Regulation (EU) 2024/590 on substances that deplete the ozone layer entered into force on 11 March 2024. The rules governing the placing on the market and use of ozone-depleting substances (ODSs) for essential laboratory and analytical uses have now changed.
Under the new regulation, standards shipped to a location within the European Union no longer need to be registered in the labODS registry.
There is no change to the procedure for shipments outside the European Union.
The reference standards of the European Directorate for the Quality of Medicines & HealthCare (EDQM) affected by this change are:
Class 1 residual solvent solution CRS |
|
Trichlorotrifluoroethane CRS |
Important notes:
In all cases, these reference standards supplied by the EDQM must be used exclusively for essential laboratory and analytical uses (i.e. for analytical uses in conjunction with the texts published in the European Pharmacopoeia).
We would also like to draw your attention to the obligations of users affected by this change that are described under Article 8(4) of this regulation.