Palestinian flour fortification formula

Palestinian National Authority Ministry of Health Primary Health Care & Public Health Directorate Nutrition Department Date: 7/2/2010 PHCGD ~\ O)jJ 4.Jt;\ ~I 4.:~.)1 ~W\ o)J'i1 ~W\ ~I.J Ref.: PNl10055.doc Palestinian Flour Fortification Formula AverageMaximum Nutrient Fortificant compoundMin. AdditionAdditionTolerance Lev. (m2fkg) Level (m!!/kl!)Level (m!!/kl!) Folate folic acid1.01.52.5 Fe ferrous sulfate dried25.034.460 B-12 Vitamin B 120.1 % WS0.00250.0040N.A B-1 Thiamin Mononitrate2.02.9N.A B-2 Riboflavin2.53.6N.A B-6 Pyridoxin2.53.6N.A Niacin Niacinamide25.035.0N.A Zn zinc oxide15.020.640 Vit. A Vit. A Palm. CWS-2501.001.52.5 Vit. 0 Vit. 03,100 CWS/A0.0150.0230.050 Filling material (CaC03): 250 - forficants Palestinian Premix Specifications Parameters Range General SpecificationsNutrient Content The same as Palestinian Premix formula 1 Particle size 100% NMT 250 microns, pass through mesh number 60 Fillers and other additives Calcium Carbonate (QS), NMT 2% of (colloidal silicon dioxide or any other suitable glidant like lactose)Humidity NMT 6.0% Bulk Density NLT 0.5 glml Packaging material Laminated aluminum General appearance Creamy to Yellowish orange Color No color addition Odor Vitamins odor Telfax.: 0097022404764 e-mail: aiaburub@usa.com P.O. Box: 752/ Ramallah 009702 2404764 :~li\:; aiaburub@usa.com :~-,fi\ ~y. .ili1t'j /752 :.'-;-1 'l>'" Safety Parameters Parameters Range Physical As mentioned above Chemical Heavy metals for raw materials TAC (NMT 3000 CFU/g).Microbiological Mold & Yeast (NMT 100 CFU/g). E. Coli, Salmonella & Staph. Aureus (Absent).LabelingName Premix powder for flour fortification Manufacturer Should be mentioned Address Should be mentioned Lot # Should be mentioned Production date Should be mentioned as (month / year) Exp. Date Six months from production date Additives Should be mentioned Weight Should be mentioned Instructions for use: (dilution) Should be mentioned on label Storage condition In a dry place at room temperatures Composition Should be mentioned Colored fortification logo Should be printed MethodsSampling Same as drug Sample size Same as drug Reference sample Same as drug Physical methods According to CPHL SOPs Chemical methods According to CPHL SOPs Microbiological Assay for Vit B12 1 Palestinian Premix Formula Micronutrients Unit/Cone. ofApplied Material Kg Micronutrient PremixVitamin A IV20,000,000Vit. A Palm. CWS-250 Vitamin D IV3,600,000 Vit. 03, 100 CWS/A Thiamine (vitamin Bl Base) mg11,600Thiamine Mononitrate Riboflavine (vitamin B2) mg14,500 Riboflavine Pyridoxine (vitamin B6) mg14,500 Pyridoxin Niacinamide mg140,000 Niacinamide Folic acid (anhydrous vitamin B9) mg6,100 Folic acid Vitamin B12 J1.g16,500Vitamin 812 0.1% WS Zinc mg80,400 Zinc oxide Iron mg136,000Ferrous sulfate dried Calcium mg57,078 Filling material (CaC03): 250- fortificants Mixing Rate: 250 g premix / Metric Ton Flour. 2 Ree:istration Requirement of Fortificants for Wheat Flour (Premix) The Importer or Premix Agent should registrate the Premix before using or marketing. The following documents should be presented to the Drug Control and Registration Department in Ministry of Health: 1. Master formula including all the materials used in the formulation & their quantities (w/w or %). 2. The specification of all active raw materials used in the master formula, & their references. 3. Original certificate of analysis of all active materials used in the master formula. 4. The physical, chemical & biological specification of the manufactured product (Premix). 5. Method of analysis of the manufactured product (Premix). 6. Certificate of analysis of the manufactured product (Premix). 7. Specification of the label & the packaging material & empty samples. 8. Samples sufficient for 3 analyses. 9. Analysis fees. 10.Registration fees. Eng. Ala'a Abu Rub Nutrition Department Director 3