Food Product Regulatory

Requirements
OBJECTIVES
◍ To be able to identify the risk
classifications of a Food Product
◍ To be able to identify between food
supplement and drug product
◍ To know the minimum requirement in
food labelling
◍ To know the application process in
obtaining a Certificate of Product
Registration (CPR)
 RA 10611

◍ FOOD SAFETY ACT OF 2013

◍ An Act To Strengthen The Food Safety
Regulatory System In The Country To
Protect Consumer Health And Facilitate
Market Access Of Local Foods And Food
Products, And For Other Purposes
◍ Two responsible agencies:
○ Department of Agriculture (DA)
○ Department of Health (DOH)
 WHAT IS A FOOD PRODUCT?
Food refers to any substance or
product whether processed, partially
processed or unprocessed that is
intended for human consumption. It
includes drinks, chewing gum, water and
other substances which are intentionally
incorporated into the food during its
manufacture, preparation and treatment.
 FOOD AND DRUG ADMINISTRATION
- CFRR (CENTER FOR FOOD
REGULATION AND RESEARCH)

◍ FOOD PRODUCTS ARE CLASSIFIED

ACCORDING TO MICROBIAL RISK

◍ LOW RISK PRODUCTS

◍ MEDIUM RISK PRODUCTS
◍ HIGH RISK PRODUCTS
 Food Categorization:
1. Low Risk Food Materials – foods that are unlikely to contain
pathogenic microorganisms and will not normally support their growth
because of food characteristics and foods that are unlikely to contain
harmful chemicals
 Food Categorization:
2. Medium Risk Food Materials – foods that may contain
pathogenic microorganisms but will not normally support their
growth because of food characteristics; or food that is unlikely to
contain harmful chemicals
 Food Categorization:
3. High Risk Food Materials – foods that may
contain pathogenic microorganisms and will
support the formation of toxins or the growth of
pathogenic microorganisms and foods that may
contain harmful chemicals.
Food Supplements /
Dietary Supplements
 Dietary Supplements

◍ – refers to a processed food product intended to

supplement the diet that bears or contains one or more of
the following dietary ingredient: vitamin, mineral, amino
acid, herb, or any other dietary substance of botanical,
animal, artificial, or natural origin to increase the total daily
intake in amounts conforming the latest Philippine
recommended energy and nutrient intake (RENI) or
internationally agreed minimum daily requirements. It is
usually in the form of capsules, tablets, liquids, gels,
powders, or pills and is not represented for use as a
conventional food or as the sole item of a meal or diet or a
replacement for drugs and medicine.
 WHAT IS THE DIFFERENCE
BETWEEN A DRUG VITAMIN & A
FOOD SUPPLEMENT VITAMIN

DRUG VITAMIN FOOD SUPPLEMENT

VITAMIN
1. Clinical therapeutic 1. No approved therapeutic
indication claims
2. Dosage strength for fat 2. Dosage strength for fat
soluble vitamins (>105% soluble vitamins (<105%
RENI) and for water RENI) and for water
soluble vitamins (>150% soluble vitamins (<150%
RENI) RENI)
DRUG VITAMIN FOOD SUPPLEMENT VITAMIN
 Food Product
Labeling Information
 Definition of Terms

Label – means a display of written, printed or graphic matter upon

the immediate container of any article and a requirement made by
or under authority of existing law that any word, statement, or other
information appearing on the label shall not be considered to be
complied with unless such word, statement or other information also
appears on the outside container or wrapper of the retail package
of such article or is easily legible through the outside container or
wrapper.
Importance of
Labeling
 Why do we need to label?
✔ Compliance to regulatory requirements
✔ Gives information to the composition of the product
(Ingredients)
✔ Informs consumers on what products to avoid
containing a specific ingredient/s (Allergen information)
✔ Choices can be made on the company producing the
product, including the brand name (Manufacturer and
Distributor)
✔ Consumers can compare value of the product based
on Net weight
✔ Consumers will know the benefits of consuming such
product
 Administrative Order
no. 2014-0030
Revised Rules and Regulations Governing the
Labeling of Prepackaged Food Products Amending
Certain Provisions of Administrative Order No. 88-B s.
1984 or the “Rules and Regulations Governing the
Labeling of Pre-packaged Food Products Distributed
in the Philippines,” and For Other Purposes
 1. Product Name
- Must describe the true nature
of food
- Must be specific and NOT
GENERIC
 2. Brand Name
- Refers to the name
appropriated by the
manufacturer, repacker,
distributors, trader or importer to
distinguish its product in the
market.
- if a brand name is registered, it
should also appear on the
name of the brand. E.g.: ® ™
3. Net weight
Net contents is the statement
on the label which provides the
amount of food in the container
or package.

