The Materials and Articles in Contact with Food (England) Regulations 2012

Type Statutory-Instrument
Publication 2012-10-17
Last updated 2025-04-01
State In force
Department King's Printer of Acts of Parliament
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[^key-8beef4994bbcd3805df4869b0c93a8ff]: Reg. 18(3)-(6) inserted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 8; 2020 c. 1, Sch. 5 para. 1(1)

[^key-6354927504fbcb7d9932daac0e01f8b1]: Words in reg. 19(1) substituted (31.12.2020 immediately after IP completion day) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments) (England) Regulations 2020 (S.I. 2020/1410), regs. 1(3), 4(19)

[^key-5d4986ad91d84e9d8f92cc1250d9fd0b]: Reg. 19B(a) substituted (31.12.2020 immediately after IP completion day) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments) (England) Regulations 2020 (S.I. 2020/1410), regs. 1(3), 4(20)

[^key-2e6c30061eea619d4dd71ef77eb120cf]: Sch. 5 inserted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), reg. 1(1), Sch. 1

[^key-8ed3036260b62a770decb9994e5ad3d0]: Words in reg. 2(1) omitted (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 2(2)(a)(i)

[^key-a654f330778ee10755ac5ecc5d6dab40]: Words in reg. 2(1) omitted (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 2(2)(a)(ii)

[^key-1d51414ce0cfc9e63fabdd21cddb42c2]: Word in reg. 2(3) omitted (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 2(2)(b)

[^key-95e44033610062954f456fce819d3303]: Word in reg. 9(a)(ii) omitted (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 2(3)(a)

[^key-6144d187e75e1e1045a599c23a37ad9e]: Reg. 9(b) omitted (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 2(3)(b)

[^key-d64791d33d3efeaedfcec8acf8571226]: Reg. 11(3) omitted (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 2(4)

[^key-d643b01daed9a4cdb2ffd3e4b9f3e3cf]: Words in reg. 12(1) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 2(5)(a)(i)

[^key-d7c788442ebbd60c8c1f71d20388d79e]: Words in reg. 12(1) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 2(5)(a)(ii)

[^key-768fffe7ac43f9f14ed6356e8eebf3d0]: Words in reg. 12(2) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 2(5)(b)

[^key-1799d2f7a2a22bfbd69630543ac024d0]: Words in reg. 30(2) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 2(6)(a)

[^key-c2c637e97872f0ac9c951d4c379e07e7]: Words in reg. 30(6) inserted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 2(6)(b)(i)

[^key-b0e2616421cb2f2a1ef36bb8d637a374]: Words in reg. 30(6) omitted (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 2(6)(b)(ii)

[^key-5bf3737da896a7f8d8d9448ab91d8a10]: Pt. 1 applied in part (with modifications) (N.I.) (1.10.2023) by The Windsor Framework (Retail Movement Scheme: Public Health, Marketing and Organic Product Standards and Miscellaneous Provisions) Regulations 2023 (S.I. 2023/959), regs. 1(2), 4(b), Sch. 2 (with regs. 7, 8)

[^key-97cba4339a95d7f6ed3cdb32a540a0fc]: Pt. 4 applied in part (with modifications) (N.I.) (1.10.2023) by The Windsor Framework (Retail Movement Scheme: Public Health, Marketing and Organic Product Standards and Miscellaneous Provisions) Regulations 2023 (S.I. 2023/959), regs. 1(2), 4(b), Sch. 2 (with regs. 7, 8)

[^key-108ffe32029adffa6719644d240d2ba6]: Sch. 2 applied in part (with modifications) (N.I.) (1.10.2023) by The Windsor Framework (Retail Movement Scheme: Public Health, Marketing and Organic Product Standards and Miscellaneous Provisions) Regulations 2023 (S.I. 2023/959), regs. 1(2), 4(b), Sch. 2 (with regs. 7, 8)

