Amendment to the Ordinance for Enforcement of the Food Sanitation Act  and the 
Specifications and Standards for Foods, Food Additives, Etc.  
 
 
On March 1, 2024, the government of Japan  designate d Polyvinyl Alcohol  as an authorized 
food additive and establish ed compositional specifications and standards for use of this 
additive.  
See Attachment for the details . 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
Polyvinyl Alcohol  
Vinyl Alcohol Polymer  
PVOH  
PVA 
ポリビニルアルコール  
 
 
Standards for Use  
Permitted for use only in foo ds not in conventional food form ( such as capsules and tablets). 
Must be used at not more than 45 g/kg in food.  
 
Compositional Specifications  
Substance Name  Polyvinyl Alcohol  
Molecular Formula   (C2H3OR) n,  R = H or COCH 3 (randomly distributed ) 
CAS Number   [9002 -89-5] 
Definition  Polyvinyl Alcohol  is obtained by partial saponification of vinyl acetate polymer in 
the presence of an alkaline catalyst.  
Description   Polyvinyl Alcohol  occurs as colorless to white or slightly yellowish white grains 
or powder . It has no odor.  
Identification  
(1) Dissolve 0.01 g of Polyvinyl Alcohol  in 10 0 mL of water  with warming, and allow to cool. 
To 5 mL of this solution, add one drop of iodine TS, mix  it, and add 5 mL of boric acid solution 
(1 in 25). A blue color develops.  
(2) Dissolve 0.5 g of Polyvinyl Alcohol  in 10 mL water  with warming , and allow to cool. Use 
this solution as the sample solution. Add one drop of iodine TS to 5 mL of the sample sol ution, 
and allow to stand. A dark red to blue color develops.  
(3) Add 10  mL of ethanol  (95) to 2 to 5 mL of the sample solution prepared in (2). A white, 
turbidity or flocculent precipitate is produced.  
⑷ Proceed as directed in the Disk Method under Infrared Spectrometry. Compare the 
spectrum obtained with the Reference Spectrum of Polyviny l Alcohol . Both spectra exhibit 
similar intensities of absorption at the same wavenumbers.  Attachment   
 Viscosity  4.8–5.8 mPa•s . 
Weigh an amount of Polyvinyl Alcohol equivalent to 6.00 g on the dried basis, add 140 mL of 
water, and stir gently to disperse it. Further add water to make the contents 150 g. While 
constantly stirring, heat it to 90°C in a water bath, maintain it at this temperature for about 
5 minutes, and stir for about 1 hour at room temperature. A dd water to replenish the 
evaporated water, then m easure the kinematic viscosity  (ν) of the resulting content s at 20C 
as directed under Method 1 in Viscosity. Then, measure the density ( ρ, g/mL) at 20 C, and 
obtain the viscosity (η, mPa•s)  by the following:  
η = νρ  
 
