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है”ह”ह

IS 12229 (1987): Positive list of constituents ofpolyalkylene terephthalates (PET, PBT) for their safe usein contact with foodstuffs, pharmaceuticals and drinkingwater [PCD 12: Petroleum, Coal, and Related Products]

IS 8 12229 - 1987

Indian Standard POSITIVE LIST OF CONSTITUENTS OF

POLY ALK.Y LENE TEREPHTHALATES ( PET AND PBT ) FOR THEIR SAFE USE IN. CONTACT

WITI FOQDSTUFFS, PHARMACEUTICAL AND DRINKING WATER

( First Reprint SEPTEMBER 1991)

UDC 678.644.142’524:621.798:663/664+615.1/1.4:614.8

BUREAU OF INDIAN STANDARDS

MANAK BHAVAN, 9 BAHADLJ R SHAH ZAFAR MARG

NEW DELHI 110002

Gr2 June 1988

Indiun Standurd 1s I 12229 - 1997

POSITIVE LIST OF CONSTITUENTS.OF POLYALKYLENE TEREPHTHALATES(PI?T AND

PBT) FOR THEIR SAFE'USE IN .CONTACT WITH FOODSTUFFS, PHARMACEUTICAL AND

DRINKING WATER

Ow FOREWORD

0.1 This Intlian Standard was adopted by the Bureau of Indian Standards on 10 December 1987, after the tlraft finalized by the Plastics Sectional Commiitee had been approved by the Petroleum, Coal and Kelatecl Products Division Council.

0.2 Plastics are now being used on a large scale for packaging of fi,odstuffs and pharmaceuticals. Where direct contact occurs between the packed commodity and the plastics, the high-molecular-mass polymer’; being inert *anil essentially insoluble in food, itself, does not pose a toxichazard. There is, however, a likelihood that some transfer will occur of polymer additives, adventitious impurities such as monomers, catalyst remnants and residual polymerization solvents and of low molecular mass polymer fractions from the plastics inio the psclcaged material with consequent toxic hazard to the consumers. The occurrence of acute toxicity due to plastics material in contact with food is most unlikely since only trace quantities of potentially toxic materials are likely to migrate. However, the accumril&ion of these toxic materials with time may lead to hazards whicll may be serious.

0.3 :\cetaldehytle is generated in small amount as a by-product during condensation and subsequent

processing of the polymer. However, no limits of acetaldebyde content are prescribed for such PO&

mers in USFDA and other overseas standards. For mineral water and cola-based drinks, it is reported IO be affecting their taste mildly after long storage. For such uses, if. required, thi? limit of acetaldehyde content and test method shall be mutually agreed to between the purchaser and the supplier.

0.4 This standard is based on infprmation available from the Federal Health Regblations of West Germany ( 1982 ) relating to polyherephthalic acid diol ester.

0.5 ‘This standard is intended to be used with the series of Indian Standards on plastics for food con- tact application which is given in Appendix A.

0.u It is emphasized that these standards need to be used in combination to provide a system of control to the manufacturers of plastics as well as the fabri- cators of thermoplastic packaging materials to drive’ maximutn benefits. Besides, it may also serve as basis for official agencies to frame suitable legisla- tion to ensure effective safeguards for the safety and health of consumers where thermoplastics for food contact applications are concerned.

1. SCOP E

1.1 ‘J’his standard prescribes positive list of conslit- uents of polyalkylene terephthalates, namely the polymers, manufacturing residue, and necessary additives, which will be regarded as safe for use when properly processed, in contact with foodstuffs, phartnaceuticals and drinking water and v:hen present in the prescribed limits of concentration.

1.2 The positive list cloes not purport to establish the suitability of the ingradient singly in a parti- culnr fi)oclstllff from othet than toxicological consi:lerations.

2. TERMINOLOGY

2.1 PET ( Polyethylene Terephthalate ) -- The basic tnatcria-1 produced 11)’ the catalytic condensa- tion at higIl temperature and redllccd pressure of dimehyl tsrephthalatc ( DMT ) tcr-ephthalic acid ( PTA 1 anal: if required, relatively snlall amounls of ditnethyl isophthalale ( DA41 ) isophthalic acid ( IPA ) with monocthylene glycol.

2.2 P BT ( P olybu ty le n e Te re ph th alatc ) - The basic material produced by the catalytic condensa- tion at high temperature and reduced pressure of DMT/PTA ( and, if required, relatively small amounts of DMI/IPA ) with 1, 4 butanediol.

3. REQUIREMENTS

3.1 Bas ic Mate ria l - To comply with this standard, thv thermoplastic ( saturated ) polyester defined in 2.1 and 2.2 shall be made in such a way that they contain no ingredients or residues of ingredients other than those listed ,in 3.2, 3.3, 3.4,

3.5 and 3.6.

3.2 Basic Raw Mate ria ls - The following basic raw m.dterials may be u;ec!:

i) IMono ethylene glycol (MEG) ii) 1, 4 Butanetliol

iii) Dimethyl terephthalate (DM’I’)

iv) Dimethyl isophthalate ( DMI )

1

IS I 12229 .1997

v) Terephthalic acid (PTA ) vi) Isophthalic acid ( IPA )

3.2.1 The polymer shall exist at least for 50 percent of units derived from PTA.

3.2.2 To the thermoplastic polyesters made from the above raw materials polyethylene up to 5 per- cent used conforming to IS : 10146-1982+ may also be added.

