On February 6, 2024, Japan Ministry of Health, Labor and Welfare (MHLW) issued Notice No. 29, announcing updates to certain provisions in the Japan's Specifications and Standards for Food Additives. The notice declares updates including various aspects such as testing and experimental requirements for food additives, ingredient specifications for additive ingredients, storage requirement, as well as requirements for manufacturing and usage. To facilitate enterprises' better adaption to the new rules, MHLW has granted them a one-year transition period.
Test Requirements
In order to ensure the practicality of the tests, additional test equipment has been introduced.
New general test methods have been established, including elemental analysis, residual solvent testing, mass spectrometry, and titration endpoint detection. Furthermore, corresponding reagents for these test methods are added simultaneously. Additionally, the quantification method for methoxy groups has been removed as it is no longer applicable to any items.
To align with the actual distribution practices, the reagent "mercuric chloride (II)" has been removed.
The reference infrared absorption spectrum for all have been eliminated, and new reference infrared absorption spectrum required for each item under "Part D Ingredient Standards and Storage Standard" have been added.
Ingredient Standards and Storage Standard
For enzymes produced using organisms obtained through recombinant DNA technology, amendments have been introduced to clearly define the exclusion of provisions related to the definition of these enzymes.
New standards for ingredients have been established for 45 existing food additives.
The ingredient standards for 128 items of 105 designated additives, 86 items of 59 existing additives, and 3 items of 2 additive formulations have undergone revisions. These revisions aim to improve the operability and accuracy of tests; achieve uniformity in naming, structural formulas, terms, examples, and calculation formulas; and incorporate changes to the reagents and test solutions used.
Amendments have been made to individually specified sub-standards for two designated additives, five existing additives, and two additive formulations. This specified sub-standards include additive origin, character and type.
Manufacturing and Usage Standards
In order to provide clarity regarding the target substances, the inclusion of "sand" has been removed. Instead, a comprehensive list of "insoluble mineral substances" has been introduced. These substances include acidic clay, kaolin, bentonite, talc, diatomaceous earth, pearlite, granite porphyry, activated clay, cristobalite, zeolite, and vermiculite.
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