EU REACH SVHC 224: Importer Compliance Guide
DOBO Technical R&D TeamUpdated 9 on Nov 2026Oct 26, 2026
Practical workflow for importers on the SVHC candidate list (224 entries as referenced): thresholds and communication obligations, documentation chain, screening steps, and common gaps that cause issues.
EU REACH SVHC 224: Importer Compliance Guide
What obligations does the SVHC candidate list impose on importers?Three key obligations: determine if any candidate list substance exceeds 0.1% by weight in your article, communicate this information through the supply chain and to consumers upon request, and— for suppliers placing articles on the EU market—assess whether SCIP notification is required. This guide outlines the practical workflow; it provides general information, not legal advice. Always verify the current list version against the official source.
What is the candidate list?
The candidate list, published under European chemicals regulations, is updated over time as new substances are added. Our documentation references a version containing 224 entries. Since the list is revised periodically, the first step of any compliance program is to confirm which version you are using and its effective date.
| Concept | What it means in practice | Who acts |
|---|---|---|
| Candidate list | Substances of Very High Concern | Importers and suppliers review their items |
| 0.1% w/w threshold | Concentration threshold above which communication duties apply to an article | The party placing the product on the market |
| Article 33 communication | Sharing supply chain and consumer information on request | Article Supplier |
| SCIP notification | Notice of articles containing candidate list substances | Suppliers placing products on the EU market |
| Documentation chain | Technical data, safety data, and batch reports | Manufacturer to importer to end user |
Importer workflow
A practical program follows the material, not the paperwork. Start with the bill of materials, map each component to its supplier declaration, and only then determine if testing is required.
| Step | Action | Evidence to retain |
|---|---|---|
| 1 | Map the bill of materials and identify chemical components | Bill of materials and supplier list |
| 2 | Collect declarations, TDS, MSDS, and batch COAs | Component-wise signed declarations |
| 3 | Compare against the current candidate list version | Screening record with list version |
| 4 | Test where a declaration is missing or questionable | Test report from an accredited laboratory |
| 5 | Prepare communications and, where applicable, notifications | Article 33 text and SCIP dossier |
| 6 | Re-run screening when the list is updated | Update log and revision history |
For plasticizer selection, the key consideration is that non-phthalate grades in the DB series are evaluated against REACH SVHC 224-item guidelines. Specific products—such as DINCH (CAS 166412-78-8), TOTM (CAS 3319-31-1), and fumarate/phosphate grades—are documented individually. Proprietary formulations are disclosed as such and do not receive a public registry number.
Where importers most often go wrong
| Common gap | Why this happens | How to close it |
|---|---|---|
| Screening against an outdated list version | The list expands over time | Record and date the version used |
| Declarations without batch evidence | Collected once at project start | Request batch COA with each delivery |
| Confusing blend and article duties | Different rules apply | Classify the product first. |
| Missing notification step | Focused solely on documentation | Review notification duties separately |
| No re-screening process | One-time project approach | Incorporate list updates into change control. |
Frequently asked questions
Is the 0.1% measurement applied to the article or the component?The threshold applies to the product as placed on the market, which is why component data must be converted into a product-level statement.
No, a TDS does not replace a compliance declaration.No. A technical data sheet describes performance; the declaration states compliance for a specific list version and must be dated.
What should a declaration include?Substance list version, whether any candidate list substance exceeds the threshold, and the name of the issuing party.
Where can I confirm the current list?Source: European Chemicals Agency (official). Always use the latest version and keep a record.
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Regulatory and standards references
The links below lead to official EU, US, and ISO sources for the compliance frameworks discussed on this page. DOBO does not control third-party content; the official text and regulations of the buyer's market take precedence.
- ECHA — Understanding REACHEU registration, evaluation, authorisation and restriction of chemicals (REACH), including the Candidate List of substances of very high concern.
- EUR-Lex — Directive 2011/65/EU (RoHS 2)Restriction on the use of certain hazardous substances in electrical and electronic equipment; Annex II lists restricted substances and their maximum concentrations.
- eCFR — 21 CFR 175.300US FDA regulations for resinous and polymeric coatings intended for repeated use as food-contact surfaces, including extraction testing conditions.
- ASTM — Plastic and plasticizer standardsASTM International publishes the test methods referenced in our TDS, including plasticizer sampling and chemical analysis, tensile properties, and heat-aging procedures.
- ASTM — Plastic and Plasticizer Testing StandardsASTM International has published the test methods referenced in the TDS, covering sampling and chemical analysis of plasticizers, as well as tensile properties and thermal aging procedures.
- ISO — ISO 10993-1Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process, establishing the foundation for biocompatibility programs.
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Related technical reading
- Medical-Grade DINCH vs. DOP/DEHP Safety Review (EN 71-3 & FDA Compliance)Contact-safety assessment of ultra-pure DINCH (CAS 166412-78-8) for medical, toy, and food-contact PVC: migration behavior, biocompatibility testing guidance, and required documentation.
- ESBO Synergistic Heat Stabilization for Rigid and Soft PVCHow epoxidized soybean oil works with Ca/Zn stabilizers in flexible PVC: HCl scavenging, zinc burn control, typical 3-7 phr dosage ranges, and processing checks.
- ATBC Bio-Based Non-Toxic Plasticizer for Food WrapATBC Citrate Ester (CAS 77-90-7) for Food Wrap: Bio-Based Chemistry, Migration Risks in Thin Films, Comparison with DINCH and ESBO, and How Food-Contact Regulations Guide Selection