Korea | Partial Revision of Food Additives Code (No. 2019-1)
The Ministry of Food and Drug Safety, Korea (MFDS) announced partial revisions for the "Specifications and Standards of Food Additives" (hereafter referred to as the "Food Additives Code") under notification no. 2019-1 on Jan 9, 2019.
Reasons for revision
The Food Additives Code has been revised to reflect the characteristics of processing aids that do not remain in final food preparations or are unlikely to be ingested; relax the scope of the safety data to be submitted when applying for designation of new items; and establish the definition of processing aids.
The application principle of the maximum residue limits (MRL) standards for food additives containing raw materials from agricultural products and the definition of β-carotene manufactured by Blakeslea Trispora has been established; and new strains has been added to the definition of "α-amylase".
Further, the compositional standards of 8 items that apply the weight loss standards limited to "magnesium silicate", which is used for anti-caking agent, have been improved. Also, the standards of use for 9 items including "Propylene Glycol" has also been improved.
Main Revisions
1) Improvement of submission of safety dossier for processing aids
a) It is necessary to improve of the scope of safety data to be submitted for new applications to reflect the characteristics of processing aids that do not remain in final food preparations or are unlikely to be ingested.
b) The definitions of processing aids are newly established, and the scope of safety data to be submitted for new applications are relaxed (I. 2.1) and [Table 1] Article 5. 6. 가. 2))
c) Relaxation of the scope of safety data to be submitted in the case of new applications for flavouring agents (I. 2.1) and [Table 1] Article 5. 6. 가. 2))
d) Enhancement of the scope of safety submission data to revitalize the food industry and improve understanding of civil petitions.
2) Establishment of new application principles of MRL standards in food additives
a) It is necessary to establish the application principles of MRL standards to ensure the safety of food additives containing raw materials from agricultural products.
b) Establishment of application principles for MRL standards of food additives (1.3.5))
c) Ensuring the safety of food additives containing raw materials from agricultural products.
3) Deletion of manufacturing standards of alkali agents for noodle preparations
a) The contents of mixed preparation manufacturing standards and the principles of alkali agents of noodle preparations are overlapping.
b) Deletion of the regulations for alkali agents in the noodles in manufacturing standards (II.1.2) (5))
c) Enhancement of understanding of civil petitions by deletion of redundant contents
4) Amendment of definition of 2 items including "α-amylase"
a) It is necessary to revise the definition of food additives for the application of various manufacturing methods.
b) Addition of "Aspergillus niger inserted with α-amylase gene of Rhizomucor pusillus” ((Ⅱ. 4. 가. α-amylase) into the manufacturing strain of "α-amylase".
c) Establishment of definition and standards for residual solvents for β-carotene (Ⅱ. 4.가.β-carotene).
d) Revitalization of food industry by expansion of manufacturing methods of food additives.
5) Amendment of compositional standard of 8 items such as "magnesium silicate" and so on
a) It is necessary to revise the regulations to provide a comprehensive explanation of related terms and the rational application of the ingredient standards according to their purpose of use.
b) Amendment of dry weight loss standards provided in the composition standard of "magnesium silicate" (Ⅱ .4.가. Magnesium silicate)
c) Amendment of the CAS number of three items such as " Monosodium L-Glutamate" (II.4. 가.Monosodium L-Glutamate, Calcium Disodium Ethylenediaminetetraacetate, Ferrous Sulfate)
d) Addition of alternative name and contents about caffeine monohydrate (Ⅱ. 4.가. Caffeine)
e) Correction of the general name of 2 "synthetic flavouring substances” (4-Hydroxy-2,5-dimethyl- 3(2H)-furanon, p-Methyl acetophenone) (Ⅱ. 4.나. Synthetic Flavouring Substances)
f) Addition of wordings to explain Rule1 and Rule 2 of "synthetic swelling agent" (Ⅱ. 4.나. Synthetic Swelling Agent)
g) Standardization of terminologies in the "Mixed Preparations" Purity Test with its definition (Ⅱ. 4. 나. Mixed Preparations)
h) Revitalization of food industry and understanding of civil petitions by improvement of composition standards and clarification of terminologies reflecting the characteristics of use.
6) Amendment of the standards for use for 9 items such as "Sodium Metabisulfite"
a) It is necessary to improve the standards for use to reflect harmonization with international standards and the necessity of using food additives at the food manufacturing site and so on.
b) Amendment of the standards for the use of 6 kinds of sulfites such as "sodium metabisulfite" for brandy and ordinary distilled liquor (Ⅱ. 5. (a) Sodium Metabisulfite, Potassium Metabisulfite, Anhydrous Sulfuric Acid, Sodium Sulfite, Sodium Dithionite)
c) Amendment of the standards for the use of "sodium hydroxide solution" to standardize its contents with that of sodium hydroxide (Ⅱ. 5. 가. Sodium Hydroxide)
d) Amendment of the standards for use for L-Ascorbyl Palmitate and Propylene Glycol) by subdividing the “other foods” in the said standards and reflecting the actual use conditions and amounts. (Ⅱ. 5. 가. L-Ascorbyl Palmitate, Propylene Glycol)
e) Clarification of regulations; revitalization of food industry; and the securing of national health with the reinforcement of safety standards by reflection of the actual conditions for use of food additives.
7) Cancelled designation items list under the current standards
a) Addition of synthetic flavouring substances that has already been cancelled for designation to the [Table 2] “list of items cancelled for designation” of synthetic flavouring substances.
b) Addition of 20 synthetic flavouring substances such as Capsaicin to [Table 2] ([Table 2])
c) Enhancement of understanding of civil petition by providing information on substances cancelled for designation.
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