FDA Issues Guidances on Assessments of Nano Risks
The United States Food and Drug Administration (FDA) last week issued two draft guidance documents on the assessment of the effects of nanotechnology on food and cosmetics safety.
The food safety document, "Guidance for Industry Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives", describes factors manufacturers should consider when determining if nanotechnology may affect the nature and the regulatory status of a food, or when a substance, such as packaging, comes into contact with food.
The draft guidance for the cosmetics industry, "Guidance for Industry Safety of Nanomaterials in Cosmetic Products" outlines FDA’s current thinking on the safety of nanomaterials in cosmetics, cautioning that standard safety tests may need to be modified, or new tests may need to be developed. According to the draft, “FDA expects that the science surrounding nanomaterials will continue to evolve and be used in the development of new testing methods.”
Manufacturers are also encouraged to meet with FDA personnel to discuss testing methods and data necessary to substantiate a product’s safety. Public comment on the drafts is invited, although the official publication of the drafts has not yet been scheduled.
“Guidance for Industry: Safety of Nanomaterials in Cosmetic Products” describes issues that manufacturers should consider to ensure that cosmetic products made with nanomaterials are safe. Nanomaterials may be used in lotions and moisturizing creams for a smoother feel. They may also be used in makeup to create a more natural look.
“Right now, we don’t have any information to make us believe that use of nanotechnology in cosmetics would cause a safety issue,” says Linda Katz, M.D., director of FDA’s Office of Cosmetics and Colors. “We will continue to monitor cosmetic products, and if safety issues arise, we will follow up to make sure that the products are safe for consumer use.” Cosmetics do not require FDA approval before being sold.
“Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes” describes factors industry should consider when determining whether a significant change in the manufacturing of a food substance affects its identity, safety or regulatory status (such as whether a substance is covered by an existing food additive regulation). A food substance is one that is added to food or to food packaging for purposes that include improving taste, texture, or shelf life.
This guidance covers “any manufacturing process change that might affect a food substance’s identity, intended uses, or the way it behaves in the body after it is eaten,” says Dennis Keefe, Ph.D., director of the Office of Food Additive Safety.
Keefe added that nanotechnology now is being studied in food packaging to combat bacteria and detect spoilage, and to improve the bioavailability (the degree and rate at which a substance is absorbed into one’s system) of nutrients, among other applications.
Source: FDA
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