Food and Drugs (Amendment) Regulations (L.N. No. 118 of 2003)

Legal Supplement Part B-Vol. 42, No. 112-4th Au.Rust, 2003 LEGAL NOTICE No. 118 REPUBLIC OF TRINIDAD AND TOBAGO THE FOOD AND DRUGS ACT, CHAP. 30:01 REGULATIONS MADE BY THE MINISTER UNDER SECTION 25(1) OF THE Foon AND DRUGS ACT THE FOOD AND DRUGS (AMENDMENT) REGULATIONS, 2003 1. These Regulations may be cited as the Food and Drugs Citation (Amendment) Regulations, 2003. 591 2. In these Regulations "the Regulations" means the Food and Interpreta D Rgulti. ~ rugs e a ons. Chap. so:01 3. Regulation 14 of the Regulations is amended by- Regulation H ( a) deleting the definition of "alcoholic beverage" substituting the following definition: d amended an " "alcoholic beverage" means a liquid food containing sufficient ethyl alcohol to make it liable to excise duty and includes (a) a spirit, liqueur, wine, cider, perry, champagne or spirit compound used as a food; and (b) a brewery prod.net containing sufficient ethyl alcohol to make it liable to excise duty, but does not include a flavouring preparation or liquid food in which ethyl alcohol is used as a preservative;"; and (b) inserting, in alphabetical sequence, the following definitions: " "alcoholic content by volume" means the volume of ehtyl alcohol in a food, expressed as a percentage of the total volume of the food; "brewery product" means a beverage which is derived from a cereal and includes a beverage which is manufar.t.nred, distributed or sold under any of the following common names: (a) ale; (b) beer; (c) lager or lager beer; 592 Regulation 16 amended Regulations 16B and 16c inserted Food and Drugs (Amendment) Regulations, 2003 (d) malta; (e) malt liquor; (f) porter; (g) shandy; or (h) stout;". 4. Regulation 16(1) of the Regulations is amended (a) in paragraph (b), by deleting subparagraphs (vi), (vii) and (viii} and substituting the following subparagraphs: "(vi) the expiry date or other date mark; (vii) storage instructions, where applicable; (viii) preparation instructions, where applicable; (ix) instructions for safe handling, where applicable; and (x) any other statement which may be required to be declared or mndo by these Regulations; and"; (b) by deleting paragraph (c) and substituting the following paragraph: "(c) on any panel, including the panel at the bottom of the package (i) the batch or lot number; and (ii) any registration number which may be required by these Regulations.". 5. The Regulations are amended by inserting after regulation 16A, the following Regulations: "Laholling of beverages containing alcohol 16B. (1) This regulation applies to the labelling of a beverage containing alcohol in addition to regulation 16. (2) The common nnmc of nn alcoholic beverage associated with a particular country or locality shall not be applied to an alcoholic beverage produced in any country unless the name is generally recognised as being associated with the distinctive type of alcoholic beverage. (3) The common name of an alcoholic beverage associated with a particular type of alcoholic beverage produced in a particular country or locality and protected by the law of the country, may only be applied to an alcoholic beverage produced in another country where the common name is preceded by a name or adjective in identical lettering, indicating the true country or locality of origin. Food and Drugs (Amendment) Regulations, 2003 Labelling of brewery producle (4) Subject to subregulations (5) and (6), the common name "wine" shall be applied to an undistilled fermented alcoholic beverage prepared from fresh or preserved grapes. (5) The common name "(naming the fruit, flower, leaf, grain or other botanical substance) wine" shall be applied to an undistilled fermented alcoholic beverage prepared wholly or principally from a fruit, flower, leaf, grain or other botanical substance, other than fresh or preserved grapes. (6) The common name "non-alcoholic wine" may be applied to a beverage prepared principally from a fruit, which although not an alcoholic beverage, resembles it but shall not be applied to a