[^key-5d6bee6c1aa50b1c5fd8f3444408ecac]: Sch. 3 applied in part (with modifications) (N.I.) (1.10.2023) by The Windsor Framework (Retail Movement Scheme: Public Health, Marketing and Organic Product Standards and Miscellaneous Provisions) Regulations 2023 (S.I. 2023/959), regs. 1(2), 4(b), Sch. 2 (with regs. 7, 8)

[^key-d44069cb96342418166bfc7ca4195270]: Sch. 4 applied in part (with modifications) (N.I.) (1.10.2023) by The Windsor Framework (Retail Movement Scheme: Public Health, Marketing and Organic Product Standards and Miscellaneous Provisions) Regulations 2023 (S.I. 2023/959), regs. 1(2), 4(b), Sch. 2 (with regs. 7, 8)

[^key-6a1c06f176387ec511850f6a1dccf097]: Word in reg. 30(2) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 1

[^key-2da294899e4c188967d473379388a1fe]: Word in reg. 30(6) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 1

[^key-1468f971eb4ff17efd1b1f4a6a1c4783]: Words in reg. 12(3) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 12 para. 1(2)(a)

[^key-5e635ef9abfd1bb926d342ae04d995a1]: Words in reg. 12(3) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 12 para. 1(2)(b)

[^key-3cab5d38496bf4dce8d8017b57136649]: Words in reg. 13 substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 12 para. 1(3)

[^key-68729503f0b6b8c6fc6a42abe9875091]: Word in reg. 14(1) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 12 para. 1(4)(a)

[^key-7509cf83f3222707c44d453c06e9d2cc]: Words in reg. 14(1) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 12 para. 1(4)(b)

[^key-cc5fd0ee21f11d60b38dfb8a1362c408]: Words in reg. 15 omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 12 para. 1(5)

[^key-16416e979346f221eb9f9bcb8de5787b]: Words in reg. 20(3)(d) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 12 para. 1(6)

[^key-b4bf34194a56535552a7bed6bf7e4933]: Sch. renumbered as Sch. 1 (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 12 para. 1(7)

[^key-912d35368a24d4def2ca4a3f6a267e58]: Words in Sch. 1 omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 12 para. 1(8)(b)

[^key-67a7828e9e935fc86966f15ea6cc4a47]: Words in Sch. 1 omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 12 para. 1(8)(a)

PART 6A — Requirements for Recycled Plastic Materials and Articles

Interpretation of this Part

15A

In this Part any reference to a numbered Article is a reference to that Article of Regulation 282/2008.

Offences of contravening Article 3(1) of Regulation 282/2008

15B

Subject to the transitional provisions contained in Article 14, any person who places on the market a material or article that fails to comply with Article 3(1) (requirements for plastic materials and articles) is guilty of an offence.

Competent authorities for the purposes of Regulation 282/2008

15C

The competent authorities for the purposes of Article 10 are the Food Standards Agency and each food authority in its area.

PART 7A — Requirements for bisphenol A

Interpretation of Part 7A

17A

In this Part, any reference to a numbered Article is a reference to the Article so numbered in Regulation 2018/213.

Offences of contravening Article 2 of Regulation 2018/213

17B

Subject to the transitional provisions contained in Article 6, any person who places on the market a material or article that fails to comply with Article 2 is guilty of an offence.

Competent authorities for the purposes of Regulation 2018/213

17C

The competent authorities for the purposes of Article 4(3) are the Food Standards Agency and each food authority in its area.

Compliance notices

19A

  • (1) If an authorised officer has reasonable grounds for believing that any person has not complied with, is not complying with, or is not likely to comply with a provision specified in regulation 19B (which provisions concern declarations of compliance with legislative requirements or supporting documentation), the officer may serve a compliance notice on that person.
  • (2) A compliance notice must state—
  • (a) the reason for the service of the notice and the steps the person on whom the notice has been served must take;
  • (b) the date and, if appropriate, the time by which each step must be taken;
  • (d) that a failure to comply with the notice is an offence; and
  • (e) the details of the right to appeal against the notice under regulation 19C.
  • (3) An authorised officer may serve a notice on a person withdrawing, varying or suspending a compliance notice.

