REACH Substance Registration: Tonnage Bands, Data Requirements, and What Each Level Costs to Achieve

REACH organizes its registration requirements around tonnage — the annual volume of a substance manufactured in the EU or imported into the EU. The higher the tonnage, the more scientific data ECHA requires before the registration is accepted. For non-EU manufacturers preparing to register a substance for the first time, understanding which tonnage band applies is the first step toward estimating what data is needed, how long registration will take, and whether existing data from other markets or safety studies can satisfy the requirements or whether new study generation is unavoidable.

The four REACH tonnage bands

The registration threshold is one tonne per year. Substances manufactured or imported below that threshold are exempt from registration. Above one tonne per year, four bands apply. The 1–10 tonne band requires a minimum data set covering physicochemical properties, basic mammalian toxicology (acute toxicity, skin and eye irritation, sensitization, mutagenicity), and basic aquatic ecotoxicology. The 10–100 tonne band requires expanded physicochemical data, additional mammalian toxicology studies (28-day repeat-dose, reproductive toxicity screening), extended ecotoxicology, and a Chemical Safety Report (CSR). The 100–1,000 tonne band adds sub-chronic toxicity (90-day repeat-dose), reproductive toxicity testing, and extended environmental fate studies. Above 1,000 tonnes per year, the data package includes long-term studies, carcinogenicity, two-generation reproductive toxicity, and comprehensive lifecycle assessment — a scientific program that can take years and cost several million euros to complete.

Using existing data to satisfy registration requirements

REACH allows registrants to satisfy data requirements through existing data — studies already conducted by the manufacturer, publicly available literature, or data shared through the joint registration system — rather than generating new studies. At the 1–10 tonne band, existing data and weight-of-evidence assessments often satisfy the minimum requirements. At higher tonnage bands, the required studies are more specific and the opportunities to rely on existing data without additional generation narrow significantly. The key tool for avoiding unnecessary new studies is the read-across approach: demonstrating that a substance is structurally and toxicologically similar to another substance with an existing complete data set. ECHA reviews read-across justifications rigorously, and inadequate justifications result in compliance check failures that require new study generation.

Joint submission and the SIEF structure

REACH requires joint submission in most cases. All manufacturers and importers of the same substance must form a Substance Information Exchange Forum (SIEF) and submit a joint registration dossier led by a lead registrant. The lead registrant holds the data package and grants access to co-registrants who pay a data access fee. For a non-EU manufacturer joining an existing SIEF through an Only Representative, the data access fee — not new study generation — is typically the primary cost. For a substance with no prior EU registrants, the first registrant becomes the lead by default and must generate all required data from scratch. Identifying whether existing SIEFs exist for a substance, and whether existing data within those SIEFs covers the volumes being supplied, is the most important early step in any REACH registration project.

How FDABridge handles REACH substance registration

FDABridge manages the full REACH registration process for non-EU manufacturers — from Only Representative appointment through SIEF participation, data gap analysis, dossier preparation, and ECHA submission. We identify which tonnage band applies, assess what data is already available versus what needs to be generated, and manage the joint submission process with existing SIEF members. Visit fdabridge.com/reach-registration for our REACH services or fdabridge.com/contact to discuss your substance registration needs.