Japan MHLW Revises Specifications and Standards for Food Additives

On November 30th, Japan Ministry of Health, Labor and Welfare announced extensive modification to Japan’s Specifications and Standards for Food Additives (MHLW Notice No. 370 of 1959).

Since the initial publication of Japan’s Specifications and Standards for Food Additives in 1960, it has been updated several times. The 8th Edition was released in 2007 and is currently in effect and will be replaced by the ninth version after a one year grace period. The main changes include:

(1) Related specifications for 89 existing additives have been newly developed;

(2) Related heavy metal limitations have been revised for 355 specific additives, 127 existing additives, 3 general food additives and raising agents;

(3) Standards for manufacturing of talc and general additives have been established to guarantee the safety of food additives;

(4) To improve precision and operability, terms and practical cases are unified, and specifications of 79 specific additives (80 items in total) and test methods of “Section A, B and C” are modified;

(5) Standards for manufacturing and use in “Section E and F” have been revised for uniformity of terms and cases.

Details are listed below:

Contents	Modifications
A. General Notices	The unit “ml” has been replaced by “mL”
B. General Tests	For ion chromatography (IC), “refined water for IC” has been used to prepare standard solutions instead of water In Lead Limit Test, preparation methods of test solution and control solution have been added Methods for viable count of fungi, detection of Coliforms and Salmonella have been added to Microbial Limit Tests Toxic mercuric bromide test paper and related test methods have been removed from Arsenic Limit Test
C. Reagents & Solutions	Some reagents and solutions have been added or deleted accompanying the addition and deletion of corresponding food additives CAS Numbers have been added to solutions while the names are modified to meet JIS standards
D. Monographs	New specifications for in 62 enzyme additives and 27 non-enzymatic additives have been established Lead (Pb) test has taken the place of heavy metal determination in purity tests The expression of arsenic content limit has been altered from As2O3 to As
E. Manufacturing	Relevant requirements for microbial strains have been added when microorganisms are used to produce enzyme additives Raw materials of talc are newly required to be free of asbestos

All these revisions came into effect on the date of their announcement. However, there will be a one-year transitional period before mandatory implementation. The previous standards are still applicable to food additives produced, processed and imported before November 29, 2018.