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

<!DOCTYPE html> <html lang="en"> <head> <title> Federal Register :: Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability </title>  <link rel="canonical" href="https://www.federalregister.gov/documents/2014/06/27/2014-15032/guidance-for-industry-safety-of-nanomaterials-in-cosmetic-products-availability" /> <link rel="alternate icon" type="image/png" href="https://www.federalregister.gov/assets/fr2_favicon-e64975e0e7df2bd990d1adf414332311038b22e3129a03d556ecffd9428d6783.png"> <link rel="icon" type="image/svg+xml" href="https://www.federalregister.gov/assets/fr2_favicon-4140f7a04934cf48501e3b03d299dae7e94a3b86834aa7cc2bddb83d9179443e.svg"> <link rel="apple-touch-icon" href="https://www.federalregister.gov/assets/fr2_favicon-e64975e0e7df2bd990d1adf414332311038b22e3129a03d556ecffd9428d6783.png"> <meta name="viewport" content="initial-scale=1.0"> <meta http-equiv="Content-Type" content="text/html; charset=utf-8" /> <meta name="keywords" content="government federal register executive rulings notices" /> <meta http-equiv="X-UA-Compatible" content="chrome=1"> <meta name="medium" content="news" /> <meta name="title" content="Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability" /> <meta name="description" content="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..." /> <meta name="format-detection" content="telephone=no" />  <meta property="og:title" content="Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability" /> <meta property="og:site_name" content="Federal Register" /> <meta property="og:image" content="https://www.federalregister.gov/assets/open_graph_site_banner.png" /> <meta property="og:image:width" content="832" /> <meta property="og:image:height" content="200" /> <meta property="og:url" content="https://www.federalregister.gov/documents/2014/06/27/2014-15032/guidance-for-industry-safety-of-nanomaterials-in-cosmetic-products-availability" /> <meta property="og:description" content="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. 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Document Details</span></div></div><div class="content-block "> <dl class='metadata_list'> <dt>Agencies</dt> <dd> <a href="https://www.federalregister.gov/agencies/health-and-human-services-department">Department of Health and Human Services</a> </dd> <dd> <a href="https://www.federalregister.gov/agencies/food-and-drug-administration">Food and Drug Administration</a> </dd> <dt>Agency/Docket Number</dt> <dd>Docket No. FDA-2011-D-0489</dd> <dt>Document Citation</dt> <dd id="document-citation" data-citation-vol='79' > 79 FR 36532 <span class="copy-to-clipboard svg-tooltip" data-toggle="tooltip" data-title="Copy to Clipboard" data-title-copied="Copied to Clipboard" data-copy-text="79 FR 36532"><svg class="svg-icon svg-icon-content-copy "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#content-copy"></use></svg></span> </dd> <dt>Document Number</dt> <dd class="doc_number"> 2014-15032 <span class="copy-to-clipboard svg-tooltip" data-toggle="tooltip" data-title="Copy to Clipboard" data-title-copied="Copied to Clipboard" data-copy-text="2014-15032"><svg class="svg-icon svg-icon-content-copy "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#content-copy"></use></svg></span> </dd> <dt>Document Type</dt> <dd>Notice</dd> <dt>Pages</dt> <dd> 36532-36533 (2 pages) </dd> <dt>Publication Date</dt> <dd> <a href="/documents/2014/06/27">06/27/2014</a> </dd> </dl> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Published Content - 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Use the PDF linked in the document sidebar for the official electronic format.</p></div></div></div></div><div class="content-block "> <div id="fulltext_content_area" class="doc-content-area" data-short-url="https://www.federalregister.gov/d/2014-15032"> <div class="citation-target-icon cj-fancy-tooltip" data-tooltip="Click to copy a short url for this paragraph" data-short-url="https://www.federalregister.gov/d/2014-15032"> <span class="icon-fr2 icon-fr2-bookmark "></span> </div> <div class="citation-target-background"></div> <div class="preamble"> <div class="document-headings"><div class="fr-box fr-box-published-alt no-footer"> <div class="fr-seal-block fr-seal-block-header with-hover"><div class="fr-seal-content"> <span class="h6">Document Headings</span><div class="fr-seal-meta"><div class="fr-seal-desc"> <p> Document headings vary by document type but may contain