4.1. Conditions for submission update
Where one of the following changes applies to a mixture in an individual or group submission, submitters shall provide a submission update before placing that mixture, as changed, on the market:
addition, substitution, or deletion of one or more components in the mixture that shall be indicated in accordance with Section 3.3;
change in the concentration of a component in the mixture beyond the concentration range provided in the original submission;
the exact concentration of a component was provided in accordance with Sections 3.4.1 or 3.4.2, and a change occurs to that concentration beyond the limits identified in Table 4.
By way of derogation from the fourth indent of the first subparagraph, the following shall apply:
a submission update for mixtures with a composition conforming with any of the standard formulas specified in Part D is required only when the composition of the mixture changes in such a manner that the mixture’s composition no longer conforms with the standard formula;
for mixtures where the information on composition is provided based on the Safety Data sheet in accordance with Section 3.6 or 3.7 a submission update is required when Section 3 of the Safety Data Sheet is updated.
Table 4
Variations of the concentration of components requiring a submission update
|
Exact concentration of the component contained in the mixture (%) |
Variations (±) of the initial component concentration requiring a submission update |
|
> 25 – ≤ 100 |
5 % |
|
> 10 – ≤ 25 |
10 % |
|
> 2,5 – ≤ 10 |
20 % |
|
≤ 2,5 |
30 % |
When perfumes in a group submission change, the list of mixtures and the perfumes they contain as required in Section 3.1 shall be updated.