When exporting hardware structural components to the EU, companies face a “chemical compliance” hurdle in addition to CE and RoHS requirements: the REACH regulation (EC 1907/2006). Many enterprises mistakenly view REACH as a “one-time test for a certificate” process; in reality, REACH is a system of obligations subject to continuous updates.
The Candidate List of Substances of Very High Concern (SVHC) is updated twice a year and currently includes 253 substances.
This article outlines the comprehensive approach to achieving REACH compliance for hardware components.
1.
Understand the Key Thresholds: 0.1% and 1 Tonne
REACH’s core requirements for “articles” (such as finished hardware structural components) center on the SVHC Candidate List. If the concentration of an SVHC in an article exceeds 0.1% (by weight—determined at the article or component level, rather than calculated based on the entire assembled unit), the enterprise must fulfill notification obligations. This involves providing downstream users and consumers with sufficient information for safe use and responding to consumer inquiries free of charge within 45 days. Furthermore, if the total annual export volume of that SVHC exceeds 1 tonne per manufacturer or importer, a notification regarding the article must be submitted to the European Chemicals Agency (ECHA) via the SCIP database.
Additionally, the restrictions and prohibitions on specific substances for specific uses outlined in the REACH Annex XVII Restricted Substances List also apply (e.g., certain phthalates).
II. How Testing is Conducted: From Bill of Materials to Report
The essence of REACH testing is “screening for SVHCs against the latest Candidate List.” The process is as follows:
- Compile the Bill of Materials (BOM): Break down hardware components into homogeneous material units (base materials, plating, coatings, seals, labels, etc.) and document supplier and composition information for each material;
- Select an Accredited Laboratory: Choose a third-party laboratory with CNAS/CMA accreditation or international recognition (such as ILAC MRA), and confirm that their testing covers the current version of the Candidate List;
- Submit Samples: Approximately 50 grams of each material is sufficient; samples must match mass-produced products and be clearly labeled with material type and part number;
- Testing and Reporting: Conduct qualitative screening and quantitative verification (using GC-MS or LC-MS) for the full set of SVHC substances (currently 253 items). The report lists detected values and compliance determinations for each substance; standard turnaround is 5–7 working days, with expedited service available in 3–5 days.
III.
Post-Report: Declaration and Continuous Updates
Upon receiving the test report, the enterprise should issue a REACH Declaration of Conformity (DoC) specifying: supplier name, product/part number, declaration date, Candidate List version used, whether SVHC content exceeds 0.1%, substance names and concentration ranges, safe-use information, and the signatory. Since the Candidate List is updated twice a year, an old report does not guarantee long-term compliance.
If new substances are added to the list while product composition remains unchanged, an assessment is required to determine if supplementary testing and an updated declaration are necessary; re-assessment is also required when product designs are modified or material suppliers are changed.
IV. High-Risk Areas and Common Misconceptions Regarding Hardware Components
- Focus on Platings and Coatings: Electroplating solutions, passivating agents, anti-rust oils, and sealants may introduce SVHCs (such as lead or phthalates). Testing must cover distinct layers of homogeneous materials rather than just the base material;
- Risk of “Expired” Reports: Reports based on an outdated version of the Candidate List lack sufficient evidentiary value; purchasers should verify both the report date and the list version;
- Declarations Are Not “Exemptions from Testing”: The quality of supplier SDSs and declarations varies; it is advisable to conduct spot checks and laboratory testing for critical materials, combining “supplier declarations” with “spot-check reports.”
V.
Trends: SCIP Notifications and Supply Chain Information Communication
The EU is strengthening obligations regarding SVHC notifications for complex products (via the SCIP database) and information communication across the supply chain; buyers increasingly require component declarations and test reports as a condition for market entry.
Industry experts recommend incorporating REACH compliance into supplier quality agreements: require suppliers to periodically update declarations based on the latest list and trigger re-testing upon significant changes.
REACH compliance is not merely a matter of a single report, but an ongoing supply chain management process that evolves alongside regulatory updates.
