Regulatory Trends is a global regulatory and compliance search engine leveraging public sources such as official journals, scientific papers, industry associations, professional organizations, general media and NGOs to provide early insights into regulatory trends and market developments related to food, feed, cosmetics, packaging and chemicals. Learn more.
By Natalie Walker, Product Manager, FoodChain ID
If you’re in the bustling world of food manufacturing, you are well aware that keeping up with food labeling regulations can be like trying to follow a recipe written by committee – constantly changing and more than a little confusing.
This month, I have been chatting with a few of our customers who have been wrestling with these challenges. They shared some real headaches over trying to stay compliant without slowing down their product rollout. So, I’m excited to share a cool solution we have implemented in FoodChain ID’s Recipes & Specifications solution called “Targets!”
From green lights to red flags, food labeling isn’t just about sticking a label on a package. It’s about giving clear, accurate and regulated information to your customers. Think of it like a nutritional traffic light system that needs to be correct all the time.
Across the EU, regulations focus on clarity and uniformity to allow consumers across member states to make informed choices about what they eat. Nutritional information is provided in a constant tabular format or a linear format – it’s a straightforward way to ensure that when you’re picking up groceries, you have all the facts at your fingertips to guide your decisions.
In the UK, a ‘Traffic Light’ system which uses colors to show if there’s high (red), medium (amber), or low (green) amounts of fats, sugars and salt – a clever way to let consumers see at a glance what they’re eating. Getting those colors right can be as tough as baking a perfect soufflé.
The U.S. have their own set of challenges with detailed regulations requiring labels to show everything from added sugars to calorie counts per serving, following the FDA’s guidelines. It’s a lot to keep track of!
So, what are “Targets!” in our Recipes & Specifications solution? Imagine having a smart assistant in your kitchen that not only keeps track of your ingredients but also tells you exactly how much salt should go into your soup to keep it heart healthy. That is “Targets!” for you.
Just set up what you need to track – like nutrition, allergens or costs – and “Targets!” keeps an eye on them for you.
It is like having a GPS for your compliance journey. You get real-time updates, so that you are always on the right path.
No more guesswork. “Targets!” ensures that everything you do meets compliance standards automatically, like a good friend who has always has your back.
To make life easier for our friends in the food business, we have rolled out some ready-to-use standard templates that match the usual compliance targets across multiple global regions. Plus, we have thrown in a feature that lets you export your ‘Traffic Light’ or EU / FDA-required data straight into Excel. It is like having a fast-track ticket to getting all your labeling sorted swiftly and correctly.
Since we have introduced “Targets!”, the feedback has been extremely positive. Our customers are seeing the value “Targets!” can bring – fewer mix-ups, quicker product turnarounds and all with straightforward and user-friendly functionality.
This feature significantly enhances the product development process by integrating various rounding rules into nutrition calculations, ensuring compliance with local regulations. Here is how it specifically benefits distinct roles within your company:
For Specification Technologists:
For Quality Managers:
Ready to Simplify Your Labelling Challenges?
If staying on top of food labelling regulations feels a bit daunting, why not give “Targets!” a try?
Click here to learn more about how FoodChain ID’s Recipes & Specifications solution helps to make your compliance tasks a piece of cake!
We are always here to chat about how we can make your food manufacturing process smoother and compliant. Let us help you keep those regulatory headaches at bay and focus on whipping up some delicious successes.
Meeting Future Needs with FoodChain ID’s Recipes & Specifications solution by Hamilton Grant. Click here to learn more.
The European Union’s Farm to Fork Strategy, part of the EU Green Deal, is poised to present significant challenges to the food industry. Our whitepaper provides a guide to navigating the complex EU food safety regulatory landscape and tips for companies to proactively manage the impact of EU’s Farm to Fork Strategy on EU pesticide maximum residue level (MRL) regulations.
Use the control panel below the whitepaper to turn on full-screen mode.
Navigate complex regulatory requirements for pesticide MRLs, veterinary drug MRLs and contaminant limits with FoodChain ID’s Regulatory Limits solution.
