Every time the European Chemicals Agency (ECHA) updates the REACH Candidate List, the same question reaches compliance and engineering teams: which of our products just became affected, and how quickly can we prove it? The list now holds 253 substances of very high concern (SVHC) following the 4 February 2026 update, and it typically grows twice a year. Each addition can create immediate legal duties. This guide sets out a practical REACH SVHC impact analysis: a repeatable five-step method to identify affected products across your bills of materials (BOMs) and suppliers, then document the result for audit.

If you need a faster read on current exposure, you can book a compliance risk assessment to map SVHC risk across your product portfolio before the next Candidate List update lands. For the underlying framework, Certivo's REACH compliance overview explains how the Candidate List connects to Article 33, Article 7(2), and SCIP obligations.

Key Takeaways

📌 A new SVHC on the REACH Candidate List can trigger Article 33 communication, SCIP notification, and, in some cases, Article 7(2) notification to ECHA.

⏳ Article 33 consumer requests must be answered within 45 days; Article 7(2) notification, where it applies, is due within six months of listing.

📊 The 0.1% w/w threshold is assessed at the article (component) level, not the finished product.

🔗 Impact analysis depends on current BOM-level substance data, not one-time supplier compliance statements.

🤖 Continuous monitoring and BOM-level substance mapping turn a twice-yearly scramble into an automated screen.

📄 Every screen should be time-stamped and retained, since REACH Article 36 requires records to be kept for 10 years.

What Happens When ECHA Adds a New SVHC

Inclusion on the Candidate List is not a ban. It is the point at which specific communication and notification duties begin for articles that contain the substance above 0.1% by weight. ECHA publishes the additions on its official Candidate List table, and the European Commission summarizes the underlying duties on its REACH regulation page. The February 2026 update, published as ECHA/NR/26/06, added n-hexane and the 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol group, a reminder that a single entry can cover multiple related substances and salts.

The obligations a new listing can trigger

Article 7(2) has two recognized exemptions: notification is not required where the substance is already registered for that use, or where exposure to people and the environment can be excluded under normal and reasonably foreseeable conditions of use, including disposal. For deeper context on parallel changes, see Certivo's briefing on REACH SVHC and Annex XVII changes.

What the 0.1% threshold is measured against

The 0.1% w/w threshold applies to each article incorporated as a component of a complex product, not to the finished product's total weight. This follows the 2015 Court of Justice of the EU ruling in Case C-106/14, often summarized as "once an article, always an article." In practice, a small part that exceeds 0.1% still triggers obligations even when the substance is negligible across the assembled product. That is why impact analysis has to run at the BOM and component level, not the product level.

REACH SVHC obligations and deadlines triggered when a new substance is added to the Candidate List

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REACH SVHC Impact Analysis: A Five-Step Method

The workflow below is the same regardless of industry. The variables are the quality of your material data and the number of suppliers you have to chase.

Step 1: Confirm the substance and its scope

Pull the exact identity from ECHA: substance name, CAS and EC numbers, and whether the entry is a group covering several substances or salts. Record the listing date, since it starts the Article 7(2) six-month clock and the immediate Article 33 duty. Note the reason for inclusion under Article 57, because it signals possible future Annex XIV authorisation or Annex XVII restriction. ECHA CHEM, live since September 2025, is the authoritative source for this data.

Step 2: Screen your BOMs and material disclosure data

Map the new substance, including every CAS number in a group entry, against your existing material data. Full Material Disclosure (FMD), IPC-1752A, and IEC 62474 declarations let you screen in minutes. Flag every part where the substance is present, or possibly present, above 0.1% w/w at the article level. Parts with only a prior yes/no compliance statement, or declarations made against an older Candidate List, are unknowns and become your follow-up list. Certivo explains why full material disclosure beats format-locked declarations for exactly this reason.

Step 3: Close data gaps with targeted supplier requests

For parts without current substance data, issue focused requests rather than a blanket campaign. Ask for updated declarations against the current Candidate List, ideally FMD with CAS-level content and concentration, not a single compliance checkbox. Prioritize by exposure: high-volume parts, parts inside EU-market products, and parts whose function or material makes the substance likely. Automated supplier data collection and self-service portals remove most of the email back-and-forth that slows this step.

