Document LJbrxzJLgnq4Yk1NvnRwY7Xbd
Fluoropolymers: Overview
Fact Sheet Created: June 14, 2012 Latest Revision: November 19, 2012
1. Fluoropolymers A category of plastics, fluoropolymers are polymer compounds mainly comprising carbon
and fluorine. Depending on the specific elemental composition, a fluoropolymer may be polytetrafluoroethylene (PTFE), perfluoroalkoxy alkane (PFA), a perfluoroethylene propene copolymer (FEP), or another variant. PTFE accounts for approximately 60 percent of all fluoropolymers. Fluoropolymers offer many advantageous properties, including thermal resistance, chemical resistance, low friction and nonadherence, which are leveraged for a wide range of applications in fields such as semiconductors, chemical plants, automobiles and beyond--even in coatings for cooking tools such as frying pans.
2. Effects on Humans Based on a 1987 assessment by the International Agency for Research on Cancer
(IARC), PTFE is classified as group 3: "The agent is not classifiable as to its carcinogenicity to humans." No report can be found on the effects of orally ingesting fluoropolymers. It is believed that, even if small fragments of a fluoropolymer that break off from a cooking tool's coating is absorbed by the human body, that substance will not cause any toxic response within the body. During animal testing, rats were provided with feed containing 25 percent PTFE for 90 days, and no toxic effect was observed. However, it has been reported that heating PTFE to an excessive degree will trigger thermal decomposition, and the resulting vapors are highly toxic if inhaled. If PTFE is heated at a temperature of between 315 and 375 degrees Celsius, it is believed that inhalation of the resulting toxic substance will produce influenza-type symptoms.
3. Overseas Study In 2005, the German Federal Institute for Risk Assessment (BfR) publicized its "Selected
questions and answers on cookware, ovenware and frying pans with a non-stick coating made of PTFE," which states that toxic fumes occur when PTFE is heated to a temperature of 360 degrees Celsius or higher, triggering influenza-like symptoms upon inhalation. It also recommended that such cookware users avoid heating empty frying pans and other such tools for three minutes or longer as a means of preventing said phenomenon. In addition, the above Q&A states that frying pans and other such cookware pose no risk when used properly, and that fragments of coating which separate from such cookware will, if absorbed by the human body, pass through the body as-is without triggering a toxic response and thus cause no harm.
4. Domestic Studies Although no fluoropolymer-based processing specifications have been established in
Japan, standard specifications for synthetic resin cooking tools, containers and packaging used with food products apply in accordance with the Food Sanitation Act. Regarding efforts among industry groups, in 2002, member companies of the Japan Paper
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Association (JPA) concluded an agreement to refrain from manufacturing high-fluorinecontent greaseproof paper products and similar due to concerns over safety when used with food products.
In FY 2010, the Food Safety Commission of Japan proposed and deliberated on selfevaluations for fluoropolymers (from among all substances eluted from cooking tools). As a result of said deliberations, it was decided that information will be provided via fact sheets. This fact sheet provides a summary of relevant information based on the results of the FY 2011 General Study for Purposes of Ensuring Food Safety.
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Fact Sheet: Fluoropolymers
Category I. Substance name(s)
Details
Fluoropolymers / fluorocarbon polymers (as general substance category names)
Polytetrafluoroethylene (PTFE)
Refer ence s
A category of plastics, fluoropolymers are polymeric compounds
mainly comprising carbon, fluorine, water and chlorine. Depending on
1, 2
the specific elemental composition, a fluoropolymer may be
II. Overview (usages, contamination incidents, food products with contamination potential, etc.)
polytetrafluoroethylene (PTFE), perfluoroalkoxy alkane (PFA), a perfluoroethylene propene copolymer (FEP), or another variant. PTFE accounts for approximately 60 percent of all fluoropolymer demand. (2002, 2008)
Fluoropolymers offer many advantageous properties, including
thermal resistance, chemical resistance, low friction and nonadherence,
which are leveraged for a wide range of applications in fields such as
1, 2
semiconductors, chemical plants, automobiles and beyond--even in
coatings for cooking tools such as frying pans. (2002, 2008)
In January 2005, the United States Environmental Protection Agency
(EPA) Science Advisory Board (SAB) declared that perfluorooctanoic
acid (PFOA), which is used as an auxiliary agent when manufacturing
III. Reason(s) for increase
the PTFE utilized widely in cookware products, is "likely to be
3, 4
in attention received by
carcinogenic to humans," which drew greater attention to the potential
this substance
hazards of PTFE. The EPA released a public statement conveying that,
although the specific risks are uncertain, they are concerned that PFOA
may pose a risk to human health. No definite conclusion has been
reached regarding this assessment; it remains in the draft phase.
