Division 3.2.3 Stability of the cosmetic product

As the requirement is to assess the stability of the cosmetic product under reasonably foreseeable storage conditions, if stability is dependent on storage conditions, information about these conditions should be passed on throughout the supply chain, and, if relevant for the end user, it should be indicated on the labelling of the product.

The methodology used to determine the product’s minimum durability should be described. Any specific preservation precautions should be mentioned.

All available data used to justify the indicated minimum durability should be listed in the safety report. In order to determine the coherence of the stability study conducted, and to check the relevance of the date of minimum durability chosen for the product, the description of the tests specific to the stability study and the results of those tests should be included in the cosmetic product safety report. In addition, the following should also be provided:

1. (1)

   evidence that the composition of the product used for stability testing corresponds to the product actually placed on the market;

2. (2)

   the results of the preservative efficacy study, e.g. challenge test, if applicable^f1;

3. (3)

   when applicable, the period-after-opening (PAO)^f2 and its justification.

The SCCS has recommended that ‘relevant stability tests, adapted to the type of cosmetic product and its intended use, should be carried out. To make sure that no stability problems are induced by the type of container and packaging used, physical stability tests are currently carried out with inert containers and those intended to be used on the market.’^f3