Is 10148 1982
Is 10148 1982
Is 10148 1982
Indian Standard
( Reaffirmed 2003 )
POSITIVE LIST OF
CONSTITUENTS OF POLYVINYL CHLORIDE
( PVC ) AND ITS COPOLYMERS IN CONTACT
WITH FOODSTUFFS, PHARMACEUTICALS
AND DRINKING WATER
0 Copyrjghr;1982
BUREAU OF INDiAN STANDARDS
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARC
NEW DELHI 110002
Gr 4 June ‘1982
'IS:10148-
EMI2
Indian Standard
POSITIVE LIST OF
CONSTITUENTS OF POLYVINYL CHLORY.CjE
(PVC ) AND ITS COPOLYMERS’IN CONTACT
WITH FOODSTUFFS, PHARMACEUTICALS
AND DRINKING WATER
Chairman
Lb K. J. BALAKRISRIQ
A-10, Shantinagar, Cantonment, Kanpur
Mrmbcrr Representing
Da P. C. ANTOXY Indian Plastics Ltd, Bombay
Sasr N. LFBIRLA ( Altmxatc )
SRSI A. S. ATHALYE All India Plastics Manukcturers’ Association,
Bombay
SECBETABY ( AIPMA ) ( Alttrnofc )
DR P. K. BANEBJEE Polyolcfins Industries Ltd, Bombay
SHRI A. T. BASAK Directorate General of Supplies and Disposals,
New Delhi
SHRI B. B. RAI ( After&c)
SEBI K. J. BHA~T State Trading Corporation of India Ltd, New
Delhi
SEBI BHAQWAN DASWANI ( Alttrnatr )
SHBI S. T. BHOJWANI Bright Brothers Ltd, Bombay
SHSI A. H. KHAN ( Alternate )
SHBI T. S. BIDDAPA National Organic Chemical Industries Ltd,
Bombay
SERI J. K. VADODARIA ( Altcrnatc )
DB R. P. DAMBAL Indian Telephone Industries Ltd, Bangalore
SFIRI G. V. RAO ( Alternate )
DB S. P. SINQE DHAKAREY Ministry of Defence (DGI)
SEBI N. C. BoSE ( Altcrnatc )
SHBI 0. P. DHABUJA Export Inspection Council of’lndia, Calcutta
SEBI hf. K. HNNIEBISHNAN ( AlWUtC )
SHBI DION FERNANDES Plastics & Linoleum Export Promotion Council,
Bombay
SHRI K. RAXANI (Alternate )
( Continued on page 2 )
( Conhuedffom page I )
Members Repyeenting
SHRI M. S. FRABCTS Central Institute of Plastics Engineering and
Tools, Madras
SHRI CHANDRAKANT B. GARWARE Garware Synthetics Pvt Ltd, Bombay
SHRI H. S. SIJRI ( Alternate )
SHRI A. GEIO~H National Test House, Calcutta
SHRI S. M. LAHIRI ( Alterngtc )
SHRI S. K. JAIN Hoechst Dyes & Chemicals Ltd, Bombay
SARI K. A. T. VARCRESE ( Altrrnate)
DR S. P. MANX Railway Board ( Ministry of Railways )
SHRI N. KRISHNANPPA ( Alternuts )
SH~I P. R. MAHALIXGAM Chemicals & Plastics ( India ) Ltd, Madras
SHRI S. S. GATTANI ( Alternate)
SHEI P. R. MALEAN Development Commissioner, Small Scale Indus-
tries, New Delhi
SHRI S. R. SINQH (‘Alternate )
SERI R. C. MISHRA Bharat Heavy Electricals Ltd, Bhopal
SARI G. L. ANAND (Alternate )
SHRI A. K. BASU ( Alternate )
SIIRI S. MXIRA Calico Chemicals ( Plastics and Fibres Division),
Bombay
DR B. R. C. ANAND (Alternate )
SARI K. R. NARASIMHAN Metal Box Ltd, Calcutta
Dx S. LAKSRMANAN ( Alternate )
SrIRl V. NIJI7AWAN Union Carbide India Ltd, Calcutta
SERI A. K. GUPTA ( Alternate )
SHRI M. S. RAMA~IURTHI Polychem Limited, Bombay
S>IRI C. U. KHANDHXRIA ( Alternate )
SHRI 0. P. RATRA National Buildings Organization, New Delhi
SITXI D. A. REVS Kosmek Plastics Manufacturing Ltd, Bombay
SHKI 0. P. BAN~RJEE ( Alternafe )
Snrtr R. SAXTIIANAM The Alkali & Chemical Corporation of India
Limited, Caicutta
SHRI D. JAIX (Alternate)
DR P. R. SESHAN Indian Petrochemicals Corporation Ltd,
Vadodara
SHHI A. K. RAY ( Alternate )
