use of ten hazardous substances within EEE in the European Union. 

The ten hazardous materials included in RoHS must be used in electronics only below specific thresholds. The allowable amount for each substance except cadmium is 1000 ppm. The allowable amount for cadmium is 100 ppm.

The materials include:

Which Products Does RoHS Restrict?

It is important that manufacturers determine whether their product fits the definition of EEE, because all EEE, including smaller components, is subject to RoHS compliance requirements. RoHS defines EEE as: “equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields” (Directive 2011/65/EU). 

RoHS breaks down restricted EEE into 11 categories. The current categories are the result of one original directive and two additions known as RoHS 2 and 3. Read more: The Difference Between RoHS 1, 2 and 3

The current categories are:

  • Category 1: Large household appliances (eg. refrigerators)
  • Category 2: Small household appliances (eg. hair dryers)
  • Category 3: Computing & communications equipment (eg. computers)
  • Category 4: Consumer electronics  (eg. televisions)
  • Category 5: Lighting (eg. lamps)
  • Category 6: Power tools (eg. electric drills)
  • Category 7: Toys, leisure and sports equipment (eg. electronic dolls)
  • Category 8: Medical devices and equipment, such as in-vitro diagnostic devices, known as IVDs
  • Category 9: Monitoring and control instruments, such as thermostats and smoke detectors
  • Category 10: Automatic dispensers (eg. vending machines)
  • Category 11: Any EEE not covered in the previous ten categories. This includes EEE products such as two-wheeled electric vehicles, e-cigarettes and vapes, and electrical cables of less than 250 volts.

Categories 8 and 9 were added by RoHS 2 (Directive 2011/65/EU), and Category 11 was added by RoHS 3 (Directive EU 2015/863). The other categories were included in the original RoHS directive. As of July 22, 2021 all EEE under every category must comply with RoHS.

What Is Included in Category 9?

Category 9 includes all EEE that falls under the definition of monitoring and control equipment. While some categories are limited to household devices, category 9 includes monitoring and control equipment designed for industrial or professional use as well.

Monitoring and control devices are intended to control settings remotely, with some automation. Often, a monitoring and control device will receive information (for example, from a sensor) and make adjustments accordingly. Monitoring devices may also work to alert people to a specific event, such as machinery malfunction or the release of carbon monoxide.

Monitoring and control devices may be used in individual households (for example, a household thermostat) or in professional settings (for example, to monitor or control operations in an industrial factory).

Monitoring and control equipment that falls within the scope of RoHS include, but are not limited to:

x ray machine - rohs category 9
X-ray machine, an example of EEE covered by RoHS Category 9
Source: Medical Equipment MSL
  • Smoke detectors
  • Thermostats (used in buildings or individual rooms)
  • Carbon monoxide detectors
  • Weighing equipment, excluding household scales
  • Light meter
  • pH and conductivity meters, excluding those used for educational purposes
  • Chromatograph
  • Equipment used to calibrate other products
  • Test instruments
  • Portable digital thermometers
  • Surveying instruments
  • Voltmeters and ammeters when they are not used as a component in another product
  • X-ray imager
  • Spectrum analyzers
  • Oscilloscopes
  • Network cable tester
  • Semiconductor parameter tester
  • Signal generator
  • Waveform monitor
  • Optical power meter
  • Roadside traffic warning beacons
  • Traffic lights
  • Veterinary products used for measurement, monitoring or control
  • Burglar alarm systems
  • Laboratory ovens that control temperature
  • Some types of CCTV monitoring equipment if they monitor only (included in category 3 if they display images)

This list is not exhaustive, and manufacturers must assess their EEE on a case by case basis to determine if it is within the scope of products regulated by RoHS.

Exemptions

RoHS includes some general exemptions that may apply to monitoring and control equipment.

Monitoring and Control Equipment that Falls under Other RoHS Exemption Categories

RoHS includes categories of EEE that are exempt from regulation. Monitoring and control equipment that falls under the following exempted categories is also exempt.

  • Equipment necessary for security, including arms, munitions and material intended for military purposes
  • Equipment designed to be sent into space
  • Large -scale stationary industrial tools
  • Large-scale fixed installations
  • Means of transport for people or goods
  • Non-road mobile machinery exclusively for professional use
  • Active implantable medical devices
  • Permanently installed photovoltaic panels to produce solar energy
  • Equipment designed for business-business research
  • Equipment that is designed to be installed in another type of equipment that is excluded under RoHS.

For example, x-ray machines for luggage that are used specifically for national security are exempt from RoHS regulation. Another example is traffic lights that meet the criteria of large-scale fixed installation.

It is important that manufacturers are certain that their non-compliant product is included under one of the exempt categories, as placing a non-exempt, non-RoHS compliant product on the market can result in penalties. 

Read more about RoHS exemptions: What is RoHS Compliant?

Restricted Substances in Monitoring and Control Equipment with No Safe Substitutions

RoHS also includes more focused exemptions for hazardous substances whose use is permitted only in specific applications, such as in specific types of devices. Manufacturers can apply for these exemptions when no safe alternative to the restricted substance can be found and the product cannot be made otherwise.

