
[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Pages 36532-36533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15032]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0489]


Guidance for Industry: Safety of Nanomaterials in Cosmetic 
Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``Guidance for 
Industry: Safety of Nanomaterials in Cosmetic Products.'' The guidance 
represents our current thinking on the safety assessment of 
nanomaterials in cosmetic products. This guidance is intended to help 
industry identify the potential safety issues of nanomaterials in 
cosmetic products and develop a framework for evaluating them.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Cosmetics and Colors, Center for Food Safety and Applied 
Nutrition (HFS-125), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels 
to assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kapal Dewan, Center for Food Safety 
and Applied Nutrition (HFS-125), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1130.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Guidance for Industry: Safety of Nanomaterials in Cosmetic 
Products.'' This guidance is being issued consistent with our good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
our current thinking on this topic. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.
    In the Federal Register of April 25, 2012 (77 FR 24722), we made 
available a draft guidance entitled ``Guidance for Industry: Safety of 
Nanomaterials in Cosmetic Products'' and gave interested parties an 
opportunity to submit comments by July 24, 2012, for us to consider 
before beginning work on the final version of the guidance. We received 
several comments on the draft guidance and have modified the final 
guidance where appropriate. Changes to the guidance include:
     The addition of several references, such as references 
pertaining to analytical techniques for measuring physicochemical 
properties of nanomaterials;
     Revised text concerning potential differences between 
nanomaterials and their larger-scale counterparts with the same 
chemical composition. For example, the guidance discusses how the small 
particle size of a nanomaterial has the potential to alter 
biodistribution and bioavailability;
     New text concerning thorough characterization of 
nanomaterials; and
     Revised text concerning toxicology considerations and 
toxicological testing.
    In addition, we made editorial changes to improve clarity.
    The guidance announced in this notice finalizes the draft guidance 
dated April 2012.

II. Comments

    Interested persons may submit either electronic comments regarding 
the guidance to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It

[[Page 36533]]

is only necessary to send one set of comments. Identify comments with 
the docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/CosmeticGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: June 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15032 Filed 6-26-14; 8:45 am]
BILLING CODE 4164-01-P


