How Regulatory Approvals Are Shaping the Development of Food Sensors

By Samudrapom DamReviewed by Bethan DaviesJun 19 2025

Food sensors are quietly reshaping how we keep our food safe and trustworthy. From detecting spoilage to identifying allergens, these technologies are becoming indispensable across the food supply chain. But their success isn’t just about innovation—it’s about approval. Behind every effective sensor is a set of regulations that determine how it’s built, tested, and deployed. These rules don’t just protect consumers; they shape the very way sensor technologies evolve and reach the market.

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Understanding Food Sensing Technologies

At their core, food sensors are tools for insight. They help producers monitor conditions like temperature and humidity, detect microbial growth, and track contaminants throughout the supply chain. Depending on their design, sensors can be chemical (detecting compounds such as toxins), biological (identifying enzymes or allergens), or electronic (like the “electronic nose,” which analyzes gases and odors to gauge freshness).

These technologies have moved beyond the lab. Biosensors, for instance, are now used to detect milk allergens such as β-lactoglobulin, protecting consumers with dairy sensitivities. Electronic noses can sense spoilage in produce long before it's visible or smells off to a human. In short, food sensors are helping producers respond faster, waste less, and deliver safer products—all while giving consumers greater confidence in what they’re buying.¹

Yet for all their potential, food sensors must first meet strict regulatory expectations before they reach market shelves. These rules ensure that the tools intended to safeguard food do not, ironically, introduce new risks.

Regulatory Landscape

Regulatory approvals are vital for food sensors, setting standards that ensure safety and accuracy. These frameworks help developers build reliable technologies that meet both industry needs and consumer expectations.^2-7

Europe

In the European Union (EU), food safety is deeply integrated into agricultural and food production laws, aiming to protect public health across the entire supply chain, including imports and exports. The EU food safety policy is built around four core areas:

• Food hygiene, which mandates that all food businesses, including importers, comply with EU standards.
• Animal health, which includes disease control and the tracking of animal movement.
• Plant health, focusing on early pest detection and prevention.
• Contaminants and residues, monitored under strict limits.

This legal foundation stems from Articles 168 and 169 of the Treaty on the Functioning of the European Union, emphasizing public health and consumer protection. The EU employs a "farm to fork" and "one health" strategy, embedding safety practices throughout production, processing, packaging, and labeling. It also applies the same stringent standards to imported goods, supporting both consumer safety and the smooth functioning of the single market.^2,3

Regulation (EC) No 1935/2004 also sets general requirements for materials intended to come into contact with food. These include active and intelligent materials, which must be produced under good manufacturing practice (GMP) to prevent harmful substance migration, compositional changes, or adverse effects on food taste, smell, or appearance. Labeling, advertising, and presentation must also avoid misleading consumers. The definitions from Regulation (EC) No 178/2002 apply, with the exception of those for ‘traceability’ and ‘placing on the market’.⁴

Commission Regulation (EC) No 2023/2006 provides GMP specifics for all stages of manufacturing and distribution, excluding the production of starting materials. It defines GMP as the quality assurance processes that ensure consistent, safe production. A quality assurance system refers to structured, documented procedures to maintain product standards, while a quality control system implements these measures to verify compliance. It also distinguishes between the "food-contact side" and the "non-food-contact side" of materials.⁵

The United States (US)

In the US, the Food and Drug Administration (FDA) is the key authority overseeing food safety. The Food Safety Modernization Act (FSMA) shifts the focus from reacting to foodborne illness to proactively preventing it. Passed by Congress in response to global food system changes and rising concerns about contamination, FSMA outlines clear responsibilities across the food supply chain, covering both human and animal food. Core FSMA components include rules on Produce Safety, Agricultural Water, Foreign Supplier Verification Programs (FSVP), Food Traceability, and more.⁶

The FDA also regulates Food Contact Substances (FCS)—materials that interact with food during processing, packaging, or handling. Companies intending to use such materials must file a Food Contact Notification (FCN) that includes data on how substances migrate into food and their toxicological safety. If the FDA deems the use safe, the FCN becomes effective. Notably, each FCN is specific to the company and intended use. These regulations reflect the FDA’s commitment to preventing contamination and safeguarding public health.^6,7

Together, the EU and FDA frameworks establish a robust regulatory environment that ensures food sensors are safe, reliable, and effective. By setting clear standards for design, testing, and application, they also support innovation across the industry.^2-7

Regulation in Action: Cold Chain Monitoring

While overarching regulations from the EU and FDA establish the foundation for food safety and sensor reliability, practical implementation often hinges on adherence to more targeted technical standards. These standards guide how specific technologies—such as temperature sensors—are applied in real-world contexts. One critical application area is cold chain monitoring, where precise temperature control is vital to preserving the safety and quality of perishable goods.

