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Statutory Rule 2000 No. 402
Plastic Materials and Articles in Contact with Food
(Amendment) Regulations (Northern Ireland) 2000
© Crown Copyright 2000
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STATUTORY RULES OF NORTHERN IRELAND
2000 No. 402
FOOD
Plastic Materials and Articles in Contact with Food (Amendment)
Regulations (Northern Ireland) 2000
| |
Made |
12th December 2000 |
|
| |
Coming into operation |
5th February 2001 |
|
The Department of Health, Social Services and Public Safety[1] in exercise
of the powers conferred on it by Articles 15(2), 16(1), 25(1)(a)
and 47(2) of the Food Safety (Northern Ireland) Order 1991[2] and of all
other powers enabling it in that behalf, having had regard in accordance
with Article 47(3A) of the said Order to relevant advice given by the Food
Standards Agency and after consultation in accordance with Article 47(3)
and (3B) of the said Order, hereby makes the following Regulations:
Citation and commencement
1. These Regulations may be cited as the Plastic Materials and Articles
in Contact with Food (Amendment) Regulations (Northern Ireland) 2000 and
shall come into operation on 5th February 2001.
Amendment of Regulations
2. The Plastic Materials and Articles in Contact with Food Regulations
(Northern Ireland) 1998[3] ("the principal Regulations") shall be amended
as follows.
3. In regulation 2(1) (interpretation), in the definition of "the
Directive", for "and 96/11/EC[4]" there shall be substituted ", 96/11/EC
and 1999/91/EC[5] (as corrected[6])".
4. For paragraph (4)(a) of regulation 3 (restriction on the
use, sale or importation of plastic materials and articles) there shall
be substituted -
" (a) if -
(i) it has been manufactured with a prohibited monomer as described
in regulation 4(1);
(ii) it has been manufactured with a prohibited additive as described
in regulation 5(1);
(iii) being a product obtained by bacterial fermentation, it does
not comply with regulation 5A; or
(iv) it does not comply with regulation 4(5), 5(4) or 7,
and no defence indicated in regulation 4(7), 5(2) or 7(5) would be available
in proceedings for an offence under these Regulations relating to that
manufacture or want of compliance; or";
5. In regulation 4 (restriction on manufacture with monomers) -
(a) in paragraph (1), after "prohibited monomer," there shall be
inserted "that is to say any monomer";
(b) in paragraph (1)(c), for "restrictions (if any) specified"
there shall be substituted "restrictions and specifications (if any) set
out"; and
(c) paragraph (3)(d) shall be deleted.
6. In regulation 5 (restriction on manufacture with additives) -
(a) for paragraph (1) there shall be substituted -
7. After regulation 5 there shall be inserted the following regulation
-
" Products obtained by bacterial fermentation
5A. A product obtained by bacterial fermentation complies with this
regulation if it is -
(a) of good technical quality;
(b) identified by PM/Ref No., CAS No. and name respectively in columns
1, 2 and 3 of Schedule 2A; and
(c) in compliance with the restrictions and specifications given
in column 4 of that Schedule.".
8. After regulation 7 (transfer of constituents) there shall be inserted
the following regulation -
" Specifications
7A. Schedule 2B shall have effect for the purpose of giving the
specifications referred to in column 4 in Schedules 1, 2 and 2A.".
9. In regulation 10 (offences) the following paragraph shall be added
at the end -
10. In Schedule 1 (monomers) -
(a) in Part I, in section A, in column 4, for the heading "Restrictions"
there shall be substituted "Restrictions and specifications";
(b) the item number and letter, PM/REF No., CAS No., name, restriction
and specification (if any) for each monomer identified in Part I of Schedule
1 to these Regulations shall be inserted in Section A of Part I of Schedule
1 to the principal Regulations at the place corresponding to the number
and letter (if any) specified for that monomer in the column headed "Item"
in that Part of that Schedule to these Regulations;
(c) in Part I, in Section A, for the entries in column 4 (restrictions
and specifications) opposite to and corresponding to the items listed in
Part II of Schedule 1 to these Regulations there shall be substituted the
corresponding entries specified in the said Part II;
(d) in Part I, in Section A, in item 196 the entry in column 4 (restrictions
and specifications) shall be deleted;
(e) in Part I, in Section B, item 67 and the entries for it shall
be deleted;
(f) in Part I, in Section B, for the entries in column 4 (restrictions)
opposite to and corresponding to the items listed in Part III of Schedule
1 to these Regulations there shall be substituted the corresponding entries
specified in Part III of Schedule 1 to these Regulations;
(g) in Part I, in Section B, after the entries relating to item 77
there shall be inserted the item number and letter, PM/REF No., CAS No.,
name and restriction for the monomer identified in Part IV of Schedule
1 to these Regulations;
(h) in Part I, the items in Section B which are listed in Part V
of Schedule 1 to these Regulations, and the entries for those items in
that Section, shall be deleted and there shall be inserted in Section A
at the place corresponding to the number and letter (if any) specified
for each item in the column headed "Item No. for Section A" in Part V of
Schedule 1 to these Regulations the entries relating to that item in the
said Part V; and
(i) in Part II there shall be added at the end the following paragraph
-
???4. Where an entry in column 4 in Part I
includes a bracketed number, that entry shall be subject to the note relating
to that number as follows:
(1) Warning: there is a risk that the specific
migration limit 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.
