Scientific Publications

ILSI Europe disseminates science by publishing articles on original research, literature reviews and gap analyses, and meeting proceedings in peer-reviewed journals.  ILSI Europe also publishes books, monographs, white papers, and other reports.

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Food Allergy Task Force

NEW APPROACHES FOR FOOD SAFETY

Quantitative risk assessment (QRA) for allergens exists in many different forms with different requirements placed on the risk assessor depending on the question that needs to be answered. An electronic workshop held in October 2020 and comprising representatives from a wide range of food allergy and allergen stakeholder groups identified that a summary of current best in class guidance, identified gaps, potential improvements & harmonization of allergen QRA arising largely from cross contact would be very beneficial. The current manuscript provides an introduction to allergen QRA and an overview of inputs potentially needed for different QRA methods, when deemed feasible and necessary. It also introduces the European branch of the International Life Sciences Institute (ILSI Europe) Expert Group (EG), created to attempt to achieve consensus on the methodologies needed for allergen QRAs by food business operators, and their implementation. Areas of focus include proactive assessments for food production under normal conditions, both in the upstream supply chain and in food production facilities, and reactive assessments as part of an allergen incident response. As a follow-up report to the October 2020 electronic workshop, the current manuscript provides an overview of allergen QRA and insights into the guidance being developed. This manuscript will itself be followed by more detailed guidance for allergen QRA published open access as an ILSI Europe report.

Link to download the full-text

Keywords Expand

Allergens; Quantitative risk assessment (QRA); Supply chain; Incidents; Cross-contact; Precautionary allergen labelling (PAL)

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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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Prebiotics Task Force

-

Probiotics Task Force

GUT MICROBIOME AND HEALTH

Citation: doi.org/10.5281/zenodo.6394213

The scientific understanding of prebiotic and probiotic mechanisms has grown substantially in recent years. Although effects are often strain and product specific, some prebiotic and probiotic benefits may be driven by common, shared mechanisms and may therefore be generalizable. The use of emerging physiological and analytical tools in a multidisciplinary research setting will enable the elucidation of further mechanisms. In this way, it will be possible to improve the understanding of prebiotic, probiotic and synbiotic health effects. Based on recent sound scientific evidence, the monograph is a valuable reference work, aimed at informing a wide audience about the intestinal microbiota and the prebiotic and probiotic nutritional concepts.

To download the publication click here

This work was commissioned by the Prebiotics and Probiotics Task Forces.

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Obesity and Diabetes

Nutrition Security and Societal Aspects

Background: The gold-standard techniques for measuring insulin sensitivity and secretion are well established. However, they may be perceived as invasive and expensive for use in dietary intervention studies. Thus, surrogate markers have been proposed as alternative markers for insulin sensitivity and secretion. This systematic review aimed to identify markers of insulin sensitivity and secretion in response to dietary intervention and assess their suitability as surrogates for the gold-standard methodology. Methods: Three databases, PubMed, Scopus, and Cochrane were searched, intervention studies and randomised controlled trials reporting data on dietary intake, a gold standard of analysis of insulin sensitivity (either euglycaemic-hyperinsulinaemic clamp or intravenous glucose tolerance test and secretion (acute insulin response to glucose), as well as surrogate markers for insulin sensitivity (either fasting insulin, area under the curve oral glucose tolerance tests and HOMA-IR) and insulin secretion (disposition index), were selected. Results: We identified thirty-five studies that were eligible for inclusion. We found insufficient evidence to predict insulin sensitivity and secretion with surrogate markers when compared to gold standards in nutritional intervention studies. Conclusions: Future research is needed to investigate if surrogate measures of insulin sensitivity and secretion can be repeatable and reproducible in the same way as gold standards.

Keywords Expand

Insulin Sensitivity; Insulin Secretion; Gold Standard; Surrogate Markers; Dietary Intervention Studies

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

This work was commissioned by the Obesity and Diabetes Task Force.

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Citation: https://doi.org/10.5281/zenodo.6651934

Allergen cross-contact and unintended allergen presence (UAP) are a significant challenge for food operators.

The aim of this document is to translate the findings of the Expert Group on 'Food Allergen Quantitative Risk Assessment (QRA)' into a Guidance document which provides tools and approaches to help harmonize the data gathering process for food allergen risk assessments and therefore aid with their implementation. This Guidance aims to promote consistency in documentation, decision making and the application of allergen QRA.

The purpose of this Guidance is not to take an allergen labelling or risk management decision for the user, but rather is intended to help them decide when allergen QRA is appropriate or necessary, and how to decide if it can actually be performed and, if it is to be undertaken, what is the most suitable methodology.

The intended audience is mainly industry wishing to understand and conduct food allergen risk assessments, and potentially QRA. However, it should be noted, that this guide could also be useful for others, including official control agencies.

Watch the webinar here.

ILSI Europe Guidance Report Series: download here.

Tools and documents developed for use with the Guidance

  • Cross-contact / Contamination estimate calculator: A practical calculator to estimate the UAP in a product can be found here. This tool was initially developed by the EU project iFAAM and is kindly provided by TNO. It can be used for free after initial registration.
  • QRA calculation worksheet v4.4: download here.
  • Incidents form: For download here. See Chapter 4 of the Guidance for more information.
  • Sampling & Analysis form: download here.

Training videos for this Guidance

  • Management of Operations: to be published soon
  • Incidents: to be published soon

For more information about the Food Allergy Task Force click here.

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Food Allergy Task Force

NEW APPROACHES FOR FOOD SAFETY

Quantitative risk assessment (QRA) for allergens exists in many different forms with different requirements placed on the risk assessor depending on the question that needs to be answered. An electronic workshop held in October 2020 and comprising representatives from a wide range of food allergy and allergen stakeholder groups identified that a summary of current best in class guidance, identified gaps, potential improvements & harmonization of allergen QRA arising largely from cross contact would be very beneficial. The current manuscript provides an introduction to allergen QRA and an overview of inputs potentially needed for different QRA methods, when deemed feasible and necessary. It also introduces the European branch of the International Life Sciences Institute (ILSI Europe) Expert Group (EG), created to attempt to achieve consensus on the methodologies needed for allergen QRAs by food business operators, and their implementation. Areas of focus include proactive assessments for food production under normal conditions, both in the upstream supply chain and in food production facilities, and reactive assessments as part of an allergen incident response. As a follow-up report to the October 2020 electronic workshop, the current manuscript provides an overview of allergen QRA and insights into the guidance being developed. This manuscript will itself be followed by more detailed guidance for allergen QRA published open access as an ILSI Europe report.

Link to download the full-text

Keywords Expand

Allergens; Quantitative risk assessment (QRA); Supply chain; Incidents; Cross-contact; Precautionary allergen labelling (PAL)

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