New Approach Methodologies (NAMs)

New Approach Methodologies (NAMs)

JOINING FORCES FOR THE REPLACEMENT OF ANIMAL STUDIES IN FOOD SCIENCES

Task Force Information

Objectives and list of Task Force members

Contact Information

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Activity Overview

Overview of ongoing and upcoming activities

Expert Groups

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Publications

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Task Force

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Completed Expert Groups

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Task Force Information

Objectives

This unique transversal and multi-stakeholder Task Force aims to:

  • review the recently developed methods and build a consensus on how and what is needed to reduce animal testing in food and beverage development;
  • provide evidence-based science and evaluate potential strategies and approaches that ultimately could replace animal testing in food sciences;
  • communicate and disseminate the opportunities for alternatives in the food and drink sector.

Task Force Members

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Contact Information

For more detailed information, please contact Geraldine Borja at gborja@ilsieurope.be 

Activity Overview

Ongoing

- What Are the Challenges to Use Vital Human Material as an Innovative Approach to Move Towards Human-Based Science and Avoid Animal Research & Testing?

Identify existing tools and approaches that are not reliant on generating data in animals for safety evaluation in the food, nutrition and beverage sector. The outputs of this activity (case studies and roadmap) will be disseminated via a peer-reviewed publication, and shared with national and international authorities probably through a workshop.

Start date: September 2021 - End date: January 2024

In the pipeline

- Prebiotics and Animal Free Testing

The Prebiotics Task Force and NAMs Task Force have developed a new project to address the implementation of NAMs in prebiotic research through a gap analysis and a strategic mapping of existing models.

Expected kick-off: Q4 2024  

Expert Groups

What Are the Challenges to Use Vital Human Material as an Innovative Approach to Move Towards Human-Based Science and Avoid Animal Research and Testing?

Background and Objectives
The translational value from animal to human physiology is questioned. The use of human material (e.g. tissues) offers a sensible opportunity for better extrapolation of safety and efficacy outcomes to humans. But several barriers and constraints exist to their feasibility and acceptance. The activity aims therefore to lead the discussion by proposing concrete actions to overcome these challenges and promote the use of human vital tissues to improve translational research. Overall, this project will contribute to the transition from animal-based to human-based safety evaluation in the food, nutrition and beverage sector. 

Output

This activity will enable the set-up of a roadmap for a network/infrastructure in Europe to make human vital tissue available for (biomedical) research (academia, public sector and industry), that can be used as an example to follow. An important output of this activity will be a peer-reviewed publication setting out the barriers and constraints and highlight gaps and needs to encourage/promote the use of human tissues as an alternative to animal testing 

Expert Group Members

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Prebiotics and Animal Free Testing

Background and Objectives

Traditionally, research heavily relied on animal models to study the effects of prebiotics. However, their relevance to human physiology is questioned, especially concerning gut microbiota composition and function. This Expert Group will investigate the challenges and opportunities in implementing new approach methodologies (NAMs), such as in vitro models and computational simulations, for prebiotic research. The central research question is whether validated animal-free models, or combinations of non-animal and human based methods, can demonstrate gut microbiome changes and their impact on prebiotic-related health benefits, focusing on gut health, immune response, and cognition.

The group aims to:

  • Map existing NAMs and evaluate their capability to simulate human physiological conditions relevant to the health outcomes of interest, through a systematic literature review.
  • Conduct a gap analysis of existing and potential New Approach Methodologies (NAMs) for prebiotic research through stakeholder workshops and expert consultation.
  • Develop a decision tree to help select appropriate models based on their mode of action. By identifying gaps and limitations, the goal is to provide guidance for the development and use of NAMs in preclinical models for prebiotic research.

The activity is shared with the Prebiotics Task Force

Output

This activity will result in a Perspective Paper.

Expert Group Members

WP DataTables

Publications

All Publications

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Alternatives to Animal Testing in Food Safety, Nutrition and Efficacy Studies

NEW APPROACHES FOR FOOD SAFETY

Background: Methods and approaches that can be used in food and nutrition research are changing at a faster pace than ever. Whereas animal methods are mostly known for their use in food safety analysis (see Part I), they also play in important role in proof-of-concept and mechanistic studies of products, as well as studying potency, efficacy, and tolerance of foods and food ingredients. Members of the International Life Sciences Institute (ILSI) Europe have formed an expert group to review possibilities, opportunities, and challenges for the potential use of alternative testing strategies in nutrition research and regulatory requirements, supporting the 3Rs principle of Replacement, Reduction, Refinement of animal research, which can ultimately be used in support of regulatory submissions for pre-market authorisation.
Scope and approach: For the different areas of food for specific groups and health claims, the acceptability of non-animal approaches is evaluated in comparison to legislative requirements in Europe. The alternative approaches considered cover emerging tools and methodologies such as organoids, organs-on-a-chip or human in vitro gastrointestinal simulators.
Conclusions: In nutrition research, there has been a long tradition of following a certain experimental trajectory for grounding scientific hypotheses starting from in vitro data moving on to in vivo verification in a preferred animal model and finally proving this in a human setting. From a regulatory perspective there is no specific requirement for animal experimentation that justifies the use of the majority of animal experiments in the
assessment of nutritional content and value of food products. However, animal data are mostly considered as the standard, and guidance for alternative approaches that would be accepted is lacking. It is therefore important to further build evidence and offer validation for the adequacy of already existing in vitro tools to ensure their suitability for substantiating dose levels and further planning clinical trials. What are we waiting for? Keywords Expand

Non-animal testing, Nutrition research, Regulation

To download this open-access article, please click here.

This work was commissioned by the Alternatives to Animal Testing in Food Safety, Nutrition and Efficacy Studies Task Force.

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Alternatives to Animal Testing in Food Safety, Nutrition and Efficacy Studies

NEW APPROACHES FOR FOOD SAFETY

Background: Methods and approaches that can be used in food and nutrition research are changing at a faster pace than ever. Whereas animal methods are mostly known for their use in food safety analysis (see Part I), they also play in important role in proof-of-concept and mechanistic studies of products, as well as studying potency, efficacy, and tolerance of foods and food ingredients. Members of the International Life Sciences Institute (ILSI) Europe have formed an expert group to review possibilities, opportunities, and challenges for the potential use of alternative testing strategies in nutrition research and regulatory requirements, supporting the 3Rs principle of Replacement, Reduction, Refinement of animal research, which can ultimately be used in support of regulatory submissions for pre-market authorisation.
Scope and approach: For the different areas of food for specific groups and health claims, the acceptability of non-animal approaches is evaluated in comparison to legislative requirements in Europe. The alternative approaches considered cover emerging tools and methodologies such as organoids, organs-on-a-chip or human in vitro gastrointestinal simulators.
Conclusions: In nutrition research, there has been a long tradition of following a certain experimental trajectory for grounding scientific hypotheses starting from in vitro data moving on to in vivo verification in a preferred animal model and finally proving this in a human setting. From a regulatory perspective there is no specific requirement for animal experimentation that justifies the use of the majority of animal experiments in the
assessment of nutritional content and value of food products. However, animal data are mostly considered as the standard, and guidance for alternative approaches that would be accepted is lacking. It is therefore important to further build evidence and offer validation for the adequacy of already existing in vitro tools to ensure their suitability for substantiating dose levels and further planning clinical trials. What are we waiting for? Keywords Expand

Non-animal testing, Nutrition research, Regulation

To download this open-access article, please click here.

This work was commissioned by the Alternatives to Animal Testing in Food Safety, Nutrition and Efficacy Studies Task Force.

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Completed Expert Groups