AQL RUTF (Ready to use Therapeutic Food paste) Definitions, penalties and Quality Control rules.

Transcription

1 Definitions, penalties and Quality Control rules. TSLOG REV3.0 : Critical: C; Major:M; Minor:m s ICRC classification definitions: Critical nonconformity : Any discrepancy which might harm a user or makes it impossible to use the product properly is considered to be critical. Lots with Critical discrepancy are subject to refusal. Major nonconformity : Any discrepancy which makes the use of the product less efficient than expected is considered to be major. Lots with Major discrepancies can be accepted. Minor nonconformity : Any discrepancy which does not have an influence on the performance of the product is considered to be minor. Lots with Minor discrepancies can be accepted. Non-Conformitie and related penalties: Acceptance Quality Level: Critical: ( 0) Nonconforming characteristic (number of nonconforming items Rejection number. ISO ) implies a penalty of 10% of the value of the total PO and is subject to lot refusal Major: ( 2.5) Nonconforming characteristic (number of nonconforming items Rejection number. ISO ) implies first time a penalty of 0.5% of the value of the total PO, second time 1 %, and + 0.5% at every occurrence for the duration of the contract per each nonconforming characteristic. >10% of nonconforming items is subject to lot refusal Minor: ( 4.0) Nonconforming characteristic (number of nonconforming items Rejection number. ISO ) implies 2 times without penalties, third time a penalty of 0.5% of the value of the total PO, fourth time 1 %, and + 0.5% at every occurrence for the duration of the contract per each nonconforming characteristic. >10% of nonconforming items is subject to lot refusal. The Method of testing is drawn from ISO International Standards (table1: Sample size code letters, and table 2-A: Single sampling plans for normal inspection). The samples will be taken randomly by the buyer from the delivered items and then inspected. The buyer can decide either to inspect the lot at ICRC QC laboratory or to use an inspection company for analysis, or both. Transport to laboratory and analysis cost for lab testing are at expense of ICRC. The seller can contest the results of the Quality Control done by the ICRC by requesting a lab testing. In this case transport to laboratory and analysis cost for lab testing are at expense of the seller. The selection of the lab in charge of testing must be validated by the ICRC. Nonconformity: non-fulfilment of a specified characteristic requirement. Nonconforming item: item with one or more nonconformities. Lot: definite amount of some product, material or service, collected together. Sample: set of one or more items taken from a lot and intended to provide information on the lot. h t t p s : / / c o l l a b. e x t. i c r c. o r g / s i t e s / L OG/ Ou r Di v i s i o n / Qu a l i t y Ma n a g e me n t / Qu a l i t y r e f e r e n c e d o c u me n t s / RUTF. x l s x CONFI DENTI AL Page 1/ 6