(9) SML(T) in this specific case means that the
restriction shall not be exceeded by the sum of the migration of the following
substances:
(a) Badge (=2,2-bis(4-hydroxyphenyl) propane bis(2,3-epoxy propyl)
ether
(b) Badge.H2O
(d) Badge.HCl
(e) Badge.2HCl
(f) Badge.H2O.HCl
However in aqueous food simulants, the SML(T) should also include Badge.2H2O(c)
unless the material or article is labelled for use in contact only with
those foods and beverages for which it has been demonstrated that the sum
of the migration levels of the five above mentioned substances (a)
(b) (d) (e) (f) cannot exceed 1 mg/kg.
11. In Schedule 2 (additives) -
(a) in Part I there shall be added an extra column, numbered "4"
and headed "Restrictions and specifications";
(b) the item number and letter, PM/REF No., CAS No., name, restriction
and specification (if any) for each additive identified in Schedule 2 to
these Regulations shall be inserted in Part I of Schedule 2 to the principal
Regulations at the place corresponding to the number and letter specified
for that additive in the column headed "Item" in Schedule 2 to these Regulations;
(c) in Part I, for the entries in column 2 (CAS No.) and column 3
(name) for item 38 there shall be substituted the following -
" 087826-41-3 Bis(methylbenzylidene) sorbitol
069158-41-4
" " "
054686-97-4
" " "
081541-12-0
" " "";
(d) in Part I, for the entry in column 2 (CAS No.) for item 179 there
shall be substituted the entry "037244-96-5";
(e) in Part I, item 195 and the entries for it shall be deleted;
and
(f) in Part II, there shall be inserted at the end the following
paragraph -
" 4. Where an entry in column 4 (restrictions
and specifications) in Part 1 includes a bracketed number, that entry shall
be subject to the note relating to that number as follows:
(1) Warning: there is a risk that the specific
migration limit could be exceeded in fatty food simulants.
(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.
(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.
(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 regulation
4(2) of the Materials and Articles in Contact with Food Regulations (Northern
Ireland) 1987[7].".
12. After Schedule 2 there shall be inserted as Schedules 2A and 2B
the contents of Schedules 3 and 4 to these Regulations.
13. In Schedule 3 (provisions applicable when testing compliance
with the migration limits) -
Sealed with the Official Seal of the Department of Health, Social Services
and Public Safety on
12th December 2000.
L.S.
