In order to successfully enforce the Act Governing Food Safety and Sanitation (hereinafter referred to as the “Act”), the Food and Drug Administration (FDA), under the Ministry of Health and Welfare, completely reviewed and amended the Enforcement Rules of the Act Governing Food Sanitation. The amended enforcement rules, renamed the “Enforcement Rules of the Act Governing Food Safety and Sanitation” to correspond to the Act, were promulgated and took effect on August 13, 2014. 
As the full text of the Act was amended on June 19, 2013, the FDA issued an advance notice on the amendment of the enforcement rules on November 26, 2013. However, the Act underwent another partial amendment and was renamed the “Act Governing Food Safety and Sanitation” on February 5, 2014. As a result, the second advance notice was issued on May 21, 2014. 

After two rounds of advance notifications, collections of opinions and comments, and adjustments, the full text of the amended enforcement rules, which contain 28 articles, was released today. The major amendments are as follows: 
1. The meaning of the competent central authority approval number set forth in the Act was added (Article 3). 
2. The product names of foods and food additives shall conform to the standards prescribed by the competent central authority; in the event that no standards have been established, food businesses may name their products on their own, provided that the names adequately reflect the nature or purpose of the products (Articles 6 and 13). 
3. The amount of ingredients and volume of solids shall be separately indicated if the ingredients contain both liquids and solids; however, only the net weight of ingredients shall be indicated if liquids and solids are evenly mixed and unlikely to be separated (Article 7). 
4. No labeling is required if food additives in foods are added through the use of legal ingredients, the content of food additives is significantly less than the amount needed when being directly added to foods and they have no effects on final products (Article 8). 
5. The definitions and labeling methods of the manufacturers and responsible domestic companies as referred to in the Act were added (Articles 9 and 10). 
6. The definitions and labeling methods of the countries of origin of foods and food additives as referred to in the Act were added (Articles 11 and 17). 
7. Due to the new labeling item provisions of this Act, the maximum surface area of the label font has increased from less than 10 cm2, with the length and width less than 2 mm to less than 80 cm2 (Article 18). 
8. The definition of bulk foods set forth in the Act was added (Article 19). 
9. The provisions on labeling of food utensils, food containers, and packaging set forth in the Act were added (Article 20). 
10. A Chinese label shall be affixed as required before the import of food cleansers. However, if food cleansers need to undergo repackaging, separate packaging, or other such processes, a Chinese label may be affixed before sale (Article 21). 
11. The meanings of the main ingredients or the ingredients of food cleansers set forth in the Act were added (Article 22). 
12. The provisions of the Act do not apply to the labeling items for exported foods, food additives, food utensils, food containers and packaging (Article 23). 
13. Information that shall be included in the disclosure of the testing method, testing unit and the evidence used for interpreting results when publishing testing information on food sanitation was explicitly stipulated (Article 24). 

For detailed information about the amendments, please check the FDA Announcements under the News section in the Chinese version of the FDA’s website (http://www.fda.gov.tw/).