TFDA releases amended Article 4 of the Hygiene Standards for Food Utensils, Containers and Packaging.
No. 18/ 2010
To strengthen hygiene management of food utensils, containers, packaging, and baby bottles, the Food and Drug Administration (TFDA) of the Department of Health, Executive Yuan, officially announced on November 22, 2000, amendments to Article 4 of the Hygiene Standards for Food Utensils, Containers, and Packaging. The main amendments concern regulations related to plastics and plastic materials.
Studies have found that plasticizers commonly added to plastics are endocrine disruptors, and long-term excessive exposure may interfere with the endocrine system. To strengthen management of food utensils containing di-(2-ethylhexyl) phthalate (DEHP) and di-n-butyl phthalate (DBP), including plastic lunch boxes, water bottles, sauce bottles, and PVC cling film, the Department of Health has announced a draft amendment to Article 4 of the Hygiene Standards for Food Utensils, Containers, and Packaging. The amendment adds limits for DEHP and DBP concentrations of less than 1.5 ppm and less than 0.3 ppm, respectively.
Similar to the draft amendment, this revision also adds bisphenol A (BPA) leaching limits for bottles made of polycarbonate (PC) (excluding baby bottles), polyethersulfone (PES) bottles, and polyphenylene sulfone (PPSU) bottles. For example, BPA leaching in sports water bottles and sippy cups must be below 0.6 ppm; the BPA leaching limit for PPSU bottles is 30 ppb. This revision also adds polylactic acid (PLA) as a regulated material, including standards for heavy metals and total lactic acid in beverage cups, ice cream cups, salad boxes, etc., used in restaurants.
The newly added items and standards are listed in the table below:
In the amended provisions, those in bold are the differences from the draft amendment.
1) General provisions:
| Product Name | Material testing items and acceptance standards | Dissolution test |
| solvent | Dissolution conditions | Project and qualification standards |
| Plastics | 鉛 (Pb):≤ 100ppm鎘 (Cd):≤ 100ppm | n-Heptane | 25℃, 1 hour | 鄰苯二甲酸二(2-乙基己基)酯(DEHP):≤ 1.5ppm鄰苯二甲酸二丁酯 (DBP):≤ 0.3ppm |
2) Regulations for plastics:
| raw materials | Material testing items and acceptance standards | Dissolution test |
| solvent | Dissolution conditions | Project and qualification standards |
| Polycarbonate (PC) – except for baby bottles | 鉛 (Pb):≤ 100ppm鎘 (Cd):≤ 100ppm | water | 95℃, 30 minutes | Potassium permanganate consumption (KMnO4): ≤ 10 ppm; Evaporation residue: ≤ 30 ppm; Bisphenol A (BPA): ≤ 0.6 ppm |
| 4% Acetic Acid | 60℃, 30 minutes | Heavy metals:≤ 1.0ppm(byPb count)Evaporation residue: ≤ 30 ppm; Bisphenol A (BPA): ≤ 0.6 ppm |
| Polyether resin (PES) – Baby bottles | 鉛 (Pb):≤ 100ppm鎘 (Cd):≤ 100ppm | water | 95℃, 30 minutes | Potassium permanganate consumption (KMnO4): ≤ 10 ppm; Evaporation residue: ≤ 30 ppm; Bisphenol A (BPA): ≤ 30 ppb |
| 4% Acetic Acid | 60℃, 30 minutes | Heavy metals:≤ 1.0ppm(byPb count)Evaporation residue: ≤ 30 ppm; Bisphenol A (BPA): ≤ 30 ppb |
| Polystyrene (PPSU) – Baby Bottles | 鉛 (Pb):≤ 100ppm鎘 (Cd):≤ 100ppm | water | 95℃, 30 minutes | Potassium permanganate consumption (KMnO4): ≤ 10 ppm; Evaporation residue: ≤ 30 ppm; Bisphenol A (BPA): ≤ 30 ppb |
| 4% Acetic Acid | 60℃, 30 minutes | Heavy metals:≤ 1.0ppm(byPb count)Evaporation residue: ≤ 30 ppm; Bisphenol A (BPA): ≤ 30 ppb |
| 聚乳酸 (PLA) a | 鉛 (Pb):≤ 100ppm鎘 (Cd):≤ 100ppm | water | 50℃, 4 hours b | Potassium permanganate consumption (KMnO4): ≤ 10 ppm; Evaporation residue: ≤ 30 ppm; Total lactic acid: ≤ 30 ppm |
| 4% Acetic Acid | Heavy metals:≤ 1.0ppm(byPb count)Evaporation residue: ≤ 30ppm |
| 20% alcohol | Evaporation residue (for alcoholic beverage containers and packaging): ≤ 30ppm |
| n-Heptane | 25℃, 1 hour | Evaporation residue (for containers and packaging of oils and fats): ≤ 30ppm |
Note:
a) Food utensils, containers and packaging made of polylactic acid shall not be used in high-temperature sterilization processing or preparation processes, nor are they suitable for holding food at temperatures above 100°C.
|
| b) For food manufacturing, processing, or preparation processes where the temperature reaches 50°C or above, or for the use of polylactic acid (PLA) composite materials, the dissolution conditions are 60°C for 30 minutes. |
source
http://www.fda.gov.tw/news.aspx?newssn=6656&key_year=2010&keyword=&classifysn=3
