CEN ISO/TR 26369:2009
(Main)Cosmetics - Sun protection test methods - Review and evaluation of methods to assess the photoprotection of sun protection products (ISO/TR 26369:2009)
Cosmetics - Sun protection test methods - Review and evaluation of methods to assess the photoprotection of sun protection products (ISO/TR 26369:2009)
ISO/TR 26369:2009 reviews and evaluates the methods which are currently used to assess, for regulatory or self-regulatory purposes, the photoprotection of sun protection products applied on human body.
It is applicable to SPF and UVA protection, and both in vivo and in vitro methods.
Kosmetik - Untersuchungsverfahren für Sonnenschutzmittel - Überprüfung und Bewertung von Methoden zur Feststellung des Lichtschutzes von Sonnenschutzmitteln (ISO/TR 26369:2009)
Cosmétiques - Méthodes d'essai de protection solaire - Revue systématique et évaluation des méthodes usuelles de mesure de la protection solaire fournie par les produits de protection solaire (ISO/TR 26369:2009)
Kozmetika - Preskusne metode za izdelke za zaščito pred soncem - Pregled in vrednotenje metod za oceno zaščite, ki jo omogočajo izdelki za zaščito pred soncem (ISO/TR 26369:2009)
To tehnično poročilo podaja pregled in vrednotenje metod, ki se trenutno uporabljajo za oceno zaščite, katero omogočajo izdelki za zaščito pred soncem, ki se nanašajo na človeško telo, za regulativne ali samo-regulativne namene. Velja za SPF in UVA zaščito v vivo in vitro metodah. To tehnično poročilo ne vključuje vidike etiketiranje v širšem pomenu.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2010
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YUHGQRWHQMHPHWRG]DRFHQR]DãþLWHNLMRRPRJRþDMRL]GHONL]D]DãþLWRSUHG
VRQFHP ,6275
Cosmetics - Sun protection test methods - Review and evaluation of methods to assess
the photoprotection of sun protection products (ISO/TR 26369:2009)
Kosmetik - Untersuchungsverfahren für Sonnenschutzmittel - Überprüfung und
Bewertung von Verfahren zum Feststellen des Lichtschutzes von Sonnenschutzmitteln
(ISO/TR 26369:2009)
Cosmétiques - Méthodes d'essai de protection solaire - Revuesystématique et évaluation
des méthodes usuelles de mesure de la protectionsolaire fournie par les produits de
protectionsolaire (ISO/TR 26369:2009)
Ta slovenski standard je istoveten z: CEN ISO/TR 26369:2009
ICS:
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
TECHNICAL REPORT
FINAL DRAFT
FprCEN ISO/TR 26369
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
April 2009
ICS 71.100.70
English Version
Cosmetics - Sun protectiontest methods - Review and
evaluation of methods to assess the photoprotectionof sun
protection products (ISO/TR 26369:2009)
Cosmétiques - Méthodes d'essai de protection solaire - Kosmetik - Untersuchungsverfahren für Sonnenschutzmittel
Revuesystématique et évaluation des méthodes usuelles - Überprüfung und Bewertung von Verfahren zum
de mesure de la protectionsolaire fournie par les produits Feststellen des Lichtschutzes von Sonnenschutzmitteln
de protectionsolaire
This draft Technical Report is submitted to CEN members for Technical Committee Approval. It has been drawn up by the Technical
Committee CEN/SS H99.
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.
Warning : This document is not a Technical Report. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a Technical Report.
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. FprCEN ISO/TR 26369:2009: E
worldwide for CEN national Members.
FprCEN ISO/TR 26369:2009 (E)
Contents Page
Foreword .3
FprCEN ISO/TR 26369:2009 (E)
Foreword
This document (FprCEN ISO/TR 26369:2009) has been prepared by Technical Committee ISO/TC 217
"Cosmetics" in collaboration with Technical Committee CEN/SS H99 “Products for household and leisure use
- Undetermined” the secretariat of which is held by CMC.
This document is currently submitted to the parallel TC Approval.
Endorsement notice
The text of ISO/TR 26369:2009 has been approved by CEN as a FprCEN ISO/TR 26369:2009 without any
modification.
TECHNICAL ISO/TR
REPORT 26369
First edition
2009-09-01
Cosmetics — Sun protection test
methods — Review and evaluation of
methods to assess the photoprotection of
sun protection products
Cosmétiques — Méthodes d'essai de protection solaire — Revue
systématique et évaluation des méthodes usuelles de mesure de la
protection solaire fournie par les produits de protection solaire
Reference number
ISO/TR 26369:2009(E)
©
ISO 2009
ISO/TR 26369:2009(E)
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ii © ISO 2009 – All rights reserved
ISO/TR 26369:2009(E)
Contents Page
Foreword .iv
1 Scope.1
2 Terms and definitions .1
3 Principle.1
4 Sun protection test methods.2
4.1 SPF in vivo .2
4.2 SPF in vitro.2
4.3 UVA in vivo.2
Bibliography.38
ISO/TR 26369:2009(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In exceptional circumstances, when a technical committee has collected data of a different kind from that
which is normally published as an International Standard (“state of the art”, for example), it may decide by a
simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely
informative in nature and does not have to be reviewed until the data it provides are considered to be no
longer valid or useful.