Innovation teams are under immense pressure to deliver new products faster, ensure compliance across multiple markets and adapt to ever-changing consumer demands. Manual systems—spreadsheets, emails and paper trails—are no longer sufficient for managing the intricate requirements of modern product development. The lack of real-time data visibility and reliance on manual data entry contributes to delays, errors and compliance risks. Digital enablement is essential to meet today’s evolving and complex requirements.
Real-Time Collaboration Across Teams and Suppliers
Automated Compliance Checks
A Single Source of Truth
Scalable Change Management
Recipes & Specifications solution provides a single source of truth to:
Digital enablement is not just an upgrade—it is a strategic necessity for businesses that want to remain competitive and compliant in today’s market.
Are you ready to future-proof your innovation processes? Discover how FoodChain ID’s Recipes & Specifications solution can revolutionize your business.
By Julie Holt, Director, Global Advisory Services
The United States Food & Drug Administration (FDA) approved FD&C Red No. 3, a petroleum-based food dye, for use in foods in 1969. Synthetic food dyes add a burst of color to many food and beverage products including beverages, cereals, confectionery, pastry, and condiments. Unfortunately, some dyes such as FD&C Red No. 3 are now linked to negative health outcomes such as behavioral disorders and even cancer. Red No. 3 has been used by the United States food and beverage industry for over 30 years. It has no nutritional value and is used solely to impart color¹.
The post-market assessment of chemicals, including colorants, in food is a significant priority for the United States Food & Drug Administration. This post-market responsibility includes an ongoing review of many additive categories. Although evidence shows Red No. 3 is not harmful to humans, the FDA was obligated to ban the colorant in foods and ingestible drugs in part due to a legal technicality. All additives, including colorants, must be approved for use by the FDA to be used in food and drugs sold in the United States.
Navigating evolving food additive regulations like the ban on Red Dye 3 can be complex, especially if you don’t have the right tools.
FoodChain ID provides digital solutions and expertise to help companies stay ahead of regulatory change and avoid compliance risks.
In 1906, Congress passed the Food and Drugs Act which prevented the use of poisonous or deleterious colors in confectionery and in food to conceal inferiority. In 1927, responsibility for enforcing the Food and Drugs Act was given to the newly formed Food and Drug Administration. By 1915, fifteen colorants were approved for use in food. FDA has approved 36 color additives, 9 of which are synthetic dyes including both Red Dye No. 3 and Red Dye No. 40².
On January 15, 2025, the U.S. FDA banned the use of Red No. 3 in foods, beverages and ingested drugs, more than three decades after the agency prohibited its use in cosmetics due to potential cancer risks³. This move came as California is poised to ban the use of synthetic food dyes in schools and as newly appointed Human Health and Services Secretary Robert F. Kennedy Jr. pushes for a nationwide ban on artificial dyes. Red Dye No 3 already is banned for sale, distribution, and manufacturing by the State of California beginning in 2027⁴.
In 2021, the California Environmental Protection Agency reviewed the existing research on synthetic dyes and found that they could negatively impact children’s behavior in terms of inattention and hyperactivity. While several other states including Illinois and Washington have proposed similar legislation to ban synthetic food dyes, there are also petitions seeking to expand the ban on certain colorants nationwide. More recently, states including Utah and Illinois are taking a closer look at many food additives, including colorants⁵.
In 1990, the FDA banned Red Dye No. 3 from being used in cosmetics and topical drugs after a study found that it caused cancer in male rats. For many years, consumers, health advocates, and NGOs (non-governmental organizations) pushed the agency to take similar action for foods since federal rules require the agency to prohibit the use of additives that have been shown to cause cancer in animals or humans. This legislation is commonly known as The Delaney Clause, and it removed any flexibility the FDA might otherwise have. The Delaney Clause prohibits the FDA authorization of a food additive or a color additive if it has been found to induce cancer in humans or animals.
When the FDA declined to allow Red No. 3 in cosmetics and topical drugs in 1990, the color additive was already permitted in foods and ingested drugs. Because research showed then that the mechanism dye causes cancer in rats does not apply to humans, the FDA did not take action to revoke the usage of Red No. 3 in food. For years, health advocates including CSPI (Center for Science in the Public Interest) and the Environmental Working Group (EWG) have asked FDA to reconsider that decision. Even Congressional members have signed petitions asking for the ban of Red No. 3 in foods, and eventually lawmakers cited the Delaney Clause as a basis for the ban⁶.
