HEB_Specification_November_24 _2014.docx

USAID Commodity Specification High Energy Biscuit v1, November, 2014

U.S. Agency for International Development

COMMODITY SPECIFICATION

HIGH ENERGY BISCUIT

(HEB)

Status:

First Draft

Last Modified:

First Draft Produced on November 4, 2014[footnoteRef:1] [1: Adapted from Version 14 WFP HEB Specification, found in the following URL address: http://documents.wfp.org/stellent/groups/public/documents/manual_guide_proced/wfp228061.pdf ]

Approver

USAID

Rufino Perez FFP Senior Food Technology Advisor

1. PRODUCT DESCRIPTION

1.1. Purpose and Use

High Energy Biscuits (HEB) are designed to be high in protein and supplemented with a premix of vitamins and minerals. They are intended for general food distribution and school feeding.

1.2. Applicable Standards

USAID High Energy Biscuits shall comply, except when specified otherwise in solicitations and contracts, with the following guidelines or standards:

a) US Food and Drug Administration (FDA) Food Safety Modernization Act

b) The 21 CFR 170.3 and 21 CFR 170.30 regulations on food ingredients and additives in regard to being Generally Recognize as Safe (GRAS).

c) Guidelines on Formulated Supplementary Foods for Older Infants and Young Children, CAC/GL 08-1991 of the Codex Alimentarius.

d) Code of Hygienic Practice for Foods for Infants and Children CAC/RCP 66 - 2008 of the Codex Alimentarius;

e) Recommended International Code of Practice: General Principles of Food Hygiene CAC/RCP 1-1969 Rev 4 - 2003 including Annex “Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its application”.

f) General principles for addition of essential nutrients to foods: CAC/GL 09-1987 (amended 1989, 1991), of the Codex Alimentarius1.

2. High Energy Biscuit Formulation

2.1. Main Ingredients. HEB must be manufactured from fresh and good quality ingredients. The product shall be free from foreign materials, substances hazardous to health, excessive moisture, insect damage and fungal contamination and must comply with all relevant national food laws and standards. HEB shall be prepared and packaged in accordance with good commercial practice (CFR - Code of Federal Regulations Title 21) and shall comply with the following U.S. Standards of Identity:

a. Wheat flour must conform to U.S. 21 CFR 137.105 and Codex STAN 152-1985.

b. Sugar must conform to U.S. 21CFR184.1854 and Codex STAN 212-1999.

c. Shortening must be prepared from oil as defined by the Food and Drug Administration in 21 CFR 101.62 and in conformance with Codex STAN 210-1999, must be free from trans fatty acids and must contain only antioxidants that comply with Codex and relevant regulations.

d. Skimmed milk powder must conform to FDA Regulation as established ib 21CFR131.110 and in conformance with Codex STAN 207-1999.

a. It must be accompanied by a ‘melamine-free’ certificate.

b. Maximum level aflatoxin M1: < 0.5 mcg/kg milk (recommended methods ISO 14501/IDF 171:2007[footnoteRef:2] or ISO 14674/IDF 190:2005[footnoteRef:3]). [2: Milk and milk powder: determination of aflatoxin M1 content, clean up by immunoaffinity chromatography and determination by HPLC.] [3: Milk and milk powder: determination of aflatoxin M1 content, clean up by immunoaffinity chromatography and determination by Thin Layer Chromatography.]

Other raw materials and additives (if used) must comply with FDA Guidelines, Codex or relevant regulations. Raw materials must be stored under dry, ventilated and hygienic conditions. Only safe insecticides (i.e. phosphine) may be used for fumigation control. Where needed, fumigation must be performed by certified operators.

2.2. Vitamins and minerals. Complete micronutrient premix must be purchased from an ISO 17025-approved supplier, as well as a GAIN-approved Premix Facility or any of the GAIN approved suppliers. A complete list is available at the following link: http://gpf.gainhealth.org/suppliers/current-suppliers

Micronutrient premix must be delivered to the processor of HEB with a complete Certificate of Analysis and a Proof of purchase. The two documents must be presented with other documents to USDA for payment. Micronutrient premix must be stored in a dry, cool and clean place.

3. PROCESS DESCRIPTION

3.1. Formula. Formulation shall be based on supplier experience and must include dry skimmed milk (Minimum of 4.0 g/100g of HEB) and Sugar (10.0-19.0 g/100g of HEB) but should not include any soybean and soybean derivatives.

3.2 Homogeneity of micronutrients. Theoretical calculations indicate that a mixing system with a Coefficient of Variation of 10% using iron as the indicator element, will enable product to meet the above variation target on 95%, provided that all conditions of mixing are rigorously applied. To conduct these calculations, see WFP handbook: Fortified Blended Food- Good Manufacturing Practice and HACCP Principles and fortification guide on http://foodqualityandsafety.wfp.org/coefficient-of-variation-calculator.

3.3 Food safety and risk assessment at manufacturing premises. For compliance with FDA Guidelines and Codex standards, the processor must be able to demonstrate by principle and practice the adoption, implementation and recording of Good Manufacturing Practice (GMP), Hazard Analysis Critical Control Point program (HACCP), Pathogen and Environmental Monitoring (PEM), zoning demarcation and a complete quality and food system program. Accordingly, USDA, USAID and/or WFP Inspector / Quality Surveyor are entitled to visit the factory without prior notice during any period when product is being manufactured to check that the above food safety and quality are in place, validated and being implemented.

