NSF 305-2014 Personal Care Products Containing Organic Ingredients.pdf

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1、NSF International Standard /American National StandardNSF/ANSI 305 - 2014 Personal Care Products Containing Organic Ingredients NSF International, an independent, not-for-profit, non-governmental organization, is dedicated to being the leading global provider of public health and safety-based risk m

2、anagement solutions while serving 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 Organic Per

3、sonal Care Products c/o NSF International 789 North 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.org NSF/ANSI 305 2014 i NSF International Standard/ American National Standard

4、for Organic Personal Care Products Personal Care Products Containing Organic Ingredients Standard Developer NSF International Designated as an ANSI Standard November 4, 2014 American National Standards Institute ii Prepared by The NSF Joint Committee on Organic Personal Care Products Recommended for

5、 Adoption by The NSF Council of Public Health Consultants Adopted by The NSF Council of Public Health Consultants February 2009 Revised April 2009 Addendum March 2011 Revised December 2011 Revised May 2012 Revised May 2015 Published by NSF International P.O. Box 130140, Ann Arbor, Michigan 48113-014

6、0, USA For ordering copies or for making inquiries with regard to this Standard, please reference the designation “NSF/ANSI 305 2014.” Copyright 2015 NSF International Previous editions 2012, 2011, 2009 Unless otherwise specified, no part of this publication may be reproduced or utilized in any form

7、 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 Disclaimers1NSF, in performing its functions in accordance with its objectives, does not assume or undertake to dischar

8、ge 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 incur any obligation or liability for damages, including c

9、onsequential damages, arising out of or in connection with the use, interpretation of, or reliance upon this Standard.Participation in NSF Standards development activities by regulatory agency representatives (federal, local, state) shall not constitute their agencys endorsement of NSF or any of its

10、 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 illustrations, if provided, are intended to assist in u

11、nderstanding 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 used to justify improper or incomplete design and const

12、ruction. 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. 1The information contained in this Disclaimer is not part of this American

13、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 contain requirements necessary for conformance to the Sta

14、ndard. iv This page is intentionally left blank.v Contents 1 General . 1 1.1 Purpose 1 1.2 Scope . 1 v HYPERLINK l “_Toc418577098“ 1.3 . Alternate products or materials 1 2 Reference documents 2 2.1 Normative references . 2 2.2 Informational references 2 3 Definitions . 3 4 General requirements . 6

15、4.1 Scope . 6 4.2 Prohibited practices 6 5 Production and handling requirements . 6 5.1 Scope . 6 5.2 Organic production system plan 7 5.3 Allowed processes and ingredients . 7 5.4 Prohibited ingredient types/classes and prohibited specific ingredients 9 5.5 Commercial availability 9 6 Determining p

16、ercent organic 10 6.1 Scope . 10 6.2 Calculating organic percentage . 10 6.3 Mined minerals, water and salt 10 6.4 Organic content of processed organic plant material 11 6.5 Organic percentage of a reacted ingredient 12 7 Labels, labeling, and market information 13 7.1 Use of the term “organic“ . 13

17、 7.2 Labeling and or representation of products . 13 7.3 Product composition . 14 7.4 Packaged products labeled “100 percent organic“ or “organic“ or “made with organic“ . 14 7.5 Packaged products labeled “contains organic ingredients” . 14 7.6 Labeling of non-retail containers used only for shippin

18、g or storage of raw or processed agricultural ingredient products . 15 7.7 Labeling of ingredients . 15 Annex A . A1 Annex B . B1 Annex C . C1 Annex D . D1 Annex E . E1 Annex F . F1 Annex G G1 Interpretations Annex . Interpretations 1 v This page is intentionally left blank.vi Foreword2 This America

19、n National Standard, NSF/ANSI 305 Personal Care Products Containing Organic Ingredients, has been developed as part of the ongoing efforts of a number of interested parties to encourage participation in the manufacturing of personal care products using organically grown ingredients within the supply

20、 chain and to address issues on chemical processes, terminology, commercial availability, product composition, calculations, and labeling. Stakeholders involved in developing the Standard included regulatory/public health, industry, trade associations, ingredient suppliers, general interest and prod

21、uct certifiers.The scope of this Standard includes, but is not limited to, rinse-off/leave-on personal care products, cosmetic products, oral care and personal hygiene products. The National Organic Program (NOP) Regulations (Standards) rinse-off and leave-on personal care products; oral care produc

22、ts; and personal hygiene products. These products may be applied to or used externally on any part of the body (e.g., hair, face, hands, and feet). For the purposes of this Standard, cosmetics are considered personal care products. This Standard does not ensure accuracy of claims specifying a produc

23、t as “safer”, “better” or of a specific quality. Like USDA National Organic Program3(NOP) regulations, this Standard includes allowances and restrictions on processes, agricultural ingredients, and methods of extraction based on the specific label claim to be made on the final product. The organic c

24、laim is a process claim, not a product claim. Testing will not necessarily determine whether or not a product is organic or meets this Standard. Product compliance with this Standard does not ensure compliance with all regulatory requirements. 1.3 Alternate products or materials An ingredient of a p

25、ersonal care product varying in design from this Standards specification may still qualify under the Standard. While specific materials are stipulated in this Standard, products or components that incorporate alternate materials may be acceptable when it is verified that the product or component mee

26、ts the applicable requirements of the Standard based on the products end use. 2015 NSF NSF/ANSI 305 2014 2 2 Reference documents 2.1 Normative references The following documents contain provisions that, through reference, constitute provisions of this Standard. At the time this Standard was written,

