“…The team has developed a similar NGRA framework for assessing the potential of chemicals to cause skin allergy, 18 again starting with existing exposure and hazard data and then using relevant in vitro assays for skin sensitisers (Figure 3). The replacement of animal tests for assessing skin allergy has been an active area of research in Unilever for over 40 years, and so the NGRA framework is primarily a way to capture the inputs and metrics used in our decision-making.…”
Section: Safety Science: Next Generation Risk Assessment (Ngra) Throu...mentioning
confidence: 99%
“…20 Currently, Unilever is collaborating with the US government NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) to adapt the SARA model for regulatory use, and the new SARA-ICE (Integrated Chemical Environment) Defined Approach is being evaluated at OECD level.Figure 3.Unilever NGRA framework for decision-making on consumer safety: Skin allergy. NGRA workflow for a skin allergy risk assessment case study (0.1% coumarin in face cream, 1% coumarin in deodorant; Reynolds et al 18 ). *These approaches were not part of the scope of this case study.…”
Section: Safety Science: Next Generation Risk Assessment (Ngra) Throu...mentioning
confidence: 99%
“…Unilever NGRA framework for decision-making on consumer safety: Skin allergy. NGRA workflow for a skin allergy risk assessment case study (0.1% coumarin in face cream, 1% coumarin in deodorant; Reynolds et al 18 ). *These approaches were not part of the scope of this case study.…”
Section: Safety Science: Next Generation Risk Assessment (Ngra) Throu...mentioning
The decisions we make on chemical safety, for consumers, workers and the environment, must be based on the best scientific data and knowledge available. Rapid advances in biology, in cell-based technologies and assays, and in analytical and computational approaches, have led to new types of highly relevant scientific data being generated. Such data enable us to improve the safety decisions we make, whilst also enabling us to avoid animal testing. Stimulated by the UK and EU bans on animal testing for cosmetics, Next Generation Risk Assessment (NGRA) approaches, which integrate various types of non-animal scientific data, have been established for assessing the safety of chemical ingredients used in cosmetics and other consumer products. In stark contrast, the chemicals regulations in Europe and other parts of the world have not kept pace with modern safety science and regulators are now mandating even more animal testing. Urgently closing this science–regulation gap is essential to upholding the EU’s legislative requirement that any animal testing is a last resort. The ongoing revisions of UK and EU chemicals strategy and regulations provide an opportunity to fundamentally change the design and assessment paradigm needed to underpin safe and more sustainable innovation, through applying the best science and tools available rather than continuing to be anchored in animal tests dating back many decades. A range of initiatives have recently been launched in response to this urgent need, in the UK as well as in the EU.
“…The team has developed a similar NGRA framework for assessing the potential of chemicals to cause skin allergy, 18 again starting with existing exposure and hazard data and then using relevant in vitro assays for skin sensitisers (Figure 3). The replacement of animal tests for assessing skin allergy has been an active area of research in Unilever for over 40 years, and so the NGRA framework is primarily a way to capture the inputs and metrics used in our decision-making.…”
Section: Safety Science: Next Generation Risk Assessment (Ngra) Throu...mentioning
confidence: 99%
“…20 Currently, Unilever is collaborating with the US government NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) to adapt the SARA model for regulatory use, and the new SARA-ICE (Integrated Chemical Environment) Defined Approach is being evaluated at OECD level.Figure 3.Unilever NGRA framework for decision-making on consumer safety: Skin allergy. NGRA workflow for a skin allergy risk assessment case study (0.1% coumarin in face cream, 1% coumarin in deodorant; Reynolds et al 18 ). *These approaches were not part of the scope of this case study.…”
Section: Safety Science: Next Generation Risk Assessment (Ngra) Throu...mentioning
confidence: 99%
“…Unilever NGRA framework for decision-making on consumer safety: Skin allergy. NGRA workflow for a skin allergy risk assessment case study (0.1% coumarin in face cream, 1% coumarin in deodorant; Reynolds et al 18 ). *These approaches were not part of the scope of this case study.…”
Section: Safety Science: Next Generation Risk Assessment (Ngra) Throu...mentioning
The decisions we make on chemical safety, for consumers, workers and the environment, must be based on the best scientific data and knowledge available. Rapid advances in biology, in cell-based technologies and assays, and in analytical and computational approaches, have led to new types of highly relevant scientific data being generated. Such data enable us to improve the safety decisions we make, whilst also enabling us to avoid animal testing. Stimulated by the UK and EU bans on animal testing for cosmetics, Next Generation Risk Assessment (NGRA) approaches, which integrate various types of non-animal scientific data, have been established for assessing the safety of chemical ingredients used in cosmetics and other consumer products. In stark contrast, the chemicals regulations in Europe and other parts of the world have not kept pace with modern safety science and regulators are now mandating even more animal testing. Urgently closing this science–regulation gap is essential to upholding the EU’s legislative requirement that any animal testing is a last resort. The ongoing revisions of UK and EU chemicals strategy and regulations provide an opportunity to fundamentally change the design and assessment paradigm needed to underpin safe and more sustainable innovation, through applying the best science and tools available rather than continuing to be anchored in animal tests dating back many decades. A range of initiatives have recently been launched in response to this urgent need, in the UK as well as in the EU.