W. B. Smith
Senior Officer of the Department of Health, Social Services and
Public Safety
SCHEDULE 1
Regulation 10
Part I
List of Monomers to be added to Section A of Part I of Schedule 1
to the Principal Regulations
| Item |
PM/REF No. |
CAS No. |
Name |
Restrictions and specifications |
| 28A |
12761 |
000693-57-2 |
12-Aminododecanoic acid |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 35A |
13180 |
000498-66-8 |
Bicyclo [2.2.1] hept-2-ene (=norbornene) |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 35B |
13210 |
001761-71-3 |
Bis(4- aminocyclohexyl)methane |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 63A |
14650 |
000079-38-9 |
Chlorotrifluoroethylene |
The quantity of this substance in the finished plastic material or
article shall not exceed 0.05 mg/6 dm2 |
| 68A |
14841 |
000599-64-4 |
4-Cumylphenol |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 93A |
16694 |
013811-50-2 |
N,N9-Divinyl-2-imidazolidinone |
The quantity of this substance in the finished plastic material or
article shall not exceed 5 mg/kg |
| 93B |
16704 |
000112-41-4 |
1-Dodecene |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 147A |
22331 |
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- trimethylhexane |
The quantity of this substance in the finished plastic material or
article shall not exceed 5 mg/6 dm2 |
| 152A |
22550 |
000498-66-8 |
Norbornene |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 163A |
23175 |
000122-52-1 |
Phosphorous acid, triethyl ester |
The quantity of this substance in the finished plastic material or
article shall be not detectable (when measured by a method with a detection
limit of 1 mg/kg) |
| 169A |
23547 |
009016-00-6 063148-62-9 |
Polydimethylsiloxane (MW >6800) |
In compliance with the specifications laid down in Schedule 2B |
| 206A |
25080 |
001120-36-1 |
1-Tetradecene |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 214A |
25385 |
000102-70-5 |
Triallylamine |
In compliance with the specifications laid down in Schedule 2B |
| 218A |
25927 |
027955-94-8 |
1,1,1-Tris(4- hydroxyphenyl)ethane |
The quantity of this substance in the finished plastic material or
article shall not exceed 0.5 mg/kg. For use only in polycarbonates |
| 223 |
26155 |
001072-63-5 |
1-Vinylimidazole |
The quantity of this substance in the finished plastic material or
article shall not exceed 5 mg/kg |
| 225 |
26320 |
002768-02-7 |
Vinyltrimethoxysilane |
The quantity of this substance in the finished plastic material or
article shall not exceed 5 mg/kg |
| 226 |
26360 |
007732-18-5 |
Water |
In compliance with Directive 98/83/EC on the quality of water intended
for human consumption[8] |
Part II
List of Monomers in Section A of Part I of Schedule 1 to the Principal
Regulations for which the content of the column "Restrictions and Specifications"
is modified
| Item |
PM/REF No. |
CAS No. |
Name |
Restrictions and specifications |
| 2 |
10060 |
000075-07-0 |
Acetaldehyde |
SML(T) = 6 mg/kg (2) |
| 40 |
13510 |
001675-54-3 |
2,2-Bis(4- hydroxyphenyl) propane bis (2,3-epoxypropyl) ether (=BADGE) |
SML(T) = 1 mg/kg (9) Authorised only until 1st January 2005 |
| 56 |
14200 |
000105-60-2 |
Caprolactam |
SML(T) = 15 mg/kg (5) |
| 57 |
14230 |
002123-24-2 |
Caprolactam, sodium salt |
SML(T) = 15 mg/kg (5) (expressed as caprolactam) |
| 79 |
