SANS 1302-2008 Toothpaste《牙膏》.pdf

1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-21439-5 SANS 1302:2008Edition 1.1 Any reference to SABS 1302 is deemed to be a reference to this standard (Government Notice No. 1373 of 8

4、 November 2002)SOUTH AFRICAN NATIONAL STANDARD Toothpaste Published by Standards South Africa 1 dr lategan road groenkloof private bag x191 pretoria 0001 tel: 012 428 7911 fax: 012 344 1568 international code + 27 12 www.stansa.co.za Standards South Africa SANS 1302:2008 Edition 1.1 Table of changes

5、 Change No. Date Scope Amdt 1 2008 Amended to change the designation of SABS standards to SANS standards, to update the definition of “acceptable,“ and to delete reference to national legislation. Foreword This South African standard was approved by National Committee StanSA SC 5140.21B, Cosmetics T

6、oothpaste, in accordance with procedures of Standards South Africa, in compliance with annex 3 of the WTO/TBT agreement. This document was published in June 2008. This document supersedes SABS 1302:1980 (first edition). A reference is made in 3.1.2 and 3.1.8 to the use of colourants and the determin

7、ation of fluoride ion content in accordance with “the current relevant national legislation“. In South Africa this means the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972). A reference is made in 4.1.1 to the allowed nominal volume of toothpaste contained in a tube in terms o

8、f the regulations framed under “the current relevant national legislation.“ In South Africa this means the Trade Metrology Act, 1973 (Act No. 77 of 1973). A vertical line in the margin shows where the text has been technically modified by amendment No.1. SANS 1302:2008 Edition 1.1 1 Contents Page Fo

9、reword 1 Scope . 3 2 Definitions. 3 3 Requirements . 4 4 Packing and marking 5 5 Sampling and compliance with the specification 6 6 Inspection and methods of test 6 6.1 Inspection . 6 6.2 Test samples 6 6.3 Methods of tests . 7 6.3.1 Consistency. 7 6.3.2 Lead content . 7 6.3.3 pH value 9 6.3.4 Abras

10、iveness. 9 6.3.5 Extrusion test 12 6.3.6 Stability 13 6.3.7 Determination of fluoride ion content 13 6.3.8 Test for contamination and attack on tube and cap 15 Figures 1-5 15-18 Appendix A Applicable standards 19 Appendix B Notes to purchasers . 19 SANS 1302:2008 Edition 1.1 2 This page is intention

11、ally left blank SANS 1302:2008 Edition 1.1 3 Toothpaste 1 Scope 1.1 This specification covers the requirements for toothpastes (fluoridated and non-fluoridated) intended for use with a brush in the cleaning of natural teeth. NOTE a) The standard referred to in the specification is noted in appendix

12、A. b) Requirements that must be specified by the purchaser are listed in appendix B. 2 Definitions 2.1 For the purposes of this specification the following definitions shall apply: acceptable acceptable to the authority administering this standard, or to the parties concluding the purchase contract,

13、 as relevant Amdt 1 batch that quantity of toothpaste made from the same materials and filled into tubes in one continuous cycle of operations composite pack a pack containing two or more tubes of toothpaste of the same nominal volume or of different nominal volumes, and in which the tubes are separ

14、ated from one another current statutory formulary one of the formularies official in the Republic of South Africa at the date of manufacture of the product dentine the calcified tissue, tubular in structure, that forms the bulk of a tooth enamel the highly calcified tissue, prismatic in structure, t

15、hat covers the crown of a tooth lot not less than 100 tubes of toothpaste of the same nominal volume, bearing the same batch identification, and packed in individual containers, from one manufacturer, or not less than 100 identical composite packs from one manufacturer, submitted at any one time for

16、 inspection and testing SANS 1302:2008 Edition 1.1 4 3 Requirements 3.1 Toothpaste 3.1.1 Type Toothpaste shall be of the fluoridated type or the non-fluoridated type, as specified by the purchaser. 3.1.2 Composition Any colourants used shall be those permitted for use in terms of the regulations fra

17、med under the current relevant national legislation (see foreword). A toothpaste shall not contain mono- or di-saccharides, except those through which acceptable clinical trials have been proved to be non-cariogenic. Ingredients that are listed in a current statutory formulary shall be of the purity

18、 laid down in that publication, all ingredients shall be of a quality suitable for the intended use, and shall comply with the relevant legal requirements. Amdt 1 3.1.3 Consistency A toothpaste shall have an acceptable consistency and, when tested in accordance with 6.3.1, shall be free from lumps a

19、nd particles that are palpable in the mouth as separate entities. 3.1.4 Freedom from toxicity a) General. A toothpaste shall not contain any substance which would be harmful if ingested during normal brushing and shall not, in normal use, cause a toxic or irritant reaction when used in the oral cavi

