Regulations, 1996

L.N. 4 Gl 19916

"'ooD, DRUGS AND DRINKING WATI::R ACT

(C AP. 23 1)

Materials and Articles In Conlact with . ' GOdsturrs

Regulations, 1996

IN exercise of the powers conferred by section 12 of the Food,

Drugs and Drinking Water Act, the Minister for Social Development,

on the advice of the Food Standards Board, has made the following

regu[ations:-

I . These regulations may be cited as the Materials and Articles Ouoioo_

in Contact with Foodstuffs Regulations, 1996, and shall come into OOILII ..............

force on Istlanuary , 1997.

(Regulation 5)

List of groups of materials and articles

Plastics, including varnish and coatings

Regenerated cellulose

Elastomers and rubber

Paper and board

Ceramics

Glass

Metals and alloys

Wood, including cork

Te~tile products

Paraffin waxes and micro-crystalline Wll)(CS

B

(I) These regulations shall apply to materials and articles, Scope.

which, in thei r finished state are brought or are intended to be brought

inlo contact with foodstuffs or with water which, in either case, are

intended for human consumption.

(2)

These regulations shall not apply 10:-

(a) coverin g or coating substa nces. includi ng the

su bstancescovenng cheesennds,prepared meat prodOClS or fmit,

which fonn pan of foodstuffs and may be consumed together

with those foodstuffs;

(b)

fi;o;ed public or private water supply equi pment.

(Regulalion 6)

Symbol that may accompany materials and articles intended to come Into

contact with foodstuffs

I

THIRD SCHED UL E

(Regulation 8)

List of Monomers a nd other Sta rting Substances which may be used

in the manufacture of Plastic Materia1s a nd Articles

Gtm~ral imroduction

I. This Schedule contains the: list of monomers or ()(her starti ng substances.

The list includes

s ubstances undergoing polymerization, which includes

polycondensalion, polyaddition or any other similar process . to manufacture

macromolecules,

natural or synthetic macromolccularsubstances used in the manufacture

of modified macromolecules. if the monomers or the other staning substances

required to synthesize them are not included in the lisl.

substances used to modify existin8 natural or synthetic macromolecular

su bstances.

2. The list does not include the salts (i ncluding double salts and acid salts) of

aluminium . ammonium. calcium. iron, magnesium . potassium, sodium and zinc of the

authori zed acids, phenols or alcohols which are also authorized. However, names

containing ' ... acid(s). salts' appear in the lists if the corresponding free acid(s) is (are)

not men tioned. In sueh eases the meaning of the tenn 'salts' is 'sullS of aluminium,

ammonium. calcium. iron, magnesium, potassium, SIXIium and zinc'.

3. The list also does not include Ihe following substances although they may be

present

substances which could be present in the fini shed product as

(a)

impurities in the substances used,

reaction intennediates.

decomposi tion products

(b) oligomers and natural or synthetic macromolecular substances as well

as their mixtures, if the monomers or staning substances required to synthesize

them are included in the list;

(c)

mixtures of the authorized substances.

The materials and articles which contain the substances indicated undcr (a).

(b) and (c) shall comply with the requirements stated in regulation 4.

Substances §haJl be of good technical quali ty as regards the purity criteria.

4.

5. The list contains the following infonnation

column I (PMIREF No): the EEC packaging material reference number

of the substances of the Jist.

column 2 (CAS No): the CAS (Chemical Abstracts Service) Registry

number.

column 3 (Name): the chemical name.

column 4 (Restrictions).

These restri ctions in column 4 may include

specific migration limit (SML)

maximum pennined quantity of the 'resid ual' su bstance in the

material or anicle (QM).

any othe r restriction specifically mentioned.

6. If a substance appearing on the list as an individual compound is also covered

by a generic tenn, the restrictions applying to this substance shall be those indicated

for the individual compou nd.

1. Where there is any inconsistency between the CAS number and the chemical

name, the chemical name shall take precedence over the CAS numbe r. If thcre is an

inconsistency between the CAS number reported in E1NECS (the European Inventory

of Existing Commercial Cbemical Substances) and the CAS Registry, the CAS number

in the CAS Registry shall apply.

8. A number of abbreviations or expressions are used in column 4 of the table.

the meanings of which arc as follows

OL = detection limit of th e method of analysis;

FP = finished material or anicle;

NCO = isocyanate moiety;

NO 0:: not detectable;

QM = maximum pennitted quantity of the 'residual· substance in the material

or article;

QM (T) = maximum penniued quantity of the 'residual' substance in the

material or article expressed as total of moiety or substance(s) ind icated;

SML = specific migration limit in food or in food simulant. unless it is

specified otherwise;

SML (T) = specifIC migration lim it in food Of in food si mulant expressed as

toull of moiety or substance(s) indicated.

B

SECTION A

List or Authorized Monomers a nd other Starting Substances

PM/Rd.N<!.

CAS No.

,3(

..

,n

")

'"

" ,

,.,.,

0CKl$14-1 0. 3

Abidic: ocid

-""

""",.,~

",,.,

<XXXl64- 1 ~ 7

A<:elic: ocid

SML _ 12 malks

CXXllOS.{)S.4

lOLa!

Acetic: ocid . vinyl C$Icr

A..,,,,,,

CXXll08-24-7

Acelic a nhydride

lOBO

00Xl74-86-2

102 10

""""""" ,

SML _ '-'D{DL - 0.0 1 ma/k,)

"'"''

Acrylamido

om

2.AcryJamicb.2-.... ylp,. oeru'pllDllk..:ill

malk,

SM.L ,.

'''''''

015214-39-8

OOJ079..1 ().. 7

'''''''

Acrylil: ocid

00249S-)5-4

Acrylic: odd, belU.yl eSlCl"

,"'.,

'"''''

CXXlI 4 1·32-2

Acrylic lOCid, n·bulyl eil ....

Acrylic IOCXl, ~·bulyl mer

OO2998~S..S

IOSIO

""'"

001663-39-4

Acrylic ocid,ltn·bulyl CW:.

OOJ I 4(l..U..~

Acrylic ocid, ethyl ell ....

11470

See 'Acrylic: Kid. n>OI"OO<Orc.

(XX)818-(;I-l

Acrylic ocid, hydro~~yl all:/"

willi ochyloneliycoi"

OCKll0M\3-8

Acrylic lOCi<!. isobulyl elle.

11390

1XX>689-12-3

Acrylic ""id. is<>prOp)'I ei1er

"""

11710

OCOO96-l3-3

Acrylic lOCi<!. merhyl "'1 ••

, ".,

Acrylic acid, monoc:lI("t with nIIyJene,bwI

00)&18-61-1

11830

AcryLic ocid, n-«f)Il_

002499-39-4

..",....

1191rl

Acrylic: ocid. pn>p)'1 ester

SML _ not dolCClabk

Acrylonilrile

12100

0CKl107· 13-1

(OL - 0.020 mglkg analytical

t<>Juanoe included)

12130

Adipic: ocid

''''''

Adipic: onhydride

AI~m i n

12310

"""

Alb1>min. «>IIgulaled by form;tldthy<.le

12373

Alcohol. , aliphatic, monohydric,

"'Uraled. Ii"" ... primary (C4-C22)

"".

I·A mino- )..ominomethyl· J ~ J-

OOruS-Jl-2

uimelhylcydohclirc

SML * 6mj1t,

002432-99-7

SML_ imalkg

II · Aminoundccanlc Kid

12788

12789

007664-4 1·7

Ammonia

128a!

0CKl11)·</9·9

A>.elaic ocid

, "".

00(191).93-6

Au-laic anhydride

"""

SMI.. _ O.oS m&fka

001.n_33~

1 ,3. Benzt:n<dillXfhanamine

" OOJI(X).SI·6

..

,>,,~

Ben~ic ocid

''''''

IlISO

Benzyl olcohol

Bis(2 ·hydro>yethy I) ether

OOJI I 1-46-6

See 'Diethyloneglyo:ol'

QOClO77.9'l.(>

2,2· B i I(hydro' ymclhy I)- 1 ·butanol

See < I .I.l.Tri .... LhyIo1f'«'P&l"'·

OOOI05~8.8

I .4 . D ;s.(bydro~Yrne1hyl) eydol\e,ane

13390

"""""".,

2.2.Bis(4-hydro>yp!Ionylj propane

''''''

QM _ I mlfkl in FPor SML

001675-j4..3

2.2. Bil(4-hydro>yphonyIJ propane-

13SlO

_ not doIerubJe(DL E 0.1)20

bis(2.3-epoxypropylj ether

mg/kg, anaiyticailOleranee

included)

Di$(hydro. YJlIOPYIl elher

1XXl11()"98-5

See'Dipn>p)'lenea!yo:ol"

005114-JO. I

B io(" ioocyarIoIocyclohuyl) n><thane

See ' Oicydohaylrnr:thaoe-

4 .4 ' -diisocyan.llle'

B

"_

CAS No.

PMlRd. No

Restrictions

,.,

'"

'"

'"

om IJIjItI

22·Bi-<4.hy<lro~yphenyJ) proparo

SML •

OJ810J.-36.-9

IJSlQ

,,..

bis(phtli ie anIIydridc)

1 J- B il(l-mco:hyl ..... hydroJ. yphenylr 2 ..

SML .. 1 J rnaIlI

0474M-97-4

indoli~

""""'" ,

See . 22 .Bis( 4-hydroA yphenyl}

8 ;,pheno1 A

See . 2.2-Oil( 4-hy<lrox yphenyl)

Bisphenol A bil(l J-e;>oxypropyl) flhtr

001675-54-3

propane bis(2,3-c"",xypropyl)

."".

0381OJ..()6.9

Bilphenol A bil(phtaJic aohydridc)

13614

Sec IlS30

QM .. I maIka in !'POI' SML

Butadiene

<3630

(.((Il()6.99.{J

.. ROI detwabk (DL •

ODJ) 1IIJItg, anaIylif;aJ

tolerance included)

1,3.B........mot

''''''

000107·83-0

[·S ucano!

IXXXl7I · l6-3

''''''

(0)106-98.9

1· lI uI~ne

13810

'''00

2· B"t~ne

OOOI07.{11·7

000123·12-8

1411 0

Dulyrallkhyde

--

(X)'}I07.92-6

Butyric Icid

14140

(XXII 06-31 .(J

\ 41 10

Butyric ... hydride

'''00

SML(T) .. IS malkc

000103·60-2

SMI.(T). IS nwtl

~.JOdium ... k

002123-24-2

'"''

....

(f x prw.<d as capn:>Iacu!II)

c.pryJie Kid

14320

00012447·2

.""

c..tx.n monoxide

143~

14380

QM .. I mglka in FP

000075-44-5

C..t.onyl ch\orido

008001 -'N-4

14411

Cilltor oil

'''00

Cellulate

009004·34·6

007781·5(}.S

14530

Chlorine

1 .a.1oft>. 2,3-cpc>xypropaoe

Sec ' Epichlorohydl'in '

000 106-89·8

''''''

000077.92-9

Citric Acid

m.c...

OOOIQ&.39-4

j·t7IO

"""""

14740

00009s-48-7

,.0_'

(.«II 06-44- S

'"''

OOOI~8

Sec ·1.4-B~y dro' )'lllClhyl )

1,4 .. Cydohe.w>edimr:dlaooJ

tyclohe ...... ·

1495(1

003173-53-3

QMm . 1 mgi\:.jj in FP

Cydohe l yl isocyanate

(.Ipressed .. NCO)

"0"

SML "' ()1l!i mg/l<lI

1.9. Deadic""

OOI647·1f>.1

"""

0003l4-48.5

D<conoic Kid

,."""",

000112-30-1

15100

Sec ·Ethylenediamine·

000107·1So3

1,2·DiaminoelMnc

Sa: ·Kc.umelhylencdiamine·

000124-09 ....

IJ>-Dianlinohuane

''''''

0001 10-00-1

1.4·Diaminobo.rtanc

"'"

0001()6..4f>.7

1 ,4. Dich!orobtn""nc

SML "'12mg/l<lI

"'00

QM (T). 1 mgft, in I'P

DicyclQhu yl .... thanc-4.4· -<Ii isocyaruue

005124·3Q. 1

("(n'sed I. NCO)

SML(T) .. 30 m"", olono 01'

000111-4M)

Die1hyJc:ncglycol

157050

with ctIIylencSlycol

SML"' 5 mgft.

o;cm)' lenetriomm.c

000 111 -4Q.O

"'"

•

"-

CASN<>.

PMlRer. No

Rewi<:tioo.

OJ

"J

0)

'"

,,..,

,,..,

'.o;nllllrUbenzop/le

OOOlotS.92.6

SML.OJ)~m""l

U

StolL .. 6 mJll<.

l.2·Dih~dro~~bcrlunc

000120-80-9

,,,..

,-

0001ll8-46-3

l.wl0

SML._l,.. m&fkl

I J-Dihydr\u~~

5ML_0,6 milk.

0001n.31 .9

1 .... Dihydnll)'brmene

1~970

SML .. 6mJ1\,

" ,4 . · Oi hydro. ybenroplocno".

000611·994

00Xl9 .....

.. "' .. -0; hydro~ ybtp/IeI1y I

SML .. 6111J1l.

000 IIlI .. O I .(l

Stott. . . . . . .

DiJrcIIo)'~

161SO

QMrrJ .. 1 "'II'kI in FP

--

000091.97.-

l.3" .Dimethyl .. "" -didocyuwobiphenyl

''''''

,...,

(upraoalu NIDI

0001l6-~9

"".

004128-73-8

DipheQyl ether 4,4' -di~

QMIT) .. I m&lkl in FP

...

(upruaed .. NCO)

,

OMen .. I mslkg in FP

Oipllctlyll!ltlhatlc l.A" .oiitlXyarlale

OOSI7l-S4-L

( •• pn:1Rd u NCO)

.. --

"".

000101-61 ••

DiphCII)'~4""-dii~

OMrn·t • • i.FP

(elprtU<d .. NCO)

",.,

,,..,..

000110-98·'

OipropyltrqJyc:ol

167SO

OM-i • • iaW

~17·j

,~

16'.:1

"".

Em, ...

000074-SS-1

",.,

000101-1S-3

E1hy1el1 diomine.

SML- l 1m&ll<.