S14rc1P. P. SHARMA Directorate General of Technical Development,
New D&i
SHRI N. K. AUARWAL ( Alternate )
DR J. VAID Peico Electronics & Electricals Ltd, Pune
DR S. P. BFlIl,E ( Alternate )
DR S. P. VOIIRA Bakelite Hylam Ltd, Hyderabad
‘Sam Y. V. CHUTAL ( Alferncfe)
SHRI M. S. SAX>.NA, Director Gem ral, IS1 ( Ex-ojicio Member )
Birector ( P&C ) ( Secretary )
( Continued on page 15 )
2
IS : 10148- 1982
Indian Standard
POSITIVE LIST OF
CONSTITUENTS OF POLYVINYL CHLORIDE
(PVC) AND ITS COPOLYMERS IN CONTACT
WITH FOODSTUFFS, PHARMACEUTICALS
AND DRINKING WATER
0. FOREWORD
0.1 This Indian Standard was adopted by the Indian Standards
Institution on 13 May 1982, after the draft finalized by the Plastics
Sectional Committee had been approved by the Petroleum, Coal and
Related Products Division Council.
0.2 Plastics are now being used on a large scale for packaging of foodstuffs
and pharmaceuticals. Where direct contact occurs between the packed
commodity and the plastics, the high-molecular-mass polymer itself does
not pose a toxic hazard being inert and essentially insoluble in food.
There is, however, a likelihood that some transfer will occur of polymer
additives, adventitious impurities, such as monomers, catalyst remnants
and residual polymerisation solvents and of low molecular mass polymer
fractions from the plastics into the packaged material with consequent
toxic hazard to the consumers. The occurrence of acute toxicity due to
plastics materials in contact 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.
0.3 Initially the Sectional Committee responsible for the preparation of
this standard had prepared three codes of practice for safe use of
polyvinyl chloride ( IS: 728%1974* ), polyethylene ( IS : 7277-19741)
and styrene polymers (IS : 7961-1976:) in contact with foodstuffs,
pharmaceuticals and drinking-water. Taking cognizance of the pressing
need to monitor the quality of plastics intended to come in contact with
foodstuffs, pharmaceuticals and drinking water which could not be done
on the basis of standard codes of practice, the Committee decided to
*Code of practice for safe use of polyvinyl chloride (PVC) and its copolymers in
contact with foodstuffs, pharmaceuticals and drinking water.
*Code of practice for safe use of polyethylene in contact with foodstuffs, pharmaceu-
tical ‘and drinking water.
SCode of practice for safe use of styrene polymers in contact with foodstuffs,
pharmaceuticals and drinking water.
3
L
IS:10148- 1982
4
Is : 10148- 1982
0.4 The list of additives prescribed in these positive lists are based on the
information available through published literature like British Plastics
Federation Reports, London ( English); FDA Regulations, USA; and
other national legislation reports.
1. SCOPE
1.1 This standard covers positive list of constituents of PVC, namely, the
polymers, copolymers, manufacturing residues and necessary additives
which may be regarded as safe for use, when properly processed
in contact with foodstuffs, phamaceuticals and drinking water and when
present in the prescribed limits of concentration.
