*Notes: This article was published on June 21 and was updated on September 27, 2023, following the latest regulatory information. The modified contents are marked in red below.
On June 20, 2023, the Ministry of Food and Drug Safety (MFDS) published a notification to solicit public opinion on the amendments to the Food Additive Code.1 Suggestions can be sent to MFDS before August 21, 2023.
The major amendments include:
(1) Expanding the Scope of Microorganisms that Can Be Exempted from Submitting Safety Data for New Food Additive Recognition.
The advances in biotechnology have led to the development of technologies that utilize microorganisms to manufacture food additives which were previously synthesized chemically. In order to facilitate applications for new registration of enzymes, amino acids, and other food additives manufactured using microorganisms, 34 species of microorganisms are proposed to be partially exempted from the safety data submission. The 34 species are strains that produce food additives listed in the Codex, whose safety has been confirmed. The details are as below:
Aspergillus pulverulentus Aspergillus sojae Bacillus brevis (Brevibacillus brevis) Bacillus macerans (Paenibacillus macerans) Bacillus pallidus Bacillus thermoproteolyticus Brevibacterium linens Candida pseudotropicalis (Kluyveromyces marxianus) Endothia parasitica (Cryphonectria parasitica) Fusarium venenatum Geobacillus caldoproteolyticus (Anoxybacillus caldiproteolyticus) Hansenula polymorpha (Ogataea polymorpha) Micrococcus caseolyticus Micrococcus violagabriella Mortierella vinacea (Umbelopsis vinacea) Mucor javanicus (Mucor circinelloides) Mucor pusillus (Rhizomucor pusillus) Penicillium decumbens Penicillium lilacinum (Purpureocillium lilacinum) Penicillium simplicissimum Rhizopus delemar Rhizopus nigrican (Rhizopus stolonifer) Rhizopus niveus Streptococcus cremoris (Lactococcus lactis subsp. cremoris) Streptomyces albus Streptomyces chromofuscus Streptomyces cinnamoneus Streptomyces fradiae Streptomyces lividans Streptomyces violaceoniger Streptomyces werraensis Thielavia terrestris Trichoderma harzianum Trichoderma longibrachiatum |
Generally, the below five kinds of safety data shall be submitted to apply for the recognition of new food additives manufactured using microorganisms. Data No. 3) to No.5) can be omitted when enterprises apply for the recognition of new food additives manufactured by utilizing the abovementioned 34 species, if the draft is passed.
1) Data confirming the authenticity of the production strain 2) Data confirming the death or residue of the strain in the final product 3) Data on the experience of consumption as food 4) Data on the usage of the strain in food manufacture 5) Data confirming the expression of pathogenicity in human or animal food |
(2) Permitting Iron Oxide to Be Used in Health Functional Food
MFDS plans to recognize Iron oxide (yellow, red, black) as a new food additive, which can be used as food color for shading purposes in health functional foods of capsule types.
Currently, titanium dioxide and copper chlorophyll are used for shading purposes. The authority expects to help enterprises produce various health functional foods by designating the new food additive.
(3) Newly Adding Four Diluents for Mixed Preparations
“Mixed preparation” is a preparation containing two or more food additives, or a preparation mixed by a diluent with one or more food additives. Considering industry field’s demands and technical needs, the authority proposes to newly add table salt, protein powder, agar, and konjac powder as the diluents for mixed preparations.
(4) Expanding the Criteria for Using Hexane
Hexane is currently only used for extracting and separating the fatty ingredients in edible oils and functional ingredients in health functional foods. As per the draft, it is proposed to be used in other foods. It is expected that the use of hexane will increase efficiency and economy.
Updates
On September 20, 2023, MFDS revised the Food Additive Code with the proposed contents above.
This regulation is effective along with its issuance. Nevertheless, the provisions related to Iron oxide used as a new food color for health functional foods are implemented on January 1, 2025. And the requirements related to the newly specified diluents for Mixed Preparations will come into effect on January 1, 2026.
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