Cosmetics -- Answers to frequently asked questions on ingredients and product characterization according to ISO 16128-1 and ISO 16128-2

This document provides answers to questions which can arise when calculating indexes and contents according to ISO 16128-1 and ISO 16128-2. It clarifies conditions on process, solvents and carbon sources to qualify ingredients regarding the ISO 16128 series. Detailed examples, explaining how to use the ISO 16128 series are also provided.

Cosmétiques -- Réponses aux questions fréquentes sur la caractérisation des ingrédients et produits conformément à l’ISO 16128-1 et l’ISO 16128-2

Le présent document apporte des réponses aux questions qui peuvent se poser lors du calcul des indices et contenus conformément à l’ISO 16128-1 et l’ISO 16128-2. Il clarifie les conditions relatives aux procédés, solvants et sources de carbone permettant de qualifier les ingrédients suivant la série ISO 16128. Des exemples détaillés expliquant comment utiliser la série ISO 16128 sont également présentés.

General Information

Status
Published
Publication Date
24-Aug-2021
Technical Committee
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
29-Jul-2021
Completion Date
29-Jul-2021
Ref Project

Buy Standard

Technical report
ISO/TR 23750:2021 - Cosmetics -- Answers to frequently asked questions on ingredients and product characterization according to ISO 16128-1 and ISO 16128-2
English language
17 pages
sale 15% off
Preview
sale 15% off
Preview
Technical report
ISO/TR 23750:2021 - Cosmétiques -- Réponses aux questions fréquentes sur la caractérisation des ingrédients et produits conformément à l’ISO 16128-1 et l’ISO 16128-2
French language
19 pages
sale 15% off
Preview
sale 15% off
Preview
Draft
ISO/PRF TR 23750:Version 10-jul-2021 - Cosmetics -- Answers to frequently asked questions on ingredients and product characterization according to ISO 16128-1 and ISO 16128-2
English language
17 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (sample)

TECHNICAL ISO/TR
REPORT 23750
First edition
2021-08
Cosmetics — Answers to frequently
asked questions on ingredients and
product characterization according to
ISO 16128-1 and ISO 16128-2
Cosmétiques — Réponses aux questions fréquemment posées sur la
caractérisation des ingrédients et des produits conformément à l'ISO
16128-1 et à l'ISO 16128-2
Reference number
ISO/TR 23750:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO/TR 23750:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TR 23750:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Questions and answers .................................................................................................................................................................................. 1

4.1 General ........................................................................................................................................................................................................... 1

4.2 Natural ingredients ............................................................................................................................................................................. 2

4.3 Physical processes for natural ingredients ..................................................................................................................... 3

4.4 Fermentation for natural ingredients ................................................................................................................................. 5

4.5 Process solvents ..................................................................................................................................................................................... 6

4.6 Mineral ingredients ............................................................................................................................................................................. 7

4.7 Derived natural ingredients ......................................................................................................................................................... 8

4.8 Calculating the natural origin index ..................................................................................................................................... 9

4.9 Examples ...................................................................................................................................................................................................12

4.10 Other chemical and biological processes ......................................................................................................................13

4.11 Index and content ..............................................................................................................................................................................13

4.12 Other FAQs ...............................................................................................................................................................................................15

Annex A (Informative) Green chemistry principles referred to in ISO 16128-1:2016 Annex B ..........16

Bibliography .............................................................................................................................................................................................................................17

© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/TR 23750:2021(E)
Foreword

ISO (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

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 collaborates 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 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 subject 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 name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 217, Cosmetics.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TR 23750:2021(E)
Introduction

The ISO 16128 series provides guidelines on definitions and criteria for natural 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 towards a consistent logical framework

for natural and organic cosmetic ingredients and products incorporating common approaches employed

in existing references.

The purpose of the ISO 16128 series is to encourage a wider choice of natural and organic ingredients in

the formulation of a diverse variety of cosmetic products to encourage innovation.

The purpose of this document is to help ingredient manufacturers and cosmetic companies, or any

reader, to qualify cosmetic ingredients as natural, natural derived or non-natural when using the

ISO 16128 series.
© ISO 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
TECHNICAL REPORT ISO/TR 23750:2021(E)
Cosmetics — Answers to frequently asked questions on
ingredients and product characterization according to ISO
16128-1 and ISO 16128-2
1 Scope

This document provides answers to questions which can arise when calculating indexes and contents

according to ISO 16128-1 and ISO 16128-2.

It clarifies conditions on process, solvents and carbon sources to qualify ingredients regarding the

ISO 16128 series. Detailed examples, explaining how to use the ISO 16128 series are also provided.

2 Normative references
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Questions and answers
4.1 General
Table 1 — General questions
No. Question Answer

0 How can an ingredient manufacturer and/or Ingredient manufacturers are recommended to provide

a cosmetic manufacturer assign the category cosmetic manufacturers with information related to com-

and index of an ingredient? position, origin and processing of ingredients to determine

ingredient indexes. For all ingredients, cosmetic manufac-
turers verify the category and index based on information
provided. Therefore, dialogue between ingredient and
cosmetic manufacturers is encouraged.

1 What are the differences between the following A cosmetic raw material is an ingredient or a mixture of

terms: ingredient, substance, raw material, and ingredients. An ingredient is a substance, i.e. a chemical

renewable material? element and its compounds in the natural state or the result
of a manufacturing process, excluding any solvent which
may be separated without affecting the stability of the
substance or changing its composition. Certain substances
are renewable if they are replenished naturally at a rate at
least the same as their consumption.

2 How does the definition of an extract relate to An extract is a substance or a mixture of substances. In most

its INCI composition? cases, its INCI name is the same as the natural ingredient
it comes from, with, when relevant, the INCI name(s) of the
ingredient solvent(s) used for extraction.
© ISO 2021 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO/TR 23750:2021(E)
Table 1 (continued)
No. Question Answer

3 Can the INCI ingredient lists be used to deter- No. More information is needed to make that determination.

mine if a product is natural, derived natural INCI ingredients can be produced in different ways and pro-

or non-natural? cess solvents used will not appear in the INCI ingredients
list. For example, it is possible to have two products with
the exact same INCI names list be classified differently when
using the methods set out in ISO 16128-1.

4 How do the different categories of solvents ISO 16128-1 refers to two categories of solvents: ingredient

relate to their INCI nomenclature? solvents and process solvents, which are defined in ISO

16128-1:2016, Annex A. Ingredient solvents appear in the
INCI ingredients list. Process solvents do not remain in the
ingredient (except as traces) and will not appear in the INCI
ingredient list.
4.2 Natural ingredients

Per ISO 16128-1, natural ingredients are cosmetic ingredients obtained only from plants, animals,

micro-organisms, or minerals, including those obtained from these materials by:
— physical processes (e.g. as grinding, drying, distillation);

— fermentation reactions occurring in nature and leading to molecules occurring in nature; and

— other processes of preparation, including traditional ones (e.g. extraction using solvents) without

intentional chemical modification.
See Table 2.
Table 2 — Questions on natural ingredients
No. Question Answer

5 How is water defined in ISO 16128-1? Water is defined as always natural in ISO 16128-1:2016, 2.4.

6 The definition of water of crystallization is not In chemistry, water of crystallization is water molecules that

provided in ISO 16128-1. How is it defined? are present inside crystals of minerals. It can be considered

as constitutive water in natural minerals. In the cases which
water is either added during or produced after a reaction,
it is considered as formulation water.

7 How is aromatic water obtained by distillation It is classified as extraction water.

classified in ISO 16128-1?

8 Are ingredients such as ethanol, amino acids, Yes. As long as the feedstock is natural, the reaction fermen-

or nucleic acids considered natural if obtained tation occurs in nature and the fermentation product is one

by fermentation reaction using a substance that occurs in nature, the result is natural.

occurring in nature as a starting material?

9 Can Formula (1) in ISO 16128-2:2017, 4.3.1 be Formula (1) in ISO 16128-2:2017, 4 3 1 is used only for ex-

used to calculate the natural index of an ingre- tracts when ingredient solvents are present. Otherwise, the

dient that does not contain ingredient solvents? natural index is assigned, according to the same paragraph,

is either 1 or 0.

10 Aromatic natural raw materials are defined “Fragrance/Parfum” are often mixtures including aromatic

according to ISO 9235. How are the indexes natural materials. The calculation of indexes of all ingredi-

of aromatic natural raw materials calculated ents containing aromatic natural raw materials follows ISO

per ISO 16128? 16128. The exact composition, according to ISO 16128-1, can
be obtained from the suppliers.
2 © ISO 2021 – All rights reserved
---------------------- Page: 7 ----------------------
ISO/TR 23750:2021(E)
4.3 Physical processes for natural ingredients
Table 3 — Questions on physical processes for natural ingredients
No. Question Answer

11 Can “processing by micro-waves” be considered Yes. Any sort of drying process can be considered as physical

as physical process? process if it does not lead to chemical modification.

