Page 24 - FoodFocusThailand No.182 May 2021

SPECIAL TALK BY FDA

During its 50 and 51 sessions, the FAO/WHO Codex Alimentarius Commission (CAC) were
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2.3 บทลงโทษ finally adopted conditions for food additive usage proposed by the Codex Committee on Food
ผู้้�ผู้ลิตหรืือนำำ�เข้��ผู้ลิตภััณฑ์์อ�ห�รืซึ่่�งมีีก�รืใช้� Additives (CCFA) to be additionally included in the General Standard for Food Additives (GSFA
วััตถุุเจืือปนำอ�ห�รืไมี่สอดคล�องต�มีปรืะก�ศ 2019). Moreover, the conditions of use for some food additives that evaluated for safety aspect
ฉบับนำี� ถุือวั่�เป็นำก�รืฝ่่�ฝ่ืนำปรืะก�ศซึ่่�งออกต�มี and approved by the Sub-committee on Problem Analysis and Technical Consideration Concerning
Foods (S.1) under the prescribed criteria, conditions, and methods issued by clause 6/1 of the
มี�ตรื� 6(4)(5) และ (9) มีีควั�มีผู้ิดต�มีมี�ตรื� 47 Notification of the Ministry of Public Health (No.281) B.E.2547 (2004) Re: Food Additives, dated
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แห่งพรืะรื�ช้บัญญัติอ�ห�รื พ.ศ.2522 ต�องรืะวั�ง the 18 of August of B.E.2547 (2004), which was revised by the Notification of the Ministry of
Public Health (No.381) B.E.2559 (2016) Re: Food Additives (No.4), dated the 21 of June of
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โทษปรืับไมี่เกินำ 20,000 บ�ท ทั�งนำี� กรืณีที�พิส้จืนำ์ B.E.2561 (2018). In this regard, in order to ensure the compatibility of the regulations for the
ได�วั่�ก�รืใช้�วััตถุุเจืือปนำอ�ห�รืดังกล่�วัเกินำปรืิมี�ณ usage of food additives with current situations and international standards concerning food
ที�กฎหมี�ยกำ�หนำดจืนำอ�จืก่อให�เกิดอันำตรื�ย manufacturing technologies and to improve consumer protection, the Thai Food and Drug
Administration has thus issued two Notifications of the Ministry of Public Health that revise the
ต่อสุข้ภั�พข้องผู้้�บรืิโภัคได�ทั�งในำรืะยะสั�นำและ requirements for the usage of food additives. These can be summarized as follows:
1. Notification of the Ministry of Public Health (No.417) B.E.2563 (2020) Issued by Virtue
รืะยะย�วั อ�ห�รืดังกล่�วัถุือเป็นำอ�ห�รืไมี่บรืิสุทธิ์ิ� of the Food Act B.E.2522 (1979) Re: Prescribing the Principle, Conditions, Methods and
ต�มีมี�ตรื� 25(1) แห่งพรืะรื�ช้บัญญัติอ�ห�รื Proportion of Food Additives (No.1)
พ.ศ.2522 มีีโทษจืำ�คุกไมี่เกินำสองปี หรืือปรืับ 1.1 The requirements for the usage of food additives for 29 food items have been listed in
ไมี่เกินำ 20,000 บ�ท หรืือทั�งจืำ�ทั�งปรืับ this notification are repealed and will be replaced by the requirements specified in the Notification
of the Ministry of Public Health Re: Food Additives, which henceforth serve as the sole valid
2.4 รืะยะเวัล�บังคับใช้� references on the conditions for food additives to be adhered to.
Presently, only the Notification of the Ministry of Public Health (No.355) B.E.2556 (2013) Re:
ปรืะก�ศกรืะทรืวังส�ธิ์�รืณสุข้ (ฉบับที� 418) Food in a Hermetically Sealed Container remains subject to the specific conditions for the usage
พ.ศ.2563 ออกต�มีควั�มีในำพรืะรื�ช้บัญญัติ of food additives.
อ�ห�รื พ.ศ.2522 เรืื�อง กำ�หนำดหลักเกณฑ์์ เงื�อนำไข้ 1.2 Enforcement Period
The Notification of the Ministry of Public Health (No.417) B.E.2563 (2020) issued by virtue
วัิธิ์ีก�รืใช้� และอัตรื�ส่วันำข้องวััตถุุเจืือปนำอ�ห�รื of the Food Act B.E.2522 (1979) Re: Prescribing the Principle, Conditions, Methods and Proportion
(ฉบับที� 2) ได�ปรืะก�ศลงในำรื�ช้กิจืจื�นำุเบกษ�ฉบับ of Food Additives (No.1) was published in the Royal Thai Government Gazette, General
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ปรืะก�ศและง�นำทั�วัไปเล่มี 137 ตอนำพิเศษ 237 ง Announcements Vol.137, Special Section 237 D, the 9 of October of B.E.2563 (2020) and shall
come into force on the day after its publication date, which was the 10 of October of B.E.2563
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ลงวัันำที� 9 ตุล�คมี พ.ศ.2563 และมีีผู้ลบังคับใช้� (2020). Manufacturers or importers of foods whose food products have been granted approval
ตั�งแต่วัันำถุัดจื�กวัันำปรืะก�ศในำรื�ช้กิจืจื�นำุเบกษ� prior to the effective date of the Notification of the Ministry of Public Health (No.417) B.E.2563
(2020) shall comply with this Notification within 2 years as from the date of this notification comes
เป็นำต�นำไป คือ วัันำที� 10 ตุล�คมี พ.ศ.2563 into force, which is the 10 of October of B.E.2565 (2022).