19B

The provisions are—

  • (a) paragraphs (2) and (3) of regulation 10A;
  • (b) paragraph (6) of regulation 12;
  • (c) Article 16 of Regulation 1935/2004;
  • (d) Article 5 of Regulation 1895/2005;
  • (e) Articles 10(3) and 12 of Regulation 282/2008;
  • (f) Articles 12 and 13 of Regulation 450/2009;
  • (g) the second sentence of Article 8, Article 15 as read with Annex 4 and Article 16 of Regulation 10/2011;
  • (h) Article 4 of Regulation 2018/213.

Appeal against a compliance notice

19C

  • (1) Any person served with a compliance notice may appeal against that notice to a magistrates’ court.
  • (2) The procedure on appeal to a magistrates’ court is by way of complaint for an order, and the Magistrates’ Courts Act 1980 applies to the proceedings.
  • (3) The period within which an appeal may be brought is one month from the date on which the compliance notice was served on the person wishing to appeal and the making of a complaint for an order is deemed for the purposes of this paragraph to be the bringing of the appeal.
  • (4) A compliance notice is not suspended pending an appeal unless—
  • (a) an authorised officer suspends it under regulation 19A(3); or
  • (b) the court directs that it be suspended.
  • (5) The court may—
  • (a) confirm the notice or any requirement contained in it;
  • (b) vary the notice or any requirement contained in it; or
  • (c) revoke the notice or any requirement contained in it.

Execution and enforcement

Offences by corporate bodies or Scottish partnerships

Offences due to the act or default of a third party

Time limit for prosecutions

General defences

Procedure where a sample is to be analysed

Secondary analysis by the Government Chemist

Application of various provisions of the Act

10A

  • (1) No person may place on the market a ceramic article that does not comply with the requirements of regulation 10(1) as read with regulation 10(2).
  • (2) At the marketing stages up to and including the retail stage, ceramic articles which are not yet in contact with foodstuffs must be accompanied by a written declaration in accordance with Article 16 of Regulation 1935/2004. That declaration is to be issued by the manufacturer or by a seller in Great Britain and must contain the information laid down in Schedule 4.
  • (3) Appropriate documentation to demonstrate that the ceramic articles comply with the migration limits for lead and cadmium set out in regulation 10 must be made available by the manufacturer or the importer to the competent authorities on request. That documentation must contain the results of the analysis carried out, the test conditions and the name and the address of the laboratory that performed the testing.
  • (4) The documentation specified in paragraph (3) is not required where documentary evidence is provided to show that the materials used to make the ceramic article did not contain lead or cadmium.
  • (5) Paragraphs (2) and (3) do not apply in relation to a ceramic article which is second-hand.

Appeal against a compliance notice

Execution and enforcement

Offences by corporate bodies or Scottish partnerships

Offences due to the act or default of a third party

Time limit for prosecutions

General defences

Procedure where a sample is to be analysed

Secondary analysis by the Government Chemist

Application of various provisions of the Act

SCHEDULE 2 — BASIC RULES FOR DETERMINING THE MIGRATION OF LEAD AND CADMIUM

1

Test liquid

2

Test conditions

  • (a) Carry out the test at a temperature of 22 ± 2 °C for a duration of 24 ± 0,5 hours.
  • (b) When the migration of lead is to be determined, cover the sample by an appropriate means of protection and expose it to the usual lighting conditions in a laboratory. When the migration of cadmium or of lead and cadmium is to be determined, cover the sample so as to ensure that the surface to be tested is kept in total darkness.

