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 14972 (2001): Positive List of Constituents ofPolycarbonate Resins in Contact with Foodstuffs,Pharmaceuticals and Drinking Water [PCD 12: Plastics]

am m,hl--l-aa-a

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I

POSITIVE

Indian Standard

LIST OF CONSTITUENTS OFPOLYCARBONATE RESINS IN CONTACT

WITH FOODSTUFFS, PHARMACEUTICALSI/ AND DRINKING WATERIt

ICS 67.250; 83.080.20

.

IBUREAU OF INDIAN STANDARDSMANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG

NEW DELHI 110002

1 (ICI[)IWY 2001 Price Group 3

I

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Plastics Sectional Committee, PCD 12

FOREWOR1)

This Indian Standard was adopted by the Bureau of Indian Standards, after the draft finalized by PlasticsSect ional Comtn it tee had been approved by the Petroleum Coal and Related Products Division Council.

Polycarbonatc linds wide use in food contact and health care applications. Some of the most important andknown applications of polycarbonate in this area are infant feeding bottles, drinking water containers, micro-ovenable food containers, blood oxygenator, dialyzer, tubes, intravenous stopcocks, etc. High molecular weight

polycarbonatc is inert and essentially insoluble in the compounds of food, water or body fluid with which itcomes in contact in the above applications and in itself does not pose any toxic hazard. It is, therefore, possiblethat some transfer will occur of polymer additives, adventitious impurities such as monomers. residual catalystsand solvents and low molecular weight polymer fractions from bulk of polycarbonate into the food, water orbody fluid \vitll consequent toxic hazard to the user. The occurrence of acute toxicity due to polycarbonate in

contact with food, water or body fluid is most unlikely, since only trace quantities of potentially toxic materialsare likely to migrate. However, the accumulation of these potentially toxic materials with time may lead tohazards which may be serious.

Polycarbonate resins are considered safe for use as articles or components of articles intended for use in producing,manufacturing, packing, processing, preparing, treating, packaging, transporting or holding food in accordancewith US FDA Regulations 21 CFR 177, 1580 and of the Regulations of several other countries like Germany.

This standard is intended to be used with 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 themanufacturers and suppliers as well as the processors and users of polycarbonate material to derive maximum

benefits. Besides, it may also serve as basis for official agencies to frame suitable legislation to ensure effectivesafeguards for the safety and health of consumers where polycarbonate in food contact and related applicationsare concerned.

The list of additives prescribed in the current positive list are based on the information available in the draftsynoptic documerlt-5 on plastic materials and articles intended to come into contact with foodstuffs issued bycommission of European Communities and 182 Notification-Federal Public Health Gazette 32,211 (1989) ofGermany,

The composition of the Committee responsible for formulation of this standard is given in Annex B.

IS 14972:2001

Indian Standard

—-...2

POSITIVE LIST OF CONSTITUENTS OFPOLYCARBONATE RESINS IN CONTACT

WITH FOODSTUFFS, PHARMACEUTICALSAND DRINKING WATER

1 SCOPE

1.1 This standard covers positive list of constituentsof polycarbonate resins namely, the polymer,copolymer, manufacturing residues and necessaryadditives which may be regarded as safe for use whenproperly processed in contact with foodstuffs,pharmaceuticals and drinking water and when presentonly in the prescribed limits of concentration.

1.2 It does not purport to establish the suitability ofthe ingredients singly in a particular foodstuffs fromother than toxicological considerations.

2 REFERENCE

The following standard contain provisions, which,through reference in this text, constitute provisions ofthe standard. At the time of publication, the editionindicated was valid. All standards is subject to revision,and parties to agreement based on the standard areencouraged to investigate the possibility of applyingthe most recent edition of the standard indicated below:

IS No. Title9833:1981 List of pigments and colorants for

use in plastics in contact with food-stuffs, pharmaceuticals and drinkingwater

3 TERMINOLOGY

3.1 Polycarbonate

A basic resin produced by condensation poly-merization of bisphenol-A either along or incombination with other bisphenols with phosgene andcondensation polymerization products of the abovecombination with phthalic acid dichlorides.

