Cosmetic Product Safety Dossier - The toxic potential of a cosmetic product depends fundamentally on its composition, i.e. on the toxicological profile characteristic of each of the substances or mixtures of which it is composed. And, obviously, of the quantity present of each of them.
When carrying out the assessment of the safety documentation of a cosmetic product, the composition is based on the composition indicated in Annex I, Part A, Section 1. Directly or indirectly, the information in the other sections is conditional on this section.
That is why, strictly speaking, any change in composition should be considered as another cosmetic product. The extent of the changes will give a measure of the complexity of the new assessment. In any case, all change in composition, however small, requires the an evaluator's analysis. I will be in charge of measuring the impact of the changes introduced on the safety of use of the cosmetic product.
More information on the Security Dossier
In its Article 2, the Regulation 1223/2009 on cosmetic products defines «cosmetic product» as: «any substance or mixture intended to be placed in contact with the superficial parts of the human body (epidermis, hair and capillary system, nails, lips and external genital organs) or with the teeth and oral mucous membranes, for the sole or principal purpose of cleansing, perfuming, modifying their appearance, protecting, maintaining them in good condition or correcting body odours”.
Therefore, we can consider that a cosmetic product is defined by its composition (substance or mixture), by the place of application and for its function. Of these three parameters, the Composition is the main determinant of the safety profile. of a cosmetic.
When considering the development of a cosmetic product, the starting point is the function for which it is intended. For example, it could be a nourishing cream for the eye contour, a deodorant for the feet, a toothpaste, etc. This function will determine the reasonably foreseeable conditions of use and exposure, the place of application, the area of the surface applied, the amount of product applied or the duration and frequency of use. These parameters alone do not determine the safety of a cosmetic product.
On the one hand, in order for a cosmetic product to perform a specific function, we must establish a composition that is not only effective but also safe. On the other hand, to establish this composition we have a large number of substances and mixtures that we can use. In most cases, in quite wide concentration ranges. Thus, we can state that the product safety The cosmetic depends primarily on:
- on toxicological profile of its components
- the present quantity of each of them.
The safety of cosmetic products in the Regulation
In the first of the 10 sections constituting the required cosmetic product safety information (Part A of Annex I), the «Quantitative and qualitative composition of the cosmetic product» is requested.
The composition will condition:
- the «physico-chemical characteristics and stability of the cosmetic product» (paragraph 2)
- microbiological quality (paragraph 3)
- the conditions of normal and reasonably foreseeable use (paragraph 5)
- that of exposure (paragraph 6).
In addition, they allow the risk profile of the cosmetic product to be established:
- data on exposure to these substances (point 7)
- their toxicological profile (point 8)
The importance of the composition in the safety of a cosmetic product
Composition is the basis on which the safety of a cosmetic product is assessed. Therefore, any change in composition, however small, requires a review by an assessor. The assessor will be responsible for determining the extent of the change. Obviously, this review will be more or less complex depending on the change introduced. Strictly speaking, a change in composition implies a different cosmetic product.
Types of compositional changes in a cosmetic product
In principle, we can consider two types of changes. On the one hand, those that a priori would produce a detoxifying effect. Such as a decrease in the concentration of a substance with a certain toxic profile, for example a preservative. On the other hand, those that could increase the risk factor, such as increasing the concentration of the same preservative. These changes must be analysed in the overall context of the composition. A decrease in the concentration of the preservative could be interpreted as a positive effect on the risk of this substance. However, it could also have a negative impact on the chemical or microbiological stability of the cosmetic product and increase the risk factors.
There are cases where the change in composition should have no effect on the safety profile of the cosmetic product. Let us look at two good examples of this:
- a small increase in the concentration of a substance to increase its viscosity and thus improve local application
- the lowering of the concentration of a dye to vary the shade.
In these cases, corroboration of the maintenance of the safety profile should also be provided by the assessor.
Changes in the impurity profile
Occasionally, changes may be made which, while not altering the composition of the cosmetic product, may change the impurity profile referred to in Annex I.A.4. When assessing this section, we consider the impurity profile of the raw materials to be used in the manufacture of the cosmetic product as provided by the supplier. The formulator of a cosmetic product must consider the range of admissible impurities for each of the substances. Therefore, he must be alert that a change of supplier does not require a re-evaluation of the documentation concerning this section.
Another example is a simple change of perfume. It is well known that in addition to a certain irritant potential, perfumes can carry certain risks of sensitisation. This is due to the possible presence of allergens in their components. The incidence of this change will vary according to the conditions of exposure (place, area, frequency, etc.). This is why, at the very least, it will require the introduction of a comment by the assessor in the Safety Dossier.
Conclusions: How compositional changes affect the Safety Dossier of a cosmetic product
Therefore, any change in the composition of a cosmetic product should be considered to require review by an assessor. What changes require further safety studies? This is another issue that can be dealt with on another occasion.
Do you need more information on cosmetic product composition changes and how they affect the Safety Dossier? Contact us Our proposal? Solutions!