FOOD ACT 1983 FOOD (AMENDMENT) (NO. 1) REGULATIONS 2015 IN exercise of the powers conferred by section 34 of the Food Act 1983 [Act 281], the Minister makes the following regulations: Citation 1. (1) These regulations may be cited as the Food (Amendment) (No. 1) Regulations 2015. (2) These regulations come into operation on _______ 2. The principal Regulations are amended by inserting after Regulation 27A the following Regulation: Plastic materials and articles 27B. 1) In these Regulations, plastic materials and articles includes packages, appliance or parts thereof consisting exclusively of plastics or plastic multi-layer or plastic multimaterial multi-layer that is intended to come into contact with food, already in contact with food or which can reasonably be expected to come into contact with food. 2) For the purposes of these Regulation, (a) food simulant means a test medium imitating food; in its behaviour the food simulant mimics migration from plastic materials and articles; (b) multi-material multi-layer means a material or article composed of two or more layers of different types of materials, at least one of them a plastic layer; (c) plastic means polymer to which additives or other substances may have been added, which is capable of functioning as a main structural component of final materials and articles; (d) plastic multi-layer means a material or article composed of two or more layers of plastic; (e) specific migration limit means the maximum permitted amount of a given substance released from plastic materials and articles into food or food simulants; and (f) total specific migration limit means the maximum 1 permitted sum of particular substances released in food or food simulants expressed as total of moiety of the substances indicated. 3) No person shall import, manufacture, advertise for sale or sell, or use or cause or permit to be used in the preparation, packaging, storage, delivery or exposure of food, any plastic materials and articles except when it complies with the maximum proportion of release of chemical substances set out in Table I of Schedule X. 4) In addition to subregulation (3), the plastic materials and articles shall not transfer their constituents to food or food simulant in quantities exceeding the maximum specific migration limit or total specific migration limit set out in Table II of Schedule X. 5) Substances with other technological function including solvents, colourants, printing inks, adhesives or coatings may be used in the production of plastic materials and articles, provided it conforms to the following criteria(a) the substance conforms 27(1)(a) and (b); and (b) to subregulation the migration of the substance into food or food simulant from the plastic materials and articles shall not exceed 0.01 mg/kg food or food stimulant. 6) For the purposes of subregulation (3), (4) and (5), plastic materials and articles shall be tested in accordance with Malaysian Standard MS 2234: Plastic Materials and Articles Intended to Come into Contact with Food. 7) Plastic materials and articles shall be labelled in accordance with the provisions of Regulation 27. Amendment Regulation 41 3. Regulation 41 of the principal Regulations is amended- 2 (a) by substituting subregulation (2) the following subregulation: “(2) No person shall expose, cause or permit to be exposed, any food, excluding water, in the course of its preparation, storage, packaging, delivery, importation or exposure for sale, to any pesticide, where such exposure will result in a residue on or in food that is greater than the amount as set out in Table I and Table II of the Sixteenth Schedule”; (b) by substituting subregulations (3)(a) and (3)(b) the following subregulations: “(3)(a) containing pesticide residue in a proportion greater than the proportion specified for that food in relation to that pesticide residue as set out in Table I and Table II of the Sixteenth Schedule; (3)(b) containing pesticide residue in a proportion greater than the proportion specified for that food in relation to that pesticide residue as recommended in the Codex Alimentarius, where the pesticide is not specified in Table I of the Sixteenth Schedule”; (c) by inserting after subregulation (3)(b) the following subregulation: “(ba) containing pesticide residue in a proportion greater than the proportion specified for that food in relation to that pesticide residue as recommended in the ASEAN Harmonized Maximum Residue Limits (MRLs), where the pesticide is not specified in Table I of the Sixteenth Schedule or Codex Alimentarius; or”; (d) by substituting subregulation (3)(c) the following subregulation: “(c) containing 0.01 miligram per kilogram (mg/kg) or more than 0.01 mg/kg of any pesticide residue, where the pesticide is not specified for that food in Table I and Table II of the Sixteenth Schedule, Codex Alimentarius or ASEAN Harmonized MRLs.”; (e) by inserting after the words ‘in respect of pesticide residue’ in subregulation (3A) the words ‘and “ASEAN Harmonized MRLs” means the ASEAN MRLs adopted by the ASEAN Ministerial Meeting on Agriculture and Forestry’; and (f) by inserting after subregulation (3A) the following subregulation: “(3B) Subregulation (3)(b) and 3(ba) shall not apply for those pesticides as set out in Table II and Table III of the Sixteenth Schedule.”