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"B COMMISSION DIRECTIVE 1999/91/EC
of 23 November 1999
amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact
with foodstuffs
(Text with EEA relevance)
(OJ L 310, 4.12.1999, p. 41)
Corrected by:
"C1 Corrigendum, OJ L 249, 4.10.2000, p. 26 (1999/91)1999L0091 — EN — 24.12.1999 — 000.001 — 1
COMMISSION DIRECTIVE 1999/91/EC
of 23 November 1999
amending Directive 90/128/EEC relating to plastic materials and articles
intended to come into contact with foodstuffs
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,Having regard to Council Directive 89/109/EEC of 21 December 1988 on the
approximation of the laws of the Member States relating to materials andarticles intended to come into contact with foodstuffs (
1) and in particular
Article 3 thereof,
After consulting the Scientific Committee on Food,
Whereas:(1) Commission Directive 90/128/EEC (
2), as last amended by Directive
96/11/EC (3), provides in Article 3(2) for the revision of Annex II
thereto.
(2) On the basis of the information available, certain m onomers
provisionally admitted at national level may be included in theCommunity list.
(3) Other monomers have been requested for use following the adoption of
Directive 90/128/EEC: the technical data supplied permit their
inclusion in the Community list.
(4) Annex III to Directive 90/128/EEC includes a list of additives, which
should be amended so as to include other additives fully evaluated bythe Scientific Committee on Food.
(5) For certain substances, the restrictions already set out should be
amended according to the information available.
(6) The current total list of additives is an incomplete list inasmuch as it
does not contain all the substances which are currently accepted in one
or more Member States; accordingly, these substances continue to beregulated by national laws pending a decision on inclusion in theCommunity list.
(7) This Directive establishes purity criteria for only a few substances, and
therefore the other substances which may require purity criteria remain
regulated in this respect by national laws pending a decision atCommunity level.
(8) The measures contained in this Directive do not go beyond what is
necessary to achieve the objectives already provided for in Directive
89/109/EEC.
(9) The measures provided for in this Directive are in accordance with the
opinion of the Standing Committee on Foodstuffs,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Directive 90/128/EEC is amended as follows:
1. the fourth indent of Article 3(5) is deleted;!B
(1) OJ L 40, 11.2.1989, p. 38.
(2) OJ L 75, 21.3.1990, p. 19.
(3) OJ L 61, 12.3.1996, p. 26.1999L0091 — EN — 24.12.1999 — 000.001 — 2
2. Article 3a is replaced by the following:
‘Article 3a
An incomplete list of additives which may be used for the manufacture of
plastic materials and articles, together with the restrictions on their use, is
set out in Annex III’;
3. the following Articles 3b and 3c are inserted:
‘Article 3b
Only the products obtained by means of bacterial fermentation listed in
Annex IV may be used in contact with foodstuffs.
Article 3c
1. The specifications relating to some substances appearing in Annexes
II, III and IV are laid down in Annex V .
2. The meaning of the numbers between brackets appearing in the
Column ‘Restrictions and/or specifications’ is explained in Annex VI’;
4. Annex II is amended as shown in Annex I to this Directive;
5. Annex III is amended as shown in Annex II to this Directive;
6. the texts set out in Annex III to this Directive are added as Annexes IV , V
and VI.
Article 2
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive not later
than 31 December 2000. They shall immediately inform the Commission
thereof.
Member States shall permit, as from 1 January 2002, the trade in and use of
plastic materials and articles intended to come into contact with foodstuffsand complying with this Directive.
They shall prohibit, as from 1 January 2003, the manufacture and importation
into the Community of plastic materials and articles intended to come into
contact with foodstuffs and which do not comply with this Directive.
2. When Member States adopt those provisions, they shall contain a
reference to this Directive or be accompanied by such a reference on the
occasion of their official publication. Member States shall determine howsuch reference is to be made.
Article 3
This Directive shall enter into force on the twentieth day following that of its
publication in the Official Journal of the European Communities .
