is 14998 (2001): positve list of constituents of melamine ... · is 14998:2001 4.5 auxiliary items...
TRANSCRIPT
Disclosure to Promote the Right To Information
Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information under the control of public authorities, in order to promote transparency and accountability in the working of every public authority, and whereas the attached publication of the Bureau of Indian Standards is of particular interest to the public, particularly disadvantaged communities and those engaged in the pursuit of education and knowledge, the attached public safety standard is made available to promote the timely dissemination of this information in an accurate manner to the public.
इंटरनेट मानक
“!ान $ एक न' भारत का +नम-ण”Satyanarayan Gangaram Pitroda
“Invent a New India Using Knowledge”
“प0रा1 को छोड न' 5 तरफ”Jawaharlal Nehru
“Step Out From the Old to the New”
“जान1 का अ+धकार, जी1 का अ+धकार”Mazdoor Kisan Shakti Sangathan
“The Right to Information, The Right to Live”
“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता है”Bhartṛhari—Nītiśatakam
“Knowledge is such a treasure which cannot be stolen”
“Invent a New India Using Knowledge”
है”ह”ह
IS 14998 (2001): Positve List of Constituents ofMelamine-Formaldehyde Resins in Contact with Foodstuffs,Pharmaceuticals and Drinking Water [PCD 12: Plastics]
IS 14998:2001
$77?a7W
aqjRmTm&Jwlm aTmFT?R,admihik
Indian Standard
POSITIVE LIST OF CONSTITUENTSOF MELAMINE-FORMALDEHYDE RESINS
IN CONTACT WITH FOODSTUFFS,PHARMACEUTICALS AND DRINKING WATER
ICS 67.250;83.080.10
@BIS 2001
BUREAU OF INDIAN STANDARDSMANAK BHAVAN, 9 BAHADUR SHAH ZAF- MARG
NEW DELHI 110002
October 2001 Ptice Group 3
Plastics Sectional Committee, PCD 12
FOREWORD
This Indian Standard was adopted by the Bureau of Indian Standards, after the draft finalized by the PlasticsSectional Committee had been approved by the Petroleum, Coal and Related Products Division Council.
Use of Plastics, and resins in the form of cured moulded articles, in packaging of foodstuffs, pharmaceuticalsand drinking water has now become a universally accepted method. In so far as there is any cause for concernin the use of plasticshesins in intimate contact with foodstuffs, etc, it arises from the migration of the constituentsof the plastics composition or residues thereof in their original or an altered form. Where direct contact occursbetween the packed commodity and the plastics, the high molecular mass polymer itself does not pose toxichazards being inert and essentially insoluble in food. There is, however, a likelihood that some transfer mayoccur of polymer additives, adventitious impurities such as monomers, catalyst remnants and residualpolymerization solvents and of low molecular mass polymer fractions from the plastics into the packagedmaterial with consequent hazard to the consumers. The occurrence of acute toxicity due to plastics material incontact with food is most unlikely, since only trace quantities of potentially toxic materials are likely to migrate.However, the accumulation of these toxic materials with time may lead to hazards which may be serious.
Melamine-formaldehyde resins commonly known as MF resins are produced by reacting one mole of melaminewith not more than three moles of formaldehyde. Part of the melamine fraction maybe replaced by urea or bybenzoguanamine. The moulding materials of the resin am produced by mixing the resin with refined wood pulp(cellulose) or with untreated wood reduced to particulate form. ‘Ilk mixture may also contain otheringredients/optional adjuvant substances like lubricants and flow promoters, catalysts, polymerization controlagents, pigments and colourants.
MF resins has the hardest surface of all plastics materials, the trade-off being its brittleness. They are transparent,but when sufficient tiller is added (to overcome the extreme brittleness of the unfilled resin), they becometranslucent and excellent diffusem of light; the colour possibilities being unlimited. They are having very highresistance to abrasion, acids and alkalis and repeated exposure to liquids. The basic property of its ability toaccept a moulded-in-decoration in addition to its having high resistance to direct heat has made it very popularfor use in dinnerware, cutlery handles, large serving utensils and bowls, etc, and various other food-contactapplications. MF resins can be moulded in flash, semi-positive and positive shut-off compression moulds andcan also readily be moulded in transfer and injection moulds.
