If you manufacture or import a chemical substance into the EU at one tonne per year or more, REACH registration is the legal gate you have to pass before placing that substance on the market. The process is built around a single principle — no data, no market — and it covers four tonnage bands, two submission types, mandatory data sharing, and a fee schedule that the European Commission raised by 19.5% on 5 November 2025. The total time from first inquiry to a valid registration number typically runs 3–6 months for joint submission members and considerably longer for lead registrants developing a new dossier.
This guide walks through every step of the procedure under Regulation (EC) No 1907/2006 as it operates in 2026: deciding your role, submitting an inquiry, joining the joint submission, building the IUCLID dossier, navigating the new ex-ante SME verification introduced by Implementing Regulation (EU) 2025/2067, paying ECHA fees, and maintaining the registration after the number is issued. It is written for EHS managers, regulatory affairs specialists, and SME compliance officers preparing their first registration or auditing an existing one.
At a glance
- Legal basis: Regulation (EC) No 1907/2006, Articles 6, 7, 8, 10, 11, 22, 26 — the REACH Regulation
- Trigger: manufacture or import of a substance at ≥ 1 t/y per legal entity into the EU/EEA
- Submission tool: IUCLID 6 dossier delivered via REACH-IT (or ECHA Cloud Services)
- Standard fees (since 5 Nov 2025): EUR 1,558 (joint, 1–10 t/y) to EUR 40,270 (individual, > 1,000 t/y) under Implementing Regulation (EU) 2025/2067
- SME reductions: up to 95% off standard fees; ex-ante verification mandatory from 5 February 2027
- Non-EU manufacturers: must appoint an EU-based Only Representative under Article 8
- Outcome: a registration number that allows lawful placing on the EU market and triggers ongoing update obligations under Article 22
What REACH registration actually is
REACH registration is the procedure through which a manufacturer, importer, or Only Representative tells the European Chemicals Agency (ECHA) what a substance is, in what tonnage they handle it, what its intrinsic hazards are, and how it can be used safely. The information is submitted in a structured technical dossier and, for tonnages of 10 tonnes per year or more, a Chemical Safety Report (CSR).
The Regulation rests on a single operational rule that ECHA states plainly: without data, the substance cannot be placed on the EU market. Registration is the mechanism that gathers that data and shifts the burden of proof onto industry rather than authorities. A registration is therefore not a one-time form — it is the entry into an ongoing regulatory relationship, with update obligations triggered by tonnage changes, new hazard data, changes in legal personality, classification updates aligned with the CLP Regulation, and inclusion of the substance on the SVHC Candidate List, among others.
Registration is conceptually different from authorisation and from restriction. Registration is a prerequisite that applies to virtually all substances above the 1 t/y threshold. Authorisation is a separate process under Annex XIV for a small subset of Substances of Very High Concern. Restrictions under Annex XVII are bans or conditions on specific uses of specific substances regardless of registration status.
Who needs to register
Under Article 6, any natural or legal person established in the EU/EEA who manufactures or imports a substance on its own, in a mixture, or in an article intended to release that substance at ≥ 1 t/y must register it. Under Article 7, certain article producers and importers have additional registration or notification duties. Companies established outside the EU cannot register directly — they must appoint an EU-based Only Representative under Article 8 (covered in the dedicated section below).
A few common situations sit outside the scope:
- Polymers as such are exempt from registration under Article 2(9), though their monomers and additives are not.
- Substances in scientific research and development below 1 t/y can use PPORD notification (Article 9) for up to five years rather than full registration.
- Non-isolated intermediates and certain transported isolated intermediates benefit from reduced data requirements under Articles 17 and 18.
- Substances already registered by another legal entity in the same supply chain may not require a new registration from a downstream user, provided that user’s role does not exceed the use covered.
If you import a mixture, you aggregate the imported volume of each contained substance across all your supply lines before applying the 1 t/y threshold. If you import an article that intentionally releases a substance (a printer cartridge, a scented candle, an ink ribbon) in quantities > 1 t/y per importer per year, that substance must be registered for that use.
Step 1 — Decide your role and tonnage band
Before any technical work begins, you need clarity on two things: which REACH role you are playing, and which tonnage band your annual EU volume falls into.