12 Are new technologies for physical extraction Yes, new technologies, such as use of micro-waves, sonication

considered as physical extraction process? and ultrasounds can be considered, as long as there is no

chemical modification. The use of solvents is defined in ISO
16128-1:2016 Table A.1.

13 In case of a plant extract extracted with a mix- If a non-natural solvent remains in the final extract as an

ture consisting of a non-natural solvent and a ingredient solvent, this extract is considered as a non-natural

natural solvent, is the final extract considered ingredient. If the non-natural solvent is eliminated, this ex-

as a natural ingredient? tract can be considered as a natural ingredient if conditions

of ISO 16128-1:2016, Table A.2 are fulfilled.
14 The value k is the dry/fresh ratio for leaves Yes.
or flowers when calculating natural/organic
index of plant extract. If a supplier can specify
the actual dry/fresh ratio and it is different
from k value, can the specified values be used
for calculation?
15 Provide index calculation examples for the EXAMPLE
extract of a dried organic plant.
5 kg of dry plant (organic flower) was extracted by 90 kg of
30 % glycerin (a derived natural solvent) aqueous solution
was obtained. (k=4,5)
— Starting materials: 5 kg of dry plant is equivalent to 5 × 4,5
= 22,5 kg of fresh plant
— Solvent: 63 kg of water, 27 kg of glycerin
— Reconstitution water: 22,5 – 5 = 17,5 kg
— Extraction water: 63 – 17,5 = 45,5 kg
NOTE Extraction water is as defined in ISO 16128-1.
Natural index of the extract: 1 − (27/(5 + 63 + 27)) = 0,71
Natural origin index of the extract: 1 as all ingredients meet
the definition of derived natural ingredients
Organic index of the extract: 1 – ((45,5+27)/ (5+63+27)) = 0,24
Organic derived index of the extract: 1 – ((45,5 + 27)/
(5 + 63 + 27)) = 0,24

16 According to ISO 16128-2:2017, 4.2: “The use The bullet from ISO 16128-2:2017, 4.2 stating that the use of

of non-natural ingredients (e.g. alcohol denatur- non-natural ingredients (e.g. alcohol denaturants) is allowed

ants) is allowed in ingredient solvent. However, in ingredient solvents means, for example, that denaturated

if the mixture contains a non-natural ingredient alcohol can be used for extraction and leads to a natural

solvent, then the entire mixture is non-natural.” extract. When phenoxyethanol is added to an extract after

filtration, this is a mixture which has no longer an index but
Does it mean, for example, that the addition of
instead has a content. The use of butylene glycol (non-natural)
phenoxyethanol to an extract is OK and only
as an extraction solvent leads to a non-natural ingredient.
affects the index value, but if an extraction
The use of polysorbate 80 during an extraction leads to a
solvent of butylene glycol (non-natural) is used,
non-natural ingredient as it is not of natural origin. But its
then the index is 0, regardless?
use after filtration leads to a mixture which has a content.
At what value does an added ingredient be-
come a solvent (i.e. polysorbate-80) or does
the definition refer only to extraction solvents?
© ISO 2021 – All rights reserved 3
---------------------- Page: 8 ----------------------
ISO/TR 23750:2021(E)
Table 3 (continued)
No. Question Answer

17 Is a dry herbal extract or a purified compound In the extent that solvents do not remain in the final ingre-

isolated from a natural source considered as dients except as traces (process solvents), they are consid-

a natural ingredient? ered as natural ingredients according to ISO 16128-1:2016,
Table A.2 if:
— renewable solvents that pose minimal safety or environ-
mental risk are used; or
— if no physical process or no renewable solvent can be
used, a non-natural solvent that poses minimal safety or
environmental risk is used.

18 What are the indexes of a rose extract, ob- As the butylene glycol is of petrochemical origin, it is a non-nat-

tained by extraction with a mixture of water ural ingredient solvent. The rose extract is a non-natural

and butylene glycol, if the butylene glycol is of ingredient. Both natural index and natural origin index are 0.

petrochemical origin?

19 What are the indexes of a rose extract, ob- As the butylene glycol is a derived natural ingredient sol-

tained by extraction with a mixture of water vent, the natural index is determined using Formula (1) in

and butylene glycol, if the butelyne glycol is of ISO 16128-2:2017, 4.3.1.
vegetal origin?
Starting material: 10 kg of flower
Total solvent introduced: 90 kg = 67,5 kg water + 22,5 kg
butylene glycol
Mass of derived natural solvent introduced = 22,5 kg bu-
tylene glycol
Total mass introduced (natural ingredients and ingredient
solvents) = 10 + 67,5 + 22,5 = 100 kg
The natural index is = 1 – (22,5/100) = 0,775
The natural origin index is 1.

20 Is native guar gum a natural ingredient? Yes, the process of native guar gum used here is a physical

separation of the molecules present in the seeds. The natural
According to a February 2010 Opinion from
index of the native guar gum is 1, if process solvents used
AFSSA (ref. 2009-SA-0214), guar gum is ob-
respect the natural category of ISO 16128-1:2016, Table A.2.
tained, using Cyamopsis tetragonolobus seeds
through traditional methods in the grain milling
industry. Guar gum is obtained through the
following process:
— seeds extracted from dried pods are me-
chanically broken down in order to eliminate
the sprout;
— the endosperm is husked to obtain flakes;
— flakes are ground then sieved to obtain a
powder;
— powder or flakes are washed using ethanol
or isopropanol to limit the microbial load.

21 How is an extract from cell culture medium The culture and extraction of a plant callus is carried out in

defined in ISO 16128? For example, an Aloe a medium. The natural index and the natural origin index

barbadensis Callus extract is an extract obtained depend on the composition of the medium as defined in

through the culture of Aloe barbadensis Callus. ISO 16128-1.
None of the ingredients are organically produced. OI=OOI =0
4 © ISO 2021 – All rights reserved
---------------------- Page: 9 ----------------------
ISO/TR 23750:2021(E)
4.4 Fermentation for natural ingredients
Table 4 — Questions on fermentation for natural ingredients
No. Question Answer
22 What is fermentation? Fermentation reactions result from a culture medium
containing micro-organisms, including bacteria, yeasts or
moulds. According to the definition of ISO 16128-1:2016 “fer-
mentation” also includes reactions generated by micro-algae
or plant cells.

23 What are the conditions for a fermentation For a fermentation process to obtain a natural ingredient,

process to obtain a natural ingredient? the process exists in nature, uses a natural substance as a

starting material and leads to molecules which occur in nature.

24 What type of carbon sources can be used to The carbon source (substrate) for the fermentation process

obtain a natural ingredient? can be a natural ingredient or mixture of natural ingredients

(sucrose for instance). See NOTE 1.

25 Are citrate salts natural? Yes, if the substrate is natural (e.g. Beetroot syrup) and as

far as the ferment: Aspergillus niger naturally produces
some citrate salt, the salt resulting from the fermentation
with Aspergillus niger and the natural substrate (as carbon
source) is natural.

26 Which type of modifications can be considered Selecting or cross-breeding native micro-organisms can be

for microorganisms? considered to obtain natural ingredients. See NOTE 2.

27 How are adjuvant in the culture medium Traces of adjuvant from the culture medium in the finished

treated? product are treated as process solvents. Adjuvant of fossil
origin can be considered provided there is no alternative.

28 Is industrial fermentation considered to be a Ingredients manufactured by industrial fermentation are

biological process? considered as natural ingredients, if the following points are

fulfilled, even if it is intentionally manufactured:
1) using a natural substance as a starting material;
2) by a fermentation reaction which exist in nature;
3) leading to molecules which occur in nature.
Ethanol for instance is natural when a native micro-organism
is used and when the carbon source is a natural ingredient
such as saccharose. See NOTE 2.

29 Is Xanthan gum a natural or derived natural Xanthan gum is obtained through the fermentation of a

ingredient? How are the indexes determined? non-genetically modified bacterium (Xanthomonas camp-

estris) using a carbohydrate substrate (corn or soy starch).
Xanthan occurs in nature, produced by micro-organisms
living in soils. As this is an ingredient - and not a mixture -
indexes are calculated, based on quantities used.
NI = 1 and NOI = 1
See NOTE 2.