beverage which contains more than 0.5 per cent alcoholic content by volume. (7) The label on the package of a beverage containing more than 1.0 per cent alcoholic content by volume, shall state on its main panel, its alcoholic strength in terms of any of the following: (a) alcoholic content by volume; (b) degrees Gay-Lussac (0 G.L.); (c) degrees proof spirit or per cent proof spirit; (d) degrees or per cent U.S. proof; or (e) any other term authorised by the Minister. (8) The com.man names "brandy", "rum", "gin" or "vodka" shall not be applied to an alcoholic beverage, the alcoholic strength of which is below seventy-five degrees proof .spirit, except in the case of fruit brandy and brandy that has been matured in a cask. (9) The common names referred to in subregulations C~) and (3) may be in a language other than English, but shall be printed in the English alphabet, with accent marks where appropriate. 16c. (1) This regulation applies to the labelling of a brewery product in addition to regulation 16 and where there is a conflict between this regulation and regulation 16, this regulation prevails. (2) The label on the package of a brewery product for retail sale shall state, on any panel except the panel at the bottom of the package (aJ the name and address of the manufactureT; 593 594 Food and Drugs (Amendment) Regulations, 2003 (b) the name and address of the person preparing the brewery product, where different from the name and addrsss of ths manufacturer; (c) the country of origin; (d) the name and address of the importer or the distributor, if any; (e) its alcoholic strength in terms of alcoholic content by volume; and (f) a declaration of the net contents. (3) Notwithstanding regulation lB(l)(d), the label on a package of shandy for retail sale shall .state, i11 additio11 to the infurrnuLiun ist:L uuL in subregulation (2) (a) the vegetable flavour, juice or extract used in the shandy, if any; and (b) a list of ingredients in descending order of proportion by weight. (4) Notwithstanding regulation 18(1)(d), the label on a package of malta for retail sale shall state, in addition to the information set out in subregulation (2) (a) the word "non-alcoholic"; and (b) a list of ingredients which may include the word "wort". (5) The label on the package of a brewery product for retail sale may state the following information: (a) nutritional information, in terms of the Recommended Daily Allowances for vitamins and minerals set by the Caribbean Food and Nutrition Institute or by authorities in the United States of America: (b) a warning as to the effects of alcohol on health or safety; (c) whether the package may be returned to the dealer or manufacturer, in which case, the word "returnable" may be used, or disposed of otherwise; Food and Drugs (Amendment) Regulations, 2003 (d) whether a refund or payment is made for an empty package which is returned; or (e) where. the package is made of plastic or metal, whether the package may be recycled. (6) The label on a bulk package of a brewery product shall state ( a) the common name; (b) the brand or trade name; (c) the name and address of the manufacturer; (d) the name and address of the person preparing the brewery product, where different from the name and address of the manufacturer; (e) the average net contents as determined by an acceptable method; (f) where the brewery product is imported or exported, the name of the country of origin; (g) the name and address of the importer or the dii:;tributor, if any; and 595 (h) the expiry date or other date mark. (7) In thi:s regulation "bulk package" includes a package in which one or more duly labelled packages of a brewery product and its contents intended for retail sale are placed for the purpose of wholesale and n barrel, cask or pressurized container in which a brewery product is placed for sale from draught.". 