Common FDA food contact materials FDA testing standards-21CFR 177.XXXX

1. Materials

a. 21CFR 177.1040 Acrylonitrile/styrene copoly-mer(AS) FDA inspection

i) maximum residual acrylonitrile monomer content

ii) Nitrogen content of the copolymer

iii) Total non-volatile extractives in distilled water

iv) Total non-volatile extractives in 3% acetic acid

v) The extracted copolymer in distilled water

b. 21CFR 177.1020 Acrylonitrile/butadiene/styrene co-polymer( ABS)

Acrylic acid-butadiene-styrene resin copolymer FDA inspection

i) Nitrogen content of the copolymer

ii) Residual acrylonitrile monomer content

iii) total non-volatile extractives in distilled water

iv) total non-volatile extractives in 3%acetic acid

v) total non-nvolatile extractives in n-heptane

vi) acrylonitrile monomer migration in distilled water

vii) acrylonitrile monomer migration in 3%acetic acid

c. 177.1460 Melamine-formaldehyde resins in molded articles (MF) FDA testing

i) Net chloroform-soluble extractives in distilled water

ii) Net chloroform-soluble extractives in n-heptane

iii) Net chloroform-soluble extractives in 8% alcohol

d. 177.1500 Nylon resins

i) Specific gravity

ii) melting point

iii) solubility in boiling 4.2NHCl

iv) maxium extractable fraction in water

v) maxium extractable fraction in 95% alcohol

vi) maxium extractable fraction in ethyl acetate

viii) maxium extractable fraction in benzene

e. Polyethylene resins (PE), 21 CFR 177.1520 polyethylene resin

i) Density

ii) Extractable fraction in n-hexane

iii) Soluble fraction in xylene

f. Polypropylene resins (PP), 21 CFR 177.1520 polypropylene resin

'i) Density

ii) Melting point

iii) Extractable fraction in n-hexane

iv) Soluble fraction in xylene

g. Ethylene-vinyl acetate copolymer (EVA), 21 CFR 177.1350

i) Total extractives in distilled water

ii) Total extractives in n-heptane

iii) Total extractives in 8% alcohol

iv) Total extractives in 50% alcohol

h. Polycarbonate resins (PC), 21 CFR 177.1580 Polycarbonate FDA test

i) Total extractives in distilled water

ii) Total extractives in 50% ethyl alcohol

iii) Total extractives in n-heptane

i. Polyethylene phthalate polymers (polyester, e.g. PET), 21 CFR 177.1630

i) Chloroform-soluble extractives in distilled water

ii) Chloroform-soluble extractives in n-heptane

iii) Chloroform-soluble extractives in 50% ethyl alcohol

j. Polyvinyl alcohol film, 21 CFR 177.1670

i) Total extractives in n-heptane

k. Polyoxymethylene copolymer (POM), 21 CFR 177.2470 Polyoxymethylene resin

i) Net-chloroform soluble extractives in distilled water

ii) Net-chloroform soluble extractives in n-heptane

iii) Net-chloroform soluble extractives in 8% alcohol

iv) Total extractives in distilled water at reflux temperature for 6 hours

v) Total extractives in n-heptane at reflux temperature for 6 hours

l. Polyphenylene sulphide (PPS), 21 CFR 177.2490

 i) Total extractives in distilled water

 ii) Total extractives in 3% acetic acid

 iii) Total extractives in 50% ethanol

iv) Total extractives in heptane

m. Poly (2,6-dimethyl-1,4-phenylene) oxide (PPO), 21 CFR 177.2460 Polyoxide resin FDA inspection

 i) Total extractives in n-heptane

n. Rubber, 21 CFR 177.2600 rubber, silicone FDA inspection

i) Total extractives in distilled water (intended to contact with aqueous food) for

 ii) Total extractives in n-hexane (intended to contact with fatty food) for

o.Acrylonitrile copolymers, Single-use, 21 CFR 180.22

i) Acrylonitrile monomer extraction for finished product in distilled water at 120°F for

appropriate time of use

ii) Acrylonitrile monomer extraction for finished product in 8% or 50% ethanol (select

one) at 120°F for appropriate time of use

iii) Acrylonitrile monomer extraction for finished product in 3% acetic acid at 120°F for

appropriate time of use

iv) Acrylonitrile monomer extraction for finished product in n-heptane at 120°F for

appropriate time of use

P. Polystyrene resins(PS), 21 CFR 177.1640 Polystyrene FDA test

i) Total residual styrene monomer content

q. Resinous and polymeric coating, 21 CFR 175.300 FDA inspection for resin and polymeric coating

i) Total extractives in distilled water

ii) Total extractives in 8% alcohol

iii) Total extractives in n-heptane

r. Phenolic resins in molded articles, 21 CFR 177.2410

i) Total extractives in distilled water

ii) Extracted phenol in distilled water

iii) Extracted aniline in distilled water

s. Ion-exchange resins, 21 CFR 173.25 ion exchange resin FDA test

i) Organic extractives in distilled water

ii) Organic extractives in 15% alcohol

iii) Organic extractives in 5% acetic acid

t. Reinforced wax, 21 CFR 178.3850 sealing wax

i) Chloroform-soluble portion in distilled water

u. Per fluorocarbon Resins, 21 CFR 177.1550 Teflon FDA test

i) Total extractives in distilled water

ii) Total extractives in n-heptane

iii) Total extractives in 50% alcohol

iv) Total extractives in ethyl acetate

v) Fluoride extractives calculated as fluorine in distilled water

vi) Fluoride extractives calculated as fluorine in n-heptane

vii) Fluoride extractives calculated as fluorine in 50% alcohol

viii) Fluoride extractives calculated as fluorine in ethyl acetate

v. Closures with sealing gaskets for food containers, 21 CFR 177.1210 FDA inspection

i) Chloroform fraction of water extractives

ii) Chloroform fraction of heptane extractives

iii) Chloroform fraction of 8% alcohol extractives