What is the difference between REACH and RoHS?

REACH, meaning Registration, Evaluation, Authorisation and Restriction of Chemicals, is European Regulation No. 1907/2006 governing chemical substances. Product compliance may involve SVHCs, the Candidate List, restrictions in Annex XVII, and, depending on the case, authorizations in Annex XIV.

RoHS, meaning Restriction of Hazardous Substances, is Directive 2011/65/EU limiting certain substances in covered electrical and electronic equipment. REACH is broad and chemical; RoHS targets specific substances and equipment. The same product may fall under both regimes.

Which substances are restricted by RoHS?

RoHS Annex II currently sets the following limits in the relevant homogeneous materials: lead 0.1%, mercury 0.1%, cadmium 0.01%, hexavalent chromium 0.1%, PBB 0.1%, PBDE 0.1%, DEHP 0.1%, BBP 0.1%, DBP 0.1%, and DIBP 0.1%.

Software should not check whether a product contains less than 0.1% lead on average. It must relate each substance to each homogeneous material, part, product version, and any applicable exemption.

What is a homogeneous material?

RoHS defines a homogeneous material as a material of uniform composition, or a combination that cannot be separated mechanically into different materials. A cable may therefore be modeled as copper conductor, plastic sheath, solder, and connector rather than one mass to dilute.

This prevents an incorrect conclusion that a substance is below the threshold because its weight is small compared with the complete product. The engine must retain the relationship substance → material → article → product.

What is an SVHC?

SVHC means Substance of Very High Concern. Reasons may include carcinogenic, mutagenic, toxic for reproduction, persistent and bioaccumulative, very persistent and very bioaccumulative, endocrine-disrupting, or equivalent concern under REACH.

An SVHC may be added to the Candidate List. On February 4, 2026, ECHA added n-hexane and the group around Bisphenol AF, bringing the list to 253 entries. This number should remain a versioned reference rather than a hard-coded business constant.

What is the difference between the Candidate List, Annex XIV, and Annex XVII?

The Candidate List identifies SVHCs and triggers information duties. It does not automatically mean that every use is prohibited. Annex XIV, the Authorisation List, covers substances whose uses may require authorization after the sunset date.

Annex XVII imposes restrictions or prohibitions for selected substances, uses, or conditions. Status should not be reduced to `SVHC = non-compliant`: software must retain substance, use, concentration, product, restriction, and any authorization.

What does REACH Article 33 require?

When an article contains a Candidate List substance above 0.1% weight by weight, its supplier must provide professional recipients with enough information for safe use, at least the substance name. A consumer can also request this information and must receive a free answer within 45 days.

Software can trigger the obligation automatically: product → article → SVHC above 0.1% → Article 33 information required. It must also distinguish this communication from the REACH Article 7(2) notification and the SCIP notification.

Does the REACH 0.1% threshold apply to the complete product?

Not necessarily. For a complex object, the 0.1% threshold is assessed at the level of each relevant article when it remains an article under REACH. A machine may therefore contain a board, connector, and plastic part whose concentration must be assessed separately.

Dividing a substance’s mass by the weight of the entire machine can hide an obligation. The model must understand product → assembly → article → substance and support where-used analysis.

What is a BOM and why is it central?

A BOM, or Bill of Materials, is the product structure. It can connect products, assemblies, parts, components, materials, and substances. The system must answer two inverse questions: which products use this part, and which products contain a newly regulated substance?

A where-used analysis traverses substance → part → assembly → product. It enables fast impact assessment when an SVHC, restriction, or supplier declaration changes.

How should compliance be assessed from supplier data?

The model can follow BOM → parts → suppliers → declarations → substances → regulatory rules → product compliance. For each component it retains supplier, internal and supplier references, REACH/RoHS declarations, substances, concentration, exemptions, date, and covered regulatory version.

The result should not be only compliant/non-compliant. It should distinguish COMPLIANT, NON-COMPLIANT, EXEMPTION APPLICABLE, DATA MISSING, REVIEW REQUIRED, and OUTDATED DECLARATION. Missing data never equals compliance.

Supplier declaration or Full Material Declaration?

