Why Hygienic Equipment Design Matters & What’s New in 2025

For today’s processors, hygienic equipment design is essential to both meeting regulations and protecting product integrity.

Manufacturers face mounting demands to comply with global safety frameworks like FSMA, HACCP, and EU directives, while staying operationally efficient. Whether dealing with food, coffee, or other sensitive materials, your equipment must not only perform but also prevent contamination.

Traditionally, hygienic design has centered on fundamentals such as smooth stainless-steel surfaces, enclosed conveyors, and accessible cleanout points. These remain essential for faster sanitation, reduced downtime, and audit success. But in 2025, regulators and industry groups are moving beyond these basics. New rules and guidelines are reshaping how processors approach hygienic design—shifting the conversation from “cleanability” alone to risk management, traceability, and environment-specific sanitation strategies.

EHEDG’s Risk-Based Hygienic Design

One of the most notable changes comes from EHEDG, which in 2025 released Document 58: Hygienic Design Risk Management. This new guideline introduces a risk-based approach, requiring processors and equipment designers to evaluate product characteristics, environmental conditions, and sanitation methods at the earliest stages of equipment development.

Rather than prescribing one-size-fits-all design standards, the framework emphasizes identifying risks, validating design choices, and monitoring outcomes. The result is equipment that not only meets hygiene goals today but can also adapt as processes, ingredients, or regulations evolve.

FSMA Section 204 Food Traceability Rule

In parallel, U.S. regulators are tightening traceability requirements under the Food Safety Modernization Act (FSMA) Section 204 Food Traceability Rule. Companies handling high-risk foods must now capture Key Data Elements (KDEs) at each Critical Tracking Event (CTE), from receiving to shipping, and maintain records for up to two years.

While the FDA has proposed extending the compliance deadline to July 20, 2028, proactive companies are acting now. By upgrading systems and equipment that can integrate with traceability workflows, processors not only prepare for enforcement but also strengthen consumer trust and improve recall readiness. For hygienic design, this means building in better documentation, monitoring, and validation capabilities.

FDA Guidance for LMRTE Sanitation Programs

Another significant update is the FDA’s Draft Guidance for Sanitation Programs in Low-Moisture Ready-to-Eat (LMRTE) Foods, released in early 2025. Covering products such as dry cereals, nut butters, and powdered mixes, the guidance stresses the unique risks in dry processing environments, where moisture intrusion can trigger microbial growth.

For equipment design, this means prioritizing moisture control, ease of dry cleaning, and rapid response protocols for contamination events. Processors are expected to demonstrate not only that their equipment is easy to sanitize, but that it actively supports ongoing pathogen control in low-moisture environments.

Why These Changes Matter for Product Integrity

Together, these three 2025 developments redefine hygienic design as a multi-layered commitment:

• Risk-based principles that anticipate hazards before they occur.

• Traceability integration that strengthens accountability and compliance.

• Environment-specific sanitation strategies that protect product integrity in real-world conditions.

The impact goes beyond compliance. Plants that embrace these approaches can expect fewer recalls, smoother audits, lower cleaning costs, and stronger consumer trust.

MPE Delivers Hygiene & Compliance

At MPE, every grinder, conveyor, and degassing silo is crafted with hygiene and regulatory readiness in mind. By aligning with international standards and anticipating tightening rules—especially those introduced this year—MPE equips processors to protect product integrity, enter new markets confidently, and stay ahead of evolving regulations.