Materials and Articles in Contact with Food Regulations 1990

Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012Regulations made under section 58A of the Food and Drug Act. MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 (LN. 1990/012) 1.2.1990 Amending enactments Relevant current provisions Commencement date 1990/019 Schedule 1 22.2.1990 EU Legislation/International Agreements involved: Directive No. 80/66/EEC Directive No. 81/432/EEC ARRANGEMENT OF REGULATIONS. Regulation PART I PRELIMINARY. 1. Title and Commencement and Revocation. 2. Interpretation. 3. Exemptions. PART II COMPOSITION AND LABELLING OF MATERIALS AND ARTICLES. 4. Sale etc of material articles. 5. Vinyl chloride monomer. 6. Regenerated cellulose film. 7. Labelling and description of materials and articles sold by retail. 8. Labelling and description of materials and articles sold otherwise than by retail.. 9. Restrictions on use of description “ food for use”. Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012 10. Materials and articles as prizes etc. PART III ADMINISTRATION AND ENFORCEMENT 11. Powers of authorised officers. 12 Analysis examination and testing. 13. Method of analysis. 14. Obstruction. 15. Confidentiality. 16. Penalties. 17. Application of various sections of the Act. SCHEDULES. SCHEDULE 1– Substances permitted for use in the manufacture of regenerated cellulose film. Part I–Substances permitted for use in the manufacture of uncoated regenerated cellulose film. Part II– Substances permitted for use in the manufacture of coated regenerated cellulose film. SCHEDULE 2– Symbol that may accompany materials and articles intended for contact with food. Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012Title, commencement and revocation. 1.(1) These regulations may be cited as the Materials and Articles in Contact with Food Regulations1990. (2) These regulations shall come into operation on the 1st day of February, 1990. (3) The Materials and Articles in contact with Food Regulations 1987 are hereby revoked. Interpretation. 2.(1) In these regulations unless the context otherwise requires “business” includes the undertaking of a canteen, club, school, hospital or institution, whether carried on for profit or not; “food” means food intended for human consumption and includes drink, water, natural mineral water, chewing gum and other products of a like nature and use, and articles and substances used as ingredients in the preparation of food, but does not include (a) live animals or birds. (b) fodder or feeding stuffs for animals, birds or fish, or (c) articles or substances used only as drugs; “import” means import in the course of a business; “Act” means the Food and Drugs Act; “preparation” in relation to food, includes manufacture and any form of treatment or process; “regenerated cellulose film” means a thin sheet material obtained from refined cellulose derived from unrecycled wood or cotton, with or without the addition of suitable substances, either in the mass or on one or both surfaces; “registered trade mark” means a trade mark which has effect in any member State of the Economic Community and is duly registered in accordance with the laws of that State; “sell” includes offer or expose for sale or have in possession for sale, and ‘sale’ and ‘sold’ shall be construed accordingly; Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012 “sell by retail” means sell to a person buying otherwise than for the purposes of re-sale, but does not include selling to a caterer for the purposes of his catering business or to a manufacturer for the purposes of his manufacturing business, and ‘sold by retail’ shall be construed accordingly; “ship” includes any boat or craft, and for this purpose ‘craft’ includes hovercraft. (2) Any reference in these regulations to a numbered regulation shall be construed as a reference to the regulation bearing that number in these regulations. Exemptions. 3.The provisions of these regulations shall not apply to (a) any fixed public or private water supply equipment; (b) any substance which, being used as a covering or coating for a food, forms part of that food and may be consumed with it, including such a substance used as covering or coating for cheese rind or prepared meat products; (c) any material or article intended for exportation to any place outside Gibraltar; (d) any material or article which is a collector’s piece of artistic, archaeological or enthnographic interest or to any other material or article of an age exceeding l00 years PART II. COMPOSITION AND LABELLING OF MATERIALS AND ARTICLES. Sale etc of materials and articles. 4.