Melamine-formaldehyde resins in the form of cured moulded articles can be safely used as the food contactsurface of moulded articles intended for use is producing, manufacturing, packing, processing, preparing,treating, packaging, transporting or holdlng foodstuffs, pharmaceuticals and drinking water in accordance withthe code of federal Regulations, FDA(USA) (21 CFR 177.1460).
This standard is intended to be used with the series of Indian Standards on plastics for food contact applicationswhich are given in Annex A.
It is emphasized that these standards need to be used in combination to provide a system of control to the resinsmanufacturers as well as the fabricators to derive maximum benefits. Besides, it may also serve as basis forofficial agencies to frame suitable legislations to ensure effective safeguards for the safety and health ofconsumer where plastics in general for food contact applications are concerned.
The composition of the Committee responsible for formulation of this standard is given in Annex B.
The list of addhives prescribed in this positive list are based on the information available through publishedliterature like The British Plastics Federation, UK; FDA Regulations, USA; and Synoptic Document (No. 5)on Plastics Materials and Ardcles intended to come into contact with foodstuffs issued by Commission of theEuropean Communities.
Is 14998:2001
Indian Standard
POSITIVE LIST OF CONSTITUENTSOF MELAMINE-FORMALDEHYDE RESINS
IN CONTACT WITH FOODSTUFFS,PHARMACEUTICALS AND DRINKING WATER
1 SCOPE
1.1 This standard covers positive list of constituentsof melamine-formaldehyde(MF) resins, namely,manufacturing residues and necessary additives whichmay be regarded as safe for use, when properlyprocessed, in contact with foodstuffs, pharmaceuticalsand drinking water and when present only in theprescribed limits of concentration.
1.2 It does not purport to establish the suitability ofthe ingredient singly in a particular foodstuff fromother than toxicological consideration.
2 REFERENCES
The following standard contains provision which,through reference in this text, constitutes provision ofthis standard. At the time of publication, the editionsindicated was valid. All standards are subject torevision, and parties to agreements based on thisstandard are encouraged to investigate the possibilityof applying the most recent edition of the standardindicated below:
IS No. Title
9833:1981 List of pigments and colou~ants foruse in plastics in contact withfoodstuffs, pharmaceuticals anddrinking water
3 TERMINOLOGY
3.1 Melamine-Formaldehyde Resin
Melamine-formaldehyde resins are those producedwhen one mole of melamine is made to react with notmore than three moles of formaldehyde in watersolution, Part of the melamine fraction may bereplaced by urea or benzoguanamine,
3Q Melamine-Formaldehyde Moulding Materials
Melamine-formaldehyde resins mixed with refinedwood pulp (cellulose) or with untreated wood reducedto particulate form. This mixture may also containother optional adjuvant substances like lubricants and
flow promoters, catalysts, polymerization controlagents.
4 REQUIREMENTS
4.1 Basic Resin — As defined in 3.1.
4.2 Moulding Materials — As defined in 3.2.
43 Manufacturing Residue
43.1 Residual Monomers
Moulded articles made from melamine-formaldehydemoulding materials shall, when subjected to thefollowing tests, not yield more than 3 g formaldehydeper 100 mm2 of exposed surface in each test.
Moulded or representative mouldings shall be filled
with or immersed in a) distilled water, b) 3 percent(W/W) aqueous acetic acid, c) 10 percent (V/V)aqueous ethanol, each at 80°C and allowed to cool atambient temperature for 30 minutes. The ratio ofextractant volume to surface area of the moulding incontact with extractant shall be 1 ml to 100 mm2.
The formaldehyde content of the extractant is thenmeasured and the amount extracted per unit surfacearea obtained by calculation.
43.2 Catalyst
The residues of the following products used as catalystmay be present in the basic resin:
a) Phthalic anhydride; andb) Tetrachlorophthalic anhydride.
