RUTF product specifications
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1 MSF International Office UNICEF SD, RUTF pre-bid conference, August 15, 2012 RUTF product specifications Odile Caron Coordinator for food quality assurance
2 Scope Item description Finished product specifications: Composition, nutritional information / Vitamin and minerals Raw material Packaging and labelling Microbiology and mycotoxins Chemical safety Stability study Production process and quality assurance Documents to provide
3 Scope RUTF paste peanut based Adaptation from Therapeutic milk F100 In accordance with United Nations (UN) guidelines for the outpatient care and management of SAM Community-Based Management of Severe Acute Malnutrition. A Joint Statement by the World Health Organization, the World Food Programme, the United Nations System Standing Committee on Nutrition, and the United Nations Children s Fund
4 Scope Item description Finished product specifications Raw material Packaging and labelling Microbiology and mycotoxins Chemical safety Stability study Production process and quality assurance Documents to provide
5 Item description Ready to use: no cooking/mixing/dilution required Portable & Portion controlled: 92g unit Storage conditions: no refrigeration required Texture: smooth uniform paste with small particle size (<200 microns) no grittiness, no lumps no oil separation easy too squeeze out of the sachet Appearance: light brown to cream
6 Scope Item description Finished product specifications: Composition, nutritional information / Vitamin and minerals Raw material Packaging and labelling Microbiology and mycotoxins Chemical safety Stability study Production process and quality assurance Documents to provide
7 Finished product specifications Composition - nutritional information
8 Finished product specifications PDCAAS PDCAAS (a) 95% minimum 100% preferably (a) Protein Digestibility-Corrected Amino Acid Score, calculated using the method proposed by FAO/WHO/UNU By calculation Amino acids profile
9 Finished product specifications Minerals (per 100g) Vitamins (per 100g) Mineral content 3-4% vitamin A mg Sodium <290 mg vitamin D mcg Potassium mg vitamin E >20 mg Calcium mg vitamin K mcg Phosphorous mg vitamin B1 (thiamin) >0.5 mg Magnesium mg vitamin B2 (riboflavin) >1.6 mg Iron mg vitamin C >50 mg Zinc mg vitamin B6 >0.6 mg Copper mg vitamin B12 >1.6 mcg Selenium mcg vitamin B9 (folic acid) >200 mcg Iodine mcg vitamin B3 (niacin) >5 mg vitamin B5 vitamin B7 (biotin) >3 mg >60 mcg
10 Scope Item description Finished product specifications Raw material Packaging and labelling Microbiology and mycotoxins Chemical safety Stability study Production process and quality assurance Documents to provide
11 Raw material >>> Milk: >50% proteins from milk/dairy products Acceptable sources of dairy protein: Skimmed milk powder / Full cream milk powder Whey protein powder Codex STAN : Codex Standard for Milk Powders and Cream Powder Codex STAN : Codex Standard for Whey Powders >>> Peanut or peanut paste Codex STAN : Codex Standard for Peanuts CAC/RCP : Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Peanuts.
12 Raw material >>> Oil: edible refined vegetable oil Type of oil judiciously chosen Specifications for oil shall be established Codex STAN : Codex Standard for Named Vegetable Oils >>> Carbohydrates (sweetener): Lactose & glucose polymers Lactose Sucrose Maltodextrine Fructose Precooked and/or gelatinised starches No honey (risk of Clostridium botulinum toxicity) => Properly ground (to avoid granulation, oil separation and leakage) Codex STAN : Codex Standard for Sugars
13 Raw material >>> Complex of minerals and vitamins (premix) Shall provide from the list of sources of premix authorized by WFP DSM Nutritional products Nicholas Piramal Healthcare Ltd BASF (SternVitamin) Fortitech Hexagon Nutrition GAIN premix facility Certificate of analysis provided to the manufacturer for each batch delivered
14 Raw material >>> Complex of minerals and vitamins (premix) Soluble & easily absorbed by patients with SAM. Added minerals water-soluble & shall not form insoluble components when mixed together. Mineral composition that does not alter the acid-base metabolism of patients with SAM: moderate positive non-metabolisable base sufficient to eliminate the risk of metabolic acidosis:
15 Raw material Guidance on forms of minerals and vitamins Calcium lactate
16 Raw material Guidance on forms of minerals and vitamins
17 >>> Emulsifying agents Raw material Lecithin Mono and diglycerides max 0.5g / 100 grams max 2g/100g Level between 1.5 and 2.0 g/100g can be accepted because there is no adverse effect - all triglyceride oil is decomposed to monoglycerides in the digestion system prior to absorption). >>> Flavouring Artificial flavourings not allowed, only natural flavours >>> Antioxidants Only natural antioxidants Ascorbyl palmitate Mixed tocopherols BHA and BHT not added as antioxidant
18 Scope Item description Finished product specifications Raw material Packaging and labelling Microbiology and mycotoxins Chemical safety Stability study Production process and quality assurance Documents to provide
