Statutory Instruments
1996 No. 2817

FOOD
The Plastic Materials and Articles in Contact with Food (Amendment) (No. 2) Regulations 1996

Made
7th November 1996

Laid before Parliament
18th November 1996

Coming into force
1st January 1997

The Minister of Agriculture, Fisheries and Food, the Secretary of State for Health and the Secretary of State for Wales, acting jointly, in relation to England and Wales, and the Secretary of State for Scotland in relation to Scotland, in exercise of the powers conferred on them by sections 6(4), 16(2), 17(1), 26(1)(a) and (3), 31 and 48(1) of the Food Safety Act 1990(1), and of all other powers enabling them in that behalf; the Minister of Agriculture, Fisheries and Food and the Secretary of State being Ministers designated(2) for the purposes of section 2(2) of the European Communities Act 1972(3) in relation to materials and articles in contact with food or drink or intended for such contact, acting jointly, in exercise of the powers conferred on them by the said section 2(2) and of all other powers enabling them in that behalf; and after consultation in accordance with section 48(4) of the said Act of 1990 with such organisations as appear to them to be representative of interests likely to be substantially affected by the Regulations (in so far as the Regulations are made in exercise of the powers conferred by that Act), hereby make the following Regulations:

Title, commencement and interpretation

1.—(1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) (No. 2) Regulations 1996 and shall come into force on 1st January 1997.

(2) In these Regulations “the principal Regulations” means the Plastic Materials and Articles in Contact with Food Regulations 1992.(4)

Amendment of the principal Regulations

2.  The principal Regulations shall be amended as follows:

(a)in the definition of “the Directive” in regulation 2(1), for the words “as amended” there shall be substituted the words “, (as corrected) and as amended by Commission Directives 92/39/EEC, 93/9/EEC, 95/3/EC and 96/11/EC”;(5)

(b)in regulation 5 (monomers) —

(i)in paragraph (1) —

(A)after the words “the following paragraphs of this regulation” there shall be inserted the words “and regulation 14A”,

(B)in sub-paragraph (a), for the date “1st January 1997” there shall be substituted the date “1st January 2002”, and

(C)in sub-paragraph (b), for the date “31st December 1996” there shall be substituted the date “31st December 2001”;

(ii)in paragraphs (3), (4), (5) and (6), after the words “the relevant fraction of”(wherever they occur) there shall be added the words “, or section F of,”;

(c)after regulation 14 there shall be inserted the following regulation —

“Manufacture until 1st January l999

14A.  Notwithstanding regulation 5(1),until lst January 1999 a plastic material or article may be manufactured using one or more of the monomers identified by PM/REF No., CAS No. (if any) and name respectively in columns 1, 2, 3 of Section F of Part I of Schedule l, if any such monomer is of good technical quality and is used in accordance with the restrictions (if any) specified in the corresponding entry in column 4 thereof.”;

(d)the Item number and letter, PM/REF No., CAS No. and name for each monomer identified in Schedule 1 to these Regulations shall be inserted in Section A of Part 1 of Schedule 1 (monomers authorised without time limit) at the place corresponding to the number and letter specified for that monomer in the column headed “Item” in Schedule l to these Regulations;

(e)the contents of Schedule 2 to these Regulations shall be substituted for Section B of Part 1 of Schedule 1;

(f)in Section D of Part 1 of Schedule l (monomers authorised until 1st April 1996), in Item 16, for the figures “51” and “115” in column 4 (restrictions) there shall be substituted the figures “17” and “58” respectively;

(g)the contents of Schedule 3 to these Regulations shall be inserted after Section E of Part 1 of Schedule 1; and

(h)the Item number and letter, PM/REF No., CAS No. (if any) and name for each additive identified in Schedule 4 to these Regulations shall be inserted in Part I of Schedule 3 (additives) at the place corresponding to the number and letter specified for that additive in the column headed “Item” in Schedule 4 to these Regulations.

