SUBJECT : REVISED REGULATORY GUIDELINES CONCERNING FOOD ADDITIVES, AND PROCESSING AIDS
The 1987 Philippine Constitution declares under Article II, Section 15 to “protect and promote the right to health of the people and instill health consciousness among them.”
Republic Act 9711 or the Food and Drug Act of 2009, Section 3 declares that it is “a policy of the State to adopt, support, establish, institutionalize, improve and maintain structures, processes, mechanisms and initiatives that are aimed, directed and designed to: (a) protect and promote the right to health of the Filipino people; and (b) help establish and maintain an effective health products regulatory system and undertake appropriate health manpower development and research, responsive to the country’s health needs and problems. Pursuant to this policy, the State must enhance its regulatory capacity and strengthen its capacity with regards to inspection, licensing and monitoring of establishments and the registration and monitoring of health products.”
The Implementing Rules and Regulations of RA 9711 further statesthat Food and Drug Administration (FDA) is tasked to “establish standards and quality measures for food and adopt measures to ensure quality and safe supply of food in the country.
Furthermore, Republic Act 10611or the Food Safety Act of 2013, Section 9 states that the Department of Health – Food and Drug Administration (DOH-FDA) “shall set the mandatory food
safety standards” and that “Standards shall be established on the basis of science, risk analysis, scientific advice from expert body/bodies, standards of other countries, existing Philippine National Standards (PNS) and the standards of the Codex Alimentarius Commission (Codex), where these exist and are applicable.”
Administrative Order (AO) No. 88-A s. 1984 and Bureau Circular (BC) No. 2006-0016 need updating to meet the current and emerging trends in food manufacturing. In view of the above and consistent with the requirements of the World Trade Organization on Technical Barriers to Trade in overcoming technical obstacles in world markets, this Order aims to update and put together the list of permitted food additives and prescribes guidelines for their use and application in food distributed in the Philippines whether locally manufactured or imported.
1. To establish a regulation prescribing:
a. The condition under which a food additive may be safely used; and
b. The maximum quantity food additive which may be used or permitted to remain in or on such food;
2. To meet the demand and ensure food safety, with the increasing awareness for safe food;
3. To harmonize local food regulation with international food control laws, rules and regulations and to ensure market access opportunities; and
4. To update the list of permitted food additives and prescribe guidelines for their use and application in food distributed in the Philippines.
5. To provide guidelines in the approval of proposed new Food Additives.
This Order shall apply to all manufacturers, importers, exporters, traders, wholesalers and distributors of food products.
IV. DEFINITION OF TERMS
As used in this document, the terms below shall be defined as follows:
1. Food Additive means 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 reasonably 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.1
2. Flavoring Substances refers to flavor preparations composed of substances derived from plant/ animal products and/or chemically synthesized substances whose significant function in food is flavoring rather than nutritional.2
3. Processing Aid means any substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients to fulfil a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product.1
4. Enzymes are proteins capable of catalyzing biochemical processes, acting on specific substrates and in relative low amounts.
5. Artificial/synthetic Food Colors are derived from petroleum distillates or coal tars and are essentially synthetic chemicals created in laboratories.
6. Natural Food Colors are derived from plant, animal or mineral sources which have been processed in some way.
7. Acceptable Daily Intake or ADI refers to an estimate by the JECFA of the amount of a food additive, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable health risk.3
8. Maximum Use Level of an additive is the highest concentration of the additive determined to be functionally effective in a food or food category and agreed to be safe by the Codex Alimentarius Commission. It is generally expressed as mg additive/kg of food.
9. The maximum use level will not usually correspond to the optimum, recommended, or typical level of use. Under GMP, the optimum, recommended, or typical use level will differ for each application of an additive and is dependent on the intended technical effect and the specific food in which the additive would be used, taking into account the type of raw material, food processing and post-manufacture storage, transport and handling by distributors, retailers, and consumers.
10. GMP refers to Good Manufacturing Practice
11. FAO refers to Food and Agriculture Organization
12. FCC refers to Food Chemicals Codex
13. GSFA refers to General Standard for Food Additives
14. CCFA refers to Codex Committee on Food Additives
15. IOFI refers to International Organization for the Flavor Industry.
16. JECFA refers to Joint FAO/WHO Experts Committee on Food Additives.
17. WHO refers to World Health Organization.
18. US FEMA refers to United States Flavor Extracts Manufacturers Association.
V. GENERAL GUIDELINES
A. General Principles for the Use of Food Additives
The use of food additives in conformance with this Order requires adherence to all the principles set forth in the following provision:
1. Food Additive Safety:
a. Only those food additives which present no appreciable risk to health of the consumer at the proposed level of use as found by JECFA and/or other internationally recognized bodies shall be endorsed and included in this Updated List, after proper evaluation by DOH-FDA.