Step 4: Map obligations to each affected article

For every confirmed article above 0.1% w/w, determine which duties apply: Article 33(1) communication to recipients, a documented 45-day consumer response process, SCIP notification for EU market placement, and an Article 7(2) assessment where aggregate volume exceeds one tonne per year. Record the negative findings too. Parts you screened and cleared are part of the audit trail, not wasted work. This is where a centralized materials and environmental compliance record keeps obligations and evidence in one place.

Step 5: Document the analysis and move to continuous monitoring

Keep a time-stamped record of which list version you screened, which parts and suppliers you assessed, what evidence you collected, and on what dates. REACH Article 36 requires this information to be retained for 10 years. Then set alerts so the next Candidate List update triggers the workflow automatically. Shifting from a twice-yearly scramble to proactive, continuous monitoring is the single change that removes most of the risk.

Five-step REACH SVHC impact analysis process from Candidate List update to audit-ready documentation

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How the Same Workflow Applies Across Industries

The method holds across sectors. The friction shifts depending on data maturity and product lifecycles.

Electronics and semiconductors

Deep multi-tier BOMs mean a new SVHC can touch thousands of parts. Solders, coatings, plasticizers, and flame retardants are common carriers. Teams that already collect IPC-1752A and IEC 62474 data can screen quickly. Those relying on distributor statements often face large unknown lists. See Certivo's guidance for electronics manufacturing compliance.

Medical devices

SVHC screening feeds into MDR technical documentation and biocompatibility review, and change control on approved suppliers is slow. Early impact analysis matters because substitution timelines are long. Certivo covers this in its medical devices and equipment resources.

Industrial electronics and test and measurement

Mixed catalog and custom parts, combined with long product lifecycles, mean legacy components frequently lack digital material data. The follow-up list in Step 3 tends to be the bottleneck, which makes structured supplier collaboration essential.

Aerospace and defense

Very long service lives, specialty alloys and coatings, and export-control-sensitive supply chains create persistent data gaps on older parts. Impact analysis here is as much a data-recovery exercise as a screening one. Certivo's aerospace and defense page addresses these constraints.

Where Manual Impact Analysis Breaks Down

Spreadsheet-driven analysis fails in predictable ways. The Candidate List updates twice a year, so the exercise repeats indefinitely. Supplier declarations go stale between cycles. Group entries mean one listing maps to many CAS numbers, which is easy to miss by hand. And a manual screen rarely produces the time-stamped, defensible evidence a customer audit or a chemical and hazmat compliance review expects. The result is a recurring fire drill that consumes senior compliance time without building durable readiness.

How Certivo Automates REACH SVHC Impact Analysis

Certivo functions as the system of record for product compliance, with CORA as its embedded intelligence layer. CORA-powered regulatory intelligence monitors Candidate List updates and other regulatory changes, so Step 1 happens without manual watching. BOM-level substance mapping screens your parts against every affected CAS number automatically, completing most of Step 2 in place of a manual search.

Where data is missing, Certivo's supplier data collection and contractor management tools trigger targeted requests through supplier portals, compressing Step 3. Screened results and evidence are retained as audit-ready documentation with the list version and dates attached, supporting Step 5. Certivo does not make a company audit-proof and does not remove compliance risk. What it does is reduce response time, improve evidence retrieval, and cut the number of surprises when a new SVHC lands.

Executive Takeaway

A new SVHC listing is not an emergency if your material data is current and your monitoring is continuous. The organizations that stay calm through each Candidate List update are the ones that have already mapped substances to BOMs, standardized supplier data collection, and made their evidence audit-ready. Treating REACH SVHC impact analysis as a repeatable system, rather than a twice-yearly project, is what separates readiness from exposure.

To see your current SVHC exposure across products, suppliers, and jurisdictions before the next update, book a compliance risk assessment with a Certivo compliance specialist.