Food Regulatory

Regulatory Update: Thailand’s FDA Introduces New Regulations for Enzymes and Food Additives (No. 3)

Thailand’s FDA has recently rolled out new regulations addressing enzymes utilized in food production, while the other specifically outlines guidelines for the prescription of principles, conditions, methods, and proportions related to food additives No. 3.

Regulation: Enzymes Used in Food Production

The Thai FDA has published a notification of the Ministry of Public Health (No. 443) for enzymes used in food production. The new regulations were enforced on August 16, 2023.

The new regulations state that enzymes used in food production will be considered food additives and subject to specifically controlled food to ensure their safety.

Enzyme:

  • means a protein used in the production of processed food, such as preparation of raw materials, processing, curing, transportation, or storage, that capable of catalyzing a specific biochemical reaction. It shall include enzyme preparations and immobilized enzymes.

Enzyme preparation:

  • means a product consisting of one or more types of enzymes which may contain other materials, such as preservatives, stabilizing agents, diluents or carriers, to preserve or prolong the shelf life of the enzymes. It shall also include immobilized enzymes.

Immobilized enzyme:

  • means an enzyme that has been made insoluble by a chemical or physical process, such as attaching it on support materials, or enlarging its molecular structure through chemical bonding or without chemical bonding which results in solidification of the enzyme to allow the enzyme to be separated from the production process and be reusable.

Processing aid:

  • means any substance or material which is not used for consumption as a food ingredient but is used in the production of processed food, preparation of raw materials or ingredients of food to fulfill a technological purpose during the processing, and which may result in the non-intentional but unavoidable presence of such substance or derivatives thereof as residues in the final product.

Approved Sources of Enzymes for Food Production:

  • Enzymes used in food production must originate from either:
    • Plant, animal, or microbial sources listed in Annex 1 of this regulation.
    • Sources specified in the JECFA Combined Compendium of Food Additive Specifications.

Procedure for Unlisted Enzymes:

  • For enzymes not included in the aforementioned sources, producers or importers must submit:
    • A comprehensive safety assessment.
    • Detailed information as outlined in Annex 2.
  • These documents will undergo thorough evaluation by the FDA.

Enzymes used in food production shall comply with the qualities or standards as follows.

(1) Enzyme activity must not less than 85% of the declared activity,

(2) Lead must not more than 5 milligrams per kilogram,

(3) Salmonella must absent in 25 grams,

(4) Coliforms must not more than 30 per gram (MPN),

(5) E. coli must absent in 25 grams,

(6) Antibiotic activity must absent in microbial enzymes,

(7) Mycotoxin must absent in enzymes are produced from fungal sources,

(8) Absence of the production strain in 1 gram of the enzyme from a genetically modified microorganism,

(9) Other qualities or standards (if any) prescribed by the FDA according to the scientific opinion provided in the report from the risk assessment association.

Applications of enzymes in food production shall follow:

(1) The conditions of use specified in Annex 1 of this regulation.

(2) The functional uses specified in the specification of enzyme preparation according to the JECFA Combined Compendium of Food Additive Specifications,

(3) The conditions of use specified in regulation regarding food additives,

Concerning any use other than (1) (2) or (3), the producer or importer must submit the data or information as specified in Annex 3 of this regulation.

The use of food additives in enzyme preparations shall comply with the conditions set in Annex 4 of this regulation.

The use of material for immobilization or supportive materials for immobilized enzymes shall comply with Annex 5 of this regulation.

This regulation shall not apply to:

(1) Enzymes used as food ingredients for nutrition purposes or other health benefits.

(2) Enzymes used in the production of food additives or processing aids.

(3) Enzymes occurring naturally from the use of microorganisms during fermentation of food.

Regulation: Prescribing the Principle, Conditions, Methods and Proportion of Food Additives (No. 3)

The Thai FDA has published a notification of the Ministry of Public Health (No. 444) for prescribing the principle, conditions, methods and proportion of food additives (No. 3). The new regulations were enforced on December 7, 2023. This update aims to enhance consumer protection and better address current needs.

The revised regulation replaces the existing list of acceptable food additives (Annex I) and the food category system & descriptors for each note (Annex II).

Manufacturers and importers can continue selling products containing previously approved food additives that complied with the prior regulation (No. 418), but this grace period only lasts for two years from the effective date.

Food and Drug Administration. (2023). Notification of the Ministry of Public Health (No.443) B.E 2566 (2023) Issued By Virtue Of The Food Act, B.E. 2522 (1979) Re: Enzymes Used in Food Production.

Food and Drug Administration. (2023). Notification of the Ministry of Public Health (No.444) B.E 2566 (2023) Issued By Virtue Of The Food Act, B.E. 2522 (1979) Re: Prescribing the Principle, Conditions, Methods and Proportion of Food Additives (No. 3).