-
Regulatory Compliance Analyst | EU/UK Product Compliance & Risk Mitigation
Regulatory Compliance Analyst at Euverify with experience in EU and UK product safety requirements. Focused on risk assessments, technical file preparation, and regulatory mapping across diverse products. Brings a creative edge to compliance work, supported by a background in AI-driven research and analysis.
- April 14, 2026Guides & TutorialsWhich EU Directive Applies to Your Electronic Product? LVD vs RED vs Ecodesign Explained
- March 24, 2026Regulatory FrameworkRoHS and REACH Compliance: What Every Business Exporting to the EU Needs to Know
- February 23, 2026Guides & TutorialsUKCA Testing & Certification: The Complete Guide for Manufacturers
- February 20, 2026Regulatory FrameworkGPSR Authorised Representative: Costs, Requirements & How to Appoint One
RoHS and REACH Compliance: What Every Business Exporting to the EU Needs to Know
If you manufacture or export products to the European Union, two regulations will come up sooner or later: RoHS and REACH. Most businesses hear about them from a customer, a distributor, or a failed customs check. At that point, they are already behind.
This guide breaks down what both regulations actually require, who they apply to, and what you need to do before your products hit the EU market. No legal jargon, no unnecessary complexity. Just the practical information you need to stay compliant and keep selling.
What Is RoHS and Who Does It Apply To?
RoHS stands for the Restriction of Hazardous Substances Directive. The current version, often called RoHS 2 or Directive 2011/65/EU, restricts the use of specific hazardous materials in electrical and electronic equipment sold in the EU.
The substances restricted under RoHS include:
- Lead (Pb)
- Mercury (Hg)
- Cadmium (Cd)
- Hexavalent chromium (Cr6+)
- Polybrominated biphenyls (PBB)
- Polybrominated diphenyl ethers (PBDE)
- Four phthalates: DEHP, BBP, DBP, and DIBP (added under RoHS 3)
Each substance has a maximum concentration value. For most, that limit is 0.1% by weight per homogeneous material. For cadmium, it drops to 0.01%.
RoHS applies to a wide range of product categories including household appliances, IT and telecommunications equipment, lighting products, electrical and electronic tools, toys, leisure and sports equipment, medical devices, and monitoring instruments. If your product plugs in, runs on batteries, or contains a circuit board, it almost certainly falls within scope.
Manufacturers, importers, and distributors each carry specific obligations. If you are placing a product on the EU market for the first time, even as an importer or authorised representative, RoHS compliance is your responsibility.
What Is REACH and How Is It Different?
REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It is one of the broadest pieces of chemical safety legislation in the world, governed by Regulation EC 1907/2006.
While RoHS focuses specifically on electrical and electronic products, REACH applies to chemical substances across virtually every industry. If your product contains, uses, or is made with chemical substances, REACH almost certainly applies to you.
The regulation works through several key mechanisms:
Registration: Companies that manufacture or import chemical substances into the EU in quantities above one tonne per year must register those substances with the European Chemicals Agency (ECHA). This involves submitting data on the substance’s properties, uses, and any risks associated with it.
SVHC (Substances of Very High Concern): ECHA maintains a Candidate List of SVHCs. These are substances with properties that are carcinogenic, mutagenic, toxic to reproduction, persistent, bioaccumulative, or toxic. If your product contains an SVHC above 0.1% by weight, you have disclosure obligations. If you are an EU supplier, you must inform your customers. If you are selling directly to consumers, you must provide this information on request, free of charge, within 45 days.
Authorisation and Restriction: Some substances require authorisation before they can be used, and others are outright restricted in certain applications. Restriction entries are listed in Annex XVII of REACH and include limits on everything from cadmium in plastics to certain PAHs in rubber articles.
Where RoHS and REACH Overlap
There is a lot of overlap between the two regulations, and this is where businesses often get confused.
Both RoHS and REACH restrict lead, cadmium, mercury, and hexavalent chromium. However, they do so differently. RoHS sets hard concentration limits in electrical products. REACH may restrict the same substance in different products, or through different mechanisms such as SVHC notification or Annex XVII restrictions.
Complying with one does not guarantee compliance with the other. A product that meets RoHS thresholds could still contain an SVHC above the REACH notification threshold, triggering separate obligations. Businesses need to assess compliance against both simultaneously rather than treating them as alternatives.
RoHS Compliance: What You Actually Need to Do
For most product manufacturers, RoHS compliance comes down to four practical steps.
- Confirm your product category falls within scope. While coverage is broad, some categories have specific exemptions. Medical devices and monitoring and control instruments, for example, were phased in later than consumer electronics.
- Conduct a materials analysis. Work with your supply chain to obtain declarations of conformity and material data sheets for all components. You need to know the substance content of each homogeneous material in your product.
- Apply for an exemption if needed. Some restricted substances cannot yet be practically eliminated from certain applications. RoHS includes a list of technical exemptions that allow continued use in specific circumstances. These are time-limited and reviewed periodically.
- Prepare your technical documentation. RoHS compliance is demonstrated through technical files, not third-party certification. You need documentation that supports your declaration of conformity, including test reports, material declarations from suppliers, and risk assessments where applicable.
The RoHS CE marking is also required. You cannot affix a CE mark to an in-scope product without addressing RoHS alongside the other applicable directives.
REACH Compliance: A Practical Approach
REACH is broader and more complex, but for most product manufacturers the key obligations fall into two areas: SVHC disclosure and Annex XVII restrictions.
- Start by mapping the substances in your product. This means going through your bill of materials and asking each component supplier for full material declarations. Many suppliers will provide Safety Data Sheets (SDS) and substance declarations, though the quality of these varies.