. Amendment Regulation 130. 4. Regulation 130 of the principal Regulations is amended by substituting subparagraph (2)(b) the following subparagraph: 3 “(b) shall not contain more than(i) 20 per cent of water; (ii) 1 per cent of ash; and (iii) 80 mg/kg of hydroxymethylfurfural”. Amendment Ragulation 178A. 5. Regulation 178A of the principal Regulations is amended by inserting after subegulation (1) the following subregulation: “(1A) For the purpose of subregulation (1)(ii), amylase, lipase and protease may be used as permitted enzyme during cleaning process, singly or in combination, and the maximum permitted proportion shall be governed by good manufacturing practice.”. New Schdule X 6. The principal Regulations are amended by inserting new Schedule X “Schedule X (Regulation 27B) MAXIMUM PROPORTION OF RELEASE OF CHEMICAL SUBSTANCES FROM PLASTIC MATERIALS AND ARTICLES Table I (2) Maximum permitted proportion in mg/kg food or food simulant. 1 0.05 5 48 0.6 0.6 25 (1) Chemical Substances Barium Cobalt Copper Iron Lithium Manganese Zinc 4 SPECIFIC MIGRATION LIMIT FROM PLASTIC MATERIALS AND ARTICLES Table II (1) Substance (2) Abbreviation (3) CAS No. (4) Specific migration limit (SML) in mg/kg food or food simulant. acrylonitrile - 00010713-1 0.01 DEHA 00010323-1 2,2-bis(4hydroxyphenyl)pro pane BPA 00008005-7 diphenyl carbonate - formaldehyde - hexamethylenetetr amine - maleic acid - maleic anhydride - α-methylstyrene - phenol - (5) Total specific migration limit (SML(T)) in mg/kg food or food simulant. #(2) adipic acid, bis(2ethylhexyl)ester phthalic acid, benzyl butyl ester phthalic acid, bis(2ethylhexyl)ester phthalic acid, dibutyl ester phthalic acid, diesters with primary, saturated C8-C10 branced alcohols, more than 60 % C9 phthalic acid, diesters with primary, saturated C9-C11 alcohols more than 90 % C10 primary aromatic amines sebacic acid, dibutyl ester semicarbazide BBP 00010209-0 00005000-0 00010097-0 00011016-7 00010831-6 00009883-9 00010895-2 00008568-7 60 18 0.6 0.05 #(3) - 15 - 30 0.05 60 - 30 DEHP 00011781-7 1.5 DBP 00008474-2 0.3 DINP 06851548-0 02855312-0 - #(2) 60 #(1) 9.0 #(2) 60 DIDP 06851549-1 02676140-0 - - - 0.01 DBS SEM 00010943-3 00056341-7 5 0.02 #(2) 60 - soybean oil, epoxidised ESBO styrene - 4-tert-butylphenol - 2,4,6-triamino1,3,5-triazine tri-n-butyl acetyl citrate MELAMINE ATBC 00801307-8 00010042-5 00009854-4 00010878-1 00007790-7 60.0 30.0* #(2) 60 60 - 0.05 - 2.5 #(2) - 60 Note: - – Not applicable # (1), # (2) - total specific migration limit, expressed as the sum of the substances # (3)- total specific migration limit, expressed as formaldehyde *in case of PVC gaskets used to seal glass jars containing infant formula, follow–up formula, canned food for infant and young children and processed cereal based foods for infants and young children. Amendment of Eleventh Schedule 7. Eleventh Schedule of the principal Regulations is amended in Table II by inserting after the item “Dried Banana” and the particulars relating thereto, the following item and particulars: (1) (2) Food Food Conditioner “Edible bird’s nest amylase lipase protease Amendment of Schedule 16 7. of the principal Regulations is amended(a) by inserting the words ‘Table I’ above the words ‘Pesticide Residue’; (b) by inserting after Table I the following tables: 6 singly or in combination “TABLE II RESTRICTED PESTICIDE The food specified in column (2) of the table below shall not contain the pesticide specified in relation thereto in column (1) in proportion greater than the maximum permitted proportion specified in column (3) thereof in relation to the food. (1) Pesticide (2) Food (3) Maximum Residue Limits (MRLs) in food (mg/kg) Acephate Coconut/coconut oil Palm oil 0.5 0.5 Methamidophos Coconut/coconut oil Palm oil 0.1 0.1 Monocrotophos Coconut/coconut oil Palm oil Rice (milled or polished) Palm oil 0.05 0.05 0.5 0.1 Paraquat TABLE III BANNED PESTICIDE The following pesticides are banned in food: 2,4,5-T Alachlor Aldicarb Aldrin Azinphos-methyl Binapacryl Butachlor Calcium cyanide Captafol Chlordane Chlordimeform Chlorobenzilate DDT Dieldrin Dinoseb DNOC 7 EDB (Ethylene dibromide) Endosulfan Ethylene dichloride Ethylene oxide Fluoroacetamide Folpet HCH (mix isomers) Heptachlor Hexachlorobenzene Lindane (Gamma BHC) Mercury compounds Methomyl Methyl-parathion Parathion Penthoate Phosphamidon Profenophos Prothiophos Quinalphos Sodium pentachlorophenate (PCP) Sodium pentachlorophenate (Sodium PCP) Toxaphene Triazophos Tributyltin compound”. Made [KKM-163/S/6 201_ ] DATUK SERI DR. S.SUBRAMANIAM Minister of Health 8
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