Allergen Management and Machine Changeover Cleaning
Why Manage Allergens?
For people with allergies, trace amounts of peanut, egg, or crustaceans can cause a severe reaction. The most common route of cross-contact in a plant is shared equipment: peanut filling left in the screw, egg wash in conveyor belt gaps, sesame on forming molds.
The regulatory basis in Taiwan:
- Article 22 of the Act Governing Food Safety and Sanitation requires packaged foods to list their contents and authorizes the competent authority to announce other items that must be labeled.
- Annex 3 of the Regulations on Good Hygiene Practice for Food (GHP, amended June 4, 2025) requires processes to include measures to prevent cross-contamination; Article 13 requires control methods to be established and records kept for items that need control during processing.
Which Allergens Must Be Labeled?
Under the TFDA's Food Allergen Labeling Regulations (食品過敏原標示規定), from July 1, 2020, packaged foods containing any of the following 11 categories must display a prominent warning on the container or outer packaging:
- Crustaceans and their products
- Mango and its products
- Peanuts and their products
- Cow's milk, goat's milk, and their products
- Eggs and their products
- Tree nuts and their products
- Sesame and its products
- Gluten-containing grains and their products
- Soybeans and their products
- Fish and their products
- Products using sulfites and the like, where the final product contains 10 mg or more of residual sulfur dioxide per kilogram
The warning can read "This product contains XX" or "This product contains XX and is not suitable for people allergic to it," or equivalent wording. Cephalopods, mollusks, and similar items are listed by the TFDA as recommended labeling.
Do You Need to Label "This Line Also Processes…"?
A shared-line warning is a recommended label under TFDA rules, worded as "The production facility for this product has equipment or production lines that also process XX," or equivalent wording. It isn't mandatory, and it can't replace cleaning: even with a shared-line warning, changeover cleaning must still be done properly. Whether to add it and how to word it is up to the business, based on its actual production and risk assessment.
False or noncompliant labeling is punishable under Article 47 of the Food Safety Act by a fine of NT$30,000 to NT$3 million, with a recall and correction deadline under Article 52.
How to Do Changeover Cleaning
A generally recommended process is below; each plant should adapt it to its own equipment and products:
- Scheduling: As far as possible, schedule allergen-free products first and allergen-containing products later, reducing the number of changeovers.
- Stop and cut power: Before disassembly and washing, always stop the machine, switch off the power, and lock out or tag out to prevent someone else from starting it by mistake (Article 57 of the Occupational Safety and Health Facilities Regulations). For the procedure, see lockout rules.
- Empty: Clear residue out of the hopper, screw, nozzles, and piping, and handle the residue as allergen-containing product.
- Disassemble: Remove contact parts and place them in dedicated containers or at a washing station, keeping them separate from parts for other products.
- Wash: Scrape first, then wash with warm water and food-safe detergent and rinse; for high-fat fillings such as peanut butter and sesame paste, confirm the oil film has been removed.
- Inspect: Check each part visually after disassembly, especially threads, seal grooves, and conveyor belt seams; plants with the means can confirm with allergen rapid tests or protein residue test strips.
- Reassemble and record: Record the changeover time, cleaning staff, inspection results, and the next product, and include them in GHP and traceability records.
- Surroundings: Also change dusting flour, scrapers, trays, work clothes, and gloves; don't just wash the machine.
Design Affects How Hard Changeovers Are
Among encrusting machines, the easier the contact parts are to remove, and the more visible every surface is once removed, the faster and more reliable changeovers will be. When buying, ask directly: how many minutes does it take to remove the filling hopper, screw, and nozzle? Are tools needed? Can the seal grooves be seen? For design principles, see hygienic design principles. For how Dong-Yih models are disassembled and washed, please call 06-257-4644.
FAQ
Q: How should we clean for a changeover involving peanuts, eggs, or crustaceans?
A: After stopping the machine, cutting power, and locking out/tagging out, clear the residue, remove the contact parts, scrape them, wash with warm water and food-safe detergent and rinse, visually inspect threads and grooves part by part, confirm with allergen rapid tests if needed, and finally record it.
Q: Which allergens must be labeled?
A: The 11 categories in the Food Allergen Labeling Regulations: crustaceans, mango, peanuts, cow's and goat's milk, eggs, tree nuts, sesame, gluten-containing grains, soybeans, fish, and sulfite products with 10 mg or more of residual sulfur dioxide per kilogram.
Q: Do we have to label "This line also processes…"?
A: It isn't mandatory. The TFDA's recommended shared-line warning is "The production facility for this product has equipment or production lines that also process XX," and businesses decide whether to add it based on their actual situation.
Q: If we have a shared-line warning, can we skip cleaning?
A: No. GHP requires processes to include measures to prevent cross-contamination, and a warning can't replace cleaning.