supply of fortified blended flour tender number: usaid ... · page 6 of 118 usaid/ kemsa mcp oit...

of 118 USAID/ KEMSA MCP OIT 001/2019-20

Supply of Fortified Blended Flour

Tender Number: USAID KEMSA MCP OIT 001/2019-2020

Release Date: December 10, 2019

Submission Date: January 7, 2020

Project: USAID KEMSA Medical Commodities Project

Contracting Entity: Kenya Medical Supplies Authority

Funded by: United States Agency for International

Development

Contract No:. AID-615-C-15-00003


INVITATION TO TENDER (ITT)

Open International Tender (OIT)

IFT No.: USAID KEMSA MCP OIT 001/2019-20


Date: 10th December, 2019

1. The Kenya Medical Supplies Authority (KEMSA), on behalf of the United States Agency

for International Development (USAID) herewith invites sealed tender(s) for Supply of

Fortified Blended Flour

2. This Tender will be conducted through Open International Tender in line with Federal

Acquisition Regulations (FAR) System ; FAC Number/Effective Date:2005-94,2005-95 /

01-19-2017.

3. Interested eligible bidders may obtain further information from KEMSA Office and inspect

the bidding documents at the address given below, Mondays to Fridays between 0900hrs

to 1600hrs except on public Holidays or download at the PPIP Supplier portal

http://supplier.treasury.go.ke. and http://www.kemsa.co.ke/tenders/. Documents

downloaded are free of charge and bidders are advised to register their bid documents at the

procurement office or via email at [email protected] (Refer to

registration form in the tender document).

4. A complete set of bidding documents in English (hardcopy) may be purchased by eligible

bidders on the submission of a written application on company letterhead to the address

below and upon payment of a non-refundable/non-transferable fee of 13 US Dollars or 1,000

Kenya Shillings. The method of payment will be by Cash, Bankers cheque or direct deposit

to the specified account no 01141217405100 for KES or 02120217405100 for USD to Co-

operative Bank, Enterprise Road Branch, Nairobi, Kenya, Swift: KCOOKENA.

5. Completed paginated and serialized bidding documents one original and a copy in plain

sealed envelopes clearly marked on top with the Tender Number and description must be

accompanied by a tender security of USD 10,000 or KES1,000,000.00 or equivalent in a

freely convertible currency and must be delivered to the address below on or before 10:00

http://supplier.treasury.go.ke/

http://www.kemsa.co.ke/tenders/

mailto:[email protected]


AM on January 7th , 2020. Tenders must be deposited at KEMSA Tender Box 2 for

Global Fund Tenders at KEMSA, Main Reception. Bulky tenders can be handed over to

KEMSA Procurement Director’s Office for registration and safe keeping till the tender

opening date. Tenders will be opened promptly in public and in the presence of the

Tenderers’ representatives who choose to attend.

6. Late bids, portion of bids, electronic bids, bids not received, bids not opened and not readout

in public at bid opening ceremony shall not be accepted for evaluation irrespective of

circumstances.

Address for information on/collection of the Tender Document and Tender Opening

venue.

Kenya Medical Supplies Authority (KEMSA) 13 Commercial Street, Industrial Area

P. O. Box 47715-00100 Nairobi, Kenya; Tel: (+254) 20-392 20 00

E-mail: [email protected]

Kenya Medical Supplies Authority reserves the right to accept or reject any or all bids

without incurring liability to the affected tenderers



REGISTRATION FORM FOR ONLINE TENDERERS/BIDDERS

IFT No.: USAID KEMSA MCP OIT 001/2019-2020 FOR SUPPLY OF FORTIFIED

BLENDED FLOUR

NOTE: Please provide your details below for purposes of communication in case you download

this tender document from PPIP or KEMSA website.

Name of the firm:…………………………………………………………………………..

Postal Address:……………………………………………………………………………..

Telephone Contacts:…………………………………………………………...…………

Company email address:………………………………………………………………..

Contact Person:……………………………………………………………………………

Once completed please submit this form to the email;[email protected]



Contents of Bidding Document: Section 1: Instructions to Tenderers

Section 2: Draft Order Terms and Conditions

Annex A: Product Specification, Pricing & Delivery

Schedule

Annex B: Branding and Marking Requirement

Annex C: Invoicing and Shipping Instructions

Annex D: Letter of Undertaking Template

Annex E: Subcontractor Evaluation Template

**PLEASE READ INSTRUCTIONS CAREFULLY FOR THIS TENDER. IF YOU DO

NOT ADHERE TO THE SPECIFIC INSTRUCTIONS OF THIS TENDER YOU MAY BE

EXCLUDED FROM CONSIDERATION.**


1.0 INSTRUCTIONS TO BIDDERS

1.1 Acronyms and Definitions

ADS USAID Automated Directives System

Agent Kenya Medical Supplies Authority.

CIF Cost, Insurance and Freight

Cooperating Country Kenya

CFR United States Code of Federal Regulations

COO Certificate of Origin

DDU Delivered Duty Unpaid

FAR United States Federal Acquisition Regulation

FOB Free On Board

FCA Free Carrier

KPPB Kenya Pharmacy and Poisons Board

RFQ Request for Quotation

US United States

USAID United States Agency for International Development

USFDA United States Food and Drug Administration

USG United States Government

VAT Value Added Tax

The delivery terms shall be DDU, named place of destination.

DDU is the INCOTERM (delivery term) under which the seller is responsible for arranging and

paying for both the transportation of the goods and shipping insurance through to a named place

of destination typically in the destination country. The seller has fulfilled his obligation when he

has properly insured the goods and bided them to the transportation carrier who, under the contract

of carriage, will accomplish this transporation to the named place of destination.

Under DDU delivery terms the Supplier shall:

1. Pack and mark the shipment to comply with contract specifications, provide commercial

invoice or electronic message, and other documentation as required by the contract agreement.

2. Obtain at own risk and cost any export licenses and authorizations and carry out all export

formalities and procedures.

3. Notify the buyer of readiness to ship and provide the documents listed below at least 7 (seven)

working day before shipment.


a. Commercial invoice

b. Certificate of Analysis

c. Certificate of Origin

d. Packing list

e. Letter of undertaking

f. Airway Bill/ Bill of Lading

g. Confirmation on booking with US flag carrier/statement of non availability of US flag

carrier (Refer to www.marad.dot.gov/documents/MAR730.US.Flag.Vessel.pdf)

4. Contract for and pay all costs of carriage and insurance to the named place of destination.

5. Deliver the goods to the named place of destination within the time period stipulated in the

sales contract.

6. Assume all risks of loss or damage to the goods until they have been delivered to the named

place of destination and handed over to the buyer.

1.2 Introduction

The Agent, acting for the USAID KEMSA MC Project is soliciting proposals from eligible and

responsible firms for the supply of commodities as described in Section 1.4 (Product Specification,

Pricing and Delivery Schedule). The KEMSA MC Project is an official program of the United

States Agency for International Development (USAID), Contract No. AID-615-C-15-00003 and

is being carried out in Kenya.

The overall objective of the USAID KEMSA MC Project is to establish and operate a safe, secure,

reliable and sustainable supply chain management system for pharmaceuticals and related supplies

and equipment (commodities) needed to provide care and treatment of persons with HIV/AIDS in

Kenya.

Tenderers are responsible for ensuring that their offers are received in accordance with the

instructions stated herein. Failure to adhere to instructions described herein may lead to

disqualification of a proposal from consideration.

1.3 Source/Origin/Nationality

All tenderers and the goods and services supplied under this order must meet USAID Geographic

Code 935 (Special Free World) in accordance with the US Code of Federal Regulations (CFR),

22 CFR §228. Tenderers must provide a Certificate of Origin (COO) for products awarded

to them. The cooperating country for this tender is Kenya.

Source: “Source” means the country from which a commodity is shipped to the

cooperating country (Kenya) or the cooperating country itself if the commodity is

located therein at the time of purchase. However, where a commodity is shipped from

http://www.access.gpo.gov/nara/cfr/waisidx_08/22cfr228_08.html


a free port or bonded warehouse in the form received therein, “source” means the

country from which the commodity was shipped to that free port or bonded warehouse.

Origin: The “origin” of a commodity is the country or area in which a commodity is

mined, grown, or produced. A commodity is produced when, through manufacturing,

processing, or substantial and major assembling of components, a commercially

recognized new commodity results that is substantially different in basic characteristics

or in purpose or utility from its components.

Nationality: “Nationality” refers to the place of incorporation, ownership, citizenship,

residence, etc. of suppliers of the goods and services.

1.4 Product Specifications

As provided for under technical specifications section.

1.5 Delivery

Delivery terms are DDU Named Final Destination. The delivery estimates presented in an offer in

response to this tender must be upheld in the performance of any resulting contract.

1.6 Transportation

U.S.-flag requirement. Any international transportation carried out under this subcontract shall

take place on US-flag vessels/carriers. Any international air transportation shall be in accordance

with FAR 52.247-63 (“Preference for U.S.-Flag Air Carriers”), FAR 47.403 (“Guidelines for

Implementation of the Fly America Act”) and 22 CFR 228.22.

While the Comptroller General's memorandum does not establish specific criteria for determining

when freight service is unavailable, it is USAID's policy that such service is not available when

the following criteria are met:

(1) When no U.S. flag air carrier provides scheduled air freight service from the airport serving

the shipment's point of origin and a non-U.S. flag carrier does;

(2) When the U.S. flag air carrier(s) serving the shipment's point of origin decline to issue a

through air waybill for transportation at the shipment's final destination airport;

(3) When use of a U.S.-flag air carrier would result in delivery to final destination at least seven

days later than delivery by means of a non-U.S. carrier;

(4) When the total weight of the consignment exceeds the maximum weight per shipment which the

U.S. flag air carrier will accept and transport as a single shipment and a non-U.S. flag air carrier

will accept and transport the entire consignment as a single shipment;


(5) When the dimensions (length, width, or height) of one or more of the items of a consignment

exceed the limitations of the U.S. flag aircraft's cargo door opening, but do not exceed the

acceptable dimensions for shipment on an available non-U.S. flag scheduled air carrier.

The US-flag requirement must be taken into account when providing CIF Proposals. If U.S.

carriers are not available to Nairobi and/or Mombasa please indicate in your Proposal.

Regulations call for an official “Statement of Unavailability of U.S.-Flag Air Carriers,” which

would be requested of the supplier and further explained should a contract be awarded.

1.7 Proposals

Prices must be quoted on a lump-sum, all-inclusive basis, including packing, insurance,

inspections, taxes, etc. Offers must remain valid for not less than ninety (90) calendar days after

the offer deadline. All prices must be expressed in US Dollars unless otherwise instructed.

1.8 Negotiations

Best-value Proposals are requested, consistent with the evaluation criteria set forth in Section 1.9

below. It is anticipated that awards will be made solely on the basis of these original Proposals.

However, KEMSA reserves the right to conduct negotiations and/or request clarifications

prior to awarding a contract. KEMSA also reserves the right to make no award, a single

award, or multiple awards ( including sharing of quantities to more than one bidder) in

response to this tender.

1.9 Evaluation and Award

The award(s) will be made on a best-value basis to a responsive offeror(s) whose offer meets ALL

tender instructions, source/origin/nationality requirements, registration requirements.

A) PRELIMINARY EXAMINATION

Required documents

1. Bidding documents must be paginated/serialized. All bidders are required to submit their

documents paginated in a continuous ascending order from the first page to the last in this

format; (i.e. 1,2,3…….. n where n is the last page) (MANDATORY).

2. Copy of Certificate of incorporation/registration (MANDATORY).

3. Copy of current Tax Compliance Certificate (For local bidders only) (MANDATORY).


4. Tender form duly completed and signed by the tenderer or his authorized agent

(MANDATORY).

5. Original Bid Bond provided and valid for 120 days from date of tender opening. Value of

bid bond should be USD 10,000.00 or KES 1,000,000.00 equivalent in a freely convertible

currency (MANDATORY).

6. Duly Completed Business Questionnaire and evidence supporting full compliance with the

requirements of business questionnaire (MANDATORY).

7. DUNS (Data Universal Numbering System) Number - Application procedure

detailed below.

NOTE: Failure to comply with Mandatory requirements will lead to disqualification. Only bidders who are successful at this stage will proceed to the next stage of evaluation.

STAGE 2: DOCUMENTARY COMPLIANCE/EVALUATION.

The following documents are mandatory and MUST be submitted together with the bid.

i) Provide dully signed Manufacturer's Authorization letter (if Tenderer is not a

Manufacturer) (MANDATORY).

ii) USAID/USFDA approval

iii) Current quality certificate as specified in the technical specifications (MANDATORY).

iv) Current and valid Product listing with QR codes from the Kenya Pharmacy and Poisons

Board (MANDATORY).

v) Submit Sample for Evaluation – 5 Satchets for each product. (MANDATORY).

NOTE: Failure to comply with Mandatory requirements will lead to disqualification. Only bidders who are successful at this stage will proceed to the next stage of evaluation.

STAGE 3: FINANCIAL EVALUATION

Bidders who are successful at preceding stages of evaluation ad offer acceptable delivery


schedules will have their prices compared and award recommended to the lowest

evaluated responsive bid.

Price Schedule:

Bidders should provide a unit price for each item they wish to bid, based on the individual line items. The applicable incorterm is DDU KEMSA Warehouse, Nairobi.

MONTHLY DELIVERY STATUS REPORT FORMAT (For awarded bidders)

Contract

Number

LPO

No.

Item

Description

Unit of

Issue Qty

Total

Value

Planned

Delivery

Dates as per

Contract/L

PO)

Actual

Deliver

y Date

Remarks

NOTE: The supplier will be required to issue monthly delivery status reports (by 5th day of

every month) during the life of the contract which will be used to assess his overall performance

and consideration for subsequent tenders.

REQUIREMENT FOR DUNS (DATA UNIVERSAL NUMBERING SYSTEM) NUMBER

"In accordance with the U.S Federal rules, all firms or individuals doing business with the U.S.

Government must have a DUNS number (Data Universal Numbering System).

A Data Universal Numbering System (DUNS) number, is the nine-digit number assigned by

Dun and Bradstreet Information Services to an establishment, and is the Identification Number

for U.S. Federal Awardees.

Vendors must obtain their own DUNS numbers. At the D&B

websitehttp://fedgov.dnb.com/webform , fill in your company information and click “submit” to

search for your company records. If your records do not exist, the site will direct you to another

window where you will click on “Get a DUNS Number”. You will then click in the box

entitled For U.S. Government Contractors, Vendors and Grant Recipients. You will then click

under web registration. Find your country in the country drop down list and proceed. You will

have your DUNS within 48 hours.

http://fedgov.dnb.com/webform


The following information is required:

1. Company legal business.

2. Tradestyle, doing business, or other name by which your entity is commonly recognized.

3. Company Physical Street Address, City, State, and ZIP Code.

4. Company Mailing Address, City, State and ZIP Code (if separate from physical).

5. Company Telephone Number.

6. Date the company was started.

7. Number of employees at your location.

8. Chief executive officer/key manager.

9. Line of business (industry).

10. Company Headquarters name and address (reporting relationship within your entity).

After you obtained your DUNS number, you must register in sam.gov (please

seehttps://www.sam.gov/portal/public/SAM/ ). Vendors’ registrations in sam.gov are important

for USAID to fulfill the validation of mandatory procurement reports.

In order to register, please find the detailed steps below:

1. Go to https://www.sam.gov/portal/public/SAM/

2. Click on create an account

3. Choose an individual account

4. Once you complete creating an individual account, a link will be sent to the email address you

will provide during registration. Click on that link and log in to activate your account.

5. Once you log in, agree to usage agreement

6. Click on manage entity and then click on register new entity

7. Follow each of the listed steps and click on submit

http://sam.gov/

https://www.sam.gov/portal/public/SAM/

http://sam.gov/

https://www.sam.gov/portal/public/SAM/


The above steps will enable you to obtain your DUNS number, and to help you register

in sam.gov.

When you get registered, please provide us with your DUNS number, and the SAM Cage Code

Number; and record such numbers for reference in any future award(s) with the U.S.

Government.

Prospective bidders are required to provide details as below:

DUNS NO._____________________________________

SAM CAGE CODE NUMBER _____________________

Responsiveness to the Tender instructions and product specifications

Unless otherwise stated, partial bids may be submitted by bidders. Bidders must present

their proposal for each commodity specified in Annex A that they wish to bid upon. If

an offeror declines to bid on a specific item, for the sake of clarity the offeror should

indicate their preference by stating “DECLINE TO BID” on a particular line item rather

than leaving it blank.

Additionally, it is required that each commodity the offeror proposes to furnish be

accompanied by the above listed documents. Proposals that do not meet the basic

responsiveness and registration criteria will not be given further consideration.

the final column on the right. See Section 1.3 for definitions.

1.10 General Conditions:

The products offered must have a minimum shelf-life of 75% at the time of arrival at the

port of entry. Please note that sea shipments require at least 30 days to arrive at the port

Products will be subject to Quality Assurance (QA) inspection and sampling prior to

distribution.

Products should be packed in properly sealed and tamper-proof packaging. Each outer

case or carton shall be five-ply and strapped.

No carton shall contain Nutraceuticals products from more than one batch.

http://sam.gov/


Each unit pack/bottle must be packaged in its individual pack with the literature insert

(patient insert) inside the pack.

Each unit pack/bottle must be marked with the following black and white text:

USAID | KEMSA- Not for Resale (no logos/emblem will be required) – See Annex B for

details.

Consignments must be palletized and shrink wrapped, properly labeled with the following information:

- Origin point (address where the shipment begins)

- Ship To Address, Ship To Attention

- Carton number (1 of ____)

- KEMSA Order number

- Item name, Batch number and expiry

- Pallet number ( 1 of ____)

- Weights (Gross and Net)

- Dimensions (Length, Width, and Height)

No pallet should contain Nutraceuticals products from more than one batch unless authorized by KEMSA

KEMSA cargo is to be put on a standard pallet size of 120 by 100 cm. Any

deviation from this standard size must be approved by KEMSA

Each pallet should be numbered serially for easy identification and that same

number should be included on the packing list

The supplier should provide container load information for a 20ft or 40ft

container

Price shall be expressed in US Dollars unless otherwise instructed.

Proposed Delivery shall be expressed in weeks.

For each line item, Bidders are also required to indicate the country of “origin”

and the “source” of each line item in the final column on the right. See Section

1.3 for definitions.

1.11 Other Terms and Conditions


Issuance of this TENDER does not in any way obligate the Agent to award a purchase

order or subcontract, nor does it commit the Agent to pay for costs incurred in the

preparation and submission of a proposal.

This solicitation is subject to the Draft Order Terms and Conditions detailed in Section 2.

Any resultant award will be governed by these terms and conditions. The Agent reserves

the right to make revisions to the content, order, and numbering of the provisions in the

actual subcontract document prior to execution by The Agent and the selected

awardee(s). Issuance of a subcontract award is subject to availability of sufficient funds

and applicable approvals from USAID.

2.0 DRAFT ORDER TERMS AND CONDITIONS 2.1 Acronyms and Definitions

Please see as referenced in Section 1 of the TENDER document.

2.2 Subcontract Price Funding Type USAID and in cooperation with the Government of Kenya, is authorized to award contracts under the authority of USAID Contract No. AID-615-C-15-00003 funded by

the US Government.

This is a fixed-price subcontract payable entirely in the currency indicated in the cover page.

The subcontractor shall be paid a fixed price for successfully supplying the commodities at the prices proposed in their bid.

The fixed price of this subcontract is $................................

No additional sums will be payable for any escalation in the cost of materials, equipment or labor, or because of the Subcontractor's failure to properly estimate or accurately

predict the cost or difficulty of achieving the results required. The Agent will not adjust the subcontract price due to fluctuations in currency exchange rates. The Agent will only

make changes in the subcontract price or time to complete due to changes made by The Agent in the work to be performed, or by delays caused by The Agent.


2.3 Source and Origin

The source and origin for all commodities and services supplied under this Subcontract must meet USAID Geographic Code 935 (Free World). Products must be freshly

manufactured and, if applicable, shipped on US vessels, carriers, or vehicles unless not available and otherwise authorized by The Agent.

2.4 Host Country Consular Fees, Duties, & Tariffs

This Subcontract is being awarded on behalf of the USAID, an official project of the Government of the United States in Kenya, and as such, it is free and exempt from any consular or legalization fees, inspection or validation charges, and any taxes, tariffs,

duties or other levies imposed by laws in effect in Kenya. No such fees, charges, tariffs, duties or levies will be paid under this Subcontract.


TAX EXEMPTION PROCESS

All procurements under USAID are exempt from Duty and Taxes.

All documentation for goods must be consigned to KEMSA because tax waiver is

granted to KEMSA. Delivery address should be Kenya Medical Supplies Authority,

P.O. Box 47715-00100 Nairobi. Notified party is the supplier or KEMSA.

The current KRA system for application of Import Declaration Forms (IDFs) and

lodging of tax exemption codes is the Integrated Customs Management System

(ICMS). Currently, only clearing agents have rights to make applications through the

ICMS system

The incoterms are DDU/DAP, KEMSA Embakasi Warehouse. Application of IDFs by

clearing agents – forwarded to KEMSA for application of Import permits (approval

by PPB) – IP forwarded to clearing agents to link with IDFs for generation of approved

IDF with UCR number.

Documents required for IDF:

a. Proforma/Commercial Invoice

b. Current Retention/Product listing by Pharmacy & Poisons Board (PPB)

Shipping Documents required for application of Tax waiver: To be submitted

Fourteen (14) working days before shipment

a. Air Waybill/Bill of Lading,

b. Commercial Invoice,

c. Packing List,

d. Copy of marine Insurance to KEMSA

e. Certificate of Analysis

f. Certificate of Origin

The process takes approximately 2-3 weeks for a tax waiver to be issued through the

Ministry of Health (MOH) and the National Treasury. MOH confirms to the National

Treasury that goods are eligible for exemption and National Treasury issues the Tax

exemption letter addressed to KRA and collected by KEMSA.

