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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

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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

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