Cosmetic Safety Assessment Using New Approach Methodologies (NAMs)

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.