Article 4
This Directive is addressed to the Member States.!B1999L0091 — EN — 24.12.1999 — 000.001 — 3
ANNEX I
Annex II is amended as follows:
1. The fourth indent of paragraph 5 is replaced by the following:
‘— Column 4 (Restrictions and/or specifications). These may include:
— specific migration limit (SML),— maximum permitted quantity of the substance in the finished material or
article (QM),
— maximum permitted quantity of the substance in the finished material or
article expressed as mg per 6 dm
2of the surface in contact with foodstuffs
(QMA),
— any other restriction specifically mentioned,
— any type of specifications related to the substance or to the polymer;’
2. The title of column 4 is modified to ‘Restrictions and/or specifications’;3. Sections A and B are amended as shown in Appendices 1 to 5.!
B1999L0091 — EN — 24.12.1999 — 000.001 — 4
‘Appendix 1
List of monomers and other starting substances inserted in Section A of Annex II to Directive 90/128/EEC
PM/REF No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
12761 000693-57-2 12-Aminododecanoic acid SML = 0,05 mg/kg
13180 000498-66-8 Bicyclo[2.2.1]hept-2-ene (= norbornene) SML = 0,05 mg/kg13210 001761-71-3 Bis(4-aminocyclohexyl)methane SML = 0,05 mg/kg14650 000079-38-9 Chlorotrifluoroethylene QMA = 0,05 mg/6 dm
2
14841 000599-64-4 4-Cumylphenol SML = 0,05 mg/kg16694 013811-50-2 N,N ’-Divinyl-2-imidazolidinone QM = 5 mg/kg in FP
16704 000112-41-4 1-Dodecene SML = 0,05 mg/kg22331 025513-64-8 Mixture of (40 % w/w) 1,6-diamino-
2,2,4-trimethylhexane and (60 % w/w)
1,6-diamino-2,4,4-trimethylhexaneQMA = 5 mg/6 dm
2
22550 000498-66-8 Norbornene See “Bicyclo[2.2.1]hept-2-ene’’
23175 000122-52-1 Phosphorous acid, triethyl ester QM = ND (DL = 1 mg/kg in FP)23547 009016-00-6
063148-62-9Polydimethylsiloxane (MW 46800) In compliance with the specifications laid
down in Annex V
25080 001120-36-1 1-Tetradecene SML = 0,05 mg/kg
25385 000102-70-5 Triallylamine In compliance with the specifications laid
down in Annex V
25927 027955-94-8 1,1,1-Tris(4-hydroxyphenyl)ethane QM = 0,5 mg/kg in FP . For use only in
polycarbonates
26155 001072-63-5 1-Vinylimidazole QM = 5 mg/kg in FP
26320 002768-02-7 Vinyltrimethoxysilane QM = 5 mg/kg in FP
26360 007732-18-5 Water In compliance with Directive 98/83/EC!
B1999L0091 — EN — 24.12.1999 — 000.001 — 5
Appendix 2
List of monomers and other starting substances in Section A of Annex II to Directive 90/128/EEC for which the content of
the column “Restriction and/or specifications’’ is modified
PM/Ref No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
10060 000075-07-0 Acetaldehyde SML(T) = 6 mg/kg (2)
13510 001675-54-3 2,2-Bis(4-hydro xyphenyl)propane
bis(2,3-epoxypropyl) ether (= BADGE)SML(T) = 1 mg/kg (9)
Authorised until 1 January 2005
14200 000105-60-2 Caprolactam SML(T) = 15 mg/kg (5)
14230 002123-24-2 Caprolactam, sodium salt SML(T) = 15 mg/kg (5)
(expressed as caprolactam)
15760 000111-46-6 Diethyleneglycol SML(T) = 30 mg/kg (3)16990 000107-21-1 Ethyleneglycol SML(T) = 30 mg/kg (3)
17160 000097-53-0 Eugenol SML = ND (DL = 0,02 mg/kg, analytical
tolerance included)
19540 000110-16-7 Maleic acid SML(T) = 30 mg/kg (4)19960 000108-31-6 Maleic anhydride SML(T) = 30 mg/kg (4)
(expressed as maleic acid)
25360 — Trialkyl(C5-C15) acetic acid, 2,3-epoxy-
propyl esterQM = 1 mg/kg in FP (expressed as epoxy
group, molecular weight = 43)!
