EN ISO TR 26369-2009 en Cosmetics - Sun protection test methods - Review and evaluation of methods to assess the photoprotection of sun protection products《化妆品 防晒测试 评估光照保护和防晒方法的预计和.pdf

1、PD CEN ISO/TR26369:2009ICS 71.100.70NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWPUBLISHED DOCUMENTCosmetics Sunprotection testmethods Reviewand evaluation ofmethods to assess thephotoprotection of sunprotection products(ISO/TR 26369:2009)This Published Documentwas published

2、 under theauthority of the StandardsPolicy and StrategyCommittee on 30 June2010 BSI 2010ISBN 978 0 580 62721 7Amendments/corrigenda issued since publicationDate CommentsPD CEN ISO/TR 26369:2009National forewordThis Published Document is the UK implementation of CEN ISO/TR26369:2009.The UK participat

3、ion in its preparation was entrusted to TechnicalCommittee CW/217, Cosmetics.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct

4、application.Compliance with a British Standard cannot confer immunityfrom legal obligations.TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN ISO/TR 26369 September 2009 ICS 71.100.70 English Version Cosmetics - Sun protection test methods - Review and evaluation of methods to assess the ph

5、otoprotection of sun protection products (ISO/TR 26369:2009) Cosmtiques - Mthodes dessai de protection solaire - Revue systmatique et valuation des mthodes usuelles de mesure de la protection solaire fournie par les produits de protection solaire (ISO/TR 26369:2009) Kosmetik - Untersuchungsverfahren

6、 fr Sonnenschutzmittel - berprfung und Bewertung von Methoden zur Feststellung des Lichtschutzes von Sonnenschutzmitteln (ISO/TR 26369:2009) This Technical Report was approved by CEN on 17 August 2009. It has been drawn up by the Technical Committee CEN/SS H99. CEN members are the national standards

7、 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

8、. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TR 26369:2009: EP

9、D CEN ISO/TR 26369:2009CEN ISO/TR 26369:2009 (E) 3 Foreword This document (CEN ISO/TR 26369:2009) has been prepared by Technical Committee ISO/TC 217 “Cosmetics“. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC

10、shall not be held responsible for identifying any or all such patent rights. Endorsement notice The text of ISO/TR 26369:2009 has been approved by CEN as a CEN ISO/TR 26369:2009 without any modification. PD CEN ISO/TR 26369:2009ISO/TR 26369:2009(E) ISO 2009 All rights reserved iiiContents Page Forew

11、ord iv 1 Scope1 2 Terms and definitions .1 3 Principle1 4 Sun protection test methods2 4.1 SPF in vivo .2 4.2 SPF in vitro.2 4.3 UVA in vivo.2 Bibliography38 PD CEN ISO/TR 26369:2009ISO/TR 26369:2009(E) iv ISO 2009 All rights reservedForeword ISO (the International Organization for Standardization)

12、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 repres

13、ented 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

14、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

15、 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 s

16、imple 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 elem

17、ents 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. PD CEN ISO/TR 26369:2009TECHNICAL REPORT ISO/TR 26369:2009(E) ISO 2009 All rights reserv

18、ed 1Cosmetics 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 s

19、un 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 def

20、initions 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

21、 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 sunscre

22、en 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

23、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 t

24、o 6 in order to enable an easy comparison of the methods. PD CEN ISO/TR 26369:2009ISO/TR 26369:2009(E) 2 ISO 2009 All rights reserved4 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 transmitt

25、ance 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 an

26、d 6. PD CEN ISO/TR 26369:2009Table 1 SPFinvivomethodscurrentlyusedParametersInternational 2006 1aFDA1999 2 Australia 19983 UV definition(UVB, UVA)UVB: 290 nmto320 nmUVA: 320 nmto400 nmUVAII 320 nm to340 nmUVAI340 nmto400 nmUVB: 290 nmto320 nmUVA: 320 nmto400 nmSolar UVR:290 nmto400nm UVB: 290 nmto32

27、0nm UVA: 320 nmto400nm Volunteersselection Ethical considerationsHelsinki, national regulations, medical statusNot defined Medical questionnaire Age limitation Yes, excluded belowage of consent Not defined Not defined Informed consent Yes, with signaturesYes Yes Exclusion criteria Pregnant, lactatin

28、g women Photosensitizing medication Dermatological problems, historyof abnormalresponse to sun Tanning bedsNo sundamage, marks, blemishes or nevi Skin disease, abnormalresponses to UV, phototoxic or photo-allergicresponse, medication(topicalor systemic) known to produce abnormal sunlight responses S

29、unburn,scars, active dermal lesions and uneven skin toneson the areas to be tested Abnormal response to medication, UVradiation, allergies totopicallyapplied cosmetics Phototoxic or photosensitizing medication Test subjects Skin phototype and skin colourFitzpatrick skin type(s) I,II, III or skin col

30、our (ITA value 28 veryfair, fair-skin and intermediate skin colour) and untanned on the test area PhototypesI, II, III FairskincolourPhototypesI, II, III FairskincolourTest area Back,between scapula line and waist Skeletal protrusionsandextreme areasof curvatureshould be avoided The back between the

31、 beltline and the shoulder blade (scapulae) and lateral tothe midline Back,clean dryskin, without anysuntan or sunburn, active dermal lesions,excessive hair, uneven skin tonesTime, interval between two tests No lessthan 2 months, sufficient interval forreversal of skin tanning untilthe site isclear

32、Not defined Not defined aThe numbers in bracketsrefer to the Bibliographicreferences.ISO/TR 26369:2009(E) ISO 2009 All rights reserved 3PD CEN ISO/TR 26369:2009Table 1 (continued)ParametersInternational 2006 1 FDA1999 2 Australia 19983 Source of UV radiation Solar simulator Filtration Continuous emi

