Skip to Menu Skip to Search Contact Us Taiwan Websites & Languages Skip to Content

Taiwan TFDA : Amendment Draft of the Sanitation Standards for Food Utensils, Containers and Packages No. 13/2010 On August 6th, 2010, the Taiwan Food and Drug Administration (TFDA) of the Department of Health (DOH) announced the amendment draft of the Article 4 in the “Sanitation Standard for Food Utensils, Containers and Packages”. The 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. This amendment draft is opening a 60-day public comment.
Key points of the amendment include:
Adding di-(2-ethylhexyl) phthalate (DEHP) and di-n-butyl phthalate (DBP) as testing items

Adding polycarbonate (PC), polyphenylene sulfone (PPSU), and polyethersulfone (PES) as testing materials with limited amount of bisphenol-A (BPA)

Adding polylactic acid (PLA) as testing material The following table lists the newly added requirements:

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:


Item 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.
Lead (Pb):
≤ 1.0ppm
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.
Lead (Pb):
≤ 1.0ppm
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.
Lead (Pb):
≤ 1.0ppm
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
Lead (Pb):
≤ 1.0ppm
Evaporation residue:
≤ 30ppm
20% Ethanol
Evaporation residue:
≤ 30ppm
Heptane
25℃ for 1 hour
Evaporation residue:
≤ 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 Know more about TFDA Press (Available only 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

The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With 59,000 employees, SGS operates a network of over 1,000 offices and laboratories around the world.