UK-REACH alternative transitional registration model (ATRm)
Public consultation on proposals being put forward by the Department for Environment, Food & Rural Affairs on an alternative transitional registration model (ATRm) was open until July 25, 2024.
The proposals offer an alternative approach to risk management of chemicals in Great Britain (GB) without the need to rely on submitting hazard information already available under EU-REACH or the need to repeat studies to comply with the full information requirements (i.e., study data).
Instead, greater reliance will be placed on detailed use and exposure information, an area considered weak under EU-REACH.
Registrants will need to provide classification and labeling of EU-REACH registered substances, PBT assessment and PNEC/s DNELs along with use and exposure information. If registrants conclude the hazard assessment for UK-REACH registered substances is different than the same substance registered under EU-REACH, then justification (e.g., study summaries) may be needed.
There are three different levels of use and exposure information that align with the volume of substance being placed on the GB market and the hazard class.
- Level 1: Use and exposure information for human health (equivalent to current 1 to 10tpa, Annex VI of UK-REACH)
- Level 2: Use and exposure information for HH and ENV (baseline for ENV use and exposure data).
Applies to: Environmental use and exposure data
Human health use and exposure data at >10tpa
Human health use and exposure data at >1tpa if meets health hazard criteria in art 14(4) triggering exposure and risk element of the Chemical Safety Assessment (CSA) - Level 3: Below 10tpa and for substances toxic to human health, Annex 13 section 1.1.3 points (b) and (c), and all categories of respiratory and skin sensitizers
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