bureau of indian standards (southern regional · pdf filesubject: preparation & review of...

BUREAU OF INDIAN STANDARDS

(Southern Regional Office)

Our Ref: 60/CM 1 10 Mar 2014

Subject: Preparation & Review of Product Manuals for Product

Certification

This has reference to CMD-I’s circular CMD-1/31 dated 11 Nov 2013 on the above subject.

In this connection, the draft Product Manual in respect of IS 5346: 1994 allotted to SRO has been prepared. The same is attached herewith for hosting on the BIS Intranet for inviting suggestions and comments for a period of 15 days.

The comments may be sent to SRO/CNBO(FCT).

(E. Devendar)

Sc.G & DDGS

HITSD

BUREAU OF INDIAN STANDARDS PRODUCT MANUAL FOR SYNTHETIC FOOD COLOUR PREPARATIONS AS PER IS 5346: 1994

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FOR BIS USE ONLY Doc No.: PM/IS 5346

PRODUCT CERTIFICATION MANUAL

FOR

SYNTHETIC FOOD COLOUR PREPARATIONS

AND MIXTURES AS PER IS 5346: 1994

(First Issue)

Date of Issue: March 2014


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Amendment Sheet

To ensure that this Product Manual contains a complete record of Amendments, this Amendment sheet shall be maintained in the Product

Manual.

AMENDMENT NUMBER DATE OF ISSUE


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CONTENTS

Item Chapter Page No

0 Foreword 4

1 Introduction 5

2 Manufacturing process 6

3 Manufacturing infrastructure 7

4 Certification criteria 8 – 9

5 Inspection and testing 10

6 Scheme of testing and inspection 11-14

ANNEXES

1 List of permitted synthetic food colours 15

2. List of testing facilities required 16-19

3. Model checklist for hygienic conditions 20

4. List of testing Laboratories 21

5. Checklists for acceptance of Applications 22 – 28


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0. FOREWORD 0.1 This Indian Standard (IS 5346: 1994) (Second Revision) was adopted by the Bureau of

Indian Standards after the draft finalized by the Food Additives Sectional Committee had been approved by the Food and Agriculture Division Council. The product was under mandatory certification under the Prevention of Food Adulteration Act, 1954.

0.2 However after the enactment of the Food Standards and Safety Act 2005 it was dropped

from the list of products under mandatory BIS certification and the Food Safety and Standards (Prohibition and Restrictions on sales) Regulations, 2011 also does not prohibit manufacture or sale of the product without BIS Certification mark.

0.3 There are presently 4 amendments to IS 5346: 1994 and all have been considered in the

drafting of the product manual of Synthetic Food Colour Preparations. Suggestions for any improvement in this Manual may be sent to CNBO (FCT) not later than 31/03/2014.


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1 INTRODUCTION 1.1 The following definitions shall apply. 1.1.1 Colour Preparations: A preparation containing one or more of the permitted synthetic food colours along with diluents and/or filler materials and meant to he used for imparting to foods. 1.1.2 Mixture: A mixture of two or more permitted synthetic food colours without diluents and filler materials and meant to be used for imparting colour to foods. 1.2 Permitted synthetic food colours used in the colour preparations or in mixtures shall conform to the relevant specifications prescribed by the Bureau of Indian Standards. A list of the permitted synthetic food colours along with the required ISS is given in Annexure I. 1.3 The colour preparations shall be either in the form of a liquid or powder. Powder preparations shall be reasonably free from lumps and any visible extraneous/ foreign matter; Liquid preparations shall be free from sediments. 1.4 Only the diluents or filler materials as given in 4.4 of IS 5346: 1994 shall be permitted to be used in colour preparations. However the commonly used diluents and filler materials are as follows: i) Potable water (conforming to IS 10500: 1991) ii) Edible common salt (conforming to IS 253: 1985) iii) Iodized Salt (conforming to IS 7224: 2006) iv) Acetic acid dilute (conforming to IS 695: 1986) 1.5 IS 5346 prescribe a number of requirements to be tested as per the methods of tests given in IS 1699: 2004. Further, some requirements have options for selection of test method to be followed. This has made the task of the inspecting official difficult and time consuming for complete assessment of adequacy of the test facilities. This Manual provides a ready reference for the inspecting official to check facilities for each of the requirements against the method given under the relevant Indian Standard and the method chosen by the firm (Annex II). 1.6 ‘The product shall be processed, packed, stored and distributed under hygienic conditions in licensed premises as per IS 2491.’ A model checklist for hygienic conditions with focus on the product is given in Annexure III. 1.7 All efforts have been made to incorporate details as per the latest versions of the standards. However, as the standards are dynamic and subject to amendments and revisions, users are encouraged to check the latest versions of the respective methods of test subsequent to issuance of this issue of the Manual, before using the information contained herein.