While Red Dye 3 is generally known to be cancerous to laboratory animals, specifically rats, there is some consensus that this mechanism of carcinogenicity is not applicable to humans. This presents a special concern for the Agency, because the Food, Drug, and Cosmetics Act contains a clause, The Delaney Clause, prohibiting the FDA from authorizing any chemical that is shown to be carcinogenic in animals or humans at any dose. Besides the issue of carcinogenicity, there are also concerns about the effects of Red Dye 3 on neurobehavior in children.
The FDA clarified that the mechanism by which Red No. 3 causes cancer in male rats does not occur in humans, and studies on other animals and humans do not show these effects. The thyroid cancer caused in male rats is not seen in humans due to differences in metabolic and hormonal pathways between rats and humans. Male rats have a unique hormonal system that makes them susceptible to certain carcinogens. The consumption levels of the colorant used in the rat studies also do not translate to human consumption levels⁷. The FDA stated that claims that the use of FD&C Red No 3 in foods and ingested drugs puts people at risk are not supported by available scientific information and that Red No. 3 is likely not genotoxic. The agency also stated that the ban is supported by the Delaney Clause.
Controversy exists around the FDA’s implementation of the Delaney Clause as evidenced by 35 years between its prohibition of Red No. 3 in cosmetics and the recent action revoking its use in foods and ingested medications. The Delaney Clause fails to consider whether there is significant correlation between cancer risk in test animals and a realistic probability of cancer occurring in humans. This failure substantially lowers the bar for opponents to FDA approved colorants that have been determined to meet the reasonable certainty of no harm standard. A strict zero tolerance application of the Delaney Clause means that any color additive found to cause cancer in any animal is at risk of being banned even if scientific evidence shows that the animal and humans are not at risk of the same outcome and that the colorant otherwise meets established FDA standards⁵.
This decision will serve as a response to a petition filed more than two years ago by the Center for Science in the Public Interest (CSPI). (7) The Environmental Working Group and other public health groups have also been asking for years that FDA ban the use of Red Dye 3 use in food and drugs³.
The Environmental Working Group is a non-profit organization that advocates environmental and health issues. This activist group currently maintains a list of chemicals that it believes should not be permitted in the food supply. This list currently includes the commonly used food preservative BHA (butylated hydroxyanisole). The EWG is also requesting action on other substances such as the synthetic sweetener aspartame⁸.
It is likely that the ban action on Red No. 3 will be further addressed in court⁴. Currently, the FDA lacks conclusive data demonstrating that Red Dye 3 causes cancer in humans, which could make the ban difficult to uphold in court and may result in class action lawsuits. At a hearing in December 2024, FDA Commissioner Robert Califf acknowledged that litigation is a risk and warned that it could be challenged in the court system.
The state ban is based on concerns that children’s consumption of these dyes is linked to negative behavioral and health effects in some children. It should be noted that these six colorants are approved for use in foods by the FDA and that regulators have not established a causal link between these colorants and health effects but do recommend further research.
Other countries including Canada permit the use of Red No. 3 under the name erythrosine. Health Canada confirmed last month that the FDA ban on Red No. 3 would not cause Canadian regulators to reconsider the status of this colorant unless new and conclusive scientific evidence demonstrated a causal relationship between Red No. 3 and cancer in humans⁹. Red No. 3 is permitted in Europe and Australia and New Zealand as erythrosine for limited uses. This status is unlikely to change because of the FDA ban on the substance.
Other additives associated with potential health risks such as sweeteners and preservatives may face increased scrutiny and be reevaluated in terms of safety. From a legal standpoint, the recent ban on Red No. 3 highlights the agency’s commitment to protecting public health and ensuring a safe food supply while navigating food industry dynamics. The FDA has publicly pledged to conduct more post-market reviews of chemicals used in food and recently collected comments on the details of this plan. The FDA will continue to monitor and review all available information about the safety and toxicology of color and food additives to determine whether the use of these continues to be safe under the Food, Dye and Cosmetic Act.
Stay ahead of regulatory change and avoid compliance risks with FoodChain ID’s digital solutions and expertise.