NOTE 1 The fermentation substrate is natural in order to obtain a natural ingredient. This requirement is consistent with

ISO 16128-1:2016, Table A.1.

NOTE 2 Ingredients obtained by fermentation using genetically modified microorganisms can be considered as natural

ingredients in certain regions of the world and derived natural ingredients in other regions of the world.

© ISO 2021 – All rights reserved 5
---------------------- Page: 10 ----------------------
ISO/TR 23750:2021(E)
4.5 Process solvents
Table 5 — Questions on process solvents
No. Question Answer

30 Can supercritical CO extraction be considered Yes, supercritical CO is one of the process solvents which

2 2
for obtaining natural ingredients? can be used to obtain a natural ingredient.

31 Can non-renewable solvents be used for ex- As process solvents of natural ingredients, natural mineral

traction? ingredients, derived natural ingredients and derived mineral
ingredients, renewable solvents that pose minimal safety or
environmental risk are used for the purpose of extraction or
reaction processes. If renewable alternatives are not available,
non-natural solvents that pose minimal safety or environ-
mental risk can be used, per ISO 16128-1:2016, Table A.2

32 Are vegetable oils and animal oils considered Yes, if they meet the definition of natural per ISO 16128-

as natural ingredients? 1:2016, Clause 2. Those manufactured by physically process

such as squeezing are considered as natural ingredients. For
those extracted with solvents, in case those solvents remain
in the final ingredients (ingredient solvents), it depends on
the origin of the solvents. ISO 16128-1:2016, Table A.1 is to
be used for verification.
In case solvents do not remain in the final ingredients except
as traces (process solvents), they are considered as natural
ingredients according to ISO 16128-1:2016, Table A.2 if:
— renewable solvents that pose minimal safety or environ-
mental risk are used; or
— no physical process or no renewable solvent can be used,
a non-natural solvent that poses minimal safety or environ-
mental risk is used.

33 For the manufacturing of lecithin, hexane is As the use of hexane for the manufacturing of lecithin is un-

commonly used as process solvent. Does it avoidable at the current state of art, according to ISO 16128-

impair the classification of lecithin as natural 1:2016 Table A.2 footnote “a”, the classification of lecithin is

due to its petrochemical origin? not affected by the use of hexane. Hexane concentration in the

final lecithin has to pose minimal safety or environmental risk.
6 © ISO 2021 – All rights reserved
---------------------- Page: 11 ----------------------
ISO/TR 23750:2021(E)
4.6 Mineral ingredients
Table 6 — Questions on mineral ingredients
No. Question Answer

34 Does ISO 16128-1:2016, Annex D contain Yes. ISO 16128-1:2016, Annex D is an illustrative, not exhaus-

natural minerals? tive, list of reaction products that may be considered derived
mineral ingredients. Ingredients on this list which are found
in nature (i.e. not chemical reaction products) are natural
mineral ingredients.

35 Is surface-coated titanium dioxide a non-nat- When physically coated by encapsulation or electrostatic

ural ingredient? surface modification, it is considered as a mixture of titani-
um dioxide and coating agent. The titanium dioxide may be
considered as a derived mineral ingredient. The natural and
natural origin indexes of the coating are to be determined
separately.
When chemically modified with a natural (except natural
mineral ingredient) or derived natural reactant that makes
up less than or equal to 50 % by weight of the ingredient, as
a surface coating or otherwise, the result is a non-natural
ingredient.
When reacted with a natural (except natural mineral ingre-
dient) or derived natural reactant that makes up greater
than 50 % by weight of the ingredient, as a surface coating
or otherwise, the result is a derived natural ingredient.
In either case, when chemically modified with non-mineral
ingredients, the result is not considered as a derived mineral
ingredient.

36 Is nano-sized titanium dioxide, considered as Since the properties other than the chemical composition,

a derived mineral ingredient, as long as it has such as crystal structure and physical properties, are not

the same chemical composition as a natural specified in the definition of derived mineral ingredient, it

mineral ingredient? may be considered as a derived mineral ingredient, as long
as the chemical composition is the same as a natural mineral
ingredient and as long as it respects the full definition of ISO
16128-1:2016, Clause 4, including process information.

37 What is the classification for KOH (potassium KOH is not found in nature, so it is non-natural and cannot

hydroxide), derived mineral or non-natural? be derived mineral.

38 Can cosmetic grade iron oxides be considered Since they are from mineral rather than biological origin,

derived natural ingredients? iron oxides are not considered derived natural ingredients.

If they meet the criteria, then cosmetic grade iron oxides are
derived mineral ingredients and contribute to natural origin
content of a product.

39 Can fumed silica be claimed derived mineral? Silica is a natural mineral. Fumed silica which has the same

composition as silica, may be classified as a derived mineral
ingredient. It is obtained through chemical processing of in-
organic substances occurring naturally in earth, which have
the same chemical composition of natural mineral ingredients.

40 When a natural mineral ingredient is reacted If it has the same chemical composition as a natural mineral

with other ingredients, what is natural origin ingredient, it is considered as a derived mineral ingredient.

index of the ingredient? If it doesn’t have the same chemical composition as natural

mineral ingredients and is greater than 50 % natural origin,
then that portion of ingredient can contribute to the natural
origin index.
© ISO 2021 – All rights reserved 7
---------------------- Page: 12 ----------------------
ISO/TR 23750:2021(E)
4.7 Derived natural ingredients
Table 7 — Questions on derived natural ingredients
No. Question Answer
41 Why does the ISO 16128 series recommend While not mandatory, the
...

RAPPORT ISO/TR
TECHNIQUE 23750
Première édition
2021-08
Cosmétiques — Réponses aux
questions fréquentes sur la
caractérisation des ingrédients et
produits conformément à l’ISO 16128-
1 et l’ISO 16128-2
Cosmetics — Answers to frequently asked questions on ingredients
and product characterization according to ISO 16128-1 and ISO
16128-2
Numéro de référence
ISO/TR 23750:2021(F)
ISO 2021
---------------------- Page: 1 ----------------------
ISO/TR 23750:2021(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2021 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO/TR 23750:2021(F)
Sommaire Page

Avant-propos ..............................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Domaine d’application ................................................................................................................................................................................... 1

2 Références normatives ................................................................................................................................................................................... 1

3 Termes et définitions ....................................................................................................................................................................................... 1

4 Questions et réponses ..................................................................................................................................................................................... 1

4.1 Généralités .................................................................................................................................................................................................. 1

4.2 Ingrédients naturels ........................................................................................................................................................................... 2

4.3 Procédés physiques des ingrédients naturels .............................................................................................................. 3

4.4 Fermentation d’ingrédients naturels ................................................................................................................................... 6

4.5 Solvants de procédé ............................................................................................................................................................................ 7

4.6 Ingrédients minéraux ........................................................................................................................................................................ 8

4.7 Ingrédients dérivés de matériaux naturels .................................................................................................................... 9

4.8 Calcul de l’indice d’origine naturelle .................................................................................................................................11

4.9 Exemples ...................................................................................................................................................................................................14

4.10 Autres procédés chimiques et biologiques ..................................................................................................................15

4.11 Indice et contenu ................................................................................................................................................................................15

4.12 Autres FAQ ...............................................................................................................................................................................................17

Annexe A (Informative) Principes de chimie verte mentionnés dans l’ISO 16128-1:2016,

Annexe B .....................................................................................................................................................................................................................18

Bibliographie ...........................................................................................................................................................................................................................19

© ISO 2021 – Tous droits réservés iii
---------------------- Page: 3 ----------------------
ISO/TR 23750:2021(F)
Avant-propos

L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes

nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est

en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.

L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents

critères d'approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www

.iso .org/ directives).

L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de

droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de

brevets reçues par l'ISO (voir www .iso .org/ brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion

de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir www .iso .org/ avant -propos.

Le présent document a été élaboré par le comité technique ISO/TC 217, Cosmétiques.

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www .iso .org/ fr/ members .html.
iv © ISO 2021 – Tous droits réservés
---------------------- Page: 4 ----------------------
ISO/TR 23750:2021(F)
Introduction

La série ISO 16128 fournit des lignes directrices relatives aux définitions et aux critères applicables

aux ingrédients et produits cosmétiques naturels et biologiques. Ces lignes directrices sont propres

au secteur des cosmétiques, la majeure partie des approches écrites existantes pour le secteur

agroalimentaire n’étant pas directement transposables aux cosmétiques. Elles reflètent un avis

scientifique et offrent des principes pour un cadre logique cohérent applicable aux ingrédients et

produits cosmétiques naturels et biologiques, et ce, en tenant compte des approches communes

adoptées dans les références existantes.

