Sanitation Standard for Food Utensils, Containers and Packaging: Are Machine Contact Parts "Food Utensils"?

The Legal Definition of Food Utensils

Article 3, Subparagraph 4 of the Act Governing Food Safety and Sanitation: "food utensils" are machinery, tools, or utensils that come into direct contact with food or food additives. The text says "machinery," so parts of an encrusting machine that touch the dough and filling directly, such as the hopper, screws, nozzles, conveyor belts, and forming molds, fall within the scope of food utensils by the letter of the law; the outside of the housing, the electrical cabinet, and other parts that don't touch food do not.

Related provisions include:

• Article 16: Food utensils that are toxic, prone to undesirable chemical reactions, or capable of harming health may not be manufactured, sold, imported, exported, or used.
• Article 17: Food utensils sold must meet hygiene, safety, and quality standards set by the central competent authority, namely the Sanitation Standard for Food Utensils, Containers and Packaging (食品器具容器包裝衛生標準).
• Article 26: Food utensils, containers, or packaging designated by the central competent authority must be labeled with the product name, material name, heat-resistance temperature, and so on; this article applies only to items "designated by public notice."

What the Sanitation Standard Says

The current text of the Sanitation Standard for Food Utensils, Containers and Packaging found at the time of writing was last amended on January 11, 2023, and it has only a few articles:

• Article 3: Utensils, containers, or packaging must not show undesirable discoloration, off-odors, off-flavors, contamination, mold, foreign matter, or shedding fibers.
• Article 6: They must meet the "general provisions" in Table 1; plastic materials must also meet Table 2.

Provisions in Table 1 most relevant to machinery:

• Utensils: Must be constructed so that there's no risk of copper, lead, or their alloys being scraped off.
• Copper or copper alloy utensils: Except for those with an inherent luster that don't rust, parts in direct contact with food must be fully tin-plated, silver-plated, or otherwise suitably treated.
• Metal alloys (contact surfaces of metal alloy): Lead 0.1% or less and antimony 5% or less in the material; migration tests with water and 0.5% citric acid solution at 60°C for 30 minutes must show arsenic 0.2 ppm, lead 0.4 ppm, and cadmium 0.1 ppm or less.
• Metal contact surfaces coated with synthetic resin paint: Additional migration requirements for phenol, formaldehyde, evaporation residue, and so on.
• Plastics: Lead and cadmium 100 ppm or less each; the individual content of 8 phthalate plasticizers must not exceed 0.1% (with separate rules for PVC); plus the migration tests for each material in Table 2.

Migration tests use different solvents to simulate different foods: water simulates foods with pH 5 or above, 4% acetic acid or 0.5% citric acid simulates pH 5 or below, n-heptane simulates fatty foods, and 20% ethanol simulates alcoholic foods; for use at 100°C or above, the migration conditions become 95°C for 30 minutes.

Do Machines Need Separate Migration Testing? Who Is Responsible?

The regulatory text establishes that "contact surfaces are food utensils and must meet the sanitation standard," but it doesn't go into detail on whether each contact part of a machine must be sent for testing, or whether the testing responsibility lies with the manufacturer, the importer, or the food business using it. In practice, the division of responsibility can be understood like this:

• The party that manufactures or imports the machine: Under GHP Article 45 (added in the June 4, 2025 amendment and phased in for non-plastic materials), food utensil manufacturers must select suitable raw materials for the final conditions of use and keep the relevant hygiene and safety data.
• The food business using the machine: Under GHP Annex 2, equipment must be used according to its labels and the correct methods provided by the supplier, with contact surfaces kept smooth, crack-free, and clean.

How an individual case is determined follows the interpretation of the TFDA or the local health bureau.

Documents Businesses Commonly Prepare

When accepting a new machine, dealing with inspections, or undergoing customer audits, food factories often ask machine suppliers for:

• A materials list of contact parts (for example, stainless steel grade, plastic type, rubber or silicone type).
• Material certificates for stainless steel (mill certificates issued by the steel mill).
• Migration test reports for plastic and rubber parts according to the Sanitation Standard for Food Utensils, Containers and Packaging.
• Food-grade registration information (for example, NSF H1) for any lubricants used that may contact food.

For the contact surface materials of each Dong-Yih model and the documents available, please call 06-257-4644 or visit our contact information page. For principles on choosing materials, continue with Materials in Contact With Food: Stainless Steel, Food-Grade Plastics, Rubber.

FAQ

Q: What standard must the food-contact parts of a machine meet?
A: Under Article 17 of the Food Safety Act, the Sanitation Standard for Food Utensils, Containers and Packaging (current version amended January 11, 2023), including the general provisions in Table 1, with plastic parts also subject to Table 2.

Q: What is the legal definition of food utensils?
A: Article 3, Subparagraph 4 of the Food Safety Act: machinery, tools, or utensils in direct contact with food or food additives.

Q: What are the migration limits for metal contact surfaces?
A: Table 1 requires metal alloys tested with water and 0.5% citric acid at 60°C for 30 minutes to show arsenic 0.2 ppm, lead 0.4 ppm, and cadmium 0.1 ppm or less; lead in the material 0.1% or less and antimony 5% or less.

Q: What documents can we request when buying a machine?
A: Commonly a materials list of contact parts, stainless steel material certificates, migration test reports for plastic and rubber parts, and registration information for food-grade lubricants; what can be provided depends on each supplier.