FDA Releases Draft Compliance Policy Guide for Food Allergen Labeling and Cross-Contact

By Food Safety Tech Staff

On May 16, the FDA released a draft Compliance Policy Guide (CPG) to provide guidance for FDA staff on the enforcement policy regarding major food allergen labeling and cross-contact. The guide reflects FDA’s thinking on major food allergen enforcement policy based on the current regulatory framework and latest science. When finalized, it will replace the existing CPG 555.250 for FDA staff.

Among the updates, the draft CPG describes the labeling requirements for major food allergens and proper use of the ingredient list and the “Contains” statement for major food allergen declarations. It also describes requirements for firms to implement controls to prevent or significantly minimize allergen cross-contact. In addition, the draft CPG describes additional allergen labeling violations and directs FDA staff to examine potential product adulteration due to allergen cross-contact as well as potential labeling violations.

The agency stated that it is aware that some manufacturers are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence. While the draft CPG does not specifically address this issue, the FDA said that it recognizes that this practice may make it more difficult for sesame-allergic consumers to find foods that are safe for them to consume—an outcome that the FDA does not support, and that the agency is engaging with stakeholders on this issue. The draft CPG does address the FDA’s enforcement policy for labeling and cross-contact controls for major food allergens, including sesame.

Stakeholders can submit electronic or written comments within 60 days of publication in the Federal Register.

May 1, 2023

FDA Warns Industry on Food Safety Risks of Transferring Genes for Proteins that are Food Allergens

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The FDA has issued a letter to developers and manufacturers of new plant varieties who intend to transfer genes for proteins that are food allergens (including allergens from foods identified as major food allergens) into new plant varieties used for food. The purpose of the letter is to remind them of the relevant legal requirements for these products, which may include adding a gene for an allergenic animal protein to a new plant variety to provide a non-animal source of the protein for use as an ingredient in another food.

While the agency noted that it is not aware of any foods currently in the U.S. market derived from these types of new plant varieties, it is aware of research and development in this area.

The FDA is asking developers to consider the food safety risks posed by such allergens and plan early in development to manage those risks, including the potential for recalls due to undeclared allergens.

“We are specifically reminding those developers who are now exploring development of these types of plant varieties of their responsibility for food safety. In particular, we are reminding them to consider the allergenicity issues related to their products, and how they would be stewarded from production to manufacturing to consumption so that they do not inadvertently or unexpectedly enter the food supply,” the FDA stated. “We are also reminding them that they need to be properly labeled when intentionally part of the food supply.”

To reduce risk to consumers as well as the risk of recalls, the FDA is encouraging developers of new plant varieties to consult with the agency through its voluntary premarket consultation program for foods from new plant varieties prior to marketing.

April 24, 2023

UN Releases Report on Safety of Cell-based Food Products

By Food Safety Tech Staff

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As regulatory bodies in the U.S. and around the globe prepare to accept cell-based food products into their markets, a new report, Food Safety Aspects of Cell-Based Food, sheds light on potential hazards posed by this new class of foods.

Published jointly by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO), the 146-page report includes country case studies from Israel, Qatar, Singapore, as well as findings and recommendations from a global technical panel of experts from academia and industry.

The panel identified 53 potential hazards that may be introduced during the Cell Sourcing, Cell Harvesting, Food Production and Food Processing Phases. All of which exist within traditionally produced foods, apart from:

The potential for expression of novel toxins, toxic metabolites, or allergens or a change in expression of toxins, toxic metabolites, or allergens as a result of genomic instability, genetic or phenotypic Instability, and / or induced through physical or biochemical stimuli during cell culture.
Physiochemical transformation of food components (i.e., altered protein structure, reactive species formation) due to food processing or storage. The panel notes that while this same hazard is present in conventionally produced food, cell-based foods may contain new inputs (e.g., scaffolds and residues) and processing ingredients that must be tested.

“Many hazards are already well-known, and they exist in conventionally produced food,” the reports reads. “For example, microbiological contamination can occur at any stages of any food production process, including those involved in producing cell-based food. The experts concluded, however, that most cases of microbial contamination during the cell growth and production stages would inhibit cell growth. If the cells have grown and reached product expectations for harvest, then occurrence of such contamination would be extremely rare during the production process, but it could occur post-harvest, as is the case with many other food products. Various existing prerequisite programmes such as good manufacturing and hygiene practices, as well as food safety management systems such as Hazard Identification and Critical Control Points (HACCP), are applicable to ensure food safety for cell-based food.”

