Selling Food Machinery in the US: What FDA, NSF, and UL Each Cover

First, Distinguish Three Levels

Food machinery sold to the US runs into requirements from three different sources:

1. Federal regulations: The FDA's food safety rules and OSHA's occupational safety rules
2. State and local rules: The food codes adopted by each state, and local electrical inspections
3. Buyer requirements: The customer's purchasing specifications, and requirements from insurers or chain brands

The answer to many "do we need such-and-such certification" questions depends on the level. The most common claim is that "the machine needs FDA certification": the FDA's rules for food equipment are mainly written into the good manufacturing practices that food plants must follow; materials in contact with food are covered by separate food contact substance rules (Title 21 of the Code of Federal Regulations, Parts 174–178). When people say "FDA compliant," they usually mean the contact surface materials comply with these rules, not that the whole machine holds an FDA certificate.

FDA: 21 CFR 117.40 Governs Food Plants

US federal regulation 21 CFR Part 117 sets out current good manufacturing practice and risk-based preventive controls for food plants, applying to facilities that manufacture, process, pack, or hold food. Section 117.40 deals specifically with equipment and utensils, and its requirements broadly include:

• Equipment must be adequately cleanable and properly maintained to protect against allergen cross-contact and contamination
• Lubricants, fuel, metal fragments, contaminated water, and the like must be kept out of food
• Equipment must be installed and maintained to facilitate cleaning of the equipment and the surrounding space
• Food contact surfaces must be corrosion resistant, nontoxic, and able to withstand the action of food, cleaning compounds, and sanitizing agents
• Seams on food contact surfaces must be smoothly bonded or properly maintained so food residue doesn't accumulate
• Instruments used for control or recording must be accurate and properly maintained
• Compressed air or gases that contact food directly must be treated

These are obligations of food plants, but to meet them, plants pass the requirements on to the equipment they buy. That's why US customers asking for quotes want to know about contact surface materials, whether parts can be removed for washing, and whether lubricants could touch food: they're confirming the machine will let them comply with 117.40.

NSF: Hygienic Design Standards and Certification

NSF is a US standards development and certification organization. Common standards for food equipment include:

• NSF/ANSI 2: Food equipment, covering the hygienic design of food handling equipment for kitchens, bakeries, and so on
• NSF/ANSI/3-A 14159-1: Hygiene requirements for the design of meat and poultry processing equipment

NSF certification itself is voluntary and not mandated by federal regulations. However, Section 4-205.10 of the Food Code, published by the FDA for adoption by states, provides that equipment certified or classified for sanitation by an ANSI-accredited certification program under American National Standards is deemed to comply with the Code's equipment materials and design requirements. States and local health departments adopt different versions of the Food Code in different ways, and inspectors at restaurant and central kitchen customers often check whether equipment carries such a certification mark. In other words, whether NSF is "required" depends on the health authority where the customer is located and on the customer's own specifications.

In addition, 3-A Sanitary Standards, which originated with dairy equipment, are also often used by food processors as a hygienic design reference.

UL: Electrical Safety

US Occupational Safety and Health Administration rules (29 CFR 1910.303) require electrical equipment used in workplaces to be "approved." Under the definition in 1910.399 of the same regulations, this generally means tested, listed, or labeled by a Nationally Recognized Testing Laboratory (NRTL) recognized by OSHA; for unlisted equipment, there are alternatives such as inspection by the authority having jurisdiction.

UL is one of the best-known NRTLs, but not the only one. The standard commonly used for commercial motor-operated food machinery is UL 763 (Motor-Operated Commercial Food Preparing Machines). When a customer says "we need UL," it usually means "we need an NRTL listing," so ask the customer up front which laboratories' marks they accept.

As for voltage and frequency, the US uses 60Hz, the same as Taiwan, but single-phase voltage is 120V and there are several three-phase voltage levels; see voltage and frequency differences by country.

What to Confirm With the Customer Before Exporting

• Whether the health departments in the customer's state and locality require sanitation certification for equipment
• Whether the customer or its brand or insurer specifies NSF or other certification
• Which NRTL listing is needed for electrical safety, or whether the local authority will inspect on site
• Contact surface material and lubricant information to help the customer comply with 21 CFR 117.40

To confirm whether Dong-Yih Machinery's models hold relevant US certifications, please call 06-257-4644 or reach us through our contact information page.

FAQ

Q: Does food machinery sold to the US need FDA certification?
A: The FDA's equipment requirements are in the good manufacturing practice rules for food plants (21 CFR 117.40): equipment must be cleanable, corrosion resistant, nontoxic, and must not contaminate food; contact surface materials are subject to separate food contact substance rules. "FDA compliant" usually means the materials and design meet these requirements, so first ask which document the customer actually wants.

Q: Is NSF certification required?
A: Federal regulations don't mandate it, but the Food Code adopted by states recognizes equipment certified under ANSI-accredited programs, and local health departments or customer specifications often require it. Ask about the customer's location and purchasing specifications first.

Q: Does the electrical system need UL?
A: OSHA requires workplace electrical equipment to be approved, usually through listing by a Nationally Recognized Testing Laboratory (NRTL). UL is one of them, and UL 763 is the standard commonly used for commercial food machinery.

Q: Is US voltage the same as Taiwan's?
A: The frequency is the same at 60Hz, but US single-phase is 120V and there are many three-phase voltage levels, so confirm the customer's plant power distribution before connecting.