The European Union (EU) enforces strict safety regulations to limit hazardous materials in products sold on the EU market. Two of the most significant are REACH and RoHS, each with distinct compliance requirements and enforcement mechanisms.
REACH compliance focuses on the Registration, Evaluation, Authorization, and Restriction of Chemicals, while RoHS compliance addresses the Restriction of Hazardous Substances in electrical and electronic products. Although EU REACH and RoHS share some similarities, understanding their differences is essential to maintaining compliance and avoiding legal risks.
The scope of EU REACH vs. RoHS
While both aim to limit hazardous substances, REACH compliance has a broader scope than RoHS compliance. EU REACH, a regulation, applies to nearly all products, whereas EU RoHS, a directive, focuses exclusively on electrical and electronic equipment (EEE).
EU REACH regulation
REACH restricts the use of certain chemicals in all parts and products manufactured, sold, or imported within the EU.
EU RoHS directive
RoHS limits the use of 10 hazardous substances in EEE that are manufactured, distributed, or imported into the EU.
Restricted substances under EU REACH and EU RoHS
REACH and RoHS each have their own list of restricted substances, both managed by the European Chemicals Agency (ECHA).
EU REACH substances
REACH restricts the use of numerous chemical substances in all parts and products manufactured, sold, or imported within the EU. These restrictions apply whether the substances are used on their own, in mixtures, or in articles.
EU RoHS substances
RoHS limits the use of 10 hazardous substances in EEE above specific concentrations:
- Benzyl butyl phthalate (BBP): < 1000 ppm
- Bis(2-Ethylhexyl) phthalate (DEHP): < 1000 ppm
- Cadmium (Cd): < 100 ppm
- Dibutyl phthalate (DBP): < 1000 ppm
- Diisobutyl phthalate (DIBP): < 1000 ppm
- Hexavalent Chromium (Cr VI): < 1000 ppm
- Lead (Pb): < 1000 ppm
- Mercury (Hg): < 1000 ppm
- Polybrominated Biphenyls (PBB): < 1000 ppm
- Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm
Certain exemptions apply under Article 4(1) of the EU RoHS directive. Annexes III & IV outline specific cases where restricted substances are permitted in certain applications. Any exemptions must be disclosed in RoHS compliance declarations.
How companies comply with EU REACH vs. RoHS
Both REACH and RoHS have specific compliance requirements that companies must follow. Maintaining compliance is an ongoing process that requires continuous monitoring and documentation.
EU REACH compliance
Companies that manufacture, distribute, or import more than one tonne of a substance per year must apply for authorization to use Substances of Very High Concern (SVHCs) listed on the REACH authorization list. Additionally, substances on the restricted list cannot be used beyond specified limits.
Need a structured approach? Read our five-step guide to EU REACH compliance for a clear, actionable roadmap.
EU RoHS compliance
RoHS is a self-declaring directive, meaning companies must ensure compliance and document it through CE Marking. This marking indicates that a technical file has been created, detailing product information and the steps taken to achieve compliance. Companies must retain this file for 10 years after the product enters the market.
Stay ahead of regulatory changes—read about the latest updates to the EU RoHS directive.
Achieving and maintaining product compliance requires the right processes and tools. Advanced solutions, such as compliance software, can help streamline REACH and RoHS compliance by automating data collection, tracking regulatory updates, and simplifying reporting. With the right technology in place, companies can reduce risk and stay focused on strategic initiatives.
EU REACH vs. RoHS enforcement
Non-compliance with REACH or RoHS can lead to significant penalties, including fines, product recalls, and reputational damage. A single recall can impact multiple suppliers, manufacturers, and brands.
EU REACH enforcement
As a regulation, REACH enforcement is established at the European Commission level under Schedule 1 of the REACH Enforcement Regulations. However, enforcement powers are delegated to individual EU member states, as outlined in Schedule 6.
Penalties for REACH non-compliance can include fines or imprisonment unless civil law provides a more appropriate resolution. Each case is investigated individually to determine if prosecution is necessary, and due diligence defenses are not admissible.
EU RoHS enforcement
Unlike REACH, RoHS is a directive, meaning each EU member state enforces it through its own legislative framework. As a result, penalties, compliance requirements, and enforcement measures can vary by country.
Deepen your understanding of EU REACH and EU RoHS with our on-demand Source Academy courses:
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Simplify REACH and RoHS compliance with Source Intelligence
Navigating EU REACH and RoHS compliance can be complex, requiring accurate supplier data and thorough documentation. Our global REACH and global RoHS solutions streamline this process with automated data collection, validation, and reporting, ensuring you have the necessary compliance documentation, including:
- Supplier declarations and product-level data
- Full Material Declarations (FMDs) and safety data sheets
- Lab test reports and compliance certificates
Whether you need software to support your internal team or expert-managed services, Source Intelligence delivers tailored product compliance solutions that align with your business needs. Stay ahead of evolving global REACH and RoHS regulations with a trusted compliance partner.
