Textiles - Cosmetotextiles

This standard document is a Technical Report which specifies general characterization of cosmetotextiles and focuses on their recommended properties.
Five parts have been established as follows:
-   general aspects;
-   safety evaluation;
-   claimed effects;
-   care resistance;
-   labelling.
These five characteristics are developed in Clause 4.

Textilien - Cosmeto-Textilien

Textiles - Cosmétotextiles

Le présent Rapport technique spécifie les caractéristiques générales des cosmétotextiles et décrit
leurs propriétés recommandées.
Les cinq parties suivantes ont été définies :
- aspects généraux ;
- évaluation de la sécurité ;
- effets revendiqués ;
- résistance à l’entretien ;
- étiquetage.
Ces cinq caractéristiques sont développées à l’Article 4.

Tekstilije - Kozmetične tekstilije

To tehnično poročilo opredeljuje splošne značilnosti kozmetičnih tekstilij in opisuje njihove priporočene lastnosti. Osnovanih je bilo pet delov, kot sledi: - splošni vidiki, - ocenjevanje varnosti, - zahtevani učinki, odpornost na nego, - etiketiranje. Teh pet značilnosti je določenih v Klavzuli 4.

General Information

Status
Published
Publication Date
22-Sep-2009
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
23-Sep-2009
Completion Date
23-Sep-2009

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SLOVENSKI STANDARD
SIST-TP CEN/TR 15917:2010
01-februar-2010
7HNVWLOLMH.R]PHWLþQHWHNVWLOLMH
Textiles - Cosmetotextiles
Textilien - Cosmeto-Textilien
Textiles - Cosmétotextiles
Ta slovenski standard je istoveten z: CEN/TR 15917:2009
ICS:
61.020 2EODþLOD Clothes
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
97.160 Tekstilije za dom. Perilo Home textiles. Linen
SIST-TP CEN/TR 15917:2010 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 15917:2010
TECHNICAL REPORT
CEN/TR 15917
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
September 2009
ICS 61.020; 71.100.70; 97.160
English Version
Textiles - Cosmetotextiles
Textiles - Cosmétotextiles Textilien - Cosmeto-Textilien

This Technical Report was approved by CEN on 3 August 2009. It has been drawn up by the Technical Committee CEN/TC 248.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 15917:2009: E

worldwide for CEN national Members.
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Contents Page

Foreword ................................................................................................................................................. 3

Introduction ............................................................................................................................................. 4

1 Scope .......................................................................................................................................... 5

2 Normative references ................................................................................................................ 5

3 Terms and definitions ............................................................................................................... 5

4 Characteristics ........................................................................................................................... 7

4.1 General ....................................................................................................................................... 7

4.2 General aspects ......................................................................................................................... 7

4.2.1 Introduction ................................................................................................................................ 7

4.2.2 Recommendations .................................................................................................................... 7

4.3 Safety evaluation ....................................................................................................................... 8

4.3.1 Introduction ................................................................................................................................ 8

4.3.2 Risk in relation to the cosmetotextile ...................................................................................... 8

4.3.3 Requirements for a cosmetic dossier ...................................................................................11

4.3.4 Notification of the cosmetic product of cosmetotextiles to national poison centres ......12

4.4 Claimed effects ........................................................................................................................12

4.4.1 Introduction ..............................................................................................................................12

4.4.2 Methodology ............................................................................................................................12

4.4.3 Examples (non-exhaustive list, without hierarchy in the listed methods) ........................14

4.5 Care resistance ........................................................................................................................16

4.5.1 Introduction ..............................................................................................................................16

4.5.2 Methodology ............................................................................................................................16

4.5.3 Materials, reagents and apparatus ........................................................................................16

4.5.4 Calculation ...............................................................................................................................17

4.5.5 Test report ................................................................................................................................17

4.5.6 Examples of extraction and chemical analyses ...................................................................17

4.6 Labelling ...................................................................................................................................17

4.6.1 Introduction ..............................................................................................................................17

4.6.2 Product labelling .....................................................................................................................18

4.6.3 Marketing labelling requirements ..........................................................................................18

Annex A (informative) Regulations .....................................................................................................19

A.1 Cosmetics regulations ............................................................................................................19

A.2 Textile regulations ...................................................................................................................19

Annex B (informative) Guidelines .......................................................................................................20

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Foreword

This document (CEN/TR 15917:2009) has been prepared by Technical Committee CEN/TC 248

“Textiles and texile products”, the secretariat of which is held by BSI.
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Introduction

Recently, new textile products have appeared on the European market. They associate textile

supports and cosmetic products, for example:
 slimming preparations: pantyhose, underwear, trousers;
 moisturizing preparations: pantyhose, underwear, T-shirts;
 refreshing preparations: houselinen (bedsheets.).

