SCIENCE &
NUTRITION
19
JAN 2017 FOOD FOCUSTHAILAND
(1)Material usedas foodor food ingredient that hasbeenusedas
food in general less than 15 years.
It canbeelaborated further that anymaterial that is usedas food
or food ingredient which has no evidence of safe use for general
consumption from 15 years andmore, it will be considered asNovel
Foodcategory.Theevidence tosupport indicating that ithasbeenused
as food ingeneral from15yearsormoremustbedocument recognized
by the official. It can be from the reliable source as government
document, peer reviewed journal or historic document from official
source. In some region as EU countries, novel food means “a food
that was not consumed to a significant degree by human in the EU
prior to15/05/1997” (Regulation (EU) 1997/258).However, according
to the new regulation “Regulation (EU) 2015/2283”, the definition is
unchanged,but therearesomeconsiderations in theareaof traditional
food in the thirdcountriesoutsideEurope. It isconsidered tobenovel
food if it is new substance, or substance from new source, or using
new techniqueof processing.
(2) Substance use as food or food ingredient obtained from
processing other than normal or general processing of such food.
Thesenewprocessingmay result inaltering thecomposition,structure,
formof that food, significantly.Suchalteringcouldaffect thenutritional
quality, metabolic process in the body, or the change in the level of
undesirable substances.
In this item, it may be a little difficult to understand. However, it
can be elaborate further as follows. The important meaning is that
“theprocessingmethodorproductionmethod”which isnot commonly
used to obtain the food or food ingredient, such as those other than
drying, steaming, frying, grilling, or extractingwithwater asexamples
of common processing. If the food or food ingredient is obtained
by extracting with concentrated alcohol or other solvent which may
extract undesirable component more thanwater extraction, the food
or food ingredient obtained isconsidered tobenovel food.Thiskindof
processmay alter the form or structure of the food, significantly. This
may also alter the nutritional value of the food, and also it may alter
thebiochemical metabolism in humanbody.
(3)Foodproduct containssubstanceasmentioned in (1) or (2) as
ingredients.However, foodadditiveand foodobtained fromgenetically
modified organismareexcluded.
Themeaning isstraightforward, if it isclassifiedas foodadditiveor
foodobtained fromgeneticallymodifiedorganism, theywillbecontrolled
under relevant notifications, such as food additive will be controlled
under theNotificationNo.281, food additive.
Novel food,according to theNotificationNo.376 issued
by the Ministry of Public Health and published in the
Royal Government Gazette, volume 133, section 159
ง
,
publishedon 15 JulyB.E.2559 (2016), means:
Whatare
“NovelFoods”
?
When the food is classified to be novel food, according to itemNos.
2 and 3, the applicant must be responsible for obtaining the full safety
assessment fromasafetyor riskassessment organization recognizedby
ThaiFDA.SuchorganizationswillbeannouncedbyThaiFDA, forexample
fromThailandRiskAssessment andSurveillanceCenter (TRAC) located
atMahidol University, Salaya campus. Beside the full safetyassessment
report, thedocuments listed in the tableattached to theNotificationNo.376
must also be submitted toThai FDA tobe considered.
In itemNo.4, it stated that thenovel foodmust conform to thequality
or standard and condition of use according to the approval of Thai FDA.
Theapplicantmust submit thedocumentsof qualityandstandard forThai
FDA to consider.
For itemNo.6, it contains requirement on labeling of novel food. It is
required that the label must follow the regulation on the labeling of the
packed food which there are some information needed to be present
in the label, such as date of manufacture, expiry date with the wording
of “manufacture”, “expire” or “consume before” on the label. Additional
requirement of label are also required as:
(1)Active ingredient (if available)
(2) Method of consumption, method of use or condition of use, such
as type of food and themaximum level of useas approved.
The important thing is those appear in the annex attached to the
notification,whichcontainsmanydetail requirements.The important items
that must be submitted toThai FDA for consideration are listed below.
1. General informationof the ingredients in the product
2. General informationof the product
3. Information on the history of useas food
4. Quality and standard (specification) of ingredients
5. Quality and standard (specification) of product
6. Analytical result
7. Storage condition
8. Manufacturingprocess/ synthesis/ extraction
9. Primary information on the chemicals used in themanufacturing
10.Appearance/ recommendation on the consumption
11. Safety information
12. Nutritional data
13. Report of the safety assessment as internationally accepted
(if available)
Note:
Please lookat theannexattached to thisnotification for furtherdetail
requirements that theapplicant needs toprovideor todoand forward toThai
FDA for consideration.
