2005 No.92
FOOD

The Plastic Materials and Articles in Contact with Food Amendment (Scotland) Regulations 2005

Made
Laid before the Scottish Parliament
Coming into force
The Scottish Ministers in exercise of the powers conferred by sections 16(2), 17(1), 26(1)(a) and (3) and 48(1) of the Food Safety Act 19901 and of all other powers enabling them in that behalf, having had regard, in accordance with section 48(4A)2 of that Act, to relevant advice given by the Food Standards Agency, hereby make the following Regulations:

Citation, commencement and extent

1.

(1)

These Regulations may be cited as the Plastic Materials and Articles in Contact with Food Amendment (Scotland) Regulations 2005 and come into force on 24th March 2005.

(2)

These Regulations extend to Scotland only.

Amendments to the Plastic Materials and Articles in Contact with Food Regulations 1998

2.

The Plastic Materials and Articles in Contact with Food Regulations 19983 (“the principal Regulations”) are amended in accordance with regulations 3 to 16 of these Regulations.

3.

In regulation 2 (interpretation) paragraph (1)–

(a)

for the definition of “additive” substitute–

““additive” means a substance as defined in paragraph 1 of the general introduction to Annex III to the Directive as read with paragraph 3 of article 4 of the Directive;”;

(b)

after the definition of “Council Directive 82/711” insert–
““Council Directive 88/388” means Council Directive 88/388/EEC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production4 as corrected by a corrigendum dated 14th December 19885 and as amended by Commission Directive 91/716;
“Council Directive 89/107” means Council Directive 89/107/EEC on the approximation of the laws of the Member States concerning food additives authorised in foodstuffs intended for human consumption7 as amended by European Parliament and Council Directive 94/348;”;

(c)

at the end of the definition of “the Directive” insert “and Commission Directive 2004/19/EC”9;

(d)

omit the definition of “EEA Agreement”;

(e)

for the definition of “EEA State” substitute ““EEA State” means a Member State (other than the United Kingdom), Norway, Iceland or Liechtenstein;”;

(f)

after the definition of “EEA State” insert–

“EFSA” means the European Food Safety Authority;”;

(g)

after the definition of “preparation” insert–
““the purity Directives” means Commission Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs10 as amended by Commission Directives 98/6611, 2000/5112, 2001/5213 and 2004/4614; Commission Directive 95/45/EC laying down purity criteria concerning colours for use in foodstuffs15 as amended by Commission Directives 1999/7516, 2001/5017 and 2004/4718 and Commission Directive 96/77/EC laying down specific purity criteria for food additives other than colours or sweeteners19as amended by Commission Directives 98/8620, 2000/6321, 2001/3022, 2002/8223 and 2003/9524;”;

4.

In regulation 4 (restriction on manufacture with monomers)–

(a)

in paragraph (2) omit sub paragraphs (a) and (b); and

(b)

in paragraph (5)(b)(ii) after “material” wherever it appears, insert “or article”.

5.

In regulation 5 (restriction on the use of additives in the manufacture of plastic materials and articles)–

(a)

at the end of paragraph (1) insert–

“(e)

any food additive authorised by Council Directive 89/107 or any flavouring authorised by Council Directive 88/388 that migrates into food–

(i)

in a quantity that has a technicological function in the final food product; or

(ii)

where the food is of a type for which the use of any such food additive or flavouring is so authorised, in quantities exceeding the limits provided for that additive or flavouring in Council Directive 89/107 or Council Directive 88/388 as appropriate, or in Schedule 2 to these Regulations, whichever is the lower;

(b)

in paragraph (4)(b)(ii) after “material” wherever it appears, insert “or article”.”

6.

After regulation 5A insert–

“Applications for inclusion of an additive in the Community list of authorised additives5B.

(1)

This regulation applies to any person who wishes to make an application for the inclusion of an eligible additive in the Community list referred to in Article 4 of the Directive.

(2)

An application mentioned in paragraph (1) including supporting data must be made to EFSA before 1st January 2007.