IV. Scientific opinions regarding toxicity (in Japan, from international institutions, and in other countries/regions)
Even if a person ingests a coating fragment which has separated
from a product coating, said fragment will pass through the body
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A. Toxicity within the body
without being absorbed, and thus trigger no toxic response in the body.
(in metabolic processes
(2005)
from intake to expulsion)
PTFE's molecular weight is large (400,000-10,000,000), and therefore most PTFE content will not decompose in response to
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solvents. (2000)
1. Acute toxicity
No information available.
2. Genetic
No information available.
toxicity
B. Toxicit
(mutagenicity)
y
3.
Based on an assessment by the IARC, PTFE is classified as group 3:
"The agent is not classifiable as to its carcinogenicity to humans." (1987)
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Carcinogenicity
4. Reproductive and/or developmenta l toxicity
No information available.
5. Other
toxicity types
No toxic effect was observed during a test in which rats were
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(short and
provided with feed containing 25 percent PTFE for 90 days. (2000)
countries/reglong
term) Union
ions
2. United
States
3. Others
VI. Exposure information (in Japan, from international institutions, and in other countries/regions)
A. Estimated daily intake
No information available.
amounts
B. Transfers from materials that come into contact with food products
No information available on material-transfer contamination. For reference: the normal amount of PTFE used for a frying pan's coating 1 is 3 grams. (2008)
VII. Risk assessments (based on ADI, TDI, ARfD, MOE, etc.)
A. In Japan
No information available.
B. International Agency for
PTFE has been assessed as group 3: "The agent is not classifiable
Research on Cancer
as to its carcinogenicity to humans." (1987)
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(IARC)
C. International institutions
No information available.
The BfR publicized its "Selected questions and answers on
cookware, ovenware and frying pans with a non-stick coating made of
PTFE," which includes the following information: (2005)
Even if a person ingests a coating fragment which has separated from
a product coating, said fragment will pass through the body without
being absorbed, and thus trigger no toxic response in the body.
D. Other
1.
Therefore, said coating fragments have no harmful effect.
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countries/reg European PTFE, which is frequently used in non-stick coatings on cooking
ions
Union
implements, emits toxic fumes when excessively heated (to a
temperature of 360C or higher). However, there is no risk if the
material is used properly.
Inhaling toxic fumes generated due to heating to 360C or higher
leads to influenza-like symptoms. However, such symptoms have not
been reported in home-use environments, but instead in PTFE
production plants where contaminant concentrations are high.
Category
2. United States 3. Others
Details
In January 2005, the EPA SAB declared that PFOA, which is used as an auxiliary agent when manufacturing the PTFE utilized widely in cookware products, is "likely to be carcinogenic to humans." The EPA released a public statement conveying that, although the specific risks are uncertain, they are concerned that PFOA may pose a risk to human health. No definite conclusion has been reached regarding this assessment; it remains in the draft phase.
No information available.
Refer ence s
3, 4
VIII. Risk management measures (standard values)
A. In Japan
Based on the Food Sanitation Act, standard specifications have been established for synthetic resin cooking tools, containers and packaging used with food products. There are no specific standards for fluoropolymer-based processing.
1, 10
B. International institutions
No information available.
C. Other countries/reg ions
1. European Union
2. United States
No information available. No information available.
3. Others
No information available.
IX. Risk management measures (excluding standard values; including contamination prevention measures, risk
mitigation methods, etc.)
A. In Japan
B. International institutions
1. European
Based on the Food Sanitation Act, standard specifications have been established for synthetic resin cooking tools, containers and packaging used with food products. There are no specific standards for fluoropolymer-based processing.
Regarding efforts among industry groups, in 2002, member companies of the JPA concluded an agreement to refrain from manufacturing high-fluorine-content greaseproof paper products and similar due to concerns over safety when used with food products.
No information available. The BfR publicized its "Selected questions and answers on
cookware, ovenware and frying pans with a non-stick coating made of PTFE." (2005)
In regard to contamination prevention measures, risk mitigation methods and similar, the following information is included:
In order to prevent overheating, refrain from heating any empty
1, 10 11
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C. Other countries/reg ions
Union
2. United States
cooking implement for three minutes or longer. If any food product is inside the frying pan or similar cooking implement during overheating, a burnt smell will occur to indicate overheating to the user, which makes overheating itself unlikely. And because coatings are susceptible to flaking, users should use wooden or plastic cooking utensils.
