A New Designated Food Additive Granted Approval in Japan

On March 1, 2024, Japan MHLW announced that "Polyvinyl Alcohol" would be regulated as "Designated Additive", which became effective since the date of promulgation.

The specifications for food additives in Japan consist of various aspects, including general rules, testing methods, reagents & testing solutions, ingredient & storage standards, manufacturing standards, and usage standards. This new addition to designated additives brings about the following changes:

Definition

Polyvinyl Alcohol is a partially saponified polymer of vinyl acetate, obtained by the partial alkaline hydrolysis of polyvinyl acetate.

It is in the form of colorless to white or slightly yellowish-white granules or powder, with no odor.

Usage standards

Polyvinyl alcohol is restricted to the usage in non-normal food forms such as capsules and tablets, and it can not be used in confectionary products. Furthermore, the maximum amount of polyvinyl alcohol in all its permitted categories is 45g per 1 kg.

Testing method

0.05 mol/L Potassium Hydroxide (KOH) Solution is newly introduced as a reagent for polyvinyl alcohol purity experiments. According to the announcement, each 1000mL of this solution must contain 2.805g of KOH, which has a molar mass of 56.11.

Additionally, confirmation tests, viscosity tests, purity tests, drying loss tests, high-temperature residue tests, and reference spectra have also been established.