1、BSI Standards PublicationBS ISO 16128-1:2016Guidelines on technicaldefinitions and criteria fornatural and organic cosmeticingredients and productsPart 1: Definitions for ingredientsBS ISO 16128-1:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 16128-1:201
2、6.The UK committee draws users attention to Note 1 in section 2.1.The committee feels that the terms “natural” and “geneticallymodified” are diametrically opposed by definition and deprecatesthe potential for GMO-sourced ingredients to be listed in adocument that defines the criteria for natural and
3、 organic cosmeticingredients. In some other regions of the world genetically modifiedingredients can be considered as natural ingredients, as stated inNote 1, but this is not the case in the UK.The UK participation in its preparation was entrusted to TechnicalCommittee CW/217, Cosmetics.A list of or
4、ganizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016. Published by BSI StandardsLimited 201
5、6ISBN 978 0 580 81112 8ICS 71.100.70Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 March 2016.Amendments/corrigenda issued since publicationDate Text affected
6、ISO 2016Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients and products Part 1: Definitions for ingredientsLignes directrices relatives aux dfinitions techniques et aux critres applicables aux ingrdients et produits cosmtiques naturels et biologiques Partie
7、 1: Dfinitions des ingrdientsINTERNATIONAL STANDARDISO16128-1First edition2016-02-15Reference numberISO 16128-1:2016(E)BS ISO 16128-1:2016ISO 16128-1:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified,
8、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. Permission can be requested from either ISO at the address below or ISOs mem
9、ber 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 16128-1:2016ISO 16128-1:2016(E)Foreword ivIntroduction v1 Scope . 12 Natural ingredients 12.1 General
10、. 12.2 Natural mineral ingredients 22.3 Organic ingredients . 22.4 Water . 23 Derived natural ingredients . 23.1 General . 23.2 Derived organic ingredients 34 Derived mineral ingredients 35 Non-natural ingredients . 3Annex A (informative) Solvents for ingredient processing and manufacturing 4Annex B
11、 (informative) List of chemical and biological processes for derived natural, derived organic, and derived mineral ingredients . 6Annex C (informative) Examples of calculations when the molecular weight is known or not known 8Annex D (informative) List of derived mineral ingredients . 9Bibliography
12、.11 ISO 2016 All rights reserved iiiContents PageBS ISO 16128-1:2016ISO 16128-1:2016(E)ForewordISO (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 th
13、rough ISO technical committees. Each member body interested in a subject for which a technical committee 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 collab
14、orates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical 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
15、 criteria needed for the different types of ISO documents should be noted. This document was drafted 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 subje
16、ct of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. 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
17、name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Techn
18、ical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 217, Cosmetics.ISO 16128 consists of the following parts, under the general title Guidelines on technical definitions and criteria for natural and organic cos
19、metic ingredients and products: Part 1: Definitions for ingredientsThe following part is under preparation: Part 2: Criteria for ingredients and productsiv ISO 2016 All rights reservedBS ISO 16128-1:2016ISO 16128-1:2016(E)IntroductionISO 16128 provides guidelines on definitions and criteria for natu
20、ral 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 to
21、wards 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
22、 cosmetic products to encourage innovation.However, it is common, based on other references in the public domain, to cover criteria for ingredients, as well as definitions and criteria for finished products. This will be covered in ISO 16128-2, which will build on and enhance this part. ISO 2016 All
23、 rights reserved vBS ISO 16128-1:2016BS ISO 16128-1:2016Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients and products Part 1: Definitions for ingredients1 ScopeThis part of ISO 16128 provides guidelines on definitions for natural and organic cosmetic ingr
24、edients.In addition to natural and organic ingredients, other ingredient categories which may be necessary for natural and organic product development are defined with associated restrictions.ISO 16128 does not address product communication (e.g. claims and labelling), human safety, environmental sa
25、fety and socio-economic considerations (e.g. fair trade), and the characteristics of packaging materials or regulatory requirements applicable for cosmetics.2 Natural ingredients2.1 GeneralNatural ingredients are cosmetic ingredients obtained only from plants, animals, micro-organisms or minerals, i
26、ncluding those obtained from these materials by physical processes (e.g. grinding, drying, distillation), fermentation reactions occurring in nature and leading to molecules which occur in nature, and other procedures of preparation including traditional ones (e.g. extraction using solvents) without
27、 intentional chemical modification (Annex A includes the definition of solvents and the categories of extracts using solvents for ingredient processing and manufacturing).The following materials, and materials originating from them, shall be considered to fall under the general heading of natural or
28、igin:a) plants including fungi and algae;NOTE 1 Ingredients coming from genetically modified plants can be considered as natural ingredients in certain regions of the world.NOTE 2 In the context of these guidelines, the term “herb” can be used as a synonym for the word plant.b) minerals;c) animals;d
29、) micro-organisms.Ingredients obtained from fossil fuels are excluded from the definition.INTERNATIONAL STANDARD ISO 16128-1:2016(E) ISO 2016 All rights reserved 1BS ISO 16128-1:2016ISO 16128-1:2016(E)For reasons of clarity, the term “natural” is not used in this part of ISO 16128 to indicate the ch
