1、Cosmetics Guidelines on technical definitions and criteria for natural and organic cosmetic ingredientsPart 2: Criteria for ingredients and productsBS ISO 161282:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06 ISO 2017Cosmetics Guidelines on technical definition
2、s and criteria for natural and organic cosmetic ingredients Part 2: Criteria for ingredients and productsCosmtiques Lignes directrices relatives aux dfinitions techniques et aux critres applicables aux ingrdients et produits cosmtiques naturels et biologiques Partie 2: Critres relatifs aux ingrdient
3、s et aux produitsINTERNATIONAL STANDARDISO16128-2First edition2017-09Reference numberISO 16128-2:2017(E)National forewordThis British Standard is the UK implementation of ISO 161282:2017.The UK participation in its preparation was entrusted to Technical Committee CW/217, Cosmetics.A list of organiza
4、tions represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017IS
5、BN 978 0 580 84877 3ICS 71.100.70Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2017.Amendments/corrigenda issued since publicationDate Text affect
6、edBRITISH STANDARDBS ISO 161282:2017 ISO 2017Cosmetics Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients Part 2: Criteria for ingredients and productsCosmtiques Lignes directrices relatives aux dfinitions techniques et aux critres applicables aux ingrdient
7、s et produits cosmtiques naturels et biologiques Partie 2: Critres relatifs aux ingrdients et aux produitsINTERNATIONAL STANDARDISO16128-2First edition2017-09Reference numberISO 16128-2:2017(E)BS ISO 161282:2017ISO 16128-2:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017,
8、Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Per
9、mission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 161282:2017ISO 16128-2:2017(E
10、)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or postin
11、g on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 7
12、49 09 47copyrightiso.orgwww.iso.orgISO 16128-2:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Approach to determine natural, natural origin, organic and organic origin indexes for cosmetic ingredients . 14.1 General . 14.2 Extracts 24.3 Determination
13、of natural and natural origin indexes of ingredients . 24.3.1 Natural index . 24.3.2 Natural origin index 34.4 Determination of organic and organic origin indexes of ingredients 34.4.1 Organic index 34.4.2 Organic origin index 45 Approaches to determine natural and/or organic content of finished cos
14、metic products 65.1 Natural content . 65.1.1 General 65.1.2 Calculation of natural content by including formulation water 65.1.3 Calculation of natural content by excluding formulation water . 75.2 Natural origin content 75.2.1 General 75.2.2 Calculation of natural origin content by including formul
15、ation water . 75.2.3 Calculation of natural origin content by excluding formulation water . 75.3 Organic content 85.3.1 General 85.3.2 Calculation of organic content by including formulation water . 85.3.3 Calculation of organic content by excluding formulation water . 85.4 Organic origin content 95
16、.4.1 General 95.4.2 Calculation of organic origin content by including formulation water . 95.4.3 Calculation of organic origin content by excluding formulation water 9Annex A (informative) Examples of calculations to determine indexes of ingredients containing a derived natural or organic component
17、 .10Annex B (informative) Examples of organic index and organic origin index determination for extracts .11Annex C (informative) Results of index determination and content calculation from Clauses 4 and 5 13 ISO 2017 All rights reserved iiiContents PageBS ISO 161282:2017ISO 16128-2:2017(E)ForewordIS
18、O (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical co
19、mmittee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electro
20、technical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was draf
21、ted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rig
22、hts. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constit
23、ute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see th
24、e following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 217, Cosmetics.A list of all parts in the ISO 16128 series can be found on the ISO website. iv ISO 2017 All rights reservedBS ISO 161282:2017ISO 16128-2:2017(E)ForewordISO (the International Organ
25、ization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been establish
26、ed has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
27、The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the
28、 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
29、 rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an
30、explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.o
31、rg/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 217, Cosmetics.A list of all parts in the ISO 16128 series can be found on the ISO website. iv ISO 2017 All rights reserved ISO 16128-2:2017(E)IntroductionISO 16128 provides guidelines on definitions and criteria for natur