The supplier/supplier’s agent should collect copy of the letter from KEMSA and

follow up with Kenya Revenue Authority for issuing of exemption code.

The supplier/Clearing agent is required to clear consignments within the stipulated

days as provided for by the Container/Cargo Freight Station (CFS) or SHED

For Air shipments, they must be cleared within 48 hours on notification by the CFS.


Sea shipment must be cleared within 4 days or within the negotiated days between

the shipper and the CFS. Suppliers should note that there is mandatory haulage of all

imports through Mombasa by SGR to the Inland Container Depot (ICD) Nairobi. If all

the goods are meant to be distributed within Coast region, suppliers should consign

their goods to Kenya Medical Supplies Authority (KEMSA), Mombasa.

If the named place of destination is KEMSA warehouse, supplier must arrange for

clearing and forwarding through their clearing agent.

If named place of destination is CIP, JKIA/Port of Mombasa/FOB, country of origin

(as clearly spelt out in contract) KEMSA’s clearing agent clears the consignment and

delivers to KEMSA.

The supplier representative/appointed agent should arrange with KEMSA

Warehouse for delivery date and be present to confirm that goods are received in

good order and condition.

It is the supplier’s/customs agent responsibility to arrange for offloading process.

The requirements for submitting a pre-delivery sample;

1. Have a signed contract

2. Copy of Purchase Order

3. Copy of Delivery Note and product/brochure to be evaluated.

4. Certificate of Analysis

5. Delivery Address is KEMSA, Embakasi Warehouse.

Pre-delivery samples form part of the consignment.

2.5 Packing All goods supplied under this contract must be packed according to the highest

international packing standards for Nutraceuticalss, suitable to prevent theft, loss or damage, including water damage, to cargo during transit and until safe arrival at the delivery point. The Goods should conform to standards specified in the following

compendia: the British Pharmacopoeia, the United States Pharmacopoeia, the French


Pharmacopoeia, the International Pharmacopoeia, or the European Pharmacopoeia, the

latter particularly for raw materials. The standards shall be the each latest edition at the time of bid submission unless

otherwise stated by the Purchaser. In case the Nutraceuticals product is not included in the specified compendium, but included in the Purchaser’s national essential drug list,

the Purchaser should clearly indicate acceptable limits and the Supplier, upon award of the Contract, must provide the reference standards and testing protocols to allow for

quality control testing. Specific packing instructions include:

Properly sealed and designed in a manner so as to prevent tampering or provide evidence of tampering

Each outer case or carton shall be five ply cardboard and strapped

No carton should contain Nutraceuticals nutritionalproducts from more than one batch

Each unit pack/bottle must be packaged in its individual pack with the literature insert (patient insert) inside the pack.

Not only the Nutraceuticalsnutritional item, but also the packaging components (e.g bottles and closures) must meet specifications suitable for use.

Each case must be palletized and shrink wrapped, and no pallet should contain Nutraceuticalsnutritional products from more than one batch unless prior

approval has been received for more efficient packaging depending on batch size. Each pallet should be numbered serially for easy identification and that same

number shall be included on the packing list.

2.6 Product Specification, Pricing & Delivery Schedule

See Annex A

2.7 Delivery Terms The applicable incorterm for this TENDER is DDU KEMSA Warehouse, Nairobi. 2.8 Packing Lists A complete, itemized packing list shall be carried in a clearly marked "packing list" envelope affixed to the outside of each shipping container used to deliver the goods. Each packing list must show complete narrative descriptions of the goods, and all catalog

numbers, if applicable.


2.9 Payment Terms The method and conditions of payment to be made to the Supplier under this Contract shall be as follows:

100% On Delivery & Acceptance: shall be paid within 60 days of delivery to Named place of delivery, and submission of documents specified in GCC Clause 11 including an

invoice (showing Purchaser’s name; the Contract number, loan number; description of payment and total amount, signed in original, stamped or sealed with the company

stamp/seal) supported by the Acceptance Certificate issued by the Purchaser, by direct bank transfer to the Supplier’s nominated bank account.

The fixed price of this sub contract shall include delivery of the deliverables as per Section 2.6, which is inclusive of all costs associated with the manufacturer producing the

products according to the specifications.

To facilitate the above payment, the supplier should provide four duly signed and stamped original invoices per consignment.

SPECIAL NOTE: In the event some items have are damaged KEMSA will make a

determination as to the quantities not available for distribution, deduct the value of the

items unavailable for distribution and authorize payment minus the value of this

quantity. KEMSA will require the supplier to provide a credit note for the value of the

quantity deducted. The supplier may also arrange for shipment of this quantity along

with quality, and packing certification from the independent laboratory, and payment

will be authorized for this quantity by, KEMSA, only on receipt, subject to quality

confirmation and goods being in good order in The Agent’s warehouse.

Instructions on the invoicing requirement can be found in Annex C.

2.10 Undertaking The subcontractor shall provide the commodities proposed in Section 1.6 once the

commodities are complete following manufacture and inspection but prior to completion of an independent quality assurance analysis. The subcontractor shall notify KEMSA that the commodities are ready for shipment and shall also provide a Letter of Undertaking


to KEMSA. KEMSA will then authorize shipment to Embakasi warehouse in Nairobi

where they will be held until QA testing is complete and acceptance is provided. 2.11 Inspection

The Agent reserves the right to inspect or test any commodities delivered by the Supplier

as a result of this purchase order. The Supplier is responsible for providing the minimum

required samples for testing. The Agent will facilitate the inspection and testing processes

and shall bear the cost of these processes.

When commodities are not ready at the time specified by the supplier for inspection or

test, the Agent may charge the supplier the additional cost of inspection or test. The Agent

may also charge the supplier for any additional cost of inspection or test when prior

rejection makes reinspection or retest necessary.

The Agent may require repair or replacement of nonconforming commodities or re-

performance of nonconforming services at no increase in purchase order price. The

Agent must exercise its post-acceptance rights within a reasonable time after the defect

was discovered or should have been discovered.

2.12 Acceptance

Acceptance of the commodities is a contract requirement. Acceptance shall be in the form

of written acknowledgement from KEMSA, either by email or hard copy, stating that all

terms and conditions of the subcontract have been met, including verification that the

commodities have been passed by Quality Assurance testing. Payment shall not be made

to the subcontractor without written acceptance by KEMSA as stated in section 2.9.

Please note, that to qualify for acceptance, all products supplied under this contract must

have a remaining shelf life of at least 75% of the stipulated shelf life at the time of arrival

at port of entry.

2.13 Warranty

If applicable, all materials supplied under this Subcontract must be covered by the

manufacturer's standard export/international warranty which shall, at a minimum,

protect The Agent from any loss due to defective workmanship, material, packing and

parts, for 18 (eighteen) months after the delivery of commodities is completed. In the


event that the warranty is breached, The Agent may require, and the Subcontractor is

bound, to remedy all defects and faults, including both workmanship and materials

within a reasonable time of notification. The Subcontractor would be responsible for all

necessary transportation charges required to ship the defective commodities to the

manufacturer and return to the customer.

In the event of the Subcontractor’s refusal, failure, or inability to remedy such

discrepancies within a reasonable time of notification, The Agent may remedy such

defects on his own and claim the reasonable cost of such remedial action from the

Subcontractor. The warranty shall be transferable without need for consent of the

Subcontractor in the event The Agent elects to fully transfer all of its ownership rights in

the commodity to any other entity at any time during the warranty period.

2.14 Eligibility of Subcontractors A. No equipment, materials or services shall be eligible for USAID financing if offered by

a Subcontractor included on the list of suspended, debarred, or ineligible bidders as defined by USAID.

B. The Subcontractor must be:

1. An individual who is a citizen or legal resident of a country or area included in the

authorized geographic code, except as stated in subparagraph (C) (1);

2. A corporation or partnership organized under the laws of a country or area

included in the authorized geographic code; 3. A controlled foreign corporation, i.e. any foreign corporation of which more than

50 percent of the total voting power of all classes of stock is owned by United States shareholders within the meaning of Section 957 et seq. of the Internal Revenue

Code (26 U.S.C. 957); or

4. A joint venture or unincorporated association consisting entirely of individuals, corporations, or partnerships which fit any of the foregoing categories.

C. Citizens of any country or area or firms or organizations located in or organized under the laws of any country or areas not included in USAID Geographic Code 935, or firms


or organizations owned in any part by citizens or organizations of any country or areas

not included in USAID Geographic Code 935, are ineligible for financing by USAID as Subcontractors of commodities or sales agents in connection with the supply of commodities. There are limited exceptions to this policy:

1. Non-U.S. citizens lawfully admitted for permanent residence in the United States

are eligible as individuals or owners, regardless of their citizenship.

2.15 Eligibility of Commodities/Source, Origin The following definitions shall be applicable to this Subcontract and all related correspondence.

A. Source

"Source" means the country from which a commodity is shipped to the cooperating country or the cooperating country itself if the commodity is located therein at the time of purchase. However, where a commodity is shipped from a free port or bonded

warehouse in the form in which received therein, "source" means the country from which the commodity was shipped to the free port or bonded warehouse.

B. Origin

The "origin" of a commodity is the country or area in which a commodity is mined, grown, or produced. A commodity is produced when, through manufacturing, processing, or substantial and major assembling of components, a commercially

recognized new commodity results that is substantially different in basic characteristics or in purpose or utility from its components.

C. Authorized Geographic Code

Except as may be specifically approved by the Cognizant USAID Subcontracting Officer, all commodities and services will be procured in accordance with the requirements in 22 CFR Part 228, “Rules on Source, Origin and Nationality for Commodities and Services

Financed by USAID”. The authorized source for this procurement is Geographic Code

935 (Free World).

2.16 Modifications Modifications to the terms and conditions of this subcontract, including any modification

to the scope of work, may only be made by written agreement between authorized personnel of both Parties. Each Party shall give due notice and consideration to any


proposals for modification made by the other Party. The responsible parties to this

subcontract shall be: On behalf of KEMSA Title: On behalf of the Subcontractor:

Title: 2.17 Changes

A. In addition to changes in unit quantities, the agent may, at any time, by written order, and without notice to the sureties, make changes within the general scope of the Subcontract, in any one or more of the following:

1. Specifications, where supplies to be furnished under this Subcontract or are to be specially arranged or packed for KEMSA;

2. Method of shipment or packing; 3. Place of delivery

B. If any such change(s) causes an increase or a decrease in the cost, or the time required for the performance, or any part of the work under the Subcontract, an equitable

adjustment shall be made in the Subcontract price or delivery schedule, or both, and the subcontract shall be modified in writing accordingly. Any claim by the Subcontractor for

adjustment under this Subcontract must be asserted within 30 (thirty) days from the date of receipt by the Subcontractor of the modification or change.

2.18 Legal Effect of USAID Approval and Decisions

The parties hereto understand that the Subcontract has reserved to USAID certain rights such as, but not limited to, the right to approve the terms and conditions of this Subcontract, the Subcontractor, and any or all plans, reports, specifications, Subcontracts,

bid documents, drawings, or any other documents related to this Subcontract and the project of which it is a part. The parties hereto further understand and agree that USAID,

in reserving any or all of the foregoing approval rights, has acted solely as a financing entity to assure the proper use of United States Government funds, and that any decision by USAID to exercise or refrain from exercising these approval rights shall be made as a

financier in the course of financing this project and shall not be construed as making USAID a party to the Subcontract.

The parties hereto understand and agree that USAID may, from time to time, exercise the

foregoing approval rights, or discuss matters related to these rights and the project with


the parties jointly or separately, without thereby incurring any responsibility or liability

to the parties jointly or to any of them. Any approval (or failure to approve) by USAID shall not bar The Agent or Owner from asserting any right, or relieve the Subcontractor from any liability which the Subcontractor might otherwise have to Agent or USAID.

2.19a Penalties

KEMSA reserves the right to apply penalties where the supplier has not adhered to

agreed delivery timelines. The penalties applied will be as follows; Two weeks delay – warning letter issued Three weeks delay – 0.5% of contract value 0.5% surcharge on contract value will be applied for every week of delay upto maximum of 10% of the contract value where upon the contract will be terminated.

KEMSA further reserves the right to terminate the contract at any time as per clause 2.19b indicated below.

2.19b Termination The agent reserves the unilateral right to terminate this fixed price subcontract at any

time, paying for all deliverables completed at the time of termination and a pro-rata share of any deliverable in progress, in accordance with FAR Clause 52.249-1, Termination for

Convenience of the Government (Fixed Price) (Short Form) (April 1984), which is incorporated by reference herein.

In the event that the Subcontractor fails to make progress so as to endanger performance of this fixed price subcontract, or is unable to fulfill the terms of this fixed price

subcontract by the completion date, the Subcontractor shall notify The Agent forthwith and The Agent shall have the right to summary termination of this fixed price subcontract

upon written notice to the Subcontractor in accordance with the incorporated FAR Clause 52.249-8, Default (Fixed-Price Supply and Service).


2.20 Force Majeure

Except with respect to default of second tier subcontractors, the Subcontractor shall not be liable for any excess costs if the failure to perform the subcontract arises out of causes

beyond the control and without the fault or negligence of the Subcontractor (Force Majeure) and if the Subcontractor, within ten (10) days from the beginning of any such Force Majeure notifies the agent of such prevention of performance and the cause thereof.

Such causes may include, but are not restricted to, acts of The Agent in its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, freight

embargoes, and unusually severe weather, but in every case the failure to perform must be beyond the control and without the fault or negligence of the Subcontractor. If the

failure to perform is caused by the fault of a second tier subcontractor and if such default arises out of causes beyond the control of both the Subcontractor and the second tier subcontractor and without the fault or negligence of either of them (Force Majeure), and

the Subcontractor, within ten (10) days from the beginning of any such Force Majeure, notifies the agent of such prevention of performance and the cause thereof, the

Subcontractor shall not be liable for any excess costs due to the failure to perform, unless the supplies or services to be furnished by the second tier subcontractor were obtainable

from other sources in sufficient time to permit the Subcontractor to meet the required delivery schedule.

2.21 Disputes, Appeals and Arbitration Every effort will be made to resolve amicably through mutual agreement any dispute

which may arise between the Parties under this agreement. In the event that such good faith efforts are unsuccessful in resolving the dispute, the Parties shall escalate the dispute to higher management levels. Failing an amicable settlement at the management level,

both Parties shall agree in writing to proceed with a claim and shall be settled in accordance with Rules of Commercial Arbitration of the American Arbitration

Association that are in force on the date of this agreement. The arbitration shall take place in Washington, D.C., unless otherwise agreed to by the Parties. The number of arbitrators

shall be three and they will be appointed in accordance with the Association’s procedures. The decision of the arbitrators will be governed by and will not rewrite, invalidate or expand upon the terms and conditions of this Agreement. The resulting

award shall be final and binding on the Parties and shall be in lieu of any other remedy. Judgment upon any award rendered by the arbitrators may be entered in any court

having jurisdiction thereof. Each party will bear its own costs of arbitration.


2.22 Assignment

The Subcontractor may not assign its obligation to perform under the Subcontract except with the prior written consent of USAID. The Subcontractor may not assign its rights to

receive payment under the Subcontract except with the prior written consent of USAID. 2.23 Vesting of Title and Diversion Rights USAID reserves the right to vest in itself title to the goods financed under this

Subcontract, provided that such goods are in a deliverable state and have not yet been off loaded in ports of entry in the cooperating country. KEMSA, acting on behalf of USAID, may direct the carriers to divert these goods to alternative destinations.

2.24 Terrorist Financing

The Subcontractor (including its employees, consultants and agents) by entering into this Subcontract certifies that it does not engage, support or finance individuals and/or

organizations associated with terrorism. The Subcontractor is reminded that U.S. Executive Orders and U.S. law prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal

responsibility of the Subcontractor to ensure compliance with these Executive Orders and laws. The Agent reserves the right to terminate the Subcontract if the Agent determines

that the Subcontractor is involved in or advocates terrorist activity or has failed to comply with any of the requirements of this provision.

2.25 Indemnity and Waiver of Benefits

The Subcontractor waives any additional benefits and agrees to indemnify and hold harmless The Agent, its officers, agents, and employees for all negligent acts, criminal

acts, errors and omissions as well as any claims of loss, damage, or injury sustained as a result of, or arising from, services rendered and duties performed in connection with the

performance of the Subcontract, including, but not limited to, any claim for damages, restitution, loss, injury or specific performance instituted by any third party as the result of, or arising from, the services rendered or duties performed under this Subcontract, or

any failure of the Subcontractor, its officers, or employees to observe the Applicable Laws, or incidental thereto.


2.26 Conditions of Subcontract for the Supply of Goods

a) Standards. (1) The Goods shall be supplied in accordance with the specifications set out in the order issued by The Agent. (2) All materials used and Goods provided from

Manufacturer, shall be new and of satisfactory quality. Where no specification or standard is stated, then all Goods shall be supplied in accordance with the relevant ISO Standard, or to a recognized national standard in the country of manufacture

acceptable to the Agent.

(b) Alteration of Specification of Plans, Drawings, Patterns and Samples. (1) The Manufacturer shall not alter the specifications, plans or drawings of any part of the Goods

unless requested in writing by, or with the prior written agreement of The Agent. (2) In the event that any such alteration requested by The Agent involves an alteration in the cost of production, and/or in the period required for delivery, such revision of the order

price, and/or of the time of delivery, shall be made in relation to the Goods which are subject to the alteration, as shall be agreed in writing between The Agent and

Manufacturer. In all other aspects the order shall remain unaltered. (3) Where the order is for the supply of Goods described in the order by reference to the Manufacturer’s proprietary specification and the Manufacturer varies that specification, the

Manufacturer may vary that specification in respect of the Goods, provided that such variation does not affect the price, size, accuracy, quality, function, performance or

interchangeability of the Goods. Full particulars of the Manufacturer variation must be provided in writing to The Agent.

(c) Guarantee. The Manufacturer shall guarantee to The Agent that (1) the Goods shall be new, of satisfactory quality, fit for the purposes for which the Goods are ordinarily

used, and for any purposes expressly made known in writing to the Supplier, and suitable for use in Kenya. The Goods shall have no defect arising from design, materials or workmanship, or from any act or omission of Manufacturer, or his sub suppliers and

which may develop under proper use of the Goods in the conditions in Kenya. (2) That the Goods shall remain free of any defect (other than those arising from reasonable wear

and tear or improper use, for which the Manufacturer is not responsible) for a period of 12 (twelve) months after the Goods or any portion thereof have been delivered to the final

destination indicated in the order, or 18 (eighteen) months after the date of shipment, whichever is shorter. (2) The Agent shall notify the manufacturer of any claims under this clause (3) Upon receipt of notification of a claim, The Agent shall promptly direct

Manufacturer to repair or replace any defect in or damage to the Goods (or any part thereof) free of charge including transport charges to The Agents’ facilities. If it is

reasonably practicable or necessary for a defective part to be returned to the Manufacturer, The Agent shall arrange for it to be returned to the Manufacturer at


Manufacturer’s cost. Where Manufacturer supplies a part in replacement of a defective

part, and does not at that time request the return of the defective part, no responsibility for the defective part shall rest with The Agent. (4) If the Manufacturer fails to remedy the defect or damage within a reasonable time, The Agent, after giving notice to the

Manufacturer, take such remedial action as may be necessary, at the Manufacturer’s risk and expense, without prejudice to any other rights which they may have against the

Manufacturer. (5) The Manufacturer of the Goods or such part thereof shall be under the same liability to the Manufacturer as the Manufacturer’s liability to The Agent. (6) No

claim shall be made against the Manufacturer by The Agent in respect of damage to property not the subject matter of the order or for loss of profit.

(d) Packing. (1) The Manufacturer shall provide such packing as is required to prevent damage to or deterioration of the Goods during transit to and storage at The Agent’s

warehouse, and as may reasonably be anticipated and prudent, bearing in mind the destination of the Goods and their mode of transport. The packing shall be sufficient,

without limitation, to withstand rough handling and exposure to extreme temperatures. The cost of such packing shall be included as part of the Manufacturer’s price. (2) The packing, marking and documentation within and outside the packages shall (without

limitation to clause (d)(1) above) comply strictly with such special requirements as provided for in the orders issued hereunder, or any subsequent instructions and, where

appropriate, with any relevant regulations governing the dispatch of Nutraceuticals cargo by sea, air or overland. (3) If compliance with an instruction concerning packing that is issued subsequent to the establishment of an order involves an addition or

reduction in the Manufacturer’s price, and/or in the period required for delivery, such deviation of the manufacturer’s price and/or time for delivery shall be agreed in writing

between the Agent and the Manufacturer. In all other respects the order shall remain unaltered.

(e)Delivery. (1) Delivery of the Goods shall be made by the Manufacturer in the manner and at the time specified in the order. (2) The Manufacturer shall provide reports on the

progress of the order in such form as may be required by The Agent. If, at any time during the performance of the order, the Manufacturer is unable to deliver the Goods within the

time or times specified in the order, the Manufacturer shall immediately give notice of the delay in writing to The Agent with and explanation of the cause. The submission and

acceptance of these reports and/or notices shall not prejudice the rights of The Agent under the Subcontract and orders issued hereunder. (3) For the purposes of the order, trade terms used to describe the obligations of the parties shall have the meanings

assigned to them set out in the ICC official rules for the interpretation of trade terms (Incoterms2011) except to the extent that they are inconsistent with these Conditions or


any provisions of the order, in which case the provision of the Subcontract and order shall

prevail. (4) Delivery of the Goods, or any installment thereof, shall be considered complete only when all the conditions of the order have been completed, including when all

documentation required to be provided by the Manufacturer has been delivered to The Agent.