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2. MANUFACTURING PROCESS Powder preparations and mixtures

Synthetic Food Colours

Salt

LIQUID PREPARATIONS

Synthetic Food Colours

Potable water, Acetic acid dilute etc

Weighing as per required quantity based on the targeted blend and total dye content Blending in a roller type

blender/ribbon blender with blending aids.

Weighing packing storage and despatch Testing for conformity to IS 5346: 1994

Weighing as per required quantity based on the targeted blend and total dye content Heating and blending in water till a

solution is prepared

Weighing filling storage and despatch Testing for conformity to IS 5346: 1994


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3. INFRASTRUCTURE FOR PRODUCTION

For solid preparations/ mixtures

i) Weighing balance – Platform

ii) Ribbon Blender/ rotary blender with blending aids

iii) Weighing balance – smaller of capacity upto 1Kg

iv) Pouch packing machine (optional)

For Liquid Preparations

i) Weighing balance – Platform

ii) Liquid blender with agitator and heating facility

iii) Weighing balance – smaller of capacity upto 1Kg

iv) Bottle packing machine (optional)


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4. CERTIFICATION CRITERIA 4.1 CRITICAL REQUIREMENTS OF THE INDIAN STANDARD To be provided by CMD 4.2 SCHEME OF TESTING AND INSPECTION DOC: STI/5346/4 June 1995. Please see enclosed. SECTION 4.3 MARKING FEE RATES

Description Value Unit 1 KG (for powder), 1 Litre (for liquid) L S Marking Fee 34000 S S Marking Fee 29000 Slab 1 Rate 0.26 Slab 1 Qty ALL Slab 2 Rate 0 Slab 2 Qty 0 Slab 3 Rate 0 Enforcement Date 20130212

Remarks 0.45 per unit for liquid 4.4 GROUPING GUIDELINES: NONE 4.5 GUIDELINES FOR WRITING SCOPE OF LICENCE "SYNTHETIC FOOD COLOUR PREPARATIONS AND MIXTURES,

i) Solid Preparations ii) Mixtures iii) Liquid Preparations

Each and every of the above shall be included separately in the scope of the licence. However there is no need for inclusion of preparations of various declared % Total Dye contents or product with blends of various synthetic food colours.

4.6 SAMPLES SIZE

i) For Solid preparations or mixtures: 100g to be packed in PE packs and further in plastic bottles


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ii) For Liquid preparations: 100ml to be packed in glass bottles

4.7 MANNER OF SEALING THE SAMPLE Samples may be packed as above, labeled and wax sealed or as an alternate code no and signatures of IO may be marked with a permanent marker pen on the packing of the product. 4.8 REMNANTS ARE RETURNABLE/NON-RETURNABLE TO BE SCRAPPED/USED OR TO BE DESHAPED DISPOSAL IN CASE OF SAFETY ITEMS Sample is normally consumed in testing and Remnants are not returnable and may be suitably disposed off by the laboratory. 4.9 PROCEDURE TO BE FOLLOWED FOR DESTROYING/ DESHAPING/RECYCLING THE PRODUCT THAT DOES NOT MEET THE QUALITY PARAMETERS DURING REGULAR PRODUCTION BIS Standard Mark to be marked only after ascertaining the quality of the material after testing as per Indian standard and STI. The material may be reprocessed if it does not meet the quality requirements. 4.10 REQUIREMENTS THAT ARE TO BE TESTED IN THE FACTORY As per the requirements of IS 5346: 1994 the requirements of % TDC, heavy metals and water insoluble matter can easily be done during an inspection and shall be tested during the visit. The other requirements can also be tested in a full day and may also be tried. 4.11 STATUS OF TEST FACILITIES IN BIS LABS AND OSLS WITH TESTING CHARGES Please See Annexure IV