15760 |
000111-46-6 |
Diethyleneglycol |
SML(T) = 30 mg/kg (3) |
| 98 |
16990 |
000107-21-1 |
Ethyleneglycol |
SML(T) = 30 mg/kg (3) |
| 102 |
17160 |
000097-53-0 |
Eugenol |
The specific migration of this substance shall be not detectable (when
measured by a method with a limit of detection of 0.02 mg/kg, analytical
tolerance included) |
| 128 |
19540 |
000110-16-7 |
Maleic acid |
SML(T) = 30 mg/kg (4) |
| 129 |
19960 |
000108-31-6 |
Maleic anhydride |
SML(T) = 30 mg/kg (4) (expressed as maleic acid) |
| 214 |
25360 |
- |
Trialkyl(C5-C15) acetic acid, 2,3-epoxypropyl ester |
The quantity of this substance in the finished plastic material or
article shall not exceed 1 mg/kg (expressed as epoxy group, molecular weight
= 43) |
Part III
List of Monomers in Section B of Part I of Schedule 1 to the Principal
Regulations for which the content of the column "Restrictions and Specifications"
is modified
| Item |
PM/REF No. |
CAS No. |
Name |
Restrictions and specifications |
| 34 |
16690 |
001321-74-0 |
Divinylbenzene |
The quantity of this material in the finished plastic material or article
shall not exceed 1 mg/kg or the specific migration of this substance shall
be not detectable (when measured by a method with a limit of detection
of 0.02 mg/kg, analytical tolerance included) |
| 56 |
20590 |
000106-91-2 |
Methacrylic acid, 2,3- epoxypropyl ester |
The quantity of this material in the finished plastic material or article
shall not exceed 5 mg/kg (expressed as epoxy group, molecular weight =
43) |
| 68 |
22720 |
000140-66-9 |
4-tert-Octylphenol |
The specific migration of this substance shall be not detectable (when
measured by a method with a limit of detection of 0.01mg/kg, analytical
tolerance included) |
Part IV
Monomer to be added to Section B of Part I of Schedule 1 to the Principal
Regulations
| Item |
PM/REF No. |
CAS No. |
Name |
Restrictions and specifications |
| 77AA |
2518255 |
000140-66-9 |
4-(1,1,3,3-Tetramethylbutyl) phenol (=4-tert-octylphenol) |
As item 68 |
Part V
List of Monomers transferred from Section B to Section A of Part
I of Schedule 1 to the Principal Regulations
| Item No. in Section B |
Item No. for Section A |
PM/REF No. |
CAS No. |
Name |
Restrictions and specifications |
| 5 |
13A |
11000 |
050976-02-8 |
Acrylic acid, dicyclopentadienyl ester |
The quantity of this substance in the finished plastic material or
article shall not exceed 0.05 mg/6 dm2 |
| 6 |
13B |
11245 |
002156-97-0 |
Acrylic acid, dodecyl ester |
The specific migration of this substance shall not exceed 0.05 mg/kg
(1) |
| 9 |
23A |
12265 |
004074-90-2 |
Adipic acid, divinyl ester |
The quantity of this substance in the finished plastic material or
article shall not exceed 5 mg/kg. For use only as comonomer |
| 12 |
33A |
13060 |
004422-95-1 |
1,3,5-Benzenetricarboxylic acid trichloride |
The quantity of this substance in the finished plastic material or
article shall not exceed 0.05 mg/6 dm2 (measured as 1,3,5-benzenetricarboxylic
acid) |
| 16 |
49A |
13780 |
002425-79-8 |
1,4-Butanediol bis (2,3-epoxypropyl) ether |
The quantity of this substance in the finished plastic material or
article shall not exceed 1 mg/kg (expressed as epoxy group, molecular weight
equal to 43) |
| 19 |
52A |
14020 |
000098-54-4 |
4-tert-Butylphenol |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 22 |