The four tonnage bands defined by REACH determine both the data you must generate and the fee you will pay:
| Tonnage band | Annexes triggered | CSR required? |
|---|---|---|
| 1 to 10 tonnes/year | Annex VII | No |
| 10 to 100 tonnes/year | Annex VII + VIII | Yes |
| 100 to 1,000 tonnes/year | Annex VII + VIII + IX | Yes |
| Above 1,000 tonnes/year | Annex VII + VIII + IX + X | Yes |
Tonnage is calculated per calendar year (1 January – 31 December) and per legal entity. If your volume reaches the lower limit of a band, that becomes your registration band — there is no rounding down. Volumes manufactured or imported as isolated intermediates under strictly controlled conditions are counted separately and registered under Articles 17 or 18 with reduced information requirements.
If your role is downstream user (you receive a substance further down the supply chain and use it), you do not register, but you may need to communicate uses upstream so they are covered in the lead registrant’s exposure scenarios. Confirming this distinction up front saves time: many companies discover months into a registration project that their actual role was downstream user, in which case the registration was never theirs to file.
Step 2 — Submit the inquiry under Article 26
Before preparing a registration dossier, the potential registrant must inquire with ECHA whether the substance has been registered before and, if so, who the previous and prospective registrants are. The pre-registration mechanism that operated between 2008 and 2018 is closed; all new registrations now go through the Article 26 inquiry process.
The inquiry dossier is prepared in IUCLID 6 and submitted via REACH-IT. It contains:
- substance identity (CAS, EC number, IUPAC name, composition, spectral and analytical data)
- the registrant’s identity and intended tonnage band
- a list of information requirements where new vertebrate animal testing might be needed
ECHA processes the inquiry, performs a substance sameness check, and returns the contact details of co-registrants and the joint submission name if one already exists. From here, the path forks: if a joint submission already exists, you negotiate access; if it does not, and you are the only intending registrant, you will become the lead registrant of a new joint submission.
A typical inquiry takes a few weeks to resolve. Practically, this is also when you start building the substance information needed for the technical dossier — physico-chemical properties, hazard data, intended uses — even though you do not yet have access to the joint registration data.
Step 3 — Join the joint submission (One Substance, One Registration)
REACH operates on the One Substance, One Registration (OSOR) principle codified in Article 11: all manufacturers, importers, and Only Representatives of the same substance must submit their registration jointly. The joint submission consists of one lead registrant who submits the common part of the dossier on behalf of the group, plus member registrants who refer to the joint data and submit only their company-specific information.
Member registrants pay the lead registrant a Letter of Access (LoA) fee in exchange for the right to refer to the joint dossier. LoA prices vary widely by substance and consortium; ranges from a few thousand euros for low-tonnage, low-hazard substances to tens of thousands for substances with extensive datasets are common. The lead registrant is required by Implementing Regulation (EU) 2016/9 to share data on a fair, transparent, and non-discriminatory (FAIR) basis, and disputes over LoA pricing can be escalated to ECHA as a last resort.
Two practical complications:
- Opt-out: under Article 11(3), a registrant can submit part or all of the data separately if the joint data is unsuitable, disproportionately expensive, or commercially sensitive. The opt-out must be justified in the dossier and ECHA performs an extra completeness check on it. Without a valid justification, the dossier fails technical completeness.
- Joint submission types: a substance can have a “full” joint submission, an “intermediate” joint submission, or both. The same substance cannot have two competing full joint submissions — that is a breach of the joint submission obligation that ECHA actively enforces.
The lead registrant’s role is operational rather than purely administrative: collecting and evaluating data, deciding on testing proposals, preparing the CSR for substances ≥ 10 t/y, and managing communications with the consortium and ECHA. For a complex high-tonnage substance, leading a joint submission is a multi-year project costing six or seven figures in data, testing, and consultancy.
Step 4 — Build the IUCLID dossier
The registration dossier has two parts: a technical dossier (mandatory for all registrations) and a Chemical Safety Report (mandatory at ≥ 10 t/y). Both are assembled in IUCLID 6 — either the locally installed version or the cloud version offered free through ECHA Cloud Services.