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5. INSPECTION AND TESTING 5.1 LIST OF REQUIRED TEST EQUIPMENT/FACILITIES WITH REQUIREMENT & FREQUENCY OF CALIBRATION Please See Annexure II 5.2 WHETHER GRANT OF LICENCE WILL BE BASED ON FACTORY TESTING BASIS---------------------------------------------No INDEPENDENT TESTING BASIS--------------------------------------Yes MIXED BASIS (FACTORY TESTING OF PRODUCT PLUS INDEPENDENT TESTING OF SOME RAW MATERIALS) ----------No 5.3 RAW MATERIAL SAMPLES TO BE GOT TESTED IF ANY FOR GOL i) All basic synthetic food colours used if they are not BIS Certified. If they are BIS

Certified, then based on the opinion of the BO where the licensee is located sample may be drawn as MS with information to the concerned BO.

ii) Diluents and filler materials to be tested as per their respective ISS wherever used and wherever specified.

5.4 DECLARATIONS TO BE OBTAINED Declaration as per Clause 4.4 and 4.7 shall be obtained from applicants for process of applications towards GOL. Declaration of declared % Total Dye Content and Synthetic Colours present shall be obtained during the drawal of sample.

Doc STI/5346/4 June 1995


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SCHEME OF TESTING AND INSPECTION

FOR CERTIFICATION OF SYNTHETIC FOOD COLOUR PREPARATIONS AND MIXTURES

ACCORDING TO IS 5346: 1994 1. Laboratory - A laboratory shall be maintained which shall be suitably equipped and staffed to carry out the different tests in accordance with the methods given in the Indian Standard Specification. 2. Test Record - All records of analysis and tests shall be kept in suitable forms approved by the Bureau of Indian Standards. (See Form 1 annexed) 2.1 Copies of any records that may be required by BIS shall be made available at any time on request. 2.2 Quality Control -It is recommended that, as far as possible, Statistical Quality Control (SQC) methods may be used for controlling the quality of the products as envisaged in this Scheme [See IS 397 (Part 1), IS 397(Part 2), and IS 397 (Part 3)]. 2.3 Quality Systems - In addition, effort should be made to gradually introduce a Quality Management System in accordance with IS/ISO 9001:2008. 3. Standard Mark - The Standard Mark(s) as given in Column (l) of the first Schedule of the licence shall be stencilled with indelible ink or printed on labels applied to the container of Synthetic Food Colour preparations and mixtures thus provided always that the material in each container to which this mark is applied conforms to every requirement of the specification subject to the provisions of the Food Adulteration Act, 1954. 3.1 Packing: The material shall be packed as per clause 5.1 of IS 5346: 1994 4. Marking – In addition the following information shall be given legibly and indelibly on each container or on the label applied to it: a) The words 'Synthetic Food Colour Preparation' or 'Synthetic food Colour Mixture", b) The names and colour index, number of the various food colours and names of other ingredients used in the preparation; c) Percentage of total synthetic dye content; d) List of ingredients in descending order of composition; e) Name and Address of the manufacturer;


f) Net quantity in g or kg. or litre or ml; g) Batch or code Dumber, h) Date of manufacture; i) Expiry date in case of liquid synthetic food colour preparations or mixtures containing