"''''

SMI..(T) .. )I) mg/k a alone or

000107·21·1

F.lbylen!:&lywl

wltlo diC1hykneglywl

OOOUI .~

SML .. "'1) (DL .. 0.01 ftI&I'ka)

'''''''

Ethylmeimmc

n.",

OM .. I mw1<. in FP

-

00007S-11-1

Erhyleneo. idr.

n.",

SML .. JO Ift&I\I

000 1()4.. 76-7

2·Erhyl. t-lloeJ.MOI

S .... (..O'OI .. 1"k1

OOXl97.jl-O

17160

061'11a..14

11170

Filly acida. DDDD

onoo

068J01..SJ..2

Fany 1cids.1Oy&

,moo

"""""'.,..

"-'Y 1cid.s.1II1 oil

061790-11·)

on.,

SML.1Sma/k1

000110-1708

Fumaric Kid

''''''

G'_

00003().1)9. 7

\J3JO

GI",,", ICid

OOOllo-~1

lBO lO

GO_

"'''''

0001011·55-4

GI"wiI: aM)'dride

18100

QOOOS6.81.'

SML .I'.-o(Dl..O,o1 rn&Ika)

HeJaclllooOUiduaoethylmnclra-

00011S-a.6

''''''

b~aciIi

"""

SML. NO (Dl. . 0;01 maJka)

Heu':hIoooe"do ..... 'hylenetel .... ·

00011S-27·'

bydrophllWic ..... ydrick

..

....

OJ66S}.82-4

"'

11310

l·tJc·.,.

, """

HoullllOi op< op~!ene

OOOllfl.-lS-<l

SML. NO (OL .Q;OI m&Ji:a)

Hoxamt'lhy Icnedi.m ine

00012~

SML .2,( maf<8

",."..,

Q Mm • I II'IJI'k8 in fp

''''''

Ho,,"mothy~ diitot:yanaJC

lupeueclu )'1 ' , 0»

"".

en.

HealmOlbylcnolctrlmino

000100-97-4)

SML.

13 """"

(uprqtal .. rormaldeh)'lk)

....

, ,,..

00011).)1·9

Set ·1 .... DibydroJ.ybc""" ... ·

Hydmtpoi .......

P.Hydnllybeuooc: IC1d

1I(lOO99 96-7

''''''''-

00011S-11 ·7

[$Ophlhalic !CicI. dimtthyl Ul(r

19210

00 14'9-9l-4

SML .on, malk,

B '48

PMlRef. No

C ... S No.

, .~

Restriclionl

0,

("

0'

(l'

""""..,..

"m

IlXOfIic .,id

"'"

(0)143-07·'

uuric oc'"

011132-73-3

19~IO

Ui"OO'lIuk><e

00:)11 ().16-7

''''''

MaJc;c acid

SML(T) .. JO """',

''''''

00l1Q3.)1-6

SML(T) .. 30 mp\:,

Maleic riydride

(upresscd .. maleic ocid)

Melamine

See '2,4,6,-Triamino- l .l.5-

(0)108-78-1

trio:tin!:'

=0

CXXlO19..r.I'"

Mcthxrylic acid

Melhacrylic acid, bcfozyl cSier

"""

00249S<37·6

!XXXl97-88-1

Melhacrylic acid. butyl ester

20110

002998- 18-7

M.l~r'JIlic ""id,l«-butyl UIt1

"''''

,..,

"'''' """"..,. ,

Mdhxrylic acid, In'I-butyl ~

00058S..(l7·9

Mcthxryt;c Icid, cdl)'J CItrr

OCO)97-86-9

21010

Melllacrylic ocid, .... Iyl .... '

~5·)4..9

Met~lic ""id. iwpropyl eole,

21 HlO

(0))8{1·62-6

21130

Melh""l)'h" ac id. melhy! est ..

Melhacrylic acid, rnonoe.Ier .. i\h

00)868·17·9

21190

tthyltnoSlyrol

.\ lelhacryJ;c acid. pIIttlyl em.-

002 1 77· 7Q..O

21!80

M<1hacrylic ""id, propyl.",.,

"'''

002210-28·8

M<!h..,rylic anhydri<k

00l76Q..93.o

21460

SM L .. not dcIcaablo (01.. ..

OOJI26-9&-7

M Clhxrylonilriie

21490

0.020 mall,. anal)1ica1

lolen .... "" included)

21S~

00)067·56-1

MClliaool

N· Melhy Iolanyllm ill<

(O)i}24-4M

'"''

SML .. ND (DL .. 0.0 1 mgfI;ll)

!XXl691 _17_2

4.-M<lhyl.[_p •• 11 ....

221~

S ML.O.D2mW\1

"'" """"'"

Myri,.ic acid

00lS44-6J..1

",.,

2.6-N~icIfbolyl ic acid.

SML .. O.os mg/ka

dimethyl eSler

003173.12-6

Mm-lm&'ka inFP

22420

I ' · Naphtha! ..... diil<lqana,e

(e"pttS5CId. NOO)

"""'"' '""

224~

"'il~II~1ost

"'"

00l143..(l8·&

I·NOIW>Ol

mm

QM (T) .. 1 mgll:g in 1'1'

0001 12.9609

Oct><lecyl ioocyanal.

,,..

(e' JnOKd .. 1"00)

'-00_

00l 1 11 ·87.~

,,""

'-Oo<~

0011 I 1·6(H)

SM L_ISma"-1

0001 I NI(" 1

22763

Oleic odd

moo

00XI~7· 1I)·3

r.lmi, ic odd

OO) J IS.77_S

"'"

r emacrythriKlI

"",

!XXlO7 I --i 1-0

I·Ptntanoi

"""

""'"'

0001011·9501

""'"

Q~I - 1 mWkg in FP

00l108-4$-2

1.:I· Phenylenediamine

oo:mS-44-5

~ 'Carbonyl chloride'

PMto& .....

PhMphoric acid

23171)

007664-].1..2

~ 'Tcreph1halic ocid '

Phlhahc acid

m",

cxxnl8·\I9-]

.,.Pluhali< .dd

(0)131 .17-9

23230

Phthalic llCid , diallyle.,er

SML_ ND(DL.OJll mglkR)

cxxnlS-44-9

Pluholic ..,hydride

23380

"""""-,

alpha, P;.....,

"'"

moo

m.,

(0)127.91.3

~P inme

02.'!322-68-3

PQI )'tIhyle .... l\lycol

CAS No.

PMlltd. /IkI

Rtlilittioo.

N_

(.)

OJ

O)

'"

,.-

PoIYP"'I'YIerqI)'DCII (~Iat .... tllht

025322-$.<1

"""

areller!1w1 400)

.-

0000:S7-5U

1 ,2-Pl."...oc:dloI

"'"

00007 J .. 2J-I

2J8OO

""" """"' ....

000067-63-0

"..,

00012}.3s.6

I'nIpionaIdrhydo

"""

Propionic 8Cid

Plopioo,je pydrido

"'"

OO'Jl~2-6

"""

00011$-07-1

f'1 09)"

2«110

00001S.5609

I'nlpy ..... o.ido

QM • I mglta in FP

s... · 1.2. DiII)'O'o~~ ·

000120-11().9

"""'"""

s. .. u .• om . ,

OOOQ89.]2-7

PyromoUidc _ydrido

"'"

(up!'\'.I«d .. pyrorne!!ilil

.dd)

"''''

Reiin IIcldt and ,00" Kick

0731J&-8~

s... ' 1.J.DilI)'droaybenz.ene"

000 I (l8..44. 3

ReN:,inoI

""""""" ,

w ..

Rooin

..."...,

.... ' Rooin'

RoI.iIo pm

''''''

''''''

0080$2010-6

ROlin IllI oil

'''''' ..........

009014-6]·5

ROlin wood

24190

R~bber, """"

.

Salicylic 8Cid

()(XXl0.7l-7

"""

", CXW61-U-'

00011 J.2().6

SebIoeic Kid

_ ...

.

"'''' ....,.,,..

SebIoeic WIhydride

" , 00Il00 I· 21-7

"'"

00])1),,82-2

Sodium 1"lphide

,."."

"'''' OO9COS-1.s.1

Swell. wible

"""

OOOO:SH I4

245:50

Stearic: Kid

000100-<12-5

"''''

"""

S_inic

"""

OOOIIJ). IU

odd

00010&-)0.5

"''''

Sw:dnie: ....... Ii ide

S_

0000:S7 • .(1).1

"""

006J62.~

24881

S-Sulphoiwphthalil: .dd.

S!>1 L. S 1IlfIl:,

,,~ i amoah

om """"

OOJ965-S.s.7

"'"

S.s..lphoilOphthalic: litld. ",o'"I"IiIl'''

S.\1 L.

iab. dimtlllyl eola'

Taq>hdWic or;id

SML-7,5mJlta

..

000100-11.0

"''''

, '"

SMLm_7J"'I!1<,

1XXl100-2I).9

Terqohtholic ocid didllDriIk

(apralCd _l=phIhillic Kid)

"""

TmphI""lic odd. dirnctllyl wc:r

000 121).61-6

""'"

00l1l1..fij).7

",.,

TctnetbyltntglyWI

"'&II:,

00'J11 6-14.}

T elral1uoroelhy Ie ...

..

SML • 0,05

00'J109-99·9

Tetrah)'droflllVl

SMLaOAm&I'<,

"''''

",

S,;" .N' .N '·Tccnltii (l'~I'JIIOP)'I"

OOJI02.a).}

",,"yknedlanU ...

QMIT) a I . , ill FP

2'1210

OOJ,84.8A-9

2 .... ToI ...... dii$Of;y"""*e

(e~ preued as NCO)

"'"

2,6. ToI .... di~

(00)) 1..()8.. 7

QM(T) a I . . . . . Fl'

(e> pru.Mld as NCO)

QMIT). I 1IIJIt, in FP

026147.90.0

"''''

2"'· ToI"" ... c!iiloOCr- dimer

(c. JRUtd III NCO)

N_

PMlRd. No

CAS No.

Iteillicliol ..

,OJ

''l

.

"'

"'

Tri.lltyl (0.(;1 S) tomic IICMI,

SML .. 6 m&!kl

2,3",po'YJII'DP)'I UIer

"".

...

SML .. 3(l maIki

2,4,6. T .......... I.l,S.triu.inc

00010PI-I

ill"

Tricd'ylnqlya>l

000112-27·6

""""-

"..

SML-6m&1k1

l .l.I -Triolm.,1olpiUjMlk

m"

.

T riprop)' Jent,t)'COl

02480:)..44.{)

, "'"' '"

U~

ro:lI»7· ll-6

Sec Cwncil DiR:cli.e

Vinylo;hloride

00007S-OI ....

78i1 42'EEC

OM .. S maIki in FPor

Viny l~ dliorick

OOOD7S-ls.4

26110

SML.IIOII~

.

( DL .Orem~

",

Vinyli6mc n . . .

SML.' mafkt

00007S-1a.7

B 25'

SECTION B

List of Monomerl'i and other Starling Substances

which may continue to be u.sed pending a Decision on Inclusion in Section A

CAS No.

Rf:$Irio:\iOno

PM/Ref.No .

N~

,.,

..

",

(3)

0'

,,,.,.,

See '2 ..... Diamin0-6-rnnlIyL .

ADtI"I......,.;~

IJJ.Iriarlne'

11)1IiO

alphl- "'celO~ ),.tyrene

002206-94-2

bcll-AcetoxySlyre ne

[0162

,"'.,

010521·96-7

Acids. llipl1alic, monocarbol yli<:.

wunted (Cl-04)

Acids. aIiphMic. moooocarbol ylic,

10510

UlISI!umcd (0-04)

lO~99no

Acid., fany. "",at.rated (el 8)

A~id •• fauy. uflSlUuraled (CIa). dil'Q(!l.

061188·8'>-4

IOS99i9OA

distilled

"''''''' "',,.....

Acids, fatty. UMIII"",1ed (Cl B) , dimon.

,.,.,-disci!led

068783-4 ]·S

Acids. rot!)'. unwuraced (CIS). dimen.

10!i99/92A

h rdl'Oj:ona!ed. diSl illed

..

06818l-41·~

Ao;id$, fait)'. unslUUt8led (el I). dimen,

"""'"

h~, f>OII-(\iJlilltd

(l(l)O66. 7] - S

Acrylic ocid. cyclol ... yI cotei'

" """

Aaylk leid. dicycloperQdienyl diet

Gm76-0z.8

II OSO

Acrylic ""id. die.let .... ith 1.4-bY....w:d;.,1

OOHnO-70-8

017&3 1.71.9

IllSO

Acrylic acid, diester with tetra<thylellO.

Ilyeol

, ....

068901~3

Acrylic Icid, diealer with uipropy\etle·

Ill"

Acrylic ""id.~l ester

00215(>.97.(1

11245

000103·11_7

"""

Acrylic acid, 2-ethylbcxyl tsl<r

Acrylic acid , 2.hydro~yOOpropy l C$lCr

00291&-'2}'2

11520

-,

( • ocrylic acid. 2-hydroxy-l.mcthylethyl

Acrylic acid 2·hydro, yPl'O!>l'I em..

11530

000999-61·1

Acrylic acid. iM>bomyl ",tor

~88S·)}.5

11560

11620

001)30-61·6

Acrylic acid. ilOdecyl ester

029590-42.9

Acrylic acid, itoocIyl ",ter

11650

"'"

Acrylic acid. 2."'""""-yfthyl QIe.

003121-61·7

OlOO9S-1}.)

Acry\lc acid. rnonoeoIef willi

11740

.. --,

1 J-bulanediol

lIno

002478·10-6

Acrylic acid. rnonotSIet with 1 ,4-b<!tant:d;,,1

"

""rylic loOid, rT"O:lfIOe"" with

OI3533~S-6

diHhy~"'&lycol

Acrylic acid. 2 .. ~lphoethyl eotcr

12010

019121 ·71-3

""rylic ocid. IUlpropoopyl esur

"''''

094160-16-6

Acrylic acid. tnester with .1)'«tOl

12055

tri, (2.hydm1ypropylj ether

07jj77-70-7

Acrylic acid. triulCr with 1.1.I.trimethy lol.

"""

propane lliJ (2·hydto. yo:!hylj ethot

.".".....,

Adjpic acid, di.Jlyl au:r

12160

Adipic acid, didocyl ester

1219(l

OOOIOS-97.S

Adipic 1Icid, diilOdc.:yl ester

12220

027178· 16-1

12250

Adipic loOk!, dioctyl •• ter

000123·79·5

"""

004074-90-2

Adipic IlCid, dl.inyl ester

RtSlricliQns

PMIR ~r. No

CAS No.

