ISO/PRF TR 23750

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

General Information

• Status: Published
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: ISO/TC 217 - Cosmetics
• Drafting Committee: ISO/TC 217/WG 4 - Terminology

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
PROOF/ÉPREUVE
Reference number
ISO/TR 23750:2021(E)
ISO 2021
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ISO/TR 23750:2021(E)
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© ISO 2021

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Published in Switzerland
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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

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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.
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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.
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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.
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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.
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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?
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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
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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.

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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.
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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.
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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
...