3

Filling

  • (a) Samples which can be filled—

Fill the article with a 4 % (v/v) acetic acid solution to a level no more than1 mm from the overflow point; the distance is measured from the upper rimof the sample. Samples with a flat or slightly sloping rim should be filled so that the distance between the surface of the liquid and the overflow point is no more than 6 mm measured along the sloping rim.

  • (b) Samples which cannot be filled—

The surface of the sample which is not intended to come into contact with foodstuffs is first covered with a suitable protective layer able to resist the action of the 4 % (v/v) acetic acid solution. The sample is then immersed in a recipient containing a known volume of acetic acid solution in such a way that the surface intended to come into contact with foodstuffs is completely covered by the test liquid.

4

Determination of the surface area

SCHEDULE 3 — METHODS OF ANALYSIS FOR DETERMINATION OF THE MIGRATION OF LEAD AND CADMIUM

1

Object and field of application

2

Principle

3

Reagents

  • All reagents must be of analytical quality, unless otherwise specified.
  • Where reference is made to water, it means distilled water or water of equivalent quality.
  • (a) 4 % (v/v) acetic acid, in aqueous solution.

Add 40 ml of glacial acetic acid to water and make up to 1 000 ml.

  • (b) Stock solutions

Prepare stock solutions containing 1 000 mg/litre of lead and at least 500 mg/litre of cadmium respectively in a 4 % acetic acid solution, as referred to in paragraph (a).

4

Performance criteria of the instrumental method of analysis

  • (a) The detection limit for lead and cadmium must be equal to or lower than— 0,1 mg/litre for lead; 0,01 mg/litre for cadmium.

The detection limit is defined as the concentration of the element in the 4 % acetic acid solution, as referred to in paragraph 3(a) which gives a signal equal to twice the background noise of the instrument.

  • (b) The limit of quantification for lead and cadmium must be equal to or lower than— 0,2 mg/litre for lead; 0,02 mg/litre for cadmium.
  • (c) Recovery. The recovery of lead and cadmium added to the 4 % acetic acid solution, as referred to in point 3(a), must lie within 80-120 % of the added amount.
  • (d) Specificity. The instrumental method of analysis used must be free from matrix and spectral interferences.

5

Method

  • (a) Preparation of the sample

The sample must be clean and free from grease or other matter likely to affect the test.

Wash the sample in a solution containing a household liquid detergent at a temperature of approximately 40 °C. Rinse the sample first in tap water and then in distilled water or water of equivalent quality. Drain and dry so as to avoid any stain. The surface to be tested is not to be handled after it has been cleaned.

  • (b) Determination of lead and/or cadmium

The sample thus prepared is tested under the conditions laid down in Schedule 2.

Before taking the test solution for determining lead and/or cadmium, homogenise the content of the sample by an appropriate method, which avoids any loss of solution or abrasion of the surface being tested.

Carry out a blank test on the reagent used for each series of determinations.

Carry out determinations for lead and/or cadmium under appropriate conditions.

SCHEDULE 4 — DECLARATION OF COMPLIANCE

1

The written declaration referred to in regulation 10A must contain the following information—

  • (a) the identity and address of the company which manufactures the finished ceramic article and of the importer who imports it into Great Britain;
  • (b) the identity of the ceramic article;
  • (c) the date of the declaration;
  • (d) the confirmation that the ceramic article meets relevant requirements in these Regulations and Regulation 1935/2004.

2

The written declaration must permit an easy identification of the goods for which it is issued and must be renewed when substantial changes in the production bring about changes in the migration of lead or cadmium or both.

