Food Allergen Risk Assessment: Comprehensive Guidance for Industry

The meeting format is being recorded, with a focus on a Q&A session for the food allergy guidance document, emphasizing the importance of a risk-based approach to sampling and analysis.

### Implementing Quantitative Risk Assessment in Allergen Management: A Comprehensive Guidance Overview
* 📊 The guidance document on quantitative risk assessment (QRA) in allergen management was developed over a **two-year period** by an expert group from ILSI Europe.
* 👥 The expert group consisted of **13 members**, with an additional stakeholder group of **52 individuals** from various backgrounds, including industry, academia, regulatory authorities, and patient organizations.
* 📑 The 188-page guidance document has been downloaded over **1,170 times** and is structured for **quick access to relevant sections** based on the user's needs.
* 🔍 Core concepts in the guidance cover **unintended allergen presence**, **intake data**, and **exposure assessment**, with detailed information on **sampling and analysis**.
* 🌍 The document is designed to be globally applicable and a living document, with **periodic revisions planned to ensure continued relevance**.
* The guidance provides tools and approaches to **harmonize data gathering processes with allergen risk assessments**, but is not intended to **make decisions for users**.
* 📊 Core Concepts, as outlined in the presentation, include **understanding unintended allergen presence scenarios**, the **amount of allergens present in food**, **intake data**, and **exposure assessment**.
* ❓ In the Q&A session, a question was raised about the quality of information on sampling for allergens, particularly for small and medium-sized enterprises without subject matter experts. The response highlighted the **lack of existing comprehensive sampling guidance** and **ongoing research in this area**.

### Challenges and Considerations in Allergen Sampling and Analysis
* 🔍 The guidance document emphasizes the importance of **proper sampling techniques**, with different levels of complexity depending on the **distribution of allergens in the consignment**.
* 🏭 It is crucial to consider where on the production line to take samples, with certain areas more likely to show **cross-contamination**.
* The speakers highlighted the importance of having a **good dialogue with the laboratory conducting the analysis**, providing them with as much information as possible about the **sample and the production process**.
* 📊 Sampling variance is a significant factor, with some situations requiring **multiple samples to accurately assess allergen presence**.
* 💰 Budget considerations were also discussed, with the reminder that **allergen analysis may be more expensive than other types of testing**.
* 🥛 In cases where only specific allergenic proteins are present (e.g., casein but not whey in milk), there may be challenges in **converting the results to total allergen content**.
* 📉 The guidance recommends using the **worst-case scenario** when faced with a wide range of results, to ensure a **conservative risk assessment**.
* 👥 The speakers emphasized the importance of **transparency in reporting allergen analysis results**, especially in the current state of flux regarding **reference doses and risk assessment methodologies**.

Demystifying Allergen Quantitative Risk Assessment Webinar

ILSI Europe

The Purpose of the Webinar on Food Allergy Guidance Document

The webinar aims to reach a wider audience and provide an extensive Q&A session, especially for those who attended the previous meeting in Amsterdam.

It focuses on the guidance document for quantitative risk assessment in food allergen management.

ILC works to foster collaboration among industry, academics, and governmental agencies to address scientific issues in the food industry.

The Expertise of Renee and Simon in Allergen Risk Assessment

Renee is a leading expert in allergen test methods and risk assessment, with involvement in various food committees and expert consultations.

The presentation is based on a talk by Ben Remington and focuses on the global interest in integrating quantitative methodology into allergen risk assessment.

The project involved over 3,500 meeting hours and had an expert group of 13 members consulting regularly with an additional stakeholder group of 52 individuals from various backgrounds.

Quick Access Guidance for Managing Allergens

The document provides guidance on proactive and reactive allergen management, including communication across supply chains and incident management.

It also offers essential information on gathering data and conducting risk assessments.

The guidance is designed for quick access to relevant sections and is globally applicable, aiming to remain relevant for a long time.

Tools and Approaches for Harmonizing Data Gathering Process with Allergen Risk Assessments

Periodic revisions are anticipated to prolong the usefulness of the guidance document.

The purpose of the document is to provide tools and approaches for harmonizing the data gathering process with allergen risk assessments, not to make decisions for the users.

Core Concepts, including unintended allergen presence, intake data, and exposure assessment, are crucial and cut across the entire guidance.

The guidance also covers the characterization of contamination, different ways to characterize cross-contamination, and the importance of sampling analysis beyond just obtaining a sample.

Guidelines for Sampling and Analysis in Risk Assessment

Sampling and analysis are crucial for a thorough risk assessment, with the need to consider the source of samples, sample size, and analytical methods.

The number of samples required for testing is determined by the level of concern, with higher concern situations requiring a larger sample size.

The quality of information on sampling for allergens is still evolving, but guidance is available for different levels of concern, from low to high, with more complex situations requiring greater effort in sampling.

The Importance of Sampling and Analysis in Allergen Testing

- Sampling variance is crucial in determining the presence of allergens, sometimes requiring significant effort and resources.

- The overall uncertainty budget in allergen analysis is currently greater than desired, emphasizing the need for thoroughness and investment in sampling.

- Good dialogue with the laboratory and a risk-based approach to testing are vital in obtaining meaningful and relevant analysis results.

Improving Dialogue and Collaboration in Food Analysis

Open communication between food manufacturers and laboratories is crucial for a better understanding of product testing and results.

Trying to drive down the price of analysis can lead to shortcuts and poor outcomes, so it's important to invest in proper testing.

The AOAC's comprehensive guidance for validating test kit methods is a significant step towards establishing good practice in the industry and is likely to have a paywall for non-members to access.

Uncertainty and Transparency in Risk Assessment

There is uncertainty about the timeline and decisions regarding the Codex process, making the area unstable.

A tool is available to perform a quantitative risk assessment without the need for analysis, based on size, weight, and amount of hang-ups.

Transparency in risk assessment is crucial until consensus is reached on the appropriate reference dose, intake size, and application of CER label.

The selection of the worst-case scenario is advised when dealing with a wide range of data in real-life situations, to ensure a conservative risk assessment.

The Significance of Measuring Specific Allergen Proteins

Measuring specific allergen proteins is mainly done in clinical laboratories for diagnostic purposes related to the degree of patient reactions.

It is particularly relevant when trying to detect derivatives of specific allergic ingredients, as it can be challenging to detect an allergen when a target protein is not present.

The process also involves informing the laboratory of the components being tested to determine the conversion factor needed for accurate measurements.

Developing Guidance for Allergen Protein Equivalents

There is a need to develop guidance for derivatives containing specific proteins to determine their total protein equivalence for allergic individuals.

It is important to have a dialogue with laboratories and kit manufacturers to ensure the analysis is fit for purpose.

The development of a community of practice is crucial for trialing, improving, and updating the guidance for the safety of allergic consumers.