L’objet de la série ISO 16128 est d’encourager un plus large choix d’ingrédients et produits cosmétiques

naturels et biologiques dans la formulation d’une plus grande variété de produits cosmétiques afin de

favoriser l’innovation.

L’objectif du présent document est d’aider les fabricants d’ingrédients et les entreprises de cosmétiques,

voire tout lecteur, à qualifier les ingrédients cosmétiques de naturels, dérivés de matériaux naturels ou

non naturels lors de l’application de la série ISO 16128.
© ISO 2021 – Tous droits réservés v
---------------------- Page: 5 ----------------------
RAPPORT TECHNIQUE ISO/TR 23750:2021(F)
Cosmétiques — Réponses aux questions fréquentes sur la
caractérisation des ingrédients et produits conformément
à l’ISO 16128-1 et l’ISO 16128-2
1 Domaine d’application

Le présent document apporte des réponses aux questions qui peuvent se poser lors du calcul des indices

et contenus conformément à l’ISO 16128-1 et l’ISO 16128-2.

Il clarifie les conditions relatives aux procédés, solvants et sources de carbone permettant de qualifier

les ingrédients suivant la série ISO 16128. Des exemples détaillés expliquant comment utiliser la série

ISO 16128 sont également présentés.
2 Références normatives
Le présent document ne contient aucune référence normative.
3 Termes et définitions
Aucun terme n’est défini dans le présent document.

L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en

normalisation, consultables aux adresses suivantes:

— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp

— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/
4 Questions et réponses
4.1 Généralités
Tableau 1 — Questions générales
N Question Réponse

0 Comment un fabricant d’ingrédients et/ou un Il est recommandé aux fabricants d’ingrédients de fournir

fabricant de cosmétiques peuvent-ils attribuer aux fabricants de cosmétiques les informations relatives à

une catégorie et un indice à un ingrédient? la composition, à l’origine et au traitement des ingrédients,

afin qu’ils déterminent les indices d’ingrédients. Pour
chaque ingrédient, les fabricants de cosmétiques vérifient
la catégorie et l’indice d’après les informations fournies. Par
conséquent, le dialogue entre fabricants d’ingrédients et de
cosmétiques est vivement encouragé.

1 Quelles sont les différences entre les termes Une matière première cosmétique est un ingrédient ou un

suivants: ingrédient, substance, matière pre- mélange d’ingrédients. Un ingrédient est une substance, c’est-

mière et matière renouvelable? à-dire un élément chimique et ses composés à l’état naturel

ou le résultat d’un procédé de fabrication, à l’exclusion de tout
solvant qui peut être séparé sans affecter la stabilité de la
substance ou modifier sa composition. Certaines substances
sont renouvelables si elles se régénèrent naturellement à une
vitesse au moins identique à leur consommation.
© ISO 2021 – Tous droits réservés 1
---------------------- Page: 6 ----------------------
ISO/TR 23750:2021(F)
Tableau 1 (suite)
N Question Réponse

2 Quel est le lien entre la définition d’un extrait Un extrait est une substance ou un mélange de substances.

et sa composition INCI? Dans la plupart des cas, sa désignation INCI est la même
que l’ingrédient naturel dont il provient et, le cas échéant,
la ou les désignations INCI du ou des solvants ingrédients
utilisés pour l’extraction.

3 Les listes d’ingrédients INCI peuvent-elles Non. Pour déterminer cela, plus d’informations sont né-

être utilisées pour déterminer si un produit cessaires. Les ingrédients INCI peuvent être produits de

est naturel, dérivé de matériaux naturels ou différentes façons et les solvants de procédé employés

non naturel? n’apparaissent pas dans la liste des ingrédients INCI. Par
exemple, il est possible que deux produits, dont la liste des
désignations INCI est parfaitement identique, soient classés
différemment lors de l’application des méthodes spécifiées
dans l’ISO 16128-1.

4 Quel est le lien entre les différentes catégories L’ISO 16128-1 spécifie deux catégories de solvants: les sol-

de solvants et leur nomenclature INCI? vants ingrédients et les solvants de procédé, qui sont définis

dans l’ISO 16128-1:2016, Annexe A. Les solvants ingrédients
apparaissent dans la liste des ingrédients INCI. Les solvants
de procédé ne subsistent pas dans l’ingrédient (sauf à l’état de
traces) et n’apparaissent pas dans la liste d’ingrédients INCI.
4.2 Ingrédients naturels

Selon l’ISO 16128-1, les ingrédients naturels sont des ingrédients cosmétiques obtenus exclusivement à

partir de végétaux, d’animaux, de micro-organismes ou de minéraux, y compris les ingrédients obtenus

à partir de ces matériaux résultant:
— de procédés physiques (tels que broyage, séchage, distillation);

— de réactions de fermentation existant dans la nature et conduisant à des molécules existant à l’état

naturel; et

— d’autres modes opératoires de préparation, y compris des méthodes traditionnelles (par exemple,

extraction à l’aide de solvants) sans intention de modifier chimiquement l’ingrédient.

Voir Tableau 2.
Tableau 2 — Questions sur les ingrédients naturels
N Question Réponse

5 Comment l’eau est-elle définie dans l’ISO 16128- L’eau est définie comme étant toujours naturelle dans

1? l’ISO 16128-1:2016, 2.4.

6 La définition de l’eau de cristallisation ne figure En chimie, l’eau de cristallisation consiste en des molécules

pas dans l’ISO 16128-1. Quelle est sa définition? d’eau présentes à l’intérieur de cristaux de minéraux. Elle peut

être considérée comme de l’eau de constitution à l’intérieur
de minéraux naturels. Dans les cas où l’eau est ou ajoutée
pendant une réaction ou produite après celle-ci, elle est
considérée comme étant de l’eau de formulation.

7 Comment l’eau florale obtenue par distillation Elle est classée comme eau d’extraction.

est-elle classée dans l’ISO 16128-1?

8 Les ingrédients comme l’éthanol, les acides Oui. Tant que la matière de base est naturelle, que la fermen-

aminés ou les acides nucléiques sont-ils consi- tation de la réaction existe dans la nature et que le produit

dérés comme naturels s’ils sont obtenus par de fermentation est un produit qui existe dans la nature, le

réaction de fermentation en utilisant une résultat est naturel.
substance qui existe dans la nature comme
matériau de départ?
2 © ISO 2021 – Tous droits réservés
---------------------- Page: 7 ----------------------
ISO/TR 23750:2021(F)
Tableau 2 (suite)
N Question Réponse

9 La Formule (1) de l’ISO 16128-2:2017, 4.3.1 La Formule (1) de l’ISO 16128-2:2017, 4.3.1 s’utilise unique-

peut-elle être utilisée pour calculer l’indice ment pour des extraits lorsque des solvants ingrédients sont

naturel d’un ingrédient qui ne contient pas de présents. Autrement, l’indice naturel attribué, conformément

solvants ingrédients? au même paragraphe, est 1 ou 0.

10 Les matières premières aromatiques natu- Les «fragrances/parfums» sont souvent des mélanges qui

relles sont définies conformément à l’ISO 9235. contiennent des matières naturelles aromatiques. Le calcul

Comment les indices des matières premières des indices de tous les ingrédients contenant des matières

aromatiques naturelles sont-ils calculés en premières aromatiques naturelles suit l’ISO 16128. La com-

appliquant l’ISO 16128? position exacte, conformément à l’ISO 16128-1, peut être
obtenue auprès des fournisseurs.
4.3 Procédés physiques des ingrédients naturels
Tableau 3 — Questions sur les procédés physiques des ingrédients naturels
N Question Réponse

11 Le «traitement par micro-ondes» peut-il être Oui. Tous procédés de séchage peuvent être considérés

considéré comme un procédé physique? comme des procédés physiques dans la mesure où ils

n’entraînent pas de modification chimique.

12 Les nouvelles technologies d’extraction phy- Oui, les nouvelles technologies, comme l’utilisation des

sique sont-elles considérées comme un procédé micro-ondes, de la sonication et des ultrasons, peuvent

d’extraction physique? être considérées comme telles, tant qu’aucune modification

chimique ne s’opère. L’utilisation des solvants est définie
dans l’ISO 16128-1:2016, Tableau A.1.