6. Regulation 21(8) of the Regulations is revoked. Regulation 21 amellded 7. Regulation 23(2) of the Regulations is revoked and the following Regulation 2a subregulation substituted: ameurled " (2) Notwithstanding regulation 16, the label on a bulk container of a food or food additive shall state ( a) the common name; (b) the name and address of the manufacturer, packager, importer or wholesaler; (c) the country of origin; (d) the net contents; and (e) the expiry date or other date mark, and may state the batch or lot number, registration number aud 1:11.uragt: iust..rui:tions.". 596 First Schedule :RmAnrlP..rl Food and Drugs (Amendment) Regulations, 2003 8. The First Schedule of the Regulations is amended by inserting after Division 16, the following Divisions: "DMSION 17-KETCHUP 1. Tomato Ketchup, To111ato Cat.sup, Tomato Catchup or a food, the common name of which is a variant of the word "catsup", (hereinafter referred to as "tomato ketchup") shall (aJ be prepared from juice, paste or puree derived from clean, sound, ripe tomatoes of a red or reddish variety, from which the skins and seeds have been removed; (b) be processed by heat; and (c) contain (i) vinegar: (ii) food grade salt; (iii) seasonings and spices; and (iv) sweetening agents. 2. (1) A grade may be declared for tomato ketchup. (2) Where the grade is declared, tomato ketchup shall be labelled "Premium Grade" or "Standard Grade", as the case may be. (3) Tomato ketchup labelled .. Premium Grade" shall have (a) tomatoes in solid form which amount to not less than 12 per cent by weight; (b) a total of solids which amounts to not less than 33 per cent by weight; and (c.l a pH valuP. not P.XCP.Ading 4.0. (4) Tomato ketchup labelled "Standard Grade" shall have (a) tomatoes in solid form which amount to not less than 6 per cent but less than 12 per cent by weight; (b) a total of solids which amounts to not less than 25 per cent but less than 33 per cent by weight; and (c) a pH value not exceeding 4.0. (5) A class II preservative and thickening agents may be used in tomato ketchup labelled "Standard Grade". (6) Whether or not a grade is declared, tomato ketchup shall be of a grade which is not les5 than that 5pecified for "Standard Grade" in subparagraph (4). 3. Tomato Ketchup ahall have no natural or artificial colour, except for the colour imparted by tomatoes. Food and Drugs (Amendment) Regulations, 2003 4. (1) (Naming the Vegetable or Fruit) Ketchup, Catsup, Catchup or a food, the common name of which is a variant of the word "catsup", [hereinafter referred t.o as "(Naming the Vegetable or Fruit) ketchup"] shall (a) be prepared from a vegetable, fruit or both; (b) be processed by heat; (c) contain (i) vinegar; (ii) food grade salt; (iii) seasonings and spices; and (iv) sweetening agents; and (d) have (i) a total of solids which amounts to not less than 25 per cent by weight; and (ii) a pH value not exceeding 4.0. (2) (Naming the Vegetable or Fruit) ketchup may contain (a) food colour; (b) a class II preservative; (c) thickening agents; and (d) tomatoes or tomato products as one of its secondary ingredients. 5. (1) The mould count for ketchup shall not exceed 40 per cent positive microscope fields as determined by the Howard Method. (2) Yeast cells present in ketchup shall be non-viable. 6. Ketchup shall be free from fly eggs and maggots, except for Drosophila fly, in the case of which, there shall not be more than twenty eggR ::md one larva or ten eggs and two larvae of Drosophila fly, per 100 grams of ketchup. DIVISION 18-IR.RADIATED Foon 1. Irradiated food shall be food which (a) h::u:1 heen subjected to safe levels of ionising and non ionising radiation; or (b) contains an ingredient which has been subjected to safe levels of ionising and non -ionising radiation. 2. Sources of irradiation for food shall include (aJ X-rays from sources operated at energy levels of up to 5MeV; 597 598 Food and Drugs (Amendment) Regulations, 2003 (b) gamma rays from the radionuclides 6°Co and 137Cs only, operated at energy levels ofup to 5MeV; (c) electrons from sources operated at energy levels of up to lOMeV; and (d) ultra violet radiation operated between the wavelengths 220 and 300 nm, where 90 per cent of the radiation consists of the wavelength 254 nm. 3. The average dose absorbed by a food or ingredient which has been subjected to irradiation shall not exceed ( a) 45 kGy, for sterile foods; (b) 10 kGy, for dried herbs and spices; (c) 3 kGy, for fresh poultry and poultry products; (d) 7 kGy, for frozen poultry and poultry products; (e) 4.5 kGy, for fresh red meats; (/) 7 kGy, for frozen red meats; (g) 3 kGy, for seafoods; (h) 2 kGy, for fresh fruits and vegetables; (i) 1 kGy, for bulbs and tubers; and (j) 1 kGy, for cereals and grains, where measured by a.n ac.ceptable method. 