B1999L0091 — EN — 24.12.1999 — 000.001 — 6
Appendix 3
List of monomers and others starting substances deleted from Section B of Annex II to Directive 90/128/EEC
PM/Ref No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
22428 051000-52-3 Neodecanoic acid, vinyl ester
Appendix 4
List of monomers and other starting substances in Section B of Annex II to Directive 90/128/EEC for which the content of
the column ‘Restrictions and/or specifications’ is modified
PM/Ref No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
16690 001321-74-0 Divinylbenzene QM = 1 mg/kg in FP or SML = ND (DL
= 0,02 mg/kg, analytical tolerance in-cluded)
20590 000106-91-2 Methacrylic acid, 2,3-epoxypropyl ester QM(T) = 5 mg/kg in FP (expressed as
epoxy group, molecular weight = 43)
22720 000140-66-9 4-tert-Octylphenol See “4-(1,1,3,3-Tetramethylbutyl)phenol’’25185 000140-66-9 4-(1,1,3,3-Tetramethylbutyl)phenol (= 4-
tert-Octylphenol)SML = ND (DL = 0,01 mgkg, analytical
tolerance included)!
B1999L0091 — EN — 24.12.1999 — 000.001 — 7
Appendix 5
List of monomers and other starting substances transferred from Section B to Section A of Annex II to Directive 90/128/
EEC
PM/Ref No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
11000 050976-02-8 Acrylic acid, dicyclopentadienyl ester QMA = 0,05 mg/6 dm2
11245 002156-97-0 Acrylic acid, dodecyl ester SML = 0,05 mg/kg (1)
12265 004074-90-2 Adipic acid, divinyl ester QM = 5 mg/kg in FP . For use only as
comonomer
13060 004422-95-1 1,3,5-Benzenetricarboxylic acid trichlor-
ideQMA = 0,05 mg/6 dm2(measured as
1,3,5-benzenetricarboxylic acid)
13780 002425-79-8 1,4-Butanediol bis(2,3-epoxypropyl)
etherQM = 1 mg/kg in FP (expressed as epoxy
group, molecular weight = 43)
14020 000098-54-4 4-tert-Butylphenol SML = 0,05 mg/kg
15130 000872-05-9 1-Decene SML = 0,05 mg/kg
16360 000576-26-1 2,6-Dimethylphenol SML = 0,05 mg/kg16450 000646-06-0 1,3-Dioxolane SML = 0,05 mg/kg18220 068564-88-5 N-Heptylaminoundecanoic acid SML = 0,05 mg/kg (1)18820 000592-41-6 1-Hexene SML = 3 mg/kg19060 000109-53-5 Isobutyl vinyl ether QM = 5 mg/kg in FP19150 000121-91-5 Isophthalic acid SML = 5 mg/kg19990 000079-39-0 Methacrylamide SML = ND (DL = 0,02 mg/kg, analytical
tolerance included)
20050 000096-05-9 Methacrylic acid, allyl ester SML = 0,05 mg/kg
20530 002867-47-2 Methacrylic acid, 2-(dimethylamino)ethyl
esterSML = ND (DL = 0,02 mg/kg, analytical
tolerance included)
21730 000563-45-1 3-Methyl-1-butene QMA = 0,006 mg/6 dm
2. For use only in
polypropylene.
22937 001623-05-8 Perfluoropropyl perfluorovinyl ether SML = 0,05 mg/kg23770 000504-63-2 1,3-Propanediol SML = 0,05 mg/kg23920 000105-38-4 Propionic acid, vinyl ester SML(T) = 6 mg/kg (2) (expressed as
acetaldehyde)
24760 026914-43-2 Styrenesulphonic acid SML = 0,05 mg/kg
26170 003195-78-6 N-Vinyl-N-methylacetamide QM = 2 mg/kg in FP’!
B1999L0091 — EN — 24.12.1999 — 000.001 — 8
ANNEX II
Annex III is amended as follows:
1. The fourth indent of paragraph 5 is replced by the following:
‘— Column 4 (Restrictions and/or specifications). These may include:
— specific migration limit (SML),— maximum permitted quantity of the substance in the finished materil or
article (QM),
— maximum permitted quantity of the substance in the finished material or
article expressed as mg per 6 dm
2of the surface in contact with foodstuffs
(QMA),
— any other restriction specifically laid down,
— any type of specification related to the substance or to the polymer;’
2. The title of the column 4 is modified into ‘Restrictions and/or specifications’;3. ‘Incomplete list of additives’ is amended as shown in Appendices 1, 2 and 3.!
