Ver18112021  
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  Website: www.fda.gov.ph  Email: info@fda.gov.ph   
 
 
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FDA CIRCULAR  
No.    Republic of the Philippines 
Department of Health  
FOOD AND DRUG ADMINISTRATION  
 
 
SUBJECT  : Guidelines for Processed Prepackaged Food Products Containing  
Trans -Fatty Acids (TFA)  
 
 
I. RATIONALE  
 
The Department  of Health  (DOH)  on 18 June 2021  issued  the Administrative  Order 
(AO) 2021 -0039 entitled “National Policy on the Elimination of Industrially -Produced 
Trans -Fatty Acids for the Prevention and Control of Non-Communicable Diseases” or 
NCD through the prohibition of industrially -produced TFA from prepackaged processed  
food products. The magnitude of NCD problem is alarming both globally and locally. As 
stated in the said DOH AO, in the Philippines about 3,000 people each year suffer from 
premature mortality related to high consumption of TFAs according to the World Hea lth 
Organization’s Non -Communicable Disease Report in 2017. The said AO further stated 
that studies  have  consistently  suggested  that there  is no safe level  of TFA  consumption  and 
that TFA intake has no known health benefit. Due to its effect on the body’s Low Density 
Lipoprotein (LDL), high intake of TFAs increases the risk of developing coronary heart 
disease and other non -communicable diseases. An exposure assessment reported that 
children under 6 years old are at most risk for exceeding the WHO recommend ation, with 
high-level consumers exceeding the upper limit by 150% (DOST - Food and Nutrition 
Research Institute, 2018). Despite the availability of such exposure assessments, there is 
still a lack of a more  rigorous  monitoring  and evaluation  system  to further  assess  the impact 
of TFA intake among Filipinos. With neighboring countries implementing bans on 
Partially -Hydrogenated Oils and setting mandatory limits on TFA content in food, the 
Philippines is vulnerable to dumping of TFA -rich food products in the absence of similar 
regulations.  
 
In accordance with FDA mandate under RA 9711 and RA 10611 and their IRRs, 
this Circular intends to regulate the TFA in processed foods and implement the 
responsibilities  of the Food  and Drug  Administration  (FDA)  within its  mandate  i.e. A to C 
of item VI. of AO 2021 -0039;  and (2) determine  the appropriate  transitory  period  that shall 
not be more than two (2) years from the effectivity of the said  AO. 
 
The FDA  with its regulatory  jurisdiction  over processed  prepackaged  food products 
joins the DOH in implementing AO 2021 -0039. Thus, the issuance of this Circular is 
deemed  imperative.  
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II. OBJECTIVES  
 
1. To provide guidelines for registration of processed prepackaged food products 
containing TFA intended to be distributed in the Philippine  market.  
 
2. To prohibit the importation, local manufacture, distribution, and sale of Partially - 
Hydrogenated Oils (PHO), and Oils and Fats blended with Partially -Hydrogenated 
Oils.  
 
3. To prohibit oils and fats with TFA content of more than 2g per 100g; processed 
prepackaged food with PHOs; and other processed prepac kaged food with high TFA 
content (as defined in this Circular).  
 
4. To set additional requirements for the registration of processed prepackaged food 
products containing TFA, and specify the transitory period of its  implementation.  
 
 
III. SCOPE  
 
This Circular sha ll cover manufacturers, traders, importers and distributors of raw 
materials and processed prepackaged food products containing TFA intended for 
Philippine market distribution.  
 
 
IV. DEFINITION OF  TERMS  
 
1. High Trans Fatty Acids (TFA) content – for the purpose of this Circular, shall refer 
to other foods and processed non -alcoholic beverages exceeding 5g per 100g or per 
100ml of fat (reference used: WHO Module 3: Legislate or Regulate; ISBN  978-92-4- 
001084 -0). 
 
2. Industrially -Produced  TFA  – refers  to artificial  trans  fat that is developed  through  the 
partial  hydrogenation  of oils, as opposed  to the naturally  occurring  trans  fatty acids  that 
are found in the fat of animal origin. Also developed in small amounts through re - 
heating and frying of oils at high  temperatures.  
 
3. Partially Hydrogenated Oil (PHO) – refers to the processed products that contain 
industrially -produced TFA, which are typically used to increase shelf -life and ensure 
flavor stability of oils. 
 
4. Processed Food Products – refer to food that has been subjected to some degree of 
processing  like milling,  drying,  concentrating,  canning,  or addition  of some  ingredients 
which changes partially or completely the physico -chemical and/or sensory 
characteristics of the food’s raw  material.  Page 3 of 5  
  
 
5. Trans -Fatty Acids (TFA) – refer to the fatty acids with at least a double bond in the 
trans configuration, regardless of whether they are produced industrially or come from 
ruminant sources, including linoleic  acid.  
 