N~

,,,

OJ

")

''l

18820

(00592-41·6

]· Hexe<IC

002628-17-3

"""

4- Hydro"yOl),"'''''

..... """

0C0l78-8J..)

,.".

,,")0

OI6669-S~)

N-{lsobuto.o ymtthyl) a:-rylami<le

",,.,

.

IlIObuIyl o;nyl ether

000109·5)",5

",,.,

OO:Xl78·84-1

Il<>bul)'raIde h)lde

025339-[7-7

'''''''''''

"""",

191 20

~lCid

19130

1~"'lCid

000121 ·9 •. $

19UO

bopillhalic ..,id dkhlorick

000099-6),1

191 80

Sec '2.M<tJoyl_I.3· ....... ione'

0C0l78-7'H

''''''''

,,..,

LoumLw;v.m

1)))947.{l4-6

,,..

Mal6: lOCid. di.allyl talef

000999-21 -3

19S70

M.Jcio: .ocid. diblllyl _

OOOl~·76-0

..,id.

,,,.,

"",

mono (2-dhyl"".yl) 00ltt

00742~Z-9

MaIejc

OOOJ79·19.()

Mtlhacrylamidc

000096-05.9

'"''''

Methacrylic add . allyl esler

""-'"

000101",,).9

Melllacrylic acid. cydolla)'l CSIU

0011159..(l8..8

MOlhacrylic kid. dialer wi,1I

"'''''

I ,)·bulanediol

002082_81_7

Melhacrylil: acid, d~tet wi,h

"""

I .4_butancdiol

000097·91).5

""'"

Metllacrylic Kid. diester with

...

.... ylttqlyrol

"'

005832..047_5

M<:llIactyIk .cOd, die$Ic:, willi

pol yelhylenea1ycol

002867-47-2

Methacrylil: acid . 2-(dimcthyllmino) ethyl

"'''''

eSter

"".,

"*'

cn!l06-91·2

Methacrylic .cid, 2"Hpo. yptOp)ll

Qlden " S mgll<l in FP

(upreu<:d lOS ~~y)

0]967(1.$.2

'"''''

Methaaylic Kid. OSIer with

,,1>0. ylrie1 lIy Ie .... glyrol

000923.26.2

M<!hacrylic acid . 2.hydrolYPf<lI>yl eS1('

'"''''

1XXl81 (,,74-0

Mecbaaylic acid. metJallyl t$ler

2111'

21220

032J6G.W..7

Metbaaylie acicI. octada:yl eile.

010595-80-9

21370

Metbaaylic acid. 2· ... lphoelbyl ester

'''00

MechllCrylic acid.lulphopropyl Wer

0S4276-35-6

21~20

QM .. ~ mall:a in FP

Mechallysu lp/lonic acid. sodium 1/11\

00 1561 ·92·8

(XD}78-79-5

2.Methyl·l .1·buLOdiene

''''''

00lS6~5-1

l- Methyl·I-bo.uene

2171O

5-Methyklltbicyclol2.2. 11hcp'·2-o'1<

21760

001694-9 1·'

buWII

Sec' I,4-B\lWlediolformai'

1 ,4- ( M ethyknedio~ y)

OOOSOS·65-7

S ML"' ND (DL ", OM mal'<a)

00 II I (,. 9(). I

4-Methyl.I,U.eudiene

21837

........ "

to:l92l-D2-4

N· Mechy loIrneth/lcryl&m ide

21910

IIIpbo. Methybryrme

22210

(XXl622·97.9

p-Mt:thybr)ftne

22240

.

Mechyl .;nyl ecm

22270

000107·25·5

"'

00 1\41·38-4

2.6-Nophlhalenedicarboxylic acid

S« <2)·Dimethyl.

0001 26-30-7

Noopentylal)'COl

l.3·propancdiol'

NcodecaIooM: 1ICid, ~inyl CSlef

051!XO-52·]

22428

000] Q4.<IO. 5

"''''

4·NOI1y lphuloi

S« 'BicycIol2.2 , l]hepr.2-ene'

000498-66-8

Norbomene

0037 10-30-3

l,7-Ck:tadicne

"'"

00014(4).9

4-1(n.oct)'lphenol

Tn'"

In these regulations, unless the context otherwise requires: -

l"""JIn'r.OOn.

"ceramic articles'- means articles manufac tured from a

mixture of inorganic materials with a generally high argillaceous

or silieate eon tent to which small quantities of organic materials

may ha ve been added; these articles are first shaped, the shape

thus obtained being pennanently fixed by firing and they may be

glazed, enamelled andIor decorated;

"EEC" as used in these regulations and in the Schedules

thereto means the European Economic Community

"foodstuffs" has the same meaning as is attributed to "food"

in section 2 of the Food, Drugs and Drinking Water Act;

"N-nitrosatable substances" means su bstances capable of

being con verted into N-nitrosamines;

"nOi detectable" means that the analy!e should not be

detected by a validated method of analysis which should delect it

at the de tection limit specified;

"plastics" means the organic macromolecular compounds

obtained by polymerization, polycondenS3tion. polyaddition or

any other similar process from molecules with a lower molecular

weight or by chemicaliliteration of natural macromolecules. and

includes silicones and other similar macromolecular compounds

to wh ic h ()(her su bstances or matter may be added, but does not

include

varnished or unvarnished regenerated cellulose

fil m;

elastomers and natural and synthetic rubber;

paper and paperboard. whether modified or not

by the addition of plastics;

surface coatings obtained from

paruffin waxes. incl uding synthetic parnffin waxes

and/or micro<rystalIine waxes; or.

mixtures of suc h waxes with each mher and/or

with plastics;

ion-exchange resins;

"regenerated cellulose film" means a thin sheet material

obtained from a refined cellulose derived from unrecyc1ed wood

or cOllon and to which suitable substances may be added either

in the mass or on the surface to meet tec hnical requirements and

which may be. coated on one or both sides

"validated method" means an analyt ical method which is

proven to give precise and accurate results.

(Regulation 8(4»

Initial list or additives which may be used In the manufacture or plastic

materiaJs and articles

Gl!nerai inrrod£lClion

1. This schedule contains the list of

(a) substances which are incorporated into plastics 10 achieve a technical

effect in the finished product. They arc intended to be present in the finished

articles

(b) subslallCeS used 10 provide a suitable medium in which polymerization

occurs (e.g. emulsifiers. surfaclants, buffering agents etc.).

The list does not include the substances whi ch directly influence the fannation of

polymers (e.g. the catalytic system).

2. The list does not include the salts (including double salts and acid salts) of

aluminium, ammonium, calcium , iron, magnesium. potassium, sodium and zinc arthe

aUlhorized acids, phenols or alcohols which are also authorized. However, names

containing' ... acid(s), saltS' appear in the listS ifthe corresponding free ac id(s) is (are)

not mentioned. In suc h cases the meaning of the term ·sallS' is 'salts of aluminium,

ammonium. calci um, iron, magnesium, potassium, sodium and zinc'.

3. The list also does not include the following substances although they may be

present

(a)

substances which could be present in the finished product as

impurities in the substances used,

reaction intermediates,

decomposition products;

(b)

mixtures of the authorized substanccs.

The materials and articles which contain the substances ind icated under (a) and

(b) shall comply with the requirements stated in regulation 4 of these regulations.

4. Substances shall be of good technical quality as regards the puri ty criteria.

5. The list contains the following infonnatioo

colum n I (PMlREF No): the EEC packaging material referen ce number

of the substances of the lis t.

col umn 2 (CAS No): the CAS (Chemical Abstracts Service) Registry

number,

column 3(Name): the chemical name.

column 4 (Restrictions). These may include

specific migrat ion limit (SML).

max imum pennined quantity of the 'residual' substance in the

material or article (QM).

any other restriction speCifi cally mentioned.

6 . If a substance appearing on the list as an individual compound is also covered

by a generic tenn . the re strictions applyi ng to this substance shall be those indicated

for the individual compound.

7 . Where there is any inconsistency between the C AS numbe r and the chemical

name . the chemical name shall tak e precedence over the CAS number. If there is an

inconsistency between the CAS number reported in EINECS (the European Inventory

of Existing Commercial Chemical Substances) and the CAS Registry. the CAS number

in the CAS Registry shall apply.

Init ial lisl o(udditi ves

PM/Rd. No

CAS No.

R~

.....

,'I

a>

'"

(OJ

... """' 3O,., , 00l,,,.,...

0IXK)6.t.. 19-7

Acetic .ad

Acetic.ad, .... ryl c:uer

ACCfic.eid, cchyl ell ..

OOO'4'-7l-6

""'"

l\ceIic dydrido

000108-24-7

"""

CXXXl67-64-1

,~-

3O'"

-

AccIylKetic: odd,,",

-

...,

""'"

AccIylaccl itI)'CUidu

-

Acids, a1iJNcic. ""'ilartxuylic (C,-c.,J,

ellen wich poIyJl)"CCfOl

-

i"' ....... rood

3132.1

Acid$, rilly , ftOnl ... HNI or

r .. ood <lib

000124-(14..9

Ad.pk .ad

)17)(1

-

))120

AIoo/IoIs. a1ip/11tic. lIOOIIOtIydric, .... ..accI.

line_, primary (C,-C,.)

,...,

A!&illic .ad

))).50

009005-32·'

-

AluminiuIII robin. flakesllld JIO"'defI

,....

~,.,

0216(S-51·2

Atuminium h)"dtoolde

OI1097·~9

"luminium mIpWwn ~ hydl'OJ(

~""

00 1 )014.23- L

A1aminiumOOide

)·AmuOXI<MOi'ic: Icid, dicilcr w ~h thiobi.

)jl20

01)56(1..<19-1

(Z-hydtooyethylj ectIef

.

,

" .,

007664-(1·1

3U!O

.

A......,..; .... bromiclt

012124-97-9

".'"

001))6..21-6

Am""",,,ium hydnlJide

" """ .,

0005(ll>.)().9

",..,hidic ICid

oom, ....

A,..,hicIonM: Kid

~I-l

)6()()()

AIaIrbic odd

"'"

OOOI"-M-6

Atcurbyl palmiwe

"'"

01060'.{)I)·1

AlCOIbyl " _

a... ••

008012-89.)

""'

,,..,

"'"'

OOJ061.''-'

BdIonk *,ocl

OOOII2-8$-fi

"''''

001:102·78-9

Bentonite

""'"

OOX)6S.gS.()

BcnroicIC!d

000 136-6(). 7

IIenmic Kid. buIyl_

"'''

"""',....

"'.,

,.,.,

IknI:o;c ICocI, ethyl _

00Xl9).S8-3

Iknl:oie .cod. modlyl epe,

38160

002315.68.6

Benwic ""Id. propyl Uttr

"'"

Bis (~)'Ibcnzyl~) IOfbitoI

079072·96-1

e. (motbylbcnzyl ........ ) ..tooIoI

01'7126-41 -3

"'"

0691SI-ol I~

OS4686-91-4

.-

....,

OIlX1O. II·'

Ik:If'Oft niu'idc

.,,'"

00l1(l6.91-1

"'"

..

00!I74)·J6.2

Calcium tM)'ftIC

41280

001:105-62-(1

C.I~ium hydro>ide

41~:ZO

Calcium o~i<k

00 I)OS. 711-1

"

Calcialll IUlpLM.bI_

012!lO4-14-7

0)7293-22-4

B ".

N_

CAS No.

PMJRd . No

Rmricliona

CO,

(l,

("

'"

. .., ~

c-klilll wu.

41760

,

Capr)olic Kid

Carbon dio:lilk

.2160

" " "no

c.booBc Kid. AIu

c.tIoo>.yontdrykdbl_

00900C).ll· ,

C.,_bowu.

00101 S-S6-9

",,.

.,..,

00900C).11 .9

C-;.

CaoIor oil. dehydnilcd

Q6.t1 41.<1Q.6

""""' - " ,..

moo

CMlOr oil. mono. IIIId diaJy«ridet

Cellulooo

4)280

...

",,.

",",,"-36-.

~lI u looc KetaI~ bulynoLe

., "'''

Celuiooc. "'~neralod

QlSl.j42-ss.J

-

CaW.

008001-1S.{I

",.,

00)077·92·9

Cinie add

0IXl077-9}.(l

CiIriI: ocid, tri(th)1_

",.,

-

""""",'"

",.,

OI~1

CriilObalilc

000101.\11 ••

Cydo" .... yllmi ...

43160

"'- ,

"'"

009IX0-16-2

"'.,

ft·Dccanoic acid

000})4...,68·$

""no

010016-20-3

alplll.· l)u.rin

"' 4637'

' 10

\:da.o.:.trin

007S8S-19·9

Q61'f90.S)·2

.

Diatomacmul taIIh

... 80

0)264 1·67.9

Dibtnlylidone JOrb;I<)I

""

1JO'221. 8(}.1

l~·Di.I." ·"" lyl ... hydro.y~ acid.

....

2,o1..Ji 'en .bul)' lphcnyl eRer

lj·Di __ ·butyl"·h)'dro.~ ..,id.

067a.S-9J.6

lle>.ad«yl _

. ,,'

lJ.Oi.ICfI-b.lyl-t-h)'dro.o)'bcnzylp/lc>opla<>

00} 1'»'1 1-O

"oc ..... doonackql ala'

-

. .""

."

~I -»-S

o,mnIo)'l Mlt,ho>..a

IXXX)6 7-61-'

~~-

000'16-»-9

"'00

on :ztd.ll . S

51760

DiP"'I'Y'-'1yaJI

00011(1.91-,

",.,

OI()Ja9·8S·1

Dolomite

52730

000112-86-7

ErucicloCid

,,",.

"~""

0OOO64-1M

037205·9')·,

53270

EI"ylcatbo> ymethykcllu"*

I)l)9OO4.. S 7· J

ElhylttlJuioM;

...

'3280

"'.,

N .N' ·Elhylr:I>d>otolumKie

000110-31-6

" '3'20

-

N .N' • Elhylencbupal mitanUde

~SIB · IB·l

.

N,N' .ElbyIeneboNWI ..... ido

00011 0.»5

",,.

,..,

ElhylmcdiaminclClruMic ICId

OOS 1:J6..44.. 7

Elhyknt·N· palmQmlde·N··~........,ide

"'"""-,

,,,,.