For example, mercury can be used above 1000ppm if it is being used in high frequency RF switches and relays (which route high frequency signals) in monitoring and control instruments (although mercury is still limited to 20mg of mercury per switch per day). This exemption exists because a safer alternative has not been found.

A full list of substances exempt from restrictions when used in monitoring and control equipment can be found in Annex IV of RoHS 2 (Directive 2011/65/EU).

The RoHS directive pushes companies to search for alternative substances and processes that are RoHS compliant, even while using the original, exempted material. If a viable alternative is not found, extension of the exemption is possible.

To encourage innovation, these specific exemptions are temporary and expire on a set date. Manufacturers must remain aware of exemption expiration dates so as not to continue use of a material or application that is no longer exempt.

Impact of RoHS Category 9

RoHS may have several impacts on monitoring and control equipment included in category 9.

Increased Price of Production

RoHS restrictions on category 9 products may increase prices for monitoring and control equipment, as manufacturers must take steps to ensure RoHS compliance. Manufacturers of this equipment must use less hazardous and often more expensive methods to produce RoHS-compliant products. Additionally, testing products and ensuring RoHS compliance may be costly.

Buyers of monitoring and control equipment may face increased prices as a result of increased production costs.

Increased Scientific & Technological Innovation

However, increased costs come hand in hand with increased innovation. RoHS pushes scientific and technological progress forward, as monitoring and control equipment and production processes are redesigned to exclude restricted substances.

Read more about the impact of RoHS: What is RoHS?

RoHS Category 8: Medical Devices

Understanding Restriction of Hazardous Substances in Electronics

Table of Contents

What Is RoHS?

RoHS stands for Restriction of Hazardous Substances. The RoHS directive, issued in the European Union, restricts the use of several hazardous materials in electronic and electrical equipment (EEE). All EEE products sold in the EU must comply with RoHS.

The RoHS directive currently limits the use of ten hazardous substances within EEE in the European Union. 

The ten hazardous materials included in RoHS must be used in electronics only below specific thresholds. The allowable amount for each substance except cadmium is 1000 ppm. The allowable amount for cadmium is 100 ppm.

The materials include:

Which Products Does RoHS Restrict?

It is important that manufacturers determine whether their product fits the definition of EEE, because all EEE, including smaller components, is subject to RoHS compliance requirements. RoHS defines EEE as: “equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields” (Directive 2011/65/EU). 

RoHS breaks down restricted EEE into 11 categories. The current categories are the result of one original directive and two additions known as RoHS 2 and 3. Read more: The Difference Between RoHS 1, 2 and 3

The current categories are:

  • Category 1: Large household appliances (eg. refrigerators)
  • Category 2: Small household appliances (eg. hair dryers)
  • Category 3: Computing & communications equipment (eg. computers)
  • Category 4: Consumer electronics  (eg. televisions)
  • Category 5: Lighting (eg. lamps)
  • Category 6: Power tools (eg. electric drills)
  • Category 7: Toys, leisure and sports equipment (eg. electronic dolls)
  • Category 8: Medical devices and equipment, such as in-vitro diagnostic devices, known as IVDs
  • Category 9: Monitoring and control instruments, such as thermostats and smoke detectors
  • Category 10: Automatic dispensers (eg. vending machines)
  • Category 11: Any EEE not covered in the previous ten categories. This includes EEE products such as two-wheeled electric vehicles, e-cigarettes and vapes, and electrical cables of less than 250 volts.

Categories 8 and 9 were added by RoHS 2 (Directive 2011/65/EU), and Category 11 was added by RoHS 3 (Directive EU 2015/863). The other categories were included in the original RoHS directive. As of July 22, 2021 all EEE under every category must comply with RoHS.

What Is Included in Category 8?

Category 8 includes all EEE that falls under the definition of medical devices and equipment. Also included are in-vitro diagnostic devices (IVDs), which are devices used to test human biological samples like blood or tissue. Note that RoHS does not apply to all medical devices, only electronic and electrical medical devices and equipment.

Medical devices that are within the scope of RoHS include, but are not limited to:

rohs category 8 - medical devices
  • Blood pressure meters
  • Blood analyzers (eg. to measure cholesterol or blood sugar) (IVD)
  • Electrical self-test kits (IVD)
  • Respiration monitors
  • Immunoassay analyzers (IVD)
  • Endoscope
  • Ultrasound
  • CT scanner
  • PET (Positron Emission Tomography)
  • X-ray imaging
  • Medical thermometer
  • Dialysis equipment
  • Medical freezers
  • Gamma camera
  • Intravenous drug infusion pumps
  • Ventilators
  • External defibrillators and pacemakers (not implanted)
  • Hearing aids
  • Surgical microscope
  • Electrical hospital beds
  • Electrical surgical tools
  • Medical lasers
  • ECG
  • Electrical anaesthesia equipment
  • Electrical operating theater equipment
  • Electrical dental equipment

This list is not exhaustive, and manufacturers must assess their EEE on a case by case basis to determine if it is within the scope of products regulated by RoHS.