The reports calls for additional research and funding to determine if cell-based foods could provide healthy, nutritious, and sustainable food for future generations, while reducing environmental impacts by using less land and water, emitting fewer greenhouse gases, reducing agriculture-related pollution, improving farm animal welfare and reducing the risk of zoonotic diseases that can spread from animals to humans.

Additional topics touched upon by the Technical Panel include the challenge of high production costs, the need for uniform terminology, potential regulatory frameworks for cell-based foods, and a need to further investigate consumer perception and acceptance (including taste and affordability).

April 23, 2023

FDA Reopens Comment Period for Draft Guidance on Labeling of Plant-Based Milk Alternatives

By Food Safety Tech Staff

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On April 20, The FDA announced that it will reopen the comment period for the draft guidance “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry” in response to requests from stakeholders to allow additional time for interested persons to develop and submit comments.

The draft guidance, originally published in the Federal Register on February 22, 2023, was developed to help ensure appropriate labeling of plant-based products that are marketed and sold as alternatives to milk (aka plant-based milk alternatives, or PBMA). It provides industry with recommendations for clear labeling to help consumers make more informed purchasing decisions. It also clarifies that the common or usual names of some PBMA have been established by common usage, and these names include “soy milk” and “almond milk.”

The FDA recommends that PBMA products that are labeled with the term “milk” in their names, such as “soy milk” or “almond milk,” and that have a nutrient composition that is different than milk, include a voluntary nutrient statement that conveys how the product compares with milk based on USDA’s Food and Nutrition Service (FNS) fluid milk substitutes nutrient criteria. The goal is to help consumers make informed dietary choices when it comes to understanding certain nutritional differences between plant-based products that are labeled with “milk” in their names and milk.

If a PBMA is not labeled with “milk” as part of its name, but instead is labeled with another term like “beverage” or “drink” and does not make a claim comparing the product to milk, then the voluntary nutrient statement recommendations in the draft guidance would not apply.

In 2018, the FDA issued notice soliciting comments from the public to gain insight into how consumers use PBMA products and how they understand the term “milk” when included in the names of products made, for example, from soy, peas and nuts. The agency received more than 13,000 comments.

In its statement announcing the draft guidance, the FDA noted that, after reviewing these comments and conducting focus group studies with consumers, it determined that consumers generally understand that PBMA do not contain milk and choose PBMA because they are not milk. However, many consumers may not be aware of the nutritional differences between milk and PBMA products. For example, almond or oat-based PBMA products may contain some calcium and be consumed as a source of calcium, but their overall nutritional content is not similar to milk.

Comments should be submitted to Regulations.gov and identified with the docket number FDA-2023-D-0451.

April 17, 2023

Yiannas Joins Chipotle Food Safety Advisory Council

By Food Safety Tech Staff

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Frank Yiannas, former FDA Deputy Commissioner for Food Policy and Response, has been appointed to Chipotle Mexican Grill’s Food Safety Advisory Council, a group of independent experts commissioned to ensure Chipotle’s food safety standards continue to evolve and serve as best practices for the restaurant industry.

Chipotle established the Food Safety Advisory Council in 2016 to complement the company’s internal food safety team in pursuit of continuous improvement and performance excellence. Yiannas joins fellow industry experts David Acheson, M.D., former FDA Associate Commissioner of Foods; Elisabeth Hagen, M.D., former USDA Under Secretary for Food Safety; Hal King, Ph.D., former CDC Research Scientist and Director of Food Safety with Chick-fil-A; and James Marsden, Ph. D., former Head of Food Safety at Chipotle and distinguished professor.

“In order to make sure our food safety culture and programs are as robust as possible, it’s critical to supplement our internal expertise with independent external guidance,” said Kerry Bridges, Vice President of Food Safety at Chipotle. “Frank’s vast experience with the FDA and other large brands will help guarantee Chipotle’s food safety standards continue to be best-in-class.”

Yiannas most recently served under two administrations as the Deputy Commissioner for Food Policy and Response at the FDA, a position he held from 2018 to 2023, after spending 30 years in leadership roles with Walmart and the Walt Disney Company.

Throughout his career, Yiannas has been recognized for his role in strengthening food safety standards in new and innovative ways, as well as building effective food safety management systems based on modern, science-based, and tech-enabled prevention principles.

“I’m delighted to join and collaborate with some of the nation’s foremost food safety authorities and serve on Chipotle’s Food Safety Advisory Council,” said Yiannas. “I look forward to lending my experience to a company committed to ‘cultivating a better world’ that benefits people and the planet.”