32、al and organic cosmetic ingredients and products. These guidelines are specific to the cosmetics sector, taking into account that most existing approaches written for the agricultural and food sector are not directly transferrable to cosmetics. They apply scientific judgment and offer principles tow
33、ards a consistent logical framework for natural and organic cosmetic ingredients and products incorporating common approaches employed in existing references. The purpose of these guidelines is to encourage a wider choice of natural and organic ingredients in the formulation of a diverse variety of
34、cosmetic products to encourage innovation. ISO 2017 All rights reserved vBS ISO 161282:2017BS ISO 161282:2017Cosmetics Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients Part 2: Criteria for ingredients and products1 ScopeThis document describes approaches
35、to calculate natural, natural origin, organic and organic origin indexes that apply to the ingredient categories defined in ISO 16128-1. This document also offers a framework to determine the natural, natural origin, organic and organic origin content of products based on the ingredient characteriza
36、tion.Neither ISO 16128-1 nor this document addresses product communication (e.g. claims and labelling), human safety, environmental safety, socio-economic considerations (e.g. fair trade), characteristics of packaging materials or regulatory requirements applicable for cosmetics.This document builds
37、 on and enhances ISO 16128-1. It is intended to be used in conjunction with ISO 16128-1.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited ap
38、plies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 16128-1:2016, Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients and products Part 1: Definitions for ingredients3 Terms and definitionsNo te
39、rms and definitions are listed in this document.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp4 Approach to determine natu
40、ral, natural origin, organic and organic origin indexes for cosmetic ingredients4.1 GeneralThis clause applies to ingredients, either as defined chemical substances, or as animal, mineral, microorganism or plant materials (in whole, in part or as an extract).In case of a mixture of two or more ingre
41、dients, each ingredient contribution shall be taken separately.INTERNATIONAL STANDARD ISO 16128-2:2017(E) ISO 2017 All rights reserved 1BS ISO 161282:2017ISO 16128-2:2017(E)4.2 ExtractsWhen a solvent is partially evaporated, the producer of the extract may utilize industry best practices (e.g. measu
42、rement by instrumentation, characterization of solvent volatility, published values of evaporation rates) to determine the index/indices of the extract. The approach and justification for this determination should be made available to interested parties, when requested.Extracts indexes calculation f
43、ollow the rules described in 4.3 and 4.4.In the case of extracts, the following principles apply when determining indexes. The indexes of finished extracts should reflect the starting materials i.e. ingredient solvent(s) and un-extracted mass. Extracts may be produced from fresh or dried materials.
44、The extraction procedure stops at separation of the extract from the insoluble residue (e.g. at filtration). If subsequent operations are performed (e.g. dilution, preservation, etc.), their contributions to the indexes are treated as additions of new ingredients. The final extract (e.g. in the case
45、 of concentration) cannot display more organic or natural content than the starting materials. Reconstitution of dry plants with water to their original fresh mass is allowed. The reconstitution water should be present in the finished extract in order to count towards its natural or organic content.
46、 When calculating the organic index, reconstitution water is considered organic while any extraction water in excess is natural. An extract made from non-organic plants has an organic index and organic origin index of 0. Ingredient solvents are defined in ISO 16128-1:2016, Table A.1. The use of non-
47、natural ingredients (e.g. alcohol denaturants) is allowed in ingredient solvents. However, if the mixture contains a non-natural ingredient solvent, then the entire mixture is non-natural.4.3 Determination of natural and natural origin indexes of ingredients4.3.1 Natural indexThe natural index is a
48、value indicating the extent to which a cosmetic ingredient meets the definition of natural ingredients from ISO 16128-1:2016, Clause 2.The value is assigned to each ingredient according to the following guidance:Natural index = 1: Ingredient meets the definition of natural ingredients. The natural i
49、ndexes of constitutive water, reconstitution water, extraction water and formulation water are each considered to equal 1.Natural index = 0: Ingredient does not meet the definition of natural ingredients.The natural index of extract is calculated according to Formula (1):ImmnDNST=1 (1)where2 ISO 2017 All rights reservedBS ISO 161282:2017ISO 16128-2:2017(E)4.2 ExtractsWhen a solvent is partially evaporated, the producer of the extract may utilize industry best practices (e.g. measurement by
