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Substance Identification

D. How to report the manufacturing process description for a UVCB substance

Do I need to give a description of the manufacturing process for the identification of my UVCB substance, and, if yes, to what level of detail?

Yes. The manufacturing process description is one of the identifiers for UVCB substances. The information should be included in the "Description" field of IUCLID Section 1.2. The description generally consists of the following:

  • Identity and ratio of starting materials;
  • Description of the relevant manufacturing steps in the order they occur;
  • The relevant operating parameters applied to control the composition (e.g. temperature, pressure, solvent, catalysis type…);
  • Details on any extraction/isolation/purification step.

In addition, you can also report the reaction schemes or process workflows to complement the description of the manufacturing process as an attachment under the "Attached description" heading of IUCLID Section 1.2.

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