Continuing animal tests on cosmetic ingredients for REACH in the EU

Knight, Jean; Rovida, Costanza; Kreiling, Reinhard; Zhu, Cathy; Knudsen, Mette Aaskov; Hartung, Thomas

doi:10.14573/altex.2104221

Cited by 21 publications

(24 citation statements)

References 7 publications

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“…This helps registrants identify additional data for their registrations and facilitates the identification of similar or identical substances ( ECHA, 2020 ). ECHA’s public chemical database may also be used to conduct retrospective data analyses and other research efforts, when the level of detailed data needed are present in such reports ( Luechtefeld et al, 2016a ; Luechtefeld et al, 2016b ; Luechtefeld et al, 2016c ; Luechtefeld et al, 2018 ; Knight et al, 2021 ).…”

Section: Industrial Chemicalsmentioning

confidence: 99%

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health

Stucki¹,

et al. 2022

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New approach methodologies (NAMs) are increasingly being used for regulatory decision making by agencies worldwide because of their potential to reliably and efficiently produce information that is fit for purpose while reducing animal use. This article summarizes the ability to use NAMs for the assessment of human health effects of industrial chemicals and pesticides within the United States, Canada, and European Union regulatory frameworks. While all regulations include some flexibility to allow for the use of NAMs, the implementation of this flexibility varies across product type and regulatory scheme. This article provides an overview of various agencies’ guidelines and strategic plans on the use of NAMs, and specific examples of the successful application of NAMs to meet regulatory requirements. It also summarizes intra- and inter-agency collaborations that strengthen scientific, regulatory, and public confidence in NAMs, thereby fostering their global use as reliable and relevant tools for toxicological evaluations. Ultimately, understanding the current regulatory landscape helps inform the scientific community on the steps needed to further advance timely uptake of approaches that best protect human health and the environment.

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Section: Industrial Chemicalsmentioning

confidence: 99%

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health

Stucki¹,

et al. 2022

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“…13 In contrast to REACH, the ban on cosmetics in 2013 was hailed as a major success in the Three Rs field, though this was put into question very recently. 14…”

Section: Introductionmentioning

confidence: 99%

“…13 In contrast to REACH, the ban on cosmetics in 2013 was hailed as a major success in the Three Rs field, though this was put into question very recently. 14 With the publication and implementation of EU Directive 2010/63, there was an increase in the establishment of national and international Three Rs initiatives, which often led to the formation of Three Rs centres and platforms. Many countries did not have national consensus platforms that satisfied ecopa's requirements of quadripartite representation in their governing body, even though they did have active Three Rs centres.…”

Section: Introductionmentioning

confidence: 99%

The Rise of Three Rs Centres and Platforms in Europe*

et al. 2022

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Public awareness and discussion about animal experiments and replacement methods has greatly increased in recent years. The term ‘the Three Rs’, which stands for the Replacement, Reduction and Refinement of animal experiments, is inseparably linked in this context. A common goal within the Three Rs scientific community is to develop predictive non-animal models and to better integrate all available data from in vitro, in silico and omics technologies into regulatory decision-making processes regarding, for example, the toxicity of chemicals, drugs or food ingredients. In addition, it is a general concern to implement (human) non-animal methods in basic research. Toward these efforts, there has been an ever-increasing number of Three Rs centres and platforms established over recent years — not only to develop novel methods, but also to disseminate knowledge and help to implement the Three Rs principles in policies and education. The adoption of Directive 2010/63/EU on the protection of animals used for scientific purposes gave a strong impetus to the creation of Three Rs initiatives, in the form of centres and platforms. As the first of a series of papers, this article gives an overview of the European Three Rs centres and platforms, and their historical development. The subsequent articles, to be published over the course of ATLA’s 50th Anniversary year, will summarise the current focus and tasks as well as the future and the plans of the Three Rs centres and platforms. The Three Rs centres and platforms are very important points of contact and play an immense role in their respective countries as ‘on the ground’ facilitators of Directive 2010/63/EU. They are also invaluable for the widespread dissemination of information and for promoting implementation of the Three Rs in general.

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“…1223/2009) [1]. At the same time, the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation can impose in vivo testing of those same ingredients under its chemical testing requirements [2], even if two important REACH amendments, Regulation EU 2016/863 and Regulation EU 2016/1688, were adopted in 2016. These require in vitro methods for the assessment, respectively, of skin/eye irritation and skin sensitization unless technically infeasible.…”

Section: Introductionmentioning

confidence: 99%

Alternative in vitro models used in the main safety tests of cosmetic products and new challenges

Filaire

Nachat‐Kappes²,

Laporte

et al. 2022

Intern J of Cosmetic Sci

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Background: Guided by ethical considerations and regulatory requirements such as the 7th Amendment to the European Cosmetics Directive N° 1223/2009, the cosmetic industry has developed and evaluated alternative test strategies such as in vitro assays, in silico approaches for toxicological endpoints and efficacy of cosmetic products and cosmetics ingredients. In consequence, the European Centre for the Validation of Alternative Methods (ECVAM) has proposed a list of validated cell-based in vitro models for predicting the safety and toxicity of cosmetic ingredients. These models have been demonstrated as valuable and effective tools to overcome the limitations of animal in vivo studies. For example, 3D human skin equivalent models are used to evaluate skin irritation potential; and excised human skin is used as the gold standard for the evaluation of dermal absorption.Objective: This review presents, in relation to the regulatory requirements, the main alternative in vitro models used in the safety tests of cosmetic products, focusing on skin sensitization, skin corrosion, skin irritation and skin absorption, with advantages and limitations of each model. Recent innovative 3D cell technologies such as Organ-on-a-Chip (OoC) models that can bring significant improvements for toxicology and efficacy testing are also presented. Conclusion:The development of OoC technology is promising for assessing the toxicity of substances contained in cosmetics, particularly for repeated dose toxicity, for which no alternative in vitro methods are currently available.Nevertheless, aside from the challenges, the technology needs to be validated and accepted by regulatory organizations as an effective method. Collaboration between researchers, regulatory organizations and industry would be required to achieve this validation. K E Y W O R D S chemical analysis, in vitro, skin, skin-on-a-chip, three-dimensional skin cell model, toxicology Résumé Contexte: Guidée par des considérations éthiques et des exigences réglementaires telles que le 7e amendement à la directive européenne sur les cosmétiques

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Continuing animal tests on cosmetic ingredients for REACH in the EU

Cited by 21 publications

References 7 publications

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health

The Rise of Three Rs Centres and Platforms in Europe*

Alternative in vitro models used in the main safety tests of cosmetic products and new challenges

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