SVHC compliance: the 0.1% threshold explained

SVHC compliance becomes urgent when a buyer asks one short question: ‘Does it contain any Candidate List substances above 0.1%?’ The answer cannot safely come from the finished product's total weight. Under REACH, the concentration is assessed in each article. A cable, coating, fastener and enclosure can be separate items in the analysis, which is why the threshold needs a clear product structure behind it.

TL;DR

SVHC compliance means identifying Candidate List substances of very high concern in articles, assessing the 0.1% weight-by-weight threshold and meeting resulting communication and, where relevant, SCIP duties. The Court of Justice confirmed the threshold applies to each article in a complex product. The useful rule is simple: decide the scope before commissioning work, retain evidence that identifies the actual product, and review it whenever the product or supply chain changes.

What the decision is really about

SVHC compliance means identifying Candidate List substances of very high concern in articles, assessing the 0.1% weight-by-weight threshold and meeting resulting communication and, where relevant, SCIP duties. The Court of Justice confirmed the threshold applies to each article in a complex product. Teams get into trouble when they treat the visible label, certificate or checklist as the beginning of compliance. It is the end of a chain that starts with an accurate product description. Write down the model, intended use, users, markets, components and functions. That short note gives engineering, purchasing and whoever approves packaging the same facts to work from. It also stops a perfectly good report being attached to a slightly different product six months later.

The European regulatory framework is deliberately product-specific. A decision that is sound for one product can be wrong for the next even when they share a supplier or a casing. That is not a reason to overcomplicate every launch. It is a reason to record the boundary of the decision, the evidence used and the owner who will revisit it after a meaningful change.

The questions worth answering before release

The table is a working aid, not legal advice. Its value is in making assumptions visible early, when changing a part or updating an instruction is still easy. Keep it next to the bill of materials and the product record rather than letting it disappear into a quotation email.

A practical working sequence

• Break the product into meaningful components before asking suppliers for information.
• Use the current ECHA Candidate List and record its date.
• Ask suppliers to name any SVHC above 0.1% in the supplied article and provide safe-use information.
• Check whether SCIP notification duties apply to your role and market.
• Set updates for list changes, substitutions and consumer requests.

Do those steps in that order. Starting with a lab quote, a label proof or a supplier certificate can feel productive, but it can also hard-code the wrong assumption into the project. The better sequence is to establish what the finished product is and which route applies, then ask for the exact evidence that route needs. That makes quotes clearer and makes it much easier to explain why a particular report, declaration or record is in the file.

Evidence that holds up when someone asks

Where an article contains a Candidate List SVHC above 0.1%, Article 33 requires information sufficient for safe use, including the substance name. Consumers can ask too, with a 45-day response duty. That gives a useful operating test: can your business answer a named product question quickly, or does it need to hunt through old inboxes and ask a supplier from scratch? If it is the latter, the file is not yet doing its job.

The best files are boring in the best sense: each document has a date, version, product link and owner. An engineer who was not part of the original project should be able to follow the trail without guessing which attachment is final. A retailer, customs officer or market-surveillance authority is not looking for an enormous folder; they need a clear account of why the product meets the requirements claimed. See what goes in a technical file for a useful shared structure.

Keep the decision live after launch

The SVHC compliance decision should not become invisible after the first shipment. Build a short review into ordinary product change control. Ask whether a proposed change affects the product description, market, intended user, materials, radio function, supplier, software, lab evidence, declaration or label. Most changes will not require starting again. The point is to make a considered decision before the change is released, with a note that someone can find later.

This is also where the person closest to the product needs a route to raise uncertainty without being treated as a blocker. A buyer may see a new material first. A support colleague may hear that a customer uses the product in a way the instructions never anticipated. An engineer may know that a firmware release alters a performance limit. Each observation can be recorded as a review trigger, checked against the original evidence, and closed with a short explanation. That approach is simpler than a giant annual audit because it catches changes while the people who understand them are still in the room.

For SVHC compliance, give that review a named owner and a realistic deadline. A task assigned to ‘compliance’ is usually a task assigned to nobody. A small, visible record of decisions is better than a perfect-looking dashboard that cannot explain why a product is green.

Mistakes that create avoidable rework

• Calculating 0.1% only against the total assembled product.
• Calling a product ‘SVHC free’ when evidence only addresses the threshold.
• Not keeping the substance name and Candidate List version.
• Treating SCIP as a substitute for Article 33 communication.

None of these errors are fixed by adding more confident wording to a declaration. The manufacturer or responsible economic operator still needs to understand the claim and have evidence for the exact configuration placed on the market. Supplier documents, test reports and software records are valuable inputs, but responsibility does not move just because a PDF has a reassuring title.

A realistic pre-launch moment

A tool kit includes an insulated cable and replacement grip. Its total weight makes a trace substance sound insignificant, but the cable is reviewed as its own article. The supplier's current declaration is clear, and the process becomes reusable when a second cable supplier is approved.

The point is not that every change needs a panic. It is that a named review gate makes the sensible response routine: record what changed, ask whether the evidence remains representative, update the file if it does not, and only then release the product. That is calmer than rediscovering the issue when stock is already in a warehouse.

What to do next

Build an article-level component list, then use REACH versus RoHS to keep the questions separate. Start by mapping one live product in the requirements checker. Once the underlying work is complete, the Declaration of Conformity generator can turn the verified details into a consistent document.