Eohylllydro~ y<:thylctllulou

''''''

-

Eohylhydro~ ylt'lClll Y let 1l~1ou

... '"'' '"

-

Ethylb ydro. )'pmpylct 1111 lou

-

Filii and oil., from ."Imal 01' v.actoblt food

... "

~

-

F.,;>nd oil., hydro(lel\llN , from .... imal 01'

vtflClablt food _~

PM/Rcf. NO)

CAS No.

N.~

Restrictions

,,,

m

(>J

"J

...

".'"

"""'-,

Fomoic acid

. ,,"" ",'"

~~120

000110.17_8

Fum.ric Kid

55190

029204-02-2

GldoIeic: acid

" .,

m_

"""". "...

Gclalin

Gluw;., acid

OOOIIO-<M-l

~8l·S

099880-64_~

GI)"'etOI di~

""'"

. "'''

Glycerol, este .. with _lie -cid

-

''''''

-

" "'"' .,

Glycerol, eslers with blItyric ""id

-

Glycerol, ",lell wilh erucic ocid

-

Glycerol. eSI ... wilb 12-hydroxyOlCaric ocid

'0>00

-

Gl)'ttrol, .. Ie ...... ith lauric acid

Glyc:t1'OJ, estell with tinokic 0Icid

-

"'''

-

G lycerol, est ... willi myristic ",id

"''''

-

Glycerol, CSlers willi oleic ""id

"""

-

Gtyarol. toW1i with paImltic acid

"'SO

-

Gtycm>l. ~ willi n<lNIIOk acid

"'"

.

-

GIyceroI • ..am willi propionic acid

"''''

"'

-

GI)'CCfOI. <$ell willi ricil>O~ acid

-

GI)'CCfOI. cstcn with 0ICaric acid

"'''

"'''

03OZ)~8

Glycerol monobehenate

..

Glycerol monohuanoale

''''''

026402-23·3

"'00

030899-62·9

C;!)'ttrul monolau ..... diattlatc

",

026402·2~6

Glycerol rnonooctaJ>O.t!.

-

'''''''

Glycerol monoolcate, ester with alCOrn",

acid

-

$7120

Glycerol monoole.l<:, .. Ier with cilric ""id

-

"'00

Glycerol monopaImilll<:, ester with ascorbic

~.

.

"'

= w ilt! citric

-

Otywrol monopaImit.ote.

~.

-

Glyoerol ~ •. esler with aocmbic

"000

~.

-

(1)'«1'01 monostt ...... OSIor with citric .IOCid

"""

"""

00)620-67·7

(1)'C<1'O lirill< pll/IQIOle

'"'00

-

Glydne, "Its

.. """" "'"

007782·42.'

Graphite

38320

,..00

GUlf Bum

,~

Gum .... In<

~I·S

Heplln<.>ic: ..,id

58720

000111·14-8

"""

HullnOK acid

000142-62·1

H~ .. "e

0193069.21·2

'9760

.... "', "','" ..

Hydrochloric ocid

00764HII-O

",.,

OOO)()

012012·9(1. 1

H['droma&nesitc

OI2J04.6S-)

Hydnxalcnc

~. Hydroo)'btnlo;c acid, ethyl e$lC

000120--17·'

'.Hydtoo)'benwic acid, ~yl w..-

004191 ·7)·'

"'''''

4. Hydrooybcnwic acid, m<thyl .....

"', .

00)1)99·76-3

"'".

4. Hydrooybcnwic acid, propyl w ..

000094·I)·J

0090::14.62-0

H ydrox \'<=lh y Ice Ilul....,

"'''''

Hydro> ytlh y I met h Y k. nu lose

009032·42-2

61120

0090H-27-O

Hydro.y.lhyl "an:h

037353-59-6

Hydro. ymclh y lcell u 10K

61390

B "'"

CAS No ,

PMIR~f. No

Ratrictionl

, .~

,'I

")

'"

(3)

.. .

, ....

00\I00' 64 1

H ydrolYl""J')'lcdluloK

" " ...

00900I9-16-7

Hydrolyp"J')'11UOdo

000106-14.9

12·Hydro. ,...;c add

.... add

HYJIOIIhc>i~

62140

OO6JOl-ll ·'

",

(013)2-17.2

I"", ""ide

''''''-

000011-'...-

"""

.. .

008001 -39-6

'''''~

"""

001 331-58·'

1{""lin

62720

-

"

K ""~n, caki-.t

",

00(l(00.11 .,

Lactic a:id

00(11)8.22.7

Uclic add, blny] eoICf

""'"

",.,

OOO14l-01·'

l.auricadd

.-..

moo

tX*Xll.-4l-'

000123-76-2

"""

l.cwIinic add

"""

OOO'H·~'

Li ........ 'itadd

~l}'l

"""

UIOOIric Kid

'''''' oum. - 79-1

LiaoknJo: add

l.YS;nr. sa/u

'''''' 001309-42-'

"""

M ...... ium hydrolidc

"".

OOIJ09-4I""

Mqncsiumolidc

00691'. 1~7

""'" 0001(1·11·2

Malic acid

Malonic .cid

""'" 0Il00t7·1.·'

MannilOl

"''''

M~~ .ymetlt)'lttlMoK

037206-01 ·2

"""

,.".,..,.,

<J09OO4.41. ,

Mtthylttllube

"""

Muhyletllylttllube

""" .,..,...,.,

-

Meth)'lhydro.ymethyla:l"',,*

"'"

'''''' 012001 .26-2

M ethyl~ydmJ. ypropylalJu"*'

Mica

67120

"''''

Molybienum diHlptlock

OOll17·J).'

-

Morunic .,~ ItIdIor \he" a.Ief1; "';!h

"""

tthylt:nqlycol.oncL'or willi 1.3·butanediol

oncIIor ... iIlI,1yttroI

67850

OOIIOOMJ.7

MOIII3nWU

.....

1XIOS46J.1

67891

Myri5lic acid

00333).62-'

H2H·Naphll>G-( I ,2-0)lriuol-l·yIJ-J •

p ...... ykOllnwin

.....

Nc,pheline .~ftilC

063187-64·.

61112'

""', ......

OOOI'l.1I}.1

0Iek acid

OOOIU.2I-l

""OO

2.2" ~tthyl·)..(3 ,S.di.ttn-hlt)" ·

070331·9+1

""'"

1oIIC]

ol-hydrm.ypdon)'l}jW /

012191.9).,

"'''''

"""""

""'"

1O:lM1.lo. l

Palmitic: Kid

00)313-49-9

Polm;!okic: Kk!

71020

009000 -69-~

P(lCl;n

71 440

,,""

(XX)IIS·"-~

Penlaerythri!ol

..

Ptnla<:l)1hrilOl le!nkiol).(J .5-di.tcn .bo.nyl.

"""

006683· 19·8

, ...... .....

4.-hydrolypchnyl~ 1

-""

11120

"""

00'766C-3I-2

B 26 1

PMlRef.No

CAS No.

N.~

Rc<triClioTU

OJ

III

("

(I)

...

74240

PhosphorouI; acid, '"*(2.4-di·lCn-

031~~

butylphenyJ) ~

,

o.PIIIhalic: .dd

0IXX)8I...9\l.)

"". .,.,,""-'

IXXXlIIS U 9

Phthalic: anhydride

PoIydimeth yl.iJoxane

76720

0631462-9

PoI)'t'Ih y Itroegl yeo]

O:m21-68·3

""'"

"'"00

061788·8S.()

Polyccnyle .... glyrol esler or hydrog~nated

c&lIOroil

-

m,"

Polyethylentgly<Ol we" or a1iphalic

carboxylic: aci<b (C,-C,,>. and \heir

.... monium orod sodium ... tphaI ..

...

,

,.,.,

.".".

PoIy~ylenoglyeol 00fbi1M .......olMIrI«

... ,

"",0><

"".

PotyecllyltNgI)O)IlOIbi ... monoolt ••

moo

.".".

PoIyccbyleneglyoollOfbiun monopaImitMe

PoIyCl~yleneMlycoi oorbitan I1IOnOSle&I.aC

",.,

009005·61-.

Polycchyleneglycol """,ilan Irio!eatc

",oo

OO9OOP()·)

" .. '"

009005·11-4

Polyechyle .... glyroi Wibj' an lriMelrl1e

.,,'"

029894·)'-1

Poly&lyuroJ ""i""leate

-

""'"

Pol yo. yolk y I(e,'c ,)di "",thy I po l),s; lox~

",n.

I'1llyplK»phonc loCids

008017·16-1

81520

007758'{)2-3

p« ... S;um bromide

"'"'

001310-'8-3

i'QMtium hydro.ide

00lm7.5U

"""

Il·1'topaAedioI

2- PlIlp.",,1

811182

000061.(0).(1

".00 "'""' ......

Propionic ocid

".",

I ,2-!'JopyJenqlywl algina«

00'J00S..37·2

"''''

I .2-!'Jopyletl<gJYCOI dilalllJlle

022188·19-8

COOI4M-6l-4

I .2-l'mp)'leneglyool diolelle

'Wl

,,,OO

031587·2I).1

1.2-Pmpy~lycol dip.o.lmitalt

006182·11 _2

I ,2.Pmpyl<n<glycol distearale

82720

027194·74_7

Il_Prop~l.negl~ool monolauf'lle

82800

",OO

Il_Propyl.n.glyool monool.ale

001330·811-9

Il_Propylc:n.glyool monopalmilole

029013.28. 3

83120

""00

001323·39.)

Il·PropyI.""glyool """,,,,"earale

-

l"ropylhydro.~ykelM'>Sc

83320

-

-..,

Propylhydrmymethykel!~1ose

83325

-

PropyI"ydro~ypropykeU"1ooe

83330

".'" ""-,

I'yTophrlophoric: acid

8~5S

013,,",5·'~2

PyrnphyUiIC

''''''

012269·78-2

"'~

"""

01.1108·6(1..7

Res;" lI;i<I$ and msin lI;ids

81610

073138·82-6

"""-,

Rosi n

"""

'''''' OOSOSG-Jl _'

Rosin. eol .. wilh gl)'Ctrol

008050-26-8

ROSin. ester wilh penlaerylhrilol

""'"

065997.{)6.(1

ROiin. hydrogen,1ed

84210

... ... ,,"

ROSIn. hydrogenaled, .SlU .. ith alyctrol

065997·13·9

,,"

.....,

(X)805(}.J'_'

Rosin. hydrogcnalCd.eMer wilh methanol

1l6<Il65-17-9

Realn. hydrog<na1cd. osler Wilh penll<ry-

... ,.,

.lIrilol

RIIbbcr ....... ral

."..,..,....

· ,.,

R_~"

PMlltd . ND

N."",

" " No.

")

OJ

'01

"'

.....

.,..

StJicylic Kid

.

00Xl69-72-7

-

Silitllfel,l\IItu..-l

"'

..,.

-

Silick: odd, &alia

-

Silicic: ocid,lil)olaord

. . """ ". ""

.. 'W

Silicon arbiIk

000..09-21 ·2

Silicon dio,ide

007631-86-9

Sodium bnlmick

0076<l7·1S-6

00131 (). 7l-2

Sodillm h~.ide

-

Sorbic ocid

"'00

000110-44-1

"''''

Sorbitan diole_

029116.9$01

...... I.

11~20

062561-1 1'()

"'"'

00 IlJI...)9.. 2

001:ua-.J-I

"'"

SortIQn otIOO

-

mw

OU266-S1·<jI

SortIilan 1IIOIIIOpIlmi . .

OOmt-41~

SortMt.n ft lO'"

"'"

"".

Sorbitan _ _ .....

06l1SUl-9

026266-SH-()

.8080

Sorbit.n triolelfe

OS4 140..204

88160

Sorbitan tril"'lm ltlic

"''''

026658·19-S

Sorbitan t,ilC'aBle

""",

. ,...

UllO

SorbirQl

...., ....,.,..

0261136-47-'

StIrdI .edibk

.",.

SWdI, ~tdoul)""

O6Ull· N-J

.- OCKlO:n· .. '"

....

SlCarkocid

QjU~~Sl-9

s-o"kDlo)'ll11Cd>1ne

Srtaroyl·2·lIcIyloc lCod, "*,,,m $U.

001793-94-2

"""

OOOIII). IS-(i

S..a;iftif; _'"

"'00

S~ KflaIC IIObuIynIe

000126-13-6

",.,

... ... .",..,...

0001260 14-7

Sucrooo: octaICCfM.

" 91920

Sulphur

007664-93-9

Sulphuric Kid

" 92160

Tok

014807·%-6

"""' - .....

T..wic.,i6

Taurint,Wu

9219'

T .... phlh.al ic: odd , ditsl., with U',metloyJe.

OnS69-41).1

9220'

ncbil( .. ...., byl-6-JM -Oulylp/leool)

...

m>o

000112060-7

T maethy !ene,tyrol

.- "". ...,.., ..

"

N .N.N' .N' • T ..... i0(2 ·hydro> ypropyl)

000102-60-3

ethylenediamine

OIl46)..67.'

TIIaftidm clio ...

alpht,- Towph:" ..

010191 ... 1.(1

........,.,

".'"

Ttqonnth 111m

.,,'"

OOOI12·21-{;

Tricfllylcnell~

I .3~·Tn""'hyl·2~.6-1fi1 O,$-di.tffl·butyl.

"'00

001709·70-2

4 . h ydro.ybfn~yl)btn_

"""

WQllutonitc

111398)·17-0

-

''''''

Wood flour IInI,\ fibfn . untreated

... '"

-

9$9J~

011138-66-2

XWNonlllm

02lW21·Sl-1

Zinc bydro. !de

Zn: o. iIk

(01)14-1)...2

'6".

z-; ... 1pIt!de

001)1<4-98-3

FTFrH SCHEDULE

(Regulation 9)

List of Substances authorized In th e

Manufacture or Regenerated Cellulose Film

The percentages in this Schedule, fi rst and second parts. are expressed in

weightfweight (w/w) and are calculated in relation to the quantity of anhydrous uncoated

regenerated cellulose film. The s ubstances used shall be of good technical quality as

regards the purity criteria.

FIRST P ART

Uncoated Regenerated Cellulose Film

Not lenll1an 72,*, (wlw)

B. Addltlon

t. Scfi_n

Not roon: (haa 17'1>(wlw) in t<nI

Only f'" films intended 10 be: COIltd ond !hell used for

_

Hi! ( l·bydm~yetbyl ) e!1>er I .. diethy.