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Indigo Carmine. and k) Any other requirements as specified under the Standards of Weights and Measures (Packaged Commodities) Rules, 1977/ Prevention of Food Adulteration Rules, 1955. 5. Levels of Control - The analysis and tests, as indicated in Table 1 attached and at the levels of control specified therein, shall be carried out on the whole production of the factory which is covered by this Scheme and appropriate records and charts maintained in accordance with clause 2 above. All the production which conforms to the Indian Standard and covered by the licence shall be marked with the certification mark of the Bureau. 6. DILUENTS – Only permitted diluents and filler materials of the quality mentioned in the specification shall be used in the colour preparations 7. RAW MATERAILS – the Synthetic Food Colours used in the preparations or mixtures shall conform to the relevant Indian Standard Specifications. If food colours are purchased from the synthetic food colour manufacturers the same shall bear BIS Certification mark. 8. CONTROL UNIT – For the purpose of this Scheme, the control unit shall be quantity of all the ingredients mixed and taken out of the homogeniser at a time. 9. HYGIENIC CONDITIONS – Synthetic Food Colour preparations and mixtures shall be processed, packed, stored and distributed under hygienic conditions and the manufacturing premises shall be maintained in a clean and hygienic manner. All the workers shall use clean, washed clothing including head – covers. Incidental contamination of the product from soiled equipment or from personnel suffering from injuries eruptions or boils shall be avoided. ( see IS 2491 : 1972). 10. FREEDOM FROM CONTAMINANTS - Precautions shall be taken to ensure that the material is free from mercury, copper and chromium in any form; aromatic amines, aromatic nitro compounds, aromatic hydrocarbons, polycyclic aromatic hydrocarbon, 2 napthyl aminebenzidene, amino-4-dipbenyl (xenylamine) or their derivatives and cyanides. 11. REJECTION – A separate record shall be maintained giving information relating to the rejection of lots of Synthetic Food Colour preparations and mixtures which do not conform to the specification and the method of their disposal. Such material, if packed in containers, shall in no case be stored together with that conforming to the specification.


12. SAMPLES – The licensee shall supply, free of charge, the sample or samples required in accordance with the Bureau of Indian Standards (Certification) Regulations from his factory or godown. BIS shall pay for the samples taken by it from the open market.


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13. REPLACEMENT – Whenever a complaint is received soon after the goods with the Standard Mark have been purchased and used, and if there is adequate evidence that the goods have not been misused, defective goods or their components shall be replaced or repaired free of cost by the licensee in case the complaint 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. 14. STOP MARKING – The marking of the product shall be stopped under intimation to BIS, if at any time, there is some difficulty in maintaining the conformity of the product to the specification or the testing equipment goes out of order. The marking may be resumed as soon as the defects are removed under intimation 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 by BIS. The information regarding resumption of marking shall also be sent to BIS. 15. PRODUCTION DATA – The licensee shall send to BIS as per the to be attached to be authenticated by a Chartered Accountant or by the manufacturer by giving an affidavit /undertaking, a statement of quantity produced, marked and exported by him and the trade value thereof end of each operative year of the licence.



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IS 5346: 1994 SYNTHETIC FOOD COLOUR PREPARATIONS TABLE 1 LEVELS OF CONTROL

(Para 5 of the Scheme of Testing and Inspection) TEST DETAILS LEVELS OF CONTROL Test Method Clause Requirements Clause Reference No. of Frequency Remarks Samples 4 Description 4.1 to 4.4 IS 5346: 1994 One Control unit

4.5 Total Dye Content 4.5 Annex B IS 5346: 1994 One

*One sample from every control unit every week

4.6 & Table 1 i) Water Insoluble matter 7 IS 1699: 1994 One Control Unit ii) Lead 15 IS 1699: 1994 One --do-- iii) Arsenic 15 IS 1699: 1994 One --do-- iv) Heavy Metals 16 IS 1699: 1994 One --do--

* For the requirement of total dye content, one sample shall be taken from a control unit at weekly intervals and conformity checked. Samples shall be taken from every control unit and kept till the result of the weekly sample is known. In case of non – conformity of this sample in total dye content, all the samples taken for the week shall be tested for total dye content. Till such time six consecutive control units pass, this procedure shall be followed. Appropriate records as per para 7.1 of this scheme regarding the receipt and issue of basic colours received at the factory shall also be maintained.

** However, a suitable spectrocolorimeter may also be used after proper calibration against a spectrophotometer.


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ANNEXURE I

List of permitted synthetic food colours along with IS No.

