Responsibly Managing EU RoHS Compliance for Easier Market Access

RoHS requirements for electrical and electronic equipment

Human health is directly tied to environmental health in many ways. From the air we breathe to the water we drink and the ground we rely on to grow our food, humans need a healthy environment.

At the intersection of human health and environmental concerns is a focus on hazardous substances, including heavy metals, flame retardants and phthalates. These substances can have negative impacts on health and the environment during the various stages of a product’s lifecycle, from production to disposal.

As human and environmental protection becomes more important to consumers and businesses alike, many governments have introduced environmental protection legislation to help regulate the use of these substances across numerous product categories, including electrical and electronic equipment (EEE).

Achieving compliance with EU RoHS

In Europe, the European Union (EU) Restriction of Hazardous Substances Directive (RoHS) is the most widespread regulation dedicated to hazardous substances in EEE.

Compliance with EU RoHS is part of the CE marking process and is required for all EEE manufacturers seeking to sell or distribute products within the EU. Other regulations exist in countries around the world.

RoHS and other regulations represent an essential focus on health and they also create challenges for manufacturers and their supply chain partners.

Earning and maintaining compliance under EU RoHS requires dedicated resources, diligence and a robust understanding of the requirements in each market.

Understanding RoHS basic restrictions and requirements

The original EU RoHS, Directive 2002/95/EC, was first published by the European Union in 2002. This Directive restricted the use of six hazardous materials found in electrical and electronic products: lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE).

Products containing any of the listed substances could not be placed on the European market if they exceeded specified thresholds (up to 0.1% for each substance except cadmium, which was restricted to 0.01%).

However, EU RoHS was created specifically to be an evolving requirement to ensure it could respond appropriately to the newly released products and latest science related to potential hazards. In 2011, Directive 2011/65/EU introduced RoHS 2 and replaced Directive 2002/95/EC.

Most notably, RoHS 2:

• Extends the scope of the requirements to all EEE, cables and spare parts. The Directive applies to EEE falling within the categories set out in Annex I; a complete definition for EEE can be found in Article 3 of the Directive.
• Provides coherence with other EU legislation.
• Adds four additional substances to the regulation — Bis(2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP) and Diisobutyl phthalate (DIBP) — following an addition in March 2015 through the Commission Delegated Directive 2015/863/EU.

Future development of EU RoHS legislation

On December 7, 2023, the European Commission (EC) officially published a report on the review of the RoHS Directive.

Based on this report, the RoHS Directive will not undergo a full revision at this point. Instead, it will be subject to a specific amendment concerning the reallocation of scientific and technical responsibilities to the European Chemicals Agency (ECHA).

Despite the points mentioned earlier, there is potential to enhance the RoHS Directive. This is particularly relevant because hazardous substances in electrical and electronic equipment (EEE) continue to be a significant concern within the context of the circular economy.

The goal to evaluate and potentially limit specific hazardous substances remains substantial, especially in cases where new substances used in EEE conflict with the Directive’s objectives.

Considering the interaction with other legislative measures currently under review (i.e., REACH Regulation), RoHS Directive could potentially face a future revision.

RoHS exemptions available to manufacturers

Along with restrictions, EU RoHS also includes a list of exemptions (Annex III and IV of the Directive) for applications lacking a suitable replacement for the substance in question. For example, mercury in fluorescent lamps or cadmium and its compounds in electrical contacts for some EEE categories.

These exemptions are constantly reviewed to keep pace with new products, evolving technologies and discoveries or developments that could potentially lead to replacements. Manufacturers may also request an exemption by submitting details regarding the necessity of the hazardous substance.

RoHS compliance management for EEE manufacturers

RoHS requires EEE manufacturers to prepare declarations of conformity and affix the CE marking on finished products to conduct a conformity assessment and demonstrate compliance.

Manufacturers must develop technical documentation and carry out an internal production control procedure (Module A, Annex II, Decision 768/2008/EC) to demonstrate RoHS compliance.

It is also mandatory to build a technical file showing the method for verifying a product’s compliance. The European Commission developed a harmonized standard on the required technical documentation for the presumption of conformity: EN IEC 63000:2018.

Manufacturers may demonstrate compliance through supplier and material declarations, contractual agreements, analytical test results or a combination of these methods. Although there is no prescriptive method, IEC 63000, IEC 62321-2 Annex B and IEC TR 62476 can be used as guidance to build a sound RoHS conformity assessment and risk assessment.

