Page 61 - FoodFocusThailand No.202 January 2023

STRONG QC&QA

What if the enzymes are used in the process? with Good Laboratory Practice (GLP) or accompanied by a clinical
When enzymes are used in the manufacturing process, it will study report in order to establish the product’s acceptable daily
be considered whether or not the enzymes used are listed in intake (ADI). In addition, the risk assessment agencies will assess
List No. 1 as attached to the Ministry of Public Health’s the ADI, the recommended dose, recommendation, or options for
Notification No. 409 (B.E. 2562), regarding enzymes for use consideration of safety and suitability of consumption as well. The
in food production, or as defined in the JECFA Combined goal is to increase consumer safety, especially among high-risk
Compendium of Food Additive Specifications. If the name groups.
appears on any of these lists, the product is considered a Summary of safety considerations for medical food
non-novel food. In the event that the enzyme is not listed in and special purposed foods
both documents, applicants must provide additional evidence • All relevant information provided in the Ministry of Public
about that specific enzyme used in the production process to Health’s Notification No. 238 (B.E. 2544) regarding special purposed
a relevant agency for safety evaluation. foods.
Information required for product safety • If the product is classified into the novel food category, it must
considerations The relevant evidence for consideration be evaluated for safety by one of the FDA’s authorized risk
required for novel food safety assessment is divided into two assessment agencies before determining acceptable daily intake
categories: (1) information on the specification of ingredients (ADI).
and the final product; and (2) information on the safety study • Entrepreneurs submit documentations to demonstrate
of a particular ingredient that requires for safety assessment. whether or not the ingredients have limitations or pose risks to
More details are available in the Ministry of Public Health’s specific groups of consumers when used for specific purposes.
Notification No. 376 (B.E. 2559) regarding novel foods. • The FDA determines that there is no risk to any specific groups.
However, because some raw ingredients have never been • Entrepreneurs submit product informations to an FDA-
consumed as food before or the manufacturing process authorized health claims agency responsible for nutrition
employs technologies or substances that have not previously assessment and health claims to evaluate the safety and health
been licensed, safety information is crucial. As a result, benefits of their product.
applicants can submit the safety assessment report from the • The assessment agency submits the result to the FDA.
international risk assessment agencies or other recognized
countries (if permission was granted in a foreign country),
genotoxicity testing, and toxicity studies in animals (including More Information Service Info C012
acute toxicity testing, sub-chronic toxicity testing, and chronic
toxicity testing). These tests should be performed in เอกสารอ้างอิง / References
accordance with international standards, such as those of the https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2018.EN-1381)
OECD. Or it should be carried out in a laboratory accredited http://www.ratchakitcha.soc.go.th/DATA/PDF/2562/E/203/T_0017.PDF

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