Serial No. Name of the Synthetic Food Colour IS No

1. Tartrazine, food grade 1694: 1994

2. Sunset Yellow, food grade 1695: 1994

3. Erythrosine, food grade 1697: 1994

4. Indigo Carmine, food grade 1698: 1994

5. Carmoisine, food grade 2558: 1994

6. Ponceau 4R, food grade 2923: 1995

7. Brilliant Blue, food grade 6406: 1994

8. Fast Green, food grade 6022: 1994


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ANNEXURE II

List of Testing Facilities required

Sr. No

Requirement Clause No of IS 5346: 1994

Clause Reference & IS No of Test method

Method Type Equipment & Chemicals required

1. % Total Dye Content

4.5 Annex B of IS 5346: 1994

Chromatographic Separation method

i) Chromatographic Paper of Whatman Filter Paper No 1 (32cm x 19.5cm)

ii) Isobutanol iii) Ammonium

hydroxide iv) Ethanol v) Trisodium Citrate vi) Hydrochloric acid vii) Sodium hydroxide viii) All glass

Chromatographic tank (50 x 30 x 25cm)

ix) Spectrophotometer with 10mm cuvettes

x) Micropipettes/micro syringe

xi) Standard Food Colours

xii) Distilled water or water distillation apparatus

Direct estimation i) Hydrochloric acid ii) Sodium hydroxide

iii) Spectrophotometer with 10mm cuvettes

iv) Distilled water or water distillation apparatus


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2. % Water Insoluble matter

Table I (i) 7 of IS 1699: 1994

NA i) Gooch or sintered glass filter

ii) Hot plate

iii) Hot air oven

iv) Analytical Balance (LC = 0.0001g)

v) Distilled water or water distillation apparatus

vi) Dessicator

vii) Filtration flask

viii) Vacuum pump/ Aspirator

3. Lead in mg/kg Table I (ii) 15 of IS 1699: 1994

Atomic Absorption Spectrophotometric method

ix) Lead nitrate

x) Nitric acid

xi) Distilled water or water distillation apparatus

xii) Kjeldahl flask

xiii) Perchloric acid

xiv) Hydrochloric acid

xv) Atomic Absorption Spectrophotometer with air & acetylene flame and hollow cathode lamp of wavelength of 283.3nm

Chemical method i) Digestion Funnel ii) Separatory Funnel Iii) Nitric acid


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v) Sulphuric acid vi) Ammonium citrate vii) Ammonium acetate viii) Ammonia solution,

concentrated ix) Dithizone x) Carbon tetrachloride xi) Potassium cyanide xii) Hydroxylamine

hydrochloride xiii) Potassium chloride xiv) Lead nitrate

4. Arsenic in mg/kg Table I (iii) 15 of IS 1699: 1994

Atomic Absorption Spectrophotometric method

a. Nitric acid b. Distilled water or water

distillation apparatus c. Kjeldahl flask d. Perchloric acid e. Hydrochloric acid f. Arsenous oxide g. Sulphuric acid h. Phenolphthalein i. Atomic Absorption

Spectrophotometer with argon & acetylene flame and hollow cathode lamp of wavelength of 193.7nm and hydride generator

Chemical method a. Guitzeit apparatus consisting of Distillation apparatus and conical flask

Or Modified Guitzeit apparatus b. Sulphuric acid — sp gr

1.84. c. Potassium

permanganate solution — 0.1 N.

d. Ferrous sulphate — freshly powdered.

e. Hydrochloric acid — 38 percent.

f. Potassium bromide solution — 20 percent.

g. Aluminium strips — 8


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mm × 8 mm × 1 mm. h. Tin chloride i. Test paper —dried

strips of filter paper soaked in saturated ethanolic solution of mercuric bromide .

5. Heavy Metals (as Pb) in mg/kg

Table I (iv) 16 of IS 1699: 1994

NA a. Ammonia Solution - 28% b. Hydrochloric acid – 10% c. Lead nitrate d. Nitric acid e. Sulphuric acid f. Hydrogen sulphide (to be

made by reaction of iron sulphide with hydrochloric acid in Kipp’s Apparatus)

g. Kipp’s Apparatus h. Muffle furnace capable of

a temperature of 500oC to 600oC

i. Silica crucible j. Steam bath k. pH indicator strip of about

2pH

NB:-

i) all chemicals used shall be of laboratory reagent grade ii) apart from the above all general glasswares like pipettes, volumetric flasks etc are required iii) the following equipments shall be calibrated:

analytical balance spectrophotometer by standard potassium dichromate solution of N/20 strength or

Holmium dioxide filter muffle furnace


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Annexure III Site Free from obnoxious fumes, smoke, odour Yes/No