1.2 The positive list does not purport to establish the suitability of the,
ingredient singly in a particular foodstuff from other than toxicological
considerations.
2. TERMINOLOGY
1) vinylidene chloride;
2) acrylonitrile;
3) styrene and substituted styrene;
4) butadiene;
5) ethylene;
6) propylene;
7) divinyl benzene;
8) vinyl acetate;
5
IS : 10148 - 1982
3. REQUIREMENTS
1) di-isocyanate 1, 6 hexane;
2) di-isocyanate 2, 4 toluene;
3) di-isocyanate 2, 6 toluene and their mixtures;
4) butane dihydric alcohol 1, 4;
5) polyester resulting from the action of adipic acid on a glycol;
and
6) addition compounds of propylene or ethylene oxide and/or
ethylene with ethylene glycol or poly propylene-glycol or
glycerine or trimethylol propane or pentaerythritol or sorbitol.
NOTE - These products should be free from isocyanates and primary amines.
a) Benzoyl peroxide;
c) tert-Butyl perbenzoate;
6
IS :10148-1982
7
IS :10148-1982
g) Calcium,sodium, potassium and ammonium salts of hydroxylic
fatty acids C,, to C&e and their sulphonyl or acetyl derivatives;
h) Products of condensation of ethylene oxide with monobasic
aliphatic acids CI, to C1, and their ammonium sulphates;
3.5 Suspension Agents - The total residues shall not be more than
1.0 percent by mass of the finished polymer. The residues of the following
may be present:
a) Gelatine,
b) Methylcellulose,
c) Hydroxyethylcellulose
d) Hydroxypropyl methylcellulose,
e) Sodium carboxymethylcellulose,
f) Methylethylcellulose,
g) Polyvinyl alcohol ( having a viscosity of at least 4 centipoise at
20°C in 4 percent aqueous solution ),
h) Polyvinyl pyrrolidone and copolymers of vinyl pyrrolidone with
vinyl ethers or esters, and
j) Copolymers of vinyl alkyl ( C, to C,z ) ethers with maleic acid
or ally1 alcohol.
3.6 Chain Transfer Agents - The total residues shall not constitute
more than O-5 percent by mass of the finished polymer. The residues of
the following may be present:
a) Trichloroethylene,
b) Perchloroethylene,
8
IS : lOids - lw2
c) trans Dichloroethylene,
d) Isobutylene,
e) Xylene, and
f) Chloroform.
a) PhthuffzteJ:
9
1s .: 10148- 1982
I$) Adijates:
1) Di-( normal-octyl )-adipate,
2) Di-( di-methyl-hexyi )-adipate,
3) Di-( P-ethyl-hexyl )-adipate, and
4) Di-iso butyl adipate.
c) Sebacates:
1) Di-( normal-octyl )-sebacate,
2) Di-( di-methyl-hexyl )-sebacate,
3) Di-( 2-ethyl-hexyl )-sebacate, and
4) di-n-butyl sebacate.
d) Aselates
1) Di-n-octyl-azelate,
2) Di-dimethyl-hexyl-azelate,
3) Di-2-ethyl-hexyl-azelate, and
4) Di-n-hexyl azelate.
e) ( 2-ethyl-hexyl )-diphenyl-phosphate.
f) Citrates:
1) Acetyl-tributyl-citrate,
2) Stearyl ( mono, di, tri ) citrate,
3) iso Propyl (mono) citrate, and
4) Triethyl citrate.
m) Epoxidized oils.
10
IS : 10148- 1982
d) Manganese compounds:
1) Manganese hydroxide; and
2) Manganese salts of aliphatic mono and polyacids, saturated
or not.
e) Epoxidized oils:
11
.IS : 10148- 1982
Groundnut
Limits to be agreed upon.
