NSF 173-2015 Dietary Supplements.pdf

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1、NSF International Standard / American National StandardNSF/ANSI 173 - 2013 Dietary SupplementsNSF International, an independent, not-for-profit, non-governmental organization, is dedicated to being the leading global provider of public health and safety-based risk management solutions while serving

2、the interests of all stakeholders. This Standard is subject to revision. Contact NSF to confirm this revision is current. Users of this Standard may request clarifications and interpretations, or propose revisions by contacting: Chair, Joint Committee on Dietary Supplements NSF International 789 Nor

3、th Dixboro Road, P.O. Box 130140 Ann Arbor, Michigan 48113-0140 USA Phone: (734) 769-8010 Telex: 753215 NSF INTL FAX: (734) 769-0109 E-mail: infonsf.org Web: http:/www.nsf.orgi NSF International Standard/ American National Standard for Dietary Supplements Dietary supplements Standard Developer NSF I

4、nternational American National Standards Institute Designated as an ANSI Standard November 22, 2015 American National Standards Institute ii Prepared by The NSF Joint Committee on Dietary Supplements Recommended for Adoption by The NSF Council of Public Health Consultants Adopted by NSF Internationa

5、l January 2003 Revised July 2005 Revised August 2006 Revised July 2007 Revised April 2008 Revised September 2008 Revised April 2009 Revised November 2010 Revised September 2011 Revised August 2012 Revised February 2014 Revised April 2016 Published by NSF International PO Box 130140, Ann Arbor, Michi

6、gan 48113-0140, USA For ordering copies or for making inquiries with regard to this Standard, please reference the designation “NSF/ANSI 173 2016.” Copyright 2016 NSF International Previous editions 2014, 2012, 2011, 2010, 2009, 2008, 2007, 2006, 2005, 2003 Unless otherwise specified, no part of thi

7、s publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from NSF International. Printed in the United States of America. iii Disclaimers1 NSF, in performing its functions in accordance with

8、 its objectives, does not assume or undertake to discharge any responsibility of the manufacturer or any other party. The opinions and findings of NSF represent its professional judgment. NSF shall not be responsible to anyone for the use of or reliance upon this Standard by anyone. NSF shall not in

9、cur any obligation or liability for damages, including consequential damages, arising out of or in connection with the use, interpretation of, or reliance upon this Standard. NSF Standards provide basic criteria to promote sanitation and protection of the public health. Provisions for mechanical and

10、 electrical safety have not been included in this Standard because governmental agencies or other national standards-setting organizations provide safety requirements. Participation in NSF Standards development activities by regulatory agency representatives (federal, local, state) shall not constit

11、ute their agencys endorsement of NSF or any of its Standards. Preference is given to the use of performance criteria measurable by examination or testing in NSF Standards development when such performance criteria may reasonably be used in lieu of design, materials, or construction criteria. The ill

12、ustrations, if provided, are intended to assist in understanding their adjacent standard requirements. However, the illustrations may not include all requirements for a specific product or unit, nor do they show the only method of fabricating such arrangements. Such partial drawings shall not be use

13、d to justify improper or incomplete design and construction. Unless otherwise referenced, the annexes are not considered an integral part of NSF Standards. The annexes are provided as general guidelines to the manufacturer, regulatory agency, user, or certifying organization. 1 The information conta

14、ined in this Disclaimer is not part of this American National Standard (ANS) and has not been processed in accordance with ANSIs requirements for an ANS. Therefore, this Disclaimer may contain material that has not been subjected to public review or a consensus process. In addition, it does not cont

15、ain requirements necessary for conformance to the Standard. This page is intentionally left blank.v Contents 1 General . 1 1.1 Purpose 1 1.2 Scope . 1 1.3 Formulation submission . 1 2 Normative references . 2 3 Definitions . 5 4 Labeling and literature requirements 7 5 Product requirements . 7 5.1 I

16、dentity 7 5.2 Quantity 7 5.3 Contaminants . 8 5.4 Disintegration . 10 5.5 Caffeine 10 5.6 Proteins 11 6 Test methods used by testing laboratories for identification and quantification of ingredients dietary ingredients and finished products . 11 6.1 Identification test methods . 11 6.2 Quantificatio

