Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 (G.N. No. 464 of 2015)

Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 1 GOVERNMENT NOTICE NO. 464 published on 23/10/2015 THE TANZANIA FOOD, DRUGS AND COSMETICS ACT (CAP 219) REGULATIONS (Made under Section 122(1) (i)) THE TANZANIA FOOD, DRUGS AND COSMETICS (FEES AND CHARGES) REGULATIONS, 2015 Citation 1. These Regulations may be cited as the Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015. Applications 2. This regulation shall apply in Tanzania Mainland. Interpretation 3. In these Regulations unless the context otherwise requires: Cap 219 “Act” means the Tanzania Food Drugs and Cosmetics Act,; “alteration or variation fee” means a fee paid by a registrant in relation to alteration to be made regarding product composition, formulation, packaging, labelling or any other changes relating to alteration made to a registered product; “annual retention fee” means a fee paid by a registrant for the purpose of retaining a registered product in the register of the Authority; “Authority” means the Tanzania Food and Drugs Authority or in its acronym “TFDA” established under the Act; “duplicate certificate” means a certificate issued to replace a certificate, permit or license, previously issued by the Authority; “fees’’ includes any charge made or levied in connections to services rendered by the Authority; Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 2 “Free on Board also describe as FBO” means a value of regulated product to be imported into Tanzania mainland; “Good Manufacturing Practices (GMP) means practices prescribed by the Authority for the manufacturing of products to ensure that such products are of good quality, safe and effective for the intended use; “large scale enterprise” means an enterprise with capital investment exceeding eight hundred million shillings; “Local Authority” includes City Council, Municipal Council, Town Council or District Council; “manufacturer” means person or firm that is engaged in the manufacture of a product regulated under the Act; “manufacturing” means all operations involved in the product preparation, processing compounding, formulating, filling, refining, transformation, packing and labelling of product regulated under the Act; “medical and complementary products representative” means a person representing a drug or medical devices manufacturer in Tanzania mainland for the purpose of marketing such company’s product; “medium scale enterprise ” means an enterprise with capital investment of not less than two hundred million but not exceeding eight hundred million shillings; “micro scale” means an enterprise with capital investment of not exceeding five million shillings; “new medicine” means a medicine whose chemical moiety is new, or little documented or in a new formulation with a new route of administration or with a new formulation; “old medicine” means a medicine whose chemical moiety is subjected to pharmacopeia documentation and its pharmacological actions are known and well documented; “person” means artificial or natural person; “pre- licensing or registration inspection” means inspection carried out on premises to verify compliance with set requirements prior to granting of a license or permit or registration certificate; “product carrier” means any box detachable compartment, tank or container, receptacle, or any other arrangement in which a product may be carried in; “product dealer” means a product manufacturer, packer, importer, Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 3 exporter, distributor, seller or any other dealer in any product business to which the Act applies; “products” means food, food products, medicines, cosmetics, medical devices including diagnostics; “registrant” means any person who under his own name or under a trade, design or word mark, trade name or other name work or mark controlled by him intends to sell or sells food, drugs, cosmetics and medical devices and includes a firm, partnership or corporation; “registration certificate” means a certificate issued by the Authority in respect of a registered products or premises; “restoration fee” means fees paid for restoration of a license or permit or registration certificate suspended by the Authority; and “small scale enterprises” means an enterprise with capital investment exceeding five million shillings but less than two hundred million shillings. Fees and charges Cap.219 4.-(1) A person shall pay a fee prescribed in the Schedules in respect of the products and services regulated under the Tanzania Food, Drugs and Cosmetics Act. (2) Fees and charges paid under these Regulations shall be paid in Tanzanian shillings or US$ equal to the amount of Tanzania shillings or any convertible shilling equal the amount payable in Tanzania Shillings. (3) The Minister may upon advice of the Director General, change or vary any fees and charges in force at any time. Appropriation of fees and charges 5.-(1) Fees and charges paid under these Regulations shall be collected and appropriated by the Authority (2) The Authority may appoint an agent or any local Authority within the area the fees paid and charges operates to be a collecting agent. (3) Fees and charges payable under these Regulations shall not be refundable or transferable (4) Failure to pay in time the fees and charges in force shall, in addition to the due charge, pay a penalty of 25% of the total amount payable. Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 4 (5) The Authority, where satisfied that the declared value do not reflect the actual cost which were to be used to calculate FOBs, may reject the importation approval or uplift the value of consignment to the cost that would be the valued amount of the product or consignment Payment by order of the court 6.-(1) When an order of the court requires a person to pay for fees and charges retrospectively for any regulated product or services, such pay shall include the calculated 25% of the total amount ought to have been paid prior to the court order. (2) The fees and charges to be paid for FOBs as cost for regulating imported products shall be calculated and paid before service being rendered in the actual value of consignment declared by the importer. Fees and charges prescribed by other Regulations 7.-(1) Any other Regulations made under the Act for which fees and charges are prescribed, shall be deemed to have been part of these Regulations (2) A person who shall be charged to pay fees and charges in force under any other regulations made under the Act, shall be deemed to have been complied with these regulations and shall have the same legal effect as charged under these Regulations Fees for GMP inspection 8.-(1) Fees paid for Good Manufacturing Practices inspections shall be determined and charged basing on the manufacturing sites of the regulated product. (2) The Authority shall charge additional fees not exceeding 25% for each additional production line or block. Validity of proforma invoice 9.-(1) All persons importing regulated product and services shall pay the amount calculated based on the proforma invoice approved by the Authority. (2) The Proforma invoice shall have the duration of six (6) months only and upon expiry, the same shall be deemed invalid. Revocation of GN No. 439 of 2005 10. The Food Drugs and Cosmetics (Fees and Charges) Regulations, 2005 are revoked. Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 5 Offence and Penalty 11. Any person who (a) contravenes or fails to comply with these Regulations; (b) aid another person to commit an offence, commits an offence and shall, on conviction, be liable to the penalty prescribed by the Act. Saving provision 12. All fees, charges, orders or action made under the revoked Regulations shall be deemed to have been made under these Regulations. Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 6 FIRST SCHEDULE TFDA Fees and charges structure REGISTRATION/RETENTION/NOTIFICATION/VARIATION Human and Veterinary medicines (Domestic) Service Currency Fee 1 Registration USD 500 2 Variation –Major USD 100 3 Variation –Minor USD 50 4 Retention USD 150 5 Duplicate Certificate USD 50 Human, Veterinary Medicines and Biologicals (Imported) 6 Registration USD 2,000 7 Registration – biological USD 3,500 8 Retention USD 300 9 Variation – major USD 1,000 10 Variation – minor USD 300 11 Duplicate certificate USD 100 12 Fast track registration Pharmaceuticals USD Double the respective fee Registration for domestic and imported food products Domestic Imported 13 Milk and milk products USD 380 450 14 Cereal and cereal products USD 320 400 15 Pulses USD 250 350 16 Nuts USD 350 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 7 250 17 Tuber and roots USD 280 360 18 Non- alcoholic beverages USD 300 350 19 Alcoholic beverages USD 200 300 20 Sugar and honeys USD 250 360 21 Iodated salt USD 200 280 22 Fats and oils USD 180 280 23 Tea and coffee USD 330 450 24 Cocoa and cocoa products USD 350 400 25 Spices and herbs USD 300 400 26 Vinegar USD 150 230 27` Fish and fish products USD 280 370 28 Meat and meat products USD 280 400 29 Fruits and fruits products USD 250 330 30 Drinking water USD 300 410 31 Vegetable and vegetable products USD 250 330 32 Food for infants and follow up formula USD 680 900 33 Food supplements USD 650 800 34 Processed cereal based foods for children USD 650 850 35 Food additives USD 160 250 36 Confectionaries USD 280 380 37 Retention Fee for registered food product USD 10 20 38 Alteration –major USD 25 60 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 8 39 Alteration –minor USD 0 0 40 Duplicate certificate USD 100 100 41 Fast track registration USD Double respective fee Double respective fee Medical devices Registration –Imported 42 Class A USD 500 43 Class B USD 2,500 43 Class C USD 2,500 44 Class D USD 2,500 45 Variation –minor USD 150 46 Variation –major USD 300 47 Retention - class A USD 200 48 Class B USD 200 49 Class C USD 200 50 Class D 200 51 Duplicate certificate USD 100 Registration -Domestic 52 Class B USD 75 53 Class C USD 250 54 Class D USD 250 59 Variation-minor USD 50 60 Variation-major USD 75 61 Retention USD 100 62 Duplicate certificate USD 30 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 9 63 Exportation Certificate USD 25 Diagnostics Registration of IVD (Imported) 64 Class A USD 350 65 Class B USD 1250 66 Class C USD 1500 67 Class D USD 2000 68 Variation - Minor USD 200 69 Variation - Major USD 500 70 Retention USD 150 71 Duplicate certificate USD 100 Registration of IVD (Domestic) 72 Class A USD 125 73 Class B USD 250 74 Class C USD 375 75 Class D USD 500 76 Variation - Minor USD 125 77 Variation - Major USD 250 79 Retention USD 250 80 Duplicate certificate USD 100 Cosmetics and Antiseptics 81 Antiseptics, disinfectants and Medicated soaps -domestic TZS 150,000 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 10 82 Retention fee TZS 100,000 83 Duplicate certificate TZS 30,000 84 Antiseptics, disinfectants and medicated soaps -imported USD 300 85 Retention fee USD 100 89 Duplicate certificate USD 30 90 Registration of cosmetics-Imported USD 100 91 Registration of cosmetics-domestic TZS 100,000 92 Duplicate certificate TZS 30,000 93 Variation –imported USD 100 94 Variation –domestic TZS 50,000 95 Retention-domestic TZS 30,000 96 Retention-imported USD 30 97 Variation -domestic Cosmetics TZS 50 000 98 Variation -domestic Cosmetics USD 50 99 *Imported cosmetic raw materials FOB 1% 100 Application to conduct clinical trials USD 3000 101 Fast track for clinical trial application Double the cost of registration and analysis fee 102 Amendments clinical trials-Major USD 300 103 Amendments clinical trials-Minor USD 300 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 11 GMP Inspection fee per block (Domestic) 104 GMP Inspection -domestic Pharmaceutical - new sites USD 250 GMP inspection fee for facilities of food, pharmaceuticals and medical devices per block (Foreign) 105 East Africa USD 4,000 106 Rest of Africa USD 5,000 107 Asia USD 6,000 108 Europe USD 7,000 109 America USD 8,000 Evaluation and Approval Pharmaceutical products 110 Promotional material-Foreign USD 100 111 Abbreviated advert-foreign USD 50 112 Promotional material-Domestic USD 50 113 Abbreviated advert-domestic USD 25 Food and Food Products 114 Label artwork of pre-packaged food 50,000 115 Label artwork of high risk food 100,000 116 Promotional material 50,000 Permits 117 Medical representative foreign per company USD 1,000 118 Trade fair permit-Foreign company USD 200 119 Change of Local Technical Representative USD 2,000 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 12 120 Large Pharmaceuticals manufacturers TZS 700,000 121 Medium Pharmaceuticals manufacturers TZS 500,000 122 Small Pharmaceuticals manufacturers TZS 300,000 123 Pharmaceutical importer TZS 300,000 124 Wholesalers’ veterinary outlets TZS 300,000 125 Medical devices importer TZS 300,000 126 Wholesalers’ cosmetics outlets TZS 300,000 127 Retails cosmetic outlets TZS 100,000 128 Retails Veterinary Pharmacy TZS 100,000 129 Retails veterinary ADDO TZS 50,000 130 Retails medical devices outlets TZS 100,000 131 Large cosmetics manufacturers TZS 500,000 132 Medium cosmetics manufacturers TZS 350,000 133 Small cosmetics manufacturers TZS 150 000 134 Medical representative domestic per company TZS 200,000 135 Certificate of pharmaceutical product (CPP) TZS 50,000 136 Disposal certificate TZS 50,000 137 Disposal charge on value of condemned products 25% 138 Hospital permit for psychotropic and narcotics drugs TZS 10,000 139 Permit for psychotropic and narcotics drugs TZS 50,000 140 New premises (medicine, medical devices, cosmetics) inspection fee TZS 50,000 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 13 141 Marketing fee -medicine/cosmetics TZS 300,000 142 Trade fair permit-domestic company TZS 200,000 143 Export Permit for regulated products TZS 50,000 144 Exportation for medical devices TZS 50,000 145 Inspection of consignments at owners premises TZS 100,000 146 Inspection of new food processing facilities - large TZS 250,000 147 Inspection of new food processing facilities -medium TZS 200,000 148 Inspection of new food processing facilities -Small TZS 100,000 149 Annual dealers permit for distributors-large scale TZS 150,000 150 Annual dealers permit for distributors-Medium TZS 100,000 151 Annual dealers permit for distributors-small scale TZS 50,000 152 Annual dealers license/permit for Manufacturers-large scale TZS 300,000 153 Annual dealers license/permit for Manufacturers-Medium scale TZS 150,000 154 Annual dealers license/permit for manufacturers- small scale TZS 50,000 155 Inspection fees for new food selling outlets TZS 50,000 156 Registration fees for mass food caterers TZS 60,000 157 Health certificate TZS 50,000 158 FOB charge for imported food product. FoB 1.5% 159 Importation of donated medicines FOB 0.5% 160 Imported cosmetic raw materials FOB 1% Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 14 161 Importation of medical devices FOB 2% 162 Permit for importation of medicines (finished product). FOB 2.0% 163 Permit for importation of pharmaceutical raw materials FOB 0.5% Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 15 SECOND SHEDULE LABORATORY ANALYSIS FEES AND CHARGES S/N Parameters Test fee (USD) ALCOHOL BEVERAGES Beer 1. pH (at 20°C) 10 2. Higher alcohols (mg/l) 45 3. Methanol (mg/l) 50 5. Reducing sugar (%w/w) 50 6. Total solids (%w/w) 30 7. Specific gravity 10 8. Total Acidity (%w/w) 25 9. Volatile Acidity (%w/w) 25 10. Alcohol (%v/v) 25 11. Carbon dioxide (Pascal) 20 12. Fixed Acidity (%w/w) 25 Heavy Metals each by AAS 13 Mercury(Hg) (mg/kg) 55 14 Lead(Pb) (mg/kg) 55 15 Arsenic(As) (mg/l) 55 16 Cadmium (mg/kg) 55 17 Copper(Cu) (mg/l) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 16 S/N Parameters Test fee (USD) 18 Other metals (each) 55 19 Microbiological requirements 20 Coliforms (cfu/ml) 125 21 Sulphate reducing bacteria 170 22 Total viable aerobic count (cfu/ml) 130 23 Yeasts (cfu/100ml) 160 24 Acetic acid bacteria in 100ml 170 25 Lactic acid bacteria in 100ml 170 Mycotoxins by HPLC 26 Ochratoxins (μg/kg) 120 27 Deoxynivalenol (μg/g) 120 28 Aflatoxins(μg/g) 120 29 Fumonisins (μg/g) 120 Flavoured Alcoholic beverages 30 Acidity (%w/v) 25 31 Alcohol (%v/v) 25 32 Methanol (mg/l) 45 33 pH (at 20°C) 10 34 Flavors 10 Heavy Metals each by AAS 35 Lead (Pb) (Mg/kg) 55 36 Arsenic (AS) (mg/1) 55 37 Mercury (Hg) (mg/kg) 55 38 0ther Metals (each) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 17 S/N Parameters Test fee (USD) Spirits 39 Alcohol (%v/v) 25 40 Ash (%w/w) 45 41 Aldehyde (mg/l) 25 42 Higher Alcohols (mg/l) 25 43 Methanol (mg/l) 45 44 pH (at 20°C) 10 45 Total solids (%w/w) 30 46 Total Acidity (%w/w) 25 Heavy Metals each by AAS 47 Lead(Pb) (mg/kg) 55 48 Arsenic(As) (mg/l) 55 49 Mercury(Hg) (mg/kg) 