FoodChain ID’s trusted regulatory solutions and expertise cover more than 220 countries and markets.
Julie Holt is a subject matter expert in the areas of food and beverage, additives, and regulatory strategy. She has beverage industry expertise and currently provides consulting support across multiple beverage categories. Ms. Holt has more than 25+ years of regulatory experience in the food and food ingredients industries and managed her own advisory firm, Scientific & Regulatory Solutions LLC, prior to joining FoodChain ID. As a consultant, Julie supported several food and beverage clients including a Fortune 50 company. Julie has provided global regulatory knowledge covering more than 200 countries.
Sources:
Our Food Safety and Food Fraud Quarterly E-newsletter provides a quarterly update of the top food safety issues, the latest food safety and food fraud news and helpful resources for industry professionals.
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The rise in food safety and food fraud issues in 2024 compared to the previous year highlight the ongoing challenges in the global food supply chain. Our first Quarterly Report of the year will review top food safety and food fraud issues reported in 2024 and recent food fraud news.
2024 Food Fraud Issues
A total of 665 food fraud records were documented in FoodChain ID’s Food Fraud Database in 2024, with numbers continuing to go up slightly over the coming weeks.
The top three commodity groups impacted by food fraud issues in 2024 include:
The three most frequently reported types of food fraud in 2024 include:
2024 Food Safety Issues
More than 18,000 food safety alerts were reported in 2024 according to data from FoodChain ID’s Ingredient Risk Identification by HorizonScan™, which is a 9.8% increase in issues compared to the previous year.
The top three commodity groups with the most food safety issues in 2024 include:
The three most frequently reported types of food safety issues in 2024 include:
Food Fraud NewsNew source of food fraud information from Türkiye
In the 4th quarter of 2024, Türkiye began publicly reporting products identified as potentially hazardous due to spoilage, “alteration,” or those considered to be “counterfeit or adulterated.” The Minister of Agriculture stated that the information will be updated in “real-time.” There are two main sites reporting this information; one is focused on “Foods that Can Endanger Health” and the other is focused on “Imitation or Adulteration of Foods.”
FoodChain ID’s Food Fraud Database analysts will be periodically monitoring both sites for information relevant to food fraud and updating Food Fraud Database records as needed. Some of the records added to date include olive oil adulterated with seeds oils and colors, various botanical and dietary supplements adulterated with active pharmaceutical ingredients, species fraud in meat and dairy products, vegetable oils in cheese and colors in various herbs, spices and vegetable oils.
6-Benzylaminopurine (6-Benzyladenine) in bean sprouts
At the end of December, media sources in Vietnam reported four people were arrested for soaking bean sprouts in a solution containing 6-Benzylaminopurine (also known as 6-Benzyladenine). Another facility with the same practice was reported a few days later. One of the four people arrested noted that the substance reduced the roots on the sprouts, made the “shoots plumper, and [gave] them a more attractive appearance.” He also reportedly told police that he felt he had to use the substance because of market competition, stating “if the whole market was clean, I would also produce clean bean sprouts.” What is 6-Benzyladenine? It is a synthetic plant growth regulator/promotor that can also preserve cut flowers and extend the shelf life of cut plant products. There does not appear to be a tolerance established for 6-Benzyladenine in sprouts in Vietnam and, reportedly, the chemical is not permitted for use in food production.
For context, in the U.S., 6-Benzyladenine has residue tolerances established for six fruits and vegetables (not including bean sprouts) at or below 0.02 ppm. There is a tolerance exemption established for apples, pears and pistachios at a specific application rate. This means, per regulation, there cannot be any detectable level of 6-Benzyladenine detected in bean sprouts. This is not a completely new type of food fraud. In 2011, an incident was reported in China in which 40 tons of bean sprouts treated with sodium nitrite, urea, antibiotics and 6-benzyladenine were seized in Shenyang.
For many food and beverage companies, the complexity of product development, staff training and ongoing compliance within a global marketplace calls for specialized expertise.
FoodChain ID delivers high-level subject matter expertise for consulting based on business needs, budget and timelines.
Featured News:
Global Pesticide Residue Incidents 2024
This article explores pesticide residue incidents by country of origin, notifying countries and high-risk commodities, and explores strategies for managing pesticide residue regulations. Read more.
