Certificate of Product Registration Requirements

1. Type of Food Product

 Product Name (eg. Grapeseed Extract with Vitamin E Plus Minerals Food
Supplement Capsule).
Product Name should indicate the true nature of the product (e.g. Vitamin A, B1 & C plus
Minerals) and shall be specific and not generic. Also, the word “Food/Dietary Supplement”
and its product form (e.g. tablet, capsule, syrup, granules, liquid, gummies, powder) must be
part of the product name.
3. Establishment Information
 Complete Name of Manufacturer
 Complete Address of Manufacturer
 Notarized Distribution Agreement or Contract Agreement
4. Complete List of Ingredients
 In Descending order of proportion. Product formulation must be consistent with the
Ingredient List on the label. Declaration of Food additives should specify its
common name not the functional name only and indiccate levels eg. LECITHIN
(Emulsifier)
 With amount per serving
 If Vitamins and Mineral with Specific Name (Form/Chemical nature of Vitamin or
Mineral) (eg. Vitamin A (Beta-Carotene) 300ugRE)
 For Herbs and Botanicals: Specific name (Scientific name) Plant Part used Amount
per Serving
 For products with Nutritional Substances of plant or animal origin
o Specific name Plant or animal source Amount per Serving (eg. Collagen from
Fish 500mg)
For Flavors: declare the classification as Natural, Artificial, Nature identical and “Flavors
(Combination of Natural and Nature identical)”.
Coloring substances - declare common name or as “Food Color(s)” or “Colors” for those
derived from or identical with substances derived from plant materials, and the common name of
the “Artificial Color(s)” for coal-tar dyes or other synthetic chemical compounds.
Usage: Indicate the recommended usage per day or Direction for Use. (e.g. 1 tbsp. once a day, 1
tablet once a day, Dissolve 1 sachet in a glass of water).
5. Product Specifications
 Physical
o I. Color
o II. Odor
o III. Taste
o IV. Texture
o V. Form (eg. Powder, liquid, gel, etc..)
 Chemical
o PH
o Moisture content
o Water activity
o Heavy metals such as lead, mercury, arsenic, cadmium
o Etc.
 Example of declaration: Not more than 10%, Minimum of 10ppm, 4-6
 Microbiological Parameters:
o Coliforms
o Total Plate Count
o Salmonella spp.
o Yeast & Molds
o E. Coli
o Commercial Sterility
o S. Aureus
 Example of declaration: Maximum 10cfu/g, <100cfu/mL, MAL
10,000cfu/mL, etc...
6. Packaging Material & Presentation
 Shelf Life Declaration (In Months)
o Packaging for products with different and/or multiple packaging material and
shelf life, please use “semi-colon” to separate/delineate declaration in the data
entry.
Example: Shelf Life Declaration (in Months): 6; 12
Packaging Material Type/Name: PLASTIC PACK; ALUMINUM FOIL
 PACK Material Type/Name
o Glass bottle; Polyethylene Terephthalate; Polyethylene; Polypropylene;
Cellophane Paper (Glassine, Vegetable Parchment); Can coared with
oleoresinous; Phenolic, Epoxy or Vinyl; Polyamide; Aluminum; Blister Pack;etc.
 Description of Product in Commercial Presentation
o Individually wrapped in pillow packs inside laminated plastic pack, in Bottle, in
Box, In 90g (2sachets x 45g) carton box
 Storage Condition Requirements
o Product should be stored in a cool and dry place with air humidity of 70%
maximum, cool storage is recommended.
  Function of the Food material
o Function of the food material applies to food additives and ingredients only (eg.
Preservative, nutrient, emulsifier, bakery ingredient)
 Usage
o For food supplement, this applies to the recommended amount per day

 Source of allergen (if any).

o Cereal containing gluten; Crustaceaans and products of these; Eggs and egg
products; Peanuts, soybeans, and products of these; Milk and Milk products
(lactose included); Tree nut and nut products; Sulphite in concentrations of
10mg/kg or more)

