Head (CMD-2)(sd/-) Circulated to All ROs/BOs/FAD and MSD Copy to: ITS for hosting on intranet

Transcription

1 क द य म हर व भ ग-2 स दभभ: CMD-2/16: व षय: आई एस 8498:2013 क प र प एस ट आई ए ददश न द श यह आई एस 8498:1977 स आई एस 8498:2013 क स श धन क स दर भ म ह यह उत प द प म णन क अध न ह और ब आई एस व बस इट क अन स र आज क त र ख म इस उत प द क ल ए ववलर न न क त य /श ख क य भ य क तहत 09 इस न स म ज द ह स ग न प र प एसट आई / 8498/3 XXXX 2017 तथ ददश ननद श अव कन क ल ए स ग न ह सर स बन न धत क य भ य स अन र ध ह कक प र प दस त व ज़ कक ज च कर ददन क तक य उसस पह स एम ड -2 क दटप पण र ज इस स दर भ म हम र ई म ददन क क अव कन कर I सर श ख क य भ य स अन र ध ह कक व इन प र प दस त व ज़ क ब र म अपन अधधक र क त म आन व आव दक / इस सध ररय क ध य न म य और यदद क ई दटप पण ह, त स एम ड -2 क र ज प म ख (CMD-2)(हस त /-) सभ क त य /श ख क य भलय /एफएड /एमएसड क पररच ललत प नतललवप: आई ट एस इ ट ट पर अपल ड कर क ललए (अद ख स ) ज न क स CENTRAL MARKS DEPARTMENT-2 Our Ref: CMD-2/16: Subject: Draft STI and guidelines as per IS 8498:2013 This has reference to revision of IS 8498:1977 to IS 8498:2013. The product is under certification and as on date there exists 09 licences for the product as per BIS website under different RO/BOs. Please find enclosed draft STI/8498/3 XXXX 2017 and guidelines for the above product for kind perusal. All concerned are requested to examine the draft documents and provide comments to CMD-2 on or before In this regard, please refer our dated All BOs are also requested to bring it to the notice of the applicants/licensees under their jurisdiction about these draft documents and forward the comments, if any, to CMD-2. Head (CMD-2)(sd/-) Circulated to All ROs/BOs/FAD and MSD Copy to: ITS for hosting on intranet (Adane Khrasi) Scientist-C, CMD-2

2 CENTRAL MARKS DEPARTMENT II Our Ref: CMD II/16: Subject: Draft Guidelines for implementation of Revised IS 8498 : 2013 Temephos, Emulsifiable Concentrate (EC) Specification (First Revision) 1. IS 8498:1977 has been revised as IS 8498 : 2013 Temephos, Emulsifiable Concentrate (EC) Specification (First Revision) and has been published and notified vide Gazette Notification S.O.2498 (E) dated The last date for implementation of the revised Standard is 01 February 2018, after which the old Standard shall stand withdrawn. 2. As per BIS website there are 9 licences for the product under the jurisdiction of different ROs/BOs. 3. All BOs may inform the Applicants and Licensees under their jurisdiction about the revised Standard. 4. The significant changes in the revision, as listed in the Table below, are given for the purpose of general guidance. BOs shall ensure that the product conforms to all the requirements, as applicable, as per the revised Standard. Clause Requirement The temephos content is to be determined by high performance liquid chromatography (HPLC) equipped with UV-VIS detector using internal standard technique as prescribed in Annex A of IS 8701 : Requirements of Marking have been modified. Clause 6 Requirements of sampling have been modified. 5. Consequent upon the issuance of the revised Standard, existing STI has been revised as Doc: STI/8498/3 and the major modifications are as follows: (i) The methods for determination of temephos content and flash point have been updated as per the latest revision. (ii) Raw Material, Marking and Packing clauses have been modified to align the same with that of IS 8498 : 2013 (iii) The definition of control unit has been modified to bring more clarity. 6. The guidelines for implementation of the revised Standard is given below: A. For Licensees: (i) Licensees shall be advised to submit the following by 01 February 2018: a. Acceptance for the revised STI in the prescribed format. b. Declaration regarding availability of testing equipment as per revised specification on CMD/PF 306. c. In-house/independent test report as per IS 8498 : (ii) On receipt of the above information necessary endorsement may be issued by BO. (iii) All Licensees shall switchover to the revided Standard by 01 February ROs/BOs shall ensure that no Licences are under operation as per the old Standard after 01 February 2018.

