Republic of the Philippines oF

HOUSE OF REPRESENTATIVES

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Quezon City, Metro Manila TS) papp29 0

EIGHTEENTH CONGRESS.
Second Regular Session

TIME: [2:27

House Bill No,_ 7202

Introduced by Hon. RONNIE L. ONG

EXPLANATORY NOTE

Noncommunicable diseases (NCDs) kill 41 million people each year, contributing
about 71% of all deaths globally. In the Philippines, NCDs account for 68% of all deaths.
One in every three Filipinos is likely to die before the age of 70 from one of the four major
NCDs — cardiovascular diseases (CVDs), cancer, diabetes, or chronic respiratory
diseases. CVDs, particularly coronary heart disease (CHD), account for nearly half of the
world's NCD related deaths and claim around 70,000 lives in the Philippines every year.

High intake of trans-fatty acids (TFA) increases the risk of death from any cause
by 34% and CHD mortality and morbidity by as much as 23% and 28%, respectively.
Every year, more than half a million deaths are attributed to TFA globally. Dubbed as the
“tobacco of nutrition,” TFA has no health benefits and is completely replaceable with no
difference in taste or cost of food. Thus, the WHO published the REPLACE Technical
Action Package as a road map towards a trans-fat free world by 2023.

Denmark, Argentina, Thailand and Singapore have introduced policies to limit TFA
consumption by banning partially hydrogenated oils (PHOs), the major source of TFA,
and/or limiting TFA content in food, that regulated TFA have seen a significant decline in
CHD deaths. Denmark’s regulation limiting TFA content to 2g per 100g of fat in food
products resulted in a 75% reduction in CHD- related deaths. In Argentina, an estimated
301 to 1,517 cardiac deaths every year were averted by eliminating industrially-produced
TFA, saving the government as much as USD 87 million in healthcare costs annually.

The importance of addressing the problem of CHDs and CVDs as a whole has
never been more pronounced than during this COVID-19 pandemic where patients with
comorbidities, such as CHD, have a higher risk of serious illness or death. As of June 8,
2020, 49% of COVID-19 deaths in the Philippines had comorbidities. Now more than ever,
the need for preventative health care and healthy lifestyle promotion must be realized in
line with the vision of universal health care.

According to the WHO, TFA elimination is considered as one of the simplest and
most straightforward public health interventions to reduce the risk of CVDs and improve
nutritional quality of diets. As more countries regulate TFA, countries without regulations
become vulnerable to dumping of TFA-rich imported food. Thus, it becomes even more
urgent to join the global movement to become TFA-free by 2023 by passing this bill now.
Together, let us protect all Filipinos from the harmful effects of TFA and promote healthy
hearts for all.

In view of the foregoing, approval of this bill is immediately sought.

RON + ONG
Representative, APPL

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Republic of the Philippines
HOUSE OF REPRESENTATIVES,
Quezon City, Metro Manila

EIGHTEENTH CONGRESS
Second Regular Session

House Bill No. 7202

Introduced by Hon. RONNIE L. ONG

AN ACT TO PROTECT FILIPINOS FROM THE HARMFUL EFFECTS OF
TRANS-FATTY ACIDS, AND FOR OTHER PURPOSES

ARTICLE I. GENERAL PROVISIONS

Section 1. Short Title — This Act shall be known as the “Trans-Fat Free Philippines
Act’.

Section 2. Declaration of Policy - It is the duty of the State to protect and promote
the Filipinos’ right to health and instill health consciousness among them. The State
recognizes the right of people to safe and nutritious food, free from substances like trans-
fatty acids (TFA) that increase their risk of contracting deadly diseases.

The State shall prioritize health promotion and preventive care as it progresses towards
universal health care. In this regard, the State shall protect Filipinos from the threat of
death and diseases linked to TFA consumption by progressively removing industrially-
produced TFA from the food supply.