Safflower
f) Di-epoxy-cycle-dodecene, and
Tri-epoxy-cycle-dodecene.
NOTE- The epoxicized products mentioned in (e) and (f) are limited t
5 percent on the whole.
_i)Polyvinyl-ethyl-ether.
4 N, N’-di-stearyl and/or palmityl-ethylene-diamine ( maximum 1
percent ).
9) Hexanetriol.
r) Di-terd-butyl-fi-cresol:
Thio-bis ( methyl-tert-butyl-n-phenol )
otherwise called 4,4’ - Thio-bis ( 6-tcrt-butyl-m-cresol ).
NOTE - The above three products are limited to a total of O-5 percent.
12
IS : 10148- 1982
toxic substance extracted from the internal walls of the pipe shall not
exceed the following limits in the test solution:
NOTE 1-The other toxic substances that are likely to be extracted are
di-n-octyl-tin-s-s’ bis iso-octyl mercapto acetate and butyl stearate.
NOTE 2 -Conformity with the requirements of this clause shall ensure that the
recommendations of the World Health Organization, 1963, concerning toxic
.’ constituents of drinking water are not excec ded.
e) Natural waxes;
g) Polyethylene waxes;
m) Esters of polyethyleneglycol;
n) Esters of polypropyleneglycol;
13
IS : 10148- 1982
t) Butyl stearate.
14
Is:10148 - 1982
( Continued from page 2 )
Mmbers
SHRI B. ANANDASWAMY Central Food Technological Research Institute
( CSIR ), Mysore
DR P. K. BAKERJEE Polyolefins Industries Ltd, Bombay
SHRI V. DORAIRAJ ( Alternate )
SERI S. T. BHOJWANI Bright Brothers Ltd, Bombay
SHRI A. H. KHAN ( Alternate)
?&RI T. S. BIDDAPA National Organic Chemicals Industries Ltd,
Bombay
SHRI J. K. VADODARIA ( Alternate )
SHRI P. V. DATAR Polychem Ltd, Bombay
SHRI C. U. KIIANDKERIA ( Alternate )
DR S. S. GOTHOSEAR Drugs Controller ( India ), New Delhi
SHRI D. S. CHADHA ( Altmate )
SHHI D. JAIN The Alkali & Chemicals Corporation of India
Ltd, Calcutta
SHRI S. K. JAIN Hoechst Dyes & Chemicals Ltd, Rombay
SHRI K. A. T. VARGHESE ( Alternate )
SHRI R. KALIDAS Chemicals & Plastics ( India ) Ltd, Madras
SHRI S. S. GATTANI ( Alternate )
SHRI K. R. NARASIMHAN Metal Box India Ltd, Calcutta
DH S. LARS~MANAN ( Alternate )
SERI P. V. NARAYANAN Indian Institute of Packaging, Bombay
SHRI G. S. PURUSHOT- ( Alternate )
‘DR N. P. RAO Defence Institute of Food Preservation & Storage,
New Delhi
SHRI V. K. MATEUP. ( Alternate )
REPRESENTATIVE Bhabha Atomic Research Centre, Bombay
Dn B. R. ROY Central Food Laboratory, Calcutta
SHRI K. C. SAH Union Carbide India Ltd, Calcutta
SH~I Y. NIJHAWAN ( Altcraatc ),
DR N. SEN Hindustan Lever Ltd, Bombay
DR P. R. SESHAN Indian Petrochemicals Corporation Ltd, Vadodara
SHRI A. K. RAY (Alternate)
SHRI P. P: SHARMA Directorate General of Technical Development,
New Delhi
SHRI N. K. AGARWAL ( Alternate )
SHRI L. SHETR Bakelite Hylam Ltd, Hyderabad
SFIRIG. K. SRIXIVASAN ( Alternate)
SERI 0. P. SRIVASTAVA Defence Food Research Laboratory, Mysore
SHRI A. N. SRIVASTAVA ( Alternate )
15
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