Guide

EU REACH for Industrial Chemicals: Registration, Authorisation, Restriction

Regulation (EC) 1907/2006 — REACH — is the EU's substance-level chemicals regulation. Any manufacturer or importer placing a substance on the EU/EEA market at one tonne per year or more must register it with ECHA, with progressively heavier data requirements as tonnage rises (Annex VII at ≥1 t/y, Annex VIII at ≥10, Annex IX at ≥100, Annex X at ≥1,000). Substances of Very High Concern (SVHC) face Authorisation under Annex XIV; restricted substances appear in Annex XVII with use bans or conditions. Non-EU manufacturers reach the market via an EU-based Only Representative (OR). This guide walks the registration mechanics, the recurring compliance failures and a practical readiness path.

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Tonnage bands and the Annex VII–X data ladder

REACH ties data requirements to annual tonnage per legal entity: Annex VII (≥1 t/y) covers physico-chemical, basic in vitro toxicology and short-term ecotox; Annex VIII (≥10 t/y) adds sub-acute toxicity, mutagenicity, reproductive screening; Annex IX (≥100 t/y) requires sub-chronic studies, developmental toxicity, longer-term ecotox; Annex X (≥1,000 t/y) demands carcinogenicity, two-generation reproductive and chronic ecotox. Substance Information Exchange Fora (SIEF), now succeeded by joint-submission mechanics, require co-registrants to share vertebrate data to avoid duplicate testing.

SVHC, the Candidate List and Annex XIV Authorisation

Substances meeting Article 57 criteria (CMR 1A/1B, PBT, vPvB, endocrine disruptors, equivalent concern) are added to the Candidate List, triggering Article 33 communication duties down the supply chain at >0.1% w/w in articles and SCIP database notification. ECHA may then recommend Candidate List substances for inclusion in Annex XIV (the Authorisation List), at which point the substance cannot be used after the sunset date without an Authorisation granted by the Commission for a specific use and applicant.

Annex XVII Restriction and the supply-chain bite

Annex XVII lists substances and mixtures with use restrictions or outright bans — recent additions include PFAS subgroups (PFOA, PFHxS, C9–C14 PFCAs), microplastics, lead in PVC, and bisphenols. Unlike Authorisation, Restriction applies regardless of registrant — anyone placing the substance/mixture on the EU market in scope of the restriction is bound. The 2023–2025 PFAS universal restriction proposal under consultation would, if adopted as drafted, be the broadest restriction in REACH history.

The Only Representative route for non-EU manufacturers

A non-EU manufacturer cannot register directly; either each EU importer registers (impractical when you ship to many), or the non-EU manufacturer appoints an EU-established Only Representative under Article 8. The OR holds the registration on behalf of the non-EU manufacturer and covers all EU importers who become 'downstream users' relieved of registration duty. Choosing the OR is consequential — they hold the dossier, manage co-registrant interactions and carry liability for the data.

A 60-day readiness path

Days 1–10: substance inventory by EU legal entity, with tonnage reconciliation across the last three years. Days 11–25: registration-status audit — every substance ≥1 t/y has either an active registration, a covered OR, an exemption (PPORD, on-site intermediate) or a stop-shipping decision. Days 26–40: Candidate List + Annex XIV review against the inventory, with Article 33 communication and SCIP notifications verified. Days 41–55: Annex XVII review with a special pass on PFAS, bisphenols and microplastics. Days 56–60: data-gap analysis against the next tonnage band for any substance approaching threshold.

Standards covered in this guide

Each standard, retailer code or assurance scheme referenced above has its own deep-dive page with scope, audit detail and common pitfalls.

Where this lives in V5 Ultimate

The clauses above aren't theoretical — every one maps to a shipped module and an industry profile. Jump to the parts of the product that turn this guide into evidence on a Monday morning.

Modules that do the work

REACH dossier control

Annex VII–X data linked to substance master.

SVHC / Annex XVII watch

Candidate List + Restriction monitoring.

Only Representative scope

OR coverage, importers and dossier ownership.

Industries this hits hardest

Specialty & Industrial Chemicals

Frequently asked

Is REACH the same as RoHS?

No. REACH (1907/2006) is a substance-level horizontal regulation; RoHS (2011/65/EU) is an article-level restriction on specific hazardous substances in electrical and electronic equipment. RoHS substances (lead, cadmium, mercury, Cr VI, PBBs, PBDEs, phthalates) overlap with REACH Annex XVII but the legal mechanisms differ.

Do polymers need to be registered?

Currently no — polymers are exempt from REACH registration under Article 2(9), though their monomers and other non-polymer constituents above 2% must be registered. The Commission has long signalled a 'Polymer Requiring Registration' (PRR) framework is coming; manufacturers should monitor proposals and prepare polymer-identity data.

What's the difference between on-site intermediate and isolated intermediate registration?

Both are 'intermediate' under Article 3(15) — substances used in chemical synthesis and consumed in production. On-site isolated intermediates (Article 17) and transported isolated intermediates (Article 18) have reduced data requirements compared to standard registration, provided strictly controlled conditions are met and documented.

How does UK REACH differ?

UK REACH (post-Brexit) mirrors EU REACH structurally but is administered by HSE in Great Britain. UK and EU registrations are now separate dossiers; a substance covered by an EU REACH registration must be re-registered into UK REACH on its own timetable (currently phased through 2030 under the Alternative Transitional Registration Model).

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