Angela Browning
Parliamentary Secretary, Ministry of Agriculture, Fisheries and Food
5th November 1996

Signed by authority of the Secretary of State for Health

Cumberlege
Parliamentary Under Secretary of State,
Department of Health
7th November 1996

Signed by authority of the Secretary of State for Wales

Gwilym Jones
Parliamentary Under Secretary of State,
Welsh Office
5th November 1996

Lindsay
Parliamentary Under Secretary of State,
Scottish Office
4th November 1996

Regulation 2(d)

SCHEDULE 1ADDITIONAL MONOMERS AUTHORISED WITHOUT TIME LIMIT

1
2
3
4

Item
PM/REF No.
CAS No.
Name
Restrictions

110C
19460
000050-21-5
Lactic-acid

111A
19480
002146-71-6
Lauric acid, vinyl ester

153A
23651
025322-69-4
Polypropyleneglycol

Regulation 2(e)

SCHEDULE 2NEW SECTION B SUBSTITUTED IN PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

“SECTION B

Monomers authorised up to the end of 2001”

1
2
3
4

Item
PM/REF No.
CAS No.
Name
Restrictions

1
15280
000542-02-9
Acetoguanamine

2
10599/90A
061788-89-4
Acids, fatty, unsaturated (C18), dimers, distilled

3
10599/91
061788-89-4
Acids, fatty, unsaturated (C18), dimers, non-distilled

4
10599/92A
068783-41-5
Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled

5
10599/93
068783-41-5
Acids, fatty, unsaturated (C18), dimers, hydrogenated, non-distilled

6
11000
050976-02-8
Acrylic acid, dicyclopentadienyl ester

7
11245
002156-97-0
Acrylic acid, dodecyl ester

8
11500
000103-11-7
Acrylic acid, 2-ethylhexyl ester

9
11530
000999-61-1
Acrylic acid, 2-hydroxypropyl ester

10
12265
004074-90-2
Adipic acid, divinyl ester

11
12910
001732-10-1
Azelaic acid, dimethyl ester

12
As item 81
000528-44-9
1,2,4-Benzenetricarboxylic acid

13
13060
004422-95-1
1,3,5-Benzenetricarboxylic acid trichloride
As item 81

14
As item 25
000091-76-9
Benzoguanamine

15
As item 30
000080-09-1
Bisphenol S

16
13720
000110-63-4
Butan-1,4-diol

17
13780
002425-79-8
Butan-1,-diol bis(2,3- epoxypropyl) ether

The quantity in the finished plastic material or article of any substance within, or any combination of substances within, items 17 and 58 (and 16 and 20 of section D) shall not exceed 5mg/kg (expressed as epoxy)