SCHEDULE5 — LIST OF SUBSTANCES AUTHORISED IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM

DESCRIPTION OF REGENERATED CELLULOSE FILM

Notes:

  • The percentages in this Schedule, in the first and second parts, are expressed in weight/weight (w/w) and are calculated in relation to the quantity of anhydrous uncoated regenerated cellulose film.
  • The usual technical denominations are given in square brackets.
  • The substances used shall be of good technical quality as regards the purity criteria.
Denominations Restrictions
A. Regenerated cellulose Not less than 72% (w/w)
B. Additives
1. Softeners Not more than 27% (w/w) in total
— Bis (2-hydroxyethyl) ether [= diethyleneglycol] Only for films intended to be coated and then used for foodstuffs which are not moist, namely which do not contain water which is physically free at the surface. The total amount of bis(2-hydroxyethyl)ether and ethanediol present in foodstuffs that have been in contact with film of this type may not exceed 30 mg/kg of the foodstuff.
— Ethanediol [= monoethyleneglycol]
— 1.3-butanediol
— Glycerol
— 1.2-propanediol [= 1.2 propyleneglycol]
— Polyethylene oxide [= polyethyleneglycol] Average molecular weight between 250 and 1200.
— 1.2-polypropylene oxide [= 1.2 polypropyleneglycol] Average molecular weight not greater than 400 and free 1.3-propanediol content not greater than 1% (w/w) in substance.
— Sorbitol
— Tetraethyleneglycol
— Triethyleneglycol
— Urea
2. Other additives Not more than 1% (w/w) in total.
First class The quantity of the substance or group of substances in each indent may not exceed 2 mg/dm² of the uncoated film.
— Acetic acid and its NH₄, Ca, Mg, K and Na salts
— Ascorbic acid and its NH₄, Ca, Mg, K and Na salts
— Benzoic acid and sodium benzoate
— Formic acid and its NH₄, Ca, Mg, K and Na salts
— Linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and also behenic and ricinoleic acids and the NH₄, Ca, Mg, K, Na, Al, Zn salts of these acids
— Citric, d- and l-lactic, maleic, l-tartaric acids and their Na and K salts
— Sorbic acid and its NH₄, Ca, Mg, K and Na salts
— Amides of linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and also the amides of behenic and ricinoleic acids
— Natural edible starches and flours
— Edible starches and flours modified by chemical treatment
— Amylose
— Calcium and magnesium carbonates and chlorides
— Esters of glycerol with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and/or with adipic, citric, 12-hydroxystearic (oxystearin), ricinoleic acids
— Esters of polyoxyethylene (8 to 14 oxyethylene groups) with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive
— Esters of sorbitol with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive
— Mono-and/or di-esters of stearic acid with ethanediol and/or bis (2-hydroxyethyl) ether and/or triethylene glycol
— Oxides and hydroxides of aluminium, calcium, magnesium and silicon and silicates and hydrated silicates of aluminium, calcium, magnesium and potassium
— Polyethylene oxide [= polyethyleneglycol] Average molecular weight between 1200 and 4000.
— Sodium propionate
Second class The total quantity of the substances may not exceed 1 mg/dm² of the uncoated film and the quantity of the substance or group of substances in each indent may not exceed 0.2 mg/dm² (or a lower limit where one is specified) of the uncoated film.
— Sodium alkyl (C₈-C₁₈) benzene sulphonate
— Sodium isopropyl naphthalene sulphonate
— Sodium alkyl (C₈-C₁₈) sulphate
— Sodium alkyl (C₈-C₁₈) sulphonate
— Sodium dioctylsulphosuccinate
— Distearate of dihydroxyethyl diethylene triamine monoacetate Not more than 0.05 mg/dm² of the uncoated film.
— Ammonium, magnesium and potassium lauryl sulphates