CEN/TC 248 WG25 has worked on this combination between textiles and cosmetic products. This new

class of product has been given the name: cosmetotextiles.

An indication that the European Commission will treat the cosmetic part of a cosmetotextile analogous

to cosmetic products is given in the “Manual of the scope of application of the European Cosmetics

Directive 76/768/EEC”. As a consequence, Article 2 of the European Cosmetics Directive 76/768/EEC

gains also central importance for the cosmetic part of cosmetotextiles, stating that a cosmetic product

should not cause damage to human health.
European Cosmetics Directive 76/768/EEC, Article 2 states:

“A cosmetic product put on the market within the Community must not cause damage to human health

when applied under normal or reasonably foreseeable conditions of use, taking account, in particular,

of the product’s presentation, its labelling, any instructions for its use and disposal as well as any other

indication or information provided by the manufacturer or his authorized agent or by any other person

responsible for placing the product on the Community market”.

Cosmetic products are regulated within the European Cosmetics Directive (76/768/EEC) at present in

accordance with the 7 amendment. Although the complete cosmetotextile product does not need to

conform to the directive, the cosmetic products of a cosmetotextile will need to fulfil the terms of the

European Cosmetics Directive if they are to be marketed in Europe.
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1 Scope

This Technical report specifies general characteristics of cosmetotextiles and describes their

recommended properties.
Five parts have been established as follows:
 general aspects;
 safety evaluation;
 claimed effects;
 care resistance;
 labelling.
These five characteristics are developed in Clause 4.
2 Normative references

The following referenced documents are indispensable for the application of this document. For dated

references, only the edition cited applies. For undated references, the latest edition of the referenced

document (including any amendments) applies.

prEN ISO 3175-1, Textiles - Dry-cleaning and finishing - Part 1: Method for assessing the cleanability

of textiles and garments (ISO 3175-1:1998)
EN ISO 3758, Textiles - Care labelling code using symbols (ISO 3758:2005)

EN ISO 6330, Textiles - Domestic washing and drying procedures for textile testing (ISO 6330:2000)

EN ISO 22716, Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good

Manufacturing Practices (ISO 22716:2007)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
textile

flexible material comprising a network of natural, man-made fibres often referred to as yarn

NOTE Yarn is produced by spinning raw wool fibres, linen, cotton, or other material on a spinning machine.

Textile fabrics are formed by weaving, knitting, or non-woven processes.
3.2
cosmetic product

substance or preparation intended to be placed in contact with the various external parts of the human

body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous

membranes of the oral cavity with a view exclusively, or mainly, to cleaning them, perfuming them,

changing their appearance and/or correcting body odours and/or protecting them or keeping them in

good condition”. [In accordance with article 1 of the European Cosmetics Directive 76/768/EEC]

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3.3
cosmetotextile

textile consumer article containing a durable cosmetic product which is released over time

NOTE Disposable products (e.g. wipes) are not considered as cosmetotextiles.
3.4
binder

material used to bind together two or more other materials (for example textiles and microcapsules).

Its two principal properties are adhesion and cohesion
3.5
microcapsule

small particle with a wall that contains the cosmetic product. Most microcapsules have diameters of a

few micrometers
3.6
cosmetic effects

effects that are in line with the general definition of a cosmetic product as mentioned in the European

Cosmetics Directive (76/768/EEC)
3.7
cosmetic claim

information, made available to the consumer and/or market, on the contents (properties, effects, etc.)

of the cosmetic product or its constituents as well as the cosmetotextile

NOTE See also Guidelines for the Evaluation of the Efficacy of Cosmetic Products, COLIPA, Annex B.

3.8
claim substantiation

process of proving the effects claimed to be generated by the cosmetotextile, e.g. via a scientifically

sound method, published data or consumer testing

NOTE This is obligatory in accordance with various laws including the European Cosmetics Directive

(76/768/EEC).
3.9
care resistance

cosmetotextile property which characterizes the quantity of the cosmetic product remaining after a

given number of care cycles

NOTE "Care resistance" should not be confused with "durability of the cosmetic effect".