(3)

If, during examination of the data referred to in paragraph (2), EFSA calls for supplementary information, the eligible additive may, if otherwise lawful, continue to be so used until EFSA has issued an opinion, provided such information is submitted within the time limits specified by EFSA.

(4)

For the purposes of this regulation an eligible additive is one whose use is permitted in one or more Member States before 1st January 2007.”.

7.

For regulation 8 (labelling) substitute–

“8.

At marketing stages other than the retail stage a person who is in possession of any plastic material or article intended to come into contact with food shall ensure that the plastic material or article is accompanied by a written declaration which–

(a)

attests that it complies with the legislation applicable to it; and

(b)

provides, in respect of substances that are subject to a restriction on quantities migrating into food, information obtained from experimental data or theoretical calculation concerning–

(i)

the levels of migration specific to those substances;

(ii)

where appropriate, purity criteria in accordance with the purity Directives

sufficient to enable the user of those materials and articles to comply with the legislation applicable to food.”.

8.

In regulation 10 (offences)–

(a)

in paragraph (1) for “8(1)” substitute “8”;

(b)

after paragraph (24) insert–

“(25)

In any proceedings for an offence under these Regulations it shall be a defence to prove that–

(a)

the act constituting the offence was committed in relation to a plastic material or article which was manufactured or imported into the European Community before 1st March 2006; and

(b)

the act constituting the offence would not have constituted an offence under these Regulations if the amendments made to them by the Plastic Materials and Articles in Contact with Food Amendment (Scotland) Regulations 2005 had not been in force at the time that act occurred.”.

9.

In Schedule 1, Part I–

(a)

in Section A (monomers authorised without time limit)–

(i)

insert in the appropriate numerical order the entries set out in Schedule 1 to these Regulations;

(ii)

for items 15A, 39, 70, 120B, 147, 147A, 147B and 188 substitute the entries set out in Schedule 2 to these Regulations; and

(iii)

omit items 76B and 76C and their corresponding entries; and

(b)

omit Sections B and C.

10.

In Schedule 1, Part II (supplementary) paragraph 4–

(a)

in note (21) for “and 18670” substitute “, 18670, 54880 and 59280”;

(b)

after note (25) insert–

“(26)

QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 10599/90A, 10599/91, 10599/92A and 10599/93.

(27)

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 13480 and 39680.

(28)

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 22775 and 69920.

(31)

Compliance testing when there is a fat contact should be performed using isoctane as substitute of simulant D (unstable).

(32)

QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14800 and 45600.”

11.

In Schedule 2, Part I (incomplete list of additives used in the manufacture of plastic materials and articles)–

(a)

insert in appropriate numerical order the entries set out in Schedule 3 to these Regulations;

(b)

for items 60A and 198A substitute the entries set out in Schedule 4 to these Regulations;

(c)

delete items 112, 173A, 195C and 240 and their corresponding entries.

12.

In Schedule 2, Part II (incomplete list of additives used in the manufacture of plastic materials and articles being additives to which paragraph 5 of Part III of Schedule 2 applies) —

(a)

insert in appropriate numerical order the entries set out in Schedule 5 to these Regulations;

(b)

delete items 28, 80 and 111A and their corresponding entries.

13.

In Schedule 2, Part III (supplementary)–

(a)

in paragraph 4–

(i)

in note (8) after “PM/REF Nos.” insert “38000” and after “64320,” insert “67896,”;

(ii)

in note (10) after “levels” insert “(expressed as Iodine”); and

(iii)

in note (21) for “and 18670” substitute “, 18670, 54880 and 59280”;

(iv)

after note (24) add–

“(25)

QM(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances mentioned as reference Nos. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.

(26)

QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 10599/90A, 10599/91, 10599/92A and 10599/93.

(27)

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 13480 and 39680.

(28)

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 22775 and 69920.

(29)

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 86480, 86960 and 87120.

(30)

Compliance testing when there is a fat contact should be performed using saturated fatty food simulants as simulant D.

(31)

Compliance testing when there is a fat contact should be performed using isoctane as substitute of simulant D (unstable).

(32)

QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14800 and 45600.