3 Actions shall be taken as per OMPC 2004, as amended from time to time / CMD guidelines on the subject, if the licensee fails to comply with guidelines given at 5 A (i) above, by 01 February (iv) Verification of additional requirements and facilities, if any, shall be done during the next surveillance visit. An early inspection shall be planned to verify the availability of additional testing equipment, as per revised specification, with the licensees, after obtaining declaration on CMD/PF 306. During the inspection, sample shall be drawn for independent testing to ensure conformity of the product to the revised standard. In case sample drawn during inspection fails in factory/independent testing as per the revised version, further actions are to be taken as per OMPC 2004, as amended from time to time. B. For Applicants: (i) Applications which are recorded henceforth shall be processed only as per IS 8498 : (ii) Existing applications, where test reports are already available or visits were already undertaken or sample of product is under testing, may be processed as per the old Standard. For any Application which is processed as per the old Standard, the applicant shall give a declaration that they will switch over to the revised Standard by 01 February (iii) Beyond 01 February 2018 no Licence shall be granted as per the old Standard. 7. The above guidelines shall come into force with immediate effect. H(CMD II) Surya Kalyani S. Sc-D DDG (Certification)

4 Draft SCHEME OF TESTING AND INSPECTION FOR CERTIFICATION OF TEMEPHOS, EMULSIFIABLE CONCENTRATE (EC) ACCORDING TO IS 8498 : 2013 (First Revision) 1 LABORATORY 1.1 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 methods given in the Indian Standard. 1.2 All test equipments shall be periodically checked and calibrated and records of such checks/calibration shall be maintained. 2 TEST RECORDS 2.1 All records of tests shall be kept in suitable forms approved by BIS. 2.2 Copies of any such records that may be required by BIS shall be made available at any time on request. 3 QUALITY CONTROL 3.1 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 (various parts)]. 3.2 In addition, effort should be made to gradually introduce a Quality Management System in accordance with IS/ISO STANDARD MARK The standard mark (s) as given in column (1) of the First schedule of the licence shall be stenciled on each container of the Temephos emulsifiable concentrates or printed on the label applied to the container, as the case may be, provided always that the material in each container to which this mark is, thus applied conforms to every requirement of the specification. 5 MARKING The following information shall be given legibly and indelibly on each container or on the label (s) applied to it, in addition to those required under the provisions of the Insecticides Act and Rules framed thereunder: a) Name of the material and its end use; b) Name and address of the manufacturer; c) Batch number/control unit No.; d) Date of manufacture; e) Date of expiry; f) Net quantity; Page 1 of 6

5 g) Nominal temephos content, percent (m/m); h) Cautionary notice worded as in the Insecticides Act, 1968 and Rules framed thereunder; and j) Any other information required under the Standards of Weights and Measures (Packaged Commodities) Rules, h) BIS website details: 6 PACKING 6.1 The material shall be packed as per clause 4 of IS 8498 : The containers shall be securely closed. 6.2 The packing shall also conform to the Tariff Rules as in force from time to time for packing of goods falling in the category of materials of high flash point. 7 RAW MATERIAL 8.1 The material shall consist of temephos, technical dissolved in suitable solvent(s) together with emulsifying agent(s) and with or without stabilizer(s). 8.1 Temephos, technical employed in the formulation of the material shall conform to IS 8701 : It is recommended that routine analysis of each consignment of other raw materials received in the factory may be carried out and appropriate records maintained. 8 LEVELS OF CONTROL 8.1 The analysis and tests, as indicated in Table 1 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 Paragraph 2 above. All the production which conforms to the Indian Standard and covered by this licence shall be marked with BIS Certification Mark. 8.2 Control Unit For the purpose of this scheme, the entire quantity of the material processed in a mixer in one operation shall constitute a control unit (Batch). 8.3 On the basis of tests and analysis reports, the decision regarding conformity or otherwise of a control unit to a given requirement shall be made as follows: The sample taken for test from the control unit shall satisfy all the requirements of the specification. If the sample fails in any of the requirements tested other than temephos technical content and emulsion stability, the entire control unit represented by the sample shall be considered as unfit for the purpose of marking In case the sample taken from the control unit fails in either temephos technical content or emulsion stability, or both, the entire material may be suitably reprocessed and the defect rectified. Such reprocessed material, when tested again shall satisfy all the requirements of specification. 8.4 In respect of all other clauses of the specification and at all stages of manufacture, the firm shall maintain appropriate control and checks to ensure that their product conform to the various requirements of the specification. Page 2 of 6