3.10
durability of the cosmetic effect

number of care and use cycles during which this (these) effect(s) can be measured and/or noticed by

the user

NOTE 1 This information is relevant for marketing claims. It should not be confused with the date of minimum

durability of the cosmetic product (shelf life) which in accordance with the European Cosmetics Directive should

be indicated by the words: “best used before the end of …”.

NOTE 2 "Durability of the cosmetic effect" should not be confused with "care resistance".

3.11
claimed effect

ability of a cosmetotextile to produce the cosmetic effect claimed when using that specific

cosmetotextile
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3.12
product label
label permanently attached to or printed onto a cosmetotextile
3.13
marketing label or hand tag
label which is not permanently attached to or printed onto a cosmetotextile
4 Characteristics
4.1 General

Five characteristics are developed below: general aspects, safety evaluation, claimed effects, care

resistances and labelling.
4.2 General aspects
4.2.1 Introduction

A cosmetotextile is a product which combines a cosmetic product and a textile (with or without a

binder). This cosmetic product may be contained in a microcapsule for example.

The cosmetic product used in a cosmetotextile shall conform to European Cosmetics regulations. One

condition for a substance or preparation to be a cosmetic is that it is intended to be released to the

body.

The present technical report focuses on some parts of the European Cosmetics Directive 76/768/EEC

which apply mainly to the cosmetotextile.

The textile of the cosmetotextile is only a “vehicle” to deliver a cosmetic product on different superficial

parts of the human body. This textile should not be considered to be a cosmetic product.

Substances which are part of the textile (dyestuffs, textile auxiliaries, binders, microcapsules…) are

not intended to be released to the body, and are therefore not considered to be cosmetic products.

A textile with those substances, which are part of the textile, falls within the scope of application of

European Textile regulations.

Textiles which claim external biocide activity are excluded. They fall within the scope of the European

Biocidal Products Directive 98/8/EC.
4.2.2 Recommendations
4.2.2.1 General
NOTE Special care should be given to the following points.
4.2.2.2 Quality control concerning textiles
The quality of the textile should be well controlled.
The following Table 1 proposes some suggestions:
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Table 1 — Quality control concerning textiles
Criteria Standard
Colour fastness to water EN ISO 105-E01
Colour fastness to rubbing EN ISO 105-X12
Colour fastness to perspiration EN ISO 105-E04
Depending on care specifications:
Colour fastness to domestic and commercial laundering EN ISO 105-C06
Colour fastness to dry cleaning EN ISO 105-D01
4.2.2.3 Good manufacturing practices for cosmetotextiles (GMP)

As far as the textile industry is concerned, cosmetotextiles should conform as closely as possible to

the standard EN ISO 22716 relative to GMP for the cosmetic products.

The requirements for cosmetotextiles are based on the main textile reference frames used in the

textile industry, such as European Ecolabel for textiles or other private labels.

4.3 Safety evaluation
4.3.1 Introduction

A cosmetotextile placed on the European market is deemed to be in accordance with the General

Product Safety Directive 2001/95/EC.

The safety of a cosmetic product placed on the market within the EU is, in accordance with the

European Cosmetics Directive 76/768/EEC, the full responsibility of the manufacturer, the first

importer into the EU market or the marketer.

Information relating to the ingredients and undesirable effects should be made easily accessible to the

public, (this is in accordance with article 7a (§1) of the European Cosmetics Directive 76/768/EEC).

4.3.2 Risk in relation to the cosmetotextile
4.3.2.1 General

The cosmetic product of a cosmetotextile usually consists of a complex composition of different

ingredients. A toxicological profile is necessary for each ingredient. An overall toxicological evaluation

for the cosmetic product is developed on the basis of these profiles.

In accordance with the SCCP (Scientific Committee on Consumer Products) notes of guidance (see

Annex B); a safety evaluation of a cosmetic product comprises the following steps:

a) a hazard identification for all ingredients;
b) a dose response assessment;
c) an exposure assessment;
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d) a risk characterization.

The safety of binders and microcapsules, shell materials as well as other auxiliaries which are

generally used in the manufacture of cosmetotextiles should also be subjected to a risk assessment.

The textile base fabrics used for cosmetotextiles should carry no substance at levels that are of

toxicological concern.
4.3.2.2 Hazard identification for ingredients

The hazard identification of the cosmetic ingredients is outlined in detail in the relevant SCCP notes of

guidance (see annex B): “Based on the results of in vivo tests, in vitro tests, clinical studies, accidents,

human epidemiological studies and, when available, Quantitative Structure Activity Relationship

(QSAR) studies. The intrinsic physical, chemical and toxicological properties of the molecule under

consideration are studied to identify whether the substance has the potential to damage human

health”.