 Lot Code and Interpretation

o Eg. 230115A where 23-day, 01-month, 15-year, and A-1st batch

 Open Date Marking/ Expiry Date

7. Nutrition Information
 Serving size (grams or ml)
 Number of Serving per Container/Pack
 Example of Nutrition Label
Specification Amount Per Serving % RENI, Mandatory for
Locally Manufactured
Products, otherwise indicate
“Not applicable”
Calories (kcal) 90 5%
Total Fat (g) 10
Saturated Fat (g) 2
Trans Fat (g) 2
Cholesterol (mg) 0
Sodium (mg) 0
Total Carbohydrates (g) 10
Sugar (g) 1
Dietary Fiber (g) 1
Total Protein (mg) 1000 1%
  Vitamins and Minerals Declaration as applicable
Specification Amount Per Serving % RENI, Mandatory for
Locally Manufactured
Products, otherwise indicate
“Not applicable”
Vitamin (mg)
Thiamin (mg)
Riboflavin (mg)
Niacin NE (mg)
Folate DFE (ug)
Vitamin B6 (mg)
Vitamin B12 (ug)
Vitamin A RE (IU)
Vitamin D (IU)
Vitamin E (IU)
Vitamin K (ug)

 Minerals
Specification Amount Per Serving % RENI, Mandatory for
Locally Manufactured
Products, otherwise indicate
“Not applicable”
Calcium (mg)
Iron (mg)
Iodine (ug)
Magnesium (mg)
Phosphorus (mg)
Zinc (mg)
Selenium (ug)
Fluoride (mg)
Manganese (mg)

8. Nutrition and Health Claims

 Do you have Nutrient Content Claim/ Nutrient Function Claim/ Other Function
Claims/ Health Claim/ Comparative Claim/ Non-addition claim/ Reduction of
disease risk claim/ Other claims?
o Upload documents to substantiate claims, such as technical, nutritional, or health
studies or reports, market-research studies, Certificate of Analysis, quantitative
analysis and computations, scientific report or studies published in peer-reviewed
scientific Journals, certifcates or certification in compliance with current labelling
regulations.
 o The certificate of analysis should be recent (issued six months from the date of
application)
9. Doctumentary Requirements
 Image of product label
 Scanned copy of clear and complete loose labels or artworks and Picture of Product
in Commercial Presentation in all angles and in different packaging sizes and from
at least two different perspectives (max file size 2mb)
o For Food Supplements: please include the artworks ans/or blister packs, alu-alu
pack and secondary packaging (ie. Paper box and Cardboard box)
 Scanned Copy of any of the original documents:
o Foreign Agency Agreement
o Certificate of Distributorship
o Appointment Letter
o Proforma Invoice
o Memorandum of Agreement from the Manufacturer
 AND Scanned copy of any of the following:
o Manufacturer’s Certificate of Registration with GMP Compliance
o Valid Sanitary Phyto-Sanitary Certificate / Health Certificate
o Valid ISO 22000 Certificate
o Valid Hazard Analysis and Critical Control Points (HACCP) Certificate
o Certificate of Free Sale attested by the recognized body Chamber of Commerce /
Phil. Consulate in the country of origin.
 As applicable, documents to substantiate claims, such as:
o Technical or Nutrition Health Studies or Reports
o Market research Studies
o Certificate of Analysis, Quantitative Analysis and Computations
o Scientific reports or studies published in peer-reviewed scientific journals
o Certificates or Certification to support use of logo/seal on Sangkap Pinoy, Halal,
Organic, Kosher and in Compliance with the current labelling requirements
10.Additional requirements for Food Supplement
 Upload stability study to justify the declared shelf life
 Upload certificate of Analysis of the finished product (Physical, Chemical,
Microbiological Analysis, Nutrient Analysis, Heavy Metals)
 Documents to determine conformance to the standard/s of product identity
 Safety data (LD50 Toxicity tests)
o Submitted stability data should indicate
 Conclusion paramaters used
 Methodology (This should declare the following: product name, batch
number, production date, dates of analysis, tabulated data results in terms
of physical and chemical properties, and name and signature of the QA
analyst and QA manager. (Accelerated Shelf Life Study until 6mos. Can
 be accepted for Initial Application and Real Time Shelf Life Study for
Renewal Applications.)
For Food Supplements: The word “Food Supplement” and “No approved therapeutic claims”
must be declared.
The precaution: “For Adult Use only. Not recommended for children, pregnant and lactating
women” should be declared if the product is not intended for children nor pregnant women. The
uploaded label should not contain therapeutic claims and unnecessary images/photographs that is
not part of the ingredients and will likely create erroneous impression regarding its character or
nature in any respect. The phrase Nutrition Facts should be used instead of Supplement Facts.