The four bands
Each band adds an annex of requirements to the one below it. A substance at 150 tonnes a year owes Annex VII, VIII and IX together — not Annex IX alone.
| Band | Annex | Broad requirement |
|---|---|---|
| 1–10 t/y | VII | Physicochemical properties, basic in vitro toxicology (skin and eye irritation, skin sensitisation, gene mutation in bacteria), acute aquatic toxicity and ready biodegradability. |
| 10–100 t/y | VII + VIII | Adds in vivo short-term toxicity, further genotoxicity, screening for reproductive toxicity, and a wider aquatic and degradation package. |
| 100–1,000 t/y | VII + VIII + IX | Adds sub-chronic toxicity, extended one-generation reproductive toxicity, long-term aquatic studies and soil and sediment effects. Testing proposals required for higher-tier studies. |
| 1,000+ t/y | VII–X | Adds long-term and carcinogenicity considerations, full environmental fate, and comprehensive exposure assessment. |
The 10 tonne cliff edge
At 10 tonnes a year the chemical safety report becomes mandatory. That single step converts a data-collection exercise into a full assessment: exposure scenarios for every identified use, derived no-effect levels, predicted no-effect concentrations, and risk characterisation. It is regularly the largest cost increase in the whole schedule, and it is triggered by one extra tonne.
Where the money actually goes
Companies budget for HSE fees and are then surprised by everything else. The fee is rarely the largest line.
| Cost | Nature | Controllable? |
|---|---|---|
| Data access | Letters of access or study purchase for existing data | Partly — through negotiation, and possibly through the ATRm |
| New testing | Laboratory studies where no adequate data exists | Yes — non-testing methods can lawfully replace many studies |
| Dossier preparation | IUCLID construction, robust study summaries, CSR | Yes — scope and quality are a choice |
| HSE registration fee | Statutory, scaled by tonnage band and company size | No, beyond SME reductions |
| Maintenance | Updates on tonnage change, new data, evaluation decisions | Partly |
Reducing the data requirement lawfully
UK REACH does not require you to run every study in the annex. It requires you to satisfy the information requirement. There are recognised ways to do that without new vertebrate testing, and using them is not a loophole — the regulation explicitly prefers them.
Read-across
Using data from a structurally similar substance, supported by a documented analogue or category justification.
QSAR
Validated computational models predicting a property or effect, with an adequacy assessment showing the substance falls inside the model's applicability domain.
Weight of evidence
Several independent sources that individually fall short but together give sufficient confidence.
Adaptation by exposure
Waiving a requirement because the exposure pattern makes the endpoint irrelevant — with the exposure argument evidenced.
Existing literature
Published studies, systematically searched and assessed for reliability against Klimisch criteria.
Data waivers
A documented technical justification that a specific study is scientifically unnecessary or technically impossible.
These arguments are accepted when they are properly built and rejected when they are asserted. The difference is documentation: a read-across without a defensible similarity hypothesis is a rejected dossier and a lost year, not a saving.
Crossing a band
If your volume grows into the next band, you must update the registration before you exceed it — not at the year end. Practically that means watching your rolling volume and starting the additional data work well before the threshold is reached, because the higher-tier studies take the longest.
Deliberately holding volume just under a threshold is a legitimate commercial decision, and a common one. It only works if you can evidence the volume actually placed on the market.
Annex VII–X requirements are summarised here in broad terms; the annexes themselves set the precise endpoints, column 2 adaptations and conditions. The Alternative Transitional Registration model may change transitional data requirements — see deadlines.