The technical dossier must cover the standard information requirements set out in Annexes VII–X to REACH, accumulated by tonnage band:
- Annex VII (≥ 1 t/y): basic physico-chemical properties, in-vitro toxicology and genotoxicity screening, acute toxicity, irritation and sensitisation, short-term aquatic toxicity, biodegradation
- Annex VIII (≥ 10 t/y): adds 28-day repeated-dose toxicity, reproductive/developmental screening, additional ecotoxicity endpoints
- Annex IX (≥ 100 t/y): adds 90-day repeated-dose, long-term aquatic toxicity, bioaccumulation, extended one-generation reproductive toxicity, terrestrial toxicity
- Annex X (≥ 1,000 t/y): adds reproductive and developmental toxicity on a second species, carcinogenicity studies, long-term terrestrial testing
The columns of each Annex specify both the standard requirement (Column 1) and the conditions for adaptation (Column 2). Adaptations using read-across, weight-of-evidence, QSAR, or grouping under Annex XI are explicitly permitted and encouraged to minimise vertebrate animal testing — but every adaptation requires a robust scientific justification documented in the dossier.
The CSR documents the chemical safety assessment: hazard assessment, PBT/vPvB assessment, exposure assessment under identified uses, and risk characterisation. The exposure scenarios produced in the CSR are then annexed to the safety data sheet for substances classified as hazardous, creating the document chain that ultimately reaches downstream users.
Use the IUCLID Validation Assistant plug-in before final dossier creation. Many submission failures at completeness check are technical — missing fields, inconsistent units, or unfilled mandatory sections — and the Validation Assistant catches them locally.
Step 5 — Apply for SME status before submission
If your company qualifies as a micro, small, or medium-sized enterprise under Commission Recommendation 2003/361/EC, you are entitled to up to 95% reduction on ECHA fees. This is the single largest cost lever in the entire registration project — for a micro enterprise filing a joint registration in the 1–10 t/y band, the ECHA fee drops from EUR 1,558 to EUR 65.
Important procedural change under Implementing Regulation (EU) 2025/2067: the SME verification process is moving from ex-post to ex-ante with effect from 5 February 2027. Until that date, the legacy system continues: registrants self-declare SME status at submission and ECHA verifies afterwards. From 5 February 2027 onwards, SMEs must apply for and obtain SME recognition from ECHA at least two months before any fee-bearing submission. Once granted, the SME decision is valid for three years and covers all submissions under REACH and other ECHA-administered legislation during that period.
Practical implication for the 2026 transition window: companies planning their first registration in 2026 can still use the self-declaration mechanism, but should build the SME application into the project timeline if the submission is expected in early 2027 or later. ECHA may charge an administrative fee for SME applications, but waives it when SME status is confirmed.
If the registrant is not an SME — or if the SME application is rejected — standard fees apply, and these were raised by 19.5% across all tonnage bands on 5 November 2025 in line with cumulative Eurostat inflation for 2021–2023.
Step 6 — Submit through REACH-IT and pay the ECHA fee
The lead registrant submits first. Once their dossier passes the business rules verification in REACH-IT, member registrants of the same joint submission can submit through the token issued to them. Members not relying on joint data submit as an opt-out and undergo a stricter completeness check.
Standard ECHA registration fees in force since 5 November 2025 under Implementing Regulation (EU) 2025/2067 — Annex I — are:
| Tonnage band | Individual submission | Joint submission |
|---|---|---|
| 1 to 10 tonnes/year | EUR 2,078 | EUR 1,558 |
| 10 to 100 tonnes/year | EUR 5,585 | EUR 4,190 |
| 100 to 1,000 tonnes/year | EUR 14,939 | EUR 11,204 |
| Above 1,000 tonnes/year | EUR 40,270 | EUR 30,202 |
Reduced fees for SMEs in joint submission, same Annex I:
| Tonnage band | Medium enterprise | Small enterprise | Micro enterprise |
|---|---|---|---|
| 1 to 10 tonnes/year | EUR 848 | EUR 457 | EUR 65 |
| 10 to 100 tonnes/year | EUR 2,279 | EUR 1,227 | EUR 175 |
| 100 to 1,000 tonnes/year | EUR 6,094 | EUR 3,282 | EUR 469 |
| Above 1,000 tonnes/year | EUR 16,428 | EUR 8,846 | EUR 1,264 |
These are the administrative fees only — payable per substance, per legal entity. They sit on top of data fees (LoA, consortium membership), testing fees where new studies are required, and any consultancy or Only Representative fees. ECHA invoices on submission and the fee must be paid for the completeness check to clear financially.
After payment, ECHA performs a completeness check — automated business rules plus manual verification of select elements — within three weeks. If the dossier passes, ECHA issues a registration number. If it fails, ECHA returns it with deficiencies to address within a deadline.
