A Comprehensive Guide to the Restriction of Hazardous Substances

What does RoHS mean? RoHS is an abbreviation that stands for “Restriction of Hazardous Substances”. It refers to a directive regulating the use of certain hazardous substances in electrical and electronic equipments (EEE) in the European Union. RoHS aims to limit the presence of certain harmful substances in electronic products in line with the aim of minimizing the environmental and health risks associated with the production, use and disposal of these products. Main purpose thereto is to promote the production of safer and environmentally friendly electronic equipments.

Scope: RoHS applies exclusively to EEE, including household appliances, consumer electronics, industrial equipments and more.

Requirements: RoHS restricts the presence of hazardous substances such as lead, mercury and certain flame retardants in EEEs. Manufacturers should assure that their products comply with these substance restrictions.

Legal Framework: Compliance with RoHS is mandatory for the EU, UAE, EAEU, China, Taiwan, Singapore, Ukraine, Japan, Türkiye, South Korea, Saudi Arabia, India, Serbia, Vietnam, California, New Jersey and Oman. Non-compliance may result in legal penalties.

Is RoHS compliance mandatory?

Pursuant to EU legislation manufacturers, importers and distributors of Electrical and Electronic Equipment (EEEs) should ensure that their products comply with the Restriction of Hazardous Substances (RoHS) Directive. This directive prohibits the use of hazardous substances such as lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBBs) and polybrominated diphenyl ethers (PBDEs) in EEEs. These substances threaten human health and the environment, therefore RoHS aims to minimize their presence in electronic products.

Failure to comply with the directive may result in legal consequences such as fines and restrictions on selling non-compliant products within the EU market. It is crucial to take RoHS compliance seriously and ensure that the products adhere to the specified substance restrictions.

Who needs to comply with RoHS?

RoHS compliance is primarily required for manufacturers, importers and distributors of EEEs within the scope of the RoHS directive. The specific categories of products requiring RoHS compliance include various electronic and electrical devices.

Here are some examples of products that typically require RoHS compliance:

Consumer Electronics: Products like smartphones, tablets, laptops, TVs, DVD players, digital cameras, and gaming require compliance with RoHS.

Household Appliances: Household appliances like refrigerators, washing machines, microwave ovens and vacuum cleaners are subject to RoHS regulations.

Industrial Equipments: Many types of industrial equipments including machinery, control systems and manufacturing equipments should comply with RoHS if they include electrical or electronic components.

Medical Devices: RoHS compliance is mandatory for medical devices like diagnostic equipments, imaging systems, patient monitors and various other medical instruments.

Telecommunication Equipments: Telecommunication equipments including routers, switches and network equipments should adhere to RoHS requirements.

Automotive Electronics: Automotive electronics such as in-car entertainment systems, navigation systems and engine control units are subject to RoHS regulations.

Lighting Products: Lighting products like LED bulbs and fluorescent lamps are subject to RoHS compliance.

Toys and Recreational Equipments: Electronic toys, gaming consoles and other recreational devices for children should comply with RoHS regulations.

Aviation and Defense Equipments: Certain electronic components and equipments used in the aviation and defense industry are required to comply with RoHS.

Exclusions:

(a) equipments necessary for the protection of fundamental interests of the security of Member States including arms, munitions and war material intended exclusively for military purposes.

(b) equipment designated to be sent into space.

Scientific Instruments: Analytical and scientific instruments with electronic components are subject to RoHS requirements.

What are the ten substances restricted within the scope of RoHS?

RoHS directive restricts the use of certain hazardous substances in EEEs. The directive primarily focuses on restricting the following ten substances, often referred to as the “RoHS 10” or the “substance restrictions”:

Lead (Pb): Maximum concentration allowed in homogeneous materials is 0.1% by weight.

Mercury (Hg): Maximum concentration allowed in homogeneous materials is 0.1% by weight.

Cadmium (Cd): Maximum concentration allowed in homogeneous materials is 0.01% by weight.

Hexavalent Chromium (Cr6+): Maximum concentration allowed in homogeneous materials is 0.1% by weight.

Polybrominated Biphenyls (PBBs): Maximum concentration allowed in homogeneous materials is 0.1% by weight.

Polybrominated Diphenyl Ethers (PBDEs): Maximum concentration allowed in homogeneous materials is 0.1% by weight.

Bis(2-Ethylhexyl) Phthalate (DEHP): Maximum concentration allowed in homogeneous materials is 0.1% by weight.

