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Le Touquet – Paris-Plage, France

Berthele H.,EXPERTOX Agency and Laboratory | Berthele H.,School of Industrial Biology | Sella O.,School of Industrial Biology | Lavarde M.,School of Industrial Biology | And 3 more authors.
International Journal of Cosmetic Science | Year: 2014

Objective: Ethanol, pH and water activity are three well-known parameters that can influence the preservation of cosmetic products. With the new constraints regarding the antimicrobial effectiveness and the restrictive use of preservatives, a D-optimal design was set up to evaluate the influence of these three parameters on the microbiological conservation. Methods: To monitor the effectiveness of the different combination of these set parameters, a challenge test in compliance with the International standard ISO 11930: 2012 was implemented. The formulations established in our study could support wide variations of ethanol concentration, pH values and glycerin concentration without noticeable effects on the stability of the products. Results: In the conditions of the study, determining the value of a single parameter, with the tested concentration, could not guarantee microbiological conservation. However, a high concentration of ethanol associated with an extreme pH could inhibit bacteria growth from the first day (D0). Besides, it appears that despite an aw above 0.6 (even 0.8) and without any preservatives incorporated in formulas, it was possible to guarantee the microbiological stability of the cosmetic product when maintaining the right combination of the selected parameters. Conclusion: Following the analysis of the different values obtained during the experimentation, there seems to be a correlation between the a w and the selected parameters aforementioned. An application of this relationship could be to define the aw of cosmetic products by using the formula, thus avoiding the evaluation of this parameter with a measuring device. © 2013 Society of Cosmetic Scientists and the Société Française de Cosmétologie. Source

Ghalleb S.,EXPERTOX Agency and Laboratory | Ghalleb S.,School of Industrial Biology | De Vaugelade S.,EXPERTOX Agency and Laboratory | Sella O.,School of Industrial Biology | And 4 more authors.
International Journal of Cosmetic Science | Year: 2015

Synopsis Objective Challenge test (CT) is essential to assure the efficiency of the preservative system in products. A previous study realized by our staff in 2012, carried out to evaluate the influence of three parameters (ethanol, pH and water) on the microbiological cosmetics products conservation. Following this work, a correlation between aw (based on the glycerine concentration) and the selected parameter has been demonstrated. In the present study, smaller limits of ethanol, pH and glycerine were applied to determinate CT necessity. Methods Sixteen stables O/W cosmetics creams with different concentration of ethanol (1-19%), glycerine (3-16%) and different pH (6-11) were formulated. To evaluate the efficiency of the different formulations, CTs were performed according to the International Standard ISO 11930:2012. To determine the influence of the parameters, a D-optimal plan generated by Design Expert® was applied. Design of Experiments software offers to plan, estimate and control the statistics and models for factorial and no-factorial designs. Results Challenge tests results show that 10 formula passed criteria A, two passed criteria B and four are not conform. Mostly, an ethanol concentration higher than 16% exempts products of CT. It has been shown that an ethanol concentration between 10.5% and 16%, and an glycerine concentration >10%; or if the ethanol concentration is between 5% and 10.5%, glycerine is >6% and pH is ≥10, the CT is not required. Ethanol has a significant impact on conservation and especially when it is correlated with glycerine and pH. Finally, a glycerine concentration higher than 16% exempts products of CT. Conclusion Following the analysis of the different concentration, a correlation between glycerine and ethanol that directly influence microbiological protection of cosmetics products has been established. Indeed, by controlling ethanol, pH and glycerine, many products may be exempted from the CT. © 2014 Society of Cosmetic Scientists and the Société Française de Cosmétologie. Source

Thomas C.,EXPERTOX Agency and Laboratory | Siong D.,EXPERTOX Agency and Laboratory | Pirnay S.,EXPERTOX Agency and Laboratory
International Journal of Cosmetic Science | Year: 2014

Synopsis Objective Since the publication of the Regulation (EC) No 1223/2009 on cosmetic products, the content-containing interaction between the packaging and the product must be considered for the safety assessment of the product. Indeed, some compounds are able to migrate from packaging to the product and may be harmful to the consumer health. The developed and validated method of investigation was applied on 79 cosmetic products. Methods Packaging materials and products at risk were determined by studying data of cosmetic product information files assessed by EXPERTOX. To evaluate the content-containing interaction, a gas chromatography-mass spectrometry method was developed and validated. Liquid-liquid extraction was used to extract contaminants (some of phthalates, volatile organic compounds and substance of very high concern) from migration simulants and products. Results Analysis of product information files showed that HDPE and PE are the most widely used plastics for cosmetic product packaging. Calibration curves showed good linearity regression from 50 to 500 ng mL-1, and detection and quantification limits were 25 and 50 ng mL-1, respectively. The accuracy, precision, repeatability of the analytical method and extraction yields were acceptable. The frequency at which the DEHP was found in products is 90% for 11 stick deodorants and 83% for 12 perfumes. Conclusion Plastic is the most material used in cosmetic due to the diversity of form and colour. The gas chromatography-mass spectrometry method was validated and can be used for the evaluation of the content-containing interaction of cosmetic products. For all tests performed on 79 products in contact with six kind of packaging, the DEHP was found at 90% for stick deodorants and 83% for perfumes. No other contaminant was found. © 2014 Society of Cosmetic Scientists. Source

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