55 50 Other Metals (each) 55 Wines 51 Alcohol (%v/v) 25 52 Fixed Acidity (%w/w) 25 53 Sucrose (%w/w) 50 54 Tannins (%w/w) 45 55 Volatile Acidity (%w/w) 25 56 Reducing sugar (%w/w) 50 Heavy Metals each by AAS 57 Mercury(Hg) (mg/kg) 55 58 Lead(Pb) (mg/kg) 55 59 Arsenic(As) (mg/l) 55 60 Other metal each 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 18 S/N Parameters Test fee (USD) Mycotoxins(cfu/ml) by HPLC 61 Patulin (μg/kg) 120 Preservatives 62 SO2 50 CEREAL AND CEREAL PRODUCTS Bakery Products 63 Acid insoluble ash (%w/w) 55 64 Acidity (%w/v) 25 65 Crude fiber (%w/w) 55 66 Fat (%w/w) 55 67 Moisture Content (%w/w) 30 68 Vitamin K (%μg/g) 65 69 Pesticide residues each eachby LC-MS-GC-MS 120 70 pH (at 20°C) 10 71 Potassium Bromate (mg/kg) 55 72 Protein (%w/w) 55 73 Total Soluble Solids (%w/w) 15 74 Sugar (%w/w) 50 Heavy Metals each by AAS 75 Lead(Pb) (mg/kg) 55 76 Arsenic(As) (mg/l) 55 77 Mercury(Hg) (mg/kg) 55 78 Other Metals (each) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 19 S/N Parameters Test fee (USD) Microbiological requirements 79 Salmonella spp in 25g 155 80 Total viable aerobic count (cfu/g) 130 81 Enterobacteriaceae (cfu/g) 130 82 Yeasts and Moulds (cfu/g) 160 Mycotoxins by HPLC 83 T. Toxin (μg/kg) 120 84 Zeralenol (μg/kg) 120 85 Ochratoxins (μg/kg) 120 86 Deoxynivalenol (μg/g) 120 Cereal Grains 87 Acid Insoluble ash (%w/w) 55 88 Acidity (%w/v) 25 89 Ash (%w/w) 45 90 Chalky (%w/w) 5 91 Coloured grains (%w/w) 5 92 Discolored grains (%w/w) 5 93 Fiber (%w/w) 55 94 Foreign Matter (%w/w) 5 95 Glutens (%w/w) 15 96 Glycosidic cyanide (%w/w) 55 97 Heat damaged grains (%w/w) 5 98 Microscopic 15 99 Moisture (%w/w) 30 100 Vitamin B6 (%μg/g) 65 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 20 S/N Parameters Test fee (USD) 101 Pesticide residues 120 102 Potassium Bromate (mg/kg) 55 103 Protein (%w/w) 55 104 Sieve test 15 105 Talc (%w/w) 35 106 Tannins (%w/w) 35 107 solubility (%w/w) 15 108 Visual appearance 5 109 Total carbohydrates (%w/w) 30 110 Atropine level (%w/w) 70 111 Immature grains (%w/w) 5 112 Insect damage (%w/w) 5 Heavy Metals each 113 Mercury(Hg) (mg/kg) 55 114 Arsenic(As) (mg/l) 55 115 Lead(Pb) (mg/kg) 55 116 Other metals (each) 55 Microbiological requirements 117 B. cereus (cfu/g) 165 118 Yeasts and Moulds (cfu/g) 160 119 E. coli (cfu/g) 130 Mycotoxins by HPLC 120 Fumonisin (μg/kg) 120 121 Total Toxin (μg/kg) 120 122 Total Aflatoxin (μg/l) 120 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 21 S/N Parameters Test fee (USD) 123 Ochratoxins (μg/kg) 120 124 Deoxynivalenol (μg/g) 120 Flours and milled Cereal Products 125 Acid insoluble ash (%w/w) 55 126 Acidity (%w/v) 25 127 Ash (%w/w) 45 128 Carbohydrate (%w/w) 30 129 Fat (%w/w) 55 130 Fiber (%w/w) 55 131 Glutens (%w/w) 15 132 Starch (%w/w) 40 133 Tannins (%w/w) 35 134 Solubility (%w/w) 15 135 Moisture (%w/w) 30 136 Vitamin K (%μg/g) 65 137 Pesticide residues each 120 138 Potassium Bromate (mg/kg) 55 139 Protein (%w/w) 55 140 Sieve test 15 141 Sodium Chloride (%w/w) 50 142 Total carbohydrates (%w/w) 30 143 Urease Acidity (%w/w) 35 144 Atropine level (%w/w) 70 Heavy Metals each 145 Lead(Pb) (mg/kg) 55 146 Arsenic(As) (mg/l) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 22 S/N Parameters Test fee (USD) 147 Mercury(Hg) (mg/kg) 55 148 Other Metals (each) 55 Microbiological requirements 149 Yeasts / Moulds (cfu/g) 160 150 Total viable aerobic count (cfu/g) 130 151 Salmonella spp in 25g 155 152 E. coli (cfu/g) 130 Mycotoxins by HPLC 153 Total Toxin (μg/kg) 120 154 Total Aflatoxin (μg/l) 120 155 Ochratoxins (μg/kg) 120 156 Deoxynivalenol (μg/g) 120 157 Fumonisin (μg/kg) 120 158 Zeralenol ((μg/g) 120 Composite food products Liquids 159 Acidity (%w/v) 25 160 Drug Residues each 135 161 pH (at 20°C) 10 162 Phytochemical 65 163 Soluble Solids (%w/w) 15 Heavy Metals each by AAS 164 Lead(Pb) (mg/kg) 55 165 Arsenic(As) (mg/l) 55 166 Mercury(Hg) (mg/kg) 55 167 Other Metals (each) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 23 S/N Parameters Test fee (USD) Microbiological requirements 168 Coliforms (cfu/ml) 125 169 Total viable aerobic count (cfu/ml) 130 Mycotoxins 170 Ochratoxins (μg/kg) 120 171 Aflatoxins M1 (μg/kg) 120 Preservatives 172 Benzoic acid (mg/l) 65 173 Citric Acid (%w/w) by HPLC 65 174 Sorbic Acid (mg/kg) 65 175 SO2 65 Solids 176 Carbohydrate (%w/w) 30 177 Moisture Content (%w/w) 30 178 Vitamin K (%µg/g) 65 179 Pesticide residues 120 180 Phytochemical 65 181 Protein (%w/w) 55 Heavy Metals each 182 Mercury (Hg) (mg/kg) 55 183 Lead (Pb) (mg/kg) 55 184 Arsenic (Na) (mg/kg) 55 185 Other Metals (each) 55 Microbiological requirements 186 Coliforms (cfu/ml) 125 187 Total viable aerobic count 130 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 24 S/N Parameters Test fee (USD) (cfu/ml) Mycotoxin 188 Orchratoxin (µg/kg) 120 CONFECTIONARIES Candy 189 Acid insoluble ash (%w/w) 55 190 Color additive 55 191 Sugar (%w/w) 50 192 Sulphates ash (%w/w) 50 Heavy Metals each 193 Mercury(Hg) (mg/kg) 55 194 Lead(Pb) (mg/kg) 55 195 Arsenic(As) (mg/l) 55 196 Other Metals (each) 55 Mycotoxin 197 T.Toxin (μg/kg) 120 198 Sweeteners each 65 Toffees and chewing gum 199 Color additive 50 200 Fats (%w/w) 55 201 Sugar (%w/w) 50 202 Sulphates ash (%w/w) 45 203 Fenitrothin (mg/kg) 40 204 Moisture (%w/w) 30 205 Acid insoluble ash (%w/w) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 25 S/N Parameters Test fee (USD) Food Additives 206 Flavor 25 Heavy Metals each 207 Lead(Pb) (mg/kg) 55 208 Arsenic(As) (mg/l) 55 209 Mercury(Hg) (mg/kg) 55 210 Other Metals (each) 55 Mycotoxins 211 Ochratoxins (μg/kg) 120 212 Total viable aerobic count (cf) 135 BREAKFAST CEREAL, CRISPS, SNACKS, FILLED OR TOPPED BISCUITS, CAKES, HERBS,SPICES,COFFEE 213 Color additive 50 214 Fats (%w/w) 60 215 Sugar (%w/w) 50 216 Moisture (%w/w) 45 217 Flavor 30 Heavy Metals each 218 Lead(Pb) (mg/kg) 55 219 Arsenic(As) (mg/l) 55 220 Mercury(Hg) (mg/kg) 55 221 Other Metals (each) 55 Mycotoxins 222 Ochratoxins (μg/kg) 120 223 Total Aflatoxin (μg/l) 120 Preservatives Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 26 S/N Parameters Test fee (USD) 224 Benzoic acid (mg/l) 115 225 Citric Acid (%w/w) 100 226 Sorbic Acid (mg/kg) 115 Microbiological requirements 227 Yeasts / Moulds (cfu/g) 160 228 Total viable aerobic count (cfu/g) 130 229 Salmonella spp in 25g 155 230 E. coli (cfu/g) 130 Herbs and spices 231 Yeasts / Moulds (cfu/g) 160 232 C. perfringes (cfu/g) 165 233 B. cereus (cfu/g) 165 234 Salmonella spp in 25g 155 235 E. coli (cfu/g) 130 FATS AND OIL 236 Free fatty acid (%w/w) 25 237 Insoluble impurities (%w/w) 25 238 Iodine value (wijs) 60 239 Melting point 25 240 Moisture (%w/w) 30 241 Peroxide (mEq/kg) 50 242 Refractive index 10 243 Relative Density (w/v) 10 244 Saponification value (mg/g) 50 245 Soap content (%w/w) 20 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 27 S/N Parameters Test fee (USD) 246 Usaponifable matters (%w/w) 50 247 Hexabromide (%w/w) 10 248 Poly bromide (%w/w) 10 249 Arachidic Acid 10 250 Vitamin A 65 251 Vitamin E (%μg/g) 65 252 Vitamin D 65 Mycotoxin 253 Total Aflatoxin 120 Heavy Metals each 254 Lead(Pb) (mg/kg) 55 255 Arsenic(As) (mg/l) 55 256 Mercury(Hg) (mg/kg) 55 257 Other Metals (each) 55 Preservatives 258 THA 65 259 TBA 65 260 Propylene glycol stearate (mg/kg) 65 Edible Fats Products- Margarine 261 Insoluble impurities (%w/w) 25 262 Moisture &V/ Matter ( 105C) (%w/w) 30 263 Melting point 25 264 Peroxide (mEq/kg) 50 265 NaCL (%w/w) 35 266 Saponification value (mg/g) 50 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 28 S/N Parameters Test fee (USD) 267 Soap content (%w/w) 20 268 Usaponifable matters (%w/w) 50 269 Lecithin (%w/w) 50 270 Acid value (%w/v) 50 271 Free fatty acid (%w/w) 25 272 Vitamin A 65 Heavy Metals each 273 Lead(Pb) (mg/kg) 55 274 Arsenic(As) (mg/l) 55 275 Mercury(Hg) (mg/kg) 55 276 Others Metals (each) 55 Edible Fats Products spreads 277 Acidity (%w/v) 25 278 Fat (%w/w) 55 279 FFA (%w/w) 25 282 Moisture (%w/w) 30 Heavy Metals 281 Lead(Pb) (mg/kg) 55 282 Arsenic(As) (mg/l) 55 283 Mercury(Hg) (mg/kg) 55 284 Other Metals (each) 55 Mayonnaise 285 Peroxide Value (mEq/kg) 50 286 Salts (%w/w) 35 287 Acidity (%w/v) 25 288 Fat (%w/w) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 29 S/N Parameters Test fee (USD) 290 FFA (%w/w) 25 Heavy Metals each 291 Lead(Pb) (mg/kg) 55 292 Arsenic(As) (mg/l) 55 293 Mercury(Hg) (mg/kg) 55 294 Nikel (mg/1) 55 295 Other Metals (each) 55 Shortenings 296 Acidity (%w/v) 25 