(33)

SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 55200, 55280 and 55360.”;

(b)

in paragraph 5 for “1st January 2004” substitute “1st July 2006”.

14.

In Schedule 2A (products obtained by bacterial fermentation)–

(a)

for the entry in Column 2 (CAS No.) substitute “080181-31-3”;

(b)

for the entry in Column 4 (restrictions and specifications) substitute–

  • “In compliance with specifications included in Schedule 2B”.

15.

For Schedule 2B (specifications) substitute the contents of Schedule 6 to these Regulations.

16.

For paragraph 4(b) of Part I (basic rules) of Schedule 4 (overall and specific migration testing using food simulants) substitute–

“(b)

omit the migration, the substitute or the alternative tests where–

(i)

there is conclusive proof that the migration limits cannot be exceeded in any foreseeable conditions of use of the material or article, or

(ii)

the conditions for non–compulsory testing set out in article 8.2 or 8.3 of the Directive are met.”.

RHONA BRANKIN
Authorised to sign by the Scottish Ministers

St Andrew’s House, Edinburgh

SCHEDULE 1(ENTRIES TO BE INSERTED IN SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS)

Regulation 9(a)(ii)

“1

2

3

4

Item

PM/REF No.

CASNo.

Name

Restrictions and specifications

6A

10599/90A

061788–89–4

Acids, fatty, unsaturated (C18), dimers, distilled

QMA(T) = 0.05 mg/6 dm2 (26)

6B

10599/91

061788–89–4

Acids, fatty, unsaturated (C18), dimers, non distilled

QMA(T) = 0.05 mg/6 dm2 (26)

6C

10599/92A

068783–41–5

Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled

QMA(T) = 0.05 mg/6 dm2 (26)

6D

10599/93

068783–41–5

Acids, fatty, unsaturated (C18), dimers, hydrogenated, non distilled

QMA(T) = 0.05 mg/6 dm2 (26)

37A

13323

000102–40–9

1,3-Bis(2-hydroxyethoxy) benzene

SML = 0.05 mg/kg

68MA

14800

003724–65–0

Crotonic acid

QMA(T) = 0.05 mg/6 dm2 (32)

87A

16210

006864–37–5

3,3'-Dimethyl-4,4'-diaminodicyclohexylmethane

SML = 0.05 mg/kg (31). To be used only in polyamides.

89A

16540

000102–09–0

Diphenyl carbonate

SML = 0.05 mg/kg

101A

17110

016219–75–3

5-Ethylidenebicyclo[2,2,1]hept-2-ene

QMA = 0.05 mg/6 dm2.

The ratio surface / quantity of food shall be lower than 2 dm2/kg

118MA

18700

000629–11–8

1,6-Hexanediol

SML = 0.05 mg/kg

120ZA

18896

001679–51–2

4&-(Hydroxymethyl)-1-cyclohexene

SML = 0.05 mg/kg

135BM

20440

000097–90–5

Methacrylic acid, diester with ethyleneglycol

SML = 0.05 mg/kg

142A

21400

054276–35–6

Methacrylic acid, sulphopropyl ester

QMA = 0.05 mg/6 dm2

156XA

22775

000144–62–7

Oxalic acid

SML(T) = 6 mg/kg(28)

161A

23070

000102–39–6

(1,3-Phenylenedioxy)diacetic acid

QMA = 0.05 mg/6 dm2”

SCHEDULE 2(ENTRIES TO BE SUBSTITUTED FOR ENTRIES IN SECTION A OF PART I OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS)

Regulation 9(a)(ii)

“1

2

3

4

Item

PM/REF No.

CASNo.