Benzyl Butyl Phthalate (BBP): Maximum concentration allowed in homogeneous materials is 0.1% by weight.

Dibutyl Phthalate (DBP): Maximum concentration allowed in homogeneous materials is 0.1% by weight.

Disobutyl Phthalate (DIBP): Maximum concentration allowed in homogeneous materials is 0.1% by weight. The restriction of these substances aims to reduce the environmental and health risks associated with the production, use and disposal of these hazardous substances. Manufacturers, importers, and distributors of EEEs within the scope of the RoHS directive should ensure that their products and materials comply with these maximum concentration limits.

What happens if a product does not comply with RoHS requirements?

Should a product, not compliant with RoHS, is placed on the European Union (EU) market, legal and financial consequences may be imposed on the manufacturer, importer, distributor or any party responsible for the non-compliant product. Here are some potential consequences of non-compliance:

Restrictions to Market Access: Non-compliant products may be barred from entering or remaining on the EU market. Customs authorities may seize and prevent the import or sales of the products not meeting RoHS requirements.

Fines and Penalties: EU member states may impose fines and penalties on businesses that fail to comply with RoHS regulations The specific penalties may vary by country and depending on the severity of the violation.

Recall and Withdrawal: Authorities may require the recall or withdrawal of non-compliant products from the market whereby the transaction can be costly and damaging to a company’s reputation.

Legal Action: Non-compliance may end up with legal proceedings including litigations initiated by regulatory authorities or affected parties.

Reputational Damages: Non-compliance may deteriorate a company’s reputation, as consumers and business partners may lose trust in a company that does not adhere to environmental and safety regulations.

Costs of Compliance: Correcting non-compliance can be expensive. Manufacturers may need to modify their products, have certain tests conducted and reconfigure their supply chains to ensure compliance which may cause them to incur additional expenses.

Lost Sales Opportunities: Non-compliant products may not be eligible for public procurement contracts or may be subjected to limited access to markets that require RoHS compliance.

Environmental Impact: One of the primary goals of RoHS is to reduce the environmental impact of electronic wastes (e-waste). Non-compliant products may contribute to higher levels of hazardous substances in e-wastes, posing ecological risks.

To avoid these consequences, businesses producing, importing, or distributing EEEs should proactively ensure that their products comply with RoHS regulations. These actions include conducting material assessments, testing for restricted substances, maintaining compliance documentation and adhering to labeling and reporting requirements.

What are RoHS exemptions?

RoHS exemptions are specific allowances or exceptions stipulated within the RoHS directive that permit the use of certain restricted substances in EEEs under certain conditions or for specific applications. These exemptions recognize that there may be cases where eliminating a restricted substance is technically or economically challenging. Exemptions are granted based on meticulous assessment of technical feasibility, availability of alternatives and potential risks.

*RoHS exemptions typically fall into two main categories:

Technical Exemptions: These exemptions are based on technical limitations or challenges associated with eliminating a restricted substance in a specific EEE category. For example, there might be exemptions for certain medical devices or aviation equipments where alternative materials/substances or technologies are not yet feasible or where compliance could compromise product safety or performance.

Time-Limited Exemptions: Some exemptions are time-limited and may be granted for a specific period. These exemptions often encourage the research and development of alternative materials or technologies. Manufacturers are expected to switch to RoHS-compliant alternatives when the exemption period expires.

Examples of RoHS exemptions are:

• Cadmium used in certain color conversion LEDs of imaging systems.
• Lead used in certain electronic soldering applications with high melting temperatures.
• Lead used in some electrical and electronic components for specific applications such as photo-detectors and high-reliability products.
• Mercury in some fluorescent lamps used for special purposes.
• Certain medical devices where the elimination of a restricted substance would affect the safety, performance or availability.

It’s important to note that RoHS exemptions are subject to periodic review and may be revised, extended or terminated based on changing circumstances, technological advancements, and safety assessments. Manufacturers in the electronics industry and the stakeholders thereof should follow the updates from regulatory authorities to stay informed about the status of specific exemptions and compliance requirements. Additionally, the specific exemptions and their conditions may be updated over time, so it’s suggested to refer to the official EU RoHS directive and related documentation for the most updated information..

Is RoHS globally required?

RoHS regulations are not globally required. RoHS is a specific set of regulations adopted by the EU and enforced within the EU and the European Economic Area (EEA) which includes Iceland, Liechtenstein, and Norway.

