Amendment to the Ordinance for Enforcement of the Food Sanitation Act  and the 
Specifications and Standards for Foods, Food Additives, Etc.  
 
The government of Japan will designate Calcium Polyvinyl  Alcohol  as an authorized 
food additive and establish compositional specifications and standards for use of 
this additive . 
 
Background  
Japan prohibits the sale of food additives that are not designated by the Minister of 
Health, Labour and Welfare  (“the Minister”)  under  Article 12 of the Food Sanitation Act 
(Act No. 233, 1947 ; “the Act”). In addition, when specifications or standards for food 
additives are stipulated in the Specifications and Standards for Foods, Food Additives, 
Etc. (Public Notice of the Ministry of Health and Welfare No. 370, 1959)  pursuant to 
Article 13 of the Act , Japan prohibits the sale of those additives unless they meet the 
specifications or the standards pursuant to Article 13 of the Act.  
 
In response to a request from the Minister , the Committee on Food Additives of the Food 
Sanitation Council established under t he Pharmaceutical Affairs and Food Sanitation 
Council has discussed the adequacy of the designation of Polyvinyl  Alcohol  as a food 
additive. The conclusion of the committee is outlined below.  
 
Outline of conclusion  
The Minister should designate Polyvinyl  Alcohol  as a food additive unlikely to cause 
harm to human health pursuant to Article 12 of the Act and should establish 
compositional specifications and use standards for this additive pursuant to Article 
13 of the Act (see Attachment for the details).  
  Attachment  
 
Polyviny l Alcohol  
Vinyl Alcohol Polymer  
PVOH  
PVA 
ポリビニルアルコール  
 
 
Standards for Use (draft)  
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 (draft)  
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 solution, 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 Polyvinyl Alcohol . Both spectra 
exhibit similar intensities of absorption at the same wa venumbers.  
Viscosity  4.8–5.8 mPa•s . 
Weigh an amount of Polyvinyl Alcohol equivalent to 6.00 g on the dried basis, add 140 Attachment  
 
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 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 wal l 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 of this solution, add 1 mL of phenolphthalein TS, titrate with 0.05 
mol/L potassium hydroxide until t he pink col or 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 titrate 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 Attachment  
 
S = the saponification 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, 
heat to 90°C in a water bath, and maintain it at this temperature for about 5 minutes. 
Stir for 1 hour at room temperature . Add water to replenish the  evaporate d 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 amou nt 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 dime thyl sulfoxide to make exactly 10 mL, 
and refer to this solution as s tandard 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 volumetric 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 sepa rate vials . Place  a stirrer in each vial , 
stopper tightly, and immediately stir at 110°C for 60 minutes to prepare the standard Attachment  
 
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).  Attachment  
 
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 standardi ze as directed for 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 = fac tor 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