297 Fat (%w/w) 55 298 FFA (%w/w) 25 299 Moisture (%w/w) 30 300 Peroxide Value (mEq/kg) 50 301 Propylene glycol stearate (mg/kg) 65 Mycotoxin 302 Total Aflatoxin (μg/kg) 120 Heavy Metals each 303 Lead(Pb) (mg/kg) 55 304 Arsenic(As) (mg/l) 55 305 Mercury(Hg) (mg/kg) 55 306 Other Metals (each) 55 Preservatives 307 Propylene glycol stearate (mg/kg) 65 Vegetable Oil 308 Usaponifable matters (%w/w) 50 309 Iodine (mg/l) 50 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 30 S/N Parameters Test fee (USD) 310 Poly bromide (%w/w) 10 311 Arachidic Acid 10 312 Viscosity 20 313 Density (m/v) 10 314 Flash Point 10 315 Acid value (%w/v) 25 316 Ash (%w/w) 45 317 Chlorides (mg/l) 25 318 Free fatty acid (%w/w) 25 319 Gossypol (%w/w) 40 320 Insoluble impurities (%w/w) 25 321 Iodine value (Wijs) 60 322 Moisture (%w/w) 30 323 Peroxide Value (mEq/kg) 50 324 Refractive index 10 325 Relative Density (w/v) 10 326 Saponification value (mg/g) 50 327 Soap content (%w/w) 10 328 Starch (%w/w) 40 Antioxidant 329 Vitamin E (%μg/g) 65 Heavy Metals each 330 Mercury(Hg) (mg/kg) 55 331 Lead(Pb) (mg/kg) 55 332 Arsenic(As) (mg/l) 55 333 Other Metals (each) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 31 S/N Parameters Test fee (USD) Mycotoxins 334 T. Toxin (μg/kg) 120 335 Total Aflatoxin (μg/l) 120 FISH AND FISH PRODUCTS Fish products 336 Ash (%w/w) 40 337 Fat Content (%w/w) 55 338 Total volatile bases (%w/w) 55 339 Trim ethylamine 50 340 Volatile fatty acid (%w/w) 50 341 Drug residues Each 135 342 Physical 5 343 Preservatives each 65 344 Protein (%w/w) 55 345 Salts (%w/w) 35 346 Pesticide residue each 120 Antioxidant 347 Vitamin E (%μg/g) 65 Heavy Metals each 348 Lead(Pb) (mg/kg) 55 349 Arsenic(As) (mg/l) 55 350 Mercury(Hg) (mg/kg) 55 351 Other Metals (each) 55 Microbiological requirements 352 Salmonella in 25g 155 353 Shigella in 25g 155 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 32 S/N Parameters Test fee (USD) 354 Staphylococcus aureus (cfu/g) 150 355 Feacal Coliforms/E. coli (MPN/g) 125 356 Total viable aerobic count (cfu/g) 130 357 Coliforms (cfu/ml) 125 Preservatives 358 Benzoic acid (mg/l) 65 359 Citric Acid (%w/w) 65 360 Sorbic Acid (Mg/kg) 65 361 SO2 60 Fresh and frozen Fish 362 Drugs residues each 135 363 Physical 5 364 Protein (%w/w) 55 365 Fat Content (%w/w) 55 366 Histamine (% μg/g) 50 367 Total volatile bases (%w/w) 55 368 Trim ethylamine 50 369 Indole (%w/w) 50 370 Hydroxyproline (mg/l) 50 371 Boric Acid (%w/w) 50 372 Pesticide residues each 120 Antioxidant 373 Vitamin E (%μg/g) 65 Heavy Metals each 374 Lead(Pb) (mg/kg) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 33 S/N Parameters Test fee (USD) 375 Arsenic(As) (mg/l) 55 376 Mercury(Hg) (mg/kg) 55 377 Other Metals (each) 55 Microbiological requirements 378 Salmonella in 25g 155 379 Shigella in 25g 155 380 Staphylococcus aureus (cfu/g) 150 381 E. coli (cfu/g) 130 382 Total viable aerobic count (cfu/g) 130 383 Coliforms (cfu/mL) 125 Salted dried fish 384 Sodium Chloride (%w/w) 35 Heavy Metals each 385 Lead(Pb) (mg/kg) 55 386 Arsenic(As) (mg/l) 55 387 Mercury(Hg) (mg/kg) 55 388 Cadmium (mg/kg) 55 389 Other Metals (each) 55 Microbiological requirements 390 E. coli (cfu/g) 130 391 Salmonella in 25g 155 392 Shigella in 25g 155 393 Staphylococcus aureus (cfu/g) 150 394 Total viable aerobic count (cfu/g) 130 FOOD ADDITIVES Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 34 S/N Parameters Test fee (USD) Acids, Anticaking, Anticaking agent and preservatives 395 Physical 5 396 Purity (%w/w) 50 397 Identification 50 Heavy Metala each 398 Lead(Pb) (mg/kg) 55 399 Arsenic(As) (mg/L) 55 340 Other Metals (each) 55 Leavening agent NaHCO3 341 Physical 5 342 Purity (%w/w) 50 343 Identification 50 Heavy Metals each 344 Lead(Pb) (mg/kg) 55 345 Arsenic(As) (mg/l) 55 346 Mercury(Hg) (mg/kg) 55 347 Nikel (mg/l) 55 348 Other Metals (each) 55 Enzymes 349 Enzyme activity (%w/w) 55 350 Identification 50 351 Physical 5 352 Purity (%w/w) 55 Heavy Metals each Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 35 S/N Parameters Test fee (USD) 353 Lead(Pb) (mg/kg) 55 354 Arsenic(As) (mg/l) 55 355 Mercury(Hg) (mg/kg) 55 356 Other Metals (each) 55 Leavening agent YEAST 357 Yeast Activity 40 358 Identification 50 359 Physical 5 360 Salmonella spp 155 361 Heavy Metals each 362 Arsenic(As) (mg/l 55 363 Lead(Pb) (mg/kg) 55 364 Mercury(Hg) (mg/kg) 55 365 Nikel (mg/l) 55 366 Other Metals (each) 55 FOOD FOR INFANTS AND CHILDREN Infants and follow up formula 367 Ash (%w/w) 45 368 Biotin 55 369 Choline (mg/l) 55 370 Cyanocabalamin (mg/l) 65 371 Fat (%w/w) 55 372 Fibre (%w/w) 55 373 Folic Acid (mg/l) 65 374 Iodine (mg/kg) 50 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 36 S/N Parameters Test fee (USD) 375 Moisture (%w/w) 30 376 Vitamin K (%μg/g) 65 377 Nicotinic Acid (% μg/g) 65 378 Pantothenic Acid (% μg/g) 65 379 Pesticide residues each 120 380 Protein (%w/w) 55 381 Riboflavin (% μg/g) 65 382 Vitamin A (%μg/g) 65 383 Vitamin D (%μg/g) 65 384 Thiamine (%μg/g) 65 Heavy Metals each 385 Mercury(Hg) (mg/kg) 55 386 Arsenic(As) (mg/l) 55 387 Lead(Pb) (mg/kg) 55 388 Other Metals (each) 55 Microbiological requirements 389 Total plate count (cfu/g) 130 390 Coliforms (cfu/g) 125 391 E.coli (cfu/g) 130 392 Staphylococcus aureus(cfu/g) 150 393 Salmonella in 25g 155 Mycotoxins 394 T. Toxin (μg/kg) 120 395 Aflatoxins (μg/kg) 120 Processed Cereal based Foods 396 Acid insoluble ash 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 37 S/N Parameters Test fee (USD) (%w/w) 397 Crude fiber (%w/w) 55 398 Fats (%w/w) 55 399 Moisture (%w/w) 30 400 Vitamin K (%μg/g) 65 401 Nicotinic Acid (% μg/g) 65 402 Pesticide residues each 120 403 Protein (%w/w) 55 404 Riboflavin (% μg/g) 55 405 Total ash (%w/w) 45 406 Caffeine (mg/kg) 65 407 Vitamin A (%μg/g) 65 408 Vitamin D (%μg/g) 65 409 Thiamine (%μg/g) 65 Heavy Metals each 410 Arsenic(As) (mg/l) 55 411 Lead(Pb) (mg/kg) 55 412 Mercury(Hg) (mg/kg) 55 413 Other Metals / Minerals (each) 55 414 Microbiological requirements 415 Total plate count (cfu/g) 130 416 Salmonella in 25g 155 417 E.coli (cfu/g) 130 418 Yeast/mould (cfu/g) 160 419 B. cereus (cfu/g) 165 420 Coliforms (cfu/ml) 125 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 38 S/N Parameters Test fee (USD) 421 Mycotoxins 422 T. Toxin (μg/kg) 120 423 Fumonisins 120 424 Aflatoxins 120 FOOD SUPPLEMENT Liquid food supplement 425 Moisture (%w/w) 30 426 Phytochemical each 40 427 Protein (%w/w) 55 428 Pesicide resudue each 120 429 Ash (%w/w) 45 430 Carbohydrate (%w/w) 30 431 Co enzymes 55 432 Essential amino acids (%mg/g) 65 433 Fats (%w/w) 55 434 Vitamin B3 (%μg/g) 65 435 Beta Carotene (mg/kg) 65 436 Disintegration 35 437 Fibre (%w/w) 65 438 Hardness (mg/l) 15 Heavy Metals each 439 Mercury(Hg) (mg/kg) 55 440 Arsenic(As) (mg/l) 55 441 Lead(Pb) (mg/kg) 55 442 Other Metals/ minerals (each) 55 Microbiological requirements Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 39 S/N Parameters Test fee (USD) 443 Salmonella spp in 25ml 155 444 Total plate count (cfu/ml) 130 445 Coliforms (cfu/m) 125 Solid food supplement 446 Vitamin A (%μg/g) 65 447 Pestiside residue each 120 448 Vitamin B12 (%μg/g) 65 449 Vitamin B3 (%μg/g) 65 450 Beta Carotene (mg/kg) 65 451 Ash (%w/w) 45 452 Carbohydrate (%w/w) 30 453 Co enzymes 55 454 Disintegration 35 455 Essential amino acids (%mg/g) 65 456 Fats (%w/w) 60 457 Fibre (%w/w) 55 458 Hardness (mg/l) 15 459 Vitamin C (%μg/g) 65 460 Moisture (%w/w) 30 461 Vitamin B6 (%μg/g) 65 462 Vitamin K (%μg/g) 65 463 Phytochemical each 65 464 Protein (%w/w) 55 Heavy Metals each 465 Lead(Pb) (mg/kg) 55 466 Arsenic(As) (mg/l) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 40 S/N Parameters Test fee (USD) 467 Mercury(Hg) (mg/kg) 55 468 Other Metals/ minerals (each) 55 Microbiological requirements 469 Salmonella spp in 25g 155 470 Total plate count (cfu/ml) 130 471 Coliforms (cfu/ml) 130 FRUITS & FRUIT PRODUCTS Dried fruits 472 Moisture (%w/w) 30 473 Pesticides Residues each 120 474 Physical 5 475 Sugar (%w/w) 50 Heavy Metals each 476 Mercury(Hg) (mg/kg) 55 477 Lead(Pb) (mg/kg) 55 478 Arsenic(As) (mg/l) 55 479 Other minerals (each) 55 Microbiological requirements 480 Salmonella in 25g 155 481 E.coli (cfu/g) 130 482 Yeasts/Moulds (cfu/g) 160 483 B. cereus (cfu/g) 165 484 C. perfringes (cfu/g) 165 Mycotoxins 485 T. Toxin (μg/kg) 120 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 41 S/N Parameters Test fee (USD) Fresh fruits 486 Pesticide residues each 120 Heavy Metals each 