433 Polymerizxztion Control Agents
The residues of the following products maybe presentin the basic resin:
a) Hexamethylene tetramine; andb) Magnesium carbonate.
4.4 Polymerization Ingredienta
Polymerization ingredients may be present providedthat the manufacturer has obtained the specificapproval of concerned authority within any limitationsimposed by the authority.
1
IS 14998:2001
4.5 Auxiliary Items for Working may be present in MF resins:
4.5.1 Lubricants and Flow Promotersa) Stearic acid;b) Zinc stearate;and
The total lubricants and flow promoters shrdl be not c) Dioctyl phthalatemore than 3 percent of the finished resin except inthose cases wherein it is specifically prescribed.
4.6 Pigments and Colorants
The pigments and colorants used shall comply with4,5.1.1 The following lubricants and flow promo~m tie list and ]imits prescribed in IS 9833.
ANNEX A
(Foreword)
LIST OF INDIAN STANDARDS ON PLASTICS SUITABLE FOR USE IN CONTACT WITHFOODSTUFFS, PHARMACEUTICALS AND DRINKING WATER
IS No.
9833:1981
9845:1998
10141:2001
10142:1999
10146:1982
10148:1982
10149:1982
10151:1982
10171:1999
10909:1984
Title
List of pigments and colorants foruse in plastics in contact withfoodstuffs, pharmaceuticals anddrinking water
Determination of overall migrationof intended to come into contact withfoodstuffs — Method of analysis(second revision)
Positive list of constituents ofpolyethylene in contact withfoodstuffs, pharmaceuticals anddrinking water (/irst revision)
Polystyrene (crystal and high impact)for its safe use in contact withfoodstuffs, pharmaceuticals anddrinking water @rst revision)
Polyethylene for its safe use in con-tact with foodstuffs, pharmaceuticalsand drinking water
Positive list of constituents ofpolyvinyl chloride (PVC) and itscopolymers in contact withfoodstuffs, pharmaceuticals anddrinking water
Positive list of constituents of poly-styrene (crystal and high impact) incontact with foodstuffs, pharmaceuti-cals and drinking water (AmendmentNo. 1)
Polyvinyl chloride (PVC) and itscopolymers for its safe use in contactwith foodstuffs, pharmaceuticals anddrinking water
Guide on suitability of plastics forfood packaging (second revision)
Positive list of constituents ofpolypropylene and its copolymers in
IS No.
10910:1984
11434:1985
11435:1985
11704:1986
11705:1986
12229:1987
12247:1988
12248:1988
12252:1987
Title
contact with foodstuffs, pharmaceutic-als and drinking water (@trevision)
Polypropylene and its copolymers forita safe use in contact with foodstuffs,pharmaceuticals and drinking water
Ionomers resins for its safe use incontact with foodstuffs, pharmaceutic-als and drinking water
Positive list of constituents ofionomer resins for its safe use in con-tact with foodstuffs, pharmaceuticalsand drinking water
Ethylene/acrylic acid (EAA)copolymers for its safe use in contactwith foodstuffs, pharmaceuticals anddrinking water
Positive list of constituents ofEthylene/acrylic acid (EAA)copolymers for their safe use in con-tact with foodstuffs, pharmaceuticalsand drinking water
Positive list of constituents ofpolyalkylene terephthalates (PET &PBT) for their safe use in contact withfoodstuffs, pharmaceuticals anddrinking water
Nylon-6 polymer for its safe use incontact with foodstuffs, pharmaceuti-cals and drinking water
Positive list of constituents of Nylon-6 polymer for its safe use in contactwith foodstuffs, pharmaceuticals anddrinking water
Polyalkylene terephthalates (PET &PBT) for their safe use in contact withfoodstuffs, pharmaceuticals anddrinking water
1
2
IS No.
13449:1992
13576:1992
13577:1992
,f
13601:1993ti
Title
Positive list of constituents of ethylenevinyl acetate (EVA) copolymem incontact with foodstuffs, pharmaceuti-cals and drinking water
Ethylene methacrylic and (EMAA)copolymers and terpolymers for theirsafe use in contact with foodstuffs,pharmaceuticals and drinking water
Positive list of constituents ofethylene methacrylic (EMAA)copolymers and terpolymers in con-tact with foodstuffs, pharmaceuticalsand drinking water
Ethylene vinyl acetate (EVA)copolymers for its safe use in contactwith foodstuffs, pharmaceuticals anddrinking water
IS No.