13 En cas d’extraction d’un extrait végétal à l’aide Si un solvant non naturel subsiste dans l’extrait final sous

d’un mélange composé d’un solvant non natu- forme de solvant ingrédient, cet extrait est considéré comme

rel et d’un solvant naturel, l’extrait final est-il un ingrédient non naturel. Si le solvant non naturel est éli-

considéré comme un ingrédient naturel? miné, cet extrait peut être considéré comme un ingrédient

naturel si les conditions de l’ISO 16128-1:2016, Tableau A.2
sont satisfaites.
14 La valeur k est le rapport du matériau sec/frais Oui.
pour les feuilles ou les fleurs lors du calcul de
l’indice naturel/biologique d’un extrait végétal.
Si un fournisseur peut spécifier le rapport réel
du matériau sec/frais et que celui-ci est différent
de la valeur k, les valeurs spécifiées peuvent-
elles être utilisées pour le calcul?
© ISO 2021 – Tous droits réservés 3
---------------------- Page: 8 ----------------------
ISO/TR 23750:2021(F)
Tableau 3 (suite)
N Question Réponse
15 Fournir des exemples de calcul des indices pour EXEMPLE
l’extrait d’un végétal biologique séché.
5 kg de végétal sec (fleur biologique) ont été extraits par
90 kg de glycérine à 30 % (un solvant dérivé de matériaux
naturels) et une solution aqueuse a été obtenue. (k = 4,5)
— Matériaux de départ: 5 kg de végétal sec équivaut à
5 × 4,5 = 22,5 kg de végétal frais
— Solvant: 63 kg d’eau, 27 kg de glycérine
— Eau de reconstitution: 22,5 – 5 = 17,5 kg
— Eau d’extraction: 63 – 17,5 = 45,5 kg
NOTE L’eau d’extraction est telle que définie dans l’ISO 16128-
Indice naturel de l’extrait: 1 − (27/(5 + 63 + 27)) = 0,71
Indice d’origine naturelle de l’extrait: 1, car tous les ingré-
dients répondent à la définition d’ingrédients dérivés de
matériaux naturels
Indice biologique de l’extrait:
1 – ((45,5 + 27)/(5 + 63 + 27)) = 0,24
Indice de dérivé de matériaux biologiques de l’extrait:
1 – ((45,5 + 27)/(5 + 63 + 27)) = 0,24

16 Conformément à l’ISO 16128-2:2017, 4.2: «L’uti- Le tiret de l’ISO 16128-2:2017, 4.2 indiquant que l’utilisation

lisation d’ingrédients non naturels (par exemple, d’ingrédients non naturels (par exemple, des dénaturants de

des dénaturants de l’alcool) est autorisée dans les l’alcool) est autorisée dans les solvants ingrédients signifie,

solvants ingrédients. Cependant, si le mélange par exemple, que l’alcool dénaturé peut être utilisé pour

contient un solvant ingrédient non naturel, le l’extraction et donne lieu à un extrait naturel. Lorsque du

mélange entier est considéré comme non naturel.» phénoxyéthanol est ajouté à un extrait après filtration, le

mélange obtenu n’a plus d’indice, mais possède à la place
Cela signifie-t-il, par exemple, que l’ajout de
un contenu. L’utilisation de butylène glycol (ingrédient non
phénoxyéthanol à un extrait est admis et affecte
naturel) comme solvant d’extraction donne lieu à un ingré-
uniquement la valeur de l’indice, mais que si un
dient non naturel. L’utilisation de polysorbate 80 au cours
solvant d’extraction comme le butylène glycol
d’une extraction donne lieu à un ingrédient non naturel,
(ingrédient non naturel) est utilisé, alors l’indice
car il n’est pas d’origine naturelle. Toutefois, son utilisation
est 0, dans tous les cas?
après filtration produit un mélange qui a un contenu.
À quelle valeur un ingrédient ajouté devient-il
un solvant (à savoir, le polysorbate 80) ou bien
la définition renvoie-t-elle uniquement aux
solvants d’extraction?

17 Un extrait végétal sec ou un composé purifié Dans la mesure où les solvants ne subsistent pas dans les

isolé d’une source naturelle est-il considéré ingrédients finaux sauf à l’état de traces (solvants de pro-

comme un ingrédient naturel? cédé), ils sont considérés comme des ingrédients naturels

conformément à l’ISO 16128-1:2016, Tableau A.2 si:
— des solvants renouvelables qui représentent un
risque minimal pour la sécurité ou l’environnement
sont utilisés; ou
— si aucun procédé physique ou solvant renouvelable
ne peut être employé, un solvant non naturel qui
représente un risque minimal pour la sécurité ou
l’environnement est utilisé.

18 Quels sont les indices d’un extrait de rose, Puisque le butylène glycol est d’origine pétrochimique,

obtenu par extraction avec un mélange d’eau il s’agit d’un solvant ingrédient non naturel. L’extrait de

et de butylène glycol, si le butylène glycol est rose est donc un ingrédient non naturel. L’indice naturel

d’origine pétrochimique? et l’indice d’origine naturelle sont tous deux 0.
4 © ISO 2021 – Tous droits réservés
---------------------- Page: 9 ----------------------
ISO/TR 23750:2021(F)
Tableau 3 (suite)
N Question Réponse

19 Quels sont les indices d’un extrait de rose, Puisque le butylène glycol est un solvant ingrédient dérivé

obtenu par extraction avec un mélange d’eau de matériaux naturels, l’indice naturel est déterminé à l’aide

et de butylène glycol, si le butylène glycol est de la Formule (1) de l’ISO 16128-2:2017, 4.3.1.

d’origine végétale?
Matériau de départ: 10 kg de fleur
Solvant total introduit: 90 kg = 67,5 kg d’eau + 22,5 kg de
butylène glycol
Masse du solvant d’ingrédient dérivé de matériaux naturels
introduite = 22,5 kg de butylène glycol
Masse totale introduite (ingrédients naturels et solvants
ingrédients) = 10 + 67,5 + 22,5 = 100 kg
L’indice naturel est = 1 – (22,5/100) = 0,775
L’indice d’origine naturelle est 1.

20 La gomme de guar native est-elle un ingrédient Oui, le procédé de la gomme de guar native employé ici est

naturel? une séparation physique des molécules présentes dans les
graines. L’indice naturel de la gomme de guar native est 1,
Selon l’avis de l’AFSSA émis en février 2010 (réf.
si les solvants de procédé utilisés respectent la catégorie
2009-SA-0214), la gomme de guar est obtenue
d’ingrédients naturels de l’ISO 16128-1:2016, Tableau A.2.
par des procédés traditionnels de minoterie à
partir des graines de Cyamopsis tetragonolobus.
Le procédé d’obtention de la gomme de guar
est le suivant:
— les graines extraites des gousses séchées
sont fractionnées par des procédés
mécaniques pour en éliminer le germe;
— l’endosperme est décortiqué pour obtenir
les flocons;
— les flocons, traités par meulage puis
tamisage permettent d’obtenir des
poudres;
— la poudre ou les flocons sont lavés avec
de l’éthanol ou de l’isopropanol afin de
contrôler la charge microbienne.

21 Comment un extrait provenant d’un milieu de La culture et l’extraction d’un cal végétal sont effectuées

culture cellulaire est-il défini dans l’ISO 16128? dans un milieu. L’indice naturel et l’indice d’origine naturelle

Par exemple, un extrait de cal d’Aloe barba- dépendent de la composition du milieu selon la définition

densis est obtenu par la culture de cal d’Aloe donnée dans l’ISO 16128-1.
barbadensis.
Aucun des ingrédients n’est produit de manière biologique.
Indice biologique = indice d’origine biologique = 0
© ISO 2021 – Tous droits réservés 5
---------------------- Page: 10 ----------------------
ISO/TR 23750:2021(F)
4.4 Fermentation d’ingrédients naturels
Tableau 4 — Questions sur la fermentation d’ingrédients naturels
N Question Réponse

22 Qu’est-ce que la fermentation? Les réactions de fermentation résultent d’un milieu de culture composé

de micro-organismes, notamment des bactéries, des levures ou des moi-
sissures. Selon la définition de l’ISO 16128-1:2016, la «fermentation»
comprend également des réactions induites par des microalgues ou des
cellules végétales.

23 Quelles sont les conditions pour Pour qu’un procédé de fermentation permette d’obtenir un ingrédient

qu’un procédé de fermentation naturel, il est nécessaire que le procédé existe à l’état naturel, qu’il emploie

permette d’obtenir un ingrédient une substance naturelle comme matériau de départ et qu’il produise des

naturel? molécules qui existent dans la nature.

24 Quel type de sources de carbone La source de carbone (substrat) d’un procédé de fermentation peut être un

est-il possible d’utiliser pour ingrédient naturel ou un mélange d’ingrédients naturels (le saccharose,

obtenir un ingrédient naturel? par exemple). Voir NOTE 1.

