Deep Dive: Navigating EU REACH & RoHS Compliance for Exporters
Placing physical goods on the European Union Single Market requires strict adherence to environmental chemical regulations. Importers, producers, and general manufacturers are primarily governed by the tandem frameworks of REACH (Regulation EC No 1907/2006) and the RoHS Directive (2011/65/EU and amendments). While both regulations restrict specific chemical substances to protect human health and environmental lifecycles, they differ significantly in scope, target components, and compliance obligations.
REACH Articles & The Court of Justice "Once an Article, Always an Article" Ruling
REACH governs chemical substances inside finished physical products, classified as Articles. An article is defined as an object that is given a specific shape, surface, or design which determines its function to a degree greater than does its chemical composition.
Historically, there was severe debate as to whether the 0.1% threshold for Substances of Very High Concern (SVHC) applied to the average concentration of the entire complex product or down to the individual component article. In 2015, the Court of Justice of the European Union (CJEU) issued a landmark ruling in Case C-106/14 (often referred to as the O5A - Once an Article, Always an Article principle).
The court ruled that any component that qualifies as an article under REACH retains its identity as an article even when incorporated as a part into a larger, more complex product. Consequently, the 0.1% w/w concentration threshold applies to each individual component article, not the overall product. For example, in a laptop containing a minute lead-based solder joint representing only 0.001% of the total laptop weight, the solder joint itself exceeds 0.1% of its own weight, triggering active reporting, customer declarations, and SCIP registrations.
The ECHA SCIP Database and Tonnage Triggers
Under the EU Waste Framework Directive, companies supplying articles containing Candidate List SVHCs in concentrations above 0.1% w/w on the EU market must submit a notification to ECHA for database registry. The SCIP Database stands for:
- Substances of Concern In articles, as such or in complex objects (Products)
The goal of SCIP is to ensure that waste operators have access to information about hazardous chemicals inside articles to support safe recycling operations. SCIP registration is completely mandatory for EU importers or producers. Sibling companies exporting to the EU must compile detailed dossier files for their EU partners.
Furthermore, under REACH Article 7(2), if an SVHC exceeds 0.1% w/w inside an article, and the total aggregate weight of that specific substance imported into the EU exceeds 1.0 metric tonne per importer/producer per calendar year, the business must file a formal notification directly to ECHA within six months of identification.
RoHS Directive Requirements & Homogeneous Materials
The RoHS Directive applies strictly to Electrical and Electronic Equipment (EEE) categories. RoHS sets maximum concentration limits on ten specific toxic compounds. Unlike REACH, which measures concentration on the scale of an entire component article, RoHS measures concentration down to the level of homogeneous materials.
A homogeneous material is any material that cannot be disjointed or separated into different materials by mechanical actions (such as unscrewing, cutting, crushing, grinding, and abrasive processes). This includes individual plastics, solder alloys, metals, and resins.
Because raw heavy metals (such as lead or hexavalent chromium) are often functionally necessary in electrical applications, RoHS defines a series of strict, timed statutory exemptions listed under Annexes III and IV. EHS managers must map their product compositions, apply appropriate active exemption codes, and keep strict technical files to qualify for the CE mark and legal import clearance.