(5) If the Goods are not delivered in accordance with the order and the terms of this Subcontract, the Manufacturer shall be liable for any loss or expense, arising as a result.

Goods shall remain at the risk and expense of the Supplier until delivery has been completed in accordance with the order.

(f)Documentation. (1) Unless otherwise specified by The Agent, documentation shall be provided at the time and in such manner as specified in section G of the Subcontract. (2)

If an export license is required from the country of manufacture or export, the Manufacturer shall be required to provide the license and the provision and cost of such

license shall be the responsibility of the Manufacturer. (g)Payment. Unless otherwise specified by The Agent in the order, payments shall be made in accordance with section 3.9 of this Subcontract.

(h)Variation. No variation in or modification of the terms of the order shall be made except by written amendment signed by both The Agent and Manufacturer.

(i)Government Regulations. (1) The Manufacturer shall be responsible for complying with the enactments, orders, regulations or other instruments issued by the government or other competent authority in the country of manufacture. (2) The Manufacturer shall

indemnify The Agent for any loss or expenses incurred as a result of the Manufacturer’s failure to comply with any of the said enactments, orders, regulations or other

instruments. (j)Inspection. (1) The Manufacturer shall arrange for inspection of Goods at the

Manufacturer’s facility by an Inspector, appointed by The Agent, prior to shipment. Details of the scope of inspection shall be set out in the orders and the following provisions shall apply. (2) The Goods shall be inspected at the Manufacturer’s works, or

any other place that the Inspector may reasonably require or approve, and if found defective or inferior in quality to, or differing in form or material from the requirement

of the order, may be rejected. The whole of any consignment may be rejected if any proportion, percentage or samples of the Goods or material comprised therein or samples

taken from bulk, are found not to conform in every respect to the requirements of the order. The Manufacturer shall, at his own expense and within the time for delivery specified in the order, replace or make good to the satisfaction of the Inspector any Goods

so rejected. (3) The Manufacturer shall, if called upon to do so, obtain the Inspector’s approval of the manner in which the Manufacturer proposes to supply or to perform


services in relation to each portion of the Goods and shall furnish such drawings and

information as the Inspector may require. Where the order is for the supply of Goods described in the Manufacturer’s proprietary specification, then the Manufacturer’s liability shall be restricted to providing the Inspector with information concerning the

material used, the method of manufacture, details of production line test and inspection procedures.

(4) The Manufacturer shall notify The Agent at least seven days in advance of the date on

which any of the Manufacturer’s Goods will be ready for inspection. Without limiting the provisions of clause – (j)(1) of these conditions, the Inspector may inspect and reject any of the Goods at any earlier stage in course of manufacture or production. (5) Where

inspection of any of the Goods, whether completed or in course of manufacture or production, is carried out at the Manufacturer’s work (or, where applicable, at lower tier

manufacturers’ works), the Manufacturer shall ensure that the Inspector has full and free access to the said works as and when required for that purpose, and shall ensure that

Manufacturer provides the Inspector with reasonable accommodations and facilities as may be required. (6) The Inspector shall not be required to sign any form of waiver or indemnity concerning his presence or actions at the place of inspection. (7) If any of the

Goods, whether completed or in course of manufacture or production, are rejected by the Inspector, they shall be marked or segregated in such manner satisfactory to the Inspector

as to ensure their subsequent identification as rejected work. (8) When independent tests and analyses, in addition to those made by the Inspector on the Manufacturer’s premises are considered necessary, such tests or analyses will be made by persons appointed by

The Agent. The Manufacturer to bear the cost of supply and transport of samples. The costs of such additional tests and analyses will be borne by Manufacturer. (9) The

Manufacturer shall not send any of the Goods forward for shipment or report the Goods ready for dispatch for shipment until The Agent shall have given its consent to the

Manufacturer to release the order. Such consent shall not release the Manufacturer from any of his liabilities under this subcontract.

2.27 Clauses Incorporated by Reference

This subcontract incorporates the following clauses of the Federal Acquisition Regulation (48 Code of Federal Regulations, Chapter 1) and USAID Acquisition Regulation (48 Code

of Federal Regulations, Chapter 7) by reference, with the same force and effect as if they were given in full text. It is understood and agreed that the Supplier may be obligated by and to the Agent for any specifications or documentation required of KEMSA under

these clauses, and that references to the Contractor may also refer to the Supplier. The Supplier hereby agrees to abide by the terms and conditions imposed by these clauses.

http://www.arnet.gov/far/

http://www.usaid.gov/policy/ads/300/aidar.pdf


With respect to documentation and approvals required under these clauses, all such

documentation and approvals shall be submitted to or requested from KEMSA. References in the text of incorporated clauses to "the Government," "USAID," or "Contracting Officer" may, depending on their context, refer to "Kenya Medical Supplies

Authority” and references to “the Contractor" may refer to "NAME OF SUPPLIER." Federal Acquisition Regulation (FAR) Clauses:

FAR CLAUSE NUMBER

TITLE AND YEAR

52.202-1 Definitions (JUL 2004)

52.203-3 Gratuities (APR 1984)

52.203-6 Restriction on Subcontractor Sales to the Government (SEP 2006)

52.203-7 Anti-Kickback Procedures (JUL 1995)

52.209-6 Protecting the Government’s Interest when Subcontracting with Contractors Debarred, Suspended, or Proposed for

Debarment (SEP 2006)

52.215-14 Integrity of Unit Prices (OCT 1997)

52.225-13 Restrictions on Certain Foreign Purchases (FEB 2006)

52.227-1 Authorization and Consent (JUL 1995)

52.227-2 Notice and Assistance Regarding Patent and Copyright Infringement (AUG 1996)

52.229-6 Taxes—Foreign Fixed-Price Contracts (JUN 2003)

52.242-15 Stop-Work Order (AUG 1989)

52.243-1 (Alt I) Changes—Fixed Price (AUG 1987) (Alt I) (APR 1984)

52.246-2 Inspection of Supplies—Fixed-Price (AUG 1996)

52.246-23 Limitation of Liability (FEB 1997)

52.249-1 Termination for Convenience of the Government (Fixed-Price) (Short Form) (APR 1984)

52.249-8 Default (Fixed-Price Supply and Service) (APR 1984)

52.247-63 Preference for U.S. Flag Air Carriers (JUN 2003)

United States Agency for International Development Acquisition Regulation (AIDAR) Clauses:

AIDAR Title

752.202 Alt.70 and Alt.72 Definitions Alt. 70 (JAN 1990)/Alt.72 (JAN 1990)

752.211-70 Language and Measurement (JUN 1992) [especially provision in (a)]


752.225-70 Source, Origin and Nationality Requirements (FEB 1997)

752.7009 Marking (JAN 1993)

PRODUCT SPECIFICATION, PRICING AND DELIVERY SCHEDULE TECHNICAL SPECIFICATIONS

1.1. Lot I: Fortified Blended Food (FBF) for Adolescents and Adults (10 years above)

1.1.1. Scope

This technical specification covers Fortified Blended food (FBF) for adults (18 years and above)

and adolescents (10 – 17 years), packaged in flexible packaging, suitable for use by Government,

humanitarian agencies, and non- governmental organizations for the treatment and prevention of

moderate acute malnutrition (MAM) in any cultural setting. The FBF – Adults is expected to be

used as part of a Nutrition Assessment Counselling and Support (NACS) intervention program

for targeted children between the 6 to 59 months diagnosed with MAM in accordance with

Integrated Management of Acute Malnutrition guidelines for the management of MAM and

NASCOP Food by Prescription protocol.

The FBF Adults may be used as the sole source of food, except water and breast milk, during the

period of use and to provide adequate energy, protein, fat, vitamins, and minerals to effectively

resolve MAM and meets the specifications of the WHO. Technical note: supplementary foods

for the management of moderate acute malnutrition in infants and children 6–59 months of age.

Geneva, 2012.

The FBF Adults shall conform to the following list which shall be specified in the contract, or

purchase order. The FBF – Adults will be used by multiple ethnic and cultural groups. No

alcohol, animal products other than dairy products, nor any known allergens except, soy, and

dairy products shall be used in the manufacture of these items. According to guidance from

WHO the FBF Adults “These foods are usually solid or semi-solid foods with low water content,

which can be cooked every day at home in the form of porridge or soups.”

1.1.2. Salient characteristics

1.1.2.1. Processing

The FBF Adults must be processed in accordance with applicable Codex Alimentarius guidelines

i.e. General Principles of food hygiene (CAC/RCP 1-1969) and Code of Hygienic practice for

powdered formulae for infants and young children (CAC/RCP 66 – 2008)

The FBF Adults may be processed under HACCP (Hazard Analysis of Critical Control Points),

International Organization for Standardization (ISO) Standard 22000, or other standards that

assure the safety and quality of the product.


The dry ingredients shall be Food Chemicals Codex (FCC) purity as appropriate, and free from

foreign materials.

Additives shall not exceed levels allowable by the Codex Alimentarius.

1.1.2.2. Ingredients

The ingredients for the FBF Adults shall comply with the requirements cited below. Any stabilizers

or emulsifiers used must be specifically identified, and the product will contain no animal products

other than dairy products.

The suggested concentrations for nutrients in the FBF Adults are calculated as an example when

supplementary foods provide 70% of energy. This does not constitute a recommendation that

supplementary foods should provide 70% of the energy intake of moderately malnourished

children. The formulation is such that it would be safe and effective if the quantity taken by

moderately malnourished children represented 100% of the energy needs and that it would also

provide benefit, although of a lesser order of magnitude, if taken in lower quantities. There is no

evidence to determine maximum levels for some nutrients. (WHO, 2012)

The Type I, Extruded FBF Adults shall have an energy content of 420 to 480 kilocalories (kcal)

per 100 grams;

The energy density of FBF Adults when they are ready to be consumed should be not less than 0.8

kcal/g. The Type I, Extruded FBF Adults shall have a protein content of between 10.0 to 12.0

percent of kcal and shall have a Protein digestibility-corrected amino acid score >70%.

Corresponds to cereal/legume mixtures, milk and animal proteins. The sources of protein may be

dairy, protein concentrates, vegetable proteins or protein isolates.

The Type I, Extruded FBF Adults shall have a lipid content between 8 and 9 percent of the kcal.

The only added oils allowed will be canola oil or soybean oil. Partially hydrogenated (Trans) fatty

acids shall not be used in Extruded FBF Adults (CODEX STAN 074-1981, Revised 1-2006).

The FBF Adults shall include omega-6 fatty acid series and should comprise at least 4.5% of

energy (5 g/1,000 kcal), the omega-3 fatty acid series should comprise at least 0.5% of energy

(0.85 g/1,000 kcal), and the total fat content of the diet used to treat moderately malnourished

children should provide 35% to 45% of the dietary energy.

The FBF Adults shall not contain artificial antioxidants and artificial flavorings.

1.1.2.3. Water Activity

The Aw of the packaged product shall not be more than 0.60

1.1.2.4. Grains, and legume ingredients

When grain and/or legume products, are used as an ingredient, the manufacturer shall provide a

Certificate of Analysis (COA) as verification of aflatoxin testing.

Permitted cereal flours are wheat, oats, rice, millet, barley, and sorghum; and manufacturers shall

present a COA as verification of applicable mycotoxin testing.


1.1.2.5. Sweeteners

The Type I – Extruded FBF Adults may contain natural sweeteners, except honey. Honey is not

permitted due to potential toxicity from Clostridium botulinum.

1.1.2.6. Stability

The Type I, Extruded, shall be stable at temperatures ranging from -15 to 49°C. There shall be no

more than slight oil separation throughout the shelf life of the product.

1.1.3. Fortification.

The FBF Adults shall be fortified with a vitamin and mineral premix, meeting the requirements in

Table I, which is in accordance WHO. Technical note: supplementary foods for the management

of moderate acute malnutrition in infants and children 6–59 months of age.

Unless otherwise required in the solicitation, contract, or purchase order, the manufacturer will

provide a COA stating that the vitamin and mineral premix meets the requirement listed in the

table below.

Table 1: Nutrient requirements of FBF Adults premix

Nutrient per 1000 kcal Unit Minimum Maximum

Proteinc g 20 43

Fat g 25 65

Minerals

Sodium (Na) mg — 500

Potassium (K) mg 1500 2200

Magnesium (Mg) mg 280 420

Phosphorus (P)d mg 850 1400

Zinc (Zn) mg 20 35

Calcium (Ca) mg 1000 1400

Copper (Cu) mg 1 3.5

Iron (Fe)e mg 18 30

Iodine (I) µg 150 350

Selenium (Se)f µg 35 90

Manganese (Mn) mg 1 2g

Vitamins, water soluble

Thiamin (B1) mg > 1 —

Riboflavin (B2) mg > 4 —

Pyridoxine (B6) mg > 2 —

Cobalamine (B12) µg > 5 —

Folate (dietary folate equivalent) µg > 400h —

Niacin mg > 25 —

Ascorbate (vitamin C) mg > 150 —

Pantothenic acid mg > 5 —

Biotin µg > 20 —

Vitamins, fat soluble

Retinol (vitamin A) µg 2000 3000


Cholecalciferol (vitamin D) µg 20 60

Vitamin E (dl-α tocopherol acetate) mg >30 —

Phytomenadione (vitamin K) µg >50 —

Fatty acids

ω-6 fatty acid % energy >4.5 <10


Trans-fatty acids % total fat 3

Ratios of nutrients (based on weight)

Ca/P ratio 1.0 1.5

Zn/Cu ratio 5 20

Zn/Fe ratio 0.8 3.5

Vitamin C/Fe 3 16

Table 2 Mineral and vitamin compounds currently used in supplementary foods available on the

market for the dietary management of moderate acute malnutrition in children

Minerals Chemical form Lipid-based

nutrient

supplements

Fortified

blended foods

Iron Ferrous sulfate x –

Ferrous fumarateb x x

Coated ferrous fumarate x x

Coated ferrous sulfate x x

Ferrous gluconate x x

NaFeEDTAa x x

Zinc Zinc sulfateb x x

Zinc oxide (x) (x)

Copperc Copper sulfated x —

Encapsulated copper sulfatee — (x)

Copper gluconatee — (x)

Iodine Potassium iodidef x x

Potassium Potassium chlorideg x x

Magnesium Magnesium sulfate x x

Magnesium oxideb — x

Magnesium citrate x x

Magnesium gluconate x x

Calcium and phosphateh Dicalcium phosphate x x

Tricalcium phosphate x x

Seleniumi Sodium selenite x x

Sodium selenate x x

Manganese Manganese sulfate x x

Manganese gluconate x x


The intake of ethylenediaminetetraacetic acid (EDTA) (including other dietary sources) should

not exceed 1.9 mg EDTA/kg of body weight/day (15, 16).

Bioavailability with low stomach acidity is questioned.

Addition of copper is recommended, unless it negatively affects product stability, such as in

blended flours. The total amount of zinc in the product should respect the limits of the Zn/Cu

ratio and thus depends on whether copper is added to the product.

Most soluble form.

Stability of fortified blended foods when adding copper needs to be tested.

A formulation is needed that avoids caking/lumping.

The amount needs to be limited because of taste impact and formulation with anti-caking

compound is needed.

Best calcium/phosphate ratio.

Ensure homogeneity in food because of the low toxicity limit for selenium

Vitamins

Chemical form

Lipid-based nutrient

supplements

Fortified blended

foods

Vitamin A Dry vitamin A acetate x –

Dry vitamin A palmitate x –

Dry vitamin A palmitate beadlet – x

Dry vitamin A palmitate spray

dried

– x

Vitamin D Dry vitamin D3 spray dried x x

Dry vitamin D3 beadlet – x

Dry vitamin E acetate 50% x x

Vitamin K Dry vitamin K 5% x x

Vitamin B1j Thiamine hydrochloride x —

Thiamine mononitrate x x

Vitamin B2k Riboflavin x —

Riboflavin fine powder — x

Vitamin B6 Pyridoxine hydrochloride x x

Niacin Niacin amide x x

Folic acid Folic acid x x

Vitamin B12 Vitamin B12 0.1% spray dried or

1% spray dried

x x

Vitamin C Ascorbic acidm x x

Ascorbic acid fine powdern x x

Sodium ascorbateo x x

Sodium selenate x x

Pantothenic

acid

Calcium p-panthothenate x x

Biotin Biotin 1% x x j Cannot be used in flour because of ability to absorb water. k Shows as yellow spots, but not visible in lipid-based nutrient supplements


l Fine powder does not show as yellow spots. m Sour taste, disappears after cooking. n Less acid taste. oLess acid taste, but more costly

1.1.4. Finished product.

1.1.4.1. Appearance and texture The Type I, FBF Adults shall be free flowing and homogeneous when reconstituted and cooked

into porridge; shall be free of lumps; the porridge shall not separate and be free of a gritty,

grainy, and sandy texture.

1.1.4.2. Flavour and odour. The Type I, FBF Adults shall be free from foreign odours and flavours such as, but not limited to

burnt, scorched, rancid, malted, sour, or stale. The FBF Adults shall not contain any artificial

flavouring.

1.1.4.3. Colour The Type I, FBF Adults shall have a cream to light brown colour. The Type I, FBF Adults shall

not have a dull, grey tinge, or other abnormal cast. The FBF Adults shall show no evidence of

over cooking during extrusion (materially darkened or scorched).

1.1.4.4. Foreign material. The FBF Adults shall be clean, sound, wholesome, and free from evidence of rodent or insect

infestation.

1.1.4.5. Age requirement (Shelf Life) Unless otherwise specified in the solicitation, contract, or purchase order the FBF Adults shall

not be more than 90 days old when it leaves the manufacturer’s plant for delivery to purchaser.

The FBF Adults shall have a shelf life of at least 12 months when stored at 25°C.

1.1.5. Product standard Unless otherwise specified in the solicitation, contract, or purchase order, a sample of the FBF

Adults shall be subjected to product demonstration model (PDM) inspection as applicable, in

accordance with the requirements of this technical specifications

The approved sample shall serve as the product standard when evaluating each production lot

Any failure to conform to the finished product requirements or any appearance or palatability

failure shall be cause for rejection of the lot

Should the manufacturer at any time plan to, or actually produce the product using different

formulation or process methodologies from the approved product standard, which result in a


product non comparable to the product standard, the manufacturer shall arrange for a replacement

PDM approval

In any event, all product produced must meet all requirements of this technical specifications

including product standard comparability.

1.1.6. ANALYTICAL REQUIREMENTS.

1.1.6.1. Proximate and microbiological testing requirements. Unless otherwise specified in the solicitation, contract, or purchase order the proximate and

microbiological testing requirements for the FBF ADULTS shall be as follows:

Test Tolerance

Energy 420 - 480kcal/100g

Protein 10-12 percent of kcal

Total Fat 9 – 10 percent of kcal

Water Activity(Aw) Less than 0.60

Crude fibre 3.0% max

Standard plate count Not more than 10,000 Colony Forming

Units(CFU)/g

Aflatoxin Less than 5 parts per billion (ppb) total

Alfatoxin

Melamine/ Cyanuric acid Less than 25 ppb

Coliform Less than 10 CFU/g or less than 3 Most

Probable Number (MPN)/g

Yeast Not more than 10 in 1g

Mould Not more than 50 in 1g

Clostridium perfrigens Negative

Salmonella Negative

E.coli Negative

Listeria monocytogenes Negative

Staphylococcus aureus Negative (coagulase positive)

Cronobacter sakazakii Negative in 10g

Vitamin A 0.8 - 1.1 mg/100 g

Vitamin B1 Minimum 0.5 mg/100 g

Vitamin C Minimum 50 mg/100 g

Iron 10 - 14 mg/100 g


1.1.6.2. Product verification When verification of the proximate, chemical, and microbiological testing requirements is

specified in the solicitation, contract, or purchase order, analytical testing shall be performed on

composite samples.

For proximate tests the composite sample shall be 500 g (0.5kg).

For the Aflatoxin test a single composite sample shall be produced from 60 randomly drawn

sachets

For microbiological tests five homogenized composite samples shall be produced from a total of

60 randomly drawn sachets (12 per composite) per production lot / batch

1.1.6.3. Test portion size for microbiological tests. The test portions for microbiological tests shall be derived from each of the five composite

samples specified.

The test portion size for testing aerobic plate count, coliform, and yeast and mould shall be 25 g

(0.025kg); Salmonella shall be 125 g (0.125kg); Staphylococcus aureus (coagulase positive),

Clostridium perfringens, E.coli, and Listeria monocytogenes shall be 25 g (0.025kg) each and

Cronobacter sakazakii shall be 10 g (0.01kg) each.

1.1.6.4. Proximate and microbiological testing When specified in the solicitation, contract, or purchase order, the analysis shall be performed in

accordance with the following methods from the AOAC International Official Methods of

Analysis (OMA), the FDA Bacteriological Analytical Manual (BAM), or as specified below:

Test Method

Protein 988.05, 992.15

Total Fat 991.36, 2007.04, 2008.06

Water Activity(Aw) 978.18

Standard plate count 966.23, 990.12, 2008.10, or BAM, Chapter 3

Aflatoxin 990.33, 991.31, 998.03, or 999.07

Melamine/ Cyanuric acid FDA LIB 4421, FDA LIB 4422, FDA LIB

4423

Coliform 966.24, 986.33, 989.19, 991.14, 2000.15,

2008.10, or BAM, Ch. 4

Yeast 997.02, 995.21

Mould 997.02, 995.21

Clostridium perfrigens 976.30 or BAM, Ch. 16

Salmonella 2004.03, 2003.09, 2011.03, or BAM, Ch. 5

E.coli 966.24, 986.33, 989.19, 991.14, 2000.15,

2009.02, or BAM, Ch.4

Listeria monocytogenes 992.18, 2003.12, 2004.02, or 2010.02

Staphylococcus aureus 2003.07, 2003.08, or 2003.11


Cronobacter sakazakii ISO 22964 or BAM ucm289378

Vitamin A 2001.13, 2011.11, or 2011.13

Vitamin B1 986.27, 957.17

Vitamin C 967.21, 985.33, or 985.33

Iron 985.35, 984.27, or 999.10

1.1.7. Test results The test results for protein shall be reported to the nearest 0.1 percent.

The test results for aflatoxin shall be reported as negative when the results are not greater than 5

ppb.