— N,N′-distearoyl diaminoethane, N,N′-dipalmitoyl diaminoethane and N,N′-dioleoyl diaminoethane
— 2-heptadecyl-4.4-bis(methylene-stearate) oxazoline
— Polyethylene-aminostearamide ethylsulphate Not more than 0.1 mg/dm² of the uncoated film.
Third class — Anchoring agent The total quantity of substances may not exceed 1 mg/dm² of the uncoated film.
— Condensation product of melamine-formaldehyde unmodified, or which may be modified with one or more of the following products:butanol, diethylenetriamine, ethanol, triethylenetetramine, tetraethylenepentamine, tri-(2-hydroxyethyl) amine, 3.3′-diaminodipropylamine, 4.4′-diaminodibutylamine Free formaldehyde content not greater than 0.5 mg/dm² of the uncoated film.Free melamine content not greater than 0.3 mg/dm² of the uncoated film.
— Condensation product of melamine-urea-formaldehyde modified with tris-(2-hydroxyethyl)amine Free formaldehyde content not greater than 0.5 mg/dm² of the uncoated film.Free melamine content not greater than 0.3 mg/dm² of the uncoated film.
— Cross-linked cationic polyalkyleneamines:(a) polyamide-epichlorhydrin resin based on diaminopropylmethylamine and epichlorhydrin;(b) polyamide-epichlorhydrin resin based on epichlorhydrin, adipic acid, caprolactam, diethylenetriamine and/or ethylenediamine;(c) polyamide-epichlorhydrin resin based on adipic acid, diethylenetriamine and epichlorhydrin, or a mixture of epichlorhydrin and ammonia;(d) polyamide-polyamine-epichlorhydrin resin based on epichlorhydrin, dimethyl adipate and diethylenetriamine;(e) polyamide-polyamine-epichlorhydrin resin based on epichlorhydrin, adipamide and diaminopropylmethylamine
— Polyethyleneamines and polyethyleneimines Not more than 0.75 mg/dm ² of the uncoated film.
— Condensation product of urea-formaldehyde unmodified, or which may be modified with one or more of the following products:aminomethylsulphonic acid, sulphanilic acid, butanol, diaminobutane, diaminodiethylamine, diaminodipropylamine, diaminopropane, diethylenetriamine, ethanol, guanidine, methanol, tetraethylenepentamine, triethylenetetramine, sodium sulphite Free formaldehyde content not greater than 0.5 mg/dm ² of the uncoated film.
Fourth class The total quantity of substances may not exceed 0.01 mg/dm ² of the uncoated film.
— Products resulting from the reaction of the amines of edible oils with polyethylene oxide
— Monoethanolamine lauryl sulphate
Denominations Restrictions
--- ---
A. Regenerated cellulose See first part.
B. Additives See first part.
C. Coating
1. Polymers The total quantity of substances may not exceed 50 mg/dm ² of the coating on the side in contact with foodstuffs.
— Ethyl, hydroxyethyl, hydroxypropyl and methyl ethers of cellulose
— Cellulose nitrate Not more than 20 mg/dm ² of the coating on the side in contact with foodstuffs; nitrogen content between 10.8 % (w/w) and 12.2 % (w/w) in the cellulose nitrate.
2. Resins The total quantity of substances may not exceed 12.5 mg/dm ² of the coating on the side in contact with foodstuffs and which is used solely for the preparation of regenerated cellulose films with cellulose nitrate based coatings.
— Casein
— Colophony and/or its products of polymerization, hydrogenation, or disproportionation and their esters of methyl, ethyl or C ₂to C ₆polyvalent alcohols, or mixtures of these alcohols
— Colophony and/or its products of polymerization, hydrogenation, or disproportionation condensed with acrylic, maleic, citric, fumaric and/or phthalic acids and/or 2.2 bis (4-hydroxyphenyl) propane formaldehyde and esterified with methyl ethyl or C ₂to C ₆polyvalent alcohols or mixtures of these alcohols
— Esters derived from bis(2-hydroxyethyl) ether with addition products of betapinene and/or dipentene and/or diterpene and maleic anhydride
