RULES AND REGULATIONS GOVERNING

THE OPERATION OF FOOD AND FOOD

PRODUCTS MANUFACTURING AND
PROCESSING ESTABLISHMENTS
 CHAPTER I-Purpose and Definitions

Section 1- Pursuant to section 26(a) of Republic Act No. 3720, Otherwise

known as the Food,Drug and Cosmetic Act, the following rules and
regulations are hereby promulgated to insure the proper operation and
maintenance of food and food products manufacturing and processing
establishments.

Section 2
(a) As used in these regulations, the term “ACT” means the Food,Drug and
Cosmetic Act and all amendments thereto,
(b) “Manufacturing and/or processing” shall include repacking or otherwise
changing the container,wrapper or labeling of food, and /or food products
in the furtherance of the distribution of the same from the original place
of manufacture to the person who makes the final delivery or sale to the
ultimate consumer,
 CHAPTER I-Purpose and Definitions

Section 2
(a) “Invested Capital” shall means all assets directly or indirectly used in the
business and shall include the current market value of the land, the
buildings, the machineries and the equipment used in the industry;
provided,however,that when the land and the building in which the
business is to be carried on is not used exclusively by the producer in his
business, but mainly as a residence,then the land and building shall not be
considered as part of the capital of the applicant; provided further,that
when the building used in the business is rented, the rental shall not be
considered an operating capital,

(b) The definitions and interpretations contained in Section10 of the

Food,Drug and Cosmetic Act shall be applicable to such terms when used
in the regulations in this section.
CHAPTER II-Application for Permit to Operate a Food and Food
Products Manufacturing and Processing Establishments

Section 3- Any person or group of person desiring to operate or establish a

food and food products manufacturing and/or processing establishment shall
file an application for permit to operate with the office of the Food and Drug
Administration under oath,in duplicate,signifying the name of the
establishment as duly registered with the bureau of Commerce,the place,city
or municipality and province where it is to be established, name, citizenship,
and domicile of the owner, administrator or manager, the invested capital and
the class of food or food products to be manufactured and/or processed.

Section 4- All existing food and food products manufacturing or processing

establishment shall comply with the requirements of these regulations within
ninety(90) days after these regulations shall have taken effect.
 CHAPTER II-Application for Permit to Operate a Food and Food
Products Manufacturing and Processing Establishments

Section 5- If, after inspection, the food manufacturing and/or processing

establishment was found to have failed to comply with the requirements of
the regulations, the Administrator may refuse to issue the necessary permit,
in which case he shall give not more than sixty (60) days to the
owner,admistrator or manager thereof, if the establishment is located in the
City of Manila and its Suburbs, cities and municipalities, and not more than
ninety (90) days if in the province, to require the establishment to comply
with such deficiencies.

Section 6- Food and food products manufacturing and processing

establishment with an invested capital of not more than five thousand
(5,000.00) pesos shall be exempted from the provisions of section 15
hereof.However,these establishment shall not be exempted from the
requirements of Section 3 of this regulations, inspection and sampling of the
products produced, distributed or sold for examination and analysis.
 CHAPTER II-Application for Permit to Operate a Food and Food
Products Manufacturing and Processing Establishments

Section 7- No food and food products manufacturing and processing

establishment shall operate without having first secured the proper
permit from the Food and Drug Administration.

Section 8- No food and food products manufacturing and processing

establishment shall transfer their location or site without first notifying
the Food and Drug Administration of such intention. The manager or
owner shall notify the Food and Drug Administration of the transfer in
writing, stating the place he intends to move and establish the plant in
accordance with requirements of the regulations.
 CHAPTER III- Requirements for Food and Food Products
Manufacturing and Processing Plant or Establishment

Section 9- BUILDING- Buildings in which food and food products are

manufactured,processed,packaged, labeled or held shall be maintained in a
clean and orderly manner and shall be suitable size, construction and
location in relations to surroundings to facilitate maintenance and
operations for their intended purpose. It must conform to the zonification
plan of the locality. The building shall:

(a) Provide adequate space for orderly and hygienic lay-out of equipment
and materials used in order to minimize any risk of mix-ups of different
food and food products, their component, packaging, or labeling and to
control the possibility of cross contamination of foreign matter or
substance, stored or handled on the same premises.
CHAPTER III- Requirements for Food and Food Products
Manufacturing and Processing Plant or Establishment
Section 9:
(a) Provide adequate lighting and ventilation when necessary for intended
production or control purposes, adequate screening dust filtration,
humidity and bacteriological control to prevent the dissemination of
micro-organisms from one area to another to facilitate sterilization as may
be required, and to provide other conditions favorable to the safety and
integrity of the products.

(a) Provide adequate washing, cleaning, toilet and locker facilities.