33、ssion spectrumwith no gaps or extreme peaks Stableoutput Xenon Arc lamprecommended with dichroicmirror and WG320 +UG11/1 mm Continuous emission spectrum290 nmto 400 nm, similar to sunlight atsea level, 10zenith angle 400 nm Stableoutput after appropriatewarm-up time Xenon arc is preferred NopeakinUV

34、B; continuation inthe UVA WG320 filter,dichroic mirror orheat absorbing filter Acceptance limits %RCEE UVA2/UVA1 % RCEE defined in different bands W.L. range:RCEE%: u290nm25Geometric progression(1,25n) for the unprotected area For theprotected areasgeometric seriesof five exposure where the middle e

35、xposure isplaced to yieldthe expected SPF plustwo other exposures placed around the middle exposure According to the expected SPF (X) SPF 15: 0,76, 0,87, 0,93,1,1,07,1,15, 1,32XUnprotectedMEDre-determined with a doserange of ca 0,6 to 1,5 provisional MEDu For protected skin the dose range ismultipli

36、ed bythe expectedSPF Increments between sub-sites no more than 1,25 u1.118 for SPF W25 Randomized UVexposure Not defined Yes if onlyone product is being tested Not defined Product removal Products maybe removed gentlyusing a cotton pad and mildlotion Not defined Not defined Ambient conditions 18 Cto

37、 26 CNot defined Not defined ISO/TR 26369:2009(E) ISO 2009 All rights reserved 7PD CEN ISO/TR 26369:2009Table 1 (continued)ParametersInternational 2006 1 FDA1999 2 Australia 19983 Response description Definitionof response The MEDis the lowest UVdose that produces thefirst perceptible unambiguous er

38、ythemawith defined bordersappearing over most of the field, 16 h to 24 h after UVexposure The MEDis the quantityof erythema-effective energyrequiredto produce the first perceptible unambiguous redness reaction with clearlydefined borders at22 h to 24 hpost-exposure Minimum quantityof radiant energyt

39、o produce a perceptible reddening of human skin. The first subsiteto showa minimalredness perceptible to the eye, (with normalvision)Units J/m2or mJ/cm2or MEDunits or time(seconds) ifthe fluxis constantthroughout the test J/m2Energyor time (if fluxconstant) Time of assessment 16 h to 24h post-exposu

40、re MEDu and MEDp on same day22 h to 24h post-exposure 16 h to 24h post-exposure Conditions of observation Sufficient and uniform illumination: at least450 lxIllumination: tungsten or warm white fluorescent lightbulb 450 lxto 550 lx(at the test site) Full daylight, ora tungstenfilament light providin

41、g adequate illumination; matt neutral wall colours Position of volunteers Same position used for the UVexposure Same position used for the UVexposure Seated or prone position Biological endpoint Erythema Erythema Erythema Evaluator Normal colour and acuityvision differentfrom the person who applied

42、the sunscreen or administered the UVdosesDifferentfromthe personwho applied the sunscreen oradministered theUVdoses Normal vision, colour vision checked Data rejection criteriaon individualtestsite All sites visibleornosite visible, responses on thetreated sites randomlyabsent Rejectionof the subjec

43、tif MEDu or MEDp of standard product not determined Allsitesvisible ornositevisible,responsesonthe treatedsites randomlyabsent (indication of uneven spreading) If the result obtainedusing thereference product ona subject variesby25 % ofthe average value ofthattest series the results ofthe subject ar

44、e excluded If morethantwo subjects returnSPFs for the test product which varyby25 % ofthe mean SPF, a newsample should obtained ISO/TR 26369:2009(E)8 ISO 2009 All rights reservedPD CEN ISO/TR 26369:2009Table 1 (continued)ParametersInternational 2006 1 FDA1999 2 Australia 19983 Referencesunscreen for

45、mulationsReference sunscreen formulationsused Expected SPF 400 nm15, the dose increase rate is15%: 0,76,0,87, 0,93, 1,00, 1,07, 1,15, 1,32XTwo dosesare added aroundthe 1,00Xdose X(expected SPF MEDu)Randomized UVexposure Not defined Not defined Not defined Product removal Not defined Not defined Not

46、defined Ambient conditions Not defined Not defined Not defined ISO/TR 26369:2009(E)12 ISO 2009 All rights reservedPD CEN ISO/TR 26369:2009Table 1 (continued)ParametersCanada 20024 Korea 2004 5 China 2002 6 Response description Definitionof response The amount ofsolar radiationor solar simulated radi

47、ation needed to produce abarelynoticeable erythema(redness) onhuman skin The minimum erythema dose isdefined asthelowest dose that produces the first perceptibleunambiguous erythema with defined borders appearingover most of the field of UVexposure, 16h to24 h after UVexposure The smallest UVdose(Jo

48、ules persquaremetre) or the shortest time(seconds) required to produce definedskinerythema inthe test site and its boundaries Units Using constant irradiation conditions MEDis proportional to theduration of exposure (seconds) Not defined Joules per square metre or seconds Time of assessment 16 h to

49、24h post exposure 16 h to 24h post exposure 24 h postexposure Conditions of observation (light) Consistent conditions of illumination, background colour Sufficient light source Not defined Position of volunteers Not defined Not defined Not defined Biological endpoint Erythema Erythema Erythema Evaluator Human eye or reflectometer,atleast one evaluatorBytwo or more trained evaluators MEDu and MEDp shallbe determined bythe samepersonin same conditions No indication Data rejection criteria All sub-sites