Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 111/2/19

25 July 2014

Dear Sirs,

Commercial Information Circular No. 692/2014

US : FDA's New Guidances on Use of Nanotechnology in Regulated Products

The US Food and Drug Administration (FDA) announced in the Federal Register (FR) of 27 June 2014 the availability of three final guidances entitled "Guidance for Industry: Considering Whether a FDA-Regulated Product Involves the Application of Nanotechnology", "Guidance for Industry: Safety of Nanomaterials in Cosmetic Products" and "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". The relevant FR notices are available at

http://www.gpo.gov/fdsys/pkg/FR-2014-06-27/pdf/2014-15033.pdf,
http://www.gpo.gov/fdsys/pkg/FR-2014-06-27/pdf/2014-15032.pdf and
http://www.gpo.gov/fdsys/pkg/FR-2014-06-27/pdf/2014-15031.pdf.

DETAILS

2.These guidances provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products. The first final guidance addresses the agency's overall approach for all products that it regulates, while the other two final guidances provide specific guidance for the areas of cosmetics and food. These guidances are available at FDA's website: http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm.

ENQUIRIES

3.For enquiries concerning this circular, please contact Mr Lewis LAU at telephone number 2398 5405.

Yours faithfully,

(Miss Janice LAU)
for Director-General of Trade and Industry