- Check your substances against the REACH Candidate List. ECHA updates this list regularly, and it currently contains over 240 substances. If any substance in your product appears on the list at a concentration above 0.1% by weight, you have communication obligations down the supply chain.
- Check Annex XVII. This annex lists restrictions on specific substances in specific uses. Some restrictions apply to all products, others only to consumer articles or children’s products. If your product falls within a restricted use case, you may need to reformulate, switch suppliers, or seek an exemption.
If you manufacture or import chemical substances into the EU above the one-tonne threshold, you also need to address registration requirements. Most finished product manufacturers are not registering substances themselves, but they depend on their upstream suppliers having done so. If a substance your product relies on is not registered, it cannot be legally used in EU manufacturing.
Common REACH Compliance Mistakes Businesses Make
Relying entirely on supplier declarations is the most common mistake. Supplier-provided data is a starting point, not proof of compliance. Companies that build their compliance case entirely on supplier statements, without any verification or audit, tend to run into problems when customers or regulators ask harder questions.
Treating REACH as a one-time exercise is another frequent issue. The Candidate List is updated twice a year. A product that was fully compliant when it launched may require disclosure obligations two years later if a substance in it is added to the list.
Ignoring the SVHC threshold calculation is also worth highlighting. The 0.1% threshold applies per homogeneous material, not per product. A product made up of many small parts needs to be assessed at the component level, not as a whole unit.
Finally, many businesses overlook the UK. Since Brexit, the UK has its own chemical regulation framework. UK REACH runs in parallel to EU REACH but is administered separately by the Health and Safety Executive. If you are selling in both markets, you need to maintain compliance with both regimes.
Do You Need an EU Representative for RoHS and REACH?
If you are based outside the EU and placing products on the EU market, you may need to appoint an EU-based authorised representative for your RoHS obligations. This representative takes on responsibility for ensuring the product file is maintained correctly and can interact with market surveillance authorities on your behalf.
For REACH, if you are a non-EU manufacturer whose substances or articles are imported by EU customers, your EU importer holds the primary compliance obligation. However, non-EU manufacturers can also appoint an Only Representative to register their substances under REACH, which can simplify the supply chain and protect commercial confidentiality.
Working with a compliance partner who understands both frameworks is genuinely useful here. The interaction between RoHS, REACH, and other EU directives like the CE marking framework is detailed, and mistakes tend to be expensive to fix.
Getting Started: A Simple Compliance Checklist for RoHS and REACH
- Confirm whether your product falls within the scope of RoHS
- Identify all substances in your product through supplier declarations and material data sheets
- Check your substance list against RoHS restricted substances and concentration limits
- Check your substance list against the REACH Candidate List (SVHCs)
- Review REACH Annex XVII for any applicable restrictions
- Establish a process for monitoring ECHA Candidate List updates
- Prepare your RoHS technical documentation and declaration of conformity
- Confirm whether an EU representative or Only Representative is required
- Check UK REACH requirements if you are also selling into Great Britain
Final Thoughts
RoHS and REACH regulations exist to protect people and the environment from exposure to harmful substances, and regulators across EU member states actively enforce them. Getting compliant before you enter the market is far less costly than dealing with a recall, a customs hold, or a prohibition notice after the fact.
If you are unsure where your products stand, the best starting point is a gap analysis against both regulations. Understanding what you have, what is in it, and how it is used gives you the foundation to build a credible compliance programme.
Euverify works with manufacturers and exporters across a wide range of product categories to understand EU and UK product compliance requirements, including RoHS, REACH, and CE marking. If you need practical guidance on where to start, get in touch with our team.
Frequently Asked Questions
Does RoHS apply to my product if it is sold in the EU but manufactured outside Europe?
Yes. RoHS applies to products placed on the EU market regardless of where they are manufactured. If you are a non-EU manufacturer selling into the EU, either directly or through a distributor, your product must meet RoHS requirements before it reaches the market.
What is the difference between RoHS and REACH compliance?
RoHS restricts specific hazardous substances in electrical and electronic equipment and sets hard concentration limits. REACH is broader and covers chemical substances across almost all product types. Complying with one does not mean you comply with the other. Many products need to satisfy both regulations simultaneously.
How often does the REACH Candidate List get updated?
ECHA updates the Candidate List of Substances of Very High Concern typically twice a year. This means a product that was fully compliant at launch could trigger new disclosure obligations if a substance it contains is added to the list later. Ongoing monitoring is essential, not just a one-time check.
What happens if my product contains an SVHC above 0.1%?
If your product contains a Substance of Very High Concern at a concentration above 0.1% by weight per homogeneous material, you are required to communicate that information down the supply chain. If you sell directly to consumers, you must provide the information free of charge within 45 days of a request.
Do I need a CE mark to show RoHS compliance?
RoHS compliance is a prerequisite for CE marking on in-scope electrical and electronic products. You cannot legally affix a CE mark without addressing RoHS alongside any other applicable directives. Compliance is demonstrated through a technical file and declaration of conformity rather than third-party certification.
Does Brexit mean UK and EU RoHS and REACH requirements are now different?
Yes. Since Brexit, Great Britain operates its own versions of both regulations, UK RoHS and UK REACH, administered separately from the EU frameworks. If you sell in both markets you need to maintain compliance with both regimes, as they are no longer identical and continue to diverge over time.
Related Resources
Electronics
Guides & Tutorials
Cosmetics
Industry Insights
Clothing
Industry Insights
Cosmetics
Guides & Tutorials
Medical
Guides & Tutorials
TOY
Industry Insights