The DUCRAY Dermatological Laboratories product formulation charter
Our products are manufactured and tested based on the strictest standards, in line with the pharmaceutical requirements of the Pierre Fabre Group. All formulas from our Laboratories are created with the greatest respect for current legislation and are used with excellent results for efficacy and tolerance. The substances used are included on the list of substances authorized by law for cosmetic substances. Before being sold on the market, a safety file is made for each cosmetic product. As manufacturers, we are responsible for marketing the product and guaranteeing its safety.
Endocrine disruptors
Consumer safety is a priority for DUCRAY Dermatological Laboratories, and we have undertaken to scrupulously evaluate product safety before market release. All our products and their ingredients are subject to strict regulations, and must meet stringent safety evaluation criteria before they are marketed.
Product safety assessment at DUCRAY Dermatological Laboratories is based on three analyses:
1. Safety assessment of raw materials. In accordance with current European regulations, our evaluation of product safety takes into consideration the physico-chemical properties of each ingredient, the toxicological profile and the level of exposure. The regulations distinguish between rinse-off products (shampoos, shower gels, etc.) and no-rinse products.
We evaluate the following:
- The concentration in the product of the ingredient that comes into contact with the skin
- The contact time, which depends on the type of product (rinse-off or no-rinse)
- The product category (face, body), and hence the surface area exposed
- The target, with particular attention paid to “sensitive” populations, i.e. babies, children, pregnant women and pathological skin.
A safety assessor prepares a safety summary document for each of the raw materials used, including all the items mentioned in addition to an in-depth study of the composition of any additives and impurities present. The assessor then issues a positive or negative opinion on the substance’s use depending on the applications requested and the target, and if necessary will define any restrictions applying to the product category, a particular population, a use concentration or any formulation conditions.
The assessment is based on:
- data provided by the supplier and bibliographic data taken from toxicological, chemical and medical databases
- internal clinical data obtained from tests performed on the finished products
- cosmetovigilance feedback, where available
If there is an insufficient amount of data, an additional series of in vitro tests and chemical analyses are organized, as determined by the safety assessor. We evaluate all our raw materials thoroughly to determine the possible risk of carcinogenic, mutagenic or reprotoxic (CMR) effects. Substances in cosmetics classified as CMR substances are subject to very strict regulations.
2. Safety assessment of finished products. Not only do we evaluate the safety of raw materials, but we also assess that of the finished product itself. For this, we proceed as follows:
Analysis of the formula composition and calculation of safety margins
Preclinical in vitro tests according to product type:
- Ocular tolerance test
- Skin tolerance test
- Vaginal tolerance test
- Phototoxicity test
In vivo clinical tolerance tests – various types of studies are carried out on healthy skin then a target according to an internal development charter:
Sensitization test under maximum exposure conditions under medical control
Skin and/or ocular tolerance test under normal conditions of use, under dermatological and/or ophthalmological and/or pediatric control.
3. Cosmetoviligance
Our cosmetovigilance department monitors tolerance to marketed products in order to answer consumers’ questions and gather any information likely to contribute to progress.
On October 4, 2017 the European Parliament rejected the endocrine disrupter definition criteria proposed by the EU Member States on July 4, 2017.
To date, Europe has not therefore provided a positive list of endocrine disrupters. We are actively monitoring all developments in scientific findings and in European Cosmetic Regulations to offer formulas guaranteeing a high level of safety.
On October 4, 2017 the European Parliament rejected the endocrine disrupter definition criteria proposed by the EU Member States on July 4, 2017.
To date, Europe has not therefore provided a positive list of endocrine disrupters. We are actively monitoring all developments in scientific findings and in European Cosmetic Regulations to offer formulas guaranteeing a high level of safety.
Methylisothiazolinone (MIT)
Methylisothiazolinone is a preservative used in numerous industries. It is an ingredient that has been used widely in everyday products, including not only household products, adhesives and printing inks but also cosmetics (mainly shampoos and shower gels), because it has a broad spectrum of activity on many bacteria and yeasts. It serves to protect formulas from microbial and fungal contamination during manufacture and use.
In June 2015, the SCCS published a proposal to change the MIT concentrations currently authorized for cosmetic products, including:
- the prohibition of MIT in no-rinse hair products
- a recommended maximum concentration of 0.0015% (15 ppm) in rinse-off products
The no-rinse products that included methylisothiazolinone have been reformulated, and we have withdrawn those still containing it from the market (February 12, 2017).
