TABLE I (B)

Total Amounts of Elemental Impurities in Materials (Digestion or Total Pool)

Type of MaterialAmount of Metal in the Material (mg/kg unless noted)Ref.
BaCaCdCuFeAsHgNiZnZr
Acrylonitrile-butadiene-styrene19NR1NRNRNRNRNRNRNR1.3<0.0143
Acrylonitrile-butadiene-styreneNRNRNRNRNRNRNRNR1.3NR13, 14
CardboardNRNR<0.01NRNRNR<0.02NRNRNR31
Cardboard + PE filmNRNR25NRNRNR0.06NRNRNR31
Paper (3 samples)NRNR<0.01–0.12NRNRNRNRNRNRNR33
Paperboard (3 samples)NRNR<0.01–0.09NRNRNRNRNRNRNR33
Type 1 glass vial10213610.50.12390.3<0.50.1<0.120624
Colorless glass283805.4%NRNR0.73%<0.1NRNRNR24657
Polyester bottle<0.521<0.5<0.52<0.5<0.5<0.510<0.524
Polycarbonate bottle<0.512<0.5<0.5<1<0.5<0.5<0.513<0.524
Polyethylene terephthalateNRNRNRNRNRNRNRNR1.20.2013, 14
Polyethylene terephthalateNRNRNRNRNRNRNRNRNRNR13, 14
Polyethylene terephthalateNRNRNRNRNRNRNRNRNRNR13, 14
Polyethylene terephthalate8NRNRNRNRNRNRNRNRNRNR21
Polyethylene terephthalateNRNR<1.3NRNRNRNRNRNRNR27
Polyethylene terephthalate15<1NR3.59.6<1NR<1NR<1NR28
Polyethylene terephthalate0.26NR<0.1NRNRNRNR<0.1NRNR29
Polyethylene terephthalateNRNR0.02NRNRNR<0.02NRNRNR31
Polyethylene terephthalate19NRNRNRNRNRNRNRNR<0.01, 1.20.08, 0.243
Polyethylene terephthalate208–3157–330NR0.2–813–1641–4NR0.1–31–9NR47
Polyethylene terephtalate21<0.72<1.7<2<0.48<71<0.04<1.3<9.1<5.9NR49
Clear PET bottle26<0.77<1.8ND<0.23ND<0.04NDND<7.5NR49
Low-density polyethyleneNRNRNRNRNRNRNR<1.2NRNR13, 14
Low-density polyethylene4NRNRNRNRNRNRNRNRNRNR21
Low-density polyethylene140.92NR<0.38112NR<1.3<0.88<1.111.6NR26
Low-density polyethylene19NRNRNRNRNRNRNRNR<0.001<0.0143
Low-density polyethylene22<0.14<0.36<0.26<0.05<5.7<0.003<0.06<0.78<0.33NR49
Polyethylene<0.1NR<0.1NRNRNRNR<0.1NRNR29
PolyethyleneNRNR<0.01NRNRNR0.01NRNRNR31
Polyethylene standard3306, 2718NR11814, 119NR<18NRNRNR20
PolyethyleneNRNR<1.3NRNRNRNRNRNRNR27
Polyethylene (5 samples)0.11–0.844–160<0.050.05–0.68<0.5–1.5<0.001<0.003NR0.07–0.16<0.3–0.860
Polyethylene0.44NR0.140.24<7.2NRNR0.7NRNR61
High-density polyethyleneNRNRNRNRNRNRNRNRNRNR13, 14
High-density polyethyleneNRNRNRNRNRNRNRNRNR4213, 14
High-density polyethyleneNRNR<0.01NRNRNR<0.02NRNRNR31
High-density polyethylene5NRNRNRNRNRNRNRNRNR0.03–4221
High-density polyethylene bottle12<0.58<0.5<0.55<0.5<0.5<0.5214<0.524
High-density polyethylene1457.4NR1131.25NR<1.3<0.882.1<2.0NR26
High-density polyethylene140.18NR<0.386.38NR<1.3<0.885.3<2.0NR26
High-density polyethylene19NRNRNRNRNRNRNRNR<0.001<0.01–4243
High-density polyethylene23<0.110.49<0.25<0.055<4<0.003<0.046<0.47<0.39NR49
PE/PP blend1430NR<0.3831NR<1.3<0.88<1.1449NR26
PE/PET/PE laminateNRNR<0.001NRNR<0.001NRNRNRNR48
PolypropyleneNRNRNRNRNRNRNRNRNRNR13, 14
PolypropyleneNRNRNRNRNRNRNRNRNRNR13, 14
Polypropylene6NRNRNRNRNRNRNRNRNRNR21
PolypropyleneNRNR<1.3NRNRNRNRNRNRNR27
PolypropyleneNRNR0.01NRNRNR<0.02NRNRNR31
Polypropylene19NRNRNRNRNRNRNRNR<0.01<0.0143
Polypropylene (5 samples)<0.001–0.00315–440NR<0.2<0.5–4.6<0.00–0.010NRNR<0.05–0.17NR60
PolypropyleneNRNR<0.001NRNR<0.001NRNRNRNR48
Polypropylene25<0.41<1<0.29<0.11<7.20.009<0.11<1.5<0.25NR49
PolystyreneNRNRNRNRNRNRNRNR110NR13, 14
PolystyreneNRNRNRNRNRNRNRNR81NR13, 14
Polystyrene (white)NRNRNRNRNRNRNRNR35NR13, 14
Polystyrene7NRNRNR1.4–16NRNRNRNR3–110NR21
PolystyreneNRNR<1.3NRNRNRNRNRNRNR27
PolystyreneNRNR0.02NRNRNR0.03NRNRNR31
Polystyrene19NRNRNRNRNRNRNRNR<0.01–110<0.0143
Polystyrene24<0.17<0.41<0.29<0.09<9<0.005<0.013<3.181NR49
White polystyrene27<3.2<2.6ND<0.46<40.11<0.05<0.535NR49
PolymethylmethacrylateNRNRNRNRNRNRNRNRNRNR13, 14
Polymethylmethacrylate9NRNRNRNRNRNRNRNR<1NR21
Polymethylmethacrylate19NRNRNRNRNRNRNRNR<0.01<0.0143
Polytetrafluoroethylene16NR8.2<0.010.2021.8NRNR0.21NRNR32
Polytetrafluoroethylene17NR3.1<0.010.131.63NRNR0.57NRNR32
Polytetrafluoroethylene18NR6.5<0.010.315.18NRNR0.98NRNR32
Chlorobutyl rubberNRNRNRNRNRNRNRNRNRNR13, 14
Chlorobutyl rubber2NRNRNRNRNRNRNRNRNRNR15
Chlorobutyl rubberNRNRNRNRNRNRNRNRNRNR42
Bromobutyl rubber113.6640<0.12.33253.0NR1.0810.724
Laminated polyolefinNRNRNRNRNRNRNRNRNRNR13, 14
Laminated polyolefinNRNRNRNRNRNRNRNRNRNR13, 14
Multi-layered polyolefinNRNR0.04NRNRNR<0.02NRNRNR31
Multi-layered polyolefinNRNR<0.01NRNRNR<0.02NRNRNR31
Prefilled syringe13<0.55<0.5131<5<0.5<0.50.14%124
Polyvinyl chloride (2 samples)NRNR80, 112NRNRNRNRNRNRNR58
Polyvinyl chlorideNRNR65NRNRNRNRNRNRNR59