Name

Restrictions and specifications

15A

11530

00999–61–1

Acrylic acid, 2-hydroxypropyl ester

QMA = 0.05 mg/6 dm2 for the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester and in compliance with the specifications laid down in Schedule 2B

39

13480

000080–05–7

2,2-Bis(4-hydroxyphenyl) propane

SML(T) = 0.6 mg/kg(27)

70

14950

003173–53–3

Cyclohexyl isocyanate

QM(T) = 1 mg/kg in FP (expressed as NCO) (25)

120B

18898

000103–90–2

N-(4-Hydroxyphenyl) acetamide

SML = 0.05 mg/kg

147

22150

000691–37–2

4-Methyl-1-pentene

SML = 0.05 mg/kg

147A

22331

025513–64–8

Mixture of (35–45% w/w) 1,6-diamino-2,2,4-trimethylhexane and (55–65% w/w) 1,6-diamino-2,4,4-trimethylhexane

QMA = 5 mg/6 dm2

147B

22332

—

Mixture of (40% w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60% w/w) 2,4,4-trimethylhexane-1,6-diisocyanate

QM(T)= 1 mg/kg (expressed as NCO) (25)

188

24190

065997–05–9

Rosin Wood”

SCHEDULE 3(ENTRIES TO BE INSERTED IN PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS)

Regulation 11(a)

“1

2

3

4

Item

PM/REF No.

CASNo.

Name

Restrictions and specifications

18A

34850

143925–92–2

Amines, bis(hydrogenated tallow alkyl) oxidised

QM = For use only:

  1. (a)

    in polyolefines at 0.1% (w/w) but not in LDPE when it is in contact with foods for which the Directive 85/572/EEC establishes a reduction factor less than 3;

  2. (b)

    in PET at 0.25% (w/w) in contact with foods other of those for which the simulant D is laid down in Directive 85/572/EEC

18B

34895

000088–68–6

2-Aminobenzamide

SML = 0.05 mg/kg. To be used only for PET for water and beverages

37AA

39680

000080–05–7

2,2-Bis(4-hydroxyphenyl) propane

SML(T) = 0.6 mg/kg(27)

51A

42880

008001–79–4

Castor oil

61A

45600

003724–65–0

Crotonic acid

QMA(T) = 0.05 mg/6 dm2 (32)

61B

45640

005232–99–5

2-Cyano-3,3-dipheneylacrylic acid, ethyl ester

SML = 0.05 mg/kg

69A

46700

—

5,7-di-tert-Butyl-3-(3,4-and 2,3-di-methylphenyl)-3H-benzofuran-2-one containing:

  1. (a)

    5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80–100% w/w); and

  2. (b)

    5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0–20% w/w)

SML = 5 mg/kg

69B

46720

004130–42–1

2,6-Di-tert-butyl-4-ethylphenol

QMA = 4.8 mg/6 dm2

109A

56535

—

Glycerol, esters with nonanoic acid

131A

59280

000100–97–0

Hexamethylenetetramine

SML(T) = 15 mg/kg (21) (expressed as Formaldehyde)

178A

68078

027253–31–2

Neodecanoic acid, cobalt salt

SML(T) = 0.05 mg/kg (expressed as Neodecanoic acid) and SML(T) = 0.05 mg/kg(13) (expressed as Cobalt). Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC

182A

69920

000144–62–7

Oxalic acid

SML(T) = 6 mg/kg(28)

195D

76866

—

Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C12–C18 or n-octanol and / or n-decanol

SML = 30 mg/kg

240ZA

85601

—

Silicates, natural (with the exception of asbestos)

280B

95000

028931–67–1

Trimethylolpropane trimethacrylatemethyl methacrylate copolymer”

SCHEDULE 4(ENTRIES TO BE SUBSTITUTED FOR ENTRIES IN PART I OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS)

Regulation 11(b)

“1

2

3

4

Item

PM/REF No.

CASNo.

Name

Restrictions and specifications

60A

45450

068610–51–5

p-Cresol-dicyclopentadiene-isobutylene, copolymer

SML = 5 mg/kg

198A

77895

068439–49–6

Polyethyleneglycol (EO = 2–6) monoalkyl (C16–C18) ether

SML = 0.05 mg/kg and in compliance with the specifications laid down in Schedule 2B”

SCHEDULE 5(ENTRIES TO BE INSERTED IN PART II OF SCHEDULE 2 TO THE PRINCIPAL REGULATIONS

Regulation 12(a)

“1

2

3

4

Item

PM/REF No.

CASNo.