Section 3. Definition of Terms — For the purposes of this Act, the following terms shall
be defined as follows:

a. Certificate of Product Registration (CPR) — an authorization issued by
the Food and Drug Authority (FDA) for specific health products including
food, after evaluation and approval of submitted registration requirements.

b. Distributor — means any person to whom a consumer product is delivered
or sold for purposes of distribution in commerce, but excluding the
manufacturer or retailer of such product. Distributors may be importers,
exporters, traders and wholesalers.

c. Food ~ 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 that were used as an ingredient
or a component in the manufacture, preparation or treatment of food, such
as oils and fats, whether sold alone or incorporated in processed food
and/or prepackaged food.

d. Food Service Establishment - means any establishment that prepares,
serves, markets, sells, or offers for sale, food or drink to be consumed within
the establishment or taken-out.

e. Healthy Alternative Oils, Fats, and Oilseeds — oils, fats, and oilseeds rich
in polyunsaturated fatty-acids or monounsaturated fatty-acids and with low
levels of saturated fatty-acids.


Section 4.

Importer — the consignee or the Philippine agent or representative of a
foreign owner or consignee of raw materials, ingredients and/or finished
products at the time of entry of such article into the Philippines.

Industrially-Produced TFA — trans fat other than trans fat naturally
occurring in fat of animal origin.

License to Operate (LTO) — a license granted by the FDA to
establishments involved in the manufacturing, packaging, re-packaging,
importation, exportation, distribution, and retailing of processed foods,
drugs, medical devices, in vitro diagnostic reagents, cosmetics, and
household hazardous substance products.

Manufacturer — means any person who manufactures, assembles or
processes food products, including any person who attaches one’s own
brand name to a consumer product manufactured, assembled, or
processed for them. In the case of imported products, the manufacturer's
representatives or, in their absence, the importer shall be deemed the
manufacturer.

Micro, small and medium enterprise (MSME) — any business activity or
enterprise engaged in industry, agribusiness and/or services, whether
single proprietorship, cooperative, partnership or corporation whose total
assets, inclusive of those arising from loans but exclusive of the land on
which the particular business entity's office, plant and equipment are
situated, and must have value falling under the following categories: (i)
Micro: not more than P3,000,000; (ji) Small: P3,000,001 - 15,000,000; and
(iii) Medium: P15,000,001 — P100,000,000. The above definitions shall be
subject to review and adjustments by the Micro, Small and Medium
Enterprises Development (MSMED) Council under Section 6 of RA 9501 or
the Magna Carta for Micro, Small and Medium Enterprises, or upon
recommendation of sectoral organizations concerned, taking into account
inflation and other economic indicators.

Partially Hydrogenated Oil (PHO) — fat or oil that has been hydrogenated,
but not to complete or near complete saturation, and with an iodine value
greater than 4, as determined by a method that is suitable for this analysis.

Prepackaged Food — processed food prepared in advance and placed in
a container, labelled and ready for sale or distribution, or for catering
purposes.

Processed Food — any food that has been subjected to any action that
substantially alters the initial raw materials or product or ingredients.

Retailer — any establishment that sells or offers to sell any food product
directly to the general public.

TFA- all fatty acids with a double bond in the trans configuration, regardless
of whether they are produced industrially or come from ruminant sources.

Scope and Application — This Act shall apply to all food business

operators as defined under Republic Act No. 10611 or the “Food Safety Act.”

ARTICLE Il.

Section 5.

ROLES AND RESPONSIBILITIES

Lead Agency — The Department of Health (DOH) shall be responsible for

ensuring that the provisions of this Act are implemented. As lead agency, the DOH shall
perform the following functions:


a. Convene and lead the inter-agency TFA Task Force composed of the
following agencies for the implementation of this Act:
i. National Nutrition Council (NNC);

FDA;
Department of the Interior and Local Government (DILG);
Department of Trade and Industry (DTI);

v. Department of Science and Technology (DOST);

vi. Department of Agriculture (DA);

vii. Department of Finance (DOF); and
vii. Other agencies identified by the DOH.

b. Issue policies, rules, regulations and standards for the implementation of
this Act; and
c. Oversee and monitor the implementation of this Act.

Section 6. Assistance and capacity building for local implementation and
enforcement — The FDA, in coordination with DILG and other relevant agencies, shall
strengthen the capacity of LGUs in implementing and enforcing the provisions of this Act
with regard to prepackaged and processed food produced and marketed in traditional
markets and food service establishments.

