Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

NINETEENTH CONGRESS
First Regular Session

HOUSE BILL NO. 2548

Introduced by: Hon. Keith Micah “Atty. Mike” D.L. Tan

AN ACT
TO PROTECT FILIPINOS FROM THE HARMFUL EFFECTS OF TRANS-FATTY
ACIDS

EXPLANATORY NOTE

Article Il, Section 15 of the1987 Constitution provides that “the State shall protect and
promote the right to health of the people and instill health consciousness among them.”

Pursuant to the aforesaid mandate of the Constitution, Republic Act No. 11223, otherwise
known as the “Universal Health Care Act”, was enacted, which, among others, adopts “An
integrated and comprehensive approach to ensure that all Filipinos are health literate, provided
with healthy living conditions, and protected from hazards and risks that could affect their
health”; and “A health care model that provides all Filipinos access to a comprehensive set of
quality and cost-effective, promotive, preventive, curative, rehabilitative and palliative health
services without causing financial hardship, and prioritizes the needs of the population who cannot
afford such services” (emphases supplied).

Accordingly, this bill, which seeks to regulate the use of trans-fatty acids (TFA), is being
filed in order to protect the Filipinos from the harmful effects of TFA.

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 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. Countries 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
contributed 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 TF A-free by 2023 by passing this bill into law.

In view of the foregoing, the passage of this important measure is earnestly sought.

Si

Keith Micah “Atty. Mike” D.L. Tan
4" District, Quezon



Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

NINETEENTH CONGRESS
First Regular Session

HOUSE BILL NO. 254 8

Introduced by: Hon. Keith Micah “Atty. Mike” D.L. Tan

AN ACT
TO PROTECT FILIPINOS FROM THE HARMFUL EFFECTS OF TRANS-FATTY
ACIDS

Be it enacted by the Senate and House of Representatives of the Philippines in Congress
assembled:

ARTICLE I
GENERAL PROVISIONS

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

SEC. 2. Declaration of Policy. —Itis 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 removing industrially-produced TFA from the food
supply.

SEC. 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 manufécture, preparation or treatment of food, such as oils and fats, whether
sold alone or incorporated in processed food and/or prepackaged food.


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.

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.

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 inthe 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; (ii)
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 concemed, 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.


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

o.  Ruminant TFA - formed by bacteria in the stomach of cattle, sheep, and goats.
These trans fats typically comprise 2-6% of the fat in dairy products and 3-9% of
the fat in cuts of beef and lamb.

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

SEC. 4. 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 I
ROLES AND RESPONSIBILITIES

SEC. 5. 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);
iv. Department of Trade and Industry (DTI);
v. Department of Science and Technology (DOST);
vi. Department of Agriculture (DA);
Department of Finance (DOF); and
|. 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.

SEC. 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.

SEC. 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

iii, 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.

SEC. 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.

SEC. 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 I
PROHIBITED ACTS

SEC. 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, excluding TFA content from
ruminant sources.

It shall be the burden of the manufacturer, importer, distributor or seller to demonstrate that
TFA in excess of 2g per 100 g is from ruminant sources.

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

SEC. 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,
excluding TFA content from ruminant sources.


It shall be the burden of the manufacturer, importer, distributor or seller to demonstrate that
TFA content in excess of 2g per 100 g is from ruminant sources.

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.

SEC. 12. Prohibition on 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.

SEC. 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 conceals or 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

SEC. 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.

SEC. 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 within
office hours, or outside office hours when necessary, to determine compliance with this Act. The
FDA shall issue guidelines on record-keeping and inspection procedures.

SEC. 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 shall apply in the enforcement of this Act.

SEC. 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.

SEC. 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,

SEC. 19. Administrative Penalties. - The following administrative penalties shall be
imposed on food business operators found to be in violation of Seetions 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 (P100,000.00) 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 (200,000.00) 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.

SEC. 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.

SEC. 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

SEC. 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.

SEC. 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.

SEC. 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.

SEC. 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 VII
INCENTIVES FOR REPLACING TFA


SEC. 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.

SEC. 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 VII
MISCELLANEOUS PROVISIONS

SEC. 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
aise 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.

SEC. 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.

SEC. 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.

SEC. 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. :


SEC. 32. Use of Fees, Charges and Penalties. - All fines and fees that may be collected
from the enforcement of this Act shall be used exclusively for its implementation.

SEC. 33. Appropriations. — The initial amount necessary for the implementation of this
‘Act shall be charged against the current appropriation of all concemed agencies. Such funds
necessary for the continued implementation of this Act shall be included in the annual General

Appropriations Act.

SEC. 34. 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.

SEC. 35. 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.

SEC. 36. 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.

SEC. 37. Effectivity Clause. - This Act shall take effect fifteen (15) days after its
publication in two (2) newspapers of general circulation.

Approved,