The test results for melamine/cyanuric acid shall be reported as negative when the results are not

greater than 25 ppb.

The test results for Aw shall be reported to the nearest 0.01 value. No individual sample shall

have an Aw value exceeding 0.60.

The test results for standard plate count and yeast and mould shall be reported to the nearest 10

CFU per g.

The test results for coliform and E. coli shall be reported to the nearest 10 CFU per g or to the

nearest MPN per g.

The test results for Clostridium perfringens, Salmonella, Listeria monocytogenes,

Staphylococcus aureus (coagulase positive), and Cronobacter sakazakii shall be reported as

negative or positive.

Test results for Vitamin A, Vitamin B1 (Thiamin), Vitamin C, iron, and fat shall be reported with

units and precision as specified or as described in the test method.

Any result not conforming to the analytical testing shall be cause for rejection of the lot/batch

1.2. PACKAGING REQUIREMENTS AND EXAMINATIONS.

1.2.1. Sachet requirements

1.2.1.1. Sachet material The sachet material shall be capable of being fabricated into sachets.

The material used for the sachet shall be generally recognized as safe (GRAS) for use with food

in accordance with accepted standards and regulations.

Recycled, recovered, or environmentally preferable materials should be used to the maximum

extent possible, provided that the material meets or exceed the material requirements cited

herein.

The size of the sachet shall be 185mm in length and 150mm in width


1.2.1.2. Oxygen transmission rate The oxygen transmission rate (O2TR) of the material shall not exceed 0.06 cc/m2/24 hrs/atm.

The O2TR of the material shall be determined in accordance with ASTM D 3985, at 23°C and 50

percent relative humidity (RH).

Any O2TR exceeding 0.06 cc/m2/24 hrs/atm shall be considered a test failure and shall be cause

for rejection of the lot.

Compliance to the O2TR requirement may be verified by COA from the packaging manufacturer.

1.2.1.3. Water vapour transmission rate. The water vapor transmission rate (WVTR) of the material shall not exceed 0.01 gm/m2/24 hrs.

The WVTR of the material shall be determined in accordance with ASTM F 372, at 38°C and 90

percent RH.

Any WVTR exceeding 0.01 gm/m2/24 hrs shall be considered a test failure and shall be cause

for rejection of the lot.

Compliance to the WVTR requirement may be verified by COA from the packaging

manufacturer.

1.2.1.4. Filled and sealed sachets. Filled and sealed sachets shall be free of damage (such as, but not limited to: tears, cuts, holes,

or if a multi-layer laminate is used, abrasions through one or more layers in the sachet material,

or leakage through any seal).

The sachet material shall not transfer any foreign flavour or odour to the product being packaged.

1.2.1.5. Closure seal The closure seal width shall be a minimum 2.5 mm.

The closure seal shall be free of impression or design on the seal surface that would conceal or

impair visual detection of seal defects.

The closure seal shall be free of wrinkles, occluded matter, or evidence of entrapped moisture or

grease that reduces the closure seal width to less than 1.6 mm at any location along its

continuous path.

1.2.1.6. Internal pressure The sachets shall be filled and hermetically sealed such that they shall withstand the applicable

pressure for 30 seconds.

1.2.1.7. Filled and sealed sachet examination The filled and sealed sachets shall be examined for the defects listed in Table 3 utilizing

ANSI/ASQC Z1.4, Sampling Procedures and Tables for Inspection by Attributes, in effect on the

date of the solicitation. The lot size shall be expressed in sachets. The sample unit shall be one

filled and sealed sachet. The inspection level shall be 1 and the acceptable quality level (AQL),

expressed in terms of defects per hundred units shall be1.5 for major defects and 4.0 for minor


defects. A minimum of 200 samples shall be examined for critical defects. The finding of any

critical defect shall be cause for rejection of the lot

Notes

Any evidence of insect or rodent infestation shall be cause for rejection of the lot.

A critical defect is a defect that judgment and experience indicate would result in hazardous or

unsafe conditions for individuals using the item.

A major defect is a defect, other than critical, that is likely to result in failure, or to reduce

materially the usability of the unit of product for its intended purpose.

A minor defect is a defect that is not likely to reduce materially the usability of the unit of

product for its intended purpose, or is a departure from established standards having little bearing

on the effective use or operation of the unit.

Aberrations in sachet material or heat seals include:

o Major fold-over wrinkles or severe wrinkles, that extend into heat seal area and

reduce effective seal width to less than 1.6 mm or

o Severe wrinkles in the body of the sachet along the inside edges of the heat seals.

o Sachets exhibiting one or more of these aberrations shall be tested in accordance

with internal pressure testing procedures

Table 3 Filled and Sealed sachets defects

Category Defect

Critical Major Minor Both sachets 1 Tear, hole, or open seal

2 Aberrations in sachet material or heat seals resulting from heat

sealing, sachet fabrication, hot filling or heat processing that

reduce the effective closure seal width to less than 1.6 mm (1/16

in)

101 Seal width not as specified

102 Not heat sealed as specified

103 Inside sachet dimensions not as specified

104 Closure seal not located as specified

105 Closure or top seal extends into or below tear notch location

106 Not clean

107 Required labeling or marking missing, incorrect, illegible or that

smudges

108 Embossed code marking not located as specified

109 Distance between inside edge of tear notch or serrations and

inside edge of seal is less than 4.7625 mm (3/16 in)

110 Presence of entrapped matter (for example, product residue) that

reduces the effective closure seal to less than 1.6 mm (1/16 in)

wide

201 Tear notch or serrations missing

202 Tear notch or serrations not located as specified


203 Depth of tear notch or serrations not as specified

204 Excess sachet material at edges exceeds 4.7625 mm (3/16in)

3 Swollen sachet

111 Sachet has foreign odour

112 Evidence of loss of vacuum

1.2.2. Sachet leakage and delamination examination All exterior surfaces and edges of the filled and sealed sachet shall be examined visually for

product leakage while applying a manual kneading action which forces the product against the

interior sachet surface in the area being observed.

After leakage testing, the sachet shall be examined for evidence of delamination.

Any product leakage from the sachet or evidence of delamination of the sachet shall be classified

as a major defect, except delamination of outer ply when located in the seal area 1.6 mm or

further from the food product edge of seal.

Sachets exhibiting this type of delamination shall be tested by manually flexing the delaminated

area 10 times. The area of delamination shall be held between the thumb and forefinger of each

hand with both thumbs and forefingers touching each other.

The delamination area shall then be rapidly flexed by rotating both hands in alternating

clockwise - counter clockwise directions.

Care shall be exercised when flexing delaminated area near the tear notches to avoid tearing the

sachet material. After flexing, the separated outer ply shall be grasped between the thumb and

forefinger and gently lifted toward the food product edge of the seal.

If the separated area is too small to be held between thumb and forefinger, a number two stylus

shall be inserted into the delaminated area and a gentle lifting force applied against the outer ply.

If separation of the outer ply can be made to extend to less than 1.6 mm (1/16 in) from the

product edge of the seal with no discernible resistance to the gentle lifting, the sachet shall be

rejected.

The lot size shall be expressed in sachets.

The sample unit shall be one filled and sealed sachet.

The inspection level shall be 1 and the AQL, expressed in terms of defects per hundred units,

shall be 0.65 for major defects

1.2.3. Internal pressure test Internal pressure resistance shall be determined by pressurizing the sachets while they are

restrained between two rigid plates.

The plates shall be 12.7 + 1.6 mm (1/2 + 1/16 in) apart or 25.4 + 1.6 mm (1 + 1/16 in) apart. If a

three-seal tester (one that pressurizes the sachet through an open end) is used, the closure seal

shall be cut off for testing the side and bottom seals of the sachet; for testing of the closure seal,

the bottom seal shall be cut off.


The sachets shall be emptied prior to testing. If a four-seal tester (designed to pressurize filled

sachets by use of a hypodermic needle through the sachet wall) is used, all four seals can be

tested simultaneously.

Pressure shall be applied gradually until 17 psig pressure is reached. The 17 psig pressure shall

be held constant for 30 seconds and then released.

The sachets shall then be examined for separation or yield of the seals.

Any rupture of the sachet or evidence of seal separation greater than 1.6 mm in the sachet

manufacturer's seal shall be considered a test failure.

Any seal separation that reduces the effective closure seal width to less than 1.6 mm shall be

considered a test failure and shall be cause for rejection of the lot.

1.2.4. Net weight examination The net weight of the filled and sealed sachets shall be determined by weighing each sample unit

on a suitable scale tared with a representative empty sachet.

Any individual net weight of less than 300 g shall be classified as a minor defect.

The lot size shall be expressed in sachets. The sample unit shall be one filled and sealed sachet

The inspection level shall be S-3 and the AQL, expressed in terms of defects per hundred units,

shall be 2.5

The results shall be reported to the nearest 0.1 g. In addition, the lot shall be rejected if the

sample average net weight is less than 200 g.

1.3. Packaging and Labelling specifications The material used for packaging shall be generally recognized as safe (GRAS) for use with food

in accordance in accordance with good manufacturing practices (see attached)or other standards

and regulations with accepted standards and regulations.

Recycled, recovered, or environmentally preferable materials should be used to the maximum

extent possible, provided that the material meets or exceed the material requirements cited herein

All labelling, package inserts and specifications shall be in English

Each Secondary package should have a Product information insert in English containing:

o Product Name (both International Non-proprietary Name)

o Nutritional information

o Composition / ingredients

o Indications

o Dosage and administration

o Contraindications

o Precautions

o Adverse effects

All branding and marking for the primary secondary and tertiary packages shall comply to the

KEMSA MCP Branding and Marking plan requirements


1.3.1. Primary package labelling requirements The primary package is a sachet of 300g; 185mm length by 150mm width

Product Name (International Non-proprietary Name)

Nutritional information

Composition / ingredients

Batch number

Manufacturing date

Best before date

Directions for use: Should indicate “For single use only”

Dosage

Should have a label “USAID/KEMSA MCP - Not for sale” clearly labelled in a place

where it is visible.

1.3.2. Secondary package requirements and labelling The secondary package for FBF Adults is a transparent low density polyethylene (LDPE) bag

300mm length x 480 mm width)

The LDPE bag contain 15 sachets of 300g each of FBF Adults and each bag shall meet the

following labelling requirements

o minimum gross weight of a bag should be 4500g or 4.5 kg

o Product Name (International Non-proprietary Name)

o Batch number

o Manufacturing date

o Best before date

o Storage instructions

o Manufacturers contact information and physical address

o Should have a label “USAID/KEMSA MCP - Not for sale” clearly labelled in a

place where it is visible

o Specified branding requirements for USAID

1.3.3. Tertiary package requirements and labelling Corrugated Fibreboard Shipping boxes (Shipping Container) – Shall contain 4 bags of 4.5kg of

FBF Adults. The shipping container will be a regular slotted container constructed of a minimum

450lb (204kg) burst test, corrugated fibreboard.

The outside dimensions of each shipping container will be no less than 280mm in height, and

cases should be designed to the optimal dimensions to fill at least 80% of the cubic capacity of a

20 foot intermodal when stacked two pallets high.

Cases of dimensions shall be no less 280mm. height x 460mm. length x 275 mm. width and will

have been found to comply with this requirement (when stacked 6 cases per layer and five tiers

high on a standard pallet).


Other case dimensions will be considered providing the height of the case does not exceed

300mm and the pallets, when double stacked, can fill at least 80% of the cubic capacity of a 20

foot intermodal

The corrugated fibreboard will meet the following labelling specifications:


o Batch number


o Best before date

o Quantity of the tertiary package will be determined by weight and should contain

4 bags of 4.5kg each of FBF Adults, the carton should have a minimum gross

weight of 18 kg

o Storage instructions

o Manufacturers contact information and physical address

o Should have a label “GOK - Not for sale” clearly labelled in a place where it is

visible.

o Should fulfil brand and marking plan of NHPplus

1.4. MANUFACTURER’S PRODUCT ASSURANCE The manufacturer shall certify that the FBF Adults provided, meets the requirements of this

technical specifications

The purchaser or procuring entity shall require proof of conformance

1.5. REGULATORY REQUIREMENTS The delivered FBF Adults shall comply with all applicable Government , County, and local by-

laws and regulations relating to the manufacturing, storage, and distribution of packaged foods

for human consumption, including all applicable provisions of Food, Drugs and Chemical

Substances Act Chapter 254 (2012), Public Health Act Cap 242 (2012) and regulations

promulgated thereunder

All certificates of analysis for both raw materials and delivered FBF Adults will be from a Kenya

National Accreditation Services (KENAS) accredited laboratories or from labs with valid ISO

17025:2005 certification.

1.6. QUALITY ASSURANCE PROVISIONS The product manufacturer shall be required to provide evidence, by certificate, that the

manufacturing plant has undertaken one of the following quality assurance measures within 12

months prior to providing a bid, or no later than 10 business days from the date of awarding of

the contract.

Failure to provide this documentation within the proper time frame may result in the contract

being terminated for cause


1.6.1. ISO 22000 Assessment A supplier quality assessment (SQA) verifies the manufacturer's capability to produce products

in a clean sanitary environment in accordance with ISO 22002-1:2009 – Prerequisite

programmes on food safety part 1 : Food Manufacturing and verifies that the manufacturer has

in place an internal quality assurance and food safety program

A supplier quality audit (SQA) based on ISO 22000:2005 by a third party auditing service is

required within 12 months prior to the date of the awarding of the contract. The food

manufacturer must have attained an SQA score of 75% or above

The food manufacturer must be ISO 22000 certified

The relevant certificate/letter bearing the name of any of the above bodies must be submitted for

scrutiny

1.6.2. Kenya Bureau of Standards (KEBS) certification KEBS is the standards authority in Kenya and therefore all food must be approved as safe for

human consumption

The locally produced FBF Adults must have the Standardization mark as this is a mandatory

product certification scheme for locally manufactured products provided for under section 10 of

the Standards Act Cap 496, Laws of Kenya

The Ministry of Health, through legal notice 62 of 15th June 2012 introduced the food

fortification logo which is administered by KEBS; manufacturers are encouraged to apply for

fortification mark for FBF Adults products

9.1 LOT II: FORTIFIED BLENDED FOOD (FBF) Pregnant or Postpartum Mothers

9.1.1 Scope

This technical specification covers Fortified Blended food (FBF) for Pregnant or Postpartum

mothers , packaged in flexible packaging, suitable for use by Government, humanitarian

agencies, and non- governmental organizations for the treatment and prevention of moderate

acute malnutrition (MAM) in any cultural setting. The FBF – Pregnant or Postpartum is expected

to be used as part of a Nutrition Assessment Counselling and Support (NACS) intervention

program for targeted pregnant or postpartum mothers diagnosed with MAM in accordance with

Integrated Management of Acute Malnutrition guidelines for the management of MAM and

NASCOP Food by Prescription protocol.

The FBF Pregnant or Postpartum may be used as the sole source of food, except water and breast

milk, during the period of use and to provide adequate energy, protein, fat, vitamins, and

minerals to effectively resolve MAM and meets the specifications of the WHO. Technical note:

supplementary foods for the management of moderate acute malnutrition in infants and children

6–59 months of age. Geneva, 2012.


The FBF Pregnant or Postpartum mothers shall conform to the following list which shall be

specified in the contract, or purchase order. The FBF – Adults will be used by multiple ethnic

and cultural groups. No alcohol, animal products other than dairy products, nor any known

allergens except, soy, and dairy products shall be used in the manufacture of these items.

According to guidance from WHO “These foods are usually solid or semi-solid foods with low

water content, which can be cooked every day at home in the form of porridge or soups.” 9.1.2 Salient characteristics

9.1.2.1 Processing

The FBF Pregnant or Postpartum mothers must be processed in accordance with

applicable Codex Alimentarius guidelines i.e. General Principles of food hygiene

(CAC/RCP 1-1969) and Code of Hygienic practice for powdered formulae for infants and

young children (CAC/RCP 66 – 2008)

The FBF Pregnant or Postpartum mothers may be processed under HACCP (Hazard

Analysis of Critical Control Points), International Organization for Standardization (ISO)

Standard 22000, or other standards that assure the safety and quality of the product.

The dry ingredients shall be Food Chemicals Codex (FCC) purity as appropriate, and free

from foreign materials.

Additives shall not exceed levels allowable by the Codex Alimentarius.

9.1.2.2 Ingredients

The ingredients for the FBF Pregnant or Postpartum mothers shall comply with the

requirements cited below. Any stabilizers or emulsifiers used must be specifically

identified, and the product will contain no animal products other than dairy products. .

The suggested concentrations for nutrients in the FBF Pregnant or Postpartum mothers

are calculated as an example when supplementary foods provide 70% of energy. This

does not constitute a recommendation that supplementary foods should provide 70% of

the energy intake of moderately malnourished children. The formulation is such that it

would be safe and effective if the quantity taken by moderately malnourished children

represented 100% of the energy needs and that it would also provide benefit, although of

a lesser order of magnitude, if taken in lower quantities. There is no evidence to

determine maximum levels for some nutrients. (WHO, 2012)

The Type I, Extruded FBF Pregnant or Postpartum mothers shall have an energy content

of 420 to 480 kilocalories (kcal) per 100 grams;

The energy density of FBF Pregnant or Postpartum mothers when they are ready to be

consumed should be not less than 0.8 kcal/g.

The Type I, Extruded FBF Pregnant or Postpartum mothers shall have a protein content

of between 10.0 to 12.0 percent of kcal and shall have a Protein digestibility-corrected

amino acid score >70%. Corresponds to cereal/legume mixtures, milk and animal


proteins. The sources of protein may be dairy, protein concentrates, vegetable proteins or

protein isolates.

The Type I, Extruded FBF Pregnant or Postpartum mother shall have a lipid content

between 8 and 9 percent of the kcal. The only added oils allowed will be canola oil or

soybean oil. Partially hydrogenated (Trans) fatty acids shall not be used in Extruded FBF

Pregnant or Postpartum mothers (CODEX STAN 074-1981, Revised 1-2006).

The FBF Pregnant or Postpartum mothers shall include omega-6 fatty acid series and

should comprise at least 4.5% of energy (5 g/1,000 kcal), the omega-3 fatty acid series

should comprise at least 0.5% of energy (0.85 g/1,000 kcal), and the total fat content of

the diet used to treat moderately malnourished children should provide 35% to 45% of

the dietary energy.

The FBF Pregnant or Postpartum mothers shall not contain artificial antioxidants and

artificial flavourings

9.1.2.3 Water Activity

The Aw of the packaged product shall not be more than 0.60 9.1.2.4 Grains, and legume ingredients

When grain and/or legume products, are used as an ingredient, the manufacturer shall

provide a Certificate of Analysis (COA) as verification of aflatoxin testing.

Permitted cereal flours are wheat, oats, rice, millet, barley, and sorghum; and

manufacturers shall present a COA as verification of applicable mycotoxin testing.

9.1.2.5 Sweeteners

The Type I – Extruded FBF Pregnant or Postpartum mothers may contain natural sweeteners,

except honey.

Honey is not permitted due to potential toxicity from Clostridium botulinum.

9.1.2.6 Stability

The Type I, Extruded, shall be stable at temperatures ranging from -15 to 49°C. There

shall be no more than slight oil separation throughout the shelf life of the product. 9.1.2.7 Fortification.

o The FBF Pregnant or Postpartum mothers shall be fortified with a vitamin and

mineral premix, meeting the requirements in Table I, which is in accordance

WHO. Technical note: supplementary foods for the management of moderate

acute malnutrition in infants and children 6–59 months of age.

Unless otherwise required in the solicitation, contract, or purchase order, the

manufacturer will provide a COA stating that the vitamin and mineral premix meets the

requirement listed in Table I.

Table 1: Nutrient requirements of FBF Pregnant or Postpartum mothers premix


Nutrient per 1000

kcal

Unit Minimum Maximum

Proteinc g 20 43

Fat g 25 65

Minerals





Zinc (Zn) mg 20 35



Iron (Fe)e mg 18 30




Vitamins, water

soluble





Folate (dietary folate

equivalent)

µg > 400h —

Niacin mg > 25 —

Ascorbate (vitamin

C)

mg > 150 —


Biotin µg > 20 —



Cholecalciferol

(vitamin D)

µg 20 60

Vitamin E (dl-α

tocopherol acetate)

mg >30 —

Phytomenadione

(vitamin K)

µg >50 —

Fatty acids





Ratios of nutrients

(based on weight)

Ca/P ratio 1.0 1.5

Zn/Cu ratio 5 20

Zn/Fe ratio 0.8 3.5

Vitamin C/Fe 3 16

Table 2: Mineral and vitamin compounds currently used in supplementary foods available on the


Minerals Chemical form Lipid-based nutrient

supplements

Fortified blended

foods



Coated ferrous

fumarate

x x



NaFeEDTAa x x


Zinc oxide (x) (x)


Encapsulated copper

sulfatee

— (x)







Magnesium

gluconate

x x

Calcium and

phosphateh

Dicalcium phosphate x x



Sodium selenate x x



2. The intake of ethylenediaminetetraacetic acid (EDTA) (including other dietary sources)

should not exceed 1.9 mg EDTA/kg of body weight/day (15, 16).