73A |
15130 |
000872-05-9 |
1-Decene |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 30 |
88A |
16360 |
000576-26-1 |
2,6-Dimethylphenol |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 32 |
88B |
16450 |
000646-06-0 |
1,3-Dioxolane |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 37 |
111A |
18220 |
068564-88-5 |
N-Heptylaminound ecanoic acid |
The specific migration of this substance shall not exceed 0.05 mg/kg
(1) |
| 41 |
118A |
18820 |
000592-41-6 |
1-Hexene |
The specific migration of this substance shall not exceed 3 mg/kg |
| 42 |
121A |
19060 |
000109-53-5 |
Isobutyl vinyl ether |
The quantity of this substance in the finished plastic material or
article shall not exceed 5 mg/kg |
| 43 |
121B |
19150 |
000121-91-5 |
Isophthalic acid |
The specific migration of this substance shall not exceed 5 mg/kg |
| 49 |
130A |
19990 |
000079-39-0 |
Methacrylamide |
The specific migration of this substance shall be not detectable (when
measured by a method with a limit of detection of 0.02 mg/kg, analytical
tolerance included) |
| 50 |
131A |
20050 |
000096-05-9 |
Methacrylic acid, allyl ester |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 55 |
135A |
20530 |
002867-47-2 |
Methacrylic acid, 2- (dimethylamino) ethyl ester |
The specific migration of this substance shall be not detectable (when
measured by a method with a limit of detection of 0.02 mg/kg, analytical
tolerance included) |
| 61 |
145A |
21730 |
000563-45-1 |
3-Methyl-1-butene |
The quantity of this substance in the finished plastic material or
article shall not exceed 0.006 mg/6 dm2. For use only in polypropylene |
| 70 |
159A |
22937 |
001623-05-8 |
Perfluoropropyl perfluorovinyl ether |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 71 |
173A |
23770 |
000504-63-2 |
1,3-Propanediol |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 72 |
177A |
23920 |
000105-38-4 |
Propionic acid, vinyl ester |
SML(T) = 6 mg/kg (2) (expressed as acetaldehyde) |
| 74 |
198A |
24760 |
026914-43-2 |
Styrenesulphonic acid |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 83 |
224 |
26170 |
003195-78-6 |
N-Vinyl-N- methylacetamide |
The quantity of this substance in the finished plastic material or
article shall not exceed 2 mg/kg |
SCHEDULE 2
Regulation 11
List of additives to be inserted in Part I of Schedule 2 to the Principal
Regulations
| Item |
PM/REF No. |
CAS No. |
Name |
Restrictions and specifications |
| 2A 7A |
30080 30610 |
004180-12-5 - |
Acetic acid, copper salt Acids C2-C24 aliphatic, linear monocarboxylic,
from natural oils and fats and their mono-, di- and triglycerol esters
(branched fatty acids at naturally occurring levels are included) |
SML(T) = 30 mg/kg (7) (expressed as copper) |
| 7B |
30612 |
- |
Acids C2-C24 aliphatic, linear, monocarboxylic, synthetic and their
mono-, di- and triglycerol esters |
|
| 9A |
31530 |
123968-25-2 |
Acrylic acid, 2,4-di-tert-pentyl- 6-[1(3,5-di-tert-pentyl-2- hydroxyphenyl)
ethyl] phenyl ester |
The specific migration of this substance shall not exceed 5 mg/kg |
| 12A |
33801 |
- |
n-Alkyl (C10-C13) benzenesulphonic acid |
The specific migration of this substance shall not exceed 30 mg/kg |
| 12B |
34240 |
- |
Alkyl(C10-C20) sulphonic acid, esters with phenols |
The specific migration of this substance shall not exceed 6 mg/kg.
