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 Toxicología al día: US: FDA Draft Guidance for Industry, Acrylamide in Foods

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FDA Aims To Reduce Cancer-Causing Chemical In Fries, Cereals, And Coffee. By Justin Caba.,  November 26, 2013. The food service and manufacturing industry may have to revise its method for producing certain types of food after the U.S. Food and Drug Administration (FDA) issued draft guidelines in hopes of reducing exposure to a possible cancer-causing chemical known as acrylamide. In 2002, a team of Swedish researchers first discovered the presence of acrylamide in food, and since then, health services have been scrambling to reduce levels of the dangerous carcinogenic, which is also found in cigarette smoke.

“Reducing acrylamide in foods may mitigate potential human health risks from exposure to acrylamide,” the FDA said in the guidelines. “This guidance is intended to suggest a range of possible approaches to acrylamide reduction, and not to identify specific recommended approaches.  This guidance also does not identify any specific maximum recommended level or action level for acrylamide.” 

According to the American Cancer Society, acrylamide is a chemical used in the production of certain industrial products, such as paper, dyes, and plastic materials. Acrylamide is also produced naturally in starchy food, when it is cooked at high-temperatures during frying, roasting, or baking. These foods include grains, coffee, and potatoes — when used to make potato chips and French fries.

When food that's high in starch is cooked at temperatures above 250 degrees Fahrenheit, sugars and the amino acid, asparagine, combine to make acrylamide. If starchy food is cooked for longer or at higher temperatures, acrylamide levels increase. Acrylamide is found in neither raw food nor food that is boiled or steamed, and the way food is packaged or stored has no effect on whether acrylamide is present. 

The National Toxicology Program characterizes acrylamide as “reasonably anticipated to be a human carcinogen.” The FDA’s non-binding drafty guidelines are designed to help all companies accommodate the effort to reduce levels of the substance and covers “raw materials, processing practices, and ingredients affecting potato-based foods (such as french fries and potato chips), cereal-based foods (such as cookies, crackers, breakfast cereals and toasted bread), and coffee.”

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Following up on data from the 2002 Swedish study, a Dutch research team from Maastricht University set out to determine acrylamide’s actual cancer risk. Their study followed 62,000 women, who had also participated in a study on diet and cancer, over an 11-year span. Researchers tracked each participant’s daily acrylamide intake and health through cancer registries.

Although acrylamide seemed to have no effect on breast cancer, women who consumed around 40 grams of acrylamide a day were twice as likely to develop womb or ovarian cancer. Participants were also asked about certain lifestyle factors, such as socioeconomic status, intake of fatty foods, and smoking. Lead researcher, Janneke Hogervorst, said that acrylamide’s effect on womb and ovarian health could mean it disrupts proteins that regulate hormone balance in the body. 

Read also Draft Guidance for Industry: Acrylamide in Foods. November 2013.
Contains Nonbinding Recommendations
Draft–Not for Implementation

This guidance is being distributed for comment purposes only.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-436-1700.


This guidance provides information to help growers, manufacturers, and food service operators reduce acrylamide in certain foods.  Acrylamide is a chemical that can form in some foods during certain types of high-temperature cooking. Reducing acrylamide in foods may mitigate potential human health risks from exposure to acrylamide.  This guidance is intended to suggest a range of possible approaches to acrylamide reduction and not to identify specific recommended approaches.  This guidance also does not identify any specific maximum recommended level or action level for acrylamide. The Food and Drug Administration (FDA or “we”) will update this guidance as needed to reflect new developments in the field of acrylamide reduction.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

Enviado por jcp el 27 noviembre 2013 00:00:00 (1089 Lecturas)

Artículos e imágenes de:
Aspectos históricos legales regulatorios
Aspectos históricos legales regulatorios
 Alimentos y Bebidas
Alimentos y Bebidas
 País: Estados Unidos y Canadá
País: Estados Unidos y Canadá

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