("""""frs which ~not moiR. i.e.. whichdo ..... --.lain

1cne,IyoolJ

"'"ter which it phylic:llily f~ at the ... rl"..:e. TIle IOtI.l

EtItInediO)I f .. monoethylo,,",iycol]

-

amounl of bil(l·hydro. yelhyl)clllcr .nd cthancdiol

present in foodlWffSIM( ha.e been in C<lIllOCI ""jlh film

of thi' type IIUOY ..... uCttd )(hnglk, of lhe (ood\lutr.

_ l.J.buWlCC5ol

-

Glycerol

1.2.propancdiol f .. 1.2 propylcne&lya>IJ

-

Ave...,. molccul •• "",;gIIt between 2$0 and I WO

-

P\)lycchylene otidc ( .. polycthyk .... SlycolJ

1.2 poly-

Average molc<:ulu ""'ig/lt oot greater till" 400 and r _

_

1,2 . polypropylene oxide [ •

IJ-propanediol content 1>0( greater than I'" ( w/w) in

propylcneglycol]

w ......

-

SorbiIOl

-

TctratthyS.""aI)'COI

T~ylmtilywl

-

-

U",a

Nor. ~ H.an I'll) (w/w) in total

2. Or~r add;,;"".

The quanthy ofille .ubWlnee or aroop of , ub$t.aJ\Ce$ in

FlRSTCU.SS

....,b indem may oot exceed 2 mlJldm' oft"" uncoated

film

ACftic.od III(! its t-:H •. Ca. Ma. K III(! N.

-

"'.

Denominations

AK:arbic Icid ond ill! NIt,_ Ca. Mlo I{ _

N~"~I

Benzoic: Kid ond lOOium IIcn.-c

Formic.ad 1Ind;1S NH,. Ca. MS. K ar.IN.

-

"'.

L.i~ f."y.ndl.1oIoUltaICd 01 UI"IUIIII'8Ied.

ramon

"';111111 CWft IlUmbrt of

IIOmI from

II to 20 indo.iye .nd II.., behenic and

c.. M

,.

ricinoleic..-ids and the NH,_

K.

1"., AI. Zn loll •• of Ihtae Kids

Citric. d on<! llacric. ""'Ide. ,·, .... nc Itid.

-

,I<

and ' .... if Na and K ..

Soobic acid .... liu NII,.Ca. Me. K ond r-iosab

_

Amide. of linear (~1ty acid., .. ,uraIN or

unsaturated. wiln ~n cvcn numberof ~

3101t1$ (rom 8 [0 20 jn<'usiv. aod .,so the

.",ides of bthenic and ridooleic "dd,

Natural edible Slate"", and nOll ..

Edible $Iar~h •• and flours modified by

chemical lteaImenl

Amy\o$c

-

Caldum IIId mognUium c~t.1 alld

chlorides

£siers oI")'C"Rl1 ... 'illlli_ fatly K'i<I<,

talUraled or un.atunlle<! ... ilh In •• en

number of carbon I'om. from 8 10 20

inclu,i •• Indfo< ... i,b adipic. dlric. 12·

hydrm ~earic (ox}'SlCZi"). ricinolcic acids

EM ..... of p<>IYOI~Yko< (8 to 14 o ' Y'

-

O1hyletle J1OIrps) wj.h linc .. fIlly acids,

lalO",.«I 0< un, l,urattd, with 10 eyell

number of ca,bon I'om. from II to 20

incluoi ••

Esc ..... of sorbitol wilh linear fany Kids,

ut" ... tcd or nn •• turatcd. with an evn

numbe, of u,bon atoms from S to 20

intlusive

MOllO-and/or di-e>t.lS of SCoaric ao:;;d with

d ~ioI arKYor bil (2·hydro~ y(lhy 1) ('Ib(r

llndIor lriflhykne &.Iy«>1

Oxides and hydroxides of alumin ium ,

calcium. maSnesium and silioon and

sillutes and hydr:l.tcd silioate< of alumin-

ium, oalcium. magne.ium and pnum;um

Average molecul . r weight bct"'ccn 1200 000 4<XXI

Polyethylene oxide [ _ polyethyleneglycol)

Sodium propionate

B 2M

RCII,.,cUO .. I

cu.ss

The IOtIJ quanlicy of IhI: IIIbwMca .... y 10)1 c.u:cal I

SECOND

mafdm' 01 w. ......-l f11 .. _

die quantiIy 0I1hc

........... or I"O"P 01 ~ I. ad! inctmt ...,.

_ ucud D.2 .......... (or • lower ijlllit wtIa'e one: is

iii ..

""",,,foed) 0( IlIc iii

SodiWl1alkyl(C.IOC.,J~IU~

-

Sodium ItoprOp)'l ~ IUlphollale

-

-

Sodium alkyl (C.1<l C,,llUlphale

-

Sodium alkyl (C;IO C,,) IlIIp/'w:::mMc

-

SodiumdioctylsulphocuctillllC

DiIIUrII. of dihydro>yflhyl diclhylcrw

NoIIIIO:n \han om lnjIdm'ohhe ....a>aIaI film

-

tri.mrw: moolllKClll<

Ammonium. m',,,«lum Ind poI.lllum

-

.... ryl .... lpIweI

N,W . dlllel'Oyl dilminoelh .... , N.N' ,

_

dip.lmhoyl dlamlnOClhlnt Ind N.N',

dioleo)'l diamlnoa/'lafte

l·heplldcql--4, 4-biJ(met/l)'~~)

-

.,-

NOI _ _ 0,1 ,.r.:trII' ofdle ~ film

-

PolyclhyIC!lc · .... iltOlluT.mldc ethyl-

ucccd I mal

nltRD CLASS _ Ancborilll"

The oouI quanbl)' of wbstIneeI may _

elm' of the wlCOllCd film

Free formaldd>,oe CIOfIIm: _ para-lhanlU mJIdm'

COIIdcll$lllion product of , ... dmlne-for·

-

malde/Iydc IUlllKldiIled. or .. ,... mey bee

ofllle"" .... film

INXIifocd ..,111 OIIeor lNII'Coithot rotlowina

FrIIf: ..... Iamifte 00fIIUII _ purer INn OJ "",<1m' at

dIe~~lm

bI,o l.nol, diclhy lue.riaminc. «"lfto],

lriCI hy l.neICI . am i nc. • ....... h rle lie pell-

I. mi .... crl(l-hydro. yeth)'l) ImlM, J.3' -

..4'

eli • ..,; I'OdiproJly lam;......

-di.minodibu.

' ylami ...

FrIIf: fonnaldehyckOlllllCnlIlOl arwer than IU ma/dm'

CooIdoMali"" product of melamine-PIT.-

-

formaIdctlydc mocIifed willi lri.-(2-hydro-

of llIe _ c d film.

Iyclhyl)amjne

FrIIf: ..... Iomine o:on1lenIlIOI ~ than 0.3 m&kIm' of

lhe uncoo1ed film

-

Crou-linked callonic polyalkylentlminea

In 1ICCOftIIooc:e .. ilh European Communily directives, if

101 polYl mlde-cpichlomydrin n.in billed

opplicl bk.

on dilmi""f'ttll'Ylmttllylamine..-d cpkb·

lOf/lydrin

(b) potyomide.lllortI)'drin ruin baed

OIIq1D1\orhyo;kift.ldipil: acid. ~

&cthylcncuiami ... JrdIor etby~arnlne

(e) polYlrnide-cpichlorhydrin ~n based

On adipic add. dielhylc""trilmiM Irwl

tpidllorllydrin. 01' mix,,,,,, of rpic:hlor·

hydrin _

lIMIOOIia

(6) pol )"'midc-poIyamine-ep;chlorII ydrio

resin blsed "" epkhloohydrin. dimethyl

adipal • • nd d~hylo;n(1""mine

(.) po Iya mi dc-pol ya mi ne-epich lQrh ydrio

""in b~ on rpic:hlomydrin. adipamOle

and di.mlroopr1)pylmelhyl.omi ...

Not """" than o.7~ msldm' of \lie UIIOOIOItd film

_

l'IlIyelhy leneaminn and poIydlIyltnrirnina

Free rmmaldeby'lll: conIcnI ..... ~ .... than o.s mWdm'

_

~iooIprodurIofu~~

unmodi ffll. "''''1Ikt1 maybe modifoed wilh

of the untOalCd film

one or """" of ,he following producu

ami nomelh y I," I phon ie acid. .u I phi oi lie

acid. 0010"01. di amirwbutanc. di.mino-

di e thylamine. dlam inodipropyl.mine.

d i.minflpropanc. diethyl.neld . minc,

ethanol. IUloidi".. melha,..,l. 'clraclhy.

le.o pe ntlmine , " iethyl.nct .lrami ••.

>Odium JUlpllile

The 10111 quantity of oubsunca may not exceed 0.01

FOUIm I Cl..AS5

mgldm'oflbe WICO.iled r.lm

Prod"C1! lUu lt ;ng from ,ho reat1ion of lhe

.mine! of cdible nils with polyethylene

oxide

MonotI .... nol.mine louryl JUlphaIe

B

""

SSOOND PART

Coated Regenerated Cellulose Film

R.ga ..... .:d cellulose

S« first P'" ol ltoi. Sc:hedI.oIe

A.

See first pan of Ini, Schedule

8. Additives

No! mort than SO rna of coatingldm'of film on U.., , ide

C. Co.ting

in contact wjlll foodstuffl

I. P<>IyrMfJ

The toI.al quaMity of ""bslaroccs may r'lOI e><ooed SO !!IiI

dm' oftbe coali", on the.side in contact with foodstuff.

illhyl. h)'drox)"tthyl. h)'dn:l~ ypropyl ll'd

-

methyl ctben of ",,1IUJOSe

NoIrnon thm 20 mafdm' of the COIIIin, on tIIe.side in

Cellulose ni_.

_

nitrosao COllIe'" bel ........ 10.~

00IU(:t";!h '"""",,lfo;

( 'II"") and 12.2"" (w"") In the cellulose ni\nlllC

Polymer1, ropolyrnen and their mixtures

-

made with the following rnonomen

vinyl ""ctlll derived from .. tu,lled

Ildehydes (e,IOC)

vi'nyllCallle

Ilkyl (C, lOC,) vinyl Hh<:rs

nuk"'. metha·

""'Ylio, croconic, iu.:onic.

cry!ic acid •• nd their e.leB

In ocoordancc with European Communily d in:ct;ves.

if applicable

-"'''''

vinylidenr chloride

acrylollitrile

melhacrylonilrile

ethyleM, propylene. I· aod 2·butyler.e

In .:corda""" with ~gulat;on 7 of tho.., ~gulatioo.

vinyl chloride

2. R~Uu

Tho toW quwity 0( $IIInIana:s may "'" e:tcud 11.5

or

the coatin, Oft the lide in contact with

maldm'

-

Cmein

fooohtulb and IOIely tot tile propanIion o f rqenonttd

Colophony and/or it. products of poly·

_

cellulooe film. with cellulose niU1llC 0.- vinyl chloride

mcriUlion. hydrogroation. or di.propor-

and vin yl ac:euote copoly ..... r ba$ed coaling<

tionati«l Md thein.loB of methyl, <'Illyl

orc.10 C, polyvalent ak:ohol._ ()f mi.lUn:s

.!coboI.

o f tile51'

_

Colophony Indlor its produCIS of poly.

meri . . ioII. h~tion. or di>propor-

tionalion condt~ '"';It! a<rylioe. maki<:,

n.....w

ondIor JWhalic Kid • ..0'

citric,

or 2.2 llio (4-"ydro~p/l(dyl propane for-

maldehyde""" eslerirlCd wilt! II'IOIhyI CIlIyL

or C, 10 C.poI)"'3Ieni alcohol. or mi .. ures

of thc:te .1<:0001 •.

_

E"en dorived from bis(2·hydro"yclnyl)

Clner ... ith addition prOOU<'1 <If btlapincllC

andlor di~nlcnc .ndlo, dil.rpc .... Ind

maleic anhydrido

_

Edible ge~ne

_ CM ..... oil and its proJdru of dehydnlion

or hydrolenation .nd iu (olllknu.ion

prodIIcIs wi'" poIygtr=ol. Idipic. .,;".;".

malck. phI""'ic IIId .abacic IIcid$

Natural gum (~damarl

Poly_bela_pinene [_ 'ctpenic lUi"'l

Urta.forrnaldehyde resinl (ICe anc~ri ng

agent.)

Tho 10111 quanlily of subManteS may 001 eaC«d 6 mal

drn' ofth< a>IIIi"l on tho:"de in coruct with foodtl\llf,

Attlylmbulyl cit"""

_

_

Attlyl tri(2-e1hylheJ.yll cilnilc

_

Di·;so!>uiyl adlpat.

_

Dj.n-butyl od i~ t.

_

Di -n-he. yl "",I.,.

NO! more lila" 2,0 m&!dm' of tho coaIinB on (he lide in

_ BUlylbenzylpluh:llllc

rontiICI wilh food~uff.

No! ....:n ll1an 3.0 ml!'dm' of tilt COIline on ,he oide in

_

Di ..... butyl phlhal"",

COIllK1 wilh fOOlblufT.

NOI more !han .,0 m&,dm' of lhe CWlllIg on Lhe $ide In

-

Die),<:lolI .. yl phlhalalc

<On!JCt ... ilh f<l<llWuff.

NO! more lhan 2.5 mj\l'dm' of lhe .,,"ling on (he ,Ide in

_

2...,{hylhexyl diphenyl phosphate

«Inlacl wilh fOO<lllUffl

GI}mol ~c [ .. rnonoaceIin]

-

-

GlyttrOl cliac(lOk \_ cliaoelin]

_

GlyttfOllriaoelllC [_ Iriaoelin]

_

o;.b.llyl ocbacIolC

Di(2. elhylhcnl) Icbacalc I"' dioclyl ·

_

.. ba<:.lc]

_

Dj.n·bulyll.nrale

_

Di. ilQ/llllyllanrale

B

1fI)

Ruark!!" ...

Denominations

Tho I<lIal quaOOly of sublwlcu may 001 aacd 6 ....

dm'in!be IIIICOMed it~1e>1Ied cdlulo6t fitm.lnclusive

of lbe <lI)IIIin& on !he" in DDnta<t with fO<><blulr.

