REACH & RoHS Compliance Guide for Manufacturers (2026)

REACH vs RoHS: What's the Difference?

A product can — and often does — fall under both. A consumer electronic device, for example, must meet RoHS substance limits and comply with REACH obligations (SVHC declaration, SCIP notification, and registration of any substances it releases) for the chemicals it contains.

REACH: Registration, Evaluation, Authorisation, Restriction

REACH (Regulation (EC) 1907/2006) places the burden of proof on industry: companies that manufacture or import chemical substances into the EU above 1 tonne per year must register them with the European Chemicals Agency (ECHA), providing data on hazards, uses, and safe handling.

• Registration — substance manufacturers/importers submit a technical dossier to ECHA; larger volumes require a more detailed Chemical Safety Report
• Evaluation — ECHA and member states check dossier compliance and may request additional testing
• Authorisation — substances on Annex XIV (Substances of Very High Concern selected for authorisation) cannot be used after a sunset date without a specific authorisation
• Restriction — Annex XVII lists substances that are banned or restricted in specific uses or products EU-wide, regardless of registration status

SVHC and the SCIP Database

The SVHC candidate list (Substances of Very High Concern) is published and updated by ECHA roughly twice a year and currently contains over 240 substances. If a listed substance is present in an article above 0.1% weight by weight, two obligations follow:

• You must provide sufficient safety information to allow safe use, free of charge, to consumers on request within 45 days and automatically to professional customers
• Since 5 January 2021, you must notify the substance's presence to ECHA's SCIP database (Substances of Concern In articles, as such or in complex objects — Products) before the article is placed on the EU market

The REACH Only Representative (OR)

A non-EU manufacturer of a substance, mixture, or an article that intentionally releases a substance can appoint an EU-established Only Representative (OR) under REACH Article 8. The OR takes on the manufacturer's REACH registration and reporting duties, which means:

• EU importers who purchase directly from that manufacturer are treated as downstream users, not importers — they do not need to register the substance themselves
• The OR must be established in the EU and have sufficient background in handling substances and their associated exposure/use information
• The OR is legally responsible for REACH compliance duties on the manufacturer's behalf, including registration, SDS/safety information, and cooperation with ECHA

Without an OR, every EU-based importer of that non-EU manufacturer's substance above the 1 tonne/year threshold must register it independently — creating duplicated cost and risk across the supply chain.

RoHS: The 10 Restricted Substances

RoHS (2011/65/EU, as amended by 2015/863) restricts the following substances in electrical and electronic equipment, each capped at a maximum concentration value in homogeneous materials (typically 0.1% w/w, 0.01% for cadmium):

RoHS applies to 11 defined equipment categories, from large and small household appliances to IT equipment, lighting, toys, and medical devices (with transitional provisions). A number of exemptions exist in the RoHS Annexes for technically unavoidable uses — these are periodically reviewed and can expire, so exemption status should be re-checked for long-lifecycle products.

RoHS and CE Marking

Unlike REACH, RoHS is one of the directives that feeds into CE marking for electrical and electronic equipment. The manufacturer must:

• Carry out an internal production control assessment (or use a Notified Body where required by another applicable directive)
• Keep technical documentation demonstrating substance limits are met — typically via material declarations from suppliers, XRF screening, or lab testing
• Include RoHS in the EU Declaration of Conformity alongside other applicable directives (LVD, EMC, RED)

Typical Compliance Costs

• RoHS material testing/screening: €500–€3,000 per product, depending on component count
• REACH SVHC screening across a bill of materials: €1,000–€5,000 for complex electronics; lower for simpler products
• REACH substance registration (per substance, per tonnage band): ECHA fees range from roughly €1,700 to €4,600 plus dossier preparation costs, which can run into tens of thousands of euros for full-tonnage registrations
• Only Representative service: typically €1,500–€6,000/year depending on substance volume and number of substances covered

Frequently Asked Questions