Food Additive Compliance for Imported Food: Scope of Use, Limits and Registration

Whenever the ingredient list of an imported food contains an additive, it must pass a two-part check under Taiwan’s “positive list” system: whether the additive is approved for the corresponding food category and within the applicable limit, and, where it is imported or exported in raw-material form, whether it holds a registration permit. This article follows the current regulatory framework to set out the points to verify and the lookup channels to use when reviewing an imported product.

1. The positive-list principle: if it is not on the list, it cannot be used

• Under the Standards for Specification, Scope, Application and Limitation of Food Additives (食品添加物使用範圍及限量暨規格標準) (Laws and Regulations Database (全國法規資料庫) pcode L0040084; the current version was last amended on 7 May of ROC year 114, issuance reference 衛授食字第1141300255號), Taiwan operates a positive list system: only the additive types, approved food scopes and maximum use levels set out in Table 1 form a lawful combination. An additive that is not listed may not be used in food shipped to Taiwan, even if it is lawfully used in the country of origin.
• Table 1 is divided into 18 categories: preservatives; bactericides; antioxidants; bleaching agents; color retention agents; leavening agents; agents for quality improvement, brewing and food manufacturing; nutritional additives; coloring agents; flavorings; seasonings; sweeteners; thickeners (pastes); binders; chemicals for the food industry; carriers; emulsifiers; and others.
• The approved scope and limit for the same additive are not identical across different food categories: for example, if a preservative is approved only for “dried foods,” it may not be used on fresh fruit and vegetables.
• Table 2 separately sets out the specification standards for the additives themselves (purity, impurity limits and the like). It complements Table 1, and both must be checked together during review.
• Effective dates are staged. Taking effect on 7 May of ROC year 114 are the Category (7) provisions on palm wax (棕櫚蠟) for use on fruit, the Category (8) provisions on sodium selenite and magnesium citrate in infant foods, and the Category (10) amendments to flavorings. Most Category (7) quality improvement agents, most Category (8) nutritional additives, Category (11) seasonings and Category (13) binders are set to take effect on 1 July of ROC year 116, so you should confirm which version applies when checking.

2. How to look up the scope-of-use and limit standards

• Official full-text download: the Laws and Regulations Database (pcode: L0040084) provides the complete Table 1 and Table 2 for download, and they may also be downloaded separately by the 18 categories.
• Online browsing: the Consumer Knowledge Service Center of the Taiwan FDA (衛生福利部食品藥物管理署) hosts an additive list search page where approved items may be browsed by category.
• Suggested verification procedure: obtain the complete ingredient list for the imported product → check each additive one by one against Table 1 → confirm that the food category the product belongs to falls within the approved “scope of food use” → verify that the amount added complies with the limit (units are usually g/kg or mg/kg) → proceed to the border inspection procedure only once every item complies.
• Regulations are amended on an ongoing basis. Searches shall be based on the “latest version in force”; an older version of the tables should not be carried over as the basis for the assessment.

3. Looking up registration permits

• The legal basis is Article 21 of the Act Governing Food Safety and Sanitation (食品安全衛生管理法): the manufacture, processing, formulation, repackaging, import and export of food additives must be registered with the central competent authority and a permit document obtained before any of these may be conducted.
• The scope of application differs from that for ordinary processed food imports, and the two are often confused in practice:
  • Importing single-ingredient or compound additive raw materials (for downstream manufacturers to use in processing) → a registration permit (查驗登記許可證) is required;
  • Importing finished processed foods that contain additives (such as biscuits, beverages or finished sauces) → no registration permit is required; these are handled under the ordinary food business registration and border inspection procedures.
• Search channels: the Taiwan FDA Consumer Knowledge Service Center “Food Additive Permit Search” (searchable by permit number, Chinese or English product name, or company name); the food business registration platform (fadenbook); and the Food Information System portal.
• Permit number formats vary with the period of issue: before July of ROC year 102 the format was 衛署食添字第XXXXXX號, and thereafter 衛部食添字第XXXXXX號. The older format remains effective within its period of validity.
• Permits are valid for five years and must be renewed periodically. The responsible contact point is the Food Division of the Taiwan FDA.

4. Common additive issues in import practice

• Color retention agents (nitrites): commonly found in processed meats such as ham and bacon. The limits are comparatively strict, and this is a focus of border inspection.
• Leavening agents used together with emulsifiers: a common combination in baked goods; Category (6) and Category (16) must both be checked.
• Preservatives used together with sweeteners: common in beverages and juices. Category (1) and Category (11-1) must each be checked one by one; checking only one of them is not sufficient.
• Thickeners used together with emulsifiers: a common combination in dairy products, involving a cross-check of Category (12) and Category (16).
• Cross-border differences in coloring agents: some colorants are approved in the country of origin but are not listed in Taiwan’s Table 1. This is the category that most needs to be confirmed in advance of import.
• Nutritional additives in infant and toddler foods: the vitamins, minerals and other items used are subject to dedicated limits and labeling requirements, and their effective dates also differ, so particular care is needed.
• If the ingredient list contains an item that is not listed in Table 1, it may not in principle be imported. To claim an additional scope of use, a separate application must be filed; the procedure is time-consuming, and in practice it is usually advisable to first confirm whether the formulation can be adjusted or the supplier’s formulation replaced.

Conclusion

The core of food additive compliance review is to examine two systems separately: the “scope of use and limit standards” and the “registration permit.” The former determines whether the additive combination in a finished imported food is lawful; the latter applies only where the additive is imported or exported in raw-material form. The two rest on different bases of review and apply to different subjects. In practice it is advisable to obtain the complete ingredient list before placing an order and to check it against the version currently in force, so as to reduce the risk of discovering non-compliance only after the goods have arrived.

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This article is a general reference, not legal advice. For actual applications, the latest announcements of the Taiwan FDA shall prevail.