EN ISO 24442-2011 en Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection《化妆品 防晒试验方法 遮光剂长波紫外线防护的体内测定》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 24442:2011Cosmetics Sun protectiontest methods In vivodetermination of sunscreenUVA protection(ISO 24442:2011)BS EN ISO 24442:2011 BRITISH STANDARDNational forewordThis

2、 British Standard is the UK implementation of EN ISO 24442:2011.The UK participation in its preparation was entrusted to Technical Committee CW/217, Cosmetics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to includ

3、e all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012 ISBN 978 0 580 61109 4 ICS 71.100.70 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the

4、authority of the Standards Policy and Strategy Committee on 29 February 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 24442 December 2011 ICS 71.100.70 English Version Cosmetics - Sun protection test methods - In vivo determination

5、 of sunscreen UVA protection (ISO 24442:2011) Cosmtique - Mthodes dvaluation de la protection solaire - Dtermination in vivo de la protection UVA (ISO 24442:2011) Kosmetik - Prfverfahren fr Sonnenschutzmittel - In-vivo-Bestimmung des UVA-Sonnenschutzes (ISO 24442:2011)This European Standard was appr

6、oved by CEN on 14 December 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nation

7、al standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own languag

8、e and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia

9、, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels

10、 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 24442:2011: EBS EN ISO 24442:2011EN ISO 24442:2011 (E) 3 Foreword This document (EN ISO 24442:2011) has been prepared by Technical Committee ISO/TC 217 “Cosmetics“ in collab

11、oration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2012, and conflicting national standards sha

12、ll be withdrawn at the latest by June 2012. 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 shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regu

13、lations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Ma

14、lta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 24442:2011 has been approved by CEN as a EN ISO 24442:2011 without any modification. BS EN ISO 24442:2011ISO 24442:2011(E) ISO 2011 All right

15、s reserved iiiContents PageForeword . ivIntroduction . v1 Scope 12 Terms and definitions .13 Principle .24 Test subjects .24.1 Selection of test subjects 24.2 Number of subjects .35 Reference sunscreen formulae .36 UVA source 36.1 Spectral characteristics .36.2 Maintenance and monitoring the UV sola

16、r simulator output 46.3 Beam size and uniformity .46.4 Total irradiance (UV, visible and near-infrared rays) .47 Product application quantity and procedure .57.1 General .57.2 Position of the subject .57.3 Defining test sites .57.4 Application procedure .68 Determination of minimal persistent pigmen

17、t darkening doses (MPPDD) 68.1 UV exposure timing and subject position 68.2 Determination of the minimal pigmenting dose on the unprotected test sites (MPPDDu) using a multiple-beam solar simulator .68.3 Determination of the MPPDDu using a single-beam output solar simulator 78.4 Determination of the

18、 MPPDDp using a multiple-beam solar simulator 78.5 Determination of the MPPDDp on the protected test site with a single-beam solar simulator .89 Product removal 810 MPPDD assessment procedure .910.1 Observation time for responses of MPPDDs .910.2 Position of subjects for MPPDD observations 910.3 MPP

19、DD evaluation .911 Calculations of the UVAPF and statistics .1011.1 Calculation of the individual UVAPF (UVAPFi) for each test product for each subject .1011.2 Calculation of the mean UVAPF 1011.3 Statistical test .1011.4 Test rejection for failure of meeting the statistical test for the reference s

20、unscreen .1012 Test report .10Annex A (normative) Selection criteria for the test subjects 11Annex B (normative) Definition of the source of UVA radiation 13Annex C (normative) UVAPF reference sunscreen S1 .15Annex D (normative) Statistics and calculations .23Bibliography .26BS EN ISO 24442:2011Fore

21、wordISO (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 techni

22、cal 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 e

23、lectrotechnical 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 th

24、e member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.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 iden

25、tifying any or all such patent rights.ISO 24442 was prepared by Technical Committee ISO/TC 217, Cosmetics.ISO 24442:2011(E)iv ISO 2011 All rights reservedBS EN ISO 24442:2011IntroductionThis International Standard specifies the procedure to determine the Ultraviolet A Protection Factor (UVAPF) of a

26、sunscreen product using the persistent pigment darkening method according to the principles recommended by the Japan Cosmetic Industry Association (JCIA) in 19951. The outcome of this test method can be used to determine the UVA classification of topical sunscreen products according to local regulat

27、ory requirements.Topical sunscreen products are primarily rated and labelled according to their ability to protect against sunburn, using a test method to determine the in vivo Sun Protection Factor (see ISO/FDIS 24444). This rating evaluates filtration of sunburn generating radiation across the ele

28、ctromagnetic UV spectrum (290 nm to 400 nm). However, knowledge of the Sun Protection Factor (SPF) rating does not provide explicit information on the magnitude of the protection provided specifically in the UVA range of the spectrum (320 nm to 400 nm), as it is possible to have high SPF products wi

29、th very modest UVA protection (e.g. SPF 50 with a UVAPF of only 3 to 4). There is demand among medical professionals, as well as knowledgeable consumers, to have fuller information on the UVA protection provided by their sunscreen product, in addition to the SPF, in order to make a more informed cho

30、ice of product, providing a more balanced and broader-spectrum protection. The UVAPF value of a product provides information on the magnitude of the protection provided explicitly in the UVA portion of the spectrum, independent of the SPF values.The test method outlined in this International Standar