4. Where re-irradiation of food or an ingredient is necessary, the total average dose absorbed shall not exceed the levels set out in paragraph 3. 5. A package of irradiated food shall carry the international irradiation symbol, the radura and a staten1ent such as "Food Irradiated", "Irradiated", "Treated with Irradiation" or "Treated by Irradiation" in close proximity to the symbol. 6. (1) Shipping documents in respect of irradiated food, including a bill of lading and an invoice, shall state the location and date of the treatment. the average dose absorbed and a lot number. (2) The importer, manufacturer or distributor of irradiated food shall retain the shipping documents for a minimum period of one year from the expiry date ofthe food. 7. A package used for holding food during irradiation shall be (a) cellophane, coated with nitrocellulose or with vinylidene chloride copolymer; (b) glassine paper; (c) paperboard coated with wax; Food and Drugs (Amendment) Regulations, 2003 (d) uncoated polyolefin films; (e) polyolefin films with a coating consisting of acrylonitrile, acrylic acid, tnconic acid, methyl acrylate and methyl methacrylate and not less than 85 per cent vinylidene chloride; (fJ kraft paper derived from unbleached sulphate pulp; (g) polyethylene terephthalate film; (h) polystyrene film; (i) rubber hydrochloride film; (j) vinylidene chloride-vinyl chloride basic copolymers, consisting of not less than 70 per cent vinylidene chloride; (k) nylon 11; (l) nylon 6; or (m) ethylene-vinyl acetate copolymers. 8. This Division shall not apply to treatments by microwave. DIVISION 19-FOOD GRADE SALT 1. This Division shall apply to salt to be used as food. 2. Food Grade salt shall (a) be white, crystalline, sodium chloride prepared from rock salt, RP.awat.P.r or natura 1 hrine; (b) contain not less than 97 per cent sodium chloride, calculated on a dry weight basis, exclusive of food additives; (c) contain not less than 99 per cent sodium chloride calculated on a dry weight basis, when sold as pure vacuum salt; and (d) have a loss on drying, of not more than 0.6 per cent by weight. 3. (1) Food grade salt may contain the food additives specified below (aJ anticaking agents, that is (i) any of the following coating agents: (A) calcium carbonate; (B) magnesium carbonate; (C) tri-calcium phosphate; (D) amorphous silicon dioxide; (E) calcium alumino-silicate; (F) magnesium alumino-silicate; (G) sodium alumino-silicate; (H) sodium calcium alumino-silicate; or (I) magnesium oxide; 599 600 Food and Drugs (Amendment) Regulations, 2003 (ii) any of the following hydrophobic agents: (A) aluminium salts of myristic acid, palmitic acid or stearic acid; (B) calcium salts of myristic acid, palmitic s:ir.id or st.P.s:irir. s:ir.id; (C) magnesium salts of myristic acid, palmitic acid or stearic acid; (D) potassium salts of myristic acid, palmitic acid or stearic acid; or (E) sodium salts of myristic acid, palmitic acid or stearic acid; or (iii) any of the following crystal modifiers: (A) calcium ferrocyanide; (B) potassium ferrocyanide; or (C) sodium ferrocyanide, in an amount not exceeding 0.0010 per cent by weight, calculated as ferrocyanide. (b) nutrients, that is (i) sodium fluoride in an amount not less than 0.015 per cent by weight and not more than 0.02 per cent by weight; and (ii) potassium iodide in an amount not less than 0.006 per cent by weight and not more than 0.01 per cent by weight; (c) propylene glycol in an amount not exceeding 0.03 per cent by weight; (d) ferric ammonium citrate in an amount not exceeding 0.0026 per cent