3. Bioavailability with low stomach acidity is questioned.

4. Addition of copper is recommended, unless it negatively affects product stability, such as in

blended flours. The total amount of zinc in the product should respect the limits of the Zn/Cu

ratio and thus depends on whether copper is added to the product.

5. Most soluble form.

6. Stability of fortified blended foods when adding copper needs to be tested.

7. A formulation is needed that avoids caking/lumping.

8. The amount needs to be limited because of taste impact and formulation with anti-caking

compound is needed.

9. Best calcium/phosphate ratio.

10. Ensure homogeneity in food because of the low toxicity limit for selenium

Vitamins

Chemical form


supplements

Fortified blended

foods

Vitamin A Dry vitamin A

acetate

x –

Dry vitamin A

palmitate

x –

Dry vitamin A

palmitate beadlet

– x

Dry vitamin A

palmitate spray dried

– x

Vitamin D Dry vitamin D3 spray

dried

x x

Dry vitamin D3

beadlet

– x

Dry vitamin E acetate

50%

x x


Vitamin B1j Thiamine

hydrochloride

x —

Thiamine

mononitrate

x x


Riboflavin fine

powder

— x

Vitamin B6 Pyridoxine

hydrochloride

x x




Vitamin B12 Vitamin B12 0.1%

spray dried or 1%

spray dried

x x


Ascorbic acid fine

powdern

x x


Sodium selenate x x

Pantothenic acid Calcium p-

panthothenate

x x

Biotin Biotin 1% x x j Cannot be used in flour because of ability to absorb water. k Shows as yellow spots, but not visible in lipid-based nutrient supplements l Fine powder does not show as yellow spots. m Sour taste, disappears after cooking. n Less acid taste. oLess acid taste, but more costly

9.2 Finished product.

9.2.1 Appearance and texture

The Type I, FBF Pregnant or Postpartum mothers shall be free flowing and homogeneous when

reconstituted and cooked into porridge; shall be free of lumps; the porridge shall not separate and

be free of a gritty, grainy, and sandy texture. 9.2.2 Flavour and odour.

The Type I, FBF Pregnant or Postpartum mothers shall be free from foreign odours and flavours

such as, but not limited to burnt, scorched, rancid, malted, sour, or stale. The FBF Pregnant or

Postpartum mothers shall not contain any artificial flavouring. 9.2.3 Colour

The Type I, FBF Pregnant or Postpartum mothers shall have a cream to light brown colour. The

Type I, FBF Pregnant or Postpartum mothers shall not have a dull, grey tinge, or other abnormal

cast. The FBF Pregnant or Postpartum mothers shall show no evidence of over cooking during

extrusion (materially darkened or scorched). 9.3 Foreign material.

The FBF Pregnant or Postpartum mothers shall be clean, sound, wholesome, and free from

evidence of rodent or insect infestation. 9.4 Age requirement (Shelf Life)

Unless otherwise specified in the solicitation, contract, or purchase order the FBF

Pregnant or Postpartum mothers shall not be more than 90 days old when it leaves

the manufacturer’s plant for delivery to purchaser.

The FBF Pregnant or Postpartum mothers shall have a shelf life of at least 12 months

when stored at 25°C.


9.5 Product standard

Unless otherwise specified in the solicitation, contract, or purchase order, a sample of the

FBF Pregnant or Postpartum mothers shall be subjected to product demonstration model

(PDM) inspection as applicable, in accordance with the requirements of this technical

specifications

The approved sample shall serve as the product standard when evaluating each

production lot

Any failure to conform to the finished product requirements or any appearance or

palatability failure shall be cause for rejection of the lot

Should the manufacturer at any time plan to, or actually produce the product using

different formulation or process methodologies from the approved product standard,

which result in a product non comparable to the product standard, the manufacturer shall

arrange for a replacement PDM approval

In any event, all product produced must meet all requirements of this technical

specifications including product standard comparability.

9.6 Analytical Requirements

9.6.1 Proximate and microbiological requirements

Unless otherwise specified in the solicitation, contract, or purchase order the proximate and

microbiological testing requirements for the FBF Pregnant or Postpartum Mothers shall be as

follows:

Test Tolerance





Crude fibre 3.0% max


Units(CFU)/g


Alfatoxin







Salmonella Negative

E.coli Negative





Vitamin A 0.8 - 1.1 mg/100 g



Iron 10 - 14 mg/100 g

9.6.2 Product verification

When verification of the proximate, chemical, and microbiological testing requirements is

specified in the solicitation, contract, or purchase order, analytical testing shall be performed

on composite samples.

o For proximate tests the composite sample shall be 500 g (0.5kg).

o For the Aflatoxin test a single composite sample shall be produced from 60

randomly drawn sachets

o For microbiological tests five homogenized composite samples shall be produced

from a total of 60 randomly drawn sachets (12 per composite) per production lot /

batch

9.6.3 Test portion size for microbiological tests

The test portions for microbiological tests shall be derived from each of the five composite

samples specified in Sec. 5.1.

o The test portion size for testing aerobic plate count, coliform, and yeast and

mould shall be 25 g (0.025kg);

o Salmonella shall be 125 g (0.125kg);

o Staphylococcus aureus (coagulase positive), Clostridium perfringens, E.coli, and

Listeria monocytogenes shall be 25 g (0.025kg) each.

o Cronobacter sakazakii shall be 10 g (0.01kg) each.

9.6.4 Proximate and microbiological testing

When specified in the solicitation, contract, or purchase order, the analysis shall be performed in

accordance with the following methods from the AOAC International Official Methods of

Analysis (OMA), the FDA Bacteriological Analytical Manual (BAM), or as specified below:

Test Method

Protein 988.05, 992.15

Total Fat 991.36, 2007.04, 2008.06


Standard plate count 966.23, 990.12, 2008.10, or BAM, Chapter 3

Aflatoxin 990.33, 991.31, 998.03, or 999.07


4423


Coliform 966.24, 986.33, 989.19, 991.14, 2000.15,

2008.10, or BAM, Ch. 4

Yeast 997.02, 995.21

Mould 997.02, 995.21



E.coli 966.24, 986.33, 989.19, 991.14, 2000.15,

2009.02, or BAM, Ch.4




Vitamin A 2001.13, 2011.11, or 2011.13

Vitamin B1 986.27, 957.17

Vitamin C 967.21, 985.33, or 985.33

Iron 985.35, 984.27, or 999.10

9.6.5 Test results

The test results for protein shall be reported to the nearest 0.1 percent.

o The test results for aflatoxin shall be reported as negative when the results are not

greater than 5 ppb.

o The test results for melamine/cyanuric acid shall be reported as negative when the

results are not greater than 25 ppb.

o The test results for Aw shall be reported to the nearest 0.01 value. No individual

sample shall have an Aw value exceeding 0.60.

o The test results for standard plate count and yeast and mould shall be reported to

the nearest 10 CFU per g.

o The test results for coliform and E. coli shall be reported to the nearest 10 CFU

per g or to the nearest MPN per g.

o The test results for Clostridium perfringens, Salmonella, Listeria monocytogenes,

Staphylococcus aureus (coagulase positive), and Cronobacter sakazakii shall be

reported as negative or positive.

o Test results for Vitamin A, Vitamin B1 (Thiamin), Vitamin C, iron, and fat shall

be reported with units and precision as specified or as described in the test

method.

o Any result not conforming to the analytical testing shall be cause for rejection of

the lot/batch

9.7 Packaging Requirements and Examinations

9.7.1 Sachet material

The sachet material shall be capable of being fabricated into sachets.


o The material used for the sachet shall be generally recognized as safe (GRAS) for

use with food in accordance with accepted standards and regulations.

o Recycled, recovered, or environmentally preferable materials should be used to

the maximum extent possible, provided that the material meets or exceed the

material requirements cited herein.

o The size of the sachet shall be 185mm in length and 150mm in width

9.7.2 Oxygen transmission rate

o The oxygen transmission rate (O2TR) of the material shall not exceed 0.06

cc/m2/24 hrs/atm. The O2TR of the material shall be determined in accordance

with ASTM D 3985, at 23°C and 50 percent relative humidity (RH).

o Any O2TR exceeding 0.06 cc/m2/24 hrs/atm shall be considered a test failure and

shall be cause for rejection of the lot.

o Compliance to the O2TR requirement may be verified by COA from the

packaging manufacturer.

9.7.3 Water vapour transmission rate.

o The water vapor transmission rate (WVTR) of the material shall not exceed 0.01

gm/m2/24 hrs.

o The WVTR of the material shall be determined in accordance with ASTM F 372,

at 38°C and 90 percent RH.

o Any WVTR exceeding 0.01 gm/m2/24 hrs shall be considered a test failure and


o Compliance to the WVTR requirement may be verified by COA from the


9.7.4 Filled and sealed sachets.

o Filled and sealed sachets shall be free of damage (such as, but not limited to:

tears, cuts, holes, or if a multi-layer laminate is used, abrasions through one or

more layers in the sachet material, or leakage through any seal).

o The sachet material shall not transfer any foreign flavour or odour to the product

being packaged.

9.7.4.1 Closure seal

o The closure seal width shall be a minimum 2.5 mm.

o The closure seal shall be free of impression or design on the seal surface that

would conceal or impair visual detection of seal defects.

o The closure seal shall be free of wrinkles, occluded matter, or evidence of

entrapped moisture or grease that reduces the closure seal width to less than 1.6

mm at any location along its continuous path.


9.7.4.2 Internal pressure

The sachets shall be filled and hermetically sealed such that they shall withstand the

applicable pressure for 30 seconds.

9.7.5 Filled and sealed sachet examination

The filled and sealed sachets shall be examined for the defects listed in Table 3 utilizing

ANSI/ASQC Z1.4, Sampling Procedures and Tables for Inspection by Attributes, in effect

on the date of the solicitation. The lot size shall be expressed in sachets. The sample unit

shall be one filled and sealed sachet. The inspection level shall be 1 and the acceptable

quality level (AQL), expressed in terms of defects per hundred units shall be1.5 for major

defects and 4.0 for minor defects. A minimum of 200 samples shall be examined for critical

defects. The finding of any critical defect shall be cause for rejection of the lot

Notes

o Any evidence of insect or rodent infestation shall be cause for rejection of the lot.

o A critical defect is a defect that judgment and experience indicate would result in

hazardous or unsafe conditions for individuals using the item.

o A major defect is a defect, other than critical, that is likely to result in failure, or

to reduce materially the usability of the unit of product for its intended purpose.

o A minor defect is a defect that is not likely to reduce materially the usability of

the unit of product for its intended purpose, or is a departure from established

standards having little bearing on the effective use or operation of the unit.

o Aberrations in sachet material or heat seals include:

o Major fold-over wrinkles or severe wrinkles, that extend into heat seal area and

reduce effective seal width to less than 1.6 mm or

o Severe wrinkles in the body of the sachet along the inside edges of the heat seals.

o Sachets exhibiting one or more of these aberrations shall be tested in accordance

with internal pressure testing procedures

Table 3 Filled and Sealed sachets defects

Category Defect


2 Aberrations in sachet material or heat seals resulting from

heat sealing, sachet fabrication, hot filling or heat

processing that reduce the effective closure seal width to

less than 1.6 mm (1/16 in)






105 Closure or top seal extends into or below tear notch location

106 Not clean

107 Required labeling or marking missing, incorrect, illegible or

that smudges


109 Distance between inside edge of tear notch or serrations and

inside edge of seal is less than 4.7625 mm (3/16 in)

110 Presence of entrapped matter (for example, product residue)

that reduces the effective closure seal to less than 1.6 mm

(1/16 in) wide




204 Excess sachet material at edges exceeds 4.7625 mm

(3/16in)

3 Swollen sachet



9.7.6 Sachet leakage and delamination examination

o All exterior surfaces and edges of the filled and sealed sachet shall be examined

visually for product leakage while applying a manual kneading action which

forces the product against the interior sachet surface in the area being observed.

o After leakage testing, the sachet shall be examined for evidence of delamination.

o Any product leakage from the sachet or evidence of delamination of the sachet

shall be classified as a major defect, except delamination of outer ply when

located in the seal area 1.6 mm or further from the food product edge of seal.

o Sachets exhibiting this type of delamination shall be tested by manually flexing

the delaminated area 10 times. The area of delamination shall be held between the

thumb and forefinger of each hand with both thumbs and forefingers touching

each other.

o The delamination area shall then be rapidly flexed by rotating both hands in

alternating clockwise - counter clockwise directions.

o Care shall be exercised when flexing delaminated area near the tear notches to

avoid tearing the sachet material. After flexing, the separated outer ply shall be

grasped between the thumb and forefinger and gently lifted toward the food

product edge of the seal.

o If the separated area is too small to be held between thumb and forefinger, a

number two stylus shall be inserted into the delaminated area and a gentle lifting

force applied against the outer ply.


o If separation of the outer ply can be made to extend to less than 1.6 mm (1/16 in)

from the product edge of the seal with no discernible resistance to the gentle

lifting, the sachet shall be rejected.

o The lot size shall be expressed in sachets.

o The sample unit shall be one filled and sealed sachet.

o The inspection level shall be 1 and the AQL, expressed in terms of defects per

hundred units, shall be 0.65 for major defects

9.7.7 Internal pressure test

o Internal pressure resistance shall be determined by pressurizing the sachets while

they are restrained between two rigid plates.

o The plates shall be 12.7 + 1.6 mm (1/2 + 1/16 in) apart or 25.4 + 1.6 mm (1 +

1/16 in) apart. If a three-seal tester (one that pressurizes the sachet through an

open end) is used, the closure seal shall be cut off for testing the side and bottom

seals of the sachet; for testing of the closure seal, the bottom seal shall be cut off.

o The sachets shall be emptied prior to testing. If a four-seal tester (designed to

pressurize filled sachets by use of a hypodermic needle through the sachet wall) is

used, all four seals can be tested simultaneously.

o Pressure shall be applied gradually until 17 psig pressure is reached. The 17 psig

pressure shall be held constant for 30 seconds and then released.

o The sachets shall then be examined for separation or yield of the seals.

o Any rupture of the sachet or evidence of seal separation greater than 1.6 mm in

the sachet manufacturer's seal shall be considered a test failure.

o Any seal separation that reduces the effective closure seal width to less than 1.6

mm shall be considered a test failure and shall be cause for rejection of the lot.

9.7.8 Net weight examination

o The net weight of the filled and sealed sachets shall be determined by weighing

each sample unit on a suitable scale tared with a representative empty sachet.

o Any individual net weight of less than 300 g shall be classified as a minor defect.

o The lot size shall be expressed in sachets. The sample unit shall be one filled and

sealed sachet

o The inspection level shall be S-3 and the AQL, expressed in terms of defects per

hundred units, shall be 2.5

o The results shall be reported to the nearest 0.1 g. In addition, the lot shall be

rejected if the sample average net weight is less than 200 g.


9.8 Packaging and Labelling specifications

9.8.1 General Requirements

o The material used for packaging shall be generally recognized as safe (GRAS) for

use with food in accordance in accordance with good manufacturing practices

(see attached)or other standards and regulations with accepted standards and

regulations.



material requirements cited herein

o All labelling, package inserts and specifications shall be in English

o Each Secondary package should have a Product information insert in English

containing:




o Indications

o Dosage and administration

o Contraindications

Precautions

Adverse effects

o ll branding and marking for the primary secondary and tertiary packages shall

comply to the NHPplus Branding and Marking plan requirements

9.8.2 Primary package labelling requirements

The primary package is a sachet of 300g; 185mm length by 150mm width




o Batch number


o Best before date

o Directions for use: Should indicate “For single use only”

o Dosage

o Should have a label “USAID/KEMSA MCP- Not for sale” clearly labelled in a

place where it is visible.

9.8.3 Secondary package requirements and labelling

o The secondary package for FBF Pregnant or Postpartum mothers is a transparent

low density polyethylene (LDPE) bag 300mm length x 480 mm width)


o The LDPE bag contain 15 sachets of 300g each of FBF Pregnant or Postpartum

mothers and each bag shall meet the following labelling requirements

minimum gross weight of a bag should be 4500g or 4.5 kg


Batch number

Manufacturing date

Best before date

Storage instructions

Manufacturers contact information and physical address

Should have a label “USAID/KEMSA MCP - Not for sale” clearly

labelled in a place where it is visible

Specified branding requirements for USAID

9.8.4 Tertiary package requirements and labelling

o Corrugated Fibreboard Shipping boxes (Shipping Container) – Shall contain 4

bags of 4.5kg of FBF Pregnant or Postpartum mothers. The shipping container

will be a regular slotted container constructed of a minimum 450lb (204kg) burst

test, corrugated fibreboard.

o The outside dimensions of each shipping container will be no less than 280mm in

height, and cases should be designed to the optimal dimensions to fill at least 80%

of the cubic capacity of a 20 foot intermodal when stacked two pallets high.

o Cases of dimensions shall be no less 280mm. height x 460mm. length x 275 mm.

width and will have been found to comply with this requirement (when stacked 6

cases per layer and five tiers high on a standard pallet).

o Other case dimensions will be considered providing the height of the case does

not exceed 300mm and the pallets, when double stacked, can fill at least 80% of

the cubic capacity of a 20 foot intermodal

o The corrugated fibreboard will meet the following labelling specifications:

Product Name (both International Non-proprietary Name)

Batch number

Manufacturing date

Best before date

Quantity of the tertiary package will be determined by weight and should

contain 4 bags of 4.5kg each of FBF Pregnant or Postpartum mothers , the

carton should have a minimum gross weight of 18 kg



Should have a label “USAID/KEMSA MCP - Not for sale” clearly

labelled in a place where it is visible.


Should fulfil brand and marking plan of NHPplus

9.9 Manufacturer’s Product Assurance

o The manufacturer shall certify that the FBF Pregnant or Postpartum mothers

provided, meets the requirements of this technical specifications

o The purchaser or procuring entity shall require proof of conformance

9.10 Regulatory Requirements

o The delivered FBF Pregnant or Postpartum mothers shall comply with all

applicable Government , County, and local by-laws and regulations relating to the

manufacturing, storage, and distribution of packaged foods for human

consumption, including all applicable provisions of Food, Drugs and Chemical

Substances Act Chapter 254 (2012), Public Health Act Cap 242 (2012) and

regulations promulgated thereunder

o All certificates of analysis for both raw materials and delivered FBF Pregnant or

Postpartum mothers will be from a Kenya National Accreditation Services

(KENAS) accredited laboratories or from labs with valid ISO 17025:2005

certification.

9.11 Quality Assurance Provisions

The product manufacturer shall be required to provide evidence, by certificate, that the



the contract.


being terminated for cause

9.11.1 ISO 22000 Assessment

o A supplier quality assessment (SQA) verifies the manufacturer's capability to

produce products in a clean sanitary environment in accordance with ISO 22002-

1:2009 – Prerequisite programmes on food safety part 1: Food Manufacturing

and verifies that the manufacturer has in place an internal quality assurance and

food safety program

o A supplier quality audit (SQA) based on ISO 22000:2005 by a third party auditing

service is required within 12 months prior to the date of the awarding of the

contract.

o The food manufacturer must have attained an SQA score of 75% or above

o The food manufacturer must be ISO 22000 certified

o The relevant certificate/letter bearing the name of any of the above bodies must be

submitted for scrutiny


9.11.2 Kenya Bureau of Standards (KEBS) certification

o KEBS is the standards authority in Kenya and therefore all food must be approved

as safe for human consumption

o The locally produced FBF Pregnant or Postpartum mothers must have the

Standardization mark as this is a mandatory product certification scheme for

locally manufactured products provided for under section 10 of the Standards Act

Cap 496, Laws of Kenya

o The Ministry of Health, through legal notice 62 of 15th June 2012 introduced the

food fortification logo which is administered by KEBS; manufacturers are

encouraged to apply for fortification mark for FBF Pregnant or Postpartum

mothers’ products.

10.0 LOT III: FORTIFIED BLENDED FOOD (FBF) Children 6 – 59 months

10.1 Scope

This technical specification covers Fortified Blended food (FBF) for children aged 6 months

to 59 months, packaged in flexible packaging, suitable for use by Government, humanitarian

agencies, and non- governmental organizations for the treatment and prevention of moderate

acute malnutrition (MAM) in any cultural setting. The FBF – Children is expected to be

used as part of a Nutrition Assessment Counselling and Support (NACS) intervention

program for targeted children between the 6 to 59 months diagnosed with MAM in

accordance with Integrated Management of Acute Malnutrition guidelines for the

management of MAM and NASCOP Food by Prescription protocol.

The FBF Children may be used as the sole source of food, except water and breast milk,

during the period of use and to provide adequate energy, protein, fat, vitamins, and minerals

to effectively resolve MAM and meets the specifications of the WHO. Technical note:

supplementary foods for the management of moderate acute malnutrition in infants and

children 6–59 months of age. Geneva, 2012.

The FBF Children shall conform to the following list which shall be specified in the

contract, or purchase order. The FBF – Children will be used by multiple ethnic and cultural

groups. No alcohol, animal products other than dairy products, nor any known allergens

except, soy, and dairy products shall be used in the manufacture of these items. According

to guidance from WHO the FBF Children “These foods are usually solid or semi-solid foods

with low water content, which can be cooked every day at home in the form of porridge or

soups for children.” 10.2 Salient characteristics

10.2.1 Processing

o The FBF Children must be processed in accordance with applicable Codex

Alimentarius guidelines i.e. General Principles of food hygiene (CAC/RCP 1-


1969) and Code of Hygienic practice for powdered formulae for infants and

young children (CAC/RCP 66 – 2008)

o The FBF Children may be processed under HACCP (Hazard Analysis of Critical

Control Points), International Organization for Standardization (ISO) Standard

22000, or other standards that assure the safety and quality of the product.

o The dry ingredients shall be Food Chemicals Codex (FCC) purity or U.S.