4 REQUIREMENTS

4.1 Basic Resin

As defined in 3.1 and-their blends in any mixingproportions.

4.2

The

Raw Materials

following raw materials shall be used:

a)

b)

c)

d)

e)

o

g)h)

j)

k)

m)

n)

P)

q)

Bis-phenol-A;

4,4-dioxy-bi-phenyl- 1,1-cyclohexane;

2,6-bis-(2,hhydroxy-5 -methyl, benzyl)-4-methylphenol, Max, 1.0 percent;

1,4-bis-(4,4’’-dihydroxytriphenymethyl)l)-benzene, Ma.x, 1.0 percent;

Diphenyl carbonates;

Phosgene;

Terphthalic acid dichloride;

Isophathalic acid dichloride;

4,4’’-dioxy-diphenyl-3,3’’-Oxindole, Max, 1.0percent;

3,3-his-( 3-methyl-4 hydroxyphenyl )-2-indolinone, Max, 1.0 percent;

Phenol, Max 2 percent;

Tertiary butyl phenol, Max 3 percenc

4-(1, 1,3,3-tetramethyl-butyl)-phenol, Max, 5percent; and

Paracumylphenol, Ma, 4 percent.

4.3 Manufacturing Residues

Following manufacturing residues can be present inthe basic polycarbonate materials within the specifiedlimits.

4.3.1 Catalyst Residues

a) Triethyl amine

}total Max 0.05 percent

b) Tributyl amine

4.3.2 Emulsljier Residues

a) Lauryl sulphate

b) Coconut butter}

total Max 0.1 percentalkyl sulphate

4.3.3 Solvent Residues

a) Methylene dichloride, Max 0.001 percent;and

b) Monochlorobenzene, Max 0.05 percent.

4.3.4 Neutralizing Agent and Bufler Residues

a) Sodium hydroxide; and

b) Phosphoric acid.

----

1

/

IS 14972:2001

4.4 Polymerization Ingredients

Polymerization ingredients may be present providedthat the manufacturer has obtained the specificapproval of concerned authority within any limitationsimposed by the authority.

4.5 Auxiliary Items for Working

4.5.1 Internal Lubricants

a)

b)

c)

d)

Calcium stearate;

Ester of montanic acids with ethanedioland/or with 1,3-butanediol and mixtures ofthese esters with unesteritied montanic acidas well as their calcium salts, A4izx0.1 per-cent in total;

Esters of aliphatic saturated acids (C,,- C24)with monovalent aliphatic saturated alcohols(C,,- C,,) also in form of hardened sperm(whale) oil, Max 3.0 percent; and

Pentaerythrotolesters of saturated evennumber aliphatic monocarboxylic acids ofthe chain length (C,~– CJ, Mizx 1.0 percent

4.5.2 Stabilizers and Antioxidants

a)

b)

c)

d)

e)

o

g)

h)

Tri-cyclohexyl phenyl-phosphite, Max 0.05percent;

2-(2 -hydroxy-5 -methyl phenyl)-benzotriazole, Max 0.6 percenq

Tris[(3-ethyloxaethanyl-3)-methyl]-phos-phite, Max 0.1 percenq

Tris(mono-nonylphenyl) phosphite alone orin combination with Tris(dinonyl phenyl)-phosphite, Max 0.1 percent;

N-octadenyl-(4-hydroxy-3,5-ditertbutyl-phe-nyl)-propionate, Mm 0.3 percent;

Sodium hydrogen sulphite ;

Tris(3 ,4-ditertbutyl-phenyl)-phosphite, Max0.3 percent;

Tetrakis-(2,4-ditertbuty lphenyl)-4,4-biphenylene-diphosphite either alone or in amixture with 2,4-tertbutylphenol (Max 5 per-

0

k)

m)

cent in mixture) and tris-(2,4-ditertbutylphenyl) phosphite (Mix 15 percentin mixture) Max 0.3 percen~

Bis-(2,4-ditertbutylphenyl)-pentaerythritol-diphosphite (stabilized with Max 1 percent);

Tri-isopropanolamine as hydrolysisprotestant), Max 0.25 percent and

2- [(2-hydroxy-3,5-bis-( 1,,1-dimethyhenzyl)-phenyl]-benzotriazole, Max 0.3 percent.