B1999L0091 — EN — 24.12.1999 — 000.001 — 9
‘Appendix 1
List of additives inserted in Annex III to Directive 90/128/EEC
PM/REF No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
30080 004180-12-5 Acetic acid, copper salt SML(T) = 30 mg/kg (7) (expressed as
copper)
30610 — Acids, C2-C24, aliphatic, linear, mono-
carboxylic, from natural oils and fats, andtheir mono-, di- and triglycerol esters(branched fatty acids at naturally occur-
ring levels are included)
30612 — Acids, C2-C24, aliphatic, linear, mono-
carboxylic, synthetic, and their mono-, di-and triglycerol esters
31530 123968-25-2 Acrylic acid, 2,4-di-tert-pentyl-6-[1-(3,5-
di-tert-pentyl-2-hydroxyphenyl)ethyl]-phenyl esterSML = 5 mg/kg
33801 — n-Alkyl(C10-C13)benzenesulphonic acid SML = 30 mg/kg
34240 — Alkyl(C10-C20)sulphonic acid, SML = 6 mg/kg. Authorised until 1
January 2002
36640 000123-77-3 Azodicarbonamide For use only as a blowing agent37360 000100-52-7 Benzaldehyde In compliance with note 10 in Annex VI38320 005242-49-9 4-(2-Benzoxazolyl)-4 ’-(5-methyl-2-ben-
zoxazolyl)stilbeneIn compliance with the specifications laid
down in Annex V
38510 136504-96-6 1,2-Bis(3-aminopropyl)ethylenediamine,
polymer with N-butyl-2,2,6,6-tetra-
methyl-4-piperidinamine and2,4,6-tri-
chloro-1,3,5-triazineSML = 5 mg/kg
38515 001533-45-5 4,4’-Bis(2-benzoxazolyl)stilbene SML = 0,05 mg/kg (1)
38810 080693-00-1 Bis(2,6-di-tert-butyl-4-methylphenyl)-
pentaerythritol diphosphiteSML = 5 mg/kg (sum of phosphite and
phosphate)
38879 135861-56-2 Bis(3,4-dimethylbenzylidene)sorbitol
39200 006200-40-4 Bis(2-hydroxyethyl)-2-hydroxypropyl-3-
(dodecyloxy)methylammonium chlorideSML = 1,8 mg/kg
39815 182121-12-6 9,9-Bis(methoxymethyl)fluorene QMA = 0,05 mg/6 dm
2
40120 — Bis(polyethyleneglycol)hydroxymethyl-
phosphonateSML = 0,6 mg/kg. Authorised until 1
January 2002
41680 000076-22-2 Camphor In compliance with note 10 in Annex VI
42320 007492-68-4 Carbonic acid, copper salt SML(T) = 30 mg/kg (7) (expressed as
copper)
43515 — Chlorides of choline esters of coconut oil
fatty acidsQMA = 0,9 mg/6 dm2
45195 007787-70-4 Copper bromide SML(T) = 30 mg/kg (7) (expressed as
copper)!B
!C1
!B
!C1
!C1!B
!B1999L0091 — EN — 24.12.1999 — 000.001 — 10
PM/REF No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
45200 001335-23-5 Copper iodide SML(T) = 30 mg/kg (7) (expressed as
copper) and SML = 1 mg/kg (expressed asiodine)
45450 068610-51-5 p-Cresol-dicyclopentadiene-is obutylene,
copolymerSML = 0,05 mg/kg (1)
46880 065140-91-2 3,5-Di-tert-butyl-4-hydroxybenzyl phos-
phonic acid, monoethyl ester, calcium saltSML = 6 mg/kg
47680 000111-46-6 Diethyleneglycol SML(T) = 30 mg/kg (3)
48460 000075-37-6 1,1-Difluoroethane
49485 134701-20-5 2,4-Dimethyl-6-(1-methylpentadecyl)-
phenolSML = 1 mg/kg
51700 147315-50-2 2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5-
(hexyloxy)phenolSML = 0,05 mg/kg
53610 054453-03-1 Ethylenediaminetetraacetic acid, copper
saltSML(T) = 30 mg/kg (7) (expressed as
copper)
53650 000107-21-1 Ethyleneglycol SML(T) = 30 mg/kg (3)
54300 118337-09-0 2,2 ’Ethylidenebis(4,6-di-tert-butylphenyl)
fluorophosphoniteSML = 6 mg/kg
54930 025359-91-5 Formaldehyde-1-naphthol, copolymer
[=Poly(1-hydroxynaphthyl-methane)]SML = 0,05 mg/kg
57800 018641-57-1 Glycerol tribehenate