Pharmacopeia (USP) - National Formulary quality, as appropriate, and free from

foreign materials.

o Additives shall not exceed levels allowable by the Codex Alimentarius.

10.2.2 Ingredients

o The ingredients for the FBF Children shall comply with the requirements cited

below. Any stabilizers or emulsifiers used must be specifically identified, and the

product will contain no animal products other than dairy products. .

o An energy intake of 25 kcal/kg/day in addition to the requirements of non-

malnourished children is likely to support a weight gain of 5 g/kg/day, based on

average tissue composition.

o The suggested concentrations for nutrients in the FBF Children are calculated as

an example when supplementary foods provide 70% of energy. This does not

constitute a recommendation that supplementary foods should provide 70% of the

energy intake of moderately malnourished children. The formulation is such that

it would be safe and effective if the quantity taken by moderately malnourished

children represented 100% of the energy needs and that it would also provide

benefit, although of a lesser order of magnitude, if taken in lower quantities.

There is no evidence to determine maximum levels for some nutrients. (WHO,

2012)

o The Type I, Extruded FBF children shall have an energy content of 420 to 480

kilocalories (kcal) per 100 grams;

o The energy density of FBF children when they are ready to be consumed should

be not less than 0.8 kcal/g.

o The Type I, Extruded FBF Children shall have a protein content of between 10.0

to 12.0 percent of kcal and shall have a Protein digestibility-corrected amino acid

score >70%. Corresponds to cereal/legume mixtures, milk and animal proteins.

The sources of protein may be dairy, protein concentrates, vegetable proteins or

protein isolates.

o The Type I, Extruded FBF Children shall have a lipid content between 8 and 9

percent of the kcal. The only added oils allowed will be canola oil or soybean oil.

Partially hydrogenated (Trans) fatty acids shall not be used in Extruded FBF

Children (CODEX STAN 074-1981, Revised 1-2006).


o The FBF Children shall include omega-6 fatty acid series and should comprise at

least 4.5% of energy (5 g/1,000 kcal), the omega-3 fatty acid series should

comprise at least 0.5% of energy (0.85 g/1,000 kcal), and the total fat content of

the diet used to treat moderately malnourished children should provide 35% to

45% of the dietary energy.

o When dairy ingredients are used, at least 8 percent of the protein shall be derived

from milk products; such as, but not limited to whole whey protein, dry whole

milk, whole fat milk, or non-fat dry milk.

o The FBF Children shall not contain artificial antioxidants and artificial

flavourings

10.2.3 Water Activity

The Aw of the packaged product shall not be more than 0.60 10.2.4 Grains and legume ingredients

o When grain and/or legume products, are used as an ingredient, the manufacturer

shall provide a Certificate of Analysis (COA) as verification of aflatoxin testing.

o Permitted cereal flours are wheat, oats, rice, millet, barley, and sorghum; and

manufacturers shall present a COA as verification of applicable mycotoxin

testing.

10.2.5 Dairy ingredients

The inclusion of dairy ingredients is not mandatory for FBF Children, however, it should

be noted that the inclusion of milk powder as an ingredient improves the amino acid

profile (has a high Protein Digestibility Corrected Amino Acid Score) and it is a good

contributor of bioavailable calcium and potassium. In addition, it has a specific

stimulating effect on linear growth and insulin growth factor 1 (IGF-1) levels in the child

and does not contain anti-nutrients. (WHO, 2012)

The dairy ingredients shall be derived from milk products such as, but not limited to:

o Whole whey protein;

o Dry whole milk (Codex Standard for Milk Powders and Cream Powder [CODEX

STAN 207-1999] 8, non-fat dry milk (Codex Standard for Milk Powders and

Cream Powder, [CODEX STAN 207-1999];

o The dry whey and dry whole milk ingredients shall be no more than 9 months old

at the time of FBF Children production.

o Dairy ingredient manufacturers must certify that the dairy ingredients provided

are melamine free and the manufacturer shall provide a COA to the purchaser.

10.2.6 Sweeteners

The Type I – Extruded FBF Children may contain natural sweeteners, except honey.

Honey is not permitted due to potential toxicity from Clostridium botulinum.


10.2.7 Stability

The Type I, Extruded, shall be stable at temperatures ranging from -15 to 49°C. There

shall be no more than slight oil separation throughout the shelf life of the product. 10.2.8 Fortification.

o The FBF Children shall be fortified with a vitamin and mineral premix, meeting

the requirements in Table I, which is in accordance WHO. Technical note:

supplementary foods for the management of moderate acute malnutrition in

infants and children 6–59 months of age.

o Unless otherwise required in the solicitation, contract, or purchase order, the

manufacturer will provide a COA stating that the vitamin and mineral premix

meets the requirement listed in Table I.

Table 1: Nutrient requirements of FBF Children premix

Nutrient per 1000 kcal Unit Minimum Maximum

Proteinc g 20 43

Fat g 25 65

Minerals





Zinc (Zn) mg 20 35



Iron (Fe)e mg 18 30




Vitamins, water soluble





Folate (dietary folate

equivalent)

µg > 400h —

Niacin mg > 25 —

Ascorbate (vitamin C) mg > 150 —


Biotin µg > 20 —



Cholecalciferol (vitamin D) µg 20 60


Vitamin E (dl-α tocopherol

acetate)

mg >30 —

Phytomenadione (vitamin K) µg >50 —

Fatty acids




Ratios of nutrients (based on

weight)

Ca/P ratio 1.0 1.5

Zn/Cu ratio 5 20

Zn/Fe ratio 0.8 3.5

Vitamin C/Fe 3 16

Table 2: Mineral and vitamin compounds currently used in supplementary foods available on the


Minerals Chemical form Lipid-based nutrient

supplements

Fortified blended

foods



Coated ferrous

fumarate

x x



NaFeEDTAa x x


Zinc oxide (x) (x)


Encapsulated copper

sulfatee

— (x)







Magnesium

gluconate

x x

Calcium and

phosphateh

Dicalcium phosphate x x




Sodium selenate x x



a) The intake of ethylenediaminetetraacetic acid (EDTA) (including other dietary sources)

should not exceed 1.9 mg EDTA/kg of body weight/day (15, 16).

b) Bioavailability with low stomach acidity is questioned.

c) Addition of copper is recommended, unless it negatively affects product stability, such as

in blended flours. The total amount of zinc in the product should respect the limits of the

Zn/Cu ratio and thus depends on whether copper is added to the product.

d) Most soluble form.

e) Stability of fortified blended foods when adding copper needs to be tested.

f) A formulation is needed that avoids caking/lumping.

g) The amount needs to be limited because of taste impact and formulation with anti-caking

compound is needed.

h) Best calcium/phosphate ratio.

i) Ensure homogeneity in food because of the low toxicity limit for selenium

Vitamins

Chemical form


supplements

Fortified blended

foods

Vitamin A Dry vitamin A

acetate

x –

Dry vitamin A

palmitate

x –

Dry vitamin A

palmitate beadlet

– x

Dry vitamin A

palmitate spray dried

– x

Vitamin D Dry vitamin D3 spray

dried

x x

Dry vitamin D3

beadlet

– x

Dry vitamin E acetate

50%

x x


Vitamin B1j Thiamine

hydrochloride

x —

Thiamine

mononitrate

x x



Riboflavin fine

powder

— x

Vitamin B6 Pyridoxine

hydrochloride

x x



Vitamin B12 Vitamin B12 0.1%

spray dried or 1%

spray dried

x x


Ascorbic acid fine

powdern

x x


Sodium selenate x x

Pantothenic

acid

Calcium p-

panthothenate

x x

Biotin Biotin 1% x x j Cannot be used in flour because of ability to absorb water. k Shows as yellow spots, but not visible in lipid-based nutrient supplements l Fine powder does not show as yellow spots. m Sour taste, disappears after cooking. n Less acid taste. oLess acid taste, but more costly

10.3 Finished Product

10.3.1 Appearance and texture

The Type I, FBF Children shall be free flowing and homogeneous when reconstituted and

cooked into porridge; shall be free of lumps; the porridge shall not separate and be free of a

gritty, grainy, and sandy texture 10.3.2 Flavour and odour.

The Type I, FBF Children shall be free from foreign odours and flavours such as, but not

limited to burnt, scorched, rancid, malted, sour, or stale. The FBF CHILDREN shall not

contain any artificial flavouring. 10.3.3 Colour

The Type I, FBF Children shall have a cream to light brown colour. The Type I, FBF

Children shall not have a dull, grey tinge, or other abnormal cast. The FBF children shall

show no evidence of over cooking during extrusion (materially darkened or scorched). 10.3.4 Foreign material.

The FBF Children shall be clean, sound, wholesome, and free from evidence of rodent or

insect infestation.


10.3.5 Age requirement (Shelf Life)

o Unless otherwise specified in the solicitation, contract, or purchase order the FBF

Children shall not be more than 90 days old when it leaves the manufacturer’s

plant for delivery to purchaser.

o The FBF Children shall have a shelf life of at least 12 months when stored at

25°C.

10.3.6 Product standard

o Unless otherwise specified in the solicitation, contract, or purchase order, a

sample of the FBF Children shall be subjected to product demonstration model

(PDM) inspection as applicable, in accordance with the requirements of this

technical specifications

o The approved sample shall serve as the product standard when evaluating each

production lot

o Any failure to conform to the finished product requirements or any appearance or

palatability failure shall be cause for rejection of the lot

o Should the manufacturer at any time plan to, or actually produce the product using

different formulation or process methodologies from the approved product

standard, which result in a product non comparable to the product standard, the

manufacturer shall arrange for a replacement PDM approval

o In any event, all product produced must meet all requirements of this technical

specifications including product standard comparability.

10.4 Analytical Requirements

10.4.1 Proximate and microbiological requirements

Unless otherwise specified in the solicitation, contract, or purchase order the proximate and

microbiological testing requirements for the FBF CHILDREN shall be as follows:

Test Tolerance





Crude fibre 3.0%


Units(CFU)/g


Alfatoxin








Salmonella Negative

E.coli Negative




Vitamin A 0.8 - 1.1 mg/100 g



Iron 10 - 14 mg/100 g

10.4.2 Product verification

When verification of the proximate, chemical, and microbiological testing requirements is

specified in the solicitation, contract, or purchase order, analytical testing shall be performed

on composite samples.

o For proximate tests the composite sample shall be 500 g (0.5kg).

o For the Aflatoxin test a single composite sample shall be produced from 60

randomly drawn sachets

o For microbiological tests five homogenized composite samples shall be produced

from a total of 60 randomly drawn sachets (12 per composite) per production lot /

batch

10.4.3 Test portion size for microbiological tests

The test portions for microbiological tests shall be derived from each of the five composite

samples specified in Sec. 5.1.

o The test portion size for testing aerobic plate count, coliform, and yeast and

mould shall be 25 g (0.025kg);

o Salmonella shall be 125 g (0.125kg);

o Staphylococcus aureus (coagulase positive), Clostridium perfringens, E.coli, and

Listeria monocytogenes shall be 25 g (0.025kg) each.

o Cronobacter sakazakii shall be 10 g (0.01kg) each.

10.4.4 Proximate and microbiological testing

When specified in the solicitation, contract, or purchase order, the analysis shall be

performed in accordance with the following methods from the AOAC International Official

Methods of Analysis (OMA), the FDA Bacteriological Analytical Manual (BAM), or as

specified below:

Test Method


Protein 988.05, 992.15

Total Fat 991.36, 2007.04, 2008.06


Standard plate count 966.23, 990.12, 2008.10, or BAM, Ch 3

Aflatoxin 990.33, 991.31, 998.03, or 999.07


4423

Coliform 966.24, 986.33, 989.19, 991.14, 2000.15,

2008.10, or BAM, Ch. 4

Yeast 997.02, 995.21

Mould 997.02, 995.21



E.coli 966.24, 986.33, 989.19, 991.14, 2000.15,

2009.02, or BAM, Ch.4




Vitamin A 2001.13, 2011.11, or 2011.13

Vitamin B1 986.27, 957.17

Vitamin C 967.21, 985.33, or 985.33

Iron 985.35, 984.27, or 999.10 10.4.5 Test results

o The test results for protein shall be reported to the nearest 0.1 percent.

o The test results for aflatoxin shall be reported as negative when the results are not

greater than 5 ppb.

o The test results for melamine/cyanuric acid shall be reported as negative when the

results are not greater than 25 ppb.

o The test results for Aw shall be reported to the nearest 0.01 value. No individual

sample shall have an Aw value exceeding 0.60.

o The test results for standard plate count and yeast and mould shall be reported to

the nearest 10 CFU per g.

o The test results for coliform and E. coli shall be reported to the nearest 10 CFU

per g or to the nearest MPN per g.

o The test results for Clostridium perfringens, Salmonella, Listeria monocytogenes,

Staphylococcus aureus (coagulase positive), and Cronobacter sakazakii shall be

reported as negative or positive.

o Test results for Vitamin A, Vitamin B1 (Thiamin), Vitamin C, iron, and fat shall

be reported with units and precision as specified or as described in the test

method.


o Any result not conforming to the analytical testing shall be cause for rejection of

the lot/batch

10.5 Packaging Requirements and Examinations

10.5.1 Sachet material

o The sachet material shall be capable of being fabricated into sachets.

o The material used for the sachet shall be generally recognized as safe (GRAS) for

use with food in accordance with accepted standards and regulations.



material requirements cited herein.

o The size of the sachet shall be 185mm in length and 150mm in width

10.5.2 Oxygen transmission rate

o The oxygen transmission rate (O2TR) of the material shall not exceed 0.06

cc/m2/24 hrs/atm. The O2TR of the material shall be determined in accordance

with ASTM D 3985, at 23°C and 50 percent relative humidity (RH).

o Any O2TR exceeding 0.06 cc/m2/24 hrs/atm shall be considered a test failure and


o Compliance to the O2TR requirement may be verified by COA from the


10.5.3 Water vapour transmission rate.

o The water vapor transmission rate (WVTR) of the material shall not exceed 0.01

gm/m2/24 hrs.

o The WVTR of the material shall be determined in accordance with ASTM F 372,

at 38°C and 90 percent RH.

o Any WVTR exceeding 0.01 gm/m2/24 hrs shall be considered a test failure and


o Compliance to the WVTR requirement may be verified by COA from the


10.5.4 Filled and sealed sachets.

o Filled and sealed sachets shall be free of damage (such as, but not limited to:

tears, cuts, holes, or if a multi-layer laminate is used, abrasions through one or

more layers in the sachet material, or leakage through any seal).

o The sachet material shall not transfer any foreign flavour or odour to the product

being packaged.

10.5.4.1 Closure seal

o The closure seal width shall be a minimum 2.5 mm.


o The closure seal shall be free of impression or design on the seal surface that

would conceal or impair visual detection of seal defects.

o The closure seal shall be free of wrinkles, occluded matter, or evidence of

entrapped moisture or grease that reduces the closure seal width to less than 1.6

mm at any location along its continuous path.

10.5.4.2 Internal pressure

The sachets shall be filled and hermetically sealed such that they shall withstand the

applicable pressure for 30 seconds. 10.5.5 Filled and sealed sachet examination

The filled and sealed sachets shall be examined for the defects listed in Table 3 utilizing

ANSI/ASQC Z1.4, Sampling Procedures and Tables for Inspection by Attributes, in effect

on the date of the solicitation. The lot size shall be expressed in sachets. The sample unit

shall be one filled and sealed sachet. The inspection level shall be 1 and the acceptable

quality level (AQL), expressed in terms of defects per hundred units shall be1.5 for major

defects and 4.0 for minor defects. A minimum of 200 samples shall be examined for critical

defects. The finding of any critical defect shall be cause for rejection of the lot

Notes

o Any evidence of insect or rodent infestation shall be cause for rejection of the lot.

o A critical defect is a defect that judgment and experience indicate would result in

hazardous or unsafe conditions for individuals using the item.

o A major defect is a defect, other than critical, that is likely to result in failure, or

to reduce materially the usability of the unit of product for its intended purpose.

o A minor defect is a defect that is not likely to reduce materially the usability of

the unit of product for its intended purpose, or is a departure from established

standards having little bearing on the effective use or operation of the unit.

o Aberrations in sachet material or heat seals include:

Major fold-over wrinkles or severe wrinkles, that extend into heat seal

area and reduce effective seal width to less than 1.6 mm or

Severe wrinkles in the body of the sachet along the inside edges of the

heat seals.

Sachets exhibiting one or more of these aberrations shall be tested in

accordance with internal pressure testing procedures

Table 3: Filled and Sealed sachets defects

Category Defect


2 Aberrations in sachet material or heat seals resulting from

heat sealing, sachet fabrication, hot filling or heat


processing that reduce the effective closure seal width to

less than 1.6 mm (1/16 in)





105 Closure or top seal extends into or below tear notch

location

106 Not clean

107 Required labeling or marking missing, incorrect, illegible

or that smudges


109 Distance between inside edge of tear notch or serrations

and inside edge of seal is less than 4.7625 mm (3/16 in)

110 Presence of entrapped matter (for example, product

residue) that reduces the effective closure seal to less than

1.6 mm (1/16 in) wide




204 Excess sachet material at edges exceeds 4.7625 mm

(3/16in)

3 Swollen sachet



10.5.6 Sachet leakage and delamination examination

o All exterior surfaces and edges of the filled and sealed sachet shall be examined

visually for product leakage while applying a manual kneading action which

forces the product against the interior sachet surface in the area being observed.

o After leakage testing, the sachet shall be examined for evidence of delamination.

o Any product leakage from the sachet or evidence of delamination of the sachet

shall be classified as a major defect, except delamination of outer ply when

located in the seal area 1.6 mm or further from the food product edge of seal.

o Sachets exhibiting this type of delamination shall be tested by manually flexing

the delaminated area 10 times. The area of delamination shall be held between the

thumb and forefinger of each hand with both thumbs and forefingers touching

each other.

o The delamination area shall then be rapidly flexed by rotating both hands in

alternating clockwise - counter clockwise directions.


o Care shall be exercised when flexing delaminated area near the tear notches to

avoid tearing the sachet material. After flexing, the separated outer ply shall be

grasped between the thumb and forefinger and gently lifted toward the food

product edge of the seal.

o If the separated area is too small to be held between thumb and forefinger, a

number two stylus shall be inserted into the delaminated area and a gentle lifting

force applied against the outer ply.

o If separation of the outer ply can be made to extend to less than 1.6 mm (1/16 in)

from the product edge of the seal with no discernible resistance to the gentle

lifting, the sachet shall be rejected.

o The lot size shall be expressed in sachets.

o The sample unit shall be one filled and sealed sachet.

o The inspection level shall be 1 and the AQL, expressed in terms of defects per

hundred units, shall be 0.65 for major defects

10.5.7 Internal pressure test

o Internal pressure resistance shall be determined by pressurizing the sachets while

they are restrained between two rigid plates.

o The plates shall be 12.7 + 1.6 mm (1/2 + 1/16 in) apart or 25.4 + 1.6 mm (1 +

1/16 in) apart. If a three-seal tester (one that pressurizes the sachet through an

open end) is used, the closure seal shall be cut off for testing the side and bottom

seals of the sachet; for testing of the closure seal, the bottom seal shall be cut off.

o The sachets shall be emptied prior to testing. If a four-seal tester (designed to

pressurize filled sachets by use of a hypodermic needle through the sachet wall) is

used, all four seals can be tested simultaneously.

o Pressure shall be applied gradually until 17 psig pressure is reached. The 17 psig

pressure shall be held constant for 30 seconds and then released.

o The sachets shall then be examined for separation or yield of the seals.

o Any rupture of the sachet or evidence of seal separation greater than 1.6 mm in

the sachet manufacturer's seal shall be considered a test failure.

o Any seal separation that reduces the effective closure seal width to less than 1.6

mm shall be considered a test failure and shall be cause for rejection of the lot.

10.5.8 Net weight examination

o The net weight of the filled and sealed sachets shall be determined by weighing

each sample unit on a suitable scale tared with a representative empty sachet.

o Any individual net weight of less than 200 g shall be classified as a minor defect.

o The lot size shall be expressed in sachets. The sample unit shall be one filled and

sealed sachet


o The inspection level shall be S-3 and the AQL, expressed in terms of defects per

hundred units, shall be 2.5

o The results shall be reported to the nearest 0.1 g. In addition, the lot shall be

rejected if the sample average net weight is less than 200 g

10.6 Packaging and Labelling specifications

10.6.1 General Requirements

o The material used for packaging shall be generally recognized as safe (GRAS) for

use with food in accordance in accordance with good manufacturing practices

(see attached)or other standards and regulations with accepted standards and

regulations.



material requirements cited herein

o All labelling, package inserts and specifications shall be in English

o Each Secondary package should have a Product information insert in English

containing:


Nutritional information

Composition / ingredients

Indications

Dosage and administration

Contraindications

Precautions

Adverse effects

All branding and marking for the primary secondary and tertiary packages shall comply to

the NHPplus Branding and Marking plan requirement

10.6.2 Primary package labelling requirements

The primary package is a sachet of 200g ; 185mm length by 150mm width




o Batch number


o Best before date

o Directions for use: Should indicate “For single use only”

o Dosage


o Should have a label “USAID/KEMSA MCP - Not for sale” clearly labelled in a

place where it is visible.