3.4. First Production Approval and subsequent audits. HEB Suppliers are expected to go through a preparatory or first production run during which baseline data on composition, microbiology, operator training, and grading table (sensory analysis) are developed, as well as all calibrations necessary before running at full capacity. During start-up run, the supplier must run all the required analyticals in this CRDdocument and ensure that the facility is capable of producing the product with the highest quality. During this phase, the contracting agency (any or multiple representatives of USDA/FGIS, USAID, and/or WFP) may choose to be present.

4 ANALYTICAL REQUIREMENTS

4.1. General Requirements (Based on 100g of Finished Product)[footnoteRef:4] [4: These values may be used for labeling purpose. Suppliers are encouraged to do accelerated shelf life studies to ensure these levels of micronutrients are achieved at consumption time]

Saturated Trans fat 12 g min 5.7g max

1.34 max

4.2 Finished Product Characteristics

· Organoleptic: HEB must have a typical color, pleasant smell and palatable taste which consumers will like and enjoy.

· Broken: percentage of broken HEB must not be more than 5.0% (by weight).

· Weight: one piece of HEB should weigh between 5 g and 10g.

4.3 Micronutrients

HEB must be fortified to provide the following target micronutrients supplement per 100g of finished product (Table 1) Table 1. Micronutrient rate and chemical form[footnoteRef:5] [5: This table may be used for labeling purpose. Suppliers are encouraged to do accelerated shelf life studies to ensure these levels of micronutrients are achieved at consumption time.]

Chemical Forms

4.4. Contaminants

Table 2. Most common contaminants and thresholds

(mg/kg body) [7: Limits are calculated from the protocols and tolerable weekly intake (PTWI) in mg/kg body as defined in the CODEX STAN 193-1995: Codex General Standard for Contaminants and Toxins in Food and Feed. Calculations were done assuming as reference a 5-kg child. Equivalent and validated methods are allowed.]

Per 1000 Kcal[footnoteRef:8] [8: Calculation based on PTWI, assuming a lower-end weight of 5kg average child and a 2100 calories daily requirement, using the formula: ((mg/kg-body x 5kg)/2100 kcal) x1000 kcal]

(mg) Analytical Method

Other Contaminants

Melamine/Cyanuric acid (ppb)

Max. 2.5mg/kg http://www.who.int/foodsafety/ fs_management/Melamine_method s.pdf

4.5. Compulsory Testing and Methods

Table 3: List of compulsory tests and reference methods

Sensorial inspection

Melamine

Max. 2.5mg/kg http://www.who.int/foodsafety/ fs_management/Melamine_method s.pdf

AACC 42-11

5 QUALITY ASSURANCE

Table 4. General guidelines for food safety and quality control

1. Audit must be HACCP-based

2. Written manifestation from the suppliers indicating commitment to comply with highest levels quality, proving all their written quality programs

3. Third party audits to be requested from potential suppliers, if sharable

2. Generation of baseline data (production, environmental, finished product compliance)

3. Validation of sampling plans for continuous monitoring by USG

2. USG will continue to test indicative parameters. For current specialized food, for microbiology, and for composition Vitamin A and Iron

2. If it is a new contract, presence will be compulsory at least for one? ?production cycle

6 PACKED PRODUCT REQUIREMENTS

6.1. Primary package

It is under supplier responsibility to select a packaging material that will protect biscuits from moisture as well as vitamins and fat degradation during shelf life.

· It must be based on supplier experience and comply with relevant regulations.

· It must be food grade, have good sealing properties and be printed as per requirement.

· It must include a metalized layer to reduce permeability to Oxygen and Vapor.

· It must be stored under dry, ventilated and hygienic conditions.

Typically a laminated composed of BOPP + VMCPP (20 and 25 microns respectively) or equivalent or stronger can be used. Each package must contain 50 grams, 75 grams, 100 grams or 250 grams biscuits (as per contractual agreement).

6.2 Secondary package

Individual packages must be stuffed in strong cardboard cartons suitable for multiple handling and must contain as per contractual agreement from 10 kg to15 kg Net biscuits. About 15-20 bags of silica gel of at least 1 Kg each should be placed in each container in order to absorb moisture. In addition, craft paper should be laid to all sides of the container.

If the contractor purchases packaging and container ingredients from a foreign country and/or the package and container is manufactured in a foreign country, the package and container SHALL NOT display country of origin labeling. Phrases similar, but not limited to “Made in [Name of Foreign Country.]” or “Product of [Name of Foreign Country.]” are strictly prohibited.

7 LABELING REQUIREMENTS

Primary Packaging

· Name of the product

· USAID’s Logo: USAID Gift of the American People

· Ingredient list

· Net content

· Code for supplier

· Batch/lot number

· Best used before

· Storage instructions

· Additional markings as per contractual agreement.

Secondary packaging

· Name of the product

· Logo: USAID Gift of the American People

· Additional markings as per contractual agreement.

8 SHELF LIFE, SHIPPING AND STORAGE

The product shall have a shelf life of 24 months at 30°C, and it shall retain all commodity specification qualities included in this specification document for at least 18 months from date of manufacture when stored dry at ambient temperatures prevalent in the country of destination. HEB must be stored under dry, ventilated and hygienic conditions.

9 HISTORY OF SPECIFICATION

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