SCHEME OF TESTING AND INSPECTION FOR CERTIFICATION OF TOOTH PASTE ACCORDING TO IS 6356: 2001 (Third Revision)

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1 SCHEME OF TESTING AND INSPECTION FOR CERTIFICATION OF TOOTH PASTE ACCORDING TO IS 6356: 2001 (Third Revision) Doc:STI/6356/4 1. LABORATORY- A laboratory shall be maintained, which shall be suitably equipped and staffed, where different tests given in the specification shall be carried out in accordance with the method given in the specification. 1.1 All the testing apparatus shall be periodically checked and calibrated and records of such checks/calibration maintained. 2. TEST RECORD- All records of tests and inspection shall be kept in suitable forms approved by the Bureau of Indian Standards. 2.1 Copies of any records and other connected papers that may be required by Bureau shall be made available at any time on request. 3. QUALITY CONTROL It is recommended that, as far as possible, Statistical Quality Control (SQC) methods may be used for controlling the quality of the product during production as envisaged in this scheme[see IS 397(Part I):1972, IS 397(Part 2):1985 and IS397(Part 3):1980]. 3.1 In addition, efforts should be made to gradually introduce a quality management system in accordance with the quality system module as per IS/ISO STANDARD MARK :- The standard mark(s) as given in column ( 1) of the first schedule of the licence shall be clearly marked legibly and indelibly on the tubes /cartons and containers, as the case may be provided always that a material in each tubes / cartons / containers to which this mark is applied conforms to every requirement of the specification. The dimension of standard mark shall be in accordance with preferred specified design. 5 PACKING- The toothpaste shall be packed as per clause 7.1 of IS 6356:2001.

2 6.0 MARKING- In addition to the standard mark,the following information shall be given on each tubes,cartons and containers. a) Name and type of tooth paste; b) Name and address of the Manufacturer; c) Net mass or volume of the material in the tube; d) Batch number, in code or otherwise; e) Month and year of manufacture; f) Fluoride ion content in ppm for type 2 tooth paste; g) Expiry date or `Best use before (month and year to be declared by the manufacturer); Note :- This requirement is exempted in case of pack sizes of 10 gm/25 ml or less and if the shelf life of the product is more than 24 months h) Foaming/non foaming; j) List of key ingredients; and Note :- This is exempted in cases of pack sizes of 30 gm/60 ml or less k) BIS Licence No.(CM/L ). 7.0 LEVELS OF CONTROL- The analysis and tests as indicated in the Table 1 and the level of control specified therein, shall be carried out on the whole production of the factory covered by this scheme and appropriate records and charts maintained in accordance with the clause 2 of this scheme. All the productions which conforms to the Indian Standard and covered by the license shall be marked with Certification Mark of the Bureau. 7.1 CONTROL UNIT- For the purpose of this scheme, the entire quantity of tooth paste of a particular type manufactured in a single mix at one time, in a day, shall constitute a control unit. 7.2 On the basis of test and analysis results, the decision regarding conformity or otherwise of a control unit to the given requirement shall be made as follows: 2

3 7.2.1 A sample of tooth paste shall be drawn from each mix and tested for composition, dispensing, fineness, ph of aqueous suspension, foaming power and available Fluoride ion. The tested samples shall satisfy the requirements, if the sample fail in any one of the requirements, the quantity of material represented by the sample shall be considered unfit for the purpose of marking. It may, however, be reprocessed and tested again for all the requirements of the specification A composite sample shall be prepared by thoroughly mixing the equal quantities of samples drawn at Para during a day and tested for the requirements of Microbial Counts. The control unit shall be marked with standard mark only when the composite sample representing the control unit is found conforming to all the requirements of the specification A weekly composite sample shall be prepared by thoroughly mixing equal quantity of the sample drawn from each line in each shift for 7 continuous days are to tested for the requirements of heavy metals & arsenic. The control unit shall be marked with standard mark only when the composite sample representing the control unit is found conforming to all the requirements of the specification In respect of the requirements of stability, packing material inertness, and shelf life, one sample from the finished product shall be tested once in a month or any change in any ingredients, which ever is earlier and the manufacturer shall maintain appropriate control and checks to ensure that his product conforms to the various requirements of the specification In respect of the requirement of abrasivity test, one sample from the finished product shall be tested once in two years or any change in any ingredients, whichever is earlier and the manufacturer shall maintain appropriate control and checks to ensure that his product conforms to the various requirements of the specification. 8.0 RAW MATERIAL- All the raw materials used in the manufacture of tooth paste shall conform to the requirements prescribed in the relevant Indian Standards where these exist. It may be ensured either by procuring certified material or through in house testing/independent evaluation. Alternatively test certificate as per relevant Indian standard may be obtained from the supplier. 3

