Division 4.3.2 Safety Evaluation of the Cosmetic Product

The safety evaluation of the cosmetic product covers three main aspects:

1. (1)

   summary of the risk assessment based on the local and systemic effects of all individual substances/mixtures^f1;

2. (2)

   additional assessment of the safety of the formulated product, which cannot be assessed by assessing the substances/mixtures separately. This could for instance be the formulation’s skin compatibility, assessment of possible combination effects, such as one ingredient that can increase the absorption rate of another ingredient, possible effects that could arise from interaction with packaging material, or possible effects due to chemical reactions between the individual substances/mixtures in the formulated product^f2;

3. (3)

   other factors that influence the safety assessment, such as stability, microbiological quality, packaging, and labelling, including use instructions and precautions for use.

The specific assessment for cosmetic products intended for use on children under the age of three which is required in accordance with Regulation (EC) No 1223/2009 should take into account the specific recommendations in the SCCS Notes of Guidance^f3.

In the specific assessment required in accordance with Regulation (EC) No 1223/2009 for cosmetic products intended exclusively for use in external intimate hygiene, the particular characteristics of the application site also are to be taken into account.

The safety assessor may accept, reject, or accept under specific conditions the formulation under consideration. A product that does not comply with Regulation (EC) No 1223/2009 is to be rejected and is not be marketed. Recommendations by the safety assessor regarding the safe use of the product should be followed.

In order to ensure that the cosmetic product safety report is kept up to date as required by Article 10(1)(c) of Regulation (EC) No 1223/2009, the safety of the finished product should be reassessed regularly.

When changes in the legal requirements occur (e.g. restrictions of one of the substances included in the formulation), it should be checked, amongst others (e.g. labelling), whether the formulation still complies with the law, and the safety assessment should be reviewed and, if necessary, updated.

The safety assessment should also be reviewed and, if necessary, updated, where one or more of the following circumstances apply:

1. (a)

   new scientific findings and toxicological data on the substances are available which could modify the result of the existing safety assessment;

2. (b)

   changes occurring in the formulation or specifications of raw materials;

3. (c)

   changes occurring in the conditions of use;

4. (d)

   a rising trend in terms of the nature, severity and frequency of undesirable effects, both under reasonably foreseeable conditions of use and in the case of misuse^f4.

Structures and processes should be established to ensure that the information relevant for the update of the cosmetic product safety report is efficiently exchanged between the responsible person and the safety assessor, and that the safety assessor is in a position to intervene where an update is necessary.