Artwork by FoodChain ID’s Susanne Kuehne
“Italian” tomato purees likely to contain forced-labor tomatoes
According to tests commissioned by the BBC World Service, 17 products sold by several UK supermarkets may contain tomatoes from China using forced labor. Read more.
Artwork by FoodChain ID’s Susanne Kuehne
Whitepaper: Navigating EU Pesticide MRL Requirements and Impact of the Farm to Fork Initiative
The European Union’s Farm to Fork Strategy, part of the EU Green Deal, is poised to present significant challenges to the food industry. Our whitepaper provides a guide to navigating the complex EU food safety regulatory landscape and tips for companies to proactively manage the impact of EU’s Farm to Fork Strategy on pesticide maximum residue level (MRL) regulations. Read more.
To maintain a competitive edge in today’s rapidly evolving food industry, companies must be able to quickly adapt to meet regulatory and consumer demands. Traditional methods of managing New Product Development (NPD) have become a barrier to innovation, leading to delays and errors.
This article explores six key benefits of embracing purpose-built tools like FoodChain ID’s Recipes & Specifications solution in food and beverage innovation to manage these complex requirements.
1. Enhanced Data Management
Data is the backbone of food product development, yet managing it can be a significant challenge. Traditional methods often involve manual entry, spreadsheets and scattered documentation, leading to errors, data silos and inefficiencies. Digital solutions offer a centralized platform where all data related to ingredients, nutritional content, allergens and more can be stored, accessed and analyzed in real-time.
With enhanced data management, you can ensure that every piece of information is accurate, up-to-date and easily retrievable. This not only reduces the risk of errors but also allows for more informed decision-making, ultimately leading to better product outcomes.
2. Streamlined Workflows
The complexity of food product development requires collaboration across various departments, including Research & Development (R&D), quality assurance, regulatory compliance and marketing. Managing these workflows manually can be time-consuming and prone to bottlenecks. Digital solutions streamline these processes by automating routine tasks, enabling seamless communication and providing visibility into every stage of development.
By streamlining workflows, your team can focus more on innovation and less on administrative tasks. This leads to faster project completion, reduced time-to-market and a more efficient use of resources.
3. Improved Decision Making
Making the right decisions at each stage of product development is crucial for success. However, traditional methods can leave decision-makers with incomplete or outdated information. Digital solutions provide real-time data and analytics, empowering you to make informed decisions based on accurate, comprehensive insights.
Whether you’re determining the nutritional profile of a new product, assessing the impact of a formulation change or creating a compliant food label, having access to the right data at the right time ensures that your decisions are aligned with business goals.
4. Accelerated Market Readiness
In the competitive food industry, speed to market can be a critical differentiator. Digital solutions accelerate market readiness by reducing the time spent on manual data entry, approval processes and compliance checks. With automated workflows and real-time data, you can quickly identify and address any issues that might delay product launch.
Faster market readiness means you can seize opportunities, respond to consumer demands and outpace competitors, all while maintaining the high standards of quality and compliance that your brand is known for.
5. Enhanced Collaboration and Knowledge Sharing
Product development in the food industry is rarely a solo endeavor. It involves input from various stakeholders, including suppliers, manufacturers, regulatory bodies and even consumers. Digital solutions foster enhanced collaboration by providing a shared platform where all stakeholders have common visibility, can collaborate on key activities, and leverage historical knowledge and best practices.
This collaborative environment not only improves communication but also ensures that everyone is working from the same set of data and standards. The result is a more cohesive development process, fewer misunderstandings and improved stakeholder relations.
6. Assured Compliance & Quality
Compliance with regulatory standards and maintaining product quality are non-negotiable in the food industry. However, keeping up with ever-changing regulations and multiple markets can be daunting without the right tools. Digital solutions help you stay ahead by automating compliance checks and maintaining detailed records of the product throughout its lifecycle.
With assured compliance and quality, you can confidently bring products to market knowing that they meet all the necessary standards.
The food industry is at a pivotal moment, where the adoption of digital solutions is no longer just an option but a necessity for staying competitive. By leveraging tools like FoodChain ID’s Recipes & Specifications solution, you can transform your product development processes, making them more efficient, collaborative and aligned with market demands.