April 10, 2023

FSSC Releases FSSC 22000 Version 6

By Food Safety Tech Staff

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On March 31, the Foundation FSSC published Version 6 of its FSSC 22000 scheme. The updated version of the FSSC 22000 scheme:

Integrates the requirements of ISO 22003-1:2022
Strengthens the requirements to support organizations in their contributions to meeting the UNs’ Sustainable Development Goals (SDGs)
Incorporates feedback of the Version 6 development survey, which received nearly 2,000 responses

Version 6 will have a 12-month transition window to allow organizations and Certification Bodies to prepare for implementation and gaining accreditation. The first audits to Version 6 will commence April 1, 2024, and all organizations must complete the V6 upgrade audit before March 31, 2025.

The Foundation has published a Version 6 Upgrade Process document, which details the transition requirements and a version of the scheme highlighting the changes between V5.1 and V6.

One of the key changes in V6 is the addition of requirements on food loss and waste. Organizations must have a documented policy and objectives detailing their strategy to reduce food loss and waste within their organization and the related supply chains. The additional food loss and waste requirements support a silo-breaking approach to help organizations contribute and move towards the UN Sustainable development goals (SDGs).

FSSC schemes support the consumer goods industry in implementing effective management systems, protecting their brands, and achieving food safety targets.

April 4, 2023

Mérieux NutriSciences Strengthens Its Food Sustainability Expertise with Blonk Acquisition

By Food Safety Tech Staff

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Mérieux NutriSciences has acquired Blonk, an international expert in food system sustainability. Blonk helps organizations better understand their environmental impact in the agri-food value chain by offering Life Cycle Assessment (LCA)-based advice and developing tailored software tools based on the latest scientific developments and data.

Blonk was founded in 1999 and today includes a team of 50 food and sustainability experts, software developers, and data and methodology specialists. The company is based in the Netherlands. Working with various players in the food chain, from ingredient producers to food manufacturers and retailers, Blonk has a proven track record of providing customized, science-based advice and intelligent software solutions to define the environmental footprint of products. They are also at the forefront of sustainability research in the agri-food sector. In particular, Blonk works with international and governmental organizations to define sector-specific standards and build databases allowing for assessment of environmental impact of food products combined with nutritional parameters for optimized diets.

“Bringing together Blonk and Mérieux NutriSciences is an exciting step in strengthening and accelerating our contribution to the sustainability of food systems,” said Nicolas Cartier, CEO of Mérieux NutriSciences. “Sustainability is at the heart of Mérieux NutriSciences’ vision, mission, and business roadmap, which is highlighted by our ESG commitments for Better Food. Better Health. Better World. Our ambition is to become the reference partner for science-based sustainability solutions in the food sector to support the transition to more positive food systems. With its specific experience in standards definition and data collection for the agri-food sector, Blonk strategically consolidates our existing capabilities in the field of environmental footprinting and enriches the sustainability solutions we already offer in packaging, new food alternatives, responsible sourcing and soil health, as well as transparent labeling.”

March 30, 2023

IFT Launches Commodity-specific Food Traceability Video Series

By Food Safety Tech Staff

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The Institute of Food Technologists (IFT), a nonprofit scientific organization committed to advancing the science of food and its application across the global food system, has released a series of educational videos designed to help food companies better understand how the FDA’s Food Traceability Rule will impact their operations as well as provide guidance on compliance.

“Supply chains were built to move product, not data, so the new regulations are going to be an enormous challenge for those working in food areas identified as being the most potentially harmful to consumers, such as seafood and fruits and vegetables,” said Sara Bratager, Food Traceability & Food Safety Scientist at IFT.

The commodity-specific videos cover the key sections of the Food Safety Modernization Act (FSMA) Rule 204 for each of the foods listed on the FDA’s Food Traceability List.

The FDA’s traceability rule is meant to help facilitate more efficient recalls during a foodborne illness outbreak by requiring a more standardized approach to capturing and sharing product identification and movement data throughout the food chain. This will allow for quicker and more accurate tracking of potentially harmful products, reducing the impact of foodborne illness outbreaks on consumers. All products covered by the rule must be in compliance by January 20, 2026.

“After the announcement by the FDA in November 2022, many food companies were left wondering how the traceability rule would impact them. Now these companies are officially on the clock and must start preparing to be in compliance in less than three years. IFT has created these commodity-specific video to help them gain a better understanding of the road ahead and provide them with the knowledge and tools to help them on their traceability journey,” said IFT Chief Science and Technology Officer Bryan Hitchcock.