Within the toxicological evaluation process of chemical substances, several toxicological parameters

and methods are described. However, due to the application route of cosmetotextiles comparable to

“leave-on” cosmetics (e.g. body lotion), the SCCP suggest, that as a minimum, the evaluation of a

selected number of toxicological endpoints, described in the following.
Acute toxicity

The term "acute toxicity" is used to describe the adverse effects on health which may result from a

single exposure to a substance via the oral, dermal or inhalation route.

For acute oral or dermal toxicity testing, which are relevant in this context, the reader may be referred

to the relevant SCCP notes of guidance (see Annex B).
Skin irritation or dermal irritation

Skin irritation or dermal irritation is defined as reversible damage of the skin following the application of

a test substance.

For skin irritation or dermal irritation testing the reader may be referred to the relevant SCCP notes of

guidance (see Annex B).
Eye irritation or mucous membrane irritation

Eye irritation or mucous membrane irritation is defined as reversible damage of the eye or mucous

membrane following the application of a test substance.

For eye irritation or mucous membrane irritation testing, the reader may be referred to the relevant

SCCP notes of guidance (see Annex B).
Skin sensitization

A skin sensitizer is an agent that is able to cause an allergic response in susceptible individuals. The

consequence of this is that following subsequent exposure via the skin, the characteristic adverse

health effects of allergic contact dermatitis may be provoked.

For skin sensitization testing, the reader may be referred to the relevant SCCP notes of guidance (see

Annex B).
Dermal / percutaneous absorption

The dermal / percutaneous absorption process is a global term which describes the passage of

compounds across the skin.
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For dermal / percutaneous absorption testing, the reader may be referred to the relevant SCCP notes

of guidance (see Annex B).
Repeated dose toxicity

Repeated dose toxicity comprises the adverse general (excluding reproductive, genotoxic and

carcinogenic effects) toxicological effects occurring as a result of repeated daily dosing with or

exposure to, a substance for a specific part of the expected lifespan of the test species.

For repeated dose toxicity testing, the reader may be referred to the relevant SCCP notes of guidance

(see Annex B).
Mutagenicity / genotoxicity

Mutagenicity refers to the induction of permanent transmissible changes in the amount or structure of

the genetic material of cells or organisms. These changes may involve a single gene or a gene

segment, a block of genes or whole chromosomes. Effects on whole chromosomes may be structural

and/or numerical.

Genotoxicity is a broader term and refers to potentially harmful effects on genetic material that are not

necessarily associated with mutagenicity. Thus, tests for genotoxicity include those providing an

indication of induced damage to DNA (but not direct evidence of mutation) via effects such as

unscheduled DNA synthesis (UDS), sister chromatid exchange (SCE), DNA strandbreaks, DNA

adduct formation or mitotic recombination (MR), as well as tests for mutagenicity.

For mutagenicity / genotoxicity testing, the reader may be referred to the relevant SCCP notes of

guidance (see Annex B).
4.3.2.3 Dose-response assessment

SCCP: “Dose-response assessment covers the process in which the relationship between the toxic

response and the exposure is studied. In the case of an effect with a threshold, the dosage at which

no adverse effects are observed (NOAEL) is determined. If the NOAEL is not available, the lowest

dosage at which an adverse effect is observed (LOAEL) is used.
4.3.2.4 Exposure assessment

SCCP: “Exposure assessment covers the process in which the amount and the frequency of human

exposure to the compound are determined (including potential specific groups at risk, e.g. children,

pregnant women).”
4.3.2.5 Risk characterization

SCCP: Risk characterization covers the process in which the probability that the molecule under

investigation causes damage to human health and the level of risk, are examined. In the case of a

threshold effect, the Margin of Safety (MoS) is calculated in accordance with the following equation:

NOAEL
MoS=
SED
where
NOAEL represents the No Observable Adverse Effect Level, and
SED represents the Systemic Exposure Dosage.
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Hazard assessment, dose-response assessment, exposure assessment and risk characterization

result in toxicological profiles of each ingredient enabling in the end a safety evaluation of the cosmetic

product.

