1.    These principles are aiming at the foods containing maleic anhydride modified starch without approval, which has violated regulations of Act Governing Food Sanitation.

2.    According to “Standards for Specification, Scope, Application and Limitation of Food Additives ”, the modified starch of food grade shall be items specified in category 12 pasting agent to increase the thickness. If it is necessary to add modified starch of food grade in foods, the manufacturer shall use items specified in preceding standards.

(1)    There are 21 types of modified starch of food grade approved by now and “maleic anhydride modified starch” is not the approved item. Therefore, the food manufacturers that use“maleic anhydride modified starch” to produce foods have violated the Act Governing Food Sanitation.

(2)    Maleic anhydride is the indirect food additive approved by the FDA and EU, which is  converted to maleic acid while reacting with water. 

(3)    Maleic acid originated from foods as follows: 

                                           i.    Existing in legal additive malic acid (500 ppm) and fumaric acid (1000 ppm). 

                                        ii.    Produced by the maillard reaction during baking at high temperature or from malic acid or fumaric acid via fermentation process.

                                     iii.    Migrating from approved packaging materials with maleic anhydride to foods.

3.    Where there is food with maleic anhydride from illegal use of maleic anhydride modified starch instead of residue from legal processing or migrated from packaging materials inspected and confirmed after investigation, the following handling principles shall be applied (see attachment 1 for flowchart) 

(1)    Dealing with the product

                                           i.    Those products violating regulations shall be recalled and destroyed in accordance with article 29 of Act Governing Food Sanitation.

                                        ii.    Ask the responsible manufacturers to implement the recall process in accordance with “Regulations of Recall and Destruction for Food and Related Products.” 

(2)    Dealing with the doer

                                           i.    The fine between NT$30,000 and NT$150,000 shall be imposed in accordance with article 33 of Act Governing Food Sanitation for violating article 12 of the same Act.

                                        ii.    In addition, if the level of maleic acid in end product is too high and it is considered harmful to human health after risk assessment, the fine between NT$60,000 and NT$6000,000 shall be imposed in accordance with article 31 of Act Governing Food Sanitation for violating subparagraph 3 of paragraph 1 of article 11 of the same Act.

4.    The manufacturer shall get non-compliant products confirmed off the shelf by deadline and stop the sales. For failure to recall the products within deadline, the aggravate punishment will be applied in accordance with Regulations of Recall and Destruction for Food and Related Products. 

5.    From now on, all the starch materials providers shall provide the letter of guarantee (see attachment 2 for the format of letter of guarantee) to all food businesses selling products containing starch, including the flat rice noodle, Taiwanese meat ball, tempura, tapioca pearl, tofu pudding, rice patty, taro ball and sweet potato ball etc. 

6.    Starting June 1, the health bureaus nationwide will launch overall inspection. For any violation or false guarantee found, the aggravate punishment will be applied.