REACH vs. CLP: Structuring Your Product Data for Dual Compliance

Modern EU product organizations face a dual challenge — proving chemical safety under REACH while communicating hazards under CLP. Success depends less on “writing better SDSs” and more on building a coherent product data model that can feed REACH‑IT, IUCLID, PCN, labels, and SCIP without contradiction or rework. This guide explains the differences, the overlaps, and how to architect your data, workflows, and governance so compliance scales with your portfolio — not your headcount.

REACH vs. CLP — what each regulation actually governs

  • REACH focuses on chemical safety and market access — registration of substances, evaluation, potential authorisation or restriction, and communication of substances of very high concern (SVHC) to customers and consumers. It also drives article reporting via SCIP when SVHCs are present.
  • CLP governs classification, labelling, and packaging — how you determine hazard classes/categories, build labels, and create downstream safety information for mixtures via Safety Data Sheets (SDS). It also introduces Poison Centre Notifications (PCN), Unique Formula Identifiers (UFI), and EuPCS intended‑use coding.

Put simply: REACH is your safety dossier and article obligations; CLP is your hazard communication and emergency response data flow. Both must be fed by the same canonical product facts — or they will conflict.

What changed — and why it matters now

  • All poison centre notifications must use the harmonised Annex VIII format from 1 January 2025 — the transition period has ended. Use the ECHA Submission Portal and ensure portfolio‑wide UFI discipline.
  • The industrial‑use‑only deadline passed on 1 January 2024 — if you supply industrial mixtures, you should already be aligned.
  • UFI management tightened — apply “one UFI — one composition”, and align labels, PCN dossiers, and SDSs accordingly.
  • New CLP hazard classes apply — endocrine disruptors, PBT/vPvB, and PMT/vPvM have been added via Delegated Regulation (EU) 2023/707, with application dates phased from 1 May 2025 for new substances and later for mixtures and existing portfolios. Plan reclassification and SDS updates.
  • Article and SCIP duties remain — disclose SVHCs in articles to recipients and consumers within 45 days when above 0.1% w/w, and submit to SCIP for articles with SVHCs since 5 January 2021.

The canonical product data model for dual compliance

Design a vendor‑neutral data model once — then publish consistently into REACH‑IT, IUCLID, PCN, labels, SDS, and SCIP. At minimum, structure:

  1. Substance master
  • Substance identity — EC/CAS, IUPAC, purity/impurities, UVCBs, tonnage band.
  • CLP classification set — including new ED/PBT/PMT classes where applicable.
  • REACH dossier linkage — registration number, joint submission details, authorisation/restriction flags.
  • Exposure and DNEL/PNEC summary — pointers to IUCLID sections.
  1. Mixture master
  • Exact composition — ingredients with concentration ranges, variability rules, mixture‑in‑mixture traceability, and formulation versioning.
  • Classification logic — algorithmic derivation from ingredient hazards plus expert overrides and justification log.
  • UFI management — UFI per composition, lifecycle rules for reformulation, and label propagation.
  • EuPCS intended use and market placement — consumer, professional, industrial; Member State coverage.
  • PCN metadata — annex VIII required elements, contact points, languages, and limited submission flags for industrial‑only where applicable.
  • SDS linkage — generation status per language, SDScom export, and revision history.
  1. Article/complex object master
  • BOM roll‑up — material categories, part‑level substance declarations, supplier attestations.
  • SVHC detection — per article component, threshold calculation, and communication content for Article 33 disclosures.
  • SCIP dossier fields — article category, material category, SVHC identifiers and concentration ranges, safe‑use instructions.
  1. Cross‑cutting governance fields
  • Legal entity roles — manufacturer, importer, downstream user, distributor.
  • Market scope — EU/EEA countries, Northern Ireland, and UK REACH divergence where relevant.
  • Evidence registry — test reports, supplier COCs, expert assessments.
  • Audit trail — who changed what, when, and why.

Tip: Store sources of truth once — e.g., composition and classification in MDM/PLM — and generate both SDS and PCN payloads directly so the label, SDS, and PCN never diverge.

System architecture — integrating GovTech and LegalTech pipes

  • Master data backbone — PIM/MDM/PLM as system of record for substances, mixtures, and articles.
  • IUCLID/REACH‑IT — author and maintain REACH dossiers; map fields to your substance master.
  • ECHA PCN Submission — use the ECHA system‑to‑system service for automated PCN submissions and updates at scale, aligning EuPCS, UFI, and composition.
  • SDS pipeline — generate SDS from the same classification/composition graph, export via SDScom format, and maintain synchronized revisions.
  • SCIP gateway — automatically assemble SCIP dossiers from article master and push updates when candidate list changes.
  • Analytics layer — monitor KPIs, deadlines, and impact of regulatory updates, including new CLP hazard classes.

