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

Contact details in case you have specific questions

Activity Overview

Overview of ongoing and upcoming activities

Expert Groups

Objectives, output and list of experts involved in each activity

Publications

List of publications of this
Task Force

Multimedia

Links to Task Force related documents, recordings and much more...

Completed Expert Groups

Details including experts involved of each activity

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

WP DataTables

Contact Information

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

Activity Overview

Ongoing

- Ethical and scientific constraints to use human material

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 alternatives to animal testing

The aim will be to understand the ways in which various prebiotic ingredients function and evaluate them using non-animal testing methods to uncover their mechanisms of action. The activity is shared with the PRE Task Force.

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 & 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

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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Multimedia

Introductory Video

One-Pager

Completed Expert Groups