by weight; (e) polyoxyethylene (20) sorbitan mono-oleate in an amount not exceeding 0.0010 per cent by weight, for the production of coarse crystal salt only; (fJ sodium alginate in an amount not exceeding 0.0015 per cent by weight, for the production of coarse crystal salt only; (g) dimethyl polysiloxane in an amount not exceeding 0.0010 per cent by weight; (h) polysorbate 80; and (i) any other additives approved by the Director. (2) Where coating agents and hydrophobic agents are used singly or in combination, the total amount used 5hall not exceed 2 per cent by weight. Food and Drugs (Amendment) Regulations, 2003 (3) Notwithstanding subparagraph ( l)(a)(iii), where ferrocyanide is used in the production of dendritic salt, the amount shs:ilJ not P.'.lC:CeP.d 0 0020 pP.r ~nt hy weight, r.alr.ulat.ru:l aR fP.rrocyimidFL 4. Naturally occuring contaminants of food grade salt shall not exceed (a) 0.5 parts per million of arsenic, calculated as arsenic; (b) 0.5 parts per million of cadmium, calculated as cadmium; (c) 2 parts per million of copper, calculated as copper; (d) 16 parts per million·ofiron, calculated as iron; (e) 2 parts per million of lead, calculated as lead; (f) o .1 parts per million of mercury, calculated as mercury; (g) 2 per cent of total calcium and magnesium, calculated as calcium; and (h) 0.3 per cent extraneous matter by weight. 5. (1) Rock salt shall be crude rock salt or halite obtained from the mining of salt. (2) Solar salt shall be salt prepared by the solar evaporation of sea water or natural brine. (3) Granulated salt shall be salt prepared by the vacuum evaporation of purified brine. (4) Table salt shall be fine, crystalline salt which may contain anticak.ing agents, crystal modifiers, iodine and fluorine . • (5) Coarse crystal salt shaH be salt to which food additives have been added to produce coarse crystals of sodium chloride. (6) Dendritic salt shall be salt which has had its crystal habit altered by incorporating sodium ferrocyanide in the brine during vacuum evaporation. (7) Flake salt shall be salt produced by the Grainer process in which the crystals are modified without the use of chemical additives. 6. The label on a package of food grade salt shall carry the statement (aJ "Food grade salt" or ''Table salt"; (b) "Iodized", where it contains potassium iodide with or without dextrose, sodium bicarbonate or sodium thiosulphate, at the levels set out in paragraph 4(1)(b); (c) "Fluoridated", where it contains levels of sodium fluoride set out in paragraph 4(1)(bJ; and (d) "Free flowing", where anticaking agents are used. 601 602 Food and DrUl(s (Amendment) lleflulations, 2003 DMSION 20-BREWERY PRODUCTS 1. In this Division "hop"' means the ripened cones of the female hop plant, humulus lupulus and includes hop extract, hop pellets and pre-isomerised hop extract; "hop extract" means an extract prepared from the female hop plant in accordance with paragraph 11( 1); "hop pellets"' means pellets produced from the female hop plant in accordance with paragraph 11(2) and (3); "pre-isomerised hop extract" or "pre-isomerised hop pellets" means an extract or hop pellets, as the case may be, prepared from the female hop plant in accordance with paragraph 11( 4); "sugar" means any saccharine substance, saccharine extract or saccharine syrup; "wort" means any extract or solution convertible into beer; "yeast" means saccharomyces cerevisiae or saccharomyces carlsbergensis. 2. Ale shall be a beverage produced by the fermentation by yeast, of a wort, to which other ingredients may have been added and which has been brewed in such a manner as to have the aroma, flavour and other characteristics that are commonly recognised in ale. 3. Beer shall be a beverage produced by the fermentation by yeast, of a wort, to which other ingredients may have been added and which has been brewed in such a manner as to have the aroma, flavour and other characteristics that are commonly recognised in beer. 4. Lager or Lager beer shall be a beverage produced by the fermentation by yeast, of a wort, which has been stored at cold temperatures during clarification and maturation and brewed in such a manner as to have the aroma, flavour and other characteristics that are commonly recognised in lager or lager beer. 5. Malta shall be a beverage produced by combining wort, sugar, hops and carbon dioxide, to which yeast flavour or other flavour may have been added, which has the aroma, flavour and other characteristics that are commonly recognised in malta but which has no alcoholic content by volume when measured by an acceptable method. 