25 Les sels de citrate sont-ils natu- Oui, si le substrat est naturel (par exemple, le sirop de betterave) et dans

rels? la mesure où le ferment: Aspergillus niger produit naturellement du sel
de citrate, le sel obtenu par la fermentation entre l’Aspergillus niger et le
substrat naturel (comme source de carbone) est naturel.

26 Quel type de modifications peut La sélection ou l’hybridation de micro-organismes natifs peut être envi-

être envisagé pour les micro- sagée pour obtenir des ingrédients naturels. Voir NOTE 2.

organismes?

27 Comment les adjuvants sont-ils Les traces d’adjuvants provenant du milieu de culture dans le produit fini

traités dans le milieu de culture? sont traitées comme des solvants de procédé. Tout adjuvant d’origine fossile

peut être envisagé sous réserve qu’il n’y ait pas d’alternative.

28 La fermentation industrielle est- Les ingrédients fabriqués par fermentation industrielle sont considérés

elle considérée comme étant un comme des ingrédients naturels, si les points suivants sont respectés, et

procédé biologique? ce même si leur fabrication est intentionnelle:
1) utilisation d’une substance naturelle comme matériau de départ;
2) par une réaction de fermentation qui existe dans la nature;
3) obtention de molécules qui existent dans la nature.
L’éthanol, par exemple, est naturel lorsqu’un micro-organisme natif est
utilisé et lorsque la source de carbone est un ingrédient naturel comme le
saccharose. Voir NOTE 2.

29 La gomme xanthane est-elle un La gomme xanthane est obtenue par la fermentation d’une bactérie non

ingrédient naturel ou un ingré- génétiquement modifiée (Xanthomonas campestris) à l’aide d’un substrat

dient dérivé de matériaux natu- d’hydrate de carbone (fécule de maïs ou de soja). Le xanthane existe dans

rels? Comment les indices sont-ils la nature, il est produit par des micro-organismes vivant dans les sols.

déterminés? Puisqu’il s’agit d’un ingrédient (et non pas d’un mélange), les indices sont

calculés d’après les quantités utilisées.
Indice naturel = 1 et indice d’origine naturelle = 1
Voir NOTE 2.

NOTE 1 Le substrat de fermentation est naturel pour obtenir un ingrédient naturel. Cette exigence est en cohérence avec

l’ISO 16128-1:2016, Tableau A.1.

NOTE 2 Les ingrédients obtenus par fermentation à l’aide de micro-organismes génétiquement modifiés peuvent

être considérés comme des ingrédients naturels dans certaines parties du monde et comme des ingrédients dérivés de

matériaux naturels dans d’autres.
6 © ISO 2021 – Tous droits réservés
---------------------- Page: 11 ----------------------
ISO/TR 23750:2021(F)
4.5 Solvants de procédé
Tableau 5 — Questions sur les solvants de procédé
N Question Réponse

30 L’extraction au CO supercritique peut-elle Oui, le CO supercritique est un des solvants de procédé qui

2 2

être envisagée pour obtenir des ingrédients peut être utilisé pour obtenir un ingrédient naturel.

naturels?

31 Des solvants non renouvelables peuvent-ils En tant que solvants de procédé d’ingrédients naturels,

être utilisés pour une extraction? d’ingrédients minéraux naturels, d’ingrédients dérivés de

matériaux naturels et d’ingrédients dérivés de matériaux
minéraux, les solvants renouvelables qui représentent un
risque minimal pour la sécurité ou l’environnement sont
utilisés à des fins de procédés d’extraction ou de réaction. Si
d’autres solvants renouvelables ne sont pas disponibles, des
solvants non naturels qui représentent un risque minimal
pour la sécurité ou l’environnement peuvent être utilisés,
selon l’ISO 16128-1:2016, Tableau A.2.

32 Les huiles végétales et les huiles animales Oui, si elles répondent à la définition d’ingrédients naturels

sont-elles considérées comme des ingrédients selon l’ISO 16128-1:2016, Article 2. Les huiles fabriquées par

naturels? un procédé physique comme la pression sont considérées
comme des ingrédients naturels. Pour celles extraites à l’aide
de solvants, si ces solvants subsistent dans les ingrédients
finaux (solvants ingrédients), cela dépend de l’origine des
solvants. L’ISO 16128-1:2016, Tableau A.1 est à consulter
pour vérification.
Lorsque les solvants ne subsistent pas dans les ingrédients
finaux sauf à l’état de traces (solvants de procédé), ils sont
considérés comme des ingrédients naturels conformément
à l’ISO 16128-1:2016, Tableau A.2 si:
— des solvants renouvelables qui représentent un risque
minimal pour la sécurité ou l’environnement sont
utilisés; ou
— aucun autre procédé ou solvant renouvelable ne
pouvant être employé, un solvant non naturel qui
représente un risque minimal pour la sécurité ou
l’environnemen
...

TECHNICAL ISO/TR
REPORT 23750
First edition
2021-08
Cosmetics — Answers to frequently
asked questions on ingredients and
product characterization according to
ISO 16128-1 and ISO 16128-2
PROOF/ÉPREUVE
Reference number
ISO/TR 23750:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO/TR 23750:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TR 23750:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Questions and answers .................................................................................................................................................................................. 1

4.1 General ........................................................................................................................................................................................................... 1

4.2 Natural ingredients ............................................................................................................................................................................. 2

4.3 Physical processes for natural ingredients ..................................................................................................................... 3

4.4 Fermentation for natural ingredients ................................................................................................................................. 5

4.5 Process solvents ..................................................................................................................................................................................... 6

4.6 Mineral ingredients ............................................................................................................................................................................. 7

4.7 Derived natural ingredients ......................................................................................................................................................... 8

4.8 Calculating the natural origin index ..................................................................................................................................... 9

4.9 Examples ...................................................................................................................................................................................................12

4.10 Other chemical and biological processes ......................................................................................................................13

4.11 Index and content ..............................................................................................................................................................................13

4.12 Other FAQs ...............................................................................................................................................................................................15

Annex A (Informative) Green chemistry principles referred to in ISO 16128-1:2016 Annex B ..........16

Bibliography .............................................................................................................................................................................................................................17

© ISO 2021 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
ISO/TR 23750:2021(E)
Foreword

ISO (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

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 collaborates 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 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 subject 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 name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 217, Cosmetics.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TR 23750:2021(E)
Introduction

The ISO 16128 series provides guidelines on definitions and criteria for natural 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 towards a consistent logical framework

for natural and organic cosmetic ingredients and products incorporating common approaches employed

in existing references.

The purpose of the ISO 16128 series is to encourage a wider choice of natural and organic ingredients in

the formulation of a diverse variety of cosmetic products to encourage innovation.

The purpose of this document is to help ingredient manufacturers and cosmetic companies, or any

reader, to qualify cosmetic ingredients as natural, natural derived or non-natural when using the

ISO 16128 series.
© ISO 2021 – All rights reserved PROOF/ÉPREUVE v
---------------------- Page: 5 ----------------------
TECHNICAL REPORT ISO/TR 23750:2021(E)
Cosmetics — Answers to frequently asked questions on
ingredients and product characterization according to ISO
16128-1 and ISO 16128-2
1 Scope

This document provides answers to questions which can arise when calculating indexes and contents

according to ISO 16128-1 and ISO 16128-2.

It clarifies conditions on process, solvents and carbon sources to qualify ingredients regarding the

ISO 16128 series. Detailed examples, explaining how to use the ISO 16128 series are also provided.

2 Normative references
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Questions and answers
4.1 General
Table 1 — General questions
No. Question Answer

0 How can an ingredient manufacturer and/or Ingredient manufacturers are recommended to provide

a cosmetic manufacturer assign the category cosmetic manufacturers with information related to com-

and index of an ingredient? position, origin and processing of ingredients to determine

ingredient indexes. For all ingredients, cosmetic manufac-
turers verify the category and index based on information
provided. Therefore, dialogue between ingredient and
cosmetic manufacturers is encouraged.

1 What are the differences between the following A cosmetic raw material is an ingredient or a mixture of

terms: ingredient, substance, raw material, and ingredients. An ingredient is a substance, i.e. a chemical

renewable material? element and its compounds in the natural state or the result
of a manufacturing process, excluding any solvent which
may be separated without affecting the stability of the
substance or changing its composition. Certain substances
are renewable if they are replenished naturally at a rate at
least the same as their consumption.