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.
ISO/TR 26369 was prepared by Technical Committee ISO/TC 217, Cosmetics.
iv © ISO 2009 – All rights reserved
TECHNICAL REPORT ISO/TR 26369:2009(E)
Cosmetics — Sun protection test methods — Review and
evaluation of methods to assess the photoprotection of sun
protection products
1 Scope
This Technical Report reviews and evaluates the methods which are currently used to assess, for regulatory
or self-regulatory purposes, the photoprotection of sun protection products applied on the human body.
It is applicable to SPF and UVA protection, and both in vivo and in vitro methods.
This Technical Report does not include the aspects of labelling in a wide sense.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
ultraviolet
UV
electromagnetic radiation with a wavelength shorter than that of visible light, but longer than soft X-rays and
so named because the spectrum consists of electromagnetic waves with frequencies higher than those that
humans identify as the color violet (purple)
NOTE In this Technical Report the following wavelengths are considered: UVA: 320 nm to 400 nm; UVB: 290 nm to
320 nm.
2.2
sun protection factor
SPF
〈of a sunscreen〉 laboratory measurement to assess the effectiveness of sunscreens against UV erythema
NOTE 1 The higher the SPF, the more protection a sunscreen offers.
NOTE 2 The SPF is a ratio between the ultraviolet dose required to produce minimal erythema reaction (redness) in
protected skin (skin with sunscreen) compared to unprotected skin (skin without any sunscreen).
3 Principle
This systematic review and evaluation of the methods are conducted for development of those ISO Standards
which assess the photoprotection provided by sun protection products applied on the human body. It will serve
as a technical/scientific framework to identify the most suitable methods for standardization.
The key parameters and elements are listed in Tables 1 to 6 in order to enable an easy comparison of the
methods.
ISO/TR 26369:2009(E)
4 Sun protection test methods
4.1 SPF in vivo
The SPF in vivo methods currently used are given in Table 1.
4.2 SPF in vitro
The SPF in vitro methods based on transmittance evolved from the Diffey proposal and new methods based
on measurement of free radicals or use of skin biopsies are given in Tables 2 and 3. The relevant parameters
of methods based on transmittance are given in Table 4.
4.3 UVA in vivo
The methods reviewed by ISO/TC 217 are given in Tables 5 and 6.
2 © ISO 2009 – All rights reserved
ISO/TR 26369:2009(E)
Table 1 — SPF in vivo methods currently used
a
Parameters International 2006 [1] FDA 1999 [2] Australia 1998 [3]
UV definition (UVB, UVA) UVB: 290 nm to 320 nm UVB: 290 nm to 320 nm Solar UVR: 290 nm to 400 nm
UVA: 320 nm to 400 nm UVA: 320 nm to 400 nm UVB: 290 nm to 320 nm
UVAII 320 nm to 340 nm UVAI 340 nm to UVA: 320 nm to 400 nm
400 nm
Volunteers selection
Ethical considerations Helsinki, national regulations, medical status Not defined Medical questionnaire
Age limitation Yes, excluded below age of consent Not defined Not defined
Informed consent Yes, with signatures Yes Yes
Exclusion criteria Pregnant, lactating women Skin disease, abnormal responses to UV, Abnormal response to medication, UV radiation,
phototoxic or photo-allergic response, allergies to topically applied cosmetics
Photosensitizing medication
medication (topical or systemic) known to
Phototoxic or photosensitizing medication
produce abnormal sunlight responses
Dermatological problems, history of
abnormal response to sun
Sunburn, scars, active dermal lesions and
uneven skin tones on the areas to be tested
Tanning beds
No sun damage, marks, blemishes or nevi
Test subjects
Skin phototype and skin Fitzpatrick skin type (s) I, II, III or skin colour Phototypes I, II, III Phototypes I, II, III
colour (ITA° value > 28° very fair, fair-skin and
Fair skin colour Fair skin colour
intermediate skin colour) and untanned on
the test area
Test area Back, between scapula line and waist The back between the beltline and the shoulder Back, clean dry skin, without any suntan or
blade (scapulae) and lateral to the midline sunburn, active dermal lesions, excessive hair,
Skeletal protrusions and extreme areas of
uneven skin tones
curvature should be avoided
Time, interval between No less than 2 months, sufficient interval for Not defined Not defined
two tests reversal of skin tanning until the site is clear
a
The numbers in brackets refer to the Bibliographic references.
ISO/TR 26369:2009(E)
4 © ISO 2009 – All rights reserved
Table 1 (continued)
Parameters International 2006 [1] FDA 1999 [2] Australia 1998 [3]
Source of UV radiation
Solar simulator Continuous emission spectrum with no gaps Continuous emission spectrum 290 nm to Xenon arc is preferred
or extreme peaks 400 nm, similar to sunlight at sea level, 10°
Filtration No peak in UVB; continuation in the UVA
zenith angle
Stable output
WG320 filter, dichroic mirror or heat absorbing
< 1 % energy < 290 nm
Xenon Arc lamp recommended wit
...
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