487 Lead(Pb) (mg/kg) 55 488 Arsenic(As) (mg/l) 55 489 Mercury(Hg) (mg/kg) 55 490 Other minerals (each) 55 Microbiological requirements 491 Salmonella spp in 25g 155 492 L. Monocytogenes in 25g 150 493 Coliforms (cfu/ml) 125 Mycotoxins 494 Patulin (μg/kg) 120 495 Ochratoxin (μg/kg 120 Fruits juices 496 Acidity (%w/v) 25 497 Carbon dioxide (Pascal) 10 498 pH (at 20°C) 10 499 Physical 5 500 Sugar(Total Soluble Solids) (%w/w) 15 501 Ascorbic Acid (mg/l) 65 502 Fenitrotin (mg/kg) 55 503 Total Acidity (%w/w) 25 Food Additives 0 504 Flavour 15 505 Food colour 65 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 42 S/N Parameters Test fee (USD) 506 Sweeteners 65 Heavy Metals each 507 Arsenic(As) (mg/l) 55 508 Lead(Pb) (mg/kg) 55 509 Mercury(Hg) (mg/kg) 55 510 Other minerals (each) 55 Microbiological requirements 511 Yeasts/Moulds (cfu/ml) 160 512 Coliforms (cfu/ml) 125 513 Total plate count (cfu/ml) 130 Mycotoxins 514 Patulin (μg/kg) 120 Preservatives 515 Sorbic Acid (mg/kg) 65 516 Benzoic acid (mg/l) 65 517 Citric Acid (%w/w) 65 518 SO2 60 Pickle 519 Acidity (%w/v) 25 520 Alcohol (%v/v) 25 521 pH (at 20°C) 10 522 Physical 5 523 Salts (%w/w) 40 Heavy Metals each by AAS 524 Lead(Pb) (mg/kg) 55 525 Arsenic(As) (mg/l) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 43 S/N Parameters Test fee (USD) 526 Mercury(Hg) (mg/kg) 55 527 Other minerals (each) 55 Microbiological requirements 528 E.coli (cfu/g) 130 529 Yeasts/Moulds (cfu/ml) 160 Preservatives 530 Benzoic acid (mg/l) 65 531 Citric Acid (%w/w) 65 532 Sorbic Acid (mg/kg) 65 533 Vitamin C (%μg/g) 65 534 SO2 60 Dates 535 Food Additive 65 536 Physical examination 5 537 Vitamin C (%μg/g) 65 538 Moisture (%w/w) 30 539 Heavy Metals each 540 Lead (Pb) (mg/kg) 55 541 Arsenic (As) (mg/l) 55 542 Mercury (Hg) (mg/l) 55 543 Other minerals (each) 55 Microbiological requirements 544 Yeasts/Moulds (cfu/ml) 160 545 E.coli (cfu/g) 130 GUM Acacia Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 44 S/N Parameters Test fee (USD) 546 Moisture 30 547 Protein (%w/w) 55 548 Sugars (%w/w) 50 549 Specific Rotation 10 550 Total solids (%w/w) 30 551 Viscosity 20 552 Glucoronic Acid (%w/w) 35 Heavy Metals each 553 Mercury(Hg) (mg/kg) 55 554 Lead(Pb) (mg/kg) 55 555 Arsenic(As) (mg/l) 55 556 Other minerals (each) 55 Gua gum 557 Moisture 30 558 Protein (%w/w) 55 559 Sugars (%w/w) 50 560 Specific Rotation 10 561 Total solids (%w/w) 30 562 Viscosity 20 563 Glucoronic Acid (%w/w) 35 Heavy Metals each 564 Mercury(Hg) (mg/kg) 55 565 Lead(Pb) (mg/kg) 55 566 Arsenic(As) (mg/l) 55 567 Other minerals (each) 55 Iodated salts Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 45 S/N Parameters Test fee (USD) Edible common salts 568 Iodine (mg/kg) 50 569 Matter Insoluble in acid (%w/w) 20 570 Moisture (%w/w) 30 571 pH (at 20°C) 10 572 Physical 5 573 Sulphates (mg/kg) 25 574 Water insoluble matter (%w/w) 25 575 Fluorides (mg/l) 35 576 Alkalinity (%w/w) 25 577 Chlorides (mg/l) 25 578 Heavy Metals each 579 Mercury(Hg) (mg/kg) 55 580 Lead(Pb) (mg/kg) 55 581 Arsenic(As) (mg/l) 55 582 Other minerals (each) 55 MEAT & MEAT PRODUCTS Cooked cured ham 583 Beef content (%w/w) 40 584 Fat (%w/w) 55 585 Nitrites (mg/kg) 60 Heavy Metals each by AAS 586 Arsenic(As) (mg/l) 55 587 Lead(Pb) (mg/kg) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 46 S/N Parameters Test fee (USD) 588 Mercury(Hg) (mg/kg) 55 589 Other Metals/ minerals (each) 55 Microbiological requirements 590 E. coli (cfu/g) 130 591 Yeasts(cfu/g) 160 592 Total viable aerobic count (cfu/g) 130 593 Salmonella spp in 25g 155 594 Veterinary drugs residues 595 Screening 60 596 ID & quatification each by LC-MS-GC 135 Corned beef 597 Beef content 40 598 Fat (%w/w) 55 599 Nitrites (mg/kg) 60 600 Salt (Nad) 40 Heavy Metals each 601 Lead(Pb) (mg/kg) 55 602 Arsenic(As) (mg/l) 55 603 Mercury(Hg) (mg/kg) 55 604 Other minerals (each) 55 Microbiological requirements 605 E. coli (cfu/g) 130 606 Total viable aerobic count (cfu/g) 130 Fresh and frozen meat Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 47 S/N Parameters Test fee (USD) 607 Total volatile bases (%w/w) 55 608 Thiobarbituric (%w/w) 40 609 Precipitin (%w/w) 55 610 Fats (%w/w) 55 611 Lean Meat (%w/w) 55 612 Peroxide Value (mEq/kg) 50 613 pH (at 20°C) 10 614 Physical 5 615 Protein (%w/w) 55 616 Free fatty acid (%w/w) 25 Heavy Metals each 617 Lead(Pb) (mg/kg) 55 618 Arsenic(As) (mg/l) 55 619 Mercury(Hg) (mg/kg) 55 620 Other minerals (each) 55 Microbiological requirements 621 E. coli (cfu/g) 130 622 Salmonella spp in 25g 155 623 Total viable aerobic count (cfu/g) 130 Veterinary Drugs 624 Screening 60 625 Quatification each by LC MS-GC-MS 135 Luncheon meat 0 626 Fat (%w/w) 55 627 Glucono delta lactones (%w/w) 65 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 48 S/N Parameters Test fee (USD) 628 Nitrites (mg/kg) 60 629 Phosphate (mg/kg) 40 630 Lactose (%w/w) 40 631 Meat content (%w/w) 55 Mycotoxins 632 Total Aflatoxin (μg/l) 120 Heavy Metals each 633 Mercury(Hg) (mg/kg) 55 634 Arsenic(As) (mg/l) 55 635 Lead(Pb) (mg/kg) 55 636 Other minerals (each) 55 Microbiological requirements 637 E. coli (cfu/g) 130 638 Salmonella spp in 25g 155 639 Total viable aerobic count (cfu/g) 130 Meat products 640 Ash (%w/w) 45 641 Colour Additives 55 642 Lean Meat (%w/w) 55 643 Nitrites (mg/kg) 60 644 Pesticide residues each 120 645 Phosphates (mg/kg) 40 646 Starch (%w/w) 40 647 Hydroxyproline (mg/kg) 40 648 Precipitin (%w/w) 55 649 Moisture Content (%w/w) 30 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 49 S/N Parameters Test fee (USD) Veterinary Drugs 650 Screening 60 651 Quantification each by LC-MS-GC-MS 135 Heavy Metals each 652 Lead(Pb) (mg/kg) 55 653 Arsenic(As) (mg/l) 55 654 Mercury(Hg) (mg/kg) 55 655 Other Metals/ minerals (each) 55 Microbiological requirements 656 E. coli (cfu/g) 130 657 Salmonella spp in 25g 155 658 Total viable aerobic count (cfu/g) 130 MILK & MILK PRODUCTS Butter 659 Moisture (%w/w) 30 660 Vitamin E (%µg/g) 65 661 Salt (Nad) 35 662 Fat 55 663 Melamine (mg/kg) 135 664 Vitamin K (%µg/g) 65 665 Pesticide residues each 120 666 Solid Not Fat (SNF) 55 667 Acidity (% w/v) 25 668 Total volatile bases (%w/w) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 50 S/N Parameters Test fee (USD) Veterinary Drugs 669 Screening 60 670 quantification each by LC-MS-GC-MS 135 Microbiological requirements 671 Straphylococcus aureus (cfu/g) 150 672 E. coli (cfu/g) 130 673 Salmonella spp in 25g 155 674 Shigella spp in 25g 155 675 Total viable aerobic count (cfu/g) 130 Mycotoxins 676 Total Aflatoxins (μg/kg) 225 Heavy metal 0 677 Mercury(Hg) (mg/kg) 55 678 Arsenic(As) (mg/l) 55 679 Lead(Pb) (mg/kg) 55 680 Other minerals (each) 55 Cheese 681 Beta Carotene (mg/kg) 65 682 Acidity (%w/v) 25 683 Ash (%w/w) 45 684 Colour additive 65 685 Drug residues each eacheach 135 686 Dry Matter (%w/w) 30 687 Fat Content (%w/w) 55 688 Melamine (mg/kg) 135 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 51 S/N Parameters Test fee (USD) 689 Vitamin B6 (%μg/g) 65 690 Pesticide residues 120 691 Total volatile bases (%w/w) 40 692 pH (at 20oC) 10 693 Phosphates (mg/kg) 40 694 Physical 5 695 Solid Not Fat (SNF) 55 696 Salt 40 Microbiological requirements 697 Straphylococcus aureus (cfu/g) 150 Mycotoxins 698 Aflatoxin M1 120 Heavy Metals each 699 Mercury (hg) (mg/kg) 55 700 Arsenic (As) mg/l) 55 701 Lead (Pb) (mg/kg) 55 702 Other minerals (each) 55 Evaporated and Condensed 703 Viscocity 20 704 Melamine (mg/kg) 135 705 Milk fat (%w/w) 60 706 Vitamin B6 (%µg/g) 65 707 Pesticide residues 120 708 pH (at 20oC) 10 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 52 S/N Parameters Test fee (USD) 709 Physical 5 710 Protein (%w/w) 55 711 Solid Not Fat (SNF) 55 712 Ash (%w/w) 45 713 Total solids (%w/w) 45 714 Sugar (%w/w) 65 Microbiology 715 Total viable aerobic count (cf) 130 Heavy Metals each 716 Arsenic (As( (mg/l) 55 717 Lead (Pb) (mg/kg) 55 718 Mercury (Hg) (mg/kg) 55 719 Other Metals/ minerals (each) 55 Mycotoxins 720 T.Toxin (µg//) 120 721 Aflatoxin M1(µg/l) 120 Fresh Milk 0 722 Melamine (mg/kg) 135 723 Milk fat (%w/w) 40 724 Vitamin B6 (%μg/g) 65 725 physical 5 726 pH (at 20°C) 10 727 Protein (%w/w) 55 728 Solid Not Fat (SNF) 55 729 Drug Residues 120 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 53 S/N Parameters Test fee (USD) 730 Total solids (%w/w) 30 731 Microbiological requirements 732 Coliforms (cfu/ml) 125 733 Total aerobic plate count (cfu/ml) 130 Heavy Metals each 734 Arsenic(As) (mg/l) 55 735 