Monitoring the entire cold chain is crucial to ensure perishable food products are kept under appropriate conditions, minimizing health risks to consumers. Continuous temperature recording plays a vital role in this process, particularly during transport, storage, and distribution of thermo-sensitive goods. The key standard governing temperature recorders for food products is EN 12830, which specifies the testing methods, performance criteria, and suitability of temperature data loggers for goods sensitive to temperatures ranging from −80 °C to +85 °C.^8,9

This standard covers the entire temperature recording system, including both integrated sensors and remote probes, with specific sensor positioning depending on whether the application is transport, storage, or distribution. EN 12830 has been in effect since September 1999, with an updated version released in August 2018 that also extends its scope to include health products. Furthermore, European regulation EU 37/2005 mandates the use of recorders compliant with EN 12830 for frozen products. The standard also addresses the integrity and security of temperature data monitoring software, requiring public or private cloud solutions and local server installations to meet defined verification and security standards, ensuring data integrity throughout.^8,9

In addition to EN 12830, the EN 13485 standard applies to thermometers used for measuring temperatures of chilled, frozen, deep-frozen food, and ice cream during their transport, storage, and distribution. Released in January 2002 and currently undergoing revision, EN 13485 focuses on testing methods, performance, and suitability of thermometers, particularly emphasizing temperature measurements in air or within the core of the product. Both standards work together to maintain food safety by regulating the tools used to monitor temperature across the cold chain.⁹

Internationally, the Codex Alimentarius, developed by the Food and Agriculture Organization (FAO) and World Health Organization (WHO), offers widely accepted food safety standards. Countries that adopt Codex norms align their food regulations accordingly, encouraging the development of food sensors that meet harmonized global benchmarks.¹⁰

By aligning local rules with Codex standards, countries promote international trade while making it easier for developers to create sensors that are safe and legally compliant worldwide.

Conclusion

Regulatory frameworks don’t just support food sensor safety; they shape the entire path from design to deployment. As food sensors become more critical to global food systems, aligning innovation with evolving regulatory standards is key to ensuring their effectiveness and public trust. Close collaboration between developers, manufacturers, and regulatory agencies will continue to be essential in building safer, smarter food systems for the future.

Interested in Related Technologies?

Explore how smart packaging, AI-based food inspections, or blockchain traceability are shaping the future of food safety. Read the following articles:

• Recent Innovations in Advanced Packaging
• AI-Based Analysis in Food Safety Strategies
• Improving Food Traceability with Sensor Technologies
• How Do Smart Sensors Prevent Cold Chain Failures?

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References and Further Reading

1. Sharma, N., Choudhari, M. A., Dabhade, D. N., & Bari, S. J. (2024). Sensors in Food Industry: A Review. International Journal of Advanced Research in Science Communication and Technology. DOI:10.48175/IJARSCT-15924, https://www.researchgate.net/publication/379491732_Sensors_in_Food_Industry_A_Review
2. Food safety in the EU [Online] Available at https://european-union.europa.eu/priorities-and-actions/actions-topic/food-safety_en (Accessed on 17 June 2025)
3. Food safety [Online] Available at https://eur-lex.europa.eu/summary/chapter/food_safety.html?root_default=SUM_1_CODED%3D30&locale=en (Accessed on 17 June 2025)
4. Document 02004R1935-20210327 [Online] Available at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02004R1935-20210327 (Accessed on 17 June 2025)
5. Document 02006R2023-20250316 [Online] Available at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02006R2023-20250316 (Accessed on 17 June 2025)
6. Food Safety Modernization Act (FSMA) [Online] Available at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma (Accessed on 17 June 2025)
7. Food Chemical Safety [Online] Available at https://www.fda.gov/food/food-ingredients-packaging/food-chemical-safety (Accessed on 17 June 2025)
8. SN EN 12830:2019 [Online] Available at https://connect.snv.ch/en/sn-en-12830-2019 (Accessed on 17 June 2025)
9. Standards and regulations about the temperature monitoring of food products [Online] Available at https://www.jri-corp.com/news/193-in-the-media/477-standards-and-regulations-about-the-temperature-monitoring-of-food-products2 (Accessed on 17 June 2025)
10.  Fernández González, A., Badía Laíño, R., M., J., & Soldado, A. (2024). Progress and Challenge of Sensors for Dairy Food Safety Monitoring. Sensors, 24(5), 1383. DOI: 10.3390/s24051383, https://www.mdpi.com/1424-8220/24/5/1383

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