6. TFA -Free Claim – refers to any claim that states or suggests that the processed food 
product does not contain TFA. This includes claims as “Trans Fat Free”, with “0 g 
Trans Fat '', or any other similar  claim.  
 
 
V. GENERAL  GUIDELINES  
 
A. Processed prepackaged food products for human consumption, commercial sale or  use 
shall not contain PHO whether as a single ingredient or as an ingredient to any 
processed prepackaged food product. Similarly, the manufacture, trading, importation 
and distribution  in the Philippine  market  of these  products  are prohibited  in accordance 
with the Department of Health Administrative Order No. 2021 -0039 and this  Circular.  
 
B. The manufacture, trading, importation, distribution, and sale of the following shall be 
prohibited:  
 
1. Partially -Hydrogenated Oils to be consumed alone or used in the preparation of 
processed food  produc ts; 
2. Oils and fats made blended with  PHOs;  
3. Oils and fats with more than 2 g TFA per 100 g or 100  ml; 
4. Processed prepackaged food with PHOs and high TFA content (as defined in this 
Circular).  
 
C. The label claim TFA-Free , 0 g Trans Fat or No transfat or any similar claim shall be 
prohibited on the label and marketing/advertising of any processed  food.  
 
D. The TFA content of food products shall be declared on the Nutrition 
Information/Nutrition Facts panel of the label in accor dance with the FDA labelling 
guidelines i.e. Administrative Order 2014 -0030 or its latest  version.  
 
 
VI. SPECIFIC GUIDELINES  
 
A. The application for product registration of any processed prepackaged food product 
containing TFA, whether local or imported shall in clude submission of the following 
documents:  
 
1. technical  specifications  of raw materials  indicating  specific  oil(s)  and/or  fat(s)  used 
and the processing it underwent;  and Page 4 of 5  
  
 
2. recent certificate of analysis of the finished product reflecting the TFA content, 
reference  methods  of analysis,  and the limit of detection  for the method  used in the 
analysis of  TFA.  
 
B. All processed  prepackaged  foods  that fall under  Section  V. letter  B. and with valid  CPR 
shall exhaust current product labels as per inventory until expiry of CPR (with  validity 
below 2 years) or until end of 2023. Upon exhaustion of said labels, the reformulated 
product shall file for an initial CPR application. Old product with remedial sticker on 
the label as a temporary remedy shall be allowed exhaustion until the end of 2023 and 
shall ensur e the remedial sticker is durable and not easily  removed.  
 
C. All processed prepackaged foods containing TFA, PHO, oils and fats blended with 
PHOs with more than 2 years validity of CPR shall apply for an Initial Certificate of 
Product Registration within 2 years upon effectivity of this Circular.  
 
D. All applications for processed prepackaged foods containing TFA, PHO, oils and fats 
blended  with PHOs  including  those  with shelf  life more  than two (2) years  shall  ensure 
the labels are consistent with its product contents in compliance with DOH AO 2021 - 
0039 and other pertinent  laws.  
 
E. The evaluation of application for product registration of processed prepackaged food 
products shall be in accordance with the prevailing FDA Circular N o. 2020 -033 or its 
latest  version.  
 
F. After the transition period, processed prepackaged food products formulation shall  not 
contain PHO, oils and fats blended with PHOs, and TFA beyond the specified limits, 
and shall be compliant to these guidelines as specified under V. B.  1-4. 
 
 
VII. TRANSITORY PROVISIONS  
 
After 2 years upon effectivity of this Circular, all product formulations and labels 
of processed prepackaged food containing TFA shall be fully compliant with these 
guidelines.  
 
 
VIII. SEPARABILI TY CLAUSE  
 
If any provision  of this Circular  be declared  as invalid  or unenforceable,  the validity 
and enforceability  of the remaining  portions  or provisions  shall  be in full force  and in effect.  Page 5 of 5  
  
 
IX. REPEALING  CLAUSE  
 
Other  issuances  inconsistent  with this Circular  are hereby  repealed  and/or  modified 
accordingly.  
 
 
X. EFFECTIVITY  
 
This Circular shall take effect fifteen (15) days after its publication in an official 
gazette or in a newspaper of general ci rculation and upon filing three (3) certified true 
copies with the University of the Philippines Law Canter.  
 
 
 
ROLANDO ENRIQUE D. DOMINGO, MD  
Director General  
 
DTN 20210922152323   
  
Name of  Organization     
 
 
 
Contact Information  
Email  address:   Tel./Cell phone  no.   
 
Title of draft Issuance:  
Section of the Draft  Comments  Rationale/ Suggested Text