Organizational Strategy - Sustainable Development - L'Oréal

10 L’oréaL - GrI DaTa SHEETS 2011
EVALUATING THE SAFETY OF SUBSTANCES USED IN PRODUCTS, FROM DISCOVERY UNTIL PRODUCT COMMERCIALISATION
Each substance that has the potential to be used as an ingredient in a cosmetic product (100% of the substances) is subject to a safety
evaluation performed by a toxicologist.
The toxicologist first analyses all of the available information pertaining to this substance - the physicochemical characteristics, the
bibliographic and experimental data – to determine its toxicological profile. If necessary, the toxicologist decides to generate new data
to complete the existing dossier (see the paragraph entitled, “Shifting to a new evaluation procedure”). Finally, the toxicologist considers
the foreseeable consumer exposure. This exposure is related to the percentage of substances used in the cosmetic products and the type
of cosmetic product in question (which will in turn determine such parameters as the exposed surface area, the time in contact with the
skin, and the sun exposure).
Subsequently, toxicologists assess the safety of each specific use of a substance integrated into a finished product. They also take into
consideration the impact of the cumulative use of substances that may be in various types of cosmetic products.
Using this information, the group’s toxicologists determine the concentration of a substance that enables it to be used in total safety.
This concentration corresponds to a level of ingredient use that is at least 100 times less than the level considered to be safe under
experimental conditions of use given the toxicological profile of and exposure to the substance. all of this information becomes an integral
part of the regulatory dossier for all substances.
This evaluation follows the development of products. In fact, the safety evaluation of a substance begins as soon as its incorporation
into a future product is foreseen. at this stage, the formulator (the person who produces future cosmetic products) asks their “reference
toxicologist” if the incorporation of this substance is possible from an end-user safety point of view.
Throughout the development stages, each of which may lead to changes in the composition of a formula, formulators refer to their
toxicologist to verify what is possible from a consumer safety point of view.
EVALUATING THE SAFETY OF FINAL COSMETIC PRODUCTS PRIOR TO COMMERCIALISATION
While substance safety is being evaluated, the toxicologist assesses the consumer tolerance of the finished cosmetic product. This
evaluation also occurs during formulation conception. Toxicologists have acquired the expertise needed to determine the formula on
paper and identify any possible substance interactions or potentiation.
This evaluation uses existing bibliographic and experimental data and can require new studies to be conducted if necessary. These new
studies can be in vitro tests or clinical trials with volunteers. The clinical trials on volunteers are only performed when the group has already
determined that product safety is satisfactory for the volunteers, since the purpose of these trials is to verify that the target population
tolerates the product before it is commercialised.
The safety evaluation of products becomes concrete when a safety certificate endorsed by a toxicologist involved with a dossier is issued.
The certificate and dossier are systematically in place for 100% of the commercialised products, and this pertained to more than 8,000
formulations in 2011.
COSMETOVIGILANCE AND THE IMPACT ON THE DEVELOPMENT OF SAFETY (PLEASE REFER TO SECTION PR2 ON THIS SUBJECT AS WELL)
Finally, after being commercialised, L’oréal continues to evaluate the use and tolerance of its products on the market worldwide through
the international cosmetovigilance network, which was created 25 years ago. This network uses rigorous, recognised methods to collect,
verify and analyse the adverse events related to the use of a product.
This tool helps identify exceptionally “abnormal” cases of intolerance on the market. In such cases, additional investigations can be
suggested to the consumers in question (see section Pr8 on Customer Privacy). The product dossier is then re-examined to identify the
cause of this intolerance so that appropriate measures can be taken, such as re-issuing labelling if it was inappropriate, adding warning
labels or even changing the composition of the formula if necessary.
This information is used to update the dossiers of substances eventually found to cause intolerance and as well as to update the
corresponding cosmetic product dossiers.
2- SHIFTING TO A NEW EVALUATION PROCEDURE
This evaluation procedure has been able to adapt to an increasingly strict regulatory environment, which prohibits, among others, the use
of animals to test product safety, since the L’oréal group anticipated this; therefore, for the last 30 years, the group has been developing
new safety evaluation methods.
a new regulatory framework, the 7 th amendment to the European Cosmetics Directive, entered into effect in 2004. In 2009, it imposed the
ban on the use of animals to assess the safety of finished cosmetic products as well as certain toxicity parameters for substances intended
for use in cosmetics in Europe.
Within this regulatory context, a new paradigm, similar in scope to that of eco-design, was developed within research and Innovation
for the safety evaluation of ingredients and products. Innovation is now part of the process of developing high-performance cosmetic
ingredients that are initially selected for having no impact on health and the environment.
This capacity is the result of L’oréal’s investment in building tools to help predict the impact of raw materials and finished products on
human health and the environment without resorting to animal testing.
The following were the main steps involved in building the L’oréal group’s expertise in safety evaluation based on predictive
methods.
1995: ECVaM/CoLIPa validation of in vitro phototoxicity test.
amalthée Prize for alternative methods (oPaL).
1997: acquisition of Episkin SNC, an industrial centre for skin engineering.
Introduction of Langerhans cells into reconstructed skin (4 th European framework programme).
1999: CoLIPa instructions on in vitro percutaneous absorption.
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