b. The inclusion of a food additive shall have taken into account any ADI, or equivalent safety assessment established for the additive by JECFA and its probable daily intake from all food sources. Where the food additive is to be used in food eaten by special groups of consumers (e.g. diabetics, those on special medical diets, sick individuals on formulated liquid diets) account shall be taken of the probable daily intake of the food additive by those consumers.
c. The quantity of an additive added to food is at or below the maximum use leveland is the lowest level necessary to achieve the intended technical effect. The maximum use level may be based on the application of procedures as recommended by JECFA, the intake assessment of Codex members or upon request by the CCFA to JECFA for an independent evaluation of national intake assessment.
2. Justification for the Use of Additives
The use of food additives is justified only when such use has an advantage, does not present an appreciable health risk to consumers, does not mislead the consumer, and serves one or more of the technological functions and the needs set out below from (a) to (d), and only where these objectives cannot be achieved by other means that are economically and technologically practicable:
a. To preserve the nutritional quality of the food; an intentional reduction in the nutritional quality of a food would be justified in the circumstances dealt with in
(b) and also in other circumstances where the food does not constitute a significant item in a normal diet;
b. To provide necessary ingredients or constituents for foods manufactured for groups of consumers having special dietary needs;
c. To enhance the keeping quality or stability of a food or to improve its sensory properties, provided that this does not change the nature, substance or quality of the food so as to deceive the consumer; and
d. To provide aids in the manufacture, processing, preparation, treatment, packing, transport or storage of food, provided that the additive is not used to disguise the effects of the use of faulty raw materials or of undesirable (including unhygienic) practices or techniques during the course of any of these activities.
3. The Permitted Levels of Use of Food Additives
The primary objective of establishing permitted levels of use of food additives in various food groups is to ensure that the intake of additives does not exceed the acceptable daily intake (ADI).
The maximum use level of food additivesare based in part on FDA commodity standards, Codex and upon request of interested parties after subjecting their proposed maximum use level to internationally accepted scientific methods, ensuring that the same shall not exceed prescribed ADI.
4. Good Manufacturing Practice (GMP)
All food additives subject to the provisions of this Order shall be used under conditions of good manufacturing practice, which include the following:
a. The quantity of at the additive added to food shall be limited to the lowest possible level necessary to accomplish its desired effect; unless specifically limited by this Order for or to a specific application;
b. The quantity of the additive that becomes a component of food as a result of its use in the manufacturing, processing or packaging of a food and which is not intended to accomplish any physical, or other technical effect in the food itself, is reduced to the extent reasonably possible; and,
c. The food additive is of food grade quality and is prepared and handled in the same way as a food ingredient.
5. Specifications for the Identity and Purity of Food Additives
Food additives used in accordance with this Order should be of appropriate food grade quality and should at all times conform with the applicable Specifications of Identity and Purity recommended by the Codex Alimentarius Commission or, in the absence of such specifications, with appropriate specifications developed by responsiblenational or international bodies. In terms of safety, food grade quality is achieved by conformance of additives to their specifications as a whole (not merely with individual criteria) and through their production, storage, transport, and handling in accordance with GMP.
B. Carry-Over of Food Additives into Foods
1. Conditions Applying to Carry-Over of Food Additives from Ingredients and Raw Materials into Foods
Other than by direct addition, an additive maybe present in food as a result of carry- over from a raw material or ingredient used to produce the food, provided that:
a. The additive is acceptable for use in the raw materials or other ingredients (including food additives) according to this Order;
b. The amount of the additive in the raw materials or other ingredients (including food additives) does not exceed the maximumuse level specified in this Order;
c. The food into which the additive is carried over does not contain the additive in greater quantity than would be introduced by the use of raw materials, or ingredients under proper technological conditions or manufacturing practice, consistent with the provisionsof this Order.
2. Special Conditions Applying to the Use of Food Additives notDirectly Authorized in Food Ingredients and Raw Materials
An additive may be used in or added to a raw material or other ingredient if the raw material or ingredient is used exclusively in the preparation of a food that is in conformity with the provisions of this Order, including that any maximum level applying to the food is not exceeded.
3. Foods for Which the Carry-Over of Food Additives is Unacceptable
Carry-over of a food additive from a raw material or ingredient is unacceptable for foods belonging to the following food categories; unless a food additive provision in the specified category is listed in this Order:
a. 13.1 – Infant formula, follow-up formula, and formula for special medical purposes for infants
b. 13.2 – Complementary foods for infants and young children.
C. Food Category System
The food category systemis a tool for assigning food additives uses in this Order. The food category system applies to all foodstuffs.