2 : Critical: C; Major: M; Minor: m. Documentation must be related to specific batch numbers. Documentation One production batch shall not exceed 300 MT and one week of C ok/nok 0 production. For every batch number, the manufacturer must be able to find all the history of the finished products (composition, raw materials used, processing parameters, analytical results, quantity produced and dispatched, customer s sites delivered, etc.). Documentation requested: Certificate of origin, Certificate of conformity to specification (Fit for Human Consumption), Health Certificate, NON GMO certificate. A Certificate of Analysis per batch (CoA) should be issued and forwarded prior to each shipment or order collection for each batch provided. This certificate must mention the laboratory name, methods of analysis, laboratory variability ranges for each nutrient, specifications and targets for all the criteria below, to be applied to the finished product after primary packaging. The batch cannot be released if there is a failure to meet the following criteria: Nutritional value and nutrients per 100 g: Moisture content <2.5% Energy value kcal/100g Protein content % by weight Fat content 45-60% total energy Vitamin A mg RE Minimum of one mineral & one vitamin tracer per premix (vitamin C, and Clorure) Microbiological and Chemical criteria: Salmonella: 0cfu per 25g Enterobacteriaceae (EB): 10cfu per g max Total aflatoxin: <10ppb maximum. Primary packaging (sachets) general quality RUTF shall be packaged in food-grade sachets, hermetically sealed and robust enough to prevent leakage and to protect the product throughout its shelf life. Sachet material shall not represent a hazard for infants and young children when sachets is opened and put in contact with mouth (packaging material can not contain any detachable parts that present a choking hazard). Inks used for marking and glue must be contact food grade, water and lipid resistant. The pouch material must not transfer any element (particle, flavour or odour) to the product. Packaging material must ensure to withstand pressure changes associated with air transport. Pouches must be free of damage, such as (but not limited to) tears, cuts, holes, abrasions through one or more layers in the pouch material, leakage through any seal, etc. The closure seal must be free of wrinkles, occluded matter, or evidence of entrapped moisture or grease. Packaging Secondary packaging (Cartons) general quality and transport RUTF sachets to be packed into a plastic translucent bag and then in strong export cardboard boxes (minimum 5 ply and weight of 800 to 1000 grams per square meter and provide protection of the goods for carriage by air, sea and/or road to final destinations worldwide, including remote locations under adverse climatic and storage conditions and high humidity.). ECT (Edge Crush test*) 9-11kN/m with minimum 60% remaining with 90% humidity at temperature of 40 C. Able to be stacked to a height of 2.4m in static, and 2.15m in dynamic, and resistant to puncturing with reinforced inlay (3 Kraft paper suitable to contain weight of the parcel). Carton's dimension should match exactly the contents. Empty space has to be avoided or filled up as this would result in crushing of the carton during transport. Closures of the carton boxes must withstand minimum 10 strong manual handlings. Transport: Inside line containers, slip sheet or plywood shall be used to provide maximum stacking strength. Vents of container should be closed or taped closed. Cartons should be stacked on pallets (80*120 or 100*120 cm as per contract) and secured in the transportation vessel in a way that prevents movement during transportation. Pallets should be wrapped with plastic wrap to protect goods from contamination and movement of cartons during shipment. Primary packaging (sachets) net weight Secondary packaging (Cartons) net weight M measurement g +/- 2 grams M measurement kg minimum (Each carton containing a minimum of 150 sachets) ht t ps: / / col l ab. ext. i cr c. or g/ si t es/ LOG/ Our Di vi si on/ Qual i t y Management / Qual i t y r ef er ence document s/ RUTF. xl sx CONFI DENTI AL Pa g e 2 / 6

3 : Critical: C; Major: M; Minor: m. All marking to be done in English (excepted requested in contract) and easily readable. Marking expected: FRONT Front side of the sachet is divided into three zones. The space limit set for each zone should be respected. The red zone should represent at least 50% of the front surface and contain the following information: Generic name: RUTF, Ready to use Therapeutic Food for children > 6 months with Severe Acute Malnutrition, 1 sachet=500 kcal. -The colour should be red, PMS 485 (Pantone Matching System). -The supplier s zone should represent a maximum of 20% of the surface and contain the following information: Product name (if applicable), Manufacturer s name and logo. -The pictogram zone should represent 30% of the surface and contain three pictograms: knead, tear & open, squeeze & eat. Packaging Primary packaging (sachets) marking m ok/nok 4.0 BACK Following information should appear on the back side of the sachet: -All the ingredients listed in order of descending quantities. Types of ingredients should be specified, e.g.: nonhydrogenated palm oil. -Information on allergens (peanut...) and ingredients of animal origin. -Name and address of manufacturer, packer, distributor, importer, exporter or vendor including country of origin. -Net weight. -Best Before date (clearly visible throughout the whole shelf life of the product.) -Lot number (clearly visible throughout the whole shelf life of the product). -Storage instructions -The statement Not for resale. -Breastfeeding message: Breastfeeding is recommended until 24 months (exclusive until 6 months) and logo. -Statement: RUTF has to be prescribed and initiated by a trained health and nutrition professional only. Secondary packaging (cartons) marking m ok/nok 4.0 All marking to be done in English (excepted requested in contract) and easily readable. Marking requested: - Red zone of boxes represents at least 20% of the front surface -Name of product, name and address of manufacturer, packer, distributor, importer, exporter or vendor, including country of origin -Storage conditions -Net weight -Number of units in the carton -Lot number and best before date Cartons should be colour coded, using PMS 485 red colour. ICRC logo upon request. Labelled d in accordance with latest version of recognized international standards and best practices and/or guidelines, such as : - Codex STAN : General standards for the labelling of and claims for pre-packaged foods for special dietary uses - Codex STAN : General standard for labelling of pre-packaged foods ht t ps: / / col l ab. ext. i cr c. or g/ si t es/ LOG/ Our Di vi si on/ Qual i t y Management / Qual i t y r ef er ence document s/ RUTF. xl sx CONFI DENTI AL Pa g e 3 / 6