2 How does the definition of an extract relate to An extract is a substance or a mixture of substances. In most

its INCI composition? cases, its INCI name is the same as the natural ingredient
it comes from, with, when relevant, the INCI name(s) of the
ingredient solvent(s) used for extraction.
© ISO 2021 – All rights reserved PROOF/ÉPREUVE 1
---------------------- Page: 6 ----------------------
ISO/TR 23750:2021(E)
Table 1 (continued)
No. Question Answer

3 Can the INCI ingredient lists be used to deter- No. More information is needed to make that determination.

mine if a product is natural, derived natural INCI ingredients can be produced in different ways and pro-

or non-natural? cess solvents used will not appear in the INCI ingredients
list. For example, it is possible to have two products with
the exact same INCI names list be classified differently when
using the methods set out in ISO 16128-1.

4 How do the different categories of solvents ISO 16128-1 refers to two categories of solvents: ingredient

relate to their INCI nomenclature? solvents and process solvents, which are defined in ISO

16128-1:2016, Annex A. Ingredient solvents appear in the
INCI ingredients list. Process solvents do not remain in the
ingredient (except as traces) and will not appear in the INCI
ingredient list.
4.2 Natural ingredients

Per ISO 16128-1, natural ingredients are cosmetic ingredients obtained only from plants, animals,

micro-organisms, or minerals, including those obtained from these materials by:
— physical processes (e.g. as grinding, drying, distillation);

— fermentation reactions occurring in nature and leading to molecules occurring in nature; and

— other processes of preparation, including traditional ones (e.g. extraction using solvents) without

intentional chemical modification.
See Table 2.
Table 2 — Questions on natural ingredients
No. Question Answer

5 How is water defined in ISO 16128-1? Water is defined as always natural in ISO 16128-1:2016, 2.4.

6 The definition of water of crystallization is not In chemistry, water of crystallization is water molecules that

provided in ISO 16128-1. How is it defined? are present inside crystals of minerals. It can be considered

as constitutive water in natural minerals. In the cases which
water is either added during or produced after a reaction,
it is considered as formulation water.

7 How is aromatic water obtained by distillation It is classified as extraction water.

classified in ISO 16128-1?

8 Are ingredients such as ethanol, amino acids, Yes. As long as the feedstock is natural, the reaction fermen-

or nucleic acids considered natural if obtained tation occurs in nature and the fermentation product is one

by fermentation reaction using a substance that occurs in nature, the result is natural.

occurring in nature as a starting material?

9 Can Formula (1) in ISO 16128-2:2017, 4.3.1 be Formula (1) in ISO 16128-2:2017, 4 3 1 is used only for ex-

used to calculate the natural index of an ingre- tracts when ingredient solvents are present. Otherwise, the

dient that does not contain ingredient solvents? natural index is assigned, according to the same paragraph,

is either 1 or 0.

10 Aromatic natural raw materials are defined “Fragrance/Parfum” are often mixtures including aromatic

according to ISO 9235. How are the indexes natural materials. The calculation of indexes of all ingredi-

of aromatic natural raw materials calculated ents containing aromatic natural raw materials follows ISO

per ISO 16128? 16128. The exact composition, according to ISO 16128-1, can
be obtained from the suppliers.
2 PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 7 ----------------------
ISO/TR 23750:2021(E)
4.3 Physical processes for natural ingredients
Table 3 — Questions on physical processes for natural ingredients
No. Question Answer

11 Can “processing by micro-waves” be considered Yes. Any sort of drying process can be considered as physical

as physical process? process if it does not lead to chemical modification.

12 Are new technologies for physical extraction Yes, new technologies, such as use of micro-waves, sonication

considered as physical extraction process? and ultrasounds can be considered, as long as there is no

chemical modification. The use of solvents is defined in ISO
16128-1:2016 Table A.1.

13 In case of a plant extract extracted with a mix- If a non-natural solvent remains in the final extract as an

ture consisting of a non-natural solvent and a ingredient solvent, this extract is considered as a non-natural

natural solvent, is the final extract considered ingredient. If the non-natural solvent is eliminated, this ex-

as a natural ingredient? tract can be considered as a natural ingredient if conditions

of ISO 16128-1:2016, Table A.2 are fulfilled.
14 The value k is the dry/fresh ratio for leaves Yes.
or flowers when calculating natural/organic
index of plant extract. If a supplier can specify
the actual dry/fresh ratio and it is different
from k value, can the specified values be used
for calculation?
15 Provide index calculation examples for the EXAMPLE
extract of a dried organic plant.
5 kg of dry plant (organic flower) was extracted by 90 kg of
30 % glycerin (a derived natural solvent) aqueous solution
was obtained. (k=4,5)
— Starting materials: 5 kg of dry plant is equivalent to 5 × 4,5
= 22,5 kg of fresh plant
— Solvent: 63 kg of water, 27 kg of glycerin
— Reconstitution water: 22,5 – 5 = 17,5 kg
— Extraction water: 63 – 17,5 = 45,5 kg
NOTE Extraction water is as defined in ISO 16128-1.
Natural index of the extract: 1 − (27/(5 + 63 + 27)) = 0,71
Natural origin index of the extract: 1 as all ingredients meet
the definition of derived natural ingredients
Organic index of the extract: 1 – ((45,5+27)/ (5+63+27)) = 0,24
Organic derived index of the extract: 1 – ((45,5 + 27)/
(5 + 63 + 27)) = 0,24

16 According to ISO 16128-2:2017, 4.2: “The use The bullet from ISO 16128-2:2017, 4.2 stating that the use of

of non-natural ingredients (e.g. alcohol denatur- non-natural ingredients (e.g. alcohol denaturants) is allowed

ants) is allowed in ingredient solvent. However, in ingredient solvents means, for example, that denaturated

if the mixture contains a non-natural ingredient alcohol can be used for extraction and leads to a natural

solvent, then the entire mixture is non-natural.” extract. When phenoxyethanol is added to an extract after

filtration, this is a mixture which has no longer an index but
Does it mean, for example, that the addition of
instead has a content. The use of butylene glycol (non-natural)
phenoxyethanol to an extract is OK and only
as an extraction solvent leads to a non-natural ingredient.
affects the index value, but if an extraction
The use of polysorbate 80 during an extraction leads to a
solvent of butylene glycol (non-natural) is used,
non-natural ingredient as it is not of natural origin. But its
then the index is 0, regardless?
use after filtration leads to a mixture which has a content.
At what value does an added ingredient be-
come a solvent (i.e. polysorbate-80) or does
the definition refer only to extraction solvents?
© ISO 2021 – All rights reserved PROOF/ÉPREUVE 3
---------------------- Page: 8 ----------------------
ISO/TR 23750:2021(E)
Table 3 (continued)
No. Question Answer

17 Is a dry herbal extract or a purified compound In the extent that solvents do not remain in the final ingre-

isolated from a natural source considered as dients except as traces (process solvents), they are consid-

a natural ingredient? ered as natural ingredients according to ISO 16128-1:2016,
Table A.2 if:
— renewable solvents that pose minimal safety or environ-
mental risk are used; or
— if no physical process or no renewable solvent can be
used, a non-natural solvent that poses minimal safety or
environmental risk is used.

18 What are the indexes of a rose extract, ob- As the butylene glycol is of petrochemical origin, it is a non-nat-

tained by extraction with a mixture of water ural ingredient solvent. The rose extract is a non-natural

and butylene glycol, if the butylene glycol is of ingredient. Both natural index and natural origin index are 0.

petrochemical origin?

19 What are the indexes of a rose extract, ob- As the butylene glycol is a derived natural ingredient sol-

tained by extraction with a mixture of water vent, the natural index is determined using Formula (1) in

and butylene glycol, if the butelyne glycol is of ISO 16128-2:2017, 4.3.1.
vegetal origin?
Starting material: 10 kg of flower
Total solvent introduced: 90 kg = 67,5 kg water + 22,5 kg
butylene glycol
Mass of derived natural solvent introduced = 22,5 kg bu-
tylene glycol
Total mass introduced (natural ingredients and ingredient
solvents) = 10 + 67,5 + 22,5 = 100 kg
The natural index is = 1 – (22,5/100) = 0,775
The natural origin index is 1.

20 Is native guar gum a natural ingredient? Yes, the process of native guar gum used here is a physical

separation of the molecules present in the seeds. The natural
According to a February 2010 Opinion from
index of the native guar gum is 1, if process solvents used
AFSSA (ref. 2009-SA-0214), guar gum is ob-
respect the natural category of ISO 16128-1:2016, Table A.2.
tained, using Cyamopsis tetragonolobus seeds
through traditional methods in the grain milling
industry. Guar gum is obtained through the
following process:
— seeds extracted from dried pods are me-
chanically broken down in order to eliminate
the sprout;
— the endosperm is husked to obtain flakes;
— flakes are ground then sieved to obtain a
powder;
— powder or flakes are washed using ethanol
or isopropanol to limit the microbial load.

