Reach and RoHS Compliant

What are RoHS and REACH, and How Do They Differ?

RoHS (Restriction of Hazardous Substances) refers to the Directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment. Its core objective is to restrict the use of six hazardous substances, including lead and mercury, in electrical and electronic products.

REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) is the EU regULation on the registration, evaluation, authorization and restriction of chemicals. It covers almost all chemical substances, integrates the restriction of use with full-life-cycle management, and safeguards human health and environmental safety.

RoHS focuses on the restriction of specific hazardous substances in electrical and electronic products, while REACH is a comprehensive chemical management regulation. Both aim to promote environmental protection, health and sustainable development.

What is RoHS?

The core objectives of implementing the RoHS Directive are as follows:

1. Reduce environmental pollution caused by hazardous substances during the disposal of waste electrical and electronic products.

2. Minimize the potential risks of hazardous substances to human health.

RoHS applies to various electrical and electronic equipment, such as large household appliances, IT and communication devices, and lighting equipment. Non-compliant products will be restricted from entering the EU market. This drives the industry to adopt eco-friendly materials and processes, transitioning towards green manufacturing.

What is REACH?

The EU implemented the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation on June 1, 2007.

Unlike RoHS, which is limited to electrical and electronic equipment, REACH applies to all chemical substances manufactured, imported, sold or used within the EU, covering multiple industries. Its core goals are to protect humans and the environment, boost competition in the chemical industry, and encourage animal-testing-free methods for hazardous substance testing.

Scope of Application of RoHS and REACH

1. Scope of the RoHS Directive

It mainly includes electrical and electronic equipment such as large household appliances, small household appliances, IT and communication devices, consumer electronics, lighting equipment, electrical and electronic tools, electronic toys, medical devices (with some exceptions), monitoring and control equipment, and vending machines.

2. Scope of the reach regulation

It covers all chemical substances, including standalone chemicals, chemicals in preparations, and intentionally released chemicals in articles. If the content of Substances of Very High Concern (SVHC) in an article exceeds the threshold, enterprises are obligated to fulfill the notification requirement.

RoHS focuses on the restriction of specific hazardous substances in electrical and electronic products, whereas REACH conducts comprehensive management of various chemical substances.

Restricted Substances Under RoHS

The RoHS Directive restricts the following hazardous substances in electrical and electronic equipment (content limits in homogeneous materials):

1. Lead (Pb), Mercury (Hg), Hexavalent Chromium (Cr6+), Polybrominated Biphenyls (PBB), Polybrominated Diphenyl Ethers (PBDE): 1000ppm (0.1%) each.

2. Cadmium (Cd): 100ppm (0.01%).

RoHS 2.0 added restrictions on four phthalates, each with a limit of 1000ppm (0.1%): Di(2-ethylhexyl) Phthalate (DEHP), Benzyl Butyl Phthalate (BBP), Dibutyl Phthalate (DBP), and Diisobutyl Phthalate (DIBP).

Requirements of the REACH Regulation

The core requirements of the REACH Regulation include:

1. Registration: Manufacturers and importers must register the chemical substances they produce or import and provide safety data.

2. Evaluation: Relevant EU authorities assess the health and environmental risks of registered substances.

3. Authorization: High-risk chemical substances can only be used after obtaining authorization.

4. Restriction: Restrict or prohibit the use of highly hazardous chemical substances.

The regulation covers various chemical substances in industrial production and daily consumer goods, urging enterprises to prioritize chemical safety and facilitating the sustainable development of the chemical industry.

What is RoHS Compliance?

RoHS compliance means that the content of hazardous substances in electrical and electronic products, as well as their components and materials, does not exceed the specified limits, and the entire process of production, sales and use complies with the requirements of the directive:

1. Accurately test and monitor the content of hazardous substances to ensure they are below the limits.

2. Establish a sound supply chain management system to trace the compliance of raw materials and parts.

3. Prepare complete technical documents and records, such as test reports and supplier declarations.

4. Ensure product labeling and instructions meet the requirements of the directive.

Only compliant products can be legally sold and circulated in the EU market.

What is reach compliance?

REACH has a wide scope of application, affecting more enterprises than RoHS does. The core of compliance includes:

1. Submit complete registration dossiers to ECHA in accordance with tonnage thresholds and deadlines.

2. Participate in data sharing and joint submissions to reduce testing costs.

3. Timely transmit information such as Safety Data Sheets (SDS) along the supply chain.

4. Monitor SVHC content and fulfill notification and reporting obligations.

5. Use authorized substances only after obtaining authorization and in accordance with regulations.

6. Comply with the usage restrictions on restricted substances.

Non-compliance may lead to product recalls, fines, trade disruptions and other consequences. Enterprises must establish a compliance management system and keep track of regulatory updates.

Exemption Scopes of RoHS and REACH

1. RoHS Exemptions

If complying with the restrictions is extremely difficult or impractical for an enterprise or industry, an exemption can be applied for. The considerations include the availability of alternatives, impacts on health and safety, and industry innovation. Current exemptions include mercury in fluorescent lamps and lead in steel alloys. The approval process for an exemption application takes 18–24 months. The complete list can be found in Annexes III and IV of RoHS 2.

2. REACH Exemptions

Exemptions are categorized into three types: full exemptions, partial exemptions and substances not subject to registration, mostly because they are regulated by other legislations:

①　Full exemptions: Radioactive substances, substances for defense purposes, non-isolated intermediates, etc.

②　Partial exemptions: Substances for scientific research and development, food and feed, pharmaceuticals, etc.

③　Not subject to registration: Low-risk substances, naturally occurring substances, recycled and regenerated registered substances, etc.

The complete list is available on the ECHA official website.

How to Develop RoHS and REACH Compliance Strategies?

1. REACH Compliance Strategy

1. Conduct in-depth research on the regulation to clarify specific requirements for registration, evaluation, etc.

2. Inventory and classify chemical substances to determine registration tonnage and scope.

3. Sign compliance contracts with suppliers to define responsibilities and obtain substance information.

4. Collect data on physical and chemical properties, toxicology, etc., and prepare registration dossiers.

5. Formulate a registration schedule and assign responsible persons to ensure timely completion.

6. Track regulatory updates and SVHC list revisions, and adjust strategies promptly.

7. Conduct employee training to enhance compliance awareness and capabilities.

2. RoHS Compliance Strategy

1. Select compliant materials and parts during the product design phase.

2. Evaluate suppliers, obtain compliance declarations and test reports, and conduct regular audits.

3. Regularly test raw materials, parts and finished products to verify the content of hazardous substances.

4. Establish internal management systems for document records, quality control and traceability.

5. Standardize product labeling and retain compliance documents and records.

6. Conduct employee training and strengthen compliance communication internally and with the supply chain.

Developing a compliance strategy requires the support of enterprise senior management, cross-departmental collaboration and continuous resource investment, as well as close attention to regulatory dynamics and timely adjustments.