Step 7 — Receive the registration number and maintain the dossier
The registration number is issued in the format 01-XXXXXXXXXX-XX-XXXX and is the proof that the substance can be lawfully placed on the EU market in the registered tonnage band. The number is also published in ECHA’s disseminated registration database along with non-confidential parts of the dossier — IUPAC name, classification, hazard pictograms, key study summaries.
Registration is a living obligation. Under Article 22, registrants must update their dossier without undue delay when:
- they increase or decrease the registered tonnage band
- new information on intrinsic properties becomes available to them
- the substance composition changes (impurities, additives, percentages outside the registered ranges)
- classification under CLP changes
- their use of the substance changes in a way affecting exposure scenarios
- the substance is identified as an SVHC and added to the Candidate List
- their company information changes (legal personality, address, contact details)
Tonnage band increases trigger a specific update fee — for example, moving a joint registration from 1–10 t/y to 10–100 t/y costs EUR 2,630 (or proportional SME reductions). Failure to keep the dossier current is the most common REACH enforcement finding in Member State inspections.
Special case — non-EU manufacturers via Only Representative (Article 8)
A company established outside the EU cannot register a substance directly. Article 8 of REACH solves this by allowing the non-EU manufacturer to appoint an Only Representative (OR) — a natural or legal person physically established in the EU/EEA with sufficient knowledge in the practical handling of substances. The OR takes on all the obligations of an EU importer for that substance, and the actual EU importers are then treated as downstream users rather than registrants.
The OR appointment is documented in a power of attorney between the non-EU manufacturer and the EU-based OR. The OR creates a separate REACH-IT account per non-EU principal, maintains an up-to-date list of EU importers covered, holds the records of imported quantities, and supplies the latest safety data sheet down the chain.
A non-EU manufacturer is free to change their OR; the legal transfer happens in REACH-IT with the agreement of the outgoing OR, the new OR, and the principal. For practical purposes, choosing the OR is a strategic decision — they hold the registration number on the principal’s behalf, and a poor OR creates compliance risk that the principal cannot directly mitigate.
For a non-EU manufacturer exporting to the EU at low volumes (< 1 t/y), no registration is needed and no OR is strictly required — but appointing one anyway is often advised, because it (1) means the supplier rather than the EU importer holds the relationship with ECHA and (2) allows the supplier to maintain market access independent of any single importer.
Timeline and total cost
For a member of an existing joint submission in a low-to-medium tonnage band, the realistic project duration is 3–6 months: a few weeks for the inquiry, 4–8 weeks for LoA negotiation and SIEF entry, and 4–6 weeks for the IUCLID member dossier preparation and completeness check.
For a lead registrant building a new joint submission from scratch in a high tonnage band, the timeline stretches to 18–36 months or longer: extensive testing campaigns, data evaluation, CSR preparation, exposure scenario development, and consortium coordination dominate the schedule.
Total registration cost has four components:
- ECHA administrative fee — fixed and predictable; see the tables above
- Data fees (LoA or consortium membership) — tonnage-dependent, substance-specific, ranging from EUR 2,500–25,000+ per substance for typical industrial chemicals; commercial in nature
- Testing fees — only if data gaps cannot be filled by adaptations; can run from a few thousand euros for simple endpoints to several hundred thousand for vertebrate studies at higher tonnages
- Service fees — paid to consultancies, ORs, or in-house specialists for IUCLID dossier preparation and submission management
A useful planning rule for budgeting: ECHA fee is typically the smallest line item. Data fees usually dominate for member registrants; testing fees dominate for lead registrants in higher tonnage bands.
Common pitfalls
- Filing as an opt-out without robust justification — ECHA’s stricter completeness check on opt-outs often rejects them, forcing the registrant to rejoin the joint submission and pay the LoA anyway
- Aggregating tonnage incorrectly — volumes across multiple EU importers under the same non-EU principal must be summed, and missing a tonnage band threshold by under-declaring is treated as non-compliance
- Treating Article 22 as optional — outdated dossiers (especially after CLP classification changes or SVHC inclusions) are the most cited deficiency in REACH-EN-FORCE inspection projects
- Missing the new SME ex-ante deadline — from February 2027, an SME submission without prior SME recognition pays the full standard fee
- Confusing pre-registration with inquiry — pre-registration was a one-time mechanism that closed in 2008 and is no longer available; new registrants must use the Article 26 inquiry process
Frequently asked questions
What is REACH registration? REACH registration is the procedure under Articles 6, 10, and 11 of Regulation (EC) No 1907/2006 through which manufacturers, importers, and Only Representatives submit a technical dossier and (for ≥ 10 t/y) a Chemical Safety Report to ECHA in order to lawfully place a chemical substance on the EU market at one tonne per year or more.