— Edible gelatine
— Castor oil and its products of dehydration or hydrogenation and its condensation products with polyglycerol, adipic, citric, maleic, phthalic and sebacic acids
— Natural gum [= damar]
— Poly-beta-pinene [= terpenic resins]
— Urea-formaldehyde resins (see anchoring agents)
3. Plasticisers The total quantity of substances may not exceed 6 mg/dm ² of the coating on the side in contact with foodstuffs.
— Acetyl tributyl citrate
— Acetyl tri(2-ethylhexyl) citrate
— Di-isobutyl adipate
— Di-n-butyl adipate
— Di-n-hexyl azelate
— Dicyclohexyl phthalate Not more than 4.0 mg/dm ² of the coating on the side in contact with foodstuffs.
— 2-ethylhexyl diphenyl phosphate (synonym: phosphoric acid diphenyl 2 ethylhexyl ester) The amount of 2-ethylhexyl diphenyl phosphate shall not exceed:(a) 2.4 mg/kg of the foodstuff in contact with this type of film; or(b) 0.4 mg/dm² in the coating on the side in contact with foodstuffs.
— Glycerol monoacetate [= monoacetin]
— Glycerol diacetate [= diacetin]
— Glycerol triacetate [= triacetin]
— Di-butyl sebacate
— Di-n-butyl tartrate
— Di-isobutyl tartrate
4. Other additives The total quantity of substances may not exceed 6 mg/dm ² in the uncoated regenerated cellulose film, inclusive of the coating on the side in contact with foodstuffs.
4.1. Additives listed in the first part Same restrictions as in the first part (however the quantities in mg/dm ² refer to the uncoated regenerated cellulose film, inclusive of the coating on the side in contact with foodstuffs).
4.2. Specific coating additives The quantity of the substance or group of substances in each indent may not exceed 2 mg/dm ² (or a lower limit where one is specified) of the coating on the side in contact with foodstuffs.
— 1-hexadecanol and 1-octadecanol
— Esters of linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and of ricinoleic acid with ethyl, butyl, amyl and oleyl linear alcohols
— Montan waxes, comprising purified montanic (C ₂₆to C ₃₂) acids and/or their esters with ethanediol and/or 1.3 butanediol and/or their calcium and potassium salts
— Carnauba wax
— Beeswax
— Esparto wax
— Candelilla wax
— Dimethylpolysiloxane Not more than 1 mg/dm ² of the coating on the side in contact with foodstuffs.
— Epoxidised soya-bean oil (oxirane content 6 to 8 %)
— Refined paraffin and microcrystalline waxes
— Pentaerythritol tetrastearate
— Mono and bis(octadecyldiethyleneoxide)-phosphates Not more than 0.2 mg/dm ² of the coating on the side in contact with foodstuffs.
— Aliphatic acids (C ₈to C ₂₀) esterified with mono- or di-(2-hydroxyethyl)amine
— 2- and 3-tert.butyl-4-hydroxyanisole [= butylated hydroxyanisole — BHA] Not more than 0.06 mg/dm ² of the coating on the side in contact with foodstuffs.
— 2.6-di-tert.butyl-4-methylphenol [= butylated hydroxytoluene — BHT] Not more than 0.06 mg/dm ² of the coating on the side in contact with foodstuffs.
— Di-n-octyltin-bis(2-ethylhexyl) maleate Not more than 0.06 mg/dm ² of the coating on the side in contact with foodstuffs.
5. Solvents The total quantity of substances may not exceed 0.6 mg/dm ² of the coating on the side in contact with foodstuffs.
— Butyl acetate
— Ethyl acetate
— Isobutyl acetate
— Isopropyl acetate
— Propyl acetate
— Acetone
— 1-butanol
— Ethanol
— 2-butanol
— 2-propanol
— 1-propanol
— Cyclohexane
— Ethyleneglycol monobutyl ether
— Ethyleneglycol monobutyl ether acetate
— Methyl ethyl ketone
— Methyl isobutyl ketone
— Tetrahydrofuran
— Toluene Not more than 0.06 mg/dm ² of the coating on the side in contact with foodstuffs.

LIST OF SUBSTANCES AUTHORISED IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM

Interpretation of Part 6 and Schedule 1

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