An RCD, or Regulatory Compliance Declaration, states that a part complies with a regulatory list or does not contain certain substances above thresholds. An FMD, or Full Material Declaration, describes materials and substances in much more detail.

BOMcheck distinguishes these two levels. A sufficiently complete and reliable FMD may allow some statuses to be recalculated when lists change, while a simple “REACH 2025 compliant” declaration will often need to be requested again in 2026.

How should outdated supplier declarations be managed?

Each declaration retains supplier, part, date, version, covered regulations, reference Candidate List, status, and original document. A new SVHC should identify earlier declarations that may be affected.

The system can first look for usable FMD data, then request a new declaration when existing data is insufficient. Supplier follow-up should retain date, scope, responses, and any lack of response.

How should RoHS exemptions be managed?

Exemptions in Annexes III and IV concern selected uses and product categories. They have a number, scope, category, application, validity date, and sometimes a renewal request.

Software should connect exemption → category → application → component → product and distinguish `ACTIVE`, `RENEWAL PENDING`, `TRANSITION PERIOD`, and `EXPIRED`. An expiry date alone is not enough to determine the actual regulatory status.

Does an expired RoHS exemption immediately make a product non-compliant?

Not always. When a renewal request was submitted on time, the existing exemption may remain valid until the Commission decides. The Commission also currently indicates that a decision takes around 18 to 24 months.

The engine should therefore manage the request, submission evidence, transition period, category, and final decision. It should not mechanically apply `expiry_date < today → NON_COMPLIANT`.

What is SCIP?

SCIP means Substances of Concern In articles as such or in complex objects (Products). Created under the Waste Framework Directive, the database makes information available for certain articles containing a Candidate List SVHC above 0.1% weight by weight.

Since January 5, 2021, relevant suppliers placing these articles on the EU market must submit information to ECHA. SCIP notification must be distinguished from REACH Article 33 communication and the REACH Article 7(2) notification.

What should a SCIP dossier contain?

Depending on the case, the dossier identifies the article, Candidate List substance, concentration range, relevant material, safe-use information, and complex-object structure. A hierarchy may follow vehicle → engine → assembly → article → SVHC.

A platform can generate this information from BOMs and supplier declarations, then retain the prepared dossier, submission, technical reference or submission success, and public dissemination when it occurs.

SCIP in 2026: how should dissemination delays be handled?

ECHA has reported continuing delays in the dissemination of some SCIP notifications due to technical problems. A successful submission should not be sent again only because it is not yet publicly visible.

Software should therefore distinguish `GENERATED`, `SUBMITTED`, `TECHNICAL SUCCESS`, `REFERENCE RECORDED`, and `DISSEMINATED/PUBLISHED`. Technical submission evidence is more reliable than a simple public-visibility check.

What changes with ECHA CHEM in 2026?

ECHA is progressively moving chemical information to ECHA CHEM. The Candidate List is available in the new database, while the former dataset remains maintained in parallel until December 2026 to support the transition.

An application should not depend on one web screen or fragile scraping. Regulatory references should be imported through maintainable, versioned, and verifiable mechanisms with an effective date.

2026 update: how should the Candidate List and PFAS be handled?

The Candidate List changes regularly: the 253 entries announced on February 4, 2026 should not be implemented as a fixed limit. Monitoring should connect list version, effective date, CAS, EC Number, groups, and declaration impact.

For PFAS, ECHA published in March 2026 a final RAC opinion and draft SEAC opinion supporting an EU-wide restriction with targeted derogations. This remains an ongoing regulatory process, not a general prohibition already in force: status should be `PROPOSED`, `UNDER REVIEW`, or `UPCOMING` until a final rule takes effect.

How should regulatory impact be generated automatically?

When a new substance is added, the flow can follow new SVHC → CAS/EC mapping → components → BOM where-used → products → suppliers → obligations → actions. The result should identify sufficient data, missing declarations, and parts requiring review.

The system can identify which products use a part containing n-hexane, which FMDs are usable, and which customers or suppliers need new information. It does not replace legal analysis; it makes impact traceable and prioritizable.

How should CAS, EC Numbers, and substance groups be managed?