To view IFT’s commodity-specific Food Traceability Rule videos, click here.

March 28, 2023

FDA Moves to Permit Salt Substitutes to Reduce Sodium in Standardized Foods

By Food Safety Tech Staff

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On March 24, the FDA announced that it intends to amend the standards of identity (SOIs) to permit the use of salt substitutes in foods for which salt is a required or optional ingredient. The proposed rule would provide manufacturers with flexibility and facilitate industry innovation to reduce sodium in standardized foods.

The proposed rule is part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health, which provides a roadmap of actions the federal government will take to end hunger and reduce diet-related diseases by 2030. The upcoming proposed rule also complements the goals of the FDA’s voluntary sodium reduction targets for processed, packaged and prepared foods.

Currently, most FDA SOIs do not permit the use of salt substitutes. The proposed rule would use a “horizontal” approach for SOIs, under which a single rule would apply to multiple SOIs across several categories of standardized foods.

Specifically, the proposed rule would amend the 80 SOIs that specify salt as a required or an optional ingredient. Because these 80 SOIs are referenced in other SOIs, the FDA notes that 140 of the 250 SOIs currently established for a wide variety of foods could be affected.

The proposed rule does not list permitted salt substitutes but defines them as safe and suitable ingredients used to replace some or all of the added sodium chloride and that serve the functions of salt in food. The extent to which salt can be replaced depends on the ability of a salt substitute to replace the functions of salt in food without compromising food safety and the characteristics of the food.

The FDA is requesting comments on potential salt substitutes that may be used as a result of the new flexibility provided in this proposed rule. Comments can be submitted until 120 days after the date of publication in the Federal Register. Electronic comments can be submitted at Regulations.gov.

March 27, 2023

United Nations FAO Sets Food Safety Priorities

By Food Safety Tech Staff

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The Food and Agriculture Organization of the United Nation (FAO) has published its Strategic Priorities for Food Safety 2022-2031. These priorities were developed collaboratively with FAO Members, international partner organizations (IAEA, WOAH, WTO/STDF, UNIDO, WHO), and FAO technical divisions and centers to “support members in continuing to improve food safety at all levels by providing scientific advice and strengthening their food safety capacities for efficient, inclusive, resilient and sustainable agrifood systems.”

The document, created at the request of the 27^th session of the FAO Committee on Agriculture (COAG) and approved by the 171^st session of FAO Council, is structured around four interconnected strategic outcomes focusing on governance, scientific advice, strengthening national food control systems and promoting public-private partnerships throughout the food chain.

The FAO noted that its goal is to encourage a more coherent integration of food safety into the development of sustainable and inclusive agrifood systems, food security, and nutrition policies as well as agricultural development strategies. “Our aspiration is that this document helps spur investments and secure adequate human and financial resources for FAO to successfully implement its food safety program,” said Corinna Hawkes, FAO Director of the Food Systems and Food Safety Division.

The four strategic outcomes include:
1. Intergovernmental and intersectoral coordination of food safety governance is reinforced at all levels.

2. Sound scientific advice and evidence are provided as the foundation for food safety decision-making.

3. National food control systems are further strengthened and are continuously improved by:

Providing technical support to FAO Members to evaluate their national food control systems, identify needs and design integrated capacity development programs
Supporting FAO Members and relevant stakeholders, particularly in developing and transition economy countries, where requested, to participate more actively in Codex Alimentarius work
Supporting FAO Members in developing and updating their food safety standards, legal frameworks and government policies, as well as operational level procedures and guidelines
Helping FAO Members generate relevant food safety data that reflects their national context/situation
Supporting FAO Members and relevant stakeholders to embrace relevant technological developments, including digital technologies, in food control and food safety management

4. Public and private stakeholder collaboration is promoted to ensure food safety management and controls throughout agrifood systems by:

Supporting both governments and food chain actors starting from primary production and including associated industries, academia, consumers and other stakeholders, in adopting gender responsive and inclusive programs of preventative food safety control and management
Providing the tools and resources for stakeholders to make informed choices and adopt food safety interventions that are specific to their countries’ priorities, safety risks and their constituents’ differentiated needs
Ensuring that lessons learned from national- and regional-level food safety control programs and initiatives can inform global level normative work and strengthen dialogues on food safety
Supporting initiatives aiming to create training programs and curricula that better reflect the complexity of food safety and the need for collaborations across disciplines

Download the full document here.

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