The RoHS directive restricts the use of certain hazardous substances in EEEs sold in the EU and EEA markets. Manufacturers, importers and distributors should comply with RoHS regulations to sell their products within these regions.

Countries and regions outside the EU and EEA may have regulations on hazardous substances used in electronics, management of e-wastes and environmental protection, however these regulations are not RoHS per se. They can vary significantly in terms of substance restrictions, requirements and enforcement.

It’s crucial for businesses that sell electronic products internationally to be aware of and comply with the specific regulations of each market they target. Some countries and regions have already adopted RoHS-like regulations while others may have different requirements or no specific regulations related to hazardous substances used in electronics.

To ensure compliance in various markets, businesses should conduct thorough research and adhere to the specific regulations and standards applicable to each region where they intend to sell their products.

What is the REACH Regulation?

The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation came into force in 2007 and aims to protect human health and the environment and enhance the competitiveness of the EU chemical industry by restricting the use of certain harmful substances in products manufactured and sold in the EU.

For potentially harmful substances to be included within the scope of REACH, they should first be identified as substances of very high concern by the European Chemicals Agency (ECHA) at the request of member states or the European Commission. Once a substance is confirmed as a SVHC (Substance of Very High Concern), it is included in the Candidate List. The Candidate List determines the substances that may further be included in the Authorization List where the priorities are determined by ECHA. The Authorization List restricts the use of certain substances in the EU without any further authorization of ECHA. Some substances enlisted on the Restricted Substances List, also known as REACH Annex XVII, are restricted from being produced, marketed or used throughout the EU whether they are authorized or not. These substances are considered to pose a significant risk to human health and the environment.

Requirements Expected from Companies within the Scope of the European Union REACH Regulation

Pursuant to the EU (European Union) REACH Regulation, the industry is obliged to monitor and disclose harmful chemicals used in the products they manufacture and sell in the EU. For a product containing more than the threshold levels of substances on the Candidate List, companies are obliged to notify downstream customers and ECHA about the presence of these substances and to provide instructions for possible safe use. Companies are not allowed to use the substances specified on the Authorization List in the products they manufacture or sell in the EU Internal Market (EEA) without obtaining permission from ECHA. Companies should also update themselves about the increasing number of substances being gradually added to the Restricted Substances List, as the restrictions with regard to the substances on this list may significantly impact the use of the substances and thereby the composition of products sold in the EU.

Compliance with REACH

To facilitate compliance with the evolving REACH Regulation, companies should follow the updated SVHCs and changing regulatory requirements and ensure the effectiveness of their product conformity. Communicating efficiently with the supply chain and accurately providing complete material declarations will help companies gain better visibility into their product composition; thus will eliminate the need to contact the supply chain each time SVHC list is updated. To maintain compliance, companies should ensure they are aware of new updates to these lists.

REACH Regulation and PFAS

Polyfluoroalkyl substances (PFAS) are referred to as a family of fluorocarbon chemicals that are persistently bio accumulative and toxic. Consequently, these substances are subjected to diversified global regulations and many PFAS chemicals are included on the candidate List of SVHCs. Once these chemicals are included in the candidate list, companies are mandated to notify ECHA if these substances are found in their products in amounts above the specified threshold or if the substance is used in excess of one metric tonne per year. Other effects of PFAS under REACH include:

• Wear Parts
• Pressure from consumers and NGOs to remove PFAS from supply chains
• Re-evaluation of investment companies for their investment decisions

Removal of PFAS from policy coverage by insurance companies

Is Compliance with REACH Mandatory?

US companies exporting to the EU already have registration and permit requirements to ensure compliance with REACH. Failure to comply with REACH chemical compatibility regulations may cause your company to be excluded from the EU. The significance of ensuring compliance with REACH depends on your company’s goals.

*Penalties to be imposed for REACH violations vary by country.

Fortunately, your contracted electronics manufacturer should already know how to ensure REACH compliance. Any good PCB design and assembly partner should be able to guide you on risks and alternatives.

What is the Difference Between Compliance with REACH and RoHS?

RoHS stands for Restriction of Harmful Substances. According to the RoHS Guide, this directive has originated in the European Union and restricts the use of certain harmful substances in electrical and electronic products. The latest version is the RoHS 3 directive.

Compliance with RoHS means that restricted substances cannot be used in the final product:

• Cables
• Components
• Circuit Boards
• Screens
• Sub-assemblies
• Cables

REACH further controls all chemicals that may be used in the manufacture of the product:

• Boxes
• Hangers
• Covering
• Paint
• Solvents
• Chemicals