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=== Safety concerns === Hydrolyzed collagen, like gelatin, is made from animal [[by-products]] from the [[meat industry]] or sometimes animal carcasses removed and cleared by [[knacker]]s, including skin, bones, and connective tissue. In 1997, the U.S. [[Food and Drug Administration]] (FDA), with support from the TSE ([[transmissible spongiform encephalopathy]]) Advisory Committee, began monitoring the potential risk of transmitting animal diseases, especially [[bovine spongiform encephalopathy]] (BSE), commonly known as ''mad cow disease''.<ref>{{Cite web|url=https://www.fda.gov/ohrms/dockets/ac/97/transcpt/3283t2.pdf|title=Transmissible Spongiform Encephalopathies Advisory Committee (CJDSAC) Meeting Start Date β 23-APR-97|website=[[Food and Drug Administration]]|url-status=live|archive-url=https://wayback.archive-it.org/7993/20170404132502/https://www.fda.gov/ohrms/dockets/ac/97/transcpt/3283t2.pdf|archive-date=2017-04-04}}</ref> An FDA study from that year stated: "... steps such as heat, alkaline treatment, and filtration could be effective in reducing the level of contaminating TSE agents; however, scientific evidence is insufficient at this time to demonstrate that these treatments would effectively remove the BSE infectious agent if present in the source material."<ref>{{cite web|url=https://www.fda.gov/RegulatoryInformation/Guidances/ucm125182.htm|title=The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use|author=U.S. Food and Drug Administration|website=[[Food and Drug Administration]]|url-status=live|archive-url=https://web.archive.org/web/20170121080011/https://www.fda.gov/RegulatoryInformation/Guidances/ucm125182.htm|archive-date=21 January 2017|df=dmy-all}}</ref> On 18 March 2016, the FDA finalized three previously issued interim final rules designed to further reduce the potential risk of BSE in human food.<ref name="FDAFinalRule">{{cite web |url=https://www.federalregister.gov/documents/2016/03/18/2016-06123/use-of-materials-derived-from-cattle-in-human-food-and-cosmetics |title=Federal Register :: Use of Materials Derived From Cattle in Human Food and Cosmetics |author=Food and Drug Administration |date=March 18, 2016 |website=Federal Register, The Daily Journal of the United States Government |access-date=May 24, 2017 |url-status=live |archive-url=https://web.archive.org/web/20170603230919/https://www.federalregister.gov/documents/2016/03/18/2016-06123/use-of-materials-derived-from-cattle-in-human-food-and-cosmetics |archive-date=3 June 2017 |df=dmy-all}}</ref> The final rule clarified that "gelatin is not considered a prohibited cattle material if it is manufactured using the customary industry processes specified."<ref name="FDAConstituentUpdate">{{cite web |url=https://www.fda.gov/food/newsevents/constituentupdates/ucm490542.htm |title=FDA Announces Final Rule on Bovine Spongiform Encephalopathy |author=U.S. Food and Drug Administration |website=[[Food and Drug Administration]] |date=March 17, 2016 |access-date=May 24, 2017 |quote=Finally, the rule provides a definition of gelatin and clarifies that gelatin is not considered a prohibited cattle material if it is manufactured using the customary industry processes specified. Gelatin was never considered a prohibited cattle material, but FDA had never specifically defined gelatin in past IFRs. |url-status=live |archive-url=https://web.archive.org/web/20170430190647/https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm490542.htm |archive-date=30 April 2017 |df=dmy-all}}</ref> The Scientific Steering Committee (SSC) of the [[European Union]] in 2003 stated that the risk associated with bovine bone gelatin is very low or zero.<ref>{{cite web|url=http://ec.europa.eu/food/fs/sc/ssc/out321_en.pdf|title=Updated Opinion On The Safety With Regard To TSE Risks Of Gelatine Derived From Ruminant Bones or Hides|author=Scientific Steering Committee, European Union|date=6β7 March 2003|archive-url=https://web.archive.org/web/20121026005256/http://ec.europa.eu/food/fs/sc/ssc/out321_en.pdf|archive-date=26 October 2012|df=dmy-all}}</ref><ref>{{cite web|url=https://www.fda.gov/OHRMS/DOCKETS/AC/03/briefing/3969B1_1d.pdf|title=The Removal and Inactivation of Potential TSE Infectivity by the Different Gelatin Manufacturing Processes|author=Gelatine Manufacturers of Europe (GME)|website=[[Food and Drug Administration]]|date=June 2003|url-status=live|archive-url=https://web.archive.org/web/20120114180148/https://www.fda.gov/OHRMS/DOCKETS/AC/03/briefing/3969B1_1d.pdf|archive-date=14 January 2012|df=dmy-all}}</ref> In 2006, the [[European Food Safety Authority]] stated that the SSC opinion was confirmed, that the BSE risk of bone-derived gelatin was small, and that it recommended removal of the 2003 request to exclude the skull, brain, and [[vertebra]]e of bovine origin older than 12 months from the material used in gelatin manufacturing.<ref>{{cite journal|author=Scientific Panel on Biological Hazards of the European Food Safety Authority (EFSA) |title=Quantitative assessment of the human BSE risk posed by gelatine with respect to residual BSE risk |year=2006|journal=EFSA Journal|volume=312|pages=1β29|doi=10.2903/j.efsa.2006.312 |doi-access=}}</ref>
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