“…Such regulatory decisions, based on NAMs, can hopefully be confidently made in the future through the generation of more data to allow comparisons with chemicals of known human toxicity which can aid interpretation and contextualization. These larger scale benchmarking approaches, collating information on reference compounds to inform safety decisions, has already been published in the context of skin allergy assessment and in the prediction of drug-induced liver injury (DILI) in candidate drugs (Reynolds et al, 2021;Williams et al, 2020). The utility of a benchmarking approach was also demonstrated in the context of interpreting specific activity assays such as the investigation of androgenic activity (Dent et al, 2019).…”
Section: Using Nams Not Rodentsmentioning
confidence: 99%
“…Assuming methods of exposurebased waiving cannot be applied (e.g. the threshold for toxicological concern (TTC) is exceeded (Yang et al, 2017), nor can simple read-across methods be used, and all topical toxicity endpoints and potential genotoxicity have been covered, as appropriate, by 'non-animal' OECD assays (skin allergy (Reynolds et al, 2021), skin and eye irritation, skin mutagenicity, phototoxicity) then the next phase involves determining a BER, which, as described above, quantifies the differences between ALTEX, accepted manuscript published July 4, 2022 doi:10.14573/altex.2204281 relevant internal exposure levels (e.g. Cmax) in humans (given the use-case of the chemical) and the concentration required to trigger bioactivity in a broad range of in vitro assays in terms PODs.…”
New Approach Methodologies (NAMs) that do not use experimental animals are, in certain settings, entirely appropriate for assuring the safety of chemical ingredients, although regulatory adoption has been slow. In this opinion article we discuss how scientific advances that utilize NAMs to certify systemic safety are available now and merit broader acceptance within the framework of Next Generation Risk Assessments (NGRA).
Introduction to the advancementsThe science of assuring the safe use of chemicals in products for the consumers who use them and the people in factories who work with them, has advanced a great deal since the 1950s when the only tools for determining the safety of chemicals were experimental animals. Over the intervening decades, an inexorable scientific progression has taken place, towards the elimination of animal testing in chemical safety assessments and the introduction of advances from biomedical sciences to focus on better protecting human and environmental health. During the 1980s and 1990s considerable investment into 'alternatives to animal testing' resulted in the development of several new tests for topical toxicity that could reliably predict the results of animal tests. A regulatory framework then grew around the animal tests and these newer 'animal replacements'.The pace of change has, however, recently quickened as advanced methodologies, that can characterize fundamental biological alterations, have been evaluated and implemented in toxicology in a concerted effort to assure safety in a more human-focused and more exposure-relevant way. A key landmark precipitating the change was the publication of the principles outlined in 'Toxicity Testing in the 21 st Century: A Vision and a Strategy' from the National Academy of Sciences and National Research Council of the USA (NRC, 2007). The book opened the door to a new paradigm whereby advances that have been made in systems biology and associated computational modelling, could be used to transform toxicity testing from its historical animal test base to one founded on in vitro and in silico methods that evaluate pathway changes in cells of human origin. Today, many industry, academic and regulatory toxicologists involved in this evolution face a decision point: whether to adopt these new ways, evaluate their use and seek to improve them, or remain wedded to using traditional animal tests (with the associated ethical and scientific issues they pose in modern society). This decision on whether to adopt or not, occurs against the backdrop of generally slow uptake from regulatory agencies in many geographies, that make it difficult to allow such a transition. Indeed, new approach methodologies (NAMs 1 ), which are increasingly used to assure consumer safety of chemicals in cosmetics (SCCS, 2021;Bernauer, et al., 2021;Dent et al., 2018 and, are generally not yet recognized as a valid route to provide the regulatory safety data in many cases, e.g., to fulfil REACH information requirements for occupational and environmental safety, of the s...
Cosmetics are personal care products that are designed to be applied to the body for the purpose of cleaning, protecting, beautifying, and producing a healthy appearance or altering appearance without changing the body's physiology. The seven categories of cosmetics include oral, skin, sun, hair, and body care products, as well as decorative cosmetics and perfumes. There are millions of cosmetic products in the marketplace, and new products are constantly introduced. Cosmetic products are not subjected to premarket evaluation and approval like food or drug products by the federal government in the United States (US). However, some states are implementing laws and regulations that are specific to cosmetic products. For example, California is the first state to ban specific ingredients from being included in any cosmetic product manufactured or sold in the state. Further, unlike in the US, preregistration of cosmetics is required in the European Union (EU). Specifically, before cosmetic products are placed or made available on the EU market, responsible persons must submit specific product information to the Cosmetic Product Notification Portal (CPNP), which then makes this information available to EU authorities and poison control centers. This chapter reviews the history of cosmetics, types of cosmetics and ingredients, contaminants in cosmetics, cosmetic ingredients of concern and prohibited ingredients, exposure assessment approaches, regulation of cosmetics in the US and in the EU, global approaches to nonanimal testing for cosmetic products, and the development and application of new approach methods (NAMs) for next generation risk assessment (NGRA) of cosmetic ingredients.
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