Your REACH Only Representative for non-EU substance manufacturers

REACH tonnage bands and information requirements

REACH scales the data a registrant must provide with the quantity it manufactures or imports each year. Knowing your tonnage band is the first step in estimating what a registration will involve.

Per registrant, per year Annexes VII to X Chemical safety report from 10 t/y Tonnage counted per legal entity

The four bands

Tonnes per yearStandard information requiredChemical safety report
1 - 10Annex VII (physicochemical, basic toxicological and ecotoxicological data)Not required
10 - 100Annexes VII and VIIIRequired (Article 14)
100 - 1,000Annexes VII, VIII and IX (including proposals for higher-tier tests)Required
1,000 and aboveAnnexes VII to XRequired

How tonnage is counted

Tonnage is counted per registrant and per calendar year, for the substance on its own and in mixtures. An Only Representative registers the total quantity covered by its appointment - the combined imports of the importers it represents for that non-EU manufacturer. If you sell the same substance through several EU customers, their quantities add up under your OR's registration.

Filling data gaps

Data does not always mean new testing. Registrants can use existing studies, read-across from similar substances, weight of evidence or (Q)SAR models where Annex XI allows it, and animal testing is a last resort. For tests in Annexes IX and X, registrants submit a testing proposal and wait for ECHA's decision before running the test.

Moving up a band

When your annual quantity reaches a higher band, you must inform ECHA immediately of the additional information that band requires (Article 12(2)) and update the registration within 3 months. Where new Annex VII or VIII tests are needed, a testing laboratory must be contracted within 3 months and the update follows within 3 months of the final reports (Implementing Regulation (EU) 2020/1435). Planning ahead matters, because higher-tier studies can take many months.

Frequently asked questions

What does the 1-10 tonnes per year band require?

The standard information in Annex VII. A chemical safety report is not required in this band.

When is a chemical safety report required?

From 10 tonnes per year per registrant (Article 14). It includes a chemical safety assessment and, for hazardous substances, exposure scenarios.

How does an Only Representative count tonnage?

The OR registers the total quantity imported by all EU importers it covers for that non-EU manufacturer, per calendar year.

Does every data point need a new animal test?

No. Existing data, read-across, weight of evidence and other adaptations under Annex XI can be used, and animal testing is a last resort.

Related guides

Note: This guide provides general information about Regulation (EC) No 1907/2006 (REACH), not legal advice. Specific obligations depend on your substance, tonnage and supply chain. Last reviewed 30 September 2026.

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