20、ty, or be otherwise harmful. b) Lead content. The lead content of a toothpaste, determined in accordance with 6.3.2, shall not exceed 5 g/g. 3.1.5 pH value The pH value of a toothpaste, determined in accordance with 6.3.3, shall be not less than 4,5 and not more than 10,5. 3.1.6 Abrasive properties

21、When tested in accordance with 6.3.4, the abrasiveness of a toothpaste shall not exceed the following limits: a) To dentine: Twice that of the reference paste. b) To enamel: Four times that of the reference paste. 3.1.7 Stability When tested in accordance with 6.3.6, a toothpaste shall not ferment,

22、segregate, or otherwise deteriorate. 3.1.8 Fluoride ion content The fluoride ion content of a fluoridated toothpaste, determined in accordance with 6.3.7, shall be as laid down in the current relevant national legislation (see foreword). Amdt 1 SANS 1302:2008 Edition 1.1 5 3.2 Tubes 3.2.1 Paint The

23、lead content, determined in accordance with 6.3.2, of the paints on a toothpaste tube shall not exceed 250 g/g. 3.2.2 Extrusion from the tube When a tube is tested in accordance with 6.3.5, at least 95 % of the nominal volume of the toothpaste shall be extruded from the tube. 3.2.3 Contamination and

24、 attack on tube and cap When a tube of toothpaste is tested in accordance with 6.3.8, neither the tube nor its cap shall show any visible sign of corrosion or other deterioration and the toothpaste shall show no sign of contamination. 4 Packing and marking NOTE The packing and marking shall comply w

25、ith all the relevant statutory requirements. 4.1 Packing 4.1.1 Tubes Toothpaste shall be packed in acceptably sealed collapsible tubes. The tubes shall have closures that are leak-proof to the product. Except as otherwise allowed in terms of the regulations framed under the current relevant national

26、 legislation (see foreword) the nominal volume (in the case of a composite pack, the total nominal volume) of the toothpaste contained in the tube(s) in a pack shall be one of the following, as specified by the purchaser: Amdt 1 Any volume up to and including 15 mL, and thereafter 25; 50; 75; 100; 1

27、25; 150; 175; or 200 mL. 4.1.2 Packaging Both individually packed tubes and composite packs shall be packed in bulk packages that are capable of protecting the contents from damage during normal transportation and storage. Only individually packed tubes of toothpaste of the same nominal volume and b

28、earing the same batch identification or only identical composite packs (i.e. packs of tubes containing the same nominal volume(s) and bearing the same batch identification(s) shall be packed together in a bulk package. 4.2 Marking 4.2.1 Tubes The following information shall appear in legible and dur

29、able marking on each tube: a) The name of the toothpaste; b) the name and business address of the manufacturer or importer or seller or person on whose behalf the toothpaste was packed; c) a description of the contents; SANS 1302:2008 Edition 1.1 6 d) in the case of fluoridated toothpaste, the words

30、 “FLUORIDE TOOTHPASTE“ or “FLUORIDE DENTAL CRME“ given in letters of height at least 3 mm in a colour which affords a distinct contrast with the background; e) the batch identification. 4.2.2 Containers and composite packs The information required in terms of 4.2.1(a)-(d) (inclusive) shall appear on

31、 a) each individual container, together with the nominal volume, in millilitres, of the contents of the tube; b) each composite pack, together with the total nominal volume, in millilitres, of the contents of the tubes in the pack. 4.2.3 Bulk packages The information required in terms of 4.2.1 and 4

32、.2.2 and the quantity of containers shall be indelibly marked on each bulk package. 5 Sampling and compliance with the specification NOTE This section applies to the sampling for inspection and testing before acceptance or rejection of single lots (consignments) in cases where no information about t

33、he implementation of quality control or testing during manufacture is available to help in assessing the quality of the lot. It is also used as the procedure for adjudicating in cases of dispute. 5.1 Sampling The following sampling procedure shall be applied (after, when relevant, checking for compl

34、iance with the requirements of 4.1.2 and 4.2.3) in determining whether a lot complies with the specification. The samples so taken shall be deemed to represent the lot. From the lot take at random 20 individual containers, or composite packs, as relevant. 5.2 Compliance with the specification The lo

35、t shall be deemed to comply with the requirements of the specification if, on inspection and testing, the sample taken in accordance with 5.1 is found to comply with all the relevant requirements of the specification. 6 Inspection and methods of test 6.1 Inspection Inspect the samples taken in accor