Name

Restrictions and specifications

4A

34650

151841–65–5

Aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert-butylphenyl) phospate

SML = 5 mg/kg

7A

38000

000553–54–8

Benzoic acid, lithium salt

SML(T) = 0.6 mg/kg(8) (expressed as Lithium)

18A

40720

025013–16–5

tert-Butyl-4-hydroxyanisole (= BHA)

SML = 30 mg/kg

27B

46640

000128–37–0

2,6-Di-tert-butyl-p-cresol (= BHT)

SML = 3.0 mg/kg

54A

54880

000050–00–0

Formaldehyde

SML(T) = 15 mg/kg (21)

54B

55200

001166–52–5

Gallic acid, dodecyl ester

SML(T) = 30 mg/kg(33)

54C

55280

001034–01–1

Gallic acid, octyl ester

SML(T) = 30 mg/kg(33)

54D

55360

000121–79–9

Gallic acid, propyl ester

SML(T) = 30 mg/kg(33)

79A

67896

020336–96–3

Myristic acid, lithium salt

SML(T) = 0.6 mg/kg(8) (expressed as Lithium)

83A

71935

007601–89–0

Perchloric acid, sodium salt monohydrate

SML 0.0 5 mg/kg(30)

88A

76680

068132–00–3

Polycyclopentadiene, hydrogenated

SML = 5 mg/kg(1)

100A

86480

007631–90–5

Sodium bisulphite

SML(T) = 10 mg/kg(29) (expressed as S02)

102A

86920

007632–00–0

Sodium nitrite

SML = 0.6 mg/kg

102B

86960

007757–83–7

Sodium sulphite

SML(T) = 10 mg/kg(29) (expressed as S02)

102C

87120

007772–98–7

Sodium thiosulphate

SML(T) = 10 mg/kg(29) (expressed as S02)

110A

94400

036443–68–2

Triethyleneglycol bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate]

SML = 9 mg/kg”

SCHEDULE 6(SUBSTITUTE FOR SCHEDULE 2B TO THE PRINCIPAL REGULATIONS)

Regulation 15

“SCHEDULE 2BSPECIFICATIONS

Regulation 7A

1

2

Item

PM/REF No.

Specifications

1

11530

Acrylic acid, 2-hydroxypropyl ester.

It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No. 002918–23–2)

2

16690

Divinylbenzene

It may contain up to 45% (m/m) of Ethylvinylbenzene

3

18888

3-Hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer

Definition

The 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-hydroxybutanoate-co–3-D-hydroxypentanoate)

CAS number

080181–31–3

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-hydroxybutanoate-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 a chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water

Restriction

QMA for crotonic acid is 0.05 mg/6 dm2

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

4

23547

Polydimethylsiloxane (Mw > 6800)

Minimum viscosity 100 × 10−6 m2/s (= 100 centistokes) at 25°C

5

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.

6

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)

7

43680

Chlorodifluoromethane

Content of chlorofluoromethane less than 1 mg/kg of the substance

8

47210

Dibutylthiostannoic acid polymer

Molecular unit = (C8H18S3Sn2)n (n = 1.5–2)

9

76721

Polydimethylsiloxane (Mw > 6800)

Minimum viscosity 100 × 10−6 m2/s (= 100 centistokes) at 25°C

10

77895

Polyethyleneglycol (EO = 2–6) monoalkyl (C16–C18) ether

The composition of this mixture is as follows:

  • polyethyleneglycol (EO = 2–6) monoalkyl (C16–C18) ether (approximately 28%)

  • fatty alcohols (C16–C18) (approximately 48%)

  • ethyleneglycol monoalkyl (C16–C18) ether (approximately 24%)

11

83595

Reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with Friedel Craft reaction product of phosphorus trichloride and biphenyl

Composition

  • 4,4'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 38613–77–3) (36–46% w/w (*))

  • 4,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 118421–00–4) (17–23% w/w (*))

  • 3,3'-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS No. 118421–01–5) (1–5% w/w (*))

  • 4-Biphenylene-0,0-bis (2,4-di-tert-butylphenyl) phosphonite (CAS No. 91362–37–7) (11–19% w/w (*))