Authorised only until 1st January 2002 |
| 27A |
36640 |
000123-77-3 |
Azodicarbonamide |
For use only as a blowing agent |
| 31A |
37360 |
000100-52-7 |
Benzaldehyde |
(10) |
| 36A |
38320 |
005242-49-9 |
4-(2-Benzoxazolyl)-49-(5-methyl-2-benzoxazolyl) stilbene |
In compliance with the specifications laid down in Schedule 2B |
| 36B |
38510 |
136504-96-6 |
1,2-Bis(3- aminopropyl)ethylenediamine, polymer with N-butyl-2,2,6,6-
tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine |
The specific migration of this substance shall not exceed 5 mg/kg |
| 36C |
38515 |
001533-45-5 |
4,49-Bis(2-benzoxazolyl)stilbene |
The specific migration of this substance shall not exceed 0.05 mg/kg
(1) |
| 36D |
38810 |
080693-00-1 |
Bis(2,6-di-tert-butyl-4- methylphenyl) pentaerythritol diphosphite |
The specific migration of this substance shall not exceed 5 mg/kg (sum
of phosphite and phosphate) |
| 36E |
38879 |
135861-56-2 |
Bis(3,4- dimethylbenzylidene)sorbitol |
|
| 37A |
39200 |
006200-40-4 |
Bis (2-hydroxyethyl)-2- hydroxypropyl-3-(dodecyloxy) methylammonium
chloride |
The specific migration of this substance shall not exceed 1.8 mg/kg |
| 37B |
39815 |
182121-12-6 |
9,9 bis(methoxymethyl) fluorene |
The quantity of this substance in the finished plastic material or
article shall not exceed 0.05 mg/6 dm2 |
| 38A |
40120 |
- |
Bis(polyethyleneglycol) hydroxymethylphosphonate |
The specific migration of this substance shall not exceed 0.6 mg/kg.
Authorised only until 1st January 2002 |
| 44A |
41680 |
000076-22-2 |
Camphor |
(10) |
| 47A |
42320 |
007492-68-4 |
Carbonic acid, copper salt |
SML(T) = 30 mg/kg (7) (expressed as copper) |
| 57A |
43515 |
- |
Chlorides of choline esters of coconut oil fatty acids |
The quantity of this substance in the finished plastic material or
article shall not exceed 0.9 mg/6 dm2 |
| 59A |
45195 |
007787-70-4 |
Copper bromide |
SML(T) = 30 mg/kg (7) (expressed as copper) |
| 59B |
45200 |
001335-23-5 |
Copper iodide |
SML(T) = 30 mg/kg (7) (expressed as copper) and the specific migration
of this substance shall not exceed 1 mg/kg (expressed as iodine) |
| 60A |
45450 |
068610-51-5 |
p-Cresol-dicyclopentadiene isobutylene, copolymer |
The specific migration of this substance shall not exceed 0.05 mg/kg
(1) |
| 72A |
46880 |
065140-91-2 |
3,5-Di-tert-butyl-4- hydroxybenzyl phosphonic acid, monoethyl ester,
calcium salt |
The specific migration of this substance shall not exceed 6 mg/kg |
| 73A |
47680 |
000111-46-6 |
Diethyleneglycol |
SML(T) = 30 mg/kg (3) |
| 73B |
48460 |
000075-37-6 |
1,1-Difluoroethane |
|
| 73C |
49485 |
134701-20-5 |
2,4-Dimethyl-6-(1- methylpentadecyl)phenol |
The specific migration of this substance shall not exceed 1 mg/kg |
| 75A |
51700 |
147315-50-2 |
2-(4,6-Diphenyl-1,3,5-triazin- 2-yl)-5- (hexyloxy) phenol |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 86A |
53610 |
054453-03-1 |
Ethylenediaminetetraacetic acid, copper salt |
SML(T) = 30 mg/kg (7) (expressed as copper) |
| 86B |
53650 |
000107-21-1 |
Ethyleneglycol |
SML(T) = 30 mg/kg (3) |
| 90A |
54300 |
118337-09-0 |
2,2-Ethylidenebis(4,6-di-tert- butyl-phenyl) fluorophosphonite |
The specific migration of this substance shall not exceed 6 mg/kg |
| 92A |
54930 |
025359-91-5 |
Formaldehyde-1-naphthol, copolymer [=poly (1 hydroxynaphthyl-methane)] |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 125A |
57800 |
018641-57-1 |
Glycerol tribehenate |
|
| 140A |
60480 |
003864-99-1 |
2-(2-Hydroxy-3,5-di-tert- butylphenyl)-5- chlorobenzotriazole |
The specific migration of this substance shall not exceed 30 mg/kg |
| 169A |
66560 |
004066-02-8 |
2,2'-Methylenebis(4-methyl-6- cyclohexylphenol) |
SML(T) = 3 mg/kg (6) |
| 169B |
66580 |
000077-62-3 |
2,2'-Methylenebis [4-methyl-6- (1-methylcyclo-hexyl) phenol] |
SML(T) = 3 mg/kg (6) |
| 172A |
66755 |
002682-20-4 |
2-Methyl-4-isothiazolin-3-one |
The specific migration of this substance shall be not detectable (when
measured by a method with a limit of detection of 0.02 mg/kg, analytical
tolerance included) |
| 173A |
67170 |
- |
Mixture of (80 to100% w/w) 5,7-di-tert-butyl-3-(3,4 dimethylphenyl)-2(3H)-
benzofuranone and (0-20% w/w) 5,7-di-tert-butyl-3- (2,3-di-methylphenyl)-2(3H)-
benzofuranone |
The specific migration of this substance shall not exceed 5 mg/kg |
| 173B |
67180 |
- |
Mixture of (50% w/w) phthalic acid n-decyl n-octyl ester, (25% w/w)
phthalic acid di-n- decyl ester, and (25% w/w) phthalic acid di-n-octyl
ester |
The specific migration of this substance shall not exceed 5 mg/kg (1) |
| 179A |
68145 |
080410-33-9 |
2,2',2"-Nitrilo[triethyl tris(3,39,5,59-tetra-tert-butyl- 1-19-bi-phenyl-2,2'-diyl)
phosphite] |
The specific migration of this substance shall not exceed 5 mg/kg (sum
of phosphite and phosphate) |
| 188A |
71635 |
025151-96-6 |
Pentaerythritol dioleate |
The specific migration of this substance shall not exceed 0.05 mg/kg.