Key steps of a RoHS assessment

Typically, a thorough assessment involves three steps:

• A materials assessment – Determines which materials and components may contain the listed hazardous substances and assigns a risk level.
• A supplier assessment – Determines the reliability and accuracy of supplier-provided information and assigns a risk level. This is an opportunity to increase the transparency and reliability of information for all parties along the supply chain.
• A final assessment – Crosses the material and supplier assessments. This final assessment must also incorporate manufacturing processes as some processes may add substances to the final product. Soldering, for example, may add lead and create a non-conformity of the final product.

In all cases, a sound EU RoHS assessment is a complex process that should begin in the earliest design phases and continue through to end-of-use and disposal.

Global hazardous substance restrictions

The EU RoHS regulation was the first regulation of its kind in Europe, but similar legislations exist in many other countries, including the United Kingdom, South Korea, China, the United Arab Emirates, Saudi Arabia and Japan. However, these regulations are not identical. For example, the Saudi Standards, Metrology and Quality Organization (SASO) RoHS shares the same original substances and limits as EU RoHS but does not include phthalates.

There are also additional regulations manufacturers must consider when preparing their products for the global market. These regulations and directives share the same larger objectives — the protection of human health and the environment — but their specific focuses differ. For example:

• The Waste Electrical and Electronic Equipment Directive (WEEE) – Aims to prevent e-waste and promote the efficient use of resources and recovery of raw materials in the EU.
• The Registration, Evaluation, Authorization and Restriction of Chemicals Regulation (REACH) — Covers virtually all substances (hazardous and non-hazardous) manufactured, imported, and used within the EU but does not address waste.
• Persistent Organic Pollutants (POPs) Regulation — Identifies substances that are highly stable in the natural environment but toxic when accumulated in animals. This regulation covers the EU and applies to a wider range of substances than EU RoHS. POPs regulations are enforced at the individual substance, mixture and article levels.
• New Battery Regulation — Published on July 28, 2023, the Regulation (EU) 2023/1542  applies to all categories of batteries and includes requirements like restriction of hazardous substances, recycled content obligation, labelling and marking and many more.
• F-Gases Regulation —  Imposes conditions and restrictions on the production, import, export, placing on the market, subsequent supply, and use of fluorinated greenhouse gases in EU, and of specific products and equipment containing or whose functioning relies upon them.
• California Proposition 65 (Cal Prop 65) — A California, United States, law intended to protect residents and drinking water sources from chemicals identified by the state of California (OEHHA) to cause cancer, congenital disabilities or other reproductive harm and inform citizens about potential exposure.

Regardless of where a product may be sold, it has never been more critical for retailers and manufacturers to understand what their products are made of and how these substances and components can affect compliance, circularity, sustainability, and human and environmental health.

UL Solutions can help you through the compliance process

Manufacturers selling their products in multiple markets must consider a variety of regulations that cover everything from safety and performance to chemical compliance. Even if you’re only pursuing a single market, managing the different requirements across various standards requires dedicated expertise and resources.

UL Solutions helps companies address RoHS compliance challenges and manage potential risks. Whether you need to test your products and materials, analyze materials within products to determine compliance or pursue a combination of both approaches, we can support you with our comprehensive services, including:

• Product and material testing – Our global network of accredited laboratories is equipped to test against all RoHS requirements. Together with verifying the compliance of your products with RoHS requirements, you may also want to test against additional requirements to cover a wider list of markets and chemical regulations. Building a chemical testing program with UL Solutions and relying on a risk-based approach helps electrical and electronic products manufacturers and retailers test for multiple regulations simultaneously.
• Certification – UL Solutions provides required certifications for specific markets, including the European Union, Saudi Arabia, the United Arab Emirates, the United Kingdom, and many others.
• Chemical data management software that analyzes material disclosures against RoHS requirements.
• Data collection software to gather and manage data on the materials and articles used in your product development and manufacturing.
• Regulatory advisory services, including chemical policy development, regulatory documents and label creation and reviews, Market Readiness Reports, and RoHS training.
• Regulatory content and automation software for creating all regulatory compliance documents (SDS authoring, reports, labels).
• Global compliance management platform.

Evolving regulations, varying regional requirements, and an increasing focus on human health and environmental impact highlight the importance of having a reliable testing, inspection, and certification provider. By easing the process every step of the way, UL Solutions can become an invaluable partner and help you remain competitive and increase market access in today’s global market.

Learn more about our chemical management services for EEE products.