Building Fly Proof and bird proof Yes/no

Ventilation and lighting in the processing Hall and Exhaust fan to provided where necessary

Satis/unsatis

Not to be used domestic purpose Yes/No

Processing floor shell be smooth, and properly sloped for drainage and the drains shall be covered

Yes/No

Walls and ceilings shall be smooth, light coloured and free from crevices and dampness

Yes/No

Building shall be clean, painted and white washed Yes/No

Store room and Packing Room

Raw material storage/packing room shall be rodent proof and fly proof

Yes/No

Separate storage room for raw material & finished goods Present/absent

Sink lavatory or garbage shall not be situated near either of the storage room

Yes/No

Potable water Supply and storage Adequate/Inad.

Employee Hygiene Periodically medical Examination Done/Not done

Proper and clean clothing and foot wear Provided/Not Provided

Hygiene Eating, spiting, nose cleaning, use of tobacco within manufacturing, packing & storage area to be prohibited and notice to the same are displayed

Yes/No

Sanitary convenience provided Satis/unsatis

Remarks:

Signature:

Name:


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ANNEXURE IV

List of BIS Laboratories

Lab Quantity Lab Type Testing Facility Remarks

CL 100 g /ml Chem C

BNBOL 100 g /100ml Chem C

WROL 100 g Chem P Except Pb

IS No. Testing Charges Remarks

IS 5346 : 1994 Rs. 1120/-

Testing Facility:: C=Complete Test facility / P=Partial Test Facility/ N=No Test Facility

List of Outside Recognized Laboratories

Sl No.

Name of the Recognized Laboratory Lab Code Testing Charges Remarks

1 Shriram Institute For Industrial Research, 19, University Road, P.B.No. 2122, Delhi-110007

8102006 Rs.20000/- efffective from 21.03.2013

2 Choksi Laboratotries Limited 6/3, Manoramaganj Indore-452001, Madhya Pradesh

8100106 BIS Test Charges Suspended w.e.f. 30.09.2013

3 FICCI Research & Analysis Centre Plot No.2A, Sector-8, Dwarka New Delhi-110077

8103115 BIS Testing Charges

4 AVON Food Lab Pvt. Ltd. C-35/23, Lawrence Road Industrial Area, Delhi-110035

8117816 BIS testing charges

10% discount to BIS

5 Shriram Institute For Industrial Research, 14-15, Sadarmangla Industrial Area, Whitefield Road, Bangalore-560048, Karnataka

6104206 Rs.4000/-


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ANNEXURE V

CHECK LIST FOR SCRUTINY OF APPLICATIONS AT THE COUNTER ( to be checked at the time of receipt of Application) 0

SR No Requirement Yes /No

1. Whether the application form is as per BIS Standard format and filled completely with no column left as blank?

2. Whether the application is signed and stamped ?

3. Whether the application is accompanied with requisite fee (DD or evidence of transfer through RTGS)

4. Whether the application is accompanied with check list?

5. Whether the application is accompanied by all documents as per “ the list of documents to be attached”? ( Please see Annexure A, Annexure A-1, Annexure A-2, Annexure A-3, Annexure B)

6. In case the application is under “ simplified procedure “, is the test report attached with application and is not older than one month from date of submission of application ?

Notes: 1. If the application is found to be complete, it shall be recorded and acknowledgement issued to the applicant across the counter. 2. If the application is found to be incomplete or deficient, the deficiencies shall be clearly communicated to the applicant in writing and acknowledgement obtained across the counter. 3. The application shall, then, be marked to the Head of the Branch Office, immediately.


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CHECK-LIST FOR SCRUTINY OF APPLICATIONS

BY CONCERNED OFFICER IN THE BO (To be checked at the time of receipt of Application)

SR No Requirement Yes /No

1. Whether the application is complete in all respects, including the availability of requisite infrastructure for manufacturing and testing as per the Indian Standard? (Please see Check- list attached as Annex B)

2. Whether the test report(s) attached with the application has / have been submitted within the specified time norms (applicable in case of simplified procedure)?