The rinse-off products containing more than 15 ppm (0.0015%) MIT (as recommended by the SCCS) are all in the process of being reformulated. Numerous studies will be necessary to assess all the possible impacts of these new formulations, and these will be carried out progressively. We will withdraw the products containing more than 15 ppm MIT from the market in the first half of 2018 at the latest. The new formulas will be available from autumn 2017.
Methylchloroisothiazolinone (MCI )
We do not use methylchloroisothiazolinone (MCI).
Triclosan
We ceased all production of products containing triclosan on October 30, 2014.
Phenoxyethanol
Most dermo-cosmetic products are water-rich environments that encourage the proliferation of bacteria, yeasts and molds. It is essential that all formulas be protected from such contamination in order to guarantee consumer safety throughout the product’s shelf-life.
Phenoxyethanol is naturally present in green tea and chicory, and is used as a preservative in cosmetics for its broad spectrum of activity on many bacteria and yeasts. It appears in the list of preservatives authorized for cosmetic products at a maximum concentration of 1% (Annex V/29 to Regulation (EC) No. 1223/2009).
Scientific studies describe hepatotoxicity when ingested, but no cases of hepatic toxicity have been reported following application to the skin, which is why the health authorities have not imposed a ban on this ingredient in cosmetics. On October 6, 2016 the SCCS confirmed that phenoxyethanol was safe at a concentration of 1% in all cosmetics, including baby products.
BHA
Butylated hydroxyanisole (BHA) is classified as a “possible carcinogen” by the International Agency for Research on Cancer (IARC). Pierre Fabre Dermo-Cosmétique does not use BHA as an ingredient.
BHT
BHT is used in many cosmetic formulations as an antioxidant at a concentration of 0.0002% to 0.5%. The Cosmetic Ingredient Review (CIR) panel of experts has evaluated the safety of BHT as follows: when applied to skin, it remains on the surface or is absorbed very slowly without causing any systemic exposure to BHT or its metabolites, unlike oral exposure; the available studies do not point to any significant irritation, sensitization or photosensitization. Given the low concentration of this ingredient used in cosmetic formulations, it was concluded that BHT does not present a risk when used in cosmetic formulations.
BHT is an antioxidant authorized by the health authorities in the composition of cosmetic products in France and the European Community. It is also used in the food and pharmaceutical industries. There are no scientific publications showing that BHT could induce endocrine disruption in humans.
Sodium Lauryl Sulfate
Sodium Lauryl Sulfate (SLS) belongs to the family of anionic surfactants.
SLS is used pure as a control for skin irritation tests.
Pierre Fabre Dermo-Cosmétique does not use SLS as an ingredient in its own right, but it is sometimes introduced into formulas in minute quantities, in trace amounts, by another raw material.
Allergens
There are 26 allergens, and they are aromatic compounds and perfuming substances found notably in essential oils and product fragrances. Their inclusion in the list of ingredients is mandatory when they exist in quantities exceeding 0.01% in rinse-off products and exceeding 0.001% in no-rinse products. A legal notice intended to warn and protect people sensitive to these allergen molecules has been obligatory since 2005, whether they are of synthetic or natural origin, but they are not harmful for people who are not allergic to them.
This legal notice serves an informative purpose, to allow consumers to make an informed choice about a product.
Butylparaben, propylparaben, sodium butylparaben, sodium propylparaben, potassium butylparaben, potassium propylparaben
Parabens are a family of preservatives that have been used for over 60 years and are included in the list of substances authorized by the current legislation (SCCS opinion) on cosmetic products at a maximum concentration of 0.4% (the total of all parabens in the same product must not exceed 0.8%). They are produced industrially by chemical synthesis, and are also found naturally in many plants, including strawberries, carrots and onions, as well as royal jelly for example. This family of preservatives has been the subject of a very large number of scientific publications, so we have extensive knowledge and considerable experience of their use.
The members of this family are not all equal:
- Safety of the short-chain parabens, ethylparaben and methylparaben (and the compounds that contain this name, for example sodium ethylparaben), has been confirmed definitively by French and European experts. The SCCS (Scientific Committee on Consumer Safety) has confirmed the safety of methylparaben and ethylparaben at the maximum authorized concentrations in all its opinions.
- According to European Regulation, use of butylparaben and propylparaben as preservatives in finished cosmetic products does not pose a risk to consumer health, provided that the sum of the individual concentrations of the substances concerned does not exceed 0.19%.
The only no-rinse products in which use of butyl- and propylparaben is prohibited are those intended to be applied to the bottoms of children under three years of age.