(1) This regulation shall apply to materials and articles which are in their finished state and are intended to come into contact with food or which are in contact with food and are intended for that purpose. (2) Materials and articles to which this regulation applies shall be manufactured in accordance with good manufacturing practice, that is to say in such a way that under normal or foreseeable conditions of use they do not Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012transfer their constituents to foods with which they are, or are likely to be, in contact, in quantities which could (i) endanger human health or (ii) bring about a deterioration in the organoleptic characteristics of such food or an unacceptable change in its nature, substance or quality. (3) No person shall (a) sell, (b) import, or (c) use in the course of a business in connection with the storage, preparation, packaging, selling or serving of food, any such material or article which does not comply with this regulation. Vinyl Chloride Monomer. 5. (1). Materials and articles to which regulation 4 applies and which are manufactured with vinyl chloride polymers or copolymers (a) shall not contain vinyl chloride monomer in a quantity exceeding 1 milligram per kilogram of the material or article as measured by the method of analysis specified in regulation 13(1); and (b) shall be manufactured in such a way that they do not transfer to foods with which they are in contact any quantity of vinyl chloride exceeding 0.01 milligrams of vinyl chloride per kilogram of food as measured by the method of analysis specified in Regulation 13(2). (2) No person shall (a) sell, (b) import, or (c) use in the course of a business in connection with the storage, preparation, packaging, selling or serving of food, any such material or article which does not comply with this regulation. any such material or article which does not comply with this regulation. Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012 Regenerated cellulose film. 6. (1) Subject to paragraph (2) below, this regulation shall apply to regenerated cellulose film which (a) constitutes a finished product in itself; or (b) is a part of a finished product containing other materials; and is intended to come into contact with food or is in contact with food and is intended for that purpose. (2) This regulation shall not apply to (a) regenerated cellulose film which has a coating exceeding 50 milligrams per square decimetre of film on the side intended to come into contact with food; (b) synthetic casings of regenerated cellulose. (3) No regenerated cellulose film to which this regulation applies shall be manufactured with any substance or group of substances other than the substances named or described in Schedule 1 (a) in column 1 of Part I, in the case of uncoated film; or (b) in column 1 of Part II, in the case of coated film; and used in accordance with the conditions and restrictions specified in the corresponding entry in column 2 of the appropriate Part of Schedule 1 as read with footnotes 1 and 2 to that Schedule. (4) Regenerated cellulose film to which this regulation applies shall be manufactured in such a way that it does not transfer any adhesive or colourant to food in any detectable quantity. (5) Coated regenerated cellulose film to which this regulation applies shall be manufactured in such a way that it does not transfer bis(2 hydroxyethyl) ether, ethanediol or both these substances to food in a quantity exceeding 50 milligrams per kilogram of food. (6) No person shall (a) sell, (b) import, or Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012(c) use in the course of a business in connection with the storage, preparation, packaging, selling or serving of food, any such regenerated cellulose film which does not comply with this regulation. (7) No person shall use in the course of a business in connection with the storage, preparation packaging, selling or serving of food (a) containing water physically free at the surface, any coated regenerated cellulose film to which this regulation applies and which contains bis(2hydroxyethyl) ether, ethanediol or both these substances; (b) any regenerated cellulose film to which this regulation applies in such a way that any printed surface of that regenerated cellulose film comes into contact with the food. Labelling and description of materials and articles sold by retail. 7.