4.5.3 MouId Release Agents

a) Zinc stearate; and

b) Organopolysilioxane with methyl and/orphenyl groups (viscosity at 20°C, 100centistokes, Max).

4.5.4 Dispensing Agents

a) Copolymers of styrene, methylmethacrylateand glycidyl methacrylate( ratio 4:4:2), Ma1.0 percent; and

b) Epoxidized soya beam oil with 8 percent Maxepoxide oxygen content and iodine numberof not more than 6, Max 0.1 percent.

4.5.5 Pigments and Colorants

The pigments and colorants used shall comply withlist and limits prescribed in IS 9833.

4.5.6 Other Additives

Acrylonitrile, butadiene and styrene terpolymerconforming to Indian standard where ever existingfor its safe use in contact with foodstuffs,pharmaceuticals and drinking water, Ma 50 percent.

In polycarbonate – ABS blends of following can alsobe incorporated as mould release agent in addition tothose mentioned in 4.5.3:

a)

b)

Glycerol esters of naturally occurringsaturated and unsaturated fatty acids, Maxpercent; and

Esters as described in 4.5.l(iii), Max 1.0percent.

/

,.9$4

-- .—.

IS 14972:2001 )k

ANNEX A:)

“1

..-..

(Forewor@)

LIST OF INDIAN STANDARDS ON PLASTICS SUITABLE FOR USE IN ~...,a

CONTACT WITH FOODSTUFFS, PHARMACEUTICALS AND DRINKING WATER1

1i.,.

1SNo.

9833:1981

9845:1998

10141:1982

10142:1999

10146:1982

10148:1982

10149:1982

10151:

10171:

10909:

982

999

000

10910:1984

11434:1985

11435:1985

Tit[e

List of pigments and colourant$ foruse in plastics in contact withfoodstuffs, pharmaceuticals anddrinking waterDetermination of overall migrationof constituents of plastics materialsand articles intended to come incontact with foodstuffs — Method ofanalysis (second revision)Positive list of constituents ofpolyethylene in contact withfoodstuffs, pharmaceuticals anddrinking water @rst rmision)Polystyrene (crystal and highimpact) for its safe use in contactwith foodstuffs, pharmaceuticals anddrinking water (first revision)Polyethylene for its safe use incontact with foodstuffs,pharmaceuticals and drinking waterPositive list of constituents ofpolyvinyl chloride and itscopolymers for safe use in contactwith foodstuffs, pharmaceuticals anddrinking waterPositive list of constituents ofpolystyrene (crystal and high impact)in contact with foodstuffs,pharmaceuticals and drinking waterPolyvinyl chloride (PVC) and itscopolymers for its safe use in contactwith foodstuffs, pharmaceuticals anddrinking waterGuide on suitability of plastics forfood packaging (second revision)Positive list of constituentspolypropylene and its copolymers forits safe use in contact with foodstuffs,pharmaceuticals and drinking water@rst revision)Polypropylene and its copolymers forits safe use in contact with foodstuffs,pharmaceuticals and drinking waterIonomers resins for its safe use incontact with foodstuffs,pharmaceuticals and drinking waterPositive list of constituents of

1S No.