Same restriction. II in tile first pan (howev .... . be

"""""ltd

quanliticI in mi/dm' rtfer to the

regenerated

cellulose film. Inclusive of lhe cooling on U>t side in

conIact with food l ,,,rrl)

The quantity of lhe o.ubswoce or i'OOP 0( sub$ll/lCQ In

each indent may not uoced 2 mWdm' (or. lower limit

.. ~ one illpec;rll.'d) of !he COOli"ll "" the >ide ill

COI'IUCt willi f<l<lCluufb

I.huodrcanol and I~

Eo .... of linear fatty llcilh. PIUnIled or

unsaIUnICd. with ... eYCfI number of carbon

.tom. f,am 8 10 20 incl"o; " and of

riciooleic IIcid wilh elnyl. butyl, omyl and

"leyllinear l icOOol.

MOOW1 ",,,,,es. comprisl", purified moo·

tanic (c,.IO C,.> adds antVor lIIti, esters.

with ""W>ediol..,.yo< t.J buWlediolIlfMil

or m.;r calcium ar.:I pota$3ium oaIu

--

_

Camaubo. wall

""",.u

-

CondelilJ. wI>

1'101 mon: than I mg/dm' <If the <Oalini on lhe lide in

-

Dimclhylpolys.ilo.ane

~onLa<:1 with food.luff.

-

Epl1idiud I()Y"bcan oU (OAirane rontent

6108')

Relined parafflnand "oic>ooySllllli .... WUCI

-

-

PmIaef)'l/lriIOIlt'UMCt.an!C

Not mc:tre t/Ian 0,2 mgldm' of lhe OOI1inl on !he .ido in

-

Mooo . 1Id bb(ocudecyldiWJyle!'Je(l~ide}-

...

oonIltCt .... ;tII f""';<luffs

,,~

Aliphllie Kid. (C, 10 Cy,) esltrifl«l wiih

-

moll()- or di·(2·hydro. yt!hyl)ami ....

1'101 m<lI'(: Ihan Oll(; mg/dm' of tlletolliini on 11>e $ide in

-

l- and ).II:It.Ilo,lly 1-4- hydn,u. yanisole [-buty.

COIlIIltCI .... itll f<>Od$lUffl

lalCd hydro.yonisole - BHA 1

_

2.fHIi ' ltn.l"uyI4-methytpheool [. buly.

1'0101 ""'"' lhan 0,06 mgldm' ot'IheCOMillj on !he ,ide in

C<lfIlIItCI .. itll f()<l(\$luff.

laced h)'droayrolume - BKT]

Di·n«ty_'o-bis(2-etloyll'ayl) ~

-

Noc ""'"' lhan 0,06 mw'dm' <If .he Cll:.1i"l on lhe >ide in

C<lfIlIItCI with fOO<b\lIff.

The Wlal quantity of ... bstanta may 1101 ucud o.6msI

dm' oftheooating on the .ide in COIlllCl with f<lOlhwff.

-

BUlyllC\'tale

-

Elhyl fICeIatc

-

150bulyi flCetlie

-

lsopmpyl",tute

Pr"P)'1 ~

-

_

Aeelone

_

I.ooLaMI

- El M"'"

_ 2·t>ulaOOl

_ 2_propanol

-

l_propatIOI

_

Cyclohex .....

-

Eibyl<ftrglyrol monobtll)'l <thrr

-

ElIoylttleglycol monoburyl "'htt IlCCtlIk

-

Elhyl"""glyool mo<IOe\hyl'''1\e<

_

E1hyleneglycollllOflOelhyl Clhct accIlllc

_

Ethyleneglycol nooooomelhyl ClIIe.

-

El hylenellyrol nKlOiOi.lClhyl ether.:ewe

_

Melhy1 <lhrl ketone

-

Melhyl isol .. llyl ketone

_

Td .... hydm'uran

NOI more ,han 0.06 mi/'dm'o( thc coaling 00 the ,iok in

-

Toilltno

00I'IU<'1 wi!b foodsruffJ

_

Ippubblio. midoDip.oni_." ""I-I.'ornoaujoni - I{ ... ~jo - ~~, """ 0 . , - . - t>f '"f~ Casi/k

Mj.""P ft.I"...."..nja tai-Gv<m _ l'rittrJ at 1M Goo.....- """"'" ,......

Materials and anic1es must be manufactured in compliance

with good manufacturi ng pracfice so that, under thei r normal o r

foreseeable conditions of use, they do not transfer their consti tuents

to foodstuffs in quantit ies wh ich could

(i)

endanger human health;

bring about an unacceptable change in the composition

(ii)

of the foods tu ff or a deterioration in the organoleptic

characteri stics thereof.

The groups of materials and anic les listed in the First

Schedule to these regulations, and, where appropriate, combinations

of these materials and anicles sha!! be subjcci to the provisions of

these regulations .

(I) W ithout prej udice to any exceptions provided for in ....

uti< ... _ oireody

these regulations, materials or anicles intended to come into, but not III_with

already in contact with foodstuffs may not be sold or imported unless I'oodSIvlf •.

accompanied by a label or other indication bearing

the words "for food use", or,

(a)

a specific indicat ion as to their use. such as coffee-

machi ne, wine bottle, soup spoon, or

a symbol as indicated in the Second Schedule to

these regulations;

(b) where appropriate, a ny special conditions to be

observed when they are being used

(c)

either the name or trade name and address o r

registered office,

or the registered trade mark

of the manufac turer or processor , or of a selle r

established in Malta .

(2) At the retail stage to the ultimate consumer, paniculars

listed in paragraph (I) of this regulation must be conspicuous, clearly

legible and indelible and shal l appear

(a)

on the materials or ankles or on their packaging; or

on labels affi xed to tnc materials or articles or 10 their

(b)

packaging: or

(e)

on a notice in the immediate vicinity of the materials

a nd articles lind clearly visible to the purchasers;

Provided thaI , in respect of those particulars refe rred to in

subparagraph (e) of paragraph (l) of this regulution, the opti on

in subparagra ph (e) of pa ragraph (2) of this regulation shall on ly

a pply if these par1iculars or a label bearing them , canno t, for

tec hnical reasons, be affixed to the said materials or articles.

(3)

Allhe marketing sl.ages other than the retail stage to

the ultimate consumer the following provisions s hall apply

(a) materials or articles mu st be accompanied by a written

declaration attesting that they comply wilh the rules applicable

to them, and

in addi tion, the particulars listed in paragraph ( I) o f

(b)

th is rcgu hllion shall appear

on the accompanying documenl~ . and

(i)

(ii)

on the labe ls or packaging. or

(i ii)

on the materials o r articles themselves.

(4) The particulars listed in subparagraph (a) of paragraph

(I) oflhis regulation and the provision re ferred to in subparagraph (a)

of paragraph (3)of this regUlation shall not be compulsory for materials

or articles which by their na ture are clearly intended to come .into

cont3C1 wi th foodstu ffs .

(5) The paniculan; provided for in subparagraphs (a) and

(b) of paragraph ( I)of th is regulation shall beconfincd to materials or

artK:!es which comply

(I) with the criteria laid down in regulation 4 of Incsc

regUlations, and

(b) with those provisions in these regulat io ns relating 10

the s pecific group of materials o r articles.

(6) The particu lan; required in this regulation shall be give n

in . at least, one of the official languages of Malta . This requirement

docs flO( however preclude the use of other languages in addition to

tnc language Of languages of Malta.

(I ) Materials or articles prepared with vi nyl chloride ~I(I ..

..

.

.

polymers or copolymers must not contain vmyl chlonde monomer In

a quantity exceeding I milli gram per ki logram in the final product.

(2) Materials or art icles re ferred to in paragraph <I) of th is

regulation must not pass on to foodstuffs which are in or have been

brought into contact with such materials or articles. any vinyl chloride

in a quantity equal to or in excess of 0.0 I mg per kilogram of the

foodstuff.

(3)

The methods of analysis for the detennination of the

vinyl chloride levels referred to in paragraphs (I) and (2) of this

regulation shall be as laid down in the European Community Directives

80n66IEEC and 81 f4321EEC respectively. The detemlination of viny l

chloride released by materials or anic les to foodstuffs referred 10 in

paragraph (2) of thi s regulation, shall preferdbly be detennined in the

foodstuffs themselves,ellcept that, when such detenninati on is shown

to be impossible for technical reasons , determination by simulants for

th ese particular foodstuffs is permitted.

(I) Materials or articles consisting ellclusively of plastics. PIoN., ............

or composed of two or more layers of materials, each consisting ..... ankle •.

clIclusivcly of plastics. which are bound together by means of adhesives

or by any other means, shall not transfertheirconstitucnts to foodstuffs

in quantities exceeding 10 milligrams per sq uare deci metre (mgldm2)

of surface area of material or article (overall migration limit)

Provided that. this limit shall be 60 m illig rams of the

constituents released per kilogram of foodstuff in the following cases

articles which arc containers or are comparable to

containers or which can be filled. with a capacity of not less than

SOD milli litres and not more than 10 Htres

arti cles which can be filled and for which it is

imprac ticable to estimate the su rface area in con tact with

foodstuffs;

caps, gaske ts, stoppers or similar devices for sealing.

(2) The provisions of this regulation shall not apply to

materials and articles composed of tWOOf more layers.one or more of

which docs not consist cllclusively of plastics, even if the one intended

to come into direct contact with foodstuffs does consist exclusively of

plastics.

(3) ( a) Only those monomers and ot he r s tarti ng

substances listed in Sections A and B of the Third Schedule: to

these regulations may be used for the manufacture of plastic

materials and articles SUbject to the restrictions specified therein

Provided Ihal1he staning substances listed in Section

B of the sa id Schedule s hall not be so used after the 151 January

1997. (b) The quanti ties specified in colu mn 4 of Sections

A and 8 of the Third Schedule to these regulat ions shall be

delennined by a validated method of analysis at the specified

limi t.

(4) An initial lis! of additives whic h may be used for the

manufacture of plastic materials and articles is sel OUI in the Fourth

Schedule to these regulations.

(5) The specific migration limits laid down in the list set

OUI in the Third Schedul e to these regulations are ex-pressed in

milligrams per kilogram (mglkg). Such limits are ex pressed in

milligrams per square decimelre (mgldm1) in the following cases

articles whic h are containers or are com parable to

containers or which can be filled, wi th a capacity of less than 500

millilitres or more than 10 litres

sheet, film or other materials which cannot be filled or

for which it is impracticable to estimate the relationShip between

the su rface area of such materials and the quanti ty of foodstuff in

contact therewith .

In Ihese cases, the limits set out in the Third Schedule to

these regulations expressed in mgl1cg shall be di vided by the

convenlional conversion factor of 6 in order to express them in

mgldml.

(6) Verification of compliance wit h the migration limits

shall be carried out in accordlil1ce with the rules laid down in European

Community Directives 82f7llfEEC. 8515721EEC and 90/ 1281EEC.

(7) Verification of compliance with the specific migration

limits laid down in the Th ird Schedule to these regu lations shall not

be compulsory, if

it can be established that compliance with the overall

migralion limit laid down in paragraph (I ) orth is regulation implies

that the specific migration limits are not exceeded; o r

if il can be established that. by assumi ng complete

migration of the residual substance in the material or anic le, it

cannot exceed the specific limit of migration.

(I) The provis io ns of this reg ul ation s hall apply 10 It.,.. ......

<dlll_ r.hD..

regenerated cellulose film , which either

constitutes a finished prodtICl in itself: or

form s part of a finished product contain ing other

materials,

and wh ich is intended to come inl0 cantaci with foodstuffs, or which,

by vi rtue of ilS purpose, does come into such contact.

(2)

The provisions of thi s regulation shall not apply m

regenerated cellulose film which on the side intended to

come into contact with foodstuffs or which,by virtue of its purposes

does come: into such contact, has a coating exceeding 5Omgldml;

syn thetic casings of regenerated cellulose.

(3) Only those substances or groups of substances listed in

the Fifth Schedule to these regulations may be used for the manufacture

of regenerated cellulose film and only under the conditio ns laid down

therein

Provided that, substances other than those listed in the Fifth

Schedule of these regulations may be used when these substances are

employed as colouring matter (dyes and pigments) or as adhesives,

provided that there is no trace of migration of the substances into or

onto foodstuffs, detectable by a validated method.

(4) Printed surfaces of regenerated cellulose film shall not

come into contact with the foodstuffs.

(I) The quantities of lead and cadmium transferred from CeranIioo.

ceramic anicles shall not exceed the limits laid down in paragraph (3)

of this regulation. Such quantities shall be determined by the methods

laid down in European Community Directive 84I.5OOJEEC.

(2) Where a ceramic article consists o f a vessel fined with

II ceramic lid, the lead andlorcadmium limit which may not be exceeded

(in mgldml or mgll) shall be that which applies to the vessel alone.

The vessel alone and the inner surface of the lid shall be tested

separately and under the same conditions. The sum of the two lead

andlor cadmium extraction levels thus obtained shall be related as

appropriate to the surface area or the volume of the vessel alone.

(3) A ceramic article shall be recognised as satisfying the

requirements of th is regu lation ifme quantities of lead andlorcadrnium

extracted as described in the preceding parugraphs do not exceed the

following limits

Category J

This category comprises

articles which cannot be filled, and

(0

(ii) articles which can be filled. the internal depth of

which. measured from the lowest poinllo the horizontal plane

passing through the upper rim. does not exceed 25 mm

0.8 mg/dm 1 for lead

0 .07 mg/dml for cadmium

An other articles which can be filled

Category 2

4 .0 mg/I for lead

0.3 mgll for cadmium

Category 3

This category comprises

(0

cooki ng ware. and

(ii) packaging and storage vessels having a capacity

of more than three lilIeS.

1.5 mgll for lead

0.1 mgll for cadmium

Provided that. if a ceramic ankle exceeds the aboVe

quantities by less than 50%. that article shall nevertheless be

recognised as satisfying the requirements of this regu lation . if, at

least three other articles with the same shape. dimension s .

decoration and glaze are subjected to a test carried oot as deocribed

in the preceeding paragra phs. and the average quantities of lead

and/or cadmium extracted from those articles do not exceed the

limits set. with none of those articles exceeding those limits by

more than 50%.

II . Teats and soothers made of elastomer or rubbe r must not T _ _

pass on to the release-test liquid (saliva test solution) under the ~.

conditions specified in European Community Directive 93/ 111EEC

any N-nitrosamine and N-nilfOsalablc substance detectable by a

validated method which can detect the following quantities

0 .01 mg in 10lal of N· nilrosaminc:s released per

kilogram of the partS of teat or soocher made of elastomer or

rubber,

0.1 mg in total of N-nitrosatable substances per

kilogram of the: parts of leat or soother made of elastomer or

rubber.

