Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City, Alabang, Muntinlupa City

The Food Safety Act of 2013

and the Responsibilities of Food
Business Operators (FBOs)

Presented By:

Cindy S. Palafox
Food-Drug Regulation Officer, Food Safety Unit
Center For Food Regulation and Research
REPUBLIC ACT 10611
Food Safety
Act of 2013
TIMELINE
2015
2010 2011 2013 2014
20 FEBRUARY
MAY MARCH – JUNE
Initial outline OCTOBER Draft Joint
JUNE Implementing Rules
prepared by Ms Irina The draft of this Act Signing of the IRR
and Regulations (IRR)
Kireeva, Short Term was presented and of RA 10611
Passed by the Joint prepared by the DA and
Expert on SPS modified through DOH Technical
Legislation of the joint meetings House Committee on
Health and Agriculture Working Groups
PHL-EU Trade between the DA and composed of the
and the Senate
Related Technical the DOH and jointly Committee on Trade concerned agencies of
Assistance Project 2 endorsed by the DA the two Departments
and DOH Secretaries
to Congress 23 AUGUST JULY
Signed into law Draft IRR was endorsed
by the DA and DOH
as RA 10611 TWGs to the DA and
DOH Secretaries

OCTOBER
DA-DOH Joint Legal
Review of IRR
Meeting between DA
and DOH Secretaries
Article II, Section 4 (n)
of RA 10611

Refers to the
assurance that food
will not cause harm
to the consumer
when it is prepared
or eaten according to
its intended use
MAIN OBJECTIVES
a) Protect the public from food-borne and water-borne
illnesses and unsanitary, unwholesome, misbranded or
adulterated foods;

b) Enhance industry and consumer confidence in the food

regulatory system; and

c) Achieve economic growth and development by promoting

fair trade practices and sound regulatory foundation for
domestic and international trade
IMPORTANT FEATURES
1. Department of Health and Department of
Agriculture as responsible for developing and
enforcing food safety regulatory measures

• Examples: Labeling Regulations, Standards

for Maximum Levels of Contaminants, Codes
of Good Practices
IMPORTANT FEATURES
2. Local Government Units as responsible for the
following:
• Sanitation on slaughterhouses, dressing plants,
fish ports, wet markets, supermarkets, school
canteens, restaurants, catering establishments
and water refilling stations, street foods

• Implement the Code on Sanitation of the

Philippines (PD 856)
IMPORTANT FEATURES
3. Delineates and links the Food Safety
Responsibilities of the DA, DOH and LGUs

• “Farm-to-Fork” approach
• “Integration and not Duplication”
Delineation of
Mandates
National Agencies
• Department of Agriculture ***

• Department of Health ***

• Department of Interior and Local Government

* Local Government Units

*** Food Safety Regulatory Agencies (FSRAs)

DA Food Safety Regulatory Agencies

Bureau of Animal National Dairy National Meat

Industry Authority Inspection Service

Fertilizer and Pesticide

Authority Sugar Regulatory
Philippine Coconut Administration
Authority

National Food Bureau of Fisheries and Bureau of Plant

Authority Aquatic Resources Industry
DOH Food Safety Regulatory Agencies

Bureau of Quarantine
 Work Process of DA, DOH and LGUs
DOH
FDA jurisdiction:
Processing & LGU jurisdiction:
Distribution stages Food Services
stages
• Regulate safety of all
fresh and raw agriculture • Regulate safety of all • Regulate safety of
and fishery resources processed and restaurants, wet
• Ensure animal and plant prepackaged food of markets,
health manufacturers and supermarkets,
• Ensure safety of farm distributors exporters, catering
inputs (agrochemicals) wholesalers, importers) establishments,
BOQ jurisdiction
school canteens,
water refilling
Domestic/international stations
Ports and Airports of entry,
In-flight catering,
DA jurisdiction: Food service
Primary & Postharvest Establishments (within
stages BOQ perimeter)
Sea vessels and Aircraft
IMPORTANT FEATURES
4. Created the Food Safety Regulation Coordinating Board
that:
• Monitors and coordinates the performance and
implementation of FSRA mandates;

• Establishes policies and procedures for coordination

among agencies
 Food Safety Regulation Coordinating Board
(FSRCB)

Chair Co-Chair

Alternate Alternate DA Undersecretary

Chair Co-Chair for Policy and
Planning, R&D and
Regulations
FSRCB MEMBERS
• Heads of the Food Safety Regulatory Agencies (FSRAs) of
the DA
• Director of the FDA CFRR
• Representative Field Operator of the DILG (Director rank)
• Heads of Leagues of Barangays, Municipalities, Cities and
Provinces
• Representative from the DTI (Director rank)
• Representative from the DOST (Director rank)
IMPORTANT FEATURES
5. FOOD BUSINESS OPERATORS are primarily
responsible for the safety of food

• FBO refers to a person engaged in the food

business including one’s agents and is
responsible for ensuring that the requirements
of this Act are met by the food business under
one’s control
Responsibilities of Food
Business Operators
(FBOs)
Article V, Section 13 of IRR of RA 10611
RESPONSIBILITIES OF FBOs
Safety
Responsibilit
y
Traceability