11704:1986

11705:1986

12229:1987

1224’7:1988

12248:1988

12252:1987

13449:1992

13576:1992

13577:1992

13601:1993

14971 : 2001

Title

ionomer resins for its safe use incontact with foodstuffs, pharma-ceuticals and drinking waterEthylene/acrylic acid (EAA) co-polymers for its safe use in contactwith foodstuffs, pharmaceuticals anddrinking waterPositive list of constituents ofEthylene/acrylic acid (EAA) copoly-mers for their safe use in contact withfoodstuffs, pharmaceuticals anddrinking waterPositive list of constituents ofpolyalkylene terephthalates (PET &PBT) for their safe use in contactwith foodstuffs, pharmaceuticals anddrinking waterNylon-6 polymer for its safe use incontact with foodstuffs, pharmac-euticals and drinking waterPositive list of constituents of Nylon-6 polymer for its safe use in contactwith foodstuffs, pharmaceuticals anddrinking waterPolyalkylene terephthlates (PET &PBT) for their safe use in contactwith foodstuffs, pharmaceuticals anddrinking waterPositive list of constituents ofethylene vinyl acetate (EVA) copoly-mers in contact with foodstuffs,pharmaceuticals and drinking waterEthylene methacrylic acid (EMAA)copolymers and terpolymers for theirsafe use in contact with foodstuffs,pharmaceuticals and drinking waterPositive list of constituents ofethylene methacrylic acid (EMAA)copolymers and terpolymers incontact with foodstuffs, pharma-ceuticals and drinking waterEthylene vinyl acetate (EVA)copolymers for its safe use in contactwith foodstuffs, pharmaceuticals anddrinking waterPolycarbonate resins for its safe usein contact with foodstuffs,pharmaceuticals and drinking water

. . ...,!. .. ’.,, ,., ., :., . >

%?

!, 94%

IS 14972:2001

ANNEX B

(Foreword)

COMMITTEE COMPOSITION

Plastics Sectional Committee, PCD 12

Organization

InternetExchangeNext,com Limited, MumbaiAmines and Plasticizers Ltd, Mumbai

Bakelite Hylam Ltd, Hyderabad

Building Materials and Technology Promotion Council,New DelhiCentral Institute of Plastics Engineeringand Technology,Chennai

Central Food Technological Research Institute,Mysore

Gas Authority of India Ltd, Noida

GE Plastics India Limited, Gurgaon

GhardaChemicals Ltd, Thane

Gujarat State Fertilizers Company Limited, Vadodara

Haldia Petrochemicals Ltd, Kolkata

Htndustan Polymers Ltd, Mumbai

Indian Centre for Plastics in Environment MurnbaiIndian PetrochemicalsCorporation Limited,Vadodara

Indian Institute of Packaging, Mumbai

Indian Plastics Institute, Mumbai

Indian Toxicological ResearchCentre, LucknowJain Irrigation Systems Ltd, Jalgaon

Larsen & Toubro Ltd, Mumbai

Mhistry ofDefence (R&D), Kanpur

Ministry ofDefence, RDSO, Lucknow

Mhristry of Health and Family Welfare, DGHS,New Delhi

Mbsistryof Food ProcessingIndustries,New DelhiNational Chemical Laboratory,Pune

National Dairy Development Board, Anand

National Organic Chemical IndustriesLt~ Mumbai

Nuchem Ltd, FaridabadPermali Wallace Ltd, Bhopal

Representative(s)

SsrruSARUPCHOWTM4RY(Chairman)

SHIUV.V.KUrXAIUQDR R. V. UTEKAR(Ahernale)

DRC. S. NARASIMHAN

DR M. BALAXSUSHNAN(Alternate)SHIUJ. SENGUPTADRVUNKW

DRK.P,w,wrvuu (Alternate)

SSSRSS. K. KW

StrruBALDEVMS (Alternate)SHSUSHIVAJSBASU

SHIUV. K. SrNCH(Alternate I)SHSUMANISHKHANDELWAL(AfferrrateII)

G~ MANACER

DR(SHIUMATI)RASHMIBHARDWAJ(Alternate)DRB. K. Dsmr

DRU. M. VAXSL(Alternate)SmoB. D.ADHVARVU

DRY. P. SINGS+(Allernate)sHRrsHANKARBANEIUES

Ssuu AhUIAVASANYAL(Alternate)Smu s. v. PARvEEN

SHSUN. C. DHOCENDSLANATH(Alternate)