Exemptions to RoHS Category 8

RoHS includes some general exemptions that may apply to medical equipment. There are also several exemptions that are specific to medical equipment.

Active Implantable Medical Devices

pacemaker - category 8 rohs
Cardiac pacemaker
Source: Steven Fruitsmaak

Any active implantable medical devices (AIMDs) are not subject to RoHS regulation. AIMDs are devices that are implanted in the human body, intended to remain in place after the procedure, and dependent on an energy source outside the human body to function.

Active Implantable Medical Devices include, but are not limited to:

  • Cardiac pacemakers
  • Neurostimulator systems
  • Brachytherapy systems
  • Cochlear implants
  • Glucose monitors
  • Defibrillators
  • Leads, electrodes, and adaptors for pulse generators
  • Ventricular Assist Devices
  • Infusion pumps
  • Micro Electro-Mechanical Systems (MEMS)

Further information on the definition of AIMDs can be found in EU Regulation 2017/745.

Read more about RoHS exemptions: What is RoHS Compliant?

Medical Devices that Fall under Other RoHS Exemption Categories

RoHS includes categories of EEE that are exempt from regulation. Medical devices that fall under the following exempted categories are also exempt.

  • Equipment necessary for security, including arms, munitions and material intended for military purposes
  • Equipment designed to be sent into space
  • Large -scale stationary industrial tools
  • Large-scale fixed installations
  • Means of transport for people or goods
  • Non-road mobile machinery exclusively for professional use
  • Active implantable medical devices
  • Permanently installed photovoltaic panels to produce solar energy
  • Equipment designed for business-business research
  • Equipment that is designed to be installed in another type of equipment that is excluded under RoHS.

Examples that may be considered exempt under one of the above categories include electric scooters used by disabled persons, as these may be considered a form of transport. Another example is a proton therapy facility that includes a particle accelerator, as this may be considered a large-scale fixed installation. 

It is important that manufacturers are certain that their non-compliant product is included under one of the exempt categories, as placing a non-exempt, non-RoHS compliant product on the market can result in penalties. Read more: RoHS Noncompliance Penalties

Hazardous Substance Exemptions for Specific Types of Medical Devices

RoHS also includes more focused exemptions for hazardous substances that may only be used in specific applications, such as in specific medical devices. For example, while lead is restricted above 1000ppm in all EEE, it is allowed to be used above this level as lead bearings in X-ray tubes.

A full list of substances exempt from restrictions when used in specific medical applications can be found in Annex IV of RoHS 2 (Directive 2011/65/EU).

The directive pushes companies to search for alternative substances and processes that are RoHS compliant, even while using the original, exempted material. If a viable alternative is not found, extension of the exemption is possible.

To encourage innovation, these specific exemptions are temporary and expire on a set date. Manufacturers must remain aware of exemption expiration dates so as not to continue use of a material or application that is no longer exempt.

Medical Devices with No Safe Substitutions

In order to be RoHS compliant, medical devices must use substitutes for restricted hazardous materials. However, these substitutions must be deemed safe before the medical device can be placed on the market. If substitutions are deemed unsafe, then the manufacturer can apply for an exemption. If the exemption is granted, the manufacturer can continue using substances restricted by RoHS above allowable limits.

While manufacturers can apply for exemptions for any substance for which there is no safe alternative, medical devices are mentioned specifically in the directive, as they must undergo a more extensive review process.

RoHS states that placing a medical device on the market requires a conformity assessment procedure according to several other EU directives concerning medical devices (Council Directive 93/42/EEC and Directive 98/79/EC). Through this process, a notified body (an official conformity assessment organization) must certify that the potential substitute for a hazardous substance also has negative socioeconomic, health, and consumer safety impacts. The manufacturer can then apply for an exemption for that medical device. (Note: The notified body is appointed by the Member State, and varies across countries.)

These exemptions are also subject to expiration dates, so manufacturers must remain aware of changing exemptions.

Impact of RoHS Category 8

RoHS may have several impacts on medical devices included in category 8.

Increased Price of Production

RoHS restrictions on medical devices may increase prices for medical devices, as manufacturers must take steps to ensure RoHS compliance. Electrical medical device manufacturers must use less hazardous and often more expensive methods to produce RoHS-compliant products. Additionally, testing electrical medical devices and ensuring RoHS compliance may be costly.

Increased Scientific & Technological Innovation

However, increased costs come hand in hand with increased innovation. RoHS pushes scientific and technological progress in the medical field forward, as medical devices and production processes are redesigned to exclude restricted substances.

Shifting Technologies for Patients

Lastly, RoHS may impact hospitals, doctors, and patients who rely on electronic medical devices. Costs may increase initially as a result of increased manufacturing and compliance costs. Additionally, the use of new devices or technologies may be required if manufacturers create new solutions to comply with RoHS.

However, RoHS will not make it difficult for patients to get necessary medical devices. The RoHS exemption rules described above were created to ensure that if no safe substitutions are available, no one goes without a necessary device, even if it uses higher than allowed restricted substances.

Read more about the impact of RoHS: What is RoHS?