FDA LFGB japan
I. Plastic Food Contact Article
TESTS Sample
Size
1. FDA Regulations for Plastic Ware
a. Acrylonitrile-butadiene-styrene copolymer (ABS), 21 CFR 177.1020
i) Total extractives in distilled water 300cm2
ii) Total extractives in 3% acetic acid 300cm2
iii) T otal extractives in n-heptane 300cm2
b. ABS, 21 CFR 180.22
300cm2
i) Acrylonitrile monomer extraction for finished product in
distilled water at 120°F for appropriate time of use
300cm2
ii) Acrylonitrile monomer extraction for finished product in 3%
acetic acid at 120°F for appropriate time of use
300cm2
iii) Acrylonitrile monomer extraction for finished product in n-
heptane at 120°F for appropriate time of use
300cm2
iv) Acrylonitrile monomer extraction for finished product in 8% or
50% alcohol at 120°F for appropriate time of use
c. Ethylene-vinyl acetate copolymer (EVA), 21 CFR 177.1350
i) Total extractives in distilled water 300cm2
ii) Total extractives in n-heptane 300cm2
iii) T otal extractives in 8% alcohol 300cm2
iv) Total extractives in 50% alcohol 300cm2
d. Melamine-formaldehyde resins (MF), 21 CFR 177.1460
i) Net chloroform-soluble extractives in distilled water 300cm2
ii) Net chloroform-soluble extractives in n-heptane 300cm2
iii) N et chloroform-soluble extractives in 8% alcohol 300cm2
e. Nylon resins, 21 CFR 177.1500
i) Specific gravity 3g
ii) Melting point 3g
iii) S olubility in boiling 4.2N HCl 2g
iv) Extractable fraction in distilled water 30g
v) Extractable fraction in 95% ethyl alcohol 30g
vi) Extractable fraction in ethyl acetate 30g
vii)Extractable fraction in benzene 30g
f. Polyethylene resins (PE) , 21 CFR 177.1520
i) Density 3g
ii) Extractable fraction in n-hexane 30g
iii) S oluble fraction in xylene 30g
g. Polypropylene resins (PP) , 21 CFR 177.1520
i) Density 3g
ii) Melting point 3g
iii) E xtractable fraction in n-hexane 30g
iv) Soluble fraction in xylene 30g
h. Polycarbonate resins (PC), 21 CFR 177.1580
i) Total extractives in distilled water 30g
ii) Total extractives in 50% ethyl alcohol 30g
iii) T otal extractives in n-heptane 30g
i. Phenolic resins in molded articles，21CFR 177.2410
i) Total extractives in distilled water 300cm2
Size j. Polyethylene phthalate polymers (polyester, e.g. PET), 21 CFR 177.1630
i) Chloroform-soluble extractives in distilled water 300cm2
ii) Chloroform-soluble extractives in n-heptane 300cm2 iii) C hloroform-soluble extractives in 50% ethyl alcohol 300cm2 k. Polystyrene resins (PS), 21 CFR 177.1640
i) Total residual styrene monomer content 3g
l. Polyoxymethylene (POM) copolymer, 21 CFR 177.2470
i) Net chloroform-soluble extractives in distilled water 300cm2
ii) Net chloroform-soluble extractives in n-heptane 300cm2 iii) Net chloroform-soluble extractives in 8% alcohol 300cm2 m. Resinous and polymeric coating, 21 CFR 175.300 * +
i) Total extractives in distilled water 300cm2
ii) Total extractives in n-heptane 300cm2 iii) Total extractives in 8% alcohol 300cm2 iv) Chromium content(For stainless steel only) 2g
n. Rubber, 21 CFR 177.2600
i) Total extractives in distilled water for 300cm2
- 7 hours
- the succeeding 2 hours
ii) Total extractives in n-hexane for 300cm2 - 7 hours
