Cosmetic Safety Assessment Using New Approach Methodologies (NAMs)

Web Training – bookable at any time

Duration: approx. 3 work days
(approx. 13 hrs video training + online exam)

Course fee: 1,500 EUR + VAT

Registration

General Terms and Conditions for participation in events of DGK eVent

Program

Chapter 1: Introduction and Landscape

No	Title	Speaker
1‑1	Cosmetic Safety Assessment: EU Perspective	Arianna Giusti, Cosmetics Europe
1‑2	Cosmetic Safety: US Perspective	Kimberly Norman, Personal Care Products Council (PCPC)
1‑3	Approach to Safety Assessment for Botanicals: Focus on New Approach Methods	Lauren Brown, ToxStrategies
1‑4	Validation and Regulatory Acceptance	David Allen, International Collaboration on Cosmetics Safety (ICCS)
1‑5	Good In-Vitro Method Practices/Good Laboratory Practices (GIVIMP/GLP) for In-Vitro Data Evaluators	Amanda Ulrey, Institute for In Vitro Sciences (IIVS)

Presentation Summaries (Chapter 1)

1-1 – Cosmetic Safety Assessment: EU perspective

This presentation explores the European Union's approach to cosmetic safety assessment, highlighting the regulations and standards that ensure the safety and quality of cosmetic products. It delves into the key principles of the European cosmetic framework, aimed at guaranteeing the safety, high quality, and efficacy of personal care products, and explains their implementation across Europe.

The first section provides an overview of the EU's perspective on cosmetic safety assessment, discussing the core principles of the European cosmetic framework. The second part focuses on the safety assessment process, detailing the steps involved in risk assessment, the methodology for ingredient evaluation, and the role of the SCCS Notes of Guidance, which offer comprehensive guidelines for testing and evaluating cosmetic ingredients. The final section addresses the prohibition of animal testing for cosmetics in Europe and explores how New Approach Methodologies (NAMs) serve as valuable alternative tools for ensuring product safety without animal testing.

1-2 – Cosmetic Safety: US Perspective

The Modernization of Cosmetics Regulation Act (MoCRA), passed in 2022, completely overhauled the cosmetic regulatory landscape in the United States. This presentation reviews the key principles of MoCRA, with an emphasis on safety assessment and adverse event reporting. New FDA tools and guidance are also covered.

1-3 – Approach to Safety Assessment for Botanicals: Focus on New Approach Methods

This presentation reviews considerations for conducting safety assessments for botanicals. Botanicals are a popular and challenging topic in safety assessment, given the complexities of the sourcing and potentially wide ranges of products and materials that could be used. Because botanicals are often complex mixtures, typical New Approach Methods (NAMs), such as QSARs and in-vitro methods, may be more difficult to use. Guidance and a workflow for using NAMs for assessing botanicals is provided.

1-4 – Validation and Regulatory Acceptance

This presentation provides a brief historical perspective on test method validation and the associated challenges presented by traditional approaches. It then summarizes efforts within the United States to develop a strategy and roadmap for establishing confidence in new approaches and updated guidance that has resulted from interagency efforts among US authorities. Finally, some overarching principles are presented for increasing scientific confidence to drive acceptance and implementation of New Approach Methodologies.

1-5 – Good In-Vitro Method Practices/Good Laboratory Practices (GIVIMP/GLP) for In-Vitro Data Evaluators

Good In-Vitro Methods Practices (GIVIMP) is essential guidance for conducting in-vitro experiments for many purposes, from regulatory submission to method development. This presentation reviews key GIVIMP principles, highlights their importance for ensuring good in-vitro science, and compares and contrasts this seminal guidance with the broader Good Laboratory Practices.

Chapter 2: Local Toxicity

No	Title	Speaker
2‑1	In-Vitro Ocular and Dermal Irritation Testing	Nathan Wilt, IIVS
2‑2	Photosafety Testing Using New Approach Methodologies	Allison Hilberer, IIVS
2‑3	Overview of Non-Animal Methods for Assessment of Skin Sensitization Potential	Argel Islas-Robles, IIVS
2‑4	In-Vitro Respiratory Test Models for Hazard Identification	Vivek S. Patel, IIVS

Presentation Summaries (Chapter 2)

2-1 – In-Vitro Ocular and Dermal Irritation Testing

Due to decades of work, there are many in-vitro and ex-vivo approaches for assessing ocular and dermal irritation and corrosion. This presentation reviews the science, conduct, and performance of these methods, and how they can be used to address various regulatory and other safety-testing needs. The lecture will also review limitations, challenges, and ways to overcome them during conduct of the assays and analysis of the data that comes from them.