Transparency

Emergency

Prevention

Co-operation
RESPONSIBILITIES OF FBOs
Safety Operators shall not place unsafe food
Responsibilit in the market
y
Traceability

Transparency

Emergency

Prevention

Co-operation
RESPONSIBILITIES OF FBOs
Safety
Operators are responsible for the
Responsibilit safety of the food they produce,
y
Traceability transport, store or sell
Transparency

Emergency

Prevention

Co-operation
RESPONSIBILITIES OF FBOs
Safety
Responsibilit
Ensure that food satisfies the
y requirements of food law and
Traceability
that control systems are in place
Transparency
to prevent, eliminate, or reduce
Emergency
risks to consumers
Prevention

Co-operation
RESPONSIBILITIES OF FBOs
Safety
Operators shall designate a Food Safety
Responsibilit
y Compliance Officer (FSCO)
Traceability  Training
 Certification
Transparency

Emergency

Prevention

Co-operation
RESPONSIBILITIES OF FBOs
Safety Food Safety Compliance Officer (FSCO)
Responsibilit
y ◦ MICRO AND SMALL ENTERPRISES, the
Traceability owner may serve as the FSCO or a
consultant FSCO may be employed on
Transparency
part-time or full-time basis.
Emergency

Prevention
◦ LARGE- AND MEDIUM- SCALE FOOD
BUSINESSES shall designate an FSCO
Co-operation who is preferably a graduate of food-
related courses
RESPONSIBILITIES OF FBOs
Safety Food Safety Compliance Officer (FSCO)
Responsibilit 1. Oversee the implementation of the food
y
Traceability safety programs and activities;
Transparency
2. Sufficiently trained through a course
recognized by DA or DOH
Emergency

Prevention

Co-operation
RESPONSIBILITIES OF FBOs
Safety
Operators should be able to
Responsibilit
y rapidly identify any supplier or
Traceability consignee
Transparency

Emergency

Prevention

Co-operation
RESPONSIBILITIES OF FBOs
Safety
Responsibilit
y
“One-step-forward-one-step
Traceability backward” approach
Transparency

Emergency

Prevention

Co-operation
RESPONSIBILITIES OF FBOs
Safety
Operators shall immediately
Responsibilit
y inform the FSRAs if they have
Traceability any reason to believe that their
Transparency food is not safe
Emergency

Prevention  Inform FDA

Co-operation
RESPONSIBILITIES OF FBOs
Safety
Responsibilit
y
Traceability
Operators shall immediately
Transparency
withdraw food from the
Emergency
market if they have reason to
Prevention believe that it is not safe
Co-operation
During recall
• Prepare and submit product recall plan/
strategy to FDA;

• Always update FDA with the progress of

your recall;

• Disposal or destruction of recalled

products shall always be witnessed by
FDA; Notice should be given 1 week prior
to conduct of activity;
RESPONSIBILITIES OF FBOs
Safety
Responsibilit
y
Operators shall identify and
Traceability regularly review the critical
Transparency points in their process and
Emergency ensure that controls are
Prevention applied at these points
Co-operation
RESPONSIBILITIES OF FBOs
Safety
Responsibilit Operators shall cooperate with
y
Traceability
the competent authorities in
actions taken to reduce risk
Transparency

Emergency

Prevention

Cooperation
IMPORTANT FEATURES
6. Strengthening of Penalties and Sanctions for
Violative Acts by both the Food Business Operators
and the Government
Prohibited Acts
• Produce, handle, offer for sale, distribute or
import food or food product non-conformant to
any food standards and food or food products
declared as banned;

• Misbranding, mislabeling, and adulteration;

• Refusal of access or entry of inspection of FSRAs

Prohibited Acts
• Failure to comply to recall orders

• Operating without appropriate authorizations

• Connivance

• Violate the IRR of this Act

 Fine Relevant Authorization Additional Penalty
1st Conviction 50K-100K Suspension for 1 mo None
2nd Conviction 100K-200K Suspension for 3 mos None
3rd Conviction 200K-300K Suspension for 6 mos None

Violation Resulting to
slight Physical Hospitalization and
Injury*** 200K-300K Suspension for 6 mos rehabilation

Violation Resulting in
less serious to serious Hospitalization and
Physical Injury*** 200K-300K Suspension for 12 mos rehabilation

Violation Resulting to
Death*** 300K-500K Permanent revocation Imprisonment
SUMMARY
• The Food Safety Act of 2013 was enacted to strengthen the
food safety regulatory system in the country.

• This Food Law serves as the framework for implementing

farm to fork Food Safety Regulatory System.

• Food Safety Regulatory Agencies of DA and DOH are

responsible in ensuring food safety from primary
production up to processing of foods.
SUMMARY
• Food Business Operators are primarily responsible for
ensuring safety of their food products and compliance to the
requirements of the law.

• FBOs are required to designate a Food Safety Compliance

Officer to oversee the implementation of food safety
programs and activities of the establishment.

• Penalties shall be given to any person who shall violate the

provisions of RA 10611.
Thank
you!
 CONTACT US
Center for Food Regulation and Research
Food and Drug Administration
Civic Drive, Filinvest City
Alabang 1781, Muntinlupa City, Philippines
Tel. No. 857-1991 to 93
Email: info@fda.gov.ph
cfrr@fda.gov.ph
report@fda.gov.ph