A substance should not be identified only by its commercial name. The model can retain CAS Number, EC Number when available, regulatory name, synonyms, group, and relationships to group members.

The Candidate List includes entries that may cover multiple members. “Bisphenol AF” or a supplier name is therefore not always enough to calculate impact; mapping must be versioned and auditable.

How should RoHS compliance evidence be managed?

For covered EEE, the dossier can gather BOMs, supplier declarations, FMDs, test reports, exemptions, risk analysis, EU Declaration of Conformity, CE marking, and product version. EN IEC 63000:2018 describes the technical documentation manufacturers compile to assess substance restrictions.

Software supports dossier preparation and traceability, but does not certify the product itself. The declaration, compliance decision, and manufacturer responsibility remain controlled organizational acts.

Does every component need chemical testing?

Not necessarily. A strategy can combine supplier information, material declarations, history, criticality, substance risk, and targeted testing. Testing every screw and connector may be disproportionate, while accepting every supplier declaration without review may be too risky.

Software can calculate an internal priority from supplier confidence, material risk, document age, regulatory change, and part criticality. This score helps plan checks; it is not by itself legal proof of compliance.

How should supplier changes be managed?

An internal part may have several sources: supplier A with a compliant declaration, supplier B with an FMD, and supplier C without current RoHS data. The product should not be marked compliant merely because one possible supplier has good data.

The system must know which supplier is approved, actually used, valid for which period, and associated with which product units or versions. This creates a direct link to supplier qualification.

How should REACH and RoHS connect to PLM, ERP, and PIM?

PLM owns technical BOMs and revisions. The ERP owns suppliers, items, and purchasing. The PIM distributes product information. The QMS owns non-conformities and actions, while the supplier portal collects declarations. The compliance engine owns substances, rules, calculations, and statuses.

The platform should not become a fourth product master. It orchestrates data from systems that already own it while retaining decisions, versions, evidence, and calculated impacts.

How should product revisions be managed?

Compliance is calculated by version. Revision A may use supplier X and component 1, revision B may replace the component, and revision C may introduce a different material. A new SVHC may therefore affect A and B but not C.

History should reconstruct compliance as it existed when the product was placed on the market, including the relevant BOM, supplier, declarations, rules, and decision.

Which product-compliance KPIs should be tracked?

Useful indicators include BOM coverage, the share of components with regulatory data; supplier response rate; expired declarations; products requiring review; SVHC exposure; active or renewal-pending RoHS exemptions; SCIP status; and time to assess regulatory impact.

The most important KPI is not the number of certificates stored, but the number of products that can actually be assessed today. Missing, outdated, or unversioned data should not artificially inflate coverage.

BOMcheck, TEEXMA, or custom compliance software?

BOMcheck/Sphera is a platform specialized in supplier declarations, REACH, RoHS, FMD, RCD, exemptions, and SCIP. TEEXMA covers BOM integration, supplier collection, substances, compliance calculation, SCIP, regulatory monitoring, and where-used. These solutions should be assessed for regulatory depth and connector quality.

Custom software becomes relevant when several PLMs/ERPs must be connected, BOMs use a specific format, a supplier portal already exists, several regulations must be combined, or the internal workflow is unusual. If a specialist platform covers the need, integrating it is often more rational than rebuilding a full regulatory engine.

How much does custom REACH / RoHS software cost?

Cost depends on the number of products, BOM size, number of suppliers, substance-data depth, RCD or FMD scope, SCIP, number of regulations, monitoring, ERP/PLM integrations, supplier portal, and migration.

Three levels should be separated: reference base with documents, due dates, and statuses; compliance engine with BOMs, substances, rules, and impact analysis; and product compliance platform with supplier portal, PLM/ERP, SCIP, reporting, and multi-regulation support. These levels are not comparable and should not be reduced to an artificial average.

How would Koragence structure this type of project?

Scoping starts with a few real products and their BOMs, together with the declarations currently used to justify compliance. The goal is to locate data across PLM, ERP, Excel, supplier documents, and external platforms.

We then separate facts — substances, concentrations, references, and suppliers — from regulatory rules that evolve over time. A first version can cover one product range and REACH/RoHS before adding SCIP, supplier portal, or other regulations.