14971:2001
14972:2001
14996:2001
14997:2001
14999:2001
IS 14998:2001
Title
Polycarbonate resins for its safe usein contact with foodstuffs, phar-maceuticals and drinking water
Positive list of constituents ofpolycarbonate resins in contact withfoodstuffs, pharmaceuticals anddrinking water
Positive list of constituents ofmodified poly (phenylene oxide)(PPO) resins in contact withfoodstuffs, pharmaceuticals anddrinking waterModified poly (phenylene oxide)(PPO) resins for its safe use in contactwith foodstuffs, pharmaceuticals anddrinking waterMelamine-formaldehyde resins forits safe use in contact with foodstuffs,pharmaceuticals and drinking water
I
. .. .
. . . . ... . . .,”. ,.J”.. . . . . . . .,
~
IS 14998:2001
ANNEX B
(Foreword)
COMMITTEE COMPOSITION
Plastics Sectional Committee, PCD 12
Organization Representative(s)
Internet Exchange Next.com Limited, Mumbai SHRISARUPCHOWDHARY(Chabnsan)
Arnines and Plasticizers Ltd, Mumbai SHRJV. V. KULKARNIDR R. V. UTEKAR (Alternate)
Bakelite Hylam Ltd, Hyderabad DRC. S.NARASIMHANDR M. BALAKRISHNAN(Alternate)
BuildingMaterialsandTechnologyPmmdm Council,New Delhi SHRJJ. SENIXWTA
Central Institute of Plastics Ettgineeritm and Technology, Chersnai DRVIJAIKUMAR-.
Central Food Technological Research Institute, Myaore
Gas Authority of India Ltd, Noida
Gharda Chemcials Ltd, Thane
GE Plastics India Limited, Gurgaon
Gujarat State Fertilizers Company Limited, Vadodara
Haldia Petrochemicals Ltd, Kolkata
HindustarrPolymers Ltd, Mumbai
Indian Centre for Plastics in Environment, MumbaiIndian Petrochemicals Corporation Limited, Vadodara
Indian Plastics Institute, Mumbai
Indian Institute of Packaging, Mumbai
Indian Toxicologicrd Research Centre, LucknowJain Irrigation Systems Ltd, Jalgaon
Larsen & Toubro Ltd, Mumbai
Ministry of Defence (R&D), Kattpur
Ministry of Dcfence, RDSO, Lucknow
Ministry of Health and Family Welfare, DGHS, New Delhi
Ministry of Food Recessing Industries, New DelhiNational Chemical Laboratory, Pssne
National Dairy Development Board, Anand
National Organic Chemical Industries Ltd, Mumbai
Nuchem Ltd, FaridabadPemrali Wallace Ltd, Bhopal
Reliance Industries Ltd, Mumbai
Saint-Gobain Vetrotex India Ltd, Hyderabad
Shivalik Agro-Poly Products Ltd, Prsrwanoo,H.P.