- the succeeding 2 hours
o. Perfluorocarbon Resins, 21 CFR 177.1550(用作涂层)
i) Total extractives in distilled water at reflux temp. for 2 hr 300cm2
ii) Total extractives in n-heptane at reflux temp. for 2 hr 300cm2 iii) Total extractives in 8% alcohol at reflux temp. for 2 hr 300cm2 iv) Fluoride extractives calculated as fluorine in distilled water at
300cm2 reflux temp. for 2 hr
300cm2 v) Fluoride extractives calculated as fluorine in n-heptane at reflux
temp. for 2 hr
300cm2 vi) Fluoride extractives calculated as fluorine in 8% alcohol at reflux
temp. for 2 hr
p. Perfluorocarbon Resins, 21 CFR 177.1550
i) Total extractives in distilled water at reflux temp. for 2 hr 300cm2
ii) Total extractives in n-heptane at reflux temp. for 2 hr 300cm2 iii) Total extractives in 50% alcohol at reflux temp. for 2 hr 300cm2 iv) Total extractives in ethyl acetate at reflux temp. for 2 hr 300cm2 v) Fluoride extractives calculated as fluorine in distilled water at
300cm2 reflux temp. for 2 hr
300cm2 vi) Fluoride extractives calculated as fluorine in n-heptane at reflux temp. for 2 hr
300cm2 vii) Fluoride extractives calculated as fluorine in 50% alcohol at
reflux temp. for 2 hr
ⅷ) Fluoride extractives calculated as fluorine in ethyl acetate at
300cm2 reflux temp. for 2 hr
q. Closures with sealing gaskets for food containers,21CFR 177.1210
Size
i) Chloroform fraction of water extractives 300cm2 ii) Chloroform fraction of heptane extractives 300cm2 iii) Chloroform fraction of 8% alcohol extractives 300cm2 r. Polyester resins,cross linked,21CFR 177.2420
i) Net chloroform-soluble extractives in distilled water 300cm2
ii) Net chloroform-soluble extractives in n-heptane 300cm2 iii) Net chloroform-soluble extractives in 8% alcohol 300cm2 iv) Net chloroform-soluble extractives in 50% alcohol300cm2 s. Reinforced wax, 21CFR 178.3850
i) Chloroform-soluble portion in distilled water a t70℉ for 48h 300cm2 t. Ion-exchange resins,21CFR 173.25
i) Organic extractives in distilled water 50ml ii) Organic extractives in 15% alcohol 50ml iii) Organic extractives in 5% acetic acid 50ml 1.1 FDA Regualation for Paper and paperboard
Paper and coated paper, 21CFR 176.170
i) Total extractives in distilled water 300cm2
ii) Total extractives in 8% alcohol 300cm2 iii) Total extractives in 50% alcohol 300cm2 iv) Total extractives in heptane 300cm2
Size
3. Japan Food Sanitation Law for Plastic Ware
a. Synthetic resins in general (For all plasic ware)
Material test
i) Cadmium 2g
ii) Lead 2g Elution test
i) Heavy metal as lead in 4% acetic acid 300cm2
ii) Consumption of Potassium Permanganate 300cm2 b1. Synthetic resins made from formaldehyde
Elution test
i) Formaldehyde 300cm2
Evaporation residue
i) in 4% acetic acid 300cm2 b2. Polyvinyl chloride (PVC)
Material test
i) Vinyl chloride 2g
ii) Dibutyle tin 2g
iii) Tricresyl phosphate 2g Evaporation residue
i) in n-heptane (For oils, fats, and fatty foods) 300cm2 ii) in 20% ethanol (Alcoholic liquors) 300cm2 iii) in distilled water (For foods whose pH value exceeds 5) 300cm2 iv) in 4% acetic acid (For foods whose pH value is 5 or less) 300cm2 b3. Polyethylene (PE) and Polypropylene (PP)
Evaporation residue
