cosmetics

[xt_go_advt_1]
TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
Listing of Color Additives Exempt From Certification; Calcium CarbonateRule2017-2419411/07/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum. We are taking this action in response … The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum. We are taking this action in response to a color additive petition submitted by the Wm. Wrigley Jr. Company.listing-of-color-additives-exempt-from-certification-calcium-carbonateFR-Doc-2017-24194
Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective DateRule2017-2005009/20/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is confirming the effective date of August 3, 2017, for the final rule that appeared in the Federal Register of July 3, 2017, and that amended the color additive regulations to provide for t … The Food and Drug Administration (FDA or we) is confirming the effective date of August 3, 2017, for the final rule that appeared in the Federal Register of July 3, 2017, and that amended the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice.listing-of-color-additives-exempt-from-certification-spirulina-extract-confirmation-of-effectiveFR-Doc-2017-20050
Listing of Color Additives Exempt From Certification; Spirulina ExtractRule2017-1386707/03/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing p … The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) filed by McCormick & Company, Inc. (McCormick).listing-of-color-additives-exempt-from-certification-spirulina-extractFR-Doc-2017-13867
Requirements To Submit Prior Notice of Imported Food; Technical AmendmentsRule2017-0620103/30/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is amending the prior notice of imported food regulations to reflect a change in the electronic data interchange system and its expanded capabilities, to correct inaccurate number desi … The Food and Drug Administration (FDA or we) is amending the prior notice of imported food regulations to reflect a change in the electronic data interchange system and its expanded capabilities, to correct inaccurate number designations in section headings, and to reflect a change in an office's name. This action is ministerial or editorial in nature.requirements-to-submit-prior-notice-of-imported-food-technical-amendmentsFR-Doc-2017-06201
Presiding Officer for an Appeal and Informal Hearing; Technical AmendmentsRule2017-0535003/17/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, the Agency, or we) is making revisions to Chapter I of its regulations. These revisions are necessary to reflect changes to the Agency's organizational structure, including the dissolution of th … The Food and Drug Administration (FDA, the Agency, or we) is making revisions to Chapter I of its regulations. These revisions are necessary to reflect changes to the Agency's organizational structure, including the dissolution of the Regional Food and Drug Director position. The revisions replace references to the Regional Food and Drug Director, who is designated to preside over administrative appeals and at informal hearings on appeal, with references to Office of Regulatory Affairs Program Directors. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.presiding-officer-for-an-appeal-and-informal-hearing-technical-amendmentsFR-Doc-2017-05350
Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper; Confirmation of Effective DateRule2017-0053401/23/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is confirming the effective date of December 2, 2016, for the final rule that appeared in the Federal Register of November 1, 2016, and that amended the color additive regulations to provide … The Food and Drug Administration (FDA or we) is confirming the effective date of December 2, 2016, for the final rule that appeared in the Federal Register of November 1, 2016, and that amended the color additive regulations to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper to color orientation marks for intraocular lenses (IOLs). We are taking this action to ensure clarity that the effective date in the final rule remains December 2, 2016.listing-of-color-additives-exempt-from-certification-titanium-dioxide-and-listing-of-color-additivesFR-Doc-2017-00534
Implementation of Statutory Amendments Requiring the Modification of the Definition of Hard CiderRule2017-0033301/23/2017DEPARTMENT OF THE TREASURYTreasury DepartmentThis temporary rule amends the Alcohol and Tobacco Tax and Trade Bureau (TTB) regulations to implement changes made to the definition of ``hard cider'' in the Internal Revenue Code of 1986 by the Protecting Americans from Tax Hik … This temporary rule amends the Alcohol and Tobacco Tax and Trade Bureau (TTB) regulations to implement changes made to the definition of ``hard cider'' in the Internal Revenue Code of 1986 by the Protecting Americans from Tax Hikes Act of 2015. The modified definition broadens the range of wines eligible for the hard cider tax rate. TTB is amending its regulations to reflect the modified definition of hard cider effective for products removed on or after January 1, 2017, and to set forth new labeling requirements to identify products to which the hard cider tax rate applies. The new labeling requirements include both a one-year transitional rule and a new labeling requirement that takes effect for products removed on or after January 1, 2018. TTB is also soliciting comments from all interested parties on these amendments through a notice of proposed rulemaking published elsewhere in this issue of the Federal Register.implementation-of-statutory-amendments-requiring-the-modification-of-the-definition-of-hard-ciderFR-Doc-2017-00333
Implementation of Statutory Amendments Requiring the Modification of the Definition of Hard CiderProposed Rule2017-0033401/23/2017DEPARTMENT OF THE TREASURYTreasury DepartmentElsewhere in this issue of the Federal Register, by means of a temporary rule, the Alcohol and Tobacco Tax and Trade Bureau (TTB) implements changes made to the definition of ``hard cider'' in the Internal Revenue Code of 1986 by the P … Elsewhere in this issue of the Federal Register, by means of a temporary rule, the Alcohol and Tobacco Tax and Trade Bureau (TTB) implements changes made to the definition of ``hard cider'' in the Internal Revenue Code of 1986 by the Protecting Americans from Tax Hikes Act of 2015. The modified definition broadens the range of wines eligible for the hard cider tax rate. TTB is amending its regulations to reflect the modified definition of hard cider effective for products removed on or after January 1, 2017, and to set forth new labeling requirements to identify products to which the hard cider tax rate applies. The new labeling requirements include both a one-year transitional rule and a new labeling requirement that takes effect for products removed on or after January 1, 2018. The text of the regulations in that temporary rule published elsewhere in this issue of the Federal Register serves as the text of the proposed regulations.implementation-of-statutory-amendments-requiring-the-modification-of-the-definition-of-hard-ciderFR-Doc-2017-00334
Changes to Certain Alcohol-Related Regulations Governing Bond Requirements and Tax Return Filing PeriodsRule2016-3141701/04/2017DEPARTMENT OF THE TREASURYTreasury DepartmentThe Alcohol and Tobacco Tax and Trade Bureau (TTB) is amending its regulations relating to alcohol excise taxes to implement certain changes made to the Internal Revenue Code of 1986 (IRC) by the Protecting Americans from Tax Hikes Act … The Alcohol and Tobacco Tax and Trade Bureau (TTB) is amending its regulations relating to alcohol excise taxes to implement certain changes made to the Internal Revenue Code of 1986 (IRC) by the Protecting Americans from Tax Hikes Act of 2015 (PATH Act). This rulemaking implements section 332 of the PATH Act, which amends the IRC to change tax return due dates and remove bond requirements for certain eligible taxpayers. Section 332 authorizes a new annual return period for taxpayers paying taxes imposed with respect to distilled spirits, wines, and beer on a deferred basis who reasonably expect to be liable for not more than $1,000 in such taxes imposed for the calendar year and who are liable for not more than $1,000 in such taxes in the preceding calendar year. Section 332 also removes bond requirements for taxpayers who are eligible to pay excise taxes on distilled spirits, wines, and beer using quarterly or annual return periods and who pay those taxes on a deferred basis. Under section 332, such taxpayers are exempt from bond requirements with respect to distilled spirits and wine only to the extent those products are for nonindustrial use. TTB is soliciting comments from all interested parties on these amendments through a notice of proposed rulemaking published elsewhere in this issue of the Federal Register.changes-to-certain-alcohol-related-regulations-governing-bond-requirements-and-tax-return-filingFR-Doc-2016-31417
Amendments To Streamline Importation of Distilled Spirits, Wine, Beer, Malt Beverages, Tobacco Products, Processed Tobacco, and Cigarette Papers and Tubes and Facilitate Use of the International Trade Data SystemRule2016-2920112/22/2016DEPARTMENT OF THE TREASURYTreasury DepartmentIn this document, the Alcohol and Tobacco Tax and Trade Bureau is amending its regulations governing the importation of distilled spirits, wine, beer and malt beverages, tobacco products, processed tobacco, and cigarette papers and tu … In this document, the Alcohol and Tobacco Tax and Trade Bureau is amending its regulations governing the importation of distilled spirits, wine, beer and malt beverages, tobacco products, processed tobacco, and cigarette papers and tubes. The amendments in this document clarify and streamline import procedures, and support the implementation of the International Trade Data System and the filing of import information electronically. The amendments include providing the option for importers to file import-related data electronically when filing entry or entry summary data electronically with U.S. Customs and Border Protection (CBP), as an alternative to current TTB requirements that importers submit paper documents to CBP upon importation.amendments-to-streamline-importation-of-distilled-spirits-wine-beer-malt-beverages-tobacco-productsFR-Doc-2016-29201
Amendments to Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee ProgramRule2016-3003312/14/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, the Agency, or we) is amending its regulations on accreditation of third-party certification bodies to conduct food safety audits and to issue certifications to provide for a reimbursement (u … The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations on accreditation of third-party certification bodies to conduct food safety audits and to issue certifications to provide for a reimbursement (user fee) program to assess fees for the work FDA performs to establish and administer the third-party certification program under the FDA Food Safety Modernization Act (FSMA).amendments-to-accreditation-of-third-party-certification-bodies-to-conduct-food-safety-audits-and-toFR-Doc-2016-30033
Submission of Food and Drug Administration Import Data in the Automated Commercial EnvironmentRule2016-2858211/29/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or a … The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy. FDA is a Partner Government Agency (PGA) for purposes of submission of import data in ACE. As of July 23, 2016, ACE became the sole EDI system authorized by CBP for entry of FDA-regulated articles into the United States. We also updated certain sections of FDA regulations related to imports. This rule will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.submission-of-food-and-drug-administration-import-data-in-the-automated-commercial-environmentFR-Doc-2016-28582
Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] CopperRule2016-2631011/01/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper to color orientation marks for intraocular lenses. This action … The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper to color orientation marks for intraocular lenses. This action is in response to a petition filed by Milton W. Chu, M.D.listing-of-color-additives-exempt-from-certification-titanium-dioxide-and-listing-of-color-additivesFR-Doc-2016-26310