Not for use with foods for which simulant D is laid down in Directive 85/572/EEC
laying down the list of simulants to be used for testing migration of constituents
of plastic materials and articles intended to come into contact with foodstuffs[9] |
| 191A |
73720 |
000115-96-8 |
Phosphoric acid, trichloroethyl ester |
The specific migration of this substance shall be not detectable (when
measured by a method with a limit of detection of 0.02 mg/kg, analytical
tolerance included) |
| 191B |
74010 |
145650-60-8 |
Phosphorous acid, bis(2,4-di- tert-butyl-6-methylphenyl) ethyl ester |
The specific migration of this substance shall not exceed 5 mg/kg (covering
the sum of phosphite and phosphate) |
| 195A |
76721 |
009016-00-6, 063148-62-9 |
Polydimethylsiloxane (mw >6800) |
In compliance with the specifications laid down in Schedule 2B |
| 195B |
76865 |
- |
Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4- butanediol and/or
polypropy- leneglycol with adipic acid, also end-capped with acetic acid
or fatty acids C10-C18 or n-octanol and/or n-decanol |
The specific migration of this substance shall not exceed 30 mg/kg |
| 198A |
77895 |
068439-49-6 |
Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether |
The specific migration of this substance shall not exceed 0.05 mg/kg |
| 208A |
81515 |
087189-25-1 |
Poly(zinc glycerolate) |
|
| 210A |
81760 |
- |
Powders, flakes and fibres of brass, bronze, copper, stainless steel,
tin and alloys of copper, tin and iron |
SML(T) = 30 mg/kg (7) (expressed as copper); the specific migration
of this substance shall not exceed 48 mg/kg (expressed as iron) |
| 239A |
85360 |
000109-43-3 |
Sebacic acid, dibutyl ester |
|
| 240A |
85610 |
- |
Silicates, natural, silanated (with the exception of asbestos) |
|
| 240B |
85840 |
053320-86-8 |
Silicic acid, lithium magnesium sodium salt |
SML(T) = 0.6 mg/kg (8) (expressed as lithium) |
| 244A |
86285 |
- |
Silicon dioxide, silanated |
|
| 259A |
88640 |
008013-07-8 |
Soybean oil, epoxidized |
In compliance with the specifications laid down in Schedule 2B |
| 263A 263B |
89200 89440 |
007617-31-4 - |
Stearic acid, copper salt Stearic acid, esters with ethyleneglycol |
SML(T) = 30 mg/kg (7) (expressed as copper) SML(T) = 30 mg/kg (3) |
| 270A |
92030 |
010124-44-4 |
Sulphuric acid, copper salt |
SML(T) = 30 mg/kg (7) (expressed as copper) |
| 276A |
92700 |
078301-43-6 |
2,2,4,4-Tetramethyl-20- (2,3-epoxypropyl)-7-oxa-3,20- diazadispiro-[5.1.11.2]-
heneicosan-21-one, polymer |
The specific migration of this substance shall not exceed 5 mg/kg |
| 276B |
92930 |
120218-34-0 |
Thiodiethanolbis(5- methoxycarbonyl-2,6- dimethyl-1,4-dihydropyri-
dine-3-carboxylate) |
The specific migration of this substance shall not exceed 6 mg/kg |
| 280A |
94960 |
000077-99-6 |
1,1,1-Trimethylolpropane |
The specific migration of this substance shall not exceed 6 mg/kg |
| 281A |
95725 |
110638-71-6 |
Vermiculite, reaction product with citric acid, lithium salt |
SML(T) = 0.6 mg/kg (8) (expressed as lithium) |
| 281B |
95855 |
007732-18-5 |
Water |
In compliance with Directive 98/83/EC |
| 281C |
95859 |
- |
Waxes, refined, derived from petroleum based or synthetic hydrocarbon
feedstocks |
In compliance with the specifications laid down in Schedule 2B |
| 281D |
95883 |
- |
White mineral oils, paraffinic, derived from petroleum based hydrocarbon
feedstocks |
In compliance with the specifications laid down in Schedule 2B |
SCHEDULE 3
Regulation 12
" SCHEDULE 2A
Regulation 5A
Products obtained by bacterial fermentation
| Item |
PM/REF No. |
CAS No. |
Name |
Restrictions and specifications |
| 1 |
18888 |
80181-31-3 |
3-hydroxybutanoic acid-3- hydroxypentanoic acid, copolymer |
The specific migration of this substance shall not exceed 0.05 mg/kg
for crotonic acid (as impurity), and in compliance with the specifications
laid down in Schedule 2B" |
SCHEDULE 4
Regulations 8 and 12
" SCHEDULE 2B
Regulation 7A
Specifications
| Item |
PM/REF No. |
Specifications |
| 1 |
18888 |
3-HYDROXYBUTANOIC ACID-3-HYDROXYPENTANOIC ACID, COPOLYMER |
| |
|
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 genetically engineered and has been derived
from a single wild-type organism Alcaligenes 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 nitrogen and used to prepare inocula for the fermenter. Fermenter
samples will be examined daily both microscopically and for any changes