2-2 – Photosafety Testing Using New Approach Methodologies

Have you ever considered how sunlight could impact the products you use or may be exposed to? These could include products that you use every day, like cosmetics, fragrances, pharmaceuticals, and personal care products. Join me in this session as we walk through photosafety assessments, conducted to understand if a test compound has the potential to become more reactive or toxic in the presence of light. This session will provide a general overview of photosafety assessments, including the triggers for the testing and the many test methods that can be used in the assessment, including those with regulatory test guidelines and some currently under development. The session will also present tiered testing approaches to address photosafety, including a case study using several NAMs to establish No-Effect Levels (NOELs) for phototoxicity.

2-3 – Overview of Non-Animal Methods for Assessment of Skin Sensitization Potential

There are many in-vitro and in-silico methods that can be used to address dermal sensitization. For this endpoint, there has also been progress in developing and adopting Integrated Approaches to Testing and Assessment (IATA) and Defined Approaches, which provide the ability to use a combination of multiple in-vitro or in-silico approaches in an internationally harmonized manner. This presentation reviews the supporting science behind existing approaches, discusses the details of a variety of methods, and previews some upcoming integrated approaches under development on the global regulatory docket.

2-4 – In-Vitro Respiratory Test Models for Hazard Identification

Historically, inhalation toxicity testing has been conducted using animal models, particularly rats. However, the inherent differences in the rat and human biology and responses complicate human health risk assessment using rat data. With advanced human in-vitro respiratory test models, it is now possible to design studies that simulate realistic scenarios and generate human-relevant data. In this presentation, we will discuss the different in-vitro respiratory models that are available and their suitability for inhalation toxicity assessment. We will also present a case study on the use of an Integrated Approach to Testing and Assessment (IATA) for a New Approach Methodology (NAM) for refining inhalation risk assessment from the point of contact toxicity of an irritant.

Chapter 3: Emerging Assays for Genotoxicity

No	Title	Speaker
3	Genotoxicity Assessments for Cosmetics and Personal Care Products: NAMs on the Horizon	Hans Raabe, IIVS

Presentation Summary (Chapter 3)

3 – Genotoxicity Assessments for Cosmetics and Personal Care Products: NAMs on the Horizon

While there have been several in vitro assays to assess various elements of genotoxicity available for many years, there are limitations to these approaches. The focus for this presentation is on the supporting science and performance of relatively new technologies, including reconstructed human skin models for the comet and micronucleus assays, and the ToxTracker assay, which includes a look at a variety of genotoxic mechanisms. While these assays have been under development and are in use by a variety of industries for some internal and regulatory applications, global regulatory acceptance is proceeding slowly, with test guidelines in development.

Chapter 4: Systemic Toxicity

No	Title	Speaker
4‑1	Cell Painting as a New Approach Method for Cosmetic Safety Assessment	Jo Nyffeler, Helmholtz Centre for Environmental Research
4‑2	Transcriptomics and Safety Pharmacology for Cosmetics Risk Assessment	Jesse Rogers, Merck

Presentation Summaries (Chapter 4)

4-1 – Cell Painting as a New Approach Method for Cosmetic Safety Assessment

Cell painting is a technique for high-content assessment of the impacts of chemical exposure on cell morphology in-vitro. Typically, it multiplexes six fluorescent dyes to reveal eight broadly relevant cellular components or organelles. The technology was developed about 10 years ago and has made its way into safety assessment as a potentially useful tool for chemical and ingredient assessment, including at US EPA. This presentation will review work to understand how the technology can be helpful for cosmetic safety assessment, including hazard and potency assessment and exploration of putative mechanisms of perturbation.

4-2 – Transcriptomics and Safety Pharmacology for Cosmetics Risk Assessment

The use of a NAM-based approach for systemic toxicity may include a variety of different NAMs in combination; it will certainly include in-vitro transcriptomics and/or in-vitro pharmacological profiling. Both methods are used frequently by companies, governments, and research institutes as part of a strategy to assess systemic toxicity potential and set in-vitro points of departure. This presentation will review each technology and discuss current potential applications, including advantages and limitations for using them for potency assessment or mechanistic understanding.

Chapter 5: ADME/IVIVE

No	Title	Speaker
5‑1	Characterization of ADME Properties Using New Approach Methods	Susana Proença, EsqLabs
5‑2	ADME and PBK Modeling	Marco Siccardi, EsqLabs
5‑3	Application of PBK Modeling in NGRA – QIVIVE: Quantitative In-Vitro to In-Vivo Extrapolation	Stella Fragki, EsqLabs

Presentation Summary (Chapter 5)

Together, these three presentations provide a comprehensive overview of the importance of assessing Absorption, Distribution, Metabolism, and Excretion (ADME), and how this can be done using in-silico and in-vitro models. Physiologically-Based Kinetic models (PBK) put ADME information together to model the behavior of chemicals in an organism, and Quantitative In-Vitro to In-Vivo Extrapolation ((Q)IVIVE) provides a methodology for extrapolating in-vivo human dose levels corresponding to in-vitro concentrations that have a demonstrated effect on receptors, cells, or tissues. The methodologies in this chapter provide a link between in-vitro assays and in-vivo risk assessment, therefore they are essential to understand and form a key element in a NAMs risk assessment framework. Each presentation will review the science behind the topic, capabilities, gaps, and needs, and important considerations for regulatory use.

