Data Submission Manual 5: How to complete a - ECHA - Europa

Data Submission Manual
Substance identifier
Each reference substance attached as a constituent, impurity or additive should at least
contain either an EC number (or a CAS number and a CAS name) or a IUPAC name.
Please note, that for the registration dossiers it is checked at the Business Rule step that
the IUPAC name has been provided.
In case of unknown impurities, you need to create a reference substance and state
in the IUPAC name field "Unknown impurities" and provide as a minimum, either
the typical concentration (with unit) or concentration range (with unit).
Molecular and structural information
Concerning the molecular and structural information, the following information must be
provided in the reference substances of IUCLID 5 section 1.2
For constituents (Figure 17):
• If you indicate "mono constituent substance" or "multi constituent substance" in
section 1.1 under "Type of substance/Composition", then the "Molecular formula",
"Molecular weight" and "Structural formula" must be provided.
• If you indicate "UVCB" in section 1.1 under "Type of substance/Composition", then
the "Molecular formula" and "Molecular weight" must be provided, or a
justification for not providing this information must be given in the "Remarks"
field.
For additives (Figure 17):
• As a minimum, the "Molecular formula", "Molecular weight" and "Structural
formula" must be provided, or a justification for not providing this information
must be given in the "Remarks" field.
For impurities (Figure 17):
• The "Molecular formula", "Molecular weight" and "Structural formula" (if available)
must be provided, or a justification for not providing this information must be
given in the "Remarks" field.
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