The FDA shall assist LGUs in regulating food service establishments, upon request of the
LGU. Such assistance shall include the use of laboratories for testing and sharing of
information relevant to products registered with the FDA.

Section 7. Research and development — The DOST shall:

a. Conduct continuing research to identify and develop healthy alternative oils
and food products such as:
i. Healthy alternative oilseeds through crop diversification programs
and agricultural research, in coordination with the DA;
ii. Healthy oils and fats through the application of oil modification
techniques and other methods; and
ili, Healthy food products through product reformulation, research and
development; and
b. _In coordination with the FDA, develop or adopt technology to reduce the
cost of TFA testing.

Section 8. Oilseeds crop diversification - The DA shall implement an oilseeds
crop diversification program and conduct continuing research and development to support
the production of healthy alternative oilseeds in coordination with DOST.

Section 9. __ Trainings and seminars on reformulation — The DOH, in coordination
with FDA, DTI, DOST-Philippine Council for Health Research and Development, DOST-
Food and Nutrition Research Institute (DOST-FNRI), DILG, and the Technical Education
and Skills Development Authority, shall conduct trainings and seminars for food business
operators and food service establishments on the reformulation of food products to
comply with the provisions of this Act, and the use of healthy alternatives of oils

ARTICLE Ill. PROHIBITED ACTS

Section 10. Prohibition on the manufacture, importation, distribution and sale of
PHOs and oils and fats with high TFA content — The manufacture, importation,
distribution and sale of the following are prohibited:

a, _ PHOs to be consumed alone or used in preparation of food products;
b. Oils and fats made or blended with PHOs; and
c. Oils and fats with TFA content of more than 2g per 100g.

No registration, license or permit shalll be issued to any food manufacturer, importer or
distributor that manufactures, imports, distributes, or sells food in violation of this
provision.


Section 11. Prohibition on the manufacture, importation, distribution and sale of
processed and prepackaged food with PHOs and high TFA content — The
manufacture, importation, distribution and sale of the following are prohibited:

a. Processed and prepackaged food prepared with PHOs, including food
prepared by food service establishments;

b. Processed and prepackaged food prepared with oils and fats made or
blended with PHOs, including food prepared by food service
establishments; and

c. Processed and prepackaged food with TFA content of more than 2g per
100g of total fat.

No registration, license, or permit shall be issued to any food manufacturer, importer, or
distributor for any processed or prepackaged food manufactured, imported, distributed or
sold in violation of this provision.

Section 12. Prohibition for trans fat free claims— Claims on the packaging, labelling,
marketing, or advertising, that a food product is TFA free is prohibited. A TFA free claim
is any claim that states or suggests that the food product does not contain TFA, such as
“Trans Fat Free,” with “Og Trans Fat,” or any other similar claim.

Section 13. Material misrepresentation — Any material misrepresentation with regard
to the requirements mandated by the FDA in the application for a CPR shall be a ground
for the imposition of appropriate penalties prescribed under this Act. For purposes of this
Act, there is material misrepresentation when the applicant makes a false representation
of a material fact in the application for a CPR, tending directly to induce the FDA to grant
the application when otherwise it will be denied.

ARTICLE IV. ENFORCEMENT

Section 14. Enforcing agencies - The FDA and local government units (LGUs) shall
be responsible for the enforcement of this Act with regard to the following food products:

a. _ Processed and prepackaged food — The FDA shall enforce the provisions
of this Act in relation to prepackaged and processed food including oils and
fats, whether domestic or imported.

b. _ Food produced and marketed in traditional markets and food service
establishments — The LGUs shall enforce the provisions of this Act with
regard to prepackaged and processed food produced and marketed in
traditional markets and food service establishments within their jurisdiction.

Section 15. Inspection powers and record-keeping — The FDA, through its authorized
agents, shall have the power to inspect the premises and records of food manufacturers
to determine compliance with this Act. The FDA shalll issue guidelines on record-keeping
and inspection procedures.

Section 16. Enforcement procedure for processed and prepackaged food — The
existing rules of procedure in administrative proceedings of the FDA shall apply in the
handling of cases and violations committed under this Act with regard to processed and
prepackaged food. In the case of imported processed and prepackaged food, the existing
rules of procedure of the DOF-Bureau of Customs shalll apply in the enforcement of this
Act.