30、aracteristics of a scent, a colour, or a taste.NOTE 3 Based on the definitions given in this part of ISO 16128 that are cosmetic product specific, an aromatic natural raw material according to ISO 9235 can be composed of natural ingredients, derived natural ingredients or a mixture of the two. ISO 9
31、235 defines aromatic natural raw materials that can be used in different sectors including cosmetics. As these are complex mixtures, the necessary information can be obtained from the aromatic raw material supplier.2.2 Natural mineral ingredientsNatural mineral ingredients are natural ingredients wh
32、ich are inorganic substances (i.e. non-carbon derived and carbonate salts) occurring naturally in the earth having a distinctive chemical formula and consistent set of physical properties (e.g. crystalline structure, hardness, colours).2.3 Organic ingredientsOrganic ingredients are natural ingredien
33、ts originating from organic farming methods or from wild harvesting in compliance with national legislation or equivalent International Standards where applicable.NOTE The term “organic farming” can be defined as per individual national jurisdiction where applicable.Water, as defined in 2.4, except
34、for constitutive water, and minerals are outside the scope of organic farming.2.4 WaterWater is considered as natural.However, the types of water defined in the following list may be treated differently. Constitutive water is the liquid (juice) content of fresh plants. Reconstitution water is equiva
35、lent to the water found in the original material and is used to restore the dry material to its original content. Extraction water is the water used to physically extract ingredients from a material mixture.For the purposes of ISO 16128, water which is not defined above is designated as “formulation
36、 water”.3 Derived natural ingredients3.1 GeneralDerived natural ingredients are cosmetic ingredients of greater than 50 % natural origin, by molecular weight, by renewable carbon content, or by any other relevant methods, obtained through defined chemical and/or biological processes with the intenti
37、on of chemical modification.An informative list of such processes is provided in Annex B. Enzymatic and microbiological processing may also give rise to derived natural ingredients, where an intentional chemical modification takes place.The degree of natural origin is generally quantified by molecul
38、ar weight or by renewable carbon resulting in certain cases of ingredients of wholly natural origin.Annex A gives information on solvents in relation to ingredient manufacturing.Annex C includes calculations in the case that the molecular weight is known or not known.2 ISO 2016 All rights reservedBS
39、 ISO 16128-1:2016ISO 16128-1:2016(E)3.2 Derived organic ingredientsDerived organic ingredients are cosmetic ingredients of organic or mixed organic and natural origin obtained through defined chemical and/or biological processes (see Annex B) with the intention of chemical modification, which do not
40、 contain any fossil fuel origin moiety.An informative list of such processes is provided in Annex B.If the chemical or biological reaction results in multiple compounds, the main chemicals determining the ingredient properties shall contain a moiety of organic origin in the molecule.Enzymatic and mi
41、crobiological processing may also give rise to derived organic ingredients, where an intentional chemical modification takes place.Annex A gives information on solvents in relation to ingredient manufacturing.4 Derived mineral ingredientsDerived mineral ingredients are cosmetic ingredients obtained
42、through chemical processing of inorganic substances occurring naturally in the earth, which have the same chemical composition as natural mineral ingredients.An informative list of such processes is provided in Annex B.Annex A gives information on solvents in relation to ingredient manufacturing.An
43、informative list of derived mineral ingredients is included in Annex D.5 Non-natural ingredientsNon-natural ingredients are ingredients that are greater than or equal to 50 % by molecular weight of fossil fuel origin or other ingredients which do not fall into one of the other categories defined in
44、these guidelines.Annex C includes calculations in the case where the molecular weight is known or not known. ISO 2016 All rights reserved 3BS ISO 16128-1:2016ISO 16128-1:2016(E)Annex A (informative) Solvents for ingredient processing and manufacturingFor the purpose of these guidelines, a solvent ca
45、n be defined as follows: a substance, usually a liquid, capable of dissolving or dispersing one or several ingredients.There are two categories of solvents: ingredient solvents: solvents in which ingredients have been dissolved or dispersed before and/or during the manufacture (ingredient extraction
46、) of an ingredient and which remain in the final ingredient. Such final ingredient is a mixture of ingredients. See Table A.1. process solvents: solvents used in the manufacture of ingredients which do not remain in the ingredient except as traces. See Table A.2.After use, process solvents should be
47、 completely removed or at least removed to such an extent that they are only contained in technologically unavoidable trace concentrations in the final ingredient.If a non-natural ingredient solvent is used alone or mixed, the final ingredient category is considered non-natural.Table A.1 Category of
48、 ingredient solventCategories of initial ingredient (dispersed or dissolved)Categories of ingredient solvents Categories of final ingredientNatural (Clause 2)Natural (Clause 2)Water (2.4)NaturalDerived natural of wholly natural or-igin (Clause 3)Mixture of natural and derived natural ingredients aNa
49、tural mineral (2.2)Natural (Clause 2)Water (2.4)NaturalDerived natural of wholly natural orig-in(Clause 3)Mixture of natural and derived natural ingredients aOrganic (2.3)Organic (2.3) OrganicDerived organic (3.2) Mixture of organic and derived or-ganic, or natural, or derived natural ingredients aNatural (Clause 2)Water (2.4)Derived natural of wholly natural or-igin (Clause 3)If mixtures of different categories of ingredient solvent are used, the classification of the final ingredients will be a mixture of different categories of ingredie
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