Chapter 6: In-Silico Approaches

No	Title	Speaker
6‑1	Methods in Computational Toxicology 1: Introduction, Databases, and Structural Alerts	Mark Cronin, Liverpool John Moores University
6‑2	Methods in Computational Toxicology 2: Read-Across	Mark Cronin, Liverpool John Moores University
6‑3	Methods in Computational Toxicology 3: Quantitative Structure-Activity Relationships (QSARs)	Mark Cronin, Liverpool John Moores University
6‑4	Methods in Computational Toxicology 4: Threshold of Toxicological Concern (TTC)	Mark Cronin, Liverpool John Moores University

Presentation Summary (Chapter 6)

There are a wide variety of in-silico approaches that can be used for cosmetics safety assessment. These four presentations review the major categories, or types, of in-silico models most heavily in use for regulatory purposes, including structural alerts, read-across, Quantitative Structure-Activity Relationships (QSARs), and Threshold of Toxicological Concern (TTC). Each presentation reviews the basic theory behind the approach, example models and databases the audience can use, and recent progress that has been made in updating, standardizing, validating, or evaluating models and model predictions for regulatory applicability.

Chapter 7: Bringing it all Together: Integrated Approaches to Testing and Assessment (IATA) and Next Generation Risk Assessment (NGRA) – Concepts and Examples

No	Title	Speaker
7‑1	Next Generation Risk Assessment (NGRA): From Concept to Application	Maria Baltazar, Unilever
7‑2	Application of NGRA to the Evaluation of Climbazole as a Cosmetic Ingredient	Maria Baltazar, Unilever
7‑3	The Propylparaben Case Study: A 10-Step Read-Across Approach Supported by NAMs	Gladys Ouédraogo, L’Oréal

Presentation Summary (Chapter 7)

This final chapter is meant to provide an overview of Next Generation Risk Assessment, a comprehensive risk assessment framework for non-animal safety assessment. The first presentation will review the concepts and elements of the NGRA framework, using several approaches reviewed in previous chapters. The second and third presentations walk comprehensively through two case studies demonstrating application of the NGRA framework for two different contexts of use. The first reviews an ab-initio case study, where the safety assessment of a cosmetics ingredient is done “from the beginning” without animal data; the second reviews a NAM-enhanced read-across approach.

Speakers

David Allen

Maria Baltazar

Lauren Brown

Stella Fragki

Arianna Giusti

Allison Hilberer

Argel Islas-Robles

Kim Norman

Jo Nyffeler

Gladys Ouédraogo

Vivek Patel

Susana Proença

Hans Raabe

Jesse Rogers

Marco Siccardi

Kristie Sullivan

Amanda Ulrey

Nathan Wilt

Preview

Watch a preview video on the DGK/IKW web trainings for safety assessors

Practical Information

Upon receipt of the payment, the subscriber will be notified that he/she may start the training. After having started the web training for the first time, the user will be able to access the course videos at any time for a period of 14 days. PDF-files of the presentations are made available for download. After completion of the web training, the participant can start the online exam within another 4 weeks. The exam must be completed within 1 hour after activation and can be repeated once.

Registration

Web Training: Cosmetic Safety Assessment Using New Approach Methodologies (NAMs)

(bookable at any time)

Course fee: 1,500 EUR + VAT

General Terms and Conditions for participation in events of DGK eVent

Cosmetic Safety Assessment Using New Approach Methodologies (NAMs)

Web Training – bookable at any time

Duration: approx. 3 work days(approx. 13 hrs video training + online exam)

Program

Chapter 1: Introduction and Landscape

Chapter 2: Local Toxicity

Chapter 3: Emerging Assays for Genotoxicity

Chapter 4: Systemic Toxicity

Chapter 5: ADME/IVIVE

Chapter 6: In-Silico Approaches

Chapter 7: Bringing it all Together: Integrated Approaches to Testing and Assessment (IATA) and Next Generation Risk Assessment (NGRA) – Concepts and Examples

Speakers

Preview

Practical Information

Registration

Duration: approx. 3 work days
(approx. 13 hrs video training + online exam)