i) in n-heptane (For oils, fats, and fatty foods) 300cm2 ii) in 20% ethanol (Alcoholic liquors) 300cm2 iii) in distilled water (For foods whose pH value exceeds 5) 300cm2 iv) in 4% acetic acid (For foods whose pH value is 5 or less) 300cm2 b4. Polystyrene (PS)
Material test
i) Volatile substances(styrene,toluene,ethyl benzene, isopropyl
2g benzene,propylbenzene)
Evaporation residue
i) in n-heptane (For oils, fats, and fatty foods) 300cm2 ii) in 20% ethanol (Alcoholic liquors) 300cm2 iii) in distilled water (For foods whose pH value exceeds 5) 300cm2 iv) in 4% acetic acid (For foods whose pH value is 5 or less) 300cm2 b5. Polyvinylidiene chloride (PVDC)
Material test
i) Barium 2g
ii) Vinyl chloride 2g Evaporation residue
i) in n-heptane (For oils, fats, and fatty foods) 300cm2 ii) in 20% ethanol (Alcoholic liquors) 300cm2 iii) in distilled water (For foods whose pH value exceeds 5) 300cm2 iv) in 4% acetic acid (For foods whose pH value is 5 or less) 300cm2
Size b6. Polyethylene terephthalate (PET)
Elution test
i) Antimony 300cm2 ii) Germanium 300cm2 Evaporation residue
i) in n-heptane (For oils, fats, and fatty foods) 300cm2
ii) in 20% ethanol (Alcoholic liquors) 300cm2 iii) in distilled water (For foods whose pH value exceeds 5) 300cm2 iv) in 4% acetic acid (For foods whose pH value is 5 or less) 300cm2 b7. Polymethyl methacrylate (PMMA)
Elution test
i) Methyl methacrylate(甲基丙烯酸甲酯) in 20%ethanol 300cm2
Evaporation residue
i) in n-heptane (For oils, fats, and fatty foods) 300cm2 ii) in 20% ethanol (Alcoholic liquors) 300cm2 iii) in distilled water (For foods whose pH value exceeds 5) 300cm2 iv) in 4% acetic acid (For foods whose pH value is 5 or less) 300cm2 b8. Nylon (PA)
Elution test
i) Caprolactam(已内酰胺)in 20% ethanol 300cm2
Evaporation residue
i) in n-heptane (For oils, fats, and fatty foods) 300cm2 ii) in 20% ethanol (Alcoholic liquors) 300cm2 iii) in distilled water (For foods whose pH value exceeds 5) 300cm2 iv) in 4% acetic acid (For foods whose pH value is 5 or less) 300cm2 b9. Polysmethyl pentene (PMP)
Evaporation residue
i) in n-heptane (For oils, fats, and fatty foods)
ii) in 20% ethanol (Alcoholic liquors)
iii) in distilled water (For foods whose pH value exceeds 5)
iv) in 4% acetic acid (For foods whose pH value is 5 or less)
b10. Polycarbonate (PC)
Material test
i) Bisphenol A(including phenol and p-tert-butylphenol) 2g
ii) Diphenyl carbonate 2g
iii) Amines(triethylamine,tributylamine) 2g
Elution test
i) Bisphenol A(+phenol and p-tert-butylphenol)in n-heptane 300cm2 ii) Bisphenol A(+phenol and p-tert-butylphenol) in 20% ethanol 300cm2 iii) Bisphenol A(+phenol and p-tert-butylphenol)in distilled water 300cm2 iv) Bisphenol A(+phenol and p-tert-butylphenol) in 4% acetic acid 300cm2 Evaporation residue
i) in n-heptane (For oils, fats, and fatty foods) 300cm2 ii) in 20% ethanol (Alcoholic liquors) 300cm2 iii) in distilled water (For foods whose pH value exceeds 5) 300cm2 iv) in 4% acetic acid (For foods whose pH value is 5 or less) 300cm2 b11.Polyvinyl alcohol
Evaporation residue
Size
i) in n-heptane (For oils, fats, and fatty foods) 300cm2
ii) in 20% ethanol (Alcoholic liquors) 300cm2