DRA.N. BHATSHRSJ.B. KAMAT

SHSUV.C. FRANCM(Alternate)Sr-rRIP.V.NARAYANAN

DRN. G. MOKASHS(AJ/ernate)SrnuD. R. PATEL

SHSUR. K. AGOARWAL(Akwnote)DRV.P. SHARMA

DRH. C. MRUEMJNJAYA

Mu S.B. Josra (AlternuteI)SHSUA. P. CHOUDHASU(AlternateII)

SHRSV.MmSmuR. SrJBARAO(Alternute)

SW M. N. SARAFDRL. D. KHANOPAL(Alfernute)

Jomrr-OR (RUBBER)

DIRSCrOR (SS)(Alternate)ADDLDmCrORGENERAL(PFA)

SssroSUNDARLAL(Akerrrute)SmuO.P. GFRADRS. S. MMSMAN

DRS. S. KULXARNS(Alternote)

DR R. S. LATHANA

SsnuS. K. KHAMELWAL(Alternate)SHRIV.K.SHARMA

SHSOJ. K. VADDDASUA(Alternate)DRR. M. -ASHSUC. C. SAKARDA

SHRIS. K. KODESSA(Affernate)

-L’

1,-–.”

,,,.,..

. ..-

:<

,

(Continued onpage 5)

4

Organization

RelianceIndustriesLtd, Mumbai

IS 14972:2001

(Continuedfiom page 4)

Representative(s)

DRY.B. VASUDEODR K. S. JADHAV(Mferwte)

Saint-GobainVetrotex India Ltd, Hyderabad

ShivalikAgro-Poly Products Ltd, Psrrwanoo(H.P.)

Shriram Fertilizers& Chemcials, Kota

Shriram Institute for Industrial Research, DeNdSupremePetrochemLtd,Mumbai‘

k“’Tata~ngg & Locom tl~eCOLtd, JaMsh8dptw ‘.: :,.,

1:The All IndiaPlastic h@rtrMtrrehAsswMon, Mumbai

The f!lsstics& Linol~u s ExportPromotionCouncil, MumbaiTVIP Industries, Mu~ba

XPRO India Ltd, Faridabad

BIS Directorate General

SHRIs. SONDARAM

Smu S. K. GHOSH(Alternate 1)DR B. J. C. BASU (Alternate 11)

SHruARoNANANDStrroYDGRAIKAPUR(Alternate)

Smu M. S. TRIPATHI

Smu R. C. GUFTA(Alternate)

DRR. C. SOODSmaR. RANGARAIAN

SHSUB. A. RAKHANGI(Alternate)

SHSOU. K.NATHSaraMATSA.D. SAmss(Akernate)

SaroR.K.AGGARWALSHRSK.B. EASWARAN(Alternate)

SmaR.P.KALYANPoRS-auSIDDHARmROY

SHRSA. S.DALVS(Alternate)

SrurrC. BhaskarSsrruMANMOHANKSUSHAN(Alternate)

SHRSANIANKmj Dkector & Head (PCD)Representing Director General (Er-oficio)]

Member-Secreta~

SmrrT.WANANJoint Director (PCD), BIS

Plastics in Food Packaging and Allied Industries Subcommittee, PCD 12:12

Organization

Central Food TechnologicalResearchInstitute,MysoreAll India Plastic IndustriesAssociation, DelhiAS& T India Limited, New DelhiBakelite Hylam Ltd, Mumbai

BritanniaIndustries Ltd, Barrgalore

Centre forProcessed Food, Bangalore

Central Committee for Food Standards (DirectorateGeneralof Health Services), New Delhi

Central Food Laboratory, Kolkata

DefenceFood Research Laboratory,Mysore

Drugs Controller(India), New DelhiGE Plastics India Ltd, Dktt Vadodara

Gujarat State Fertilizers Co Ltd, Vadodara

Haldia Petrochemicals Ltd, Kolkata

Hlndustan Lever Ltd, Mumbai

Hitkari Potteries Ltd, New DelhiIndian Institute of Packaging, Mumbai

Representative(s)