the following: </p> <ol class="bullets"> <li> the agency or agencies that issued and signed a document </li> <li> the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to </li> <li> the agency docket number / agency internal file number </li> <li> the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions </li> </ol> <p> See the <a href="https://www.archives.gov/files/federal-register/write/handbook/ddh.pdf#page=9"> Document Drafting Handbook </a> for more details. </p> </div></div> </div></div> <div class="content-block "> <h6 class="agency">Department of Health and Human Services</h6> <h6 class="sub-agency">Food and Drug Administration</h6> <ol><li>[Docket No. FDA-2011-D-0489]</li></ol> </div> </div></div> <div id="agency"> <h1 id="h-1">AGENCY:</h1> <p id="p-1" data-page="36532">Food and Drug Administration, HHS.</p> </div> <div id="action"> <h1 id="h-2">ACTION:</h1> <p id="p-2" data-page="36532">Notice.</p> </div> <div id="summary"> <h1 id="h-3">SUMMARY:</h1> <p id="p-3" data-page="36532">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.</p> </div> <div id="dates"> <h1 id="h-4">DATES:</h1> <p id="p-4" data-page="36532">Submit either electronic or written comments on FDA guidances at any time.</p> </div> <div id="addresses"> <h1 id="h-5">ADDRESSES:</h1> <p id="p-5" data-page="36532"> 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 <strong class="minor-caps">SUPPLEMENTARY INFORMATION</strong> section for electronic access to the guidance. </p> <p id="p-6" data-page="36532"> Submit electronic comments on the guidance to <em><a href="http://www.regulations.gov" class="external" target="_blank" rel="noopener noreferrer">http://www.regulations.gov</a>.</em> Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. </p> </div> <div id="for-further-information-contact"> <h1 id="h-6">FOR FURTHER INFORMATION CONTACT:</h1> <p id="p-7" data-page="36532">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.</p> </div> </div> <div class="supplemental-info"> <h1 id="h-7">SUPPLEMENTARY INFORMATION:</h1> <p id="p-8" data-page="36532"></p> <h2 id="h-8">I. Background</h2> <p id="p-9" data-page="36532">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 (<a href="https://www.ecfr.gov/current/title-21/section-10.115" class="cfr external" target="_blank" rel="noopener noreferrer">21 CFR 10.115</a>). 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.</p> <p id="p-10" data-page="36532"> In the <strong>Federal Register</strong> of April 25, 2012 (<a href="/citation/77-FR-24722" class="fr-reference" data-reference="77 FR 24722">77 FR 24722</a>), 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: </p> <ul class="bullets" > <li id="p-11" data-page="36532">The addition of several references, such as references pertaining to analytical techniques for measuring physicochemical properties of nanomaterials;</li> <li id="p-12" data-page="36532">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;</li> <li id="p-13" data-page="36532">New text concerning thorough characterization of nanomaterials; and</li> <li id="p-14" data-page="36532">Revised text concerning toxicology considerations and toxicological testing.</li> </ul> <p id="p-15" data-page="36532">In addition, we made editorial changes to improve clarity.</p> <p id="p-16" data-page="36532">The guidance announced in this notice finalizes the draft guidance dated April 2012.</p> <h2 id="h-9">II. Comments</h2> <p id="p-17" data-page="36532"> Interested persons may submit either electronic comments regarding the guidance to <em><a href="http://www.regulations.gov" class="external" target="_blank" rel="noopener noreferrer">http://www.regulations.gov</a></em> or written comments to the Division of Dockets Management (see <strong class="minor-caps">ADDRESSES</strong> ). It <span class="printed-page-inline unprinted-element document-markup" data-page="36533"> (<svg class="svg-icon svg-icon-doc-generic"><use xlink:href="/assets/fr-icons.svg#doc-generic"></use></svg> print page 36533) </span><span class="printed-page-details unprinted-element document-markup" id="page-36533" data-page="36533"><svg class="svg-icon svg-icon-doc-generic"><use xlink:href="/assets/fr-icons.svg#doc-generic"></use></svg></span> 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 <em><a href="http://www.regulations.gov" class="external" target="_blank" rel="noopener noreferrer">http://www.regulations.gov</a>.