18
13810
000505-65-7
Butan-1,4-diol formal

19
13932
000598-32-3
But-3-en 2-ol

20
14020
000098-54-4
4-tert-Butylphenol

21
14260
000502-44-3
Caprolactone

22
As item 101 Section A
000115-28-6
Chlorendic acid
As item 101, Section A

23
14800
003724-65-0
Crotonic acid

24
15130
000872-05-9
Dec-1-ene

25
15310
000091-76-9
2,4-Diamino-6-phenyl-1,3,5,-triazine

26
15370
003236-53-1
1,6-Diamino-2,2,4- trimethylhexane

27
15400
003236-54-2
1,6-Diamino-2,2,4- trimethylhexane

28
15610
000080-07-9
4,4'-Dichlorodiphenyl sulphone

29
15730
000077-73-6
Dicyclopentadiene

30
16090
000080-09-1
4,4'-Dihydroxydiphenyl sulphone

31
16210
006864-37-5
3,3'-Dimethyl-4,4'-diamino- dicyclohexylmethane

32
16360
000576-26-1
2,6-Dimethylphenol

33
16390
000126-30-7
2,2-Dimethylpropan-1,3-diol

34
16450
000646-06-0
1,3-Dioxolane

35
16540
000102-09-0
Diphenyl carbonate

36
16690
001321-74-0
Divinylbenzene

37
16697
000693-23-2
Dodecanedioic acid

38
17110
016219-75-3
5-Ethylidenebicyclo- [2 2 1]hept-2-ene

39
18220
068564-88-5
N-Heptylaminoundecanoic acid

40
18370
000592-45-0
Hexa-1,4-diene

41
18441
000085-42-7
Hexahydrophthalic anhydride

42
18700
000629-11-8
Hexan-1,6-diol

43
18820
000592-41-6
Hex-1-ene

44
19060
000109-53-5
Isobutyl vinyl ether

45
19150
000121-91-5
Isophthalic acid

46
19180
000099-63-8
Isophthalic acid dichloride

47
As item 62
000078-79-5
Isoprene

48
19490
000947-04-6
Laurolactam

49
19570
000999-21-3
Maleic acid, diallyl ester

50
19600
000105-76-0
Maleic acid, dibutyl ester

51
19990
000079-39-0
Methacrylamide

52
20050
000096-05-9
Methacrylic acid, allyl ester

53
20260
000101-43-9
Methacrylic acid, cyclohexyl ester

54
20380
001189-08-8
Methacrylic acid, diester with butan-1,3-diol

55
20410
002082-81-7
Methacrylic acid, diester with butan-1,4-diol

56
20440
000097-90-5
Metacrylic acid, diester with ethyleneglycol

57
20530
002867-47-2
Methacrylic acid, 2- (dimethylamino)-ethyl ester

58
20590
000106-91-2
Methacrylic acid, 2,3- epoxypropyl ester
As item 17

59
21370
010595-80-9
Methacrylic acid, 2- sulphoethyl ester

60
21400
054276-35-6
Methacrylic acid, sulphopropyl ester

61
21520
001561-92-8
Methallysulphonic acid, sodium salt
The quantity of this substance in the finished plastic material or article shall not exceed 5mg/kg

62
21640
000078-79-5
2-Methylbut-1,3-diene

63
21730
000563-45-1
3-Methylbut-1-ene

64
As item 18
000505-65-7
1,4-(Methylene-dioxy)butane

65
21970
000923-02-4
N-Methylolmethacrylamide

66
22210
000098-83-9

alpha-Methylstyrene

67
22360
001141-38-4
2,6-Naphthalene-dicarboxylic acid

68
As item 33
000126-30-7
Neopentylglycol

69
22428
051000-52-3
Neodecanoic acid, vinyl ester

70
13180 (also used for bicyclo[2.2.1]hept- 2-ene)
000498-66-8
Norbornene
As item 39, Section C

71
22720
000140-66-9
4-tert.-Octylphenol

72
22900
000109-67-1
Pent-1-ene

73
22937
001623-05-8
Perfluoropropyl perfluorovinyl; ether

74
23770
000504-63-2
Propan-1,3-diol

75
23920
000105-38-4
Propionic acid, vinyl ester

76
24370
000106-79-6
Sebacic acid, dimethyl ester

77
24760
026914-43-2
Styrenesulphonic acid

78
25380

Trialkyl(C5-C15) acetic acid, vinyl ester (=vinyl versatate)

79
25390
000101-37-1
Triallyl cyanurate

80
25450
026896-48-0
Tricyclodecanedimethanol

81
25540
000528-44-9
Trimellitic acid
The quantity of this substance alone or together with item 82 in the finished plastic material or article shall not exceed 5mg/kg

82
25550
000552-30-7
Trimellitic anhydride
The quantity of this substance alone or together with item 81 in the finished plastic material or article shall not exceed 5mg/kg (expressed as trimellitic acid)

83
25810
015625-89-5
1,1,1-Trimethylolpropane triacrylate

84
25840
003290-92-4
1,1,1-Trimethylolpropane trimethacrylate

85
25900
000110-88-3
Trioxane

86
25480
000102-71-6
Tris(2-hydroxyethyl)amine

87
26170
003195-78-6
N-Vinyl-N-methyl- acetamide
The quantity of this substance in the finished plastic material or article shall not exceed 5mg/kg

88
26230
000088-12-0
Vinylpyrrolidone

89
22240
000622-97-9

p-Vinyltoluene

90
16300
000105-67-9

m-Xylenol

91
16270
000526-75-0

o-Xylenol

92
16330
000095-87-4

p-Xylenol

Regulation 2(g)

SCHEDULE 3NEW SECTION F INSERTED IN PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

“SECTION F

Monomers authorised until 1st January 1999”

1
2
3
4

Item
PM/REF No.
CAS No.
Name
Restrictions

1
10160
002206-94-2
alpha-Acetoxystyrene

2
10162
010521-96-7
beta-Acetoxystyrene

3
10480
—
Acids, aliphatic, monocarboxylic, saturated (C2-C24)

4
10510
—
Acids, aliphatic, monocarboxylic, unsaturated (C3-C24)

5
10599/70
—
Acids, fatty, unsaturated (C18)

