SIST-TP CEN/TR 15917:2010

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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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
th
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
th
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
...