Organizational Strategy - Sustainable Development - L'Oréal

More documents

Recommendations

Info

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. 2/6
10 L’oréaL - GrI DaTa SHEETS 2011 2005: Participation in the SENS-IT-IV evaluation of alternative methods for allergens (6 th European framework programme). Founding member of the EPaa (European Partnership for alternative approaches to animal Testing). acquisition of SkinEthic. 2007: Validation of the Episkin model for skin irritation. 2008: Validation of the SkinEthic rHE model for skin irritation. 2009: L’oréal’s disclosure of its predictive method strategy during the 7 th International Congress on alternative methods in rome . 2010: Entry of the HCE model for corneal reconstruction into the validation phase for ocular irritation. 2011: Production of 130,000 units of reconstructed tissue (skin and cornea) in Gerland. The predictive capacity of these tools is augmented day after day by contributions from new tissue engineering technologies, modern biology, mathematical modelling, computer calculations and century-long database development. Thanks to this array of predictive methods, L’oréal was able to comply with the 2009 regulatory deadline set forth by the 7 th amendment to the Cosmetics Directive without any negative impact on the innovation and safety of its ingredients and products. From now on, the group intends to build an integrated strategy of safety evaluation and take part in the “toxicology of the 21 st century” by continuing to develop these tools and refining their relevance. In this context, the programme to simulate the first human application using a combination of predictive and in vitro tools was pursued. It pertains to certain ingredients used exclusively for cosmetic purposes. In 2010, this integrated safety evaluation strategy, along with the tools that support it, were presented by research and Innovation at the SoT Congress in Baltimore, at the ESTIV Congress in Linz and at the CoLIPa contact allergies workshop. PREDICTIVE METHODS Predictive methods combine data and tools to predict the safety of ingredients and formulas. L’oréal’s added value in evaluating the safety of its ingredients and finished products comes from the investments it made in tissue engineering as well as a panel of diverse predictive methods, including statistical and mathematical models, in silico methodology and QSar models developed internally or during external collaborations. They are used in combination to optimise their predictive capacities. They now help perform raw material safety evaluations, thereby helping avoid the use animal models 99% of the time. RECONSTRUCTED TISSUE L’oréal research has long been performing cellular biology research and developing tissue engineering in order to reconstruct various human skin and tissue models. The various models have five main applications: • Developing an understanding of the skin without using invasive clinical trials. • Developing and evaluating the efficacy of new active ingredients. • Contributing to the evaluation of the safety of raw materials and finished products. • Creating, validating and standardising alternative new tests to assess product safety. • Developing tests to assess efficacy (e.g., sunscreens). In 2010, the commercialisation of reconstructed tissue models used to evaluate ingredient and formula safety continued. The HCE reconstructed human corneal epithelium model has entered into the validation phase. as soon as the methods are validated, L’oréal will make them available to manufacturers and university laboratoriess. ASSESSMENT OF SKIN IRRITATION research and Innovation developed two validated methods to evaluate skin irritation using skin models (Episkin and rHE). The entire raw material portfolio of L’oréal and The Body Shop has been tested using these models. This action helped deepen the understanding of the ingredients and enrich the database as well as the ingredient regulatory dossiers. EVALUATION OF OCULAR IRRITATION SkinEthic’s HCE model of reconstructed corneal tissue is undergoing regulatory validation for ocular irritation. In 2010, a published study demonstrated the reliability of the protocol developed by L’oréal, which has been proven on more than 400 ingredients. New ingredients are systematically tested on this HCE model. Moreover, the evaluation of formulas for skin and ocular irritation continues. In total, since 2006, more than 12,000 formulas and 2,000 ingredients have been evaluated. > For more information, read: 2011 <strong>Sustainable</strong> <strong>Development</strong> report, p. 12: article on predictive evaluation. The IEDS/EWC (Instance Européenne de Dialogue Social/European Works Council) encourages discussions and meetings with the IEDS/ EWC members on the group’s current and future situation. 3/6
Page 1 and 2:
1 L’oréaL - GrI DaTa SHEETS 2011
Page 3 and 4:
2 L’OréaL - GrI DaTa SHEETS 2011
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11 and 12:
Page 13 and 14:
3 EXPErT L’oréaL - GrI DaTa SHEE
Page 15 and 16:
Page 17 and 18:
Page 19 and 20:
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
Page 27 and 28:
Page 29 and 30:
Page 31 and 32:
Page 33 and 34:
Page 35 and 36:
Page 37 and 38:
Page 39 and 40:
Page 41 and 42:
Page 43 and 44:
Page 45 and 46:
Page 47 and 48: 5 L’oréaL - GrI DaTa SHEETS 2011
Page 67 and 68: 7 L’OréaL - GrI DaTa SHEETS 2011
Page 97: 10 L’oréaL - GrI DaTa SHEETS 201
show all

Organizational Strategy - Sustainable Development - L'Oréal

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?