EU REACH: Tonnage Band Changes Will Be Considered by ECHA in Dossier Evaluation Process

Companies that downgrade the tonnage band in their registrations after ECHA has communicated the draft decision to them will need to prove the volume of their substance.

On July 27, 2022, European Chemical Agency (ECHA) published a notice that under EU REACH, the Agency may now take changes to registrants’ tonnage band information into account until the date an adopted dossier evaluation decision has been communicated to such registrants. This change follows a decision by the Board of Appeal. Tonnage band information is needed to determine the information requirements that companies must fulfil.

Data Needed in Tonnage Band Downgrade Under EU REACH

If registrants wish ECHA to consider a tonnage band downgrade in the decision-making process after receipt of a draft evaluation decision, registrants need to inform ECHA of this update. Registrants also need to provide data demonstrating that the volume of the substance that has been imported and/or manufactured over the preceding calendar year is at the lower tonnage band and provide documentary evidence supporting this data.

ECHA will take the elements available into account to determine whether the change of tonnage band has been substantiated and whether there is a need to amend the draft decision accordingly.

Once the adopted dossier evaluation decision has been communicated to registrants, registrants must fulfil all information requirements as outlined in the decision, regardless of any tonnage band change or cease of manufacture that may occur afterwards.

More information and instructions are available in the updated practical guide: How to Act in Dossier Evaluation-ECHA.

Reprinted from: ECHA

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