3. Whether the test report(s) is / are from BIS or BIS recognized laboratory(ies) only?

4. Whether the test report(s) show conformity of the sample(s) tested to the relevant Indian Standard(s)?

5. Whether all the requirements as per the relevant Indian Standard(s) have been tested?

6. Whether, in case of application under the Foreign Manufacturers’ Certification Scheme, additional requirements, as given in Annex C, have been checked and found in order?

Note - After scrutiny of the application, the concerned Officer shall communicate the deficiencies, if any, to the applicant and also indicate the date on which the preliminary / verification inspection is proposed to be carried out, clearly indicating that all deficiencies shall have to be completed by the applicant within the stipulated period in order to enable the BIS officer to verify the same during the preliminary / verification inspection.


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LIST OF DOCUMENTS TO BE ATTCAHED WITH APPLICATION SR NO TITLE OF DOCUMENT PAGE

1. Check list( Please see Annexure B)

2. In case the application is filed under “ simplified Procedure” , the test report(s) in original from BIS or its recognized laboratories for all the requirement s of the product and , where applicable, of basic dyes or water

3. Document of Central/ State government ( e.g. Registration Certificate, Memorandum of Articles, etc) authenticating the address and purpose of the establishment of the manufacturing unit for which the application is made for grant of license.

4. In case the applicant applies as SSI Unit , copy of valid Registration Certificate from the Local/ State authority or from a Chartered Accountant?

5. In case the application is signed by the authorized signatory of the applicant, authorization letter from CEO in the name of the authorized signatory.

6. Process Flow- chart covering all processes of manufacture ( from raw material to finished product stage) , including details of in- process controls at each stage, even for those stages which have been outsourced?

7. Complete list of manufacturing machinery , clearly indicating the name of the machinery, the details of the process for which have been outsourced?

8. Complete list of testing facilities, clearly indicating the name of the equipments , the test for which it is used (mention clause No of the Indian Standard ), range / least count/ accuracy of the test equipment, calibration status and quantity in Annexure A-2

9. Copies of calibration certificate of testing equipment valid till 3 months of acceptance of application.

10. Plant Layout clearly indicating location of manufacturing machinery, lab, office, workshop, amenities , storage area etc, available in the factory premises, with the application?

11. Appointment letter of QC personnel indicating names, experience, qualifications, date of appointment and also attach a copy each of the qualification certificate

12. Copy each of the test reports/ suppliers test certificate for each of the raw materials/ components.

13. Copy of in-house or independent test report for the product covering all requirements as per the relevant Indian Standard.

14. In case application is under simplified procedure, an undertaking on his letter head that the license if granted to him shall be put under Stop Making by BIS if the verification sample(s) drawn during verification visit of the BIS officer prior to grant of license fail to conform to the Indian Standard. In case the License does not take corrective actions, informs BIS and offers two improved lots to BIS for inspectional testing within one month o f the date of Stop Marking, the license shall be processed for cancellation and no further chance would be given to the license.


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CM/PF 305

ANNEX A-1 (Sl. No. 7 on the List of Documents)

DECLARATION REGARDING MANUFACTURING MACHINERY No entry to be crossed

Applicant Name: _______________________ Application No.: ________________________ Name/Address ___________________________________

I hereby declare that the machinery of which details are given overleaf is owned by me and are actually installed in the premises.* I also declare that in case of grant of licence, I will send prior intimation to BIS whenever any equipment is taken out of the premises of the firm due to any reason.

Signature of Firm’s Representative _____________________

Name _________________________ Designation _________________________

Date ______________________ * I also declare that in case of grant of licence, I will send prior intimation to BIS whenever any machinery is taken out of the premises of the firm due to any reason.

I have checked and found that machinery of which details are given overleaf was available during my inspection.

Sig. of BIS I.O. ___________________________

Name ______________________________

Designation _____________________________

Date of verification _________________________

Sl. No. & date

Machinery Make Capacity Number Remarks


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CM/PF 306 ANNEX A-2

(Sl. No. 9 on the List of Documents) DECLARATION REGARDING TEST EQUIPMENT

No entry to be crossed 1. Application No. _________________ 2. Licence No. ______________ 3. Name /Address __________________________________________ Sl. No. & Date

Test Equipment/Chemicals and Identification Numbers (Where applicable)

Least Count & Range (Where applicable)

Valid Calibration (Where required) Yes/No

Tests Used in with Clause Reference

Remarks (Indicate number of Equipment)

I hereby declare that the test equipments of which details are given overleaf are owned by me and are actually installed in the premises.

