Pursuant to Section 15 (b) of the Food Safety Act of 2013 (FSA), promulgated as Republic Act No. 10611, the FDA shall be responsible for the safety of processed and prepackaged food, locally produced or imported. Section 9 (b) of the FSA states that standards shall be establish based on science risk analysis, scientific advice from expert bodies, standards of other countries, existing PNS and the standards of Codex. Policies and procedures adopting Codex standards shall be developed except when these are in conflict with what is necessary to protect consumers and scientific justification exists for the action taken. Codex standards include, food commodity standards, and use of food additives, among others.
The Codex Committee on Pesticide Residues (CCPR), with the scientific evaluation and expert advice from the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) has established and has been updating the list of the acceptable levels of pesticide residues or Maximum Residue Limit (MRL) in specific commodity, mostly in unprocessed food, moving in international trade. The Codex Pesticides Residues in Food Online Database contains the Pesticide Index with corresponding acceptable MRLs of specific pesticide residues in food. This can serve as a guide for both the food industry and regulators.
Globally, recent public concerns were raised regarding the presence of pesticide residues, specifically ethylene oxide in food. Ethylene oxide is a gas used in some countries as a fungicide, bactericide and insecticide in foods. Although its residue dissipates with time, this was found carcinogenic, mutagenic, and therefore banned in some countries. However, due to lack of uniform regulations on its MRL in food, a number of notifications about prohibition of ethylene oxide residue in food were issued among regulatory bodies.
As the current Codex Pesticide Index does not include ethylene oxide, there is no MRL and no safe level that is recommended for prepackaged processed foods. Thus, this Circular is issued to protect public health and guide the Food Business Operators (FBOs).
This Circular aims to regulate the presence of ethylene oxide residue in processed prepackaged food products, ingredients, or food additives in the Philippines.
This Circular shall cover manufacturers, traders, and distributors (importers and wholesales) of processed prepackaged food products, food additives including flavor mixes, intended to be sold and distributed in the Philippines.
IV. DEFINITION OF TERMS
For purposes of this issuance, the terms used shall be defined as follows:
A. Adulterated refers to food that has been produced which:
1. Bears or contains any poisonous or deleterious substance that may render it injurious to the health of the public;
2. Bears or contains any added poisonous or deleterious substance in amounts exceeding established maximum limits or standards for good manufacturing practice;
3. Contains in whole or in part filthy, putrid or decomposed substance that is unfit for human consumption;
4. Has been prepared, packed or held under unsanitary conditions;
5. In whole or in part, is the product of a diseased animal or an animal which has died through ways other than slaughter;
6. Is in a container having in whole or in part any poisonous or deleterious substance;
7. Has been intentionally subjected to radiation unless the use of radiation is in conformity with an existing regulation or exemption;
8. Becomes injurious to health because of the omission or abstraction of a valuable constituent; or if any substance has been substituted wholly or in part; or if damaged or made inferior which has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its strength or to make it appear better or greater than it is;
9. Has not been prepared in accordance with current acceptable manufacturing practice as promulgated by way of regulation; and
10. Uses expired ingredients.
B. Ethylene oxide refers to the chemical intermediate in the manufacture of ethylene glycol. It is also used as a sterilizing agent for medical equipment and a fumigating agent for spices. It is concluded that Ethylene Oxide is carcinogenic to humans and has acute and chronic adverse effects.
C. Food additive refers to any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value, the intentional addition of which to food for a technological (including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food results, or may be reasonable expected to result (directly or indirectly), in it or its by-products becoming a component of or otherwise affecting the characteristics of such foods. The term does not include contaminants or substances added to food for maintaining or improving nutritional qualities.
D. Ingredient refers to any substance, including a food additive, used as a component in the manufacture or preparation of food and present in the final product (in its original or modified form).
E. Manufacturer refers to an establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding, formulating, filling, packaging, repacking, altering, ornamenting, finishing and labelling with the end in view of its storage, sale or distribution.
F. Maximum Residue Limit or MRL refers to the highest level of a pesticide residue that is legally tolerated in or on food or feed when pesticides are applied correctly in accordance with Good Agricultural Practice.
G. Raw materials refer to all substances that are employed in the processing of a finished product, packed in bulk containers and not labelled as finished product. Raw Materials or ingredients would have product specifications that comply with the client requirements and not necessarily a single component.
H. Spices and dried aromatic herbs refer to dried components or mixtures of dried plants used in foods for flavoring, coloring, and imparting aroma. This term equally applies to whole, broken, sliced, ground and blended forms.
V. GENERAL GUIDELINES
A. Ethylene oxide shall not be used in processed prepackaged food products.
B. Where ethylene oxide is used in the primary stage or post-harvest stage of the raw materials/ingredients, its residue level in the raw material shall not exceed 0.1 ppm.
VI. SPECIFIC GUIDELINES
A. Raw materials and processed prepackaged food products found to contain ethylene oxide residue beyond 0.1 ppm shall be considered adulterated and shall be pursued in accordance with the implementing rules and regulations of RA No. 9711 and 10611.
B. Applications for initial, renewal, and amendment of Certificate of Product Registration (CPR) under raw materials classification of the ingredients, namely: carob bean gum or locust bean gum, guar gum, xanthan gum, and calcium carbonate; and any prepackaged processed food product containing the aforementioned ingredients, sesame seeds, spices and dried aromatic herbs, dried vegetables, sunflower seeds, and any other ingredients that may be known or identified to contain ethylene oxide residue, shall include the submission of recent (within 12 months) certificate of analysis for the raw material used or finished product issued by an accredited laboratory of the FDA and Philippine Accreditation Board/Office (PAB/PAO) or an ISO 17025 certified laboratory abroad, reflecting the level of ethylene oxide residue, reference method of analysis, and the limit of detection for the method used in the analysis of ethylene oxide.
C. The FBOs that make use of or distribute ingredients/food additives that may be identified to contain ethylene oxide, which may have been used in the primary food production or post-harvest stages of the food supply chain, shall include in their food control system the measures to ensure that their finished product does not contain ethylene oxide residue beyond limit. This may be evidenced by supplier audit, submission of COA, testing of raw materials for ethylene oxide residue level, or any other means that will assure that the finished product does not contain ethylene oxide residue beyond limit.
D. Non-compliance to this Circular shall be considered ground for disapproval of application for authorizations.
VII. PENALTY CLAUSE
After due process, FBOs found in violation of this Circular shall be penalized in accordance with applicable provisions of implementing rules and regulations of the RA No. 9711 or the FDA Act of 2009 and RA No. 10611 or the Food Safety Act of 2013.
VIII. SEPARABILITY CLAUSE
If any of the provisions of this Circular is declared invalid or unenforceable, the validity and enforceability of the remaining provisions shall be in full force and in effect.
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 Center.