EU REACH vs. RoHS vs. CE: Key differences, overlaps, and compliance strategy

Many teams struggle to understand how EU REACH, RoHS, and CE markings relate. Each plays a different role in product safety and market access in the European Union (EU). However, they often overlap in substance restrictions, technical documentation, and supplier data requirements. That overlap creates confusion about what’s required, what’s optional, and where responsibility sits across the product’s lifecycle. 

What is EU REACH?

EU REACH focuses on the Registration, Evaluation, Authorization, and Restriction of Chemicals. It’s an EU regulation governing chemical substances in products, mixtures, and manufacturing processes, and applies to nearly every product placed on the EU market. 

EU REACH regulation highlights:  

• REACH is a regulation, meaning it is directly enforceable across EU member states.
• It restricts certain substances and requires communication on Substances of Very High Concern (SVHCs). 
• Companies that manufacture or import more than one tonne of a substance per year must meet registration and authorization requirements. 
• Standard REACH obligations apply regardless of product category. 

REACH is broad, supplier-dependent, and documentation-intensive, making structured compliance essential. 

What is EU RoHS?

EU RoHS addresses the Restriction of Hazardous Substances and limits the use of 10 hazardous substances in electrical and electronic equipment (EEE). RoHS compliance is required for many EEE products to obtain CE RoHS. 

EU RoHS directive highlights: 

• The current directive is Directive 2011/65/EU, commonly called RoHS 2. 
• RoHS requires manufacturers to meet concentration limits, verify supplier data, and maintain a Technical File. 
• RoHS compliance is required for many EEE products to obtain a CE marking. 
• Companies must prepare a CE Declaration of Conformity, maintain documentation for 10 years, and update it as the regulation evolves. 

What is the CE marking, and how does RoHS relate? 

The CE marking is the manufacturer’s declaration that a product meets all applicable EU rules necessary for sale in the European Economic Area (EEA). It is not a product standard, but rather a market access requirement. RoHS and CE certifications are directly linked because electrical and electronic equipment must meet RoHS substance restrictions before it can be CE-marked. The CE marking is required only for products governed by EU legislation that explicitly mandates it. 

Examples include: 

• Toys 
• Recreational watercraft 
• PPE 
• Machinery 
• Some pressure equipment 
• Medical and diagnostic devices 

CE marking highlights: 

• Manufacturers must ensure the product meets every applicable EU requirement. 
• Compliance may require self-assessment or involvement of a notified body, depending on risk level. 
• The CE marking requires a completed Declaration of Conformity and full technical documentation. 

Scope differences: REACH vs. RoHS vs. CE

While the EU REACH regulation applies to nearly all articles sold or imported into the EU, the EU RoHS directive applies only to EEE, and CE applies only to products covered by CE-mandated directives.  

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. 

Compliance requirements: REACH vs RoHS vs CE 

EU REACH compliance

Companies must:  

• Track SVHCs in all parts and materials 
• Notify ECHA when SVHCs exceed 0.1% w/w at the article level 
• Avoid restricted substances unless permitted under defined conditions 
• Manage registration responsibilities for large-volume substances 

Read our five-step guide to EU REACH compliance to learn how to navigate compliance confidently.  

EU RoHS compliance

Companies must: 

Verify substance concentrations through declarations, testing, or Full Material Declarations (FMDs).

• Maintain CE Technical Files demonstrating RoHS conformity 
• Prepare and sign a Declaration of Conformity 
• Retain documentation for 10 years

Stay ahead of regulatory changes—read about the latest updates to the EU RoHS directive. 

CE marking compliance

Manufacturers must: 

• Identify all applicable directives
• Determine whether a self-assessment or a notified body is required 
• Prepare and sign a Declaration of Conformity 
• Compile a full Technical File available for authorities upon request 

CE is a market access requirement, not a chemical compliance framework, but RoHS is one of the directives that often supports CE compliance. 

Key differences

EU REACH vs. RoHS enforcement

Non-compliance with EU REACH or RoHS may lead to significant penalties, including fines, product recalls, and reputational damage. A single recall can impact multiple suppliers, manufacturers, and brands. 

EU REACH enforcement

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 may 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

RoHS is a directive, meaning each EU member state handles enforcement 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.  

• Already have an account? Sign in to enroll.  
• New to Source Academy? Sign up and request an access code to get started. 

Automate REACH & RoHS compliance with Source Intelligence

Managing REACH, RoHS, and CE certifications manually is time-consuming—especially when supplier engagement slows verification. Source Intelligence centralizes everything in one platform, so teams can stay ahead of regulatory changes and maintain audit-ready evidence. 

Our product compliance solutions help you: 

• Track compliance across multiple regulations simultaneously 
• Analyze materials and components at the Bill of Materials (BOM) level 
• Monitor new SVHCs, RoHS exemptions, and regulatory updates 
• Automate supplier outreach, data validation, and documentation collection 
• Generate declarations and compliance summaries instantly 

Whether you rely on our software or fully-managed services, Source Intelligence gives you a complete, connected view of your product compliance posture—reducing risk and protecting EU market access. Explore how our REACH and RoHS solutions help you create a proactive approach to compliance.