19 92g only Packaging and labelling >>> Primary packaging (sachet) No detachable parts that present a choking hazard Ex: Aluminium polymer film, polyethylene terephthalate (PET) Packaging materials (aluminum foil, cups, etc), inks and glue food-contact approved Requirement for fat O2 moisture barrier Packaging under nitrogen protects from oxidation; Seal: pouch free of damage, hermetically sealed, minimum 2.5 mm (0.010 in), free of impression or design on the seal surface that would conceal or impair visual detection of seal defects. Air and watertighness control implemented during the filling process
20 Packaging and labelling Confusion between different packagings
21 Packaging and labelling PMS 485 preferred Proportion without the seal area Seal area excluded from the zone calculation No modification/addition allowed in the red zone
22 Packaging and labelling
23 >>> Secondary packaging (carton) Sturdy quality: - ECT (Edge Crush test*) > 11kN/m with minimum 60% remaining with 90% humidity at temperature of 40 C - Able to be stacked to a height of 2.4 m, and resistant to puncturing. - Plastic bag Packaging and labelling Information printed: - Red zone = same information as red zone of sachets - Name and address of the manufacturer, packer, distributor, importer, exporter or vendor including the country of origin - Storage conditions: product to be stored below X degrees celcius - Net weight - Numbers of units in a carton, - Batch number and best before date
24 Packaging and labelling >>> leaflet Information printed: - Red zone = same information as red zone of sachets - Name and address of the manufacturer incl. the country of origin - Composition: all ingredients (in order of descending quantities) - Information of allergens and ingredients of animal origin - Nutritional values in 100g: energy, proteins, lipids and detailed content of each vitamins and minerals - Reference to joint statement on management of SAM - Instructions for use: - Storage instructions
25 Scope Item description Finished product specifications Raw material Packaging and labelling Microbiology and mycotoxins Chemical safety Stability study Production process and quality assurance Documents to provide
26 Microbiology and mycotoxins
27 Scope Item description Finished product specifications Raw material Packaging and labelling Microbiology and mycotoxins Chemical safety Stability study Production process and quality assurance Documents to provide
28 - Pesticides and heavy metal Chemical safety CAC/RCP : Code of Practice for Source Directed Measures to Reduce Contamination of Food with Chemicals. CODEX STAN : General Methods of Analysis for Contaminants. CODEX STAN : Codex General Standard for Contaminants and Toxins in Food and Feed. CODEX STAN , REV : Analysis of Pesticide Residues: Recommended Methods. - Radioactivity < 370bq/kg (Cs 134&Cs137) -Melamine: use of milk and soy products from China forbidden Directive 2009/39/EC Eur Parlement and of Council of 6th May 2009 on foodstuff intented for particular uses:
29 Scope Item description Finished product specifications Raw material Packaging and labelling Microbiology and mycotoxins Chemical safety Stability study Production process and quality assurance Documents to provide
30 Stability study => To confirm the product shelf life Long term (0, 3, 6, 9, 12, 18, 24 months) at 30±2 C Accelerated data at 40±2 C for 6 months may support extrapolation of shelf life (0, 3, 6 months) Long term stability studies at 40 C also expected => Stability studies must verify: Organoleptic stability: taste, odour, product consistency and behavior (absence of oil separation, absence of oxidation) Integrity of the packing materials ) Nutritional value and nutrient stability (maintenance of a level of vitamin and minerals over or within specified levels for at least one water soluble and one fat soluble micronutrient). Demonstrate absence of microbial growth Commitment if stability study not available
31 Scope Item description Finished product specifications Raw material Packaging and labelling Microbiology and mycotoxins Chemical safety Stability study Production process and quality assurance Documents to provide
32 Production process and quality assurance Food safety policy in place Complete quality management system based on a Hazard Analysis and Critical Control Points (HACCP) approach Applicable standards reference: CAC/RCP , Rev : Recommended International Code of Practice. General Principles of Food Hygiene ISO 22000:2005 (ISO/TS 22004) )- Food safety management systems Requirements for any organization in the food chain. Manufacturer responsible to elaborate an analytical plan, with analysis methods on Raw material and RUTF finished product Iso certified laboratories preferably used.
33 Scope Item description Finished product specifications Raw material Packaging and labelling Microbiology and mycotoxins Chemical safety Stability study Production process and quality assurance Documents to provide
34 Documents to provide Certificate of analysis (every batch delivered) Full analysis results (once a year) On demand: Certificate of Origin Certificate of Conformity Health certificate Certificate of non-radioactivity If applicable: GMO Free Certificate, Halal certificate
35
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