pH  5.0– 6.5 (1 g, water 25 mL).  
Purity  
(1) Acid value   Not more than 3.0.  
Weigh  accurately about 10 g of Polyvinyl Alcohol, and transfer it  into a 500 -mL round -
bottom flask containing 200 mL of water while stirring. Heat it under a reflex condenser in a 
water bath for 30 minutes while stirring. After cooling, transfer into a 250 -mL volumetric flask. 
Wash the inside wall of the round -bottom flask with a small amount of water, add the washings 
to the volumetric flask, and add water to  volume. Take exactly 50  mL o f this solution, add 1 
mL of phenolphthalein TS, titrate with 0.05 mol/L potassium hydroxide until t he pink color 
persists for 15 seconds. Calculate  the acid value (A) by the formula:  
A = MW  ×  V × 0.05 × 5 / M 
MW = molecular weight of potassium hydroxide  (56.11), 
V = volume (mL) of 0.05 mol /L potassium hydroxide consumed,  
M = amount (g) of the sample taken.  
(2) Ester value  125–153. 
Weigh  accurately about 1 g of Polyvinyl Alcohol  into a 250 -mL round -bottom flask, and add 
exactly 25 mL of 0.5mol/L  ethanolic potassium hydroxide . Add 25 mL of water and a few glass 
beads in the flask, and heat under a reflux condenser in a water bath for 30 minutes while 
occasionally shaking. After cooling, add 1 mL of phenolphthalein TS, and immediately titra te 
with 0.5  mol/L hydrochloric acid. Separately, perform a blank test  in the same manner  and 
calculate the saponification  value ( S) by the  formula : 
S = MW  × (a−b) × 0.5 / M 
MW = molecular weight of potassium hydroxide  (56.11),  
a = volume (mL) of 0.5 mol/L hydrochloric acid  consumed in the blank test,  
b = volume (mL) of 0.5 mol/L hydrochloric acid  consumed in the test,  
M = amount (g) of the sample taken.  
Calculate the ester value by the formula:  
The ester value =  S−A  
 S = the saponifi cation value,  
A = the acid value.  
(3) Degree of hydrolysis   86.5–89.0 mol%. 
Convert the saponification value (S) obtained in Purity (2)  to the dried basis to obtain 
saponification ( Sdb) by the formula:   
Sdb=S ×100  /(100 −loss  on drying (%)) 
Obtain the degree of hydrolysis by the formula:  
The hydrolysis  degree = 100 −[7.852 × Sdb/(100 −0.07492  × Sdb)]  
Sdb = the s aponification value converted to  the dried basis.  
(4) Water insoluble matter   Not more than 0.1%.  
Weigh accurately about 6 g of Polyvinyl Alcohol, add 140 mL of water, and stir gently to 
disperse  it. Further  add water to make the content s 150 g . While  constant ly stirring, h eat to 
90°C in a water bath, and maintain it at this temperature for about 5 minutes. Stir for 1 hour 
at room temperatur e. Add water to replenish the  evaporated water.  Filter the resulting liquid 
through a tarred 100 -mesh stainless steel screen. Wash the residue on the screen with about 
200 mL of water, and dry the screen with the residue at 105°C for 2 hours , and weigh the mass 
accurately. Then, obtain the amount of the residue.  
(5) Lead   Not more than 2 μg/g as Pb (2.0 g, Method 1, Control Solution: Lead Standard 
Solution 4.0 mL, Flame Method).  
(6) Methanol   Not more than 1.0%.  
Methyl acetate   Not more than 1.0%.  
Test Solution   Weigh accurately about 0.2 g of Polyvinyl Alcohol  into a 20 -mL specified 
headspace  vial, and add exactly 1 mL of the internal standard solution and 4 mL of dimethyl 
sulfoxide.  Place a stirrer in the vial, stopper tightly, and immediately stir at 110°C for 60 
minutes.  
Internal Standard Solution   Dissolve 0.5 g of 1 -propanol in dimethyl sulfoxide to make 
exactly 100 mL.  
Standard Solutions  Weigh accurately about 5.0 g each of methanol and methyl acetate, 
add dimethyl sulfoxide to  each to make exactly 50 mL, and refer to these solutions as standard 
solutions A 1 and A 2, respectively . Measure exactly 1 mL each of standard solution s A1 and A 2, 
mix them , add dimethyl sulfoxide to make exactly 10 mL, and refer to this solution as s tanda rd 
solution B.  Next, measure  exactly  5 mL of standard solution B, add dimethyl sulfoxide to make 
exactly 50 mL, and refer to  this as standard solution C.  Measure exactly 1 mL, 4 mL, 8 mL, 
and 10 mL of standard solution C , place them in to separate 20 -mL vol umetric flasks, add 
exactly 4 mL of the internal standard solution  to each , and add dimethyl sulfoxide to volume . 
Measure exactly 5 mL each of these solutions, and place  them in separate vials . Place  a stirrer 
in each vial , stopper tightly, and immediately stir at 110°C for 60 minutes to prepare the 
standard solution s for the calibration curve.  
Procedure   Analyze the test solution and the four standard solutions by h eadspace gas  
 chromatography  using  the following operating conditions . Determine the amounts of methanol 
and methyl acetate by the Internal Standard Method from the calibration curve.  
Operating  Conditions  
Detector: Flame ionization detector.  
Column: A fused silica tube (0.25 mm internal diameter and 30 m length) coated with a 
0.25-μm thick layer of polyethylene glycol  for gas chromatography . 
Column temperature: Maintain 40°C  for 10 minutes, raise the temperature at a  rate of 
20°C/minute to 180 °C, and maintain at 180 °C for 4 minutes . 
Injection port temperature: 180°C.  
Detector temperature: 200 °C. 
Carrier gas: Nitrogen.  
Flow rate: Adjust so that the peak of methyl acetate  appears about 4 minutes after  
injection.  
Injection method: Split.  
Split ratio: 1 : 10.  
Headspace sampler  
     Equilibrium temperature in the vial: 110 °C. 
     Equilibrium time in the vial: 30 minutes.  
Injection  volume : 1.0 mL.  
Loss on Drying   Not m ore than 5.0 % (1 g, 105 C, 3 hours).  
Residue on Ignition  Not more than 1.0% (1 g, 600 ±  50 °C, 1 hour).   
 Reference  Spectrum  
 
Reagents, Solutions, and Other Reference Materials  
Methyl Acetate   CH 3COOCH 3 [K8382, special grade] [79 -20-9] 
0.05 mol/L Potassium Hydroxide  
This solution contains 2.805 g of potassium hydroxide (KOH, molecular weight 56.11)  per 
1000 mL.  
Dilute 1 mol/L potassium hydroxide with water (carbon dioxide -removed) to 20 times its 
original volume.  Do not perform standardization , instead use the factor of 1 mol/L potassium 
hydroxide ; or standardize  as directed f or 1 mol/L Potassium Hydroxide, using about 0.12 –0.13 
g of amidosulfuric acid (reference material).  
Each mL of 0.05mol/L potassium hydroxide = 4.855mg of HOSO 2NH 2 
The factor is calculated by the formula : 
f = m/(0.004855  × V) × A/100  
f = factor of 0.05mol/L potassium hydroxide , 
m = amount  (g) of amidosulfuric acid ( reference material) taken,  
A = content (%) of amidosulfuric acid ( reference material) , 
V = volume  (mL)  of 0.05mol/L potassium  hydroxide  consum ed. 
 
 
 Polyvinyl Alcohol