  • Tris (2,4-di-tert-butylphenyl) phosphite (CAS No. 31570–04–4) (9–18% w/w (*))

  • 4,4'-Biphenylene-0,0-bis (2,4-di-tert-butylphenyl) phosphonate-0,0-bis (2,4-di-tert-butylphenyl) phosphonite (CAS No. 112949–97-0) (<5% w/w (*))

Other specifications

  • Phosphor content of minimum 5.4% to maximum 5.9%

  • Acid value of maximum 10 mg KOH per gram

  • Melt range of 85–110°C

12

88640

Soyabean oil, epoxidized

Oxirane < 8%, iodine number < 6

13

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

14

95883

White mineral oils, paraffinic derived from petroleum 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

Note:–”

(*)

Quantity of substance used/quantity of formulation.

(This note is not part of the Regulations)

These Regulations, which extend to Scotland only, further amend the Plastic Materials and Articles in Contact with Food Regulations 1998 (S.I. 1998/1376), (“the 1998 Regulations”), which extend to the whole of Great Britain. These Regulations implement, in Scotland, Commission Directive 2004/19/EC (O.J. No. L 71, 10.3.04, p.8) amending Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs (O.J. No. L 220, 15.8.02, p.18), (“the Directive”).

The Regulations amend the 1998 Regulations by–

(a)

substituting the definition of “additive” used in the Directive, for consistency (regulation 3(a));

(b)

removing references to lists of substances whose authorisations are now spent (regulation 4(a));

(c)

extending to articles the provisions of regulation 4(5) of the 1998 Regulations that formerly only applied to materials (regulation 4(b));

(d)

adding a restriction on the use of additives in the manufacture of plastic materials and articles which relates to substances also used as food additives or flavourings (regulation 5(a));

(e)

extending to articles the provisions of regulation 5(4) of the 1998 Regulations that formerly only applied to materials (regulation 5(b));

(f)

making provision for the procedure to be followed and the time limits to be observed by any person wishing to have an additive included in the Community list of authorised additives (regulation 6);

(g)

imposing additional labelling requirements for plastic materials and articles at the pre-retail stage so as to make additional information available to users (regulation 7);

(h)

making a consequential amendment to regulation 10 (offences) brought about by the amendment to the labelling requirements (regulation 8(a));

(i)

providing a defence to breach the 1998 Regulations as last amended by these Regulations in respect of plastic materials or articles manufactured or imported into the European Community before 1st March 2006 (regulation 8(b)).

They also amend the Schedules to the 1998 Regulations by–

(a)

inserting new entries, and amending or deleting some existing ones, in the list of monomers authorised without time limit in Section A of Part I of Schedule 1 (regulation 9(a) and Schedules 1 & 2);

(b)

removing the list of entries for monomers authorised with a time limit that has now expired (regulation 9(b));

(c)

adding further supplementary specifications in Part II of Schedule 1 (regulation 10);

(d)

inserting new entries and amending or deleting some existing entries in the list of additives used in the manufacture of plastic materials and articles in Part I of Schedule 2 (regulation 11 and Schedules 3 & 4);

(e)

inserting new entries and deleting some existing entries in the list of additives used in the manufacture of plastic materials and articles set out I Part II of Schedule 2 (regulation 12 and Schedule 5);

(f)

adding further supplementary specifications to Part III of Schedule 2, and extending the time limit applicable to substances listed in Part II of that Schedule (regulation 13);

(g)

amending the restrictions and specifications in the entry in Schedule 2A relating to products obtained by bacterial fermentation (regulation 14);

(h)

inserting new entries and amending or deleting some existing ones in the specifications set out in Schedule 2B (regulation 15 and Schedule 6);adding a provision to the basic rules for overall and specific migration testing using food simulants set out in Part I of Schedule 4, to allow for migration testing to be omitted in the specific circumstances provided for in the Directive (regulation 16).

A Regulatory Impact Assessment, which includes a compliance cost assessment of the effect which these Regulations are likely to have on business costs, has been prepared and has been placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency, 6th Floor, St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ.