Back New conditions for ordering Ph. Eur. RS R0250000 – Residual solvent solution class 1 CRS

EDQM Strasbourg, France 30/11/2020
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Starting 1 January 2021, specific permits will be required to order R0250000 – Residual solvent solution class 1 CRS.

Reference standard R0250000 – Residual solvent solution class 1 CRS contains 2 controlled substances (Carbon tetrachloride and 1,1,1–Trichloroethane).

Regulation (EC) No. 1005/2009 of the European Parliament and of the European Council prohibits the use of ozone-depleting substances (ODSs) within the EU. However, exemptions from this prohibition are granted under certain conditions for laboratory and analytical uses.

Orders for delivery within the EU: under this regulation, any EU end-user laboratory or EU internal distributor must have and provide to the European Directorate for the Quality of Medicines & HealthCare (EDQM) a valid LabODS number when ordering reference standard R0250000. The EDQM cannot process any order for this product, for delivery within the EU, without a valid LabODS number.

Registration on the LabODS portal (https://webgate.ec.europa.eu/ods2/domain/labods) is necessary to obtain a LabODS number.

Orders for delivery outside the EU: the export and import of ODSs are subject to licensing requirements. Licences are granted by the European Commission by means of the ODS Licensing System at the following address: https://ec.europa.eu/clima/policies/ozone/ods_en.

When receiving an order for reference standard R0250000, the EDQM will systematically request an export licence. In addition, it is essential that users check the legal status of the substances contained in this reference standard in their respective country and undertake any formalities required by their own authorities.

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