Lead(Pb) (mg/kg) 55 736 Mercury(Hg) (mg/kg) 55 737 Other minerals (each) 55 Mycotoxins 738 Total Toxin (μg/kg) 120 739 Aflatoxin M1(μg/l) 120 Fermented Milk 740 Acidity (%w/v) 25 741 Colour Additives 65 742 Vitamin B6 (%μg/g) 65 743 Physical 5 744 Solid Not Fat (SNF) 55 745 Sugar (%w/w) 65 746 Viscosity 20 747 Melamine (mg/kg) 135 748 Milk Fat (%w/w) 40 749 pH (at 20oC) 10 Microbiological requirements 750 E. coli (cfu/ml) 130 751 Yeast (cfu/ml) 160 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 54 S/N Parameters Test fee (USD) 752 Coliforms (cfu/g) 125 753 Enterobacteriaceae (cfu/g) 130 Mycotoxins 135 754 T. Toxin (μg/kg) 135 755 Aflatoxin M1(μg/l) 210 Heavy Metals each 756 Mercury(Hg) (mg/kg) 55 757 Lead(Pb) (mg/kg) 55 758 Arsenic(As) (mg/l) 55 759 Other minerals (each) 55 Ghee 760 Fat (%w/w) 55 761 Moisture (%w/w) 30 762 Melamine (mg/kg) 135 763 Free fat Acid (FFA) (%w/w) 25 764 Peroxide Value (mEq/kg) 50 765 Saponification value (mg/g) 50 766 Acidity (%w/w) 25 767 Drug Residues 135 768 Iodine value (wijs) 60 769 Pesticide residues 120 770 Solid Not Fat (SNF) 55 Heavy Metals each 771 Lead(Pb) (mg/kg) 55 772 Mercury(Hg) (mg/kg) 55 773 Arsenic(As) (mg/l) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 55 S/N Parameters Test fee (USD) 774 Other Metals/ minerals (each) 55 Mycotoxins 775 T. Toxin (μg/kg) 120 776 Aflatoxin M1(μg/l) 120 Liquid Milk-UHT 777 Milk fat (%w/w) 25 778 Vitamin B6 (%μg/g) 65 779 Pesticide residues 220 780 pH (at 20°C) 10 781 Phosphatase test 25 782 Physical 5 783 Protein (%w/w) 65 784 Solid Not Fat (SNF) 50 785 Total solids (%w/w) 30 786 Specific gravity 10 787 Creaming index 15 788 Melamine (mg/kg) 135 789 Lactose (%w/w) 15 790 Acidity (%w/v) 25 791 Freezing Point 15 792 Ash (%w/w) 45 793 Drug residues 135 794 Freezing Point 15 Microbiological requirements Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 56 S/N Parameters Test fee (USD) 795 Total viable aerobic count (cfu/g) 135 Mycotoxins 796 Aflatoxin M1(μg/l) 120 Heavy Metals each 797 Lead(Pb) (mg/kg) 55 798 Other minerals (each) 55 Milk and Dried /Cream Powder 799 Solubility (%w/w) 20 800 Lactose (%w/w) 35 Acidity (%w/w) 25 801 Drug residues 120 802 Food additives 65 Milk fat (%w/w) 20 803 Moisture content (%w/w) 45 804 Vitamin K (%µg/g) 65 Drug residues 135 805 Protein (%w/w) 65 806 Solid Not Fat (SNF) 50 Viscocity 20 807 Melamine (mg/kg) 135 Heavy Metals each 808 Mercury (Hg) (mg/kg) 55 809 Arsenic (As) (mg/l) 55 810 Lead (Pb) (mg/kg) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 57 S/N Parameters Test fee (USD) 811 Other metals/ minerals (each) 55 Microbiological 812 Total Plate Count (cfu/g) 135 813 Coliforms (cfu/g) 130 814 E. Coli (cfu/ml) 135 815 Salmonellae spp 155 816 Straphylococcus aureus (cfu/g) 210 Mycotoxins 817 T. Toxin (µg/kg) 120 818 Aflatoxin (M1( µg/l) 120 Ice cream 819 Acidity (%w/v) 25 820 Drug Residues 135 821 Total solids (%w/w) 30 822 Mass per leter 15 823 Milk fat (5w/w) 40 824 Vitamin B6 (%µg/g) 65 825 Pesticide residues 120 826 Physical 5 827 Solid Not Fat (SNF) 55 828 Viscocity 20 829 Melamine (mg/kg) 135 Heavy Metals each 830 Mercury (Hg) (mg/kg) 55 831 Lead (Pb) (mg/kg) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 58 S/N Parameters Test fee (USD) 832 Arsenic (As) (mg/l) 55 833 Other minerals (each) 55 Microbiological requirements 834 Total plate count (cfu/ml) 135 835 Coliforms (cfu/ml) 130 836 E. Coli (cfu/ml) 135 837 S. aureus (cfu/g) 210 838 Salmonella spp 155 NON ALCOHOLIC BEVERAGE Ice Rollies 839 pH (at 20°C) 10 840 Physical 5 841 Sugar (Total Soluble Solids) (%w/w) 15 842 Total solids (%w/w) 30 843 Acidity (%w/w) 25 Microbiological requirements 844 Total viable aerobic count (cfu/ml) 135 845 Coliforms (cfu/ml) 130 846 Yeasts/Moulds (cfu/ml) 160 Heavy Metals each 847 Lead(Pb) (mg/kg) 55 848 Arsenic(As) (mg/l) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 59 S/N Parameters Test fee (USD) 849 Cadmiums (mg/kg) 55 850 Other Metals/ minerals (each) 55 Food Additives 851 Food colour 65 Powdered Drinks 852 Acidity (%w/v) 25 853 pH (at 20°C) 10 854 Physical 5 855 Sugar (Total Soluble Solids) (%w/w) 15 856 Total solids (%w/w) 30 Heavy Metals each 857 Lead(Pb) (mg/kg) 55 858 Arsenic(As) (mg/l) 55 859 Mercury(Hg) (mg/kg) 55 860 Other Metals/ minerals (each) 55 Microbiological requirements 861 Total viable aerobic count (cfu/g) 130 862 Coliforms (cfu/g) 130 863 Yeasts/Moulds (cfu/g) 160 Food Additives 864 Food colour 65 865 Sweeteners each 65 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 60 S/N Parameters Test fee (USD) Soft & Energy Drinks 866 Acidity (%w/v) 25 867 Alcohol (%v/v) 25 868 Carbon dioxide (Pascal) 25 869 Sugar (Total Soluble Solids) (%w/w) 15 870 pH (at 20°C) 10 871 Physical 5 872 Total solids (%w/w) 30 Additives 873 Sweeteners each 65 874 Food colour 65 Microbiological requirements 875 Total viable aerobic count (cfu/ml) 130 876 Coliforms (cfu/ml) 125 877 Yeasts/Moulds (cfu/ml) 160 Heavy Metals each 878 Lead(Pb) (mg/kg) 55 879 Arsenic(As) (mg/l) 55 880 Mercury(Hg) (mg/kg) 55 881 Other minerals (each) 55 Mycotoxins 882 Patulin (μg/kg) 120 Preservatives 883 Benzoic acid (mg/l) 65 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 61 S/N Parameters Test fee (USD) 884 Sorbic Acid (mg/kg) 55 885 Citric Acid (%w/w) 55 886 SO2 50 Groundnuts, Cashewnut 887 Fat (%w/w) 55 888 FFA (%w/w) 55 889 Moisture (%w/w) 30 890 Mouldy kernel (%w/w) 5 891 Peroxide (mEq/kg) 85 892 Protein (%w/w) 55 893 Vitamin K (%w/w) 65 Heavy Metals each 894 Mercury(Hg) (mg/kg) 55 895 Lead(Pb) (mg/kg) 55 896 Arsenic(As) (mg/l) 55 Microbiological requirements 897 Salmonella spp in 25g 155 898 E. coli (cfu/g) 160 899 Yeasts and moulds (cfu/g) 165 900 Total viable aerobic count (cfu/g) 130 901 B. cereus (cfu/g) 165 902 C. perfringens (cfu/g) 165 Mycotoxin 903 Aflatoxin 120 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 62 S/N Parameters Test fee (USD) Roasted nuts and peanut butter 904 Acid insoluble ash (%w/w) 55 905 Fat (%w/w) 55 906 FFA (%w/w) 55 907 Moisture (%w/w) 30 908 Vitamin K (%μg/g) 65 909 Peroxide (mEq/kg) 50 910 Protein (%w/w) 55 911 Total ash (%w/w) 45 912 Mycotoxins 913 Aflatoxins 120 Heavy Metals each 914 Lead(Pb) (mg/kg) 55 915 Arsenic(As) (mg/l) 55 916 Mercury(Hg) (mg/kg) 55 917 Other minerals (each) 55 Microbiological requirements 918 Salmonella spp in 25g 155 919 E. coli (cfu/g) 130 920 Yeasts and moulds (cfu/g) 160 Portable water Drinking water/Mineral Water 921 pH (at 20°C) 10 922 Physical 5 923 Sulphates (mg/kg) 40 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 63 S/N Parameters Test fee (USD) 924 Fluorides (mg/l) 40 925 Total Dissolved solids (mg/l) 15 926 Total hardness (mg/l) 35 927 Turbidity 40 928 Total Suspended solids (w/v) 10 929 Polyaromatic Hydrocarbons (PAH) 115 930 Sulphides (%w/w) 40 931 Alkalinity (%w/w) 25 932 Chlorides (mg/l) 35 933 Conductivity (μS/cm) 10 934 Nitrate (mg/kg) 60 935 Odor 5 936 Pesticide residues each 120 Heavy Metals each 937 Arsenic(As) (mg/l) 55 938 Lead(Pb) (mg/kg) 55 939 Mercury(Hg) (mg/kg) 55 940 Other minerals (each) 55 Microbiological requirements 941 Coliforms (MPN/100ml) 125 942 Faecal coliforms (MPN/100ml) 125 943 Faecal streptococci (MPN/100ml) 125 944 Pseudomonas auruginosa (MPN/100ml) 125 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 64 S/N Parameters Test fee (USD) 945 Sulphite reducing anaerobes (MPN/100ml) 125 Protein concentrates (Vegetable, milk, egg, collagen and gelatine ) 946 Ash (%w/w) 45 947 Moisture (%w/w) 30 948 Protein (%w/w) 55 949 Pesticide residues each 120 Heavy Metals each 950 Lead(Pb) (mg/kg) 55 951 Arsenic(As) (mg/l) 55 952 Mercury(Hg) (mg/kg) 55 953 Other Metals/ minerals (each) 55 Microbiological requirements 954 Salmonella spp in 25g 155 955 E. coli (cfu/g) 130 956 Yeasts and moulds (cfu/g) 160 Pulses Extruded Products 957 Moisture (%w/w) 30 958 Protein (%w/w) 55 959 Vitamin K (%µg/g) 9. Heavy Metals each 65 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 65 S/N Parameters Test fee (USD) 960 Lead(Pb) (mg/kg) 55 961 Arsenic(As) (mg/l) 55 962 Mercury(Hg) (mg/kg) 55 963 Other Metals/ minerals (each) 55 Microbiological requirements 964 B. cereus (cfu/g) 165 965 Yeast /Mould (cfu/g) 160 966 E.coli (cfu/g) 130 967 C. perfringens (cfu/g) 160 Mycotoxins 968 T. Toxin (µg/kg) 120 Legumes 969 Colored grains seeds (%w/w) 5 970 Discoloured seeds (%w/w) 5 971 Foreign matter (%w/w) 5 972 Heat damaged seeds (%w/w) 5 973 Immature or shrivelled (%w/w) 5 974 Insect damage seeds (%w/w) 