Page 25 - FoodFocusThailand No.182 May 2021

SPECIAL TALK BY FDA
SPECIAL TALK BY FDA
SPECIAL TALK BY FDA
The Most Recently Enforced Food Regulations
Revision of the Regulations on the Usage of Food Additives:
The Notification of the Ministry of Public Health (No.418)
B.E.2563 (2020) Issued by virtue of the Food Act B.E.2522 (1979)

Re: Prescribing the Principle, Conditions,
Methods and Proportion of Food Additives (No.2)

Annex II: Additional explanations on the content of the Annex I, divided
into 2 parts:
Part I: Description of food categories
Part II: Description of notes
o The condition of use mixture of two or more food additives prescribed
with numerical maximum permitted use level performing the same
functional classes, the sum of the mixture proportions obtained by dividing
the amount of each food additive used by the maximum permitted level
for that food additive must not be more than one. The usage of food
additives under this condition shall be subject to existing and specific notes
in the Annex II of the Notification of the Ministry of Public Health (No.418)
B.E.2563 (2020).
o In case the use of food additives is not complied with the Notification the Principle, Conditions, Methods and Proportion of Food Additives (No.2)
of the Ministry of Public Health (No.418) B.E.2563 (2020), this use shall was published in the Royal Thai Government Gazette, General
be evaluated for safety aspect and approved by the Food and Drug Announcements Vol.137, Special Section 237 D, on the 9 of October of
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Administration. The safety evaluation shall follow the rules, conditions and B.E.2563 (2020) and came into force on the day after its publication date,
procedures for permission as follows; which was the 10 of October of B.E.2563 (2020).
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(1) Food additives shall have the qualities or standards according to Manufacturers or Importers of Foods, which food additive contained
the Codex Advisory Specification for the Identity and Purity of Food in such food has been approved prior to this notification comes into force
Additives (the latest version) or the Announcement of the Food and Drug and the provisions of food additive adopted in B.E. 2563 (2020) is different
Administration from the annex of this notification, shall comply with this notification, as
(2) The dietary exposure of food additives shall be evaluated according the case may be within 2 years as from the date of this notification comes
to the principle. into force.
(3) Technical documents or reliable research publications regarding (1) The provisions of food additive adopted in B.E.2559 (2016) shall
the use of food additives and its function shall be submitted to support the comply with this notification since the 21 of December of B.E.2561 (2018).
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necessity of using such additives in food (2) The provisions of food additive adopted in B.E.2561 (2018) shall
(4) Use of food additives shall be complied with the current law and comply with this notification since the 26 of July of B.E.2563 (2020).
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regulation of at least two countries, which have the reliable risk assessment (3) The provisions of food additive adopted in B.E.2563 (2020) shall
system, for example, the European Union, Australia, New Zealand, the comply with this notification within the 10 of October of B.E.2565 (2022).
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United States of America, and Japan, etc.
More information on the procedure for the submission of documents
and evidence can be retrieved from the Public Handbook Re: Application
for Safety Assessment of Food Additives at http://www.fda.moph.go.th/
sites/food/manual/9.2_M44_Health_claims.pdf กฎหมายที่่�เก่�ยวข้้อง/Relevant Regulation
For more clarity, further informations and explanations can be retrieved 1. ประกาศกระทรวงสาธารณสุข (ฉบัับัท่� 417) พ.ศ.2563 ออกตามความในพระราชบััญญัติ
from the Announcement of the Food and Drug Administration Re: อาหาร พ.ศ.2522 เร่�อง กำาหนดหลัักเกณฑ์์ เง่�อนไข วิธ่การใช้ แลัะอัตราส่วนของวัตถุุเจื่อปน-
Clarifications on the Notification of the Ministry of Public Health (No.418) อาหาร (ฉบัับัท่� 1) ลังวันท่� 2 กันยายน พ.ศ.2563 ส่บัค้นได้จืาก http://www.ratchakitcha.
B.E.2563 (2020) issued by virtue of the Food Act B.E.2522 (1979) Re: soc.go.th/DATA/PDF/2563/E/237_1/10.PD
Prescribing the Principle, Conditions, Methods and Proportion of Food Notification of the Ministry of Public Health (No.417) B.E.2563 (2020) Issued by
Additives (No.2) which comprises the following (see the Table): Virtue of the Food Act B.E.2522 (1979) Re: Prescribing the Principle, Conditions,
nd
2.3 Punitive Measures Methods and Proportion of Food Additives (No.1), dated the 2 of September
B.E.2563 (2020) Available from: http://www.ratchakitcha.soc.go.th/DATA/PDF/
Manufacturers or importers of food products containing food additives 2563/E/237_1/10.PDF [Thai ver.]
that do not comply with this Notification shall be deemed violators of the
Notification issued in accordance with the Section 6(4)(5) and (9) and thus 2. ประกาศกระทรวงสาธารณสุข (ฉบัับัท่� 418) พ.ศ.2563 ออกตามความในพระราชบััญญัติ
be subject to fine of not exceeding THB 20,000 as dictated by the Section อาหาร พ.ศ.2522 เร่�อง กำาหนดหลัักเกณฑ์์ เง่�อนไข วิธ่การใช้ แลัะอัตราส่วนของวัตถุุเจื่อปน-
47 of the Food Act B.E.2522 (1979). In case that the food products อาหาร (ฉบัับัท่� 2) ลังวันท่� 2 กันยายน พ.ศ.2563 ส่บัค้นได้จืาก http://www.ratchakitcha.
containing very high dose of food additives that might cause of illness to soc.go.th/DATA/PDF/2563/E/237_1/18.PDF [เลั่มท่� 1] แลัะ http://www.ratchakitcha.
consumer, are classified as impure food as stipulated in the Section 25(1) soc.go.th/DATA/PDF/2563/E/237_2/18.PDF [เลั่มท่� 2]
of the Food Act B.E.2522 (1979), and the violators are subject to imprisoned Notification of the Ministry of Public Health (No.418) B.E.2563 (2020) Issued by
not more than 2 years or fined not more than THB 20,000 or both. Virtue of the Food Act B.E.2522 (1979) Re: Prescribing the Principle, Conditions,
Methods and Proportion of Food Additives (No.2), dated the 2 of September
nd
2.4 Enforcement Period B.E.2563 (2020) Available from: http://www.ratchakitcha.soc.go.th/DATA/
The Notification of the Ministry of Public Health (No.418) B.E.2563 PDF/2563/E/237_1/18.PDF [No. 1 Thai ver.] and http://www.ratchakitcha.soc.go.th/
(2020) issued by virtue of the Food Act B.E.2522 (1979) Re: Prescribing
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