31、d is derived primarily from the UVAPF test methods as developed by the JCIA. Modifications have been made to attempt to harmonize with other methodologies without changing the integrity of the fundamental underlying principles of the test method.ISO 24442:2011(E) ISO 2011 All rights reserved vBS EN

32、ISO 24442:2011BS EN ISO 24442:2011INTERNATIONAL STANDARD ISO 24442:2011(E)Cosmetics Sun protection test methods In vivo determination of sunscreen UVA protection1 ScopeThis International Standard specifies an in vivo method for assessment of the UVA protection factor (UVAPF) of topical sunscreen pro

33、ducts. This International Standard is applicable to cosmetics, drugs and other products intended to be topically applied to human skin, including any component able to absorb, reflect or scatter UV rays.It provides a basis for the evaluation of sunscreen products for the protection of human skin aga

34、inst UVA radiation from solar or other light sources.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1ultraviolet radiationelectromagnetic radiation in the range of 290 nm to 400 nmNOTE UVB null 290 nm to 320 nm; UVA null 320 nm to 400 nm (UVA II

35、 null 320 nm to 340 nm; UVA I null 340 nm to 400 nm).2.2erythemareddening of the skin caused by UV radiation2.3persistent pigment darkeningPPDskin darkening that persists more than 2 h after the end of UVA exposure2.4minimal persistent pigment darkening doseMPPDDlowest Ultraviolet A (UVA) dose that

36、produces the first perceptible unambiguous persistent pigment darkening response with defined borders appearing over most of the field of UVA exposure, observed between 2 h and 24 h after the end of the UVA exposureNOTE The MPPDD on unprotected skin is referenced as “MPPDDu”, and the MPPDD on sunscr

37、een-protected skin is referenced as “MPPDDp”.2.5individual Ultraviolet A protection factorUVAPFiratio of the minimal persistent pigment darkening dose on product-protected skin (MPPDDp) to the minimal persistent pigment darkening dose on unprotected skin (MPPDDu) of the same subject:UVAPFiMPPDDpMPPD

38、Dunull2.6UVA protection factor of a productUVAPFarithmetic mean of all valid individual UVAPFi values obtained from all subjects in the test ISO 2011 All rights reserved 1BS EN ISO 24442:20112.7test areaback between the scapula line and the waist2.8test sitearea of skin to which a test product or re

39、ference sunscreen is applied within the test areaNOTE The area used to determine the MPPDDu is also a test site.2.9test subsiteskin areas within a test site exposed to UVA radiation3 PrincipleThe UVAPF test method is analogous to the test method used to determine the SPF of a sunscreen product. Howe

40、ver, it utilizes only the UVA portion of the xenon arc lamp solar simulator of defined and known output to determine the protection provided by sunscreen products on human skin in the UVA portion of the spectrum.The UVAPF test method uses persistent pigment darkening (PPD) responses of the skin as t

41、he end point for evaluating transmitted UVA radiation. The test is restricted to the area of the back of selected human subjects. An area of each subjects skin is exposed to UVA light without any protection and another (different) area is exposed after application of the sunscreen product under test

42、. One further area is exposed after application of a reference UVA sunscreen formulation, which is used to validate the procedure.To determine the UVAPF, incremental series of UVA exposures are delivered to five or six small subsites on the skin to induce darkening responses. These responses are vis

43、ually assessed for pigment darkness 2 h to 24 h after UVA exposure, by the judgement of a trained evaluator. The minimal persistent pigment darkening dose (MPPDD) for unprotected skin (MPPDDu) and the MPPDD obtained after application of a sunscreen product (i.e. the MPPDD for product-protected skin,

44、 MPPDDp) are determined on the same subject on the same day. An individual sun protection factor (UVAPFi) for each subject tested is calculated as the ratio of MPPDDp/MPPDDu.4 Test subjects4.1 Selection of test subjects4.1.1 GeneralFor subject inclusion and exclusion criteria, refer to Annex A.4.1.2

45、 Age restrictionTest subjects below age of consent or older than 70 years shall not be included in the UVAPF test panel.4.1.3 Skin phototype of test subjectsThe skin of subjects shall be Fitzpatrick phototype2II, III and IV. Alternatively, the colorimetric ITA value of subjects shall be within the r

46、ange of 20 and 41.4.1.4 Frequency of participation in testsSince a sufficient interval after a previous test is needed in order to allow for reversal of skin tanning resulting from that previous test, a test site that has been exposed to UV should not be used in a subsequent test before two months h

47、ave elapsed and the site is free of any sign of previous pigmentation marks.ISO 24442:2011(E)2 ISO 2011 All rights reservedBS EN ISO 24442:20114.1.5 ConsentInformed, written (signature) consent shall be obtained from all test subjects.4.1.6 Ethical aspectAll testing shall be done in accordance with

48、the Declaration of Helsinki and national regulations regarding human studies, if any.4.2 Number of subjectsThe test subjects shall be required to provide a minimum of 10 valid UVAPFi values and a maximum of 20 valid results. A maximum of five individual invalid results may be excluded from the calcu

49、lation of the mean UVAPF, but each exclusion shall be justified according to 10.3.3 or other non-compliance with protocol. Consequently, the total number of subjects will be between a minimum of 10 and a maximum of 25 subjects.In order to determine the number of subjects, the 95 % confidence interval (CI) shall be taken into account. The 95 % confidence interval should lie within null17 % of the mean UVAPF, and a minimum of 10 subjects is required. Otherwise, the number of subjects is increased stepwise from 10 until the statistic