60480 003864-99-1 2-(2-Hydroxy-3,5-di-tert-butyl-phenyl)-
5-chlorobenzotriazoleSML = 30 mg/kg
66560 004066-02-8 2,2 ’Methylenebis(4-methyl-6-cyclohexyl-
phenol)SML(T) = 3 mg/kg (6)
66580 000077-62-3 2,2 ’Methylenebis[4-methyl-6-(1-methyl-
cyclo-hexyl)phenol]SML(T) = 3 mg/kg (6)
66755 002682-20-4 2-Methyl-4-isothiazolin-3-one SML = ND (DL = 0,02 mg/kg, analytical
tolerance included)
67170 — Mixture of (80 to 100 % w/w) 5,7-di-tert-
butyl-3-(3,4-dimethyphenyl)-2(3H)-ben-
zofuranone and (0 to 20 %w/w)5,7-di-tert-butyl-3-(2,3-di-methylphenyl)-2(3H)-benzofuranoneSML = 5 mg/kg
67180 — Mixture of (50 % w/w) phthalic acid, n-
decyl n-octyl ester, (25 % w/w) phthalicacid di-n-decyl ester, and (25 % w/w)
phthalic acid di-n-decyl ester, and (25 %
w/w) phthalic acid di-n-octyl esterSML = 5 mg/kg (1)
68145 080410-33-9 2,2 ’,2@-Nitrilo[triethyl tris(3,3 ’,5,5’-tetra-
tert-butyl-1,1 ’-bi-phenyl-2,2 ’-diyl)pho-
sphite]SML = 5 mg/kg (sum of phosphite and
phosphate)!
B
!C1
!B
!C1
!B
!C1
!B
!C1
!B1999L0091 — EN — 24.12.1999 — 000.001 — 11
PM/REF No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
71635 025151-96-6 Pentaerythritol dioleate SML = 0,05 mg/kg. Not for use in
polymers contacting foods for whichsimulant D is laid down in Directive 85/572/EEC
73720 0000115-96-8 Phosphoric acid, trichloroethyl ester SML = ND (DL = 0,02 mg/kg, analytical
tolerance included)
74010 145650-60-8 Phosphorous acid, bis (2,4-di-tert-butyl-
6-methylphenyl) ethyl esterSML = 5 mg/kg (sum of phosphite and
phosphate)
76721 009016-00-6
063148-62-9Polydimethylsiloxane (MW 46800) In compliance with the specifications laid
down in Annex V
76865 — Polyesters of 1,2-propanediol and/or 1,3-
and 1,4-butanediol and/or polypropylene-glycol with adipic acid, also end-cappedwith acetic acid or fatty acids C10-C18 or
n-octanol and/or n-decanolSML = 30 mg/kg
77895 068439-49-6 Polyethyleneglycol(EO = 2-6) m ono-
alkyl(C16-C18) etherSML = 0,05 mg/kg
81515 087189-25-1 Poly(zinc glycerolate)
81760 — Powders, flakes and fibres of brass,
bronze, copper, stainless steel, tin and
alloys of copper, tin and ironSML(T) = 30 mg/kg (7) (expressed as
copper); SML = 48 mg/kg (expressed as
iron)
85360 000109-43-3 Sebacic acid, dibutyl ester85610 — Silicates, natural, silanated (with the
exception of asbestos)
85840 053320-86-8 Silicic acid, lithium magnesium sodium
saltSML(T) = 0,6 mg/kg (8) (expressed s
lithium)
86285 — Silicon dioxide, silanated88640 008013-07-8 Soybean oil, epoxidised In compliance with the specificatins laid
down in Annex V
89200 007617-31-4 Stearic acid, copper salt SML(T) = 30 mg/kg (7) (expresed as
copper)
89440 — Stearic acid, esters with ethyleneglycol SML(T) = 30 mg/kg (3)92030 010124-44-4 Sulphuric acid, copper salt SML(T) = 30 mg/kg (7) (expressed as
copper)
92700 078301-43-6 2,2,4,4-Tetramethyl-20-(2,3-epo xypro-
pyl)-7-oxa-3,20-diazadispiro[5.1.11.2]-
heneicosan-21-one, polymerSML = 5 mg/kg
92930 120218-34-0 Thiodiethanolbis(5-methoxycarbonyl-
2,6-dimethyl-1,4-dihydropyri- dine-3-car-boxylate)SML = 6 mg/kg
94960 000077-99-6 1,1,1-Trimethylolpropane SML = 6 mg/kg
95725 110638-71-6 Vermiculite, reaction product with citric
acid, lithium saltSML(T) = 0,6 mg/kg (8) (expressed as
lithium)
95855 007732-18-5 Water In compliance with Directive 98/83/EC!
