The European cosmetics regulations (Directive 76/768/EEC amended March 11, 2003) requires manufacturers to mandatorily use alternative methods available to test new cosmetic raw materials and finished products.
Recognizing this need, we have stopped for many years all tests on animals to assess the safety of our cosmetic products during their development and have implemented a program that has materialized through the following actions:
- Development of alternative tests on cell cultures in our own skin culture lab.
- Implementation of various methods available on the market and active participation in validation programs implemented by the French and European official agencies.
In practice, to test our products and provide consumers with the necessary security to be guaranteed by any cosmetic product, we rely primarily on existing data about the safety of raw materials used.
The tolerance of our finished products is then verified by the implementation of alternative methods (in vitro methods) and clinical tolerance tests in healthy volunteers in accordance with the laws on the protection of persons participating in biomedical research, supplemented by usage tests of effectiveness in humans.
Finally, we practice on each batch or raw materials delivered to our manufacturing plants high-level physico-chemical and bacteriological controls, to verify the identity, purity and quality of ingredients used in our formulas.
This type of control is also performed on each batch of finished products, allowing us to avoid any risk of manufacturing errors.
No, our products do not contain animal by-products. The exhaustive formula is on all packaging according to the current legislation.
Our products are manufactured and tested according to the highest standards, falling in line with the requirements of the Pierre Fabre pharmaceutical Group.
All formulas are developed in our laboratories in the highest respect of current legislation and are used with excellent results for efficacy and safety and, for some of them, on atopic or hypersensitive skin.
We wish to specify that the substances used by the Laboratoires Pierre Fabre Dermo-Cosmétiques are part of the list of substances permitted by current legislation on cosmetic products.
Before being launched on the market, each cosmetic product is subject to a safety file and we are, as a manufacturer, responsible for putting it on the market and required to ensure product safety.
In answer to your question on parabens, please kindly take note of the Vigilance Bulletin no.30 of AFSSAPS (Agence française de sécurité sanitaire des produits de santé) that is available on the website: http://afssaps.sante.fr/htm/5/indbvigi.htm
As you can see, the AFSSAPS confirmed that the use of principal paraben esters of the most commonly used in cosmetics, do not present any risk.
Parabens constitute a family and we use only those whose safety has been demonstrated.
However we are closely monitoring the evolution of knowledge on these substances and obviously take special precautions when we offer the products to young children.
We are also involved in working groups of the FEBEA which re-examines the security margins for baby products to make recommendations to the AFSSAPS.
- Why are there still parabens in our products?
Parabens are good preservatives, widely used for decades in several sectors: the cosmetic industry, but also in the pharmaceutical and food industry.
We have complete toxicological data, which is updated along with the progress of science assessments on chemicals.
Hence we possess good knowledge of these substances, which allows us to use them safely.
- Are we going to remove parabens from our products?
The health risks associated with any bacterial contamination are much higher than those associated with the use of preservatives such as parabens and we cannot seriously consider removing them altogether.
This is also widely recognized by the international scientific community.
However, although the parabens that we use have demonstrated their safety, we take into account public opinion on this family of conservatives by actively seeking alternative credible solutions. These solutions must be at least as effective in their conservation function, allowing a high level of security. We primarily focus on products for babies, children and pregnant women.
With particular regard to phenoxyethanol, this preservative belongs to a chemical family widely criticized: glycol ethers.
However, within this family composed of a hundred molecules, some are known to have carcinogenic properties, while others have none such as phenoxyethanol (molecule that is not classified in IARC – International Agency for Research in Cancer).
The CSHPF (Conseil Supérieur d'Hygiène Publique en France), joined by the AFSSAPS has recommended banning 7 glycol ethers for their toxic effect on reproduction. There are others found in low concentration in cosmetic products declared safe by AFSSAPS according to cosmetic regulations (for example phenoxyethanol).
Accordingly, the maximum of phenoxyethanol concentration authorized in cosmetic products is limited to 1% (AFSSAPS – Committee of vigilance coordination of health products – results of 2003).
Finally, for more information on glycol ethers, please read «glycol ethers – new toxicological date – INSERM edition – 2006».
Since 2010, the A-DERMA presentation of the ranges has changed. This new segmentation with new forms of well differentiated bottles according to the A-DERMA universe enables our consumers to easily identify the products: treating care, family, woman:
- The pink lines, with sleek curve packaging, feminine, well-rounded, targeting women with delicate and fragile skin
- The green lines, treating care, represented by strict and straight packaging are indicated for atopic or very dry and irritated skin
- Then, the family lines: with soft, rounded curves, that are indicated for fragile and delicate skin of babies, newborns and to all the daily needs of the family.