1.2. (I ) No peBOn may impon, sell, keep for sale, or supply

by way of compensation or otherwise. any material or article or any

foodsmffwhich has been or is in contact with such material or anicle

in either case unless the material or article is in compliance with the

provisions of these regulations.

(2) No person may manufacture any material or anicle or

put. wrap or pack any foodstuff in such material or article which in

either case does not comply with the provisions of paragraph (I) of

this regulation.

B 24()

Gaiai.i u soothers maghmula mill-elastomer jew la~tiku rna Oahli"

I00I100 •.

ghandhomx jghaddu lir~release·test liquid (sali~'a test solution) taht

il-kondizzjonijiet specifikati fid-Direttiva tal-Kornunita EWropea

93111IEEC xi N-nitrosamine u IIi sustanza N-nitrosatable Ii jkunu

jistghu jinstabu b'metodu validat Ii jista' jsib dawn il-kwantitajiet Ii

geJJm

O.O l mg fit-total ta' N-nitrosamines rilanati ghal kull

kilogramm tal-partijiet tal-gai.ai.a jew soother maghmula mill-

elastomer jew lastiku

O.lmg fit-total ta' sustanzi N-nitrosatabie ghal kull

kilogramm tal-partijiet tal-gai.aia jew soother maghmula mill-

elastomer jew lastiku.

(1) Ebda persuna rna tisla' timpona, tbiegh,izzomm ghall- lliari ... ' dawn

j'· reg<>ll""',";.

bejgh,jew tissupplixxi b'kurnpensjew xort'ohra,xi rnaterjal jew oggett

jew xi haga ta' I-ikelli tkun gietjew tkun fkuntatt rna' dak iI-mate rjal

jew oggett fil-kai: il-wiehed u I-iehor kernrn-il darba I-materjal jew

oggett rna jkunll f'konforrnit<'l mad-dispozizzjonijiet ta' dawn Ir-

regolamenti.

(2) Ebda persuna rna tisla' timrnanifattura xi materjal jew

oggett jew tqieghed, tgezwer jew tippakkja xi haga ta' I-ikel f dak il-

materjal jew oggett Ii fil-kaz il-wiehed u I-iehor majkunx fkonfonnita

mad -dispozizzjonijict tal-paragrafu (I) ta ' dan ir-regolamcnt.

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(Regoiament 8(4»

Llsta inlzjall ta' addltlvl li jistghu jlntutaw RI-manlrattura ta' materjali u

oggettl tal-plastika

Introduv,joni Cenerali

I.

Din I-iskeda fiha I-lista la

(a) sustanl.i Ii huma inkorporati fil-piastika biex jinkiseb effett tekniku fiI-

prodou lest. Dawn huma rnahsuba biex ikunu prei:enti fl-oggetti lesti;

(b) sustanl.i wiati biex j ipprovdu medium adattat Ii fih tokkorri 1-

polimerizzazzjoni (e.g. emulsifier!, sur/octonts, buffering ogtntS eet.).

D-lista rna tinkludix is-sustanzi Ii direttament j influwenzaw il-formazl.jon i ta'

polymers (e.g. is-sistema katalitib).

2. II-Usta rna tinklud ix iI-melh (inkluzi melh doppju u melh addu) ta' l-aluminju,

ammonju, kaltju, hadid, manjesju, polassju, sodju u zingu ta' l-aCidi, pherwls jew

alkoholi awtorizzati Ii huma wkoU awtorizzati. lida.ismijiet Ii fihom 'Atidu(i), melh ... '

jidhro fil-listijekk I-addu liberojew aCidi li beri korrispondenti majkunxjew ma jkunux

imsemmija. F'dawn il-kaiijiet il-tifsira tal-kelma 'melh' hija 'melh ta' l-aJuminju,

ammonju, kalcju, hadid, manjesju, powsju, sodju u iingu' .

3. II-lista wkoll rna tinkludix dawn is-sustanzi Ii gcjjin ghalkcmm jistghujkunu

preunti

sustanzi Ii jistghu jkunu prezcnti fil-prodott lest bhala

(a)

irnpuritajiel fis-sust3nzi wiati;

reaction intermediates;

prodoui tad-dckompozizzjoni;

(b)

tahlitict tas-sustanzi aWlorizzali.

I1-materjali jcw oggclti Ii jkun fihom is-sustanzi indikati tahl (a) u (b) ghandhom

ikunu skond il-htigict imsemrnija fir-regolament 4 ta' dawn ir.regolamenti.

4. Is-sustanz i ghandhom ikunu ta' kwalitA tcknika tajbaghar-rigward tal-kritclji

ta' puritA .

5. II-!isla fiha din I-informazzjoni Ii gcila

kolonna I (PMJREF No): in-n umru ta' rifcrenza la' I-EEC tas-sustanzi

taI-lista gball-matcrjal la' I-ippakkjar;

kolonna 2 (CAS No): in-numru tar-Rcgistnl tal-CAS (Chemical Abstracts

Service);

kolonna 3 (bern): I-isem kimiku

kolonna 4 (Restrizzjonijiel): Dawn jisighu jinkludu

specific migration limit (SML) ,

kwantilA massima permessa tas-sustanza 'residwali' fiI-materjai

jew oggen (QM ),

kul! restrizzjoni ohra spei:ifikament imsemmija.

6. Jekk sustanza Ii tidher fuq il-lista bhala komposl individwali tkun ukoJl koperta

b'cspressjoni generika, ir-restrizzjonijiclli japplikaw ghal dik is-s ustanza ghandhom

ikunu dawk indikati ghall-komposl individwali.

7. Metajkun hemm xi ink:onsislenza bejn in-numru tal-CAS u I-isem kim iku, I-

isem kimiku gbandu jiehu preeedenz.a fuq in-numru tal-CAS. Jekk ikun hemm xi

inkonsistenza bejn in-numru tal-CAS irrapponat fl -EJNECS (ii-European Inventory of

ais/ing CQl7Utlerciaf Chemical Substances) u t-Registru tal-CAS, in-numru tal-CAS

fir-Registru tal-CAS ghandu japplika.

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.,.,,.,,,1' ,

00010M0-]

N.N.N·.N·.TtfnlkUtl~J

"...

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o.jou.idIlII-riIaIoja

OIJ..l6J..67.'

"'.,

_/poV.T""""" .01

QOIX159.oM

.,..

01019141..0

"""",.,

.".,

rra,IKII.uh tlUll

r

000112 .. 27-4

rle</Iyk<te,lycoI

001 7()C). 7(). 2

IJ.J·1i'/ltwdt~·1.4.6-"u (J,J..ti-u .. ·bwyl·

"""

4-1cydrruJb<'ItJII~

r,.

OI)98J...J7.{l

Woll<U~/'

"'"

"'.,

-

. .

II fobri 110" I-ill}am mhu~ !!MIll;

011138-66-2

X""'''''N I _

"''' ,'"

020427-SS-j

Idroukiu 1.'.:!in&"

".

0s,id" Ili-i.inS"

00131 4- 13.2

"'.,

tat-tin,u

001314-98-3

S~lpI!lM

lL-HAMES SKEDA

(Rego]ament 9)

Llsla ta' Sustand Awtorlzzati fil-Manlfattura la '

Film ta' Celluloia Rigenerala

Il-percentaggi f'di n l-Is keda, l-ewweJ U I-lieni laqsimict. hurna espressi

fweightlweight (11'/11') U huma kkalkulati b'relazzjoni ghall .kwanti!:' ta' film ta'

ce!luloill rigcnerata ani dru mhux ikkowtjal. Is-sustanzi wiati ghandhom iku nu la'

kwalilll tcknika tajba ghar-rigward tal -kritcrji ta ' puri tA .

L-EWWEL T AQSIMA

Film ta' Cellulota rlgenerata mhux Ikkowljat

Rutriujonijin

B.

Addllhl

Mbu. itjcd mjrm 27'l> 1"""'/ ro t-lOll'

1. ScfI~""r:1

ElliS ,l'1li1 r,l"" mah$ubo. biel ji," kkoW\iali " mbag/'lad

- 81, (2·hJd""xJ~lhJIJ "hu I • di~lhJ'

uiMi i hal hwejjeill' I· ikel li majkun •• "midi, i.e. Ii

IOI.,/yroi/

rna jkun. fil>om illlll Ii j k"n r,t itlmem libeN fiI -w icc.

£I~jul. f. ~'hyl,,,,,,IY"oI1

-

L-Imm<lnl ,nt.1i IB' bil l2 -hydroxyethyl/ ",hu u

"h<Jn,ditJl ))teem; fiI- hwejje, la' l·ike1 Ii jkyny iew

rkunlln ma' film to' din i. ·.orta m. jiStl.< jcCCedi 30

m&fi:1I tol.haja la' I·i kel.

_ I,J./"',,,,,.dio/

G/yc~roi

-

1.2,prop<lrWiol {~ 1.2 propyU~:lycoI{

-

PolJ'I~~"'~ oWk (E poIyer~:lycoIl

-

Pii no:lIek"1ari mcdju bejn lXIlIId 1200

mII""

'" f 1.2 poi,.

iijed miJWt <100 • konleflUI

o~id.

-

1.2·po/ypmpy" '"

Pi! moletulari mcdju

to' I. J.propiJMdiq/ libeN mhu1 iije4 minn I .. ( ..... )

p~,lycotl

li~suKInD

-

Sorbilol

_ T""""~:lycoI

Tn.t~JtCl<:tywl

-

-U~

1. AdJ,';". MnI

Mhu1 iije4 miM 1 .. ( ..... ) frt·1OLII

lI·k ... 'lIItitlo 1ill-luWIIIU jew &fliP!) II' IUI~ f kul l

L.-EWWEl. KU.SSI

indontllu .. ma listu lotadi 2 m&ldm' tal·film mh".

i"-_Ijlt

ACidu .tet'ku" 1·"",111 NH .. Ca. Mr. K u

N~ lie","

Acidu u kOlt>iku u )·rndh NH ~ Ca, 101,. X"

No t;'g/lu

""_,e

Arid. berwIj'tu M>tliJIM

c., 101,. X •

A6du fonnih u I-mell Nil,

Na tie","

Atid; , raui lineari. " "Prali jew mhu.

saI_i, b'nu",", pori II' _ i "Harbonju

miDn 8 "' 20 ;Dtluiiyl kif utoll .tid;

c...

I>mnIk u .. icIi ril!inole~I.I·mdI HH,

101,. X. Na. Ill. z" ",' dawn I·Kidj

_

Atid; titriki. d " IIac,ie adds . .eidl IIIIlej.

Ci,/-IlUltJric <Jridsg I-mellI Nil U X1II£b/'IOm

N._

c... 101,. K.

A8du lOIbiI;u u I-melll NH,

Amid., II- .tidi ...... ; lintari. ~;o ...

nth • • sat .... i, b· .... rrnI pui II' 110m; IaI-

kubonju minn 8 sa 20 iDklutlvj kif utolll·

DltliM611' atidi bdwlli<' u ":idi ritinolojti

~i • dqiq ...nnIi ti jinioHo

Lamt; u dqiq Ii jin icUa modifibti bi

....,...

u.tamonl kimih

"-"'-i."""

ilkllaI.bltjoo • manjo:ojD

E:sIers \.ll·,lJnrol b'Kid; arMSi lintari,

""""i, b'ng......, pMi II'

sal"""; jew mho .

IIOmi Ia' .karbonja mi.., I .. 20 inkJuiiy;

,.r,.,.. b'atidi odipiti.ltidi tilrit;. Itidi 12·

.,....,., ___ (~ __ ). .tid; ritiDoki-

o

b.",. w.poqo..y.dI"~~e (I sa 14 Jf1Ippi

ta' 1." .. ~'h,I~ ~~J b'Kidi IfUl; li ... ri.

oaru""ijrw mlln AI.,..;' b'numN pori II'

lIomi w . kIrtJonju minn • sa 20 inkhliiy;

Bu •• I&HOrbitol b'lItidi fIUIi linuri .

_

........ i Fw m/Iu .... _i. b' •• ""," pui .. "

.. om; ta).k...oonju minn 8 ... 20 inkluiiy;

M(»fI)- uljew Ji4!Sl~' II' .tidu JI.Iri~u bl·

oltDlVdioi W,IOW biJ (2 ,~)Idrw:yWI1I1 erAer

w,.w

'~lIll1efW ,1yaH

o.sid; u idroSiidi I.' [ .• Iuminj" , kaJ.'ju

manjuju u .ilicon u .il;hl; u .;Ilkat; idnl;

\.0.' 1·lI1um lnju, kalCiu, manjcljU" poWSj"

Pit ml'dju moIokullri bojn 1200 • .aoo

PoIyelhylefW <»ide f. poI~,IryI~,ly(C>I/

-

Propjonll u'&-Iodj"

Denominazzjonijiel

Reocriu;ooijicl

lJ·tWll>lilllIOllli tal IRIll .... maliow..cttedi 1 msfdm'

IT-llENI KLASSI

... Fw

1al-fi1m mh ... itkowtjlt u l·twamlll .... _

JIIIPP t.I' nscaml fhU indenuuua rna liliu teUedi

0.2 m&fdm' (jtw limilll okt. t-n r~jn ikun brmm ope-

tifibl wiehod) gJ_film mhu ~ iUDWljII

SodiwrIdIJ:yI(C.",C,JIH~...Jp/tofwe

-

_ StlJUJm ~ N>pIrlIlDkM~~

_ Sod'- alkyl/C, '" C,,) sWpIoale

- Sodu-tJlkJI/C .... C,.J~e

Sodiwrl ~tIIXiroalr

-

Oi3teamu Uo' JjhyJ~'hyi dktl.,to..

Mhu~ lijed mJMO.(lS maf¢m' \ai_film ""'. , ikkDWIjal

-

_w~eltJl"

- ""'-'_ -t""i_"~ '-'YI

,,.,,..,,,

-

N,N'·d<fleamJI,U"".;nQello"ne. N.N',

dipalJrWoyI ~tltoIIe .. N,N'-dkMQyI

diamu-~

Nwp~.4.IHJ("'tlhyu"' -JIt"mli!J

-

""""""

Mhu, ;'jot! minn 0,1 mgldm' tal _film mh., ikkoWlj.o.t

P" I yn h y/" M ·am I nOll "a ."m idtl ", h Y /_

. .. Iphale

IT· T1EIEr KLASSI _Anellori", ,,~"'

lI-k"""",lt. total; w-sus .. ",1 m. 'i~ lCttcdi I mgldm'

tal·m", mhuxlkkoWljat

ProdDlllal.kollden .... jonll.· ",.I"",/>Ul-

Konlenu. ra' JiK_l4thy.k ]ib<ru mh". iljtd mmn 0,5

formQ/dthytk mhux modifiht .jew Ii ji,u'

maldm' taI·liIm mhu. ikkow1jar

jig; modifik., bi prodoct jew iijcd min n

Kon.enu, .a' """am; •• liberu mh"x it jed minn 0.3

mh". ikkoWljll

da .... n Ii ;elii"

m8ldm' taI·lilm

h 'a" 01. d j ,,'hyl tnt Sr;"", j n t. ., h"n"l.

