SOUTH AFRICAN NATIONAL STANDARD

Transcription

1 ISBN SOUTH AFRICAN NATIONAL STANDARD Sunscreen products WARNING This document references other documents normatively. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001 Tel: Fax: SABS

2 Table of changes Change No. Date Scope Amdt Amended to update referenced standards, and to modify the table on permitted UV filters. Amdt Amended to update the acknowledgement, delete the definition of broad spectrum and renumber the definitions accordingly, update referenced standards, add UVA requirements and renumber subclauses accordingly, change cross references, delete the subclause on broad spectrum claims, modify tables 3 and 5, and replace the bibliography with a new annex on UVA symbol for the labelling of sunscreen products. Amdt Amended to update the table on permitted UV filters (table B.1). Acknowledgement The SABS Standards Division wishes to acknowledge the valuable assistance derived from publications of the following organizations: a) The Cosmetic, Toiletry and Fragrance Association of South Africa (CTFA); b) The European Cosmetic, Toiletry and Perfumery Association (Cosmetics Europe); Amdt 2 c) The International Organization for Standardization; d) The Japan Cosmetic Industry Association (JCIA); and e) The Personal Care Products Council of the United States of America. Foreword This South African standard was approved by National Committee SABS/TC 217, Cosmetics, in accordance with procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This document was published in June This document supersedes SANS 1557:2013 (edition 3.2). A vertical line in the margin shows where the text has been technically modified by amendment No. 3. A reference is made in 4.1 to sunscreen product compliance with the relevant statutory requirements. In South Africa this means the Trade Metrology Act, 1973 (Act No. 77 of 1973). Annexes B, C, D and E form an integral part of this document. Annexes A and F are for information only.

3 Contents Page Acknowledgement Foreword 1 Scope Normative references Definitions and abbreviations General requirements Statutory requirements Documented test results Classification Good Manufacturing Practices (GMP) Requirements for the product Ingredient requirements UV filters Performance requirements Advertising and labelling of sunscreen products Advertising of sunscreen products Labelling of sunscreen products Test methods Principle Selection criteria for test subjects Number of test subjects Test areas Test method for the determination of in vivo SPF Apparatus and materials Test procedure Procedure for UV exposure Product removal Procedure for MED assessments Calculation of the sun protection factor (SPF) and statistics Test reports

4 Contents (concluded) 9 Test methods for the determination of water resistant and very water resistant properties of sunscreen products Apparatus and materials Test method for the determination of water resistant Test method for the determination of very water resistant Annex A (informative) Quality verification of screen products Annex B (normative) Permitted UV filters Annex C (normative) Calculations and statistics Annex D (normative) SPF reference sunscreen formulations Annex E (normative) Test procedure and chronology for the determination of water resistance Annex F (informative) UVA symbol for the labelling of sunscreen products Amdt 2 Page 2

5 Sunscreen products 1 Scope This standard specifies requirements for primary and secondary sunscreen products, suitable for topical use, for the protection of human skin against the adverse effects of solar UVA and UVB rays, and provides a basis for the evaluation of sunscreen products in accordance with performance criteria. It also specifies requirements for the advertising and labelling of sunscreen products. 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. Information on currently valid national and international standards can be obtained from the SABS Standards Division. 2.1 Standards ISO 24442, Cosmetics Sun protection methods In vivo determination of sunscreen UVA protection. Amdt 2 ISO 24443, Cosmetics Sun protection methods Determination of sunscreen UVA photoprotection in vitro. Amdt 2 ISO 24444, Cosmetics Sun protection test methods In vivo determination of the sun protection factor (SPF). Amdt 2 SANS 98, Ingredient labelling of cosmetic products. SANS 241-1, Drinking water Part 1: Microbiological, physical, aesthetic and chemical determinands. Amdt 1 SANS 1937, Cosmetics products Quantity and marking. 2.2 Other publications The Code of Advertising Practice (ASA). CTFA Cosmetic Compendium. 1) 1) The CTFA Cosmetic Compendium is available from the CTFA, PO Box 721, Randpark Ridge, Tel.: (011) Fax: (011) technical@ctfa.co.za. Worldwide web: 3