Page 98 - 2021 Taiwan Food and Drug Administration Annual Report

Date of Subject of announcement Key point descriptions
announcement

December S t i p u l a t e d t h e “ R e g u l a t i o n s Specify the relevant rules for 2’-Fucosyllactose fermented
16
o n t h e U s e a n d L a b e l i n g o f with genetically modified E. coli BL21 (DE3) #1540 strain,
December
25 2’-Fucosyllactose, a Food Material LQFOXGLQJ WKH SURFHVVLQJ VSHFL¿FDWLRQV WR EH PHW VFRSH RI
)HUPHQWHG ZLWK *HQHWLFDOO\ 0RGL¿HG use, amount allowed for use, and labeling of place of origin
December E. Coli BL21 (DE3) #1540 Strain” of raw materials.
28
1. Submission of supplementary documents: The submission
December
30 time for the initial and secondary reviews is changed

from 2 months to 1 month, respectively, and the rule on

1-month extension, if needed, is retained. The number of

submissions of supplementary documents for the initial

and secondary reviews is limited to 1 time each only.

2. Delivery for inspection: Written review and product

Amended the “Regulations for inspection can be carried out simultaneously, shortening
Application of Health Food Permit” the case processing time.
3. Relief channels: Industry practitioners that fail the initial

UHYLHZ DQG VHFRQGDU\ UHYLHZ IRU WKH ¿UVW WLPH FDQ ¿OH D UH

review once each within 6 months, reducing the need for

an appeal and conserving administrative resources.

4. Verification practice: Added the requirements of on-site

YHUL¿FDWLRQ DFFRUGLQJ WR WKH DFWXDO QHHGV GLUHFWO\ FODULI\LQJ

the information in the applications, and reducing the time

for document submission to speed up the process.

Amended the “Import Regulations of

F01 and F02 in Import Commodity $GGHG &&& FRGHV IRU NLGQH\ RI VZLQH DQG RႇDO RI VZLQH DQG
Classification of Republic of China”, other items.

HႇHFWLYH VWDUWLQJ -DQXDU\

7KH VRXUFH RI ¿VK RLO FRPHV IURP HGLEOH ¿VK :KHQ XVHG

as a general food ingredient, the daily consumption is less

Stipulated the “Restrictions on the than 2 grams based on the total amount of EPA and DHA.
Use of Fish Oil as Food Materials”
7KH GDLO\ FRQVXPSWLRQ RI ¿VK RLO UDZ PDWHULDOV IRU ³)RUPXOD
foods for specific diseases” that have been inspected

and registered and are given permits is less than 5 grams

based on the total amount of EPA and DHA.

In conjunction with the amendment of the “Standards for

Abolished the “Standard for the the treatment of foods containing dioxin and polychlorinated

Tolerance of Polychlorinated Biphenyl biphenyl”, the “Standards for limits of polychlorinated

in Foods” biphenyl in foods” was abolished, and expired on January 1,

2021.

Remarks: Commodity classification code list: according to Article 30 of the Act Governing Food Safety and
Sanitation, the import of food and other related products announced by the central competent authority shall be
LQ DFFRUGDQFH ZLWK WKH FRPPRGLW\ FODVVL¿FDWLRQ FRGH OLVW VSHFL¿HG E\ WKH FXVWRPV %\ WKH HQG RI WKHUH
ZHUH DQQRXQFHG FRPPRGLW\ FODVVL¿FDWLRQ FRGH IRU WKH LQVSHFWLRQ RI LPSRUWHG IRRGV ZLWK WKH LPSRUW
regulation F01, 125 with import regulation F02, 373 with import regulation 508, and 83 with complex import

regulation.

96