(1) The following particulars shall be shown with any material or article which, being in its finished state, is intended to come into contact with food but is not already in contact with food when such material of or article is sold by retail: (a) unless the material or article is by its nature clearly intended to come into contact with food (i) the description “for food use”, or (ii) a specific indication of the particular use for which the material or article is intended, or (iii) the symbol that appears in Schedule 2 to these regulations, (b) any special conditions to be observed when the material or article is being used, and (c) either (i) the name or trade name and address or registered office, or (ii) the registered trade mark of the manufacturer or processor or article, of a seller thereof established within the Economic Community. Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012 of the manufacturer or processor or article, or of a seller thereof established within the Economic Community. (2) Such particulars shall be shown clearly, legibly and indelibly (a) on the material or article or on its packing, or (b) on a label affixed to the material or article or to its packaging, or (c) on a sign which is in the immediate vicinity of the material or article and is clearly visible to purchasers, but the particulars mentioned in paragraph (1)(c) of this regulation shall appear on such a sign only if it was not reasonably practicable for such particulars, or a label bearing them, to be marked on, or affixed to, the material or article or to its packaging at the time of manufacture or sale. (3) No person shall sell by retail any such material or article, unless the particulars mentioned in paragraph (1) of this regulation are shown in the manner required by paragraph (2) of this regulation. Labelling and description of materials and articles sold otherwise than by retail. 8.(1) The following particulars shall be shown with any material or article which, being in its finished state. is intended to come into contact with food but is not already in contact with food when such material or article is sold otherwise than by retail or is imported (a) (i) the description “for food use” or (ii) a specific indication of the particular use for which the material or article is intended, or (iii) the symbol that appears in Schedule 2 to these regulations, (b) any special conditions to be observed when the material or article is being used, and (c) either (i) the name or trade name and address or registered office. or Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012 (ii) the registered trade mark of the manufacturer or processor of the material or article, or of a seller thereof established within the Economic Community. (2) Such particulars shall be shown clearly, legibly and indelibly (a) on the material or article or on its packaging, or (b) on a label affixed to the material or article or to its packaging, or (c) in the accompanying documents. (3) No person shall sell otherwise than by retail or import any such material or article, unless the particulars mentioned in paragraph (1) of this regulation are shown in the manner required by paragraph (2) of this regulation. Restriction on use of description “for food use”. 9.(1) No person shall sell any material or article under the description “for food use” or under any other description directly leading a purchaser to believe that he is purchasing a material or article suitable for use with food, unless that material or article complies with the provisions of regulation 4(2) and, if applicable, of regulation 5(l) or of regulation 6(3), 6(4) and 6(5). (2) No person shall sell any material or article in relation to which the symbol that appear in Schedule 2 to these regulations or any symbol substantially similar thereto is used, unless that material or article complies with the provisions of regulation 4(2) and, if applicable, of regulation 5(1) or of regulation 6(3), 6(4) and 6(5). (3) No person shall publish, or be a party to the publication of, an advertisement for a material or article in which a description of the kind mentioned in paragraph (1) of this regulation is used, or in which the symbol that appears in Schedule 2 to these regulations or any symbol substantially similar thereto is used unless the material or article to which the advertisement relates, complies with the requirements of regulation 4(2) and, if applicable, or regulation 5(1) or of regulation 6(3), 6(4) and 6(5). (4) In any proceedings brought under paragraph (3) of this regulation against the manufacturer, producer or importer of any material or article or of any food it shall rest on the person charged to prove that he did not publish, and was not party to the publication of, the advertisement. Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012 (5) In any proceedings brought under paragraph (3) of this regulation it shall be a defence for the person charged to prove that, being a person whose business it is to publish, or arrange for the publication of, advertisements, he received the advertisement for publication in the ordinary course of business and did not know and had no reason to suspect that its publication would amount to an offence under this regulation. (6) Where a person sells a material or article to a purchaser in response to a request in which a description of the kind mentioned in paragraph (1) of the regulation is used, he shall be deemed to have sold that material or article under that description, unless he clearly notifies the purchaser at the time of sale that the material or article is not suitable for use with food. Materials and articles offered as prizes, etc. 10.(1) Regulations 4, 5, 6, 7 and 9 shall apply to (a) any material or article which is offered as a prize or reward in connection with any entertainment to which the public are admitted, whether on payment of money or not, as if the material or article were, or has been, exposed for sale by each person concerned in the organisation of the entertainment; (b) any material or article which is offered as a prize or reward or given away for the purpose of advertisement, or in furtherance of any trade or business, as if the material or article were, or had been, exposed for sale by the person offering or giving away the material or article; and (c) any material or article which is exposed or deposited in any premises for the purpose of being so offered or given away as aforesaid, as if the material or article were, or had been, exposed for sale by the occupier of the premises. (2) In this regulation the expression ‘entertainment” includes any social gathering, amusement, exhibition, performance, game, sport or trial of skill. PART III. ADMINISTRATION AND ENFORCEMENT. Powers of authorised officers. 11.An authorised officer may (a) if he has reasonable cause to suspect that an offence under these regulations has been committed require any person Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012carrying on a trade or business or employed in connection with a trade or business, to produce any books or documents relating to the trade or business, and he may take copies of any such book or document, or of any entry in any such book or document; (b) for the purposes of ascertaining whether any offence under these regulations has been committed purchase or take samples of any material or article to which these regulations apply and of any food which has come into contact with any such material or article. Amalysis exarnination and testing. 12.(1) The provisions of Sections 35 (which relate to right to have sample analysed) and 47(1) and (2) (which relate to evidence of analysis) of the Act shall have effect as regards any sample of any material or article to which these regulations apply or of any food which has come into contact with any such material or article, as they apply to samples of food in the said sections of the Act. (2) The court before which any proceedings are taken under these regulations, may, if it thinks fit for the purposes of the proceedings, cause (a) any material or article which is the subject of the proceedings and. if it has already been analysed, examined or tested, is capable of being further analysed, examined or tested, or (b) any food which has been in contact with any such material or article, to be sent to the Government Chemist in the United Kingdom, who shall make such analysis, examination or test as is appropriate and transmit to the court a certificate of the result thereof, and the costs of the analysis, examination or test shall be paid by the prosecutor or the person charged as the court may order. (3) If in a case where an appeal is brought, no action has been taken under paragraph (2) of this regulation, the provisions thereof shall apply also in relation to the court by which the appeal is heard. (4) Any certificate of the results of an analysis, examination or test transmitted by the Government Chemist under this regulation shall be signed by or on behalf of the Government Chemist, but the analysis, examination or test may be made by any person under the direction of the person by whom the certificate is signed; and any certificate so transmitted by the Government Chemist shall be evidence of the facts stated therein Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012 unless any party to the proceedings requires that the person by whom it is signed shall be called as a witness. Method of analysis. 13.