FDA registration / FDA testing services / FDA Regulatory Advisory
The U.S. food and drug administration, FDA official website http://www.fda.gov
U.S. Food and Drug Administration The U.S. food and drug administration -
referred to as "the FDA”
U.S. Food and Drug Administration The
U.S. food and drug administration is responsible for controls access to the
U.S. market of food, medicines, medical equipment, cosmetics products such as
anti-terrorism and prosecution.
The purpose of the FDA is by ensuring that the food safety, hygiene, health and
correct marks and cosmetics safety and correct.
The FDA's job is to ensure that the domestic production or import of food,
cosmetics, drugs, biologics, medical devices and radiation products safety.
The FDA is recognized to be one of the world's biggest food and drug
administration.
The FDA is the U.S. government in the health and human services (DHHS) and the
ministry of public health (PHS) set up in one of the actuator.
The FDA is responsible for the mandate of food-grade materials, relevant
laboratory qualification of the third party lab can according to the FDA laws
related to test and issue a report on the FDA's testing.
Note: Completion of an FDA registration does not represent FDA approval or
approval of a business or product, Any representation in labeling or
advertising that creates an impression of official approval because of
registration or possession of a registration number is considered misleading.
FDA registration and testing services
FDA registration include: Food FDA registration, Animal feed FDA
registration, medical device FDA registration, drug FDA registration etc.
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Jeston can provide food contact material FDA standard test service.
The FDA testing food contact materials
The FDA issued test standard FDA tests including food contact materials and
cosmetics, cosmetics tests to see the left column to the FDA, the FDA food
contact materials testing requirements are as follows:
■Organic coating and metal and electroplating products require U.S. FDA 21 CFR
175.300
Water extractives Deionized water leaching method
8% alcohol extractives 8% Alcohol leaching method
N-heptane extractives N-heptane leach process
■Paper products requirements U.S. FDA CFR 21 176.170
Net chloroform soluble extractives for water fraction Soluble in
chloroform extract, deionized water leaching method)
Net chloroform soluble extractives for 8 % alcohol fraction Soluble in
chloroform extract (8% alcohol leaching method)
Net chloroform soluble extractives for 50 % alcohol fraction Soluble in
chloroform extract (50% alcohol leaching method)
Net chloroform soluble extractives for n-heptane fraction Soluble in
chloroform extract (n-heptane leach process)
■Bamboo and wood products requirementsU.S. FDA CFR 21 178.3800
Pentachlorophenol and its salt Five chlorine phenol PCP
■ABS/SAN requirements U.S. FDA CFR 21 180.22 or 181.32.
Residual Acrylonitile in n-heptane Acrylonitrile residues of n-heptane
Residual Acrylonitile in 8% ethanol 8% Of acrylonitrile residual
ethanol
Residual Acrylonitile in 50% ethanol 50% Acrylonitrile residual ethanol
Residual Acrylonitile in 3% acetic acid 3% Residual acrylonitrile in
acetic acid
Residual Acrylonitile in water The water acrylonitrile residues
■Acrylic resin(Acrylic)requirements
U.S. FDA CFR 21 177.1010
The total extract(in water,8%,50%alcohol
fraction,heptane)Deionized water, 8% / 50% ethanol,
n-heptane
KMnO4 oxidizable extractive(in water,8%,50%alcohol fraction)Potassium
permanganate oxidation extraction
Ultraviolet-absorbing(in water,8%,50%alcohol fraction)Ultraviolet absorption
(water, 8% ethanol, 50% ethanol)
Ultraviolet-absorbing(in heptane fraction)The ultraviolet absorption
(n-heptane))
■Food container sealing ring, sealing gasket requirements, such as silicone
rubber ring U.S. FDA CFR 21 177.1210
Net chloroform soluble extractives for water fraction Soluble in chloroform
extract, deionized water leaching method)
Net chloroform soluble extractives for 8 % alcohol fraction Soluble in
chloroform extract (8% alcohol leaching method)
Net chloroform soluble extractives for n-heptane fraction Soluble in chloroform
extract (n-heptane leach process)
■EVA requirements U.S. FDA CFR 21 177.1350
Net chloroform soluble extractives for water fraction Soluble in chloroform
extracts of water extraction
Net chloroform soluble extractives for 8 % alcohol fraction 8%Soluble in
chloroform extracts of ethanol extraction
Net chloroform soluble extractives for 50 % alcohol fraction 50%Soluble in
chloroform extracts of ethanol extraction
Net chloroform soluble extractives for n-heptane fraction Soluble in chloroform
extracts of n-heptane extraction
■Melamine resin (melamine) requirements U.S. FDA CFR 21 177.1460
Net chloroform soluble water extractives Soluble in chloroform extract,
deionized water leaching method)
Net chloroform soluble 8% alcohol extractives Soluble in chloroform extract (8%
alcohol leaching method)
Net chloroform soluble n-heptane extractives Soluble in chloroform extract
(n-heptane leach process
■Nylon plastic requirements U.S. FDA CFR 21 177.1500
Specific gravity The density
Melting point Melting point
Solubility / boiling 4.2 N HCI The solubility of hydrochloric acid
Water extractives Deionized water leaching method
95% ethanol extractives 95%Alcohol leaching method
Ethyl acetate extractives Acetic ester leach process
Benzene extractives Benzene leach process
■PP requirements U.S. FDA CFR 21 177.1520
Specific gravity The density of
Melting point Melting point
