ANSI NSF 305-2016 Personal Care Products Containing Organic Ingredients.pdf

1、NSF International Standard /American National StandardNSF/ANSI 305 - 2016 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 i NSF/ANSI 305 2016 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 August 08, 2016 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 Revised December 2016 Published by NSF International P.O. Box 130140, Ann Arbo

6、r, Michigan 48113-0140, USA For ordering copies or for making inquiries with regard to this Standard, please reference the designation “NSF/ANSI 305 2016.” Copyright 2017 NSF International Previous editions 2015, 2012, 2011, 2009 Unless otherwise specified, no part of this publication may be reprodu

7、ced 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 its objectives, does not as

8、sume 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 incur any obligation or liabil

9、ity for damages, including consequential 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 end

10、orsement 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 illustrations, if provid

11、ed, 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 used to justify improper

12、 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 contained in this Disclaim

13、er 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 contain requirements nece

14、ssary 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 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 4.1

15、 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 6 Determining percent organic 10 7 Labels, labeling, and market information 13 Annex A . A1 Annex B . B1 Annex C.C1 Annex D.D1

16、 Annex E . E1 Annex F . F1 Annex G . G1 Interpretations Annex Interpretations 1 This page is intentionally left blank.vii Foreword2 This American National Standard, NSF/ANSI 305 Personal Care Products Containing Organic Ingredients, has been developed as part of the ongoing efforts of a number of in

17、terested parties to encourage participation in the manufacturing of personal care products using organically grown ingredients within the supply chain and to address issues on chemical processes, terminology, commercial availability, product composition, calculations, and labeling. Stakeholders invo

18、lved in developing the Standard included regulatory/public health, industry, trade associations, ingredient suppliers, general interest and product certifiers.The scope of this Standard includes, but is not limited to, rinse-off/leave-on personal care products, cosmetic products, oral care and perso

19、nal hygiene products. The National Organic Program (NOP) Regulations (Standards) rinse-off and leave-on personal care products; oral care products; 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

20、purposes of this Standard, cosmetics are considered personal care products. This Standard does not ensure accuracy of claims specifying a product as “safer”, “better” or of a specific quality. Like USDA National Organic Program3 (NOP) regulations, this Standard includes allowances and restrictions o

21、n processes, agricultural ingredients, and methods of extraction based on the specific label claim to be made on the final product. The organic claim 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 co

22、mpliance with this Standard does not ensure compliance with all regulatory requirements. 1.3 Alternate products or materials An ingredient of a personal care product varying in design from this Standards specification may still qualify under the Standard. While specific materials are stipulated in t

23、his Standard, products or components that incorporate alternate materials may be acceptable when it is verified that the product or component meets the applicable requirements of the Standard based on the products end use. 2017 NSF NSF/ANSI 305 2016 2 Reference documents 2.1 Normative references The

24、 following documents contain provisions that, through reference, constitute provisions of this Standard. At the time this Standard was written, the editions listed below were valid. All documents are subject to revision, and parties are encouraged to investigate the possibility of applying the most

25、recent editions of the documents indicated below. The most recent published edition of the document shall be used for undated references. 7 CFR Part 205, National Organic Program3 40 CFR Part 141, National Primary Drinking Water Regulations3 Commission Regulation (EC) No 889/2008 of 5 September 2008

26、 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control4 Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organ

27、ic products and repealing Regulation (EEC) No 2092/915 IASC, Aloe Vera Quality Standard6 International Cosmetic Ingredient Dictionary and Handbook (INCI), 13th edition, 20107 WHO, Guidelines for Drinking-Water Quality8 2.2 Informational references The following documents are references that provide

28、supplemental information to the provisions of this Standard. At the time this Standard was written, the editions indicated were valid. All documents are subject to revision, and parties are encouraged to investigate the possibility of applying the most recent edition of the document indicated below.