B
!C1
!B
!C1
!B
!C1
!B1999L0091 — EN — 24.12.1999 — 000.001 — 12
PM/REF No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
95859 — Waxes, refined, derived from petroleum
based or synthetic hydrocarbon feed-stocksIn compliance with the specifications laid
down in Annex V
95883 — White mineral oils, paraffinic, derived
from petroleum based hydrocarbon feed-stocksIn compliance with the specifications laid
down in Annex V
Appendix 2
List of additives in Annex III to Directive 90/128/EEC for which the content of column ‘CAS No’ is modified
PM/REF No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
39890 087826-41-3
069158-41-4
054686-97-4081541-12-0Bis(methylbenzylidene)sorbitol
68125 037244-96-5 Nepheline syenite
Appendix 3
List of additives in Annex III to Directive 90/128/EEC deleted
PM/REF No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
76720 009016-00-6
063148-62-9Polydimethylsiloxane’!B1999L0091 — EN — 24.12.1999 — 000.001 — 13
ANNEX III
The following Annexes IV , V and VIare added:
‘ANNEX IV
PRODUCTS OBTAINED BY MEANS OF BACTERIAL FERMENTATION
PM/REF No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
18888 80181-31-3 3-hydroxybutanoic acid-3-hydro xypenta-
noic acid, copolymerSML = 0,05 mg/kg for crotonic acid (as
impurity) and in compliance with thespecifications laid down in Annex IV
ANNEX V
SPECIFICATIONS
Part A: General specifications
(to be fixed later)
Part B: Other specifications
PM/Ref No Other specifications
18888 3-HYDROXYBUTANOIC ACID-3-HYDROXYPENTANOIC ACID, COPOL YMER
Definition These copolymers are produced by the controlled fermentation of
Alcaligenes eutrophus using mixtures of glucose and propanoic acid
as carbon sources. The organism used has not been geneticallyengineered and has been derived from a single wild-type organismAlcaligenes eutrophus strain H16 NCIMB 10442. Master stocks of the
organism are stored as freeze-dried ampoules. A submaster/working
stock is prepared from the master stock and stored in liquid nitrogenand used to prepare inocula for the fermenter. Fermenter samples willbe examined daily both microscopically and for any changes incolonial morphology on a variety of agars at different temperatures.The copolymers are isolated from heat-treatment bacteria by
controlled digestion of the other cellular components, washing and
drying. These copolymers are normally offered as formulated, melt-formed granules containing additives such as nucleating agents,plasticisers, fillers, stabilisers and pigments which all conform to thegeneral and individual specifications.
— Chemical name Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate)
— CAS No 80181-31-3
— Structural formula
(-O-CH3
CH-CH2-O
C-)m - (CH2CH3
O-CH-CH2-O
C-)n
where n/(m + n) greater than 0 and less or
equal to 0,25!B
!C1
!B1999L0091 — EN — 24.12.1999 — 000.001 — 14
PM/Ref No Other specifications
— Average molecular
weightNot less than 150 000 daltons
(measured by gel permeationchromatography).