Smr K. R. KUMAR(Convenor)Sr+ruRAWKUMARSmrrG. D.AGRAWALDRC.SHANKAR

SmuS.N. MurtIHY(Alternate)

SrmrG. S. AURORA

SmuM. R. SONDAR(Alternate)

Sara R. PRAKASHSr-troCm?rANL. HANfX41%(Akwnate)

THEASSmDtRECTORGStWRM(PFA)

DRK.C. GuwDR S. VANCMNATHAN(Alternate)

Stau&n. AOARWALSMUA.N. SIUVASTAVA(Afternate)

DRP.DASGUPTA

DRG. MUXHOPADHVAYA

DR(SrnaMATS)RAsmrrBHARDWAI(Alternate)

SHSUB.D.ADHVARVUDRY.P. SrNGH(Alternate)

SHtUkAVA SANYALSHSUh DAITA(Alternate)

SarrrM. K. LASMUSsmoP. S. LAXSHMANAN(Alternate)

SrurIIWumBHorxMs M. C. Dortm

SsrruN. C. SAHA(Alternate)

,,

I

/

(Continued onpage 6)

5

IS 14972:2001

(Continuedfrom page 5)

Organization

Indian PetrochemicalsCorporation Ltd, Vadodara

IndianToxicological Research Centre, LuckrrowNational Dairy Development Board, ArmndNational Organic Chemicals Industries Ltd, Mumbai

Reliance Industries Ltd,Mumbai

Rolkmtainers Ltd, FaridabadSriram Fertilizers& Chemicals, Kota

Supreme Petrochem Ltd, Mumbai

XPRO lndi~ Faridabad

6

Representative(s)

SmuJ. B. K.4M4TSHFOV. C. FRANCIS(Alternate)

DKP.K. SrmrSENSORExmmvEStrruJ. K. VAOGDARIA

SEUUV. K. SHARMA(Alternate)DrrK. S.JADHAV

DRR. RANGAPRASAD(Alternate)

SHRISANIAYAVAIIMA

SIN M. S. TiUPATHr

SrDUR. C. GUFTA(Ahernute)

SrurIR. RANGARAIANSrrroB. A. RAKHANGI(Alternate)

SsrroPN4K,4JMr’rlmSriIUVrM?ETGOPTA(Alternate)

Bureau of Indian Standards

BIS is a statutory institution established under the Bureau of Indian Standards zfct,. 1986 to promoteharmonious development of the activities of stardardization, marking and quality certification of goods andattend ing to connected matters in the country.

Copyright

BIS has the copyright of all its publications. No part of these publications may be reproduced in any formwithout the prior permission in writing of BIS. This does not preclude the free use, in the course ofimplementing the standard, of necessary details, such as symbols and sizes, type or grade designations.Enquiries relating to copyright be addressed to the Director (Publication), BIS.

Review of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments. Standards are also reviewedperiodically; a standard along with amendments is reaffirmed when such review indicates that no changes areneeded; if the review indicates that changes are needed, it is taken up for revision. Users of Indian Standards

should ascertain that they are in possession of the latest amendments or edition by referring to the latest issueof ‘BIS Handbook’ and’ Standards: Monthly Additions’.

This Indian Standard has been developed from Dot: No. PCD 12 ( 1328).

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: Manaksanstha

Telephones: 3230131,3233375,3239402 (Common to all offices)

Regional Offices: Telephone

Central : Manak Bhavan, 9 Bahadur Shah Zafar Marg 323’7617,3233841

NEW DELHI 110002

Eastern : 1/14 C.I.T. Scheme VII M, V.I.P. Road, Kankurgachi{

3378499,3378561

CALCUTTA 700054 3378626,3379120

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603843602025

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2541216,25414422542519,2541315

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