iii) in distilled water (For foods whose pH value exceeds 5) 300cm2
iv) in 4% acetic acid (For foods whose pH value is 5 or less) 300cm2
b12.phenol resin, melamine resin or urea resin
Elution test
i) Formaldehyde 300cm2
ii) Phenol 300cm2
Evaporation residue
i) in 4% acetic acid 300cm2
c1. Rubber (except nursing utensils)
Material test
i) Cadmium 2g
ii) Lead 2g
iii) 2-mercaptoimidazoline 2g
Dissolution test
i) Phenol 300cm2
ii) Formaldehyde 300cm2
iii) Zinc 300cm2
iv) Heavy metal as lead in 4% acetic acid 300cm2
Evaporation residue
i) in distilled water 300cm2
ii) in 4% acetic acid 300cm2
iii) in 20% ethanol 300cm2
c2. Rubber (Nursing utensils)
Material test
i) Cadmium 2g
ii) Lead 2g
Dissolution test
i) Phenol 300cm2
ii) Formaldehyde 300cm2
iii) Zinc 300cm2
iv) Heavy metal as lead in 4% acetic acid 300cm2
Evaporation residue
i) in distilled water 300cm2
4. Plactic Food Contact Article Test (Korea Standard)
A. Acrylonitrile-butadiene-styrene copolymer (ABS) / AS
Material test
a.Cadmium 2g
b.Lead 2g
c. Volatile materials (styrene, toluene, ethylbenzene, isopropyl
2g
benzene, n-propylbenzene)
Elution test
a.Heavy metal as lead 300cm2
b.Consumption of Potassium Permanganate 300cm2
Nonvolatile residues
a.in n-heptane 300cm2
b.in 20% ethanol 300cm2
Size
c.in distilled water 300cm2
d.in 4% acetic acid 300cm2
Acrylonitrile 5g Total for above tests
B. Polystyrene (PS)
Material test
a.Cadmium 2g
b.Lead 2g
2g
c.Volatile materials (styrene, toluene, ethylbenzene, isopropyl
benzene, n-propylbenzene)
Elution test
a.Heavy metal as lead 300cm2
b.Consumption of Potassium Permanganate 300cm2
Nonvolatile residues
a.in n-heptane 300cm2
b.in 20% ethanol 300cm2
c.in distilled water 300cm2
d.in 4% acetic acid 300cm2
Total for above tests
C. Polyethylene terephthalate (PET)
Material test
a.Cadmium 2g
b.Lead 2g
Elution test
a.Heavy metal as lead 300cm2
b.Consumption of Potassium Permanganate 300cm2
Nonvolatile residues
a.in n-heptane 300cm2
b.in 20% ethanol 300cm2
c.in distilled water 300cm2
d.in 4% acetic acid 300cm2
Antimony300cm2
Germanium 300cm2
Total for above tests
5. LFGB Regulation for Plastic Wares (Germany Standard)
A. General Test for Synthetic Resins
- Overall migration in distilled water 300cm2
- Overall migration in acetic acid 300cm2
- Overall migration in 10% ethanol 300cm2
- Overall migration in fatty stimulant 300cm2
- If coloured sample, need to do Colorants Test : Soluble Heavy
300cm2
Metals and Primary aromatic amines
- Sensory test
B. Additional tests for Different Plastic Material
B1. Acrylonitrile-butadiene-styrene copolymer (ABS)
- Remaining peroxides test 5g
- Volatile organic matters 5g
Size - Specific migration of acrylonitrile 5g - Residual 1,3-butadiene test 5g
B2. Polycarbonate resins (PC)
- Specific migration of Bisphenol A 300cm2 B3. Nylon
- Remaining peroxides test 5g - Primary Aromatic Amines (waived if quoted in A) 300cm2 B4. Polypropylene resins (PP)
- Remaining peroxides test 5g
B5. Polyethylene (PE)
- Remaining peroxides test 5g
B6. Polyvinyl chloride (PVC)
- Vinyl chloride Monomer 5g - Remaining peroxides 5g
B7. Polystyrene (PS)
- Volatile organic matters 5g
- Remaining peroxides test 5g