29、 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 scum or solids removed in primary, secondary, or advanced wastewater treatment processes, and material derived from sewage sludge. Sewage sludge does not

30、 include ash generated during the firing of sewage sludge in a sewage sludge incinerator, or grit and screenings generated during preliminary treatment 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

31、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 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 s

32、odium hydroxide to produce a surfactant. 3.45 surfactant: A compound designed to reduce the surface tension of a liquid or to reduce the interfacial tension between two liquids, or between a liquid and a solid. 2017 NSF NSF/ANSI 305 2016 3.46 volatile content: The amount of moisture and other volati

33、le compounds present in plant material, generally measured by gentle drying (oven or microwave) until a constant weight is achieved. The loss of weight is considered the volatile content; similar to moisture content. 3.47 water: Water that meets or exceeds safe drinking water standards USEPA Nationa

34、l Primary Drinking Water Regulations (40 CFR part 141)3 or WHO Guidelines for Drinking-Water Quality8. 4 General requirements 4.1 Scope A personal care product using any “contains organic ingredients” claim shall be produced and handled in accordance with this Standard. 4.2 Prohibited practices 4.2.

35、1 Non-organic ingredients The non-organic ingredients shall not be produced using excluded methods, sewage sludge, ionizing radiation or genetically engineered organisms (GEOs) or its product, nor shall they contain any petroleum compounds except as allowed for specifically in this Standard. 4.2.2 P

36、rohibited labeling practices 4.2.2.1 The labeling of whole products or ingredients as organic or contains organic ingredients is prohibited if those products or ingredients are created using any of the following: ingredients or catalyst and reagent produced using excluded methods; ingredients that h

37、ave been produced using applications of sewage sludge; ingredients that have been processed with ionizing radiation; ingredients that have been made using any GEOs or its product; ingredients with petroleum compounds, except as specifically allowed in this Standard; or substances not on the NOP Nati

38、onal List3 or permitted under this Standard; 4.2.2.2 Use of the phrase “organic when available” or a similar statement on labels or in market information when referring to products composed of non-organic ingredients used in place of specified organic ingredients is prohibited. 4.2.2.3 Labeling as “

39、contains organic ingredients” of any product containing both organic and non-organic forms of the same ingredient specified as “organic” on the label is prohibited. 5 Production and handling requirements 5.1 Scope The producer or handler of a production, handling, or warehouse operation intending to

40、 sell, label, or represent agricultural products as “contains organic ingredients” shall conform to the applicable provisions of this Standard. Mechanical or biological methods, including but not limited to cooking, heating, drying, mixing, grinding, churning, separating, distilling, extracting, cut

41、ting, fermenting, preserving, dehydrating, freezing, chilling, or otherwise manufacturing, and the acts of packaging, jarring, or otherwise enclosing a product in a 2017 NSF NSF/ANSI 305 2016 container may be used to process an organically produced personal care product for the purpose of retarding

42、spoilage or otherwise preparing the agricultural product for market. 5.2 Organic production system plan The producer or handler of a production or handling operation intending to sell, label, or represent agricultural products as “contains organic ingredients” shall develop an organic production or

43、handling system plan. An organic production or handling system plan shall include: a description of activities, practices, and procedures to be performed, including the frequency with which they shall be performed; a list of substances and/or ingredients to be used as production or handling input, i

44、ndicating their compositions, organic content (expressed as a whole percentage, rounded down to the closest percent and excluding all non-organic materials), sources, location where they will be used, and documentation of commercial availability, as applicable; a description of the monitoring activi

45、ties, practices, and procedures to be performed and maintained, including the frequency with which they shall be performed, to verify that the plan is effectively implemented; a description of the record keeping system implemented to demonstrate compliance with this Standard; a description of the ma

46、nagement activities and practices and the physical barriers established to prevent commingling of organic and non-organic ingredients in a split operation, to prevent adulteration of the product as specified in Annex F, and to prevent contact of organic production and handling operations and product

47、s 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 syst

48、em plan, provided that the submitted plan meets all the requirements of this section. 5.3 Allowed processes and ingredients All processes allowed under the NOP3 are allowed under this Standard to produce ingredients such as vegetable oils, non-synthetic waxes and essential oils. These ingredients ma

49、y be used in conventional form. Of particular relevance are the following NOP-allowed processes: cooking vegetable oils or animal fats with NOP-allowed alkali to make soap (saponification); utilizing NOP-allowed enzymes or alkali to hydrolyze organic proteins, and carbohydrates; and cooking organic oil and alcohol together, optionally in the presence of NOP-allowed alkali, to make organic ester ingredients (transesterification). Ingredients produced from saponification, transesterfication, and hydrolysis shall be used in organic for