n-hexane extractives N-hexane leach process
Xylene extractives Xylene leach process
■ PE,OP requirements U.S. FDA CFR 21 177.1520
Specific gravity of the density
n-hexane extractives N-hexane leach process
Xylene extractives Xylene leach process
■The fluorine carbon resin(Perfluorocarbon resins)requirements.U.S. FDA CFR 21 177.1550
50% ethanol extractives at refluxing temperature for 2 hours 50%Ethanol reflux
extraction 2h
N-heptane extractives at refluxing temperature for 2 hours N-heptane reflux
extraction 2h
Ethyl acetate extractives at refluxing temperature for 2 hours Ethyl acetate
reflux extraction 2h
Fluoride extractives (as fluorine) in distilled water Fluoride in distilled
water extraction
Fluoride extractives (as fluorine) in 8% ethanol (for coating) 8%Fluoride in
ethanol extraction (with fluorine)
Fluoride extractives (as fluorine) in 50% ethanol 50%Fluoride in ethanol
extraction (with fluorine)
Fluoride extractives (as fluorine) in ethyl acetate Fluoride in ethyl acetate
extraction (with fluorine)
Fluoride extractives (as fluorine) in n-heptane Fluoride in n-heptane
extraction (with fluorine)
■ PC requirements .U.S. FDA CFR 21 177.1580
Water extractives at refluxing temperature Water reflux extraction
50% ethanol extractives at refluxing temperature 50%Alcohol
reflux extraction
n-heptane extractives at refluxing temperature N-heptane reflux extraction
■PET requirements U.S. FDA CFR 21 177.1630
Net chloroform soluble fraction of distilled water Soluble in chloroform
extracts of water extraction
Net chloroform soluble fraction of n-heptane Soluble in chloroform extracts of
n-heptane extraction
Net chloroform soluble fraction of 8 % ethanol 8%Soluble in chloroform extracts
of ethanol extraction
Net chloroform soluble fraction of 50 % ethanol 50%Soluble in chloroform
extracts of ethanol extraction
Net chloroform soluble fraction of 95% ethanol 95%Soluble in chloroform
extracts of ethanol extraction
■ PS requirements U.S. FDA CFR 21 177.1640
Residual styrene monomer Styrene monomer residue
■Poly (maple resin(Polysulfone resin)requirements U.S. FDA CFR 21 177.1655
Water extractives Deionized water leach process
3 % acetic acid extractives 3%Acetic acid leach process
50 % alcohol extractives 50%Alcohol leaching method
n-heptane extractive N-heptane leach process
■Polyurethane resin(PU)requirements
U.S. FDA CFR 21 177.1680
Adhesive resistance test Abrasion test
water extractives Deionized water leaching method
8% ethanol extractives 8%Alcohol leaching method
■Styrene block polymers(Styrene block polymer)U.S. FDA CFR 21 177.1810
Water extractives Deionized water leaching method
50% ethanol extractives 50%Alcohol reflux extraction
solubility solubility
molecular weight The molecular weight
glass transition point Glass transition temperature
■MMA、MBS Methyl methacrylate, methyl
methacrylate/styrene copolymer.. U.S. FDA CFR 21 177.1830
Non-volatile residue Non volatile residue
KmnO4 oxidized water extractives The water extract of potassium permanganate
oxidation
KmnO4 oxidized 8% ethanol extractives 8%The ethanol extract of potassium
permanganate oxidation
UV absorbing water extractives The water extract of ultraviolet absorption
UV absorbing 8% ethanol extractives 8%The ethanol extract of ultraviolet
absorption
UV absorbing n-heptane extractives Ultraviolet absorption is - heptane extract
■Urea formaldehyde resin(UF)requirements
U.S. FDA CFR 21 177.1900
water extractives Deionized water leaching method
8% alcohol extractives 8%Alcohol leaching method
n-heptane extractives N-heptane leach process
■PVCPolyvinyl chloride (PVC) requirements U.S. FDA CFR 21 177.1975
water extractives Deionized water leaching method
n-heptane extractives N-heptane leach process
8% alcohol extractives 8%Alcohol leaching method
Residual vinyl chloride monomer VCMMonomer residue
■Minerals, such as glass fiber reinforced nylon66(Mineral
reinforced nylon)requirements U.S. FDA CFR 21 177.2355
Water extractives at refluxing temperature for 24 hoursWater reflux extraction
for 24 hours
50% ethanol extractives at refluxing temperature for 24 hours50%Ethanol reflux
extraction for 24 hours
Ashes of total extractives (Water )Water extraction ash
Ashes of total extractives (50% ethanol )The ethanol extraction of ash
■Polyester resin(Polyester resin)requirements U.S. FDA CFR 21 177.2420
Net chloroform soluble fraction in water Soluble in chloroform extract,
deionized water leaching method)
Net chloroform soluble fraction in 8 % ethanol Soluble in chloroform extract
(8% alcohol leaching method)
Net chloroform soluble fraction in 50 % ethanol Soluble in chloroform extract
(50% alcohol leaching method)
n-heptane extractives N-heptane leach process
■Polyamide-imide resin(Polyamide-imide resin)requirementsU.S. FDA CFR 21 177.2450
Water extractives Water extraction
3 % acetic acid extractives 3%Acetic acid extraction
50 % ethanol extractives 50%Acetic acid extraction
n-heptane extractives N-heptane extraction
■Rubber requirements(SBS,TPR,TPE)Such as silicone elastomer U.S. FDA CFR 21 177.2600
water extractives Deionized water leaching method
n-hexane extractives N-hexane leach process (only for fatty food contact)
■Silver plated products requirements U.S. FDA CPG 7117.05
extractable lead Lead extraction
■Ceramics, glass, enamel ware U.S. FDA CPG 7117.06,07
extractable lead and cadmium Dissolution of lead and cadmium test
■Metal requirements U.S. FDA CFR 175.300 & CPG 7117.05
water extractives Deionized water leaching method
8% alcohol extractives 8%Alcohol leaching method
n-heptane extractives N-heptane leach process
extractable lead Lead extraction