</em></p> <h2 id="h-10">III. Electronic Access</h2> <p id="p-18" data-page="36533"> Persons with access to the Internet may obtain the guidance at either <em><a href="http://www.fda.gov/CosmeticGuidances" class="external" target="_blank" rel="noopener noreferrer">http://www.fda.gov/CosmeticGuidances</a> or <a href="http://www.regulations.gov" class="external" target="_blank" rel="noopener noreferrer">http://www.regulations.gov</a>.</em> Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. </p> <div class="signature"> <p class="signature-date">Dated: June 23, 2014.</p> <p class="signature-name">Leslie Kux,</p> <p class="signature-title">Assistant Commissioner for Policy.</p> </div> </div> <div class="end-matter"> <p class="frdoc">[<a href="/d/2014-15032">FR Doc. 2014-15032</a> Filed 6-26-14; 8:45 am]</p> <p class="billing-code">BILLING CODE 4164-01-P</p> </div> </div> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Published Document: 2014-15032 (79 FR 36532)</span></div></div> </div> </div> </div> <div class="clearfix" style="height: 100px;"></div> </div> </div>  </div>  </div> </main> <div class="site-footer" id="footer"> <div class="col-xs-3 col-md-3"> <h2>Home</h2> <ul class="bullets"> <li><a href="/" title="Home">Home</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Sections</h2> <ul class="bullets"> <li><a href="/money">Money</a></li> <li><a href="/environment">Environment</a></li> <li><a href="/world">World</a></li> <li><a href="/science-and-technology">Science & Technology</a></li> <li><a href="/business-and-industry">Business & Industry</a></li> <li><a href="/health-and-public-welfare">Health & Public Welfare</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Browse</h2> <ul class="bullets"> <li><a href="/agencies">Agencies</a></li> <li><a href="/topics">Topics (CFR Indexing Terms)</a></li> <li><a href="/documents/current">Dates</a></li> <li><a href="/public-inspection/current">Public Inspection</a></li> <li><a href="/presidential-documents/executive-orders">Executive Orders</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Search</h2> <ul class="bullets"> <li><a href="/documents/search">Document Search</a></li> <li><a href="/documents/search#advanced">Advanced Document Search</a></li> <li><a href="/public-inspection/search">Public Inspection Search</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Reader Aids</h2> <ul class="bullets"> <li><a href="/reader-aids/office-of-the-federal-register-announcements">Office of the Federal Register Announcements</a></li> <li><a href="/reader-aids/using-federalregister-gov">Using FederalRegister.Gov</a></li> <li><a href="/reader-aids/understanding-the-federal-register">Understanding the Federal Register</a></li> <li><a href="/reader-aids/recent-updates">Recent Site Updates</a></li> <li><a href="/reader-aids/federal-register-statistics">Federal Register & CFR Statistics</a></li> <li><a href="/reader-aids/videos-tutorials">Videos & Tutorials</a></li> <li><a href="/reader-aids/developer-resources">Developer Resources</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures">Government Policy and OFR Procedures</a></li> <li><a href="/reader-aids/congressional-review">Congressional Review</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>My FR</h2> <ul class="bullets"> <li><a href="/my/">My Clipboard</a></li> <li><a href="/my/subscriptions">My Subscriptions</a></li> <li><a href="/my/comments">My Comments</a></li> <li><a href="/auth/sign_in">Sign In</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Information</h2> <ul class="bullets"> <li><a href="/reader-aids/government-policy-and-ofr-procedures/about-this-site">About This Site</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/about-this-site#legal-status">Legal Status</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/contact-us">Contact Us</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/privacy">Privacy</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/accessibility">Accessibility</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/foia">FOIA</a></li> <li><a href="https://www.archives.gov/eeo/policy/no-fear-notice.html">No Fear Act</a></li> <li><a href="https://www.archives.gov/federal-register/write/newsletter/2024-may">Continuity Information</a></li> </ul> </div> <div id="zendesk-link"> <a href="" class="btn site-feedback-button" aria-label="Site Feedback"> <span class="icon-fr2 icon-fr2-Chat "></span> <span class="desktop-only">Site Feedback</span> </a> </div> </div> </body> </html>

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