" it I II ylt ... <l,,3m ine, Itlr""/oyie". P'"_

--

,""' ... ". 'n(2 - ~ydro~'hyIJ <lmirw, 3.3'·

diaminodipropy/amill<!. 4, 4 '~"".

Pmdon tal.kond<nuujoni .a' md,vni",,·

KontcnUl u,' ft>nnaJJrlrytk liberu mhu •• ijecI minn 0,5

lITeo"onft4/J~~yd. modilika, bi ,,/s-/l·

m&fdm'taI,/ilm mini. ikkowtjll

hydrtu)'erhyl/ anUM

KO!L\eIII/I ta' "..lmrtiM libenr mhw. i'jed minn OJ

rn&Idm'taI./ilm mhIu iUowrjll

Cro .. ·linhd~poI)t<'lky~s

-

Skond Id·dl.enivi 'al.Kom".;,1 Ew,opn, .ie kk

oppIihbbli

(a) p<>/y'" "id'.'pkilUHhyJ';rr Ttsirr ib-

baiala fuq dillmirropropy/_,hy/ll",lrw u

. pidtkNhydr'"

(b) poIJamiIk~'u",ibbaia,

.a fuq .pidl".hyd.i •. • cid" Idipiku.

"'fr""

copral"cra"" d;e.hyl.rr.lfia",;".

erh~ilImw.

le) poIyom~IIIo< ~)Idr", ,uift i!JbUa.

,. f"'l':idu lIdipiku. di.lloyl."milvltiov u

rpic/tl~~ydrill. jew \.lI!li!1 I.' rpkltJ",·

~yrIrUo u Immonjl

(d ) poI",,,,id.-poI_iov-qlt'loJerll"', ,,,

~Ii" ,bba1ata fpq q>idJo~lIpl~ . JiIrI.lltyi

<U/i"",. " dklltyienori<J"';rtI!

(e) PO/J"II"idI!-pol)lQl'll"N'pld !orlo1flritt

n .... jbbo;." filii ~. iJdiptJ-

d"""""""..,)/Ao,.,,'

r..

IIIiM •

__ ,

MhIl>. lijed ....... 0.75 1JlIIdm'1aI.llbn ....... ~

PDi,..u.,u~,,~ykrv

It,.

Prodo!! tll . kondenuujoft ; II' .rea·

KonICaOl la' Jon-s.kIIyd.t. libenI mhu. Ujed IIIiM 0,",

p

mhD. DIOdifit..jcw ti jIu'

IIIfIdm'lII-tilm ...... ikkowtjII

'1

jii; .nodiriu !Ii prodaa jew lijrd III ....

<In" Ii IiFjjift

ll,"i ,,""'t'ltyIIMlp"""~ «id. 1 .. lplllUril~

add. bl<IIl .. "I. diaJIIi .. ub .. wII •. dia",;" o·

dinhylllllt;n,. dill",jllodipl'O,.yl" ", iM.

.,It II,

dill'" j 1\01' "'1'''11'. di ,It "j"", 1M.

"IImtoI, ,...."iJill •• _IIomool. ~1_'It,.

i", .

ItMpnll a", ill'. "in It ,It nr U Ir" '"

><><Ii"", •• lpIoi ••

IR_RABA' Kt,..\SS1

I"rocIorIJ II jitriholtaw miNuujOfti la' I·

lI.k ...... iol...wi 1af ... 1IIWIZi .... tiaw. I.ttafi 0,01

"'IIdrn' til_film ... Iou itkoo>".

"",j..n la' jJIIIli pnalll mI' poq.rllykow

m,,"

",_,."otOI_mtllll<ryI.lIlpItDIt

B 2Z7

IT-T1ENI TAQSIMA

Film ikkowtjat (a ' telluloia rigenerata

RestriZl'jonijict

Denominau.jonijicl

A. Cclluloia rigcnerata

"'no l-e ...... ellaq$ima ta' din 1_I'ktda

A .. l-ewwellaq<ima ... • din I-bl:eda

B. Additlvi

MhuA iljed minn SO "'Ilai-COOli",ldm' I.Milm ruq in.

fAI'II r hnoo maI·h_.iiei \.II' l ·i ~ 1

I . I''*!-,.

1I_!:...."liu 100. li w_o. stlm;; "'" Ii" .. Jetted; ~

ma/dm'taI ......... ill8 fuq i ... nahI f'kuncan g

.h_Dei la'

I·ikel

£'~11. JoyJ,,,ry~/Jo]I. ~Jd"'AypT('PJI u

_Illy! nNT> tK..ceuuJoi.a

MhuA iijtd minn 20 mgldm' 1.1.,-" ,,,1.., fuq In·nalla

Nitral t.c..celluJoia

f"kUnI&tI mol ·h_jjeg ta' I· ikel; konlenUI ta' nltrotenu

bcjn 11).8% ( ... 1 ... ) u ! 2.2% ( ....... ) nn·n itra\ ta/:·telluloia

PoIymt rs, CQPOry-n U ' _lalll;!; .. taghhom

ml.ghmu l. minn dawn il . ..,,,,,,,,,,.,, I!

tejjin

.Iwyl ac~'at. de.i"l; minn ~ld.Joydu

SlltU""; (C, sa C)

""""u

.Iny!

al!yl (C, .. CJ vi~yl oWn

ACid; atriliti. ~. iukoNti. malejti.

Skond id-direttlwi toJ· Komuniti Ewropca,.leU

mwb'iliti U Hl"'1J1JihhOm

lIppIibbbll

INtlt>dit ..

styr ...

~'h)'ISI),rtll'

a<:')'iolli,rilt

_''''''''1I(},,;,,;I •

• ,IIJ't .. , propyl._ . 1_ u 1.b""I.",

."')'1-

SkOtKl ir· rqollomon! 7 ta' da"", ir·rqoIamtnti

lI·kwantltl totali w· .... tanzl mil !I>ln tKtedi 12~

m&ldm'tal~"8 fuq in-naJIa ("kwKMI. moI,~jjei:~'

1·lh l u unikamen! ghal1.proparanjonl ta' filml la '

'",,"'al'

Cellulo'a rijeMratI b 'l'<I<Ili"l'

f"'l in, nina!

tal: -a II. Iob;ow ";~yl clr10riJeu o;"y! <JalDluo"o/)'I'V'

_ K" •• illlJ

Co/cpAoll1 "' jew il'prodon i t"ilbh. I"

polimuir.uujoni. idrogenazzjoni, jew

d isproponjonaujoni " J •• ",,, ioahhc)m

· ""

II' ~ nlryl jew alko/lWj poIiv-"; C,

.. C.;.w IatIliticll.l' ........ l-aII<oIIoIl

C"IopIuNt, aljew il. prod"tli ,.phl tl '

idro*.n ...

~"i.jew

polirneriUIUjofli,

di$plopoitjO<laujoni kO<ldo:_1 b'lItidi

abillti, mak;;;, ~ilriti . flunariti 1II',ew /\all-

ti..rFW2.2bU {4·~I """'"

/tN- ,(1 ",*. esttrifiktli bi'--'/1:)01 ttlt:JI

c, .. CJ- lINibCI

jew alkolloli p:::>Ii ¥&Icnti

II' ....... ~oIWf\ol i

_ urn. dorin.; minn In. /l~ltylJ

bii·tieda uo· prodoni II' ~

_

..r,ew diporletW.r,ew djurpDW u anidrid.

"",kjku

_ Gelll'.a l; rinichl

Zejt i •.• itnu " l-pt'OdoIll li.l~u II' di.-

idraw.zjoni jew idr'oFnaujonl u l.pnx!oItl

,i,.bu "" kOllCkI\Sl~i b'otidi toJ.pot,.

,lywvl, lItidi Idi~i.t~riti . .... jH nail.

tiu~~i

Gom .... IIOIIInI; ,_ iboocvl

-

-

p~·,,;-wI·"'_"'''''''1

- Uw.fo_.r+lo,. ....... ( ..... Ikoo",

..... J

_.....w

fnII liIlu l..tttdi 6 m,MnI

U·k.";di I(U)j

.... -nwi"" fuq ___ r t _ maI-II .. cjjci .. 'J-ike!

ci,,,.,.

_ .4--,1 lrit>wyl

_ A".,ryl fri(2·t'I!,/Jou:yI) ci/ff"~

_ f)j.isobt.lyI t>dip<lf~

_

tJdipalr

()j· ~ · bwyl

_

Di.~.1IuyI tI:J!ldU

Mhu~ itjod minn 2.0 maldm't.lI<O<Ili", rllll in-naIII

f kul'llall ma1·1\wejjei: 'a' I·itel

Mh • • ;'jed minn 3J) ma/dm' Ia1<O<1li", fuq ; ...... N

f kunun onaI·lN.~jjei !a'I·ik.1

Mha .. iijed miM 4.0 m&ldm'taI·('o,lIl.., fuq "'·naIII

fkuntatt maJ.II\o.'ejjei II' I·ikel

Mh,,, iijM minn 2" "'I"dm' ,aI-('OQll", I\Iq i ... na/II

rk~nllII mal.b_iitj ta' I·ik.]

f .. _ , ... /

-

ClYC~rrHmtNttItIU_

-

GlYCnrH"","_ f_ d>lllUlitl1

CI:JUrrH ~ /- "",",.",

-

Resnir.zjonijiet

,.,.,.",

-

Di(2·,tlhylhualJ s~""ca'~ ,_ 41«'1"

- Di·~_

II·twantidi total, w·SIISIaml nil. ti.w. tcCCedi 6 m"<Im'

fil·lilm II' a:Uuloia ri~ mhu ikko .. ,jat. inklo'

;I..-lin, fuq ;n·nat\I rkuntlll maj.hwejjcli II' 1-ikel

lobleiS fUlri~jon;jiCl bbal n-ewwell"'ni (iida 1·

kw .... iUljkt rnWdm' jirrd'eru gllall_film 1/1' <'.ellulo"

rii"""rall mhux ikkowljat. inkl"' il"""",' i"" ("'I in-naI'II

rkuntllllllll.hwcjjei II' I-ikel

lI· kwlnt it. tIH'\'$lanUi jew grupp II' ,ustanz; null

indentl'UrI rna lista. te<:tedi 2 mgldm'{jcw Umiru okta.

~ .. (ejn ikun ~mm .peeifikat widled) 1I1'''''<IIiIIs fuq

in.fIl/\a f"kuntall m.o.I.hwcjjcil II' I·i kd

&tn, to' "'idi....,..i lineari. lIIuraU jew

mho. latwai. b'numri I*i II' .wmi IIJ·

karbonju miM I .. :20 inkJuiiv j " \&' Kid.

OOnoIejkll b' tJl<yi. bool)oI. ~ G oIeyi liIwfu

"""'"'"

MOMa" .. azu. Ii jiUon,iatu ('.tieli

purl'' '.; . . .

<c,. ..

JeW ].

montarriCi

C .. )

eSU .. t&&bhom bI...,lMIvdl<ll ..... jtw I. J

b~",,..diol uljew il-melll I.,·bltju jfc ..

poUSlju IagfIhom

Mh .. iijed min" I mgldm't.,-coo';", 'U'I in-nlha

num.1t m.o.I.l\weijcll ... • I·ikel

Epo~ldiUd 'QYQ ·bean 011 (konlenu' II'

o.tirdM 6 sa 8%)

Xc rnl' II' par.rrina , drin .1I u urnl

rnikrokri'laUinl

p."t""ryt~rito/ l~r ..... I ... "".

MOII(I u bll(ocroJ"Jldi"~Jl~"~o;<id~!,

Mhu. Iljed monn 0;.1 mWdnt'l2I..,oorj"" flKl in-Mho

nUlllan ltIIl,hwcjjci II' l-ikcl

PMSPMUS

Atidi .I ' fll iti (C, 10 C.l ~Ilcrifihl; bi

_ _ jtw Ji~ UI:;dro.ryttJo:tljQmJlW

1- u J-I~r1./""JI4.~~ /_bl"y-

-

MhuI iijed minn 0,06 msfdrn'I2I""""'i ..... rllq on-naha

'-J~ - BH"'/

f'hllllll mal_llwejjcj II- l-ikcl

•

2JO

MIll .. iljod minn 0 ,1)6 m"dnI'~-cora/"" fbq m.rWII

-

2,6.J'·'''rI''''''JI.~,''''''hylp''''<WlI· tHuy-

Im~d hydroxy<clUeM- Birr'

rkllllWl maI.b .. jjej II' I·;k~l

"'t., i.ijed .... OD6 ~ QI-"'I r.q .........

f)i"'-«f7IIu.-hiI(l~,uouy/) ~

-

n _ mal·1IwItiiri II' l·iUJ

lI · kwlnr~lIlOuH w ' lu'tanzi ma rillL>. ,cUed; 0.6

n _ ma/-"-»-*

mcfd"""'~ fIIQ ... _

\OJ' I·in]

- BWJI ""_

- £I""

/lct:UUr

_ IsoIn.,yI QC~'me

/lOpmpyl acelllU

-

--

_ Propyl «&>Ie

- 2 too ;""""

- 1_

-

/ -propoAO/

- C~~

b~t,nJ -n..,I erlter

-

-

/:".ItyI"." lycqI -OOW1]/ erN, "". lDIe

f..)hyleM,iyrni ",_,lryl ./,...,

_

-

ElAyklltt,lyct>I _,lryl,"/,,,auUJl'

-

ElIry/nv,lyroI _ " Y / "N'

"M' .. U UIU

_ £lI,yl"."lyroI _ _ tlrJl

_ /tInlryi nlryl ",,,,,..

_ M" "' ~u

_ TnrrlltyJmfoo ....

Ial-ro<>'' ' (1Iq In-1IlIII

-

To/.fIt

Mhul irjecl minn 0.(16 "",dm'

rk.>IIan mal·h~.i.it* I.' I.ike!