a) Talc, free of asbestos: 0.25 percent, MUX

b) Sodium benzoate: 0*25 percent, Max

3.5 Au xiliary Itcm a fm ,r Workin g - The following auxiliary items may be present with limits prescribed against each:

a> Calcium stearate b) Zinc stearate 1

Together 0.5 percent, MUX

3.3 Re m idral Catalysts - Residues of oxides of antimony, calcium, gallium, germanium, cobalt, lithium, manganese, phosphorus, zinc and titanium may be present with limits as prescribed. against each:

a) Antimony : 350 mg/kg ( 350 ppm ), MUX b) Gallium : 20 mg/kg ( 20 ppm’), MUX c) Germanium : 100 mg/kg ( 100 ppm ), Max

d) Cobalt : 125 mg/kg ( 125 ppm ), MUX e) Lithium : 130 mg/kg ( 130 ppm ), MUX f) Manganese : 80 mg/kg ( 80 ppm ), MUX g) Zinc : 80 mg/kg ( 80 ppm ), MUX

h) Titanium : 120 mg,‘kg ( 120 ppm ), i&x

3.4 Cty~tallizotion Acce le rators - The follow- ing crystallization accelerators may be present with maximum limits prescribed against each:

*Specification for polyethylene for its safe’4se in contact with foodstuffs, pharmaceuticals and drinking water.

IS : 9833-1981

IS : 9845-1986

IS : 10141-1982

IS : 10142-1982

IS : 10146-1982

c) Silica

d) Paraffin wax

e) Synthetic paraffin, 0.25 percent, Max f) iso-butyl stearate, @2 percent, Max g) Even numbered, saturated, aliphatic primary

alcohols of the chain length C,a to Cze, 0.05 percent, MUX

h) Low molecular polyolefins 0’5 percent, MUX in combination with silicon oil 0’3 percent, MUX ( mould release parting agent ).

j) Penta-erythrite-ester of saturated even numbered. alipbatic monocarbonic acids of the chain length Cl4 to Csz, 1’0 percent, MUX.

3.6 P igm e n ts an d Colou ran tm - The pigments and coiourants shall be as specified in IS : 9833- 1981*.

*Classification of pigments and colourants for use in plastics in contact with foodstuffs, pharmaceuticals and drink- ing water.

APPENDIX A

( Cfause 0.5 )

LIST OF INDIAN STANDARDS ON FOOD CONTACT P LASTICS

Classification of pigments and IS : 10148-1982 colourants for use in plastics in contact with foodstuffs, pharmace- uticals and drinking water

Methods of analysis hr the determination of specific and/or IS : 10149-1982 overall migration of constituents of piastics materials and articles intended to come into contact with foodstuffs (first m&ion )

Is : 10151-1982 Positive list of constituents of polye- thylene in contact with foodstuffs, pharmace,uticals and drinking water

Styrene polymers for its safe use in IS : 10171-1986 contact with foodstuffs, pharmaceu- ticals and drinking water

IS : 10909-1984 Polyethylene for its safe use in contact with foodstuffs, pharmaceu- ticals and drinking water

2

Positive list of constituents of polyvinyl chloride ( PVC ) and its copolymers in contact with food- stuffs, pharmaceuticals and drink- ing water

Positive list of constituents of styrene polymers in contact with foodstuffs, pharmaceuticals and drinking water

.

Polyvinyl. chloride PVC and its copolymers for its safe use in cont- act with foodstuffs, pharmaceuticals and drinking water

Guide on sllitability of plastics for food packaging ( jrst revision )

Positive list of constituents of polypropylene and its copolymers in contact with foodstuffs, pharma- ceuticals and drinking water

18 : 1 2 2 2 9 - 1 9 8 7

IS : 10910-1984 Polypropylene and its copolymers for its safe use in contact with foodstuffs, pharmaceuticals and drinking water

IS t 11252-1987 Positive list of constituents of polyalkylene terephthalates (PET & PBT .) for their safe use in contact with foodstuffs, pharma- ceuticals and drinking water

IS : I 1434-1985 Ionomer resins for its safe use in contact with foodstuffs, pharma- ceuticals and drinking water

IS : 11435-1985 Positive list of constituents of ionbmer resins for its safe use in contact with foodstu%, pharma- ceuticals and drinking water

IS : 11704-1986 Ethylene/acrylic acid ( EAA ) copolymers for its safe use in cont- act with foodstuffs, pharmaceuticals and drinking water

IS : 11705-1986 Positive list of constituents of ethylene/acrylic acid ( EAA ) copo- lymers for their safe use in contact with foodstuffs, pharmaceuticals and drinking water

3

c

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Reprography Unit, BIS, New Delhi, India ’

AMENDMENT NO. 1 MARCH 2002

TO lb –’.—. - “+=

IS 12229:1987 POSITIVE LIST OF CONSTITUENTS OF#

i------

—-.

POLYALKYLENE TEREPHTHALATES (PET AND PBT)

FOR THEIR SAFE USE IN CONTACT WITH FOODSTUFFS,

~ ..”...:.:

PHARMACEUTICAL AND DRINKING WATER ~

( Page 2, clause 3.5) — Insert the following at the end:I

k) Pentaerythritol

m) 1, 4, cyclohexane dimethanol

n) Phosphoric acid

(PCD12)Reprography Unit, BIS, New Delhi, India

AMENDMENT NO. 2 JUNE 2013

TO

IS 12229 : 1987 POSITIVE LIST OF CONSTITUENTS OF

POLYALKYLENE TEREPHTHALATES (PET AND PBT)

FOR THEIR SAFE USE IN CONTACT WITH

FOODSTUFFS, PHARMACEUTICAL AND

DRINKING WATER

(Page 2, clause 3.5) — Insert the following note at the end of clause: ‘NOTE — Amorphous Hydrogenated Carbon (AHC) is used for coating in PET/PBT containers either through dry or wet process to enhance barrier properties with  maximum  thickness  of  0.15µ.’ (PCD 12)

Reprography Unit, BIS, New Delhi, India