Division 4.1 Conditions for submission updateF1

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:

• when the mixture product identifier or the UFI has changed,

• when the mixture classification for health or physical hazards has changed,

• when relevant new toxicological information that is required in Section 11 of the Safety Data Sheet becomes available on the hazardous properties of the mixture or its components,

• if a change in the composition of the mixture fulfils one of the following conditions:

  1. (a)

     addition, substitution, or deletion of one or more components in the mixture that shall be indicated in accordance with Section 3.3;

  2. (b)

     change in the concentration of a component in the mixture beyond the concentration range provided in the original submission;

  3. (c)

     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:

1. (a)

   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;

2. (b)

   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.

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.