21 How is an extract from cell culture medium The culture and extraction of a plant callus is carried out in

defined in ISO 16128? For example, an Aloe a medium. The natural index and the natural origin index

barbadensis Callus extract is an extract obtained depend on the composition of the medium as defined in

through the culture of Aloe barbadensis Callus. ISO 16128-1.
None of the ingredients are organically produced. OI=OOI =0
4 PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 9 ----------------------
ISO/TR 23750:2021(E)
4.4 Fermentation for natural ingredients
Table 4 — Questions on fermentation for natural ingredients
No. Question Answer
22 What is fermentation? Fermentation reactions result from a culture medium
containing micro-organisms, including bacteria, yeasts or
moulds. According to the definition of ISO 16128-1:2016 “fer-
mentation” also includes reactions generated by micro-algae
or plant cells.

23 What are the conditions for a fermentation For a fermentation process to obtain a natural ingredient,

process to obtain a natural ingredient? the process exists in nature, uses a natural substance as a

starting material and leads to molecules which occur in nature.

24 What type of carbon sources can be used to The carbon source (substrate) for the fermentation process

obtain a natural ingredient? can be a natural ingredient or mixture of natural ingredients

(sucrose for instance). See NOTE 1.

25 Are citrate salts natural? Yes, if the substrate is natural (e.g. Beetroot syrup) and as

far as the ferment: Aspergillus niger naturally produces
some citrate salt, the salt resulting from the fermentation
with Aspergillus niger and the natural substrate (as carbon
source) is natural.

26 Which type of modifications can be considered Selecting or cross-breeding native micro-organisms can be

for microorganisms? considered to obtain natural ingredients. See NOTE 2.

27 How are adjuvant in the culture medium Traces of adjuvant from the culture medium in the finished

treated? product are treated as process solvents. Adjuvant of fossil
origin can be considered provided there is no alternative.

28 Is industrial fermentation considered to be a Ingredients manufactured by industrial fermentation are

biological process? considered as natural ingredients, if the following points are

fulfilled, even if it is intentionally manufactured:
1) using a natural substance as a starting material;
2) by a fermentation reaction which exist in nature;
3) leading to molecules which occur in nature.
Ethanol for instance is natural when a native micro-organism
is used and when the carbon source is a natural ingredient
such as saccharose. See NOTE 2.

29 Is Xanthan gum a natural or derived natural Xanthan gum is obtained through the fermentation of a

ingredient? How are the indexes determined? non-genetically modified bacterium (Xanthomonas camp-

estris) using a carbohydrate substrate (corn or soy starch).
Xanthan occurs in nature, produced by micro-organisms
living in soils. As this is an ingredient - and not a mixture -
indexes are calculated, based on quantities used.
NI = 1 and NOI = 1
See NOTE 2.

NOTE 1 The fermentation substrate is natural in order to obtain a natural ingredient. This requirement is consistent with

ISO 16128-1:2016, Table A.1.

NOTE 2 Ingredients obtained by fermentation using genetically modified microorganisms can be considered as natural

ingredients in certain regions of the world and derived natural ingredients in other regions of the world.

© ISO 2021 – All rights reserved PROOF/ÉPREUVE 5
---------------------- Page: 10 ----------------------
ISO/TR 23750:2021(E)
4.5 Process solvents
Table 5 — Questions on process solvents
No. Question Answer

30 Can supercritical CO extraction be considered Yes, supercritical CO is one of the process solvents which

2 2
for obtaining natural ingredients? can be used to obtain a natural ingredient.

31 Can non-renewable solvents be used for ex- As process solvents of natural ingredients, natural mineral

traction? ingredients, derived natural ingredients and derived mineral
ingredients, renewable solvents that pose minimal safety or
environmental risk are used for the purpose of extraction or
reaction processes. If renewable alternatives are not available,
non-natural solvents that pose minimal safety or environ-
mental risk can be used, per ISO 16128-1:2016, Table A.2

32 Are vegetable oils and animal oils considered Yes, if they meet the definition of natural per ISO 16128-

as natural ingredients? 1:2016, Clause 2. Those manufactured by physically process

such as squeezing are considered as natural ingredients. For
those extracted with solvents, in case those solvents remain
in the final ingredients (ingredient solvents), it depends on
the origin of the solvents. ISO 16128-1:2016, Table A.1 is to
be used for verification.
In case solvents do not remain in the final ingredients except
as traces (process solvents), they are considered as natural
ingredients according to ISO 16128-1:2016, Table A.2 if:
— renewable solvents that pose minimal safety or environ-
mental risk are used; or
— no physical process or no renewable solvent can be used,
a non-natural solvent that poses minimal safety or environ-
mental risk is used.

33 For the manufacturing of lecithin, hexane is As the use of hexane for the manufacturing of lecithin is un-

commonly used as process solvent. Does it avoidable at the current state of art, according to ISO 16128-

impair the classification of lecithin as natural 1:2016 Table A.2 footnote “a”, the classification of lecithin is

due to its petrochemical origin? not affected by the use of hexane. Hexane concentration in the

final lecithin has to pose minimal safety or environmental risk.
6 PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 11 ----------------------
ISO/TR 23750:2021(E)
4.6 Mineral ingredients
Table 6 — Questions on mineral ingredients
No. Question Answer

34 Does ISO 16128-1:2016, Annex D contain Yes. ISO 16128-1:2016, Annex D is an illustrative, not exhaus-

natural minerals? tive, list of reaction products that may be considered derived
mineral ingredients. Ingredients on this list which are found
in nature (i.e. not chemical reaction products) are natural
mineral ingredients.

35 Is surface-coated titanium dioxide a non-nat- When physically coated by encapsulation or electrostatic

ural ingredient? surface modification, it is considered as a mixture of titani-
um dioxide and coating agent. The titanium dioxide may be
considered as a derived mineral ingredient. The natural and
natural origin indexes of the coating are to be determined
separately.
When chemically modified with a natural (except natural
mineral ingredient) or derived natural reactant that makes
up less than or equal to 50 % by weight of the ingredient, as
a surface coating or otherwise, the result is a non-natural
ingredient.
When reacted with a natural (except natural mineral ingre-
dient) or derived natural reactant that makes up greater
than 50 % by weight of the ingredient, as a surface coating
or otherwise, the result is a derived natural ingredient.
In either case, when chemically modified with non-mineral
ingredients, the result is not considered as a derived mineral
ingredient.

36 Is nano-sized titanium dioxide, considered as Since the properties other than the chemical composition,

a derived mineral ingredient, as long as it has such as crystal structure and physical properties, are not

the same chemical composition as a natural specified in the definition of derived mineral ingredient, it

mineral ingredient? may be considered as a derived mineral ingredient, as long
as the chemical composition is the same as a natural mineral
ingredient and as long as it respects the full definition of ISO
16128-1:2016, Clause 4, including process information.

37 What is the classification for KOH (potassium KOH is not found in nature, so it is non-natural and cannot

hydroxide), derived mineral or non-natural? be derived mineral.

38 Can cosmetic grade iron oxides be considered Since they are from mineral rather than biological origin,

derived natural ingredients? iron oxides are not considered derived natural ingredients.

If they meet the criteria, then cosmetic grade iron oxides are
derived mineral ingredients and contribute to natural origin
content of a product.

39 Can fumed silica be claimed derived mineral? Silica is a natural mineral. Fumed silica which has the same

composition as silica, may be classified as a derived mineral
ingredient. It is obtained through chemical processing of in-
organic substances occurring naturally in earth, which have
the same chemical composition of natural mineral ingredients.

40 When a natural mineral ingredient is reacted If it has the same chemical composition as a natural mineral

with other ingredients, what is natural origin ingredient, it is considered as a derived mineral ingredient.

index of the ingredient? If it doesn’t have the same chemical composition as natural

mineral ingredients and is greater than 50 % natural origin,
then that portion of ingredient can contribute to the natural
origin index.
© ISO 2021 – All rights reserved PROOF/ÉPREUVE 7
---------------------- Page: 12 ----------------------
ISO/TR 23750:2021(E)
4.7 Derived natural ingredients
Table 7 — Questions on derived natural ingredients
No. Question Answer
41 Why does the ISO 16128 series recommend While not mandatory, the use
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.