A further human sensitization test (Human Repeated Insult Patch Test, HRIPT) of the cosmetic

product on a textile [to be defined, e.g. White cotton] should be used as a confirmatory test to ensure

that the final product is not sensitizing for the population.
4.3.3 Requirements for a cosmetic dossier

Beside the toxicological evaluation of a cosmetic product in accordance with the European Cosmetics

Directive 76/768/EEC any manufacturer, importer of a cosmetic product to the EU or marketer of a

cosmetotextile is obliged to keep the following information readily available for the competent

authorities:

a) the qualitative and quantitative composition of the cosmetic formulation; in the case of perfume

compositions and perfumes, the name and code number of the composition and the identity of the

supplier;

b) the physical, chemical and microbiological specifications of the raw materials and the finished

cosmetic product and the purity and microbiological control criteria of the cosmetic product;

c) the method of manufacture conforming to the good manufacturing practice for cosmetics laid

down by Community law or, failing that, laid down by the law of the Member State concerned; the

person responsible for manufacture or first importation into the Community should possess an

appropriate level of professional qualification or experience in accordance with the legislation and

practice of the Member State which is the place of manufacture or first importation;

d) assessment of the safety for human health of the finished product. To that end, the manufacturer

should take into consideration the general toxicological profile of the ingredients, their chemical

structure and their level of exposure. It should take particular account of the specific exposure

characteristics of the areas on which the product will be applied or of the population for which it is

intended. There should be inter alia a specific assessment for cosmetic products intended for use

on children under the age of three and for cosmetic products intended exclusively for use in

external intimate hygiene. Should the same product be manufactured at several places within

Community territory, the manufacturer may choose a single place of manufacture where that

information will be available. In this connection, and when so requested for monitoring purposes,

it is obliged to indicate the place so chosen by the monitoring authority or authorities concerned.

In this case this information should be easily accessible;

e) the name and address of the qualified person or persons responsible for the assessment referred

to in (d). That person should hold a diploma as defined in Article 1 of Council Directive 89/48/EEC

in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline;

f) existing data on undesirable effects on human health resulting from use of the cosmetic product;

g) proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or

product;

h) data on any animal testing performed by the manufacturer, his agent or suppliers, relating to the

development or safety evaluation of the product or its ingredients, including any animal testing

performed to conform to the legislative or regulatory requirements of non-member countries.

The above requested information might be filed in the form of a cosmetic dossier, which should be

stored at the address mentioned on the labelling (see 4.6.3). In case of several addresses, the above

mentioned one should be highlighted.
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4.3.4 Notification of the cosmetic product of cosmetotextiles to national poison centres

Before a cosmetotextile can be placed on the market, in some countries of the EU, a notification of the

cosmetic product of the cosmetotextile is necessary. In these countries, the relevant national poison

centres have to be notified. The rationale is, that if unexpected health effects, to the consumer, occur,

medical personnel can request, from the poison centres, information on the composition of the

cosmetic product for an effective first aid. The notification usually comprises the INCI ingredient list of

the cosmetic product, their quantities as well as the intended use of the application. The notification

shall also include identification of the cosmetic product (e.g. name, code) (see 4.6.2).

4.4 Claimed effects
4.4.1 Introduction

The objective of this clause is to assist manufacturers of cosmetotextiles substantiate the claims of

cosmetotextiles. Since new claims and the techniques to confirm them are constantly evolving, it is not

an intention to provide obligatory and/or binding methodologies. In this respect, state-of-the art

methods and/or generally accepted methods should be taken into account.

Within the European Cosmetics Directive 76/768/EEC, article 7 requires proof of the effects claimed

for cosmetic products, where justified by the nature of the effect or product and this proof should be

made readily available to competent authorities. In addition, in accordance with the European

Cosmetics Directive 76/768/EEC (7 amendment) article 6, “Member States shall take all measures

necessary to ensure that, in the labelling, putting up for sale and advertising of cosmetic products,

text, names, trade marks, pictures and figurative or other signs are not used to imply that these

products have characteristics which they do not have“. The European Cosmetics Directive

76/768/EEC as well as other laws and guidelines are further defined at the EU and/or international or

national levels and are not negated or refined by this policy.

No legally binding standards are available for cosmetic testing although generally accepted methods

are available. A number of documents are available describing cosmetic claimed effect testing. These

all serve as a loose framework in which the manufacturer can find guidance (see Annex B).

It is important to note, that use of cosmetic claims are subject to restriction in accordance with

advertising laws and other national or international legislation.

Furthermore, they may not be deceptive or mislead the consumer. The wording of the claim should

reflect the level of data used to substantiate the claim. A claim can be subjective, e.g. “skin looks

better”, without needing substantial scientific support or it can be founded on objective data, e.g.

“moisturizes the skin”.
Although full adherence is not necessary (see also J. S
...

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