10.6.3 Secondary package requirements and labelling

o The secondary package for FBF Children is a transparent low density

polyethylene (LDPE) bag 300mm length x 480 mm width)

o The LDPE bag contain 15 sachets of 200g each of FBF Children and each bag

shall meet the following labelling requirements

minimum gross weight of a bag should be 3000g or 3 kg


Batch number

Manufacturing date

Best before date



Should have a label “GOK - Not for sale” clearly labelled in a place where

it is visible

Specified branding requirements for USAID

10.6.4 Tertiary package requirements and labelling

o Corrugated Fibreboard Shipping boxes (Shipping Container) – Shall contain 5

bags of 3kg of FBF Children. The shipping container will be a regular slotted

container constructed of a minimum 450lb (204kg) burst test, corrugated

fibreboard.

o The outside dimensions of each shipping container will be no less than 280mm in

height, and cases should be designed to the optimal dimensions to fill at least 80%

of the cubic capacity of a 20 foot intermodal when stacked two pallets high.

o Cases of dimensions shall be no less 280mm. height x 460mm. length x 275 mm.

width and will have been found to comply with this requirement (when stacked 6

cases per layer and five tiers high on a standard pallet).

o Other case dimensions will be considered providing the height of the case does

not exceed 300mm and the pallets, when double stacked, can fill at least 80% of

the cubic capacity of a 20 foot intermodal

o The corrugated fibreboard will meet the following labelling specifications:


Batch number

Manufacturing date

Best before date


Quantity of the tertiary package will be determined by weight and should

contain 5 bags of 3kg each of FBF Children, the carton should have a

minimum gross weight of 15kg



Should have a label “GOK - Not for sale” clearly labelled in a place where

it is visible.

Should fulfil brand and marking plan of NHPplus

10.7 Manufacturer’s Product Assurance

The manufacturer shall certify that the FBF Children provided, meets the requirements of

this technical specifications

The purchaser or procuring entity shall require proof of conformance

10.8 Regulatory Requirements

The delivered FBF Children shall comply with all applicable Government , County, and

local by-laws and regulations relating to the manufacturing, storage, and distribution of

packaged foods for human consumption, including all applicable provisions of Food,

Drugs and Chemical Substances Act Chapter 254 (2012), Public Health Act Cap 242

(2012) and regulations promulgated thereunder

All certificates of analysis for both raw materials and delivered FBF Children will be

from a Kenya National Accreditation Services (KENAS) accredited laboratories or from

labs with valid ISO 17025:2005 certification.

10.9 Quality Assurance Provisions

The product manufacturer shall be required to provide evidence, by certificate, that the



the contract.


being terminated for cause 10.9.1 ISO 22000 Assessment

o A supplier quality assessment (SQA) verifies the manufacturer's capability to

produce products in a clean sanitary environment in accordance with ISO 22002-

1:2009 – Prerequisite programmes on food safety part 1 : Food Manufacturing

and verifies that the manufacturer has in place an internal quality assurance and

food safety program

o A supplier quality audit (SQA) based on ISO 22000:2005 by a third party auditing

service is required within 12 months prior to the date of the awarding of the

contract.


o The food manufacturer must have attained an SQA score of 75% or above

o The food manufacturer must be ISO 22000 certified

o The relevant certificate/letter bearing the name of any of the above bodies must be

submitted for scrutiny

10.9.2 Kenya Bureau of Standards (KEBS) certification

o KEBS is the standards authority in Kenya and therefore all food must be approved

as safe for human consumption

o The locally produced FBF Children must have the Standardization mark as this is

a mandatory product certification scheme for locally manufactured products

provided for under section 10 of the Standards Act Cap 496, Laws of Kenya

o The Ministry of Health, through legal notice 62 of 15th June 2012 introduced the

food fortification logo which is administered by KEBS; manufacturers are

encouraged to apply for fortification mark for FBF Children products


1. Annual Production Plan /Schedule

The annual production plan will cover the period of one calendar year and will determine type and

quantity of products that will be processed during the period including the amount of goods in the inventory, and the rate at which goods are being distributed out of the inventory to determine the materials required to process the planned quantities of the nutrition commodities. The annual production plan will help to ensure that commodities processed are the right quantity of each type and delivered on time and will assist the subcontractor in raw material planning and continuous improvement on efficiency of its production processes.

2. ISO 22000 certificate

The ISO 22000 family of International Standards addresses food safety management. The consequences of unsafe food can be serious and ISO’s food safety management standards help organizations identify and control food safety hazards. International Standards are needed to ensure the safety of the global food supply chain. The ISO 22000 family contains a number of standards each focusing on different aspects of food safety management.

ISO 22000:2005 contains the overall guidelines for food safety

management.

ISO 22004:2014 provides generic advice on the application of ISO 22000

ISO 22005:2007 focuses on traceability in the feed and food chain

ISO/TS 22002-1:2009 contains specific prerequisites for food

manufacturing

ISO/TS 22002-2:2013 contains specific prerequisites for catering

ISO/TS 22002-3:2011 contains specific prerequisites for farming

ISO/TS 22002-4:2013 contains specific prerequisites for food packaging manufacturing

ISO/TS 22003:2013 provides guidelines for audit and certification bodies

3. KEBS Standardization Mark Certificate

This is a mandatory product certification scheme for locally manufactured products provided for under section 10 of the Standards Act Cap 496, Laws of Kenya.

4. KEBS Diamond Mark Certificate

The Diamond Mark of Quality (also referred to as D-Mark) is a voluntary product certification scheme operated by Kenya Bureau of Standards (KEBS). It is a mark of excellence awarded to manufacturers which have demonstrated high degree of excellence in product manufacturing and

quality. D-Mark permit holders thus qualify automatically for the standardization mark (SM) without any additional payments. The permit to use the mark is valid for period of three years subject to satisfactory quality performance and full compliance to other contractual obligations signed between KEBS and the permit holder.

5. Supplier Quality Audit Score of 75% or above

The supplier quality audit is an assessment of the five fundamental aspects of a food safety system

i.e. good manufacturing practices, regulatory compliance, HACCP, sanitation and quality control. The overall assessment is scored and this indicates the relative effectiveness of the food


manufacturer’s ability to contain food safety risk. Kenya Nutrition and Health Program plus requires a score of 75% and above which indicates that the food manufacturer has a good food safety program which is fully executable for both risk identification and management. Hence low

associated risk of system failure.

6. Laboratory Analysis plan

The subcontractor shall provide FBF products that meet all required national standards of Food quality and safety. To provide assurance and verification of the proximate, chemical, and microbiological levels of the processed, the subcontractor will require to submit Food Analysis plan using accredited Food Analysis laboratory.

7. Conformity to Packaging and Labelling Requirements

The material used for packaging shall be generally recognized as safe (GRAS) for use with food in accordance in accordance with good manufacturing practices or other standards and regulations with accepted standards and regulations. Recycled, recovered, or environmentally preferable materials shall be used to the maximum extent possible, provided that the material meets or exceed the material requirements cited herein. All labelling, package inserts and specifications shall be in English (or Kiswahili where applicable) as defined in the technical specification for each product.

Shelf Life

The subcontractor guarantees a 75% shelf life on all its blended food products delivered to the designated warehouse.

I/We agree to abide with the above conditions.

Name of Applicant (Officer).......................................................................

Authorised Signature...............................................................................

Position in the Company/Title................................................... Date ---------------

1.12 OTHER TERMS AND CONDITIONS:

Issuance of this bidding document does not in any way obligate the Agent to award a purchase

order or subcontract, nor does it commit the Agent to pay for costs incurred in the preparation

and submission of a proposal.

This solicitation is subject to the Draft Order Terms and Conditions detailed in Section 2. Any

resultant award will be governed by these terms and conditions. The Agent reserves the right

to make revisions to the content, order, and numbering of the provisions in the actual

subcontract document prior to execution by The Agent and the selected awardee(s). Issuance

of a subcontract award is subject to availability of sufficient funds and applicable approvals

from USAID.


2.0 DRAFT ORDER TERMS AND CONDITIONS

2.1 Acronyms and Definitions

Please see as referenced in Section 1 of the bidding document.

2.2 Subcontract Price Funding Type

USAID and in cooperation with the Government of Kenya, is authorized to award contracts under

the authority of USAID Contract No. AID-615-C-15-00003 funded by the US Government.

This is a fixed-price subcontract payable entirely in the currency indicated in the cover page.

The subcontractor shall be paid a fixed price for successfully supplying the commodities at the

prices proposed in their bid. The fixed price of this subcontract is $................................

No additional sums will be payable for any escalation in the cost of materials, equipment or labor,

or because of the Subcontractor's failure to properly estimate or accurately predict the cost or

difficulty of achieving the results required. The Agent will not adjust the subcontract price due to

fluctuations in currency exchange rates. The Agent will only make changes in the subcontract

price or time to complete due to changes made by The Agent in the work to be performed, or by

delays caused by The Agent.

2.3 Source and Origin The source and origin for all commodities and services supplied under this Subcontract must meet

USAID Geographic Code 935 (Free World). Products must be freshly manufactured and, if

applicable, shipped on US vessels, carriers, or vehicles unless not available and otherwise

authorized by The Agent.

2.4 Host Country Consular Fees, Duties, & Tariffs

This Subcontract is being awarded on behalf of the USAID, an official project of the Government

of the United States in Kenya, and as such, it is free and exempt from any consular or legalization

fees, inspection or validation charges, and any taxes, tariffs, duties or other levies imposed by laws

in effect in Kenya. No such fees, charges, tariffs, duties or levies will be paid under this

Subcontract.

2.5 Packing

All goods supplied under this contract must be packed according to the highest international

packing standards suitable to prevent theft, loss or damage, including water damage, to cargo

during transit and until safe arrival at the delivery point. The Goods should conform to standards


specified in the following compendia: the British Pharmacopoeia, the United States

Pharmacopoeia, the French Pharmacopoeia, the International Pharmacopoeia, or the European

Pharmacopoeia, the latter particularly for raw materials. The standards shall be the each latest

edition at the time of bid submission unless otherwise stated by the Purchaser. In case the

pharmaceutical product is not included in the specified compendium, but included in the

Purchaser’s national essential drug list, the Purchaser should clearly indicate acceptable limits and

the Supplier, upon award of the Contract, must provide the reference standards and testing

protocols to allow for quality control testing.

Specific packing instructions include:

Properly sealed and designed in a manner so as to prevent tampering or provide evidence

of tampering

Each outer case or carton shall be five ply cardboard and strapped

No carton should contain Nutraceuticals products from more than one batch

Each unit pack/bottle must be packaged in its individual pack with the literature insert

(patient insert) inside the pack.

Not only the Nutraceuticals item, but also the packaging components (e.g bottles and

closures) must meet specifications suitable for use.

Each case must be palletized and shrink wrapped, and no pallet should contain

Nutraceuticals products from more than one batch unless prior approval has been received

for more efficient packaging depending on batch size. Each pallet should be numbered

serially for easy identification and that same number shall be included on the packing list.

2.6 Price Schedule

PRICE SCHEDULE A- SEA FREIGHT

PRICE SCHEDULE For each line item. Bidders are also required to indicate the country

of “origin” and the “source” of each line item in the final column on the right. See

Section 1.3 for definitions. Case packing, weight & volume per case should also be

provided for each product.


No. Item Description

Unit of Measure

Quantity Unit Price

(USD)

Total Price

(USD)

Proposed Delivery schedule (effective date of contract signing)

Bidders Delivery schedule

Source and

Origin

Quantity in container e.g XX of 40ft + XX of 20ft

1 FBF for Children 6mths - <10 years Sachets 555,872

8-12 weeks (Indicate availability

of ex-stock quantities)

2 FBF for Pregnant and Lactating Women Sachets 169,837

8-12 weeks (Indicate availability of ex-stock quantities)

3 FBF for Adult Patients (including Children > age 10 years) Sachets 2,324,381

8-12 weeks (Indicate availability of ex-stock quantities)

Applicable incorterm for this Tender is DDU KEMSA Warehouse, Nairobi.

PRICE SCHEDULE B- AIR FREIGHT

PRICE SCHEDULE For each line item. Bidders are also required to indicate the country of “origin” and the “source” of each line item in the final column on the right. See Section 1.3 for definitions. Case packing, weight & volume per case

should also be provided for each product.


Item No.

Item Description

Unit of Measure

Quantity Unit Price (USD)

Total Price

(USD)

Proposed Delivery schedule

(effective date of contract signing)

Bidders Delivery schedule

Source and

Origin

Quantity in container e.g XX of 40ft + XX of 20ft

1 FBF for Children 6mths - <10 years Sachets 555,872

8-12 weeks (Indicate

availability of ex-stock

quantities)

2 FBF for Pregnant and Lactating Women Sachets 169,837

8-12 weeks (Indicate


quantities)

3 FBF for Adult Patients (including Children > age 10 years) Sachets 2,324,381

8-12weeks (Indicate


quantities)

Applicable incorterm for this Tender is DDU KEMSA Warehouse, Nairobi.


1.11 SUBMISSION OF SAMPLES

The Supplier is responsible for providing the minimum required samples for quality evalaution

prior to delivery as shown in the table below:

# Item Description MINIMUM NO. OF

SAMPLES REQUIRED

1 FBF for Children 6mths - <10 years

1 Carton

2 FBF for Pregnant and Lactating Women

1 Carton

3 FBF for Adult Patients (including Children > age 10 years)

1Carton

BIDDERS SHOULD PROVIDE QUOTES FOR BOTH SEA AND AIR FREIGHT ANNEX B MARKING AND BRANDING REQUIREMENT

To promote and communicate to Kenyan beneficiaries that this USAID-funded activity is from the American People and to reduce the chances of commodities leaking into the

private market, USAID marking requirements will apply as hereunder: Each unit pack/Satchet must be marked with the black and white text only that reads

USAID | KEMSA - Not for Resale

(no logos/emblem will be required)

KEMSA has been in discussion with the Pharmacy and Poisons Board on the above issue

and wish to advise manufacturers that upon award of any commodity, the successful bidders will be required to undertake an amendment with the Pharmacy and Poisons

Board of Kenya to obtain approval for the above marking for supply of the awarded commodity to KEMSA.

The steps that will be required are:


Manufacturers through their local agents will need to submit a notification letter to Pharmacy and Poisons Board of Kenya to inform on the additional text on the

labels/packaging as indicated above.

This letter needs to include the reasoning for the change, clarify the text that will be included, attach a design of the old and new labels/packaging to demonstrate the difference.

Upon submission of the notification letter and payment of the required fees, copies of the same should be sent to KEMSA.

The Pharmacy and Poisons Board of Kenya has indicated that the lead time for approval

for the above is estimated to be seven (7) working days. The manufacturers will be required to inform KEMSA in the event of a delay of more than 15 days from submission

of documentation to the Pharmacy and Poisons Board of Kenya. ANNEX C

Invoicing and Shipping Instructions

INVOICE TO: USAID Kenya C/o American Embassy

UN Avenue, Gigiri Nairobi, Kenya.

CONSIGNED TO: Kenya Medical Supplies Authority (KEMSA)

Commercial Street, Industrial Area Nairobi/Kenya

SHIPPING MARKS: Kenya Medical Supplies Authority (KEMSA)

Commercial Street, Industrial Area Nairobi/Kenya

BY E-MAIL: Copy of Invoice

Copy of Packing list Copy of Certificate of Origin Copy of Airway Bill


Copy Certificate of Analysis for each

batch WITH THE GOODS OR TO DHL 3 Original invoices signed in ink

3 Original Packing lists 1 Original Certificate of Origin

1 Original Airway Bill 1 Original set of Certificate of Analysis

for each batch BY COURIER (FOR PAYMENT): Original Invoice

Original Packing list Original Certificate of Origin

Original Airway Bill Original Certificate of Analysis for each

batch Copy of certificate of receipt duly stamped by DHL

Complete bank details

2.7 Delivery Terms

Delivery terms are: DDU, named place of destination.

2.8 Packing Lists

A complete, itemized packing list shall be carried in a clearly marked "packing list" envelope

affixed to the outside of each shipping container used to deliver the goods. Each packing list must

show complete narrative descriptions of the goods, and all catalog numbers, if applicable.

2.9 Payment Terms

The method and conditions of payment to be made to the Supplier under this Contract shall be as

follows:

100% On Delivery & Acceptance: shall be paid within 60 days of delivery to Named place of

delivery, and submission of documents specified in GCC Clause 11 including an invoice (showing

Purchaser’s name; the Contract number, loan number; description of payment and total amount,

signed in original, stamped or sealed with the company stamp/seal) supported by the Acceptance

Certificate issued by the Purchaser, by direct bank transfer to the Supplier’s nominated bank

account.


The fixed price of this sub contract shall include delivery of the deliverables as per Section 2.6,

which is inclusive of all costs associated with the manufacturer producing the products according

to the specifications. To facilitate the above payment, the supplier should provide four duly signed

and stamped original invoices per consignment.

SPECIAL NOTE: In the event some items have not been received or have been short packed or

are damaged or appear to be unusable, KEMSA will make a determination as to the quantities not

available for distribution, deduct the value of the items unavailable for distribution and authorize

payment minus the value of this quantity. KEMSA will require the supplier to provide a credit

note for the value of the quantity deducted. The supplier may also arrange for shipment of this

quantity along with quality, and packing certification from the independent laboratory, and

payment will be authorized for this quantity by, KEMSA, only on receipt, subject to quality

confirmation and goods being in good order in The Agent’s warehouse.

Instructions on the invoicing requirement can be found in Annex C.

2.10 Undertaking

The subcontractor shall provide the commodities proposed in Section 1.6 once the commodities

are complete following manufacture and inspection but prior to completion of an independent

quality assurance analysis. The subcontractor shall notify KEMSA that the commodities are ready

for shipment and shall also provide a Letter of Undertaking to KEMSA.

KEMSA will then authorize shipment to named place of destination where supplier will install,

training and commission equipment before clearance by KEMSA QA department.

ANNEX D

Letter of Undertaking Template

<INSERT LETTERHEAD OF MANUFACTURER HERE>

Kenya Medical Supplies Authority (KEMSA)

Commercial Street, Industrial Area

Nairobi/Kenya.

Attention: Procurement Manager

Dear Sir/Madam,


RE: LETTER OF UNDERTAKING FOR CONTRACT NO: …………& INVOICE NO:

…………….

We are supplying the product …… (name of product) bearing batch numbers …………. (attach

packing list) per the contract number and invoice number referenced above.

This letter confirms KEMSA shall accept from our warehouse and take possession (“undertake”)

the products listed above after completion of quality assurance procedures which confirm the

quality standards and parameters stipulated by the above-listed contract. If quality assurance

procedures confirm the product does not comply with the quality standards and parameters

stipulated by this contract we, the manufacturer, will be responsible for all the costs incurred in

the shipment of the goods and its subsequent destruction at a place of KEMSA choosing. We also

affirm that we, the manufacturer, shall replace the product within the same time period as stipulated

in the contract at no extra cost.

If you have any questions please contact me at insert email or insert phone number.

Sincerely,

NAME, POSITION & COMPANY

1.Manufacturer’s Authorization Form

Manufacturer’s or Producer’s letterhead

Kenya Medical Supplies Authority (KEMSA), Nairobi/Kenya

WHEREAS [ insert: name of the manufacturer or producer ] (hereinafter, “we” or “us”) who

are established and reputable manufacturers or producers of [ insert: name and/or description of

the Goods requiring this authorization ] (hereinafter, “Goods”) having production facilities at

[ insert: address of factory ] do hereby authorize [ insert: name and address of Bider ]

(hereinafter, the “Bider”) to submit a bid, and subsequently negotiate and sign the Contract with

you against IFT [ insert: title and reference number of the Invitation for Bids ] including the

above Goods produced by us.

We hereby extend our full guarantee and warranty for the above specified Goods against these bid

documents.

For and on behalf of the Manufacturer or Producer


Signed: ___________________________________________________________

Date: ______________________________________

In the capacity of [ insert: title, position, or other appropriate designation ] and duly authorize to

sign this Authorization on behalf of [ insert: name of manufacturer or producer ]


2. Tender Security Form

ITT No USAID/KEMSA/MCP OIT 001/2019-2020


To: Kenya Medical Supplies Authority (KEMSA)

13 Commercial Street, Industrial Area

P.O. Box 47715-00100

Nairobi, Kenya;

WHEREAS [insert: name of Tenderer] (hereinafter called “the Tenderer”) has submitted its

tender dated [insert: date of tender] for the performance of the above-named Contract (hereinafter

called “the Tender”)

KNOW ALL PERSONS by these present that WE [insert: name of bank] of [insert: address of

bank ] (hereinafter called “the Bank”) are bound unto [ insert: name of Purchaser ] (hereinafter

called “the Purchaser”) in the sum of: [ insert: amount ], for which payment well and truly to be

made to the said Purchaser, the Bank binds itself, its successors and assigns by these presents.

Sealed with the Common Seal of the said Guarantor this [insert: number] day of [insert: month],

[insert: year].

THE CONDITIONS of this obligation are:

1. If after tender opening the tenderer withdraws his tender during the period of tender validity

specified in the instructions to tenderers or

2. If the tenderer rejects the correction of an error upon prompt notice by the procuring

entity and

3. If the tenderer, having been notified of the acceptance of his tender by the employer

during the period of tender validity:

a) Fails or refuses to execute the form of agreement in accordance with the

instructions to tenderers if required or

b) Fails or refuses to furnish the Performance Security, in accordance with

instructions to tenderers

We undertake to pay to the Procuring Entity up to the above amount upon receipt of its first written

demand, without the Procuring Entity having to substantiate its demand, provided that in its


demand the Procuring Entity will note that the amount claimed by it is due to it, owing to the

occurrence of one or both of the two conditions specifying the occurred condition or conditions.

This guarantee will remain in full force up to and including thirty (30) days after the period of

tender validity and any demand in respect thereof should reach the Guarantor not later than the

above date.

Signature of the Guarantor……………………………………..