Section 17. Enforcement for traditional markets and food service establishments
— LGUs, through an appropriate issuance, shall establish a mechanism to enforce the
provisions of this Act with regard to prepackaged and processed food produced and
marketed in traditional markets and food service establishments within their jurisdiction
and shall impose penalties for violations thereof.


Section 18, Civil society participation for monitoring and surveillance — The FDA
shall implement programs encouraging citizen participation in the conduct of post-market
monitoring and surveillance of TFA content in food and reporting violations of this Act.
For this purpose, the FDA shall develop and publicize a web-based user-friendly
consumer complaints portal to encourage citizen participation.

ARTICLE V. FINES AND PENALTIES

Section 19. Administrative Penalties — The following administrative penalties shall be
imposed on food business operators found to be in violation of Sections 10, 11, and 12
of this Act:

a. For the first violation, a fine of not less than Fifty Thousand Pesos
(P50,000.00) but not more than One Hundred Thousand Pesos
(P 100,000.00) and suspension of the CPR and/or LTO for one (1) month;

b. For the second violation, a fine of not less than One Hundred Thousand
Pesos (P100,000.00) but not more than Two Hundred Thousand Pesos
(P200,000.00) and suspension of CPR and/or LTO for three (3) months;
and

c. For the third violation, a fine of not less than Two Hundred Thousand Pesos
(P200,000.00) but not more than Three Hundred Thousand Pesos
(P300,000.00). Suspension of CPR and/or LTO for one (1) year or
revocation of the CPR, LTO, and other relevant licenses and permits.

The following administrative penalties shall be imposed on food businesses operators
found to be in violation of Section 13 of this Act:

a. For the first violation, a fine of not less than One Hundred Thousand Pesos
(P100,000.00) but not more than Two Hundred Thousand Pesos
(P200,000.00) and suspension of the CPR and/or LTO one (1) year; and

b. For the second violation, a fine of not less than Two Hundred Thousand
pesos (P200,000.00) but not more than Three Hundred Thousand Pesos
(P300,000.00) and revocation of CPR and/or LTO.

The imposition of fines shall take into consideration the annual gross sales, capital
investment and employee size of the food business operator.

Section 20. Imprisonment — In addition to administrative penalties, the following
penalties of imprisonment may be imposed on food business operators:

a. For violations under Sections 10, 11, and 12, imprisonment of not less
than one (1) month but not more than six (6) months; and
b. For violations under Section 13, imprisonment of not less than six (6)

months but not more than one (1) year.

Criminal and administrative actions for violations of this Act may be instituted separately
and independently from one another.

Should the offense be committed by a juridical person, the Chair of the Board of
Directors, the President, General Manager, or the partners and/or the persons directly
responsible therefor shall be penalized.

If the offender is an alien, he shall be deported after service of sentence and payment of
fine without further deportation proceedings.

In case the violation is committed by, or in the interest of, a foreign juridical person duly
licensed to engage in business in the Philippines, such license to engage in business in
the Philippines shall immediately be revoked.

The above penalties shall not preclude the imposition of applicable penalties by LGUs,
and any other sanctions under applicable laws, rules, and regulations.


Section 21. Other Penalties — In addition to the foregoing fines and penalties, the
following sanctions may also be imposed:

a. Seizure and condemnation, destruction and/or appropriate disposition of
non-compliant food products by the FDA; and/or
b. Closure of establishment by the LGUs having jurisdiction.

ARTICLE VI. TFA TESTING AND ENFORCEMENT CAPACITY

Section 22. Accredited laboratories and testing centers - The FDA and DTI-
Philippine Accreditation Board (PAB) shall jointly accredit public and private laboratories
capable of testing TFA content in food. The FDA and DTI-PAB shall develop, issue, and
publish accreditation procedures and qualification requirements for testing facilities within
six (6) months from the effectivity of this Act. The FDA shall adopt mechanisms to reduce
the cost of TFA testing in all accredited laboratories and testing centers.

Section 23. Regional laboratories and testing centers — Regional laboratories and
testing centers shall assist LGUs in monitoring and enforcing the provisions of this Act
within their respective jurisdictions as provided in Section 14.