5 975 Moisture (%w/w) 30 976 Pesticide residues each 120 977 Vitamin K (%µg/g) 65 978 Physical 5 Heavy Metals each Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 66 S/N Parameters Test fee (USD) 979 Lead(Pb) (mg/kg) 55 980 Arsenic(As) (mg/l) 55 981 Mercury(Hg) (mg/kg) 55 982 Other minerals (each) 55 Microbiological requirements 983 B. cereus (cfu/g) 165 984 Yeast /Mould (cfu/g) 160 985 E.coli (cfu/g) 130 986 C. perfringens (cfu/g) 165 Mycotoxins 987 Total Toxin (µg/kg) 120 Legumes Flours 0 988 Ash (%w/w) 45 989 Crude fat (%w/w) 55 990 Crude fiber (%w/w) 55 991 Foreign matter (%w/w) 5 992 Moisture (%w/w) 30 993 Pesticide residues each 120 994 Protein (%w/w) 55 995 Vitamin K (% µg/g) 65 Heavy Metals each 996 Lead(Pb) (mg/kg) 55 997 Arsenic(As) (mg/l) 55 998 Mercury(Hg) (mg/kg) 55 999 Other minerals (each) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 67 S/N Parameters Test fee (USD) Microbiological requirements 1000 B. cereus (cfu/g) 165 1001 Yeast /Mould (cfu/g) 160 1002 E.coli (cfu/g) 130 1003 C. perfringens (cfu/g) 165 Mycotoxins 1004 Total Toxin (µg/kg) 120 Spices and Herbs 1005 Acid insoluble ash (%w/w) 55 1006 Alcohol extract 40 1007 Crude fiber (%w/w) 55 1008 Chromate test 25 1009 Moisture (%w/w) 30 1010 Non-Volatile oils 50 1011 Physical 5 1012 (NaCl) (%w/w) 25 1013 Sugar (%w/w) 55 1014 Total ash (%w/w) 45 1015 Water soluble ash (%w/w) 50 1016 Volatile oils 55 1017 Extraneous matter (%w/w) 5 1018 Pesticide residues each 120 Heavy Metals each 1019 Lead(Pb) (mg/kg) 55 1020 Arsenic(As) (mg/l) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 68 S/N Parameters Test fee (USD) 1021 Mercury(Hg) (mg/kg) 55 1022 Other Metals/ minerals (each) Microbiological requirements 1023 B. cereus (cfu/g) 165 1024 Yeast /Mould (cfu/g) 160 1025 E.coli (cfu/g) 130 1026 C. perfringens (cfu/g) 165 1027 Salmonella spp in 25g 155 Vinegar 1028 Fixed Acidity (%w/w) 25 1029 pH (at 20°C) 10 1030 Relative Density (w/v) 10 1031 Total ash (%w/w) 45 1032 Total Acidity (%w/w) 25 1033 Volatile Acidity (%w/w) 25 Heavy Metals each 1034 Lead(Pb) (mg/kg) 55 1035 Arsenic(As) (mg/l) 55 1036 Mercury(Hg) (mg/kg) 55 1037 Other minerals (each) 55 Sugar and Honey Honey 1038 Moisture (%w/w) 30 1039 Pesticide residues each 120 1040 pH (at 20°C) 10 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 69 S/N Parameters Test fee (USD) 1041 Reducing sugar (%w/w) 65 1042 Sucrose (%w/w) 65 1043 Total nitrogen (%w/w) 55 1044 Proline (%w/w) 55 1045 Free acidity (%w/w) 40 1046 Dextrose (%w/w) 65 Drug residues 1047 Screening 60 1048 Quatification each by LC-MS-GC-MS 135 1049 Diastase activity (%w/w) 55 1050 HMF (mg/kg) 50 Heavy Metals each 1051 Lead(Pb) (mg/kg) 55 1052 Arsenic(As) (mg/l) 55 1053 Mercury(Hg) (mg/kg) 55 1054 Other minerals (each) 55 Sugar 1055 Sulphur dioxide (mg/kg) 50 1056 Total ash (%w/w) 45 1057 Colour in ICUMSA 30 1058 Water insoluble matter (%w/w) 1059 Conductivity Ash (%w/w) 25 1060 Moisture (%w/w) 45 1061 Pesticide residues each 120 1062 Physical 5 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 70 S/N Parameters Test fee (USD) 1063 Polarization (%w/w) 25 Heavy Metals each 1064 Lead(Pb) (mg/kg) 55 1065 Arsenic(As) (mg/l) 55 1066 Mercury(Hg) (mg/kg) 55 1067 Other Metals/ minerals (each) 55 TEA , COFFEE & COCOA Chocolate and Chocolate products 1068 Additive 65 1069 Fat free coco solids (%w/w) 15 1070 Milk fat (%w/w) 60 1071 Pesticide residues each 120 1072 Physical 5 1073 Starch (%w/w) 40 1074 Total coco solids (%w/w) 15 1075 Total coco butter (%w/w) 40 1076 Vitamin K (%µg/g) 65 Microbiological requirements 1077 Total viable aerobic count (cfu/g) 130 1078 Yeast /Mould (cfu/g) 160 1079 E.coli (cfu/g) 130 1080 Salmonella spp in 25g 155 Heavy Metals each Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 71 S/N Parameters Test fee (USD) 1081 Lead(Pb) (mg/kg) 55 1082 Arsenic(As) (mg/l) 55 1083 Mercury(Hg) (mg/kg) 55 1084 Other minerals (each) 55 Coco butter 1085 Water soluble ash (%w/w) 40 1086 Total coco solids (%w/w) 25 1087 Acid insoluble ash (%w/w) 55 1088 Alkalinity of soluble ash (%w/w) 40 1089 Coco butter 35 1090 Crude fiber (%w/w) 55 1091 Pesticide residues each 120 1092 Physical 5 1093 Vitamin K (%µg/g) 65 Heavy Metals each 1094 Lead(Pb) (mg/kg) 55 1095 Arsenic(As) (mg/l) 55 1096 Mercury(Hg) (mg/kg) 55 1097 Other minerals (each) 55 Coco mass and Coco Cake 1098 Additive 65 1099 Pesticide residues each 120 1100 Physical 5 1101 Total coco butter (%w/w) 40 1102 Coco germ 10 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 72 S/N Parameters Test fee (USD) 1103 Vitamin K (%µg/g) 65 8. Mycotoxins each 120 1104 Arsenic(As) (mg/l) 55 1105 Mercury(Hg) (mg/kg) 55 1106 Other Metals/ minerals (each) 55 Coco milo 1107 Moisture (%w/w) 30 1108 Vitamin K (%µg/g) 65 1109 Water soluble ash (%w/w) 40 1110 Total coco solids (%w/w) 30 1111 Cold water extract 25 1112 Acid insoluble ash (%w/w) 50 1113 Alkalinity of soluble ash (%w/w) 40 1114 Caffeine (mg/kg) 65 1115 Crude fiber (%w/w) 55 1116 Fat (%w/w) 60 1117 Pesticide residues each 120 1118 Physical 5 Heavy Metals each 1119 Lead(Pb) (mg/kg) 55 1120 Arsenic(As) (mg/l) 55 1121 Mercury(Hg) (mg/kg) 55 1122 Other Metals/ minerals (each) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 73 S/N Parameters Test fee (USD) Microbiological requirements 1123 Total viable aerobic count (cfu/g) 130 1124 Yeast /Mould (cfu/g) 160 1125 E.coli (cfu/g) 135 1126 Salmonella spp in 25g 160 Coffee 1127 Starch (%w/w) 40 1128 Sugar (%w/w) 55 1129 Total ash (%w/w) 45 1130 Acid insoluble ash (%w/w) 55 1131 Alkalinity of soluble ash (%w/w) 50 1132 Caffeine (mg/kg) 65 1133 Fat (%w/w) 60 1134 Microscopic 15 1135 Moisture (%w/w) 45 1136 Pesticide residues each 120 1137 pH (at 20°C) 10 1138 Physical 5 1139 Protein (%w/w) 65 1140 Vitamin K ((%µg/g) 65 Mycotoxins 1141 Ochratoxins 120 Heavy Metals each Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 74 S/N Parameters Test fee (USD) 1142 Mercury(Hg) (mg/kg) 55 1143 Lead(Pb) (mg/kg) 55 1144 Arsenic(As) (mg/l) 55 1145 Other minerals (each) 55 Microbiological requirements 1146 Total viable aerobic count (cfu/g) 130 1147 E.coli (cfu/g) 130 1148 Salmonella in 25g 155 1149 Yeasts/Moulds 160 TEA 1150 Acid insoluble ash (%w/w) 55 1151 Alkalinity of water Soluble ash (%w/w) 40 1152 Caffeine (mg/kg) 55 1153 Moisture (%w/w) 30 1154 Pesticide residues each 120 1155 pH (at 20°C) 10 1156 Physical 5 1157 Total ash (%w/w) 45 1158 Water soluble ash (%w/w) 40 1159 Water extractive (%w/w) 25 Mycotoxins Heavy Metals each 1160 Mercury(Hg) (mg/kg) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 75 S/N Parameters Test fee (USD) 1161 Lead(Pb) (mg/kg) 55 1162 Arsenic(As) (mg/l) 55 1163 Other Metals/ minerals (each) 55 Microbiological requirements 1164 Total viable aerobic count (cfu/g) 130 1165 E. coli (cfu/g) 130 1166 Yeasts/Moulds 160 1167 Salmonella in 25g 155 TUBER & ROOTS Cassava and Products 1168 Carbohydrate (%w/w) 30 1169 Glycosidic Cyanide (%w/w) 65 1170 Moisture (%w/w) 30 1171 Starch (%w/w) 40 1172 Pesticide residues each 120 Heavy Metals each 1173 Lead(Pb) (mg/kg) 55 1174 Arsenic(As) (mg/l) 55 1175 Mercury(Hg) (mg/kg) 55 1176 Other Metals/ minerals (each) 55 1177 Microbiological requirements Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 76 S/N Parameters Test fee (USD) 1178 Total viable aerobic count (cfu/g) 130 1179 E.coli (cfu/g) 130 1180 Salmonella in 25g 155 1181 Yeasts/Moulds 160 Preservatives SO2 50 Roots 1182 Carbohydrate (%w/w) 30 1183 Moisture (%w/w) 30 1184 Pesticide residues each 120 1185 Starch (%w/w) 40 1186 Vitamin K (%µg/g) 65 Heavy Metals each 1187 Mercury(Hg) (mg/kg) 55 1188 Lead(Pb) (mg/kg) 5 1189 Arsenic(As) (mg/l) 55 1190 Other minerals (each) 55 VEGETABLES & VEGETABLE PRODUCTS Dried vegetables 1191 Moisture (%w/w) 30 1192 Pesticide residues each 120 1193 Physical 5 Heavy Metals each 1194 Mercury(Hg) (mg/kg) 55 1195 Lead(Pb) (mg/kg) 55 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 77 S/N Parameters Test fee (USD) 1196 Arsenic(As) (mg/l) 55 1197 Other Metals/ minerals (each) 55 Microbiological requirements 1198 B. cereus (cfu/g) 165 1199 E.coli (cfu/g) 130 1200 Moulds/Yeasts (cfu/g) 160 1201 C. perfringens (cfu/g) 165 Mycotoxins 1202 Patulin (µg/g) 120 Fresh and frozen vegetables 1203 Pesticides Residues each 120 1204 Physical 5 Microbiological requirements 1205 Salmonella spp in 25g 155 1206 L. monocytogenes in 25g 150 1207 E. coli (cfu/g) 130 1208 Coliforms (cfu/ml) 125 Heavy Metals each 1209 Lead(Pb) (mg/kg) 55 1210 