17、n test methods . 12 7 Test methods used by testing laboratories for detection of contaminants dietary ingredients and finished products. 15 7.1 Test methods for metals. 15 7.2 Pesticides . 15 7.3 Test methods for microbiological contaminants . 16 7.4 Test methods for chemical contaminants 17 7.5 Tes

18、t methods for industrial contaminants 18 8 Good manufacturing practices 18 8.1 Written recall procedures . 18 8.2 Compliance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 . 18 8.3 Compliance with the Dietary Supplement and Non Prescription Drug Consumer Prote

19、ction Act . 18 8.4 Requirement for testing of diethylene glycol (DEG) in glycerin ingredients . 19 8.5 Requirement for oils . 19 Annex A . A1 Annex B . B1 Annex C.C1 Annex D.D1 This page is intentionally left blank.vii Foreword2 The purpose of NSF/ANSI 173 is to serve as an evaluation tool for analy

20、zing dietary supplements. Certification to this Standard serves as a communication tool between manufacturers of ingredients and finished product, retailers, healthcare practitioners, and consumers. This Standard provides test methods and evaluation criteria to allow for the determination that a die

21、tary supplement contains the ingredients claimed on the label, either qualitatively or quantitatively, and that it does not contain specific undeclared contaminants. In some instances, validated laboratory methods are not yet available for analyzing certain ingredients. In such cases, new methods wi

22、ll be added to this Standard as they become available. NSF/ANSI 173 was developed with participation from the dietary supplements industry, public health regulators, and distributors of dietary supplements. Participation and technical guidance was provided by representatives of the American Herbal P

23、roducts Association, the American Pharmaceutical Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the National Institutes of Health, and the National Nutritional Foods Association. This edition of the Standard (NSF/ANSI 173-2016) includes the followin

24、g revisions, which allow NSF International increased flexibility in selecting finished product claims for analysis based on the number of finished product claims and ingredients present on the product label. Issue 49 This ballot revised language in 5.3.1.1 to provide transparency to manufacturers (i

25、.e. purchasers of raw materials) and consistency between raw material evaluations and finished product evaluations. Issue 50 This ballot added new language that required a prescribed protein method for measuring and subtracting non-protein nitrogen sources as well as free amino acids from the protei

26、n result. Issue 51 This ballot added language specifying maximum caffeine levels per serving. Issue 54 This ballot is added new language that exempted probiotic products from the required Total Aerobic Microbial Count and Total Combined Yeast Mold Count due to the nature of the product. Issue 57 Thi

27、s ballot revised the way that NSF/ANSI 173 addresses the oil rancidity requirement by removing the oil rancidity requirement from testing verification section (NSF/ANSI 173, Section 5-7) and shifting it to the Good Manufacturing Practices Section 8. Issue 58 This ballot created a more current list o

28、f pesticides for NSF/ANSI 173. 2 The information contained in this Foreword is not part of this American National Standard (ANS) and has not been processed in accordance with ANSIs requirements for an ANS. Therefore, this Foreword may contain material that has not been subjected to public review or

29、a consensus process. In addition, it does not contain requirements necessary for conformance to the Standard. viii Issue 60 This ballot updated NSF/ANSI 173 to replace the term “raw material” with either “component”, “components, including dietary ingredients”, or “dietary ingredient” as appropriate

30、. NSF offers a certification program to this Standard. Products certified by NSF carry the NSF Mark, the leading mark in public health and safety certification around the world. The NSF Mark on a product gives consumers and retailers assurance that the product meets the requirements of the NSF Stand

31、ard. For more information on the NSF certification program, please contact the General Manager of Dietary Supplements, P.O. Box 130140, Ann Arbor, Michigan 481130140 or at 734-769-8010. Suggestions for improvement of this Standard are welcome. This Standard is maintained on a Continuous Maintenance

32、schedule and can be opened for comment at any time. Comments should be sent to Chair, Joint Committee on Dietary Supplements at standardsnsf.org, or c/o NSF International, Standards Department, P.O. Box 130140, Ann Arbor, Michigan, 48113-0140, USA. 1 2016 NSF NSF/ANSI 173 2016 NSF International Stan

33、dard for Dietary Supplements Dietary supplements 1 General 1.1 Purpose This Standard provides test methods and evaluation criteria for dietary supplement products to allow for the determination that the ingredients in the product are accurately identified, that the product contains the quantity of d

34、ietary ingredients and marker constituents declared on the product label, and that the product does not contain unacceptable quantities of contaminants. This Standard provides criteria for determining that Good Manufacturing Practices were followed in the production of dietary supplements. 1.2 Scope

35、 This Standard contains requirements for dietary supplements that contain one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by humans to supplement the diet by increasing the total dietary intake, or a conce

36、ntrate, metabolite, constituent, extract, or combinations of these ingredients. Products and ingredients deemed a hazard to public health or safety by a regulatory agency having jurisdiction shall be excluded from the scope of this document. Conventional foods are excluded from the scope of this Sta

37、ndard. Manufacturers shall exercise due diligence to ensure compliance with all applicable regulatory requirements, but compliance with this Standard in itself does not imply that all regulatory requirements have been met. 1.3 Formulation submission The manufacturer shall submit, at a minimum, the f

38、ollowing information for each product: complete formulation information, which includes the following: the composition of the formulation (in percent or parts by weight for each ingredient in the formulation including excipients); NOTE Ranges shall be considered acceptable. the reaction process, if

39、applicable; the component ID number (if applicable), chemical/material name, trade name and supplier(s) for each chemical present in the formulation; a list of known or suspected impurities associated with the finished product; and 2016 NSF NSF/ANSI 173 2016 2 when available, an analytical method us

40、ed to verify the claims listed on the label or certificate of analysis. 2 Normative references The following documents contain provisions that, through reference in this text, constitute provisions of this Standard. At the time this Standard was written, the editions indicated were valid. All docume

41、nts are subject to revision, and parties are encouraged to investigate the possibility of applying the most recent edition of the document indicated below. 21 CFR Chapter 9, Federal Food, Drug and Cosmetic Act (FFDCA)3 21 CFR 101.9. Nutrition Labeling of Food3 21 CFR 101.36. Nutrition Labeling of Di

42、etary Supplements3 21 CFR Chapter 21, Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements3 40 CFR Part 141, National Primary Drinking Water Regulations3 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Ashwa

43、gandha Root, April 20004 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Astragalus Root, August 19994 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Bilberry fruit, 20014 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Black Cohash root, 20024 AHP, Amer

44、ican Herbal Pharmacopoeia and Therapeutic Compendium, Black Haw Bark, June 20004 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Chaste Tree Fruit, 20014 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Cramp Bark, February 20004 AHP, American Herbal Pharmacopoeia and Th

45、erapeutic Compendium, Cranberry, 20024 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Dang Gui Root, 20034 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Echinacea purpurea Root, 20044 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Ginkgo Leaf, 20034 A

46、HP, American Herbal Pharmacopoeia and Therapeutic Compendium, Goldenseal, 20014 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Hawthorn Berry, June 19994 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Hawthorn Leaf with Flower, February 19994 3 US Government Printing

47、Office, Washington, D. C. 20402 . 4 American Herbal Pharmacopoeia (AHP), P. O. Box 66809, Scotts Valley, CA 95067 . 2016 NSF NSF/ANSI 173 2016 3 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Reishi Mushroom, September 20004 AHP, American Herbal Pharmacopoeia and Therapeutic Compendi

48、um, St. Johns Wort, July 19974 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Schisandra Berry, October 19994 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Valerian Root, April 19994 AHP, American Herbal Pharmacopoeia and Therapeutic Compendium, Willow Bark, December

49、 19994 AHPA, Herbs of Commerce, 2nd Edition, 20005 AOAC, Official Methods of Analysis, 18th edition (2005)6 AOAC Guidelines for Single Laboratory Validation of Chemical Methods for Dietary Supplements and Botanicals, 20026 AOAC/FDA, Bacteriological Analytical Manual, (BAM) 8th edition, 19986 AOCS Official Method Cd 18-90, p-Anisidine Value, Sampling and Analysis of Commercial Fats and Oils, 19977 BHMA, British Herbal Pharmacopeia (BHP), 19968 CSI, Analytical Method for the Determination of Quintozene and Its Degradates and Impurities in Ground