4 : Critical: C; Major: M; Minor: m. Packaging Leaflets m ok/nok 4.0 Each carton must contain a leaflet in English (and if relevant, in another language according to the contract). The following information should appear on the leaflet: Generic name: RUTF Ready to use Therapeutic Food for children > 6 months with Severe Acute Malnutrition Name and address of manufacturer including country of origin. Composition: all ingredients listed in order of descending quantities. Information of allergens and ingredients of animal origin. Nutritional values per 100g: energy content, proteins, lipids, carbohydrates and detailed content of each vitamin and mineral. Protocol and instructions for use: RUTF paste is suitable for children aged 6 months and above. Children below 6 months have to be exclusively breastfed or if necessary given other therapeutic product prescribed by clinician. RUTF paste has to be prescribed and initiated by a trained health and nutrition professional only. RUTF paste should not be shared with other members of the family. RUTF paste should be used according to the national protocols on the management of SAM. If there is no national protocol, recommended dosage standard regimen is 2 sachets per day for a child between 5 and 6.9 kg, 3 sachets per day for a child between 7 and 9.9 kg, and 4 sachets per day for a child more than 10 kg for an average period of 6 to 8 weeks. For more details on dosage and length of treatment refer to existing international and national guidelines. RUTF consists in a lipid-based matrix with an added vitamins and minerals fortification. The main most commonly used ingredients are: peanut paste, vegetable oil, sugar and skimmed milk powder and with added vitamin and mineral premix. Apart from peanut, other ingredients such as soy protein concentrate, sesame, sun flower seeds, lentils, chickpeas, rice, sorghum or other cereals can be used provided the recipe complies with the nutritional composition. Suppliers must provide evidence of suitability of such formulations for the treatment of SAM by submitting acceptability studies for the recipient population(s). Ingredients must comply with Codex or other internationally recognized standards. Codex STAN : Codex Standard for Peanuts, CAC/RCP : Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Peanuts. Texture Moisture content Water activity Energy (for 100g of product) M measurement 2.5 Smooth, homogeneous, thick paste, easy to squeeze out of sachet. M measurement % maximum M measurement maximum M measurement to 550 kcal Product Carbohydrates (sweetener) Lactose, sucrose, fructose and glucose polymers can be used as sweeteners. Honey should not be used. Particular attention should be given to the sugar particle size, which if not properly ground, could cause oil separation from the paste and lead to leakage when opening the sealed part of the sachet. Added carbohydrates should not be more than 25% of the recipe. Codex STAN : Codex Standard for Sugars. Dairy powder products At least half of the proteins contained in RUTF shall come from milk/dairy products. Acceptable source of dairy protein are : Full cream milk powder, Skimmed milk powder, Whey powder. Codex STAN Codex Standard for Milk Powders and Cream Powder and/or Codex STAN : Codex Standard for Whey Powders. Codex Standard for Evaporated Milks (CODEX STAN ), Codex Standard for Sweetened Condensed Milks (CODEX STAN ) Codex Standard for Edible Casein Products (CODEX STAN ) Proteins M measurement to 16.2% by weight. AOAC Oil Lipids If refined only edible veg oil can be used. Codex STAN : Codex Standard for Named Vegetable Oils. M measurement % total energy. ISO ht t ps: / / col l ab. ext. i cr c. or g/ si t es/ LOG/ Our Di vi si on/ Qual i t y Management / Qual i t y r ef er ence document s/ RUTF. xl sx CONFI DENTI AL Pa g e 4 / 6