FoodChain ID’s Recipes & Specifications solution is an end-to-end tool built from the ground up to support food and beverage innovation and change management. This cloud-based platform supports supplier collaboration, digital specification management, advanced recipe development, compliant label generation, automated product data sheets and more.
In this e-book, we guide you through the latest regulatory developments in the U.S. and Canada affecting the food industry, provide comments from industry experts including members of the International Food Additives Council (IFAC) and the American Bakers Association (ABA) and outline how companies can remain compliant.
Click to read Regulatory Outlook: Key Updates in Food Labeling & FormulationDiscover how digital tools such as FoodChain ID’s Recipes & Specifications solution can help streamline reformulation, enhance traceability and automate compliance processes, ensuring that your company stays ahead of regulatory changes with minimal disruption. Whether you’re managing ingredient sourcing, product development or labeling requirements, this platform provides purpose-built tools and actionable insights to design for and maintain compliance in an increasingly complex regulatory environment.
By Sureyya Topaloglu, Regulatory Researcher and Regulatory Trends Consultant
For food and beverage product developers looking to streamline processes and manage recipes, specifications, suppliers and labels in one solution, Recipes & Specifications offers efficiency, collaboration and auditability.
As we approach 2025, the world of flavors is evolving with a blend of cultural diversity, scientific advancements and a renewed focus on sustainability. Interest in global flavors remains strong, with consumers enthusiastically trying new flavors that connect them to distant cultures and innovative culinary ideas. This trend goes beyond dining out; people are recreating bold flavors from restaurants in their own kitchens, experimenting with natural and synthetic ingredients alike. The interplay of taste and smell is transforming our understanding of flavor, while rising concerns for food safety and eco-friendly sourcing guide these developments.
The current flavor landscape is defined by adventurous global tastes and distinct culinary influences. Sour and spicy flavors, such as tamarind, calamansi, and gochujang, take center stage, bringing tang complexity to dishes. Korean, Thai, and Filipino ingredients are making waves, blending spicy, sweet, and umami flavors in innovative ways. Fusion flavors are popular as well, creatively pairing traditional tastes with new cultural elements. These creative combinations reflect a demand for culinary exploration and authenticity, allowing consumers to experience the world on their plates.
A significant trend in flavor innovation is the use of bioengineered enzymes to create sustainable natural flavors. In May 2024, A team from Tokyo University developed a genetically modified enzyme that efficiently converts ferulic acid from plants into vanillin, the primary compound in vanilla flavoring. This process is eco-friendly, producing vanillin at high yields without additional catalysts. Such advancements offer scalable solutions to meet the high demand for natural vanilla and reduce reliance on traditional vanilla production, which is often constrained by climate and limited crop yields.
As flavor innovation progresses, food safety is paramount. The EU has recently moved to phase out eight smoke flavorings, following the European Food Safety Authority’s (EFSA) findings on genotoxicity risks. These smoke flavorings, once popular as alternatives to traditional smoking methods, will be gradually banned, especially in processed foods like soups and sauces. This regulatory action reflects a broader trend of strengthening health standards to ensure that both traditional and synthetic flavors meet rigorous safety criteria, aligning with the global emphasis on safe and high-quality food.
In 2024, the world of flavors is vibrant, diverse, and driven by a balance of cultural curiosity and scientific innovation. From sour global flavors to cutting-edge bioengineering in natural ingredients, the push for unique, sustainable, and safe tastes is transforming how we experience food. With nostalgic flavors, thoughtful fusions, and strict safety regulations guiding the way, current flavor trends reflected a unique blend of authenticity and novelty, promising an exciting future for culinary exploration and creativity.
Traditional compliance methods, such as manual checks and fragmented data systems, are increasingly insufficient due to their time-consuming and error-prone nature. This whitepaper explores how FoodChain ID’s Recipes & Specifications solution integrated with our Compliance Analysis platform is transforming regulatory compliance for food manufacturers.
Streamline New Product Development and enhance regulatory compliance with FoodChain ID’s Recipes & Specifications solution. Click here to learn more.
Benefits of Recipes & Specifications Solution with Integrated Compliance Analysis:
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