6
10930
003066-71-5
Acrylic acid, cylohexyl ester

7
11050
001070-70-8
Acrylic acid, diester with 1,4-butanediol

8
11180
017831-71-9
Acrylic acid, diester with tetraethylenglycol

9
11195
068901-05-3
Acrylic acid, diester with triprophyleneglycol

10
11520
002918-23-2
Acrylic acid, 2- hydroxisopropyl ester (= acrylic acid, 2-hydroxy-l- methylethyl ester)

11
11560
005888-33-5
Acrylic acid, isobornyl ester

12
11620
001330-61-6
Acrylic acid, isodecyl ester

13
11650
029590-42-9
Acrylic acid, isooctyl ester

14
11695
003121-61-7
Acrylic acid, 2-methoxyethyl ester

15
11740
010095-13-3
Acrylic acid, monoester with 1,3-butanediol

16
11770
002478-10-6
Acrylic acid, monoester with 1,4-butanediol

17
11800
013533-05-6
Acrylic acid, monoester with diethyleneglycol

18
12010
040074-09-7
Acrylic acid, 2-sulphoethyl ester

19
12040
039121-78-3
Acrylic acid, sulphopropyl ester

20
12055
094160-26-6
Acrylic acid, triester with glycerol tris(2- hydroxypropyl) ether

21
12062
075577-70-7
Acrylic acid, triester with 1,1,1-trimethylolpropane tris(2-hydroxyxethyl) ether

22
12160
002998-04-1
Adipic acid, diallyl ester

23
12190
000105-97-5
Adipic acid, didecyl ester

24
12220
027178-16-1
Adipic acid, diisodecyl ester

25
12250
000123-79-5
Adipic acid, dioctyl ester

26
12370
—
Alcohols, aliphatic, monohydric, saturated, linear, secondary or tertiary (C4-C22)

27
12610
000107-18-6
Allyl alcohol

28
12700
000150-13-0
p-Aminobenzoic acid

29
12790
000080-46-6
p-tert-Amylphenol

30
12850
029602-44-6
Azelaic acid, bis(2- hydroxyethyl) ester

31
13328
000104-38-1
Bis(-2 hydroxyethyl) ether of hydroquinone

32
13660
000584-03-2
1,2-Butanediol

33
13750
000513-85-9
2,3-Butanediol

34
13960
001852-16-0
N-(Butoxymethyl) acrylamide

35
15020
002182-55-0
Cyclohexyl vinyl ether

36
15280
000542-02-9
2,4-Diamino-6-methyl-1,3,5- triazine

37
15340
000109-76-2
1,3-Diaminopropane

38
15490
002215-89-6
4,4'-Dicarboxydiphenyl ether

39
15580
001653-19-6
2,3-Dichloro-1,3-butadiene

40
16270
000526-75-0
2,3-Dimethylphenol

41
16300
000105-67-9
2,4-Dimethylphenol

42
16330
000095-87-4
2,5-Dimethylphenol

43
17040
000149-57-5
2-Ethylhexanoic acid

44
17350
000105-75-9
Fumaric acid, dibutyl ester

45
18400
000592-42-7
1,5-Hexadiene

46
18905
002628-17-3
4-Hydroxystyrene

47
18970
000078-83-1
Isobutanol

48
19030
016669-59-3
N-(Isobutoxymethyl) acrylamide

49
19090
000078-84-2
Isobutyraldehyde

50
19120
025339-17-7
Isodecanol

51
19130
026896-18-4
Isononanoic acid

52
19936
007423-42-9
Maleic acid, mono(2- ethylhexyl)ester

53
20470
025852-47-5
Methacrylic acid, diester with polyethyleneglycol

54
20740
039670-09-2
Methacrylic acid, ester with ethoxytriethylene-glycol

55
20950
000923-26-2
Methacrylic acid, 2-hydroxypropyl ester

56
21115
000816-74-0
Methacrylic acid, methallyl ester

57
21220
032360-05-7
Methacrylic acid, octadecyl ester

58
21760
000694-91-7
5-Methylenebicyclo [2.2.1]hept-2-ene

59
21837
001116-90-1
4-Methyl-1,4-hexadiene
The specific migration of this substance shall not be detectable (when measured by a method with a limit of detection of 0.05 mg/kg).