End‑to‑end workflows that actually scale

  1. Substance lifecycle
  • Onboard substance → check registration status/tonnage → perform classification including ED/PBT/PMT assessment → update IUCLID and labels/SDS.
  • Trigger events — supplier SDS update, new harmonised classification, or 2023/707 reclassification.
  1. Mixture lifecycle
  • Formulate or change composition → generate or reuse UFI → derive classification → create SDS → build PCN dossier with EuPCS and submission per Member State → print/validate labels.
  • Industrial‑only mixtures — consider limited submission where appropriate and maintain local emergency contact; convert to full submission if market moves to professional/consumer.
  1. Article lifecycle
  • Engineer BOM → collect supplier declarations → detect SVHCs > 0.1% w/w per article → prepare Article 33 communication → file SCIP dossier and maintain upon SVHC list updates.

Governance — clear owners, crisp controls

  • RACI by object
    • Substance — Regulatory science owns classification; Regulatory ops owns IUCLID.
    • Mixture — Formulation owns composition; Regulatory ops owns PCN; Quality owns label check.
    • Article — Engineering owns BOM; Compliance owns SVHC and SCIP.
  • Change control
    • Categorize changes — composition, classification, supplier‑driven, regulatory.
    • Link to obligations — PCN update triggers, UFI changes, SDS revision thresholds, label reprint rules.
  • Auditability
    • Preserve justifications for ED/PBT/PMT decisions, mixture‑in‑mixture assumptions, and limited submission use.

KPIs and dashboards for Tech Leaders and Regulators

  • Coverage — % substances registered; % mixtures with valid PCN per placing‑on‑market country; % articles with SCIP.
  • Freshness — median days from formulation change to SDS/PCN/label updates; % UFIs synchronized across assets.
  • Accuracy — automated cross‑checks passing between SDS vs PCN vs label; discrepancy rate trend.
  • Risk — # SKUs impacted by new CLP hazard classes; reclassification backlog vs. 2025/2026/2028 milestones.

Implementation roadmap — 90 days to operational readiness

  1. Weeks 1–3 — inventory and gap assessment
  • Catalog substances, mixtures, articles, and markets; map current PCN/SCIP/SDS status; identify systems generating classification and composition.
  • Flag high‑risk SKUs — consumer/professional mixtures without PCN in harmonised format and substances likely affected by ED/PBT/PMT.
  1. Weeks 4–6 — data model and connectors
  • Stand up the canonical product data model in MDM/PLM; implement UFI management and EuPCS mapping; build SDScom and PCN payload generators.
  • Configure system‑to‑system connections to ECHA for PCN and to SCIP gateway.
  1. Weeks 7–10 — portfolio remediation
  • Backfill missing PCN dossiers and convert legacy national notifications to Annex VIII harmonised format by country; verify “industrial” vs “professional/consumer”.
  • Reassess classifications for 2023/707 hazard classes and pre‑stage SDS updates for substances impacted.
  1. Weeks 11–13 — go‑live and governance
  • Enable change control, event‑based resubmissions, and dashboarding; perform label spot checks vs. UFI and PCN facts; train teams on “one UFI — one composition”.

Common pitfalls — and how to avoid them

  • Mixture‑in‑mixture opacity — insist on upstream UFI and concentration ranges, or require sufficient compositional detail for classification and PCN; document assumptions and set review intervals.
  • Limited submission overuse — valid for industrial‑only mixtures, but becomes non‑compliant if the same product reaches professional or consumer channels. Monitor market routing and upgrade to full submission proactively.
  • Divergent facts across artifacts — prevent “SDS says X, PCN says Y” by generating both from a single composition/classification source of truth and blocking manual edits downstream.
  • Missed timeline for new hazard classes — create a watchlist of substances likely to trigger ED/PBT/PMT and plan label/SDS updates tied to inventory depletion and reprint cycles.

Quick checklist — dual compliance in one pass

  • Canonical model in place — substances, mixtures, articles with versioned composition and classification.
  • UFI regime — lifecycle rules, “one UFI — one composition”, label validation.
  • PCN coverage — harmonised Annex VIII format for all hazardous mixtures and system‑to‑system submission enabled.
  • SDS alignment — SDS generated from same data as PCN; SDScom exports validated.
  • SCIP automation — dossiers auto‑built for articles with SVHCs; Article 33 communications templated.
  • CLP 2023/707 readiness — reclassification plan and deadlines tracked for substances and mixtures.

Product‑Led GTM — turning compliance into an advantage

Use compliance correctness as a product feature — instant SDS and label availability in customer language, automatic PCN/SCIP confirmations, and machine‑readable SDScom feeds into customer ERPs. Integrate with GovTech pipes — ECHA portals and system‑to‑system flows — and package it as a differentiator in tenders for regulated verticals. This is where GovTech integration meets LegalTech automation — and where your compliance engine becomes part of your product value proposition.

Summary: Treat REACH and CLP as two consumers of one canonical truth — not two separate projects. Model your product data once, automate IUCLID/REACH‑IT, PCN, labels, SDS, and SCIP from that source, and govern change tightly. With the 2025–2028 CLP updates and the end of the PCN transition, the winners will be the teams that industrialize their data — and make compliance a competitive edge.