In regard to perfluorocarbons and fluorocarbons, the United States Food and Drug Administration (FDA) has established standards for tools and packaging that come into contact with food products, as well as elution-related specifications and similar.
3. Others
No information available.
X. Reference information (containing PTFE references) A. Material name (IUPAC) Poly(difluoromethylene) B. CAS name and number Ethene, 1,1,2,2-tetrafluoro-, homopolymer / 9002-84-0
C. Molecular/structural formula
D. Physical properties 1. Form(s) 2. Melting point (Celsius)
(CF2-CF2)n Atomic weight: 400,000-10,000,000 (average for commercially available granular resin products)
Granular, fine powder, aqueous dispersion 327C-342C (327C)
Category
Details
3. Boiling point (Celsius) 4. Specific gravity (g/cm3) 5. Solubility
E. Effects of formulation, processing, and cooking
F. References
No information available. 2.1-2.7
Insoluble Emits toxic fumes when excessively heated (to a temperature of
360C or higher). However, there is no risk in the case of frying pans and similar products when the product is used properly.
12, 13
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6 6 Refer ence s 6 6 5
Reference materials
1. Fusso Jushi Seihin Toriatsukai Manyuaru (Fluoropolymer Product Handling Manual). Edited by the Japan Fluoropolymers Industry Association Environmental Committee, 8th edition.
Japan Fluoropolymers Industry Association, 2008.
2. Shitteimashita ka? Fusso Jushi no Koto (Did You Know? About Fluoropolymers). Japan Fluoropolymers Industry Association, 2002.
3. Perfluorooctanoic Acid (PFOA) and Fluorinated Telomers / Risk Assessment. United States Environmental Protection Agency, updated 29 April 2010, http://www.epa.gov/ oppt/pfoa/pubs/pfoarisk.html.
4. Draft Risk Assessment of the Potential Human Health Effects Associated with Exposure to Perfluorooctanoic Acid and Its Salts. United States Environmental Protection Agency, 2005.
5. "Frequently Asked Questions about cookware and roastware with a non-stick coating." German Federal Institute for Risk Assessment, 2005, https://www.bfr.bund.de/en/selected_questions_and_answers_on_cookware__ovenw are_and_frying_pans_with_a_non_stick_coating_made_of_ptfe-60855.html.
6. Naito, Hiroshi. Kagaku Busshitsu Dokusei Handobukku Dai-V-Maki (Chemical Substance Toxicity Handbook Volume Five). Maruzen Publishing, Translation supervision by Noriko Yokote, 2000, pp. 200-06.
7. "Agents Classified by the IARC Monographs." International Agency for Research on Cancer [IARC], http://monographs.iarc.fr/ENG/Classification/index.php.
8. The Guide to the Safe Handling of Fluoropolymer Resins. The Society of the Plastics Industry, fourth Edition, 2005, pp. 76-77.
9. Johnston et al. Toxicology and Applied Pharmacology. "Pulmonary Effects Induced by Ultrafine PTFE Particles," 168: 2000, pp. 208-215.
10. Shokuhin, Tenkabutsu Nado no Kikaku Kijun (Showa 34-nen Kyu-Koseisho Kokuji Dai-370-go) (Specifications and Standards for Food Products, Additives and Similar (1959 Former Ministry of Health and Welfare Report No. 370)). Japanese Ministry of Health, Labour and Welfare, http://www.mhlw.go.jp/topics/bukyoku/iyaku/kigu/dl/4.pdf.
11. Japan Paper Association meeting, 18 October 2011.
12. Code of Federal Regulation Title 21 "Food and Drugs," Part 177 "Indirect Food Additives: Polymers," Section 177.1550 "Perfluorocarbon resins," http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=177.1550.
13. Code of Federal Regulation Title 21 "Food and Drugs," Part 177 "Indirect Food additives: Polymers," Section 177.1380 "Fluorocarbon resins," www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=177 .1380.
Note: All webpages cited were last accessed on 31 May 2012. URLs may have been changed by the hosting organizations during the interval.
Revision history Created: June 14, 2012 Latest Revision: November 19, 2012 Revisions: Changes were made to "3. Overseas Study" following careful examination