Section 24. Resources and manpower - The FDA shall determine and ensure the
sufficient number of resources and manpower needed for the implementation of this Act.

a. _ In coordination with DOST, the FDA shall ensure that all FDA and DOST
regional laboratories have the equipment and resources to conduct testing
of TFA content in food.

b. In coordination with relevant agencies, the FDA shall determine and ensure
the adequacy of personnel trained on TFA regulation, testing, monitoring
and surveillance.

Section 25. Duty-free importation of TFA testing equipment — The importation of
laboratory equipment for testing TFA shall be exempt from payment of customs duties
and taxes.

ARTICLE Vil. INCENTIVES FOR REPLACING TFA

Section 26. Early compliance incentives for MSMEs — The DTI and LGUs, through
its business process and licensing offices, shall develop and implement policies and
programs providing incentives for MSMEs to encourage early voluntary compliance with
this Act.

Section 27. Expedited processing for CPR applications on reformulated products
- The FDA shall expedite the assessment of new CPR applications for food products
reformulated in compliance with this Act.

ARTICLE Vill. MISCELLANEOUS PROVISIONS

Section 28. Consumer information, education and communication program - The
DOH, in coordination with the Philippine Information Agency, Department of Education,
Commission on Higher Education, and Department of Information and Communication
Technology shall develop and implement a comprehensive information, education and
communications program to raise public awareness on the provisions of this Act, the
health harms resulting from TFA, sources of TFA in the diet, and ways to replace PHOs
with healthy alternative oils and fats.

Section 29. Implementing Rules and Regulations — Within sixty (60) days from the
effectivity of this Act, the DOH shall develop and issue implementing rules and regulations


(IRR) of this Act in consultation with NNC, FDA, DILG, DTI, DOST, DA, and other relevant
government agencies and stakeholders.

Section 30. Transitory Provisions — Within two (2) years from the effectivity of this Act:

a. Food manufacturers and importers shall comply with the additional
requirements for CPR application as determined by the FDA; and

b. Food business operators shall be allowed to sell their existing food products
that do not comply with Sections 10 and 11 of this Act.

All manufacturers, importers, distributors, and retailers of oils and fats, and food service
establishments shall be required to submit their existing inventory of food products as of
the date of effectivity of this Act to the FDA and DTI. Food business operators shall submit
their inventory within sixty (60) days from the effectivity of the IRR of this Act to monitor
the phase out of non-compliant food products.

Section 31. Monitoring and evaluation - The DOH shall periodically report to the
President and the Congressional Committees on Health, Agriculture and Food, and Trade
and Industry on the implementation of this Act. The DOH shall, in coordination with DOST-
FNRI, further monitor and evaluate the following:

a. TFA exposure screening and surveillance ~ The DOST-FNRI shall include
the regular screening and monitoring of TFA population consumption in the
Expanded National Nutrition Survey; and

b. TFA nutrient profiling — The DOST-FNRI shall include the testing and
monitoring of TFA content in food in the Food Composition Table and Food
Composition Databases.

Section 32. Appropriations and Use of Fees, Charges and Penalties — The initial
amount necessary for the implementation of this Act shall be charged against the current
appropriation of all concerned agencies. Such funds necessary for the continued
implementation of this Act shall be included in the annual General Appropriations Act.

All fines and fees that may be collected from the enforcement of this Act shall be used
exclusively for its implementation.

Section 33. Conflict of Interest — Pursuant to the fundamental objective of this Act to
advance public health, the implementation and enforcement of this Act and the
development of related polices shall promote multisectoral coordination while
safeguarding against potential conflict of interest.

Section 34. Separability Clause — If any provision or part hereof is held invalid or
unconstitutional, the remainder of the law or the provision not otherwise affected shall
remain valid and subsisting.

Section 35. Repealing Clause — Except as otherwise expressly provided in this Act, all
other laws, decrees, executive orders, proclamations and administrative regulations or
parts thereof inconsistent herewith are hereby repealed or modified accordingly.

Section 36. Effectivity Clause — This Act shall take effect fifteen (15) days after its
publication in two (2) newspapers of general circulation.

Approved,