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สำ�หรืับผู้้�ผู้ลิตหรืือผู้้�นำำ�เข้��อ�ห�รืซึ่่�งผู้ลิตภััณฑ์์ 2. Notification of the Ministry of Public Health (No.418) B.E.2563 (2020) Issued by Virtue
อ�ห�รืมีีก�รืใช้�วััตถุุเจืือปนำอ�ห�รืซึ่่�งแตกต่�งจื�ก of the Food Act B.E.2522 (1979) Re: Prescribing the Principle, Conditions, Methods and
Proportion of Food Additives (No.2)
บัญช้ีแนำบท��ยปรืะก�ศกรืะทรืวังส�ธิ์�รืณสุข้ 2.1 The Annex I and Annex II of the Notification of the Ministry of Public Health (No.389)
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(ฉบับที� 418) พ.ศ.2563 และได�รืับอนำุญ�ตอย้่ก่อนำ B.E.2561 (2018) Re: Food Additives (No.5), the 21 of June of B.E.2561 (2018) are repealed and
replaced with the Annex of this Notification of the Ministry of Public Health (No.418) B.E.2563
วัันำที�ปรืะก�ศนำี�ใช้�บังคับให�ปฏิิบัติต�มีปรืะก�ศ (2020). The year adopted of these revised or added provisions on the usage of food additives
กรืะทรืวังส�ธิ์�รืณสุข้ (ฉบับที� 418) พ.ศ.2563 แล�วั shall be defined as “B.E.2563 (2020)”.
2.2 The usage of food additives shall follow to the existing principles that specified in the
แต่กรืณีดังนำี� Notification of the Ministry of Public Health (No.381) B.E.2559 (2016) Re: Food Additives (No.4).
(1) กรืณีข้�อกำ�หนำดเงื�อนำไข้ก�รืใช้�วััตถุุเจืือปนำ- In other words, the usage of food additives shall be carried out in accordance with the names of
อ�ห�รืดังกล่�วัได�รืับก�รืรืับรืองค่�กำ�หนำดในำปี food additives, the categories or types of food, the technological functions, and maximum permitted
use levels established by the Annex of the Notification as follows:
พ.ศ.2559 จืะต�องปฏิิบัติให�ถุ้กต�องต�มีปรืะก�ศ o The conditions for the usage of food additives shall be prescribed in accordance with the
ฉบับนำี� ตั�งแต่วัันำที� 21 ธิ์ันำวั�คมี พ.ศ.2561 following annexes of the Notification of the Ministry of Public Health (No.418) B.E.2563 (2020):
Annex I: The requirements for the usage of food additives shall be prescribed in accordance
(2) กรืณีข้�อกำ�หนำดเงื�อนำไข้ก�รืใช้�วััตถุุเจืือปนำ- with the names of food additives, food categories, food types, functions classes, maximum
อ�ห�รืดังกล่�วัได�รืับก�รืรืับรืองค่�กำ�หนำดในำปี permitted use level, notes, and year adopted. The food additives shall be listed in alphabetical
พ.ศ.2561 จืะต�องปฏิิบัติให�ถุ้กต�องต�มีปรืะก�ศ order (A to Z).
In case where an additive is recognized for use in a general category, such as 14.1.4, it is
ฉบับนำี� ตั�งแต่วัันำที� 26 กรืกฎ�คมี พ.ศ.2563 recognized for use in all its sub-categories, such as 14.1.4.1, 14.1.4.2, and 14.1.4.3. In contrast,
(3) กรืณีข้�อกำ�หนำดเงื�อนำไข้ก�รืใช้�วััตถุุเจืือปนำ- when an additive is recognized for use in a sub-category, its use is recognized in only under such
อ�ห�รืดังกล่�วัได�รืับก�รืรืับรืองค่�กำ�หนำดในำปี sub-category or individual foodstuffs mentioned in such sub-category.
The maximum permitted use level (mg/kg), which is prescribed with “GMP”, is based on
พ.ศ.2563 จืะต�องปฏิิบัติให�ถุ้กต�องต�มีปรืะก�ศ the lowest possible amount of food additives that can effectively yield desired results in terms
ฉบับนำี� ภั�ยในำวัันำที� 10 ตุล�คมี พ.ศ.2565 of food manufacturing technology and in accordance with the Good Manufacturing Practice
(GMP). Hence, the food additives prescribed with “GMP” cannot unconditionally be used without
any limits. Manufacturers must conduct relevant research on the food additives to be used in
their food products to figure out the lowest possible amount required to yield desired food
manufacturing results, under GMP protocols. For example, a study on efficacy of some preservative
in various proportions to extend shelf life.
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