FDA Releases Guidances on Bottled Water, Nanomaterials in Food and Cosmetics
The Food and Drug Administration recently announced the availability of the following guidance and draft guidances:
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Small Entity Compliance Guide: Bottled Water: Quality Standard: Establishing an Allowable Level for di(2-ethylhexyl)phthalate (here): The small entity compliance guide is being issued for a final rule published in the Federal Register of October 19, 2011, that amended its bottled water standard of quality regulations by establishing an allowable level for di(2-ethylhexyl)phthalate (DEHP). This final rule is effective April 16, 2012. This Small Entity Compliance Guide represents the Agency’s current thinking on di(2-ethylhexyl)phthalate in bottled water, and is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation.
Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products (here): The FDA said the draft guidance, when finalized, will represent the FDA's current thinking on the safety assessment of nanomaterials in cosmetic products. This guidance is intended to assist industry in identifying the potential safety issues of nanomaterials in cosmetic products and developing a framework for evaluating them. Comments are due by July 24, 2012.
Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives (here): The draft guidance, when finalized, will explain the FDA's current thinking on the factors to be considered when determining whether changes in manufacturing process, including the intentional reduction in particle size to the nanoscale, for a food substance already in the market affects the safety and regulatory status of the food substance, and whether a new regulatory submission to the FDA is warranted. Comments are due by July 24, 2012.