Date:………………………………

(Witness) …………………………………….. Date:………………………………

Common Seal of the Bank


3. Form of Tender

ITT No USAID/KEMSA/MCP OIT 001/2019-2020


To:

Kenya Medical Supplies Authority (KEMSA)

13 Commercial Street, Industrial Area

P.O. Box 47715-00100

Nairobi, Kenya;

Dear Sir or Madam,

1. Having examined the tender documents including Addenda Nos.……………………[Insert

numbers] the receipt of which is hereby duly acknowledged, we, the undersigned, offer to

Supply of Fortified Blended Flour in conformity with the said tender documents for the sum

of [Insert: Total tender amount in words and figures]

…………………………………………………………………………………………………

…………………………………………………………………………………………………

………………………..

or such other sums as may be ascertained in accordance with the Schedule of Prices attached

herewith and made part of this Tender.

2. We undertake, if our Tender is accepted, to deliver the goods in accordance with the delivery

schedule specified in the Schedule of Requirements.

3. If our Tender is accepted, we will obtain the guarantee of a bank in a sum equivalent to 10%

Percent of the Contract Price for the due performance of the Contract, in the form prescribed

by Kenya Medical Supplies Authority (KEMSA).

4. We agree to abide by this Tender for a period of 90 days from the date fixed for tender opening

of the Instructions to Bidders, and it shall remain binding upon us and may be accepted at any

time before the expiration of that period.


5. Until a formal Contract is prepared and executed, this Tender, together with your written

acceptance thereof and your notification of award, shall constitute a binding Contract between

us.

6. We understand that you are not bound to accept the lowest or any tender you may receive.

Dated this …………………… day of …………………. 20………………………

Signed………………………………………….

In the capacity of [insert: title or position]…………………………………………………..

Duly authorized to sign tender for and on behalf of [insert: name of tenderer]


4.Declaration of Undertaking (Integrity Statement)

Ethics and Anti – Corruption Policy in the Procurement Process

Undertaking by Bidder on Anti – Corruption Policy / Code of Conduct and Compliance

Programme

The governments of Kenya is committed to fighting corruption in all its forms and in all its

institutions to ensure that all the government earned revenues are utilized prudently and for the

purpose intended with a view to promoting economic development as the country work towards

actualizing Vision 2030.

Kenya Medical Supplies Authority (KEMSA) is a state corporation under the Ministry of Health

established under the KEMSA Act 2013 to procure, warehouse and distribute drugs and medical

supplies for prescribed public health programs, the national strategic stock reserve, prescribed

essential health packages and national referral hospitals in Kenya, on behalf of the government,

we are highly committed to fighting any form of corruption in our organization to ensure that all

the monies that the government entrust with us, is optimally and prudently utilized for the benefits

of all the people we serve.

The following is a requirement that every Bidder wishing to do business with KEMSA

must comply with:

(1) Each bidder must submit a statement, as part of the tender documents, in the format given

and which must be signed personally by the Chief Executive Officer or other appropriate

senior corporate officer of the bidding company and, where relevant, of its subsidiary in

Kenya. If a tender is submitted by a subsidiary, a statement to this effect will also be

required of the parent company, signed by its Chief Executive Officer or other appropriate

senior corporate officer.

(2) Bidders will also be required to submit similar No-bribery commitments from their

subcontractors and consortium partners; the bidder may cover the subcontractors and

consortium partners in its own statement, provided the bidder assumes full responsibility.

(3) a) Payment to agents and other third parties shall be limited to appropriate compensation for

legitimate services.

b) Each bidder will make full disclosure in the tender documentation of the beneficiaries and

amounts of all payments made, or intended to be made, to agents or other third parties

(including political parties or electoral candidates) relating to the tender and, if successful,

the implementation of the contract.


c) The successful bidder will also make full disclosure [quarterly or semi- annually] of all

payments to agents and other third parties during the execution of the contract.

d) Within six months of the completion of the performance of the contract, the successful

bidder will formally certify that no bribes or other illicit commissions have been paid. The

final accounting shall include brief details of the goods and services provided that are

sufficient to establish the legitimacy of the payments made.

e) Statements required according to subparagraphs (b) and (d) of this paragraph will have to

be certified by the company's Chief Executive Officer, or other appropriate senior corporate

officer.

(4) Tenders which do not conform to these requirements shall not be considered.

(5) If the successful bidder fails to comply with its No-bribery commitment, significant

sanctions will apply. The sanctions may include all or any of the following:

a) Cancellation of the contract;

b) Liability for damages to the public authority and/or the unsuccessful

competitors in the bidding possibly in the form of a lump sum

representing a pre-set percentage of the contract value (liquidated).

(6) Bidders shall make available, as part of their tender, copies of their anti-Bribery

Policy/Code of Conduct, if any, and of their-general or project - specific - Compliance

Program.

(7) The Government of Kenya through Ethics and Anti-Corruption Commission has made

special arrangements for adequate oversight of the procurement process and the execution

of the contract. Those charged with the oversight responsibility will have full access if need

be to all documentation submitted by Bidders for this contract, and to which in turn all

Bidders and other parties involved or affected by the project shall have full access (provided,

however, that no proprietary information concerning a bidder may be disclosed to another

bidder or to the public).

MEMORANDUM (FORMAT)

(Clause 41, 62 and 66 of Kenya Public Procurement and Asset Disposal Act 2015)

This company ____________________________(name of company) has issued, for the purposes

of this tender, a Compliance Program copy attached -which includes all reasonable steps necessary

to assure that the No-bribery commitment given in this statement will be complied with by its


managers and employees, as well as by all third parties working with this company on the public

sector projects or contract including agents, consultants, consortium partners, subcontractors and

suppliers')"

Authorized Signature:

Name and Title of Signatory:

Name of Bidder:

Address:


5. Supplier Data Record

SUPPLIER BUSINESS DETAILS (fill in Block letters)

Company Name:

Company Post Office Address:

Telephone Nos:

Office No. ----------------

---

Mobile No. ---------------

___________________

Fax No.

(with entering your fax no.

here you consent that this

means of communication will

be used for any

communication during the

tender process and that you

will ensure that notice will be

taken):

________________________

e-Mail Address

(with entering your e-Mail address here

you consent that this means of

communication will be used for any

communication during the tender

process and that you will ensure that

notice will be taken):

_____________________________

Company Registration Number:

1. Location of business premises ------------------------

2. Building name and number -------------------------------

3. Floor Number -----------------------------------

4. Room number ------------------------------------

5. Plot Number -------------------------------------

6. VAT Certificate Number ----------------------------------

7. Local Authority License Number ------------------------------------ Expiry Date -------------------------

---

8. PIN certificate Number --------------------------------------------------

9. Website if any ----------------------------------------------------------

When submitting your bid, please ensure that you submit copies of the following documents;

1. Copy of Certificate of incorporation

2. Copy of current Tax Compliance Certificate

Contact Name: Job Title:


Telephone No.

___________________

Fax No.

(with entering your fax no.

here you consent that this

means of communication will

be used for any

communication during the

tender process and that you

will ensure that notice will be

taken):

________________________

e-Mail Address

(with entering your e-Mail address here

you consent that this means of

communication will be used for any

communication during the tender

process and that you will ensure that

notice will be taken):

_____________________________

Main business activity

Please NOTE giving false information in this section will lead to outright Disqualification from

tendering process.

Type of organization (please tick as necessary)

1. Partnership

2. Co-operative

3. Private Ltd.

4. Public Company

5. Other.

Type of premises (tick as necessary)

1. Factory

2. Warehouse

3. Other.

Freehold

Leasehold


Names of executives

Chairman ------------------------------ ---------Nationality ---------------------------------Shares held --------

Managing Director ------------------------------Nationality --------------------------------Shares held -------

Company Secretary ---------------------------Nationality ----------------------------------Shares held --------

Name of Directors

1. --------------------------- ------------Nationality ----------------------------------- Shares held -------

2. ------------------------------ --------Nationality ----------------------------------- Shares held -------

3. ---------------------------------------Nationality ----------------------------------- Shares held -------

4. ----------------------------------------Nationality ----------------------------------- Shares held --------

5. --------------------------------- -----Nationality ----------------------------------- Shares held --------

Name and address of ultimate holding company and any subsidiary companies

Total no. of employees in group No. of locations/premises in group

Member of a Trade Association?

Details of any Certification e.g. ISO 9000 (attach copies of valid certificates)

Name product(s) for which you act as an Authorized Dealer / Distributor and attach copies of

valid certificates of authority.

1. 5.

2. 6.

3. 7.

4. 8.

Bidders should only provide documentation for products they are offering to supply in the tender

Bank References and other details


A) Primary Bank (The Main Bank)

1) Name: ----------------------------------------------------------------------------------

2) Postal Address:---------------------------------------------------------------------

3) Telephone Land line number:-------------------------------------------------------

4) Fax Number: ------------------------------------------------------------------------------

5) Email Address:----------------------------------------------------------------------------

Name of the account: ----------------------------------------------------------------------------------

Account number: -----------------------------------

Number of years operated:----------------------------

SECONDARY BANKERS (if applicable)

Bank name and address: ---------------------------------------------------------------------

Name of the account: ----------------------------------------------------------------------------

Account number: -----------------------------------

Years of operation ---------------------------------------

Commercial References

Provide names and contact details of four customers that have done business with you in the last three

years.

A) Trade References - customer 1


Activity: ----------------------------------------

Period of relationship: (Year) -------------------------------

Contact name: ---------------------------------

---------------------------------------------------

Fax no. ----------------------------------------------------------

Email address: -------------------------------------------------

Value of contract orders in USD-----------------------------------------------------------------------

Telephone No. -------------------------------------------------------------------

Physical address; -----------------------------------------------------------------------------------------------------

B) Trade References - Customer 2

Activity: ----------------------------------------

Period of relationship: (Year) -------------------------------

Contact name: ---------------------------------

---------------------------------------------------

Fax no. ----------------------------------------------------------

Email address: -------------------------------------------------

Value of contract orders in USD-----------------------------------------------------------------------


Telephone No. -------------------------------------------------------------------

Physical address; -----------------------------------------------------------------------------------------------------

Trade References - customer 3

Business Activity: ----------------------------

---------------------------------------------------

Period of relationship (year) ---------------------------------

Contact name: ---------------------------------

---------------------------------------------------

Fax no.-----------------------------------------------

Email address: --------------------------------------------

Value of contract orders in Kenya Shillings KSHS -------------------------------------------------------------

Telephone No. Mobile ---------------------------------------------------------------------------------------------

Telephone Number Land line --------------------------------------------------------------------------------------

Physical address: -----------------------------------------------------------------------------------------------------

Trade References - customer 4

Business Activity: ----------------------------

Period of relationship (year) ---------------------------------

Contact name: ---------------------------------

---------------------------------------------------

Fax no.-----------------------------------------------

Email address: --------------------------------------------


Value of contract orders in Kenya Shillings KSHS -------------------------------------------------------------

Telephone No. Mobile ---------------------------------------------------------------------------------------------

Telephone Number Land line --------------------------------------------------------------------------------------

Physical address: -----------------------------------------------------------------------------------------------------

SUPPORT SERVICES AVAILABLE

What after sales / warranty / spare parts / support services / local agent / repair are available?

(Please feel free to attach any further supporting information with this form)

DECLARATION BY THE APPLICANT

Full names: ---------------------------------------

Telephone Number mobile --------------------

Telephone No. Land Line -----------------------

Job title of signatory:---------------------------------------

Signature of the

applicant……………………

Date of application: ----------------------------------------

Please affix company rubber stamp or seal


6.Performance Security Bank Guarantee (Unconditional)

Date:………………………………………………………………….

Tender Number: USAID/KEMSA MCP OIT 001/2016-17


To: Kenya Medical Supplies Authority, Nairobi/Kenya acting for an on behalf of the United

States Agency for International Development (USAID).

Dear Sir or Madam:

We refer to the Contract Agreement (“the Contract”) signed on [ insert: date ] between you and

[ insert: name of Supplier ] (“the Supplier”) concerning the provision of [ insert: a brief

description of the Goods]. By this letter we, the undersigned, [ insert: name of bank], a bank (or

company) organized under the laws of [insert: country of bank ] and having its

registered/principal office at [insert: address of bank ], (hereinafter, “the Bank”) do hereby jointly

and severally with the Supplier irrevocably guarantee payment owed to you by the Supplier,

pursuant to the Contract, up to the sum of [ insert: amount in numbers and words ]. This

guarantee shall be reduced or expire as provided for by GCC Sub-Clause 8.4.

We undertake to make payment under this Letter of Guarantee upon receipt by us of your

first written demand signed by your duly authorized officer declaring the Supplier to be in default

under the Contract and without cavil or argument any sum or sums within the above-named limits,

without your need to prove or show grounds or reasons for your demand and without the right of

the Supplier to dispute or question such demand. Our liability under this Letter of Guarantee shall

be to pay to you whichever is the lesser of the sum so requested or the amount then guaranteed

under this Letter in respect of any demand duly made under this Letter prior to expiry of this Letter

of Guarantee, without being entitled to inquire whether or not this payment is lawfully demanded.

This Letter of Guarantee shall be valid from the date of issue until the date of expiration of the

guarantee, as governed by the Contract. Except for the documents herein specified, no other


documents or other action shall be required, notwithstanding any applicable law or regulation. Our

liability under this Letter of Guarantee shall become null and void immediately upon its expiry,

whether it is returned or not, and no claim may be made under this Letter after such expiry or after

the aggregate of the sums paid by us to you shall equal the sums guaranteed under this Letter,

whichever is the earlier. All notices to be given under this Letter shall be given by registered

(airmail) post to the addressee at the address herein set out or as otherwise advised by and between

the parties hereto.

We hereby agree that any part of the Contract may be amended, renewed, extended,

modified, compromised, released, or discharged by mutual agreement between you and the

Supplier, and this security may be exchanged or surrendered without in any way impairing or

affecting our liabilities hereunder without notice to us and without the necessity for any additional

endorsement, consent, or guarantee by us, provided, however, that the sum guaranteed shall not be

increased or decreased.

No action, event, or condition that by any applicable law should operate to discharge us

from liability hereunder shall have any effect, and we hereby waive any right we may have to

apply such law, so that in all respects our liability hereunder shall be irrevocable and, except as

stated herein, unconditional in all respects.

For and on behalf of the Bank

Signed:

Date:

in the capacity of: [ insert: title or other appropriate designation ]

Common Seal of the Bank


SUPPLIER PERFORMANCE APPRAISAL

ANNEX E

Subcontractor Evaluation Template

Evaluation Date:

Period of Evaluation:

Prime Contract Number:

KEMSA Member Name/Title:

Subcontractor Name:

Subcontract Number:

Subcontract Value:

Subcontract Period of Performance:

Type of Business (check all that apply)

Local

Foreign

Description of Subcontract and Principle Elements: (Including details on

deliverables/services)

5. PERFORMANCE INDICATORS FOR GOODS SUPPLIERS

The performance of suppliers for goods are monitored at contract level to ensure all the terms and

conditions of the contract are met. The extent of performance monitoring applied to a supplier

shall be determined by the level of risk and the nature of the goods. Good monitoring of suppliers

anticipates, identifies and facilitates correction of shortcomings before the relationship with the

supplier is adversely affected and before compromising value for money.

5.1. Time

The time measures the duration in days for the supplier to deliver as specified in the contract. The

required data will be captured from the source document and into the tool and shall include the

following: Item code, item description, contract number, purchase order(s) supplier name, contract


signing date, contract effective date, contractual delivery date, earliest delivery date, extended

delivery date, actual delivery date supplier offered delivery date and latest delivery date. The

earliest delivery date and the latest delivery date are derived from the issued tender document. The

supplier offered delivery date is derived from the bid.

Contract Delivery Period: The number of calendar days from the date of signing the contract to

the date the delivery is required per the contract. If a contract is extended, the additional days are

confirmed by way of an addendum (letter) and the duration added to the Contract Delivery Period.

In call-off orders under framework agreements, Contract Delivery Period is the number of calendar

days from the date of the call off order to the required delivery date in the purchase order.

Actual Delivery Period: The number of calendar days from contract effective date to the actual

delivery date. In call-off orders under framework agreement, the Actual Delivery Period is the

number of calendar days from the date of call off order to actual delivery date.

Delivery on Time: Delivery of goods on or within the Contract Delivery Period yields a Delivery

on Time indicator score of 100%. Delivery after the Contract Delivery Period yields a Delivery on

Time indicator score of less than 100%, as prorated. Example: If the Contract Delivery Period is

90 days but Actual Delivery Period is 120 days, the Delivery on Time indicator is 90*100/120 =

75%.

5.2. Quantity

The supplier is required to deliver the ordered quantity in full. Due to warehouse capacity and

other factors, a supplier may be requested in writing to deliver a portion of the order. The quantity

indicator measures delivery in full; the difference between the quantity in the purchase order or

contract and the quantity received. The required data are: order quantity, delivered quantity, and

deferred quantity.

Delivery in Full: The indicator is measured by the percentage of the ordered quantity which is

actually received into the warehouse. Example: If the purchase order quantity was 200,000 units.

Of this, quantity received was 190,000 units. The indicator of Delivery in Full is

(190,000/200,000)*100=90%. Delivery of quantities above the ordered quantities does not earn

points. The target performance score for Delivery in Full indicator is 100%.

5.3. Cost

The historical unit prices for each item are captured in the ERP system. The Award Price arise

from recommendation for award and signed supplier contract. The Final Price is the award price

plus the price variation that arise during contract implementation, excluding those from application

of a price adjustment formula if provided for in the signed contract.

The Price Ratio is defined as [Award Price x 100/Final Price]; which should be 100% where

the Final Price is equal to the Award Price or where the Final Price is less than the Award Price.


Where the Final Price is higher that the Award Price, the performance score is prorated. Example:

Final Price is KES2,700, Award Price is KES2,400, then the Price Ratio is [2,400*100/2700 =

89%].

Data: The data to be captured in the ERP system include the following: Item code, item

description, contract number, order number, supplier name, Plan Price, Award Price, Price

Variation, Final Price;

5.4. Quality

The contract provides the technical specifications for the goods being delivered. At the delivery

point, the goods are inspected and tested to ensure they comply with the quality specifications. An

assessment shall be made to check if seven quality parameters have been met as shown in

Table 1. The performance score are on a pass (100%) or fail (0).

Table 1. Quality measures (Yes=100%; No=0). Example below:

# Indicator Description of measure Score %)

1 Fit to Specification The goods as delivered comply with contract specifications. 100

2 Damage Goods are delivered without damages. 100

3 Packaging The supplier did suitable packaging and labelling. 0

4 Shelf life The product shelf life is at least 75 percent. 100

5 Surveillance There have not been recalls on surveillance. 100

Quality Index 80

Data: The required data and records are the specifications, inspection test certificates, damage

reports, visual inspection of packaging and labelling, check of the shelf life, certificate of analysis,

product surveillance reports.

5.5. Service

The service of the supplier shall be measured through a structured and continuous online survey

carried out by the staff in procurement, finance, warehousing and other departments. The service

survey shall be done soon after delivery of each contract consignment. Table 2 shows the questions

to be assessed for each supplier. The rating and scores: 1(1) Poor, (2) Fair, (3) Good, and (4)


Excellent. The service indexes from each of the survey participants shall be averaged to derive the

overall service index for a supplier.

Table 2. Service survey (Example below)

# Service

Factor

Description of measure Poor

(1)

Fair

(2)

Good

(3)

Excellent

(4)

Score

1 Responsive The order was attended to within expectations

X 1

2 Complaint The complaints or queries were resolved within reasonable time.

X 3

3 Innovation The supplier provided market insights, innovation, and solutions

X 2

4 Risk The supplier managed risks to minimise the exposure.

X 1

5 Pro-active Delivery was made without expediting or prompting.

X 4

6 Feedback Provided regular updates on progress of the contract.

X 2

7 Conforms

to

Requireme

nts

Adhered to the agreed requirements and quality systems

X 1

8 Documents All documents were accurate on

first submission as per the contract X 4

Total Score (Max 32) 18

Service Index (Max 100%) 56.3

5.6. Ratings and Scores


The supplier contract performance scores provides a structured way of rating suppliers with an

aim of identifying areas of improvement and a basis for future engagement depending on

historical performance. The scorecard will be used to measure, rate, or rank suppliers on a

continuous basis with the aim of ensuring suppliers consistently meet and surpass their

contractual obligations. Table 3 summarises the ratings and scores.

Table 3. Ratings and scores measurement system

Rating Score (%) Performance Description Performance

1 0-20 Falls far below expectations: Performance

jeopardised the achievement of contract

requirements, despite additional oversight.

Very Poor

2 21-40 Missed expectations: There are a number of

performance issues that required KEMSA to provide

an additional oversight to ensure that contract

requirements are met.

Poor

3 41-60 Mostly meets expectations: There are minor

performance issues but supplier has otherwise met

the contract requirements.

Fair

4 61-80 Consistently meets expectations: There are few

performance issues but the supplier has largely met

the contract requirements

Good

5 81-100 Exceeds Expectations: Supplier has demonstrated a

performance level in measurable excess of contract

requirements.

Very Good

5.7. Supplier Performance Index

The Supplier Performance Index combines the indices for (a) Delivery time, (b) quantity, (c) cost,

(d) quality, and (e) service as shown in Table X.

Table 4. Supplier performance index

# Indicator Score (%) Rating

1 Delivery Time 70 Good

2 Quantity 60 Fair

3 Cost 55 Fair


Table 4. Supplier performance index

4 Quality 40 Poor

5 Service 25 Poor

Supplier Performance Index 50 Fair

5.8 Performance Decision – by KEMSA

A supplier with a performance index score of less than 50% shall be not be eligible to supply goods

to KEMSA for a period of one year from the date of publication of the Supplier Performance Index.

After the end of one year, the supplier shall receive debriefing and shall be eligible for award of

contracts.

Evaluating

officer

Signature Date

Please indicate any suggestions for improvement or comment on any topics not covered above (For Official Use only)