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No. 18/2010 On November 22nd, 2010, the Taiwan Food and Drug Administration (TFDA) of the Department of Health (DOH) announced the amendment of the Article 4 in the “Sanitation Standard for Food Utensils, Containers and Packages”. Like the draft amendment, which was published in August 2010, the primary modifications are focused on the limitation of plasticizers in plastic materials with the purpose to reinforce the sanitary control in food utensils, containers, packages, and feeding bottles.
The following tables list the newly added requirements:
Between the draft version and the amendment, there is a slight change in wording, which is shown in the bold font.
1) General requirements:

Item
Material test item and passing standard
Migration test
Solvent
Migration Condition
Item and passing standard
Plastics
Lead (Pb):
≤ 100ppm
Cadmium (Cd):
≤ 100ppm
Heptane
25℃
for
1 hour
Di-(2-ethylhexyl) phthalate (DEHP):
≤ 1.5ppm
Di-n-butyl phthalate (DBP):
≤ 0.3ppm
2)  Requirements for plastics:

Raw
materials
Material test item and passing standard
Migration test
Solvent
Migration Condition
Item and passing standard
Polycarbonate
(PC) –
except
feeding bottles
Lead (Pb):
≤ 100ppm
Cadmium (Cd):
≤ 100ppm
Water
95℃
for
30 mins
Consumption of potassium permanganate (KMnO4):
≤ 10ppm
Evaporation residue:
≤ 30ppm
Bisphenol-A (BPA):
≤ 0.6ppm
4% Acetic acid
60℃
for
30 mins.
Heavy Metal:  ≤ 1.0ppm (using measurement of Pb) Evaporation residue:
≤ 30ppm
Bisphenol-A (BPA):
≤ 0.6ppm
Polyphenylene
sulfone (PPSU)
– for
feeding bottles
Lead (Pb):
≤ 100ppm
Cadmium (Cd):
≤ 100ppm
Water
95℃
for
30 mins
Consumption of potassium permanganate (KMnO4):
≤ 10ppm
Evaporation residue:
≤ 30ppm
Bisphenol-A (BPA):
≤ 30ppb
4% Acetic acid
60℃
for
30 mins.
Heavy Metal:  ≤ 1.0ppm (using measurement of Pb) Evaporation residue:
≤ 30ppm
Bisphenol-A (BPA):
≤ 30ppb
Polyethersulfone
(PES) – for
feeding bottles
Lead (Pb):
≤ 100ppm
Cadmium (Cd):
≤ 100ppm
Water
95℃
for
30 mins
Consumption of potassium permanganate (KMnO4):
≤ 10ppm
Evaporation residue:
≤ 30ppm
Bisphenol-A (BPA):
≤ 30ppb
4% Acetic acid
60℃
for
30 mins.
Heavy Metal: ≤ 1.0ppm (using measurement of Pb) Evaporation residue:
≤ 30ppm
Bisphenol-A (BPA):
≤ 30ppb
Polylactic
acid (PLA) a
Lead (Pb):
≤ 100ppm
Cadmium (Cd):
≤ 100ppm
Water
50℃
for
4 hours b
Consumption of potassium permanganate (KMnO4):
≤ 10ppm
Evaporation residue:
≤ 30ppm
Lactic acid:
≤ 30ppm
4% Acetic acid
Heavy Metal:  ≤ 1.0ppm (using measurement of Pb) Evaporation residue:
≤ 30ppm
20% Ethanol
Evaporation residue (alcohol container, packaging):
≤ 30ppm
Heptane
25℃
for
1 hour
Evaporation residue (oily and fatty food container, packaging) :
≤ 30ppm
Footnote: a) Food utensils, containers and packages made of polyactic acid materials shall not be used in the process of high-temperature sterilization and shall not contain food which is at the temperature above 100℃.
b) The migration condition shall be at 60℃ for 30 minutes when processing food at the temperature above 50℃ or using polylactic acid composites.
Information Source:
Amendment of the Sanitation Standards for Food Utensils, Containers and Packages (Only available in Chinese). SGS Taiwan Ltd. Taipei Multi Chemical Laboratory
t: +886 2 2299 3279
Ext.3103-3124
f: +886 2 2299 3237
Email
Web: www.tw.sgs.com
SGS Taiwan Ltd. Kaohsiung Multi Chemical Laboratory
t: +886-7-3012121
Ext. 4101 ~ 4106
f: +886-7-3010867

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