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

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ADMINISTRATIVE ORDER

NO. 2014-0029

GUIDELINES IN THE REGISTRATION OF

PROCESSED FOOD PRODUCTS

Overview of Legal Bases

Administrative Order 37 s. 1979

Registration of food and food products

intended for import/export

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)

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

Administrative Order No. 2014-0029

Section VI. Guidelines in the Registration of

Processed Food Products

General Principles

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

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

SHORT QUIZ!!!

(Separate CPR or Single

CPR)

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

SINGLE

MILA

MILA

MILA

MILA

MILA A

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

SINGLE

MILA

MILA

MILA

MILA

MILA A

MILA

CASE # 3

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

SEPARATE

MILA

ILAM

CASE # 4

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

SINGLE

MILA

Design#1

Design#2

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

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

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

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!

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!

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

Quality and Safety Standard

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

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

Product Classification

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

Requirements for Medium and

High Risk Products

Requirements for Medium and High Risk Products

1.General Info

2. Establishment Info

3. Product Info

5. Sources & Clients

6. Applicant Info

Raw Materials, Additives, and or Ingredients

Lot Code Interpretation

Physical Description

Chemical and/or Microbiological Specifications

Label

Must be fully compliant toAdministrative Order No. 2014-0030

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