Shriram Fertifizcrs & Chemcials, Kota
Shriram Institute for Industrial Research, Delhi
DR K. PALANNELU(Alternate)SHIUS. K. KUMAR
SHRIBALDEVRAJ (Alternate)SHRISHIVAHBASU
SHRIV. K. SINGH(Alternate I)SHRIMANJSHKHANDELWAL(Alternate II)
DRB. K. DESAIDR U. M. VAKIL(Alternate)
GENERALMANAGERDR RASHMIBHARDWAJ(Alternate)
SHRIB. D. ADHVARWDRY. P. SJNGH(Alternate)
SHRISHANKARBANERIEESHRJAMtTAVASANYAL(Alternate)
SHRtS. V. PARVEENSHRIN. C. DHOCENDRANATH(Alternate)
DRA. N. BHATSHRJJ. B. KAMAT
SHRIV. C. FRANCJS(Alternate)SHRID. R. PATSL
SHRIR. K. AGGARWAL(Alternate)SHRIP. V. NARAYANAN
DR N. G. MOKASHI(Alternate)DRV. P. SHARMADRH. C. MRUTHYUNIAYA
SHRIS. B. JOSHI(Alternate 1)SHRIA. P. CHOUDHARt(Alternate II)
SHRtV. MOHANSHRIR. SUBAfio (Alternate)
SHRJM. N. SAWDs L. D. KHANDPAL(Alternate)
JomrrDIRECTOR(RUBBER)DItSS~R (SS) @ltemate)
ADDLDntscros GENERAL(PFA)SHRISUNDARLAL(Alternate)
SHRJO. P. WDs S. S. MAHAJAN
DRS. S. KULKARNI(Alternate)DRR. S. LATNANA
SHRtS. K. KHANDELWAL(Alternate)SHRIV. K. SHARMA
SHRJJ. K. VADDDARtA(Alternate)DRR, M. MEHTASHRJC. C. SAKARDA
SHRJS. K. KODE.WA(Alternate)DRY. B. VASUDEG
DRK. S. JADHAV(Alternate)SHRJS. SUNDARAM
SHRJS. K. GHOSH(Alternute I)DRB. J. C. BASU(Ahemute 11)
SHRJARUNANANDSHruYcroIW KAPUR(Alternate)
SHrttM.S.TRIPATH1SHRIR. C. GUPTA(Alternate)
DRR. C. SOOD
4
IS 14998:2001
\
(Corrfirsuedjrom page 4)
Organization
Supreme Petrochem Ltd, Mumbai
The All India Plastics Manufacturers Association, Mumbai
Tara Engineering& Locomotive Co Ltd, Jamshedpur
The Plastics & Lhroleums Export Promotion Council, MumbaiVIP Industries, Mumbai
XPRO India Ltd. Faridabad
BIS Directorate General
Representative(s)
SHRIR. RANCiARAJANSHRIB. A.RAKHANOI(Ahemate)
SHRIR. K. AGOARWALSHRIK. B. fMSWARAN(Akemate)
SHRIU. K. NATHSMTA. D. SATJSE(Alternate)
SHRIR. P. KALYANPURSHRISIDDHARTHAROY
SHRIA. S. DALvE(Afternate)SHRIC. BHASKAR
SHRIMAN~OHANKSUSHAN(Alternate)StrtuANJANKAtL Drector & Head (PCD)‘ [Representing Director General (Ek-oflcio Member)]
● Merrrber-SecretarySHRtT, KALAIVANAN
Joint Dicector(pCD), BIS
Plastics in Food Packaging and Allied Industries Subeommittee, PCD 12:12.
Central Food Technological Research Institute, MysoreAll India Plastic Industries Association, DelhiAS& T India Limited, New DelhiBakelite HykurrLtd, Mumtil
Britannia Industries Ltd, Bangafore
Centre for Processed Food, Bangalore
Central Committee for Food Stan&rds(Dircetorate General of Health Services), New Delhi
Central Food Laboratory, Kolkata
Defence Food Research Laboratory, Mysore
Drugs Controller (India), New DelhiGE Plastics India Limited, Distt Vadodara
Gujarat State Fertilizers Company Limited, Vadodara
Haldia Petrochemicals Ltd, Kolkata
Hindustan Lever Ltd, Mumbai
Hitkan Potteries Ltd, New DelhiIndian Institute of Packaging, Mumbai
Indian Petrochemicals Corporation Limited, Vadodara
Indian Toxicological Research Centre, LucknowNational Dairy Development @ard, AnandNational Organic Chemicals Industries Ltd, Mumbai
Reliance Industries Ltd, Mumbai
Rollantainers Ltd, FaridabadShrimm Fertilizers& Chemicals, Kota
Supreme Petrochem Ltd, Mumbai
XPRO India Ltd, Faridabad