4 Appropriate test records/test certificates in respect of these raw materials shall be maintained. 8.1 In case all the raw materials are evaluated for Heavy metals and Arsenic, then the Toothpaste need not be evaluated for these constituents for each control unit. In case the total Heavy metal content and total Arsenic content of all the ingredients in a Toothpaste formulation exceeds the prescribed limit in Table 1 of IS 6356:2001, the Mix shall be reprocessed. However, since there is a possibility of entry of heavy metal from process equipment, etc. in the Toothpaste, Heavy metals and Arsenic contents shall be evaluated on a weekly composite sample. 8.2 The dyes and pigments used in manufacture of toothpaste shall comply with the provisions of IS 4707(Part 1). Ingredients other than dyes and pigments used in formulation of toothpaste shall comply with the provisions of IS 4707(Part 2). 9.0 HYGIENIC CONDITIONS As a good management practices (GMP) Toothpaste shall be manufactured, packed and stored under hygienic conditions. All the processing equipment should be properly cleaned and care should be taken to prevent infestation ADDITIONAL REQUIREMENTS FOR ECO-MARK (OPTIONAL) 10.1 The Toothpaste shall conform to the requirements for Quality, safety and performance prescribed as under: All the ingredients that go into formulation of Toothpaste shall comply with the provisions of IS 4707(Part 2). The Toothpaste shall also meet specific requirements as given in IS 6356: The Toothpaste package shall display a list of key ingredients in descending order of quantity present The Toothpaste shall not be manufactured from any carcinogenic ingredients. 4

5 Dec Environmental consent clearance as per the provisions of the Water (Prevention and Control of Pollution)Cess Act, 1977 the Air (Prevention and Control of Pollution) Act 1981 along with the authorization, if required under the Environment (Protection) Act, 1986 shall be up to date and shall be produced to BIS. Additionally, provisions of the Drugs and Cosmetics Act and Rules there under shall also be complied with Heavy metals calculated as Lead (Pb) and Arsenic (As2O3) shall not exceed the limits prescribed in clause of IS 6356: REJECTION- A separate record providing the detailed information regarding the rejected control units and mode of their disposal shall be maintained. Such material shall in note be stored together with that conforming to the specifications SAMPLES - The licensee shall supply free of charge the sample(s) required in accordance with Bureau of Indian standards (Certification) Regulations,1988, as subsequently amended from his factory or godowns. The BIS shall pay for the samples taken from the open market REPLACEMENT: Whenever a compliant is received soon after the goods with standard mark have been purchased and used, and if there is adequate evidence that the goods have not been misused, defective goods are replaced free of cost by the licensee, in case the compliant is proved to be genuine and the warranty period (where applicable) has not expired. The final authority to judge conformity of the product to the Indian Standard shall be with BIS In the event of any damages caused by the goods bearing the standard mark, or claim being filed by the consumer against BIS standard mark and not conforming to the relevant Indian Standards, entire liabilities arising out of such non conforming products shall be of licensee and BIS shall not in any way be responsible in such cases. 5

6 Dec STOP MARKING: The marking of the product shall be stopped under the intimation of the Bureau if, at any time, there is some difficulty in maintaining the conformity of product to the specification, or the testing goes out of order. The marking may be resumed as soon as defects are removed under intimations to BIS. The marking of the product shall be stopped immediately if directed to do so by BIS for any reason. The marking may then be resumed only after permission is given by the BIS. The information regarding resumption of marking shall also be sent to the Bureau PRODUCTION DATA: The license shall sent to the Bureau as per the enclosed proforma, a statement of the quantity produced, marked and exported by him and the trade value thereof during the half year ending 30 th June and 31 st December. This statement is required to be forwarded to the BIS on or before the 31 st day of July and January for the proceeding half-year. 6

7 Dec 2003 IS 6356:2001 (Third Revision) TABLE 1 LEVELS OF CONTROL ( Para 7 of the Scheme of Testing and Inspection) TEST DETAILS LEVELS OF CONTROL Remarks Clause Requirement Test Methods Clause Reference No. of samples Frequency 5.1 Composition 5.1 IS 6356:2001 One Each Control unit 5.2 Dispensing 5.2 -do- -do- -do- 5.5 & Fineness Annex B -do- -do- Each Control unit Table 1 a) Particles retained on 150 micron IS sieve b)particles retained on 75 micron IS sieve -do- -do & Table 1 ii) ph of aqueous solution iii) Heavy metals (as Lead) Annex C -do- -do- -do- Annex D -do- i) One ii) One (in case of ECO mark) i) Weekly* composite sample ii) Each control unit iv)arsenic (as As 2 O 3 ) Annex E -do- -do- -dov) Foaming Power** Annex F -do- One Each control unit vi)fluoride ion Annex G -do- -do- -dovii) Microbial Counts IS 6356:2001 One a) Total viable counts b) Gram negative pathogens Daily composite sample***

8 TEST DETAILS LEVELS OF CONTROL REMARKS Clause Requirement Test Methods Clause Reference No. of samples Frequency 5.3 Stability 5.3 -do- One Once in a month or when a change in ingredients whichever is earlier 5.4 Packing material 5.4 -do- One -doinertness 5.6 Shelf life 5.6 -do- -do- -do- This test shall be done for each type of toothpaste and each container combination. 6.0 Abrasivity (Type test) Annex H -do- One Once in two years or when a change in ingredients whichever is earlier * Weekly Composite sample One sample drawn from each line in each shift for continuous days are to be pooled to give a weekly composite for Heavy metal and arsenic content tests. ** Applicable to foaming toothpaste only. *** Composite sample shall be prepared by thoroughly mixing quantities of samples for each type drawn from each mix prepared in one day. 8

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