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All concerned stakeholders may submit comments in MSWord format via email to [email protected] with copy furnished to  [email protected] using the format. Deadline of submission of comments shall be by 09 December 2021.

downloadable MSWord Format

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 Health 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 recommendation, 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.

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 prepackaged 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 shall 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.
  5. TransFatty 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. 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 products;
  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 accordance 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 include 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
  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 ensure 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 No. 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. SEPARABILITY 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.

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 circulation and upon filing three (3) certified true copies with the University of the Philippines Law Canter.