in colonial 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 the general and individual specifications. |
| |
|
Chemical name |
Poly (3-D-hydroxybutanoato-co-3-D-hydroxypentanoate). |
| |
|
CAS number |
80181-31-3. |
| |
|
Structural formula |
where n/(m+n) greater than 0 and less or equal to 0.25
|
| |
|
Average molecular weight |
Not less than 150,000 Daltons (measured by gel permeation chromatography). |
| |
|
Assay |
Not less than 98% poly (3-D- hydroxybutanoato-co-3-D-hydroxypentanoate)
analysed after hydrolysis as a mixture of 3-D-hydroxybutanoic and 3-D-hydroxypentanoic
acids. |
| |
|
Description |
White to off-white powder after isolation. |
| |
|
Characteristics |
|
| |
|
Identification tests:
Solubility
|
Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane
but practically insoluble in ethanol, aliphatic alkanes and water. |
| |
|
Migration |
The migration of crotonic acid should not exceed 0.05 mg/kg food. |
| |
|
Purity |
Prior to granulation the raw material copolymer powder must contain: |
| |
|
- Nitrogen |
Not more than 2,500 mg/kg of plastic |
| |
|
- Zinc |
Not more than 100 mg/kg of plastic |
| |
|
- Copper |
Not more than 5 mg/kg of plastic |
| |
|
- Lead |
Not more than 2 mg/kg of plastic |
| |
|
- Arsenic |
Not more than 1 mg/kg of plastic |
| |
|
- Chromium |
Not more than 1 mg/kg of plastic |
| 2 |
23547 |
POLYDIMETHYLSILOXANE (MW>6800)
Minimum viscosity 100 centistokes at 25°C |
| 3 |
25385 |
TRIALLYLAMINE
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. |
| 4 |
38320 |
4-(2-BENZOXAZOLYL)-4'-(5-METHYL-2-BENZOXAZOLYL) STILBENE
Not more than 0.05% w/w (quantity of substance used/quantity of the
formulation) |
| 5 |
76721 |
POLYDIMETHYLSILOXANE (Mw>6800)
Minimum viscosity 100 × 10-6 m2/s (=100 centistokes) at 25°C |
| 6 |
88640 |
SOYBEAN OIL, EPOXIDIZED
Oxirane <8%, iodine number <6 |
| 7 |
95859 |
WAXES, REFINED DERIVED FROM PETROLEUM BASED OR SYNTHETIC
HYDROCARBON FEEDSTOCKS
The product shall 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 × 10-6 m2/s (=11 centistokes)
at 100°C
- Average molecular weight not less than 500
|
| 8 |
95883 |
WHITE MINERAL OILS, PARAFFINIC DERIVED FROM PETROLEUM
BASED HYDROCARBON FEEDSTOCKS
The product shall 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 × 10-6 m2/s (=8.5 centistokes)
at 100°C
- Average molecular weight not less than 480
" |
EXPLANATORY NOTE
(This note is not part of the Regulations.)
These Regulations amend the Plastic Materials and Articles in Contact
with Food Regulations (Northern Ireland) 1998 ("the 1998 Regulations")
in implementation of Commission Directive 1999/91/EC amending Directive
90/128/EEC relating to plastic materials and articles intended to come
into contact with foodstuffs.
The Regulations -
(a) update the lists of monomers and additives which can be used
in the manufacture of plastic materials and articles intended to come into
contact with food (regulations 10 and 11 and Schedules 1 and 2);
(b) impose restrictions and specifications in respect of some of
those monomers and additives (regulations 5(a), 6, 8, 10, 11 and
12 and Schedules 1, 2 and 4); in particular, a new type of restriction
is introduced (maximum permitted quantity of the substance in the finished
material or article expressed as mg per 6 dm2 of the surface
in contact with food);
(c) bring products obtained by bacterial fermentation within the
scope of the 1998 Regulations and impose restrictions and specifications
for such products (regulations 4, 5(b), 7 and 12 and Schedule 3);
(d) include a transitional provision (regulation 9); and
(e) make some consequential amendments (regulations 3 and 13(a))
and a drafting correction (regulation 5(a)), and correct two errors
in the 1998 Regulations (regulations 10(d) and 13(b)).
Notes:
[1] Formerly the Department of Health and Social Services; see
S.I. 1999/283 (N.I. 1) Article 3back
[2] S.I. 1991/762 (N.I. 7) as amended by S.I. 1996/1633 (N.I. 12)
and paragraphs 26 to 42 of Schedule 5 and Schedule 6 to the Food Standards
Act 1999 c. 28back
[3] S.R. 1998 No. 264back
[4] O.J. No. L161, 12.3.96, p. 26back
[5] O.J. No. L310, 4.12.99, p. 41back
[6] O.J. No. L249, 4.10. 2000, p. 26back
[7] S.R. 1987 No. 432back
[8] O.J. No. L330, 5.12.1998, p. 32back
[9] O.J. No. L372, 31.12.85, p. 14back
ISBN 0-337-01110-9
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