Use of Ozone-Depleting SubstancesRule2016-2585110/26/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, the Agency, or we) is amending its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as ``essential use … The Food and Drug Administration (FDA, the Agency, or we) is amending its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as ``essential uses'' under the Clean Air Act. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. The products that will no longer constitute an essential use are: Sterile aerosol talc administered intrapleurally by thoracoscopy for human use and metered-dose atropine sulfate aerosol human drugs administered by oral inhalation. FDA is taking this action because alternative products that do not use ODSs are now available and because these products are no longer being marketed in versions that contain ODSs.use-of-ozone-depleting-substancesFR-Doc-2016-25851
Use of Ozone-Depleting SubstancesProposed Rule2016-2585010/26/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as ``ess … The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as ``essential uses'' under the Clean Air Act. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. This action, if finalized, will remove the essential-use exemptions for sterile aerosol talc administered intrapleurally by thoracoscopy for human use and for metered-dose atropine sulfate aerosol human drugs administered by oral inhalation. FDA is proposing this action because alternative products that do not use ODSs are now available and because these products are no longer being marketed in versions that contain ODSs.use-of-ozone-depleting-substancesFR-Doc-2016-25850
Use of Ozone-Depleting SubstancesProposed Rule2016-2585210/26/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as ``ess … The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as ``essential uses'' under the Clean Air Act. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. This action, if finalized, will remove the essential-use exemption for anesthetic drugs for topical use on accessible mucous membranes of humans where a cannula is used for application. FDA is proposing this action because these products are no longer being marketed in approved versions that contain ODSs and because alternative products that do not use ODSs are now available.use-of-ozone-depleting-substancesFR-Doc-2016-25852
Amendments to Registration of Food FacilitiesRule2016-1653107/14/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is amending its regulations for registration of food facilities that require domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in t … The Food and Drug Administration (FDA or we) is amending its regulations for registration of food facilities that require domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA. This rule amends and updates FDA's registration regulations and is part of our implementation of the FDA Food Safety Modernization Act (FSMA), which added new provisions for the registration of food facilities. These amendments will further enhance FDA's capabilities with respect to responding to food safety issues, and in addition, provide FDA with information that we can use to focus and better utilize our limited inspection resources.amendments-to-registration-of-food-facilitiesFR-Doc-2016-16531
Submission of Food and Drug Administration Import Data in the Automated Commercial EnvironmentProposed Rule2016-1568407/01/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic dat … The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, foster U.S. economic security through lawful international trade and policy, and to replace the Automated Commercial System (ACS). FDA is a Partner Government Agency (PGA) in the initiative to establish ITDS, the ``single window'' for the submission of import and export data to the United States Government. The proposed rule would also update certain sections of FDA regulations related to imports. This rule, as proposed, does not affect the ability of filers to continue to submit their import entries and entry summaries by paper for FDA-regulated products that are being imported or offered for import. Once finalized, this action will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.submission-of-food-and-drug-administration-import-data-in-the-automated-commercial-environmentFR-Doc-2016-15684
Amendments To Streamline Importation of Distilled Spirits, Wine, Beer, Malt Beverages, Tobacco Products, Processed Tobacco, and Cigarette Papers and Tubes, and Facilitate Use of the International Trade Data SystemProposed Rule2016-1435906/21/2016DEPARTMENT OF THE TREASURYTreasury DepartmentIn this document, the Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to amend its regulations governing the importation of distilled spirits, wine, beer and malt beverages, tobacco products, processed tobacco, and cigarette pa … In this document, the Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to amend its regulations governing the importation of distilled spirits, wine, beer and malt beverages, tobacco products, processed tobacco, and cigarette papers and tubes. The proposed amendments are intended to clarify and streamline import procedures, and support the implementation of the International Trade Data System and the filing of import information electronically in conjunction with an electronic import filing with U.S. Customs and Border Protection (CBP). The proposed amendments include providing the option for importers to file import-related data electronically when filing entry or entry summary data electronically with CBP, as an alternative to the current TTB requirements that importers submit paper documents to CBP upon importation.amendments-to-streamline-importation-of-distilled-spirits-wine-beer-malt-beverages-tobacco-productsFR-Doc-2016-14359
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Technical AmendmentRule2016-0978404/28/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is amending a final rule published in the Federal Register of November 27, 2015. That final rule established requirements for importers to verify that food they import into the United States is … The Food and Drug Administration (FDA) is amending a final rule published in the Federal Register of November 27, 2015. That final rule established requirements for importers to verify that food they import into the United States is produced consistent with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. The final rule published with some editorial and inadvertent errors. This document corrects those errors.foreign-supplier-verification-programs-for-importers-of-food-for-humans-and-animals-technicalFR-Doc-2016-09784
[xt_go_advt_2]
Leave a Reply

Your email address will not be published. Required fields are marked *