— Assay Not less than 98 % poly(3-D-
hydroxybutanoato-co-3-D-hydro-
xypentanoate) analysed after hy-
drolysis as a mixture of 3-D-hydroxybutanoic and 3-D-hydro-xypentanoic acids
Description White to off-white powder after
isolation
Characteristics
— Identification tests:
— Solubility Soluble in chlorinated hydrocar-
bons such as chloroform or di-chloromethane but practically in-soluble in ethanol, aliphatic al-kanes and water.
— Migration The migration of crotonic acid
should not exceed 0,05 mg/kgfood.
— Purity Prior to granulation the raw
material copolymer powder must
contain:
— NitrogenNot more than 2 500 mg/kg of
plastic
— ZincNot more than 100 mg/kg of
plastic
— CopperNot more than 5 mg/kg of plastic
— LeadNot more than 2 mg/kg of plastic
— ArsenicNot more than 1 mg/kg of plastic
— ChromiumNot more than 1 mg/kg of plastic.
23547 POL YDIMETHYLSILOXANE (Mw 46 800)
Minimum viscosity 100 × 10
-6m2/s (= 100 centistokes) at 25 °C
25385 TRIALL YLAMINE
40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel. For use only in
hydrogels intended for non-direct food contact use.
38320 4-(2-BENZOXAZOL YL)-4’-(5-METHYL-2-BENZOXAZOL YL) STILBENE
Not more than 0,05 % w/w (quantity of substance used/quantity of the formulation)
76721 POLYDIMETHYLSILOXANE
(Mw46 800)
Minimum viscosity
100 × 10–6m2/s (= 100
centistokes at 25 °C
88640 SOYBEAN OIL, EPOXIDISED
Oxirane 58 %, iodine number 56
95859 WAXES, REFINED, DERIVED FROM PETROLEUM BASED OR SYNTHETIC HYDROCARBON
FEEDSTOCKS!B
!C1
!B
!C1
!B1999L0091 — EN — 24.12.1999 — 000.001 — 15
PM/Ref No Other specifications
The product should have the following specifications:
— Content of mineral hydrocarbons with carbon number less than 25: not more than 5 %
(w/w)
— Viscosity not less than 11 × 10-6m2/s (= 11 centistokes) at 100 °C
— Average molecular weight not less than 500
95883 WHITE MINERAL OILS, PARAFFINIC DERIVED FROM PETROLEUM BASED HYDROCARBON
FEEDSTOCKS
The product should have the following specifications:
— Content of mineral hydrocarbons with carbon number less than 25: not more than 5 %
(w/w)
— Viscosity not less than 8,5 × 10-6m2/s (= 8,5 centistokes) at 100 °C
— Average molecular weight not less than 480!B1999L0091 — EN — 24.12.1999 — 000.001 — 16
ANNEX VI
NOTES RELATED TO THE COLUMN ‘RESTRICTIONS AND/OR SPECIFI-
CATIONS’
(1) Warning: there is a risk that the SML could be exceeded in fatty food simulants.
(2) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as PM/REF Nos:
10060 and 23920.
(3) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as PM/REF Nos:
15760, 16990, 47680, 53650, 89440.
(4) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as PM/REF Nos:19540, 19960.
(5) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as PM/REF Nos:14200, 14230.
(6) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as PM/REF Nos:66560 and 66580.
(7) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as PM/REF Nos:30080, 42320, 45195, 45200, 53610, 81760, 89200, 92030.
(8) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as PM/REF Nos:85840 and 95725.
(9) SML(T) = in this specific case means that the restriction shall not be exceeded by
the sum of the migration levels of the following substances:
(a) Badge (=2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether:
(b) Badge.H
2O.
(d) Badge.HCl.(e) Badge.2HCl
(f) Badge.H
2O.HCl
However in aqueous food simulants, the SML(T) should also include
Badge.2H 2O (c) unless the material or article is labelled for use in contact
only with those foods and/or beverages for which it has been demonstrated thatthe sum of the migration levels of the five abovementioned substances(a)(b)(d)(e)(f) cannot exceed 1 mg/kg.
(10) Warning: there is a risk that the migration of the substance deteriorates the
organoleptic characteristics of the food in contact and then, that the finished
product does not comply with the second indent of Article 2 of Directive 89/109/EEC.!
B1999L0091 — EN — 24.12.1999 — 000.001 — 17