Arsenic(As) (mg/l) 55 1211 Mercury(Hg) (mg/kg) 55 1212 Other Metals/ minerals (each) 55 TOMATOE SAUCE, KETCHUP, PASTE & CHILL SAUCE Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 78 S/N Parameters Test fee (USD) 1213 Acidity (%w/v) 25 1214 Pesticide residues each 10 1215 Preservatives 65 1216 Sodium Chloride (%w/w) 50 1217 Sugar(Total Soluble Solids) (%w/w) 15 1218 Starch (%w/w) 35 1219 Specific gravity 10 Heavy Metals each 1220 Lead(Pb) (mg/kg) 55 1221 Arsenic(As) (mg/l) 55 WQ1 222 Mercury(Hg) (mg/kg) 55 1223 Other Metals/ minerals (each) 55 Microbiological requirements 1224 Total viable aerobic count (cfu/g) 130 1225 Yeasts/Moulds (cfu/g) 160 Preservatives 1226 Sorbic Acid (mg/kg) 65 1227 Benzoic acid (mg/l) 65 1228 Citric Acid (%w/w) 65 1229 SO2 50 Food Additives 1230 Food colour 65 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 79 S/N Parameters Test fee (USD) Tablets / Capsules / Sachets Physical examination 5 Identification 1231 by UV/VIS 65 1232 by HPLC @ API 435 1233 by FTIR 100 1234 by TLC 175 1235 by Colour reaction 80 Pharmaceutical Categories Parameters 1236 by Melting point 30 1237 by Optical rotation 30 Assay 1238 by UV/VIS 180 1239 by HPLC @ API 625 1240 by Titration 225 1241 Bioassay 175 Dissolution 1242 by UV/VIS 130 1243 by HPLC @ API 720 Uniformity of dosage unit 1244 Content of uniformity ( CU) by UV/VIS 320 1245 CU by HPLC @ API 1290 Uniformity of dosage unit Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 80 S/N Parameters Test fee (USD) 1246 by weight variation 25 Related Substances/impurities @ STD 1247 by HPLC 510 1248 by HPLC (limit) 645 1249 by TLC 355 1250 by TLC( limit) 60 Limit tests 1251 Sulphated Ash 230 1252 Heavy metals by AAS @ element 255 1253 Heavy metals by colour limit 160 Moisture Content 1254 by Loss on drying 70 1255 by KF 450 1256 by direct titration 455 1257 by distillation 55 1258 Disintegration 35 1259 Hardness 10 1260 Friability 25 Microbial limit 1261 Total Aerial Microbial Count 170 1262 Yeast/Mould Count 145 1263 E. coli 120 1264 Pseudomonas aeroginosa 125 1265 Salmonella 155 1266 S. aureus 150 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 81 S/N Parameters Test fee (USD) Syrups/Suspensions/ Solutions/Powder or granules for suspension 1267 Physical examination 5 Identification 1268 by UV/VIS 65 1269 by HPLC 435 1270 by FTIR 105 1271 by TLC 175 1272 by Colour reaction 80 1273 by Optical rotation 30 Assay 1274 by UV/VIS 180 1275 by HPLC 625 1276 by Titration 225 1277 Bioassay 175 Uniformity of dosage unit 1278 CU by UV/VIS 320 1279 CU by HPLC 1290 Uniformity of dosage unit 1280 Weight variation Related Substances/impurities 1281 by HPLC 510 1282 by HPLC (limit) 645 1283 by TLC 355 1284 by TLC( limit) 60 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 82 S/N Parameters Test fee (USD) Deliverable volume 25 Limit tests @ element 1285 Sulphated Ash 230 1286 Heavy metals by AAS 255 1287 Heavy metals by colour limit 160 1288 pH 10 1289 Weight /ml 24 Moisture Content 1290 by Loss on drying 70 1291 by KF 450 1292 by direct titration 455 1293 by distillation 55 Microbial limit 1294 Total Aerial Microbial Count 170 1295 Yeast/Mould Count 145 1296 E. coli 120 1297 Pseudomonas aeroginosa 125 1298 Salmonella 155 1299 S. aureus 150 Injectables (Small & large volume Parenteral) + dry powder for injections 1300 Physical examination 5 Assay 1301 by UV/VIS 180 1302 by HPLC @ API 625 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 83 S/N Parameters Test fee (USD) 1303 by Titration 225 1304 Bioassay 170 Identification 1305 by UV/VIS 65 1306 by HPLC @ API 435 1307 by FTIR 105 1308 by TLC 175 1309 by Colour reaction 80 1310 by Optical rotation 30 1311 Moisture Content 1312 by Loss on drying 70 1313 by KF 450 1314 by direct titration 455 1315 by distillation 55 1316 pH 10 1317 Related Substances/impurities @ STD 1318 by HPLC 510 1319 by HPLC (limit) 645 1320 by TLC 355 1321 by TLC( limit) 60 Uniformity of dosage unit 1322 CU by UV/VIS 320 1323 CU by HPLC @ API 1290 Uniformity of dosage unit Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 84 S/N Parameters Test fee (USD) 1324 Weight variation 25 Limit of other impurities 1325 Heavy metals by colour limit 160 1326 Sulphated Ash 230 1327 Deliverable volume 25 1328 Clarity of solution 25 1329 Colour of solution 355 1330 Particulate Matter 25 Sterility 1331 by filtration 140 1331 by steritest 150 1332 Bacterial endotoxins 150 External Preparation Cream/Ointments/ Gel/ lotion (sterile+non sterile) 1333 Physical examination 5 1334 Assay 1335 by UV/VIS 180 1336 by HPLC @ API 625 1337 by Titration 225 1338 Bioassay 175 Identification 1339 by UV/VIS 65 1340 by HPLC @ API 435 1341 by FTIR 105 1342 by TLC 175 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 85 S/N Parameters Test fee (USD) 1343 by Colour reaction 80 Uniformity of dosage unit 1344 Weight variation 25 Water content 1345 by KF 450 1346 by direct titration 455 1347 by distillation 55 Limit of other impurities 1348 Heavy metals by colour limit 160 1349 Sulphated Ash 230 Viscocity Microbial limit 1350 Total Aerial Microbial Count 170 1351 Yeast/Mould Count 145 1351 Inhaler + Aerosols Physical examination 5 Identification 1352 by UV/VIS 65 1352 by HPLC @ API 435 1352 by FTIR 105 1352 by TLC 175 1352 by Colour reaction 80 1352 by Melting point 30 1352 by Optical rotation 30 Assay 1353 by UV/VIS 180 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 86 S/N Parameters Test fee (USD) 1354 by HPLC @ API 625 1355 by Titration 225 1356 Bioassay 170 Uniformity of delivered dose @ STD 1357 by determination of contents 625 1358 Deposition of the Emitted dose @ STD 625 Related Substances/impurities @ STD 1359 by HPLC 510 1360 by HPLC (limit) 645 1361 by TLC 355 1362 by TLC( limit) 60 Limit tests 1363 Sulphated Ash 230 1364 Heavy metals by AAS @ element 255 1365 Heavy metals by colour limit 160 Moisture Content 1366 by Loss on drying 70 1367 by KF 450 1368 by direct titration 455 1369 by distillation 55 Leak test 1370 Direct measurement 25 Microbial limit 1371 Total Aerial Microbial Count 170 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 87 S/N Parameters Test fee (USD) 1372 Yeast/Mould Count 145 Eye/ear drops 1373 Physical examination 5 Assay 1374 by UV/VIS 180 1375 by HPLC @ API 625 1376 by Titration 225 1377 Bioassay 175 Identification 1378 by UV/VIS 65 1379 by HPLC @ API 435 1380 by FTIR 105 1381 by TLC 175 1382 by Colour reaction 80 1383 by Optical rotation 30 Water Content 1384 by KF 450 1385 by direct titration 455 1386 by distillation 55 1387 pH 10 Related Substances/impurities @ STD 1388 by HPLC 510 1389 by HPLC (limit) 645 1390 by TLC 355 1391 by TLC( limit) 60 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 88 S/N Parameters Test fee (USD) Uniformity of dosage unit 1392 CU by UV/VIS 320 1393 CU by HPLC 1290 Uniformity of dosage unit 1394 Weight variation 25 Limit of other impurities 1395 Heavy metals by colour limit 160 1396 Sulphate Ash 230 1397 Leakage 25 1398 Metal particles 25 Sterility 1399 by filtration 140 1400 by steritest 150 Raw Materials(Active Pharmaceutical Ingredient) Appearance/Description 10 Assay 1401 by UV/VIS 180 1402 by HPLC @ API 625 1403 by Titration 225 1404 Bioassay 175 Identification 1405 by UV/VIS 65 1406 by HPLC @ API 435 1407 by FTIR 105 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 89 S/N Parameters Test fee (USD) 1408 by TLC 180 1409 by Colour reaction 80 1410 by Optimal rotation 30 1411 by melting point 30 Moisture Content 1412 by Loss on drying 70 1413 by KF 450 1414 by Direct titration 455 1415 by Distillation 55 Related Substances/impurities @ STD 1416 by HPLC 510 1417 by HPLC (limit) 645 1418 by TLC 355 1419 by TLC (limit) 60 Limit of other impurities 1420 Heavy metals by limits test 160 1421 Sulphated Ash 230 Microbial limit 1422 Total Aerial Microbial Count 170 1423 Yeast/Mould Count 145 1424 E. coli 120 1425 Pseudomonas aeroginosa 125 1426 Salmonella 156 1427 S. aureus 150 Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 GN. No. 464 (contd.) 90 S/N Parameters Test fee (USD) Cosmetics Cream/Ointments/Gel/lotion 1428 Physical examination 5 Identification for banned ingredients 1429 by TLC 175 1430 by HPLC 305 1431 by HPTLC 175 1432 by GC - MS 170 Determination of heavy Metals @ element 1433 by AAS 155 Microbial limit 1434 Total Aerial Microbial Count 170 1435 Yeast/ Mould Count 145 Dar es Salaam SEIF SELEMAN RASHID 10th October, 2015 Minister for Health and Social Welfare