A Substance is defined by its composition. The composition of a Substance can consist of constituents, impurities and additives. This section is a repeatable block section. It enables to enter multiple compositions for a Substance, e.g. to allow different profiles of impurities provided it does not change the identification of the Substance. For detailed instructions on how to define the substance composition in IUCLID, see chapter D.4.1 Substance (create and update substance related information)
Substance composition
Click the green Plus button
to open the repeatable block. If more than one
Substance composition has to be specified, add a new block for each
composition.
Name: The name field gives the possibility to make
the distinction between the different compositions, in case there is more
than one. Select a name representative of the composition (e.g. degree of
purity). If there is only one composition, the name of the substance can be
filled in this field.
Brief description: Enter a brief description f the
substance if appropriate.
Degree of purity
Set the confidentiality flag and regulatory purpose.
Indicate the degree of purity (or the appropriate range); give the typical percentage purity with the upper and lower limit for typical commercial batches of the substances.
Note
For REACH purposes specifying only the degree of purity in not sufficient. The composition of the substance has to be fully described.
Constituents
This part is a repeatable block subsection
enabling to provide detail on all constituents of the substance.
Click the green Plus button
to open the repeatable block. If more than one
constituent has to be specified, add a new block for each
constituent.
Set the confidentiality flag and regulatory purpose. For a description of these flags see chapter D.4.5.7 Flags used for filtering data.
Reference substance: Specify the Reference
substance for fully identifying the constituent under consideration. This is
done by creating a link with the desired Reference substance element stored
in the Reference substance inventory. Click the Link
button 
. If the constituent is not present in your database, click the
New button and proceed as described in
chapter D.11.3 Feature "Reference substance - New": How
to create a Reference substance.
Proportion (typical): Give the typical purity
percentage of the Substance. If the Substance is a multi-constituent
substance, give the typical percentage purity with upper and lower limits
for each of the main constituents.
Proportion (real): Give the percentage of the
component(s) with the upper and lower limit.
Remarks: If necessary provide any additional
comments.
Impurities
This part is a repeatable block
subsection enabling to provide detail on all impurities of the
substance. Click the green Plus button
to open the repeatable block. If more than one
impurity has to be specified, add a new block for each one.
Set the confidentiality flag and regulatory purpose. For a description of these flags see chapter D.4.5.7 Flags used for filtering data.
Reference substance: Specify the Reference
substance for fully identifying the impurity under consideration. This is
done by creating a link with the desired Reference substance element stored
in the Reference substance inventory. Click the Link button . If the impurity is not
present in your database, click the New
button and proceed as described in chapter D.11.3
Feature "Reference substance - New": How to create a Reference
substance.
Proportion (typical): Give the typical purity
percentage of the impurity.
Proportion (real): Give the percentage of the
impurity, with the upper and lower limit.
Remarks: If necessary provide any additional comment.
Additives
This part is a repeatable block
subsection enabling to provide detail on all additives of the
substance. Click the green Plus button
to open the repeatable block. If more than one
additive has to be specified, add a new block for each one.
Note
Additives in the REACH regulation are stabilising agents, necessary to preserve the substance stability. Thus, additives are an essential constituent of the substance and are taken into account, when making the mass balance.
Outside the definition of REACH the term "additive" is used for intentionally added substances with other functions, e.g. pH-regulators or coloring agents. These intentionally added substances are not part of the substance as such, and for REACH they are not taken into account, when making the mass balance. Preparations, as defined in REACH, are intentional mixtures of substances and are consequently not to be considered as multi-constituent substances.
Set the confidentiality flag and regulatory purpose. For a description of these flags see chapter D.4.5.7 Flags used for filtering data.
Reference substance: Specify the Reference
substance for fully identifying the additive under consideration. This is
done by creating a link with the desired Reference substance element stored
in the Reference substance inventory. Click the Link button . If the additive is not
present in your database, click the New
button and proceed as described in chapter D.11.3
Feature "Reference substance - New": How to create a Reference
substance.
Proportion (typical): Give the typical purity
percentage of the additive.
Proportion (real): Give the percentage of the
impurity, with the upper and lower limit.
Remarks: If necessary provide any additional
comments.