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ADMINISTRATIVE ORDER NO. 2014 - 0029 GUIDELINES IN THE REGISTRATION OF PROCESSED FOOD PRODUCTS

Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

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Page 1: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

ADMINISTRATIVE ORDER

NO. 2014-0029

GUIDELINES IN THE REGISTRATION OF

PROCESSED FOOD PRODUCTS

Page 2: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Overview of Legal Bases

Page 3: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Administrative Order 37 s. 1979

Registration of food and food products

intended for import/export

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Bureau Order No. 163 s. 1997

Specific requirements for the registration

of imported food and food products

Basis for the product classification

(Category I or II)

Page 5: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Registration means the process of approval of an

application to register health products prior to

engaging in the manufacture, importation,

exportation, sale, offer for sale, distribution, transfer,

and where applicable, the use, testing, promotion,

advertisement and/or sponsorship of health products.

Republic Act 9711

Page 6: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Administrative Order No. 2014-0029

Section VI. Guidelines in the Registration of

Processed Food Products

Page 7: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015
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General Principles

All processed food products before beingdistributed, supplied, sold or offered forsale or use and advertised shall first beregistered with the FDA

Page 9: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

General Principles

Only one (1) CPR shall be given to:(1) Product with Multiple Packaging Sizes,(2) Product with Multiple Artwork Design &(3) Product previously registered for localdistribution but is to be exported

Provided they conform to the following conditions:(a) Same brand name(b) Same product name/variant(c) Same product formulation(d) Same label information except net weight

Page 10: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

SHORT QUIZ!!!

(Separate CPR or Single

CPR)

Page 11: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

CASE # 1Same Brand NameSame Product NameSame Product FormulationSame DesignSame Label InfoDifferent Net Weight Same Packaging Material

SINGLE

MILA

MILA

MILA

MILA

MILA A

Page 12: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

CASE # 2Same Brand NameSame Product NameSame Product FormulationSame DesignSame Label InfoDifferent Net Weight Different Packaging Material

SINGLE

MILA

MILA

MILA

MILA

MILA A

MILA

Page 13: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

CASE # 3

Different Brand NameSame Product NameSame Product FormulationSame DesignSame Label InfoSame Net Weight Same Packaging Material

SEPARATE

MILA

ILAM

Page 14: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

CASE # 4

Same Brand NameSame Product NameSame Product FormulationDifferent DesignSame Label InfoSame Net Weight Same Packaging Material

SINGLE

MILA

Design#1

Design#2

Page 15: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

CASE # 5

Same Brand NameDifferent Product NameSame Product FormulationSame DesignSame Label InfoSame Net Weight Same Packaging Material

MILA

Chocolate PowderedDrink Mix Choco-Mocha

Powdered Drink Mix

#1#2

SEPARATE

Page 16: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

General Principles

Only food additives listed in the followingshall be issued a CPR:

(a) Codex General Standards for FoodAdditives

(b) Latest FDA Listing of Food Additives(c) Approved pharmaceutical excipients list

intended for Food Supplement

Page 17: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

General Principles

Imported and Locally Manufactured RawMaterials, Ingredients and Food Additivesfor distribution shall secure a CPR

Local food manufactures importing RawMaterials, Ingredients and Food Addditivesfor own use or further processing, need notsecure a CPR

Page 18: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Example

A company has an LTO No. CFRR-NCR-FI-201 with the activity as an Importer/ Distributor/Wholesaler who wants to import bulk cheese products for distribution to manufacturers for further processing.

REGISTER!

Page 19: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Example

A company has an LTO No. CFRR-NCR-FM-143 with the activity as a Trader who is importing bulk pasta for repacking to Repack Co.

NOT REGISTER!

Page 20: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Validity

Certificates of Product Registration havethe option of choosing between 2 to 5 yearsof validity for INITIAL (except for FoodSupplement 2 years validity for initial)

For RENEWAL applications, 5 years

Page 21: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Quality and Safety Standard

Food Products shall be evaluated based ontechnical documents submitted for safetyand quality

Page 22: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Product Claims and Labeling

Products, Advertising and Promotionalmaterials shall not have curative claims ortherapeutic claims.

No food samples are needed provided thatthe labels are clear and bears the completelabel information.

EXCEPT FOOD SUPPLEMENTS

Page 23: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Product Classification

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Page 34: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Certification of Product

Registration Requirements

Low Risk Food Products shall strictly followthe E-Registration procedure (FDA CircularNo. 2014-029)

Medium and High Risk Food Products shalluse the following requirements

Page 35: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Requirements for Medium and

High Risk Products

Page 36: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Requirements for Medium and High Risk Products

Page 37: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

1.General Info

2. Establishment Info

3. Product Info

5. Sources & Clients

6. Applicant Info

Page 38: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Raw Materials, Additives, and or Ingredients

Lot Code Interpretation

Physical Description

Chemical and/or Microbiological Specifications

Page 39: Administrative Order No. 2014-0029 QPIRA 23 24 April 2015

Label

Must be fully compliant toAdministrative Order No. 2014-0030

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SUBSTANTIATE???

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SUBSTANTIATE???

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SUBSTANTIATE???

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SUBSTANTIATE???

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SUBSTANTIATE???

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SUBSTANTIATE???

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SUBSTANTIATE???

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SUBSTANTIATE???

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