SPECIAL TALK
BY FDA
27
MAY 2017 FOOD FOCUSTHAILAND
The documents specified in theAnnex of thisNotification cover
general informationonnovel food; specifications regardingqualityor
standardsof suchnovel food; historyof safeuseas food; production
processes; analyticalmethodsand results; consumptionmethodsor
advice on consumption; safety information, including evidence of
toxicological experiments in animals or humans; nutritional
information; and reports of safety considerations from international
or foreign agencies, or information on the granting of permission to
distribute suchnovel foodas food or food ingredient abroad.
4
Onceanovel food isassessedsafe forconsumptionandapproved
by theThaiFDAtobeusedas foodor food ingredient, theapproval
letterwill be issued to theapplicant for furtherapply togetherwith the
application for permission to produce or import such novel food
(followingproduct authorization requirements). Thenovel foodmust
havequalities, standards, and conditionsof useasapprovedby the
FoodandDrugAdministration.
5
Producersor importersofnovel foods forsaleordistributionmust
complywith thisNotificationof theMinistryofPublicHealth,other
MOPHNotificationsconcerningnovel foods,andany relevantMOPH
Notificationswith such foodproducts.
6
Labeling of novel foods shall follow the MOPH Notification
regarding the labeling of prepackaged foods. The information
required on the label includes date of manufacture and expiration
date by stating date, month and year, respectively. The wording
“Manufacture”, “Expire”, or “Consume before” shall be specified.
Additional labeling requirements include:
(1) Nameof active ingredients (if any);
(2) Instructionofuse,orconditionofusesuchas typeorcategory
of food andmaximum permitted level of use.
7
This Notification is not applicable to novel foods produced for
export or novel foods that producersor importerswerepermitted
toproduce or import prior to 16
th
JulyB.E.2559 (2016).
8
Manufacturersor importersnot complyingwith the requirements
of thisMinistryof PublicHealthNotificationare considered tobe
inviolationof theNotification issuedunderSections6 (3) (9)and (10)
of theFoodAct B.E. 2522 (1979), and shall be liable topunishment
as follows:
(1) Quality or standards not inaccordancewith thoseapproved
in the permit are liable toa fine of up toTHB 50,000.
(2) Assessment results inconsistentwith theconditionsapproved
in the permit are subject to penalties up toTHB 20,000.
(3) Incorrect labeling is subject to a fineup toTHB30,000.
9
This notification is effective from 16
th
July B.E. 2559 (2016)
onwards.