Drained weight is defined as the

weight of the solid portion of the
product that remain after the
liquids in which they have been
prepared are removed
 4. Ingredients List
- any substance, including a food
additive, used as a component in
the manufacture or preparation of
food and present in the final
product (in its original or modified
form)
- ingredients should be listed in
descending order
- specific name of the ingredient
must be declared not the
collective (generic) name

Food additives declaration on Ingredients list

- Declared Food additives on the Ingredients
List should be declared in its Common
name and Functional Category
5. Expiry or Expiration Date/
Use-by-date/ Consume before
date (Recommended last
consumption date)
The date which signifies the end
of the estimated period under
any stated storage condition,
after which the product will not
have the quality attributes
normally expected by the
consumers. After this date, the
food should not be regarded as
marketable.
6. Lot Identification/ Lot code/
Lot number
Refers to a specific code
indicating food produced during
a period of time and under more
or less the same manufacturing
condition.
The lot identification code shall
be embossed or otherwise
permanently marked individually
on the immediate packages or
containers.
Nutrition Facts
Serving Size:
No. of servings per container/pack:
Amount per serving: % RENI*

Calories (kcal) ____ Calories from Fat ____

Total fat (g)
Saturated fat** (g) ________
Trans fat (g) ________
Cholesterol (mg) ________
Sodium (mg) ________
Total Carbohydrates (g) ________
Dietary fiber (g) ________
Sugar (g) ________
Total Protein (g) ________
*Percent RENI values are based on FNRI reference adult requirement of 19-29 years
old. However, if a product is specifically intended for a different age bracket group,
percent RENI values are based on the appropriate FNRI Reference requirement.

7. Nutrition Information/ Nutrition

Facts
-A standardize statement or listing of
the nutrient content of a food
-For locally manufactured product,
RENI (Recommended Energy
Nutrient Intake) must be declared
 Nutrition Labeling Exemptions
Foods for Special Medical Purpose
Bottled Water
Infant formula
Foods for immediate consumption (Cafeteria, airplane,
hotels/restaurants)
Packaging size around 10cm²
Foods that contain insignificant amount of nutrients
(Spices, Food color)
Bulk materials for further processing (except for products
covered under Food Fortification Law)
Alcoholic beverages
8. Name and address of
Manufacturer, Repacker, Packer,
Importer, Trader and Distributor
The name and address of the
manufacturer, repacker, packer,
importer, trader or distributor of the
food shall be declared on the label
of locally manufactured products.

The complete name and address of

importer and the country of origin
shall be declared for imported
products.
9. Storage Condition
Refers to the prevailing specified
temperature range, humidity and
other environmental factors within
which optimal stability of the food
product is ensured based on
laboratory data.
10. Food Allergen Information
Food allergen is any food or ingredient known to cause
hypersensitivity that contains protein, peptide derive from
any of, but not limited to the following: milk, egg, fish,
crustacean shellfish, tree nuts, wheat, peanuts and
soybeans

(e.g. Contains food allergens: egg or “Allergen Information:

may contain _____” / Manufactured in equipment that
processes ____” or similar expression)
10. Food Allergen Information
The following ingredients known to cause hypersensitivity shall always
be declared:
a. Cereal containing gluten, i.e. Wheat, rye, barley, oat, spelt or their
hybridized strain and products of these;
b. Crustaceans and products of these;
c. Eggs and egg products;
d. Fish and fish products;
e. Peanuts, soybeans and product of these;
f. Milk and milk products (lactose included);
g. Tree nut and nut products
h. Sulphite in concentration of 10mg/kg or more
i. Such other ingredient as may be included by FDA through
appropriate issuance
11. Direction / Instruction (s) for
Use
Refers to the relevant
information regarding the
reconstitution, preparation and
consumption of a food product.
 Exemptions from the Labeling
Requirements
A. Food materials to be served in restaurants or to be served in airline
catering, which are not labeled and prepackaged available to
the consumer (e.g. Schools, cafeterias, trains, airplanes and retail
stores) and for immediate consumption.
B. Bulk food materials (including raw materials, ingredients and
processed food products) for further processing or repacking or for
catering or food service use and not intended for retail sale, on
condition that these are properly identified as may be appropriate
and product specifications are provided in supporting documents.
C. Foods in primary packages with available label space of less than
10cm² (e.g. Pack of gum, individually wrapped candies), provided
that the secondary packaging contains all the required labeling
information.
 Other Labeling Requirements
Declaration of Claims
Declared claims should be in accordance to Codex
Alimentarius:
• General Guidelines on Claims (CAC/GL 1-979)
• Guidelines on Nutrition Labeling (CAC/GL 2-1985)
- Declared claims must be substantiated and should not
be misleading
Declaration of HACCP, Kosher, Halal, Non-GMO, Organic
logos should have a supporting documents such as their
valid certification that supports the said claim
Misleading Declaration / Representation
/ Prohibited Claims
Misleading Declaration / Representation
/ Prohibited Claims
Misleading Declaration / Representation
/ Prohibited Claims
Misleading Declaration / Representation
/ Prohibited Claims
FOOD PRODUCT CPR APPLICATION
That’s ALL!
SALAMAT!