FDA registration / FDA testing services/ FDA Regulatory Advisory
The U.S. food and drug administration, FDA official website
U.S. Food and Drug Administration The U.S. food and drug administration -referred to as "the FDA”
U.S. Food and Drug Administration TheU.S. food and drug administration is responsible for controls access to theU.S. market of food, medicines, medical equipment, cosmetics products such asanti-terrorism and prosecution.
The purpose of the FDA is by ensuring that the food safety, hygiene, health andcorrect 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 drugadministration.
The FDA is the U.S. government in the health and human services (DHHS) and theministry of public health (PHS) set up in one of the actuator.
The FDA is responsible for the mandate of food-grade materials, relevantlaboratory qualification of the third party lab can according to the FDA lawsrelated to test and issue a report on the FDA's testing.
Note: Completion of an FDA registration does not represent FDA approval orapproval of a business or product, Any representation in labeling oradvertising that creates an impression of official approval because ofregistration or possession of a registration number is considered misleading.
FDA registration and testing services
FDA registration include: Food FDA registration, Animal feed FDAregistration, medical device FDA registration, drug FDA registration etc.
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The FDA testing food contact materials
The FDA issued test standard FDA tests including food contact materials andcosmetics, cosmetics tests to see the left column to the FDA, the FDA foodcontact materials testing requirements are as follows：
■Organic coating and metal and electroplating products require U.S. FDA 21 CFR175.300
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 inchloroform extract, deionized water leaching method)
Net chloroform soluble extractives for 8 % alcohol fraction Soluble inchloroform extract (8% alcohol leaching method)
Net chloroform soluble extractives for 50 % alcohol fraction Soluble inchloroform extract (50% alcohol leaching method)
Net chloroform soluble extractives for n-heptane fraction Soluble inchloroform 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 residualethanol
Residual Acrylonitile in 50% ethanol 50% Acrylonitrile residual ethanol
Residual Acrylonitile in 3% acetic acid 3% Residual acrylonitrile inacetic acid
Residual Acrylonitile in water The water acrylonitrile residues
■Acrylic resin（Acrylic）requirementsU.S. FDA CFR 21 177.1010
The total extract（in water,8%,50%alcoholfraction,heptane）Deionized water, 8% / 50% ethanol,n-heptane
KMnO4 oxidizable extractive(in water,8%,50%alcohol fraction)Potassiumpermanganate 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 siliconerubber ring U.S. FDA CFR 21 177.1210
Net chloroform soluble extractives for water fraction Soluble in chloroformextract, deionized water leaching method)
Net chloroform soluble extractives for 8 % alcohol fraction Soluble inchloroform extract (8% alcohol leaching method)
Net chloroform soluble extractives for n-heptane fraction Soluble in chloroformextract (n-heptane leach process)
■EVA requirements U.S. FDA CFR 21 177.1350
Net chloroform soluble extractives for water fraction Soluble in chloroformextracts of water extraction
Net chloroform soluble extractives for 8 % alcohol fraction 8%Soluble inchloroform extracts of ethanol extraction
Net chloroform soluble extractives for 50 % alcohol fraction 50%Soluble inchloroform extracts of ethanol extraction
Net chloroform soluble extractives for n-heptane fraction Soluble in chloroformextracts 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 refluxextraction 2h
N-heptane extractives at refluxing temperature for 2 hours N-heptane refluxextraction 2h
Ethyl acetate extractives at refluxing temperature for 2 hours Ethyl acetatereflux extraction 2h
Fluoride extractives (as fluorine) in distilled water Fluoride in distilledwater extraction
Fluoride extractives (as fluorine) in 8% ethanol (for coating) 8%Fluoride inethanol extraction (with fluorine)
Fluoride extractives (as fluorine) in 50% ethanol 50%Fluoride in ethanolextraction (with fluorine)
Fluoride extractives (as fluorine) in ethyl acetate Fluoride in ethyl acetateextraction (with fluorine)
Fluoride extractives (as fluorine) in n-heptane Fluoride in n-heptaneextraction (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％Alcoholreflux 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 chloroformextracts of water extraction
Net chloroform soluble fraction of n-heptane Soluble in chloroform extracts ofn-heptane extraction
Net chloroform soluble fraction of 8 % ethanol 8%Soluble in chloroform extractsof ethanol extraction
Net chloroform soluble fraction of 50 % ethanol 50%Soluble in chloroformextracts of ethanol extraction
Net chloroform soluble fraction of 95% ethanol 95%Soluble in chloroformextracts 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）requirementsU.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, methylmethacrylate/styrene copolymer.. U.S. FDA CFR 21 177.1830
Non-volatile residue Non volatile residue
KmnO4 oxidized water extractives The water extract of potassium permanganateoxidation
KmnO4 oxidized 8% ethanol extractives 8%The ethanol extract of potassiumpermanganate oxidation
UV absorbing water extractives The water extract of ultraviolet absorption
UV absorbing 8% ethanol extractives 8%The ethanol extract of ultravioletabsorption
UV absorbing n-heptane extractives Ultraviolet absorption is - heptane extract
■Urea formaldehyde resin（UF）requirementsU.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（Mineralreinforced nylon）requirements U.S. FDA CFR 21 177.2355
Water extractives at refluxing temperature for 24 hoursWater reflux extractionfor 24 hours
50% ethanol extractives at refluxing temperature for 24 hours50%Ethanol refluxextraction 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