27、 the editions listed below were valid. All documents are subject to revision, and parties are encouraged to investigate the possibility of applying the most recent editions of the documents indicated below. The most recent published edition of the document shall be used for undated references. 7 CFR

28、 Part 205, National Organic Program340 CFR Part 141, National Primary Drinking Water Regulations3 Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic product

29、s with regard to organic production, labelling and control4 Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/915IASC, Aloe Vera Quality Standard6International Cosmetic Ingredient Dictionary and Handbook

30、 (INCI), 13thedition, 20107WHO, Guidelines for Drinking-Water Quality82.2 Informational references The following documents are references that provide supplemental information to the provisions of this Standard. At the time this Standard was written, the editions indicated were valid. All documents

31、are subject to revision, and parties are encouraged to investigate the possibility of applying the most recent edition of the document indicated below. The most recent published edition of the document shall be used for undated references. 21 CFR Chapter 9, Federal Food, Drug and Cosmetic Act (FD sc

32、um or solids removed in primary, secondary, or advanced wastewater treatment processes, and material derived from sewage sludge. Sewage sludge does not include ash generated during the firing of sewage sludge in a sewage sludge incinerator, or grit and screenings generated during preliminary treatme

33、nt of domestic sewage in a treatment works. 3.42 soap: A cleansing and emulsifying agent, made usually by action of alkali on fat or fatty acids, that consists essentially of sodium or potassium salts of such acids. 3.43 solvent: A substance that dissolves one or more other substances or that causes

34、 another substance to disperse. 3.44 sulfation: The manufacture of a sulfate ester of a fatty alcohol that is then neutralized with an alkali such as sodium hydroxide to produce a surfactant. 2015 NSF NSF/ANSI 305 2014 6 3.45 surfactant: A compound designed to reduce the surface tension of a liquid

35、or to reduce the interfacial tension between two liquids, or between a liquid and a solid. 3.46 volatile content: The amount of moisture and other volatile compounds present in plant material, generally measured by gentle drying (oven or microwave) until a constant weight is achieved. The loss of we

36、ight is considered the volatile content; similar to moisture content. 3.47 water: Water that meets or exceeds safe drinking water standards USEPA National Primary Drinking Water Regulations (40 CFR part 141)3or WHO Guidelines for Drinking-Water Quality8. 4 General requirements 4.1 Scope A personal c

37、are product using any “contains organic ingredients” claim shall be produced and handled in accordance with this Standard. 4.2 Prohibited practices 4.2.1 Non-organic ingredients The non-organic ingredients shall not be produced using excluded methods, sewage sludge, ionizing radiation or genetically

38、 engineered organisms (GEOs) or its product, nor shall they contain any petroleum compounds except as allowed for specifically in this Standard. 4.2.2 Prohibited labeling practices 4.2.2.1 The labeling of whole products or ingredients as organic or contains organic ingredients is prohibited if those

39、 products or ingredients are created using any of the following: ingredients or catalyst and reagent produced using excluded methods; ingredients that have been produced using applications of sewage sludge; ingredients that have been processed with ionizing radiation; ingredients that have been made

40、 using any GEOs or its product; ingredients with petroleum compounds, except as specifically allowed in this Standard; or substances not on the NOP National List3or permitted under this Standard; 4.2.2.2 Use of the phrase “organic when available” or a similar statement on labels or in market informa

41、tion when referring to products composed of non-organic ingredients used in place of specified organic ingredients is prohibited. 4.2.2.3 Labeling as “contains organic ingredients” of any product containing both organic and non-organic forms of the same ingredient specified as “organic” on the label

42、 is prohibited. 5 Production and handling requirements 5.1 Scope The producer or handler of a production, handling, or warehouse operation intending to sell, label, or represent agricultural products as “contains organic ingredients” shall conform to the applicable provisions of this Standard. 2015

43、NSF NSF/ANSI 305 2014 7 Mechanical or biological methods, including but not limited to cooking, heating, drying, mixing, grinding, churning, separating, distilling, extracting, cutting, fermenting, preserving, dehydrating, freezing, chilling, or otherwise manufacturing, and the acts of packaging, ja

44、rring, or otherwise enclosing a product in a container may be used to process an organically produced personal care product for the purpose of retarding spoilage or otherwise preparing the agricultural product for market. 5.2 Organic production system plan The producer or handler of a production or

45、handling operation intending to sell, label, or represent agricultural products as “contains organic ingredients” shall develop an organic production or handling system plan. An organic production or handling system plan shall include: a description of activities, practices, and procedures to be per

46、formed, including the frequency with which they shall be performed; a list of substances and/or ingredients to be used as production or handling input, indicating their compositions, organic content (expressed as a whole percentage, rounded down to the closest percent and excluding all non-organic m

47、aterials), sources, location where they will be used, and documentation of commercial availability, as applicable; a description of the monitoring activities, practices, and procedures to be performed and maintained, including the frequency with which they shall be performed, to verify that the plan

48、 is effectively implemented; a description of the record keeping system implemented to demonstrate compliance with this Standard; a description of the management activities and practices and the physical barriers established to prevent commingling of organic and non-organic ingredients in a split op

49、eration, to prevent adulteration of the product as specified in Annex F, and to prevent contact of organic production and handling operations and products with prohibited substances; and additional information as applicable that is required in order to demonstrate conformance to this Standard. NOTE A producer may substitute a plan prepared to meet the requirements of another federal, state, or local government regulatory program for the organic system plan, provided that the submitted plan meets all the requirements of this section.