36、dance with 5.1 for compliance with the relevant requirements of 4.1.1, 4.2.1, and 4.2.2. 6.2 Test samples 6.2.1 For tests on tubes Use 10 tubes (of, in the case of composite packs, each nominal size) for the extrusion test (see 6.3.5) and retain the emptied tubes for the determination of the lead co

37、ntent of the paint (see 6.3.2.3(b), and the toothpaste for the preparation of the composite sample(s) (see 6.2.2). Use SANS 1302:2008 Edition 1.1 7 ix well. the other 10 tubes (of, when relevant, each nominal size) for the test for contamination and attack on tube and cap (see 6.3.8). 6.2.2 For test

38、s on toothpaste From the toothpaste extruded from each set of tubes bearing the same batch identification, prepare a composite sample of sufficient size for all the remaining tests by taking an approximately equal volume of paste from each of the 10 appropriate measuring cylinders used in the extrus

39、ion test (see 6.2.1 and 6.3.5). Mix thoroughly and store in a plastics container (tightly closed). Submit each composite sample to all the relevant tests on toothpaste given in 6.3. 6.3 Methods of test 6.3.1 Consistency Test a portion of the composite sample for compliance with the requirements of 3

40、.1.3. 6.3.2 Lead content 6.3.2.1 Apparatus a) Spectrophotometer An atomic absorption spectrophotometer with a lead hollow cathode lamp (of wavelength 283,3 nm) and an air/ acetylene flame. b) Sand bath. 6.3.2.2 Reagents NOTE Unless inconsistent with the text, use only reagents of analytical reagent

41、grade (or if this is unobtainable, of the purest grade available) and distilled or demineralized water. a) Acetone. b) iso-Butyl methyl ketone (4-methylpentan-2-one), saturated with water. c) Ethanol, lead free, 99 % (V/V). d) Nitric acid, concentrated (density = 1,42 g/mL). e) Nitric acid, dilute,

42、c(HNO3) = 5 mol/L. f) Ammonia solution, dilute, c(NH3) = 5 mol/L. g) Ammonium pyrrolidin-1-yl-dithioformate*solution prepared as follows: Wash about 1,5 g of ammonium pyrrolidin-1-yl-dithioformate with 20 mL of the acetone in a sintered glass crucible. Dry with suction. Dissolve 1 g in water, dilute

43、 to 100 mL with water and mh) Standard lead solutions 1) Stock solution. Dissolve 159,9 mg of lead nitrate (Pb(NO3)2) in 1 % (V/V) nitric acid in a 100 mL volumetric flask. Dilute to the mark with the nitric acid and mix. This solution has a lead content of 1 mg/mL. *Ammonium pyrrolidin-dithiocarbam

44、ate. SANS 1302:2008 Edition 1.1 8 2) Work solutions. To 5 mL of the stock solution in a 100 mL volumetric flask, add 0,5 mL of the concentrated nitric acid, dilute to the mark with water, and mix. Into each of six 50 mL volumetric flasks pipette 1 mL of the concentrated nitric acid, then, by adding

45、0, 1, 2, 4, 6, 8 mL of the diluted stock solution, diluting to the mark with water and mixing, obtain solutions that contain respectively 0, 1, 2, 4, 6, 8 g of lead/mL. 6.3.2.3 Preparation of sample solutions a) Toothpaste. Weigh out accurately about 5 g of the composite sample into a silica evapora

46、ting dish. So add 10-15 mL of the ethanol to the paste as to form a slurry, and then evaporate to dryness in a water bath. Place in a muffle furnace at 100 C and slowly raise the temperature (by 50 C steps to avoid ignition) to 450 C, and complete the ashing at 450 C. If the ash is dark coloured, mo

47、isten it with a few drops of the concentrated nitric acid and reheat in the furnace at 450 C for 1 h. Add 5 mL of water and 10 mL of the dilute nitric acid to the cooled ash and boil gently for 5 min. Filter the cooled solution into a 100 mL volumetric flask, rinsing with two successive 5 mL volumes

48、 of water and retaining as much as possible of the insoluble matter in the dish. Add 10 mL of the dilute nitric acid to the insoluble matter in the dish and boil for 5 min. Cool and filter into the volumetric flask, rinsing with water as before. Dilute to the mark with water and mix. Prepare a blank

49、 by repeating the above procedure, omitting the toothpaste sample. b) Paint. Remove the paint from the appropriate tubes from the extrusion test (see 6.2.1 and 6.3.5), using a suitable lead-free organic solvent. Evaporate the solvent and then dry to constant mass. Mix the residue thoroughly, and weigh out accurately about 0,5 g into each of two test tubes. Add 5 mL of the concentrated nitric acid to each test tube and to one empty test tube (blank), and add two boiling chips to each tube. So place the tubes in the sand bath at 90-110 C that the liquid surface is just