5 : Critical: C; Major: M; Minor: m. The seller can contest the results of the Quality Control done by the ICRC by requesting a lab testing. In this case transport to laboratory and M measurement to 10% total energy n-3 fatty acids M measurement to 2.5% total energy Trans-fatty acids M measurement 2.5 3% total fat maximum Fibre M measurement 2.5 5% maximum Mineral and vitamin premix The added minerals should be water-soluble and should not form insoluble components when mixed together. Product Vitamin A (Retinol Equivalent) (for 100g of product) Vitamin B1 (Thiamine) (for 100g of product) Vitamin B2 (Riboflavin) (for 100g of product) Vitamin B3 (Niacin) (for 100g of product) Vitamin B5 (Pantothenic acid) (for 100g of product) Vitamin B6 (Pyridoxine) (for 100g of product) Vitamin B7 (Biotin) (for 100g of product) Vitamin B9 (Folic acid) (for 100g of product) Vitamin B12 (Cyanocobalamin) (for 100g of product) Vitamin C (Ascorbic acid) (for 100g of product) Vitamin D (Cholecalciferol) (for 100g of product) Vitamin E (Tocopherol) (for 100g of product) Vitamin K (Phytonadione) (for 100g of product) Sodium (for 100g of product) Potassium (for 100g of product) Calcium (for 100g of product) Phosphorous (expressed in non-phytate phosphorus) (for 100g of product) Magnesium (for 100g of product) Iron (for 100g of product) Zinc (for 100g of product) M measurement to 1.1mg RE. EN (should be tested at least once a year) M measurement mg minimum M measurement mg minimum M measurement mg minimum M measurement mg minimum M measurement mg minimum M measurement mcg minimum M measurement mcg minimum M measurement mcg minimum M measurement mg minimum. NF V M measurement mcg M measurement mg minimum M measurement mcg M measurement mg maximum M measurement mg M measurement to 600 mg M measurement to 600 mg M measurement to 140 mg M measurement to 14 mg. NF EN M measurement to 14 mg ht t ps: / / col l ab. ext. i cr c. or g/ si t es/ LOG/ Our Di vi si on/ Qual i t y Management / Qual i t y r ef er ence document s/ RUTF. xl sx CONFI DENTI AL Pa g e 5 / 6

6 : Critical: C; Major: M; Minor: m. Copper (for 100g of product) Selenium (for 100g of product) Iodine (for 100g of product) Organoleptic characteristic M measurement to 1.8 mg M measurement to 40 mcg M measurement mcg No off-flavour (such as, but not limited to burnt, scorched, rancid, malted, sour, or stale). Colour RUTF paste should have cream to light or orangey brown colour. The RUTF paste should not have a dull, grey tinge, or other abnormal cast. It should show no evidence of excessive heating (materially darkened or scorched). Shelf life The product should be delivered with a shelf life of minimum 24 months with no refrigeration. Emulsifier (additive allowed) C ok/nok 0 CODEX STAN Acceptable emulsifiers for canned baby foods intended for infants and young children as specified Acceptable emulsifier are: Lecithin: max 0.5g/100g, Mono or Diglycerides: max 0.15g- 2g/100g. Flavouring: (additive allowed) C ok/nok 0 Artificial flavours are prohibited. Only natural flavours can be added. Antioxidants: (additive allowed) C ok/nok 0 Butylhydroxyanisol (BHA) and Butylated hydroxytoluene (BHT) are prohibited. Allowed antioxidants are Ascorbic palmitate and mixed tocopherols. Product Salmonella Enterobacteriaceae Pesticides Carbamates Pesticides Organochlorine Pesticides Organophosphorus Pesticides Pyrethroid Heavy metals Arsenic Heavy metals Cadmium Heavy metals Lead Heavy metals Mercury C measurement 0 Absent in 30 samples of 25 g ( 2 class plan) ISO 6579 C measurement 0 10 cfu/g maximum. ISO C measurement 0 Maximum 0.06 mg/kg C measurement 0 Maximum 0.03 mg/kg C measurement 0 Maximum 0.1 mg/kg C measurement 0 Maximum 0.02 mg/kg Radioactivity C measurement 0 Only ingredients certified free of radioactivity can be used. If the limits are not defined, the value must not exceed 370bq/kg max (Cs 134&Cs137) Melamine Aflatoxin Ochratoxin Other contaminants C measurement 0 The level of melamine must not exceed 1mg/kg C measurement 0 Total Aflatoxins. 10ppb maximum. ISO C measurement 0 Total Ochratoxin. 15ppb maximum. ISO COMMISSION REGULATION (EU) No 594/2012 C ok/nok 0 The product should be free from residues of hormones, antibiotics and pharmacologically active substance ht t ps: / / col l ab. ext. i cr c. or g/ si t es/ LOG/ Our Di vi si on/ Qual i t y Management / Qual i t y r ef er ence document s/ RUTF. xl sx CONFI DENTI AL Pa g e 6 / 6