6 9 REJECTIONS A separate record shall be maintained giving information relating to the rejection of the production not conforming to the requirements of the Specification and the method of disposal. Such material shall in no case be stored together with that conforming to the Specification. 10 SAMPLES The licensee shall supply, free of charge, the samples required in accordance with the Bureau of Indian Standards (Certification) Regulations, 1988, as amended from time to time, from the factory or godown. BIS may draw samples from the open market, if available. 11 REPLACEMENT 11.1 Whenever a complaint 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 shall be replaced free of cost by the licensee in case the complaint is found to be genuine and the warranty period (where applicable) has not expired. The final authority to judge the conformity of the product to the Indian Standard shall be with BIS In the event of any damage caused by the goods bearing the Standard Mark, or any claim being filed by the consumers against BIS Standard Mark and not conforming to the relevant Indian Standard, entire liability arising out of such non-conforming product shall be of the licensee and BIS shall not in any way be responsible in such cases. 12 STOP MARKING 12.1 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 their 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. 13 PRODUCTION DATA The licensee shall send to BIS a statement of quantity produced, marked and exported by him and the value thereof at the end of each operative year of the licence as per the enclosed proforma (Annex I) which has to be authenticated by a Chartered Accountant. Page 3 of 6

7 TABLE 1 LEVELS OF CONTROL TEMEPHOS, EMULSIFIABLE CONCENTRATE (EC) ACCORDING TO IS 8498 : 2013 (Clause 8 of the Scheme of Testing and Inspection) TEST DETAILS LEVELS OF CONTROL REMARKS Clause Requirement Clause Reference No. of Sample Frequency Description Visual IS 8498 : 2013 One Every Control Unit Please see Clause of STI Cold Test 13.1 IS 6940 : do- -do- -do Flash Point (Abel) - IS 1448 (Part 20) : do- -do- -do Emulsion Stability 13.3 IS 6940 : do- -do- Please see Clause of STI & 6 Temephos Content Annex A IS 8701 : do- -do- -do Acidity 13.5 IS 6940 : do- -do- Please see Clause of STI Page 4 of 6

8 Sl. No. Date of Manufacture Batch No./Control unit No. IS 8498 : 2013 TEMEPHOS, EMULSIFIABLE CONCENTRATES FORM I RECORDS OF TESTS (Para 2 of the Scheme of Testing and Inspection) Quantity Description Cold test Flash Point (Abel) Emulsion Stability Temephos Content Acidity Remarks (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) Page 5 of 6

9 Annex I PROFORMA FOR OBTAINING PRODUCTION DETAILS Period covered Name of Licensee CM/L No. Name of Articles (s) IS No. Grade/Type/Size/Variety/Class/Rating Brand/Trade/Name(s) of Product covered under BIS Certification Mark Total production of the articles(s) licensed for certification marking Total production of the article(s) conforming to Indian Standard Production covered with BIS Certification Mark and its Value : a) Quantity b) Value (Rs.) Brand Name used on production covered under BIS Certification Mark Calculation of marking fee on unit-rate basis; Marking Fee per unit a) Unit b) Quantity covered with BIS Certification Mark c) Marking fee rounded off in whole rupees as obtained by applying unit rates given in (a) on quantity given in (b) NOTE: In case a clause is not applicable, suitable remarks may be given against it Quantity not covered with BIS Certification Mark, if any. Reasons for such non-coverage Brand Name under which non-isi goods were sold Quantity exported with BIS Standard Mark and its value Brand Name under which BIS Certified goods are exported Authentication by Chartered Accountant Page 6 of 6