(1) The method used in analysing any sample for the purpose of establishing the quantity of vinyl chloride monomer present in order to determine whether it complies with the provisions of regulation 5(1)(a) shall be the method specified in the Annex to Commission Directive No. 80/66/EEC laying down the Community method of analysis for the official control of the vinyl chloride monomer level in materials and articles which are intended to come into contact with foodstuffs. (2) The method used in analysing any food for the purpose of establishing the quantity of vinyl chloride present in the food in order to determine whether a material or article which is or has been in contact with the food complies with the provisions of regulation 5(l)(b) shall be the method specified in the Annex to Commission Directive No.81/432/EEC laying down the Community method for analysis for the official control of vinyl chloride released by materials and articles into foodstuffs. Obstruction. 14.No person shall (a) intentionally obstruct an authorised officer acting in execution of these regulations; or (b) without reasonable cause fail to give to any such authorised officer acting as foresaid any assistance or information or to provide such facilities as the authorised officer may reasonably require of him for the purposes of his functions under these regulations. Confidentiality. I5. No information obtained from any books or documents provided in accordance with regulation 11(a) shall, without the previous consent of the person carrying on the trade or business in question, be disclosed except for the purpose of any proceedings for an offence against any of these regulations or any report of those proceedings. Penalties. 16. If any person contravenes or fails to comply with any of the provisions of these regulations, he shall be guilty of an offence and liable on summary Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012conviction in the case of regulation 14 to a fine not exceeding £500 and in any other case to a fine not exceeding £1,000. Application of various sections of the Act 17. Sections 46(2) and (3) (which relate to prosecutions), 50 (which relates to a contravention due to some person other than the person charged), 51 (which relates to conditions under which warranty may be pleaded as a defence) and 52 (which relates to offences in relation to warranties and certificates of analysis) of the Act shall apply for the purposes of these regulations as if references therein to proceedings, or a prosecution, under or taken or brought under the Act included references to proceedings, or a prosecution, as the case may be, taken or brought for an offence under these regulations. Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012 SCHEDULE 1. Regulation 6(3) SUBSTANCES PERMIT’TED FOR USE IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM. PART I. SUBSTANCES PERMITTED FOR USE IN THE MANUFACTURE OF UNCOATED REGENERATED CELLULOSE FILM Column 1 Substances Column 2 Conditions and restrictions 1. Regenerated cellulose Not less than 72% 2. Additives Softeners Not more than 27% in total 1, 3-buranediol glycerol I 2-propanediol [=1,2-propylene glycol] polyethylene oxide [= polyethylene glycol] Average molecular weight between 250 and1,200 1,2-polypropylene oxide [=1,2 polypropylene glycol] Average molecular weight shall not exceed 400, free 1, 3-propanediol content shall not exceed 1% sorbitol triethylene glycol urea Other additives Not more than 1% in total First class The quantity of the substance or group of substances in each entry shall not exceed 2 mg/dm2 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 Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012and also behenic and ricinoleic acids and the NH4, Ca, Mg, K, Na, Al, Zn salts of these acids citric, dl- lactic, maleic, 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 amids of behenic acid and ricinoleic acid natural edible starches and flour edible starches and flours modified by chemical treatment amylose 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) and ricinoleic acid esters of polyoxyethylene (8-14 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 diesters 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 [=polyethylene glycol] Average molecular weight between 1,200 and 4,000 sodium propionate Second class Not more than 1 mg/dm2 in total; the quantity of the substance or group of substances in each entry shall not exceed 0.2 mg/dm2 (or a Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012 lower limit where one is specified) sodium alkyl (C8 to C18) benzene sulphonate sodium isopropyl naphthalene suiphonate sodium alkyl (C8 to C18) sulphate sodium alkyl (C8 to C18) suiphonate sodium dioctylsulphosuccinate