SHRJK. R. KUMAR(Convener)SHRIRAWKUMARSHRIG. D. AGRAWALDR C. SANKAR
SHRIS. N. MURTHY(Alternate)SHRIG. S. AURORA
SHRIM. R. SUNDAR(Alternate)SHRtR. PRAKASH
SHRICHETAN L. HANCHATE(Alternate)THE AssTT DIRECKIRGENERAL(PFA)
DR K. C. GUHADRS. VANCHINATHAN(Alternate)
SHRIANILAGARWALSHRIA. N. SRIVASTAVA(Akwnate)
DRP. DASGUPTADRG. MUKHOPADHAYA
DR RASHMIBHARDWAJ(Alternate)SHRIB. D. ADHVARYU
DRY, P. SiNGH(Alternate)SHRIAMITAVASANYAL
SHRIRAJ DATTA (Alternate)SHRIM. K. LAHIRI
SHRIP. S. LAKSHMANAN(Alternate)SHRIMILINDBHOLEMs M. C. DORDI
SHRIN. C. SAHA(Alternate)SHRIJ. B. KAMAT
SHRIV. C. FRANCIS(Altemute)DRP. K. SETHSREXECUTIVESHRIJ. K. VADDDARtA
SHR]V. K. SHARhSA(Alternate)DRK. S. JADHAV
DRR. RANGAPRASAD(Alternate)SHRISANJAYAVARMASHRIM. S. TRIPATHI
SHRtR. C. GUPTA(Alternate)SHRIR. RANGARAJAN
SHRIB. A. RAKHANGI(Alternate)SHRIPANKAJMJTHEL
SHRIVtt.rEs’TGUPTA(Alternate)
w
5
—.9 e%
Bureau of Indian Standards
BIS is a statutory institution established under the Bureau of Indian Standards Act, 1986 to promoteharmonious development of the activities of standardization, marking and quality certification of goodsand attending to connected matters in the country.
Copyright
61S has the copyright of all its publications. No part of these publications may be reproduced in anyform without the prior permission in writing of 61S. This does not preclude the free use, in the courseof implementing the standard, of necessary details, such as symbols and sizes, type or gradedesignations. Enquiries relating to copyright be addressed to’the Director (Publications), 61S.
Review of Indian Standards
Amendments are issued to standards as the need arises on the basis of comments. Standards arealso reviewed periodically; a standard along with amendments is reaffirmed when such review indi-cates that no changes are needed; if the review indicates that changes are needed, it is taken up forrevision. Users of Indian Standards should ascertain that they are in possession of the latest amend-ments or edition by referring to the latest issue of ‘BIS Catalogue’ and ‘Standards: Monthly Additions’.
This Indian Standard has been developed from Doc : No. PCD 12( 1331).
Amendments Issued Since Publication
Amend No. Date of Issue Text Affected
BUREAU OF INDIAN STANDARDS
Headquarters :
Manak Bhavan, 9 Bahadur Shah Zafar Marg, New Delhi 110002 Telegrams : ManaksansthaTelephones :3230131, 3233375,3239402 (Common to all offices)
Regional Offices : Telephone
Central :
Eastern :
Northern :
Southern :
Western :
Branches :
Manak Bhavan, 9 Bahadur Shah Zafar Marg
{
3237617NEW DELHI 110002 3233841
1/1 4 C.I.T. Scheme Vll M, V. 1.P. Road, Kankurgachi
{
3378499,3378561KOLKATA 700054 3378626,3379120
SCO 335-336, Sector 34-A, CHANDIGARH 160022
{
603843602025
C.I.T. Campus, IV Cross Road, CHENNAI 600113
{
2541216,25414422542519,2541315
Manakalaya, E9 MlDC, Marol, Andheri (East)
{
8329295,8327858MUMBAI 400093 8327891,8327892
AHMEDABAD. BANGALORE. BHOPAL. BHUBANESHWAR. COIMBATORE.FARIDABAD. GHAZIABAD. GUWAHATI. HYDERABAD. JAIPUR. KANPUR.LUCKNOW. NAGPUR. NALAGARH. PATNA. PUNE. RAJKOT. THIRUVANANTHAPU RAM.
Printedat Prabhat Offset Press, New Del-ii-z