The food category descriptors are not to be legal product designations nor are they intended for labelling purposes.
The food category system is based on the following principles:
1. The food category system is hierarchical, meaning that when an additive is recognized for use in a general category, it is recognized for use in all its sub-categories, unless otherwise stated
Similarly, when an additive is recognized for use in a sub-category, its use is recognized in any further sub-categories or individual foodstuffs mentioned in a sub-category.
2. The food category system is based on product descriptors of foodstuffs as marketed, unless otherwise stated.
3. The food category systems take into consideration the carry-over principle. By doing so, the food category system does not need to specifically mention compound foodstuffs (e.g. prepared meals, such as pizza, because they may contain, pro rata, all the additives endorsed for use in their components), unless the compound foodstuff needs an additive that is not endorsed for use in any of its components.
4. The food category system is used to simplify the reporting of food additive uses for assembling and constructing this Order.
D. Provision for Mislabeled or Adulterated Food
Any food additive used not in accordance with the requirements of this Order shall be deemed to be an act which results in the food being misbranded or adulterated, as the case may be.
For violations of this Order, the sanctions provided under RA 9711 and its Implementing Rules and Regulations, and other allied laws and regulations may be imposed as far as applicable and after due notice and summary hearing.
VI. FORMAT OF THE FOOD ADDITIVE LISTING
The food additives herein have been grouped into major functional groups. For each food additive (or food additive group) within each major functional class, their maximum levels of use as well as conditions of use for each are specified (see Annexes A to D).
VII. FLAVORING SUBSTANCES
If food additives are to be used as flavoring substances they shall abide by the regulation set by FEMA and/or IOFI.
VIII. PROCESSING AIDS
For Processing Aids, its use shall be guided by at least any one of the following latest revision:Food Chemicals Codex, USFDA CFR Title 21, Codex Standard on Inventory of Processing Aids (CXA_003e or CAC/MISC 3) and the Guidelines on Substances used as Processing Aids (CXG 075e/ CAC/GL 75-2010). For enzymes not listed in the Codex Inventory of Processing Aids, there should be certification from competent authority of country of origin.
IX. REVIEW AND REVISION OF THE LISTING
The food additives enumerated in the ANNEXES attached to this Order shall be reviewed, amended and/or revised by the Center for Food Regulation and Research in coordination with the FDA Food Laboratory and in consultation with concerned stakeholders every five (5) years.
Annual Codex GSFA issuance on its new specific provisions* shall be adopted automatically by the FDA. (*Note/Meaning: all Codex adopted new levels of specific food additives, additional food categories under each food additives and/or other new food additives included shall be adopted by FDA.)
X. TRANSITORY PROVISION
Manufacturers, importers, exporters, traders, wholesalers and distributors of processed food products distributed in the Philippines are given a maximum of two (2) years transition period starting from the effectivity date of this order to phase out existing stock and labels, also to reformulate the product(s) to meet the standard specification for the food additive.
XI. FINAL PROVISIONS
A. Separability Clause
If any provision/s in this Order, or application of such provision to any circumstances, is held invalid, the remainder of its provisions shall not be affected thereby.
B. Repealing Clause
This Order repeals AO 88-A, BC 2006-0016, and other administrative order, rules and regulations, and administrative issuances or parts thereof that is/are inconsistent with its provisions.
C. Effectivity Clause
This Order shall take effect 15 days after its publication in an official gazette or in a newspaper of general circulation.
PAULYN JEAN B. ROCELL-UBIAL, MD, MPH, CESO II
Secretary of Health
LIST OF ANNEXES
(approx. 300 pages of Annexes)
ANNEX A –
Part I: Food Category System
Part II: Food Category Descriptors
ANNEX B –
Table 1: Additives Permitted for Use Under Specified Conditions in Certain Food Categories or Individual Food Items
Table 2: Additives Permitted for Use in Food in General, Unless Otherwise Specified, In Accordance with GMP
Table 3: Food Additives Functional Classes, Definitions and Technological Purposes
1. Administrative Order (AO) 88-A s. 1984 refers to Regulatory Guidelines Concerning Food Additives
2. Bureau Circular (BC) 2006-0016 refers to Updated List of Food Additives
3. Administrative Order (AO) 103-A s. 1984 refers to Regulation on Non-nutritive Sweeteners Applicable to Both Food and Drug
4. Administrative Order (AO) 112 s. 1985 refers to Regulation Governing Importation of Food Color Additives
5. Administrative Order (AO) 122 s. 1970 refers to General Regulation Governing the Prohibition of the use of Cyclamic Acid and its Salts (B-6.3 Food Additives and Preservatives)