The Ministry of Health and Welfare of Taiwan published the Proposed Amendments of the Charge Standards on Examination Fee of Registration or Related Others and License Fee of Food and Food Additives (預告「食品及食品添加物查驗登記等相關審查費及證書費收費標準」修正草案) (the Proposal) on 24 July 2018. The Proposal, once adopted, would amend the fees for the inspection and registration of special dietary foods, such as medical foods in Taiwan. The Proposal is expected to become effective on 1 January 2019. Public consultation on the Proposal is open until 25 September 2018.
Verisk 3E Review
Under the current Charge Standards on Examination Fee of Registration or Related Others and License Fee of Food and Food Additives (食品及食品添加物查驗登記等相關審查費及證書費收費標準) (the Standards), the inspection and registration fee for special dietary foods is 3,000 New Taiwan Dollars (TWD) per application. This fee rate applies to infant formula, follow-up formula, as well as medical food for certain diseases. The Proposal, once adopted, would impose different fee rates on each type of special dietary foods, as follows:
- Infant formula and follow-up formula (嬰兒與較大嬰兒配方食品): 3,000 TWD per application; and
- Medical food for certain diseases (特定疾病配方食品):
- Initial review: 60,000 TWD per application
- Final review: 140,000 TWD per application
As defined under the Rules for the Inspection and Registration of Special Dietary Foods (特殊營養食品查驗登記相關規定), medical foods refer to food products that provide nutrients and calories that are essential to maintaining the minimum needs of patients who suffer from physiological dysfunctions and are unable to eat, digest, absorb or metabolize specific nutrients in regular foods. This type of food adjusts (increases or decreases) specific nutrients based on balanced nutrition. Medical foods also include foods that regulate the content of protein, amino acids, fats, or minerals in the regular diet of a patient.
The Proposal is expected to become effective on 1 January 2019, if it is adopted within 2018.
Public comments on the Proposal can be submitted to the Ministry of Health and Welfare of Taiwan by 25 September 2018 via one of the following methods:
- By phone: +886 (02)27878000 Ext. 7337
- By fax: +886 (02)26531062
- By email: email@example.com
Article 21 of the Act Governing Food Safety and Sanitation (食品安全衛生管理法) stipulates that food, food additives, food utensils, packaging and containers for food, as well as food detergents may only be manufactured, processed, distributed, imported, or exported in Taiwan if they pass the inspection conducted by the Ministry of Health and Welfare. The Standards were issued to regulate the rates of inspection and registration fee to be collected by the Ministry of Health and Welfare.
Verisk 3E Analysis
Companies that operate in the food industry should note that Taiwan proposed increasing the inspection and registration fees applicable to medical foods for certain diseases. This fee rate would be increased from 3,000 TWD to 60,000 TWD for an initial review and 140,000 TWD for the final review. Affected parties may submit their comments to the Ministry of Health and Welfare of Taiwan by 25 September 2018.