SPECIAL TALK
BY FDA
26
MAY 2017
FOOD FOCUSTHAILAND
The “Thailand 4.0” policy focuses on an innovation-driven economy
byswitching frommanufacturingproductswhicharecommonlyproduced
around theworld to innovativeproducts. Traditional industries arebeing
transformed by utilizing technology, employing creative and innovative
thinking,andprovidingfirst-classservice to respond tochangingconsumer
behaviors and lifestyles. In the food and beverage industry, substances
whichhaveneverhadahistoryofbeingconsumedas foodarenowbeing
usedas ingredientsorconstituentsof food,orbeingsolddirectlyas food.
Therehavealsobeennewdevelopments in foodprocessing technology.
Thesenewsubstancesor foodsaswell as foodsmanufacturedwithnew
technologies may not be safe to consume and may harm consumers.
Therefore, theFoodandDrugAdministration (ThaiFDA)as thecompetent
authority responsible for food safety oversight under the Food Act of
B.E.2522 (1979) has issuedNotification of theMinistry of PublicHealth
(No.376) B.E.2559 (2016) Re: Novel Food
(1)
in order to proactively
safeguardconsumerhealth in linewithmanycountrieswhoalreadyhave
regulations regardingnovel foods.Forexample, theEuropeanUnionhas
implementedRegulation (EC)No.258/97of theEuropeanParliamentand
of theCouncil of27January1997concerningnovel foodsandnovel food
ingredients
(2)
;AustraliaandNewZealand follow theFoodStandardsCode
1.5.1Novel Foods
(3)
; and theUnitedStatesdistinguishesbetween those
substances fallingoutside thescopeofGRAS (GenerallyRecognizedAs
Safe) under Codeof Federal RegulationsTitle21
(4)
.
All of these regulations have similar principles especially that novel
foods as prescribed by the definition shall be evaluated for a safety
assessment and receive approval from the food authority prior to be
consumedorused for foodproductionor imported fordistribution.Safety
assessmentsmustbebasedonreliableresearchevidenceandprocedures
following internationally acceptedprinciples.
Therefore, to create a better understanding and awareness among
producers, importers,andconsumers, theessential pointsof theMinistry
of Public Health Notification regarding novel foods are summarized as
follows:
1
Novel foodsmust firstpassasafetyassessment,and their labelmust
besubmitted to theFoodandDrugAdministration forapproval before
use.
2
“Novel food” shall be definedas either of following scopes:
(1) Any substance used as food or food ingredients which has
been significantly used for human consumption less than
fifteen years based on scientific or reliable evidence. An
examplewouldbeusingapartof theginsengplantother than
its root for foodwhen thehistory of consumptionof that part
is less than15 years.
or;
(2) Anysubstanceusedas foodor food ingredients towhichhas
beenappliedaproductionprocessnot currentlyused,where
that process gives rise to significant changes in the
composition or structure of such food which affect their
nutritional value, metabolism or level of undesirable
substances. Examples include products derived from
nanotechnology whereby the resulting composition of the
food has particles smaller than those in food produced by
conventional methods; and products undergoing a non-
thermal food pasteurization process, etc.
or;
(3) Any foodproduct contains either (1) or (2) as an ingredient.
This does not include food additives and genetically-modified
foods.
3
Results of a novel food safety assessment as conducted by a
risk assessment center recognized by the Food and Drug
Administration (which ison the listofFDA-recognized riskassessment
centersdated22
nd
AugustB.E.2559 (2016))mustbesubmittedalong
with supporting documents and details as specified in the annex of
this Notification. There are three FDA-recognized risk assessment
centers on the current list:
(1) BureauofQualityandSafetyofFood,DepartmentofMedical
Sciences, Ministry of PublicHealth
(2) National Food Institute, Ministry of Industry
(3) ThailandRiskAssessment andSurveillanceCenter (TRAC),
Institution of Nutrition, Mahidol Univiersity
TheMostRecentFoodRegulations
havebeenEnforced
NotificationoftheMinistryofPublicHealth (No.376)
B.E.2559 (2016)Re:NovelFood