Who needs to register under REACH? Any manufacturer or importer established in the EU/EEA placing a substance on the EU market at ≥ 1 t/y, plus EU-based Only Representatives appointed by non-EU manufacturers. Downstream users do not register but have separate communication obligations.
How much does REACH registration cost? The ECHA administrative fee starts at EUR 1,558 for a joint submission in the 1–10 t/y band and rises to EUR 40,270 for an individual submission above 1,000 t/y. Total project cost — including data fees, testing, and consultancy — is typically several multiples of the ECHA fee.
What is a REACH registration number?
A unique identifier in the format 01-XXXXXXXXXX-XX-XXXX issued by ECHA after a successful completeness check. It demonstrates lawful placing on the EU market for the registered tonnage band and uses.
What are the REACH registration deadlines? The phase-in deadlines (2010, 2013, 2018) for legacy substances have closed. Today, registration must occur before the substance is manufactured or imported above the 1 t/y threshold — there is no general grace period for new registrations.
What is the difference between lead registrant and member registrant? The lead registrant submits the common part of the joint dossier on behalf of all co-registrants, including hazard data and (where required) the CSR. Member registrants reference the lead’s dossier via a Letter of Access and submit only their own company-specific information.
Do non-EU companies need a REACH Only Representative? A non-EU manufacturer cannot register directly. They appoint an EU-based Only Representative under Article 8, who fulfils all importer obligations on their behalf. This shifts the burden away from individual EU importers, who then operate as downstream users.
How long does REACH registration take? For a member of an existing joint submission: 3–6 months from inquiry to registration number. For a lead registrant of a new joint submission at higher tonnage, 18–36 months or more depending on data gaps and testing campaigns.
Related articles in this pillar
- REACH compliance — pillar overview — the broader REACH framework including evaluation, authorisation, and restriction
- SVHC Candidate List and obligations — what happens when your registered substance becomes a Substance of Very High Concern
- CLP Regulation overview — the classification system that determines what hazard information enters your REACH dossier
- Safety Data Sheets under REACH — Article 31 and Annex II requirements that follow registration
Cross-domain tools: substance-by-substance hazard data on the GHS Symbols substance database, and the Label Constructor for building CLP-compliant labels once your classification is settled.
Sources
- European Commission. Commission Implementing Regulation (EU) 2025/2067 of 15 October 2025 amending Regulation (EC) No 340/2008 on the fees and charges payable to ECHA. Official Journal of the EU, 16 October 2025. https://eur-lex.europa.eu/eli/reg_impl/2025/2067/oj
- European Parliament and Council. Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). OJ L 396, 30 December 2006. https://eur-lex.europa.eu/eli/reg/2006/1907/oj
- ECHA. Registration — process, dossier, completeness check. https://echa.europa.eu/regulations/reach/registration
- ECHA. Information requirements under REACH Annexes VII to X. https://echa.europa.eu/regulations/reach/registration/information-requirements
- ECHA. Only Representative — Article 8 of REACH. https://echa.europa.eu/support/getting-started/only-representative
- ECHA. Joint submission of data. https://echa.europa.eu/regulations/reach/registration/data-sharing/joint-submission-of-data
- ECHA. Tonnage thresholds and the one-tonne rule. https://echa.europa.eu/support/registration/your-registration-obligations/do-i-reach-the-one-tonne-a-year-threshold
- ECHA. REACH-IT — dossier submission tool. https://echa.europa.eu/support/dossier-submission-tools/reach-it
- ECHA. ECHA Cloud Services and IUCLID 6. https://echa.europa.eu/support/dossier-submission-tools/echa-cloud-services
- European Commission. Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises. OJ L 124, 20 May 2003. https://eur-lex.europa.eu/eli/reco/2003/361/oj
- European Commission. Commission Implementing Regulation (EU) 2016/9 on joint submission of data and data-sharing. OJ L 3, 6 January 2016.
- ECHA. Candidate List of Substances of Very High Concern for Authorisation, last updated 4 February 2026 (253 entries). https://echa.europa.eu/candidate-list-table