HS
k whl of be Philepives
HOUSE OF REPRESENTATIVES
von City
Qeccon Ci
EIGHTEENTH CONGRESS
Second Regular Session

HousE BILL No, 8993

Introduced by HON. LUIS RAYMUND “LRAY” F. VILLAFUERTE, JR.

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

According to the World Health Organization (WHO), noncommunicable diseases
(NCDs) kill 41 million people each year, equivalent to 71% of all deaths globally.
NCDs are diseases of long duration and generally slow progression. In the
Philippines, NCDs account for 68% of all deaths

Every year, more than half a million deaths are attributed to trans-fatty acids (TFA)
globally. High intake of TFA increases the risk of death from any cause by 34% and
coronary heart disease mortality and morbidity by as much as 23% and 28%,
respectively.

TFA has no health benefits. The WHO believes that TFA elimination is considered as
one of the simplest public health interventions to reduce the risk of corona heart
disease and improve nutritional quality of diets. The WHO published the REPLACE
Technical Action Package as a road map towards a trans fat free world by 2023.
Accordingly, this measure is pursuant to a global effort to eliminate TFA and help
improve the diet of Filipinos.

In view of the foregoing, the immediate passage of this bill is earnestly sought.

fitful

LUIS RAYMUND “LRAY” F, VILLAFUERTE, JR.



R ublec oj the. Philipines

HOUSE OF REPRESENTATIVES
von City
Quexen Cit

EIGHTEENTH CONGRESS
Second Regular Session.

HOUSE BILL NO. 8093

Introduced by HON. LUIS RAYMUND “LRAY” F. VILLAFUERTE, JR.

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

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

Article |. 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 policy of the State to protect and
promote the right to health of the people 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
progressive* removing industrially-produced TFA from the food supply.

SECTION 3. Definitions 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-adds or monounsaturated fatty-acids and with low levels of
saturated fatty-acids.

(f) 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.

(g) Industrially-Produced TFA - trans-fatty acids created as a byproduct when fats
and oils are modified by the use of industrial processing techniques.

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

(i) 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.

(i) 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 3,000,000;
(ii) Small: P3,000,001 - 15,000,000; and
(iii) Medium: P15,000,001 -P 100,000,000.


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.

(k) 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.

(m) 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.

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

SECTION 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 Il. Roles and Responsibilities

SECTION 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);

ii. FDA;

iii. Department of the Interior and Local Government (DILG);
iv. Department of Trade and Industry (DT1);

v. Department of Science and Technology (DOST);

vi. Department of Agriculture (DA);

vii. Department of Finance; and

vili. 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 local government units (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 Altemative 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, DTT, 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 health
alternatives of oils.

Article III. 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 shall 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 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.

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. Enforcement agencies. - The FDA and 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 shall 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.

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 (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
(P 100,000.00) 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
noncompliant 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 DTT-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. 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. 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 VII. 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 VIII. 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, Fats, and Oilseeds.

SECTION 28. 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 390. 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 noncompliant 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:

(2) 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 policies 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. - Any law, presidential decree or Issuance,
executive order, letter of Instruction, administrative order, rule or regulation contrary
to or inconsistent with the provisions of this Act Is hereby repealed, modified, or
amended accordingly.

SECTION 36. Effectivity Clause. - Notwithstanding the non-issuance of the IRR, this
Act shall take effect fifteen (15) days after its complete publication in the Official
Gazette or in a newspaper of general circulation.

Approved,