I also declare that in case of grant of licence, I will send intimation to BIS whenever any equipment is taken out of the premises of the firm due to any reason.

Signature of firm’s

Representative _____________________

Name ___________________________

Designation ________________________

Date ______________________________

I have checked and found that the test equipment of which details are given overleaf were available during my inspection.

Sig. of BIS I.O. _____________________

Name ______________________

Designation ____________________

Date of verification __________________


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(Sl. No. 16 on the List of Documents) UNDERTAKING BY APPLICANT APPLYING UNDER SIMPLIFIED PROCEDURE

(To be submitted on the letter head by CEO/Authorized Signatory to concerned Head of the Branch office along with the Application and other documents) The Director and Head BIS ____________ Dear sir I, -----------------( name of person), ----------------------( designation) have applied for a licence to you for use of BIS standard mark on --------------------(name of product) being manufactured at our factory at ------- -----( give address). I give an undertaking that the licence if granted against his application shall be put under Stop Marking by BIS if the verification sample(s) drawn during verification visit of the BIS officer prior to grant of licence fail to conform to the Indian Standard. In such a case, I shall take necessary corrective actions and inform the same to BIS within 15 days along with offering fresh lot of products manufactured after taking corrective actions, from which samples (of rating/size/variety which facilitates verification of corrective actions on the reported failures) shall be drawn by BIS for independent testing . I agree that the resumption of marking in such cases shall be allowed only on the basis of independent satisfactory Test Reports of the fresh samples offered (including long duration tests where failures were in long duration tests). In case the fresh sample drawn by BIS for independent testing fails, or the licensee does not inform corrective actions taken and does not offer improved samples within 15 days of the date of Stop Marking, the licence shall be processed for cancellation without any further chance to me Date:

(Name) (Designation)

(Seal)

Annex B


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CHECK-LIST FOR APPLICATION TO BE SUBMITTED BY APPLICANT TO BIS WHILE APPLYING FOR BIS LICENCE UNDER PRODUCT CERTIFICATION SCHEME OF BIS

The following check-list is required to be submitted with all the applications for grant

of BIS licence under the Product Certification Scheme of BIS. Please tick (√) in the

relevant box.

Whether applied under: Simplified Procedure r or Normal Procedure Note: Refer BIS website or details of “Simplified Procedure” and “Normal Procedure” for grant of licence.

No. Check-point Requirement Observations Page

No.

General Is the application form completely filled?

Name &

Address Is the name and address of applicant (manufacturing unit

applying for licence) same in the application as given in

the attached document of Central/State Government

Status of

Applicant

(Manufacturing Unit)

a. Has it been indicated whether the applicant is a large

scale or small scale unit?

b. In case the applicant is a small scale unit, does the

applicant hold valid Registration Certificate from the

Local / State authority or from a Chartered Accountant, and

is the certificate attached.

c. Has it been indicated whether the applicant is a Public

Sector or a Private Sector company?

IS No. &

Varieties a. Has applicant recorded the applicable Indian Standard

with correct title of the Standard?

b. Where applicable, has applicant mentioned designation,

grade, type, variety, size, etc., of the product for which

the BIS licence is sought?

History a. Where applicable, has the applicant provided information

regarding earlier BIS licence(s) held by them and / or

cancelled in the past?

b. Where applicable, has the applicant provided information

regarding BIS licences currently held by them?

Signature a. Is the application signed by the CEO of the applicant?

b. In case the application is signed by a person other than

the CEO, is the application signed by the authorized

signatory of the applicant and his authorization is

attached by the authorized signatory? Machinery a. Does applicant possess requisite manufacturing

infrastructure to manufacture the product as per the Indian

Standard?

b. Is installed capacity of production indicated in the

application?

c. Does applicant have all machineries installed as per

manufacturing process at the applicant’s manufacturing


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premises?

d. If answer to ‘c’ above is no, does the applicant

outsource any of its manufacturing processes and possesses

valid agreement(s) with other manufacturing units for the

outsourced processes and traceability of material, thus

produced, etc.?