60
22240
000622-97-9
p-Methylstyrene

61
22270
000107-25-5
Methyl vinyl ether

62
22540
000104-40-5
4-Nonylphenol

63
22585
003710-30-3
1,7-Octadiene

64
22932
001187-93-5
Perfluoromethyl perfluorovinyl ether

65
23530
025190-06-1
Poly(1,4-butyleneglycol) (Molecular weight greater than 1000)

66
23650
025322-69-4
Polypropyleneglycol (Molecular weight greater than 400)

67
24560
000111-63-7
Stearic acid, vinyl ester

68
25030
016646-44-9
Tetra(allyloxy)ethane

69
25161
000085-43-8
1,2,3,6-Tetrahydrophtalic anhydride

70
25300
000088-19-7
o-Toluenesulphonamide

71
25480
000102-71-6
Triethanolamine

72
26290
025013-15-4
Vinyltoluene

73
26320
002768-02-7
Vinyltrimethoxysilane
The quantity of this substance in the finished material or article shall not exceed 5mg/kg.

Regulation 2(h)

SCHEDULE 4ADDITIONAL ADDITIVES

1
2
3
4

Item
PM/REF No.
CAS No.
Name

12A
34281
—
Alkyl (C8-C22) sulphoric acids, linear, primary, with an even number of carbon atoms

12B
34475
—
Aluminium calcium hydroxide phosphite, hydrate

65A
46380
068855-54-9
Diatomaceous earth, soda ash flux-calcined

74A
52720
000112-84-5
Erucamide

92A
55520
—
Glass fibers

92B
55600
—
Glass microballs

96A
56486
—
Glycerol, esters with acids, aliphatic, saturated, linear, with an even number of carbon atoms (C14-C18) and with acids, aliphatic, unsaturated, linear with an even number of carbon atoms (C16-C18)

172A
68960
000301-02-0
Oleamide

199A
80800
025322-69-4
Polypropyleneglycol

252A
88960
000124-26-5
Stearamide

Explanatory Note

(This note is not part of the Regulations)
These Regulations, which extend to Great Britain, amend the Plastic Materials and Articles in Contact with Food Regulations 1992, as amended (“the principal Regulations”) and implement Commission Directive 96/11/EC (OJ No. L61, 12.3.96, p.26), amending Directive 90/128/EEC (OJ No. L75, 21.3.90, p.19,) as read with the corrigendum in OJ No. L349, 13.12.90, p.26) relating to plastic materials and articles intended to come into contact with foodstuffs.
The Regulations —
(a)modify the prohibition in regulation 5(1) of the principal Regulations on manufacture of plastic materials and articles before and after specified dates, using monomers other than those specified, by substituting later dates (regulation 2(b)(i)(B) and (C));
(b)permit, until 1st January 1999, the manufacture of plastic materials and articles, using monomers specified in Section F (as inserted by regulation 2(g) and Schedule 3 into Part 1 of Schedule 1 to the principal Regulations), (regulation 2(c));
(c)add specified monomers to those monomers authorised without time limit specified in Section A of Part I of Schedule 1 to the principal Regulations (regulation 2(d) and Schedule 1);
(d)substitute for the list of monomers in Section B of Part I of Schedule 1 to the principal Regulations (monomers authorised up to the end of 1996) an amended list, omitting certain monomers previously included, those remaining being authorised up to the end of 2001 (regulation 2(e) and Schedule 2);
(e)add specified additives to those which are specified in Part I of Schedule 3 to the principal Regulations, and which it is prohibited to use, if they are not of good technical quality, in the manufacture of plastic materials and articles, (regulation 2(h) and Schedule 4); and
(f)make consequential amendments to the principal Regulations (regulation 2(a), 2(b)(i)(A) and (ii), and (f)).
A compliance cost assessment of the effect that this Instrument would have on the cost of business, is available from Food Contaminants Division B of the Ministry of Agriculture, Fisheries and Food, Ergon House, 17 Smith Square, London SW1P 3JR.


(1)
1990 c. 16; "the Ministers" is defined in section 4(1) of the Act.

(2)
S.I. 1976/2141.

(3)
1972 c. 68.

(4)
S.I. 1992/3145, amended by S.I. 1995/360 and S.I. 1996/694.

(5)
Corrigendum in OJ No. L349, 13.12.90, p.26; amending Directives in OJ No. L168, 23.6.92, p.21, OJ No. L90, 14.3.93, p.26, OJ No. L41, 23.2.95, p.44 and OJ No. L61, 12.3.96, p.26.