distearate of dihydroxyethyldiethylene triamine monoacetate Not more than 0.05 mg/dm2 in total on the side for contact with food ammonium, magnesium and potassium lauryl sulphates N.N’-distearoyl diaminoethane [=N, N’distearoyl ethylenediaminel] and N.N’-dipalmitoyl diaminoethane [=N ,N’-dipalmitoyl ethylenediamine] and N.N’-dioleoyl diaminoethane [N N’ dioleoyl ethylenediamine] 2-heptadecyl-4,4’ bis– (methylenestearate) oxazoline polyethylene aminostearamide ethyl sulphate Not more than 0.1 mg/dm2 in total on the side for contact with food Third class-Anchoring Agents Not more than 1 mg/dm2 in total condensation product of melamine formaldehyde unmodified, or modified with one of more of the following products: Free formaldehyde content on the side for contact with food shall not exceed 0.5 mg/dm2: Free melamine content on the side for contact with food shall not exceed 0.3mg/dm2 butanol, diethylenetriamine, ethanol, triethylenetetramine, tetraethylenepentamine. tris(2 hydroxyethyl)amine. 3.3’ diaminodipropylamine, 4, 4’ diaminodibutylamine condensation product of melamine urea formaldehyde modified with tris(2-hydroxyethyl)amine Free formaldehyde content on the side for contact with food shall not exceed 0.5 mg/dm2: free melamine content on the side for contact with food shall not exceed 0.3 mg/dm2 cross-linked cationic polyalkyleneamines: (a) Polyamide-epichlorohydrin recin based on diaminopropylmethylamine and epichlorohydrin Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012(b) polyamide-epichlorohydrin resin based on epichlorohydrin, adipic acid, caprolactam, diethylenetriamine and/or ethylenediamine (c) polyamide-cpichlorohydrin resin based on adipic acid, diethylenetriamine and epichiorohydrin, or a mixture of epichiorohydrin and ammonia (d) polywnide-polyamine epichiorohydrin resin based on epichiorohydrin, dimethyl adipate and dietbylenetriamine (e) polyamide-polyamine epichlorohydrin resin based on epichiorohydrin, adipainide and diaminopropylmethylamine polyethylenearnines and polyethyleneiminc Not more than 0.75 mg/dm2 in total condensation products of urea fonnaldehyde unmodified, or modified with one or more of the following products: Free formaldehyde content on the side for contact with food shall not exceed 0.5mg/dm2 aminomethyl suiphonic acid, suiphanilic acid, butanol, diaminobutane, diaminodipropylamine, diaminopropane dietbylenetriamine, ethanol, guanidine, methanol, tetraethylenepentamine, triethylenetetramine, sodium suiphite Fourth class Not more than 0.01 mg/dm2 in total products resulting from the reaction of the amines of edible oils with polyethylene oxide monoethanolamine lauryl sulphate 3. Adhesives and colourants In accordance with regulation 6(4) PART II SUBSTANCES PERMITTED FOR USE IN THE MANUFACTURE OF COATED REGENERATED CELLULOSE FILM COLUMN 1 COLUMN 2 SUBSTANCES CONDITIONS AND RESTRICTIONS Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012 1. Regenerated cellulose For that part of the film other than the coating Not less than 72% 2. Additives For that part of the film other than the coating Softener Not more than 27% in total (a) Any softener specified in item 2 of Part I (b) - bis (2-hydroxyethly) ether) [=diethylene glycol] – ethanediol) [=minoethylene glycol] ) Any condition or restriction specified in relation to that additive In accordance with regulation 6(5) Other additives Not more than 1% in total Any other additive specified in item 2 of Part I. Any condition or restriction specified in relation to that additive. 3. Coating substances Polymers: –ethyl, hydroxyethyl, hydroxpropyl and methyl ethers of cellulose cellulose nitrate Not more than 20 mg/dm2 on the side for contact with food. nitrogen content between l0.8 and 12.2% polymers. copolymers and their mixtures made with the following monomers: vinyl acetals derived from saturated aldehydes (C1 to C6) vinyl acetate alkyl C1 to C4 vinyl ethers acrylic, Crotonic. itaconie, maleic, methacrylic acids and their esters butadiene styrene methylstyrene vinylidene chloride actylonitrile methacrylonitrile ethylene, propylene, I-and 2-butylene vinyl chloride In accordance with regulation 5(1)(a) and 5(1)(b) Resins Not more than 12.5mg/dm2 in total on the side for contact with food and solely for the preparation of regenerated cellulose films with coatings based on nitrocellulose or polymers or copolymers of vinyl chloride and vinyl acetate Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012casein colophony and/or its products of polymerization, hydrogenation, or disproportionation, and their ester of methyl, ethyl or C2 to C6 polyhydric 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 