6. Malt liquor shall be a beverage produced by the fermentation by yeast, of a wort, to which other ingredients may have been added and which has been brewed in such a manner as to have the aroma, flavour and other characteristics that are commonly recognised in malt liquor. Food and Drugs (Amendment) Regulations, 2003 7. Milk stout shall be a stout to which lactose has been added. 8. Porter shall be a beverage produced by the fermentation by yeast, of a wort, to which other ingredients may have been added and which has been brewed in such a manner as to have the aroma, flavour and other characteristics that ;:ire r.ommnnly rP.r.ogniRecl in porter. 9. (1) Shandy shall be a beverage containing bright beer, shandy concentrate, sugar, carbon dioxide and water. (2) Shandy shall not contain more than 1.2 per cent alcoholic content by volume. 10. Stout shall be a beverage produced by the fermentation by yeast, of a wort, to which other ingredients may have been added and which has been brewed in such a manner as to have the aroma, flavour and other characteristics that are commonly recognised in stout. 11. (1) Hop extract to be used in a brewery product shall be produced by (a) a process in which carbon iliux.ide or ethanol is used as a solvent in accordance with good manufacturing practice; or (b) any other method approved by the Director. (2) Hop pellets to be used in a brewery product shall be produced by hammering or milling hops to a fine powder, running the powder through a high pressure pelletising disc and cooling and vaccum-packing the resulting pellets. (3) No additives shall lJe used iu prodm:ing hup pelletis. (4) Pre-isomerised hop extract or pre-isomerised hop pellets to be used in n brewery product shall be produced by using carbon dioxide or ethanol from which the alpha-acids have been isolated and isomerised with dilute acid and heat. 12. (1) Near beer, non-alcoholic beer, non-alcoholic ale, non-alcoholic stout or non-alcoholic porter, as the case may be, shall be a brewery product which has an alcoholic content by volume of 0.5 per cent or less. (2) Low alcohol beer, low alcohol ale, low alcohol stout or low alcohol porter, as the case may be, shall be a brewery product which has an alcoholic content by volume of more than 0,5 per cent but not more than 1.2 per cent. 603 604 Food and Drugs (Amendment) Regulations, 2003 (3) Extra light beer, extra light ale, extra light stout or extra light porter, as the case may be, shall be a brewery product which has an nlcoholic content by volume of more than 1.2 per cent but not more than 2.5 per cent. (4) Light beer, light ale, light stout or light porter, as the case may be, shall be a brewery product which has an alcoholic content by volume of more than 2.5 per cent but not more than 4.0 per cent. (l5) Ale, beer, stout or porter, as the case may be, shall be a brewery product which has an alcoholic content by volume of more than 4.0 per cent but not more than 5.5 per cent. (6) Strong beer, strong ale, strong stout, strong porter or malt liquor, as the case may be, shall be a brewery product which has an alcnhnlic contAnt hy vnlume of morP. than Fi.Fi pP.r cent hut nnt mnrP. than 8.5 per cent. (7) Extra strong beer, extra strong ale, extra strong stout, extra strong porter or extra strong malt liquor, as the case may be, shall be a brewery product which has an alcoholic content by volume of more than 8.5 per cent.". Dated this 17th day of June, 2003. C. IMBERT Minister of Health PRlNTED BY THE GoVERNMENT PRINTER, PoRT-OF-SPAIN REPUBLIC OF TIIINIDAD AND TOBAG0-2003