acid and/or bisphenol formaldehyde and esterified with methyl, ethyl or C2 to C6 polyhydric alcohols or mixtures of these alcohols esters derived from gis-(2 hydroxyethyl) ether with addition products of β-pinene 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- β -pinene [=terpenic resin] urea-formaldehyde resin (see Anchoring agents in item 2 of Part I) Plasticisers Not more than 12.5 mg/dm2 in total on the side for contact with food and, except as specified below, solely for the preparation of regenerated cellulose films with coatings based on nitrocellulose or polymers or copolymers of vinyl cholride and vinyl acetate di-isobutyl and di-n-butyl adipate di-n-hexyl azelate butyl benzyl phthalate butyl methylcarboxbutyl phthalate [=butylphthalyl butyl glycolate] di-n-butyl phthalate and di-isobutyl phthalate Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012 dicyclohexyl phthalate di(methylcyclohexy) phthalate and its isomers [=sextolphthalate] 2-ethylhexyl diphenyl phosphate Not more than 2.5 mg/dm2 on the side for contact with food glycerol monoacetate [=monoacetin] glycerol diacetate [=diacetin] glycerol triacetate [=triacetin] methylmethyl carboxyethyl phthalate [=methylphthaly ethyl glycolatel] bis(2-ethylhexyl) sebacate [=dioctyl sebacate] di-n-butyl tartrate and di-isobutyl tartrate tributyl acetyl citrate tris(2-ethylhexyl) acetyl citrate Also for the preparation of regenerated cellulose films with coatings based on vinylidene chloride provided that they bear a distinctive indication that the film coating is based on vinylidene chloride and contains tributyl acetyl citrate or tris - (2-ethylhexyl) acetyl citrate, as the case may be Other coating additives (a) Any additive specified in item 2 of Part I Not more than 6mg/dm2 in total on the side for contact with food. Any condition or restriction specified in relation to that additive (b) Specific coating additives The quantity of the substance or group of substances in each entry may not exceed 2 mg/dm2 (or a lower limit where one is specified) on the side for contact with food hexadecan-1-ol and octadecan-1-ol 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 oleoy linear alcohols montan waxes, comprising purified montanic (C26 to C32) acids and/or their esters with ethanediol and/or 1,3-butanediol and/or their calcium and potassium salts Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012carnauba wax beeswax esparto wax candelilla wax dimethylpolysiloxane Not more than 1mg/dm2 on the side for contact with food epoxidized soya-bean oil (oxirane content 6 to 8%) refined paraffin and microcrystalline waxes pentaerythritol tetrastearate mon-and bis(octadecyldiethyleneoxide) Not more than 0.2mg/dm2 on the side for contact with food aliphatic acids (C8 to C20) esterified with non-or bis(2 hydroxyethyl)amine 2-and 3-tert. butyl-4-hydroxyanisole Not more than 0.06 mg/dm2 on the side for contact with food [=butylated Hydroxyanisole-BHA] 2,6-di-tert. butyl-4-methylphenol [=butylated hydroxytoluene-BHT] Not more than 0.06mg/dm2 on the side for contact with food di-n-octyltin-bis(2-ethylhexyl) maleate Not more than 0.06mg/dm2 on the side for contact with food 4. Solvents for coating substances Total quantity of all solvents may not exceed 0.6 mg/dm2 on the side for contact with food n-butyl acetate ethyl acetate isobutyl acetate isopropyl acetate propyl acetate butan-1-ol [=butyl alcohol] ethanol [=ethyl alcohol] butan-2-ol [isobutyl alcohol] propan-2-ol [isopropyl alcohol] propa-1-ol [=propyl alcohol] cyclohexane ethanediol monobutyl ether [=ethylene glycol monobutyl ether] ethanediol monobutyl ether acetate [=ethylene glycol monobutyl ether acetate] ethanediol monoethyl ether [=ethylene glycol monethyl ether] ethanediol monoethyl ether acetate [=ethylene glycol monoethyl ether Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012 acetate] ethanediol monoethyl ether [=ethylene glycol monoethyl ether] ethanediol monomethyl ether acetate [=ethylene glycol monomethyl ether acetate] acetone butanone [=methyl ethyl ketone] 4-methylpentan 2-one[=methyl isobutylketone] terahydrofuran toluene 5. Adhesives and colourants In accordance with regulation 6(4) (1) All percentages specified in this Schedule are by weight and are to be calculated in relation to the total quantity of anhydrous regenerated cellulose film. (2) Substances named or described in this Schedule shall be of good commercial quality. Food and Drugs MATERIALS AND ARTICLES IN CONTACT WITH FOOD REGULATIONS, 1990 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1990/012 SCHEDULE 2 Symbol that may accompany materials and articles intended for contact with food.